Tender GB Ultra (MON 78708) - Bundesamt für Verbraucherschutz

Transcription

Part A
National Assessment – Germany
TENDER GB ULTRA (MON 78708)
Registration Report – Central Zone
Page 1 of 26
REGISTRATION REPORT
Part A
Risk Management
Product name:
Tender GB Ultra
(MON 78708)
Active Substance:
360 g/L glyphosate,
486 g/L as isopropylamine salt
COUNTRY: Germany
Central Zone
Zonal Rapporteur Member State: Germany
NATIONAL ASSESSMENT
Applicant:
Date:
Applicant: Monsanto Europe SA
Monsanto Europe SA
24/03/2014
Date: 24/03/2014
Part A
National Assessment - Germany
Page 2 of 26
Table of Contents
PART A – Risk Management
4
1
Details of the application
4
1.1
Application background
4
1.2
Annex I inclusion
5
1.3
Regulatory approach
5
1.4
Data protection claims
5
1.5
Letters of Access
5
2
Details of the authorisation
6
2.1
Product identity
6
2.2
Classification and labelling
6
2.2.1
Classification and labelling under Directive 99/45/EC
6
2.2.2
Classification and labelling according to Regulation (EC) No 1272/2008
6
2.2.3
R and S phrases under Directive 2003/82/EC (Annex IV and V)
6
2.2.4
Restrictions linked to the PPP
6
2.2.5
Other phrases linked to specific uses
7
2.3
Product uses
9
3
Risk management
11
3.1
Reasoned statement of the overall conclusions taken in accordance
with the Uniform Principles
11
3.1.1
Physical and chemical properties (Part B, Section 1, Points 2 and 4)
11
3.1.2
Methods of analysis (Part B, Section 2, Point 5)
11
3.1.2.1
Analytical method for the formulation (Part B, Section 2, Point 5.2)
11
3.1.2.2
Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
12
3.1.3
Mammalian Toxicology (Part B, Section 3, Point 7)
12
3.1.3.1
Acute Toxicity (Part B, Section 3, Point 7.1)
12
3.1.3.2
Operator Exposure (Part B, Section 3, Point 7.3)
12
3.1.3.3
Bystander Exposure (Part B, Section 3, Point 7.4)
12
3.1.3.4
Worker Exposure (Part B, Section 3, Point 7.5)
12
3.1.4
Residues and Consumer Exposure (Part B, Section 4, Point 8)
13
3.1.4.1
Residues (Part B, Section 4, Points 8.3 and 8.7)
13
3.1.4.2
Consumer exposure (Part B, Section 4, Point 8.10)
13
3.1.5
Environmental fate and behaviour (Part B, Section 5, Point 9)
13
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3.1.5.1
3.1.5.2
3.1.5.3
3.1.5.4
Predicted Environmental Concentration in Soil (PECsoil)
(Part B, Section 5, Points 9.4 and 9.5) ......................................................................................13
Predicted Environmental Concentration in Ground Water (PECGW)
(Part B, Section 5, Point 9.6) .....................................................................................................14
Predicted Environmental Concentration in Surface Water (PECSW)
(Part B, Section 5, Points 9.7 and 9.8) ......................................................................................16
Predicted Environmental Concentration in Air (PECAir)
(Part B, Section 5, Point 9.9) .....................................................................................................16
3.1.6
Ecotoxicology (Part B, Section 6, Point 10)
17
3.1.6.1
Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
17
3.1.6.2
Effects on Aquatic Species (Part B, Section 6, Point 10.2)
19
3.1.6.3
Effects on Bees and Other Arthropod Species
(Part B, Section 6, Points 10.4 and 10.5
19
Effects on Earthworms and Other Soil Macro-organisms
(Part B, Section 6, Point 10.6)
20
3.1.6.5
Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
21
3.1.6.6
Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
21
3.1.6.7
Assessment of Potential for Effects on Other Non-target Organisms
(Flora and Fauna) (Part B, Section 6, Point 10.8)
21
3.1.7
Efficacy (Part B, Section 7, Point 8)
23
3.2
Conclusions
24
3.3
Further information to permit a decision to be made or to support
a review of the conditions and restrictions associated with the authorisation
25
3.1.6.4
Appendix 1 – Copy of the product authorisation
26
Appendix 2 – Copy of the product label
26
Appendix 3 – Letter of Access
26
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Part A
National Assessment – Germany
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PART A – Risk Management
This document describes the acceptable use conditions required for the re-registration of TENDER GB
ULTRA (MON 78708) containing glyphosate in Germany. This evaluation is required subsequent to the
inclusion of glyphosate on Annex 1.
The risk assessment conclusions are based on the information, data and assessments provided in
Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for Germany.
The information, data and assessments provided in Registration Report, Parts B includes assessment of
further data or information as required at national re-registration by the EU review. It also includes
assessment of data and information relating to where that data has not been considered in the EU review.
Otherwise assessments for the safe use of TENDER GB ULTRA (MON 78708) have been made using
endpoints agreed in the EU review of glyphosate.
This document describes the specific conditions of use and labelling required for Germany for the reregistration of TENDER GB ULTRA (MON 78708).
Appendix 1 of this document provides a copy of the final product authorisation Germany.
Appendix 2 of this document is a copy of the approved product label for Germany.
The submitted draft product label has been checked by the competent authority. The applicant is
requested to amend the product label in accordance with the decisions made by the competent authority.
The final version of the label has to fulfil the requirements according to Article 16 of Directive
91/414/EEC.
Appendix 3 of this document contains copies of the letters of access to the protected data / third party data
that was needed for evaluation of the formulation.
Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
1
Details of the application
1.1
Application background
This application was submitted by Monsanto on 11 January 2012.
The application was for approval of MON 78708, a water soluble concentrate (SL) formulation
containing 360 g a.s./L glyphosate for use as a herbicide on non cultivated areas for the control of
monocotyledonous weeds, dicotyledonous weeds and woody plants.
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1.2
Annex I inclusion
Glyphosate was included on Annex I of the EU Directive 91/414/EEC with entry into force by 1 July
2002 and implemented under Regulation (EU) No 540/2011. The corresponding EU Commission
Directive 2001/99/EC has been published in the Official Journal of the European Communities on 20
November 2001.
Glyphosate has been completely and sufficiently assessed in the review of the dossier for inclusion into
Annex I (Review report for the active substance glyphosate, finalised on 29 June 2001 in view of the
inclusion of glyphosate in Annex I of Directive 91/414/EEC). The overall conclusion was that plant
protection products containing glyphosate will fulfil the safety requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC. These conclusions were reached within the framework of the following
uses:
•
Herbicide against terrestrial annual weeds, perennial weeds and shrubs in fruit, vegetables,
forestry, grassland, ornamentals and arable crops as well as non-crop uses
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
active substance glyphosate, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 29/06/2001, shall be taken into account. In this
overall assessment:
Member States must pay particular attention to the:
•
protection of the groundwater in vulnerable areas, in particular with respect to non-crops uses
These concerns were all addressed in the submission.
1.3
Regulatory approach
To obtain re-approval the product TENDER GB ULTRA (MON 79708) must meet the conditions of
Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III,
with an assessment to Uniform Principles, using Annex I agreed end-points.
This application was submitted in order to allow the re-registration of an already approved product in
Germany in accordance with the above.
1.4
Data protection claims
Where protection for data is being claimed for information supporting registration of Tender GB Ultra, it
is indicated in the reference lists in Appendix 1 of the Registration Report, Part B, sections 1-7 and Part
C.
1.5
Letters of Access
A letter of access isn’t necessary. The applicant is owner of the data of the product as well as the active
ingredient. For the few active substance studies of third parties protection has been expired.
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2
Details of the authorisation
2.1
Product identity
Product Name
Authorization Number
(for re-registration)
Function
Applicant
Composition
Formulation type
Packaging
Tender GB Ultra (MON78708)
043981-00
herbicide
Monsanto Europe SA
360 g/L glyphosate (486 g/L as isopropylamine salt)
Soluble concentrate [Code: SL]
1 L bottle, HDPE (professional use)
5, 10, 20 L container, HDPE,
640 and 1000 L IBC tanks, HDPE
2.2
Classification and labelling
2.2.1
Classification and labelling under Directive 99/45/EC
The following is proposed in accordance with Directive 99/45/EC in combination with the latest
classification and labelling guidance under Directive 67/548/EEC (i.e. in the 18th ATP published as
Directive 93/21/EEC):
Hazard symbol(s):
Indication(s) of danger:
Risk phrases:
Safety phrases:
Labelling texts and
restrictions:
2.2.2
Classification and labelling according to Regulation (EC) No 1272/2008
Hazard class(es), categories:
Signal word:
Hazard statement(s):
Labelling texts and
restrictions:
2.2.3
none
none
none
none
To avoid risks to man and the environment, comply with the instructions
for use.
none
none
none
[EUH 401] - To avoid risks to man and the environment, comply with
the instructions for use.
15 percent of the mixture consists of ingredients of unknown inhalation
toxicity.
None.
2.2.4
Restrictions linked to the PPP
Labelling phrases for human health protection
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SB001
Avoid any unnecessary contact with the product. Misuse can lead to health damage.
SB010
Keep out of the reach of children.
SF245-01
Treated areas/crops may not be entered until the spray coating has dried.
Labelling phrases for fate and ecotoxicology
NW 468
NG351
Fluids left over from application and their remains, products and their remains, empty
containers and packaging, and cleansing and rinsing fluids must not be dumped in water.
This also applies to indirect entry via the urban or agrarian drainage system and to rainwater and sewage canals.
A maximum of 2 treatments with a minimum interval of 90 days may be carried out with
this product and other products containing glyphosate within one calendar year on the
same area. The maximum application rate for the active substance of 3.6 kg per hectare
and year must not be exceeded.
Labelling phrases for IPM/sustainable use
WMG
Mode of Action (HRAC-Group): G
NB6641
The product is classified as non-hazardous to bees, even when the maximum application
rate or concentration, if no application rate is stipulated, as stated for authorisation is
applied. (B4)
2.2.5
Other phrases linked to specific uses
Labelling phrases for IPM/sustainable use
WH914
The instructions for use must include a summary of weeds, and if applicable woody plants,
which can be controlled well, less well and insufficiently by the product.
Labelling phrases for fate and ecotoxicology
NG404
NT103
Between treated areas with an incline of more than 2% and surface water - except only
occasionally but including periodically water-bearing surface water - there must be a
border under complete plant cover. The border's protective function must not be impaired
by the use of implements. It must be at least 20 m wide. This border is not necessary if: sufficient catching systems are available for the water and soil transported by run-off,
which do not flow into surface water or are not connected with the urban drainage system
or - the product is used for mulch or direct drilling methods.
In a strip at least 20 m wide which is adjacent to other areas, the product must be applied
using loss reducing equipment which is registered in the index of 'Loss Reducing
Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be
registered in at least drift reducing class 90 % (except agriculturally or horticulturally used
areas, roads, paths and public places). Loss reducing equipment is not required if the
product is applied with portable plant protection equipment or if adjacent areas (field
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boundaries, hedges, groups of woody plants) are less than 3 m wide or the product is
applied in an area which has been declared by the Biologische Bundesanstalt in the "Index
of regional proportions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13
April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and
semi-natural structures.
NS660-1
The product may only be applied on field areas which are not used for agricultural, forestry
or horticultural purposes with the approval of the competent national authority. Such areas
include all areas which are not permanently covered by buildings or roofing, including all
traffic areas such as railway tracks, roads, paths, yards and business sites and other pieces
of land changed by civil engineering measures. Violations may be punished by fines of up
to 50 000 EUR.
NW642-1
The product may not be applied in or in the immediate vicinity of surface or coastal waters.
Irrespective of this, the minimum buffer zone from surface waters stipulated by state law
must be observed. Violations may be punished by fines of up to 50 000 EUR.
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2.3
Product uses
GAP rev. (2), date: 2013-July-12
PPP (product name/code)
active substance 1
Tender GB Ultra MON78708
Glyphosate
Formulation type:
Conc. of as 1:
safener
synergist
-
Conc. of safener:
Conc. of synergist:
Applicant:
Zone(s):
Monsanto Europe SA
Central Zone
professional use
non professional use
SL
360 g/L
(486 g/L glyphosate isopropylamine salt)
-
Verified by MS: yes
1
UseNo.
2
3
Member Crop and/
state(s)
or situation
(crop destination /
purpose of crop)
4
F
G
or
I
5
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
6
7
8
10
Application
Method /
Kind
Timing / Growth
stage of crop &
season
11
12
Application rate
Max. number
(min. interval
between
applications)
a) per use
kg, L product /
ha
g, kg as/ha
Water L/ha
a) max. rate per
appl.
a) max. rate
per appl.
min / max
b) per crop/
season
b) max. total rate b) max. total
per crop/season rate per
crop/season
13
PHI
(days)
14
Remarks:
e.g. safener/synergist per ha
e.g. recommended or
mandatory tank mixtures
001
DE,
AT
YGLES
Railway tracks
F
spraying
TTTMM
monocotyledonous weeds,
TTTDD
dicotyledonous weeds
During growing
season
a) 1
b) 1
a) 10.0
b) 10.0
a) 3.6
b) 3.6
500 - 1000
N
WH914
NS660-1
NW642-1
002
DE,
AT
YGLES
Railway tracks
F
TTTMM
spraying
TTTDD
During growing
season
a) 2
b) 2
(3 month(s))
a) 5.0
b) 10.0
a) 1.8
b) 3.6
500 - 1000
N
WH914
NS660-1
NW642-1
003
DE,
AT
YGLES
Railway tracks
F
TTTMM
wiping;
During growing
monocotyledonous weeds, single plant season
a) 1
b) 1
a) 33 %
b) 33 %
a) 3.6
b) 3.6
10.9
N
WH914
NS660-1
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Draft Registration Report – Central Zone
Page 10 of 26
TTTDD
dicotyledonous weeds,
NNNVP
woody plants
treatment
NW642-1
004
DE,
AT
YNKOB
Non-cultivated land
without woody plants
F
TTTMM
spraying
TTTDD
During growing
season
a) 1
b) 1
a) 10.0
b) 10.0
a) 3.6
b) 3.6
500 1000*)
N
No authorization in
Germany
005
DE,
AT
YNKOB
Non-cultivated land
F
spraying
TTTMM
TTTDD
During growing
season
a) 2
b) 2
(3 months)
a) 5.0
b) 10.0
a) 1.8
b) 3.6
500 1000*)
N
WH914
NG404
NT103
NS660-1
NW642-1
006
DE,
AT
YNKOB
Non-cultivated land
F
wiping;
During growing
TTTMM
TTTDD
treatment
NNNVP
woody plants
a) 1
b) 1
a) 33 %
b) 33 %
a) 3.6
b) 3.6
N
10.9
WH914
NS660-1
NW642-1
Remarks:
1) Numeration of uses in accordance with the application/as verified by MS
(2) Member State(s) or zone for which use is applied for
(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
situation should be described (e.g. fumigation of a structure)
(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages
(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
equipment used must be indicated
(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of
application
(8) The maximum number of applications possible under practical conditions of use for each single
application and per year (permanent crops) or crop (annual crops) must be provided
(9) Min. interval between applications (days) were relevant
(10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season
must be given in metric units (e.g. kg or L product / ha)
(11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per
crop/season must be given in metric units (e.g. g or kg / ha)
(12) The range (min/max) of water volume under practical conditions of use must be given (L/ha)
*) A water volume of 500 to 1000 L/ha might not be considered common practice in all MS; e.g.
in Germany 100 to 400 L/ha are recommended.
(13) PHI - minimum pre-harvest interval
(14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
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3
Risk management
3.1
Reasoned statement of the overall conclusions taken in accordance with the
Uniform Principles
3.1.1
Physical and chemical properties (Part B, Section 1, Points 2 and 4)
Overall Summary:
The product Tender GB Ultra (MON 78708) is a soluble concentrate. All necessary studies have been
conducted with the formulation MON 52276, the conclusions apply also to MON 78708.
MON 78708 is a blue-green homogeneous liquid. It is not explosive, has no oxidising properties and a self
ignition temperature of 440 °C. In aqueous solution, it has a pH value of 4.8. The stability data indicate a
shelf life of at least two years at ambient temperature. The technical characteristics are acceptable for a
soluble concentrate formulation.
Implications for labelling: None
Compliance with FAO specifications:
There are FAO specifications for glyphosate SL formulations (284/SL (2000)) and for glyphosate
isopropylamine salt TK (284/TK (2000)). The product Tender GB Ultra (MON78708) complies with both
of them.
Compliance with FAO guidelines:
The product Tender GB Ultra (MON 78708) complies with the general requirements according to
FAO/WHO manual (2010).
Compatibility of mixtures:
No tank mixtures are recommended.
Nature and characteristics of the packaging:
Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,
leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents
of the packaging, have been submitted, evaluated and is considered to be acceptable.
Nature and characteristics of the protective clothing and equipment:
Information regarding the required protective clothing and equipment for the safe handling of MON
78708 has been provided and is considered to be acceptable.
3.1.2
Methods of analysis (Part B, Section 2, Point 5)
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)
The method for assay of glyphosate in SL formulation MON 52276 (and hence MON 78708) was
successfully validated and meets the EU criteria with respect to specificity, linearity, accuracy and
repeatability.
Methods for the assay of the relevant impurities formaldehyde and N-nitrosoglyphosate in the formulation
are available on the FAO website, but their applicability for MON78708 has not been demonstrated by
the applicant.
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3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
All analytical methods are active substance data and were provided in the EU review of glyphosate. No
methods for crops are needed since all uses are applied for treatments of railroad tracks and non crop
areas.
The assessment according to the guidance document SANCO/825/00 rev. 8.1 has shown that not all of the
analytical methods for monitoring which were found acceptable for the Annex I inclusion are still in
compliance with the current data requirements. Two data gaps were identified regarding confirmatory
methods for soil and water. However, there are other acceptable studies available which can be used for
this application.
For soil a study has been provided from another applicant which is now unprotected in Germany: Szuter,
1996, “Glyphosate Acid: Independent Laboratory Validation of the Method for Determining Residues of
N-(Phosphonomethyl)glycine and (Aminomethyl)phosphonic Acid in Soil (WRC-96-082) (WINO
23013)”.
For drinking/surface water a new study has been submitted for national authorisations and for the renewal
of glyphosate: Knoch, E. (2010), “Validation of an analytical method: Determination of glyphosate and
AMPA in water matrices using FMOC derivatization, manual SPE cleanup and LC-MS/MS quantitation”
3.1.3
Mammalian Toxicology (Part B, Section 3, Point 7)
3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1)
Acute toxicity studies for “Tender GB Ultra” were not evaluated as part of the EU review of glyphosate.
Therefore, all relevant data were provided and are considered adequate.
3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3)
Operator exposure to “Tender GB Ultra” was not evaluated as part of the EU review of glyphosate.
Therefore all relevant data and risk assessments have been provided and are considered to be adequate.
3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4)
Bystander exposure to “Tender GB Ultra” was not evaluated as part of the EU review of glyphosate.
Therefore, all relevant data and risk assessments have been provided and are considered adequate. It is
concluded that there is no undue risk to any bystander after accidental short-term exposure to “Tender GB
Ultra”. This has no labelling implications.
3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5)
Worker exposure to “Tender GB Ultra” was not evaluated as part of the EU review of glyphosate.
Therefore, all relevant data and risk assessments have been provided and are considered adequate. It is
concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing
(but no PPE), when re-entering areas treated with “Tender GB Ultra”.
Implications for labelling resulting from operator, worker, bystander assessments:
Hazard Symbol: Indication of danger: Risk Phrases: Safety Phrases: R and S phrases under Directive 2003/82/EC (Annex IV and V): -
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Other phrases: -
3.1.4
Residues and Consumer Exposure (Part B, Section 4, Point 8)
3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7)
Not relevant since all uses are applied for treatments of railroad tracks and non crop areas.
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)
Not relevant since all uses are applied for treatments of railroad tracks and non crop areas.
3.1.5
Environmental fate and behaviour (Part B, Section 5, Point 9)
A full exposure assessment for the plant protection product TENDER GB ULTRA (MON 78708) in its
intended uses in various crops is documented in detail in the core assessment of the plant protection
product TENDER GB ULTRA (MON 78708) dated from March 2013 performed by Germany.
The following chapters summarise specific exposure assessment for soil and surface water and the
specific risk assessment for groundwater for the authorization of TENDER GB ULTRA (MON 78708) in
Germany according to its intended uses.
General
The use of plant protection products containing glyphosate is not approvable on areas with the risk
for runoff. An exemption (§ 12 para 2 German Plant Protection Act) may be given, in which a
method of application is prescribed (eg, application of a roll coating device, wiping or single plant
treatment), which excludes the risk of runoff. An application on walks and places via spraying
technique is therefore not approvable, as this technique does not counter risk for run-off.
Metabolites
New studies on the fate and behaviour of glyphosate or TENDER GB ULTRA (MON 78708) have been
performed. However, no potentially new metabolites need to be considered for environmental risk
assessment.
The risk assessment for the metabolites of glyphosate has already been performed for EU approval (see
SANCO/6511/VI/99-final, 21 January 2002). The metabolites are considered ecotoxicologically not
relevant and did not penetrate into groundwater. Therefore, no new risk assessment is necessary.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points
9.4 and 9.5)
For the intended use of the plant protection product TENDER GB ULTRA (MON 78708) according to
use in non–arable land and railways PECsoil was calculated for the active substance glyphosate and its
metabolite AMPA considering a soil depth of 2.5 cm. Due to the slow degradation of the active substance
glyphosate in soil (DT90 > 365 d, field data) the accumulation potential of glyphosate needs to be
considered. Therefore PECsoil used for risk assessment comprises background concentration in soil
(PECaccu) considering a tillage depth of 5 cm (permanent crops) and the maximum annual soil
concentration PECact considering the relevant soil depth of 2.5 cm, respectively.
The results for PEC soil for the active substance and its metabolites were used for the ecotoxicological
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risk assessment.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,
Section 5, Point 9.6)
Direct leaching into groundwater
Groundwater contamination by direct leaching of glyphosate and/or its metabolite AMPA is not expected
as both substances are strongly absorbed to soil particles. Therefore, groundwater model calculations are
not provided.
Consequences for authorization:
None
Ground water contamination by bank filtration due to surface water exposure via run-off and drainage
According to modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L for
the active substance glyphosate due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration cannot be excluded for the intended use No. 00-004.
According to modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L for
the active substance glyphosate due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded for the intended use No. 00-005 in case risk mitigation
measures (vegetated buffer strip of 20 m) are applied.
For the intended uses 00-001 and 00-002 (spraying on railways), a possible contamination of surface
water via run-off from railway system can currently not be excluded. A contamination of groundwater
and a risk for aquatic organisms might arise from an entry of glyphosate in surface waters via runoff from
railway systems and subsequent bank infiltration.
According to modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L
with the soil metabolite AMPA due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of 5 m)
are applied for the intended use No. 00-004.
with the soil metabolite AMPA due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded for the intended use No. 00-005.
Use no 004 can not be authorized
The authorization of the plant protection product TENDER GB ULTRA (MON 78708) is linked with
following labelling:
Use No. 00-001 and 00-002 Authorization coupled with the requirement that application of ‘Tender
GB Ultra’ on railway systems will not lead to groundwater
contamination > 0.1 glyphosate/L following run off and subsequent
bank infiltration. Submission of the relevant information (see below,
concerning fate and behaviour of glyphosate following application on
railway systems) within 2 years from registration.
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General
NG351
Use No. 00-005
A maximum of 2 treatments with a minimum interval of 90 days may
be carried out with this product and other products containing
glyphosate within one calendar year on the same area. The maximum
application rate for the active substance of 3.6 kg per hectare and year
must not be exceeded.
NG 404
Between treated areas with an incline of more than 2% and surface
water - except only occasionally but including periodically waterbearing surface water - there must be a border under complete plant
cover. The border's protective function must not be impaired by the use
of implements. It must be at least 20 m wide. This border is not
necessary if: - sufficient catching systems are available for the water
and soil transported by run-off, which do not flow into surface water or
are not connected with the urban drainage system or - the product is
used for mulch or direct drilling methods.
and a risk for aquatic organisms might arise from an entry of glyphosate in surface waters via runoff from
railway systems and subsequent bank infiltration.
According to available information, in actual track constructions vertical infiltration into the railway
roadbed system is being avoided by means of inserted barrier layers into the roadbeds up to the track
level. As a consequence, during rain events, lateral leaching to both sides of the roadbeds will occur –
possibly in drainage channels. This run-off water might discharge into runoff ditches or be collected
separately.
Since the sorption of active ingredients to crushed material, like gravel, is deemed to be lower than to the
agricultural soils usually considered in the risk assessment of plant protection products, a higher mobility
of glyphosate might occur (e.g. Strange-Hansen, R., PE Holm, OS Jacobsen and CS Jacobsen, 2004:
Sorption, mineralization and mobility of N-(phosphonomethyl)glycine (glyphosate) in five different types
of gravel. Pest Management Science 60, 570-578).
There are a few results available from studies investigating the behaviour of glyphosate in railway
systems in Switzerland (e. G. Brauchli-Theotokis, J. (2004): Bestimmung von Glyphosat und AMPA auf
Bahnanlagen. In: BUWAL Bundesamt für Umwelt, Wald und Landschaft (eds.) UMWELTMATERIALIEN NR. 170 Umweltgefährdende Stoffe/Gewässerschutz. Bern, Schweiz, 58 S.). These
investigations show that at similar application rates as in the intended uses of ‘Tender GB Ultra’,
concentrations up to 100 µg glyphosate/L are detected in the drainage water of the experimental set-ups.
In general, it was shown that the higher the rainfall quantity, the higher the cumulative amount of
glyphosate that was washed-off. During normal operation, glyphosate concentrations along railway tracks
reached values up to 10 µg / L in the drainage water.
Similar concentrations were also detected in drainage ditches alongside railway lines in England. There,
about 1800 g of glyphosate/ha were applied experimentally and 12 µg/L glyphosate was measured in runoff water (Heather, AIJ, JM Hollis & AJ Shepherd, 1999. Losses of six herbicides from a disused railway
formation. Final report to Hard Surfaces project Consortium. February, 1999. pp. 30.)
Following these considerations and based on the available studies, it cannot be excluded that glyphosate
concentrations might exceed 0.1 µg/L in groundwater after bank filtration from surface water when
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‘Tender GB Ultra’ is applied in the intended uses for weed control on railways. For this initial evidence to
be substantiated or dispelled, we therefore require additional information in order to assess the potential
contamination of surface water by runoff as well as the potential contamination of groundwater via runoff in surface water with subsequent bank filtration due to the application of glyphosate on railway
facilities.
In particular, within 2 years from the date of registration following information should be made available:
- the existing roadbed construction types of and their characteristics that might affect run-off, drainage
and infiltration
- the behaviour of glyphosate when applied to the roadbeds for weed control (i.e. degradation, sorption
and translocation)
- the estimated amount of run-off water from roadbeds constructed according to state-of-the-art
technologies
- the expected concentration of glyphosate in run-off water and – if relevant – in ditches adjacent to
railways that are fed by drained water
- the expected concentration of glyphosate in groundwater
Furthermore, information is needed relating to the potential risk for local populations of protected species
in conservation areas and other protected areas [§ 22 and 32 Federal Nature Conservation Act] and of
water conservation [by WHG § 50-53] if ‘‘Tender GB Ultra’ is applied in the intended use on railway
systems.
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B,
Section 5, Points 9.7 and 9.8)
For the intended use of the plant protection product TENDER GB ULTRA (MON 78708) in non–arable
land and railways PECsw was calculated for the active substance glyphosate considering the two routes of
entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately.
The vapour pressure at 20 °C of the active substance glyphosate is between 10-5 und 10-4 Pa. Hence the
active substance glyphosate is regarded as semivolatile (volatilisation only from plant surfaces).
Therefore exposure of surface water by the active substance glyphosate due to deposition following
volatilization was considered.
The results for PEC surface water for the active substance and its metabolites were used for the ecotoxicological risk assessment.
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point
9.9)
Calculation of PECAir is deemed not relevant due to the low volatility of the active substance.
Implications for labelling resulting from environmental fate assessment
Based on the data on the active substance glyphosate the plant protection product TENDER GB ULTRA
(MON 78708) is considered to be not readily degradable in the sense of the CLP regulation.
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3.1.6
Ecotoxicology (Part B, Section 6, Point 10)
A full risk assessment according to Uniform Principles for the plant protection product TENDER GB
ULTRA (MON 78708) in its intended uses is documented in detail in the core assessment of the plant
protection product TENDER GB ULTRA (MON 78708) dated from November 2013 performed by
Germany, UBA. The intended use of TENDER GB ULTRA (MON 78708) in Germany is generally
covered by the uses evaluated in the course of the core assessment.
The following chapters summarises specific risk assessment for non-target organisms and hence risk
mitigation measures for the authorization of TENDER GB ULTRA (MON 78708) in Germany according
to its intended uses.
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
Birds
The risk assessment for effects on birds and other terrestrial vertebrates is carried out according to the
European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals
(EFSA Journal 2009; 7(12): 1438).
Acute toxicity
Based on the highly conservative presumptions of the screening step, the calculated TER values for the
acute risk resulting from an exposure of birds to the active substance glyphosate according to the GAP of
the formulation Tender GB Ultra achieve the acceptability criteria TER ≥ 10, according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute
effects. The results of the assessment indicate an acceptable risk for birds.
Long-term toxicity
Based on Tier 1 assessment step, the calculated TER values resulting from an exposure of the formulation
Tender GB Ultra do achieve the acceptability criteria TER ≥ 5 according to commission implementing
regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for long-term effects
with an application rate of max. 3.6 kg a.s./ha. The results of the assessment indicate an acceptable risk
for birds due to the intended use of Tender GB Ultra in the scenarios representing the use in railways and
non-crop areas with an application rate of max. 3.6 kg a.s./ha.
Consequences for authorisation:
None
Mammals
The risk assessment for effects on mammals is carried out according to the European Food Safety
Authority Guidance Document on Risk Assessment for Birds and Mammals (EFSA Journal 2009; 7(12):
1438). An assessment based on updated data taking into account the latest knowledge from the
dRAR (Red draft) is included.
Acute toxicity
Based on the screening step, the calculated TER values for the acute risk resulting from an exposure of
mammals to glyphosate according to the GAP of the formulation Tender GB Ultra does achieve the
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acceptability criteria TER ≥ 10/ TER ≥ 5 (Microtus arvalis, Apodemus sylvaticus)* according to
commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point
2.5.2. for acute effects. The results of the assessment indicate an acceptable risk for mammals due to the
intended use of Tender GB Ultra in the scenarios “bare soil” and “grassland“ representing the use in
railways and non-crop areas according to the label.
* In cases where the relevant model species for assessment of the risk from the intended uses is a Wood
mouse (Apodemus sylvaticus L.) or a Common vole (Microtus arvalis), the TER acceptability criterion
may be modified (TER ≥ 5 in the acute exposure scenario and TER ≥ 2 in the long-term exposure
scenario).
Long-term toxicity
Scenario “bare soil” representing the use in railways areas
long-term risk resulting from an exposure of mammals in the scenarios “bare soil” representing the use in
railways areas does achieve the acceptability criteria TER ≥ 5/ TER≥ 2* (Microtus arvalis, Apodemus
siylvaticus), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2.
Specific principles, point 2.5.2. for long-term effects. The results of the assessment indicate an acceptable
risk for mammals due to the intended use of Tender GB Ultra in the scenario “bare soil” representing the
use in railways areas according to the label.
Scenario “grassland“ representing the use in non-crop areas
Based on the refined assessment, the calculated TER values for the long-term risk resulting from an
exposure of mammals to the active substance glyphosate according to the GAP of the formulation Tender
GB Ultra does not achieve the acceptability criteria TER ≥ 5/ TER≥ 2* (Microtus arvalis), according to
2.5.2. for long-term effects with an max. application rate of max. 3.6 kg a.s. /ha. The results of the
assessment indicate an unacceptable risk for mammals due to the intended use of Tender GB Ultra in the
scenario “grassland“ representing the use in non-crop areas according to the label with an max.
application rate of max. 3.6 kg a.s. /ha.
GB Ultra does achieve the acceptability criteria TER ≥ 5/ TER≥ 2* (Microtus arvalis), according to
2.5.2. for long-term effects with an application rate of max. 2 ×1.8 kg a.s./ha. The results of the
assessment indicate an acceptable risk for mammals due to the intended use of Tender GB Ultra in the
application rate of max. 2×1.8 kg a.s. /ha.
* In cases where the relevant model species for assessment of the risk from the intended uses is a wood
mouse (Apodemus sylvaticus L.) or a common vole (Microtus arvalis), the TER acceptability criterion
scenario).
Consequences for authorisation
Use No. 00-004:
No authorization
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3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)
Risk assessments for aquatic organisms were conducted based on the Guidance Document on Aquatic
Ecotoxicology (SANCO/3268/2001 rev. 4 final).
Currently, the active substance glyphosate is in the Renewal Assessment (AIR2). In the course of this
environmental endpoints were re-evaluated and new endpoints were defined. An evaluation with regard to
the agreed endpoints (Review Report (SANCO/6511/VI/99-final)) displays currently a worse case and in
consequence has no impact on the risk assessment.
Predicted environmental concentrations in surface water have been calculated in accordance with German
national requirements for drift, run-off and drainage entry into surface water.
Based on the calculated concentrations of glyphosate the calculated TER-values for the acute and longterm risk resulting from an exposure of aquatic organisms to glyphosate according to the GAP of the
formulation TENDER GB ULTRA (MON 78708) achieve the acceptability criteria TER ≥ 10. The results
of the assessment indicate an acceptable risk for aquatic organisms for to the intended use of TENDER
GB ULTRA (MON 78708) in all indications applying up to max. 3600g glyphosate/ha without risk
mitigation measures.
Labelling:
Because of the toxicity of the active ingredients following labels are needed:
NW 468:
NS 660-1:
The product may only be applied on field areas which are not used for agricultural,
forestry or horticultural purposes with the approval of the competent national authority.
Such areas include all areas which are not permanently covered by buildings or roofing,
including all traffic areas such as railway tracks, roads, paths, yards and business sites and
other pieces of land changed by civil engineering measures. Violations may be punished
by fines of up to 50 000 EUR.
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and
10.5
Bees
In a single dose limit test under laboratory conditions oral and contact toxicity of the formulated product
MON 52276 (41% glyphosate-isopropylamine, equivalent to 31% glyphosate-acid-equivalent) to young
adult worker bees (Apis mellifera L.) were tested using a single nominal dose of 330 µg product/bee (134
µg glyphosate isopropylamine/bee or 100 µg glyphosate acid equivalent/bee) for contact exposure and
254 µg product/bee (103 µg glyphosate isopropylamine/bee or 77 µg glyphosate a.s./bee) for oral
exposure. Five replicate cages containing 10 bees each were used for the test item treatments and the
untreated control. In the toxic standard treatment honeybees were treated with dimethoate at
concentrations ranging from 0.075 to 0.3 µg a.s./bee. Three replicate cages containing each 10 bees each
were used for the reference standard. Assessment of mortality was done after 1, 3, 24 and 48 hours.
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The mortality in control varied between 2% and 4% in the 48-hour exposure. For both oral and contact
exposures with the test item the mortality did not reach or exceed 50%. The highest mortality was
recorded in the contact toxicity test with 6%. Therefore the LD50 (48 h) was > 254 µg product/bee in the
oral toxicity test and > 330 µg product/bee in the contact toxicity test. No test item induced behavioural
effects were observed at any time of the test. LD50 values of the reference item were in the expected range
of 0.1 to 0.35 and 0.1 to 0.30 µg dimethoate/bee for oral and contact exposure, respectively. Validity
criteria were fulfilled and the test is considered valid.
Labelling:
NB6641
The product is classified as non-hazardous to bees, even when the maximum application
rate or concentration, if no application rate is stipulated, as stated for authorisation is
applied. (B4)
Other non-target arthropods
The toxicity of Tender GB Ultra to non-target arthropods has been investigated for the indicator species
Aphidius rhopalosiphi, Typhlodromus pyri and Poecilius cupreus.
The effects of MON 52276 on the predatory mite, (Typhlodromus pyri) were evaluated under extended
laboratory test conditions (2-dimensional). The 7-day LR50 (median lethal rate) was found to be higher
than 16000 mL/ha (nominally 5760 g a.s./ha), the maximum rate tested. MON 52276 had no significant
effect on the reproductive capacity of mites at treatment rates up to and including a treatment rate of 8000
mL formulation/ha (nominally 2880 g a.s./ha). The treatment rate of 12000 mL formulation/ha caused a
significant reduction in mean egg number/female after 14 days and the effects on reproduction compared
to control were 44.9%. For risk assessment zRMS used ER50 ≥12000ml MON 52276/ha (4320 g a.s./ha).
The off-field TER values for non-target arthropods (here calculated with the EC50 for T. pyri) without risk
mitigation measures are below the trigger value, indicating that Tender GB Ultra does not pose an
unacceptable risk to non-target arthropods in off-field areas.
None
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point
10.6)
Risk assessments for earthworms and other soil non-target macro-organisms were conducted following
the Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC
(SANCO/10329/2002 rev. 2 final). The assessments for acute and chronic exposure have been conducted
based on the formulation MON 52276.
Predicted environmental concentrations in soil were calculated based on German national requirements;
i.e. for a soil penetration depth of 2.5 cm for substances with KOC < 500 L/kg.
Based on the worst case scenario considering an application rate of 10 L/ha Tender GB Ultra (3600 g
a.s./ha), the acceptability criteria TER ≥ 10 resp. TER ≥ 5 for acute and long-term effects, according to
Annex VI to directive 1107/2009 (EG), uniform principles, point 2.5.2.5 is reached, indicating that
Tender GB Ultra poses low acute and long-term risk to earthworms when applied at the maximum
application rate.
As the metabolite AMPA is considered to be of no greater toxicological concern than its parent
compound in general and has a lower NOEC (≥ 28.12 mg/kg), it can be assumed that the toxicity of
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AMPA is addressed via the longterm study. The risk for earthworms is considered to be acceptable.
None
Tests on other soil non-target macro-organisms were not performed and not required according to the
Guidance Document on Terrestrial Ecotoxicology.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
Tests on organic matter breakdown were not performed and not required according to the Guidance
Document on Terrestrial Ecotoxicology.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
For the active ingredients in Tender GB Ultra, the soil concentrations which caused no deviations greater
than ±25% in the activity of the soil microorganisms are at least 2-times higher than the corresponding
maximum PEC in soil. Considering concurrent exposure to both the active ingredients in Tender GB
Ultra at the time of application, a low risk to soil microflora is also concluded.
None
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and
Fauna) (Part B, Section 6, Point 10.8)
For the risk assessment the endpoint of the active ingredient glyphosate is used. The most sensitive
species of the 10 tested species tested postemergence was Lycopersicon esculentum with an EC50 of 146 g
a.s. /ha. As for the active substance glyphosate results are available with 10 species, it is possible to lower
the acceptability TER ≥ 5. However, to ensure a sufficient and an adequate protection of non target plants
in the off –field environment it is recommended to correct the TER trigger > 5 by a factor of 3 upwards
for the following reasons:
Around the treated area non target plants will be exposed to Tender GB Ultra mainly via spray drift
(driftable portion of application rate: 2.77% at 1 m from treated field edges and 0.57% at 5 m). It is
important to remember that for the assessment of the effects on terrestrial plants toxicity studies with the
product are more appropriate than studies with the active ingredient. Since it can not be excluded that the
formulants enhance toxicity, it seems that using data of the active ingredient glyphosate only will not
display potential harmful effects of Tender GB Ultra towards non target plants. Nevertheless test results
on terrestrial plants with the formulation Tender GB Ultra have not been submitted. Based on the
available data from other glyphosate-containing preparations it is recognizable that the preparations
typically are about a factor of 3 more toxic than the active ingredient. In order to meet the precautionary
principle in risk assessment the acceptability is therefore modified (TER ≥ 15).
The risk assessment based on the lowest effect endpoint for vegetative vigour and the relevant predicted
environmental rates in the off-field area after treatment with Tender GB Ultra in accordance to the
proposed use rate is presented in the tables. For the proposed use pattern in of Tender GB Ultra on
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railways risk assessment is based on spray drift values modified according to Wygoda et al. 2006 (Drift
measurements for a spraying train, Nachrichtenblatt Deut. Pflanzenschutzdienst, 58 (12), S. 323–326,
2006, ISSN 0027-7479.)
Based on the most sensitive endpoints for vegetative vigour, exposure to Tender GB Ultra according to
the proposed uses with an application rate of max. 1×3600 g a.s/ ha and with an application rate of max.
2 ×1800 g a.s/ ha poses an acceptable risk to terrestrial non-target plants under consideration of risk
mitigation measures in terms of NT 103 (drift reduction of 90 % and 1m buffer zone).
An acceptable risk to terrestrial non-target plants due to treatment with Tender GB Ultra with the
proposed worst-case application rate of max. 3600 g a.s./ha is indicated by TER-values above the trigger
of 15 according to the risk assessment for railways.
Labelling:
In order to protect terrestrial non-target plant species in off-field areas a risk mitigation measure is
required in form of 90 % drift reduction for an application rate of 1 x 3600g a.i./ha and 2 x 1800 g a.i./ha.
NT103
Implications for labelling resulting from ecotoxicological assessment:
None
Relevant toxicity data
TENDER GB ULTRA (MON 78708)/ MON 52276
ErC50 = 284 mg/L (Selenastrum capricormutum)
Classification & Labelling according directives 67/548/EEC, 78/631/EEC and 1999/45/EEC
Danger Symbol
none
Risk Phrases
none
C&L according directive 1272/2008
Danger Symbol
none
Hazard Statements
none
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Hazard symbol(s):
Identification of danger:
none
none
none
Risk Phrases:
Safety Phrases:
3.1.7
none
none
Efficacy (Part B, Section 7, Point 8)
Glyphosate is an organic phosphorus compound, belonging to the chemical class of glycines, with no or
low soil residual activity. Herbicides containing glyphosate differ in the salt formulation. Glyphosate may
present as glyphosate-ammonium-salt, as glyphosate-isopropylammonium-salt or as glyphosatepotassium-salt. Glyphosate is a non-selective herbicidal active substance. Glyphosate is taken up by the
leaves and other green parts of the plant and is translocated systemically (apoplastic and symplastic) in
the whole plant, also in underground parts like roots, rhizomes or stolons. Glyphosate uptake through the
roots is negligible because the active substance is strongly adsorbed in the soil. The extensive adsorption
of glyphosate together with a ready degradation in soil, are the principal deactivation and dissipation
mechanisms in the soil environment.
In plants, glyphosate inhibits the shikimic acid pathway. Glyphosate binds to and blocks the activity of its
target enzyme EPSPS (5-enolpyruvylshikimate-3-phosphate synthase), an enzyme of the aromatic amino
acid biosynthetic pathway. The inhibition of the enzyme prevents the plant from synthesizing the essential
aromatic amino acids (e.g. phenylalanine, tyrosine, and tryptophan) needed for protein biosynthesis. This
reduces the production of protein in the plant, and inhibits plant growth. EPSPS is present in all plants. It
leads to an accumulation of the amino acids glutamine, glutamic acid, shikimic acid and ammonia. As a
consequence of missing aromatic amino acids the formation of phenolic compounds is inhibited (e.g.
lignin, flavanoids) (HRAC-classification G).
Label applied: WMG
The submission of the present draft Registration Report (dRR) serves the core registration of MON78708
(glyphosate) in the central registration zone (B) of the European Union. Germany is zRMS. The national
label for Germany is available. A master label for the central zone (B) is missing.
The applicant applies for a herbicide containing the active substance glyphosate. The evaluation of the
test compound is based on results of field trials conducted in Germany. Essentially the trials satisfy the
requirements for registration with regard to comprehension and quality of the studies. In many cases the
GEP-requirement is taken care of. The applicant refers to documents of other registered glyphosate
herbicides in Germany.
Minimum effective dose tests were conducted regarding the control of mono- and dicotyledonous weeds.
For all intended uses the requested dose rate is needed. A limited number of trials were submitted. But
overall the effectiveness of herbicides containing glyphosate and the required spray rate is well known.
Label applied: WH914
Efficacy tests (spray and wiping application) were conducted regarding the control of mono- and
dicotyledonous weeds. MON78708 was tested in comparison to commercial standard reference products.
In the trials MON78708 demonstrated a level of efficacy against the different weed species present in the
trials similar to that of the commercial standard reference products. No usable data were submitted for the
intended use 003, 004 and for some intended uses only one-year result were submitted. Results can be
transferred from other indications. The spectrum of weed species and dates of application are sufficiently
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comparable through the indications. A limited number of trials were submitted. Overall the effectiveness
of herbicides containing glyphosate is well known.
As MON78708 is non-selective herbicide the product should be used with care and in line with good
plant protection practice. Directions for use for example in regard to uncontrolled spay drift to
neighbouring fields, weather conditions or water volumes have to be observed. If requirements of good
plant protection practice are observed it can be assumed that there are no negative impacts on other
plants, including adjacent crops.
MON78708 is intended to be used as non-selective herbicide against monocotyledonous and
dicotyledonous weeds in on a number of field crops as well as in vineyards and orchards (pome fruit) for
desiccation and on non cropped areas. The active substance glyphosate is a commonly used herbicide in
agriculture worldwide. Despite the intensive use of glyphosate in many important crops on a worldwide
scale, the number of documented cases of resistance is still comparatively low. However, the increasing
use of glyphosate in many cropping systems in the Central Zone of Europe constitutes an increasing risk
of resistance. The general resistance risk of MON78708 is therefore assessed as being low to medium.
The herbicide Tender GB Ultra (MON 78708, 360 g/L glyphosate, SL) has been proposed for a single
application with a rate of 10 L/ha and for two applications with rates of 5 L/ha each, both in nonagricultural land without woody plant and on railway track installations. The maximum recommended use
rate per year is 3.6 kg a.s. Due to the intended use of Tender GB Ultra, complete vegetation control on
non-cultivated areas, exposure of beneficial arthropods is considered negligible. So no assessment has
been made.
The data submitted by the applicant demonstrate that MON78708 fulfils all criteria for the authorization
of preparations described in Directive 97/57/EC (Uniform Principles, Annex VI to Directive
91/414/EEC).
3.2
Conclusions
With respect to phys./chem. and technical properties, analytical methods (formulation), residue analysis
and efficacy/sustainable use an authorisation can be granted.
Regarding compliance with MRLs set according to Reg. (EC) No 396/2005, health protection of
operators, workers, bystanders, residents, and consumers following the intended uses of “Tender GB
Ultra” an authorisation can be granted.
Concerning fate and ecotoxicology an authorisation can be granted for the uses 001, 002, 003, 005 and
006.
For use 004 groundwater contamination due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration contamination cannot be excluded. Concerning effect on mammals the
calculated TER values for use 004 for the long-term risk resulting from an exposure to the active
substance glyphosate do not achieve the acceptability criteria. An authorization can therefore not be
granted.
An authorisation can be granted.
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3.3
Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation
For the intended uses 00-001 and 00-002 (spraying on railways) within 2 years from the date of
registration following information should be made available:
and infiltration
and translocation)
technologies
Furthermore, information is needed relating to the potential risk for local populations of protected species
in conservation areas and other protected areas [§ 22 and 32 Federal Nature Conservation Act] and of
water conservation [by WHG § 50-53] if ‘‘Tender GB Ultra’ is applied in the intended use on railway
systems.
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Appendix 1 – Copy of the product authorisation
See below.
Appendix 2 – Copy of the product label
The submitted draft product label has been checked by the competent authority. The applicant is
requested to amend the product label in accordance with the decisions made by the competent authority.
The final version of the label has to fulfil the requirements according to Article 16 of Directive
91/414/EEC.
Appendix 3 – Letter of Access
Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
Date: 24/03/2014
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig
Dr. Dietmar Gottschild
Referent
TELEFON +49 (0)531 299-3512
TELEFAX +49 (0)531 299-3002
E-MAIL [email protected]
Monsanto Agrar
Deutschland GmbH
Vogelsanger Weg 91
40470 Düsseldorf
IHR ZEICHEN
IHRE NACHRICHT VOM
AKTENZEICHEN 200.22100.043981-00/00.63212
(bitte bei Antwort angeben)
DATUM 17. April 2014
ZV1 043981-00/00
Tender GB Ultra
Zulassungsverfahren für Pflanzenschutzmittel
Bescheid
Das oben genannte Pflanzenschutzmittel
mit dem Wirkstoff:
360 g/l
Glyphosat (als Isopropylamin-Salz 486 g/l)
Zulassungsnummer:
043981-00
Versuchsbezeichnung:
MOT-98321-H-2-SL
Antrag vom:
11. Dezember 2011
wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen
Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates
(ABl. L 309 vom 24.11.2009, S. 1), wie folgt zugelassen:
Zulassungsende
BVL_FO_05_2437_200_V1.3
Die Zulassung endet am 31. Dezember 2016.
Festgesetzte Anwendungsgebiete bzw. Anwendungen
Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1):
Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de
SEITE 2 VON 19
Anwendungs-
Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck
nummer
Zweckbestimmung Objekte
043981-00/00-001, Einkeimblättrige
Gleisanlagen
043981-00/00-002 Unkräuter, Zweikeimblättrige
Unkräuter
043981-00/00-005 Einkeimblättrige
Unkräuter, Zwei-
Nichtkulturland ohne
Holzgewächse
keimblättrige
Unkräuter
Gleisanlagen
Unkräuter, Zweikeimblättrige
Unkräuter, Holzgewächse
Unkräuter, Zwei-
Holzgewächse
keimblättrige
Unkräuter, Holzgewächse
Festgesetzte Anwendungsbestimmungen
Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum
Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I
S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 87 des Gesetzes vom 7. August 2013
(BGBl. I S. 3154) festgesetzt:
(NG351)
Mit diesem und anderen glyphosathaltigen Pflanzenschutzmitteln dürfen innerhalb eines
Kalenderjahres auf derselben Fläche maximal 2 Behandlungen mit einem Mindestabstand
von 90 Tagen durchgeführt werden. Die maximale Wirkstoff-Aufwandmenge von 3,6 kg pro
ha und Jahr darf dabei nicht überschritten werden.
Begründung:
Der im Pflanzenschutzmittel enthaltene Wirkstoff Glyphosat weist ein hohes Potenzial für
Einträge in das Grundwasser über den Pfad Oberflächenabfluss mit anschließender inverser
BVL_FO_05_2437_200_V1.3
Uferfiltration auf. Ausgehend von einem Datensatz charakteristischer Eigenschaften des
Wirkstoffs und einer Berechnung der zu erwartenden Einträge mit dem Modell Exposit 3.01
unter Berücksichtigung der substanzspezifischen Eliminationsrate bei der Uferfiltration können Konzentration im Grundwasser > 0,1 µg/L nur durch entsprechende Risikominderungs-
SEITE 3 VON 19
maßnahmen ausgeschlossen werden.
(NW468)
Anwendungsflüssigkeiten und deren Reste, Mittel und dessen Reste, entleerte Behältnisse
oder Packungen sowie Reinigungs- und Spülflüssigkeiten nicht in Gewässer gelangen lassen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe
sowie Regen- und Abwasserkanäle.
Begründung:
Aufgrund der Auswirkungen des Wirkstoffs Glyphosat gegenüber aquatischen Organismen
besitzt das o.g. Pflanzenschutzmittel einen den Naturhaushalt schädigenden Charakter, so
dass jeder weitergehende, d. h. den als Folge der sachgerechten und bestimmungsgemäßen
Anwendung des Pflanzenschutzmittels "Tender GB Ultra" übersteigende Eintrag von Rückständen in Gewässer zu einer erheblichen Gefährdung des Naturhaushaltes führen würde.
Angesichts der Umstände, dass ein erheblicher Anteil an Pflanzenschutzmittelfrachten im
einzelnen Gewässer auf Einträge aus kommunalen Kläranlagen zurückzuführen ist (vgl.
Umweltpolitik - Wasserwirtschaft in Deutschland, 10.5.2 Pestizide, S. 156 ff., BMU, Februar
1998 und Fischer, Bach, Frede: Abschlussbericht zum DBU-Projekt 09931, April 1998), ist es
unverzichtbar, der Gefahr, die eine Verbringung von Pflanzenschutzmitteln in Gewässer mit
sich bringt, durch die bußgeldbewehrte Anwendungsbestimmung im Sinne der Zweckbestimmung des Pflanzenschutzgesetzes durchsetzbar zu begegnen.
Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3.
Verpackungen
Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend
näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen:
Verpackungs-
Verpackungs-
Anzahl
Inhalt
art
material
von
Flasche
HDPE
1
1,00
Kanister
HDPE
1
5,00
20,00
l
Tank
HDPE
1
640,00
1000,00
l
bis
von
bis
Einheit
l
Die Verpackungen für den beruflichen Anwender sind wie folgt zu kennzeichnen:
BVL_FO_05_2437_200_V1.3
Anwendung nur durch berufliche Anwender zulässig.
Auflagen
Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden:
SEITE 4 VON 19
Kennzeichnungsauflagen:
(SB001)
Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschäden führen.
(SB010)
Für Kinder unzugänglich aufbewahren.
(SF245-01)
Behandelte Flächen/Kulturen erst nach dem Abtrocknen des Spritzbelages wieder betreten.
(WMG)
Wirkungsmechanismus (HRAC-Gruppe): G
Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2.
Sonstige Auflagen:
(VH368)
Der Gehalt an N-Nitrosoglyphosat im technischen Konzentrat von Glyphosat oder Glyphosatsalzen darf 1mg/kg nicht überschreiten. Der Gehalt an Formaldehyd darf 1,3 g/kg bezogen
auf die Äquivalenzmasse der Glyphosatsäure nicht überschreiten.
Vorbehalt
Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder
Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.
Angaben zur Einstufung und Kennzeichnung gemäß § 4 Gefahrstoffverordnung
Gefahrenhinweise (R-Sätze):
- keine -
Sicherheitshinweise (S-Sätze):
BVL_FO_05_2437_200_V1.3
- keine -
Zur Vermeidung von Risiken für Mensch und Umwelt ist die Gebrauchsanleitung einzuhalten.
SEITE 5 VON 19
Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG)
Nr. 1272/2008
Signalwort:
- keine Gefahrenpiktogramme:
- keine -
Gefahrenhinweise (H-Sätze):
(EUH 401)
Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.
Sicherheitshinweise (P-Sätze):
- keine -
Abgelehnte Anwendungsgebiete bzw. Anwendungen
Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe
Anlage 2):
Anwendungs-
Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck
nummer
Zweckbestimmung Objekte
Unkräuter, Zwei-
Holzgewächse
keimblättrige
Unkräuter
Hinweise
Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden:
(NB6641)
Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder
Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienengefährlich eingestuft (B4).
Weitere Hinweise und Bemerkungen
Zu KIIIA1 6.2.8:
BVL_FO_05_2437_200_V1.3
Hinweis und Begründung für die Kennzeichnungsauflage zum Wirkungsmechanismus
(WMG: Glyphosat):
Die HRAC-Klassifizierung ist als neutrale Information direkt dem Wirkstoff zuzuordnen. Die
SEITE 6 VON 19
Kennzeichnung erleichtert der Praxis die Bestimmung des Wirkungsmechanismus von Herbiziden und ermöglicht so ein gezieltes Wirkstoffmanagement.
Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben,
soweit sie noch nicht erfüllt sind.
Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu
schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulassungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen.
Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid.
Rechtsbehelfsbelehrung
Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch
erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und
Lebensmittelsicherheit, Messeweg 11/12, 38104 Braunschweig, schriftlich oder zur
Niederschrift einzulegen.
Mit freundlichen Grüßen
im Auftrag
gez. Dr. Karsten Hohgardt
stellvertretender Abteilungsleiter
Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.
BVL_FO_05_2437_200_V1.3
Anlage
SEITE 7 VON 19
Anlage 1 zugelassene Anwendung: 043981-00/00-001
1
Anwendungsgebiet
Schadorganismus/Zweckbestimmung: Einkeimblättrige Unkräuter, Zweikeimblättrige Unkräuter
Pflanzen/-erzeugnisse/Objekte:
Gleisanlagen
Verwendungszweck:
2
Kennzeichnungsauflagen
2.1
Angaben zur sachgerechten Anwendung
Einsatzgebiet:
Nichtkulturland
Anwendungsbereich:
Freiland
Anwendung im Haus- und
Kleingartenbereich:
Nein
Anwendungszeitpunkt:
Während der Vegetationsperiode
Maximale Zahl der Behandlungen
- in dieser Anwendung:
1
- für die Kultur bzw. je Jahr:
1
Anwendungstechnik:
spritzen
Aufwand:
2.2
10 l/ha in 500 bis 1000 l Wasser/ha
Sonstige Kennzeichnungsauflagen
(NS660-1)
Die Anwendung des Mittels auf Freilandflächen, die nicht landwirtschaftlich, forstwirtschaftlich oder gärtnerisch genutzt werden, ist nur mit einer Genehmigung der zuständigen
Behörde zulässig. Zu diesen Flächen gehören alle nicht durch Gebäude oder Überdachungen ständig abgedeckten Flächen, wozu auch Verkehrsflächen jeglicher Art wie Gleisanlagen, Straßen-, Wege-, Hof- und Betriebsflächen sowie sonstige durch Tiefbaumaßnahmen
veränderte Landflächen gehören. Zuwiderhandlungen können mit einem Bußgeld bis zu
einer Höhe von 50.000 Euro geahndet werden.
BVL_FO_05_2437_200_V1.3
(NW642-1)
Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstengewässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorgegebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können
mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.
(WH914)
In die Gebrauchsanleitung ist eine Zusammenstellung der Unkräuter und ggf. Holzgewächse
aufzunehmen, die durch die Anwendung des Mittels gut, weniger gut und nicht ausreichend
bekämpft werden können.
SEITE 8 VON 19
2.3
(N)
Wartezeiten
Freiland: Gleisanlagen
Die Festsetzung einer Wartezeit ist ohne Bedeutung.
BVL_FO_05_2437_200_V1.3
3
Anwendungsbezogene Anwendungsbestimmungen
- keine -
SEITE 9 VON 19
1
Anwendungsgebiet
Gleisanlagen
Verwendungszweck:
2
2.1
Einsatzgebiet:
Nichtkulturland
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
2
2
- Abstand:
3 Monat(e)
Anwendungstechnik:
spritzen
Aufwand:
2.2
(NS660-1)
BVL_FO_05_2437_200_V1.3
(NW642-1)
(WH914)
SEITE 10 VON 19
2.3
(N)
Wartezeiten
BVL_FO_05_2437_200_V1.3
3
- keine -
SEITE 11 VON 19
1
Anwendungsgebiet
Schadorganismus/Zweckbestimmung: Einkeimblättrige Unkräuter, Zweikeimblättrige Unkräuter, Holzgewächse
Gleisanlagen
Verwendungszweck:
2
2.1
Einsatzgebiet:
Nichtkulturland
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
1
1
Anwendungstechnik:
- Erläuterungen:
streichen
zur gezielten Einzelpflanzenbehandlung
Aufwand:
-
33 %
- Erläuterungen:
maximaler Mittelaufwand 10 l/ha
2.2
BVL_FO_05_2437_200_V1.3
(NS660-1)
(NW642-1)
(WH914)
SEITE 12 VON 19
2.3
(N)
Wartezeiten
BVL_FO_05_2437_200_V1.3
3
- keine -
SEITE 13 VON 19
1
Anwendungsgebiet
Nichtkulturland ohne Holzgewächse
Verwendungszweck:
2
2.1
Einsatzgebiet:
Nichtkulturland
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
2
2
- Abstand:
3 Monat(e)
Anwendungstechnik:
spritzen
Aufwand:
2.2
(NS660-1)
BVL_FO_05_2437_200_V1.3
(NW642-1)
(WH914)
SEITE 14 VON 19
2.3
(N)
3
Wartezeiten
Freiland: Nichtkulturland ohne Holzgewächse
BVL_FO_05_2437_200_V1.3
(NG404)
Zwischen behandelten Flächen mit einer Hangneigung von über 2 % und Oberflächengewässern - ausgenommen nur gelegentlich wasserführender, aber einschließlich periodisch
wasserführender - muss ein mit einer geschlossenen Pflanzendecke bewachsener Randstreifen vorhanden sein. Dessen Schutzfunktion darf durch den Einsatz von Arbeitsgeräten
nicht beeinträchtigt werden. Er muss eine Mindestbreite von 20 m haben. Dieser Randstreifen ist nicht erforderlich, wenn: - ausreichende Auffangsysteme für das abgeschwemmte
Wasser bzw. den abgeschwemmten Boden vorhanden sind, die nicht in ein Oberflächengewässer münden bzw. mit der Kanalisation verbunden sind, oder - die Anwendung im Mulch oder Direktsaatverfahren erfolgt.
Begründung:
Der im Pflanzenschutzmittel Tender GB Ultra enthaltene Wirkstoff Glyphosat weist ein hohes
Potenzial für Einträge in das Grundwasser über den Pfad Oberflächenabfluss mit anschließender inverser Uferfiltration auf. Ausgehend von einem Datensatz charakteristischer Eigenschaften des Wirkstoffs (Wasserlöslichkeit = 18000 mg/L; DT50 Boden = 77.2 d; KOC =
17855) und einer Berechnung der zu erwartenden Einträge mit dem Modell Exposit 3.1 sind
nach dem Stand der wissenschaftlichen Erkenntnisse die Vorgaben der Anwendungsbestimmung NG 404 einzuhalten, um einen ausreichenden Schutz des Grundwassers vor Rückständen des Wirkstoffs Glyphosat (Konzentration im Grundwasser < 0,1 µg/L) zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft
Registration Report zu entnehmen (Kapitel IV, 2.2/Sektion 5, Kapitel 5.6.).
(NT103)
Die Anwendung des Mittels muss in einer Breite von mindestens 20 m zu angrenzenden Flächen (ausgenommen landwirtschaftlich oder gärtnerisch genutzte Flächen, Straßen, Wege
und Plätze) mit einem verlustmindernden Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 90 % eingetragen ist. Bei der
Anwendung des Mittels ist der Einsatz verlustmindernder Technik nicht erforderlich, wenn
die Anwendung mit tragbaren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z.
B. Feldraine, Hecken, Gehölzinseln) weniger als 3 m breit sind oder die Anwendung des Mittels in einem Gebiet erfolgt, das von der Biologischen Bundesanstalt im "Verzeichnis der
regionalisierten Kleinstrukturanteile" vom 7. Februar 2002 (Bundesanzeiger Nr. 70a vom 13.
April 2002) in der jeweils geltenden Fassung, als Agrarlandschaft mit einem ausreichenden
Anteil an Kleinstrukturen ausgewiesen worden ist.
Begründung:
Das Pflanzenschutzmittel Tender GB Ultra bzw. der darin enthaltene Wirkstoff Glyphosat
SEITE 15 VON 19
BVL_FO_05_2437_200_V1.3
weist ein hohes Gefährdungspotenzial für terrestrische Nichtzielpflanzen auf. Bewertungsbestimmend ist hier die ER50 > 146 g a.s./ha (Vegetative vigour). Ausgehend von den geltenden Modellen zur Abdrift und einem Sicherheitsfaktor von 15 ist nach dem Stand der wissenschaftlichen Erkenntnisse die Anwendungsbestimmung NT 103 erforderlich, um einen ausreichenden Schutz von terrestrischen Nichtzielpflanzen in Saumbiotopen vor Auswirkungen des
Mittels Tender GB Ultra zu gewährleisten. Weitere Informationen hierzu sind dem nationalen
Addendum zum Part B des Draft Registration Report zu entnehmen (Kapitel IV, 6/9/Sektion
6, Kapitel 6.8.1.1).
SEITE 16 VON 19
1
Anwendungsgebiet
Schadorganismus/Zweckbestimmung: Einkeimblättrige Unkräuter, Zweikeimblättrige Unkräuter, Holzgewächse
Verwendungszweck:
2
2.1
Einsatzgebiet:
Nichtkulturland
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
1
1
Anwendungstechnik:
- Erläuterungen:
streichen
zur gezielten Einzelpflanzenbehandlung
Aufwand:
-
33 %
- Erläuterungen:
maximaler Mittelaufwand 10 l/ha
2.2
BVL_FO_05_2437_200_V1.3
(NS660-1)
(NW642-1)
(WH914)
SEITE 17 VON 19
2.3
(N)
Wartezeiten
Freiland: Nichtkulturland ohne Holzgewächse
BVL_FO_05_2437_200_V1.3
3
- keine -
SEITE 18 VON 19
Anlage 2 nicht zugelassene Anwendung: 043981-00/00-004
1
Anwendungsgebiet
Verwendungszweck:
2
Einsatzgebiet:
Nichtkulturland
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
1
1
Anwendungstechnik:
spritzen
Aufwand:
3
Begründung
BVL_FO_05_2437_200_V1.3
Naturhaushalt.
Die Prüfung des oben genannten Pflanzenschutzmittels hat ergeben, dass für die Anwendung -004 die Zulassungsvoraussetzungen gemäß Artikel 29 Absatz 1 Buchst. e i.V.m. Artikel
4 Absatz 3 Buchst. e der Verordnung (EG) Nr. 1107/2009 nicht erfüllt sind.
a) Grundwasser
Potenzial für Einträge in das Grundwasser über den Pfad Oberflächenabfluss mit anschließender inverser Uferfiltration auf. Ausgehend von einem Datensatz charakteristischer Eigenschaften des Wirkstoffs (Wirkstoffs (Wasserlöslichkeit = 18000 mg/L; DT50 Boden = 77.2 d;
KOC = 17855) und einer Berechnung der zu erwartenden Einträge mit dem Modell Exposit
3.1 können Konzentration im Grundwasser > 0,1 µg/L auch bei Ausschöpfung aller praktikablen Risikominderungsmaßnahmen nicht ausgeschlossen werden. Unvertretbare Auswirkungen auf das Grundwasser infolge der bestimmungsgemäßen und sachgerechten Anwendung
von Tender GB Ultra sind somit nicht auszuschließen. Weitere Informationen hierzu sind dem
Bewertungsbericht/nationalen Addendum zum Part B des Draft Registration Report zu entnehmen (Kapitel IV, 2.2/Sektion 5, Kapitel 5.6).
b) Säugetiere
Gefährdungspotential für Vögel und Säugetiere auf. Bewertungsbestimmend ist hier die
SEITE 19 VON 19
BVL_FO_05_2437_200_V1.3
NOAEL 50 mg/kg bw/day. Ausgehend von den Modellen der Exposition gemäß dem "Guidance Document on Risk 6 Assessment for Birds & Mammals on request from EFSA", EFSA
Journal 2009; 7(12):1438 wird das Akzeptabilitätskriterium TER =>10 (für Feld- und Waldmaus modifiziert auf 5) gemäß Verordung (EU) Nr. 546/2011 Anhang, Teil C Entscheidungsverfahren, 2. Spezielle Grundsätze, Punkt 2.5.2.1 für akute Effekte bzw. TER =>5 (für Feldund Waldmaus modifiziert auf 2) gemäß Anhang, Teil C Entscheidungsverfahren, 2. Spezielle Grundsätze, Punkt 2.5.2.1 für langfristige Effekte auch bei Ausschöpfung der möglichen
Verfeinerungsoptionen nicht erreicht. Unvertretbare Auswirkungen auf Vögel und Säugetiere
infolge der bestimmungsgemäßen und sachgerechten Anwendung von "Tender GB Ultra"
sind somit nicht auszuschließen. Weitere Informationen sind dem nationalen Addendum zum
Part B des Registration Reports zu entnehmen (Sektion 6, Kapitel 6.2 und 6.3).
Part B – Section 1
Core Assessment –
Germany
Tender GB Ultra / MON78708
Page 1 of 28
REGISTRATION REPORT
Part B
Section 1: Identity, physical and chemical
properties, other information
Detailed summary of the risk assessment
Product code:
Tender GB Ultra
(MON 78708)
Active Substance:
Glyphosate 360 g/L
Central Zone
Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant:
Date:
Monsanto Europe SA
24/03/2014
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 2 of 28
Table of Contents
IIIA 1
IDENTITY OF THE PLANT PROTECTION PRODUCT ..........................................7
IIIA 1.1
Applicant............................................................................................................................7
IIIA 1.2
Manufacturer of the Preparation, Manufacturer and Purity of the Active
Substance(s) .......................................................................................................................7
IIIA 1.2.1
Manufacturer(s) of the preparation ................................................................................7
IIIA 1.2.2
Manufacturer(s) of the active substance(s) .....................................................................7
IIIA 1.2.3
Statement of purity (and detailed information on impurities) of the active
substance(s)........................................................................................................................7
IIIA 1.3
Trade Names and Manufacturer’s Code Numbers for the Preparation......................7
IIIA 1.4
Detailed Quantitative and Qualitative Information on the Composition of the
Preparation ........................................................................................................................8
IIIA 1.4.1
Content of active substance and formulants...................................................................8
IIIA 1.4.2
Certified limits of each component ..................................................................................8
IIIA 1.4.3
Common names and code numbers for the active substance(s)....................................9
IIIA 1.4.4
Co-formulant details: identity, structure, codes, trade name, specification and
function...............................................................................................................................9
IIIA 1.4.5
Formulation process..........................................................................................................9
IIIA 1.4.5.1
Description of formulation process..................................................................................9
IIIA 1.4.5.2
Discussion of the formation of impurities of toxicological concern ..............................9
IIIA 1.5
Type of Preparation and Code.........................................................................................9
IIIA 1.6
Function .............................................................................................................................9
IIIA 1.7
Other/Special Studies......................................................................................................10
IIIA 2
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT
PROTECTION PRODUCT ...........................................................................................11
IIIA 2.16
Summary and Evaluation of Data Presented Under Points 2.1 to 2.15......................11
IIIA 3
DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT.............12
IIIA 3.1
Field of Use.......................................................................................................................12
IIIA 3.2
Nature of the Effects on Harmful Organisms...............................................................12
IIIA 3.3
Details of Intended Use ...................................................................................................12
IIIA 3.3.1
Details of existing and intended uses .............................................................................12
IIIA 3.3.2
Details of harmful organisms against which protection is afforded ...........................12
IIIA 3.3.3
Effects achieved ...............................................................................................................12
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 3 of 28
IIIA 3.4
Proposed Application Rates (Active Substance and Preparation)..............................12
IIIA 3.5
Concentration of the Active Substance in the Material Used......................................12
IIIA 3.6
Method of Application, Type of Equipment Used and Volume of Diluent ................12
IIIA 3.7
Number and Timings of Applications, Timing, Growth Stages (of Crop and
Harmful Organism) and Duration of Protection..........................................................12
IIIA 3.7.1
Maximum number of applications and their timings ..................................................12
IIIA 3.7.2
Growth stages of crops or plants to be protected .........................................................12
IIIA 3.7.3
Development stages of the harmful organism concerned ............................................13
IIIA 3.7.4
Duration of protection afforded by each application...................................................13
IIIA 3.7.5
Duration of protection afforded by the maximum number of applications...............13
IIIA 3.8
Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on
Succeeding Crops ............................................................................................................13
IIIA 3.8.1
Minimum waiting periods or other precautions between last application and sowing
or planting succeeding crops ..........................................................................................13
IIIA 3.8.2
Limitations on choice of succeeding crops ....................................................................13
IIIA 3.8.3
Description of damage to rotational crops ....................................................................13
IIIA 3.9
Proposed Instructions for Use as Printed on Labels ....................................................13
IIIA 3.10
IIIA 4
FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT .........14
IIIA 4.1
Packaging and Compatibility with the Preparation ....................................................14
IIIA 4.1.1
Description and specification of the packaging ............................................................14
IIIA 4.1.2
Suitability of the packaging and closures......................................................................15
IIIA 4.1.3
Resistance of the packaging material to its contents....................................................15
IIIA 4.2
Procedures for Cleaning Application Equipment ........................................................15
IIIA 4.2.1
Procedures for cleaning application equipment and protective clothing...................15
IIIA 4.2.2
Effectiveness of the cleaning procedures.......................................................................15
IIIA 4.3
Re-entry Periods to Protect Man, Livestock and the Environment............................15
IIIA 4.3.1
Pre-harvest interval (in days) for each relevant crop ..................................................15
IIIA 4.3.2
Re-entry period (in days) for livestock, to areas to be grazed.....................................15
IIIA 4.3.3
Re-entry period (in hours or days) for man to crops, buildings or spaces treated....15
IIIA 4.3.4
Withholding period (in days) for animal feeding stuffs ...............................................16
IIIA 4.3.5
Waiting period (in days) between application and handling of treated products .....16
IIIA 4.3.6
Waiting period (in days) between last application and sowing or planting succeeding
crops .................................................................................................................................16
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 4 of 28
IIIA 4.3.7
Information on specific conditions under which the preparation may or may not be
used ...................................................................................................................................16
IIIA 4.4
Statement of the Risks Arising and the Recommended Methods and Precautions
and Handling Procedures to Minimise Those Risks ....................................................16
IIIA 4.4.1
Warehouse storage ..........................................................................................................16
IIIA 4.4.2
User level storage.............................................................................................................16
IIIA 4.4.3
Transport .........................................................................................................................17
IIIA 4.4.4
Fire....................................................................................................................................17
IIIA 4.4.5
Nature of protective clothing proposed.........................................................................17
IIIA 4.4.6
Characteristics of protective clothing proposed ...........................................................17
IIIA 4.4.7
Suitability and effectiveness of protective clothing and equipment............................17
IIIA 4.4.8
Procedures to minimise the generation of waste ..........................................................17
IIIA 4.4.9
Combustion products likely to be generated in the event of fire ................................18
IIIA 4.5
Detailed Procedures for Use in the Event of an Accident During Transport, Storage
or Use................................................................................................................................18
IIIA 4.5.1
Containment of spillages.................................................................................................18
IIIA 4.5.2
Decontamination of areas, vehicles and buildings........................................................18
IIIA 4.5.3
Disposal of damaged packaging, adsorbents and other materials ..............................18
IIIA 4.5.4
Protection of emergency workers and bystanders .......................................................18
IIIA 4.5.5
First aid measures ...........................................................................................................19
IIIA 4.6
Neutralisation Procedure for Use in the Event of Accidental Spillage.......................19
IIIA 4.6.1
Details of proposed procedures for small quantities....................................................20
IIIA 4.6.2
Evaluation of products of neutralization (small quantities) ........................................20
IIIA 4.6.3
Procedures for disposal of small quantities of neutralized waste ...............................20
IIIA 4.6.4
Details of proposed procedures for large quantities ....................................................20
IIIA 4.6.5
Evaluation of products of neutralization (large quantities) ........................................20
IIIA 4.6.6
Procedures for disposal of large quantities of neutralized waste................................20
IIIA 4.7
Pyrolytic Behaviour of the Active Substance................................................................20
IIIA 4.8
Disposal Procedures for the Plant Protection Product ................................................20
IIIA 4.8.1
Detailed instructions for safe disposal of product and its packaging .........................20
IIIA 4.8.2
Methods other than controlled incineration for disposal ............................................21
IIIA 4.9
IIIA 11
FURTHER INFORMATION.........................................................................................21
IIIA 11.1
Information of Authorisations in Other Countries ......................................................21
IIIA 11.2
Information on Established Maximum Residue Limits (MRL) in Other Countries 21
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 5 of 28
IIIA 11.3
Justified Proposals for Classification and Labelling....................................................21
IIIA 11.4
Proposals for Risk and Safety Phrases ..........................................................................23
IIIA 11.5
Proposed Label ................................................................................................................23
IIIA 11.6
Specimens of Proposed Packaging.................................................................................23
Appendix 1:
List of data used in support of the evaluation...............................................................24
Appendix 2:
Critical Uses – justification and GAP tables.................................................................25
Appendix 3:
Experimental testing of the product's physico-chemical and technical
characteristics:.................................................................................................................28
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 6 of 28
Introduction
This document summarises the information related to the identity, the physical and chemical properties,
the data on application, further information and the classification for the product Tender GB Ultra, a
soluble concentrate formulation containing 360 g/l glyphosate acid which was approved according to
Regulation (EC) No 1107/2009.
This product was not the representative formulation. The product has not been previously evaluated
according to Uniform Principles.
The formulation composition of MON 78708 is based on that of MON 52276. The only difference in
composition is that MON 78708 contains 29 ppm (0.0029%) of a blue, food-approved dye. Since this dye
is approved for use in foodstuffs, its inclusion in MON 78708 is not considerer to have any impact on the
toxicological properties of MON 78708 versus those of the parent formulation MON 52276. Information
on the detailed compositions of MON 78707 and MON 52276 can be found in the confidential dossier of
this submission (Registration Report - Part C).
Where appropriate this document refers to the conclusions of the EU review of glyphosate acid. This will
be where:
the active substance data are relied upon in the risk assessment of the formulation; or when
the EU review concluded that additional data/information should be considered at national re-registration.
The key documents from the EU review of glyphosate acid (2001/99/EC) is considered to provide the
relevant review information or a reference to where such information can be found. This Part B document
only reviews data (Annex II or Annex III) and additional information that has not previously been
considered within the EU review process, as part of the Annex I inclusion decision.
The following table provides the EU endpoints to be used in the evaluation.
Agreed EU End-points
End-Point
Glyphosate
(Reg. (EU) No 540/2011)
Purity of active substance
min 950 g/kg
The Annex I Inclusion Directives for glyphosate acid (2001/99/EC) provide specific provisions under Part
B which need to be considered by the applicant in the preparation of their submission and by the MS prior
to granting an authorisation (see Part A of this submission). However, these provisions do not pertain the
information given for the product Tender GB Ultra in this section.
Appendix 1 of this document contains the list of references included in this document for support of the
evaluation. Appendix 2 of this document is the table of intended uses for Tender GB Ultra.
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 7 of 28
Information on the detailed composition of Tender GB Ultra can be found in the confidential dossier of
IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT
IIIA 1.1
Applicant
Monsanto Europe S.A.
Avenue de Tervuren 270-272
B-1150 Brussels, Belgium
Contact person:
Richard Garnett
Tel.No.:
+32 02-776.76.14
Fax No:
+32 02-776.76.42
e-mail:
[email protected]
IIIA 1.2
Manufacturer of the Preparation, Manufacturer and Purity of the Active
Substance(s)
IIIA 1.2.1
Manufacturer(s) of the preparation
Confidential information - data provided separately (Part C).
IIIA 1.2.2
Manufacturer(s) of the active substance(s)
Confidential information - data provided separately (Part C).
IIIA 1.2.3
Statement of purity (and detailed information on impurities) of the active
substance(s)
Glyphosate:
minimum
950 g/kg
Further information/justification is provided in Part C.
IIIA 1.3
Trade Names and Manufacturer’s Code Numbers for the Preparation
Trade name:
Tender GB Ultra
Company code number:
MON 78708
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 8 of 28
IIIA 1.4
Detailed Quantitative and Qualitative Information on the Composition of the
Preparation
IIIA 1.4.1
Content of active substance and formulants
The formulation was not the representative formulation.
Pure active substance:
content of pure glyphosate:
360 g/L
limits glyphosate (according to applicant)
351 - 374 g/L
limits glyphosate (according FAO/WHO manual, 2010)
342 – 378 g/L
content of pure isopropylamine salt:
486 g/L
Technical active substance:
content of technical Isopropylamine salt of 511.5 g/L
glyphosate
(43.87 % w/w)
at minimum purity (95.0 %):
Further information on the active substances and on the certified limits of formulants is considered
confidential and is provided separately (Part C).
IIIA 1.4.2
Certified limits of each component
This is not an EC data requirement/ not required by regulation (EU) 2011/545.
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
IIIA 1.4.3
Page 9 of 28
Common names and code numbers for the active substance(s)
Data
Point
Type
Name/Code Number
1.4.3.1
ISO common name
Glyphosate
1.4.3.2
CAS No.
1071-83-6
1.4.3.2
EINECS No.
213-997-4
1.4.3.2
CIPAC No.
284
1.4.3.2
ELINCS
-
1.4.3.3
Salt, ester anion or cation
present
Isopropylamine salt
IIIA 1.4.4
Co-formulant details: identity, structure, codes, trade name, specification
and function.
CONFIDENTIAL information - data provided separately (Part C).
IIIA 1.4.5
Formulation process
IIIA 1.4.5.1
Description of formulation process
This is not an EC data requirement/ not required regulation (EU) 2011/545.
IIIA 1.4.5.2
Discussion of the formation of impurities of toxicological concern
According to FAO specifications 2000/2001 for technical glyphosate acid the relevant impurities and
maximum concentrations are:
• Formaldehyde: maximum 1.3 g/kg of the glyphosate acid content
• N- Nitrosoglyphosate: maximum 1.0 mg/kg
• Insolubles in 1 M NaOH: maximum 0.2 g/kg
IIIA 1.5
Type of Preparation and Code
Type : soluble concentrate
IIIA 1.6
Code : SL
Function
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 10 of 28
The product will be used as a herbicide.
IIIA 1.7
Other/Special Studies
None.
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
IIIA 2
Page 11 of 28
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE
PLANT PROTECTION PRODUCT
Tender GB Ultra (MON 78708) was not the representative formulation. MON 52276 was one of the
representative formulations. MON 52276 is very similar to Tender GB Ultra with exception of colour. So
the physical properties of MON 78708 are identical to those of MON52276 as descriped in the monograph of
glyphosate.
Tabelle 1: Summary of the physical, chemical and technical properties of the plant protection
product
Test or study
&
Annex
point
Metho
d
used
Colour, odour
and physical
state
(IIIA 2.1)
IIIA 2.16
Test
material
purity
and
specification
Findings
Referen
ce
Acceptability
comments
MON 78708
blue liquid with aminelike
odour,
Safety
data
sheet
Acceptable
/
Summary and Evaluation of Data Presented Under Points 2.1 to 2.15
The product MON 78708 is a soluble concentrate. All necessary studies have been conducted with the
formulation MON 52276, the conclusions apply fully to MON 78708.
MON 78708 is a blue-green homogeneous liquid. It is not explosive, has no oxidising properties and a self
ignition temperature of 440 °C. In aqueous solution, it has a pH value of 4.8. The stability data indicate a
shelf life of at least 2 years at ambient temperature. Its technical characteristics are acceptable for a soluble
concentrate formulation.
Experimental testing of the product's physico-chemical and technical characteristics:
See Annex 3.
Implications for labelling:
MON 78708 is not classified as hazardous due to its physical and chemical properties.
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 12 of 28
IIIA 3
DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT
IIIA 3.1
Field of Use
The application was for approval of MON 78708, a water soluble concentrate (SL) formulation
containing 360 g a.s./L) glyphosate for use as a herbicide on non cultivated areas for the control of
monocotyledonous weeds, dicotyledonous weeds and woody plants.
IIIA 3.2
Nature of the Effects on Harmful Organisms
In plants, glyphosate inhibits the shikimic acid pathway. Glyphosate binds to and blocks the activity of its
target enzyme EPSPS (5-enolpyruvylshikimate-3-phosphate synthase), an enzyme of the aromatic amino
acid biosynthetic pathway. The inhibition of the enzyme prevents the plant from synthesizing the essential
aromatic amino acids (e.g. phenylalanine, tyrosine, and tryptophan) needed for protein biosynthesis. This
reduces the production of protein in the plant, and inhibits plant growth. EPSPS is present in all plants. It
leads to an accumulation of the amino acids glutamine, glutamic acid, shikimic acid and ammonia. As a
consequence of missing aromatic amino acids the formation of phenolic compounds is inhibited (e.g.
lignin, flavanoids) (HRAC-classification G).
IIIA 3.3
Details of Intended Use
IIIA 3.3.1
Details of existing and intended uses
Glyphosate was first registered in Germany in the mid -1970’s. It is extensively registered
throughout the world for a wide range of uses at a range of dose rates. For intended uses please
refer to Appendix 2: Critical Uses – justification and GAP tables.
IIIA 3.3.2
Details of harmful organisms against which protection is afforded
Please refer to Appendix 2 and Part B Section 7.
IIIA 3.3.3
Effects achieved
Please refer to Part B Section 7.
IIIA 3.4
Proposed Application Rates (Active Substance and Preparation)
IIIA 3.5
Concentration of the Active Substance in the Material Used
IIIA 3.6
Method of Application, Type of Equipment Used and Volume of Diluent
IIIA 3.7
Number and Timings of Applications, Timing, Growth Stages (of Crop and
Harmful Organism) and Duration of Protection
IIIA 3.7.1
Maximum number of applications and their timings
IIIA 3.7.2
Growth stages of crops or plants to be protected
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 13 of 28
IIIA 3.7.3
Development stages of the harmful organism concerned
IIIA 3.7.4
Duration of protection afforded by each application
Please refer Part B Section 7.
IIIA 3.7.5
Duration of protection afforded by the maximum number of applications
IIIA 3.8
Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects
on Succeeding Crops
IIIA 3.8.1
Minimum waiting periods or other precautions between last application and
sowing or planting succeeding crops
IIIA 3.8.2
Limitations on choice of succeeding crops
IIIA 3.8.3
Description of damage to rotational crops
IIIA 3.9
Proposed Instructions for Use as Printed on Labels
Please refer to Registration Report – Part A, Appendix 2 for the relevant country.
IIIA 3.10
This is not an EC data requirement/ not required by Directive 91/414/EEC.
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 14 of 28
IIIA 4
FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT
IIIA 4.1
Packaging and Compatibility with the Preparation
Packaging Summary
Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,
leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents
of the packaging, have been submitted, evaluated and is considered to be acceptable.
IIIA 4.1.1
Description and specification of the packaging
Tender GB Ultra(MON 78708) is to be marketed in high-density polyethylene containers.
1 litre bottle:
5, 10, 20
container:
material:
HDPE
shape/size:
Round and rectangular
opening:
63 mm diameter
closure:
HDPE Screw cap top with induction seal
litre material:
640, 1000 litre IBC:
HDPE
shape/size:
Rectangular
opening:
5 L and 10 L: 63 mm diameter
20 L: 61 mm diameter
closure:
HDPE screw cap
seal:
5 L and 10 L: HDPE Screw cap with induction seal
20 L: HDPE screw cap with foam seal
material:
HDPE
shape/size:
Rectangular, rigid IBC
opening:
150 mm diameter
closure:
HDPE screw cap
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
IIIA 4.1.2
Page 15 of 28
Suitability of the packaging and closures
A 1.0 litre HDPE commercial pack was tested in the physical and chemical properties and storage stability
tests. At the start of the test, after 14 days accelerated storage, and after 1 and 2 years storage at room
temperature the packaging material showed no deterioration, had not been altered by the test item, and there
was no sign of contamination on the outer surface or of leakage during shaking or turning. This small pack
is of the same material as the larger packs and is considered representative of the complete range of
packaging.
All the containers listed in 4.1.1 are UN approved for substances which are non-classified. MON 78708 is
not classified for transport following ADR regulations.
IIIA 4.1.3
Resistance of the packaging material to its contents
The product was visually checked for influence on the original container after 24 month storage in
accordance to EC regulations and in compliance with GLP principles. The product had no adverse effects
on the container, seal and closure after 24 months storage at room temperature.
Package: 1 L HDPE bottle.
Weight loss after 24 month: not significant.
IIIA 4.2
Procedures for Cleaning Application Equipment
IIIA 4.2.1
Procedures for cleaning application equipment and protective clothing
It is essential to thoroughly clean out the entire equipment and protective clothing: sprayer system, using a
detergent cleaner.
IIIA 4.2.2
Effectiveness of the cleaning procedures
Common agricultural practice implies cleaning of application equipment with water. This will remove any
remainders of BAS 512 00 F so efficiently that no plant damage can be caused when the equipment is used
subsequently for the treatment of different crops. The product is soluble in water. It can be removed from
surfaces with water. Study report of rinsing of containers supplied in the Annex II dossier.
Protective clothing will be cleaned effectively when washed with usual laundry detergents.
IIIA 4.3
Re-entry Periods to Protect Man, Livestock and the Environment
IIIA 4.3.1
Pre-harvest interval (in days) for each relevant crop
See section 4.
IIIA 4.3.2
Re-entry period (in days) for livestock, to areas to be grazed
See section 4.
IIIA 4.3.3
Re-entry period (in hours or days) for man to crops, buildings or spaces
treated
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 16 of 28
See section 4.
IIIA 4.3.4
Withholding period (in days) for animal feeding stuffs
See section 4.
IIIA 4.3.5
Waiting period (in days) between application and handling of treated
products
See section 4.
IIIA 4.3.6
Waiting period (in days) between last application and sowing or planting
succeeding crops
See section 4.
IIIA 4.3.7
Information on specific conditions under which the preparation may or may
not be used
See section 4.
IIIA 4.4
Statement of the Risks Arising and the Recommended Methods and
Precautions and Handling Procedures to Minimise Those Risks
Report:
Anonymous, 2009
Title:
Safety data sheet – MON 78708
Document No:
2246023
Guidelines:
EEC 1907/2006
GLP
No, not subject to GLP regulations
The safety data sheet complies with actual EEC regulations and is based on the present state of
knowledge.
Good industrial practice in housekeeping and personal hygiene should be followed.
Information on safe handling:
Avoid contact with eyes
When using do not eat, drink or smoke
Wash hands thoroughly after handling or contact
Thoroughly clean equipment after use
Do not contaminate drains, sewers and waterways when disposing of equipment rinse water
Emptied containers retain vapour and product residue
Observe all labelled safeguards until container is cleaned, reconditioned or destroyed
IIIA 4.4.1
Warehouse storage
Storage temperature (minimum - maximum): (-15°C) – (50°C).
Compatible materials for storage: stainless steel, aluminium, fibre-glass, glass lining
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 17 of 28
Incompatible materials for storage: galvanized steel, unlined mild steel
Keep only in the original container
Partial crystallization may occur on prolonged storage below the minimum storage temperature
If frozen, place in warm room and shake frequently to put back into solution.
Minimum shelf life: 2 years
IIIA 4.4.2
User level storage
Keep out of the reach of children.
Keep away from food, drink and animal feed.
See AIII, 4.4.1.
IIIA 4.4.3
Transport
The data provided in this section is for information only. Please apply the appropriate regulations to
properly classify your shipment for transportation.
Not regulated for transport.
IIIA 4.4.4
Fire
Extinguishing media:
Recommended: water, foam, dry chemical, carbon dioxide (CO2)
Unusual fire and explosion hazards:
Minimise use of water to prevent environmental contamination.
Environmental precautions see AIII 4. 5
Hazardous products of combustion:
Carbon monoxide (CO), phosphorus oxides (PxOy), nitrogen oxides (NOx)
Fire fighting equipment:
Self-contained breathing apparatus
Equipment should be thoroughly decontaminated after use.
IIIA 4.4.5
Nature of protective clothing proposed
If products are handled while not enclosed, and if skin contact may occur:
Respiratory protection: no special requirement when used as recommended
Skin protection: If repeated or prolonged contact: wear chemical resistant gloves
Wear chemical resistant clothing/footwear
Eye protection: no special requirement when used as recommended
When recommended, consult manufacturer of personal protective equipment for the appropriate type of
equipment for a given application
IIIA 4.4.6
Characteristics of protective clothing proposed
Gloves: impermeable to water.
IIIA 4.4.7
Suitability and effectiveness of protective clothing and equipment
See AIII, TII, Section 3, point 7.3 Operator Exposure.
IIIA 4.4.8
Procedures to minimise the generation of waste
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 18 of 28
Only purchase and store quantities of product required in order to reduce waste in the short term. Do not
open larger containers than is necessary for immediate requirements. Do not mix a volume of spray solution
greater than is required for immediate use.
IIIA 4.4.9
Combustion products likely to be generated in the event of fire
In the event of fire, the formation of phosphorous oxide, carbon monoxide and nitrogen oxides must be
anticipated. (See 4.4.4)
IIIA 4.5
Detailed Procedures for Use in the Event of an Accident During Transport,
Storage or Use
Personal precautions
Use personal protection recommended in AIII 4.4.5.
Environmental precautions
Small quantities: Low environmental hazard.
Large quantities: Minimise spread.
Keep out of drains, sewers, ditches and water ways.
Notify authorities.
Methods for cleaning up
Absorb in earth, sand or absorbent material
Dig up heavily contaminated soil
Collect in containers for disposal
Flush residues with small quantities of water
Minimise use of water to prevent environmental contamination
IIIA 4.5.1
Containment of spillages
Spillage is not expected to occur with this formulation.
Small quantities: Flush spill area with water
Large quantities: Absorb in earth, sand or absorbent material.
Dig up heavily contaminated soil.
Collect in containers for disposal.
Flush residues with small quantities of water.
Minimize use of water to prevent environmental contamination.
IIIA 4.5.2
Decontamination of areas, vehicles and buildings
See AIII, 4.5.1.
IIIA 4.5.3
Disposal of damaged packaging, adsorbents and other materials
Product
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 19 of 28
Recycle if appropriate facilities/equipment available.
Dispose of hazardous industrial waste.
Burn in proper incinerator.
Burn in special controlled high temperature incinerator.
Follow all local/regional/national/international regulations
Containers
See the individual container label for disposal information
Empty packaging completely
Triple or pressure rinse empty containers
Pour rinse water into spray tank
Ensure packaging cannot be reused
Do NOT re-use containers
Store for collection by approved waste disposal service
Recycle if appropriate facilities/equipment available
IIIA 4.5.4
Protection of emergency workers and bystanders
Use the personal protective equipment proposed/ recommended.
IIIA 4.5.5
First aid measures
Eye contact:
Immediately flush with plenty of water.
If easy to do, remove contact lenses.
If there are persistent symptoms, obtain medical advice
Skin contact:
Take off contaminated clothing, wristwatch, jewellery
Wash affected skin with plenty of water
Wash clothes and clean shoes before re-use
Inhalation
Remove to fresh air
Ingestion
Immediately offer water to drink
Do NOT induce vomiting unless directed by medical personnel
If symptoms occur, get medical attention
Advice to doctors
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 20 of 28
This product is not an inhibitor of cholinesterase.
Antidote
Treatment with atropine and oximes is not indicated.
IIIA 4.6
Neutralisation Procedure for Use in the Event of Accidental Spillage
See procedures to minimize the generation of waste (4.4.8).
IIIA 4.6.1
Details of proposed procedures for small quantities
IIIA 4.6.2
Evaluation of products of neutralization (small quantities)
IIIA 4.6.3
Procedures for disposal of small quantities of neutralized waste
IIIA 4.6.4
Details of proposed procedures for large quantities
IIIA 4.6.5
Evaluation of products of neutralization (large quantities)
IIIA 4.6.6
Procedures for disposal of large quantities of neutralized waste
IIIA 4.7
Pyrolytic Behaviour of the Active Substance
Complete pyrolysis of glyphosate occurs after 15 minutes at 800°C. The major product is carbon dioxide,
other volatiles included acetonitrile, alkylpyrazines and alkylpyridines. Data submitted in the Annex II
dossier on glyphosate.
IIIA 4.8
Disposal Procedures for the Plant Protection Product
IIIA 4.8.1
Detailed instructions for safe disposal of product and its packaging
Product
Recycle if appropriate facilities/equipment available.
Dispose of hazardous industrial waste.
Burn in proper incinerator.
Burn in special controlled high temperature incinerator.
Containers
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 21 of 28
See the individual container label for disposal information
Empty packaging completely
Triple or pressure rinse empty containers
Pour rinse water into spray tank
Ensure packaging cannot be reused
Do NOT re-use containers
Store for collection by approved waste disposal service
Recycle if appropriate facilities/equipment available
IIIA 4.8.2
Methods other than controlled incineration for disposal
Collect in dry containers and close securely. Dig up heavily contaminated soil and place in drums. Flush
spill area with water.
IIIA 4.9
No additional studies were performed.
IIIA 11
FURTHER INFORMATION
IIIA 11.1
Information of Authorisations in Other Countries
throughout the world for a wide range of uses at a range of dose rates.
IIIA 11.2
Information on Established Maximum Residue Limits (MRL) in Other
Countries
MRLs set at European Level are stated in the Regulation (EC) No 396/2005 (see: EU Pesticides database,
as published on June 8, 2010, Internet: http://ec.europa.eu/sanco_pesticides/public/
index.cfm).
IIIA 11.3
Justified Proposals for Classification and Labelling
Proposals for classification and labelling of MON 78708 in accordance with the EC Directive on
dangerous preparations 1999/45/EC and Directive 2001/59/EC (as amended) are presented below:
Physico-chemical properties
Table 11.3-1
Study Type
Findings
Reference
(triggered risk phrase)
Explosivity
Not explosive (-)
Alexander, Harper, Dinwoodie,
MacLean, 1992,
2246149
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Table 11.3-1
Page 22 of 28
Study Type
Findings
Reference
Oxidizing
properties
Not oxidizing (-)
Krips, 1995,
2246151
Flammability
Auto-ignition temperature is 440°C
Alexander, Harper, Dinwoodie,
MacLean, 1992,
2246291
Content of
hydrocarbon
< 10 %
Toxicology
Table 11.3-2
Toxicology
Study Type
Results
Reference
Acute oral
LD50 > 5000 mg/kg bw (rat)
Blaszcak, D. L.; 1991
Acute dermal
LD50 > 5000 mg/kg bw (rat)
Acute inhalation
Not submitted, not necessary. Justification presented in Annex 2.
Skin irritation
Non-irritant (rabbit)
Eye irritation
Non-irritant (rabbit)
Skin sensitization
(Buehler Test)
Non-sensitizing (guinea pig)
Griffon, B.; 2001
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 23 of 28
IIIA 11.4
Proposals for Risk and Safety Phrases
Table 11.4-1
Classification proposed
Hazard symbol(s):
None
Indications of danger:
None
Risk phrases:
None
Safety phrases
None
Table 11.4-2
Labelling proposed
Hazard symbol(s):
None
None
Risk phrases:
None
Safety phrases:
None
Additional labelling
phrases:
To avoid risks to man and the environment, comply with the instructions
for use.
IIIA 11.5
Proposed Label
Please refer to Registration Report – Part A.
IIIA 11.6
Specimens of Proposed Packaging
Specimens of the packaging were not provided as there was no request.
.
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 24 of 28
Appendix 1: List of data used in support of the evaluation
Annex
point
Author
Year
-
-
-
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
-
Data
protectio
n claimed
Yes/No
Owner
-
-
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 25 of 28
Appendix 2: Critical Uses – justification and GAP tables
active substance 1
Tender GB Ultra MON78708
Glyphosate
Formulation type:
Conc. of as 1:
safener
synergist
-
Conc. of safener:
Conc. of synergist:
Applicant:
Zone(s): Central Zone
Monsanto Europe SA
professional use
non professional use
SL
360 g/L
(486 g/L glyphosate isopropylamine salt)
-
Verified by MS: yes
1
UseNo.
2
3
Member Crop and/
state(s)
or situation
(crop destination /
purpose of crop)
4
F
G
or
I
5
controlled
(additionally:
6
7
8
10
Application
Method /
Kind
Timing / Growth
stage of crop &
season
11
12
Application rate
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
kg, L product /
ha
g, kg as/ha
Water L/ha
a) max. rate per
appl.
a) max. rate
per appl.
min / max
13
14
PHI Remarks:
(days)
e.g. recommended or
b) max. total rate b) max. total
per crop/season rate per
crop/season
001
DE,
AT
YGLES
Railway tracks
F
TTTMM
spraying
TTTDD
During growing
season
a) 1
b) 1
a) 10.0
b) 10.0
a) 3.6
b) 3.6
500 - 1000
N
WH914
002
DE,
AT
YGLES
Railway tracks
F
TTTMM
spraying
TTTDD
During growing
season
a) 2
b) 2
(3 month(s))
a) 5.0
b) 10.0
a) 1.8
b) 3.6
500 - 1000
N
WH914
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 26 of 28
003
DE,
AT
YGLES
Railway tracks
F
TTTMM
wiping;
During growing
treatment
TTTDD
NNNVP
woody plants
a) 1
b) 1
a) 33 %
b) 33 %
a) 3.6
b) 3.6
10.9
N
WH914
004
DE,
AT
YNKOB
Non-cultivated land
F
TTTMM
spraying
TTTDD
During growing
season
a) 1
b) 1
a) 10.0
b) 10.0
a) 3.6
b) 3.6
500 1000*)
N
WH914
005
DE,
AT
YNKOB
Non-cultivated land
F
TTTMM
spraying
TTTDD
During growing
season
a) 2
b) 2
(3 month(s))
a) 5.0
b) 10.0
a) 1.8
b) 3.6
500 1000*)
N
WH914
006
DE,
AT
YNKOB
Non-cultivated land
F
TTTMM
wiping;
During growing
treatment
TTTDD
NNNVP
woody plants
a) 1
b) 1
a) 33 %
b) 33 %
a) 3.6
b) 3.6
N
WH914
10.9
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Remarks:
Page 27 of 28
(1) Numeration of uses in accordance with the application/as verified by MS
(2)
Member State(s) or zone for which use is applied for
(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, develeopmental stages
(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997,
application
(8) The maximum number of applications possible under practical conditions of use for each single
application and per year (permanent crops) or crop (annual crops) must be provided
(9) Min. interval between applications (days) were relevant
(10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season
must be given in metric units (e.g. kg or L product / ha)
(11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per
crop/season must be given in metric units (e.g.g or kg / ha)
(12) The range (min/max) of water volumn under practical conditions of use must be given (L/ha)
(13) PHI - minimum pre-harvest interval
(14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
Evaluator: BVL / DE
Date: 24/03/2014
Core Assessment –
Germany
Page 28 of 28
Appendix 3: Experimental testing of the product's physico-chemical and technical
characteristics:
The following physical, chemical and technical properties of the plant protection product were
experimentally tested:
density, colour, pH, surface tension, storage stability at high temperatures (14 d at 54 °C), low
temperature stability (7 d at 0 °C), persistent foaming and dilution stability.
No significant deviations from the data submitted by the applicant were detected.
The formulation complies with the chemical, physical and technical criteria which are stated for this type
of formulation in the FAO/WHO manual (2010).
Evaluator: BVL / DE
Date: 24/03/2014
Tender GB Ultra (MON 78708)
Part B Section 2
Core Assessment –
Germany
Registration Report –Central Zone
Page 1 of 13
REGISTRATION REPORT
Part B
Section 2: Analytical Methods
Product code:
Tender GB Ultra
(MON 78708)
Active Substance:
Glyphosate
360 g/L
Central Zone
Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant:
Monsanto Europe S.A.
Date:
24/03/2014
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
Page 2 of 13
Table of Contents
IIIA 5
METHODS OF ANALYSIS.............................................................................................3
IIIA 5.1
Analytical Standards and Samples ..................................................................................3
IIIA 5.1.1
Samples of the preparation...............................................................................................3
IIIA 5.1.2
Analytical standards for the pure active substance .......................................................3
IIIA 5.1.3
Samples of the active substance as manufactured..........................................................4
IIIA 5.1.4
Analytical standards for relevant metabolites and all other components
included in the residue definition.....................................................................................4
IIIA 5.1.5
Samples of reference substances for relevant impurities...............................................4
IIIA 5.2
Methods for the Analysis of the Plant Protection Product ............................................4
IIIA 5.2.1
Description of the analytical methods for the determination of the active
substance in the plant protection product.......................................................................4
IIIA 5.2.2
For preparations containing more than one active substance, description of
method for determining each in the presence of the other ............................................4
IIIA 5.2.3
Applicability of existing CIPAC methods .......................................................................5
IIIA 5.2.4
Description of analytical methods for the determination of relevant impurities.........5
IIIA 5.2.5
Description of analytical methods for the determination of formulants ......................6
IIIA 5.3
Description of Analytical Methods for the Determination of Residues........................6
IIIA 5.3.1
Description of analytical methods for the determination of residues in cropsFehler! Textmarke nic
IIIA 5.3.2
Storage stability of working solutions in analytical methodologyFehler! Textmarke nicht definiert.
IIIA 5.4
Description of Methods for the Analysis of Soil ........ Fehler! Textmarke nicht definiert.
IIIA 5.5
Description of Methods for the Analysis of SedimentFehler! Textmarke nicht definiert.
IIIA 5.6
Description of Methods for the Analysis of Water.... Fehler! Textmarke nicht definiert.
IIIA 5.7
Description of Methods for the Analysis of Air ......... Fehler! Textmarke nicht definiert.
IIIA 5.8
Description of Methods for the Analysis of Body Fluids and TissuesFehler! Textmarke nicht definie
IIIA 5.9
Other/Special Studies................................................... Fehler! Textmarke nicht definiert.
Appendix 1 – List of data submitted in support of the evaluation........................................................11
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
IIIA 5
Page 3 of 13
METHODS OF ANALYSIS
This document summarises the information related to the analytical methods for the product Tender GB
Ultra (MON 78708) containing 360 g/l glyphosate (486 g/L as isopropylamine salt) which was approved
according to Regulation (EC) No 1107/2009.
This product was not the representative formulation. The product has not been previously evaluated
according to Uniform Principles.
Where appropriate this document refers to the conclusions of the EU review of glyphosate. This will be
where:
• the active substance data are relied upon in the risk assessment of the formulation; or when
• the EU review concluded that additional data/information should be considered at national reregistration.
The key documents from the EU review of glyphosate acid (2001/99/EC) are considered to provide the
relevant review information or a reference to where such information can be found. This Part B document
only reviews data (Annex II or Annex III) and additional information that has not previously been
considered within the EU review process, as part of the Annex I inclusion decision.
The Annex I Inclusion Directives for glyphosate acid (2001/99/EC) provide specific provisions under Part
B which need to be considered by the applicant in the preparation of their submission and by the MS prior
to granting an authorisation (see Part A of this submission). However, these provisions do not pertain the
methods of analysis of the active ingredients and the authorization of the product Tender GB Ultra (MON
78708).
Appendix 1 of this document contains the list of references included in this document for support of the
evaluation.
Information on the detailed composition of Tender GB Ultra (MON 78708) can be found in the
confidential dossier of this submission (Registration Report - Part C).
composition is that MON 78708 contains 29 ppm (0.0029%) of a blue, food-approved dye. The inclusion
of this dye in MON 78708 is not considered to have any impact on the analytical techniques developed
for the formulation MON 52276.
IIIA 5.1
Analytical Standards and Samples
IIIA 5.1.1
Samples of the preparation
A sample of the preparation was provided by the applicant but no analysis of the content of the active
substance or the relevant impurities was performed.
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
IIIA 5.1.2
Page 4 of 13
Analytical standards for the pure active substance
Samples will be provided upon request.
IIIA 5.1.3
Samples of the active substance as manufactured
No samples were provided because there was no request.
IIIA 5.1.4
Analytical standards for relevant metabolites and all other components
included in the residue definition
IIIA 5.1.5
Samples of reference substances for relevant impurities
IIIA 5.2
Methods for the Analysis of the Plant Protection Product
Analytical methods for the determination of glyphosate, impurities and relevance of CIPAC methods
were evaluated as part in the EU review. The respective data are considered adequate and are not included
in this submission.
Additional studies to support the registration of Tender GB Ultra (MON 78708) not previously assessed
are given below. All relevant data are provided and are considered adequate.
IIIA 5.2.1
Description of the analytical methods for the determination of the active
substance in the plant protection product
The following validation of the analytical method for the determination of the active substance in the
plant protection product performed on MON 52276 has not previously been reviewed and is provided in
support of this assessment.
Report:
KIIIA 5.2.1, Vanbellinghen, C, 2000
Title:
Method validation for assay of glyphosdate containing test items by HPLC.
Document No:
MLL 31345
Guidelines:
Directive 96/46/EC amending Council Directive 91/414/EEC
GLP:
Yes
Principle of the method
From homogenized glyphosate formulations, approximately 1g was weighed in a calibrated volumetric
flask and dissolved in the mobile phase (0.81 g/l KH2PO4 in (96 - 4 v/v) methanol/water adjusted to pH 2
with o-phosphoric acid). The active ingredient content is assayed by HPLC with UV detection at 195 nm.
Method validation
The method has been validated for the determination of glyphosate in formulation MON 52276 and is
considered applicable also to MON 78708.
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
Page 5 of 13
Specificity
No interferences due to other components have been identified by analyzing the blank formulation, the
sample and the standard, demonstrating good specificity.
The UV spectra of the standard and the sample are similar.
Linearity
The calibration curve of glyphosate standards is linear in a range of 750 – 2000 µg/L, with a correlation
coefficient (r²) of 0.9996 (criteria of acceptance: r > 0.99)
Accuracy
The accuracy of the method has been determined by analyzing 5 replicates of MON 52276. The recovery
on the analysed samples was min. 98.1 % (criteria of acceptance: accuracy 98 – 102 %).
Repeatability
The repeatability of the method defined by five determinations on samples at the nominal range yielded a
relative standard deviation of 0.7 % (criteria of acceptance: RSD < RSD Horwitz x 0.67 = 1.6 %).
Summary
The method for assay of glyphosate in SL formulation MON 52276 (and hence MON 78708) was
successfully validated and meets the EU criteria with respect to specificity, linearity, accuracy and
repeatability.
IIIA 5.2.2
For preparations containing more than one active substance, description of
method for determining each in the presence of the other
Please refer to chapter 5.2.1 as Tender GB Ultra (MON 78708) contains only one active substance.
IIIA 5.2.3
Applicability of existing CIPAC methods
There is a CIPAC method available for the determination of glyphosate in SL formulations (Handbook
1C, 2132).
IIIA 5.2.4
Description of analytical methods for the determination of relevant
impurities
The following impurities are stated as relevant in the FAO specifications:
- Formaldehyde 1.3 g/kg of the glyphosate content
- N-Nitrosoglyphosate 1 mg/kg
- Insolubles in 1M NaOH
Analytical methods for the determination of these impurities are described in Annex II 4.1.2 (Document
KII, Confidential Studies).
Further on, analytical methods are publicly available on the FAO website. However, these methods are
applicable for TC and TK formulation. There applicability for SL formulations has not been proved by
the applicant.
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
IIIA 5.2.5
Page 6 of 13
Description of analytical methods for the determination of formulants
No formulants with toxicological or ecotoxicological relevant compounds are present in the formulation.
Therefore, no analytical methods for the determination of formulants are necessary.
IIIA 5.3
Description of Analytical Methods for the Determination of Residues
IIIA 5.3.1
Evaluation of glyphosate
Note: For the evaluation for Annex I inclusion several analytical methods were submitted to Germany as
Rapporteur Member State. Many of those methods are no longer consistent with the current guidance
document SANCO/825/00 rev. 8.1. One new analytical study for residues in water (Reichert, 2000,
MET2000-534) was supplied with this application. This study is not described in the Draft Assessment
Report. The additional study is not evaluated here, because the same method was successfully validated in
an earlier study, which was evaluated for Annex I inclusion of glyphosate.
Table IIIA Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-1: Information on the
active substance glyphosate
Name of component of residue definiton
substance code
IUPAC name
formula
Structural formula
glyphosate
PMG
N-(Phosphonomethyl)-glycin
C3H8NO5P
AMPA (metabolite)
Aminomethylphosphonic acid
CH6NO3P
III 5.3.1.1
Overview of residue definitions and levels for which compliance is required
Compared to the residue definition proposed in the Draft Assessment Report (incl. its addenda) the
current legal residue definition is identical.
Table IIIA Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-2: Relevant residue
definitions
Matrix
Relevant residue
Reference
Remarks
plant material
glyphosate
Regulation (EU) No 441/2012, annex
II; annex III part B
foodstuff of animal origin
glyphosate
Regulation (EU) No 441/2012, annex
II; annex III part B
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
Page 7 of 13
soil
glyphosate and metabolite AMPA
DAR, vol. 1, section 2.6.2
surface water
drinking/ground water
air
glyphosate
generally defined
body fluids/tissue
not residue relevant
not classified as T / T+
Table IIIA Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-3: Levels for which
compliance is required
Matrix
MRL
Reference for MRL/level
Remarks
soil
0.05 mg/kg
common limit
drinking water
0.1 µg/L
general limit for drinking water
surface water
640 µg/L (glyphosate)
EC50 Algae, DAR, Vol. 1, List of end
points, Chapter 2.6
89800 µg/L (AMPA)
EC50 Algae, DAR, Vol. 1, List of end
points, Chapter 2.6
air
60 µg/m3
AOEL sys.: 0.2 mg/kg bw/d
tissue (meat or liver)
not required
body fluids
not required
III 5.3.1.2
Description of Analytical Methods for the Determination of Residues of
glyphosate in Plant Matrices (OECD KIII A 5.3.1)
The intended field of use is non-agricultural land (area of application: railway tracks), therefore analytical
methods for residues of glyphosate in plant matrices are not required.
III 5.3.1.3
Description of Analytical Methods for the Determination of Residues of
glyphosate in Animal Matrices (OECD KIII A 5.3.1)
The intended field of use is non-agricultural land (area of application: railway tracks), therefore analytical
methods for residues of glyphosate in animal matrices are not required.
III 5.3.1.4
Description of Methods for the Analysis of glyphosate in Soil (OECD KIII A
5.4)
An overview of the acceptable methods and possible data gaps for analysis of glyphosate in soil is given
in the following tables. Acceptable new studies were not provided.
Table Fehler! Kein Text mit angegebener Formatvorlage im Dokument.-4:
primary and confirmatory methods for soil
Component(s) of residue definition
glyphosate
Primary method
Waggoner, 1995
1
Overview of suitable
Confirmatory method
missing
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
Page 8 of 13
Waggoner, 1995 1
AMPA
1
missing
EU agreed method, see DAR
Methods for soil
Author(s), year
Method LOQ
Principle of method
Waggoner, 1995
MET9600120
0.05 mg/kg
HPLC-FLD with OPA no
confirmation;
glyphosate and
AMPA
III 5.3.1.5
Comment
Evaluated in
section B.4.3.1 of
the DAR
Description of Methods for the Analysis of glyphosate in Water (OECD KIII
A 5.6)
An overview of the acceptable methods and possible data gaps for analysis of glyphosate in surface and
drinking water is given in the following table. New studies were not provided.
primary and confirmatory methods for water
Component(s) of residue
definition
Matrix
Primary method
Confirmatory method
glyphosate
drinking water
Roth, 1995 2
missing
drinking water
Roth, 1995
2
missing
2, 3
missing
missing
AMPA
glyphosate
surface water
Roth, 1995
AMPA
surface water
Roth, 1995 2, 3
2
3
Surface water analysis allow dilution by a factor of 6400 due to high action limit. Therefore, methods for drinking water are apllicable.
water and surface water
Methods for drinking
Author(s), year
Method LOQ
Principle of method
Roth, 1995
MET9600114
0.1 µg/L
HPLC-FLD with OPA no confirmasection B.4.3.2 of
tion; results of 5 the DAR
labs
III 5.3.1.6
Comment
Evaluated in
Description of Methods for the Analysis of glyphosate in Air (OECD KIII A
5.7)
An overview of the acceptable methods and possible data gaps for analysis of glyphosate in air is given in
the following table.
primary and confirmatory methods for air
Component(s) of residue definition
glyphosate
Primary method
Roth, 1994
4
Confirmatory method
not required
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
4
Page 9 of 13
Author(s), year
Method LOQ
3
Roth, 1994
MET9600138
III 5.3.1.7
9 µg/m
Methods for air
Principle of method
Comment
Evaluated in
HPLC-FLD
no confirmation section B.4.3.3 of
the DAR
Description of Methods for the Analysis of glyphosate in Body Fluids and
Tissues (OECD KIII A 5.8)
Methods for body fluids and tissues are not required, because glyphosate is not considered to be toxic or
very toxic (T / T+) nor is it classified according to GHS as follows: Acute toxicity (cat. 1 - 3), CMR (cat.
1) or STOT (cat. 1).
III 5.3.1.8
Other Studies/ Information
Further studies were provided by the applicant for the determination of residues in soil and water. These
were not considered for the following reasons (studies in alphabetical order):
Bushong, Eschbach, 1992, OECD KIIA 4.4 (MET9600132): additional data for the considered method of
Waggoner, 1995 (MET9600120)
Egloff, 1995, OECD KIIA 4.5 (MET9600117): validation data are included in the considered method of
Roth, 1995 (MET9600114)
Klumpp, 1995, OECD KIIA 4.5 (MET9600079): validation data are included in the considered method of
Roth, 1995 (MET9600114)
Kunstmann, 1985, OECD KIIA 4.5 (MET9600133): LOQ does not meet the drinking water limit
Oppenhuizen, Cowell, 1987, OECD KIIA 4.5 (MET9600134): LOQ does not meet the drinking water
limit
Oppenhuizen, 1993, OECD KIIA 4.4 (ASB2009-4452): extent of validation data not sufficient
Reichert, 2000, OECD KIIA 4.5 (MET2000-534): additional, acceptable method for drinking and surface
water, but not needed for this application
Roth, 1995, OECD KIIA 4.5 (ASB2010-14762): uncomplete version of the considered method of Roth,
1995 (MET9600114)
Royer, 2000, OECD KIIA 4.4 (ASB2011-9180): method is generally too laborious for routine monitoring
and not sufficiently precise for soil analysis; characteristics of soil not reported
Schulz, 1995, OECD KIIA 4.5 (MET9600116): validation data are included in the considered method of
Roth, 1995 (MET9600114)
Schulz, 1995, OECD KIIA 4.4 (MET9600121): precision for glyphosate not sufficient and selectivity
poor
Schulz, Reichert, 1995, OECD KIIA 4.3 (MET9600118): method for crops is not needed for this
application
Weber, 1995, OECD KIIA 4.5 (MET9600115): validation data are included in the considered method of
Roth, 1995 (MET9600114)
III 5.4
Conclusion on the availability of analytical methods for the determination of
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
Page 10 of 13
residues
Sufficiently sensitive and selective analytical methods are not available for all analytes included in the
residue definition of soil and water.
Noticed data gaps are:
1. A confirmatory method for glyphosate and AMPA in soil is missing.
2. A confirmatory method for glyphosate and AMPA in drinking and surface water is missing.
It should be noted that the DAR (Germany 1998) describes such method in the study of
Schneider (1995) Glyphosate and AMPA: Validation of an analytical method for the
determination in tap water with a determination limit of 100 ng/l, Study no. PR94/036
(MET9600103)
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
Page 11 of 13
Appendix 1 – List of data submitted in support of the evaluation
Annex point/
reference No
Author(s)
Year
OECD: KIIA 4.3
Bushong, J. M.; Eschbach,
J. C.
1992
OECD: KIIA 4.3
Oppenhuizer, M.; Schuette,
S.
1995
OECD: KIIA 4.3
Pijanowski, P.
1988
OECD: KIIA 4.3
Royer, A.
2000
OECD: KIIA 4.3
Schulz, H.; Reichert, H.
1995
OECD: KIIA 4.3,
OECD: KIIA 4.8
Reding, M.-A.
1999
OECD: KIIA 4.3,
OECD: KIIA 4.8
Todd, M.
1993
OECD: KIIA 4.4
Bushong, J. M.; Eschbach,
J. C.
1992
OECD: KIIA 4.4
Oppenhuizen, M. E.
1993
Title
Data
Report-No.
protection
Authority registration No
claimed
Analytical method for the determination
of N-(phosphonomethyl) glycine
(glyphosate) and its metabolite
(animomethyl) phosphonic acid
(AMPA) in various matrices
BD-045-91
BVL-2240924, MET9600122
Supplement to validation of an
analytical method for the determination
of Glyphosate and AMPA in animal
tissues
MSL-7358
BVL-2240925, MET9600119
Validation of an analytical method for
the determination of Glyphosate
residues in animal tissues
MSL-7358 ! 171-4
BVL-2240921, MET9600140
Development and validation of an
of Glyphosate and AMPA in plant
(wheat, tomato, maize and lemon),
animal (milk, egg and meat) products,
soil and water (groundwater and surface
water) - incl. amendment dated
02.05.2001
MON/GLYPH/2000.01 ! AA045979
BVL-2240944, ASB2011-9180
Compilation of glyphosate analytical
methods used for analysis of samples
from residue trials conducted in the UK
in 1992 and 1993 (wheat, barley, oats,
grass, linseed, oilseed rape, peas and
beans) and in Portugal in 1993 (apples)
IF-94/21320-00
BVL-2240926, MET9600118
Validation of the analytical method for
the determination of Glyphosate and
AMPA residues in cow tissues, raw cow
milk and chicken eggs
MLL 31027 ! ES-ME-0073-01
BVL-2240920, BVL-2240942,
MET1999-959
Glyphosate [N(phosphonomethyl)glycine]: The
development of an analytical method for
the determination of residues in the
edible tissues and milk of dairy cattle
676/10-1012
BVL-2240922, BVL-2240943,
MET9600139
Analytical method for the determination
of N-(phosphonomethyl) glycine
(Glyphosate) and its metabolite
(aminomethyl)phosphonic acid (AMPA)
in soil
BD-035-91
BVL-2240928, MET9600132
Analytical method for Glyphosate and
AMPA in soil
RES-014-91
BVL-2240927, ASB2009-4452
Owner
How
considered in
dRR *
N
N
N
N
N
N
N
N
N
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
Page 12 of 13
Annex point/
reference No
Author(s)
Year
OECD: KIIA 4.4
Schulz, H.
1995
OECD: KIIA 4.4
Waggoner, T. B.
1995
OECD: KIIA 4.5
Egloff, K.
1995
OECD: KIIA 4.5
Klumpp, M.
1995
OECD: KIIA 4.5
Kunstman, J. L.
1985
OECD: KIIA 4.5
Oppenhuizen, M. E.;
Cowell, J. E.
1987
OECD: KIIA 4.5
Reichert, N.
2000
OECD: KIIA 4.5
Roth, A.
1995
OECD: KIIA 4.5
Roth, A.
1995
OECD: KIIA 4.5
Schulz, M.
1995
OECD: KIIA 4.5
Weber, H.
1995
OECD: KIIA 4.7
Anon.
1993
Title
Data
Report-No.
protection
claimed
Summary report: compilation of
glyphosate and AMPA analytical
methods used for analysis of soil
samples from field soil dissipation
experiments in Germany and
Switzerland conducted in 1990 and 1991
IF -95/11387-00
BVL-2240929, MET9600121
Appendix 1 to Analytical method for the
determination of N(phosphonomethyl)glycine (Glyphosate)
and its metabolite
(aminomethyl)phosphonic acid
(AMPA)in soil
BD-035-91
BVL-2240930, MET9600120
Bestimmung der Konzentration an
Glyphosat und AMPA in 6
Trinkwasserproben
IF-94/15512-01
BVL-2240934, MET9600117
Analyse von Glyphosat und AMPA in
Wasser
94120/02-RW
BVL-2240938, MET9600079
Validation of residue method for
determination of Glyphosate and
Aminomethylphosphonic acid (AMPA)
in water - A round-robin study
MSL-4268
BVL-2240933, MET9600133
Interlaboratory validation of an
of Glyphosate and its metabolite,
Aminomethylphosphonic acid (AMPA)
in environmental water
MSL-7200 ! 066300
BVL-2240932, MET9600134
the determination of Glyphosate and
AMPA in surface water (pond and river
water)
IF-99/38276-00
BVL-2242997, MET2000-534
Analyse von dotierten
Trinkwasserproben zur Demonstration
der allgemeinen Anwendbarkeit der
Methode DFG 405 in verschiedenen
Laboratorien
EF 94-26-01 ! DFG 405
BVL-2240931, MET9600114
Analyse von dotierten
Trinkwasserproben zur Demonstration
der allgemeinen Anwendbarkeit der
Methode DFG 405 in verschiedenen
Laboratorien
EF-94-26-01
BVL-2240937, ASB2010-14762
Determination of the residues of
Glyphosate and its metabolite AMPA in
drinking water
RCC 379743
BVL-2240935, MET9600116
Bestimmung der Rückstände von
Glyphosat und AMPA in Trinkwasser
ECO-9401 ! 23973/94
BVL-2240936, MET9600115
Determination of Glyphosate (CAS No.
1071-83-6) in air.
Owner
How
considered in
dRR *
N
Y
N
N
N
N
N
Y
N
N
N
N
Evaluator: BVL / DE
Date: 24/03/2014
Part B Section 2
Core Assessment –
Germany
Page 13 of 13
Annex point/
reference No
Author(s)
Year
OECD: KIIA 4.7
J. E. B.
1989
OECD: KIIA 4.7
Roth, A.
1994
Title
Data
Report-No.
protection
claimed
AM 342
BVL-2240941, ASB2010-14761
Analytical method for determination of
Glyphosate isopropylamine salt in air
42-EH-92-89 ! 4144
BVL-2240940, MET9600137
the determination of glyphosate, the IPA
salt of Glyphosate and AMPA in air
EF-94-26-03
BVL-2240939, MET9600138
Owner
How
considered in
dRR *
N
Y
* Y
Yes , relied on
N
No, not relied on
Add: Relied on, study not submitted by applicant but necessary for evaluation
Annex point/
reference No
Author(s)
Year
Title
company)
Report-No.
GLP or GEP status (where relevant),
Published or not
Data
protection
claimed
Owner
How considered in
dRR
Study-Status / Usage*
KIIIA1 5.2.1
Vanbelling
hen, C.
2000
Method validation for assay of
glyphosdate containing test
items by HPLC,
MLL 31345
GLP, Unpublished
Y
MOT
1
* 1
2
3
4
5
accepted (study valid and considered for evaluation)
not accepted (study not valid and not considered for evaluation)
not considered (study not relevant for evaluation)
not submitted but necessary (study not submitted by applicant but necessary for evaluation)
supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)
Evaluator: BVL / DE
Date: 24/03/2014
Tender GB Ultra (MON 78708) – ZV1043981-00/00
Part B – Section 3 - Core Assessment
REGISTRATION REPORT
Part B
Section 3: Mammalian Toxicology
Product code:
Tender GB Ultra
(MON 78708)
Active Substance:
Glyphosate, 360 g/L
Central Zone
CORE ASSESSMENT
Date: 24/03/2014
Page 1 / 35
Table of Contents
3
Mammalian Toxicology (IIIA 7) .........................................................................................4
3.1
Summary..............................................................................................................................4
3.2
Toxicological Information on Active Substance(s) .............................................................7
3.3
Toxicological Evaluation of Plant Protection Product.........................................................7
3.4
Dermal Absorption (IIIA 7.6) ..............................................................................................8
3.5
Exposure Assessment of Plant Protection Product ..............................................................9
3.5.1
Selection of critical use(s) and justification.........................................................................9
3.5.2
Operator exposure (IIIA 7.3) ...............................................................................................9
3.5.2.1
Estimation of operator exposure ..........................................................................................9
3.5.2.2
Measurement of operator exposure....................................................................................10
3.5.3
Worker exposure (IIIA 7.5) ...............................................................................................11
3.5.3.1
Estimation of worker exposure ..........................................................................................11
3.5.3.2
Measurement of worker exposure......................................................................................11
3.5.4
Bystander and resident exposure (IIIA 7.4) .......................................................................12
3.5.4.1
Estimation of bystander and resident exposure .................................................................12
3.5.4.2
Measurement of bystander and/or resident exposure.........................................................12
3.5.5
Statement on combined exposure ......................................................................................13
Appendix 1
Reference list .....................................................................................................................13
Appendix 2
Detailed evaluation of the studies relied upon...................................................................14
A 2.1
Statement on bridging possibilities....................................................................................14
A 2.2
Acute oral toxicity (IIIA1 7.1.1) ........................................................................................14
A 2.3
Acute percutaneous (dermal) toxicity (IIIA1 7.1.2) ..........................................................15
A 2.4
Acute inhalation toxicity (IIIA1 7.1.3) ..............................................................................16
A 2.5
Skin irritation (IIIA1 7.1.4)................................................................................................17
A 2.6
Eye irritation (IIIA1 7.1.5).................................................................................................18
A 2.7
Skin sensitisation (IIIA1 7.1.6)..........................................................................................19
A 2.8
Supplementary studies for combinations of plant protection products (IIIA1 7.1.7) ........21
A 2.9
Data on co-formulants (III1 7.9)........................................................................................21
A 2.9.1
Material safety data sheet for each co-formulant...............................................................21
A 2.9.2
Available toxicological data for each co-formulant...........................................................21
A 2.10
Studies on dermal absorption (IIIA 7.6) ............................................................................21
A 2.10.1
Dermal absorption, in vitro using human skin (epidermis) ...............................................21
Exposure calculations..................................................................................................................................26
A 2.11
Operator exposure calculations (IIIA1 7.3.1) ....................................................................26
A 2.11.1
Calculations for glyphosate ...............................................................................................26
A 2.12
Worker exposure calculations (IIIA1 7.5.1) ......................................................................33
Page 2 / 35
A 2.12.1
A 2.13
Bystander and resident exposure calculations (IIIA1 7.4.1)..............................................34
A 2.13.1
Page 3 / 35
3
Mammalian Toxicology (IIIA 7)
3.1
Summary
Table 3.1-1:
Information on Tender GB Ultra *
Product name and code
Tender GB Ultra
Company code: MON78708
BVL-code : MOT-98321-H-2-SL
Formulation type
SL
Active substance (incl. content)
Glyphosate; 360 g/L (as its isopropylamine-salt 486 g/L)
Function
Herbicide
Product already evaluated as the ‘representative
formulation’ during the Annex I inclusion
No
Product previously evaluated in an other MS according
to Uniform Principles
No
* Information on the detailed composition of Tender GB Ultra can be found in the confidential dRR
Part C.
Justified proposals for classification and labelling
In accordance with Directives 67/548/EEC and 1999/45/EC and according to the criteria given in
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 the
following classification and labelling with regard to toxicological data is proposed for the preparation:
Table 3.1-2:
Justified proposals for classification and labelling
C&L according to Directives 67/548/EEC and 1999/45/EC
Hazard symbols:
None
None
Risk phrases:
None
Safety phrases:
None
Additional labelling phrases:
To avoid risks to man and the environment, comply with the instructions for
use.
C&L according to Regulation (EC) No 1272/2008
Hazard classes, categories:
None
Signal word:
None
Hazard statements:
None
Precautionary statements:
None
Additional labelling phrases:
To avoid risks to man and the environment, comply with the instructions for
use. [EUH401]
' 15 percent of the mixture consist of ingredients of unknown inhalation
toxicity.'
Page 4 / 35
Table 3.1-3:
Summary of risk assessment for operators, workers, bystanders and residents
for Tender GB Ultra
Result
PPE / Risk mitigation measures
Operators
Acceptable
- Avoid any unnecessary contact with the product. Misuse can lead to
health damage (SB001).
- Keep out of the reach of children (SB010).
Workers
Acceptable
- Treated areas/crops may not be entered until the spray coating has
dried (SF245-01).
Bystanders
Acceptable
None
Residents
Acceptable
None
No unacceptable risk for operators, workers, bystanders and residents was identified when product is used
as intended. No specific PPE is necessary
A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and
bystanders/residents is presented in Table 3.1-4.
Page 5 / 35
Table 3.1-4 Critical uses and overall conclusion of exposure assessment
Railway tracks
and noncultivated land
without woody
plants
Railway tracks
and noncultivated land
without woody
plants
F
F
Spraying,
(hand-held
equipment)
1
6
kg as/ha
Water
L/ha
a) max. rate per
appl.
min / max
b) max. total rate
per crop/season
3.6
500/1000
3.6
500/1000
7
Remarks:
8
Acceptability of
exposure
surfactant (i.e. Trend 90) assessment
L/ha
critical gap for operator,
worker, bystander or
resident exposure based
on [Exposure model]
Critical gap for operator,
resident exposure based on
German model and UKPOEM.
Critical gap for operator,
resident exposure based on
German model and UKPOEM.
Exposure acceptable without PPE / risk mitigation measures
Further refinement and/or risk mitigation measures required
Exposure not acceptable/ Evaluation not possible
1)
Pooled critical GAPS with the same max. application rate per application and using the same application technique
F: field or outdoor application, G: greenhouse application, I: indoor application
3)
e.g. LC: low crops, HC: high crop, TM: tractor-mounted, HH: hand-held
2)
Page 6 / 35
Residents
Method / Kind Max. number
(incl. application (min. interval
technique 3))
between
applications)
a) per use
b) per crop/
season
Spraying,
1
(tractor
mounted
equipment)
5
Application rate
Bystander
4
Worker
2
3
F/G
Application
or I 2)
Operator
1
Crops 1) and
situation
(e.g. growth
stage of crop)
3.2
Toxicological Information on Active Substance(s)
Information regarding classification of the active substances and on EU endpoints and critical areas of
concern identified during the EU review are given in Table 3.2-1.
Table 3.2-1:
Information on active substance(s)
Classification and proposed labelling
With regard to toxicological
enpoints (according to the
criteria in Dir. 67/548/EEC)
Xi
R41
- Irritant
- Risk of serious damage to eyes
With regard to toxicological
enpoints (according to the
criteria in Reg. 1272/2008)
Serious eye damage, cat. 1
H318 - Causes serious eye damage
Additional C&L proposal
None
Agreed EU endpoints
AOEL systemic
0.2 mg/kg bw/d
Reference
Review Report 6511/VI/99-final (21 January 2008)
3.3
Toxicological Evaluation of Plant Protection Product
A summary of the toxicological evaluation for Tender GB Ultra is given in Table 3.3-1. Full summaries
of studies on the product are presented in Appendix 2. MSDS on Tender GB Ultra can be found in the
confidential dRR Part C.
Table 3.3-1:
Summary of evaluation of the studies on acute toxicity including irritancy and
skin sensitisation for Tender GB Ultra
Type of test, model
system (Guideline)
Result
Acceptability
Classification
(acc. to the
criteria in Dir.
67/548/EEC)
Classification
(acc. to the
criteria in Reg.
1272/2008)
Reference
LD50 oral, rat
(U.S. EPA 81-1, 1984;
OECD 401, 1987;
EC B.1, 1984) *
> 5000 mg/kg
bw
Yes
None
None
XXXXX
LD50 dermal, rat
(U.S. EPA 81-2, 1984;
OECD 402, 1987;
EC B.3, 1984) *
> 5000 mg/kg
bw
Yes
None
None
XXXXX
LC50 inhalation, rat
Not submitted, not necessary. Justification presented in Annex 2.
Skin irritation, rabbit
(U.S. EPA 81-5, 1984;
OECD 404, 1991;
EC B.4, 1984) *
Non-irritant
Yes
None
None
XXXXX
Eye irritation, rabbit
(U.S. EPA 81-4, 1984;
OECD 405, 1987;
EC B.5, 1984) *
Non-irritant
Yes
None
None
XXXXX
Skin sensitisation,
guinea pig
Non-sensitising
Yes
None
None
XXXXX
Page 7 / 35
(OECD 406, 1992; EC
B.6, 1996; Buehler -9
applications) *
Supplementary studies
for combinations of
plant protection
products
No data – not
required
*studies were performed with Roundup Ultra (MON52276), similar formulation without dye
Table 3.3-2:
Additional toxicological information relevant for classification/labelling of
Tender GB Ultra
Substance
(Concentration
in product,
% w/w)
Toxicological
properties of active
substance(s) (relevant
for classification of
product)
Classification of the
substance
(acc. to the criteria in
Dir. 67/548/EEC and/or
in Reg. 1272/2008)
Reference
Classification of product
(acc. to the criteria in
Dir. 67/548/EEC, in Dir.
1999/45/EC and/or in
Reg. 1272/2008)
None
Toxicological
None
properties of non-active
substance(s) (relevant
for classification of
product)
Further toxicological
information
1
No data – not
required
Material safety data sheet by the applicant
3.4
Dermal Absorption (IIIA 7.6)
In the EU evaluation of glyphosate, a dermal absorption rate of 3% was agreed that was based on
information from various sources and may be considered a conservative estimate. Since that decision was
taken, the database has been improved with regard to more precise information on dermal absorption of
certain formulations.
In case of Tender GB Ultra (MON 78708), no study on dermal absorption is available but an in vitro
percutaneous absorption study on human skin had been conducted with the closely related formulation
MON 52276 (see Appendix A 2.10). These data predict that the dermal absorption of glyphosate from
potential exposure to this 360 g glyphosate /L SL formulation (MON 52276) would be minimal, i.e., less
than 1%. Valid studies of this type are considered to reflect dermal absorption in man sufficiently well
without a need for further corrections or adjustments (OECD, 2011; EFSA, 2012).
The formulation composition of MON 78708 is based on that of MON 52276. The only difference is that
MON 78708 additionally contains a very low amount of 29 ppm (0.0029%) of a blue, food-approved dye.
Since this dye is approved for use in foodstuffs, its inclusion in MON 78708 is not considerer to have any
impact on the toxicological properties of MON 78708 versus those of the parent formulation MON
52276. Likewise, it is not expected that this dye might significantly affect (enhance) dermal absorption.
Thus, the data presented below for MON 52276 have been used in the exposure assessment for MON
78706.
Page 8 / 35
Table 3.4-1:
Dermal absorption endpoints for active substances in Tender GB Ultra
Glyphosate
Value
Reference
Concentrate
1%
See study in Appendix A 2.10
Dilution
1%
See study in Appendix A 2.10
3.5
Exposure Assessment of Plant Protection Product
Table 3.5-1:
Product information and toxicological reference values used for exposure
assessment
Product name and code
Formulation type
Category
Container sizes, short
description
Active substance
(incl. content)
AOEL systemic
Inhalative absorption
Oral absorption
Dermal absorption
3.5.1
Tender GB Ultra
SL
Herbicide
1 L bottle, High Density Polyethylen (HDPE)
5-20 L canister, High Density Polyethylen (HDPE)
640-1000 L tank, High Density Polyethylen (HDPE)
Glyphosate
360 g/L
0.2 mg/kg bw/d
100 %
30 %
Concentrate: 1 %
Dilution: 1 %
Roundup Ultra, company-code: MON 52276 (SL, 360 g/L glyphosate)
Selection of critical use(s) and justification
The critical GAPs used for the exposure assessment of the plant protection product are shown in Table
3.1-4.
3.5.2
Operator exposure (IIIA 7.3)
3.5.2.1
Estimation of operator exposure
A summary of the exposure models used for estimation of operator exposure to the active substance(s)
during application of Tender GB Ultra according to the critical use(s) is presented in Table 3.5-2.
Outcome of the estimation is presented in Table 3.5-3. Detailed calculations are in Appendix 3.
Table 3.5-2:
Exposure models for intended uses
Critical use(s)
Railway tracks and non-cultivated land without woody plants (max. 10 L /ha)
Model(s)
German model
[Uniform Principles for Safeguarding the Health of Applicators of Plant Protection
Products (Uniform Principles for Operator Protection), Mitteilungen aus der
Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277,
1992]
Critical use(s)
Railway tracks and non-cultivated land without woody plants (max. 10 L /ha)
Model(s)
Revised UK-POEM
[Estimation of Exposure and Absorption of Pesticides by Spray Operators, Scientific
subcommittee on Pesticides and British Agrochemical Association Joint Medical Panel
Report (UK MAFF), 1986 and the Predictive Operator Exposure Model (POEM) V 1.0,
(UK MAFF), 1992]
Page 9 / 35
Table 3.5-3:
Estimated operator exposure
Glyphosate
Model data
Level of PPE
Total absorbed dose
(mg/kg/day)
Tractor mounted boom spray application outdoors to low crops
Application rate: 3.6 kg a.s./ha
German Model
Body weight: 70 kg
no PPE1)
0.047
UK POEM
10 L preparation/ha
500 L water / ha
Container: 10 L
Body weight: 60 kg
1)
2)
3)
4)
5)
23.7
with PPE3)
0.023
11.4
no PPE2)
0.207
103.5
with PPE4)
0.065
32.3
Hand-held sprayer application outdoors (HCHH, German model, ‘worst case’)5)
Hand-held sprayer application outdoor (low level target, UK POEM)
Application rate 3.6 kg a.s./ha
German Model
Body weight: 70 kg
no PPE1)
0.144
UK POEM
10 L preparation/ha
500 L water / ha
Container: 10 L
Body weight: 60 kg
% of systemic AOEL
72.1
with PPE3)
0.040
19.9
no PPE2)
0.218
108.9
with PPE4)
0.141
70.4
no PPE: Operator wearing T-shirt and shorts
no PPE: Operator wearing long sleeved shirt, long trousers (“permeable”) but no gloves
with PPE: Operator wearing gloves during mixing/loading (PPE acc. to the Federal Office of Consumer Protection and
Food Safety (BVL); 2006; Personal protective equipment for handling plant protection products – Guidelines for
requirements concerning personal protective equipment in plant protection)
with PPE: Operator wearing gloves during mixing/loading
No scenario for hand-held applications (low level target) in the German model is available, therefore HCHH application
model is used as a ‘worst case’ scenario.
3.5.2.2
Measurement of operator exposure
Since the operator exposure estimations carried out indicated that the acceptable operator exposure level
(AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of
operator exposure was not necessary and was therefore not performed.
Page 10 / 35
3.5.3
Worker exposure (IIIA 7.5)
3.5.3.1
Estimation of worker exposure
Table 3.5-4 shows the exposure model(s) used for estimation of worker exposure after entry into a
previously treated area or handling a crop treated with Tender GB Ultra according to the critical use(s).
Outcome of the estimation is presented in Table 3.5-5. Detailed calculations are in Appendix 3.
Table 3.5-4:
Critical use(s)
Railway tracks and non-cultivated land without woody plants
(max. 1 x 10 L product/ha)
Model
German re-entry model, Krebs et al. (2000)
[Uniform Principles for Safeguarding the Health of Workers Re-entering Crop
Growing Areas after Application of Plant Protection Products, Nachrichtenbl. Deut.
Pflanzenschutzdienst., 52(1), p. 5-9]
Table 3.5-5:
Estimated worker exposure
Glyphosate
Model data
Level of PPE
Total absorbed dose (mg/kg/day)
% of systemic AOEL
Number of applications and application rate: 1 x 3.6 kg a.s./ha
2 hours/day 1),
TC: 5000 cm2/person/h 2)
Body weight: 60 kg
1)
2)
3)
4)
no PPE 3)
with PPE
4)
0.006
3
0.0003
0.2
2 h/day for professional applications for maintenance, inspection or irrigation activities etc.
US-EPA policy paper [EPA, Science Advisory Council for Exposure; 2000; Agricultural Default Transfer Coefficients,
Policy # 003.1, May 7 1998 revised 7 August 2000].
no PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves
with PPE: see 'Instructions for use'
3.5.3.2
Measurement of worker exposure
Since the worker exposure estimations carried out indicated that the acceptable operator exposure level
(AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of
worker exposure was not necessary and was therefore not performed.
Page 11 / 35
3.5.4
Bystander and resident exposure (IIIA 7.4)
3.5.4.1
Estimation of bystander and resident exposure
Table 3.5-6 shows the exposure model used for estimation of bystander and resident exposure to
glyphosate. Outcome of the estimation is presented in Table 3.5-7. Detailed calculations are in
Appendix 3.
Table 3.5-6:
Critical uses
Railway tracks and non-cultivated land without woody plants
(max. 1 x 10 L product/ha)
Model
Martin, S. et al. (2008) [Guidance for Exposure and Risk Evaluation for Bystanders and
Residents Exposed to Plant Protection Products During and After Application; J. Verbr.
Lebensm. 3 (2008): 272-281 Birkhäuser Verlag Basel] and Bundesanzeiger (BAnz), 06
January 2012, Issue No. 4, pp. 75-76
Table 3.5-7:
Estimated bystander and resident exposure
Glyphosate
Model data
Total absorbed dose (mg/kg/day)
% of systemic AOEL
Outdoor application (low level target)1)
Application rate: 3.6 kg a.s./ha
Bystanders (adult)
Drift rate: 8.02 %
Body weight: 60 kg
0.005062
2.53
Bystanders (children)
Drift rate: 8.02 %
Body weight: 16.15 kg
0.004288
2.14
Residents (adult)
Deposit: 100 % 2)
Body weight: 60 kg
0.0046562
2.33
Residents (children)
Deposit: 100 % 2)
Body weight: 16.15 kg
0.0230285
11.51
1)
2)
No drift values for hand held applications (low level target) is available in the German model, therefore drift values for air
assisted application to high crops are used as ‘worst case’.
Intended use are e. g. non-cultivated land without woody plants. It can not be completely ruled out that these areas are
open to the public. Therefore, exposure was estimated using 100 % deposit as a worst case scenario.
3.5.4.2
Measurement of bystander and/or resident exposure
Since the bystander and/or resident exposure estimations carried out indicated that the acceptable operator
exposure level (AOEL) for glyphosate will not be exceeded under conditions of intended uses, a study to
provide measurements of bystander/resident exposure was not necessary and was therefore not
performed.
Page 12 / 35
3.5.5
Statement on combined exposure
Not relevant. The product contains only one active substance.
Appendix 1 Reference list
Annex point/
reference No
Author(s)
Year
Polveche et al.
1999
OECD: KIIIA1
7.1.1
XXXXX
1991
OECD: KIIIA1
7.1.2
XXXXX
1991
OECD: KIIIA1
7.1.4
XXXXX
1991
OECD: KIIIA1
7.1.5
XXXXX
1992
OECD: KIIIA1
7.1.6
XXXXX
2001
* Y:
N:
Add:
Title
Data
Report-No.
protection
claimed
Measurements of granulometry and
distribution of a spray nozzle Comparison of different glyphosate
formulations
106/Pulv
BVL-2315980, ASB2012-12069
Mon 52276: Acute oral toxicity study in
rats
BD-91-261 ! 6097-91
BVL-2247823, TOX9552438
Mon 52276: Acute dermal toxicity study
in rats
BD-91-262 ! 6098-91
BVL-2247831, TOX9552439
MON 52276: Primary dermal irritation
study in rabbits
BD-91-263 ! 6099-91
BVL-2247839, TOX9552440
Primary eye irritation study in rabbits Test material MON 52276
BD-91-60 ! 5999-91
BVL-2247847, TOX9552441
MON 52276: Skin sensitization test in
guinea pigs (Modified Buehler test : 9
applications).
CI-2001-153 ! 22008 TSG
BVL-2247854, TOX2005-1135
Yes, relied on
No, not relied on
Relied on, study not submitted by applicant but necessary for evaluation
Page 13 / 35
Owner
How
considered in
dRR *
Add
Y
Y
Y
Y
Y
Appendix 2 Detailed evaluation of the studies relied upon
A 2.1
Statement on bridging possibilities
Toxicity-studies for Tender GB Ultra (MON78708) were performed with Roundup Ultra (MON52276),
containing 360 g/L glyphosate (the full composition can be found in the confidential part C). The only
difference in composition is that Tender GB Ultra contains 29 ppm (0.0029 %) of a blue, food-approved
dye. Since this dye is approved for use in foodstuffs, its inclusion in Tender GB Ultra is not considered to
have any impact on the toxicological properties of Tender GB Ultra versus those of Roundup Ultra.
Comments of zRMS: Acceptable.
A 2.2
Acute oral toxicity (IIIA1 7.1.1)
Comments of zRMS: Acceptable (no deviations from below mentioned test guideline),
used for evaluation.
Reference:
Report
7.1.1
Acute Oral Toxicity Study in Rats; XXXXX 1991; Project No. 6097-91;
Monsanto Reference No. BD-91-261; TOX9552438
U.S. EPA Guideline No. 81-1 (1984)
OECD Guideline No. 401 (1987)
EC Method B.1 (1984)
No
Yes
Yes
Guidelines:
Deviations:
GLP:
Acceptability:
Materials and methods
Test material (Lot/Batch No.)
MON 52276 (Lot/Batch No. LLN-9105-3135-F)
Species
Albino Rat, Sprangue-Dawley [CD®-Crl: CD® (SD)BR]
No. of animals (group size)
5 rats/sex
Dose(s)
5000 mg/kg bw
Exposure
Once by gavage
Vehicle/Dilution
None
Post exposure observation period
14 days
Remarks
None
Results and discussions
Table A 1:
Dose
(mg/kg)
Results of acute oral toxicity study in rats of MON 52276
Toxicological results 1)
Duration of signs
Time of death
LD50 (mg/kg bw)
(14 days)
-
> 5000
-
> 5000
Male rats
5000
0/5/5
1 day
Female rats
5000
1)
0/5/5
1 day
Number of animals which died/number of animals with clinical signs/number of animals used
Page 14 / 35
Table A 2:
Summary of findings of acute oral toxicity study in rats of MON 52276
Mortality:
No mortality occurred.
Clinical signs:
Yes. Faecal staining and / or soft stool were noted in all animals after dosing on day 1. A few
animals also showed oral and / or nasal discharge, as well as hypoactivity.
Body weight:
Body weight gain was considered to be normal.
Macroscopic
examination:
The necropsies performed at the end of the study revealed no apparent findings.
Conclusion
Under the experimental conditions, the oral LD50 of MON52276 (Roundup Ultra) is greater than
5000 mg/kg bw in rats. Thus, no classification is required according to the classification criteria of
Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No.
1272/2008.
Tender GB Ultra (MON78708) has a similar composition to MON52276 (Roundup Ultra), in Tender GB
Ultra there is only a food-approved blue dye added. Hence it can be considered that the oral LD50 of
Tender GB Ultra will be greater than 5000 mg/kg bw in rats, too. Thus, no classification is required for
Tender GB Ultra.
A 2.3
Acute percutaneous (dermal) toxicity (IIIA1 7.1.2)
Comments of zRMS: Acceptable (no deviations from below mentioned test guideline),
Reference:
Report
Guideline(s):
Deviations:
GLP:
Acceptability:
7.1.2
Acute Dermal Toxicity Study in Rats; XXXXX 1991; Project No. 609891; Monsanto Reference No. BD-91-262; TOX9552439
No
Yes
Yes
Species
Albino Rat, Sprangue-Dawley [CD®-Crl: CD® (SD)BR]
5 rats/sex
Dose(s)
5000 mg/kg bw
Exposure
24 hours (dermal, semi-occlusive)
Vehicle/Dilution
None
14 days
Remarks
None
Page 15 / 35
Table A 3:
Dose
(mg/kg)
Results of acute dermal toxicity study in rats of MON 52276
Toxicological results 1)
Duration of signs
Time of death
LD50 (mg/kg bw)
(14 days)
-
> 5000
-
> 5000
Male rats
5000
0/0/5
Female rats
5000
1)
0/0/5
-
Number of animals which died/number of animals with clinical signs/number of animals used
Table A 4:
Summary of findings of acute dermal toxicity study in rats of MON 52276
Mortality:
Clinical signs:
There were no dermal effects observed in any of the animals throughout the study period.
Two animals showed red ocular discharge and one additional animal had red-stained urine at
day 1.
Body weight:
Body weight gain was considered to be normal.
Macroscopic
examination:
The necropsies performed at the end of the study revealed no apparent findings.
Conclusion
Under the experimental conditions, the dermal LD50 of MON52276 (Roundup Ultra) is greater than
5000 mg/kg bw in rats. Thus, no classification is required according to the classification criteria of
Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No.
1272/2008.
Ultra there is only a food-approved blue dye added. Hence it can be considered that the dermal LD50 of
Tender GB Ultra will be greater than 5000 mg/kg bw in rats, too. Thus, no classification is required for
Tender GB Ultra.
A 2.4
Acute inhalation toxicity (IIIA1 7.1.3)
Comments of zRMS: Justification for waiving of the study acceptable.
Study not submitted, submission not necessary (vapour pressure of active
substances: glyphosate 1. x 10-5 Pa at 20 °C (below 10-2 Pa); no significant
proportion (> 1 % on a weight basis) of particles of diameter < 50 µm.
An inhalation LC50 study is not appropriate for the water-soluble concentrate formulation of MON 78708.
Indeed MON 78708 (1) is not a gas, (2) is not used as a fumigant, with smoke generation or fogging
equipment, (3) does not contain ingredients with a vapour pressure greater than 1 x 10-2 Pa and thus
cannot be considered as a vapour releasing preparation, (4) will not be applied from aircraft and, (5) will
not be used in enclosed spaces. The concentrated formulation will not be applied as an aerosol; only
dilutions will be sprayed with equipment yielding typically into medium coarse droplet spectra.
Spray droplet size characteristics for MON 52276 formulations and the nozzle specimen: Teejet 11003 vs
(Polveche et al., 1999, ASB2012-12069)
Formulation
VMD (µm)
NMD (µm)
Page 16 / 35
% by volume
< 50 µm
< 10 µm
MON 52276
246
55
0.71
0.00
Note: VMD, volume median diameter; NMD, number median diameter
A 2.5
Skin irritation (IIIA1 7.1.4)
Comments of zRMS: Acceptable; no deviations, according to mentioned guidelines,
Reference:
Report
7.1.4
Primary dermal irritation study in rabbits; XXXXX 1991; Project
No. 6099-91; Monsanto Reference No. BD-91-263; TOX9552440
No
Yes
Yes
Guideline(s):
Deviations:
GLP:
Acceptability:
Species
Rabbit, New Zealand White
4 males and 2 females
Initial test using one animal
No
Exposure
0.5 mL (4 hours, semi-occlusive)
Vehicle/Dilution
None
3 days
Remarks
The test substance was applied on two sites of each animal (right
and left).
Table A 5:
Skin irritation of MON 52276
Scores after treatment 1)
Animal
No.
1 (male)
Right
Left
2 (male)
Right
Left
3 (female)
Right
Left
4 (male)
Right
Erythema
Oedema
Erythema
Oedema
Erythema
Oedema
Erythema
Oedema
Erythema
Oedema
Erythema
Oedema
Erythema
Oedema
0.5 h
24 h
48 h
72 h
0
0
1
0
1
0
2
0
2
0
1
0
1
0
0
0
0
0
0
0
0
0
1
0
1
0
0
0
0
0
0
0
0
0
0
0
1
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0 2)
0
0
Page 17 / 35
Mean scores
(24-72 h)
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.67
0.0
0.67
0.0
0.0
0.0
Reversible
[day]
1
1
3
1
Left
Erythema
Oedema
5 (male)
Right
Erythema
Oedema
Left
Erythema
Oedema
6 (female) Right
Erythema
Oedema
Left
Erythema
Oedema
1)
2)
1
0
1
0
1
0
1
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1
1
scores in the range of 0 to 4
desquamation reported
Clinical signs:
Conclusion
Under the experimental conditions, MON 52276 (Roundup Ultra) is not a skin irritant. Thus, no
classification is required according to the classification criteria of Council Directive 67/548/EEC and
subsequent regulations as well as according to Regulation (EC) No. 1272/2008.
Ultra there is only a food-approved blue dye added. Hence it can be considered that Tender GB Ultra will
be not a skin irritant. Thus, no classification is required for Tender GB Ultra.
A 2.6
Eye irritation (IIIA1 7.1.5)
Comments of zRMS: Acceptable; no deviations, according to mentioned guidelines,
Reference:
Report
Guidelines:
Deviations:
GLP:
Acceptability:
7.1.5
Primary Eye Irritation Study in Rabbits,
XXXXX 1992, Project No. 5999-91; Monsanto Reference No. BD-91-60,
TOX9552441
No
Yes
Yes
Species
Rabbit, New Zealand White
3 males and 3 females
Initial test using one animal
No
Exposure
0.1 mL (single instillation in conjunctival sac)
Irrigation (time point)
No
Vehicle/Dilution
None
7 days
Page 18 / 35
None
Remarks
Table A 6:
Eye irritation of MON 52276
Scores after treatment 1)
Animal
No.
1h
24 h
48 h
72 h
Mean scores
(24-72 h)
Reversible
[day]
1 (female)
Corneal opacity
Iritis
Redness conjunctivae
Chemosis conjunctivae
0
0
1
1
0
0
1
0
0
0
1
0
0
0
0
0
0.0
0.0
0.67
0.0
0
0
3
1
2 (male)
Corneal opacity
Iritis
0
0
1
1
0
0
1
0
0
0
1
0
0
0
0
0
0.0
0.0
0.67
0.0
0
0
3
1
3 (female)
Corneal opacity
Iritis
0
0
2
1
0
0
0
0
0
0
0
0
0
0
0
0
0.0
0.0
0.0
0.0
0
0
1
1
4 (male)
Corneal opacity
Iritis
0
0.5
2
1
0
0
2
0
0
0
2
0
0
0
1
0
0.0
0.0
1.7
0.0
0
1
7
1
5 female)
Corneal opacity
Iritis
0
0
1
1
0
0
2
0
0
0
2
0
0
0
1
0
0.0
0.0
1.67
0.0
0
0
7
0
6 (male)
Corneal opacity
Iritis
0
0
1
1
0
0
2
0
0
0
2
0
0
0
2
0
0.0
0.0
2.0
0.0
0
0
7
1
1)
scores in the range of 0 to 4 for cornea opacity and chemosis, 0 to 3 for redness of conjunctivae (1 is not considered positive
by the applicants) and 0 to 2 (including 0.5 which is not considered positiv) for iritis
Clinical signs:
No mortality occurred. No clinical signs of systemic toxicity were reported.
Conclusion
Under the experimental conditions, MON 52276 (Roundup Ultra) is not an eye irritant, no classification is
required according to the classification criteria of Council Directive 67/548/EEC and subsequent
regulations as well as according to Regulation (EC) No. 1272/2008.
be not an eye irritant. Thus, no classification is required for Tender GB Ultra.
A 2.7
Skin sensitisation (IIIA1 7.1.6)
Comments of zRMS: Acceptable; no deviations, according to mentioned guidelines, no justification
given for using the Buehler-test although an adjuvant-test is clearly favoured by
testing guideline B.6 (Commission Directive 96/54),
used for evaluation
Page 19 / 35
Reference:
Report
7.1.6
Skin Sensitization Test in Guinea Pigs (Modified Buehler test: 9
Applications),
XXXXX 2001, Project No. CI-2001-153, Study No. 22008 TSG,
TOX2005-1135
No
Yes
Yes
Guidelines:
Deviations:
GLP:
Acceptability:
MON 52276 (A1C1204104)
Species
Guinea pig, Hartley Crl: (HA) BR
Test substance group: 10 male and 10 female guinea pigs
Vehicle control goup: 5 male and 5 femaleguinea pigs
Range finding:
Yes
Exposure (concentration(s), no. of
applications)
Vehicle
Purified water
Reliability check
Mercaptobenzothiazole (topical induction: 1st to 4th ind. 20 % w/w,
5th and 6th ind. 10 % w/w, 7th and 8th ind. 5 % w/w and 9th ind. 2.5 %
w/w and challenge: 20 %)
Remarks
None
Table A 7:
Results of skin sensitisation study of MON 52276
24 hours
48 hours
After challenge
MON 52276
Control Group (Vehicle)
Positive control
1)
0/20
0/10
2/10
0/20
0/10
7/10
Number of animals with positive dermal response (scores of 1-3)/number of animals in dose group
Clinical signs:
No deaths occurred. No signs of systemic toxicity were reported.
Conclusion
Under the experimental conditions, MON 52276 (Roundup Ultra) is not a skin sensitiser. Thus, no
classification is required according to the classification criteria of Council Directive 67/548/EEC and
subsequent regulations as well as according to Regulation (EC) No. 1272/2008.
be not a skin sensitiser. Thus, no classification is required for Tender GB Ultra.
Page 20 / 35
A 2.8
Supplementary studies for combinations of plant protection products (IIIA1
7.1.7)
No combination intended.
A 2.9
Data on co-formulants (III1 7.9)
A 2.9.1
Material safety data sheet for each co-formulant
Material safety data sheets of the co-formulants can be found in the confidential dossier of this
submission (Registration Report - Part C).
A 2.9.2
Available toxicological data for each co-formulant
Available toxicological data for each co-formulant can be found in the confidential dossier of this
submission (Registration Report - Part C).
A 2.10
Studies on dermal absorption (IIIA 7.6)
A 2.10.1
Dermal absorption, in vitro using human skin (epidermis)
Report:
Title:
Document No:
Guidelines:
GLP
KIIIA 7.6.2, Ward R.J., 2010
360 g/L Glyphosate SL Formulation (MON 52276)
In Vitro Absorption of Glyphosate through Human
Epidermis
Monsanto Report Number: JV2084-REG
OECD 428, no deficiencies with the exception that
the origin of human skin samples was not well
defined with regard to, e.g., age and sex of the
donors
Yes
I. MATERIALS AND METHODS
A. MATERIALS:
1. Test Material: MON 52276 (proprietary formulation) with 14C labeled glyphosate
i) Unlabeled ingredient:
MON 0139, isopropylamine salt of glyphosate
Description: clear, water white to amber viscous liquid (solution in water)
Batch #: A8B60170S0
Purity: 63.81% w/w glyphosate isopropylamine salt (a.i.), corresponding to 47.28% w/w glyphosate acid
equivalent (a.e.)
Stability of test compound: stable under ambient conditions
Expiry Date: January 25, 2012
ii) Labeled ingredient: 14C glyphosate (as glyphosate acid)
Description: off white solid
Lot #: 53463-3-23
Purity: 99.8%
Specific Activity: 47 mCi/mol
Stability of test compound: stable under deep freeze (-20°C)
iii) Unlabeled ingredient: Proprietary surfactant blend (MON 8153)
Page 21 / 35
Batch #: not reported
2. Test System: Human excised skin obtained from a tissue bank (not specified in the original study
report) that was immersed in water at 600C for 40-45 seconds to separate the epidermis; glass diffusion
cells and physiological saline
Temperature: Water bath at 32 ºC ± 1 ºC
B. STUDY DESIGN AND METHODS:
The absorption and distribution of glyphosate from an SL formulation (MON 52276) were measured in
vitro using heat-separated human epidermis samples conforming to OECD 428. The doses were applied
as the concentrate formulation (360 g glyphosate/L) and as 1:12.5 v/v and 1:150 v/v (nominally 28.8 and
2.4 g glyphosate /L) aqueous spray strength dilutions of the formulation. The doses were applied to
human epidermal membranes at a rate of 10 µL/cm2 and left unoccluded for an exposure period of 24
hours.
Each dose was tested in up to six diffusion cells with intact membranes from at least three different
donors. The receptor chambers of the cells containing small magnetic stirrer bars were filled with a
recorded volume of receptor fluid (physiological saline) and placed in a water bath maintained at a
temperature of 32 ºC ± 1 ºC. The physiological saline receptor fluid was chosen to ensure that the test
substance could freely partition into the receptor fluid from the skin membrane and never reached a
concentration that would limit its diffusion.
The formulation was applied to the skin membranes and left unoccluded for the duration of the exposure
period (24 hours).
1. In life dates: 9 June to 26 August 2009
2. Test procedures
a) Assembly of diffusion cells
The type of glass diffusion cell used in this study had an exposed membrane area of 2.54 cm2. Discs of
approximately 3.3 cm diameter of prepared skin membrane from several different skin samples were
mounted, dermal side down, in diffusion cells held together with individually numbered clamps. The total
volume of the receptor fluid chamber was approximately 4.5 mL.
b) Assessment of membrane integrity
Membrane integrity was assessed by measurement of electrical resistance across the membrane.
Membranes with a resistance <10 kΩ were discarded. After the completion of the integrity assessment,
the contents of the donor and receptor chambers were discarded.
c) Selection of cells and dosing
The area of epidermis exposed to the test formulation in each cell was 2.54 cm2, with 10 uL/ cm2 applied
to each diffusion cell. Glyphosate concentrations for each dose were 3693 µg ai/cm2 (formulation
concentrate), 296 µg ai/cm2 (1:12.5 dilution) and 25.2 µg ai/cm2 (1:150 dilution).
Where necessary, the applications were spread over the surface of the epidermis using silicone rubber
loops or glass rods. These spreaders were extracted with deionised water (5 mL) and samples were
analysed for inclusion in mass balance determinations. After dosing, the cells were replaced in a water
bath maintained at 32 °C ± 1°C. The applications were left unoccluded, for the 24 hour duration of
exposure.
d) Sampling of receptor fluid
Samples of the receptor fluid (500 µL) were taken from the receptor chambers at 0.5, 1, 2, 3, 4, 6, 8, 10,
12, 16, 20 and 24 hours after application. The receptor chambers were stirred continuously and the
volume of fluid in the receptor chamber maintained by the replacement of a volume of fresh receptor
fluid, equal to the sample volume, after each sample was taken.
e) Measurement of mass balance
The amount of radioactivity in the receptor fluid was determined by liquid scintillation counting (LSC).
All apparatus and epidermis upper surface were washed with deionised water and Teepol® L and
sponged thoroughly until decontamination appeared complete or until it was apparent that radiolabel may
be being extracted from the epidermis using a Geiger counter. All sponges were digested in Soluene
350®. The digests were made up to a recorded volume and a sample taken for LSC analysis.
To assess penetration through human stratum corneum/epidermis, a tape stripping technique was
employed. The surface of the skin was allowed to dry naturally, prior to the removal of successively
Page 22 / 35
deeper layers of the stratum corneum by the repeated application of adhesive tape (Scotch 3M Magic
Tape, 1.9 cm wide)(Ramsey et al, 1994) up to a maximum of 5 strips. The strips were extracted
individually for approximately 20 hours in a solution of 30% v/v methanol in water. The extracts were
sequentially numbered and analysed by LSC. If the epidermis started to tear and/or pieces came away
during the tape stripping procedure, the process was terminated as soon as noticed. In such cases, the last
strip taken was digested with the remaining epidermis to avoid underestimating residual penetrant in the
epidermis. The total number of tape strips was recorded for each epidemis sample. The remaining
epidermis was then carefully removed from the receptor chamber and digested in Soluene 350®, together
with the final tape strip taken if tearing had occurred, and analysed by LSC. In case any test material had
washed into the receptor chamber during decontamination, the inside of the chamber and the grid were
rinsed with receptor fluid (5 ml) and the rinsate added to the 24 hour skin wash digest.
3. Statistics
This type of data does not warrant statistical analysis, other than group means and standard deviations.
II. RESULTS AND DISCUSSION
The achieved concentrations of glyphosate (acid) in the dose preparations were 369.3, 29.6, and 2.52 g
glyphosate/L in the formulation concentrate and the two dilutions, respectively, an in all cases, sufficient
homogeneity was proven.
The overall total recovery for the three dose levels was good, with mean values of 99.0 – 101 % of the
applied dose.
Glyphosate absorption from the 360 g/L concentrate formulation was essentially constant over the entire
24 hour exposure period with a mean rate of 0.014 µg/cm2/h. By the end of the exposure period, the mean
total amount of absorbed glyphosate in the receptor fluid was extremely low with only 0.322 µg/cm2
(0.009% of applied dose).
From the intermediate and low-dose aqueous dilutions of the formulation, absorption was fastest during
the early period of absorption, with 0.010 µg/cm2/h (0-1h) and 0.004 µg/cm2/h (0-2h), respectively. The
rates after this early period until the end of the exposure at 24 h were 0.003 µg/cm2/h and 0.001 µg/cm2/h
for the intermediate and low dose dilutions, respectively. At the end of the exposure period, the mean
total amounts of absorbed glyphosate in the receptor fluid were 0.086 and 0.023 µg/cm2 (0.029% and
0.092% of applied dose), respectively.
In all concentrations, the vast majority of the applied glyphosate was removed from the surface of the
epidermis during the washing procedure at the end of the 24-hour exposure period (mean 97.4-99.0%).
The amounts that were detected in the tape strips and the remaining epidermis (after tape stripping) were
low.
In the three following tables, distribution of the radioactivity to the different compartments of the test
system is given for the three concentrations on test.
Table A 8: Formulation concentrate; n=4*
Compartment
Donor chamber
Skin wash (at 24h
Stratum corneum
Remaining in
epidermis
Receptor fluid
(absorbed)
Potentially absorbable
Mean recovered (ug/cm2)
83.4
3656
2.39
2.02
SD
167
181
0.711
0.820
SEM
83.4
90.3
0.355
0.410
Mean % of dose
2.26
99.0
0.065
0.055
0.322
0.318
0.159
0.009
2.343
0.680
0.340
0.063
Page 23 / 35
(without tape strips)
Mass balance
3744
104
51.8
101
* Two cells excluded as the analytical data indicated that epidermal membranes may have been damaged
during application.
Table A 9: 1/12.5 v/v Aqueous dilution; n=6
Compartment
Donor chamber
Skin wash at 24h
Stratum corneum
Remaining in
epidermis
Receptor fluid
(absorbed)
Potentially absorbable
(without tape strips)
Mass balance
Mean recovered (ug/cm2)
6.67
288
0.386
0.310
SD
6.12
5.54
0.371
0.143
SEM
2.50
2.26
0.152
0.058
Mean % of dose
2.26
97.4
0.130
0.105
0.086
0.038
0.016
0.029
0.396
0.121
0.049
0.134
296
4.45
1.82
100
Table A 10: 1/150 v/v aqueous dilution; n=4*
Compartment
Mean recovered (ug/cm2) SD
SEM
Mean % of dose
Donor chamber
<LOQ
0
0.008
Skin wash at 24 h
31.7
0.496
0.248
98.4
Stratum corneum
0.045
0.082
0.041
0.320
Remaining in
0.241
0.041
0.021
0.185
epidermis
Receptor fluid
0.015
0.017
0.009
0.092
(absorbed)
Potentially absorbable 0.256
0.046
0.023
0.276
Mass balance
32.0
0.540
0.270
99.0
* Two cells excluded as the analytical data indicated that epidermal membranes may have been damaged
during application.
The applicant as well as the study author had excluded the whole amount in the tape strips as nonabsorbed from the calculation. However, if recent guidance documents are followed (e.g., OECD, 2011),
only the radioactivity that was found in the first upper tape strips should be excluded although this
approach is subject on ongoing discussions. If the different tape strips were not analysed separately or if
the results of this analysis were not reported (as it was the case in this study), the whole amount in the
tape strips should be considered as “potentially absorbable”. For the concentrate, this approach would
give a still very low estimate of about 0.118 % of the total dose. For the low dilution, dermal absorption
would be 0.264% and for the high dilution 0.596%. These are worst-case assumption because it can be
expected that a major part of the material retained in the stratum corneum would be lost by desquamation
and not become systemically available.
III. CONCLUSIONS
The results of this in vitro dermal absorption study with a 360 g glyphosate /L SL formulation (MON
52276) indicate that the absorption of glyphosate through human epidermis is very low. The amount of
potentially biologically available glyphosate (absorbed + epidermis after tape striping) for the
concentrate, intermediate and low dose dilutions accounted 0.064%, 0.134% and 0.277% respectively.
This data was obtained following extraction with five tape strips instead of the standard two tape strips.
This could potentially lead to a certain underestimation of the absorbable amount. However, even if the
whole radioactivity in the tape strips would be included, dermal absorption would never exceed 0.6%.
Page 24 / 35
Thus, dermal absorption can be estimated in any case to be below 1 % and a conservative, rounded
dermal uptake value of 1% was proposed by the applicant for the purpose of the exposure assessment
which is sufficient to outweigh a possible impact of the number of tape strips.
Because of the similarity of the two formulations, it is proposed to use a value of 1% to estimate dermal
absorption of Tender GB Ultra, based on the study on MON 52276. This is considered more appropriate
then the dermal penetration rate of 3% as calculated in the EU evaluation. The results obtained in this in
vitro study indicate that the absorption of glyphosate through human epidermis is very low and that the
vast majority of glyphosate will be washed off the skin during normal washing procedures.
Additional references mentioned in this section:
OECD (2011): Guidance Notes on Dermal Absorption. ENV/JM/WRPR(2011)30, Environment
Directorate, Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides
and Biotechnology, 20/06/11; www.oecd.org/dataoecd/0/1/46257610.pdf
EFSA (2012): Guidance on Dermal Absorption. Scientific Opinion, EFSA Panel on Plant Protection
Products and their Residues (PPR). EFSA J. 2012, 10(4), 2665
Page 25 / 35
Exposure calculations
A 2.11
Operator exposure calculations (IIIA1 7.3.1)
A 2.11.1
Calculations for glyphosate
Table A 11:
Input parameters considered for the estimation of operator exposure (FCTM)
Formulation type:
Application rate (AR):
Area treated per day (A):
Dermal absorption (DA):
Inhalation absorption (IA):
Body weight (BW):
AOEL
Table A 12:
SL
3.6
20
1
1
100
70
0.2
kg a.s./ha
ha
% (concentr.)
% (dilution)
%
kg/person
mg/kg bw/d
Application technique:
Field Crop Tractor Mounted
Dermal hands m/l (DM(H)):
Dermal hands appl. (DA(H)):
Dermal body appl. (DA(B)):
Dermal head appl. (DA(C)):
Inhalation m/l (IM):
Inhalation appl. (IA):
2.4
0.38
1.6
0.06
0.0006
0.001
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
Estimation of operator exposure towards glyphosate using the German model
(FCTM)
Without PPE
Operators: Dermal exposure
Dermal mixing/loading
Hands
SDEOM(H) = (DM(H) x AR x A x DA) / BW
(2.4 x 3.6 x 20 x 1%) / 70
External exposure
172.8 mg/person
External exposure
2.468571 mg/kg bw/d
Absorbed dose
0.024686 mg/kg bw/d
Dermal application
Hands
SDEOA(H) = (DA(H) x AR x A x DA) / BW
(0.38 x 3.6 x 20 x 1%) / 70
External exposure
27.36 mg/person
External exposure
0.390857 mg/kg bw/d
Absorbed dose
0.003909 mg/kg bw/d
Body
SDEOA(B) = (DA(B) x AR x A x DA) / BW
(1.6 x 3.6 x 20 x 1%) / 70
External exposure
115.2 mg/person
External exposure
1.645714 mg/kg bw/d
Absorbed dose
0.016457 mg/kg bw/d
Head
SDEOA(C) = (DA(C) x AR x A x DA) / BW
(0.06 x 3.6 x 20 x 1%) / 70
External exposure
4.32 mg/person
External exposure
0.061714 mg/kg bw/d
Absorbed dose
0.000617 mg/kg bw/d
Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) +
SDEOA(B) + SDEOA(C)
Total dermal external exposure
319.68 mg/person
4.566857
mg/kg bw/d
Total dermal absorbed dose
0.045669
mg/kg bw/d
With PPE
Hands
SDEOM(H) = (DM(H) x AR x A x PPE 1) x DA) / BW
(2.4 x 3.6 x 20 x 0.01 x 1%) / 70
External exposure
1.728 mg/person
External exposure
0.024686 mg/kg bw/d
Absorbed dose
0.000247 mg/kg bw/d
Hands
SDEOA(H) = (DA(H) x AR x A x PPE 1) x DA) / BW
(0.38 x 3.6 x 20 x 1 x 1%) / 70
External exposure
27.36 mg/person
External exposure
0.390857 mg/kg bw/d
Absorbed dose
0.003909 mg/kg bw/d
Body
SDEOA(B) = (DA(B) x AR x A x PPE x DA) / BW
(1.6 x 3.6 x 20 x 1 x 1%) / 70
External exposure
115.2 mg/person
External exposure
1.645714 mg/kg bw/d
Absorbed dose
0.016457 mg/kg bw/d
Head
SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW
(0.06 x 3.6 x 20 x 1 x 1%) / 70
External exposure
4.32 mg/person
External exposure
0.061714 mg/kg bw/d
Absorbed dose
0.000617 mg/kg bw/d
Total systemic dermal exposure: SDEO = SDEOM(H) +
SDEOA(H) + SDEOA(B) + SDEOA(C)
Total dermal external
148.608 mg/person
exposure
2.122971 mg/kg bw/d
exposure
Total dermal
0.02123 mg/kg bw/d
absorbed dose
Operators: Inhalation exposure after application on railway tracks and non-cultivated land
Inhalation mixing/loading
SIEOIM = (IM x AR x A x IA) / BW
SIEOIM = (IM x AR x A x PPE x IA) / BW
(0.0006 x 3.6 x 20 x 100%) / 70
(0.0006 x 3.6 x 20 x 1 x 100%) / 70
External exposure
0.0432 mg/person
External exposure
0.0432
mg/person
External exposure
0.000617 mg/kg bw/d
External exposure
0.000617
mg/kg bw/d
Absorbed dose
0.000617 mg/kg bw/d
Absorbed dose
0.000617
mg/kg bw/d
Inhalation application
Page 26 / 35
SIEOIA = (IA x AR x A x IA) / BW
(0.001 x 3.6 x 20 x 100%) / 70
External exposure
0.072 mg/person
External exposure
0.001029 mg/kg bw/d
Absorbed dose
0.001029 mg/kg bw/d
Total systemic inhalation exposure: SIEO = SIEOM + SIEOA
Total inhalation external exposure
0.1152
0.001646
mg/kg bw/d
Total inhalation absorbed dose
0.001646
mg/kg bw/d
Total systemic exposure: SEO = SDEO + SIEO
Total systemic exposure (absorbed
3.312
dose)
Total systemic exposure
(absorbed dose)
0.047314
SIEOIA = (IA x AR x A x PPE x IA) / BW
(0.001 x 3.6 x 20 x 1 x 100%) / 70
External exposure
0.072 mg/person
External exposure
0.001029 mg/kg bw/d
Absorbed dose
0.001029 mg/kg bw/d
Total systemic inhalation exposure: SIEO = SIEOM +
SIEOA
Total inhalation
0.1152 mg/person
external exposure
Total inhalation
0.001646 mg/kg bw/d
external exposure
Total inhalation
0.001646 mg/kg bw/d
absorbed dose
Total systemic
1.60128 mg/person
exposure (absorbed
dose)
Total systemic
0.022875
mg/kg bw/d
exposure (absorbed
dose)
% of AOEL
11.4 %
mg/person
mg/person
mg/kg bw/d
% of AOEL
23.7 %
1)
reduction factor for gloves is 0.01 (professional appl.)
Table A 13:
Input parameters considered for the estimation of operator exposure (HCHH)
Formulation type:
Area treated per day (A):
Inhalation absorption (IA):
Body weight (BW):
AOEL
Table A 14:
SL
3.6
20
1
1
100
70
0.2
Application technique:
kg a.s./ha
ha
% (concentr.)
% (dilution)
%
kg/person
mg/kg bw/d
Dermal hands m/l (DM(H)):
Dermal hands appl. (DA(H)):
Dermal body appl. (DA(B)):
Dermal head appl. (DA(C)):
Inhalation m/l (IM):
Inhalation appl. (IA):
High Crops, Hand Held
205
10.6
25
4.8
0.05
0.3
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
mg/person/kg a.s.
Estimation of operator exposure towards glyphosate using the German model
(HCHH)
Without PPE
Operators: Dermal exposure
Dermal mixing/loading
Hands
SDEOM(H) = (DM(H) x AR x A x DA) / BW
(205 x 3.6 x 1 x 1%) / 70
External exposure
738
External exposure
10.542857
Absorbed dose
0.105429
Dermal application
Hands
SDEOA(H) = (DA(H) x AR x A x DA) / BW
(0.38 x 3.6 x 20 x 1%) / 70
External exposure
38.16
External exposure
0.545143
Absorbed dose
0.005451
Body
SDEOA(B) = (DA(B) x AR x A x DA) / BW
(1.6 x 3.6 x 20 x 1%) / 70
External exposure
90
External exposure
1.285714
Absorbed dose
0.012857
Head
SDEOA(C) = (DA(C) x AR x A x DA) / BW
(4.8 x 3.6 x 1 x 1%) / 70
External exposure
17.28
With PPE
mg/person
mg/kg bw/d
mg/kg bw/d
mg/person
mg/kg bw/d
mg/kg bw/d
mg/person
mg/kg bw/d
mg/kg bw/d
mg/person
Hands
SDEOM(H) = (DM(H) x AR x A x PPE 1) x DA) / BW
(205 x 3.6 x 1 x 0.01 x 1%) / 70
External exposure
7.38 mg/person
External exposure
0.105429 mg/kg bw/d
Absorbed dose
0.001054 mg/kg bw/d
Hands
SDEOA(H) = (DA(H) x AR x A x PPE 1) x DA) / BW
(0.38 x 3.6 x 20 x 1 x 1%) / 70
External exposure
38.16 mg/person
External exposure
0.545143 mg/kg bw/d
Absorbed dose
0.005451 mg/kg bw/d
Body
SDEOA(B) = (DA(B) x AR x A x PPE x DA) / BW
(1.6 x 3.6 x 20 x 1 x 1%) / 70
External exposure
90 mg/person
External exposure
1.285714 mg/kg bw/d
Absorbed dose
0.012857 mg/kg bw/d
Head
SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW
(4.8 x 3.6 x 1 x 1 x 1%) / 70
External exposure
17.28 mg/person
Page 27 / 35
External exposure
0.246857 mg/kg bw/d
Absorbed dose
0.002469 mg/kg bw/d
Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) +
SDEOA(B) + SDEOA(C)
883.44 mg/person
External exposure
0.246857 mg/kg bw/d
Absorbed dose
0.002469 mg/kg bw/d
Total systemic dermal exposure: SDEO = SDEOM(H) +
SDEOA(H) + SDEOA(B) + SDEOA(C)
152.82 mg/person
exposure
12.620571 mg/kg bw/d
2.183143 mg/kg bw/d
exposure
Total dermal absorbed dose
0.126206 mg/kg bw/d
Total dermal
0.021831 mg/kg bw/d
absorbed dose
Operators: Inhalation exposure after application railway tracks and non-cultivated land
Inhalation mixing/loading
SIEOIM = (IM x AR x A x IA) / BW
SIEOIM = (IM x AR x A x PPE x IA) / BW
(0.05 x 3.6 x 1 x 100%) / 70
(0.05 x 3.6 x 1 x 1 x 100%) / 70
External exposure
0.18 mg/person
External exposure
0.18
mg/person
External exposure
0.002571 mg/kg bw/d
External exposure
0.002571 mg/kg bw/d
Absorbed dose
0.002571 mg/kg bw/d
Absorbed dose
0.002571 mg/kg bw/d
Inhalation application
SIEOIA = (IA x AR x A x IA) / BW
SIEOIA = (IA x AR x A x PPE x IA) / BW
(0.3 x 3.6 x 1 x 100%) / 70
(0.3 x 3.6 x 1 x 1 x 100%) / 70
External exposure
1.08 mg/person
External exposure
1.08 mg/person
External exposure
0.015429 mg/kg bw/d
External exposure
0.015429 mg/kg bw/d
Absorbed dose
0.015429 mg/kg bw/d
Absorbed dose
0.015429 mg/kg bw/d
Total systemic inhalation exposure: SIEO = SIEOM + SIEOA
Total systemic inhalation exposure: SIEO = SIEOM +
SIEOA
1.26 mg/person
Total inhalation
1.26 mg/person
external exposure
0.018 mg/kg bw/d
Total inhalation
0.018 mg/kg bw/d
external exposure
Total inhalation absorbed dose
0.018 mg/kg bw/d
Total inhalation
0.018 mg/kg bw/d
absorbed dose
10.0944 mg/person
Total systemic
2.7882 mg/person
dose)
exposure (absorbed
dose)
Total
systemic
exposure 0.144206
mg/kg bw/d
Total systemic
0.039831
mg/kg bw/d
(absorbed dose)
exposure (absorbed
dose)
% of AOEL
72.1 %
% of AOEL
19.9 %
1)
reduction factor for gloves is 0.01 (professional appl.)
Table A 15:
Estimation of operator exposure towards glyphosate using the UK-POEM
(FCTM), without PPE
THE UK PREDICTIVE OPERATOR EXPOSURE MODEL (POEM)
Active substance
Glyphosate
Product
Tender GB Ultra
Formulation type
water-based
Concentration of a.s.
360 mg/mL
Dose
10 L preparation/ha
(3.6 kg a.s./ha)
Application volume
500 L/ha
Application method
Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Container
10 litres 63 mm closure
Work rate/day
50 ha
Duration of spraying
6 h
PPE during mix./loading
None
PPE during application
None
Dermal absorption from product
1 %
Dermal absorption from spray
1 %
EXPOSURE DURING MIXING AND LOADING
Container size
10 Litres
Page 28 / 35
Hand contamination/operation
0,05 mL
Application dose
10 Litres product/ha
Work rate
50 ha/day
Number of operations
50 /day
Hand contamination
2.5 mL/day
Protective clothing
None
Transmission to skin
100 %
Dermal exposure to formulation
2.5 mL/day
DERMAL EXPOSURE DURING SPRAY APPLICATION
Application technique
Application volume
500 spray/ha
Volume of surface contamination
10 mL/h
Distribution
Hands
Trunk
Legs
65%
10%
25%
Clothing
None
Permeable
Permeable
Penetration
100%
5%
15%
Dermal exposure
6.5
0.05
0.375
Duration of exposure
6 h
Total dermal exposure to spray
41.55 mL/day
ABSORBED DERMAL DOSE
Mix/load
Application
Dermal exposure
2.5 mL/day
41.55
Concen. of a.s. product or spray
360 mg/mL
7.2
Dermal exposure to a.s.
900 mg/day
299.16
Percent absorbed
1 %
1
Absorbed dose
9 mg/day
2.992
INHALATION EXPOSURE DURING SPRAYING
Inhalation exposure
0.01 mL/h
6 h
Concentration of a.s. in spray
7.2 mg/mL
Inhalation exposure to a.s.
0.432 mg/day
Percent absorbed
100 %
Absorbed dose
0.432 mg/day
PREDICTED EXPOSURE
Total absorbed dose
12.424 mg/day
Operator body weight
60 kg
Operator exposure
0.207 mg/kg bw/day
Amount of AOEL
Table A 16:
mL/h
mL/day
mg/mL
mg/day
%
mg/day
103.5 %
(FCTM), with PPE (gloves during mixing/loading)
Active substance
Glyphosate
Product
Tender GB Ultra
Formulation type
water-based
360 mg/mL
Dose
10 L preparation/ha
(3.6 kg a.s./ha)
Application volume
500 L/ha
Application method
Container
Work rate/day
50 ha
6 h
Gloves
None
1 %
1 %
Page 29 / 35
Container size
10 Litres
0,05 mL
Application dose
Work rate
50 ha/day
50 /day
Hand contamination
2.5 mL/day
Protective clothing
Gloves
5 %
0.125 mL/day
Application volume
500 spray/ha
10 mL/h
Distribution
Hands
Trunk
Legs
65%
10%
25%
Clothing
None
Permeable
Permeable
Penetration
100%
5%
15%
Dermal exposure
6.5
0.05
0.375
6 h
41.55 mL/day
Mix/load
Application
Dermal exposure
0.125 mL/day
41.55
360 mg/mL
7.2
45 mg/day
299.16
Percent absorbed
1 %
1
Absorbed dose
0.45 mg/day
2.992
Inhalation exposure
0.01 mL/h
6 h
7.2 mg/mL
0.432 mg/day
Percent absorbed
100 %
Absorbed dose
0.432 mg/day
PREDICTED EXPOSURE
Total absorbed dose
3.874 mg/day
60 kg
Operator exposure
0.065 mg/kg bw/day
Amount of AOEL
Table A 17:
mL/h
mL/day
mg/mL
mg/day
%
mg/day
32.3 %
(LCHH), without PPE
Active substance
Glyphosate
Product
Tender GB Ultra
Formulation type
water-based
360 mg/mL
Dose
10 L preparation/ha
(3.6 kg a.s./ha)
Application volume
500 L/ha
Application method
Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level target
Container
Work rate/day
0.8 ha
6 h
None
None
1 %
Page 30 / 35
1
%
Container size
10 Litres
0,05 mL
Application dose
Work rate
0.8 ha/day
27 /day
Hand contamination
1.35 mL/day
Protective clothing
None
100 %
1.35 mL/day
Application volume
500 spray/ha
50 mL/h
Distribution
Hands
Trunk
Legs
25%
25%
50%
Clothing
None
Permeable
Permeable
Penetration
100%
20%
18%
Dermal exposure
10
2.5
4.5 mL/h
6 h
102 mL/day
Mix/load
Application
Dermal exposure
1.35 mL/day
102 mL/day
360 mg/mL
7.2 mg/mL
486 mg/day
734.4 mg/day
Percent absorbed
1 %
1 %
Absorbed dose
4.86 mg/day
7.344 mg/day
Inhalation exposure
0.02 mL/h
6 h
7.2 mg/mL
0.864 mg/day
Percent absorbed
100 %
Absorbed dose
0.864 mg/day
PREDICTED EXPOSURE
Total absorbed dose
13.068 mg/day
60 kg
Operator exposure
0.218 mg/kg bw/day
Amount of AOEL
Table A 18:
108.9 %
(LCHH), with PPE (gloves during mixing/loading)
Active substance
Glyphosate
Product
Tender GB Ultra
Formulation type
water-based
360 mg/mL
Dose
10 L preparation/ha
(3.6 kg a.s./ha)
Application volume
500 L/ha
Application method
Container
Work rate/day
0.8 ha
6 h
Gloves
None
Page 31 / 35
1
1
%
%
Container size
10 Litres
0,05 mL
Application dose
Work rate
0.8 ha/day
27 /day
Hand contamination
1.35 mL/day
Protective clothing
Gloves
5 %
0.068 mL/day
Application volume
500 spray/ha
50 mL/h
Distribution
Hands
Trunk
Legs
25%
25%
50%
Clothing
None
Permeable
Permeable
Penetration
100%
20%
18%
Dermal exposure
10
2.5
4.5 mL/h
6 h
102 mL/day
Mix/load
Application
Dermal exposure
0.068 mL/day
102 mL/day
360 mg/mL
7.2 mg/mL
24.3 mg/day
734.4 mg/day
Percent absorbed
1 %
1 %
Absorbed dose
0.243 mg/day
7.344 mg/day
Inhalation exposure
0.02 mL/h
6 h
7.2 mg/mL
0.864 mg/day
Percent absorbed
100 %
Absorbed dose
0.864 mg/day
PREDICTED EXPOSURE
Total absorbed dose
8.451 mg/day
60 kg
Operator exposure
0.141 mg/kg bw/day
Amount of AOEL
70.4 %
Page 32 / 35
A 2.12
Worker exposure calculations (IIIA1 7.5.1)
A 2.12.1
Table A 19:
Input parameters considered for the estimation of worker exposure
Intended uses:
Number of applications (NA):
Body weight (BW):
AOEL
Table A 20:
Railway and noncultivated land
3.6 kg a.s./ha
1
60 kg/person
1 % (worst case)
0.2 mg/kg bw/d
Dislodgeable foliar
residues (DFR):
Transfer coefficient (TC):
Work rate per day (WR):
PPE
1
5000
8
5
µg/cm2/kg a.s.
cm2/person/h
h/d
%
Estimation of worker exposure towards glyphosate using the German re-entry
model
Without PPE 1)
With PPE 2)
Worker (re-entry): Dermal exposure after application
SDEW = (DFR x TC x WR x AR x NA x DA) / BW
SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW
(1 x 5000 x 2 x 3.6 x 1 x 1%) / 60
(1 x 5000 x 2 x 3.6 x 1 x 5% x 1%) / 60
External exposure
36 mg/person
External exposure
1.8 mg/person
External exposure
0.6 mg/kg bw/d
External exposure
0.03 mg/kg bw/d
0.36 mg/person
0.018 mg/person
dose)
(absorbed dose)
0.006 mg/kg bw/d
0.0003 mg/kg bw/d
(absorbed dose)
(absorbed dose)
% of AOEL
3 %
% of AOEL
0.2 %
1)
No PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves
2)
With PPE: see ‘Instruction for use’
Page 33 / 35
A 2.13
Bystander and resident exposure calculations (IIIA1 7.4.1)
A 2.13.1
Table A 21:
Intended use(s):
Input parameters considered for the estimation of bystander exposure
Railway and non-cultivated
land
3.6 kg a.s./ha
60
Body weight (BW):
16.15
kg/person (adults)
Intended use(s):
Number of applications
(NA):
Body weight (BW):
Dermal absorption
(DA):
Inhalation absorption
(IA):
Oral absorption (OA)
AOEL
% (HC, 3 m)
Exposed Body Surface
Area (BSA):
Specific Inhalation
Exposure (I*A):
1
0.21
0.3
m² (adults)
m² (children)
mg/kg a.s. (6
hours, adults)
mg/kg a.s. (6
hours, children)
ha/d (based on )
min
0.172414
Area Treated (A):
Exposure duration (T):
1
5
Estimation of bystander exposure towards glyphosate
Adults
Bystander: Dermal exposure (via spray drift)
SDEB = (AR x D x BSA x DA) / BW
(360 x 8.02% x 1 x 1%) / 60
External exposure
28.872 mg/person
External exposure
0.4812 mg/kg bw/d
Absorbed dose:
0.004812 mg/kg bw/d
Bystander: Inhalation exposure via spray drift)
SIEB = (I*A x AR x A x T x IA) / BW
(0.3 / 360 x 3.6 x 1 x 5 x 100%) / 60
External exposure
0.015 mg/person
External exposure
0.00025 mg/kg bw/d
Absorbed dose:
0.00025 mg/kg bw/d
Total systemic exposure: SEB = SDEB + SIEB
0.30372 mg/person
(absorbed dose)
0.005062 mg/kg bw/d
(absorbed dose)
% of AOEL:
2.53 %
Table A 23:
8.02
kg/person (children)
1 % ('worst case')
100 %
Inhalation absorption
(IA):
0.2 mg/kg bw/d
AOEL:
* ‘worst case’ for hand-held applications
Table A 22:
Drift (D):
Children
SDEB = (AR x D x BSA x DA) / BW
(360 x 8.02% x 0.21 x %) / 16.15
External exposure
6.06312
External exposure
0.375425
Absorbed dose:
0.003754
mg/person
mg/kg bw/d
mg/kg bw/d
SIEB = (I*A x AR x A x T x IA) / BW
(0.172414 / 360 x 3.6 x 1 x 5 x 100%) / 16.15
External exposure
0.008621 mg/person
External exposure
0.000534 mg/kg bw/d
Absorbed dose:
0.000534 mg/kg bw/d
Total systemic exposure: SEB = SDEB + SIEB
0.069252 mg/person
(absorbed dose)
0.004288 mg/kg bw/d
(absorbed dose)
% of AOEL:
2.14 %
Input parameters considered for the estimation of resident exposure
3.6
kg a.s./ha
Deposit (D):
Transfer coefficient (TC):
kg/person (adults)
kg/person
(children)
% ('worst case')
Turf Transferable Residues
(TTR):
Exposure Duration (H):
Airborne Concentration of
Vapour (ACV):
Inhalation Rate (IR):
1
60
16.15
1
100
%
30
0.2
%
mg/kg bw/d
100
7300
2600
5
% ‘worst case’
cm2/h (adults)
cm2/h (children)
%
2
0.001
h
16.57
m3/d (adults)
8.31
Saliva Extraction Factor (SE):
Surface Area of Hands (SA):
Frequency of Hand to Mouth
(Freq):
Dislodgeable foliar residues
(DFR):
Ingestion Rate for Mouthing of
Grass/Day (IgR):
Page 34 / 35
m3/d (children)
50
20
20
%
cm2
events/h
20
%
25
cm2/d
Table A 24:
Estimation of resident exposure towards glyphosate
Adults
Children
Residents: Dermal exposure after application (via deposits caused by spray drift)
SDER = (AR x NA x D x TTR x TC x H x DA) / BW
SDER = (AR x NA x D x TTR x TC x H x DA) / BW
(0.036 x 1 x 100% x 5% x 7300 x 2 x 1%) / 60
(0.036 x 1 x 100% x 5% x 2600 x 2 x 1%) / 16.15
External exposure
26.28 mg/person
External exposure
9.36 mg/person
External exposure
0.438 mg/kg bw/d
External exposure
0.579567 mg/kg bw/d
Absorbed dose:
0.00438 mg/kg bw/d
Absorbed dose:
0.005796 mg/kg bw/d
Residents: Inhalation exposure to vapour
SIER = (ACV x IR x IA) / BW
SIER = (ACV x IR x IA) / BW
(0 x 16.57 x 100%) / 60
(0 x 8.31 x 100%) / 16.15
External exposure
0.01657
mg/person
External exposure
0.00831
mg/person
External exposure
0.000276 mg/kg bw/d
External exposure
0.000515 mg/kg bw/d
Absorbed dose:
0.000276 mg/kg bw/d
Absorbed dose:
0.000515 mg/kg bw/d
Residents: Oral exposure (hand-to-mouth transfer)
SOEH = (AR x NA x D x TTR x SE x SA x Freq x H x OA) / BW
(0.036 x 1 x % x 5% x 50% x 20 x 20 x 2 x 30%) / 16.15
External exposure
0.72 mg/person
External exposure
0.044582 mg/kg bw/d
Absorbed dose
0.013375 mg/kg bw/d
Residents: Oral exposure (object-to-mouth transfer)
SOEO = (AR x NA x D x DFR x IgR x OA) / BW
(0.036 x 1 x % x 20% x 25 x 30%) / 16.15
External exposure
0.18
mg/person
External exposure
0.011146 mg/kg bw/d
Absorbed dose
0.003344 mg/kg bw/d
Total systemic exposure: SER = SDER + SIER
Total systemic exposure: SER = SDER + SIER + SOEH + SOEO
0.27937 mg/person
0.37191 mg/person
(absorbed dose)
(absorbed dose)
Total systemic exposure 0.004656 mg/kg bw/d
0.023028 mg/kg bw/d
(absorbed dose)
(absorbed dose)
% of AOEL:
2.33 %
% of AOEL:
11.51 %
Page 35 / 35
Ultra (MON 78708) – ZV1 043981-00/00
REGISTRATION REPORT
Part B
Section 4: Metabolism and Residues
Product code:
Tender GB Ultra
(MON 78708)
Active Substance:
Glyphosate, 360 g/L
Central Zone
CORE ASSESSMENT
Date:
24/03/2014
Page 1 / 13
Ultra (MON 78708) – ZV1 043981-00/00
Table of Contents
IIIA 8
METABOLISM AND RESIDUES DATA .........................................................................3
IIIA 8.1
Evaluation of the active substances .....................................................................................3
IIIA 8.1.1
Glyphosate...........................................................................................................................3
IIIA 8.1.1.1
Storage stability ...................................................................................................................3
IIIA 8.1.1.2
Metabolism in plants and plant residue definition(s)...........................................................3
IIIA 8.1.1.3
Metabolism in livestock and animal residue definition(s)...................................................5
IIIA 8.1.1.4
Residues in rotational crops.................................................................................................5
IIIA 8.1.1.5
Residues in livestock ...........................................................................................................5
IIIA 8.2
Evaluation of the intended use(s) ........................................................................................7
IIIA 8.2.1
Selection of critical use and justification.............................................................................7
IIIA 8.2.2
Railway tracks, non-cultivated land without woody plants...............................................10
IIIA 8.2.2.1
Residues in primary crops .................................................................................................10
IIIA 8.2.2.2
Distribution of the residue in peel/pulp .............................................................................10
IIIA 8.2.2.3
Residues in processed commodities ..................................................................................10
IIIA 8.2.2.4
Proposed pre-harvest intervals, withholding periods.........................................................10
IIIA 8.3
Consumer intake and risk assessment................................................................................10
IIIA 8.3.1
Glyphosate.........................................................................................................................10
IIIA 8.4
Proposed maximum residue levels (MRLs) ......................................................................11
IIIA 8.5
Conclusion.........................................................................................................................11
Appendix 1
List of data submitted in support of the evaluation ...........................................................12
Appendix 2
Detailed evaluation of the additional studies relied upon..................................................12
A 2.1
Storage stability .................................................................................................................12
A 2.2
Residues in primary crops .................................................................................................12
A 2.3
Residues in processed commodities ..................................................................................12
A 2.4
Residues in rotational crops...............................................................................................12
A 2.5
Residues in livestock .........................................................................................................12
A 2.6
Other studies/information ..................................................................................................12
Appendix 3
Pesticide Residue Intake Model (PRIMo) .........................................................................13
Page 2 / 13
Ultra (MON 78708) – ZV1 043981-00/00
IIIA 8
METABOLISM AND RESIDUES DATA
IIIA 8.1
Evaluation of the active substances
IIIA 8.1.1
Glyphosate
Table 8.1-1:
Information on the active substance glyphosate
Structural formula
Common Name
IIIA 8.1.1.1
Glyphosate
Storage stability
A brief summary of the storage stability data on glyphosate is given in the following table. Data has been
previously evaluated at EU level and is described in detail in the DAR for glyphosate (RMS: Germany,
ASB2010-10302).
Table 8.1-2:
Stability of residues (Annex IIA, point 6 Introduction, Annex IIIA, point 8
Introduction)
Stability of glyphosate, AMPA, N-acetylglyphosate and N-acetyl-AMPA
The following periods of storage stability have been
shown:
- Clover, maize grain, sorghum stover, soya bean
forage, tomatoes: at least 24 months (glyphosate
and AMPA)
- Maize (green plant, forage, grain): at least 9
months (N-acetyl-glyphosate, glyphosate, AMPA
and N-acetyl-AMPA)
- Maize stover: at least 1 month (N-acetylglyphosate, glyphosate, AMPA and N-acetylAMPA)
- Soya bean (forage, seeds, hay): at least 12 months
(N-acetyl-glyphosate, glyphosate, AMPA and Nacetyl-AMPA)
RIP9501332, ASB2008-2655, ASB2008-2656,
ASB2008-2654, ASB2010-14764, ASB2010-14803,
ASB2012-12452, ASB2012-12488, ASB2010-14765,
ASB2010-14766
IIIA 8.1.1.2
Metabolism in plants and plant residue definition(s)
A brief summary of the metabolism of glyphosate in plants is given in the following table. Data has been
previously evaluated at EU level and is described in detail in the DAR for glyphosate (RMS: Germany,
ASB2010-10302) and in EFSA’s Reasoned Opinion on Modification of the residue definition of
Glyphosate in genetically modified maize grain and soybeans, and in products of animal origin (EFSA
Journal 2009; 7(9): 1310; ASB2012-3480).
Page 3 / 13
Ultra (MON 78708) – ZV1 043981-00/00
Table 8.1-3:
Plant groups covered
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.Nr
and 8.6)
Non-tolerant plants:
–Almond (foliar spray to soil, RIP9501196)
–Apples (foliar spray to soil and trunk, RIP9501190)
–Barley (roots, via soil, hydroponic solution,
RIP9501189)
–Citrus (foliar spray to soil, RIP9501194)
–Coffee plants (roots via soil, foliar spray to trunks,
hydroponic solution, RIP9501192)
–Cotton (roots via soil, hydroponic solution,
RIP9600099)
–Grass/Pasture (foliar spray, RIP9501197, RIP9501213)
–Grapes (foliar spray to soil and trunk, hydroponic–
solution, RIP01191)
–Kale (RIP9501212)
–Maize (roots via soil, hydroponic solution,
RIP9600099)
–Oats (roots via soil, hydroponic solution, RIP9501189)
–Pecan (foliar spray to soil, RIP9501196)
–Potatoes (foliar spray to soil, RIP9501193)
–Rice (roots via soil, hydroponic solution, RIP9501189)
–Sorghum (roots via soil, hydroponic solution,
RIP9501189)
–Soya beans (roots via soil, hydroponic solution,
RIP9600099)
–Sugar beets (foliar spray to soil, RIP9501195)
–Sugar cane (foliar spray, hydroponic solution,
RIP9501198)
–Walnut (foliar spray to soil, RIP9501196)
–Wheat (roots via soil, hydroponic solution,
RIP9501209, RIP9600099)
In all plants investigated a very slow metabolism of
glyphosate to the metabolite AMPA was observed. Most
of the residue consisted of unchanged parent. The uptake
from soil via the roots was very limited.
Tolerant plants (CP4-EPSPS- and GOX-modified):
–Cotton (foliar spray, roots via soil, RIP9700619)
–Maize (foliar spray, roots via soil, RIP9700618)
–Oilseed rape (foliar spray, RIP9800118)
–Soya beans (foliar spray, roots via soil, RIP9800117)
-Sugar beets (foliar spray, RIP2001-906, RIP2003-1134)
Genetically GOX-modified plants show an increased rate
of biotransformation of glyphosate into AMPA. AMPA
was the dominant residue in all plant species, Unchanged
parent was still present, although at lower levels in
comparison to unmodified plants.
Tolerant plants (NAG-modified):
–Maize (foliar spray, ASB2008-2657)
–Soya beans (foliar spray, ASB2008-2658)
-Rape (foliar, ASB2011-13744)
In genetically NAG-modified plants most of the
glyphosate is transformed into N-acetyl-glyphosate
(NAG) instead of AMPA. N-acetyl-AMPA was also
found, but at a very low level.
Page 4 / 13
Ultra (MON 78708) – ZV1 043981-00/00
Rotational crops
Barley, carrots, lettuce (confined study, RIP9501201,
RIP9501202)
Lettuce, radish, wheat (confined study, RIP2003-1112)
Two older studies on rotational crops were also available
(RIP9501199, RIP9501200). For further metabolism
studies involving uptake via roots from soil see plant
metabolism. No transfer of glyphosate into follow-up
crops is expected.
yes
Metabolism in rotational crops similar to
metabolism in primary crops? (yes/no)
Distribution of the residue in peel/ pulp
Processed commodities (nature of residue)
Residue pattern in raw and processed commodities
similar? (yes/no)
Plant residue definition for monitoring
Plant residue definition for risk assessment
Conversion factor(s) (monitoring to risk
assessment)
IIIA 8.1.1.3
not applicable
Glyphosate (ASB2012-12432) & N-acetyl-glyphosate
(ASB2008-2675): stable (pH5, 80°C, 20min, pH6,
100°C, 60min and pH7, 120°C, 20min).
yes
Glyphosate
(Note: EFSA also proposed to include N-acetylglyphosate for soybeans and maize. This was not
supported by BfR.)
Glyphosate (non-tolerant crops)
Sum of glyphosate, N-acetyl-glyphosate, AMPA and Nacetyl-AMPA, calculated as glyphosate (tolerant crops)
not specified
Metabolism in livestock and animal residue definition(s)
A brief summary of the metabolism of glyphosate in livestock is given in the following table. Data has
been previously evaluated at EU level and is described in detail in the DAR for glyphosate (RMS:
Germany, ASB2010-10302).
Table 8.1-4:
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.Nr
and 8.6)
Animals covered
Time needed to reach a plateau concentration in
milk and eggs
Animal residue definition for monitoring
Animal residue definition for risk assessment
Conversion factor(s) (monitoring to risk
assessment)
Metabolism in rat and ruminant similar (yes/no)
Fat soluble residue: (yes/no)
IIIA 8.1.1.4
Lactating goats, laying hens (glyphosate, N-acetylglyphosate and AMPA)
Glyphosate, N-acetyl-glyphosate and AMPA are
metabolised to a negligible amount. Most of the residue
was excreted unchanged via urine or faeces.
RIP9501207, RIP9501208, RIP9501203, RIP9501204,
RIP9501205, RIP9501206, ASB2008-2660, ASB20082659
2-3 days
Glyphosate
Sum of glyphosate, N-acetyl-glyphosate, AMPA and Nacetyl-AMPA, calculated as glyphosate
not specified
yes
no
Residues in rotational crops
No studies available and none required.
IIIA 8.1.1.5
Residues in livestock
An actual calculation of the dietary burden (based on all relevant uses within the zone) is provided in the
Page 5 / 13
Ultra (MON 78708) – ZV1 043981-00/00
following table.
Table 8.1-5:
Feedstuff
Calculation of the dietary burden (based on all relevant uses within the zone)
Chicken
1.9 kg bw
daily
maximum feed
(DM) 120 g
–
Dairy cattle
550 kg bw
daily
maximum feed
(DM) 20 kg
–
Beef cattle
350 kg bw
daily
maximum feed
(DM) 15 kg
–
Residue
(mg/kg)
Pig
75 kg bw
daily
maximum feed
(DM) 3 kg
–
142.8a
Kale/ Cabbage 14
–
–
–
–
0.05b
Grains, except 86
maize
Maize
86
55
–
–
60
–
–
–
Bran (Wheat 89
and Rye)
Straw cereals 86
15
20
–
Pulses
–
Grasses
%
DM
20
86
Percent of daily livestock diet (dry feed basis)
Intake (mg/kg, dry feed basis)
Chicken
Dairy
cattle
Beef
cattle
Pig
–
–
–
–
–
–
–
–
5.8c
3.709
–
–
4.047
–
0.25d
–
–
–
–
20
20
9.9c
1.669
2.225
2.225
2.225
20
50
–
198c
–
46.05
115.1
–
–
–
–
0.3e
–
–
–
–
h
Roots and
15
Tubers (e.g.
potatoes)
Swede/Turnip 10
20
30
–
–
0.59
0.787
1.18
–
–
–
–
0.08g
–
–
–
–
Sugar and
20
fodder beet
Oilseed (meal, 86
cake)
–
–
–
–
0.35f
–
–
–
–
10
30
30
20
6.65i
0.773
2.32
2.32
1.55
7.8
Intake (mg/kg dry weight feed)
6.9
51.8
119.7
Intake (mg/kg bw/d)
0.44
1.88
5.13
0.31
Intake (mg/animal/d)
0.83
1035.4
1794.9
23.5
a
HR, based on the following cGAP: 1 x 1.4 kg as/ha, PHI: not specified (The application is on grassland intended for recultivation. Since glyphosate damages the pasture it is not expected to be fed to animals in significant amounts, although
not explicitly prohibited by the label.)
b
HR, based on the following cGAP: up to 4.3 kg as/ha and year, PHI: F, seed bed preparation (EU-use)
c
STMR, based on the following cGAP: 1 x 1.8 kg as/ha, PHI: 7 d, PF: wheat -> bran = 9
d
STMR, based on the following cGAP: 1 x 1.4 kg as/ha, PHI: 90 d
e
STMR, based on the following cGAP: 1 x 2.16 kg as/ha, PHI: 7 d (EU-Use)
f
HR, based on the following cGAP: 2 x 1.1 kg as/ha, PHI: F d
g
HR, based on the following cGAP: 1 x 1.4 kg as/ha, PHI: F
h
HR, based on the following cGAP: 1 x 2.2 kg as/ha, PHI: 7 d (EU-use)
i
STMR, based on the following cGAP: 1 x 1.4 kg as/ha, PHI: 7 d, PF: rapeseed -> cake = 7
Table 8.1-6:
Conditions of requirement of livestock feeding studies on glyphosate
Ruminant:
Poultry:
Pig:
yes
Expected intakes by livestock ≥0.1 mg/kg diet (dry yes
119.7 mg/kg feed 6.9 mg/kg feed
weight basis) (yes/no – If yes, specify the level)
DM
DM
yes
7.8 mg/kg feed DM
Potential for accumulation (yes/no):
no
no
no
Metabolism studies indicate potential level of
residues ≥0.01 mg/kg in edible tissues (yes/no)
yes
yes
yes
Page 6 / 13
Ultra (MON 78708) – ZV1 043981-00/00
A brief summary of the available livestock feeding studies is given in the following table. Data has
previously been evaluated at EU level and is described in detail in the DAR for glyphosate (RMS:
Germany, ASB2010-10302).
Table 8.1-7:
Results of livestock feeding studies (Annex IIA, point 6.4)
Ruminant:
Poultry:
Pig:
Feeding levels (mg/kg feed dry matter) in feeding
studies
Lactating cows:
40, 120, 400
(RIP9501250,
ASB2008-2653)
Laying hens: 40,
120, 400
(RIP9501252,
ASB2008-2652)
Swine: 40, 120, 400
(RIP9501251)
Relevant dosing levels in feeding study:
120
40
40
Expected residue levels in animal matrices (mg/kg):
Muscle
<0.05
<0.05
<0.05
Liver
0.07
0.07
<0.05
Kidney
0.79
0.38
0.37
Fat
<0.05
<0.05
<0.05
Milk
<0.05
Eggs
<0.05
IIIA 8.2
Evaluation of the intended use(s)
IIIA 8.2.1
Selection of critical use and justification
The GAPs used for consumer intake and risk assessment are presented in Table IIIA 8.2-1.
Page 7 / 13
Ultra (MON 78708) – ZV1 043981-00/00
Table IIIA 8.2-1:
Critical Use (worst case) used for consumer intake and risk assessment
1
2
3
UseNo.
Member
state(s)
Crop and/
or situation
4
F
G
or
(crop destination / I
purpose of crop)
(b)
(a)
5
6
Pests or Group of
pests controlled
Application
Application rate
Method /
Kind
Timing /
Max.
Growth stage of number
crop & season
(min.
interval
(g)
between
applications)
a) per use
b) per crop/
season
(h)
L product /
ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
kg as/ha
(additionally:
developmental stages
of the pest or pest
group)
(d-f)
(c)
7
8
9
10
11
Water
L/ha
12
13
PHI
(days)
(i)
Remarks:
a) max. rate
per appl.
min / max
b) max.
total rate
per
crop/season
e.g. safener/synergist per
ha
e.g. recommended or
(j)
1
DE
Railway tracks
F
Monocotyledonous
Spraying
weeds, Dicotyledonous
weeds
During vegetative a) 1
period
b) 1
a) 10
b) 10
a) 3.6
b) 3.6
500 - 1000 N
2
DE
Railway tracks
F
Monocotyledonous
Spraying
weeds
period
b) 2
a) 5
b) 10
a) 1.8
b) 3.6
500 - 1000 N
Monocotyledonous
Painting
weeds, Dicotyledonous (single
period
b) 1
weeds, woody plants
plant
treatment)
a) 33 %
b) 10
a) n.a.
b) 3.6
N
(3 months)
3
DE
Railway tracks
F
4
DE
Non-cultivated land F
without woody
plants
Monocotyledonous
Spraying
weeds
period
b) 1
a) 10
b) 10
a) 3.6
b) 3.6
500 - 1000 N
5
DE
without woody
plants
Monocotyledonous
Spraying
weeds
period
b) 2
a) 5
b) 10
a) 1.8
b) 3.6
500 - 1000 N
a) 33 %
b) 10
a) n.a.
b) 3.6
N
33 % (119 g/l)
(3 months)
6
DE
without woody
plants
Monocotyledonous
Painting
weeds, Dicotyledonous (single
period
b) 1
weeds, woody plants
plant
treatment)
Page 8 / 13
33 % (119 g/l)
Ultra (MON 78708) – ZV1 043981-00/00
Remarks:
(a)
(b)
(c)
(d)
(e)
(f)
For crops, the EU and Codex classifications (both) should be used; where relevant,
the use situation should be described (e.g. fumigation of a structure)
Outdoor or field use (F), glasshouse application (G) or indoor application (I)
e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
All abbreviations used must be explained
Method, e.g. high volume spraying, low volume spraying, spreading, dusting,
drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the
plants - type of equipment used must be indicated
Page 9 / 13
(g)
(h)
(i)
(j)
Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season
at time of application
The minimum and maximum number of application possible under practical
conditions of use must be provided
PHI - minimum pre-harvest interval
Remarks may include: Extent of use/economic importance/restrictions
Ultra (MON 78708) – ZV1 043981-00/00
IIIA 8.2.2
Railway tracks, non-cultivated land without woody plants
IIIA 8.2.2.1
Residues in primary crops
The intended uses are not relevant in terms of consumer health protection. The submission of supervised
residue trials is not necessary.
IIIA 8.2.2.2
Distribution of the residue in peel/pulp
Not relevant.
IIIA 8.2.2.3
Residues in processed commodities
Not relevant.
IIIA 8.2.2.4
Proposed pre-harvest intervals, withholding periods
Since the intended uses are not relevant in terms of consumer health protection the setting of a pre-harvest
interval (PHI) is not necessary.
IIIA 8.3
Consumer intake and risk assessment
IIIA 8.3.1
Glyphosate
The envisaged uses are not relevant in terms of consumer health protection. Thus risk assessment is made
for long term exposure only.
Table IIIA 8.3-1:
Residue input values for the consumer risk assessment
Chronic risk assessment
Acute risk assessment
Commodity
Input value
(mg/kg)
Comment
Input value
(mg/kg)
All commodities
MRLs
Reg. (EC) No
396/2005
Not applicable
Table IIIA 8.3-2:
Comment
Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)
ADI
0.3 mg/kg bw
TMDI (% ADI) according to EFSA PRIMo
43.9 % (based on WHO cluster diet B)
NTMDI (% ADI) according to NVS II model
22.1 % (based on 2-4 year old German children)
IEDI (EFSA PRIMo) (% ADI)
Not required
NEDI (NVS II model) (% ADI)
Not required
Factors included in IEDI and NEDI
None
ARfD
Not necessary
IESTI (EFSA PRIMo) (% ARfD)
Not applicable
NESTI (NVS II model) (% ARfD)
Not applicable
Factors included in IESTI and NESTI
None
Page 10 / 13
Ultra (MON 78708) – ZV1 043981-00/00
IIIA 8.4
Proposed maximum residue levels (MRLs)
Since the intended uses are not relevant in terms of consumer health protection no new MRLs are
required.
IIIA 8.5
Conclusion
The intended use does not affect commodities relevant for human consumption or animal feed. No MRLs
are required. The chronic and the short-term intake of glyphosate residues are unlikely to present a public
health concern.
As far as consumer health protection is concerned, the BfR agrees with the authorization of the intended
uses.
Page 11 / 13
Ultra (MON 78708) – ZV1 043981-00/00
Appendix 1 List of data submitted in support of the evaluation
No new data were submitted in support of the evaluation.
Appendix 2 Detailed evaluation of the additional studies relied upon
A 2.1
Storage stability
No further study on storage stability submitted/needed.
A 2.2
Residues in primary crops
The intended uses are not relevant in terms of consumer health protection. The submission of supervised
residue trials is not necessary.
A 2.3
Residues in processed commodities
No new study on residues in processed commodities has been submitted and none is needed.
A 2.4
Residues in rotational crops
No new study on residues in rotational crops has been submitted.
A 2.5
Residues in livestock
No new study on residues in livestock has been submitted.
A 2.6
Other studies/information
None
Page 12 / 13
Ultra (MON 78708) – ZV1 043981-00/00
Appendix 3 Pesticide Residue Intake Model (PRIMo)
Glyphosate
Status of the active substance:
LOQ (mg/kg bw):
Code no.
proposed LOQ:
Toxicological end points
ADI (mg/kg bw/day):
0,3
Source of ADI:
Year of evaluation:
ARfD (mg/kg bw):
n.n.
Source of ARfD:
Year of evaluation:
Explain choice of toxicological reference values.
The risk assessment has been performed on the basis of the MRLs collected from Member States in April 2006. For each pesticide/commodity the highest national MRL was identified (proposed temporary MRL = pTMRL).
The pTMRLs have been submitted to EFSA in September 2006.
Chronic risk assessment
No of diets exceeding ADI:
Highest calculated
TMDI values in %
of ADI
43,9
36,7
32,6
30,9
27,1
23,4
23,4
23,3
21,4
20,9
20,0
18,5
16,2
16,0
14,7
14,5
13,4
13,2
12,2
11,5
10,5
9,8
9,2
8,2
7,0
4,7
1,0
MS Diet
WHO Cluster diet B
DK child
WHO cluster diet D
WHO cluster diet E
WHO Cluster diet F
IE adult
UK Toddler
IT kids/toddler
DE child
NL child
PT General population
ES child
UK Infant
WHO regional European diet
IT adult
FR all population
ES adult
SE general population 90th percentile
FR toddler
NL general
DK adult
UK vegetarian
LT adult
UK Adult
FI adult
FR infant
PL general population
Highest contributor
to MS diet
(in % of ADI)
28,5
18,3
21,7
13,1
12,0
8,3
13,1
22,2
13,7
15,8
13,1
14,8
8,7
9,9
13,8
11,0
7,8
10,7
8,7
6,9
6,7
6,8
3,6
5,6
3,3
2,8
0,6
Commodity /
group of commodities
Wheat
Wheat
Wheat
Wheat
Wheat
Barley
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Wheat
Rye
Wheat
Wheat
Wheat
Potatoes
TMDI (range) in % of ADI
minimum - maximum
1
44
--2nd contributor to
MS diet
(in % of ADI)
4,9
14,7
3,3
5,4
4,3
7,7
7,6
0,1
2,6
1,0
2,0
0,8
3,4
2,2
0,2
2,2
3,3
1,0
1,1
2,5
2,3
1,3
3,5
1,3
2,3
0,7
0,1
Commodity /
Sunflower seed
Rye
Sunflower seed
Barley
Soya bean
Wheat
Sugar beet (root)
Potatoes
Rye
Potatoes
Soya bean
Sunflower seed
Sugar beet (root)
Barley
Wild fungi
Sunflower seed
Barley
Rye
Sunflower seed
Barley
Rye
Sugar beet (root)
Wheat
Sugar beet (root)
Rye
Potatoes
Pome fruit
3rd contributor to
MS diet
(in % of ADI)
4,0
2,6
2,5
3,9
4,0
1,3
0,6
0,1
1,4
0,7
1,9
0,8
1,7
0,9
0,1
0,7
0,7
0,7
0,8
0,5
0,8
0,3
0,6
0,2
0,6
0,4
0,1
Commodity /
Soya bean
Oats
Soya bean
Soya bean
Barley
Sunflower seed
Potatoes
Wild fungi
Oats
Oats
Sunflower seed
Lentils
Oats
Sunflower seed
Potatoes
Table and wine grapes
Sunflower seed
Potatoes
Potatoes
Potatoes
Oats
Oats
Oats
Potatoes
Oats
Milk and cream,
Peas
Conclusion:
The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI.
A long-term intake of residues of Glyphosate is unlikely to present a public health concern.
Acute risk assessment /children
Acute risk assessment / adults / general population
Acute risk assessment is not necessary.
Page 13 / 13
pTMRLs at
LOQ
(in % of ADI)
Core Assessment
Registration Report
Central Zone
Page 1 of 28
REGISTRATION REPORT
Part B
Section 5 Environmental Fate
Product code: Tender GB Ultra (MON 78708)
Active Substance(s): Glyphosate 360 g/L
Central Zone
CORE ASSESSMENT
Applicant:
Monsanto Europe SA
Date:
24/03/2014
Applicant (Monsanto Europe SA)
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 2 of 28
Table of Contents
TABLE OF CONTENTS.......................................................................................................................................2
SEC 5
FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ........................................3
5.1
GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3
5.2
PROPOSED USE PATTERN ........................................................................................................................ 3
5.3
INFORMATION ON THE ACTIVE SUBSTANCES........................................................................................... 4
5.3.1 Glyphosate......................................................................................................................................... 4
5.4
SUMMARY ON INPUT PARAMETER FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ................................. 6
5.4.1 Rate of degradation in soil................................................................................................................. 6
5.4.2 Adsorption/desorption ..................................................................................................................... 10
5.4.3 Rate of degradation in water and sediment ..................................................................................... 13
5.5
ESTIMATION OF CONCENTRATIONS IN SOIL (PECSOIL) (KIIIA1 9.4)....................................................... 16
5.6
ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (PECSW/PECSED) (KIIIA1 9.7)
17
5.7
RISK ASSESSMENT GROUND WATER (KIIIA1 9.6)................................................................................. 18
5.7.1 Predicted environmental concentration in groundwater (PECGW) calculation for active substance
and its metabolite (Tier 1 and 2)................................................................................................................... 18
5.7.2 Summary of risk assessment for ground water................................................................................ 18
5.8
POTENTIAL OF ACTIVE SUBSTANCE FOR AERIAL TRANSPORT ................................................................ 18
APPENDIX 1
LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ..........................21
APPENDIX 2
DETAILED EVALUATION OF STUDIES RELIED UPON..............................................26
KIIIA1 9 FATE AND BEHAVIOUR IN THE ENVIRONMENT – PLANT PROTECTION PRODUCT................................. 26
KIIIA1 9.1. Vanbellinghen, 2002................................................................................................................. 26
APPENDIX 3
TABLE OF INTENDED USES JUSTIFICATION AND GAP TABLES...........................27
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 3 of 28
Sec 5
FATE AND BEHAVIOUR IN THE ENVIRONMENT
(KIIIA 9)
This document comprises the risk assessment for groundwater and the exposure assessment of surface
water and soil for the plant protection product Tender GB Ultra (MON 78708) containing the active
substanceglyphosate in its intended uses in railways and non-crop areas according to Appendix 3.
National Addenda are included containing country specific assessments for some annex points.
5.1
General Information on the formulation
Table 5.1-1:
General information on the formulation Tender GB Ultra (MON 78708)
Code
Plant protection product
Applicant
Monsanto Europe SA
Date of application
20/12/2011
Formulation type
(WP, EC, SC, …; density)
SL
Active substance
Glyphosate
Concentration of as
360 g/L
5.2
Proposed use pattern
The critical GAPs used for exposure assessment is presented in Table 5.2-1. It has been selected from
the individual GAPs in the zone for Tender GB Ultra (MON 78708). A list of all intended uses within
the zone is given in Appendix 3.
Table 5.2-1:
Critical use pattern of Tender GB Ultra (MON 78708)
Group*
Crop/growth
stage
Application
Number of applications, Application rate,
method /
Minimum application
cumulative
Drift scenario interval, interception,
(g as/ha)
application time
(season)
Soil effective
application rate
(g as/ha)
A
Railways
Spraying
1
3600
3600
B
Railways
Spraying
2, 3 months
1800 × 2
1800 × 2
C
Railways
Wiping,
1
single plant
treatment (33
%)
3600
3600
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 4 of 28
D
Non-crop
areas, no
woody plants
Spraying
1
3600
3600
E
Non-crop
areas, no
woody plants
Spraying
2, 3 months
1800 × 2
1800 × 2
F
Non-crop
areas, no
woody plants
Wiping,
1
single plant
treatment (33
%)
3600
3600
5.3
Information on the active substances
5.3.1
Glyphosate
5.3.1.1
Identity, further information of glyphosate
Table 5.3-1:
Identity, further information on glyphosate
Active substance (ISO common name)
Glyphosate
IUPAC
N-(phosphonomethyl)-glycin
Function (e.g. fungicide)
Herbizide
Status under Reg. (EC) No 1107/2009
Approved
Date of approval
07/01/2002
Conditions of approval
Member States must pay particular attention to the protection of
the groundwater in vulnerable areas, in particular with respect to
non-crop uses.
Confirmatory data
None.
RMS
Germany
Minimum purity of the active substance
as manufactured (g/kg)
950 g/kg
Molecular formula
C3H8NO5P
Molecular mass
169.1 g/mol
Structural formula
OH
HO C CH2 NH CH2
O
5.3.1.2
P O
OH
Physical and chemical properties of glyphosate
Physical and chemical properties of glyphosate as agreed at EU level (see LOEP 2001) and considered
relevant for the exposure assessment are listed in Table 5.3-2.
Table 5.3-2:
EU agreed physical chemical properties of glyphosate relevant for exposure assessment
Value
Reference
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 5 of 28
Vapour pressure (at 20 °C) (Pa)
6.8⋅ 10-6 Pa
SANCO/6511/VI/99-final –
21/01/2002
LOEP (2001)
(calculated at 20°C)
1.31 ⋅ 10-5 Pa
(25 °C, acid)
³
-1
LOEP (2001)
Henry’s law constant (Pa × m × mol )
2.1 ⋅ 10-7 Pa ⋅ m³ ⋅mol-1
pH 2: 10.5 ± 0.2 g/L
(20 °C, 995 g/kg)
pH 7: 18.8 g/L
Solubility in water (at 25 °C in mg/L)
LOEP (2001)
Russel, 1995
Partition co-efficient (at 25 °), log POW
pH 5 – 9: - 3.2 at 25 °C LOEP (2001)
(999 g/kg)
Dissociation constant, pKa
2.34 (20 °C), 5.73 (20
°C),
10.2 (25 °C)
LOEP (2001)
Hydrolytic degradation
pH 5,7 and 9: stable
(25 °C)
LOEP (2001)
Photolytic degradation
33 d (pH 5),
69 d (pH 7),
77 d (pH 9)
(Xenon lamp).
LOEP (2001)
Quantum yield of direct phototransformation
in water > 290 nm
Not determined.
LOEP (2001)
Photochemical oxidative degradation in air
(calculation according to Atkinson)
DT50 = 1.6 d
LOEP (2001)
5.3.1.3
Metabolites of glyphosate
New studies on the degradation of glyphosate have been performed. These are summarized in the
Renewal Assessment Report, Volume 3 Annex B.8, Red Draft. Environmental occurring metabolites
of glyphosate requiring further assessment according to the results of the assessment are summarized
in Table 5.3-3.
Table 5.3-3:
Metabolite
Metabolites of glyphosate potentially relevant for exposure assessment
(> 10 % of as or > 5 % of as in 2 sequential measurements or > 5 % of as and maximum of
formation not yet reached at the end of the study)
Structural
formula/Molecular
formula
occurrence in compartments
(Max. at day/
Status of Relevance
(Glyphosate 6511/VI/99-final
21 January 2002)
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 6 of 28
Aminomethylphosphonic
acid (AMPA)
molar mass:
111.0 g/mol
O
HO P CH2 NH2
OH
Soil:
aeroblab: max. 50.1 % after 90
days
aerobfield: max. 53.8 % after
271 days
Aquatic organism:
Water: not relevant
Sediment:not relevant
Terrestrial organism: not
relevant
Water:
max. 15.7 % after 14 days
correction
factor: 0.656
Sediment:
(Hydroxymeth
yl)-phosphonic
acid
molar mass:
112.0 g/mol
Water:
OH
HO P C
H2
O
OH
Aquatic organism:
Water: not relevant
Sediment: not relevant
Terrestrial organism: :not
relevant
correction
factor: 0.662
1)
According to Guidance Document on the assessment of the relevance of metabolites in groundwater
of substances regulated under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25
February 2003)
5.4
Summary on input parameter for environmental exposure assessment
5.4.1
Rate of degradation in soil
5.4.1.1
Laboratory studies
Glyphosate and AMPA
Within the EU assessment Annex I Renewal 2 (AIR 2) of glyphosate currently in process, new studies
on soil degradation (Ponte, 2010a, Ponte 2010b) have been submitted. Furthermore, the endpoints
reported in the studies evaluated during the first EU review (DAR 1998, LOEP 2001) are not
appropriate for risk assessment and exposure modelling of the environmental fate of glyphosate
anymore, since they are not evaluated according to the state of the art in science and technology. The
aerobic degradation rates of glyphosate and AMPA from the old and new route and rate of degradation
studies Ponte (2010a & b), Goodyear (1996), Esser (1996a), Nakanashi (1995), Galicia & Morgenroth
(1993), Galicia & Flückinger with addendum Mamouni (2002) and Matla & Vonk (1993) were recalculated by Dorn (2012) – also submitted within the EU assessment Annex I Renewal 2 (AIR 2) of
glyphosate – in accordance with the kinetic approaches recommended in the latest guidance (FOCUS,
2006, 2011). A detailed evaluation of these studies is presented in the Renewal Assessment Report,
Volume 3 Annex B.8, Red Draft. The reviewed DT50 values of glyphosate and AMPA of this
Renewal Assessment Report are used for the present assessment and summarized in Table 5.4-1 and
Table 5.4-2, respectively.
Table 5.4-1:
Summary of aerobic degradation rates for glyphosate (modelling endpoints) - laboratory studies
Modelling endpoints
Study
Soil
pH
H 2O
recalculated
SFO DT50
actual
(d)
Normalised
SFO DT50 (d)
20 °C, pF2
f.f.
AMPA
χ2
error
(%)
Model
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 7 of 28
Glyphosate
DT90
FOMC/
3.32
DFOP
slow phase
DT90
FOMC/
3.32
DT90
FOMC/
3.32
DT90
FOMC/
3.32
DT90
FOMC/
3.32
DT90
FOMC/
3.32
DFOP
slow phase
DT90
FOMC/
3.32
DT90
FOMC/
3.32
DT90
FOMC/
3.32
DFOP
slow phase
DT90
FOMC/
3.32
Ponte (2010a)
Gartenacker,
loam
7.1
17.79
16.0
0.1817
4.6
Nakanishi &
Dean (1995)
Arrow, sandy
loam
6.5*
300.7
257.1
0.46981)
2.47
Goodyear
(1996)
Soil B, sandy
loam
6.7
6.2
6.6
0.2646
6.92
Galicia &
Morgenroth
(1993)
Les Evouettes,
silt loam
6.1§
48.46
43.3
0.3618
6.17
Matla &
Vonk (1993)
Maasdjik, sandy
loam
7.5*
17.05
15.2
n.m.
3.79
Drusenheim,
loam
7.4
5.35
4.2
0.2578
3.5
Pappelacker,
loamy sand
7.0
13.09
12.0
0.1835
4.1
18-Acres, clay
loam
5.7
173.2
160.5
0.21691)
2.9
Speyer 2.2,
Sand
6.0
45.4
45.4
2)
1.59
Speyer 2.3,
Lomay Sand
6.9
7.2
7.2
0.3435
3.84
Speyer 2.1, sand
6.5*
19.5
19.5
0.5201)
5.72
Speyer 2.2,
loamy sand
6.2*
72.2
72.2
0.60761)
4.97
Speyer 2.3,
loamy sand
6.9*
3.76
3.76
0.4283
7.67
Dupo,
silt loam
7.3§
2.80
3.70
0.3637
3.80
DT90
FOMC/
3.32
Speyer 2.2,
loamy sand
6.0
43.53
40.6
n.m.
6.95
SFO
Speyer 2.1
sand
6.9§
43.06$
43.06
0.5851$
3.91$
Beedon Manor
clay loam
7.8§
18.97
18.97
n.m.
Ponte (2010b)
Galicia &
Flückiger
(1993)/
Mamouni,
2002
McLaughin &
Schanné
(1996)
Kesterson &
Atkins, 1991
& add.
Honegger,
1992
Runnalls,
1991
Lewis &
Turnbull 1992
DT90
FOMC/
3.32
DT90
FOMC/
3.32
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 8 of 28
Geometric mean (n = 17)
21.03
-3)
Arithmetic mean (n=13)
-3)
0.3680
1)
Acceptable visual fit for formation phase of AMPA, however no statistically acceptable fit for the
transformation rate of AMPA could be obtained in this pathway
2)
no statistically reliable fit could be obtained (high chi2 error and/ or t-test not passed at 0.05)
3)
statistically not appropriate, according to FOCUS (2006, 2011) the geometric mean should be used for
averaging degradation rates and half-lives while the arithmetric mean should be used for formation
fractions
n.m.
not measured
*
converted from given pH value in CaCl2 and KCl in order to allow pH dependency tests of the degradation
§
buffer solution unknown
$
labelled in the phosphonomethyl-glycine anion of glyphosate-trimesium
The DT50 values of glyphosate do not show any pH dependency.
Table 5.4-2:
Study
Summary of aerobic degradation rates for AMPA (modelling endpoints) - laboratory studies
Soil
Metabolite AMPA
Gartenacker,
Ponte (2010a)
loam
Nakanishi &
Arrow, sandy
Dean (1995)
loam
Goodyear
Soil B, sandy
(1996)
loam
Galicia &
Les Evouettes,
Morgenroth
silt loam
(1993)
Matla & Vonk Maasdjik, sandy
(1993)
loam
Drusenheim,
loam
Pappelacker,
Ponte (2010b)
loamy sand
18-Acres, clay
loam
Galicia &
Speyer 2.2, sand
Flückiger
(1993)/
Speyer 2.3,
Mamouni
loamy sand
(2002)
Speyer 2.1, sand
McLaughin & Speyer 2.2,
Schanné
loamy sand
(1996)
Speyer 2.3,
loamy sand
Kesterson &
Dupo, silt loam
pH
H 2O
recalculated
SFO DT50
actual
(d)
Modelling endpoint
Normalised
SFO DT50
χ2 error (%)
(days), 20 °C
pF2
Model
Parent_Met.
7.1
133.69
119.9
8.9
FOMC_SFO
6.5*
-1)
-1)
-1)
DFOP_SFO
6.7
99.1
106.2
6.98
FOMC_SFO
6.1
337
300.9
14.00
FOMC_SFO
7.5*
n.m.
n.m.
n.m.
n.m.
7.4
47.04
36.8
2.1
FOMC_SFO
7.0
126.5
116.3
6.2
FOMC_SFO
5.7
-1)
-1)
-1)
DFOP_SFO
6.0
-2)
-2)
-2)
-2)
6.9
70.92
70.92
11.41
FOMC-SFO
6.5*
-1)
-1)
-1)
FOMC_SFO
6.2*
-1)
-1)
-1)
DFOP_SFO
6.9*
42.14
42.14
9.41
DFOP_SFO
7.3§
48.32
30.5
7.57
FOMC_SFO
Evaluator: Germany
Date: November 2013
Core Assessment
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Atkins, 1991
& add.
Honegger,
1992
Runnalls, 1991
Lewis &
Turnbull, 1992
Speyer 2.2,
loamy sand
Speyer 2.1,
sand
Beedon Manor
clay loam
6.0
n.m.
n.m.
n.m.
n.m.
6.9
230.7$
230.7$
4.29$
FOMC_SFO
7.8§
n.m.
n.m.
n.m.
n.m.
Minimum
30.5
Maximum
300.9
Geometric mean (n=9)
88.84
1)
No decline of AMPA was observed in parent study; thus, no acceptable fit for AMPA could be obtained
2)
no statistically reliable fit could be obtained (high chi2 error and/ or t-test not passed at 0.05) for parent
and metabolite
n.m.
not measured
*
converted from given pH value in CaCl2 and KCl in order to allow pH dependency tests of the
degradation
§
buffer solution unknown
$
labelled in the phosphonomethyl-glycine anion of glyphosate-trimesium
The DT50 values of AMPA do not show any pH dependency.
5.4.1.2
Field studies
Glyphosate and AMPA
All field degradation studies provided below are evaluated during the first EU review (DAR 1998,
LOEP 2001). The endpoints reported in this EU review are not appropriate for risk assessment and
exposure modelling of the environmental fate of glyphosate anymore, since they are not evaluated
according to the state of the art in science and technology. Within the EU assessment Annex I
Renewal 2 (AIR 2) of glyphosate currently in process, a new kinetic evaluation (Kreschnak, 2012) to
derive dissipation half-lives was submitted in accordance with the latest guidance (FOCUS, 2006,
2011) in order to refine risk assessment. A detailed evaluation of this study is presented in the
Renewal Assessment Report, Volume 3 Annex B.8, Red Draft. The reviewed DT50 values of
glyphosate and AMPA of this Renewal Assessment Report are used for the present assessment and
summarized in Table 5.4-3 and Table 5.4-4, respectively.
Table 5.4-3:
Field degradation studies of glyphosate (persistence endpoint and trigger for higher tier studies)
Soil / location pH
DT50 (d) DT90
(d)
Fit, Kinetic,
Parameters
χ2
SFO
error (%) recalculated*
Parameter Reference
Diegten,
Switzerland,
sandy clay
7.1
6.1
116.1
DFOP
4.96
210.0
k1 0.1437
k2 0.0033
g 0.854
Schulz, 1992a
Menslage,
Germany,
sandy loam
4.7
5.7
200.8
DFOP
9.4
169.1
k1 0.1786
k2 0.0041
g 0.771
Schulz, 1992d
Evaluator: Germany
Date: November 2013
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Buchen,
Germany,
loamy sand
6.4
40.9
187.3
DFOP
6.6
3.0E13
k1 0.019
Hill, 1992
k2 2.3E-14
g 0.927
Kleinzecher,
Germany,
sandy loam
7.0
38.3
386.6
DFOP
11.7
187.3
k1 0.0384
k2 0.0037
g 0.575
Hill, 1992
Unzhurst,
Germany,
loam
6.7
27.7
122.3
DFOP
8.4
778.8
k1 0.0280
k2 8.9E-4
g 0.922
Hill, 1992
Rohrbach,
Germany, silt
loam
8.5
20.1
66.9
SFO
Top down
3.8
-
k 0.0344
Hill, 1992
Herrngiersdorf 8.0
, Germany,
clay loam
33.7
111.9
SFO
10.6
-
k 0.0206
Hill, 1992
Wang7.2
17.8
165.5
FOMC
8.7
49.8
Inzkofen,
Germany, silt
loam
* DT50 = FOMC-DT90/3.32 or DT50 = ln2/kslow for DFOP and HS kinetics
Table 5.4-4:
alpha
Hill, 1992
0.975
beta 17.207
Field degradation studies of AMPA (persistence endpoint and trigger for higher tier studies)
Soil / location pH
DT50
(d)
DT90
(d)
ff
Fit, Kinetic,
Parameters
χ2
error
(%)
Parameter Reference
Kleinzecher,
Germany,
sandy loam
7.0
514.9
>1000
0.508
DFOP-SFO
15.9
k 0.0013
Hill, 1992
Unzhurst,
Germany,
loam
6.7
633.1
>1000
0.332
DFOP-SFO
13.3
k 0.0011
Hill, 1992
Rohrbach,
8.5
Germany, silt
loam
374.9
>1000
n.d.
SFO
Top down
8.6
k 0.0018
Hill, 1992
Herrngiersdor 8.0
f, Germany,
clay loam
288.4
958.1
n.d.
SFO
Top down
10.9
k 0.0024
Hill, 1992
Wang7.2
Inzkofen,
Germany, silt
loam
283.6
942.3
0.547
FOMC-SFO
15.6
k 0.0024
Hill, 1992
5.4.2
Adsorption/desorption
Glyphosate
Within the EU assessment Annex I Renewal 2 (AIR 2) of glyphosate currently in process, there are
three additional studies of the adsorption and desorption behaviour of glyphosate in soil available but
not considered during the 2001 evaluation (Thomas & Lane, 1996, van Noorloos & Slangen, 2001,
Evaluator: Germany
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Kolk, 1996). Furthermore, there is one more study available (Schneider, 1993) submitted during
national authorisation in Germany. Details of these studies are provided in the Renewal Assessment
Report, Volume 3 Annex B.8, Red Draft. The reviewed Kfoc/kdoc values of this Renewal Assessment
Report are used for the present assessment and summarized in Table 5.4-5.
Table 5.4-5:
Kf, Kfoc and 1/n (Freundlich exponent) values for glyphosate
Soil Type
OC
(%)
pH
(-)
Kf
(mL g-1)
Kfoc/kdoc
(mL g-1)
1/n
(-)
Reference
Silty clay loam
1.45
6.5 2)
324.0
22300
0.92
Livingston
et al., 1986
Silt loam
0.87
7.4 2)
33.0
3800
0.80
Livingston
et al., 1986
Loamy sand
1.10
5.2 2)
660.0
60000
1.16
Livingston
et al., 1986
Sand
0.80
5.7 2)
-
32838 6)
1.00 7)
Waring,
1992
Sand loam
1.60
7.1 2)
-
50660 6)
1.00 7)
Waring,
1992
Sandy clay loam
1.40
7.8 2)
-
3598 6)
1.00 7)
Waring,
1992
Loamy sand
0.60
8.32)
-
884 6)
1.00 7)
Waring,
1992
Silt loam
1.40
6.1 2)
-
3404 6)
1.00 7)
Waring,
1992
Loam
3.00
7.1 2)
-
17010 6)
1.00 7)
Waring,
1992
Sand
0.29
5.7 2)
64.0
22000
0.75
Thomas &
Lane, 1996
Sandy loam
0.58
8.4 2)
9.4
1600
0.72
Thomas &
Lane, 1996
Silty clay loam
2.26
5.7 2)
470.0
21000
0.93
Thomas &
Lane, 1996
Silty clay loam
2.15
6.2 2)
700.0
33000
0.94
Thomas &
Lane, 1996
Sandy loam
1.80
7.4 2)
90.0
5000
0.76
Thomas &
Lane, 1996
Sand
0.56
6.0 3)
57.2 4)
10000
0.90 8)
van
Noorloos &
Slangen,
2001
Clay loam
1.70
7.9 2)
216.0 4)
12500
0.90 8)
van
Noorloos &
Slangen,
2001
Silt loam
3.00
7.1 2)
897.0 4)
30000
0.73
van
Noorloos &
Slangen,
2001
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Sandy loam
1.10
5.4 2)
222.5 4)
20000
0.9 8)
van
Noorloos &
Slangen,
2001
sand
0.62
5.9 3)
29.5 5)
4762
0.84
Kolk, 1996
loamy sand
2.32
5.6 3)
71.7 5)
3091
0.84
Kolk, 1996
loamy sand
1.22
6.4 3)
37.7 5)
3092
0.84
Kolk, 1996
-
0.70
5.9
-
9486 6)
1.00 7)
Schneider,
1993
-
1.34
6.3
-
5709 6)
1.00 7)
Schneider,
1993
-
1.20
7.3
-
4533 6)
1.00 7)
Schneider,
1993
15844
0.914
Arithmetic mean
1) BBA Soil Texture Parametrisation
2) Buffer Solution = H2O
3) Buffer Solution = CaCl2
4) For this study, the units of the Kf and Kfoc values were converted from [102 cm3/g] and [103 cm3/g] to [mL/g].
5) For this study, the Kfoc values were not rounded.
6) Kdoc values determined for a single concentration.
7) default value, due to the fact that no investigations of the relationship between soil solution concentration and
adsorption behaviour were conducted in the study
8) default value, since no reliable 1/n value could be derived in the original study
The Kfoc and Kdoc values (combined) of glyphosate do not show any pH dependency.
AMPA
Within the EU assessment Annex I Renewal 2 (AIR 2) of glyphosate currently in process, two new
studies (Knoch, 2003b, Wittig & Bockholt, 2002) with a wide range of soil characteristics are
available. Neither of these studies was evaluated during the glyphosate 2001 EU evaluation or at EU
Member State level. One additional AMPA adsorption and desorption study (Muller & Lane, 1996),
conducted by a Glyphosate Task Force (GTF) member to support its own registrations, has also been
evaluated at the EU-Member State level. Details of these studies are provided in the Renewal
Assessment Report, Volume 3 Annex B.8, Red Draft. The reviewed Kfoc values of this Renewal
Assessment Report are used for the present assessment and summarized in Table 5.4-6.
Table 5.4-6:
Kf, Kfoc and 1/n (Freundlich exponent) values for AMPA
Soil Type
OC
(%)
pH
(-)
Kf
(mL g-1)
Kfoc
(mL g-1)
1/n
(-)
Reference
Clay loam
2.09
7.71)
77.1
3640
0.79
Weeden,
1992
Sand
18.683)
4.71,3)
1570.03)
83103)
0.903)
Weeden,
1992
Sand
1.33
7.41)
15.7
1160
0.75
Weeden,
1992
Clay loam
0.93
7.61)
53.9
5650
0.79
Weeden,
Evaluator: Germany
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1992
Loamy sand
1.57
6.31)
110.0
6920
0.77
Weeden,
1992
Sand
0.29
4.61)
73.0
24800
0.79
Weeden,
1992
Sand
0.29
5.71)
133.0
45900
0.86
Mueller &
Lane, 1996
Sandy loam
0.58
8.41)
10.0
1720
0.78
Mueller &
Lane, 1996
Silty clay loam
2.26
5.71)
509.0
22500
0.91
Mueller &
Lane, 1996
Silty clay loam
2.15
6.21)
237.0
11100
0.86
Mueller &
Lane, 1996
Sandy loam
1.80
7.41)
74.2
4130
0.84
Mueller &
Lane, 1996
Silt loam
1.59
6.11)
137.4
8642
0.98
Knoch,
2003b
Silt loam
1.24
6.11)
87.9
7089
0.92
Knoch,
2003b
Silty clay
2.25
8.31)
33.9
1507
0.91
Knoch,
2003b
Sand
0.90
5.22)
16.7
1861
0.904)
Wittig &
Bockholt,
2002
Loamy sand
2.30
5.62)
189.7
8248
0.904)
Wittig &
Bockholt,
2002
Sandy silty loam
2.60
7.12)
29.1
1119
0.904)
Wittig &
Bockholt,
2002
9749
0.853
Arithmetic mean
1) buffer Solution = H2O
2) buffer Solution = CaCl2
3) not included for calculation of statistics (mean values, correlations) due to high OC content
4) default value, since no reliable 1/n value could be derived in the original study
The Kfoc values of AMPA do not show any pH dependency.
5.4.3
Rate of degradation in water and sediment
Glyphosate and AMPA
Within the EU assessment Annex I Renewal 2 (AIR 2) of glyphosate currently in process, one
glyphosate water/sediment study (Heintze, 1996) and three AMPA water/sediment studies (FeserZügner, 2002, McEwen, 2004b and Knoch, 2003c) are available which were not reviewed during the
2001 EU glyphosate evaluation. The endpoints as reported in the original DAR/LOEP are not
appropriate for risk-assessment and exposure modelling of the environmental fate of glyphosate and
AMPA in the EU anymore, since they are not evaluated according to the state of the art in science and
Evaluator: Germany
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technology. The degradation and dissipation rates of glyphosate and AMPA from both old and new
water/sediment studies were re-calculated by Partsch (2012) – also submitted within the EU
assessment Annex I Renewal 2 (AIR 2) of glyphosate – and the RMS Germany in accordance with the
kinetic approaches recommended in the latest guidance (FOCUS, 2006, 2011). A detailed evaluation
of these studies is presented in the Renewal Assessment Report, Volume 3 Annex B.8, Red Draft. The
reviewed DT50 values of glyphosate and AMPA of this Renewal Assessment Report are used in the
present assessment and summarized in Table 5.4-7 and Table 5.4-8, respectively.
Table 5.4-7:
Reference
Degradation in water/sediment of glyphosate - Persistence and modelling endpoints
System
Glyphosate (total system)
Bowler &
Cache
Johnson (1999) Putah
Loamy
Möllerfeld &
Sediment
Römbke (1993)
Sandy Sediment
Heintze
Creek
(1996)
Pond
TNO
Muttzall (1993)
Kromme Rijn
Minimum
Maximum
Geometric mean (n = 7/68))
Glyphosate (water phase)
Bowler &
Cache
Loamy
Möllerfeld &
Sediment
Römbke (1993)
Sandy Sediment
Heintze
Creek
(1996)
Pond
TNO
Muttzall (1993)
Kromme Rijn
Minimum
Maximum
Glyphosate (sediment phase)
Bowler &
Cache
Loamy
Möllerfeld &
Sediment
Römbke (1993)
Sandy Sediment
Heintze
Creek
(1996)
Pond
TNO
Muttzall (1993)
Kromme Rijn
Persistence endpoints
at Level P-I
Modelling endpoints
at Level P-I
Model
DT504)
(days)
DT904)
(days)
SFO
DT504)
(days)
Model
SFO DT504)
(days)
FOMC
DFOP
8.47
210.66
45.89
976.54
13.825)
294.145)
FOMC
DFOP
13.821)
329.852)
FOMC
70.48
∞
-6)
-3)
-3)
HS
SFO
HS
FOMC
DFOP
16.03
16.78
67.45
93.06
28.86
-
346.81
55.74
281.39
>1000
232.92
-
104.465)
16.78
84.765)
>301.205)
70.165)
13.82
301.20
74.52
HS
SFO
HS
-3)
DFOP
154.192)
16.78
92.422)
-3)
88.672)
13.82
329.85
67.74
HS
FOMC
4.98
8.25
26.84
72.40
8.085)
21.815)
SFO
FOMC
6.94
21.811)
FOMC
1.06
24.11
7.265)
FOMC
7.261)
DFOP
SFO
HS
-3)
-3)
2.03
13.15
1.00
-3)
-3)
-
22.63
43.67
26.89
-3)
-3)
-
6.825)
13.15
8.105)
-3)
-3)
6.82
21.81
9.88
DFOP
SFO
HS
-3)
-3)
6.821)
13.15
8.101)
-3)
-3)
6.82
21.81
9.63
SFO
-3)
34.05
-3)
113.10
-3)
34.05
-3)
SFO
-3)
34.05
-3)
-3)
-3)
-3)
-3)
-3)
-3)
FOMC
-3)
-3)
-3)
SFO
383.86
-3)
-3)
-3)
75.61
∞
-3)
-3)
-3)
251.16
-6)
-3)
-3)
-3)
75.61
-3)
-3)
-3)
-3)
SFO
-3)
-3)
-3)
-3)
75.61
Evaluator: Germany
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Minimum
34.05
Maximum
75.61
-7)
1) Back-calculated from DT90 of bi-phasic model (DT90/3.32)
2) Calculated from slower k-rate
3) no reliable fit achieved
4) DT50 = degradation DT50 for total system, Dissipation DT50 for water and sediment phase
5) Back-calculated SFO to derive endpoints for P criteria (SFO DT50 = DT90/3.32)
6) Back-calculation of SFO DT50 not possible
7) Not calculated, since a sufficient number of DT50 values were not available
8) Number of values for deriving persistence endpoint (SFO DT50) and the modelling endpoint
Table 5.4-8:
Reference
34.05
75.61
-7)
Degradation in water/sediment of AMPA - Persistence and modelling endpoints
System
AMPA (total system)
Feser-Zügner
Rückhaltebecken
(2002)
Schäphysen
Knoch
Bickenbach
(2003)
Unter-Widdersheim
Knoch &
Bickenbach
Spirlet
Unter-Widdersheim
(1999)
McEwen
A
(2004b)
B
Minimum
Maximum
Geometric mean (n = 5/47))
AMPA (water phase)
Feser-Zügner
Rückhaltebecken
(2002)
Schäphysen
Knoch
Bickenbach
(2003)
Unter-Widdersheim
Knoch &
Bickenbach
Spirlet
Unter-Widdersheim
(1999)
McEwen
A
(2004b)
B
Minimum
Maximum
AMPA (sediment phase)
Feser-Zügner
Rückhaltebecken
(2002)
Schäphysen
Knoch
Bickenbach
(2003)
Unter-Widdersheim
Knoch &
Bickenbach
Persistence endpoints
at Level P-I
Model
DT504)
(days)
DT904)
(days)
SFO
DT504)
(days)
Modelling endpoints
at Level P-I
SFO
Model
DT504)
(days)
FOMC
-3)
HS
HS
HS
13.80
-3)
10.54
77.36
44.53
1513.00
-3)
191.25
307.19
205.21
455.725)
-3)
57.615)
92.535)
61.815)
DFOP
-3)
HS
HS
HS
102.872)
-3)
77.832)
98.982)
69.312)
FOMC
20.13
885.03
266.585)
-3)
-3)
-3)
-6)
-3)
-6)
-
-3)
-6)
-
-3)
-6)
57.61
455.72
131.97
-3)
-6)
-3)
-6)
69.31
102.87
86.09
FOMC
FOMC
DFOP
FOMC
DFOP
2.20
1.00
2.54
2.13
6.59
22.50
7.80
47.57
26.31
51.47
6.785)
2.355)
14.335)
7.925)
15.505)
FOMC
FOMC
DFOP
FOMC
DFOP
6.781)
2.351)
14.331)
7.921)
15.501)
HS
2.02
17.15
5.175)
HS
5.171)
FOMC
DFOP
0.69
1.28
-
8.87
6.87
-
2.675)
2.075)
2.07
15.50
5.47
FOMC
DFOP
2.671)
2.071)
2.07
15.50
5.47
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
-3)
Evaluator: Germany
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Unter-Widdersheim
-3)
-3)
-3)
-3)
-3)
3)
3)
3)
3)
McEwen
A
-3)
(2004b)
B
-6)
-6)
-6)
-6)
-6)
1) Back-calculated from DT90 of bi-phasic model (DT90/3.32)
2) Calculated from slower k-rate
3) no reliable fit achieved
4) DT50 = degradation DT50 for total system, Dissipation DT50 for water and sediment phase
5) Back-calculated SFO to derive endpoints for P criteria (SFO DT50 = DT90/3.32)
6) excluded from kinetic evaluation due to analytical problems
7) Number of values for deriving persistence endpoint (SFO DT50) and the modelling endpoint
5.5
-3)
-3)
-6)
Estimation of concentrations in soil (PECsoil) (KIIIA1 9.4)
PECsoil calculations are based on the recommendations of the FOCUS workgroup on degradation
kinetics. A soil bulk density of 1.5 g/cm3, a soil depth of 5 cm and a tillage depth of 5 cm (permanent
crops) were assumed. The PECsoil calculations were performed with ESCAPE based on the input
parameters as presented in tables below.
Table 5.5-1:
Input parameters related to application for PECSoil calculations
Use No.:
D (worst case)
Crop:
Non-crop areas
Application rate:
3600 g as/ha
Number of application/interval:
1/-
Crop interception:
0%
Table 5.5-2:
Input parameter for active substance for PECsoil calculation
Active substance
DT50
Glyphosate
38.3 d (DFOP, k1 0.0384, k2 0.0037, g 0.575, Maximum, Field studies,
not normalised, see Table 5.4-3)
AMPA
633.1 d (SFO, k 0.0011, Maximum, Field studies, not normalised, see
Table 5.4-4)
See glyphosate
Due to the slow degradation of glyphosate and its metabolite AMPA in soil (DT90 > 365 d, Kinetic,
field data) the accumulation potential of both substances needs to be considered. Therefore an
accumulated soil concentration (PECaccu) is used for risk assessment that comprises background
concentration in soil (PECbkgd) considering a tillage depth of 5 cm and the maximum annual soil
concentration PECact for a soil depth of 5 cm.
Beside PECact values also PECtwa, 21 d values are required for risk assessment. PECtwa,21 d values are
also presented in Table 5.5-3.
Table 5.5-3:
Results of PECsoil calculation for application of Tender GB Ultra (MON 78708) in non-crop areas
(soil bulk density 1.5 g/cm-3, soil depth 5 cm) according to use No. D (worst case)
active substance/
preparation
soil relevant
application rate
PECact
(mg/kg)
PECtwa 21 tillage
d**
depth (cm)
PECbkgd
(mg/kg)
PECaccu =
PECact +
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
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(g/ha)
(mg/kg)
PECbkgd
(mg/kg)
Glyphosate
3600
4.8000
3.8593
5
0.7132
5.5132
AMPA
1271
1.6947
1.6753
5
3.4497
5.1443
Tender GB Ultra
(MON 78708)
11660
15.5467
-
-
-
-
* soil relevant application rate = 10 L/ha · 1166 g/L (the density of Tender GB Ultra (MON 78708):
1.166 g/cm³)
** after 1 year
5.6
Estimation of concentrations in surface water and sediment
(PECsw/PECsed) (KIIIA1 9.7)
PECsw and PECsed calculations are provided according to the recommendations of the FOCUS working
group on surface water scenarios in a stepwise approach considering the pathways drainage and
runoff.
The relevant input parameters used for PEC calculation are summarized in the tables below.
Table 5.6-1:
Input parameters for glyphosate for PECsw/sed calculations
Parameter
Endpoint used for
PECsw/sed calculation
Remarks
Active substance
Glyphosate
-
Molecular weight (g/mol) 169.1
-
Water solubility (mg/L)
10500
See Table 5.3-2Table 5.3-2
Koc (mL g-1)
15844
Arithmetic mean
(see Table 5.4-5)
DT50,soil (d)
21.03
Geomean, Normalised (20 °C, pF2),
Laboratory data (see Table 5.4-1)
DT50,water (d)
67.74
Geomean of whole system (SFO, 20 °C),
Modelling endpoints at Level P-I
(see Table 5.4-7)
DT50,sed (d)
67.74
(see Table 5.4-7)
DT50,whole system (d)
67.74
(see Table 5.4-7)
Table 5.6-2:
Input parameters related to application for PECsw/sed calculations
Use No.
D (worst case)
Crop:
Non-crop areas (representative in FOCUS Surface
Water: grass/ alfalfa)
Application rate:
3600 g as/ha
Number of application/interval:
1/-
Evaluator: Germany
Date: November 2013
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Application method:
Spraying
Crop interception:
0%
Results of FOCUS SW calculations for the worst-case application scenario (Use No. D) of Tender GB
Ultra (MON 78708) are summarized in the table below.
Table 5.6-3:
Glyphosate
FOCUS Step 1 and Step 2 PECsw and PECsed (Actual, 0 d) of glyphosate for the application of
Tender GB Ultra (MON 78708) in non-crop areas according to use No. D (worst case)
FOCUS Step 1
PECsw (µg/L)
PECsed (µg/L)
87.34
8.59E+03
FOCUS Step 2
PECsw (µg/L)
PECsed (µg/L)
Northern Europe, Oct. - Feb.
33.11
3.99E+03
Southern Europe, Oct. - Feb.
33.11
3.23E+03
Northern Europe, Mar. - May 33.11
1.73E+03
Southern Europe, Mar. - May 33.11
3.23E+03
However, regarding the intended uses on railways, there are no agreed FOCUS scenarios available.
For the intended use 01-001 and 01-002 (spraying on railway systems), a possible contamination of
surface water via run-off from railway system can currently not be excluded. A contamination of
groundwater and a risk for aquatic organisms might arise from an entry of glyphosate in surface waters
via runoff from railway systems and subsequent bank infiltration. Following these considerations we
cannot exclude that glyphosate concentrations might exceed 0.1µg/L in groundwater after bank
filtration from surface waters when ‘Tender Ultra’ is applied in the intended uses for weed control on
railways.
5.7
Risk assessment ground water (KIIIA1 9.6)
5.7.1
Predicted environmental concentration in groundwater (PECGW)
calculation for active substance and its metabolite (Tier 1 and 2)
Groundwater contamination by direct leaching of the active substance and its metabolites, degradation
or reaction products through soil is generally assessed by groundwater model calculations.
Glyphosate and AMPA
Groundwater contamination by direct leaching of glyphosate and/or its metabolite AMPA is not
expected as both substances are strongly adsorbed to soil particles. Therefore, groundwater model
calculations are not provided.
5.7.2
Summary of risk assessment for ground water
expected.
5.8
Potential of active substance for aerial transport
The vapour pressure at 20 °C of the active substance glyphosate is < 10-5 Pa. Hence the active
substance glyphosate is regarded as non-volatile. Therefore exposure of adjacent surface waters and
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 19 of 28
terrestrial ecosystems by the active substance glyphosate due to volatilization with subsequent
deposition does not need to be considered.
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 21 of 28
Table A 1:
Annex
point/referenc
e No
List of data submitted in support of the evaluation
Author(s)
Year
Title
company)
Report-No.
GLP or GEP status (where
relevant),
Published or not
Data
Owner
protection
claimed
How considered
in dRR
StudyStatus/Usage*
IIA 7.1.1/01
Ponte, M.
- newly
submitted with
renewal
dossier
2010a Rate and route of degradation Y
of [14C]glyphosate in one soil
incubated under aerobic
conditions
Report No.: PTRL1923W-1
(study)
MSL0023070 (sponsor)
Date: October 6, 2010
GLP: yes
Not published
GTF
1)
IIA 7.2.1/01
Ponte, M.
- newly
submitted with
renewal
dossier
2010b Rate of degradation of
[14C]glyphosate in three soils
conditions
Report No.: PTRL1946W-1
(study);
MSL0023071 (sponsor)
Date: October 6, 2010
GLP: yes
Not published
Y
GTF
1)
IIA 7.2.1/02
Mamouni,
- newly
A.
submitted with
renewal
dossier
2002
First amendment (addendum) Y
to report - Degradation of 14Cglyphosate in three soils
conditions
RCC Study No. : 271618
Date: June 3, 2002
GLP: No
Not published
CHE
1)
IIA 7.2.1/03
Dorn, S.
- newly
submitted with
renewal
dossier
2012
Kinetic modelling analysis of
the degradation behaviour of
glyphosate and its metabolite
AMPA from aerobic
laboratory soil degradation
studies
Report No.: 303604-1
Date: May 3, 2012
GLP: no (kinetic evaluation:
GTF
1) Partly
acceptable
Y
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 22 of 28
does not contain laboratory
work)
Not published
IIA 7.3.1/01
Kreschnak, 2012
- newly
C
submitted with
renewal
dossier
the degradation behaviour of
glyphosate and its metabolite
AMPA in field soil
dissipation studies
Date: April 27, 2012
work)
Not published
Y
GTF
1)
IIA 7.4.1/01
- newly
submitted with
renewal
dossier
van
Noorloos,
B.,
Slangen,
P.J.
2001
Adsorption/desorption of
glyphosate on soil
Report No.: 320164 (study)
Date: December 10, 2001
GLP: yes
Not published
Y
AGC
1)
IIA 7.4.1/02
- newly
submitted with
renewal
dossier
Thomas,
P.K.,
Lane
M.C.G.6
1996
Glyphosate acid: adsorption
N
and desorption properties in 5
soils
Report No: RJ2152B
Date: September 12, 1996
GLP: yes
Not published
SYN
1)
1996
Glyphosate: determination of Y
adsorption and desorption
properties based on the OECD
method 106
Report No.: 95-111-1020
(study)
GLP: yes
Not published
SIN
1)
Schneider, 1993
E.
Behaviour of Glyphosate in
N
water and soil, Part 2
Adsorption/desorption on soil
PR90/002
Date: June 17, 1993
GLP: yes
Not published
FSG
(GTF)
1)
ALS
1)
IIA 7.4.1/03
Kolk, J.
- newly
submitted with
renewal
dossier
IIA 7.4.1/04
- submitted
during
national
authorisation
in Germany
IIA 7.4.2/01
Knoch, E.
- newly
submitted with
renewal
2003b Aminomethylphosphonic
acid: adsorption-desorption
Report No.: IF-02/00005220
(study)
N
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 23 of 28
dossier
Date: February 07, 2003
GLP: yes
Not published
IIA 7.4.2/02
Wittig, A., 2002
- newly
Bockholt,
submitted with K.
renewal
dossier
N
behaviour of AMPA on soil
according OECD 106
(adopted January 2000)
Report No.: PR02/007 (study)
Date: June 24, 2002
GLP: yes
Not published
FSG
(GTF)
1)
Muller, K., 1996
Lane,
M.C.G.
Glyphosate acid: adsorption
N
and desorption properties of
the major metabolite, AMPA,
in soil
Report No: RJ2129B
Date: August 27, 1996
GLP: yes
Not published
SYN
1)
IIA 7.8.3/01 - Feser2002
newly
Zügner, W.
submitted with
renewal
dossier
N
acid: fate and behaviour in
water-sediment
A&M Labor für Analytik und
Metabolismusforschung
Service GmbH, Bergheim,
Germany
Report No.: A &M 01-106
(study)
Date: November 12, 2002
GLP: yes
Not published
FSG
1)
IIA 7.4.2/03
IIA 7.8.3/02 - Knoch, E.
newly
submitted with
renewal
dossier
2003c Aerobic aquatic degradation
N
of aminomethylphosphonic
acid according to SETAC,
part 1.8.2 (March 1995)
CALLIOPE S.A.S. (sponsor)
Institut Fresenius Chemische
und Biologische Laboratorien
AG , Herten, Germany
Report No.: IF-02/00005222
(study)
Date: February 07, 2003
GLP: yes
Not published
ALS
(GTF)
1)
IIA 7.8.3/03- McEwen,
newly
A.
submitted with
renewal
2004b [14C]-AMPA: Degradation
and fate in water/sediment
systems
BioDynamics Research
SIN
1)
Y
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 24 of 28
dossier
Limited, Northhamptonshire,
UK
Report No.: SNN/03 (study)
Date: June 7, 2004
GLP: yes
Not published
IIA 7.8.3/04 - Heintze, A. 1996
newly
submitted with
renewal
dossier
Degradation and metabolism Y
of glyphosate in two
water/sediment systems under
aerobic conditions Laboratory test
Report No.: 96138/01-CUWS
(study)
Date: December 16, 1996
GLP: yes
Not published
MON
1)
IIA 7.8.3/05 – Partsch, S. 2012
newly
submitted with
renewal
dossier
the disappearance behaviour
of glyphosate and its
metabolite AMPA in watersediment studies
work)
Not published
GTF
1) Partly
acceptable
MON
2)
KIIIA1 9.6.1
Vanbelling 2002
hen, C.
Y
Predicted environmental
Y
concentrations of glyphosate
and its soil metabolite AMPA
in groundwater in the
European Union using the
FOCUS groundwater
scenarios.
Codes of owner
AGC Agrichem B.V.
ALS
Arysta Lifesciences SAS
CHE
Cheminova A/S
FSG
Feinchemie Schwebda GmbH
GTF
Glyphosate Task Force
MON Monsanto Europe S.A./N.V.
NUF
Nufarm
SIN
Sinon Corporation
SYN
Syngenta Crop Protection AG
1)
2)
3)
4)
accepted (study valid and considered for evaluation)
not accepted (study not valid and not considered for evaluation)
not considered (study not relevant for evaluation)
not submitted but necessary (study not submitted by applicant but necessary for evaluation)
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 25 of 28
5)
supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for
evaluation)
Remark:
Studies submitted by the applicant were alone sufficient to fulfil the data requirements.
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
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Appendix 2 Detailed evaluation of studies relied upon
Within the EU assessment Annex I Renewal 2 (AIR 2) of glyphosate currently in process, new studies on
rate of degradation in soil, adsorption/desorption as well as rate of degradation in water and sediment
have been submitted. These studies were used for this core assessment but not evaluated here, since a
detailed evaluation is presented in the Renewal Assessment Report, Volume 3 Annex B.8, Red Draft.
KIIIA1 9 Fate and Behaviour in the Environment – Plant protection product
KIIIA1 9.1. Vanbellinghen, 2002
Reference:
Author:
Report:
Date:
Guideline(s):
Deviations:
GLP:
Acceptability:
IIIA 9.6.1
Vanbellinghen, C.
Predicted environmental concentrations of Glyphosate and its soil metabolite AMPA
in groundwater in the European Union using the FOCUS groundwater scenarios
October 2002
Not necessary (calculation)
No
Comments of zRMS
The leaching potential of glyphosate and its primary soil metabolite AMPA was assessed using FOCUS
versions of the models PELMO, PRZM, PEARL and MACRO and their groundwater FOCUS shells.
Thereby, the applicant used DT50 values, which were not evaluated according to FOCUS Degradation
Kinetics (2006) as required for deriving PECgw values. Thus, the study is not discussed in detail.
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
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Page 27 of 28
Appendix 3 Table of Intended Uses justification and GAP tables
Crop and/
or situation
Zone
Product code
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
Formulation
Application
Application rate per treatment
(c)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
growth
stage & season
(j)
number
min max
interval
between
applications
(min)
(k)
L/ha
water L/ha
kg as/ha
min max
min max
min max
PHI
(days)
Remarks:
(l)
(m)
Railways
Germany,
Austria
MON 78708
F
Monocotyledonous and
SL
360 g/l
Spraying
During the
growing season
1
-
10
500 1000
3.6
-
-
Railways
Germany,
Austria
MON 78708
F
SL
360 g/l
Spraying
During the
growing season
2
3 months
5
500 1000
1.8 × 2
-
-
Railways
Germany,
Austria
MON 78708
F
SL
360 g/l
Wiping,
single plant
treatment
(33 %)
During the
growing season
1
-
10
-
3.6
-
-
Non-crop
areas, no
woody
plants
Germany,
Austria
MON 78708
F
SL
360 g/l
Spraying
During the
growing season
1
-
10
500 1000
3.6
-
-
Non-crop
areas, no
woody
plants
Germany,
Austria
MON 78708
F
SL
360 g/l
Spraying
During the
growing season
2
3 months
5
500 1000
1.8 × 2
-
-
Evaluator: Germany
Date: November 2013
Core Assessment
Registration Report
Central Zone
Page 28 of 28
Crop and/
or situation
Zone
Product code
(a)
MON 78708
F
G
or
I
(b)
Formulation
Application
(c)
Type
Conc.
of as
method
kind
(d-f)
(i)
(f-h)
Non-crop
areas, no
woody
plants
Germany,
Austria
Remarks:
(a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989
(f) All abbreviations used must be explained
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
F
Pests or
Group of pests
controlled
SL
360 g/l
Wiping,
single plant
treatment
(33 %)
growth
stage & season
(j)
number
min max
interval
between
applications
(min)
(k)
During the
growing season
1
(i)
(j)
-
10
L/ha
water L/ha
kg as/ha
min max
min max
min max
-
3.6
PHI
(days)
Remarks:
(l)
(m)
-
-
g/kg or g/l
application
(k) The minimum and maximum number of application possible under practical conditions of use
must be provided
(l) PHI - minimum pre-harvest interval
(m) Remarks may include: Extent of use/economic importance/restrictions
Evaluator: Germany
Date: November 2013
National Addendum– Germany
Registration Report
Central Zone
zRMS: Germany
Page 1 of 20
REGISTRATION REPORT
Part B
Section 5 Environmental Fate
Product code: Tender GB Ultra (MON 78708)
Active Substance(s): Glyphosate
360 g/L
Central Zone
NATIONAL ADDENDUM – Germany
Applicant:
Monsanto Europe SA
Date:
24/03/2014
Evaluator: Germany
Date: November 2013
Registration Report
Central Zone
zRMS: Germany
Page 2 of 20
Table of Contents
TABLE OF CONTENTS.......................................................................................................................................2
SEC 5
FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ........................................3
5.1
GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3
5.2
PROPOSED USE PATTERN ........................................................................................................................ 3
5.3
INFORMATION ON THE ACTIVE SUBSTANCES........................................................................................... 4
5.3.1 Glyphosate......................................................................................................................................... 4
5.4
SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ............................... 4
5.4.1 Rate of degradation in soil................................................................................................................. 4
5.4.2 Adsorption/desorption ....................................................................................................................... 5
5.4.3 Rate of degradation in water/sediment .............................................................................................. 5
5.5
ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4)........................................................................ 5
5.6
ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) ............................ 6
5.6.1 PECSW after exposure by spraydrift and deposition following volatilisation .................................... 6
5.6.2 PECSW after exposure by surface run-off and drainage..................................................................... 7
5.7
RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6)............................................................................. 8
5.7.1 Direct leaching into groundwater ...................................................................................................... 9
5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and
drainage .......................................................................................................................................................... 9
APPENDIX 1
APPENDIX 2
DETAILED EVALUATION OF STUDIES RELIED UPON..............................................16
KIIIA1 9 FATE AND BEHAVIOUR IN THE ENVIRONMENT ................................................................................... 16
APPENDIX 3
TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL 16.07.2012)....19
Evaluator: Germany
Date: November 2013
Registration Report
Central Zone
zRMS: Germany
Page 3 of 20
Sec 5
FATE AND BEHAVIOUR IN THE ENVIRONMENT
(KIIIA 9)
The exposure assessment of the plant protection product Tender GB Ultra (MON 78708) in its
intended uses in in railways and non-crop areas is documented in detail in the core assessment of the
plant protection product Tender GB Ultra (MON 78708) dated from 04/2013 performed by Germany.
This document comprises the risk assessment for groundwater and the exposure assessment of surface
water and soil for authorization of the plant protection product Tender GB Ultra (MON 78708) in
Germany according to uses listed in Appendix 3.
Regarding PECgw relevant risk mitigation measures, if necessary, are documented in this document.
PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary
(see National addendum Germany, part B, section 6 and part A).
5.1
General Information on the formulation
Table 5.1-1:
General information on the formulation Tender GB Ultra (MON 78708)
Code
Applicant
Monsanto Europe SA
Date of application
20/12/2011
Formulation type
(WP, EC, SC, …; density)
SL
Active substance
Glyphosate
Concentration of as
360 g/L
Data pool/task force
Letter of access/cross reference
Existing authorisations in DE
5.2
The intended uses in Germany classified according the soil effective application rate (cumulative,
disregarding degradation in soil) is presented in Table 5.2-1. Full details of the proposed uses that will
be assessed is included in Appendix 3.
Evaluator: Germany
Date: November 2013
Registration Report
Central Zone
zRMS: Germany
Page 4 of 20
Table 5.2-1: Classification of intended uses in Germany for Tender GB Ultra (MON 78708)
Group*
Crop/growth
stage
Application
Number of
Application rate,
method / Drift applications, Minimum cumulative
scenario
application interval,
(g as/ha)
interception,
application time
(season)
Soil effective
application rate
(g as/ha)
00-001
Railways
Spraying
1
3600
3600
00-002
Railways
Spraying
2, 3 months
1800 × 2
1800 × 2
00-003
Railways
Wiping,
1
single plant
treatment (33
%)
3600
3600
00-004
Non-crop
areas, no
woody plants
Spraying
1
3600
3600
00-005
Non-crop
areas, no
woody plants
Spraying
2, 3 months
1800 × 2
1800 × 2
00-006
Non-crop
areas, no
woody plants
Wiping,
1
single plant
treatment (33
%)
3600
3600
* For administrative purposes, each intended use of a plant protection product in Germany is assigned
with an individual use number from the German Federal Office of Consumer Protection and Food
Safety (BVL). A complete list of the individual GAPs in Germany together with their assigned use
numbers is given in Appendix 3 of this Addendum.
5.3
Information on the active substances
5.3.1
Glyphosate
Please refer to the core assessment (November 2013), part B, section 5, point 5.3.1.
5.4
Summary on input parameters for environmental exposure assessment
5.4.1
Rate of degradation in soil
Glyphosate
Evaluator: Germany
Date: November 2013
Registration Report
Central Zone
zRMS: Germany
Page 5 of 20
5.4.2
Glyphosate
5.4.3
Rate of degradation in water/sediment
Glyphosate
Accumulation of active substance and relevant metabolites in the sediment
active substance
Glyphosate
accumulation potential in sediment
yes (DT90,whole system > 1 year, persistence endpoint at Level P-I,
maximum, see core assessment, part B, section 5, chapter 5.4.3)
accumulation factor (SFO)
faccu = e-kt/(1 – e-kt)
0.76 based on DT50, whole system = 301.20 d (recalculated (SFO)
persistence endpoint at Level P-I, maximum, see core assessment,
part B, section 5, chapter 5.4.3), t = 356 d
5.5
Estimation of concentrations in soil (KIIIA1 9.4)
Results of PECsoil calculation for Tender GB Ultra (MON 78708) according to EU assessment
considering 5 cm soil depth are given in the core assessment November 2013 , part B, section 5,
chapter 5.5.
For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler,
Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a
soil depth of 2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is
applied. As soil bulk density 1.5 g cm-3 is assumed.
Due to the slow degradation of the active substance glyphosate in soil (DT90 > 365 d, field data) the
accumulation potential of glyphosate needs to be considered. Therefore PECsoil used for risk
assessment comprises background concentration in soil (PECaccu) considering a tillage depth of 5 cm
(permanent crops) and the maximum annual soil concentration PECact considering the relevant soil
depth of 2.5 cm, respectively.
The PECsoil calculations were performed with ESCAPE 1.0 based on the input parameters for
glyphosate as presented in Table 5.5-1.
Table 5.5-1:
Input parameters for Tender GB Ultra (MON 78708) for PECsoil calculation
Active substance
DT50
Glyphosate
38.3 d (DFOP, k1 0.0384, k2 0.0037, g 0.575, maximum, field studies, not
normalised, see core assessment)
AMPA
633.1 d (SFO, k 0.0011, maximum, field studies, not normalised, see core
assessment)
Tender GB Ultra (MON
78708)
see glyphosate
Evaluator: Germany
Date: November 2013
Registration Report
Central Zone
zRMS: Germany
Page 6 of 20
Additional PECsoil,act was calculated for the formulation GB Ultra (MON 78708) for a soil depth of
2.5 cm.
No short-term and long-term PECsoil were calculated since PECsoil,act is considered sufficient for
German risk assessment.
The calculated PECsoil used for German risk assessment for glyphosate, AMPA and for the formulation
GB Ultra (MON 78708) are summarized in Table 5.5-2.
Table 5.5-2:
Results of PECsoil calculation for the intended use in non-crop areas used for
German risk assessment
plant protection product:
use:
00-004 (worst case)
Number of applications/intervall
1/-
application rate:
3600 g as/ha
crop interception:
0%
active substance/
formulation
soil relevant
application rate
(g/ha)
soil depthact PECact
(cm)
(mg/kg)
tillage
depth (cm)
PECbkgd
(mg/kg)
PECaccu =
PECact +
PECbkgd
(mg/kg)
Glyphosate
3600
2.5
9.6000
5
0.7132
10.3132
AMPA
1271
2.5
3.3893
5
3.4497
6.8390
Tender GB Ultra
(MON 78708)
11660
2.5
31.0933
-
-
-
* soil relevant application rate = 10 L/ha · 1166 g/L (the density of Tender GB Ultra (MON 78708):
1.166 g/cm³)
5.6
Estimation of concentrations in surface water and sediment (KIIIA1 9.7)
Results of PECsw calculation of glyphosate for the intended for uses of Tender GB Ultra (MON
78708) in in railways and non-crop areas using FOCUS Surface Water are given in the core
assessment November 2013, part B, section 5, chapter 5.6.
For authorization in Germany, exposure assessment of surface water considers the two routes of entry
(i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in
order to allow risk mitigation measures separately for each entry route.
Surface water exposure via spray drift and volatilization with subsequent deposition is estimated with
the models EVA 2.1. Surface water exposure via surface run-off and drainage is estimated using the
model EXPOSIT 3.01.
The German surface water exposure assessment is outlined in the following chapters.
5.6.1
PECSW after exposure by spraydrift and deposition following volatilisation
The calculation of concentrations in surface water is based on spray drift data by Rautmann and
Ganzelmeier. Eventhough glyphosate is considered as semivolatile with a vapour pressure of 1.31 x105
Pa (25 °C, acid) , the contribution of volatilasation is negligible.
The calculation of PECsw after exposure via spray drift and volatilization with subsequent deposition
is performed using the model EVA 2.1. For a single application, the exposure assessment via spray
Evaluator: Germany
Date: November 2013
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drift is based on the application rate in conjunction with the 90th percentile of the drift values. For
multiple applications, lower percentiles of the drift values for each application are applied, resulting in
an overall 90th percentile of drift probabilities. Only one volatilization event following the last use of
pesticide is generally considered.
The endpoints used for modelling surface water exposure via spray drift and volatilization with
subsequent deposition with EVA 2.1 are summarized in Table 5.6-1.
Table 5.6-1
Endpoints of glyphosate used for the PECSW calculations with EVA 2.1
Parameter
vapour pressure at 20 °C (Pa)
Active substance Glyphosate
1.31 x10-5 Pa (25 °C, acid)
Solubility in water (mg/L)
10500
DT50 hydrolysis/photolysis (d)
1000 (default)
Reference
See core assessment, section 5, point
5.3.1.1
see core assessment, section 5, point
5.3.1.2
The calculated PECsw values after exposure via spray for the active substance glyphosate for the
intended use in non crop areas (worst case application rate) are summarized in Table 5.6-2.
Table 5.6-2
PECSW for the active substance glyphosate after exposure via spray drift and
volatilization with subsequent deposition modelled with EVA 2.1
active substance
use pattern/gap:
application rate/number of
applications / interval
Glyphosate
Non –crop areas
1x3600 g/ha(worst case)
scenario/percentile:
distance
PECsw via drift
(m)
(%)
(µg/L)
0
100.00 1200
Agriculture/90
PECsw via
volatilisation
(%)
(µg/L)
1/3
5.6.2
2.77
PECsw (via drift and volatilisation) (µg/L)
depending on application technique (drift reduction)
common
90% red.
75% red.
50% red.
1200
33.2
33.24
120
3.3
300
8.3
1200
16.6
PECSW after exposure by surface run-off and drainage
The concentration of the active substance glyphosate in adjacent ditch due to surface runoff and
drainage is calculated using the model EXPOSIT 3.01.
The parameters for glyphosate used for modelling surface water exposure via run-off and drainage in
an adjacent ditch with EXPOSIT 3.01 are summarized in Table 5.6-3.
Table 5.6-3
Input parameters for glyphosate used for PECSW calculations with
EXPOSIT 3.01
Parameter
K foc, Runoff
Glyphosate
15844
Reference
arithm. mean (see core assessment,
section 5, point 5.4.2)
Kfoc, mobility class
3091
10th percentile as realistic worst case,
(see core assessment, section 5, point
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DT50 soil (d)
40.9 d
10500
Reduction by bank filtration (only
relevant for PECgw see 5.7.2)
23.5 %
5.4.2)
DFOP (overall DT50), maximum, filed
studies, not normalised (see core
assessment, section 5, point 5.4.1.2)
5.3.1.2
measured values, see Schmidt (2005,
TZW Karlsruhe)
The calculated PECSW in an adjacent ditch due to surface run-off and drainage for the active substance
glyphosate for the intended for use in non-crop areas (worst case application rate) are summarized in
Table 5.6-4.
Table 5.6-4
PECSW of glyphosate in an adjacent ditch due to surface run-off and drainage
Glyphosate
Active substance:
00-004 (worst case)
Use pattern/GAP:
3600 g/ha (worst case), crop interception: 0 %
Application rate:
Exposure by surface runoff
vegetated buffer strip (m)
PECsw in adjacent ditch
(PECini Runoff)
(µg/L)
0
4.08
5
3.54
10
3.03
20
2.12
Exposure by drainage
time of application
autuum/winter/early spring
Spring/summer
5.7
PECsw in adjacent ditch
(PECini Gesamtaustrag)
(µg/L)
29.35
25.43
21.80
15.26
PECsw in adjacent ditch (µg/L)
1.64
0.53
Risk assessment for groundwater (KIIIA1 9.6)
Results of PECgw calculation of glyphosate for the intended uses of Tender GB Ultra (MON 78708)
in railways and non-crop areas according to EU assessment are given in the core assessment
November 2013 part B, section 5, chapter 5.7.
For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct
leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and
drainage of the active substance into an adjacent ditch with subsequent bank filtration into the
groundwater.
Direct leaching after soil passage is assessed following the recommendations of the publication of
Holdt et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental
concentrations of active substances of plant protection products and their metabolites in groundwater
(PECGW) in the National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011)
for tier 1 and tier 2 risk assessment. According to Hold et al, 2011, endpoints for groundwater
modelling are derived with the program INPUT DECISION 3.1 and subsequent simulations are
Evaluator: Germany
Date: November 2013
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performed for the groundwater scenarios “Hamburg” or with the scenarios “Hamburg” and
“Kremsmünster” of FOCUS PELMO 4.4.3.
In tier 3 risk assessment, results of experimental studies (lysimeter studies and/or field leaching
studies) can also be considered in German groundwater risk assessment.
Surface run-off and drainage into an adjacent ditch with subsequent bank filtration into the
groundwater are estimated using the model EXPOSIT 3.01.
The German risk assessment for groundwater is given in the following chapters.
5.7.1
Direct leaching into groundwater
5.7.1.1
PECGW modelling
Glyphosate and AMPA
expected as both substances are strongly adsorbed to soil particles. Therefore, groundwater model
calculations are not provided.
5.7.1.2 Summary on risk assessment for groundwater after direct leaching
expected.
-
5.7.2
Ground water contamination by bank filtration due to surface water
exposure via run-off and drainage
The input parameters for glyphosate used for modelling surface water exposure via run-off and
drainage in an adjacent ditch with subsequent bank filtration into the groundwater with EXPOSIT 3.01
are summarized in Table 5.7-1.
Table 5.7-1
Input parameters for glyphosate used for PECGW calculations with
EXPOSIT 3.01
Parameter
K foc, Runoff
Glyphosate
15844
Reference
3091
DT50 soil (d)
40.9 d
10500
5.4.2)
5.3.1.2
Mobility class
1
-
Reduction by bank filtration
23.5 %
TZW Karlsruhe)
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Date: November 2013
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The calculated PECgw for glyphosate after surface run-off and drainage with subsequent bank
filtration are summarized in the following tables.
Table 5.7-2
PECgw for glyphosate after surface run-off and drainage with subsequent bank
filtration (modelled with EXPOSIT 3.01 )
Active substance
Use No.
application
rate
interception
Glyphosate
PECgw due to
run-off
vegetated buffer
strip
(m)
00-004 (worst 3600 g/ha, 0 % 0
case)
5
10
20
No authorization.
required labelling
Table 5.7-3
bank filtrate
(µg/L)
Time of
application
bank filtrate
(µg/L)
0.250
0.216
0.185
0.130
autumn/winter/
early spring
0.101
spring/summer
0.033
PECgw for glyphosate after surface run-off and drainage with subsequent bank
filtration (modelled with EXPOSIT 3.01 )
Active substance
Use No.
application
rate
interception
00-005
drainage
1800 g/ha × 2,
0 %, 91 d
required labelling
Glyphosate
PECgw due to
run-off
vegetated buffer
strip
(m)
0
5
10
20
NG 404
drainage
bank filtrate
(µg/L)
Time of
application
bank filtrate
(µg/L)
0.152
0.131
0.113
0.079
autumn/winter/
early spring
0.061
spring/summer
0.020
According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L
by the active substance glyphosate due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration cannot be excluded for the intended use No. 00-004.
by the active substance glyphosate due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded for the intended use No. 00-005 in case risk mitigation
measures (vegetated buffer strip of 20 m) are applied.
and a risk for aquatic organisms might arise from an entry of glyphosate in surface waters via runoff
from railway systems and subsequent bank infiltration.
According to available information, in actual track constructions vertical infiltration into the railway
roadbed system is being avoided by means of inserted barrier layers into the roadbeds up to the track
level. As a consequence, during rain events, lateral leaching to both sides of the roadbeds will occur –
Evaluator: Germany
Date: November 2013
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possibly in drainage channels. This run-off water might discharge into runoff ditches or be collected
separately.
Since the sorption of active ingredients to crushed material, like gravel, is deemed to be lower than to
the agricultural soils usually considered in the risk assessment of plant protection products, a higher
mobility of glyphosate might occur (e.g. Strange-Hansen, R., PE Holm, OS Jacobsen and CS
Jacobsen, 2004: Sorption, mineralization and mobility of N-(phosphonomethyl)glycine (glyphosate) in
five different types of gravel. Pest Management Science 60, 570-578).
There are a few results available from studies investigating the behaviour of glyphosate in railway
systems in Switzerland (e. G. Brauchli-Theotokis, J. (2004): Bestimmung von Glyphosat und AMPA
auf Bahnanlagen. In: BUWAL Bundesamt für Umwelt, Wald und Landschaft (eds.) UMWELTMATERIALIEN NR. 170 Umweltgefährdende Stoffe/Gewässerschutz. Bern, Schweiz, 58 S.). These
investigations show that at similar application rates as in the intended uses of ‘Tender GB Ultra’,
concentrations up to 100 µg glyphosate/L are detected in the drainage water of the experimental setups. In general, it was shown that the higher the rainfall quantity, the higher the cumulative amount of
glyphosate that was washed-off. During normal operation, glyphosate concentrations along railway
tracks reached values up to 10 g / L in the drainage water.
Similar concentrations were also detected in drainage ditches alongside railway lines in England.
There, about 1800 g of glyphosate/ha were applied experimentally and 12 µg/L glyphosate was
measured in run-off water (Heather, AIJ, JM Hollis & AJ Shepherd, 1999. Losses of six herbicides
from a disused railway formation. Final report to Hard Surfaces project Consortium. February, 1999.
pp. 30.)
Following these considerations and based on the available studies, we cannot exclude that glyphosate
concentrations might exceed 0.1 µg/L in groundwater after bank filtration from surface water when
‘Tender GB Ultra’ is applied in the intended uses for weed control on railways. For this initial
evidence to be substantiated or dispelled, we therefore require additional information in order to assess
the potential contamination of surface water by runoff as well as the potential contamination of
groundwater via run-off in surface water with subsequent bank filtration due to the application of
glyphosate on railway facilities.
In particular, we ask for information within 2 years from the date of registration as regard to:
and infiltration
and translocation)
technologies
Furthermore, we ask for information relating to the potential risk for local populations of protected
species in conservation areas and other protected areas [§ § 22 and 32 Federal Nature Conservation
Act] and of water conservation [by WHG § § 50-53] if ‘‘Tender GB Ultra’ is applied in the intended
use on railway systems.
Evaluator: Germany
Date: November 2013
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Metabolites
The soil metabolite of glyphosate (see core assessment, part B, section 5, point 5.3.1.3) is formed >
10 % in soil. Therefore potential ground water contamination due to bank filtration via surface water
exposure by run-off and drainage needs to be assessed using EXPOSIT 3.01.
The input parameter for the model EXPOSIT 3.01 are summarized in Table 5.7-4, the results are given
in Table 5.7-5 and Table 5.7-6.
Table 5.7-4:
Input parameter for the soil metabolite AMPA for EXPOSIT 3.01
Parameter
Metabolite AMPA
Molecular weight (g/mol)
111.0
Correction factor molecular weight
0.656
Maximum occurrence in soil (%)
53.8 %
K foc, Runoff
9749 (arithmetic mean, (see core assessment,
1334 (10th percentile as realistic worst case, (see
core assessment, section 5, point 5.4.2)
DT50 soil (d)1)
244.74 d (SFO, 90th percentile, laboratory study,
see core assessment, part B, section 5, point
5.4.1.1)
See glyphosate (Table 5.7-1)
Mobility class
1
1)
only relevant for mobility class
Table 5.7-5:
PECgw for the soil metabolite AMPA after surface run-off and drainage with
subsequent bank filtration (modelled with EXPOSIT 3.01 beta)
Metabolite
Use No.
00-004 (worst
case)
AMPA
application
rate
interception
drainage
vegetated buffer bank filtrate
strip
(µg/L)
(m)
Time of
application
bank filtrate
(µg/L)
0.037
0.012
0.111
5
0.096
autumn/winter/
early spring
10
0.082
spring/summer
20
0.058
See glyphosate
PECgw for the soil metabolite AMPA after surface run-off and drainage with
subsequent bank filtration (modelled with EXPOSIT 3.01 beta)
Metabolite
Use No.
run-off
1271 g/ha, 0 % 0
required labelling
Table 5.7-6:
PECgw due to
AMPA
application
PECgw due to
Evaluator: Germany
Date: November 2013
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00-005
rate
interception
run-off
drainage
vegetated buffer bank filtrate
strip
(µg/L)
(m)
Time of
application
bank filtrate
(µg/L)
635 g/ha × 2,
0 %, 91 d
0
0.098
0.033
5
0.085
autumn/winter/
early spring
10
0.073
spring/summer
0.011
20
0.051
required labelling
See glyphosate
by the the soil metabolite AMPA due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of
5 m) are applied for the intended use No. 00-004.
by the soil metabolite AMPA due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded for the intended use No. 00-005.
The authorization of the plant protection product Tender GB Ultra (MON 78708) is linked with
following labeling:
General
NG351
A maximum of 2 treatments with a minimum interval of 90 days
may be carried out with this product and other products
containing glyphosate within one calendar year on the same area.
The maximum application rate for the active substance of 3.6 kg
per hectare and year must not be exceeded.
Use No. 00-001 and
Use No. 00-002
Authorization coupled to the requirement, that application of
‘Tender GB Ultra’ on railway systems will not lead to
groundwater contamination > 0.1 glyphosate/L following run off
and subsequent bank infiltration. Submission of the relevant
information (see above, concerning i.a. fate and behavior of
glyphosate following application on railway systems) within 2
years from registration.
Use No. 00-004
No authorization
Use No. 00-005
NG 404
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Date: November 2013
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Page 15 of 20
No additional data for national assessment submitted.
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Date: November 2013
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Report Please refer to the core assessment November 2013 part B, section 5, Appendix 2.
KIIIA1 9 Fate and Behaviour in the Environment
No studies submitted.
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Date: November 2013
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Appendix 3 Table of Intended Uses in Germany (according to BVL 16.07.2012)
active substance 1
1
UseNo.
2
Member
state(s)
3
Crop and/
or situation
(crop destination /
purpose of crop)
Glyphosate
4
F
G
or
I
5
controlled
(additionally:
Formulation type:
Conc. of as 1:
6
7
8
SL
360 g/L
10
Application
Method /
Kind
Timing / Growth
stage of crop &
season
11
12
Application rate
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
L product / ha
g, kg as/ha
a) max. rate per
appl.
Water L/ha
a) max. rate
b) max. total rate per appl.
per crop/season b) max. total
rate per
crop/season
min / max
13
14
Remarks:
PHI
(days)
e.g. recommended or mandatory tank
mixtures
00001
DE
Railways
F
Spraying
During the growing 1
season
10
3.6
500 - 1000
-
-
00002
DE
Railways
F
Spraying
During the growing 2 (3 months)
season
5
1.8 × 2
500 - 1000
-
-
00003
DE
Railways
F
Wiping,
single plant season
treatment
(33 %)
10
3.6
-
-
-
00004
DE
Non-crop areas, no
woody plants
F
Spraying
season
10
3.6
500 - 1000
-
-
00005
DE
Non-crop areas, no
woody plants
F
Spraying
During the growing 2 (3 months)
season
5
1.8 × 2
500 - 1000
-
-
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00006
DE
Non-crop areas, no
woody plants
F
Wiping,
single plant season
treatment
(33 %)
10
Evaluator: Germany
Date: November 2013
3.6
-
-
-
Tender GB Ultra
Core Assessment – DE
Registration Report
Central Zone
Page 1 of 90
REGISTRATION REPORT
Part B
Section 6 Ecotoxicological Studies
Product code:
Active Substance: Glyphosate 360 g/L
(Isoproylaminsalt 487 g/L)
Central Zone
Zonal Rapporteur Member State: Germany (DE)
CORE ASSESSMENT
Applicant:
Date:
Applicant Monsanto Europe SA
Monsanto Europe SA
24/03/2014
Evaluator: zRMS DE
Date April 2013
Tender GB Ultra
Registration Report
Central Zone
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Table of content
SEC 6
ECOTOXICOLOGICAL STUDIES ...............................................................................5
6.1 PROPOSED USE PATTERN AND CONSIDERED METABOLITES ..............................................................6
6.1.1 Proposed use pattern ..............................................................................................................6
6.1.2 Consideration of metabolites..................................................................................................6
6.2 EFFECTS ON BIRDS............................................................................................................................7
6.2.1 Overview and summary .........................................................................................................7
6.2.2 Toxicity to exposure ratio for birds (K III A 10.2.1) ...........................................................11
6.2.3 Drinking water exposure ......................................................................................................16
6.2.4 Details on formulation type in proportion per item..............................................................16
6.2.5 Acute toxicity of the formulation .........................................................................................16
6.2.6 Metabolites...........................................................................................................................16
6.2.7 Supervised cage or field trials ..............................................................................................17
6.2.8 Acceptance of bait, granules or treated seeds (palatability testing) .....................................17
6.2.9 Effects of secondary poisoning ............................................................................................17
6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS ....................................................17
6.3.1 Overview and summary .......................................................................................................17
9.1.1 Toxicity exposure ratio.........................................................................................................19
9.1.2 Drinking water exposure ......................................................................................................25
9.1.3 Details on formulation type in proportion per item..............................................................25
9.1.4 Acute toxicity of the formulation .........................................................................................26
9.1.5 Metabolites...........................................................................................................................26
9.1.6 Supervised cage or field trials ..............................................................................................26
9.1.7 Acceptance of bait, granules or treated seeds (palatability testing) .....................................26
9.1.8 Effects of secondary poisoning ............................................................................................26
9.2 EFFECTS ON AQUATIC ORGANISMS ................................................................................................27
9.2.2 Toxicity to Exposure ratio....................................................................................................30
9.2.3 Acute toxicity and chronic toxicity of the formulation ........................................................31
9.2.4 Metabolites of Glyphosate ...................................................................................................31
9.2.5 Accumulation in aquatic non-target organisms....................................................................32
9.3 EFFECTS ON BEES ...........................................................................................................................33
9.4 EFFECTS ON ARTHROPODS OTHER THAN BEES..............................................................................34
9.4.2 Risk assessment for Arthropods other than Bees .................................................................38
9.5 EFFECTS ON EARTHWORMS, OTHER NON-TARGET SOIL ORGANISMS AND ORGANIC MATTER
BREAKDOWN ..........................................................................................................................................40
9.5.2 Toxicity to Exposure Ratio ..................................................................................................44
9.5.3 Residue content of earthworms ............................................................................................44
9.6 EFFECTS ON SOIL MICROBIAL ACTIVITY .......................................................................................44
9.7 EFFECTS ON NON-TARGET PLANTS ................................................................................................46
APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION .................49
APPENDIX 3 DETAILED EVALUATION OF STUDIES RELIED UPON .....................................53
ACTIVE SUBSTANCE (GENERALLY ONLY RELEVANT IN THE CASE THAT NEW ANNEX II DATA
IS PROVIDED AFTER GLYPHOSATE APPROVAL) ......................................................................................53
A2-1
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IIA 10.8 Effects on Non-Target Plants .............................................................................................53
IIA 8.1.1 TERRESTRIAL PLANTS..........................................................................................................53
A2-2 FORMULATION...............................................................................................................................54
MIII A 10.2 Effects on Aquatic Organisms ...................................................................................54
MIIIA1 10.2.2 Acute toxicity of the formulation...........................................................................54
IIIA 10.2.2.1/01 Fish........................................................................................................................54
IIIA 10.2.2.1/02 Fish.........................................................................................................................55
IIIA 10.2.2.2/01 Aquatic invertebrates (Daphnia)...........................................................................57
IIIA 10.2.2.3 Algae ........................................................................................................................58
MIII A 10.4 Effects on Bees ..........................................................................................................60
MIII A 10.5 Effects for Arthropods ...............................................................................................61
IIIA 10.5.1 LABORATORY STUDIES ........................................................................................................61
IIIA 10.5.2/01 EXTENDED LABORATORY STUDIES ..............................................................................61
IIIA 10.6/01
EFFECTS ON EARTHWORMS AND OTHER SOIL NON-TARGET MACRO-ORGANISMS ....66
EFFECTS ON EARTHWORMS AND OTHER SOIL NON-TARGET MACRO-ORGANISMS ....68
IIIA 10.6/02
IIIA 10.7 EFFECTS ON SOIL MICRO-ORGANISMS .................................................................................69
APPENDIX 5 TABLE OF INTENDED USES JUSTIFICATION AND GAP TABLES ..................72
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Sec 6
ECOTOXICOLOGICAL STUDIES
This document reviews the ecotoxicological studies for the product Tender GB Ultra containing the active
substance Glyphosate which is currently approved under Reg. (EC) No 1107/2009 (repealing Directive
91/414/EEC) and fulfills the criteria according to commission implementing regulation (EU) No
546/2011, Annex, Part I C , 2.
A full risk assessment according Commission Regulation (EU) No 546/2011 is provided.
Addenda are included containing country specific assessments for some annex points. In those cases this
document should be read in conjunction with the relevant addenda.
Appendix 1 of this document contains the list of references included in this document in support of the
evaluation.
Appendix 2 of this document reports the detailed evaluation of studies relied upon.
Appendix 4 of this document is the table of intended uses for Tender GB Ultra.
Information on the detailed composition of Tender GB Ultra can be found in the confidential dossier of
The DAR of the active substance glyphosate dates 11 December 2008 (RMS DE). Several addenda to the
monograph have been compiled, the most recent from January 2000. The review report for glyphosate
dates 2002 (6511/IV/99-final, 21 January 2002). Tender GB Ultra was not the representative formulation
considered in the EU review process as part of the approval of the glyphosate.
Currently, the active substance glyphosate is in the Renewal Assessment (AIR2) with Germany as RMS.
In the course of this, the environmental endpoints were re-evaluated and new relevant endpoints are
proposed.
•
Article 36 of Regulation (EC) No 1107/2009 states that „the Member State examining the
application shall make an independent, objective and transparent assessment in the light of
current scientific and technical knowledge using guidance documents available at the time of
application“, an assessment based on updated data taking into account the latest knowledge from
the dRAR (Red draft) is included. For transparency reasons the former endpoints according to
SANCO (6511/IV/99-final, 21 January 2002) as well as updated endpoints according to dRAR
(Red draft, November 2013) are presented in tables presenting toxicity data, and assessment on
updated data according to dRAR (Red draft, November 2013) is added.
•
Considering the legal requirement resulting from Article 29(1) -e of the Regulation (EC) No
1107/2009 the risk regulation for product authorization has to be based on an assessment in the
light of current scientific and technical knowledge as also mentioned in chapter 4 of the proposal
for revision 9 of the SANCO/10328/2004 guidance document. The compliance with this objective
requires an immediate evaluation (prior to a renewal according to Art. 14) for those new active
substance data for which the consideration in the product risk assessment would either result in a
non-authorization or to the necessity to derive stricter risk mitigation measures to ensure that the
plant protection product under realistic conditions of use meets the requirements set up in Art. 4
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(3) of the Regulation (EC) No 1107/2009 with respect to acceptability of risk to human health
and environment. According to the proposal of the current version of the guidance document (as
also in previous revisions) new annex II data would only have to be immediately evaluated if they
are considered as ´adverse data´ in the sense of Art. 56 (chapter 4.4, not covered in detail in the
guidance document) or if they are (presumably) in support of the authorization of the applied uses
(chapter 4.1 to 4.3).
For transparency reasons the former endpoints according to SANCO (6511/IV/99-final, 21 January
2002) as well as updated endpoints according to dRAR (Red draft, November 2013) are presented
in tables presenting toxicity data, and an assessment on updated data according to dRAR (Red
draft, November 2013) is added. Relevant data referring to the EU assessment Annex Renewal 2
(AIR 2) of glyphosate is marked in bold in the following document.
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6.1
Proposed use pattern and considered metabolites
Introduction
draft, November 2013) is added.
Section 6 of the submission summarizes the ecotoxicological effects of the formulation Tender GB Ultra
containing the active substance glyphosate and evaluates the potential risk to various representatives of
terrestrial, aquatic and soil organisms. Full details or the proposed use patterns that will be assessed are
shown in Appendix 3 of this document and summarized below. Moreover, an overview of the metabolites
of glyphosate that will be addressed in the risk assessment is given below.
6.1.1
The critical GAP used for exposure assessment is presented in Table 6-1 that reports also a classification
of intended uses for Tender GB Ultra (see also Section 5). A list of all intended uses within the central
zone/EU is given in Appendix 3.
Table 6-1:
Critical use pattern of Tender GB Ultra (MON 78708)
Group/
use No
Crop/growth
stage
Application
method Drift
scenario
No. of applications, Application rate, Soil effective
Min. application
cumulative
application rate
interval, application (g as/ha)
(g as/ha)
time, interception
A
Railways
Spraying
1
3600
3600
B
Railways
Spraying
2, 3 months
1800 × 2
1800 × 2
C
Railways
Wiping,
single plant
treatment (33 %)
1
3600
3600
D
Non-crop areas, Spraying
no woody plants
1
3600
3600
E
Non-crop areas, Spraying
no woody plants
2, 3 months
1800 × 2
1800 × 2
F
Non-crop areas, Wiping,
no woody plants single plant
treatment (33 %)
1
3600
3600
6.1.2
Consideration of metabolites
The occurrence and risk from potentially ecotoxicologically relevant metabolites have been considered in
the EU review of glyphosate. Further information is provided and in Part B, Section 5. Environmental
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occurring metabolites of glyphosate requiring further assessment according to the results of the
assessment of glyphosate for EU approval are summarized in Table 6-2.
Table 6-2:
Metabolit
acid (AMPA)
molar mass:
111.0 g/mol
correction
factor: 0.656
(Hydroxymeth
yl)-phosphonic
acid
molar mass:
112.0 g/mol
correction
factor: 0.662
Metabolites of glyphosate potentially relevant for exposure assessment (> 10 % or > 5 % in 2 sequential
measurements or > 5 % and maximum of formation not yet reached at the end of the study)
Structural
formula/Molecular
formula
Occurence in compartements Satus of Relevance
(Max. at day/
(Review report 6511/IV/99final, 21 January 2002)
Soil:
Max. 29.3 % at day 84
O
HO P CH2 NH2
OH
Water:
Max. 16 % at day 14
Sediment:
Max. 16 % at day 120
OH
HO P C
H2
O
OH
Aquatic organism:
Water: not relevant
Sediment:
not relevant
Terrestrial organism: : not
relevant
Groundwater: not relevant
(Step 2)1)
Water:
Aquatic organism:
Max. 10.0% at day 61, 7.5% at Water: not assessed
day 100 / 2 x > 5 %
1)
According to Guidance Document on the assessment of the relevance of metabolites in groundwater of
substances regulated under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February
2003)
6.2
Effects on Birds
6.2.1
Overview and summary
Birds are exposed to residues of glyphosate on their food items following spraying of the formulated
product. According to current data requirements in Commission Regulation 1107/2009 of 21 October
2009 amending Council Directive 91/414/EEC the acute oral toxicity of an active substance to a quail
species (Japanese quail, Coturnix coturnix japonica or bobwhite quail, Colinus virginianus) or to mallard
duck (Anas platyrhynchos) must be determined.
In order to evaluate the acute risk to birds, the endpoint LD50 > 2000 mg/kg bw was chosen, as agreed
during the EU review of the active substance glyphosate.
For the current Renewal Assessment (AIR2) a large number of acute studies in birds without any
mortality at limit doses were submitted. EFSA guidance document 1438/2009 indicates that “it is
permissible to extrapolate an LD50 value in cases where there is no mortality or a single mortality at
a limit dose in an acute avian toxicity study”. Using the study with the Bobwhite quail with a limit
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dose of 2000 mg/kg bw, the extrapolation factor for no mortalities at the limit dose and 20 birds per
dose group (the actual number of birds tested at this limit dose exceeded 20), the acute LD50 to be
used in a bird risk assessment according to EFSA guidance document 1438/2009 is proposed to be
2000 x 2.167 = 4334 mg/kg bw.
Regarding the endpoint used to assess the long-term risk to birds, please refer to the next chapter for
detailed discussion.
Effects on birds of Tender GB Ultra were not evaluated as part of the EU review of glyphosate. However,
the provision of further data on the formulation Tender GB Ultra is not considered essential as the
available data on glyphosate are deemed to be sufficient to assess the risk of birds exposed to Tender GB
Ultra. Tender GB Ultra is intended for weed control in non-crop areas and railways.
(EFSA Journal 2009; 7(12): 1438).
6.2.1.1
Toxicity
The studies with the relevant acute and long-term endpoints which are used in the risk assessment
procedure are listed in the following table.
Table 6-3: Toxicity of glyphosate to birds with reference to agreed endpoints
Species
Substance
System
Results
Reference
Colinus
virginianus
glyphosate
1d
LD50 > 2000 mg/kg bw 1)
Colinus
virginianus
glyphosate
1d
LD50 > 3851 mg/kg bw 2)
XXX 1991, Rep. 26907
No. CHV
48/91266, LOEP
XXX, 1978, WL- 39344
78-27
Colinus
virginianus
glyphosate
1d
Colinus
virginianus
glyphosate
119d
LD50 = 4334 mg/kg bw
(extrapolated according to
EFSA GD 1438/2009)3)
NOEC = 200 mg/kg food or
NOEL = 18.1 mg/kg bw/d 1)
NOAEL = 96.3 mg/kg bw/d
Colinus
virginianus
glyphosate
140d
ICS-No.
dRAR (Red
draft, November
2013)
XXX, 1978,
35159/
Report No.: WI- 37256
78-52,
The study is not considered XXX 1999; 123- 44176
to be acceptable and valid 186
3) 4)
Anas
platyrhynchos
glyphosate
147d
NOEL/NOAEL = 117
mg a.s./kg bw/day 3)
XXX 1999; 123- 44174
187
1) Review report 6511/IV/99-final, 21 January 2002
2) New study submitted by the applicant
3) Updated endpoints according to dRAR (Red draft, November 2013)
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In order to evaluate the acute risk to birds, the updated endpoint LD50 =4334 mg/kg bw is used for
risk assessment.
Concerning the effects of glyphosate on bird reproduction, studies have been conducted with bobwhite
quail (XXX 1978/ WI 78-52 and XXX, 1999; 123-186) and mallard duck (XXX 1978/ WI 78-53, XXX;
123-187) for the active substance glyphosate. All studies have been reevaluated according to current
guidelines.
The new submitted study for mallard duck by XXX, 1999; 123-187 is considered to be valid.
Nevertheless, due to significant reduction in mean body weight in the 2250 ppm treatment group in 14day old survivors, the NOEL for mallard ducks exposed to glyphosate acid in a reproduction study was
determined to be 1000 mg glyphosate acid/kg feed, corresponding to 116 mg/kg/bw/d.
The new submitted study for bobwhite quail by XXX (1999; 123-186) does not fulfill the validity criteria
according to OECD 206. The mortality of the control exceeded 10 % at the end of the test. In addition, the
minimum floor area of pen per pair was too small (0.138 instead of 0.25 m2). This minor space could be a
reason why six birds died in the control group and two in each treatment group.
The study by XXX 1978/ WI 78-52 provides the endpoints of the EU LOEP (EU Review Report
6511/IV/99-final, 21 January 2002). In this study a significant reduction in egg weight was observed at
the highest concentration tested (1000 ppm). Therefore, a NOEC of 18.1 mg a.s./kg b.w./d. was
determined and agreed during the EU review process. However, changes in egg weight are not considered
a standard endpoint in avian reproduction studies according to guideline OECD 206 and all other relevant
endpoints determined did not show any unacceptable differences compared to the control treatment –
including No. of eggs, No. 14 d old survivals and hatchlings weight. The differences in egg weight
between control and the treatment with 1000 ppm amounted to a decrease of approx. 7.5 % (10.26 g ±
0.38 g vs. 9.48 g ± 0.47 g in control and 1000 ppm treatment, respectively). Since especially all
parameters concerning hatchling weight and survival were not affected at any concentration, it can be
assumed that the observed changes in egg weight do not represent a population relevant adverse effect.
Therefore, this endpoint will be considered as a NOAEL of 1000 ppm, corresponding to 96.3
mg/kg/bw/d, and will be used for the risk assessment of the chronic risk for birds.
Conversion of endpoints from ppm to mg a.s./kg bw/d was performed according to EFSA Guidance
Document on Risk Assessment for Birds and Mammals (2009). The daily dose for birds in each treatment
group of each test, expressed as test substance (TS) intake, was calculated by treatment group using the
following formula:
Test substance intake (mg TS/g bw/day) = (Consumption mean x ConcFeed ) / BWmean
Consumption mean= Group Mean Feed Consumption (g/bird/day)
Concede = Concentration (mg TS/kg feed);
BWmean= Group Mean Body Weight for Start of Treatment and Exposure Termination (g)
The values used in the calculations and the daily dose values are presented in the tables below.
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Table 6-4: Daily dose from glyphosate acid avian reproduction studies
Nominal Dose
(mg a.s./kg feed)
Daily mean food consumption
(g feed/bird/day)
Mean body weight (g)
Daily dose
(mg a.s./kg bw/day)
218.5
208.0
218.3
211.8
0
4.9
18.1
96.3
1154.3
1078.3
1135.5
1161.3
0
5.5
22.7
125.3
1098
1083
1093
1069
0
64.6
117
300
KIIA 8.1.4/03, Bobwhite quail; XXX, 1978
Control
50
200
1000
21.1
20.3
19.8
20.4
KIIA 8.1.4/04 Mallard duck XXX, 1978
Control
50
200
1000
131.1
118.8
128.9
145.5
KIIA 8.1.4/02 Mallard duck, XXX 1999
Control
500
1000
2250
6.2.1.2
140.6
140.0
128.0
142.4
Exposure
Tender GB Ultra is a water soluble concentrate formulation containing 360 g a.s./L glyphosate acid (486
g/L glyphosate isopropylamine salt; 30.8% w/w as the isopropylamine salt).
Tender GB Ultra is an herbicide for weed control in non-crop areas and railways. Birds could be exposed
to the formulation via consumption of glyphosate acid (a.s.) residues on food items.
Exposure to standard generic focal species was estimated according to the Guidance Document on Risk
Assessment for Birds and Mammals (EFSA Journal 2009; 7(12): 1438)
PD i × FIR total
× RUD × AR × PT
bw
i
FIR i
=∑
× RUD × AR × PT
bw
i
DDD = ∑
Where:
DDD
PDi
FIRi
bw
RUD
AR
PT
= Daily dietary dose (mg/kg bw/day)
= composition of diet obtained from treated area
= Food intake rate of indicator species i (g fresh weight/d)
= Body weight (g)
= Residue per unit dose, bases on an application rate of 1 kg a.s./ha and assuming
broadcast seedling
= Application rate (kg/ha)
= Proportion of diet obtained in the treated area (0…1)
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In a first approach, it is assumed that birds do not avoid contaminated food items that they feed
exclusively in the treated area and on a single food type. Factors PT and PD are therefore equal to 1.
The risk assessment procedure follows a stepwise approach. A first screening step involves standard
scenarios and default values for the exposure estimate, representing a “reasonable worst case”. If a
potential risk is indicated in the screening step, then one or several refinement steps (Tier 1, Tier2) may
follow. According to the Guidance Document, no further assessment is required if all uses are safe in the
screening step.
6.2.1.3
Risk Assessment –overall conclusions
The results of the acute and reproductive risk assessments are summarized in the following table.
Table 6-5:
TER for birds according to re-evaluated endpoints (dRAR (Red draft, November 2013)
Compound
Assessment level Indicator species
Time scale
TER
TER trigger
Glyphosate,
Screening
Large herbivorous bird "goose"
Acute
40
10
Screening
Long-term
3.1
5
Tier 1
Long-term
3.1
5
Tier 1
Large insectivorous bird "wagtail"
Long-term
4.5
5
Tier 2
Long-term
8.6
5
Tier 2
Long-term
4.5
5
application
rate 3.6 kg
a.s./ha
TER shown in bold are below the relevant trigger
Table 6-6: TER for birds according to (EU Review Report 6511/IV/99-final, 21 January 2002)
Compound
Assessment level Indicator species
Time scale
TER
TER trigger
Glyphosate,
Screening
Acute
18
10
Screening
Long-term
3.1
5
Tier 1
Long-term
3.1
5
Tier 1
Long-term
4.5
5
Tier 2
Long-term
8.6
5
application
rate 3.6 kg
a.s./ha
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Tier 2
Long-term
4.5
5
TER shown in bold are below the relevant trigger
implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for acute
Based on refined Tier 1 assessment step, the calculated TER values resulting from an exposure of the
formulation Tender GB Ultra do not achieve the acceptability criteria TER ≥ 5 according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for longterm effects with an application rate of 3.6 kg a.s /ha. The results of the assessment indicate an acceptable
risk for birds due to the intended use of Tender GB Ultra in the scenarios representing the use in railways
and non-crop areas with an application rate of 2 ×1.8 kg a.s /ha with an interval of 3 months.
Further refinement options were considered for the application rate of 3.6 kg a.s /ha
Based on refined assessment step, the calculated TER values resulting from an exposure of the
formulation Tender GB Ultra achieve the acceptability criteria TER ≥ 5 according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for longterm effects in the scenario “bare soil” representing the use on railways. The results of the assessment
indicate an unacceptable risk for birds due to the intended use of Tender GB Ultra in the scenario
representing the use in non-crop areas with an application rate of 1x3.6 kg a.s /ha.
The only area of concern regarding the avian risk assessment is the long-term risk from in the scenario
“grassland” via the consumption of treated insects. The presented long-term risk assessment does not
meet the trigger values but might still be considered as very conservative. For the refinement of
consumption of insects a TWA approach is not used in the guidance document. A generic PT-refinement
is used in DE according to the announcement BVL 10/02/14 in Bundesanzeiger and might be suitable for
the national authorization depending on the national particularities.
For the intended use in non crop areas with an application method “single plant treatment” the long-term
risk towards birds displays a worse case. The application is considered to reach only the over-sprayed
vegetation single plant and minimizes the soil effective rate. Therefore, contamination of soil
invertebrates might be reduced. In consequence a TER value of 4.5 might indicate an acceptable risk for
birds due to the intended use of Tender GB Ultra in the scenario representing the use in non-crop areas
with an application rate of 1x3.6 kg a.s /ha with the specific application method of wiping/single plant
treatment.
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Drinking water risk assessment
Drinking water assessment is not required as the ratio of effective treatment rate to toxicological endpoint
does not exceed the trigger. Please refer to chapter 6.2.3.
Food chain behavior
An assessment of the risk from secondary poisoning is not required due to log POW values of glyphosate
being below the trigger. Please refer to chapter 6.2.9.
6.2.2
Toxicity to exposure ratio for birds (K III A 10.2.1)
6.2.2.1
Acute toxicity to exposure ratio (TERA)
Screening step
In the screening step, the risk to indicator bird species from an exposure to Tender GB Ultra is assessed.
These indicators are considered to have highest exposure in a specific crop at a particular time due to their
size and feeding habits and represent a worst case scenario.
To estimate the daily dietary doses, following equations were used:
Daily dietary dose (DDD):
DDDsingle application = application rate [kg a.s./ha] × shortcut value1
1
see section 4.1 of EFSA/2009/1438
Toxicity exposure ratio (acute):
TER A =
LD 50 ( mg/kg bw/day)
Acute DDD (mg/kg bw/day)
The resulting TERA values are summarized in the following table, along with the indicator species and the
respective shortcut values.
Table 6-7:
Acute screening risk assessment (TERA) for birds. See text for details
Substance Indicator species
Applic.
rate
Shortcut
value,
acute
MAF
(kg/ha)
DDD
LD50
(mg/kg
bw)
(mg/kg
bw)
Current Renewal
glyphosate small graniv. bird
Assessment
(AIR2), dRAR
(Red draft,
November 2013)
large herbiv.bird
3.6
30.5
1
109.8
SANCO
(6511/IV/99-
3.6
24.7
1
88.92
small graniv. bird
3.6
24.7
1
88.92
TERA
49
4334
40
2000
25
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final, 21 January
2002)
large herbiv. bird
3.6
30.5
1
109.8
18
TERs shown in bold fall below the relevant trigger.
6.2.2.2
Short -term toxicity exposure ratio (TERST)
There is no requirement for the calculation of TERST for birds under the EFSA birds and mammals
guidance document (EFSA Journal 2009; 7(12): 1438) and, consequently, a risk assessment for shortterm toxicity will not be conducted.
6.2.2.3
Long-term toxicity exposure ratio (TERLT)
Screening step
For the reproductive risk assessment, the calculation of the long-term toxicity exposure ratio (TERLT) in
principle follows the same procedure as for the acute risk assessment. However, the defined daily dose is
obtained by multiplying the application rate with the mean short-cut values (based on mean RUD
according to the new Guidance Document (EFSA, 2009)) as summarized in the following table.
Table 6-8:
Avian generic focal species for the intended uses of Tender GB Ultra and relevant shortcut values for
long-term exposure
Crop
Indicator species
Shortcut value
(mean RUD)
Bare soils
small granivorous bird
11.4
Grassland
Large herbivorous bird
16.2
As stated in the guidance document, it is justified to apply a time-weighted average (TWA) factor of 0.53
based on a default observation interval of 21 days and a default DT50 of 10 days for the calculation of the
DDD (daily dietary dose):
DDDsingle application = application rate [kg/ha] × shortcut value × TWA*
* see section 4.3 of EFSA/2009/1438
Toxicity exposure ratio (Long-term):
TER LT =
NOEL (mg/kg bw/day)
Long - term DDD (mg/kg bw/day)
The relevant lowest NOAEL for the reproduction exposure scenario for glyphosate is 96.3
mg a.s./kg bw/d. Conversion of endpoints from ppm to mg a.s./kg bw/d was performed according to
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EFSA Guidance Document on Risk Assessment for Birds and Mammals (2009). A recalculated value of
96.3 mg a.s./kg bw/d instead of 102.23 mg a.s./kg bw/d has been used. The relevant long-term endpoints
is provided in the following table as well as calculated long-term toxicity exposure ratios (TERLT) for
birds exposed to glyphosate following applications of Tender GB Ultra.
Table 6-9:
Substance
glyphosate
Long-term screening risk assessment (TERLT) for birds exposed to Tender GB Ultra according to the
intended uses
Indicator bird
Application Shortcu fTWA
rate
t value
(kg/ha)
(longterm)
MAF
DDD
(mg/kg
bw/day)
NOAEL TERLT
(mg/kg
bw/day)
Small granivorous bird
3.6
11.4
0.53
1
21.751
96.3
4.4
3.6
16.2
0.53
1
30.910
96.3
3.1
Based on the conservative presumptions of the screening step, the calculated TER values for the longterm risk resulting from an exposure of birds to the active substance glyphosate according to the GAP of
the formulation Tender GB Ultra does not achieve the acceptability criteria TER ≥ 5, according to
commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point
2.5.2. for long-term effects. The results of the assessment indicate an unacceptable risk for birds, further
refinement is necessary.
Tier 1
For glyphosate the TERLT was below the trigger of 5 in the screening step for the intended uses in the
scenarios “bare soil” and “grassland” representing the use in railways and non-crop areas.
PT of 1 according to EFSA Guidance Document on Risk Assessment for Birds and Mammals (2009) is
used. On the base of a weight of evidence approach which also implies national particularities the risk
assessment might be adapted (PT=0.5) and reference can be made to the National addendum of DE.
Based on an application rate of 3600 g/ha the risk was assessed for the generic focal species summarized
in the following table:
The relevant short-cut values for these scenarios are summarized in the following table:
Table 6-10:
Avian generic focal species for the intended uses of Tender GB Ultra and relevant shortcut values for
long-term risk assessment
Intended use
Crop
Growth Stage
Generic Focal Species
Railway
Bare Soil , BBCH <10
Small granivorous bird "finch"
11.4
Small omnivorous bird "lark"
8.2
Small insectivorous bird "wagtail"
5.9
Small granivorous bird "sparrow"
9.4
11.4
Grassland
All season
Shortcut value (mean RUD)
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16.2
11.3
The outcome of the Tier 1 risk assessment step is presented in the following table:
Table 6-11:
Scenario
Reproductive bird risk assessment of Tender GB Ultra uses (Tier 1)
Applicati MAF
on Rate x twa
(kg
a.s./ha)
Bare Soil, Small granivorous bird "finch"
BBCH
<10
3.6
Short
cut
Value
PT
value
(Mean
RUD)
0.53
11.4
1
DDD
NOAEL
(mg
a.s./kg
bw/d)
(mg a.s./
kg bw/d)
21.751
96.3
TER
4.4
8.2
15.646
6.2
5.9
11.257
8.6
9.4
17.935
5.4
11.4
21.751
4.4
16.2
30.910
3.1
11.3
21.428
4.5
Grassland Small granivorous bird "sparrow"
2 × 1.8 0.53
BBCH
with 91
<10
days
Small insectivorous bird "wagtail" intervall
11.4
1
10.876
96.3
8.9
8.2
7.823
12.3
5.9
5.629
17.1
9.4
8.968
10.7
11.4
10.876
8.9
16.2
15.455
6.2
11.3
10.714
9.0
Based on refined Tier 1 assessment step, the calculated TER values resulting from an exposure of the
formulation Tender GB Ultra do not achieve the acceptability criteria TER ≥ 5 according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for longterm effects with an application rate of 3.6 kg a.s /ha. The results of the assessment indicate an acceptable
risk for birds due to the intended use of Tender GB Ultra in the scenarios representing the use in railways
and non-crop areas with an application rate of 2 ×1.8 kg a.s /ha with an interval of 3 months.
Further refinement options were considered for the application rate of 3.6 kg a.s /ha
Higher tier risk assessment concerning residue decline
Default assumptions are based on a DT50 of 10 days on plants and a time window of 21 days, which leads
to a default TWA factor of 0.53. Dissipation and degradation of residues from plant material may be more
rapid in the environment. Glyphosate is known to rapidly decline in plant material with a DT50 of about
2.8 days (please refer to chapter B.8.1.5 of the glyphosate Monograph). Therefore, for the food type
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‘plant material’ the default ftwa has been recalculated resulting in ftwa = 0.19 (based on a DT50 of 2.8
days and averaging time of 21 days).
The outcome is presented in the following tables:
Scenario
Applic. MAF
Rate x twa
Short
cut
Value
(kg
a.s./ha)
(Mean
RUD)
3.6
0.19
11.4
PT
DDD
NOAEL
TER
(mg (mg a.s./
a.s./kg kg bw/d)
bw/d)
1
7.851
96.3
Bare Soil, BBCH<10
Small graniv. bird "finch"
12.3
Grassland
Small graniv. bird "finch"
11.4
7.851
12.3
Large herbiv. bird "goose"
16.2
11.156
8.6
Small insectiv. bird
"wagtail"
11.3
21.428
4.5
Based on refined assessment step, the calculated TER values resulting from an exposure of the
formulation Tender GB Ultra achieve the acceptability criteria TER ≥ 5 according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for longterm effects in the scenario “bare soil” representing the use on railways. The results of the assessment
indicate an unacceptable risk for birds due to the intended use of Tender GB Ultra in the scenario
representing the use in non-crop areas with an application rate of 1x3.6 kg a.s /ha.
The only area of concern regarding the avian risk assessment is the long-term risk from in the scenario
“grassland” via the consumption of treated insects. The presented long-term risk assessment does not
meet the trigger values but might still be considered as very conservative. For the refinement of
consumption of insects a TWA approach is not used in the guidance document. A generic PT-refinement
is used in DE according to the announcement BVL 10/02/14 in Bundesanzeiger and might be suitable for
the national authorization depending on the national particularities.
For the intended use in non crop areas with an application method “single plant treatment” the long-term
risk towards birds displays a worse case. The application is considered to reach only the over-sprayed
vegetation single plant and minimizes the soil effective rate. Therefore, contamination of soil
invertebrates might be reduced. In consequence a TER value of 4.5 might indicate an acceptable risk for
birds due to the intended use of Tender GB Ultra in the scenario representing the use in non-crop areas
with an application rate of 1x3.6 kg a.s /ha with the specific application method of wiping/single plant
treatment.
6.2.3
Drinking water exposure
In case of early post-emergence uses as intend for Tender GB Ultra birds might be exposed via drinking
water from puddles. According to the new Guidance Document (EFSA, 2009), no specific calculations of
drinking water exposure and TER are necessary when the ratio of effective application rate (in g/ha) to
the relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case of less sorptive substances
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(Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg). This is due to the
characteristics of the exposure scenario in connection with the standard assumptions for water uptake by
birds (for further details please refer to chapter 5.5. of the Guidance Document). The puddle scenario has
been taken into account to calculate the exposure concentration of glyphosate formed on a field after
rainfall The ratios do not exceed the value of 3000 for glyphosate (Koc = 15844 L/kg) thus it is not
necessary to conduct a drinking water risk assessment for birds.
6.2.4
Details on formulation type in proportion per item
6.2.4.1
Baits: Concentration of active substance in bait in mg/kg
Tender GB Ultra is not formulated as bait. The formulation is intended for use as a foliar spray, and
therefore this information is not required.
6.2.4.2
Pellets, granules, prills or treated seed
Tender GB Ultra is not formulated as pellets, granules, prills or treated seeds. Tender GB Ultra is
intended for use as a foliar spray, and therefore this information is not required.
Amount of active substance in or on each item
Not applicable.
Proportion of active substance LD50 per 100 items and per gram of items
Not applicable.
Size and shape of pellet, granule or prill
Not applicable.
6.2.5
Acute toxicity of the formulation
Avian toxicity tests with the formulation were not performed and are not considered necessary.
6.2.6
Metabolites
Avian toxicity tests with metabolites of glyphosate were not performed and are not considered necessary.
The primary metabolite of glyphosate is aminomethylphosphonic acid (AMPA). According to Sanco
6511/VI/99-final, 21 January 2002 the toxicologically significant compound is the parent glyphosate.
Glyphosate is nearly completely excreted (approx. 30% via urine) and glyphosate is poorly metabolized
to AMPA (< 0.5 %).
6.2.7
Supervised cage or field trials
The risk assessment above has demonstrated that the proposed uses of Tender GB Ultra pose no
unacceptable acute or long-term risks to birds, and therefore further studies are not considered necessary.
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6.2.8
Acceptance of bait, granules or treated seeds (palatability testing)
Tender GB Ultra is intended for use as a foliar spray, and therefore this information is not required.
6.2.9
Effects of secondary poisoning
The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a
log Know ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6
"Bioaccumulation and food chain behavior"). Since the log Kow values of glyphosate is logP <–3.2 (pH 2–
5, 20°C), the active substance is deemed to have a negligible potential to bioaccumulate in animal tissues.
No formal risk assessment from secondary poisoning is therefore required.
to AMPA (< 0.5 %). Furthermore log Kow was estimated via EpisuiteProgramm and SMILES code
(C(N)P(=O)(O)O) to be -2.47 for AMPA and therefore indicates not the potential for bioaccumulation.
6.3
Effects on Terrestrial Vertebrates Other Than Birds
draft, November 2013) is added. Relevant data referring to the EU assessment Annex Renewal 2
(AIR 2) of glyphosate is marked in bold in the following document.
Ender GB Ultra is an herbicide intended for weed control in non-arable areas and railways. Wild
mammals could be exposed to the formulation via consumption of glyphosate acid (a.s.) on food items,
including over-sprayed vegetation, insects, earthworms, or vertebrate prey.
6.3.1
1438).
6.3.1.1
Toxicity
Table 6-12:
Toxicity of glyphosate to mammals with reference to agreed endpoints
Species Substance System
Results
Reference
Rat
1)
glyphosate Acute oral toxicity
LD50 > 2000 mg/kg bw
Review report 6511/IV/99-final, 21
January 2002
Rat
3)
glyphosate Acute oral toxicity LD50 > 2000 mg/kg bw
AIR2 dRAR (Red draft, November
2013)
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Mouse
1)
Glyphosate Acute oral toxicity
(IPA-salt)
XXX (1987), Rep. No. TX58AO1
Glyphosate Monograph , chapter B.8.1.5
Rat
MON
52276
LD50 > 5000 mg/kg bw
XXX, 1991, BD-91-261
Rat
1)
glyphosate Prenatal
developmental
toxicity to mammals
glyphosate Teratogenic study,
toxicity to mother
animals
NOAEL / NOEL=
300 mg/kg bw/d 1)
XXX (1993), Glyphosate Monograph ,
chapter B.5.5. 1
Review report 6511/IV/99-final, 21,2002
EU Monograph, XXX 1980
Rabbit
1)
Acute oral toxicity
NOEL = 75 mg/kg bw/d
(NOEL reproduction
= 150 mg/kg bw/d)
Rabbit glyphosate Teratogenic study, NOAEL = 50 mg/kg
3)
toxicity to mother bw/day;
animals
Maternal: bw gain↓,
Dev.:post-implantation loss
1) Review report 6511/IV/99-final, 21 January 2002
XXX;
(1996, ASB2012-11499); Renewal
Assessment Report, Volume 3 Annex
B.9.3.3, Red Draft
3) Renewal Assessment Report, Volume 3 Annex B.9, Red Draft
In the Review Report for the active substance glyphosate (SANCO/6511/VI/99-final, 21 January 2002,
p.1-56), a LD50 of > 2000 mg/kg bw was determined deriving from acute toxicity studies with rats. Also
in the current Renewal Assessment Report for Glyphosate (Volume 3 Annex B.9, Red Draft), an
overall a LD50 of > 2000 mg/kg bw was determined. Furthermore a mammal toxicity test with the
formulation was performed.
Concerning reproductive toxicity the Review Report for the active substance glyphosate
(SANCO/6511/VI/99-final, 21 January 2002, p.1-56) states the relevant lowest NOEL to be
300 mg a.s./kg bw/d for rats.
However, zRMS gave in the past notice that in rabbits maternal mortalities occurred at doses of
75 mg/kg/bw/day and above -which were lower than those found effective in developmental toxicity,
subacute an subchronic studies in rats and might indicate a high vulnerability of this species (Volume 3 B
5.6.2.2.2, Tasker , 1980). A NOEL = 75 mg/kg bw/d was set as lowest relevant endpoint.
In the current Renewal Assessment Report for Glyphosate (Volume 3 Annex B.9, Red Draft), an
overall NOAEL of 50 mg/kg bw/day is proposed for risk assessment. The lowest NOAEL for
developmental effects is 50 mg/kg bw/day, based post-implantation loss in the rabbit at 200 mg/kg
bw/day in the study by XXX (1996, ASB2012-11499). Due to dose spacing, the NOAELs in other
studies were higher (XXX, 1980, TOX2552390; XXX, 1991, TOX9552391; XXX, TOX2000-2002)
but consistently below 200 mg/kg bw/day. Beside post-implantation losses and late embryonic death
(XXX, 1989, TOX9551960; XXX, 1991, TOX9552391), developmental findings at higher dose levels
included a lower foetal weight and delayed ossification (please refer to RAR, Vol. 1, chapter
2.6.7.2.2.).
Both endpoints from the study are considered in the risk assessment. Full details of the toxicity
studies are provided in the respective EU DAR and Annex 3 of this document.
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6.3.1.2
Exposure
Exposure to standard generic indicator species was estimated according to the ‘EC Guidance Document
on Risk Assessment for Birds and Mammals Council (EFSA/2009/1438).
6.3.1.3
Risk assessment –overall conclusions
The overall conclusion on the risk assessment for mammals and the calculated TER-values are shown in
the following table.
Table 6-13:
Minimum TER values for mammals after uses of Tender GB Ultra in the intended uses
Substance
Risk assessment level
Glyphosate,
Application
rate:
3.6 kg
a.s./ha
Screening
Acute
>4
10
Screening (endpoint according to LoEP, 2002)
Long-term
2
5
Screening (endpoint according to dRAR, Nov,
2013)
Long-term
0.4
5
Acute
>11
10
6
5
1.3
5
Acute
>8
10
Long-term
3
5
Long-term
0.5
5
Acute
>22
10
2.6
5
Tier 2
Tier 2 (endpoint according to LoEP, 2002)
Indicator Time scale TER
mammal
Small
herbiv.
mammal
TER
trigger
Long-term
Tier 2 (endpoint according to dRAR, Nov, 2013)
Long-term
Glyphosate, Screening
Application
Screening (endpoint according to LoEP, 2002)
rate:
2 times 1.8
Screening (endpoint according to dRAR, Nov,
kg a.s./ha
2013)
Tier 2
Small
herbiv.
mammal
Tier 2 (endpoint according to dRAR, Nov, 2013)
Long-term
Based on the presumptions of Tier 1, the calculated TER values for acute risk resulting from an exposure
of mammals to the active substance glyphosate according to the GAP of the formulation Tender GB Ultra
up to 3600 g glyphosate/ha achieve the acceptability criteria TER ≥ 10 according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2.
Based on refined assessment step, the calculated TER values for the long-term risk resulting from an
exposure of mammals to glyphosate according to the GAP of the formulation Tender GB Ultra achieve
the acceptability criteria TER ≥ 5 according to commission implementing regulation (EU) No 546/2011,
Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects for the scenario “bare soil”
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representing use on railways. The results of the assessment indicate an acceptable risk for mammals due
to the intended use of Tender GB Ultra representing the use in railways according to the label.
After refinement an area of concern regarding the mammalian long-term risk assessment must be
considered in the scenario “grassland” via the consumption of treated food items by small herbivorous
mammals. The calculated TER values for the long-term risk according to the GAP of the formulation
Tender GB Ultra do not achieve the acceptability criteria TER ≥ 5 according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for longterm effects for the scenario “grassland” representing use in non cultivated areas.
does not exceed the trigger. Please refer to chapter 6.2.3.
Food chain behavior
being below the trigger. Please refer to chapter 6.2.9.
6.3.2
Toxicity exposure ratio
6.3.2.1
Acute toxicity exposure ratio (TERA)
Screening step
In the screening step, indicator species are used. These indicators are considered to have highest exposure
in a specific crop at a particular time due to their size and feeding habits and represent a worst case
scenario. The indicator mammal species for the intended uses are listed in the following table.
Table 6-14:
Indicator species for mammals according to intended use of Tender GB Ultra and shortcut values.
Shortcut values from section 4.1 of EFSA/2009/1438
Crop
Indicator species
Shortcut value (90th percentile
RUD)
bare soils
small granivorous mammals
14.4
grassland
Small herbivorous mammal
136.4
For the estimation of Daily dietary doses (DDD) and the calculation of TER-values please refer to 6.2.2.1
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Table 6-15:
Substance
glyphosate
Acute screening risk assessment (TERA) for mammals. See text for details
Indicator species
Shortcut
Application
MAF
value,
rate
acute
DDD
LD50
(kg/ha)
(mg/kg
bw)
(mg/kg
bw)
TERA
Small granivorous mammal
3.6
14.4
1
51.84
> 2000
>9
3.6
136.4
1
491.04
> 2000
>4
acute risk resulting from an exposure of mammals to the active substance glyphosate according to the
GAP of the formulation Tender GB Ultra does not achieve the acceptability criteria TER ≥ 10, according
to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point
2.5.2. for acute effects. The results of the assessment indicate an unacceptable risk for mammals due to
the intended use of Tender GB Ultra in the scenarios “bare soil” and “grassland“ representing the use in
railways and non-crop areas according to the label, further refinement is necessary.
Tier 1
In the Tier 1 risk assessment step, the defined daily doses and TER values were calculated for so-called
generic focal species (see EFSA 1438/2009, Annex I). Please refer to chapter 6.2.2.1 for general
considerations when choosing generic focal species.
In the Review Report for the active substance glyphosate (SANCO/6511/VI/99-final, 21 January 2002, p.
1-56), a LD50 of > 2000 mg/kg bw is determined and derives from acute toxicity studies in rat with the
active substance. Furthermore a mammal toxicity test with the formulation was performed.
The relevant short-cut values for assessed scenarios are summarized in the following table.
Table 6-16:
Mammal generic focal species for the use on railways and non arable land of Tender GB Ultra and
relevant shortcut values
Intended
use
Crop
Growth Stage
Shortcut value (90th
percentile RUD)
bare soil
BBCH < 10
Small omnivorous mammal "mouse"
14.3
grassland
All season
Large herbivorous mammal "lagomorph"
32.6
Small herbivorous mammal "vole"
136.4
The outcome of the Tier 1 risk assessment step is presented in the following table.
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Table 6-17:
Assessment of the acute risk to mammals from Tender GB Ultra in the intended uses (Tier 1)
Substance Crop /
Stage
Applic. MAF x
Rate
twa
LD50
TER
14.3
51.480
Grassland Large herbiv.mammal
All season "lagomorph"
32.6
117.360
>17
Small herbiv. mammal
"vole"
136.4
491.040
>4
14.3
25.74
>77
Grassland Large herbiv. mammal
All season "lagomorph"
32.6
58.68
>34
Small herbiv. mammal
"vole"
136.4
245.52
>8
bare soil, Small omniv. mammal
BBCH<10 "mouse"
3.6
DDD
(90th
(mg a.s./kg (mg a.s./kg
percentil
bw/d)
bw/d)
e)
(kg
a.s./ha)
glyphosate bare soil, Small omniv. mammal
BBCH<10 "mouse"
SV
1.8
1
> 2000
>39
Further refinement options were considered:
Refinement of the ecotoxicological endpoint:
In further acute oral toxicity studies with mouse, however, lethal doses were determined (please refer to
glyphosate monograph, chapter B.5.2.1.1). In an acute oral toxicity study with glyphosate IPA-salt in
mouse (Wang et al., 1987), the LD50 amounted to 3669 mg/kg bw and is the lowest reported in the
monograph. In conclusion a LD50 >2000 mg/kg bw might be considered as very conservative. In a
further acute mammalian oral toxicity study in rats with the formulation MON 52276 (Kirk, A.M., 1991,
BD-91-261) a LD50 > 5000 mg/kg bw was proposed and is uses for risk assessment.
Composition of diet:
It is possible to refine the diet using published data. In common voles inhabiting a meadow in central
Europe, dicotyledonous species predominate in the diet during spring and summer, while in autumn the
proportion of monocotyledons increases. The average number of plant species was 4.3 per stomach
(range: 1-9). When comparing the available biomass it was conclusive that a supply of about 70%
monocotyledon and 30% dicotyledonous biomass meets a food intake of roughly 33% monocotyledon
and 67% dicotyledons (Rinke, T. 1936691. Percentage of volume versus number of species: availability
and intake of grasses and forbs in Microtus arvalis. Folia Zoologica 40(2): 143-151).
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Table 6-18:
Applic.
rate
(kg/ha)
3.6
Refinement of acute risk assessment for small herbivorous mammal “vole” exposed to glyphosate
according to EFSA Journal (2009) in scenario “grassland” representing use in non-crop areas. For
details see text
Species
/ Diet
Small herbiv.mammal
"vole"
33% monocot.
67% dicot.
MAF
FIR/
bw
1
0.5
1.01
PD
33%
monocot.
67% dicot.
RUD
PT
DDD
Endpoint TER
(mg/kg (10)
bw/d)
102.3
70.3
1
183.671
256.261
>2000
> 4.5
>5000
>11.4
Based on refined Tier 1 assessment step, the calculated TER values for the acute risk resulting from an
exposure of mammals to glyphosate according to the GAP of the formulation Tender GB Ultra does
achieve the acceptability criteria TER ≥ 10, according to commission implementing regulation (EU) No
546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for acute effects. The results of the
scenarios “bare soil” and “grassland“ representing the use in railways and non-crop areas according to the
label.
6.3.2.2
Short-term toxicity exposure ratio (TERST)
There is no requirement for the calculation of TERST for mammals under the EFSA birds and mammals
guidance document (EFSA Journal 2009; 7(12): 1438) and, consequently, a risk assessment for shortterm toxicity has not been performed.
6.3.2.3
Screening step
For the reproductive risk assessment, the calculation of the long-term toxicity exposure ratio (TERLT)
follows in principle the same procedure as for the acute risk assessment.
The defined daily dietary dose is obtained by multiplying the application rate with the mean short-cut
value (based on the mean RUD according to the new Guidance Document (EFSA, 2009)) as summarized
in the following table.
Table 6-19:
Mammal generic focal species for the intended uses of Tender GB Ultra and relevant shortcut values
for long-term exposure
Crop
Indicator species
bare soils
6.6
grassland
72.3
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Please refer to section 6.2.2.3 for the equation employed in the estimation of the daily dietary doses and
the calculation of TER-values.
In the current Renewal Assessment Report for Glyphosate (Volume 3 Annex B.9, Red Draft), an overall
NOAEL of 50 mg/kg bw/day is proposed for risk assessment. The lowest NOAEL for developmental
effects is 50 mg/kg bw/day, based post-implantation loss in the rabbit at 200 mg/kg bw/day in the study
by XXX (1996, ASB2012-11499). Due to dose spacing, the NOAELs in other studies were higher (XXX,
1980, TOX2552390; XXX, 1991, TOX9552391; XXX, TOX2000-2002) but consistently below 200
mg/kg bw/day. Beside post-implantation losses and late embryonic death (XXX, 1989, TOX9551960;
XXX, 1991, TOX9552391), developmental findings at higher dose levels included a lower foetal weight
and delayed ossification (please refer to RAR, Vol. 1, chapter 2.6.7.2.2.).
Both endpoints from the study are considered in the risk assessment. Full details of the toxicity studies are
provided in the respective EU DAR and Annex 3 of this document.
Table 6-20:
Long-term screening risk assessment (TERLT) for mammals exposed to Tender GB Ultra according to
the intended uses
Indicator bird
SANCO
(6511/IV/99-final,
21 January 2002)
Small graniv.
mammals
Applic. rate Shortcu fTWA
(kg/ha)
t value
(longterm)
3.6
Small herbiv.
mammal
Small graniv.
mammals
Small graniv.
mammals
2x 1.8
1
6.6
0.53
1
72.3
3.6
Small herbiv.
mammal
Small graniv.
mammals
0.53
6.6
0.53
1
72.3
2x1.8
Small herbiv.
mammal
6.6
72.3
0.53
DDD
(mg/kg
bw/day)
72.3
Small herbiv.
mammal
Current Renewal
Assessment
(AIR2), dRAR
(Red draft,
November 2013)
6.6
MAF
1
12.59
NOAEL TERLT
(mg/kg
bw/day)
300
24
137.94
2
8.814
34
96.56
3
12.59
50
4
137.94
0.4
8.814
6
96.56
0.5
long-term risk resulting from an exposure of mammals to the active substance glyphosate according to the
GAP of the formulation Tender GB Ultra does not achieve the acceptability criteria TER ≥ 5, according
to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point
2.5.2. for long-term effects. The results of the assessment indicate an unacceptable risk for mammals due
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to the intended use of Tender GB Ultra in the scenarios “bare soil” and “grassland“ representing the use
in railways and non-crop areas according to the label, further refinement is necessary.
Refined risk assessment
For the Tier 1 risk assessment, the defined daily doses and TER values were calculated for so-called
generic focal species (see EFSA 1438/2009. Annex I). Please refer to section 6.2.2 for general
consideration in the choice of generic focal species in risk assessment procedures.
The relevant short-cut values for scenarios evaluated are summarized in the following table.
Table 6-21:
Mammal generic focal species for the in the scenarios “bare soil” and “grassland „representing the use
in railways and non-crop areas of Tender GB Ultra and relevant shortcut values for long-term risk
assessment
Intended
use
Crop
Growth Stage
Shortcut value
(mean RUD)
bare soil
BBCH<10
Small omnivorous mammal "mouse"
5.7
Grassland
All season
Large herbivorous mammal "lagomorph"
17.3
Small herbivorous mammal "vole"
72.3
Further refinement options were considered:
It is possible to refine the diet using published data. In common voles inhabiting a meadow in central EU,
dicotyledonous species predominate in the diet during spring and summer, while in autumn the proportion
of monocotyledons increases. The average number of plant species was 4.3 per stomach (range: 1-9).
When comparing the available biomass it was conclusive that a supply of about 70% monocotyledons and
30% dicotyledonous biomass meets a food intake of roughly 33% monocotyledon and 67% dicotyledons
(Rinke, T. 1991. Percentage of volume versus number of species: availability and intake of grasses and
forbs in Microtus arvalis. Folia Zoologica 40(2): 143-151).
Residues on food items:
The outcome of the refined risk assessment step is presented in the following table:
Table 6-22:
Reproductive mammal risk assessment of Tender GB Ultra uses in the scenarios “bare soil” and
“grassland“ representing the use in railways and non-crop areas (Tier 1)
Generic Focal Species Application MAF
Rate
x twa
SV
PT
DDD
NOEL
TER
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(kg a.s./ha)
Large herbivorous
SANCO
(6511/IV/99-final, 21 mammal "lagomorph"
January 2002)
Small herbivorous
mammal "vole"
3.6
Current Renewal
Large herbivorous
Assessment (AIR2), mammal
dRAR (Red draft,
"lagomorph"
November 2013)
Small herbivorous
mammal "vole"
3.6
Large herbivorous
mammal
"lagomorph"
Small herbivorous
mammal "vole"
(Mean
RUD)
0.19
17.3
(mg a.s./kg (mg a.s./
bw/d)
kg bw/d)
1
72.3
0.19
17.3
0.19
17.3
54.2
(monocot)
+
28.7
(dicot.)
25
49.791
1
54.2
(monocot)
+
28.7
(dicot.)
2x1.8
300
11.914
6
11.914
50
18.615
(monocot)
+
20.013
(dicot.)
1
5.91
1.3
50
9.308
(monocot)
+
10.007
(dicot.)
4.2
8.5
2.6
Based on refined assessment step, the calculated TER values for the long-term risk resulting from an
exposure of mammals to glyphosate according to the GAP of the formulation Tender GB Ultra achieve
the acceptability criteria TER ≥ 5 according to commission implementing regulation (EU) No 546/2011,
Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects for the scenario “bare soil”
representing use on railways. The results of the assessment indicate an acceptable risk for mammals due
to the intended use of Tender GB Ultra representing the use in railways according to the label.
Within the EU assessment Annex I Renewal 2 (AIR 2) of glyphosate currently in process, new
studies on long-term reproductive and developmental toxicity have been submitted. The evaluation
according to the state of the art in science and technology proposes an overall NOAEL of 50 mg/kg
bw/day for risk assessment. The lowest NOAEL for developmental effects is 50 mg/kg bw/day,
based post-implantation loss in the rabbit at 200 mg/kg bw/day in the study by XXX (1996,
ASB2012-11499).
A detailed evaluation of these studies is presented in the Renewal Assessment Report, Volume 3
Annex Vol.3, B.6.6, Red Draft and Appendix III of this document.
The evaluation according to an overall NOAEL of 50 mg/kg bw/day for risk assessment results to
an area of concern regarding the mammalian long-term risk assessment after a risk refinement. A
risk must be considered in the sceanario “grassland” via the consumption of treated weeds by small
herbivorous mammals. The calculated TER values for the long-term risk according to the GAP of
the formulation Tender GB Ultra do not achieve the acceptability criteria TER ≥ 5 according to
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commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles,
point 2.5.2. for long-term effects for the scenario “grassland” representing use non cultivated areas
considering the updated ecotoxicological endpoint proposed in the Renewal Assessment Report,
Volume 3.
For further refinement options and risk management related to the use pattern according to German
requirements please refer to the DE National addendum.
6.3.3
Drinking water exposure
In case of early post-emergence uses as intend for Tender GB Ultra birds might be exposed via drinking
water from puddles. According to the new Guidance Document (EFSA, 2009), no specific calculations of
drinking water exposure and TER are necessary when the ratio of effective application rate (in g/ha) to
the relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case of less sorptive substances
(Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg). This is due to the
characteristics of the exposure scenario in connection with the standard assumptions for water uptake by
birds (for further details please refer to chapter 5.5. of the Guidance Document). The puddle scenario has
been taken into account to calculate the exposure concentration of glyphosate formed on a field after
rainfall The ratios do not exceed the value of 3000 for glyphosate (Koc = 15844 L/kg) thus it is not
necessary to conduct a drinking water risk assessment for birds.
6.3.4
Details on formulation type in proportion per item
Please refer to section 6.2.4 for details on the formulation type of Tender GB Ultra.
6.3.4.1
Baits: Concentration of active substance in bait in mg/kg
Please refer to section 6.2.4.
6.3.4.2
Pellets, granules, prills or treated seed
Amount of active substance in or on each item
Proportion of active substance LD50 per 100 items and per gram of items
Size and shape of pellet, granule or prill
6.3.5
Mammal toxicity tests with the formulation were performed and were considered for risk assessment.
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6.3.6
Metabolites
Mammal toxicity tests with metabolites of glyphosate were not performed, since it is possible to
extrapolate from data obtained with the active substances.
to AMPA (< 0.5 %).
6.3.7
Supervised cage or field trials
The risk assessment above has demonstrated that the proposed uses of Tender GB Ultra pose no
unacceptable acute or long-term risks to mammals, and therefore further studies are not considered
necessary.
6.3.8
Acceptance of bait, granules or treated seeds (palatability testing)
Tender GB Ultra is intended for use as a foliar spray, and therefore this information is not required.
6.3.9
Effects of secondary poisoning
Log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6
"Bioaccumulation and food chain behavior"). Since the log Kow values of glyphosate is logP <–3.2 (pH 2–
5, 20°C), the active substance is deemed to have a negligible potential to bioaccumulate in animal tissues.
No formal risk assessment from secondary poisoning is therefore required.
to AMPA (< 0.5 %). Furthermore log Kow was estimated via EpisuiteProgramm and SMILES code
(C(N)P(=O)(O)O) to be -2.47 for AMPA and therefore indicates not the potential for bioaccumulation.
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6.4
Effects on Aquatic Organisms
6.4.1
Currently, the active substance glyphosate is in the Renewal Assessment (AIR2). In the course of
this environmental endpoints were re-evaluated and new endpoints were defined. An evaluation
with regard to the agreed endpoints (Review Report (SANCO/6511/VI/99-final)) displays currently
a worse case but has no consequence on the risk assessment, as even the older worse case endpoint
reaches the aquatic TER values for glyphosate, indicating a low and acceptable acute risk for
aquatic organisms. For further details please refer to the following chapter 6.4.1.1 on the toxicity.
The applicant provided further studies on the risk for aquatic organisms with the formulation Tender GB
Ultra and for the active substance glyphosate and its major metabolites. Detailed study summaries for the
studies performed with the formulated product Tender GB Ultra as well as the Annex II data are
presented in Appendix 2.
6.4.1.1
Toxicity
Acute toxicity testing has been conducted with MON 52276 for rainbow trout (Oncorhynchus mykiss),
common carp (Cyrinus carpio), water flea (Daphnia magna) and green algae (Pseudokirchneriella
subcapitata).
composition is that MON 78708 contains 29 ppm (0.0029%) of a blue, food-approved dye. Since this dye
is approved for use in foodstuffs, its inclusion in MON 78708 is not considered to have any impact on the
toxicological properties of MON 78708 versus those of the parent formulation MON 52276. Information
on the detailed compositions of MON 78707 and MON 52276 can be found in the confidential dossier of
Relevant results of these studies as well as EU endpoints of the Review Report (SANCO/6511/VI/99final) are summarized in the following table:
Table 6-23:
Ecotoxicological endpoints for aquatic species exposed to glyphosate and Tender GB Ultra with
indication to agreed endpoints
Species
Substance
System
Toxicity
Reference
LC50
>989
(>306 mg
a.s./L)
XXX 1992, Study no. TO-91-296;
ICS: 35244
LC50
>895
(>277 mg
a.s./L)
XXX 1992, Study no. TO-91-293;
ICS: 35243
Fish, acute toxicity
O.mykiss
MON 52276
Cyprimus carpio
MON 52276
O.mykiss
glyphosate
O.mykiss
AMPA
96 h
LC50
38
LC50
> 180
Review Report
(SANCO/6511/VI/99-final)
Monograph glyphosate, Volume 3,
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Species
Substance
System
Toxicity
Reference
Annex B-8: Ecotoxicology
11 December 1998
Fish, long-term toxicity
P. promelas
glyphosate
254 days
NOEC
25.7
Review Report
Invertebrates, acute toxicity
D.magna
676 mg/L
(209mg
a.s./L)
MON 52276
glyphosate
48 h
EC50
40
AMPA
> 180
Linnot, D.R.1992, Studyno. TO91-295; ICS: 35237
Review Report
11 December 1998
Invertebrates, long-term toxicity
Daphnia magna
glyphosate
21 days
NOEC
30
ErC50
284 mg/L
(88 mg
a..s./L)
Review Report
Algae
72 h
Selenastrum
capricormutum
MON 52276
N. pelliculosa
S.costatum
P. subcapitata
EbC50
178 mg/L
(55 mg
a.s./L)
Neven, B. 1993, Studyno. LI-91389; ICS: 35239
glyphosate
7 days
EbC50
0.64
Review Report
(SANCO/6511/VI/99-final)*
AMPA
72 h
EyC50
89.8
11 December 1998
7 days
EyC50
14 days
EC50
Aquatic higher plants
L.gibba
L. gibba
Mesocosm study
glyphosate
-
-
-
12
-
Review (SANCO/6511/VI/99final)
-
* The EU review report for glyphosate (6511/VI/99-final) lists an EC50-value for algae of 0.64 mg/L.
This was the endpoint used for the assessment of the risk for algae exposed to glyphosate acid. This
endpoint was determined in the study from Hughes, 1987 using Skeletonema costatum as a test
species. During the Renewal Assessment (AIR2) the environmental endpoints were re-evaluated
and new endpoints were defined. The test did not meet the actual guidelines critical criteria.
During the Renewal Assessment (AIR2) the environmental endpoints were re-evaluated and new
endpoints were defined. For the aquatic environment the former algae endpoint is supposed to
display a worse case, as no lower endpoint was defined. The Renewal Assessment (AIR2) shows that
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the risk for aquatic organisms is triggered by the possible long-term effects on macrophytes and
acute effects on fish. Therefore, risk assessment based on the acute fish value LC50 = 38 mg/l taking
into account a safety factor of 100, was added to the risk assessment.
Glyphosate forms two major metabolites; Aminomethyl-phosphonic acid (AMPA), max. 16 % at day 14
and (Hydroxymethyl)-phosphonic acid (max. 10.0% at day 61, 7.5% at day 100).
As the metabolite AMPA shows a clearly lower toxicity for fish, daphnids and algae than the active
substance, no quantitative risk assessment was performed. The risk assessment for the active substance is
supposed to address the risk resulting from metabolite as well.
Since no data are available for the metabolite (Hydroxymethyl)-phosphonic acid, a ten-fold higher
toxicity for aquatic organisms can be assumed for risk assessment purposes. As degradation of glyphosate
results in equal or less than 10 % of this metabolite and the Mol correction factor is 0.6, the risk
assessment for the metabolite (Hydroxymethyl)-phosphonic acid is covered by that of glyphosate.
It is predicted that the risk for aquatic organisms exposed to glyphosate metabolites according to the
intended use of Tender GB Ultra will be low.
6.4.1.2
Exposure
Aquatic organisms may be exposed to MON 78708 as a consequence of drift by spray application into the
aquatic compartments or as a consequence of run-off events.
Tender GB Ultra (MON 78708) is a water soluble concentrate formulation containing 360 g a.s./L
glyphosate acid (486 g/L glyphosate isopropylamine salt; 30.8% w/w as the isopropylamine salt).
According to the GAP table of intended uses (Appendix 3) Tender GB Ultra is intended for use as a
broad-spectrum herbicide on railways and of non-agricultural situations like non arable land. The
applications are considered to take place once with a maximal application rate o f 3600 g a.s./ha via spray
application (group A and D) and twice with applications of 1800 g a.s./ha (Group B and E). No drift into
aquatic compartments or run-off events are expected for Group C and F, when application is considered
by wiping and single plant treatment.
Aquatic organisms may be exposed to plant protection products as a result of emission from treated areas.
When Tender GB Ultra (MON 78708) is applied according to good agricultural practice, the active
ingredients can reach surface waters unintentionally by spray-drift during application, by run-off and
drainage.
The predicted environmental concentrations in surface water (PECSW) have been calculated based on the
application rates of 3600 g a.s./ha glyphosate g/ha. For details on the FOCUS modeling, see dRR CA Part
B, Section 5.6.
The relevant global maximum FOCUS Step 1 and 2 PECSW for risk assessments covering the intended
uses in non-crop area are summarized in the following table.
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Table 6-24:
FOCUS Step 1 and Step 2 PECsw and PECsed (Actual, 0 d) of glyphosate for the application of Tender
GB Ultra (MON 78708) in non-crop areas according to use No. D (worst case)
Plant protection product:
Use No evaluated
D (worst case)
Crop
Non-crop areas (representative in FOCUS Surface Water:
grass/ alfalfa)
Application method (-)
Spraying
Crop interception:
O%
Number of applications/interval
1
Application rate:
3600 g a.s./ha
FOCUS STEP
Scenario
PECSW (µg/L)
Actual, 0 h
TWA, 21 d
Actual, 0 h
STEP 1
87.38
-
8.59E+03
Northern Europe, Oct. - Feb.
33.11
-
3.99E+03
Southern Europe, Oct. - Feb.
33.11
-
3.23E+03
Northern Europe, Mar. - May
33.11
1.73E+03
Southern Europe, Mar. - May
33.11
3.23E+03
PECSED (µg/kg)
Regarding the intended uses on railways, there are no agreed FOCUS scenarios available. For the
intended use 01-001 and 01-002 (spraying on railway systems), a possible contamination of surface water
via run-off from railway system can currently not be excluded. A contamination of groundwater and a
risk for aquatic organisms might arise from an entry of glyphosate in surface waters via runoff from
railway systems and subsequent bank infiltration. Following these considerations we cannot exclude that
glyphosate concentrations might exceed 0.1µg/L in groundwater after bank filtration from surface waters
when ‘Tender Ultra’ is applied in the intended uses for weed control on railways.
Please refer to Section 5 (Fate and Behavior in the Environment) for consideration on possible
contamination pathways of groundwater.
6.4.1.3
Based on the FOCUS Step 2 PECs, the aquatic TER values for glyphosate are above the trigger of 10,
indicating a low and acceptable acute risk for aquatic organisms from glyphosate and its water
metabolites following application of Tender GB Ultra at the proposed application rates.
TER values for the most sensitive aquatic organisms based on PECSW FOCUS calculations are
summarized in the following table.
Table 6-25:
Aquatic TER values for glyphosate after applications of Tender GB Ultra (MON 78708).
Test organism
EC50
FOCUS
Step
Scenario
Max. PECSW
worst case
TERLT
Trigger
value
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(µg/L)
Skeletonema costatum
640 (EbC50)
(µg/L)
1
2
O. mykiss
38000
N-EU, Mar.-May
1
2
N-EU, Mar.-May
87.38
7.3
33.11
19
87.38
434
33.11
1147
10
100
TER-values in bold are below the relevant trigger
6.4.2
Toxicity to Exposure ratio
The risk for aquatic organisms exposed to glyphosate was assessed according to the intended uses.
As first step, the initial maximum PECSW values (Step 2) were compared to the relevant acute and longterm toxicity endpoints available for gglyphosate. In the table below, the TER values relative to the most
sensitive endpoint of each organism’s group are given.
Table 6-26:
Scenario
Aquatic organisms: PECsw for glyphosate and relevant ecotoxicological endpoints for each organism’
group.
PEC global
max
(µg/L)
FOCUS
Step 1
Step 2
N.Europe
S.Europe
TER criterion
87.38
33.11
33.11
Fish acute
Fish
prolonged
Invertebrates Invertebrates
Algae
acute
prolonged
O. mykiss
O. mykiss
D. magna
D. magna
[P.
Subcapitata]*
LC50
(µg/L)
NOEC
(µg/L)
EC50
(µg/L)
NOEC
(µg/L)
[EbC50
(µg/L)
38000
434
25700
295
>38400
>439
30000
343
640]
1147
1147
100
776
776
10
1159
1159
100
906
906
10
[8]
[19]
[19]
[10]
* During the Renewal Assessment (AIR2) the environmental endpoints were re-evaluated and new endpoints were
defined. For the aquatic environment the former algae endpoint is supposed to display a worse case, as no lower
endpoint was defined.
Based on the calculated concentrations of glyphosate in surface water (PECSW FOCUS), the calculated
TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to
glyphosate according to the GAP of the formulation Tender GB Ultra (MON 78708) achieve the
acceptability criteria TER ≥ 100 and TER ≥ 10, according to commission implementing regulation (EU)
No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for long-term effects. The results of the
assessment indicate an acceptable risk for aquatic organisms due to the intended use of Tender GB Ultra
(MON 78708) according to the label.
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6.4.3
Acute toxicity and chronic toxicity of the formulation
Please refer to section 6.4.1.1 for a summary of the provided studies on the effects of Tender GB Ultra on
aquatic organisms. Section 6.4.2, page 35, gives the details of the risk assessment for aquatic organisms
on the basis of all available data.
6.4.4
Metabolites of Glyphosate
Please refer to section 6.4.1.1 for a summary of the provided studies on the effects of glyphosate
metabolites on aquatic organisms. Section 6.4.1.1 gives the details of the risk assessment for aquatic
organisms on the basis of all available data.
Glyphosate forms two major metabolites in surface water: glyphosate metabolite Aminomethylphosphonsäure (AMPA) (max. 16 % at day 14) and (Hydroxymethyl)-phosphonic acid (max. 10.0% at
day 61, 7.5% at day 100). The glyphosate metabolite AMPA is also formed in sediment (max. 16 % at
day 120). Moreover, the glyphosate metabolite AMPA is formed in soil with max. 29.3 % at day 84.
Contamination via run-off and drainage cannot be excluded. Ecotoxicological studies are available for the
metabolite AMPA for fish, daphnia and algae. For (Hydroxymethyl)-phosphonic acid no ecotoxicological
studies are available.
The comparison of the study results for the metabolite AMPA with the results of studies performed with
glyphosate shows that glyphosate is more toxic for aquatic organisms than the metabolite. It is predicted
that the risk for aquatic organisms exposed to glyphosate metabolites according to the intended use of
Tender GB Ultra will be low.
6.4.5
Accumulation in aquatic non-target organisms
Bioaccumulation of any of the active substances under natural conditions is not expected to occur and a
study is not necessary to determine bioaccumulation in aquatic non-target organisms.
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6.5
Effects on Bees
6.5.1
Effects on bees from MON 78708 were not evaluated as part of the EU review of glyphosate. However,
the bee toxicity study performed on MON 52276 provided in support of the assessment has already been
evaluated in line with national registration of glyphosate containing products in Germany and is
considered adequate. MON 52276 is similar to MON 78708 with the exception that MON 78708 contains
a blue, food approved dye. The study on technical glyphosate (Fraser, W.D., Jenkins, G., 1972) has been
evaluated as part of the Annex II dossier for inclusion of glyphosate in Annex I of the 91/414/EEC
Directive and is not reported here since the study was not conducted according to GLP and recognized
guidelines.
6.5.1.1
Toxicity
The following bee acute oral toxicity study performed on MON 52276 provided in support of the
assessment of MON 78708 has already been evaluated in line with national registration of glyphosate
containing products in Germany. Since no major deviations from the guideline were reported which could
have influenced the results of the study only a brief summary and the endpoints are presented below.
Report:
KIIIA1 10.4.2.1/01
Title:
Baxter, I. (2001): Laboratory Bioassays to Determine Acute Oral and Contact
Toxicity of MON 52276 to the Honeybee, Apis mellifera. Study Number: MON-002. Mambo-Tox Ltd., Agrochemical Science Building, Southampton, UK.
Document No:
Report number MON-00-2- version 2
Guidelines:
OECD 213 and 214
GLP
Yes
Test procedure
In a single dose limit test under laboratory conditions oral and contact toxicity of the formulated product
MON 52276 (41% glyphosate-isopropylamine, equivalent to 31% glyphosate-acid-equivalent) to young
adult worker bees (Apis mellifera L.) were tested using a single nominal dose of 330 µg product/bee (134
µg glyphosate isopropylamine/bee or 100 µg glyphosate acid equivalent/bee) for contact exposure and
254 µg product/bee (103 µg glyphosate isopropylamine/bee or 77 µg glyphosate a.s./bee) for oral
exposure. Five replicate cages containing 10 bees each were used for the test item treatments and the
untreated control. In the toxic standard treatment honeybees were treated with dimethoate at
concentrations ranging from 0.075 to 0.3 µg a.s./bee. Three replicate cages containing each 10 bees each
were used for the reference standard. Assessment of mortality was done after 1, 3, 24 and 48 hours.
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Conclusions
The mortality in control varied between 2% and 4% in the 48-hour exposure. For both oral and contact
exposures with the test item the mortality did not reach or exceed 50%. The highest mortality was
recorded in the contact toxicity test with 6%. Therefore the LD50 (48 h) was > 254 µg product/bee in the
oral toxicity test and > 330 µg product/bee in the contact toxicity test (Table 6.5.1.1-1). No test item
induced behavioural effects were observed at any time of the test. LD50 values of the reference item were
in the expected range of 0.1 to 0.35 and 0.1 to 0.30 µg dimethoate/bee for oral and contact exposure,
respectively. Validity criteria were fulfilled and the test is considered valid.
Table 6.5.1.1-1 Results of laboratory bee toxicity studies
Test substance
Exposure
route
LD50
Reference
MON 78708
(tested as MON 52276)
oral 48 h
> 254 µg product/bee
contact 48 h
Baxter, I. (2001);
MON-00-2
6.5.1.2
Exposure
The recommended use pattern for Tender GB Ultra (MON 78708) includes application in non-agricultural
situations at a maximum application rate of up to 10 L/ha corresponding to 11690 g product/ha. This
maximum single application rate is equivalent to 3600 g/ha glyphosate (acid equivalent).
Bees may be exposed by direct spraying while bees are foraging on flowers and weeds, through contact
with fresh or dried residues or by oral uptake of contaminated pollen, nectar and honey dew.
6.5.2
Hazard quotients
Hazard quotients for oral and contact exposure according to EPPO (2003) Environmental risk assessment
scheme for plant protection products (Chapter 10: Honeybees (PP 3/10(2)). Bulletin OEPP/EPPO Bulletin
33: 141-145) were calculated as follows:
Hazard Quotient = max. application rate [g product/ha] / LD50 [µg product/bee]
Table 6.5.2-1 Hazard quotients for honeybees
Product
Exposure
route
LD50
oral
contact
MON 78708
Max. single
Hazard
application
HQ trigger
quotient (HQ)
rate
11690 g
product/ha
<47
50
< 36
50
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6.5.3
Risk assessment
Due to the results of laboratory tests Tender GB Ultra (MON 78708) is considered to be practically nontoxic to bees. All hazard quotients are clearly below the trigger of 50, indicating that the intended uses
pose a low risk to bees in the field. Bee brood testing is not required since exposure of bee brood to MON
78708 is considered negligible.
6.5.4
Overall conclusions
It is concluded that Tender GB Ultra (MON 78708; 486 g/L glyphosate isopropylamine salt) will not
adversely affect bees or bee colonies when used as recommended.
Label applied: NB6641
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6.6
Effects on Arthropods Other Than Bees
6.6.1
Effects on arthropods other than bees for Tender GB Ultra (MON78708) were not evaluated as part of the
EU review of glyphosate. Data on Tender GB Ultra (MON78708) have been submitted by the applicant
and are evaluated here. They are considered adequate to assess the risk for non-target arthropods
following the use of Tender GB Ultra according to the intended uses.
6.6.1.1
Toxicity
The toxicity of Tender GB Ultra (MON78708) to non-target arthropods has been investigated with the
soluble concentrate (SL) formulation containing the active ingredient glyphosate (3600 g.a.s/ha) for the
indicator species Aphidius rhopalosiphi, Typhlodromus pyri and Aleocharabilineata in extended
laboratory studies. The critical endpoints employed in the risk assessment for non-target arthropods are
indicated in the table below.
Table 6-27:
Toxicity of Tender GB Ultra to non-target arthropods with reference to agreed endpoints
Species
Substance
Exposition
Results
Reference
.
ICS-No.
Aphidius
rhopalosiphi
MON 52276
Extended
laboratory
(whole plant)
Stevens, 2010 1)
81045
Typhlodromus pyri
MON 52276
Extended
laboratory
(leaf discs)
LR50 > 16L
MON 52276/ha
(5760 g a.s./ha)
ER50 ≥12L/ha
(4320 g a.s./ha)
Aleochara bilineata
MON 52276
Extended
Laboratory
(soil)
ER50 >12L/ha
(4320 g a.s./ha)
Spincer, 2010 1)
Fallowfield, 2010 1) 81047
81046
6.6.1.2
Exposure
In field
Non-target arthropods living in the crop can be exposed to residues from Tender GB Ultra by direct
contact either as a result of overspray or through contact with residues on plants and soil or in food items.
The maximum application rate of Tender GB Ultra (MON78708) is 10 L/ha, i.e. 3.6 kg a.s./ha. The
intended effect is control of weeds in non- crop areas and on railways. If all the vegetation in the target
area is controlled, then populations of foliar dwelling arthropods living on these weeds will lose their
habitat. Off-field areas adjacent to treated vegetation may be exposed to MON 78708 by drift from spray
application. In these areas all arthropod groups are relevant to the risk assessment.
The in-field exposure, given as predicted environmental rates, PER, for non-target arthropods resulting
from the intended uses of Tender GB Ultra is calculated according to published agreement after ESCORT
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2 workshop (Candolfi et al. 20011 -hereafter referred to as ‘Guidance Document’) using the following
equation:
P E R in − fie ld = A p p licatio n rate (g a.s./h a) × M A F
Where:
MAF = generic multiple application factor used to take into account the potential build-up of
applied substances between applications. This factor integrates number of applications,
application interval and degradation kinetics of the active substance
Default MAF values for given numbers of applications are listed in the Guidance Document. Since
Tender GB Ultra will be applied in once a season at a maximum application rate of 10 L/ha, i.e.
3.6 kg a.s. /ha, assuming 0% crop interception for the calculation of the rates reaching the soil, this worst
case application scheme was identified and chosen for the risk assessment covering the risk assessment
for the dual application rate of 2 times 5 L/ha, i.e. 1.8 kg a.s. /ha.
The maximum predicted environmental rate (PER) occurring in the field after application of Tender GB
Ultra at the maximum application rate is presented in the following table.
Table 6-28:
In-field predicted environmental rates (PER) for Tender GB Ultra
Substance
MON 52276
Application rate
in-field PER foliar
in-field PER soil
1x 10 L/ha, i.e. 3.6 kg a.s./ha
10 L/ha, i.e. 3.6 kg a.s./ha
10 L/ha, i.e. 3.6 kg a.s./ha
Off-field
Exposure of non-target arthropods living in non-target off-field areas to Tender GB Ultra will mainly be
due to spray drift from field applications. Off-field predicted environmental rates (PER-values) were
calculated from in-field PERs in conjunction with drift values published by the BBA (20002) as shown in
the following equation:

Maximum in − field PER x  drift percentile
100 

Off − field PER =
vegetation distribution factor (vdf )
1
Candolfi, M.P.; Barrett, K.L.; Campbell, P.; Forster, R.; Grandy, N.; Huet, M.C.; Lewis. G.; Oomen, P.A.; Schmuck, R.; Vogt,
H. (2001): Guidance document on regulatory testing and risk assessment procedures for plant protection products with
non-target arthropods. ESCORT2 Workshop European Standard Characteristics of Non-Target Arthropod Regulatory
Testing. Wageningen, The Netherlands, 46 pp.
2
BBA (Biologische Bundesanstalt für Land- und Forstwirtschaft) (2000): Abtrifteckwerte für Flächen- und Raumkulturen sowie
für den gewerblichen Gemüse-, Zierpflanzen- und Beerenobstanbau. Bundesanzeiger 100, 26. Mai 2000, Köln, pp.
9879.
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Where:
vdf =
vegetation distribution factor used in combination with test results derived from 2dimensional exposure set-ups
To account for interception and dilution by three-dimensional vegetation in off-crop areas, a vegetation
distribution or dilution factor (vdf, see above) is incorporated into the equation when calculating off-field
exposure in conjunction with toxicity endpoints derived from two-dimensional studies (e.g. glass plate or
leaf discs). A dilution factor of 10 is recommended by the Guidance Document, but has been questioned.
The risk assessment procedure here considers a dilution factor of 5 more appropriated. For endpoint
resulting from 3-dimensional studies, i.e. where spray treatment is applied onto whole plants, the dilution
factor is not used.
The drift rate at 1 m distance is 2.77% of the application rate (90th percentile drift).
The drift factor (% drift/100) is therefore 2.77/100 = 0.0277. As for this herbicide a ground-directed
application is given, the field crop drift values are used for all crops.
For the results of study with T. pyri exposed to MON 52276 a vegetation distribution factor has to be
considered (study conducted in 2D environment).
The resulting PER off-field values are shown in the following table.
Table 6-29:
Study
type
Off-field predicted environmental rates (PER) resulting from the intended uses of Tender GB Ultra
Max. rate
MAF
(ml Prod./ha)
Maximum in-field
PER
Drift rate
(ml Prod./ha)
(% appl. rate)
vdf
Off-field
PER
(g a.s./ha)
2-D
1x 10000
1
10000 mL/ha
(3600 g a.s./ha)
2.77%
5
19.944
3- D
1x 10000
1
10000 mL/ha
(3600 g a.s./ha)
2.77%
1
99.72
Reduction of the amount of drift reaching the off-field areas can be achieved by implementing an in-field
buffer strip of a given width. The resulting drift values (according also to spray-drift predictions of
Ganzelmeier & Rautmann (2000)3) are given in the table below.
Table 6-30:
Maximum off-field PER (predicted environmental rates) of Tender GB Ultra at increasing distances
from the sprayed areas following intended uses
Maximum intended
in-field rate
3
Maximum PERoff-field
at 1m (2.77% drift)
at 5m (0.57% drift)
at 10m (0.29% drift)
Ganzelmeier H., Rautmann D. (2000) Drift, drift-reducing sprayers and sprayer testing. Pesticide Application, Aspects of
Applied Biology 57
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(ga.s.ha)
10000 mL/ha
19.94 (2D)
4.10 (2D)
2.1 (2D)
3600 g a.s./ha) (worse case
99.72 (3D)
20.52 (3D)
10.44 (3D)
The outcome of the risk assessment for non-target arthropods exposed to Tender GB Ultra is given in the
table below.
Higher tier
Table 6-31:
Species
Acceptability criteria for higher tier data and minimal TER values for arthropod species other than
bees after use of Tender GB Ultra
Test
type
Endpoint
L(E)R50
PER infield
effects
<50% at
calc. rate?
PER offPER offfield (1 m) field x
correction
factor 5
(g a.s./ha)
A. rhopalosiphi
T. pyri
3D
2D
A.bilineata. soil
LR50 > 16000 mL
MON52276/ha
(5760 g a.s./ha)
10000
mL/ha
ER50 ≥12000 ml (3600 g
MON52276/ha a.s./ha)
(4320 g a.s./ha
worse case
ER50 >12000ml
MON52276/ha
(4320 g a.s./ha
effects
<50% at
calc. rate?
TER Offfield
(g a.s./ha)
yes
99.72
498.7
yes
12
yes
19.9
99.5
yes
43
yes
99.72
498.7
yes
9
Based on the calculated rates of glyphosate in in-field and off-field areas, the calculated HQ and TER
values describing the potential risk resulting from an exposure of non-target arthropods to Tender GB
Ultra according to the GAP of the formulation Tender GB Ultra achieve the acceptability criteria HQ ≤ 2
resp. of less than 50% effects at calculated drift rates resp. TER ≥ 5 (higher Tier), according to
2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the
intended use of Tender GB Ultra in non-crop areas and railways according to the label.
6.6.2
Risk assessment for Arthropods other than Bees
6.6.2.1
In-field
Higher Tier
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The potential risk for non-target arthropods exposed in-field to Tender GB Ultra was assessed by
comparing the environmental rate (PER in-field) to the lowest lethal rate (LR50) estimated in toxicity tests
with non-target arthropods. With regard to extended laboratory tests and semi-field tests, lethal and
sublethal effects of less than 50 % are considered acceptable, provided that the tests covered the
appropriate field rate.
Table 6-32:
Risk assessment for non-target arthropods other than bees and acceptability criteria for higher tier
data
Species
L/ER50
PER in-field
effects < 50% at
calc. rate?
Typhlodromus pyri
ER50 ≥12L MON 52276/ha
(4320 g a.s./ha)
10L /ha
(3600 g a.s./ha)
yes
Aphidius rhopalosiphi
LR50 > 16L MON 52276/ha
(5760 g a.s./ha)
10L/ha
(3600 g a.s./ha)
yes
Aleochara bilineata
ER50 >12L MON 52276/ha
(4320 g a.s./ha)
10L/ha
(3600 g a.s./ha)
yes
The results indicate that Tender GB Ultra poses low risk to non-target arthropods in-field following
application according to the intended uses.
6.6.2.2
Off field
HQ approach
In order to assess the potential risk of Tender GB Ultra to non-target arthropods in off-field areas, the
predicted environmental rate in the Off-field (see chapter 6.6.1.2) is compared to the toxicity endpoints
according to the following formula:
Off − field HQ =
Off − field PER
× correction factor
LR50
Where:
Correction factor (also ‘safety factor’) = amounts to 10 in conjunction with Tier I data from tests
on glass plates; amounts to 5 for Tier II data from extended laboratory tests/field tests.
The factor accounts for extrapolation from testing few representative species to the
species diversity expected in off-crop areas.
With regard to extended laboratory tests and semi-field tests, lethal and sublethal effects of less than 50 %
at the calculated deposition rates are considered acceptable provided that the tests covered the appropriate
field rate.
Table 6-33:
Species
Acceptability criteria for higher tier non-target arthropods data
Test
type
L/ER50
PER infield
Distance PER off-field PER off-field x
correction
factor
(m)
(g a.s./ha)
effects <50%
at calc. rate?
(g a.s./ha)
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Typhlodromus 2 D
pyri
ER50 ≥12 L/ha
(4320 g a.s./ha)
Aphidius
3D
rhopalosiphi
Aleochara
bilineata
LR50 > 16L
MON 52276/ha
(5760 g a.s./ha)
Soil
ER50 >12L
MON 52276/ha
(4320 g a.s./ha)
10 L /ha
(3600 g
a.s./ha)
10 L /ha
(3600 g
a.s./ha)
10 L /ha
(3600 g
a.s./ha)
1
19.9
99.5
yes
5
4.1
20.5
yes
10
2.0
10
yes
1
99.72
498.6
yes
5
20.52
102.6
yes
10
10.44
52.2
yes
1
99.72
498.6
yes
5
20.52
102.6
yes
10
10.44
52.2
yes
At the calculated deposition rates, the effects in the extended laboratory tests are lower than 50%,
indicating that Tender GB Ultra does not pose an unacceptable risk to non-target arthropods in off-field
areas.
TER approach
Additionally to the HQ-approach, the assessment of the risk to non-target arthropods due to an exposure
to Tender GB Ultra was performed on basis of the calculation of toxicity-exposure ratios (TER values)
according the following formula:
TER =
L( E ) R50 ( L product / ha)
Off − field PER ( L product / ha)
The risk is considered acceptable if the values obtained are TER off-field > 10 when the ecotoxicological
data resulted from Tier 1 tests on glass plates or TER off-field > 5 when the data were obtained in higher
tier test (extended lab or field tests).
The resulting TER off-field values are given in the following table.
Table 6-34:
Species
Calculated TER values for non-target arthropods exposed to Tender GB Ultra in off-field areas
according to intended uses
Test Correction L/ER50
type factor
Typhlodromus 2D
pyri
5
PER in-field
Distance PERoff-field
TER
(mL product/ha) (mL product/ha) (m)
(g a.s./ha)
ER50 ≥12L/ha
(4320 g a.s./ha)
1
19.9
< 217
5
4.1
< 1053
10
2.0
< 2160
10L /ha
(3600 g a.s./ha)
TER values in bold are below the trigger
Based on the calculated rates of Tender GB Ultra in off-field areas, the calculated TER values for the risk
resulting from an exposure of non-target arthropods to glyphosate according to the GAP of the
formulation Tender GB Ultra achieve the acceptability criteria of TER > 5, according to commission
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implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The
results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of
Tender GB Ultra in non –arable land and on railways according to the label.
Management practices relevant for Germany are given in the respective Addendum.
6.7
Effects on Earthworms, other Non-target Soil Organisms and Organic
Matter Breakdown
6.7.1
Earthworms, other soil non-target macro and meso-fauna as well as soil organisms involved in the
breakdown of dead organic matter will be exposed to plant protection products containing glyphosate
whenever contamination of soil may occur as a result of the intended uses of Tender GB Ultra.
Effects on earthworms and other soil non-target organisms resulting from an exposure to Tender GB Ultra
were not evaluated as part of the EU review of glyphosate. All relevant study data for the assessment of
the risk to earthworm and other soil non-target macro-and mesofauna from the intended uses of Tender
GB Ultra are provided here. New data are listed in Appendix 1 and summarized in Appendix 2 (new
studies).
6.7.1.1
Toxicity
Table 6-35:
Ecotoxicological endpoints for terrestrial non-target soil fauna and organic matter breakdown
following exposure to glyphosate and Tender GB Ultra with indication to agreed endpoints
Species
Substance
Eisenia
fetida
glyphosate
(IPA-salt)
glyphosate
System
chronic
56 d
AMPA
Eisenia
fetida
glyphosate
Results
Reference
ICSNo.
NOEC ≥28.79 Reproduction
NOEC ≥ 21.31
Hayward, J.C. and Mallet, M.
41621
Report no: CEMR – 1173
1)
(LOEP)
NOEC ≥ 28.12
acute 14d
Eisenia
fetida
Review Report for the active
LC50 > 480 mg a.s./kg Mortalität substance glyphosate
(SANCO/6511/ VI/99-final)
LC50 > 1000 mg MON 0139/kg
Friedrich, S. ,2009 ,
soil d.w
T001934-09; 2)
Corr. 472,8 mg glyphosate
(a.s.)/kg dry soil
MON0139
(IPA-salt, 64% ; chronic
56 d
corr. 47%
glyphosate)
Eisenia MON52276
acute
LC50> 1250 mg/kg soil d.w
Hoxter, K.A., 1992
fetida
(31%
14d
(388 mg a.s/kg dry soil)
glyphosate)
1) Review Report for the active substance glyphosate (SANCO/6511/ VI/99-final)
79809
35278
The endpoint for the acute oral toxicity of glyphosate stated in the EU Review Report (6511/IV/99-final,
21 January 2002) is LC50> 480 mg as / kg, and the endpoint for the chronic toxicity NOEC ≥ 21.31 mg
a.s./kg (Hayward, JC and Mallet, M.Report no: CEMR - 1173). This study was performed with 2
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concentrations of glyphosate isopropylaminesalt (5.76 and 28.79 mg / kg dry soil, corresponding to 4.27
mg glyphosate and 21.31 mg/kg dry soil). In both concentrations, no significant differences were
observed in comparison to the untreated control in relation to body weight, behavior or reproduction. The
test was considered valid according to the OECD Test Guideline 222 and the endpoints were used for risk
assessment of glyphosate in the EU (see table above).
Furthermore a new study was submitted by the applicant (Friedrich, S., 2009, MON0139 - sublethal
toxicity to the earthworm Eisenia fetida, 0910 48056S). This study was also performed with glyphosateisopropylaminesalt (30, 50, 100, 500 and 1000 mg MON0139/kg dry soil, corresponding to 14.1, 23.6,
47.3, 236, and 473 mg a.s./ kg dry soil). In the study, no effects on behavior and body weight were
observed. Treatments with 50 and 100 mgMON0139/kg dry soil showed a mortality rate was 2.5 %, but
was not assessed as being statistically significant, and therefore the proposed endpoint NOEC=1000 mg
MON0139/kg dry soil, corresponding to 473 mg of glyphosate acid. The proposed endpoint will be used
for risk assessment.
The log KOW value for glyphosate is below the agreed trigger value of 2. Therefore, no correction of the
endpoints is required in order to account for the relatively high organic matter content of the artificial test
soil compared to agricultural soils and a resulting lower bioavailability of the active substance to soil
organisms.
6.7.1.2
Exposure
According to the GAP, Tender GB Ultra is intended to be applied once with an application rate of 3600 g
a.s./ha (10 L product) or twice with an application rate of 1800 g a.s./ha (2x 5L products) in non-arable
land and railways against weeds.
For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the
environmental fate section (Part B, Section 5) of this submission. The resulting maximum PECsoil values
for the active substances glyphosate and the major soil degradation products are presented in the table
below. Calculations considered the maximum application rate of 10L formulation/ha and a minimum of
0 % foliar interception for applications. PEC values for the soil metabolites were calculated considering
the maximum percentage of their formation observed in either the aerobic or anaerobic soil degradation
studies and correcting for molecular weight.
All calculations assumed an even distribution of the substances in the top 5 cm horizon with a soil bulk
density of 1.5 g/mL. Accumulation in the soil profile due to the persistence of glyphosate was considered
when necessary.
Table 6-36:
Maximum predicted environmental concentrations in soil PECS1) for glyphosate / Tender GB Ultra and
major soil degradation products of glyphosate following application in the intended use on railways
and non-arable land.
plant protection product:
Tender GB Ultra
use:
non-crop areas and railways
1x 3600 ga.s./ha (10L) and 2x1800 g a.s./ha (2x 5L)
application rate:
see above
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crop interception:
0%
active substance/
preparation
soil relevant
application rate
(g/ha)
PECact
(mg/kg)
PECtwa 21 tillage depth PECbkgd
d**
(cm)
(mg/kg)
(mg/kg)
PECaccu =
PECact +
PECbkgd
(mg/kg)
Glyphosate
3600
4.8000
3.8593
-
0.7132
5.5132
AMPA
1271
1.6947
1.6753
-
3.4497
5.1443
Tender GB Ultra
(MON 78708)
11660
15.54
-
* Soil relevant application rate = 10L/ha · 1166 g/L (the density of Tender GB Ultra (MON 78708): 1.166
g/cm³) ** after 1 year
6.7.1.3
Risk assessment –TER values and overall conclusions
The risk assessment results are summarized in the following table:
Table 6-37:
Ecotoxicological endpoints, PECsoil values and Toxicity to Exposure ratios to assess the risk for
earthworms and other soil macro- and mesofauna following application of Tender GB Ultra according
to the intended uses
Test
substance
Timescale
Endpoint
(mg/kg dw soil)
Glyphosate
(IPA-salt)
Acute
LC50 > 480 mg a.s./kg
5.5132
> 87
10
(Long-term
NOEC ≥ 21.31
5.5132
> 3.8
5)
(Long-term
NOEC ≥ 28.79
(IPA-salt)
5.5132
> 5.2
5)
Acute
-
5.1443
-
10
Long-term
NOEC ≥ 28.12
5.1443
>5.5
5
Acute
LC50>1250 mg/kg soil d.w
(IPA-salt) (388 mg a.s/kg dry
soil)
5.5132
> 70
10
AMPA
MON52276
MON0139
PEC
TER
(mg/kg soil
dw)
TER trigger
Long-term
-
-
5
acute
-
-
10
Long-term
NOEC > 1000 mg MON
0139/kg soil d.w (IPA-salt)
corresponding to
472.8 mg glyphosate (a.s.)/kg
dry soil
>85
5
5.5132
Based on the predicted concentrations of glyphosate in soils, the TER values describing the acute and
long-term risk for earthworms and other non-target soil organisms following exposure to Tender GB
Ultra according to the GAP of the formulation achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5
according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific
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principles, point 2.5.2. The results of the assessment indicate an acceptable risk for soil organisms due to
the intended use of Tender GB Ultra in non –arable land and railways according to the label.
6.7.2
Toxicity to Exposure Ratio
6.7.2.1
Acute risk
The potential acute risk for earthworms and other non-target soil macro- and meso-fauna resulting from
an exposure to Tender GB Ultra as well as the major soil degradation products of glyphosate was assessed
by comparing the maximum PECsoil with the 14-day LC50 value to generate acute TER values. The TERA
was calculated as follows:
TER A =
LC 5 0 (m g/kg)
PEC soil (m g/kg)
The resulting TERA values are shown in Table 6-37 above.
6.7.2.2
Chronic risk
According to the Guidance Document on Terrestrial Ecotoxicology, a test for assessing effects on organic
matter breakdown (litterbag) is required where:
− DT90field of the active substance is > 365 days or
− DT90field of the active substance is between 100 and 365 days and
− Effects on soil microflora > 25 % or TERLT earthworm < 5
− or Collembola TERLT < 5
None of these criteria is met for Glyphosate, since DT90field value is less than 365 days and no risk was
identified for soil fauna and soil micro-organisms (see next chapter).
The potential chronic risk for earthworms, other non-target soil macro- and meso-fauna and organic
matter breakdown resulting from an exposure to Tender GB Ultra as well as the major soil degradation
products of glyphosate was assessed by comparing the maximum PECsoil with the NOEC value to
generate chronic TER values. The TERLT was calculated as follows:
TER
LT
=
N O E C ( m g/ k g )
P E C s oi l ( m g / k g )
The resulting TERLT values are shown in Table 6-37 above.
6.7.3
Residue content of earthworms
The log Kow values of glyphosate < 3. Thus, glyphosate is not deemed to bioaccumulate in earthworms.
Therefore, studies determining residue content of glyphosate in earthworms are not necessary.
6.8
Effects on Soil Microbial Activity
6.8.1
Soil microorganisms will be exposed to plant protection products containing glyphosate whenever
contamination of soil may occur as a result of the intended uses of Tender GB Ultra.
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Effects on soil microorganisms resulting from an exposure to Tender GB Ultra were not evaluated as part
of the EU review of glyphosate. All relevant study data for the assessment of the risk to soil
microorganisms from the intended uses of Tender GB Ultra are provided here. New studies are listed in
Appendix 1 and summarized in Appendix 2. Studies have been conducted with MON 52276 (similar
formulation) to determine the effects on soil microorganisms.
6.8.1.1
Toxicity
Table 6-38:
Ecotoxicological endpoints for soil microbial activity following exposure to glyphosate and Tender GB
Ultra with indication to agreed endpoints
Process
Substance
Application rate
(L/ha)
Exposition Results
Reference
ICSNo.
Ntranformation
MON 52276
53
(5.3 x PEC)
28d
< 25% deviation
from control
Carter, J.N.,
2001 1)
81056
CMON 52276
transformation
53
(5.3 x PEC)
28d
< 25% deviation
from control
Carter, J.N.,
2001 1)
81056
6.8.1.2
Exposure
Please refer to section 6.7.1.2 above for the predicted environmental concentrations in soil (PECsoil) of
glyphosate.
6.8.1.3
The Predicted Environmental Concentrations of the formulation Tender GB Ultra the active substance(s)
glyphosate and the major soil degradation product AMPA are below the concentrations at which no
unacceptable effects (< 25%) regarding the soil microbial activity were observed after 28 days of
exposure.
The results of the comparison expressed as Margin of Safety (MoS) are presented in the following table.
Table 6-39:
Substance
MON 52276
Summary of risk assessment for soil micro-organisms exposed to Tender GB Ultra
Test type
Maximum initial
PEC
Effects <25%
(mg/kg soil dw)
(mg/kg soil dw)
MoS
N-transformation
5.5
25.4 mg /kg dry soil
4.6
C-transformation
5.5
4.6
For the active ingredients in Tender GB Ultra, the soil concentrations which caused no deviations greater
than ±25% in the activity of the soil microorganisms are at least 5-times higher than the corresponding
maximum PEC in soil. Based on the predicted concentrations of glyphosate in soils, the risk to soil
microbial processes following exposure to Tender GB Ultra according to the GAP of the formulation
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Tender GB Ultra is considered to be acceptable according to commission implementing regulation (EU)
No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2.
6.9
Effects on Non-Target Plants
6.9.1
Effects on non-target plants resulting from an exposure to Tender GB Ultra were not evaluated as part of
the EU review of glyphosate. Therefore, all relevant study data for the assessment of the risk to non-target
plants from the intended uses of glyphosate are provided here, whereas the data on the formulated product
have not been submitted.
6.9.1.1
Toxicity
Table 6-40:
Ecotoxicological endpoints for non-target plants following exposure to glyphosate in Tender GB Ultra
with indication to agreed endpoints
Species
Substance
glyphosate
Lycopersicon esculentum,
Glycine max, Lactuca sativa,
Raphanus sativus, Cucumis
sativus, Brassica oleracea,
Avena sativa, Lolium perenne
Zea mays, Allium cepa
Exposition Results
Reference
ICS-No.
Vegetative ER50 > 146 g a.s./ha
vigour
Chetram, R.S. and 35146
Lucash, K.J. al.,
1994, MSL-13320
For the risk assessment the endpoint of the active ingredient glyphosate is used. The most sensitive
species of the 10 tested species tested post emergence was Lycopersicon esculentum with an EC50 of 146
g a.s. /ha. As for glyphosate results are available with 10 species, it is possible to lower the acceptability
criterion to TER ≥ 5. However, to ensure a sufficient and an adequate protection of non target plants in
the off –field environment it is recommended to correct the TER trigger > 5 by a factor of 3 upwards for
the following reasons:
Around the treated area in the scenario non –arable land non target plants will be exposed to Tender GB
Ultra mainly via spray drift (driftable portion of application rate: 2.77% at 1 m from treated field edges
and 0.57% at 5 m). For the proposed use pattern in of Tender GB Ultra on railways risk assessment is
based on spray drift values are modified according to Wygoda et al. 2006 (Drift measurements for a
spraying train, Nachrichtenbl. Deut. Pflanzenschutzd., 58 (12), S. 323–326, 2006, ISSN 0027-7479.)
It is important to remember that for the assessment of the effects on terrestrial plants toxicity studies with
the product are more appropriate than studies with the active ingredient. Since it cannot be excluded that
the formulants/ surfactants enhance toxicity, it seems that using data of the active ingredient glyphosate
only, will not display potential harmful effects of Tender GB Ultra towards non target plants.
Nevertheless, test results on terrestrial plants with the formulation Tender GB Ultra have not been
submitted. Based on the available data from other glyphosate-containing preparations it is recognizable
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that the preparations typically are about a factor of 3 more toxic than the active ingredient. In order to
meet the precautionary principle in risk assessment the acceptability is therefore by modified (TER ≥ 15).
6.9.1.2
Exposure
Effects on non-target plants are of concern in the off-field environment, where they may be exposed to
spray drift. The amount of spray drift reaching off-crop habitats is calculated using the 90th percentile
estimates derived by the BBA (2000) from the spray-drift predictions of Ganzelmeier & Rautmann
(2000). For the proposed use pattern in of Tender GB Ultra on railways risk assessment is based on spray
drift values are modified according to Wygoda et al. 2006 (Drift measurements for a spraying train,
Nachrichtenbl. Deut. Pflanzenschutzd., 58 (12), S. 323–326, 2006, ISSN 0027-7479.)
Any dilution over the 3-dimensional vegetation surface is accounted for in the study design. Therefore, in
contrast to the assessment of risks to arthropods from standard laboratory tests, no vegetation distribution
factor is considered here.
PER off-field= Maximum in-field PER (including MAF) x %drift
PER off-field (single application) = 3600 g a.s./ha x 2.77% (non-arable land)/ 0.019% (railways)
PER off-field (double application) = 1800 g a.s./ha x 1.7 x 2.77%
For calculation of PER in-field, please refer to section 6.6.1.2, page 40.
The resulting maximum off-field predicted environmental rates (PER off-field) are summarized in the
following table:
Table 6-41:
Maximum
intended
in-field rate
Maximum off-field predicted environmental rates of Tender GB Ultra following intended uses
Maximum
PERoff-field
at 1m (2.77%
drift)
Maximum
PERoff-field
at 5m (0.57%
drift)
Maximum
PERoff-field
at 10m (0.29%
drift)
Maximum
PERoff-field
at 3m
(0.019% drift)
1x 10 L/ha
99.72
(3600 g a.s./ ha)
as worst case
20.52
10.44
0.684
2 x5 L/ha
84.76
(2x1800 g a.s./
ha) as worst case
17.44
8.87
(ga.s.ha)
6.9.1.3
Risk assessment –TER values and overall conclusions
The risk assessment results are summarized in the following table:
Table 6-42:
Summary of risk assessment for non-target terrestrial plants exposed to glyphosate
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Scenario
Non-arable land
Non-arable land
Railways
ER50
ER50 = 146
g a.s./ha
PERin-field
Max. 3600 g
a.s./ha
Max. 2 times
1800 g a.s. /ha
Distance
Exposure PERoff-field
(m)
(g a.s./ha)
1
99.72
TER
1.5
5
20.52
7.1
10
10.44
14
1
84.74
1.7
5
17.44
8.3
10
8.87
16
3
0.684
213
Based on the predicted rates of glyphosate in off-field areas, the TER values describing the risk for nontarget plants following exposure to glyphosate according to the GAP of the formulation Tender GB Ultra
does not achieve the modified acceptability criteria TER ≥ 15 according to commission implementing
regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. The results of the
assessment indicate an unacceptable risk for non-target terrestrial plants due to the intended use of Tender
GB Ultra in non arable land according to the label. Risk mitigation measures will have to be implemented
to reduce the exposure of non-target terrestrial plants to Tender GB Ultra comparable to 10 m in-field
buffer strip. Risk mitigation can also be achieved with techniques like low pressure nozzles, anti-drift
nozzles, drift reductions. Management practices relevant for Germany are given in the respective
Addendum.
For the proposed use on railways the TER values describing the risk for non-target plants following
exposure to glyphosate according to the GAP of the formulation Tender GB Ultra does achieve the
modified acceptability criteria TER ≥ 15 according to commission implementing regulation (EU) No
546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. The results of the assessment indicate an
acceptable risk for non-target terrestrial plants due to the intended use of Tender GB Ultra on railways
according to the label.
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Table A 1: List of data submitted in support of the evaluation
Annex
Author(s) Year Title
Data
Owner
point/reference
Source (where different from company) protection
No
Report-No.
claimed
GLP or GEP status (where relevant),
Published or not
How
considered
in dRR
StudyStatus/
Use*
OECD: KIIA
5.6.11/01
XXX
Y
1996 Glyphosate technical: Oral gavage
teratology study in the rabbit.
Report No: 434/020, ASB2012-11499
Date: 1996-07-04
GLP: yes
not published
NUF
4)
OECD: KIIA
8.1.4/01
XXX
1999 Glyphosate Acid: A reproduction study N
with the Northern Bobwhite (Colinus
virginianus).
Report No: 123-186
Date: 1999-05-13
GLP: yes
not published
SYN
4)
OECD: KIIA
8.1.4/02
XXX
1999 Glyphosate Acid: A reproduction
Study with the Mallard (Anas
platyrhynchos).
Report No: 123-187
Date: 1999-01-11
GLP: yes
not published
N
SYN
4)
OECD: KIIA
8.9.2/01
Friedrich, 2009 MON 0139 - Sublethal toxicity to the
S.
earthworm Eisenia fetida.
Report No: 09 10 48 056 S
Date: 2009-11-30
GLP: yes
not published
Y
MON
1)
OECD: KIIA
8.12/01
Chetram, 1994 Tier 2 vegetative vigor non-target
R.S.,
phytotoxicity study using glyphosate.
Lucash,
Report No: MSL-13320
K.J.
Date: 1994-01-14
GLP: yes
not published
Y
MON
1)
OECD: KIIIA
XXX
Y
MON
1)
10.2.2.1/01
1992 MON 52276: Acute toxicity to
rainbow trout, Oncorhynchus mykiss,
under flow-through test conditions
Toxicon Environmental Sciences,
Jupiter, Florida 33477, USA
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Report No: TO-91-296
Date: 1992-01-23
GLP: yes
not published
XXX
Y
1992 MON 52276: Acute toxicity to the
common carp, Cyprinus carpio, under
flow-through test conditions.
Toxicon Environmental Sciences,
Jupiter, Florida 33477, USA
Date: 1992-01-24
GLP: yes
not published
MON
1)
Lintott,
D.R.
1992 MON 52276: Acute toxicity to the
water flea, Daphnia magna, under
flow-through test conditions
ToxiKon Environmental Sciences,
Jupiter, Florida, USA
Date: 1992-01-23
GLP: yes
Not published
Y
MON
1)
Neven,
B.
1992 A1ga, Growth Inhibition Test Effect of Y
MON 52276 on The Growth Of
Selenastrum capricornutum
LISEC, B-3600 Genk Belgium
Report No: LI-91-389
Date: 1992-01-10
GLP: yes
Not published
MON
1)
Y
Baxter, I. 2001 Laboratory bioassays to determine
acute oral and contact toxicity of MON
52276 to the honeybee, Apis mellifera
Mambo-Tox Ltd, Bassett Crescent
East, Southampton S016 7PX, UK
Report No: MON-00-2 version 2
Date: 2001-01-08
GLP: yes
not published
MON
1)
1999 A laboratory evaluation of the effects Y
of MON 52276 on the green lacewing,
Chrysoperla carnea.
Monsanto report no. US-99-093.
GLP: yes
not published
MON
1)
OECD
Fallowfie 2010 An extended laboratory bioassay of the Y
IIIA 10.5.2/01 ld, L.
effects of MON 52276 on the
MON
1)
OECD: KIIIA
10.2.2.1/02
OECD: KIIIA
IIIA 10.2.2.2
OECD: KIIIA
IIIA 10.2.2.3
OECD: KIIIA
IIIA 10.4.2.1
OECD
Barton,
IIIA 10.5.1/05 R.
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predatory mite, Typhlodromus pyri
(Acari: Phytoseiidae)
Mambo-Tox Limited, 2 Venture Road,
Chilworth Science Park, Southampton
SO16 7NP, UK
Report No: MT-2009-404
Date: 2010-04-27
GLP: yes
not published
Y
OECD
Stevens, 2010 A rate-response extended laboratory
IIIA 10.5.2/02 J.
test to determine the effects of MON
52276 on the parasitic wasp, Aphidius
rhopalosiphi (Hymenoptera,
Braconidae)
Mambo-Tox Ltd., Southampton, UK
Report No: MON-09-2 (MT-2009-405)
Date: 2010-04-27
GLP: yes
not published
MON
1)
Y
OECD
Spincer, 2010 An extended laboratory test to
IIIA 10.5.2/03 D.
determine the effects of MON 52276
on the ground-active beetle, Aleochara
bilineata (Coleoptera, Staphylinidae)
Report No: MON-09-4 (MT-2009-403)
Date: 2010-04-27
GLP: yes
not published
MON
1)
1992 MON 52276: An acute study with the Y
earthworm in an artificial soil
substrate.
Wildlife International Ltd. Easton,
Maryland, USA
Report No: 139-306
Date: 1992-09-18
GLP: yes
Not published
MON
1)
Y
MON
1)
Y
2001 MON 52276 - Effects on soil nontarget micro-organisms: nitrogen
transformation, carbon transformation.
Huntingdon Life Sciences Ltd.,
Alconbury,
MON
1)
OECD
IIIA 10.6.2
Hoxter,
K.A.;
Smith,
G.J.
OECD
IIIA 10.6.3
Friedrich, 2009 MON0139 - Sublethal toxicity to the
S.
earthworm Eisenia fetida. BioChem
agrar Laboratory, Laboratory Study
Number 09 10 48 056 S.
Date: 2009-11-30
GLP: yes
Not published
OECD
IIIA 10.7.1
Carter,
J.N.
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Huntingdon, Cambridgeshire, UK.
Report No: 256/004346
Date: 2001-10-05
GLP: yes
Not published
1)
Accepted (study valid and considered for evaluation)
2)
Not accepted (study not valid and not considered for evaluation)
3)
Not considered (study not relevant for evaluation)
4)
Not submitted but necessary (study not submitted by applicant but necessary for evaluation)
5)
Supplemental (additional information, alone not sufficient to fulfill a data requirement,
considered
for evaluation)
Remark:
Studies submitted by the applicant were alone sufficient to fulfil the data requirements.
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A2-1
Active substance (generally only relevant in the case that new annex II data is
provided after glyphosate approval)
KII A 8.1 Effects on Birds
KIIA 8.1.4/01
Author:
Title:
XXX
Glyphosate Acid: A reproduction study with the Northern Bobwhite (Colinus
virginianus)
13.05.1999
2310916 /123-186
OECD
FIFRA Guideline 71-4
OECD Guideline 206
NO
Date:
Doc ID:
Guidelines:
GLP:
Validity:
Materials and Methods
Test item:
Glyphosate acid
Purity:
95.6%
positive
control:
Species:
None
Bobwhite quail (Colinus virginianus)
Age:
Young adults, 30 weeks (at test initiation)
Sex
Males and females
Weight
196 to 250 g (at test initiation)
Source:
K & L Quail, Oroville, CA, 95965, USA
Loading
Approx. 0.138 m2 for 2 birds (1 males and 1 female per pen)
Feed/Diet:
Game bird ration, ad libitum
Acclimation
period:
Temperature:
10 weeks
Humidity:
23.1 ± 1.8°C (adults); 27.3± 1.2°C (hatchling)
38°C (brooding compartment)
66 ± 12% (adults); 40 ± 17% (hatchling)
Photoperiod:
17 hours light / 7 hours dark, (approx. 265 lux), 8 hours light / 16 hours dark (first seven weeks)
Methods:
A reproductive toxicity study was performed by feeding adult bobwhite quail ad libitum on a series
of 3 nominal dietary doses, encompassing 0, 500, 1000 and 2250 mg /kg diet. Sixteen replicates (1
male and 1 female per pen) were used for each treatment group and control. The birds were
exposed to the treated diets for approximately 20 weeks and were evaluated for treatment-related
effects upon bird health and reproduction. Eggs were collected daily and stored at 13.6 ± 0.6°C and
82 ± 8% relative humidity. All eggs laid within a week were considered as one lot and incubated in
a Petersime Incubator. On day 21 of incubation, eggs were placed in a Petersime Hatcher and
allowed to hatch. The hatchlings were maintained on untreated diet until 14 days of age.
Homogeneity of the test substance in treated diets was evaluated by collecting 6 samples of each
treatment group on day 0 of week 1. During weeks 2, 3, 4, 8, 12, 16 and 20 of the test, a single
sample was collected from the control diet and an additional duplicate sample was collected from
treatment group diet, to measure and/ or verify test concentrations.
Adult birds were observed daily for signs of toxicity and abnormal behaviour throughout the study.
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Adult body weight was measured at study initiation and termination, in addition to on weeks 2, 4,
6, and 8. For each pen, food consumption was measured weekly throughout the study except for
the last interval, where food consumption was measured over a 6 day period. At the end of each
week, all collected eggs were counted and a single egg was randomly selected for eggshell
thickness measurements. The remaining eggs were candled to detect egg shell cracks or abnormal
eggs before incubation. During the incubation period, eggs were candled again on day 11 or 12 to
evaluate embryo viability and on day 21 to determine embryo survival. During the study, total egg
production, number of eggs cracked, eggshell thickness, embryo viability, embryo survival,
number of hatchlings, body weight of new hatchlings, body weight of 14 day old hatchlings and
survivorship of 14 day old hatchlings were determined.
An analysis of variance (ANOVA) was used to determine significant differences among the groups
followed by Dunnett’s multiple comparison procedure as the post-hoc test.
Results
Evaluation according to current OECD 206 test validity criteria was performed. According to OECD 206
the age of the test organisms should range between 20-24 weeks.
Adult bobwhite quail birds in the present study were 30 weeks. Moreover, the test guideline recommends
a minimum floor area of pen per pair of 0.25m2, whereas in the present study the loading was 2 birds on
0.138m2, probably leading to unfavorable conditions to test animals. For the test to be valid, the mortality
in the controls should not exceed 10 per cent at the end of the test. At start of week 19, 12 mortalities
occurred, all of which were hens. Of the 12 mortalities, six occurred in the control group and two
occurred in each of the three treatment groups, probably due to limited space leading to stress.
Conclusions
Validity criteria according to OECD 206 were not fulfilled, as the mortality of the control exceeded 10%
at the end of the test. Therefore, the test is considered as not valid. In addition, the minimum floor area of
pen per pair was too small (0.138 instead of 0.25 m2). This minor space could be a reason why six birds
died in the control group and two in each treatment group. The study is not considered to be acceptable
and valid.
KIIA 8.1.4/02
Author:
Title:
Date:
Doc ID:
Guidelines:
GLP:
Validity:
XXX
Glyphosate Acid: A reproduction Study with the Mallard (Anas platyrhynchos)
11.01.1999
2310918 /123-187
FIFRA Guideline 71-4
OECD Guideline 206
YES
YES
Materials and Methods
Test item:
Glyphosate acid
Lot/Batch #:
P24
Purity:
95.6%
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Positive control:
None
Species:
Mallard duck (Anas platyrhynchos)
Age:
21 weeks (at test initiation)
Sex:
Males and females
Weight:
868 to 1259 g (at test initiation)
Source:
Whistling Wing Inc., Hanover, IL 61041-0509, USA
Loading:
Approx. 0.675 m2 for 2 birds (1 males and 1 female per pen)
Feed/Diet:
Game bird ration, ad libitum
Acclimation period:
6 weeks
Temperature:
22.4 ± 0.9°C (adults); 29 °C (hatchling);
38°C (brooding compartment)
Humidity:
69 ± 13% (adults); 61 ± 15% (hatchling)
Photoperiod:
17 hours light / 7 hours dark, (approx. 292 Lux)
Methods:
A reproductive toxicity study was performed by feeding young adult mallard
ducks ad libitum on a series of 3 nominal dietary doses, encompassing 500, 1000,
and 2250 mg glyphosate acid/kg feed. Sixteen replicates (1 male and 1 female per
pen, 16 pen per treatment group) were used for each treatment group and control.
The birds were exposed to the treated diets for approximately 21 weeks, and were
evaluated for treatment-related effects on bird health and reproduction. Eggs were
collected daily, washed and stored in a cold room at 13.6 ± 0.6°C and 82 ± 8%
relative humidity. All eggs laid within a week were considered as one lot and were
incubated in a Petersime incubator. On day 24 of incubation, eggs were placed in a
Petersime hatcher and were allowed to hatch. The hatchlings were maintained on
untreated diet until 14 days of age. Homogeneity of the test substance in treated
diet was evaluated by collecting 6 samples from each treatment group on day 0 of
week 1. During weeks 2, 3, 4, 8, 12, 16 and 20 of the test, a single sample was
collected from the control diet and an additional duplicate sample was collected
from treatment group diet, to measure and/ or verify test concentrations.
Parental birds were observed daily throughout the study for signs of toxicity and
abnormal behavior. Adult body weights were measured at study initiation and
termination in addition to on weeks 2, 4, 6, and 8 of the adult in-life period. For
each pen, feed consumption was measured weekly. At the end of each week, all
eggs collected were counted and selected by indiscriminate draw for eggshell
thickness measurement. The remaining eggs were candled to detect egg shell
cracks or abnormal eggs before incubation. During the incubation period, eggs
were candled again on day 14 to investigate embryo viability and on day 21 to
determine embryo survival.
During the study, total egg production, number of eggs cracked, eggshell
thickness, embryo viability, embryo survival, number of hatchlings, body weight
of new hatchlings, body weight of 14 day old hatchlings and survivorship of
hatchlings after 14 days were determined.
An analysis of variance (ANOVA) was used to determine significant differences
among the groups and Dunnett’s multiple comparison procedure was used as posthoc test.
Results
All validity criteria according to OECD 206 were fulfilled, as the mortality of the control group did not
exceed 10 % at the end of the test and the average number of 14-day-old survivors per hen in the control
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was greater than 14. Also, the average egg shell thickness for the control group was greater than 0.34 and
the lowest treatment level did not result in compound-related mortality or observable toxic effects.
There were no treatment related mortalities at any of the concentrations. However, three incidental adult
mortalities occurred during the course of the study. One incidental mortality occurred in the control group
and in both the 500 and 1000 ppm treatment groups. Except for incidental clinical findings, all birds
appeared normal throuout the study. Clinical sign as lameness and wing droop were observed and
frequently were associated with the incidental injuries.
There were no treatment related effects upon reproductive performance at any of the concentrations
tested. There were no statistically significant differences between the control group and the tratment
groups. However, offspring in the 2250 ppm treatment group did show a slight , but statistically
significant (p<0.05) reduction in the mean body weight of 14-day old survivors when compared to the
control. The mean body weight value for 14 day old survivors in the control group was 262±32g while
mean values for the 500, 100 and 2250 ppm treatment groups were 236g ±35g, 260g ±16g, 235g±23g,
respectively. As especially the parameter concerning hatchling weight were affected at, it cannot be
excluded that the observed changes in hatchling weight do not represent a population relevant adverse
effect. Therefore, this endpoint will be considered as a NOAEL of 1000 ppm, corresponding to
116 mg/kg/bw/d.
Conclusion
Due to significant reduction in mean body weight in the 2250 ppm treatment group in 14-day old
survivors, the NOEL for mallard ducks exposed to glyphosate acid in a reproduction study was
determined to be 1000mg glyphosate acid/kg feed, corresponding to 116 mg/kg/bw/d.
The study is considered valid.
KIIA 8.9.2/01
Reference:
KIIA 8.9.2/01
Report
Friedrich, S.
MON0139 - Sublethal toxicity to the earthworm Eisenia fetida
2311032 /09 10 48 056 S
Guideline(s):
OECD 222 (2004)
Deviations:
No
GLP:
Yes
Acceptability:
Yes
Original study evaluation
No
Test item:
MON 0139 (glyphosate isopropylamine salt)
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Lot/Batch #:
A8B60170S0
Purity:
63.81% w/w glyphosate isopropylamine salt (analysed)
47.28% w/w glyphosate acid equivalent (analysed)
2. Vehicle and/or
positive control:
Species:
None
Earthworm (Eisenia fetida andrei)
Age:
Adults, approx. 3 months old with clitellum
Weight:
304 – 472 mg
Source:
In-house rearing
Food:
Air-dried and finely ground horse manure
Acclimation period:
Approx. 24 hours in the artificial substrate
Temperature:
18.6 – 21.8 ºC
Photoperiod:
16 h light / 8 h dark (600 Lux)
Soil pH:
Soil moisture
content:
6.1 – 6.2 (test start); 6.0 – 6.1 (test termination)
35.1 – 35.2 % (test start); 34.6 – 34.8 % (test termination)
A sublethal test was conducted with five nominal test concentrations of MON 0139, encompassing 30,
50, 100, 500 and 1000 mg test item/kg dry soil, equivalent to an analyzed content of 14.1, 23.6, 47.3, 236,
and 473 mg glyphosate acid equivalent/kg dry soil, respectively. In addition, a control group was exposed
to soil mixed with deionised water only. The test concentrations were prepared by dispersing an exactly
weighed amount of the test item in deionised water (stock solutions) and thereafter diluted to obtain
different test concentrations, which were thoroughly mixed with the artificial soil, achieving desired test
doses with a final nominal water content of 40-60 % of WHC. The artificial soil substrate was composed
of 10% Sphagnum-peat; 20% kaolin clay, 69.5% industrial quartz sand and 0.5% calcium carbonate. Four
replicate test containers (test item) and 8 replicate test containers (control) with 810 g soil wet weight
(corresponding to 600 g dry weight) and 5 cm soil depth were prepared for each treatment group. 10 adult
earthworms per replicate (a total of 40 worms) were exposed for 56 days.
At test initiation, individual fresh weight and behavioral responses of earthworms were recorded.
Behavioral and pathological symptoms including feeding activity were observed on a weekly basis. Four
weeks after test initiation, number of surviving adult earthworms and fresh weight of surviving adult
earthworms per replicate were recorded. At test termination (8 weeks after test initiation), number of
surviving juveniles per replicate, were observed.
The behavioral and pathological symptoms, including morphological alterations were observed 4 and 8
weeks after test initiation. Water content and pH measurements were performed at test initiation and at
test termination. The temperature was continuously recoded throughout the test.
Fisher’s Exact Binomial Test and Dunnett’s t-test were used for mean comparison. For statistical
evaluation of the biomass change, mean fresh weight of surviving worms was used.
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The validity criteria according to guideline OECD 222 are fulfilled as each replicate (containing 10
adults) has produced ≥ 30 juveniles by the end of the test in the control and the coefficient of variation of
reproduction was ≤ 30 % in the control. Also, the adult mortality over the initial 4 weeks of the test was ≤
10 % in the control.
Lethal and sublethal effects of MON 0139 (glyphosate isopropylamine salt) on earthworms
MON 0139 (mg test item/kg dry soil)
Mortality of adult worms after 4 weeks (%)
Control
0
30
0
50
2.5
100
2.5
500
0
1000
0
Mean biomass change (%)
40.7
46.7
39.8
41.8
37.5
36.3
Juveniles after 8 weeks (mean No.)
79.0
78.5
83.8
71.8
80.3
74.3
CV (%)
18.7
19.1
15.0
34.1
28.7
22.1
Change of reproduction compared to control (%)
Test item (MON 0139)
EC50
glyphosate isopropylamine salt
Test item (MON 0139)
NOEC
glyphosate isopropylamine salt
0.6
-6.0
> 1000 mg/kg dry soil
> 638.1/kg dry soil
1000 mg/kg dry soil
638.1/kg dry soil
9.2
-1.6
6.0
The test item MON0139 (glyphosate isopropylamine salt) caused no mortality at concentrations of 30,
500 and 1000 mg MON 0139/kg dry soil. No mortality occurred in the control group. At 50 and 100 mg
MON 0139/kg dry soil, 2.5 % mortality was observed. No effects on behavior (including feeding activity)
of the worms were observed during the test. The test item caused no statistically significant change in
biomass (change in fresh weight after 4 weeks relative to initial fresh weight) when compared to the
control.
Conclusion
The study is considered to be valid and acceptable. The relevant NOEC for earthworms determined in this
study is 1000 mg MON 0139 /kg dry soil, equivalent to 473 mg glyphosate acid equivalent/kg dry soil.
The EC50 of MON 0139 for earthworm was determined to be > 1000 mg test item/kg dry soil, equivalent
to > 473 mg glyphosate acid equivalent/kg dry soil.
K IIA 5.6 Effects on Terrestrial Vertebrates Other than Birds
KIIA 5.6.11/09
The following evaluation originates from the first draft (August 2013) of BfR RAR, Vol.3, B.6.6.:
Reference:
KIIA 5.6.11/09
Report
XXX (1996)
Glyphosate technical: Oral gavage teratology study in the rabbit
434/020/ASB2012-11499
BVL: 2309448
Guideline(s):
OECD 414 (1981), JMAFF 59 NohSan 4200 (1985), US-EPA 83-3 (1984)
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GLP:
Please refer to comment by RMS in the RAR, Vol.3, B.6.6.
Acceptability:
Please refer to comment by RMS in the RAR, Vol.3, B.6.6.
Identification:
Lot/Batch #:
Purity:
Stability of test
compound:
Vehicle and/
or positive control:
Test animals:
Species:
Strain:
Source:
Age:
Sex:
Weight at dosing:
Acclimation period:
Diet/Food:
Water:
Housing:
Environmental
conditions:
Glyphosate technical
H95D161A
95.3%
not reported
1% carboxymethyl cellulose
Rabbit
New Zealand White
Charles River (UK) Ltd., Margate, Kent, UK
17 - 19 weeks
Females (time-mated)
2.2 - 4.1 kg
At least 4 days
SQC Standard Rabbit Diet (SDS Ltd., Witham, Essex, UK), ad libitum
Tap water, ad libitum
Individually in stainless steel cages with grid floor
Temperature:
20 ± 3°C, Humidity:
50 ± 20% ,Air changes: 15/hour , 12
hours light/dark cycle
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Methods:
Animal assignment and treatment in the preliminary study:
Twenty-four time-mated females were supplied. Sexually mature, virgin females were paired
with stud males. The day of copulation was designated Day 0 of gestation. The females were
delivered to Safepharm Laboratories Ltd. at or before Day 3 of gestation and were allocated
randomised to treatment groups. Groups of 6 mated New Zealand white female rabbits received
0, 50, 200 or 400 mg/kg bw/day test substance in 1% carboxymethyl cellulose by gavage (5
mL/kg bw) from gestation Day 7-19. The dose levels were chosen based on results of a
preliminary dose finding study with 6 female nulliparous rabbits, where administration of 500
or 1000 mg/kg bw resulted in toxicity signs (scours, fluid filled caecum, stomach ulceration,
body weight loss, reduced food consumption). Based on these findings dose levels of ≥ 500
mg/kg bw were considered to be too high for a prolonged study.
Animal assignment and treatment in the main study:
Seventy-two time-mated females were supplied as described for the preliminary study (see
above). Groups of 18 mated New Zealand white female rabbits received 0, 50, 200 or 400
mg/kg bw/day test substance in 1% carboxymethyl cellulose by gavage (5 mL/kg bw) from
gestation Day 7-19.
Dose formulation and analysis:
For each dose level, the test material was suspended daily in 1% carboxymethyl cellulose by
weighing the required amount into a glass jar and adding vehicle to make the appropriate final
volume. Homogeneity was assured by mixing the formulation with a homogeniser. The
concentration, stability and homogeneity of the test material were analyzed. The formulation
was stable for at least 1 h.
Clinical observations:
A check for clinical signs of toxicity, ill-health or behavioural changes was made once daily
during the pre- and post-dosing periods and twice daily (before and after dosing) during the
dosing period.
Individual body weights were recorded on Day 3, 7, 10, 13, 16, 19, 22, 25 and 29 of
gestation.
Food consumption of females was recorded on Days 3 to 7, Days 7 to 10, Days 1013, Days 13-16, Days 16-19, Days 19-22, Days 22-25 and Days 25-29 of gestation.
Sacrifice and pathology:
Females were euthanatized by an i.v. injection of an overdose of sodium pentobarbitone into
the auricular vein on Day 29 of gestation, examined for macroscopic abnormalities and
subjected to caesarean sectioning. The ovaries and uteri were removed, weighed and then
examined for the number of corpora lutea and for the number and position of implants and dead
or live foetuses. Resorptions and foetal deaths were classified into implantation sites, placental
remnants, and macerated foetuses according to the difference in developmental stage at which
deaths had occurred. After examination of the ovaries and conceptuses, each female was
necropsied.
Developmental parameters:
The foetuses were killed by intrathoracic injection of sodium pentobarbitone. All foetuses were
dissected and examined for visceral abnormalities macroscopically. The heads of alternate
foetuses were removed and identified using an indelible marker and placed in Bouin‘s fixative.
After a minimum of 14 days, the heads were transferred to 90% industrial methylated spirits
(IMS) in distilled water and examined for visceral anomalies under a low power binocular
microscope. All foetuses were identified using colour coded wires and placed in 70% IMS in
distilled water. The foetuses were eviscerated, processed and the skeletons stained with alizarin
red.The foetuses were examined for skeletal development and anomalies.
Statistics in the main study
Female bodyweight change (relative to Day 7 of gestation) and food consumption were
analysed statistically by one-way analysis of variance with the Bonferroni multiple comparison
test followed by pair wise analysis of control values against treated group values using Students
‘t‘ test where appropriate.
All foetal parameters, skeletal development, group incidence of specific visceral and
skeletal anomalies were analysed statistically by Kruskall-Wallis non parametric analysis of
variance followed by pair wise analysis of control values against treated values using the
Mann-Whitney U - test where appropriate.
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Results
Analysis of dose formulations
The test substance was detected at the levels of 81-102% of the target concentrations in each dosing
solution.
Food consumption
In the preliminary study, significantly reduced food consumption was observed while administering in the
high dose level of 400 mg/kg/day (Days 7 to19 of gestation). This observation was confirmed in the main
study. At the high dose level, there was a reduction in food consumption during the dosing period
compared to controls (Days 10 to 13, p < 0.05; Days 13 to 19, p < 0.01). No other significant changes
were observed in the remaining groups during the main study.
Mortality
In the preliminary study, two does were killed in extremis in the high dose group, one had aborted
foetuses and the other was bleeding from the vagina. No mortalities occurred at any dose up to 400
mg/kg/day in the preliminary study.
In the main study, two rabbits were found dead or moribund at the high dose level. One female was found
dead prior to dosing on Day 19 of treatment. One female was killed in extremis on Day 20 of treatment.
Clinical observations noted at this time included hunched posture, lethargy, ptosis, hypothermia and
blood on the litter tray. At the intermediate dose level, one female was found dead after dosing on Day 16
of treatment. Necropsy findings of reddened lungs, a fluid filled thorax and test material in thoracic cavity
are consistent with mal-dosing. At the low dose level, no mortalities occurred. One female was found
dead two minutes after dosing in the control group. Necropsy findings of blood in thorax, inflated
appearance of lungs and a large area of congestion on the right caudal lobe are consistent with maldosing.
Clinical Observations
In both the preliminary and the main study, the clinical signs were in general the same. There was a
toxicologically significant increase in the incidence of clinical observations, particularly scours, reduced
faecal output and diarrhoea at the high dose level (400 mg/kg bw/day). Observations of lethargy, ptosis,
hunched posture, hypothermia and blood on tray were noted for one animal of the main study killed in
extremis.
At 200 mg/kg bw/day, vaginal bleeding and blood on tray were noted for one animal of the main study.
Scours were also noted in animals at 200 and 50 mg/kg bw/day as well as in the control group, but the
incidence and duration were not as severe as at the high dose level (see Table). No other treatment-related
observations were evident.
Thus, for the findings observed at doses below 400 mg/kg bw/day, a clear dose-response could not be
established.
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Table:
Observed clinical signs during the dosing period
Number of rabbits affected in dose group#
Clinical sign
Control
Low
Intermediate
High
(0 mg/kg/day)
(50 mg/kg/day)
(200 mg/kg/day)
(400 mg/kg/day)
Scours
5/14 (4)
10/18 (0)
7/16 (2)
16/16 (2)
Reduced faecal output
0/14 (4)
1/18 (0)
2/16 (2)
2/16 (2)
Diarrhoea
0/14 (4)
1/18 (0)
0/16 (2)
10/16 (2)
Diuresis
0/14 (4)
0/18 (0)
1/16 (2)
0/16 (2)
Blood on tray
0/14 (4)
0/18 (0)
1/16 (2)
1/16 (2)
Noisy respiration
0/14 (4)
0/18 (0)
1/16 (2)
1/16 (2)
Lethargy
0/14 (4)
0/18 (0)
0/16 (2)
1/16 (2)
Ptosis
0/14 (4)
0/18 (0)
0/16 (2)
1/16 (2)
Hunched posture
0/14 (4)
0/18 (0)
0/16 (2)
1/16 (2)
Hypthermia
0/14 (4)
0/18 (0)
0/16 (2)
1/16 (2)
Anal staining
0/14 (4)
0/18 (0)
0/16 (2)
1/16 (2)
Subdued behaviour
0/14 (4)
0/18 (0)
0/16 (2)
1/16 (2)
Vaginal bleeding
0/14 (4)
0/18 (0)
1/16 (2)
0/16 (2)
#
x/y: number affected / total number of animals in group
Figures in parentheses represent the number of animals having no grossly observable conceptus.
Body weight
In the preliminary, study a toxicologically significant decrease in body weight gain from Day 13 to 19
post coitum was evident at the high and intermediate dose levels.
Likewise a reduction in group mean bodyweight gain from Days 9 to 29 post coitum was observed in the
high dose level group during the main study. The difference in group mean bodyweight change compared
to controls was statistically significant (P<0.05 to 0.01) from Days 13 to 29 post coitum. Also in the
intermediate dose level group a slight reduction (although not statistically significant) in group mean
bodyweight gain from Day 9 to Day 29 post coitum was noted. In the low dose level group bodyweight
gain was comparable to controls throughout the study period (see Table).
Table:
Mean body weight gain during gestation
Dose level
No. of
Body weight change (g) at Day (relative to Day 7)
(mg/kg bw)
animals
10
13
16
19
22
25
0 (Control)
14
29
95
202
260
314
375
50
18
12
75
158
223
278
325
200
15
-11 54
143
198
263
309
400
15
-33 -45*
11**
21**
96**
153**
* Significantly different from control at p < 0.05.
** Significantly different from control at p < 0.01.
29
409
395
294
250*
Pathology, Necropsy
The macroscopic necropsy findings of the two does of the high-level dose group that died or were killed
in extremis included fluid filled large intestines, haemorrhage, ulceration and sloughing of the stomach,
duodenum congested and colon, rectum and appendix gas distended. These findings indicate that the test
material may affect the gastrointestinal tract. The animal killed in extremis at this level also had both
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uterine horns containing blood and dead foetuses in the uterus. This may be a result of maternal toxicity.
All other necropsy findings were not treatment-related.
Observations on the ovary and uterus
No treatment related effects were evident in both the preliminary and the main study.
In the control, low, intermediate and high dose level groups 14, 18, 16, and 16 females, respectively,
survived to termination of the main study and were proven to be pregnant. The number and distribution of
females that were not pregnant indicate that there were no treatment-related effects on pregnancy rates.
Litter size at caesarean necropsy was comparable in all treatment groups.
Developmental parameters
Number and viability of foetuses
The litter size at caesarean section was comparable in all treatment groups. In the high dose level group,
there were slight, but not statistically significant, increases in late foetal deaths and post implantation loss,
mainly due to one animal that had nine late deaths, resulting in a post implantation loss of 69.2%. This
was therefore considered not to be a treatment-related effect. At 200 mg/kg bw/day, there were
statistically significant increases (p<0.05) in total foetal deaths and post implantation loss. These
increases were caused by a slight, but not statistically significant, rise in early foetal deaths. As at this
dose level, there was no rise in late foetal deaths, as seen at the high level; the effect on early foetal deaths
was considered not to be treatment-related.
Foetal body weights
No statistically significant differences were noted in the mean foetal body weights between the control
group and the treated groups. Mean total litter weights were comparable in all treatment groups.
External, visceral and skeletal examination
At the high dose level, there was one litter with one foetus with major malformations. This foetus was
found to have spina bifida and clubbed and malrotated hind limbs. At the intermediate dose level, two
foetuses of two different litters had major malformations. One foetus had retinal infolding and a
haemorrhage in the retinal layer, the other acephaly, small kinked tail, bilateral forelimb flexure,
interrupted aorta and an intraventricular septal defect. At skeletal examination, this foetus was found to
have multiple rib and vertebral column abnormalities. At the low dose level, three foetuses of two
different litters had major abnormalities. In one litter, one foetus had forked ribs with a displaced
vertebral centrum. In another litter, one foetus had a small eye with retinal infolding and aphakia. A
second foetus from this litter had nostrils close together, and a thin nasal septum not attached at posterior
pole near the front of the nasal passages. In the control group, there were two foetuses from two different
litters with major abnormalities. One foetus had gastroschisis and the other foetus had an extra vertebral
arch resulting in scoliosis.
These findings were considered to be within the range of normal variation for this species. There were no
treatment-related effects on the degree of skeletal development.
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Table:
Incidence of foetal malformations and variations in rabbits treated with glyphosate acid
Foetal findings
No. of litters examined
No. of foetuses examined
Skeletal malformations
Total no. of foetuses with skeletal malformations
Total no. of litters with skeletal malformations
Percentage of litters with skeletal malformations (%)
Skeletal variations
Total no. of foetuses with skeletal variations
Total no. of litters with skeletal variations
Percentage of litters with skeletal variations (%)
External and visceral findings
No. of litters examined
No. of foetuses examined
No of litters with anomalous foetuses
Percentage of litters with anomalous foetuses (%)
No. of litters with major malformations
Percentage of litters with malformed foetuses (%)
Dose level (mg/kg bw/day)
0
50
200
14
18
15
128
157
119
400
15
134
1
1
7.1
0
0
0.0
1
1
6.7
0
0
0.0
43
13
92.8
48
18
100
39
15
100
49
15
100
14
128
2
14.3
2
14.3
18
157
5
27.8
2
11.1
15
119
2
13.3
2
13.3
15
134
3
20
1
6.7
Conclusion by the Notifiers
The oral administration of glyphosate technical to pregnant rabbits by gavage from gestation Day 7-19
resulted maternal toxicity at 400 mg/kg bw/day. There were no treatment-related effects on pregnancy or
foetuses at any dose level. Therefore the ‘No Observed Adverse Effect Level’ (NOAEL) was considered
to be 200 mg/kg bw/day for maternal toxicity. The ‘No Observed Adverse Effect Level’ (NOAEL) for
developmental toxicity was considered to be 400 mg/kg bw/day.
Comment by RMS:
The study is considered acceptable. The NOAEL of 200 mg/kg bw/d for maternal toxicity is not supported.
The NOAEL is considered to be 50 mg/kg bw/d due to slight reduction in body weight gain at 200 mg/kg
bw/d.
The NOAEL of 400 mg/kg bw/d for developmental toxicity is neither supported. The NOAEL is considered
to be 50 mg/kg bw/d due to significantly increased post-implantation loss at 200 mg/kg bw/d. The
statement, that this increase was caused by a slight rise in early foetal deaths and not in late foetal
deaths, as seen at the high dose level and therefore considered not to be treatment-related, cannot be
followed, because there is no information given regarding the mechanism behind this foetal deaths. Due
to some reporting deficiencies, it remains unclear, whether the heart was part of visceral examination.
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KIIA 10.8 Effects on Non-Target Plants
KIIA 8.1.1
Terrestrial plants
IIA 8.1.1.2 Vegetative vigour
Reference:
KII8
Report
Chetram, R.S., Lucash, K.J. (1994). Tier 2 vegetative vigor non-target
phytotoxicity study using glyphosate. Monsanto report no. MSL-13320.
Guideline(s):
USEPA subdivision J, Guideline 123-1 (b).
Deviations:
From USEPA subdivision J, Guideline 123-1 (b): Greenhouse temperature
exceeded the 18 - 35°C range specified in the protocol on several occasions from
June to September. The study was not affected as plants exhibited normal growth.
Also, trays containing pots were not rotated as indicated in the protocol because the
drip system tubes did no allow for this. Artificial light was supplied as needed to
enhance growth. These deviations were not considered to have affected the
outcome of the study.
GLP:
YES
Acceptability:
Yes
Original study evaluation of the applicant was acceptable without any correction by
the zRMS and therefore no commenting box is necessary]
A Tier 2 vegetative vigour study using glyphosate acid and a non-ionic surfactant was conducted on 6
dicotyledonous and 4 monocotyledonous species: soybean, lettuce, radish, tomato, cucumber, cabbage,
oat, ryegrass, corn and onion. The test material was applied to plants at the 1 to 3 leaf stage at rates
ranging from 0.078 to 5.04 kg a.s./ha. Radish and tomato were also tested at 5 additional rates ranging
from 0.005 to 0.078 kg a.s./ha. Phytotoxicity observations were recorded on at 7, 14 and 21 days after
treatment. Dry weight and plant height were determined 21 days after treatment. The most sensitive
species tested were tomato and radish.
The most sensitive species tested were tomato and radish. Based on EC50 data, the most sensitive
parameter among those analysed was dry weight, with EC50 values of 0.146 kg a.s./ha for tomato and
0.246 kg a.s./ha for radish. Results for phytotoxicity, survival, plant height and plant dry weight are
summarised in Table 10.8-1. EC50 values were calculated based on regression analysis conducted on
percent effect data (untransformed) that exhibited a definite dose-response. Measured glyphosate
concentrations in the dosing solutions were between 100 - 107% of nominal values, so endpoint
calculations were based on nominal values.
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Table A 2:
Crop
Ryegrass
Corn
Onion
Oat
Soybean
Lettuce
Cucumber
Cabbage
Radish
Tomato
NOEC
1.232
0.627
5.040
2.576
5.040
1.232
2.576
1.232
0.314
0.314
Survival
EC50
4.592
1.680
> 5.040
> 5.040
> 5.040
2.800
4.032
4.592
0.918 a
0.515 a
Endpoint (kg a.s./ha) at Day 21
Plant height
NOEC
EC50
0.627
2.352
0.627
0.918
0.627
> 5.040
0.627
1.344
0.627
1.568
0.627
1.344
0.314
1.456
0.627
1.456
0.078
0.358 a
0.039
0.336 a
Plant dry weight
NOEC
EC50
0.627
1.344
0.627
0.750
0.627
1.792
0.157
0.874
0.314
0.974
0.314
0.762
0.314
0.896
0.157
0.739
0.039
0.246 a
0.039
0.146 a
Conclusion
After exposure to glyphosate applied post-emergence, the most sensitive species tested were tomato and
radish. Based on EC50 data, the most sensitive parameter among those analysed was dry weight, with
EC50 values of 0.146 kg a.s./ha for tomato and 0.246 kg a.s./ha for radish.
A2-2 Formulation
MIII A 10.2 Effects on Aquatic Organisms
MIIIA1 10.2.2
IIIA 10.2.2.1/01 Fish
The following fish acute toxicity studies performed with MON 52276 are provided in support of the
assessment.
Reference:
IIIA 10.2.2.1/01
Report
XXX, 1992
MON 52276: Acute toxicity to rainbow trout, Oncorhynchus mykiss, under flowthrough test conditions
Toxicon Environmental Sciences, Jupiter, Florida 33477, USA
Date: 1992-01-23
GLP: yes
not published
Guideline(s):
US EPA FIFRA 72-1 (1982), OECD 203, and EEC Method C.1.
Deviations:
The pH of the test system was correlated with MON 52276 concentration,
and varied by more than 1 unit across the 5 dose levels. Within each test
concentration, the pH variation was less than one unit. The range of
temperature during the test was 2.3 ºC, rather than the maximum range of
2 ºC specified in the guideline. The dissolved oxygen concentration during
the holding period was not reported. Fish length ranged from 3.1 – 4.1
cm, outside the recommended length of 4.0 – 8.0 cm. Fish were not
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inspected after the first 2 to 4 hours of the test. These deviations were not
considered to have affected the outcome of the study.
GLP:
YES
Acceptability:
YES
original study evaluation of the applicant was acceptable
The effects of MON 52276 (31% glyphosate acid) on rainbow trout (Oncorhynchus mykiss) were
evaluated in a 96-hour flow-through toxicity test. Two groups of ten fish each were exposed for 96 hours
to nominal concentrations of MON 52276 at 0 (controls), 130, 216, 360, 600 and 1000 mg/L. The test
water was a blend of treated municipal water and treated well water. Mortality and signs of toxicity were
recorded at 24, 48, 72 and 96 hours after test initiation.
Mortality to one fish was observed at the lowest test concentration (119 mg/L), but it was judged to be not
treatment-related. No mortality was observed at the higher test concentrations. No sublethal effects were
observed at any test concentration. The present study is considered valid according to OECD guideline
203.
Conclusion
Based on mean measured concentrations, the 96-hour LC50 for rainbow trout (Oncorhynchus mykiss)
exposed to MON 52276 in a flow-through test system was > 989 mg/L (> 306 mg a.s./L). The
corresponding no observed effect concentration (NOEC) was 989 mg/L (306 mg a.s./L), based on the
absence of mortality and abnormal sublethal effects at this concentration.
Comments of zRMS [Commenting box]
Study Comments:
Study is considered acceptable .
Agreed Endpoints:
LC50 > 989 mg/L (> 306 mg a.s./L).
IIIA 10.2.2.1/02 Fish
Reference:
IIIA 10.2.2.1/02
Report
XXX, 1992
MON 52276: Acute toxicity to the common carp, Cyprinus carpio, under flowthrough test conditions.
Toxicon Environmental Sciences, Jupiter, Florida 33477, USA
Date: 1992-01-24
GLP: yes
not published
Guideline(s):
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Deviations:
Yes:
For an estimated period of 4-6 hours, beginning at 8 hours prior to test termination,
only dilution water was delivered to test chambers due to a malfunction in the
diluter system. Test fish were exposed to nominal test concentrations for
approximately 88 hours, followed by a slow dilution of test concentration for 4
hours, and then the exposure was adjusted to nominal concentrations for the
remaining 4 hours of the test. Since there were no indications of stress or any other
effects, it is unlikely that the reduction in exposure concentration for this short
period had any effect on the outcome of the test. The pH of the test system was
correlated with MON 52276 concentration, and varied by more than 1 unit across
the 5 dose levels. Within each test concentration, the pH variation was less than one
unit. The temperature range during the test was 2.1 ºC, rather than the maximum
range of 2 ºC specified in the guideline. The dissolved oxygen concentration during
the holding period was not reported. During the test period, the dissolved oxygen
during the test fell below 60% of the air saturation value in at least one replicate at
every dose level and in both replicates at the two highest dose levels; the fish did
not appear stressed as a result. Fish length ranged from 2.7 – 5 cm, outside the
recommended length of 4.0 – 8.0 cm. Fish were not inspected after the first 2 to 4
hours. These deviations were not considered to have affected the outcome of the
study.
GLP:
Yes
Acceptability:
Yes
original study evaluation of the applicant was acceptable, corrections see
commenting box.
The effects of MON 52276 (31% glyphosate acid) on common carp (Cyprinus carpio) were evaluated in a
96-hour flow-through toxicity test. Two groups of ten fish each were exposed for 96 hours to nominal
concentrations of MON 52276 at 0 (controls), 130, 216, 360, 600 and 1000 mg/L. The test water was a
blend of treated municipal water and treated well water.
Mortality and signs of toxicity were recorded at 24, 48, 72 and 96 hours after test initiation.
The mean measured concentrations during the 96-hour exposure ranged from 98 to 895 mg test item/L
and from 75 to 90% of nominal.
Mortality to one fish was observed at the lowest test concentration (119 mg/L), but it was judged to be not
treatment-related. No mortality was observed at the higher test concentrations. No sublethal effects were
observed at any test concentration.
Conclusion
Based on mean measured concentrations, the 96-hour LC50 for common carp (Cyprinus carpio) exposed
to MON 52276 in a flow-through test system was > 895 mg/L (> 277 mg a.s./L). The corresponding no
observed effect concentration (NOEC) was 895 mg/L (277 mg a.s./L).
Comments of zRMS :
Study Comments:
Study does not fullfill the validity criteria concerning the oxygen
saturation to be 60% of the air saturation. Nevertheless, zRMS does not
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consider these deviations to have affected the outcome of the
study.Study is considered acceptable.
Agreed Endpoints:
LC50 > 895 mg/L (> 277 mg a.s./L).
IIIA 10.2.2.2/01 Aquatic invertebrates (Daphnia)
The following aquatic invertebrate toxicity study performed with MON 52276 is provided in support of
the assessment.
Reference:
IIIA 10.2.2.2
Report
Lintott, D.R.,1992
MON 52276: Acute toxicity to the water flea, Daphnia magna, under flow-through test
conditions
ToxiKon Environmental Sciences, Jupiter, Florida, USA
Date: 1992-01-23
GLP: yes
Not published
Guideline(s):
Deviations:
The pH of the test system was correlated with MON 52276 concentration, and varied
by more than 1 unit across the 5 dose levels. Within each test concentration, the pH
variation was less than one unit. The temperature range during the test was 3.8 ºC,
rather than the maximum range of 2 ºC specified in the guideline. These deviations
were not considered to have affected the outcome of the study
GLP:
Yes
Acceptability:
Yes
Original study evaluation of the applicant was acceptable. Corrections see commenting
box.
The effects of MON 52276 (30.95% w/w glyphosate acid) on Daphnia magna were evaluated in a 48hour flow-through toxicity test. Neonates of Daphnia magna were exposed to nominal concentrations of
MON 52276 at 130, 216, 360, 600, and 1000 mg/L and a negative control consisting of dilution water.
The test consisted of two replicates per treatment group and control. 10 daphnids were exposed per
replicate and were not fed during the test. Total number of Daphnia magna exhibiting immobility and
other clinical signs of toxicity was recorded at 24 and 48 hours after test initiation.
Temperature, pH values and dissolved oxygen concentrations were measured at the beginning, at
approximately 24 hours during the test and at the end of the test. At 0 and 48 hours, samples of test
medium were taken for quantification of glyphosate by HPLC. The analysed test concentrations ranged
between 95 and 105% of the nominal values.
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The analysed test concentrations ranged between 95 and 105% of the nominal values. No mortality to
Daphnia magna from exposure to MON 52276 was observed at test concentrations < 356 mg/L. At 580
mg/L, 20% mortality was observed at 48 hours, with 100% mortality observed at 948 mg/L. Sublethal
effects were observed only at the 580 mg/L concentration. After 48h the pH dropped from initial 8.3 to
5.8. These deviations were not considered to have affected the outcome of the study
Conclusion
Based on mean measured concentrations, the 48-hour EC50 for Daphnia magna exposed to MON 52276
in a flow-through test system was calculated to be 676 mg/L (equivalent to 209 mg a.s./L). The
corresponding no observed effect concentration (NOEC) was 356 mg/L (110 mg a.s./L), based on the lack
of mortality and sublethal effects at this concentration.
Comments of zRMS:
Study Comments:
Study does formally not fullfill the validity criteria concerning the pH.
The pH decrease correlated to increasing test concentrations due to the
intrinsic characteristics of the test item to be an acid. These deviations
were not considered to have affected the acceptability of the study.
Agreed Endpoints:
48-hour EC50 = 676 mg/L (equivalent to 209 mg a.s./L).
IIIA 10.2.2.3 Algae
The following algae toxicity study performed with MON 52276 is provided in support of the assessment.
Reference:
IIIA 10.2.2.3
Report
Neven, B., 1992
A1ga, Growth Inhibition Test Effect of MON 52276 on The Growth Of
Selenastrum capricornutum
LISEC, B-3600 Genk Belgium
Report No: LI-91-389
Date: 1992-01-10
GLP: yes
Not published
Guideline(s):
OECD Guideline 201 (2006)
Deviations:
No analysis of glyphosate in the test system was conducted. However,
no degradation of glyphosate is expected to have occurred over the
course of the study, since glyphosate concentrations have been
demonstrated to be stable over a 72-hour period in other formulation
studies. The pH of the test system was correlated with MON 52276
concentration, and varied by more than 1.5 units across the 5 dose
levels. Within each test concentration, the pH variation was less than
1.5 units. These deviations were not considered to have affected the
outcome of the study.
GLP:
Yes
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Acceptability:
Yes
Original study evaluation of the applicant was acceptable without any
correction by the zRMS.
The effects of the test item MON 52276 on Pseudokirchneriella subcapitata (formerly named
Selenastrum capricornutum) were evaluated in a 72-hour static toxicity test. After a range-finding test
suspensions of Pseudokirchneriella subcapitata were exposed to five nominal concentrations (50, 90,
160, 290 and 500 mg test item/L). In addition, algae were exposed to test medium without test substance
(negative control).
For each concentration, three replicates with an initial cell density adjusted to 104 cells/mL were prepared.
For the control group, six replicates were prepared. The culture vessels were incubated on a shaking plate
over several generations for 72 h. After 24, 48, and 72 hours, mean cell densities for each test
concentration and control were determined based on spectrophotometrical measurements and direct cell
counts. The inhibition of cell growth and reduction of cell growth rate were thereafter calculated. The
concentrations resulting in 50% reduction of growth rate (ErC50) and 50% inhibition of cell growth
(EbC50) were determined, as well as the associated NOEC values.
Based on absorbance, the 72 h ErC50 and the 72 h EbC50 for Pseudokirchneriella subcapitata exposed to
MON 52276 were calculated to be 393 mg test item/L and 150 mg test item/L, equivalent to 121.8 mg
glyphosate acid/L and 46.5 mg glyphosate acid/L, respectively. The NOEC was determined to be 90 mg
test item/L equivalent to 27.9 mg glyphosate acid/L. For the cell counting method, the 72 h ErC50 and the
72 h EbC50 for Pseudokirchneriella subcapitata exposed to MON 52276 were calculated to be 284 mg
test item/L and 178 mg test item/L, equivalent to 88 mg glyphosate acid/L and 55.2 mg glyphosate acid/L
respectively. The NOEC was determined to be 90 mg test item/L equivalent to 27.9 mg glyphosate
acid/L.
Table A 3:
Percentage reduction of growth rate and inhibition of cell growth of Pseudokirchneriella
subcapitata exposed for 72 hours to MON 52276
MON 52276 [mg/L]
Control
50
90
160
290
500
Glyphosate acid [mg a.s./L]
-
15.5
27.9
49.6
89.9
155
Mean cell densities
[x 1000 cells/mL]
644
741
663
315
45
33
Cell growth rate reduction
[%]
--
-13.6
-8.4
10.9
42.8
58.2
Cell growth inhibition
[%]
--
-36.9
-27.7
50.3
81.5
89.6
The cell density decreased continuously as the test concentrations increase, reaching 33 x 103 cells/mL at
the highest test concentration, against 644 x 103 cells/mL observed in the blank control. The mean cell
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numbers observed for the two lowest test concentrations were numerically higher that those observed in
control.
Inhibition of cell growth increased with increasing concentration of MON 52276 from a nominal
concentration of 160 mg test item/L upwards. For the two lowest test concentration of 50 mg test item/L
and 90 mg test item/L, increases in cells growth of 36.9% and 27.7%, respectively, compared to the
control were observed.
Reduction of algal growth rate increased with increasing concentration of MON 52276 from a nominal
concentration of 160 mg test item/L upwards. For the two lowest test concentration of 50 mg test item/L
and 90 mg test item/L, increases of algal growth rate of 13.6% and 8.4%, respectively, compared to the
control were observed.
Conclusion
Endpoint
MON 52276 [mg/L]
Glyphosate acid [mg a.s./L]
absorbance
cell counting
absorbance
cell counting
ErC50 (72 hours)
393
284
121.8
88.0
EbC50 (72 hours)
150
178
46.5
55.2
NOEC (72 hours)
90
27.9
Based on nominal concentrations, the 72-hour ErC50 (growth rate) and EbC50 (biomass) of MON 52276
to Pseudokirchneriella subcapitata under static test conditions were determined to be 284 mg/L
(87 mg a.s./L) and 178 mg/L (55 mg a.s./L), respectively. The corresponding 72-hour no observed effect
concentration (NOEC) for both parameters was 90 mg/L (28 mg a.s./L).
Study Comments:
Study is acceptable.
Agreed Endpoints:
ErC50 = 284 mg/L (87 mg a.s./L)
MIII A 10.4 Effects on Bees
Reference:
IIIA 10.4.2.1
Report
Baxter, I., 2001
Laboratory bioassays to determine acute oral and contact toxicity of MON
52276 to the honeybee, Apis mellifera
Mambo-Tox Ltd, Bassett Crescent East, Southampton S016 7PX, UK
Report No: MON-00-2 version 2
Date: 2001-01-08
GLP: yes
not published
Guideline(s):
OECD Guidelines 213 (1998) and 214 (1998)
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Deviations:
In the oral test, the bees were deprived of food for 3-4 hours, instead of the 2
hours as specified in the guideline. The range of relatively humidity of the test
chamber was larger than the guideline-recommended range of 60 – 70%. The
condition of the bees in the control treatment indicated that these minor
deviations from the protocol did not affect the survivor ship of the bees.
GLP:
Yes
Acceptability:
Please refer to JKI-report
Yes
Study Comments:
Agreed Endpoints:
MIII A 10.5 Effects for Arthropods
IIIA 10.5.1 Laboratory studies
Please refer to Glyphosate Monograph
IIIA 10.5.2/01
Extended laboratory studies
Reference:
IIA 10.5.2/01
Report
Fallowfield, L.,2010
An extended laboratory bioassay of the effects of MON 52276 on the
predatory mite, Typhlodromus pyri (Acari: Phytoseiidae)
Mambo-Tox Limited, 2 Venture Road, Chilworth Science Park, Southampton
SO16 7NP, UK
Report No: MT-2009-404
Date: 2010-04-27
GLP: yes
Guideline(s):
IOBC/BART/EPPO (Blümel et al., 2000)
Deviations:
It was intended that the bioassay would take place in a cabinet maintained at
60-90% RH, although minor fluctuations outside of these parameters for
periods of <2h were con to be considered as deviations (according to the
guideline of Blümel et al., 2000). However, in the range-finding bioassay the
ambient conditions actually recorded were 51.9%-61.4% RH. These deviations
were due to inadequate control being achieved by the cabinet. Since all
treatments were exposed to similar conditions (and this was in the rangefinding bioassay), it was considered that this deviation did not affect the
outcome of the bioassay, nor the integrity of the study.
GLP:
Yes
Acceptability:
Yes
revised by zRMS
Original study evaluation of the applicant was acceptable. Corrections/Comments see
commenting box.
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The toxicity of MON 52276 to the predatory mite (Typhlodromus pyri) was determined in an extended
laboratory test. MON 52276 was evaluated at five rates, equivalent to 16000, 12000, 8000, 6000, 3000
mL formulation/ha (nominally 5760, 4320, 2880, 2160, and 1080 g a.s/ha). These were compared to a
control treatment of deionised water (negative control) and a toxic reference treatment of BASF
Perfekthion (nominally 400 g/L dimethoate) applied at a rate of 30 mL formulation/ha (nominally 12 g
a.s./ha). Treatments were applied to 5-cm-diameter leaf discs (n = 3 per treatment) cut from French bean
plants (Phaseolus vularis L.). Once residues had dried, a ring of sticky gel was drawn on each of the leaf
discs to create arenas in which mites were then confined. Twenty protonymphal T. Pyri were placed in
each replicate unit, with three replicates (i.e., 60 mites) prepared per treatment. The mites were provided
daily with untreated almond and apple pollen for food and their survival was assessed at 1 and 7 days
after treatment, by which time they were adult. Assessments were then made of the reproductive capacity
of the mites surviving in the control treatment and in all test item treatments in which < 50% corrected
mortality had been observed. The sex of the mites was determined and they were left on the leaf discs,
with untreated pollen being provided for food daily. Egg production was assessed at 10, 13, and 14 days
after treatment (DAT) and the mean number of eggs produced per female was calculated.
Validity criteria according to Candolfi et al. (2000) were fulfilled; mortality in control group did not
exceed 20%, the mortality in the toxic reference treatment was between 50-100%, and the mean
cumulative umber of eggs produced between 7 and 14 days exceeded 4.0 per female in the control
treatment.
The test item resulted in 40% mortality of Typhlodromus pyri when applied at concentration of 16000
mL/ha. In the fecundity assessment, no dose-response relationship was observed.The 7-day LR50
(median lethal rate) was found to be higher than 16000 mL formulation/ha (nominally 5760 g a.e./ha).
MON 52276 had no adverse effects on the reproductive performance of surviving mites up to and
including a treatment rate of 8000 mL formulation /ha (nominally 2880 g a.e./ha).
Table A 4:
Toxicity of MON 52267 to predatory mites (Typhlodromus pyri) in a 7 d laboratory test
Mortality after
7 days
[%]1
Abbott corrected
mortality
[%]2
Mean egg number/
female after 14 days
Effects on
Reproduction3
Control
15
-
6.9
-
16000
40*
29
3.0*
56.5
12000
32
20
3.8*
44.9
8000
23
9
5.9
14.5
6000
18
4
4.2
39.1
3000
13
0
8.1
-17.4
Test concentration
[L/ha]
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Toxic reference
(Perfekthion, 12 g a.s./ha)
87*
85
-
-
Conclusion
laboratory test conditions. The 7-day LR50 (median lethal rate) was found to be higher than 16000 mL/ha
(nominally 5760 g a.e./ha), the maximum rate tested. MON 52276 had no significant effect on the
reproductive capacity of mites at treatment rates up to and including a treatment rate of 8000 mL
formulation/ha (nominally 2880 g a.e./ha).
Study Comments:
The treatment rate of 12000 mL formulation /ha caused a significant
reduction in Mman egg number/ female after 14 days and the effects on
reproduction compared to control were 44.9%.
Agreed Endpoints:
zRMS used ER50 ≥12000ml MON 52276/ha (4320 g a.s./ha) for risk
assessment.
IIIA 10.5.2/02
Reference:
IIA10.5.1/02
Report
Stevens, J.,2110
A rate-response extended laboratory test to determine the effects of MON 52276 on
the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae)
Mambo-Tox Ltd., Southampton, UK
Report No: MON-09-2 (MT-2009-405)
Date: 2010-04-27
GLP: yes
Guideline(s):
Mead-Briggs et al. (2010). An extended laboratory test for evaluating the effects of
plant protection product on the parasitic wasp, Aphidius rhopalosiphi (De StefaniPerez) (Hymenoptera
Deviations:
No
GLP:
Yes
Acceptability:
Yes
revised by zRMS
the zRMS.
The toxicity of MON 52276 to the parasitic wasp, Aphidius rhopalosiphi was determined in an extended
laboratory test. Adult parasitic wasps approximately 48 h old were exposed in a definitive rate-response
test to 4000, 6000, 8000, 12000 and 16000 mL product/ha (nominally 1440, 2160, 2880, 4320, and 5760
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g a.s./ha). In addition, a water control (negative control) and a toxic reference (Perfekthion, 400 g/L
dimethoate) were tested.
Treatments were applied at a volume rate equivalent to 400 L spray solution/ha to pots of seedling barley.
Once dry, the barley plants were enclosed within cylindrical, ventilated collars. Five female wasps were
exposed per replicate, with six replicates (i.e. a total of 30 wasps) prepared for each treatment. Mortality
and sublethal effects were recorded 2 (3), 24 and 48 hours after application.
To assess any significant sub-lethal effects, reproduction assessments were then carried out for the highest
three treatment rates of the test item that resulted in < 50% mortality and from the control. Up to 15
female wasps were confined individually for 24 h over untreated barely plants infested with the cereal
aphids, Rhopalosiphi padi (L.) and Metopolophium dirhodum (Walk). The wasps were then removed and
the plants were left for a further 10 days before the number of aphid mummies that had developed was
recorded.
Treatment with the reference item Perfekthion at a concentration of 10 mL/ha resulted in 90% mortality
after 48 h of exposure. The mortality in the control treatments did not exceed 10%, the corrected mortality
in the reference treatment was >50%. In the control treatments, more than a minimum mean value of 5.0
mummies was produced per female. Not more than two of the surviving wasps of the control treatments
did not reproduce. Therefore, the test is considered valid according to Mead-Briggs et al. (2010).
Table A 5:
Toxicity of MON 52276 to parasitic wasps (Aphidius rhopalosiphi) in a 48 h extended
laboratory test
Test rate [mL/ha]
Mortality [%]
Corrected mortality [%] 1
Control
0
-
4000
0
0
6000
0
0
8000
0
0
12000
3.3
3.3
16000
0
0
Conclusion
In an extended laboratory test to determine the effects of MON 52276 on the parasitic wasp, Aphidius
rhopalosiphi, the 48-h LR50 was higher than 16000 mL product/ha. MON 52276 had no adverse effects
on the reproductive performance of surviving wasps up to and including a treatment rate of 16000 mL
product/ha.
Study Comments:
Study is acceptable
Agreed Endpoints:
48-h LR50 > 16000 mL product/ha
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IIIA 10.5.2/03
Reference:
IIA 10.5.1/03
Report
Spincer, D., 2010
An extended laboratory test to determine the effects of MON 52276 on the groundactive beetle, Aleochara bilineata (Coleoptera, Staphylinidae) Report No: MON-09-4
(MT-2009-403)
Date: 2010-04-27
GLP: yes
not published
Guideline(s):
Grimm et al (2000). A test for evaluating the chronic effects of plant protection
products on the rove beetle, Aleochara bilineata Gyll. (Coleoptera: Staphylinidae),
under laboratory and extended laboratory conditions
Deviations:
No
GLP:
Yes/
Acceptability:
Yes
the zRMS .
In the extended laboratory study the toxicity of MON 52276 to the rove beetle, Aleochara bilineata was
tested. Adult rove beetles (3 - 4 days old) were exposed in the definitive rate-response test to 6000, 8000
and 12000 mL product/ha. In addition, a water control (negative control) and a toxic reference (Cyren,
480 g/L chlorpyrifos) were tested.
Ten female and ten male beetles were introduced in each testing arena, with two replicates (i.e. a total of
20 beetles) prepared for each treatment. Assessments of the condition of the beetles were made at 1, 7
and 28 days after treatment (DAT). The parasitic success of their larval offspring was assessed by the
provision of ca. 500 onion fly pupae (Delia antiqua) in each replicate box on three weekly occasions, i.e.
at 7, 14 and 21 DAT. The original adult beetles were removed from the arenas at 28 DAT and the
number of new adults (F1 progeny) that subsequently developed from the parasitized fly pupae was
recorded over a further 46-day period. The validity criteria according to Grimm et al. (2000) are fulfilled.
The findings and observations concerning mortality and reproduction are described in the following table:
Test rate
[mL/ha]
Mortality [%]
Corrected
mortality [%] 1
Control
6000
8000
12000
32.5
38.8
47.5
38.8
9.3
22.2
9.3
Mean number of
F1 progeny per
arena 1
862.5
706.3
846.0
778.0
Standard
deviation
66.8
84.6
109.5
102.6
Effect on
reproduction
[%] 2
-18.1
1.9
9.7
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1
2
The numbers of progeny emerging in the control and test item treatments were compared by ANOVA, but treatment means
did not differ significantly (P > 0.05). For the toxic reference treatment (where all values were zero), no statistical
comparisons were made.
The percentage change in numbers of F1 progeny, relative to the control was calculated using the formula: R = (1-(Rt/Rc))
x 100, where Rt and Rc are the numbers of offspring observed in the treatment and control groups, respectively. Positive
values indicate a decrease, relative to the control.
The average number of beetles emerging from parasitized fly pupae in the control treatment was >400 per
replicate, and a minimum reduction of 50% reproductive capacity was achieved in the reference item
treatment when compared to the control. The validity criteria according to Grimm et al. (2000) are
therefore fulfilled.
Conclusion
In the extended laboratory test to determine the effects of MON 52276 on the rove beetle (Aleochara
bilineata), no significant effect on the parasitisation success of the beetles were observed up to and
including the highest treatment rate of 12000 mL/ha.
Study Comments:
Study is acceptable
Agreed Endpoints:
48-h LR50 > 12000 mL product/ha
IIIA 10.6/01 Effects on Earthworms and Other Soil Non-target Macro-organisms
Reference:
IIIA 10.6.2
Report
Hoxter, K.A.; Smith, G.J, 1992
MON 52276: An acute study with the earthworm in an artificial soil substrate.
Wildlife International Ltd. Easton, Maryland, USA
Report No: 139-306
Date: 1992-09-18
GLP: yes
Not published
OECD Guideline No. 207
Deviations:
Light intensity measurements were not taken during the exposure period. The test
chambers were covered with a metal lid with ventilation holes, rather than a glass
plate or plastic film. The average temperature was slightly higher than specified in
the guideline. These deviations were not considered to have affected the outcome of
the study because conditions for the validity of the study were met.
GLP:
Yes
Acceptability:
Appendix 3
Yes
the zRMS.
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The effects of MON 52276 on the earthworm Eisenia fetida andrei were tested in a 14 days acute
laboratory test with regard to the parameters mortality, development of body weight and alteration in
behaviour and appearance. The test was conducted with five test concentrations (162, 270, 450, 750 and
1250 mg/kg dry soil) and a negative control in OECD soil containing 10% peat moss.
After 14 days, no mortality was observed in any of the treatment groups and in the control. Furthermore,
no treatment related effect on worm body weight was observed.
No mortality was observed in any of the treatment groups and in the negative control. There appeared to
be no treatment related effect on worm body weight but worms in the treatment groups did not show the
10% weight increase observed in the control group. All worms at the 162 and 270 mg/kg dry soil
treatment levels were normal in appearance and behaviour at each observation interval. At the 450 mg/kg
dry soil concentration, four worms were noted as shortened and stiff at day 7, but all worms in this group
appeared normal at day 14. In the 750 mg/kg dry soil group, sixteen worms were found to be shortened
and stiff on day 7, with only one worm from this group remaining shortened and stiff by day 14. In the
1250 mg/kg dry soil group, twelve worms were noted as shortened and stiff on day 7, with six worms
found to be shortened and abnormally coloured by day 14
Table A 6:
1
Nominal MON 52276
(mg/kg dry soil)
% Mortality
Day 14
0
162
270
450
750
1250
0
0
0
0
0
0
Day 7
Observations1
Day 14
40 AN
40 AN
40 AN
36 AN/4 SS
24 AN/16 SS
28 AN/12 SS
40 AN
40 AN
40 AN
40 AN
39 AN/ 1 SS
34 AN/ 6 SA
Day 14 mean
bodyweight as % of
Day 0 value
+ 10.1
+ 3.7
+ 1.5
- 4.0
+ 1.4
+ 0.2
AN – appeared normal; SS – shortened and stiff; SA – shortened & abnormally coloured.
Conclusion
The 14-day LC50 for earthworms (Eisenia fetida andrei) exposed to the test item MON 52276 in an
artificial soil substrate was determined to be > 1250 mg/kg dry soil >386.9 mg a.s./kg dry soil), the
highest dose tested. The corresponding no-mortality concentration was 1250 mg/kg dry soil (386.9 mg
a.s./kg dry soil). The corresponding NOEC was determined to be 270 mg/kg dry soil (83.6 mg a.s./kg dry
soil), based on abnormalities noted at higher dose levels.
Study Comments:
Study is acceptable
Agreed Endpoints:
14-day LC50 > 1250 mg/kg dry soil ( >386.9 mg a.s./kg dry soil)
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IIIA 10.6/02 Effects on Earthworms and Other Soil Non-target Macro-organisms
Reference:
IIIA 10.6.3
Report
Friedrich, S., 2009
MON0139 - Sublethal toxicity to the earthworm Eisenia fetida. BioChem agrar
Laboratory, Laboratory Study Number 09 10 48 056 S.
Date: 2009-11-30
GLP: yes
Not published
Guideline(s):
Deviations:
No
GLP:
Yes
Acceptability:
Yes
the zRMS.
The sublethal toxicity of MON 0139 (MON 0139 (contains glyphosate isopropylamine salt) to the
earthworm (Eisenia foetida) was determined in a laboratory test. The definitive test was carried out using
the test concentrations of 30, 50, 100, 500, 1000 mg MON 0139/kg dry soil (equivalent to 14.18, 23.64,
47.28, 236.4, 472.8 mg glyphosate acid (a.s.)/kg dry soil, respectively) plus an untreated control. Each
treatment was replicated four times.
MON 0139 did not result in significant mortality to the earthworm, Eisenia fetida, at treatment rates up to
and including the maximum tested, i.e. 1000 mg MON 0139/kg soil dry weight.
None of the test-item treatments had apparent effects on the change in biomass, behaviour or the health
and the 56-d reproduction of the earthworms up to and including the maximum tested, i.e. 1000 mg MON
0139/kg soil dry weight.
Table A 7:
MON 0139
(mg/kg dry
soil) 1
Mortality and observations of the earthworm (Eisenia fetida andrei) exposed to MON 52276
Number of
juveniles per
replicate
(Coeff. Var.)
% decrease in numbers of
juveniles, relative to
control3
%
Mortality
%
Mortality
Corrected
Mean %
Weight Gain 2
(±1 SD)
0 (control)
0
0
40.7 (9.1)
79.0 (14.7)
-
30
0
0
46.7 (8.0)
78.5 (15.0)
0.6
50
2.5
2.5
39.8 (10.0)
83.8 (12.5)
-6
100
2.5
2.5
41.8 (11.2)
71.8 (24.5)
9.2
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500
0
0
37.5 (6.9)
80.3 (23.0)
-1.6
1000
0
0
36.3 (9.3)
74.3 (16.4)
6
1
Nominal concentrations.
The mean for percentage change in worm weights in replicate arenas between 0 and 28 DAT. A positive value indicates an
increase in fresh weight.
3
A positive value indicates a decrease and a negative value an increase in reproduction, relative to the control.
2
Conclusion
Based on nominal concentrations, the 56-d reproduction NOEC was determined to be 1000 mg MON
0139/kg soil d.w (highest concentration tested). The EC50 could not be calculated, but it can be
concluded that the 28-day EC50 is higher than 1000 mg MON 0139/kg soil d.w., this being the highest
concentration tested.
Study Comments:
The study is acceptable
Agreed Endpoints:
NOEC =1000 mg MON 0139/kg soil d.w
IIIA 10.7
Effects on soil micro-organisms
Reference:
Report
IIIA 10.7.1
Carter, J.N., 2001
MON 52276 - Effects on soil non-target micro-organisms: nitrogen transformation,
carbon transformation.
Huntingdon Life Sciences Ltd., Alconbury,
Huntingdon, Cambridgeshire, UK.
Report No: 256/004346
Date: 2001-10-05
Guideline(s):
OECD 216 and 217 (draft, 1999; final, 2000)
Deviations:
Deviations from OECD 216 and 217: The 1× and 5× exposure levels were
computed assuming a soil bulk density of 1.7 g/cm3, as indicated in the draft
guidelines. This resulted in exposure levels of 10.6 and 53 L/ha (correct to 1.5
g/cm3 bulk density, which are 1.06× and 5.3× the maximum use rate of 10
L/ha.
GLP:
Yes
Acceptability:
Yes
the zRM.S
The effects of MON 52276 on the carbon and nitrogen transformation pathways were assessed in a sandy
loam (PT 190 (21.8.00) obtained from Ipswich, Suffolk, UK which had received no pesticides or
Evaluator zRMS DE
Date: April 2013
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Core Assessment
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Page 87 of 90
fertilizers for at least 18 months prior to sampling. The transformation rates were determined in replicate
soil samples treated with MON 52276 at rates of 10.6 and 53 L/ha product/ha (equivalent to 1.06 and 5.3x
the maximum predicted environmental concentration) and compared to a control treatment of deionized
water. Substrate-induced (glucose) respiration measurements were made on Day 0, 7, 14 and 28 by
measuring the carbon dioxide evolution over a 12 hour period. Similarly, the products of the process of
nitrification were extracted from the soil, initially amended with ground lucerne, on Days 0, 7, 14 and 28
after treatment.
In soil exposed to MON 52276 at concentrations up to 53L/ha, deviations from control values for
nitrogen transformation and carbon mineralisation rates were < 25% after 28 days. Therefore, no longterm influence on nitrogen and carbon transformations is expected to occur after application of MON
52276.
Table A 8:
Effects of MON 52276 on carbon transformation, ammonium, and nitrate in soil
Study Day
MON 52276 (L/ha)
Group 2
Group 3
Group 1
0 (control)
10.6
53
Carbon transformation (mg CO2/kg soil dry weight/hour) 1,2
0
35.85
30.04
33.90
7
30.72
27.66
33.57
14
33.72
30.37
36.23
28
30.40
26.30
31.50
Ammonium (µg N/g soil dry weight) 1, 3
0
9.11
10.36
10.94
7
1.39
1.43
0.91
14
3.93
3.79
3.87
28
0.93
0.85
1.05
Nitrate (µg N/g soil dry weight) 1, 3
0
10.12
8.93
12.07
7
36.68
34.44
42.79
14
48.87
49.50
49.40
28
58.53
59.66
65.04 *
% Deviation from Control
Group 2
Group 3
-16.2
-10.0
-9.9
-13.5
-5.4
+9.3
+7.4
+3.6
+13.72
+8.47
-3.56
-8.60
+20.09
-34.53
-1.53
+12.90
-11.76
-6.11
+1.29
+1.93
+19.27
+16.66
+1.08
+11.12
Conclusion
In soil exposed to MON 52276 at concentrations equivalent to 10.6 and 53 L/ha, deviations from control
values for nitrogen transformation and carbon mineralisation were < 25% on Day 28. No long-term
influence on nitrogen and carbon transformations is therefore expected to occur after application of MON
52276.
Comments of zRMS
Study Comments:
The study is acceptable
Agreed Endpoints:
Effects on nitrogen and carbon transformations <25 % on day 28.
Evaluator zRMS DE
Date: April 2013
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Appendix 4 Table of Intended Uses justification and GAP tables
Crop and/ Zone
or situation
Product
code
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
Formulation
Application
PHI Remarks:
(days)
(c)
(l)
Type
Conc.
method
growth
number
of as
kind
stage & season
min
max
(i)
(f-h)
(j)
(d-f)
interval
between
applications
(min)
L/ha
water L/ha
kg as/ha
min max
min max
min max
(m)
(k)
Railways
Germany,
Austria
MON 78708
F
SL
360 g/l
Spraying
During the
growing season
1
-
10
500 - 1000 3.6
-
-
Railways
Germany,
Austria
MON 78708
F
SL
360 g/l
Spraying
During the
growing season
2
3 months
5
500 - 1000 1.8 × 2
-
-
Railways
Germany,
Austria
MON 78708
F
SL
360 g/l
Wiping,
single plant
treatment
(33 %)
During the
growing season
1
-
10
-
3.6
-
-
Non-crop
areas, no
woody
plants
Germany,
Austria
MON 78708
F
SL
360 g/l
Spraying
During the
growing season
1
-
10
500 - 1000 3.6
-
-
Evaluator zRMS DE
Date April 2013
Tender GB Ultra
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Crop and/ Zone
or situation
Product
code
(a)
F
G
or
I
(b)
Pests or
Group of pests
controlled
Formulation
Application
PHI Remarks:
(days)
(c)
(l)
Type
Conc.
method
growth
number
of as
kind
stage & season
min
max
(i)
(f-h)
(j)
(d-f)
interval
between
applications
(min)
L/ha
water L/ha
kg as/ha
min max
min max
min max
(m)
(k)
Non-crop
areas, no
woody
plants
Germany,
Austria
MON 78708
F
SL
360 g/l
Spraying
During the
growing season
2
3 months
5
500 - 1000 1.8 × 2
-
-
Non-crop
areas, no
woody
plants
Germany,
Austria
MON 78708
F
SL
360 g/l
Wiping,
single plant
treatment
(33 %)
During the
growing season
1
-
10
-
-
-
Remarks:
(a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989
(f) All abbreviations used must be explained
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type
of equipment used must be indicated
3.6
(i)
(j)
g/kg or g/l
application
(k) The minimum and maximum number of application possible under practical conditions of use
must be provided
(l) PHI - minimum pre-harvest interval
(m) Remarks may include: Extent of use/economic importance/restrictions
Evaluator zRMS DE
Date April 2013
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Core Assessment DE
Evaluator zRMS DE
Date April 2013
National AddendumGermany
Tender GB Ultra
Registration Report –
Central Zone
Page 1 of 34
REGISTRATION REPORT
Part B
Section 6 Ecotoxicological Studies
Product code:
Tender GB Ultra
Active Substances:
Glyphosate 360 g/L
(Isopropylaminesalt 487 g/L)
Central Zone
NATIONAL ADDENDUM – Germany
Applicant:
Monsanto Europe SA
Submission Date:
November 2013
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 2 of 34
TABLE OF CONTENT
SEC 6
6.1
6.2
6.2.1
6.2.2
6.3
6.3.1
6.3.2
6.3.3
6.4
6.4.1
6.4.2
6.5
6.6
6.7
6.7.1
6.7.2
6.7.3
6.8
6.8.1
6.8.2
6.9
6.9.1
6.9.2
6.10
6.11
6.11.1
6.11.2
6.11.3
6.11.4
6.11.5
ECOTOXICOLOGICAL STUDIES........................................................................................3
PROPOSED USE PATTERN ...............................................................................................................4
EFFECTS ON BIRDS .......................................................................................................................5
Toxicity........................................................................................................................................5
Toxicity to exposure ratio for birds (K III A 10.2.1) ...................................................................7
EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS .................................................11
Toxicity......................................................................................................................................11
Risk assessment .........................................................................................................................11
Exposure ............................................................................. Fehler! Textmarke nicht definiert.
EFFECTS ON AQUATIC ORGANISMS ............................................................................................15
Overview and summary .............................................................................................................15
Toxicity exposure ratios.............................................................................................................18
EFFECTS ON BEES .......................................................................................................................19
EFFECTS ON ARTHROPODS OTHER THAN BEES (IIIA1 10.5) ......................................................19
EFFECTS ON EARTHWORMS AND OTHER SOIL NON-TARGET MACRO-ORGANISMS (IIIA1 10.6) .21
Overall conclusion .....................................................................................................................22
Effects on organic matter breakdown (IIIA1 10.7) ....................................................................23
EFFECTS ON SOIL MICROBIAL ACTIVITY (IIIA1 10.7) ................................................................23
EFFECTS ON NON-TARGET PLANTS (IIIA1 10.8) ........................................................................24
EFFECTS ON NON-TARGET AQUATIC PLANTS (IIIA 10.8.2)..........................................................27
SUMMARY AND EVALUATION OF POINTS 5 AND 6 (IIA1 10.11)..................................................28
Predicted distribution and fate in the environment and time courses involved (IIIA1 10.11.1) 28
Non-target species at risk and extent of potential exposure (IIIA1 10.11.2)..............................28
Short- and long-term risks for non-target species, populations, communities and processes
(IIIA1 10.11.3)...........................................................................................................................28
Risk of fish kills and fatalities in large vertebrates or terrestrial predators (IIIA1 10.11.4).......30
Precautions necessary to avoid/minimise environmental contamination and to protect non-target
species (IIIA1 10.11.5) ..............................................................................................................30
APPENDIX 1
APPENDIX 2
TABLE OF INTENDED USES ..............................................................................................33
APPENDIX 3
ADDITIONAL INFORMATION PROVIDED BY THE APPLICANT.............................34
Evaluator: zRMS, DE
Date: April 2013
Sec 6
Tender GB Ultra
Central Zone
Page 3 of 34
ECOTOXICOLOGICAL STUDIES
This document presents the national addendum for Germany and should be read in conjunction with the
core assessment for section 6. The national addendum addresses national requirements differing from the
standard EU modeling and risk assessment procedures. It refers moreover to specific management and
risk mitigation practices that can be implemented in Germany.
Currently, the active substance glyphosate is in the Renewal Assessment (AIR2) with Germany as RMS.
In the course of this, the environmental endpoints were re-evaluated and new relevant endpoints are
proposed.
•
Article 36 of Regulation (EC) No 1107/2009 states that „the Member State examining the
application shall make an independent, objective and transparent assessment in the light of
current scientific and technical knowledge using guidance documents available at the time of
application“, an assessment based on updated data taking into account the latest knowledge from
the dRAR (Red draft) is included.
•
Considering the legal requirement resulting from Article 29(1) -e of the Regulation (EC) No
1107/2009 the risk regulation for product authorization has to be based on an assessment in the
light of current scientific and technical knowledge as also mentioned in chapter 4 of the proposal
for revision 9 of the SANCO/10328/2004 guidance document. The compliance with this objective
requires an immediate evaluation (prior to a renewal according to Art. 14) for those new active
substance data for which the consideration in the product risk assessment would either result in a
non-authorization or to the necessity to derive stricter risk mitigation measures to ensure that the
plant protection product under realistic conditions of use meets the requirements set up in Art. 4
(3) of the Regulation (EC) No 1107/2009 with respect to acceptability of risk to human health
and environment. According to the proposal of the current version of the guidance document (as
also in previous revisions) new annex II data would only have to be immediately evaluated if they
are considered as ´adverse data´ in the sense of Art. 56 (chapter 4.4, not covered in detail in the
guidance document) or if they are (presumably) in support of the authorization of the applied uses
(chapter 4.1 to 4.3).
For transparency reasons the updated endpoints according to dRAR (Red draft, November 2013)
are presented in tables presenting toxicity data, and an assessment on updated data according to
dRAR (Red draft, November 2013) is added. Relevant data referring to the EU assessment Annex
Renewal 2 (AIR 2) of glyphosate is marked in bold in the following document.
Evaluator: zRMS, DE
Date: April 2013
6.1
Central Zone
Page 4 of 34
Tender GB Ultra
The critical GAPs used for exposure assessment is presented. It has been selected from the individual
GAPs in the zone for Tender GB Ultra (MON 78708). A list of all intended uses within the zone is given
in Appendix 3.
Group*
Crop
Application method No. of applic.,
/ Drift scenario
Min. applic.
interval,
Applic. rate,
cumulative
(g as/ha)
Soil effective
applic. rate
(g as/ha)
A
Railways
Spraying
1
3600
3600
B
Railways
Spraying
2, 3 months
1800 × 2
1800 × 2
C
Railways
Wiping,
single plant
treatment (33 %)
1
3600
3600
D
Non-crop
Spraying
areas, no
woody plants
1
3600
3600
E
Non-crop
Spraying
areas, no
woody plants
2, 3 months
1800 × 2
1800 × 2
F
Non-crop
Wiping,
areas, no
single plant
woody plants treatment (33 %)
1
3600
3600
Applications of plant protection products (use groups D, E ,F ) are not considered to be approvable in
areas which are not used for agricultural, forestry or horticultural purposes with the approval of the
competent national authority (§ 6 (2) and (3) PflSchG (Plant Protection Act)). Such areas include all areas
which are not permanently covered by buildings or roofing, including all traffic areas, track systems,
roads, paths, yards and business sites and other pieces of land changed by civil engineering. Violations
may be punished by fines of up to 50.000 Euro.
Please refer also to PflSchG § 15 Abs. 3 Nr. 3 (Dritte Verordnung zur Änderung der PflanzenschutzAnwendungsverordnung vom 23. Juli 2003, Anlage 3, Nr. 4).
The use of plant protection products containing glyphosate is not approvable on areas with the risk for
runoff. An exemption (§ 6, 3 Plant Protection Act) may be given, in which a method of application is
prescribed (e.g., application of a roll coating device, wiping or single plant treatment), which excludes the
risk of runoff.
According to the Federal Environment Agency, an application on walks and places via spraying technique
is therefore not approvable, as this technique does not counter risk for run-off.
Evaluator: zRMS, DE
Date: April 2013
6.2
Tender GB Ultra
Central Zone
Page 5 of 34
Effects on Birds
(EFSA Journal 2009; 7(12): 1438).
6.2.1
Toxicity
Birds are exposed to residues of glyphosate on their food items following spraying of the formulated
product. According to current data requirements in Commission Regulation 1107/2009 of 21 October
2009 amending Council Directive 91/414/EEC the acute oral toxicity of an active substance to a quail
species (Japanese quail, Coturnix coturnix japonica or bobwhite quail, Colinus virginianus) or to mallard
duck (Anas platyrhynchos) must be determined.
For the current Renewal Assessment (AIR2) a large number of acute studies in birds without any
mortality at limit doses were submitted. EFSA guidance document 1438/2009 indicates that “it is
permissible to extrapolate an LD50 value in cases where there is no mortality or a single mortality at
a limit dose in an acute avian toxicity study”. Using the study with the Bobwhite quail with a limit
dose of 2000 mg/kg bw, the extrapolation factor for no mortalities at the limit dose and 20 birds per
dose group (the actual number of birds tested at this limit dose exceeded 20), the acute LD50 to be
used in a bird risk assessment according to EFSA guidance document 1438/2009 is proposed to be
2000 x 2.167 = 4334 mg/kg bw.
Concerning the effects of glyphosate on bird reproduction, studies have been conducted with bobwhite
quail (XXX 1978/ WI 78-52 and XXX 1999; 123-186) and mallard duck (XXX 1978/ WI 78-53, XXX
1999; 123-187) for the active substance glyphosate. All studies have been reevaluated according to
current guidelines.
The new submitted study for mallard duck by XXX 1999; 123-187 is considered to be valid.
Nevertheless, due to significant reduction in mean body weight in the 2250 ppm treatment group in 14day old survivors, the NOEL for mallard ducks exposed to glyphosate acid in a reproduction study was
determined to be 1000 mg glyphosate acid/kg feed, corresponding to 116 mg/kg/bw/d.
The new submitted study for bobwhite quail by XXX (1999; 123-186) does not fulfill the validity criteria
according to OECD 206. The mortality of the control exceeded 10 % at the end of the test. In addition, the
minimum floor area of pen per pair was too small (0.138 instead of 0.25 m2). This minor space could be a
reason why six birds died in the control group and two in each treatment group.
The study by XXX 1978/ WI 78-52 provides the endpoints of the EU LOEP (EU Review Report
6511/IV/99-final, 21 January 2002). In this study a significant reduction in egg weight was observed at
the highest concentration tested (1000 ppm). Therefore, a NOEC of 18.1 mg a.s./kg b.w./d. was
determined and agreed during the EU review process. However, changes in egg weight are not considered
a standard endpoint in avian reproduction studies according to guideline OECD 206 and all other relevant
endpoints determined did not show any unacceptable differences compared to the control treatment –
including No. of eggs, No. 14 d old survivals and hatchlings weight. The differences in egg weight
between control and the treatment with 1000 ppm amounted to a decrease of approx. 7.5 % (10.26 g ±
0.38 g vs. 9.48 g ± 0.47 g in control and 1000 ppm treatment, respectively). Since especially all
parameters concerning hatchling weight and survival were not affected at any concentration, it can be
assumed that the observed changes in egg weight do not represent a population relevant adverse effect.
Therefore, this endpoint will be considered as a NOAEL of 1000 ppm, corresponding to 96.3
mg/kg/bw/d, and will be used for the risk assessment of the chronic risk for birds.
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 6 of 34
Tender GB Ultra
Table 6-1: Toxicity of glyphosate to birds with reference to agreed endpoints
Species
Substance
System
Results
Reference
Colinus
virginianus
glyphosate
1d
Colinus
virginianus
glyphosate
119d
dRAR (Red
draft, November
2013)
XXX, 1978,
35159/
Report No.: WI- 37256
78-52,
Colinus
virginianus
glyphosate
140d
(extrapolated according to
EFSA GD 1438/2009)3)
NOEC = 200 mg/kg food
or NOEL = 18.1 mg/kg
bw/d 1)
NOAEL = 96.3 mg/kg
bw/d
The study is not considered
to be acceptable and valid
ICS-No.
XXX, 1999;
123-186
44176
XXX, 1999;
123-187
44174
3) 4)
Anas
platyrhynchos
glyphosate
147d
NOEL/NOAEL = 117
mg a.s./kg bw/day 3) 4)
Conversion of endpoints from ppm to mg a.s./kg bw/d was performed according to EFSA Guidance
Document on Risk Assessment for Birds and Mammals (2009). The daily dose for birds in each treatment
group of each test, expressed as test substance (TS) intake, was calculated by treatment group using the
following formula:
Test substance intake (mg TS/g bw/day) = (Consumption mean x ConcFeed ) / BWmean
Consumptionmean= Group Mean Feed Consumption (g/bird/day)
ConcFeed = Concentration (mg TS/kg feed);
BWmean= Group Mean Body Weight for Start of Treatment and Exposure Termination (g)
The values used in the calculations and the daily dose values are presented in the tables below.
Table 6-2: Daily dose from glyphosate acid avian reproduction studies
Nominal Dose
(mg a.s./kg feed)
Daily mean food consumption
(g feed/bird/day)
Mean body weight (g)
Daily dose
(mg a.s./kg bw/day)
6.1.1.1.1.1 KIIA 8.1.4/03, Bobwhite quail; Beaver and Fink, 1978
Control
50
200
1000
218.5
208.0
218.3
211.8
0
4.9
18.1
96.3
6.1.1.1.1.2 KIIA 8.1.4/04 Mallard duck Beaver and Fink, 1978
Control
131.1
1154.3
50
118.8
1078.3
200
128.9
1135.5
1000
145.5
1161.3
0
5.5
22.7
125.3
6.1.1.1.1.3 KIIA 8.1.4/02 Mallard duck, Frey et al., 1999
Control
140.6
500
140.0
1000
128.0
2250
142.4
0
64.6
117
300
21.1
20.3
19.8
20.4
Evaluator: zRMS, DE
1098
1083
1093
1069
Date: April 2013
6.2.1.1
Tender GB Ultra
Central Zone
Page 7 of 34
Exposure
Tender GB Ultra is a water soluble concentrate formulation containing 360 g a.s./L glyphosate acid (486
g/L glyphosate isopropylamine salt; 30.8% w/w as the isopropylamine salt).
Tender GB Ultra is an herbicide for weed control in non-crop areas and railways. Birds could be exposed
to the formulation via consumption of glyphosate acid (a.s.) residues on food items.
Exposure to standard generic focal species was estimated according to the Guidance Document on Risk
Assessment for Birds and Mammals (EFSA Journal 2009; 7(12): 1438)
PD i × FIR total
× RUD × AR × PT
bw
i
FIR i
=∑
× RUD × AR × PT
bw
i
DDD = ∑
Where:
DDD
PDi
FIRi
bw
RUD
AR
PT
= Daily dietary dose (mg/kg bw/day)
= composition of diet obtained from treated area
= Food intake rate of indicator species i (g fresh weight/d)
= Body weight (g)
= Residue per unit dose, bases on an application rate of 1 kg a.s./ha and assuming
broadcast seedling
= Application rate (kg/ha)
= Proportion of diet obtained in the treated area (0…1)
In a first approach, it is assumed that birds do not avoid contaminated food items that they feed
exclusively in the treated area and on a single food type. Factors PT and PD are therefore equal to 1.
The risk assessment procedure follows a stepwise approach. A first screening step involves standard
scenarios and default values for the exposure estimate, representing a “reasonable worst case”. If a
potential risk is indicated in the screening step, then one or several refinement steps (Tier 1, Tier2) may
follow. According to the Guidance Document, no further assessment is required if all uses are safe in the
screening step.
does not exceed the trigger. Please refer to chapter 6.2.3 in the core assessment.
Food chain behavior
being below the trigger. Please refer to chapter 6.2.9 in the CA.
6.2.2
Toxicity to exposure ratio for birds (K III A 10.2.1)
6.2.2.1
Acute toxicity to exposure ratio (TERA)
Screening step
In the screening step, the risk to indicator bird species from an exposure to Tender GB Ultra is assessed.
These indicators are considered to have highest exposure in a specific crop at a particular time due to their
size and feeding habits and represent a worst case scenario.
To estimate the daily dietary doses, following equations were used:
Daily dietary dose (DDD):
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 8 of 34
Tender GB Ultra
DDDsingle application = application rate [kg a.s./ha] × shortcut value1
1
see section 4.1 of EFSA/2009/1438
Toxicity exposure ratio (acute):
TER A =
LD 50 ( mg/kg bw/day)
Acute DDD (mg/kg bw/day)
The resulting TERA values are summarized in the following table, along with the indicator species and the
respective shortcut values.
Table 6-3: Acute screening risk assessment (TERA) for birds. See text for details
Substance
Indicator
species
Applic.
rate
Shortcut
value
MAF
(kg/ha)
Current Renewal
Assessment
(AIR2), dRAR
(Red draft,
glyphosate
November 2013)
small graniv.
bird
Max. 3.6
large
herbiv.bird
Max. 3.6
24.7
1
DDD
LD50
(mg/kg
bw)
(mg/kg
bw)
88.92
TERA
49
4334
30.5
1
109.8
40
6.2.2.2
Short -term toxicity exposure ratio (TERST)
There is no requirement for the calculation of TERST for birds under the EFSA birds and mammals
guidance document (EFSA Journal 2009; 7(12): 1438) and, consequently, a risk assessment for short-term
toxicity will not be conducted.
6.2.2.3
Screening step
For the reproductive risk assessment, the calculation of the long-term toxicity exposure ratio (TERLT) in
principle follows the same procedure as for the acute risk assessment. However, the defined daily dose is
obtained by multiplying the application rate with the mean short-cut values (based on mean RUD
according to the new Guidance Document (EFSA, 2009)) as summarized in the following table.
Evaluator: zRMS, DE
Date: April 2013
Table 6-4:
Central Zone
Page 9 of 34
Tender GB Ultra
Avian generic focal species for the intended uses of Tender GB Ultra and relevant
shortcut values for long-term exposure
Crop
Indicator species
Shortcut value
(mean RUD)
Bare soils
11.4
Grassland
16.2
As stated in the guidance document, it is justified to apply a time-weighted average (TWA) factor of 0.53
based on a default observation interval of 21 days and a default DT50 of 10 days for the calculation of the
DDD (daily dietary dose):
DDDsingle application = application rate [kg/ha] × shortcut value × TWA*
* see section 4.3 of EFSA/2009/1438
Toxicity exposure ratio (Long-term):
TER LT =
NOEL ( mg/kg bw/day)
Long - term DDD (mg/kg bw/day)
The relevant lowest NOAEL for the reproduction exposure scenario for glyphosate is 96.3
mg a.s./kg bw/d. Conversion of endpoints from ppm to mg a.s./kg bw/d was performed according to
EFSA Guidance Document on Risk Assessment for Birds and Mammals (2009). A recalculated value of
96.3 mg a.s./kg bw/d instead of 102.23 mg a.s./kg bw/d has been used. The relevant long-term endpoints
is provided in the following table as well as calculated long-term toxicity exposure ratios (TERLT) for
birds exposed to glyphosate following applications of Tender GB Ultra.
Table 6-5:
Substance
glyphosate
Long-term screening risk assessment (TERLT) for birds exposed to Tender GB Ultra
according to the intended uses
Indicator bird
Application Shortcu fTWA
rate
t value
(kg/ha)
(longterm)
MAF
DDD
(mg/kg
bw/day)
NOAEL TERLT
(mg/kg
bw/day)
Max. 3.6
11.4
0.53
1
21.751
96.3
4.4
Max. 3.6
16.2
0.53
1
30.910
96.3
3.1
Based on the conservative presumptions of the screening step, the calculated TER values for the longterm risk resulting from an exposure of birds to the active substance glyphosate according to the GAP of
the formulation Tender GB Ultra does not achieve the acceptability criteria TER ≥ 5, according to
2.5.2. for long-term effects. The results of the assessment indicate an unacceptable risk for birds, further
refinement is necessary.
Tier 1
For glyphosate the TERLT was below the trigger of 5 in the screening step for the intended uses in the
scenarios “bare soil” and “grassland” representing the use in railways and non-crop areas.
PT of 1 according to EFSA Guidance Document on Risk Assessment for Birds and Mammals (2009) is
used. On the base of a weight of evidence approach which also implies national particularities the risk
assessment might be adapted (PT=0.5).
Based on an application rate of max. 3600 g/ha the risk was assessed for the generic focal species
summarized in the following table:
Evaluator: zRMS, DE
Date: April 2013
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Page 10 of 34
Tender GB Ultra
The relevant short-cut values for these scenarios are summarized in the following table:
Table 6-6:
Avian generic focal species for the intended uses of Tender GB Ultra and relevant
shortcut values for long-term risk assessment
Intended use
Crop
Growth Stage
Railway
Bare Soil , BBCH <10
11.4
8.2
5.9
Small granivorous bird "sparrow"
9.4
11.4
16.2
11.3
Grassland
All season
The outcome of the Tier 1 risk assessment step is presented in the following table:
Table 6-7:
Scenario
Reproductive bird risk assessment of Tender GB Ultra uses (Tier 1)
Applicati MAF
on Rate x twa
(kg
a.s./ha)
Short
cut
Value
PT
value
(Mean
RUD)
Max. 3.6 0.53
BBCH
<10
11.4
0.5
DDD
NOAEL
(mg
a.s./kg
bw/d)
(mg a.s./
kg bw/d)
10.809
96.3
TER
8.9
8.2
15.646
6.2
5.9
11.257
8.6
9.4
8.913
11
11.4
10.809
8.9
16.2
15.360
6.3
11.3
10.714
9.0
regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects
with an application rate of max. 3.6 kg a.s /ha. The results of the assessment indicate an acceptable risk
non-crop areas with an application rate of max. 3.6 kg a.s /ha.
The use of plant protection products containing glyphosate is not approvable on areas with a risk
for runoff. An exemption (§ 6, 3 Plant Protection Act) may be given, in which a method of
application is prescribed (e.g., application of a roll coating device, wiping or single plant treatment),
which excludes the risk of runoff. According to the Federal Environment Agency, an application on
walks and places via spraying technique is therefore not approvable, as this technique does not
counter risk for run-off.
Evaluator: zRMS, DE
Date: April 2013
6.3
Central Zone
Page 11 of 34
Tender GB Ultra
Effects on Terrestrial Vertebrates Other Than Birds
6.3.1
Toxicity
Table 6-8: Toxicity of glyphosate to mammals with reference to updated endpoints (dRAR,
Nov.2013)
Species Substance System
Results
Rat
1)
glyphosate Acute oral toxicity
LD50 > 2000 mg/kg bw AIR2 dRAR (Red draft, November 2013)
Rat
MON
52276
LD50 > 5000 mg/kg bw XXX, 1991, BD-91-261
Acute oral toxicity
Reference
Rabbit glyphosate Teratogenic study,
toxicity to mother
1)
animals
NOAEL = 50 mg/kg XXX;
bw/day;
(1996, ASB2012-11499); Renewal
Maternal: bw gain ↓, Assessment Report, Volume 3 Annex
Dev.:
B.9.3.3, Red Draft
post-implantation
loss
1) Updated endpoints according to dRAR (Red draft, November 2013)
In the Renewal Assessment Report for Glyphosate (Volume 3 Annex B.9, Red Draft), an overall a
LD50 of > 2000 mg/kg bw was determined. Furthermore a mammal toxicity test with the formulation
MON 52276 was submitted.
In the Renewal Assessment Report for Glyphosate (Volume 3 Annex B.9, Red Draft), an overall
effects is 50 mg/kg bw/day, based post-implantation loss in the rabbit at 200 mg/kg bw/day in the
study by XXX (1996, ASB2012-11499). Due to dose spacing, the NOAELs in other studies were
higher (XXX, 1980, TOX2552390; XXX, 1991, TOX9552391; XXX, 1996, TOX2000-2002) but
consistently below 200 mg/kg bw/day. Beside post-implantation losses and late embryonic death
(XXX, 1989, TOX9551960; XXX., 1991, TOX9552391), developmental findings at higher dose levels
2.6.7.2.2.).
6.3.2
Risk assessment
6.3.2.1
Acute toxicity exposure ratio (TERA)
Screening step
In the screening step, indicator species are used. These indicators are considered to have highest exposure
in a specific crop at a particular time due to their size and feeding habits and represent a worst case
scenario. The indicator mammal species for the intended uses are listed in the following table.
Evaluator: zRMS, DE
Date: April 2013
Table 6-9:
Central Zone
Page 12 of 34
Tender GB Ultra
Indicator species for mammals according to intended use of Tender GB Ultra and
shortcut values. Shortcut values from section 4.1 of EFSA/2009/1438
Crop
Indicator species
Shortcut value (90th percentile RUD)
bare soils
small granivorous mammals
14.4
grassland
136.4
For the estimation of Daily dietary doses (DDD) and the calculation of TER-values please refer to 6.2.2.1
Table 6-10:
Substance
glyphosate
Acute screening risk assessment (TERA) for mammals. See text for details
Indicator species
Shortcut
Application
MAF
value,
rate
acute
DDD
LD50
(kg/ha)
(mg/kg
bw)
(mg/kg
bw)
TERA
3.6
14.4
1
51.84
> 2000
> 9*
3.6
136.4
1
491.04
> 2000
> 4*
scenario).
6.3.2.2
Short-term toxicity exposure ratio (TERST)
There is no requirement for the calculation of TERST for mammals under the EFSA birds and mammals
guidance document (EFSA Journal 2009; 7(12): 1438) and, consequently, a risk assessment for short-term
toxicity has not been performed.
6.3.2.3
In the Renewal Assessment Report for Glyphosate (Volume 3 Annex B.9, Red Draft), an overall
effects is 50 mg/kg bw/day, based post-implantation loss in the rabbit at 200 mg/kg bw/day in the
study by XXX (1996, ASB2012-11499). Due to dose spacing, the NOAELs in other studies were
higher (XXX, 1980, TOX2552390; XXX, 1991, TOX9552391; XXX, 1996, TOX2000-2002) but
consistently below 200 mg/kg bw/day. Beside post-implantation losses and late embryonic death
(XXX, 1989, TOX9551960; XXX, 1991, TOX9552391), developmental findings at higher dose levels
2.6.7.2.2.).
This endpoint is considered in the risk assessment. Full details of the toxicity studies are provided in the
respective EU DAR and Core assessment, Annex 3 of this document.
Evaluator: zRMS, DE
Date: April 2013
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Page 13 of 34
Tender GB Ultra
Screening step
For the reproductive risk assessment, the calculation of the long-term toxicity exposure ratio (TERLT)
follows in principle the same procedure as for the acute risk assessment.
The defined daily dietary dose is obtained by multiplying the application rate with the mean short-cut
value (based on the mean RUD according to the new Guidance Document (EFSA, 2009)) as summarized
in the following table.
Table 6-11:
Mammal generic focal species for the intended uses of Tender GB Ultra and
relevant shortcut values for long-term exposure
Crop
Indicator species
bare soils
small granivorous mammal
6.6
grassland
72.3
Please refer to section 6.2.2.3 for the equation employed in the estimation of the daily dietary doses and
the calculation of TER-values.
Table 6-12: Long-term screening risk assessment (TERLT) for mammals exposed to Tender GB
Ultra according to the updated endpoints (dRAR, Nov. 2013)
Indicator bird
Renewal
Assessment
(AIR2), dRAR
(Red draft,
November 2013)
Small graniv.
mammals
Applic. rate Shortcu fTWA
(kg/ha)
t value
(longterm)
Max.3.6
Small herbiv.
mammal
Small graniv.
mammals
6.6
0.53
MAF
(mg/kg
bw/day)
1
72.3
Max.
2x1.8
Small herbiv.
mammal
6.6
0.53
72.3
DDD
1
12.59
NOAEL TERLT
(mg/kg
bw/day)
50
4*
137.94
0.4*
8.814
6*
96.56
0.5*
scenario).
Scenarios “bare soil” representing the use in railways
GAP of the formulation Tender GB Ultra does achieve the acceptability criteria TER ≥ 5/ TER≥ 2*
(Microtus arvalis, Apodemus siylvaticus), according to commission implementing regulation (EU) No
546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for long-term effects. The results of the
scenarios “bare soil” representing the use in railways areas according to the label.
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 14 of 34
Tender GB Ultra
Scenarios “grassland“ representing the use non-crop areas
GAP of the formulation Tender GB Ultra does not achieve the acceptability criteria TER ≥ 5/ TER≥ 2*
(Microtus arvalis; Apodemus siylvaticus), according to commission implementing regulation (EU) No
546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for long-term effects. The results of the
scenario “grassland“ representing the use in non-crop areas according to the label, further refinement is
necessary.
Refined risk assessment
It is possible to refine the diet using published data. In common voles inhabiting a meadow in central EU,
dicotyledonous species predominate in the diet during spring and summer, while in autumn the proportion
of monocotyledons increases. The average number of plant species was 4.3 per stomach (range: 1-9).
When comparing the available biomass it was conclusive that a supply of about 70% monocotyledons and
30% dicotyledonous biomass meets a food intake of roughly 33% monocotyledon and 67%
dicotyledonous (Rinke, T. 1991. Percentage of volume versus number of species: availability and intake
of grasses and forbs in Microtus arvalis. Folia Zoologica 40(2): 143-151).
Residues on food items:
The outcome of the refined risk assessment step is presented in the following table:
Table 6-13: Reproductive mammal risk assessment of Tender GB Ultra uses in the scenarios “bare
soil” and “grassland“ representing the use in railways and non-crop areas (Tier 1)
according to updated endpoints (dRAR, Nov.2013)
Generic Focal Species Application MAF Short cut PT
Rate
x twa
Value
(kg a.s./ha)
Renewal Assessment Large herbivorous
(AIR2), dRAR (Red mammal "lagomorph"
draft, November
Small herbivorous
2013)
mammal "vole"
Large herbivorous
mammal "lagomorph"
Max.3.6
(Mean
RUD)
0.19
Max.2x1.8
0.19
17.3
54.2
(monocot)
+
28.7
(dicot.)
Evaluator: zRMS, DE
NOEL
TER
bw/d)
kg bw/d)
1
54.2
(monocot)
+
28.7
(dicot.)
Small herbivorous
mammal "vole"
17.3
DDD
11.914
50
18.615
(monocot)
+
20.013
(dicot.)
1
5.91
9.308
(monocot)
+
10.007
(dicot.)
4.2
1.3*
50
8.5
2.6*
Date: April 2013
Central Zone
Page 15 of 34
Tender GB Ultra
Generic Focal Species Application MAF Short cut PT
Rate
x twa
Value
(kg a.s./ha)
(Mean
RUD)
DDD
NOEL
TER
bw/d)
kg bw/d)
scenario).
2.5.2. for long-term effects with an max. application rate of max. 3.6 kg a.s. /ha. The results of the
application rate of max.3.6 kg a.s. /ha.
2.5.2. for long-term effects with an application rate of max. 2 ×1.8 kg a.s. /ha. The results of the
6.4
Effects on Aquatic Organisms
6.4.1
Please refer to the core assessment.
6.4.1.1
Toxicity
Acute toxicity testing has been conducted with MON 52276 for rainbow trout (Oncorhynchus mykiss),
common carp (Cyrinus carpio), water flea (Daphnia magna) and green algae (Pseudokirchneriella
subcapitata). Relevant results of these studies as well as EU endpoints of the Review Report
(SANCO/6511/VI/99-final) are summarized.
The EU review report for glyphosate (6511/VI/99-final) lists an EC50-value for algae of 0.64 mg/L.
This endpoint was determined in the study from Hughes, 1987 using Skeletonema costatum as a test
species. This endpoint was used for the risk assessment so far. During the Renewal Assessment
(AIR2) the environmental endpoints were re-evaluated and new endpoints were defined. According
to actual guidelines the aforementioned test does not meet validity criteria anymore.
The Renewal Assessment (AIR2) shows that the risk for aquatic organisms is triggered by the
possible long-term effects on macrophytes and acute effects on fish. Therefore, risk assessment
based on the acute fish value LC50 = 38 mg/l taking into account a safety factor of 100, was added to
the risk assessment. For the aquatic environment the former algae endpoint is supposed to display
a worse case, as no lower endpoint was defined.
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 16 of 34
Table 6-14: Toxicity endpoints for aquatic organisms
Species
Substance
System
Toxicity
(mg/L)
Reference/ ICS-Nr.
MON 52276
96 h
LC50
>989
(>306 mg
a.s./L)
XXX 1992, Studyno. TO-91-296; ICS:
35244
LC50
>895
(>277 mg
a.i./L)
XXX 1992, Studyno. TO-91-293; ICS:
35243
LC50
38
Review Report (SANCO/6511/VI/99final)
LC50
> 180
Monograph glyphosate, Volume 3, Annex
B-8: Ecotoxicology 11 December 1998
25.7
Fish, acute toxicity
O.mykiss
MON 52276
O.mykiss
glyphosate
O.mykiss
AMPA
Fish, long-term toxicity
P. promelas
glyphosate
254 days NOEC
Invertebrates, acute toxicity
D.magna
MON 52276
glyphosate
>676
(>356 mg
a.i./L)
48 h
EC50
AMPA
40
> 180
Linnot, D.R.1992, Studyno. TO-91-295;
ICS: 35237
Invertebrates, long-term toxicity
Daphnia magna
glyphosate
21 days
NOEC
30
ErC50
284 mg/L
(88 mg a.s./L)
EbC50
178 mg/L
(55 mg a.s./L)
7 days
EbC50
0.64
Review Report (SANCO/6511/VI/99final)*
72 h
EyC50
89.8
EC50
12
Review (SANCO/6511/VI/99-final)
Algae
Selenastrum
capricormutum
MON 52276
72 h
N. pelliculosa
S.costatum
P. subcapitata
glyphosate
AMPA
Neven, B. 1993, Studyno. LI-91-389; ICS:
35239
Aquatic higher plants
L. gibba
glyphosate
14 days
* According to actual guidelines the test does not meet validity criteria anymore
Glyphosate forms two major metabolites; Aminomethyl-phosphonic acid (AMPA), max. 16 % at day 14
and (Hydroxymethyl)-phosphonic acid (max. 10.0% at day 61, 7.5% at day 100).
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 17 of 34
Tender GB Ultra
As the metabolite AMPA shows a clearly lower toxicity for fish, daphnids and algae compared to the
active substance, no quantitative risk assessment was performed. The risk assessment for the active
substance is supposed to address the risk resulting from metabolite as well.
It is predicted that the risk for aquatic organisms exposed to glyphosate metabolites according to the
intended use of Tender GB Ultra will be low.
6.4.1.2
Exposure
In agreement with the German modelling scheme, TERs are calculated for all relevant exposure routes;
i.e. spraydrift, run-off and drainage entry. The Predicted Environmental Concentrations in surface water
(PECSW) have been calculated based on the maximum application rates of max. 3600 g glyphosate/ha.
In addition to the FOCUS based evaluation presented in the core dossier, an aquatic risk assessment is
presented based on the two German evalution models: EXPOSIT 3.0 and EVA 2.1. The risk evaluations
are based on the endpoint LC50 = 38 mg/L (O.mykiss) according to the dRAR, Nov.2013.
The calculation of concentrations in surface water is based on spray drift data by Rautmann and
Ganzelmeier. The vapour pressure at 20 °C of the active substance glyphosate is between 10-5 and 10-4 Pa.
Hence the active substance glyphosate is regarded as semivolatile (volatilisation only from plant
surfaces).
For details on the EXPOSIT modelling in accordance with German national requirements, reference is
made to the dRR document Part B, Section 5, Point 6 (national addendum Germany). The input
parameters for glyphosate used for modelling surface water exposure via run-off and drainage in an
adjacent ditch with EXPOSIT 3.01 are summarized in the following table.
Table 6-15:
Input parameters for glyphosate used for modelling surface water exposure via runoff and drainage with EXPOSIT 3.01
Parameter
Glyphosate
Reference
K foc, Runoff
15844
3091
5.4.2)
DT50 soil (d)
40.9 d
10500
5.3.1.2
Reduction by bank filtration (only
relevant for PECgw see 5.7.2)
23.5 %
TZW Karlsruhe)
Evaluator: zRMS, DE
Date: April 2013
6.4.1.3
Central Zone
Page 18 of 34
Tender GB Ultra
Overall conclusion
The risk for the entry routes run-off and drainage is acceptable without drift buffer zones or drift
reduction technique for all indication groups. The risk to aquatic organisms following exposure Tender
GB Ultra via spraydrift is acceptable without drift buffer zones or drift reduction technique.
Table 6-16: Predicted environmental concentrations in surface water – spraydrift. run-off and
drainage entry
Test organism
Test substance
EC50
[µg/L]
Buffer
distance
[m]
PECSW [µg/L]
TERLT
Trigger
value
Drift entry (agriculture; max. 1 x 3600 g a.s./ha)
Aquatic
invertebrates
glyphosate
38000
0
1200
32
5
33.2
1143
0
29.35
>100
5
25.43
>100
Autumn/winter/
early spring
1.64
>100
Spring/summer
0.53
>100
100
Run-off entry
Aquatic
invertebrates
glyphosate
38000
100
Drainage entry
Aquatic
invertebrates
glyphosate
38000
100
TER in bold fall below the relevant trigger
6.4.2
Toxicity exposure ratios
6.4.2.1
Toxicity Exposure Ratios (TER) for the entry into surface waters via spraydrift
The toxicity of the formulated product Tender GB Ultra is mainly driven by the active substance
glyphosate. The calculation of PECsw after exposure via spray drift is performed using the model
EVA 2.1. Eventhough glyphosate is considered as semivolatile with a vapour pressure of 1.31 x10-5 Pa
(25 °C, acid) , the contribution of volatilasation is negligible.
Classification for the intended uses in Germany for Tender GB Ultra are presented in document Part B,
Section 5, Point 6 (national addendum Germany). For the indications “non-crop areas” , the scenario
"agriculture with 0 % interception" has been used as a worst case assumption, as application of Tender
GB Ultra is ground directed. Both calculations are based on the LC50 = 38 mg a.s./L (O.mykiss) and the
respective PEC values leading to following TERs.
Based on the calculated concentrations of glyphosate in surface waters, the calculated TER-values for the
acute and long-term risk resulting from an exposure of aquatic organisms to glyphosate according to the
GAP of the formulation Tender GB Ultra achieve the acceptability criteria TER ≥ 10. The results of the
in all the indications applying an application rate of max.3600 g a.s./ha without risk mitigation measures.
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 19 of 34
Tender GB Ultra
Table 6-17: TER-values regarding the exposure via spraydrift scenario “agriculture” (Model: EVA
2.1.)
Compound:
glyphosate
Crop / Application rate:
agriculture; 1 x 3600 g a.s./ha
Growth stage and season
0 % interception
DT50 water (SFO):
-
PEC-selection:
actual
Drift-Percentile:
90th percentile of drift probabilities
Buffer
zone
Entry
spraydrift
via
Entry via deposition
following
volatilization
PECsw [µg as/L]; conventional and drift reducing
technique
[m]
[%]
[µg/L]
[%]
0% conv.
90% red.
75% red.
50% red.
0
100.00
1200
1200
120
300
600
1
2.77
33.24
33.2
3.3
8.3
16.6
5
0.57
6.84
6.8
0.7
1.7
3.4
[µg/L]
Relevant toxicity endpoint: LC50 = 38 mg a.s./L (O.mykiss)
Relevant TER: 100
Buffer zone [m]
TER
0
32
--
--
--
1
1143
11432
4572
2286
Risk mitigation measures
6.5
none
Effects on Bees
Please refer to Part B Section 6 of the core RR.
6.6
Effects on Arthropods Other Than Bees (IIIA1 10.5)
Please refer to the core dossier for the central zone.
The endpoints considered for the risk assessment for arthropods are indicated in the following tables.
Only the most sensitive endpoints of valid studies are presented here.
6.6.1.1
Toxicity
Information about ecotoxicological endpoints for non target arthropods is considered to be relevant for all
countries. Therefore please refer to the core assessment Part B, section 6, chapter 6.
Table 6-18: Toxicity endpoint for arthropods
Species
Substance
Exposition
Results
Reference
ICS-No.
Aphidius
rhopalosiphi
MON 52276
Extended
laboratory
(whole plant)
LR50 > 16000mL
MON 52276/ha
(5760 g a.s./ha)
Stevens, 2010 3)
81045
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 20 of 34
Tender GB Ultra
Typhlodromus pyri MON 52276
Extended
laboratory
(leaf discs)
ER50 ≥12000ml/ha
(4320 g a.s./ha)
Fallowfield, 2010 3) 81047
Aleochara bilineata MON 52276
Extended
Laboratory
(soil)
ER50 >12000ml/ha
(4320 g a.s./ha)
Spincer, 2010 3)
81046
The toxicity of Tender GB Ultra to non-target arthropods has been investigated for the indicator species
Aphidius rhopalosiphi, Typhlodromus pyri and Poecilius cupreus.
laboratory test conditions (2-dimensional). The 7-day LR50 (median lethal rate) was found to be higher
than 16000 mL/ha (nominally 5760 g a.s./ha), the maximum rate tested. MON 52276 had no significant
effect on the reproductive capacity of mites at treatment rates up to and including a treatment rate of 8000
mL formulation/ha (nominally 2880 g a.s./ha). The treatment rate of 12000 mL formulation/ha caused a
significant reduction in mean egg number/female after 14 days and the effects on reproduction compared
to control were 44.9%. For risk assessment zRMS used ER50 ≥12000ml MON 52276/ha (4320 g a.s./ha).
6.6.1.2
Exposure
The calculation of PECsw after exposure via spray-drift is performed using the model EVA 2.1. The
amount of spray drift reaching off-crop habitats is calculated using the 90th percentile estimates derived
by the BBA (2000) from the spray-drift predictions of Ganzelmeier & Rautmann (2000).
6.6.1.3
Overall Conclusion
Table 6-19:
Risk assessment for terrestrial non-target arthropods exposed to of Tender GB
Ultra
Tender GB Ultra
Worst-case application
Max.1 x 3600 g a.s./ha
1
Agriculture / 90th
None
Substance:
Indication:
Application rate
MAF:
Scenario/Percentile:
Interception:
Volatilisation/ Deposition
PECact (g/ha)
(incl. Volatilisation, Interception)
(g/ha)
(%)
(g/ha)
konv. T.
90% Red.
75% Red.
50% Red.
2.77
99.72
-
-
19.94
1.99
4.99
9.97
0.57
20.52
-
-
4.10
0.41
1.03
2.05
866
433
Distance
Drift
(m)
(%)
1
5
relevant toxiciy:
ER50 ≥12000ml MON 52276/ha (4320 g a.s./ha).
relevant TER:
5
Distance (m)
TER
1
217
Risk mitigation:
2166
none
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 21 of 34
Tender GB Ultra
6.7
Effects on Earthworms and Other Soil Non-target Macro-organisms (IIIA1
10.6)
6.7.1
6.7.1.1
Toxicity
Information about ecotoxicological endpoints for earthworms and other soil non-target macro-organisms
is considered to be relevant for all countries. Therefore please refer to the core assessment Part B, section
6, chapter 6.
Table 6-20: Toxicity endpoint for earthworms
Species
Substance
Eisenia
fetida
System
Results (mg a.s./kg)
Reference
glyphosate (IPA- chronic
salt)
56 d
NOEC ≥28.79 Reproduction
glyphosate
NOEC ≥ 21.31
Hayward, J.C. and
Mallet, M.
Report no: CEMR – 1173
(LOEP)1)
AMPA
NOEC ≥ 28.12
Eisenia
fetida
glyphosate
acute 14d
LC50 > 480 mg a.s./kg Mortalität
Eisenia
fetida
MON0139
(IPA-salt, 64% ;
corr. 47%
glyphosate)
MON52276 (31%
glyphosate)
chronic
56 d
LC50 > 1000 mg MON 0139/kg
soil d.w
Corr. 472,8 mg glyphosate
(a.s.)/kg dry soil
LC50> 1250 mg/kg soil d.w
Eisenia
fetida
acute
14d
Review Report for the
active substance
glyphosate
(SANCO/6511/ VI/99final)
Friedrich, S. ,2009 ,
T001934-09; 2)
Hoxter, K.A., 1992
ICSNo.
41621
79809
35278
Exposure
Results of PECsoil calculation for Tender GB Ultra according to EU assessment considering 5 cm soil
depth are given in Part B, Section 5, of the core assessment. Results of PECsoil calculation for Tender GB
Ultra according to national requirements assessment considering2.5 cm soil depth are given in Part B,
Section 5, National addendum , chapter 5.5.
Table 6-21: Results of PECsoil calculation for the intended use in orchards and vineyards used for
German risk assessment
Plant protection product:
Tender GB Ultra
Use:
1x3600 g a.s. /ha worse case
1
Application rate:
10 L/ha (3600 g glyphosate / ha) as worst case
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 22 of 34
Tender GB Ultra
0%
Crop interception:
active substance/
formulation
soil relevant
application rate
(g/ha)
soil depthact PECact
(cm)
(mg/kg)
tillage
depth (cm)
PECbkgd
(mg/kg)
PECaccu =
PECact +
PECbkgd
(mg/kg)
glyphosate
3600
2.5
9.600
-
0.7132
10.3132
AMPA
1271
2.5
3.3893
-
3.4497
6.8390
Tender GB Ultra
11660
2.5
31.09
-
-
-
For German exposure assessment, the calculated predicted environmental concentration soil (PEC soil) is
based on experimental data (Fent et al., 19991). Generally, for active substances with a Kf,oc < 500, a soil
depth of 2.5 cm is taken into account whereas for active substances with a Kf,oc > 500 a soil depth of 1
cm is taken into account. As soil bulk density 1.5 g cm-3 is assumed. In case of glyphosate, additional
data do not support the assumption of a very low mobility (Schmidt, 2005; see also chapter 5.7.2).
Therefore, a soil depth of 2.5 cm is considered for the predicted distribution of glyphosate in the soil
profile after application.
A risk assessment with an max. application rate of 10 L/ha (3600 g a.s./ha) including the calculated
PECsoil values for the active substance glyphosate and the major soil degradation product AMPA, which is
formed in amounts of >10 %, is presented. For details please refer to Part B-Section 5.
6.7.2
Overall conclusion
Earthworms may be directly exposed to Tender GB Ultra residues deposited onto the soil surface after
spray application. The TER-values were derived using the toxicity data for the active substance
glyphosate as well as for the metabolite AMPA. The results of the risk assessment are summarized in the
following table.
Table 6-22: Risk assessment for earthworms.
Test
substance
Worst-case
use pattern
glyphosate
10 L/ha (3600 Acute
g a.s./ha)
as worst case
MON52276
(31%
glyphosate)
MON0139
(IPA-salt, 64%
; corr. 47%
glyphosate)
1
Timescale
Endpoint
(mg/kg dw soil)
PEC
(mg/kg
dw soil
TER
TER
trigger
10.3
>44
10
LC50 > 450
Acute
14d
LC50> 1250 mg/kg soil
d.w
31.09
>12
10
Long-term
NOEC > 1000 mg MON
0139/kg soil d.w
Corr. 472.8 mg
glyphosate (a.s.)/kg dry
soil
10.3
> 45
5
Fent, Löffler, Kubiak (1999): Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter
Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum
Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999).
Evaluator: zRMS, DE
Date: April 2013
AMPA
Central Zone
Page 23 of 34
Tender GB Ultra
10 L/ha (3600 Long-term
g a.s./ha) as
worst case
NOEC ≥ 28.12
6.8
>4
5
TER values in bold are below the trigger
The formulation MON0139 ((IPA-salt, 64% ; corr. 47 % glyphosate) was submitted by the applicant,
which proposes an endpoint NOEC=1000 mg MON0139/kg dry soil, corresponding to 473 mg of
glyphosate acid and secondly a study with the formulation MON52276 was conducted leading to an
LC50>1250 mg/kg soil d.w (IPA-salt) corresponding to 388 mg a.s/kg dry soil .
application rate.
As the metabolite AMPA is considered to be of no greater toxicological concern than its parent
compound in general and has a lower NOEC (≥ 28.12 mg/kg), it can be assumed that the toxicity of
AMPA is addressed via the longterm study. The risk for earthworms is considered to be acceptable.
6.7.3
Effects on organic matter breakdown (IIIA1 10.7)
6.8
Effects on Soil Microbial Activity (IIIA1 10.7)
6.8.1
6.8.1.1
Toxicity
Please refer to the core dossier for the central zone. All effects were below the trigger value < 25% after
28d exposure, indicating that the proposed use of Tender GB Ultra poses acceptable risk.
6.8.1.2
Exposure
Please see registration Report national addendum Part B , Section 5.
6.8.1.3
Overall conclusion
SANCO/10329/2002 rev 2-final states that testing soil micro-organisms is always required when
contamination of the soil is possible. The Predicted Environmental Concentrations of the formulation, the
the active substances and the major soil degradation product AMPA are below the concentrations at
which no unacceptable effects (< 25 %) were observed after 28 days of exposure.
Studies have been conducted with MON 52276 to determine the effects on soil micro-organisms. Effects
of MON 52276 showed effects < 25 % on respiration, soil nitrate formation, when applied up 53 L /ha, in
5 cm soil depth / >5.3x PEC) after 28 d of exposure. The risk assessment results are summarized in the
following table.
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 24 of 34
Tender GB Ultra
Table 6-23: Risk assessment for soil microbial activity functions
Substance
Endpoint
Effect (NOEC) / dose
(mg/kg soil dw)
PECS (mg/kg)
MoS
MON 52276
Carbon
respiration
< 25 % derivation from control/
10.3
2.4
MON 52276
Nitrogen
transforamation
10.3
2.4
< 25 % derivation from control/
For the active ingredient glyphosate, the tested application rates ofTender GB Ultra caused no deviations
> 25% in the soil microbial acivity studies. Moreover, the tested appliacation rates are > 2.4 times the
estimated PEC according to the worst case intended use of 10 L /ha. Consequently it can be concluded
thatTender GB Ultra applied at the proposed worst-case use patterns does not pose an unacceptable risk to
soil microorganisms.
6.8.2
Please refer to the previous chapter
6.9
Effects on Non-Target Plants (IIIA1 10.8)
6.9.1
the proposed uses with an application rate of 1x3600 g a.s/ ha and with an application rate of max.
2x1800 g a.s/ ha poses an acceptable risk to terrestrial non-target plants under consideration of risk
proposed worst-case application rate of 3600 g a.s./ha is indicated by TER-values above the trigger of 15
according to the worst case intended use of 10 L /ha Tender GB Ultra in the risk assessment for railways.
6.9.1.1
Toxicity
The potential effects ofTender GB Ultraon seedling emergence and vegetative vigour non-target
terrestrial plants have been tested with 6 and 10 non-target terrestrial plant species, respectively.
Table 6-24: Ecotoxicological endpoints for non-target plants following exposure toTender GB Ultra
Species
Substance
Exposition
Results
Reference
glyphosate
Vegetative
vigour
ER50 > 146 g
a.s./ha
Chetram, R.S. and
35146
Lucash, K.J. al., 1994,
MSL-13320
ICS-No.
Vegetative vigour
Lycopersicon esculentum,
Glycine max, Lactuca sativa,
Raphanus sativus, Cucumis
sativus, Brassica oleracea,
Avena sativa, Lolium perenne
Zea mays, Allium cepa
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 25 of 34
For the risk assessment the endpoint of the active ingriedient glyphosate is used. The most sensitive
species of the 10 tested species tested postemergence was Lycopersicon esculentum with an EC50 of 146 g
a.s. /ha. As for glyphosate results are available with 10 species it is possible to lower the acceptability
TER ≥ 5. However, to ensure a sufficient and an adequate protection of non target plants in the off –field
environment it is recommended to correct the TER trigger > 5 by a factor of 3 upwards for the following
reasons:
Around the treated area non target plants will be exposed to Tender GB Ultra mainly via spray drift
(driftable portion of application rate: 2.77% at 1 m from treated field edges and 0.57% at 5 m). It is
important to remember that for the assessment of the effects on terrestrial plants toxicity studies with the
product are more appropriate than studies with the active ingredient. Since it cannot be excluded that the
formulants enhance toxicity, it seems that using data of the active ingredient glyphosate only will not
display potential harmful effects of Tender GB Ultra towards non target plants. Nevertheless test results
on terrestrial plants with the formulation Tender GB Ultra have not been submitted. Based on the
available data from other glyphosate-containing preparations it is recognizable that the preparations
typically are about a factor of 3 more toxic than the active ingredient. In order to meet the precautionary
principle in risk assessment the acceptability is therefore by modified (TER ≥ 15).
6.9.1.2
Exposure
The calculation of PECsw after exposure via spray-drift is performed using the model EVA 2.1. The
amount of spray drift reaching off-crop habitats is calculated using the 90th percentile estimates derived
by the BBA (2000) from the spray-drift predictions of Ganzelmeier & Rautmann (2000) for use in noncrop land. For use in railways spray drift values are modified according to Wygoda et al. 2006 (Drift
measurements for a spraying train, Nachrichtenbl. Deut. Pflanzenschutzd., 58 (12), S. 323–326, 2006,
ISSN 0027-7479.)
6.9.2
The risk assessment based on the lowest effect endpoint for vegetative vigor and the relevant predicted
environmental rates in the off-field area after treatment with Tender GB Ultra in accordance to the
proposed use rate is presented in the tables. For the proposed use pattern in of Tender GB Ultra on
railways risk assessment is based on spray drift values are modified according to Wygoda et al. 2006
(Drift measurements for a spraying train, Nachrichtenbl. Deut. Pflanzenschutzd., 58 (12), S. 323–326,
2006, ISSN 0027-7479.)
Evaluator: zRMS, DE
Date: April 2013
Table 6-25:
Central Zone
Page 26 of 34
Tender GB Ultra
Risk assessment for terrestrial non-target plants exposed to of Tender GB Ultra
Substance:
Tender GB Ultra
Indication:
Non-crop land
Application rate
1 x 3600 g a.s./ha
MAF:
1
Agriculture / 90th
Interception:
None
(g/ha)
Volatilisation/
Deposition
(%)
(g/ha)
PECact (g/ha)
konv. T.
90% Red.
75% Red.
50% Red.
2.77
99.72
-
-
99.72
9.97
24.93
49.86
0.57
20.52
-
-
20.52
2.05
5.13
10.26
Distance
(m)
Drift
(%)
1
5
relevant toxiciy:
ER50 : ER50 > 146 g a.s./ha
relevant TER:
15
Distance (m)
TER
1
2
15
6
3
5
7
71
29
15
Risk mitigation:
NT 103
Substance:
Tender GB Ultra
Indication:
Non-crop land
Application rate
Max. 2 x 1800 g a.s./ha (90d)
MAF:
1
Agriculture / 80th
Interception:
None
(g/ha)
Volatilisation/
Deposition
(%)
(g/ha)
PECact (g/ha)
konv. T.
90% Red.
75% Red.
50% Red.
2.38
72.83
-
-
72.83
7.28
18.21
36.41
0.47
14.38
-
-
14.38
1.44
3.60
7.19
Distance
(m)
Drift
(%)
1
5
relevant toxiciy:
ER50 : ER50 > 146 g a.s./ha
relevant TER:
15
Distance (m)
TER
1
2
20
8
4
5
10
101
41
20
Risk mitigation:
NT 103
Evaluator: zRMS, DE
Date: April 2013
Central Zone
Page 27 of 34
Tender GB Ultra
the proposed uses with an application rate of 1x3600 g a.s/ ha and with an application rate of max.
2x1800 g a.s/ ha poses an acceptable risk to terrestrial non-target plants under consideration of risk
Table 6-26:
Risk assessment for terrestrial non-target plants exposed to of Tender GB Ultra on
railways
Substance:
Indication:
Application rate
Tender GB Ultra
railways
1 x 3600 g a.s./ha
MAF:
1
Interception:
Distance
Drift
(m)
(%)
Gleisanlagen
0%
Volatilisation/
Deposition
(g/ha)
(%)
(g/ha)
PECact (g/ha)
konv. T.
90% Red.
75% Red.
50% Red.
3
0.684
0.684
0.171
0.342
854
427
0.019
relevant toxiciy:
relevant TER:
Distance (m)
3
Risk mitigation:
-
-
0.0684
ER50 > 146 g a.s./ha
15
TER-values (calculated)
213
2135
none
proposed worst-case application rate of 3600 g a.s./ha is indicated by TER-values above the trigger of 15
according to the worst case intended use of 10 L /ha Tender GB Ultra in the risk assessment for railways.
6.10
Effects on non-target aquatic plants (IIIA 10.8.2)
Please refer to assessment made under chapter 6.4.
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 28 of 34
6.11
Summary and Evaluation of Points 5 and 6 (IIA1 10.11)
6.11.1
Predicted distribution and fate in the environment and time courses involved
(IIIA1 10.11.1)
6.11.2
Non-target species at risk and extent of potential exposure (IIIA1 10.11.2)
General
The use of plant protection products containing glyphosate is not approvable on areas with the risk
for runoff. An exemption (§ 6 para 3 Plant Protection Act) may be given, in which a method of
application is prescribed (eg, application of a roll coating device, wiping or single plant treatment),
which excludes the risk of runoff. According to the Federal Environment Agency, an application on
walks and places via spraying technique is therefore not approvable, as this technique does not
counter risk for run-off.
6.11.3
Short- and long-term risks for non-target species, populations, communities
and processes (IIIA1 10.11.3)
Birds
(EFSA Journal 2009; 7(12): 1438).
Acute toxicity
Long-term toxicity
regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects
with an application rate of max. 3.6 kg a.s /ha. The results of the assessment indicate an acceptable risk
non-crop areas with an application rate of max. 3.6 kg a.s /ha.
Terrestrial vertebrates other than birds
Acute toxicity
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 29 of 34
scenario).
Long-term toxicity
GAP of the formulation Tender GB Ultra does achieve the acceptability criteria TER ≥ 5/ TER≥ 2*
(Microtus arvalis, Apodemus siylvaticus), according to commission implementing regulation (EU) No
546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects. The results of the
scenarios “bare soil” representing the use in railways areas according to the label.
2.5.2. for long-term effects with an max. application rate of max.3.6 kg a.s. /ha. The results of the
application rate of max 3.6 kg a.s. /ha.
2.5.2. for long-term effects with an application rate of max. 2 ×1.8 kg a.s. /ha. The results of the
scenario).
Aquatic organisms
Based on the calculated concentrations of glyphosate in surface waters, the calculated TER-values for the
acute and long-term risk resulting from an exposure of aquatic organisms to glyphosate according to the
GAP of the formulation Tender GB Ultra achieve the acceptability criteria TER ≥ 100. The results of the
in all the indications applying an application rate of 3600 g a.s./ha without risk mitigation measures.
Honeybees
Arthropods other than bees
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 30 of 34
Earthworms and other soil macro-organisms
Risk assessments for earthworms and other soil non-target macro-organisms were conducted following
the Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC
(SANCO/10329/2002 rev. 2 final). The assessments for acute and chronic exposure have been conducted
based on the formulated product Tender GB Ultra.
application rate.
Soil Microbial Activity
The risk assessment for soil microflora functions was conducted following the Guidance Document on
Terrestrial Ecotoxicology Under Council Directive 91/414/EEC (SANCO/10329/2002 rev. 2 final) based
on data for the formulated product Tender GB Ultra.
For the active ingredient glyphosate, the tested application rates ofTender GB Ultra caused no deviations
> 25% in the soil microbial acivity studies. Moreover, the tested appliacation rates are > 2.4 times the
estimated PEC according to the worst case intended use of 10 L /ha. Consequently it can be concluded
thatTender GB Ultra applied at the proposed worst-case use patterns does not pose an unacceptable risk to
soil microorganisms.
Non-target organisms (flora and fauna)
the proposed uses with an application rate of max. 1x3600 g a.s/ ha and with an application rate of
max. 2x1800 g a.s/ ha poses an acceptable risk to terrestrial non-target plants under consideration of risk
proposed worst-case application rate of max. 3600 g a.s./ha is indicated by TER-values above the trigger
of 15 according to the worst case intended use of 10 L /ha Tender GB Ultra in the risk assessment for
railways without risk mitigation.
6.11.4
Risk of fish kills and fatalities in large vertebrates or terrestrial predators
(IIIA1 10.11.4)
6.11.5
Precautions necessary to avoid/minimise environmental contamination and to
protect non-target species (IIIA1 10.11.5)
Because of the toxicity of the active ingredient as well as the formulation Tender GB Ultra following
labels have to be signed out in Germany:
NW 468:
NT 103:
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 31 of 34
In order to protect terrestrial non-target plant species in off-field areas a risk mitigation
measure is required in form of 90 % drift reduction in indication group D and E with an
application rate of max. 1x 3600g a.s./ha and max. 2x 1800 g a.s./ha in non crop areas.
NS 660
The product may only be applied on field areas which are not used for agricultural,
forestry or horticultural purposes with the approval of the competent national authority (§
6 (2) and (3) PflSchG (Plant Protection Act)). Such areas include all areas which are not
permanently covered by buildings or roofing, including all traffic areas, track systems,
roads, paths, yards and business sites and other pieces of land changed by civil
engineering. Violations may be punished by fines of up to 50.000 Euro.
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 32 of 34
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 33 of 34
Appendix 2 Table of Intended Uses
Evaluator: zRMS, DE
Date: April 2013
Tender GB Ultra
Central Zone
Page 34 of 34
Appendix 3 Additional information provided by the applicant
Evaluator: zRMS, DE
Date: April 2013
Core Assessment
MON78708
043981-00/00
Registration Report
Central Zone
Page 1 of 35
REGISTRATION REPORT
Part B
Section 7: Efficacy Data and Information
Detailed Summary
Product Code: MON78708
Reg. No.: 043981-00/00
Active Substance: 360 g/L glyphosate acid (486 g/L
glyphosate isopropylamine salt)
Central Zone
CORE ASSESSMENT
Date: 2011-12-12
Evaluator: Julius Kühn-Institut
Date: 2013-11-05
Julius Kühn-Institut
2013-11-05
Core Assessment
MON78708
043981-00/00
Registration Report
Central Zone
Page 2 of 35
Table of Contents
IIIA1 6
Efficacy Data and Information on the Plant Protection Product............................ 3
General information............................................................................................. 3
Recent registration situation/history of the PPP................................................... 4
Information on the active ingredients (Uptake and mode of action) ..................... 4
Information on crops and pests ........................................................................... 5
Information on the intended uses ........................................................................ 5
IIIA1 6.1
Efficacy data........................................................................................................ 7
IIIA1 6.1.1
Preliminary range-finding tests ............................................................................ 8
IIIA1 6.1.2
Minimum effective dose tests .............................................................................. 8
IIIA1 6.1.3
Efficacy tests ..................................................................................................... 11
IIIA1 6.1.4
Effects on yield and quality................................................................................ 17
IIIA1 6.1.4.1
Impact on the quality of plants and plant products............................................. 17
IIIA1 6.1.4.2
Effects on the processing procedure ................................................................. 17
IIIA1 6.1.4.3
Effects on the yield of treated plants and plant products.................................... 17
IIIA1 6.2
Adverse effects ................................................................................................. 17
IIIA1 6.2.1
Phytotoxicity to host crop................................................................................... 17
IIIA1 6.2.2
Adverse effects on health of host animals ......................................................... 18
IIIA1 6.2.3
Adverse effects on site of application ................................................................ 18
IIIA1 6.2.4
Adverse effects on beneficial organisms (other than bees)................................ 18
IIIA1 6.2.5
Adverse effects on parts of plant used for propagating purposes ...................... 22
IIIA1 6.2.6
Impact on succeeding crops.............................................................................. 22
IIIA1 6.2.7
Impact on other plants including adjacent crops ................................................ 22
IIIA1 6.2.8
Possible development of resistance or cross-resistance ................................... 24
IIIA1 6.3
Economics ........................................................................................................ 29
IIIA1 6.4
Benefits ............................................................................................................. 29
IIIA1 6.4.1
Survey of alternative pest control measures...................................................... 29
IIIA1 6.4.2
Compatibility with current management practices including IPM........................ 29
IIIA1 6.4.3
Contribution to risk reduction............................................................................. 29
IIIA1 6.5
Other/special studies......................................................................................... 29
IIIA1 6.6
Summary and assessment of data according to points 6.1 to 6.5 ...................... 29
IIIA1 6.7
List of test facilities including the corresponding certificates .............................. 30
Appendix 1:
List of data submitted in support of the evaluation............................................. 31
Appendix 2:
GAP table.......................................................................................................... 34
2013-11-05
Core Assessment
IIIA1 6
MON78708
043981-00/00
Registration Report
Central Zone
Page 3 of 35
Efficacy Data and Information on the Plant Protection Product
General information
Germany is zRMS and belongs according to Regulation EC No 1107/2009 to the central registration zone (zone B). According to EPPO PP1/241 (zones of comparable climate in the EPPO
region) Germany is part of the maritime EPPO zone. In the notification letter to all concerned
member states (cMS) filed in July 2011 the following countries were defined as cMS in the Central Zone: Austria
Austria belongs to the maritime EPPO climate zone and according to Regulation EC No
1107/2009 to the central registration zone (zone B).
This document summarises the information related to the efficacy of the plant protection product
MON78708 containing 360 g/L glyphosate which was included into Annex I of Directive 91/414
EEC by 1 July 2002 (Commission Directive 2001/99/EC).
MON 78708 (360 g a.s./L) is a water soluble concentrate (SL) formulation. The formulation
composition of MON 78708 is based on that of MON 52276, which is registered in Germany
since 1995 under name Roundup Ultra. Roundup Ultra was renewed by 23.06.2006 and is approved until end of 2016. The only difference in composition is that MON 78708 contains a blue,
food-approved dye. The inclusion of this dye is not considered to have any impact on the use,
handling and efficacy of MON 78708. It follows that MON 78708 and MON 52276 are identical
and therefore the efficacy and selectivity of the two products are also identical. Biological Assessment Dossiers (BAD) have been prepared and submitted for MON 52276 under the Directive 91/414 EEC addressing the efficacy and selectivity in a range of uses in Germany including
non-cropped situations.
Roundup Ultra (MON 52276) should therefore be referred to when considering efficacy of MON
78708. The data demonstrate that MON 78708 fulfils all the criteria for the authorization of
preparations described in Directive 97/57/EEC (Uniform principles, Annex VI to Directive 91/414EEC).
Information of the applicant on glyphosate formulations included in efficacy trials
Product name
Tender GB Ultra
MON78708
Development code
Formulation type
Water-soluble concentrate (SL)
Active substance and content in the formulation
Glyphosate – 360 g/L
Registration number in Germany
033981-00
Product name
Development code
Formulation type
Roundup Ultra
MON52276
024142-00
Product name
Development code
Formulation type
Roundup (now Durano®)
MON2139
2013-11-05
Core Assessment
MON78708
043981-00/00
Registration Report
Central Zone
Page 4 of 35
052389-00
Product name
Development code
Formulation type
Roundup UltraMax
MON78294
005191-00
Product name
Development code
Formulation type
n.a.
MON79351
006921-00
Recent registration situation/history of the PPP
throughout the world for a wide range of uses at a range of dose rates.
Information on the active ingredients (Uptake and mode of action)
Glyphosate is an organic phosphorus compound, belonging to the chemical class of glycines,
with no or low soil residual activity. Herbicides containing glyphosate differ in the salt formulation.
Glyphosate
may
present
as
glyphosate-ammonium-salt,
as
glyphosateisopropylammonium-salt or as glyphosate-potassium-salt. Glyphosate is a non-selective herbicidal active substance. Glyphosate is taken up by the leaves and other green parts of the plant
and is translocated systemically (apoplastic and symplastic) in the whole plant, also in underground parts like roots, rhizomes or stolons. Glyphosate uptake through the roots is negligible
because the active substance is strongly adsorbed in the soil. The extensive adsorption of glyphosate together with a ready degradation in soil, are the principal deactivation and dissipation
mechanisms in the soil environment.
In plants, glyphosate inhibits the shikimic acid pathway. Glyphosate binds to and blocks the activity of its target enzyme EPSPS (5-enolpyruvylshikimate-3-phosphate synthase), an enzyme of
the aromatic amino acid biosynthetic pathway. The inhibition of the enzyme prevents the plant
from synthesizing the essential aromatic amino acids (e.g. phenylalanine, tyrosine, and tryptophan) needed for protein biosynthesis. This reduces the production of protein in the plant, and
inhibits plant growth. EPSPS is present in all plants. It leads to an accumulation of the amino
acids glutamine, glutamic acid, shikimic acid and ammonia. As a consequence of missing aromatic amino acids the formation of phenolic compounds is inhibited (e.g. lignin, flavanoids).
First signs of wilting occur in annual weeds 4 days and in perennial weeds 7 to 10 days after
herbicide application. Leaf symptoms are usually detected 7 to 14 days after application, while a
complete death of the plant takes up to 30 days. As light affects the metabolism via photosynthesis, a higher activity in plants means a better distribution of glyphosate and thus greater herbicidal effect. Increasing temperatures result in increased biochemical activity, and thus in an
increased rate of efficacy. Optimum temperatures are 10 to 20° C. High humidity affects the
quality of the leaf surface and thus promotes the uptake of the herbicide.
Plant metabolism studies have been conducted on numerous crops. The only significant metabolite in plants was aminomethylphosphonic acid (AMPA).
2013-11-05
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Page 5 of 35
Information on crops and pests
According to the importance (occurrence, cultivation) in the member states (MS) the intended
pest/crop can be classified in Germany as follows:
Table 6-1: Importance of intended pest/crop in Germany
Pest/Crop
EPPO
Country
Classification
Monocotyledonous weeds
TTTMM
Germany
major
Dicotyledonous weeds
TTTDD
Germany
major
Railway tracks
YGLES
Germany
minor
Non-cultivated land without
woody plants
YNKOB
Germany
minor
Weed
Crop and/or situation
Information on crops and pests from concerned member states is not reported by the applicant.
Corresponding information should be submitted.
Information on the intended uses
Use No.
Area of application
Crop(s)/object(s)
Pest(s)/target(s)/aim(s)
Area of use
Time of treatment
Max. number of treatments
for the use
per crop or season
Application technique/ type
of treatment
Dose rate(s) in amount of
water to be used
---------------------------Use No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
for the use
per crop or season
Interval between treatments
043981-00/00-001
Non cultivated areas
railway tracks
monocotyledonous weeds, dicotyledonous weeds
Outdoors
During growing season
1
1
spraying
10 L/ha in 500 to 1000 L water/ha
---------------------------043981-00/00-002
railway tracks
Outdoors
2
2
3 month(s)
spraying
2013-11-05
Core Assessment
of treatment
water to be used
---------------------------Use No.
Area of application
Crop/Situation
Area of use
Time of treatment
for the use
per crop or season
of treatment
Notes on application technique
water to be used
Notes on dose rate
---------------------------Use No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
for the use
per crop or season
of treatment
water to be used
---------------------------Use No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
for the use
per crop or season
MON78708
043981-00/00
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Page 6 of 35
---------------------------043981-00/00-003
railway tracks
monocotyledonous weeds, dicotyledonous weeds, woody
plants
Outdoors
1
1
wiping
single plant treatment
33%
maximum dose rate for the intended use per year 10 L/ha
---------------------------043981-00/00-004
non-cultivated land without woody plants
Outdoors
1
1
spraying
---------------------------043981-00/00-005
Outdoors
2
2
2013-11-05
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MON78708
043981-00/00
Interval between treatments
of treatment
water to be used
---------------------------Use No.
Area of application
Crop(s)/object(s)
Area of use
Time of treatment
for the use
per crop or season
of treatment
Notes on application technique
water to be used
Notes on dose rate
----------------------------
Registration Report
Central Zone
Page 7 of 35
3 month(s)
spraying
---------------------------043981-00/00-006
monocotyledonous weeds, dicotyledonous weeds, woody
plants
Outdoors
1
1
wiping
single plant treatment
33%
maximum dose rate for the intended use per year 10 L/ha
----------------------------
Remark: Use No. -004 and -005; amount of water to be used: 500 to 1000 l water/ha are unusual in Germany.
IIIA1 6.1
Efficacy data
The applicant refers to documents of other registered glyphosate herbicides in Germany. Glyphosate containing formulations are registered for more than 30 years for several uses (e.g.
Roundup (now Durano, MON2139), Roundup Ultra (MON52276) or Roundup UltraMax
(MON78294)) in Germany. An agreed efficacy program done in 1993 showed that both glyphosate formulations, Roundup Ultra (MON52276) and Roundup (MON2139, now Durano),
were seen to be equivalent. Furthermore it is important to mention that according to the letter of
BBA for project MON-52776 (Roundup Ultra), dated June 22nd, 2001 and to the minutes of the
‚Meeting on Glyphosate Efficacy Data (BBA/Monsanto)’ dated August 10th, 2001, further efficacy
data was required by BBA, which are suitable to address questions on dose justification and
efficacy. An agreement was made to generate 2 years data on dose rate on different weed species covering efficacy dose including different glyphosate containing products like Roundup
(now Durano, MON2139), Roundup Ultra (MON52276), Roundup TURBO (MON14420) or
Roundup UltraMax (MON78294). Data of 32 trials (crop areas) performed in Germany during
the years 2001 and 2002 were evaluated on effectiveness of the various dose rates against a
wide spectrum of annual and perennial weeds. In addition, data of 2 trials were presented, performed on non-crop areas. All this field data confirmed the findings of 1995 in which Roundup
and Roundup Ultra were already proven to be equivalent. Report of the data package was send
to Bundesamt für Verbraucherschutz und Lebensmittelsicherheit in 2003 and should be used
also in the context of this renewal assessment.
2013-11-05
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IIIA1 6.1.1
MON78708
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Central Zone
Page 8 of 35
Preliminary range-finding tests
No preliminary range finding tests were submitted. The applicant has made references to authorisations of Tender GB Ultra (033981-00), Roundup/Durano and Roundup Ultra in Germany
as to the EU dossier for the admission of glyphosate in Annex I of Dir 91/414.
Otherwise the applicant indicates that glyphosate is a well-known herbicide active substance
and range finding tests (conducted in the laboratory, in the glasshouse or as small scale field
trials) are not required.
IIIA1 6.1.2
Minimum effective dose tests
A small number of trials were conducted with Tender GB Ultra or other products containing glyphosate formulation to evaluate the minimum effective dose.
Intended use 001
In total 5 trials (done in 2009) were evaluated, in which spray application techniques were used
under non cropped situations (plot sprayer application and rail-mounted Unimog application).
Tender GB Ultra and MON79351 glyphosate formulation were included in these trials. In the
individual trials the product was applied using spray solutions with 2250 and 3600 g a.s./ha.
Tab. 6.1.2-1: Number of efficacy trials
2009
Germany
5
Tab. 6.1.2-2: Guidelines and trial design.
GEP
yes
standards
EPPO, no detailed information
number of replications 4
Tab. 6.1.2-3: Minimum effective dose (%) of Tender GB Ultra. Trials from 2009 – plot sprayer
application - maritime EPPO zone
Tender GB Ultra Tender GB Ultra
3600 g a.s./ha
2250 g a.s./ha
weed
EPPO
n
mean
mean
Artemisia spec.
ARTSS
1
68
68
Bromus spec.
BROSS
1
100
100
Cerastium glomeratum CERGL
1
100
83
Calamagrostis spec.
CLMSS
3
96
91
Convolvulus spec.
CONSS 1
72
53
Epilobium spec.
EPISS
2
87
78
Equisetum arvense
EQUAR 1
0
0
Festuca spec.
FESSS
1
87
75
Holosteum umbellatum HLOUM 1
100
100
Hypericum perforatum
HYPPE
3
100
96
Rumex spec.
RUMSS 2
99
100
Senecio spec.
SENSS
1
100
100
Solidago spec.
SOOSS 2
100
100
Taraxacum officinale
TAROF
3
100
100
Tab. 6.1.2-4: Minimum effective dose (%) Tender GB Ultra. Trials from 2009 – rail-mounted
Unimog application - maritime EPPO zone
Tender GB Ultra Tender GB Ultra
weed
EPPO
n
3600 g a.s./ha
2250 g a.s./ha
2013-11-05
Core Assessment
Artemisia spec.
Betula spec.
Bromus spec.
Cerastium glomeratum
Calamagrostis spec.
Convolvulus spec.
Carduus spec.
Daucus L. spec.
Epilobium spec.
Equisetum arvense
Erigeron canadensis
Festuca spec.
Galium L. spec.
Geranium robertianum
Holosteum umbellatum
Myosotis arvensis
Poa L. spec.
Rubus L. spec.
Rumex acetosa
Rumex spec.
Senecio spec.
Spergula arvensis
Urtica spec.
Vicia spec.
MON78708
043981-00/00
ARTSS
BETSS
BROSS
CERGL
CLMSS
CONSS
CRUSS
DAUSS
EPISS
EQUAR
ERICA
FESSS
GALSS
GERRO
HLOUM
HYPPE
MYOAR
POASS
RUBSS
RUMAC
RUMSS
SENSS
SPRAR
TAROF
URTSS
VICSS
1
1
1
2
1
1
1
1
2
1
2
2
1
1
1
1
1
1
1
1
1
2
1
1
1
2
mean
94
38
100
99
100
53
100
86
66
0
100
76
95
20
98
80
100
73
78
60
85
100
100
86
89
38
Registration Report
Central Zone
Page 9 of 35
mean
90
57
100
92
81
43
98
40
70
0
100
63
67
60
93
75
100
60
77
80
72
100
100
81
80
22
Generally the results from these trials (Tab. 6.1.2-3, Tab. 6.1.2-4) demonstrate that reducing the
dose rate of MON78708 (Tender GB Ultra) below 3600 g a.s./ha will cause in this indication a
lower degree of efficiency for many weed species. Therefore, 10.0 L/ha MON78708 is
considered to be the lowest dose rate providing reliable control of a broad spectrum of weed
species. Only one dose rate below the requested dose rate was tested.
Conclusions
One year trials were submitted for the maritime EPPO zone. 10.0 L /ha is considered to be the
lowest dose rate providing reliable control of a broad spectrum of weed species. But overall the
effectiveness of herbicides containing glyphosate and the required spray rate is well known.
Intended use 002
under non cropped situations. The applications in the two trials on track systems were carried
out at the beginning or the end of September 2002, respectively. That means that the efficacy of
glyphosate could not be assessed finally before winter, especially against perennial weeds or
woody shrubs.
Tab. 6.1.3-5: Number of efficacy trials.
2002
Germany
2
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Page 10 of 35
GEP
yes
standards
plot design, plot size
RCBD
plot size
20 – 30 m2
Tab. 6.1.3-7: Minimum effective dose (%) of Roundup Ultra in the maritime EPPO zone. Trials
from 2002 - assessment 18 – 49 days after application
Roundup Ultra
g a.s./ha
weed
EPPO
n
1800
1440
1080
540
Arrhenatherum elatius
ARREL
1
100
100
93
93
Galium mollugo
GALMO 1
0
35
0
0
Geranium dissectum
GERDI
1
50
80
Betula spec.
BETSS
1
0
0
0
0
Cirsium arvense
CIRAR
1
100
Convolvulus arvensis
CONAR 1
66
97
66
93
Phragmites australis
PHRCO 1
70
60
45
0
Urtica dioica
URTDI
1
40
50
70
50
The results (Tab. 6.1.3-7) show no clear tendency in application rate. On the other hand, there
are little data available. A detailed assessment of the results is difficult; but long term experience
with herbicides containing glyphosate is available. Due to these experiences the requested dose
rate is considered to be the lowest dose rate providing reliable control of several weed species
in this indication.
Conclusions
5.0 L/ha (1800 g a.s./ha) is considered to be the lowest dose rate providing reliable control of
several weed species. In general, only a limited number of trials were submitted. But overall the
effectiveness of herbicides containing glyphosate and the required spray rate is well known.
Intended use 003
No results were submitted for this indication.
Many experiences are available with the requested dose rate. The effectiveness of herbicides
containing glyphosate is well known in wiping application.
Conclusions
A dose rate of 33% is considered to be the lowest dose rate providing reliable control of several
weed species. Overall the effectiveness of herbicides containing glyphosate and the required
spray rate is well known.
Intended use 004
No results were submitted for this indication. Results can be transferred from indication 001.
The spectrum of weed species, date of application and are sufficiently comparable through indication 001 and 004. There is no need for submitting additional results.
Intended use 005
In total 2 trials (done in 2001 and 2002) were evaluated, in which spray application techniques
were used under non cropped situations. Roundup Ultra and other glyphosate formulations
were tested with an application rate of 540, 1080, 1440 and 1800 g a.s./ha. Applications were
carried out during a period from mid of July to end of September.
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Page 11 of 35
Material and methods
Tab. 6.1.3-8: Number of trials.
2001
Germany
1
2002
1
total
2
GEP
yes
standards
RCBD
plot size
20-30 m2
Tab. 6.1.3-10: Minimum effective dose (%) of Roundup Ultra in the maritime EPPO zone. Trials
from 2001-2002, assessment 20-249 days after application
Roundup Ultra
g a.s./ha
weed
EPPO
n
1800
1440
1080
540
Agropyron repens
AGRRE 1
100
100
100
Betula spec.
BETSS
1
85
58
41
15
Cirsium arvense
CIRAR
1
31
29
30
perennial grasses
GGGPE 1
89
63
31
18
PHRCO 1
100
100
100
Poa trivialis
POATR
1
100
99
98
Stellaria media
STEME
1
100
100
100
Urtica dioica
URTDI
1
92
90
74
Generally the results (Tab. 6.1.3-10) from these trials demonstrate that reducing the dose rate
of Roundup Ultra below 1800 g a.s./ha will cause in this indication a lower degree of efficiency
for several weed species (e.g. BETSS, GGGPE). Therefore, 5.0 L/ha MON78708 is considered
to be the lowest dose rate providing reliable control of several weed species.
Conclusions
5.0 L/ha is considered to be the lowest dose rate providing reliable control of several weed
species. In general, only a limited number of efficacy trials were submitted. Overall the effectiveness of herbicides containing glyphosate and the required spray rate is well known.
Intended use 006
No results were submitted for this indication.
Many experiences are available with the requested dose rate. The effectiveness of herbicides
containing glyphosate is well known in wiping application.
Conclusions
A dose rate of 33% is considered to be the lowest dose rate providing reliable control of several
weed species. Overall the effectiveness of herbicides containing glyphosate and the required
rate is well known.
IIIA1 6.1.3
Efficacy tests
Intended use 001
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Page 12 of 35
under non cropped situations (plot sprayer application and Unimog application). Tender GB Ultra and MON79351 glyphosate formulation were included in these trials. In the individual trials
the product was applied using spray solutions up to 3600 g a.s./ha. Occurring weeds assessed
up to one year after application. The trials were carried out according to EPPO-standards and
GEP.
2009
Germany
5
GEP
yes
standards
Tab. 6.1.3-3: Efficacy (%) of Tender GB Ultra. Trials from 2009 – plot sprayer application maritime EPPO zone
Tender GB Ultra
MON79351
3600 g a.s./ha
3600 g a.s./ha
weed
EPPO
n
mean
mean
Artemisia spec.
ARTSS
1
68
100
Bromus spec.
BROSS
1
100
100
1
100
100
Calamagrostis spec.
CLMSS
3
96
97
Convolvulus spec.
CONSS 1
72
85
Epilobium spec.
EPISS
2
87
80
Equisetum arvense
EQUAR 1
0
Festuca spec.
FESSS
1
87
92
Holosteum umbellatum HLOUM 1
100
100
HYPPE
3
100
100
Rumex spec.
RUMSS 2
99
100
Senecio spec.
SENSS
1
100
100
Solidago spec.
SOOSS 2
100
100
TAROF
3
100
100
Tab. 6.1.3-4: Efficacy (%) of Tender GB Ultra. Trials from 2009 – rail-mounted Unimog application - maritime EPPO zone
Tender GB Ultra
MON79351
3600 g a.s./ha
3600 g a.s./ha
weed
EPPO
n
mean
mean
Artemisia spec.
ARTSS
1
94
98
Betula spec.
BETSS
1
38
50
Bromus spec.
BROSS
1
100
100
2
99
100
Calamagrostis spec.
CLMSS
1
100
98
Convolvulus spec.
CONSS 1
53
30
Carduus spec.
CRUSS
1
100
100
Daucus L. spec.
DAUSS
1
86
50
Epilobium spec.
EPISS
2
66
64
Equisetum arvense
EQUAR 1
0
0
Erigeron canadensis
ERICA
2
100
100
2013-11-05
Core Assessment
weed
Festuca spec.
Galium L. spec.
Geranium robertianum
Holosteum umbellatum
Myosotis arvensis
Poa L. spec.
Rubus L. spec.
Rumex acetosa
Rumex spec.
Senecio spec.
Spergula arvensis
Urtica spec.
Vicia spec.
MON78708
043981-00/00
EPPO
n
FESSS
GALSS
GERRO
HLOUM
HYPPE
MYOAR
POASS
RUBSS
RUMAC
RUMSS
SENSS
SPRAR
TAROF
URTSS
VICSS
2
1
1
1
1
1
1
1
1
1
2
1
1
1
2
Registration Report
Central Zone
Page 13 of 35
Tender GB Ultra
MON79351
3600 g a.s./ha
3600 g a.s./ha
mean
mean
76
77
95
100
20
98
80
80
100
100
100
73
100
78
87
60
90
85
50
100
100
100
100
86
86
89
38
50
In general Tender GB Ultra demonstrates a good level of effectiveness against several different
weed species present in the trials similar to that of a specific standard reference product (Tab.
6.1.3-3, Tab. 6.1.3-4). Summarizing the data available it can be concluded that the tested glyphosate formulation showed on railway tracks a sufficient weed control for the yearly vegetation
period.
Conclusions
One year efficacy results were submitted by the applicant. The effectiveness is demonstrated
with an application rate of 10.0 L/ha for several relevant weed species in this indication. In
general, only a limited number of efficacy trials was submitted. But overall the effectiveness of
herbicides containing glyphosate is well known.
Intended use 002
under non cropped situations. The applications in the two efficacy trials on track systems were
carried out at the beginning or the end of September 2002, respectively. That means that the
efficacy of glyphosate could not be assessed finally before winter, especially against perennial
weeds or woody shrubs.
Material and methods
2002
Germany
2
GEP
yes
standards
RCBD
plot size
20-30 m2
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Page 14 of 35
Tab. 6.1.3-7: Efficacy (%) of glyphosate (1800 g/ha) in the maritime EPPO zone. Trials from
2002 - assessment 18-49 days after application
Roundup
MON
MON
weed
EPPO
n Roundup
Ultra
78294
78568
Arrhenatherum elatius
100
100
98
ARREL
1
100
Galium mollugo
0
0
30
GALMO 1
0
Geranium dissectum
100
GERDI
1
100
Betula spec.
0
0
0
BETSS
1
0
Cirsium arvense
100
CIRAR
1
Convolvulus arvensis
66
100
98
CONAR 1
100
70
35
PHRCO 1
30
Urtica dioica
40
100
97
URTDI
1
100
In general Tender GB Ultra demonstrates a good level of effectiveness against several different
weed species present in the trials similar to that of a specific standard reference product (Tab.
6.1.3-7). Summarizing the data available it can be concluded that the tested glyphosate formulations showed on railway tracks a sufficient weed control for the yearly vegetation period. A
limited number of efficacy trials was submitted.
Conclusions
One year efficacy results were submitted by the applicant. The effectiveness is demonstrated
with an application rate of 5.0 L/ha for several relevant weed species in this indication. Two
applications with a dose rate of 5.0 L/ha are requested. In general, only a limited number of
efficacy trials was submitted. But overall the effectiveness of herbicides containing glyphosate is
well known.
Intended use 003
The spectrum of weed species and dates of application are sufficiently comparable through indication 003 and 006. There is no need for submitting additional results.
Intended use 004
The spectrum of weed species and dates of application are sufficiently comparable through indication 001 and 004. There is no need for submitting additional results.
Intended use 005
In total 2 trials (done in 2001 and 2002) were evaluated, in which spray application techniques
were used under non cropped situations. Roundup Ultra was tested with an application rate of
1800 g a.s./ha and 2 x 1800 g a.s./ha. Applications were carried out during a period from mid of
July to end of September. In the set-aside trial conducted in 2001 assessments were carried out
at 20 and 229 days after application (DAA), while assessments in the further trial were performed at 28 and 97 DAA.
2002
2001
Germany
1
1
total
2
GEP
yes
standards
2013-11-05
Core Assessment
number of replications
plot size
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Registration Report
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Page 15 of 35
4
RCBD
20-30 m2
Tab. 6.1.3-10: Efficacy (%) of Roundup Ultra in the maritime EPPO zone. Trials from 2001-2002
- assessment 20 – 249 days after application
Roundup Ultra
Roundup Ultra
1800 g a.s./ha
2 x 1800 g a.s./ha
weed
EPPO
n
mean
min max
mean
min max
Agropyron repens
AGRRE 1
100
Betula spec.
BETSS
1
85
95
Cirsium arvense
CIRAR
1
31
perennial grasses
GGGPE 1
89
100
PHRCO 1
100
Poa trivialis
POATR
1
100
Stellaria media
STEME
1
100
Urtica dioica
URTDI
1
92
The evaluation of the assessment data of the 2 trials performed on set-aside has confirmed that
a dose rate of 1800 g a.s./ha of glyphosate applied one time can be said to be appropriate to
ensure an effective and reliable control of several annual and perennial weed species occurring
on set-aside locations. For the control of woody plants like BETSS or high infestation of perennial grass weeds on set-aside areas a second glyphosate treatment at a dose rate of 1800 g
a.s./ha applied approximately 8-9 weeks after the first was necessary to achieve a high and
reliable level of control, especially of woody shrubs. Comparing the total mean efficacy levels of
the individual formulations achieved by equivalent dose rates, the tested formulations can be
said to be not significantly different, excepting the mean levels of the 540 and 1080 g a.s./ha
treatment of MON78568, which were only based on the values of BETSS and GGGPE. Comparing the total levels achieved by 1800 g a.s./ha to the levels achieved by the reduced rates of
1080 or 540 g a.s./ha, a significant effect on dose response was observable for each of the
tested formulations.
Conclusions
Two year efficacy results were submitted by the applicant. The effectiveness is demonstrated
with an application rate of 5.0 L/ha and 2 x 5.0 L/ha for a limited number of weed species. In
general, only a limited number of efficacy trials was submitted. But overall the effectiveness of
herbicides containing glyphosate is well known.
Intended use 006
In total 16 trials were conducted in Germany. All trials are located in the maritime EPPO climate
zone.
The trials from 1987 were carried out with MON2139 (Roundup). The applicant pointed out that
MON2139 (Roundup) is comparable to MON78708 (Tender GB Ultra).
The trials from 2004 and 2005 were carried out with MON78294 (Roundup UltraMax) and MON
14420. The applicant pointed out that MON78294 (Roundup UltraMax) is comparable to MON
78708 (Tender GB Ultra).
The trials from 2009 were carried out with the requested herbicide (MON78708, Tender GB Ultra).
2004
1987
Germany
8
3
2005
3
2009
2
total
16
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GEP
1987 (official trials), yes 2004, 2005, 2009
standards
No information
RCBD
application method
wiping, single plant treatment
target dose rate
33 %
reference products
Ustinex, Basta, Vorox plus
Tab. 6.1.3-13: Efficacy (%) of MON2139 (Roundup) in the
1987 - assessment 28 days after application
MON 2139
weed
EPPO
n
mean
min
Agropyron repens
AGRRE 4
100
100
Poa annua
POAAN
6
99
95
Dactylis glomerata
DACGL
3
98
95
Urtica dioica
URTDI
3
96
90
TAROF
3
100
100
Senecio vulgaris
SENVU
2
100
100
Trifolium repens
TRFRE
2
100
100
Vicia L. spec.
VICSS
1
95
Artemisia vulgaris
ARTVU
1
90
Atriplex patula
ATXPA
1
100
Plantago media
PLAME
1
90
Aegopodium podaAEOPO 1
85
graria
Impatiens parviflora
IPAPA
1
100
-
maritime EPPO zone. Trials from
max
100
100
100
100
100
100
100
-
ref. product
mean
min max
50
10
90
71
10
100
91
85
98
63
30
95
68
10
100
100
100
100
85
10
10
10
-
-
-
-
-
-
-
-
-
8 trials from 1987 were evaluated (Tab. 6.1.3-13), in which Roundup (MON2139) efficacy
against tough weeds under non-crop situation was tested. In the individual trials the product was
applied using wiping solution. Several weeds were assessed. With the exception of AEOPO for
all weed species a good control was estimated. Trials were not carried out according GEP.
Therefore consideration of results is only partly possible.
Tab. 6.1.3-14: Efficacy (%) of Roundup UltraMax (MON78294) in the maritime EPPO zone. Trials from 2004 and 2005, assessment 21-63 days after application.
MON78294
Roundup UltraMax
weed
EPPO
n
mean
min max
Cirsium arvense
CIRAR
2
100
100
100
Rumex acetosella
RUMAA 1
100
Prunus serotina
PRNSO 1
82
Polygonum amphibium POLAM 1
91
Artemisia vulgaris
ARTVU
1
100
Six trials (3 in 2004 and 3 in 2005) were evaluated (Tab. 6.1.3-14), in which Roundup UltraMax
efficacy against tough weeds under grass land and non-crop situation was tested. In the individual trials the product was applied using wiping solution and different dose rates. Assessed
weeds were CIRAR (2x), RUMAA, PRNSO, POLAM and ARTVU in BEAVU.
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On mean of the evaluated trials 3 weeks after application Roundup UltraMax has achieved good
to excellent levels of control against the occurred weed species. Only for PRNSO lower efficacy
1 year after application was assessed, which might be an experimental failure due to root/shoot
connection.
In conclusion, MON78294 applied as single plant treatment (wiping) can be considered to be
appropriate for an effective weed control on ways and places with woody plants. These results
support also
• weed control after wiping applications in non-crop situations and ways and places
with/without woody plants
• weed control after wiping applications in tree nurseries
• weed control after wiping applications in non-crop situations and ways and places
with/without woody plants (lawn and garden situation)
• weed control after wiping applications in tree nurseries
• weed control after wiping applications on railway tracks
Tab. 6.1.3-15: Efficacy (%) of Tender GB Ultra in the maritime EPPO zone. Trials from 2009 assessment 25 – 31 days after application
Tender GB Ultra
MON79351
weed
EPPO
n
mean
min max
mean
min max
Betula spec.
BETSS
2
97
94
100
93
87
99
(leaf application)
Betula spec.
BETSS
2
0
0
0
0
0
0
(trunk application)
Trials from 2009 showed good control of Betula spec. after leaf application. Trunk application
was not successful (Tab. 6.1.3-15).
Conclusions
Efficacy results from several years were submitted by the applicant. The effectiveness is demonstrated after wiping application.
IIIA1 6.1.4
Effects on yield and quality
Not relevant. MON78708 is used on railway tracks and on ways and places.
IIIA1 6.1.4.1 Impact on the quality of plants and plant products
IIIA1 6.1.4.2 Effects on the processing procedure
IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products
IIIA1 6.2
Adverse effects
IIIA1 6.2.1
Phytotoxicity to host crop
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Adverse effects on health of host animals
IIIA1 6.2.3
Adverse effects on site of application
IIIA1 6.2.4
Adverse effects on beneficial organisms (other than bees)
Effects on relevant beneficial arthropods
The herbicide Tender GB Ultra (MON 78708, 360 g/L glyphosate, SL) has been proposed for a
single application with a rate of 10 L/ha and for two applications with rates of 5 L/ha each, both
in non-agricultural land without woody plant and on railway track installations. The maximum
recommended use rate per year is 3.6 kg a.s.
Due to the nature of the intended use of Tender GB Ultra (complete vegetation control), beneficial arthropods and their effects in the target area are not considered to be relevant. Thus no
assessment has been made.
Effects on soil quality
Effects on soil macro-organisms being used as indicators of soil quality
Effects on earthworms
Toxicity
An acute earthworm toxicity study was carried out with MON 52276. Earthworms were directly
exposed to MON 78708 residues mixed into the soil. The 14-day LC50 of MON 52276 for earthworms is considered to be > 1250 mg/kg dry soil (equivalent to 386.9 mg a.s./kg dry soil). The
no observed effect concentration (NOEC) was determined to be 270 mg/kg dry soil (equivalent
to 83.6 mg a.s./kg dry soil) .
Sublethal earthworm studies were conducted with MON 0139 and AMPA (aminomethylphosphonic acid). MON 0139 had no significant effects on the reproductive capacity of worms at
treatment rates up to and including the maximum tested, i.e. 1000 mg MON 0139/kg soil dry
weight (equivalent to 472.8 mg glyphosate (a.s.)/kg dry weight). Therefore, the NOEC was determined to be 472.8 mg a.s./kg dry weight. The EC50 could not be calculated, but it can be
concluded that the EC50 is higher than 472.8 mg a.s./kg dry weight, this being the highest concentration tested. This new study supersedes an earlier study reviewed by ECCO for the Glyphosate Monograph Monsanto report no. CE-1999-257), where the highest concentration tested
of 21.3 mg a.s./kg dry soil had no effect on all measured endpoints.
In the same study (Monsanto report no. CE-1999-257), the chronic toxicity of the metabolite
AMPA to earthworms was evaluated at two treatment rates and no significant effects on the
reproductive capacity of worms was observed at the maximum rate tested (i.e. 28.12 mg/kg soil
dry weight). Therefore, the 56-d NOEC was determined to be 28.12 mg/kg dry weight. After review of this study by ECCO for the Glyphosate Monograph, it was concluded that AMPA poses
no chronic risk to earthworms.
Earthworm toxicity endpoints considered in the risk assessment of Tender GB Ultra (MON
78708)
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Endpoint
Value
(mg a.s. or AMPA/kg
dry soil)
14-d LC50
NOEC
> 386.9
83.6
MON 0139
56-d NOEC
472.8
AMPA
56-d NOEC
28.1
Test substance
Registration Report
Central Zone
Page 19 of 35
Reference
Acute toxicity
MON 52276
Hoxter, K.A., Smith, G.J.
(1992)
Report No.: 139-306
Chronic toxicity
Friedrich, S. (2009)
No.: 09 10 48 056 S
Monsanto Study
CE-1999-257
Exposure
The exposure to soil organisms was estimated by calculating the maximum instantaneous predicted environmental concentrations in soil (PECS) (see Registration Report - Part B, Section 5).
For MON 78708, the PECS values were calculated following the maximum label rate of 3.6 kg
a.s./ha. Since MON 78708 is rapidly broken down into its constituent parts on contact with soil
and/or plant material, it was appropriate to calculate the PECS following a single application
only.
The soil depth was assumed to be 1 cm and the soil dry bulk density was assumed to be 1.5
g/cm3.
The resulting maximum instantaneous PECS value was determined to be 24 mg a.s./kg dry soil.
This is an overly conservative exposure estimate as some vegetation will be present in the
treated areas at the time of MON 78708 application.
PECs values for the metabolite AMPA were estimated using the results of the laboratory glyphosate degradation studies. The Glyphosate Review Report reported that 29% of the initial
theoretical concentration of glyphosate was converted into AMPA (Annex Point IIIA 9.1). Therefore the initial PECs for AMPA was taken to be 29% of the initial PECs of glyphosate (Annex
Point IIIA 9.4.1) corrected for molecular weight and was calculated to be 4.56 mg/kg dry soil,
assuming a 1 cm soil depth.
Toxicity exposure ratios, TERA and TERLT
Acute risk
The potential acute risk of MON 78708 to earthworms was assessed by comparing the maximum instantaneous PECS with the 14-day LC50 value. The log KOW value of glyphosate acid is
less than 2, hence there was no need to reduce the LC50 by a factor of 2 in order to account for
the relatively high organic matter content of the artificial test soil compared to agricultural soils.
The TERA was calculated as follows:
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LC50 (mg a.s./kg)
PECS (mg a.s./kg)
The resulting TERA values are shown in Table 10.6.1-1.
Acute TER values for earthworms exposed to MON 78708
Test substance
LC50
(mg a.s./kg dry soil)
Maximum instantaneous PECS (mg a.s./kg) 1
TERA
MON 78708
> 386.9
24
>16.1
1
Assuming application rate of 3.6 kg a.s./ha, a soil incorporation depth of 1 cm and a soil bulk
density of 1.5 g/cm3.
Conclusion
The acute TER value is higher than the Annex VI acute trigger value of 10, indicating that MON
78708 poses low acute risk to earthworms when applied at the maximum application rate.
Long-term risk
The chronic toxicity of glyphosate to earthworms was investigated in Glyphosate Task Force
study no. T001934-09. The results indicate no effects on earthworm mortality or reproduction at
doses up to 1000 mg MON 0139/kg dry soil (equivalent to 472.8 mg a.s./kg dry soil). An additional study was conducted with AMPA indicating no effects on earthworm mortality or reproduction at concentrations up to 28.1 mg/kg.
The potential long-term risk of MON 78708 to earthworms was assessed by calculating longterm TER (TERLT) values from the 56-day toxicity endpoint for MON 0139 and AMPA and the
worst-case PECs soil concentrations using the following equation:
TER LT =
NOEC (mg a.s./kg)
PECS (mg a.s./kg)
The resulting TERLT values are presented below:
Long-term TER values for earthworms exposed to MON 78708 based on glyphosate IPA salt
and AMPA toxicity
Test substance
56-day NOEC
(mg a.s. or AMPA/kg
dry soil)
Maximum instantaneous PECS 1
(mg a.s. or AMPA/kg
dry soil)
TERLT
(for active substance)
MON 0139
472.8 2
24
19.7
AMPA
28.1 2
4.56
6.2
1
Assuming application rate of 3.6 kg a.s./ha, a soil incorporation depth of 5 cm and a soil bulk
density of 1.5 g/cm3.
2
Highest concentration tested
Conclusion
The long-term TER values exceed the Annex VI long-term trigger value of 5, indicating that
MON 78708 and AMPA pose a low long-term risk to earthworms. Considering a PEC using a
1 cm incorporation the TERLT still greatly exceeds the VI long-term trigger value of 5.
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Field tests
Field studies are not required as the risk for earthworms from exposure to MON 78708 is considered to be low.
Effects on other non-target soil macro-organisms
Studies carried out on earthworms and soil micro-organisms indicate low toxicity of MON 78708.
Additionally, literature studies were reviewed in the Glyphosate Monograph leading to the same
conclusion. The risk to soil non-target macro-organisms is therefore considered low and no further formulation testing is required.
Effects on organic matter breakdown
Studies carried out on earthworms and soil micro-organisms indicate low toxicity of MON 78708.
Additional published data were reviewed in the Glyphosate Monograph leading to the same
conclusion. Therefore, the potential for effects on organic matter breakdown is considered low
for MON 78708 and no further formulation testing is required.
Overall conclusion with respect to effects on soil macro-organisms
It is concluded that the proposed use of Tender GB Ultra (MON 78708) will not pose an unacceptable risk to populations of earthworms or other soil macro-organisms, when applied according to the recommended use pattern.
Instructions and information: None
Effects on soil micro-organisms being used as indicators of soil quality
Effects on soil non-target micro-organisms exposed to Tender GB
Studies have been conducted with MON 52276 (similar formulation) to determine the effects on
soil micro-organisms.
Ecotoxicological endpoints for soil micro-organisms
Test
EU agreed endpoints
Test item
design1
Reference
Carter, J.N. (2001): Huntingdon Life Sciences Ltd., AlAt 53.0 L product/ha:
MON 52276
conbury, Huntingdon, Cam< 25% effect after 28 days
N
bridgeshire, UK. Report No:
256/004346
1
C = Carbon mineralization, N = Nitrogen transformation.
C
Risk assessment for soil microflora functions
Test substance
NOEC
(< 25% effect at 28 d)
Maximum PECsoil
MoS*
MON 52276
19.08 kg a.s./ha
3.6 kg a.s./ha
5.3
* Margin of Safety; 1
According to the GAP, Tender GB is intended to be applied with a maximum application rate of
3.6 kg glyphosate/ha for the proposed uses.
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The results of these studies showed no effects of > ± 25% compared to the control on soil microbial activity up to a maximum tested concentration of 19.08 kg a.s/ha, after 28 days. As this
maximum tested concentration was higher than the maximum initial PECsoil (3.6 kg a.s./ha).
As the proposed use of Tender GB an acceptable risk to soil microbial activity can be concluded.
Overall conclusion with respect to effects on soil quality
There is no indication of any unacceptable adverse effects on soil macro- or soil microorganisms relevant for the maintenance of soil quality.
IIIA1 6.2.5
Adverse effects on parts of plant used for propagating purposes
This point is not relevant because MON78708 is used on railway tracks and on ways and
places. There are no studies required.
IIIA1 6.2.6
Impact on succeeding crops
This point is not relevant because MON78708 is used on railway tracks and on ways and
places. There are no studies required. Glyphosate has no soil activity it can be assumed that
there is no negative impact on succeeding crops.
IIIA1 6.2.7
Impact on other plants including adjacent crops
A complete risk assessment for adjacent growing plants on the basis of the EPPO standard
PP1/256 was not carried out. The applicant mentioned that MON78708 is a non selective herbicide. Therefore, MON78708 should be used with care and in line with good plant protection
practice. Directions for use for example in regard to uncontrolled spay drift to neighbouring
fields, weather conditions or water volumes have to be observed. If requirements of good plant
protection practice are observed it can be assumed that there are no negative impacts on other
plants, including adjacent crops.
Results from vegetative vigour tests can be used for evaluation. The potential effects of MON
78708 on vegetative vigour of 10 non-target terrestrial plants have been examined using glyphosate acid and a non-ionic surfactant.
Tab. 6.2.7-1 Toxicity of glyphosate to non-target plants
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Endpoint (kg a.s./ha) at Day 21
Survival
Plant height
Plant dry weight
NOEC
EC50
NOEC
EC50
NOEC
EC50
Ryegrass
1.232
4.592
0.627
2.352
0.627
1.344
Corn
0.627
1.680
0.627
0.918
0.627
0.750
Onion
5.040
> 5.040
0.627
> 5.040
0.627
1.792
Oat
2.576
> 5.040
0.627
1.344
0.157
0.874
Soybean
5.040
> 5.040
0.627
1.568
0.314
0.974
Lettuce
1.232
2.800
0.627
1.344
0.314
0.762
Cucumber
2.576
4.032
0.314
1.456
0.314
0.896
Cabbage
1.232
4.592
0.627
1.456
0.157
0.739
Radish
0.314
0.918 a
0.078
0.358 a
0.039
0.246 a
Tomato
0.314
0.515 a
0.039
0.336 a
0.039
0.146 a
a
Most sensitive EC50, used for TER calculations.
The amount of spray drift reaching off-crop habitats is calculated using the 90th percentile estimates derived by the spray-drift predictions of Rautmann et al. (2001): 2.77% at 1 m from
treated field edges and 0.57% at 5 m. Only a single application was considered as factors such
as plant growth will reduce residues per unit area between multiple applications. Expected exposure concentrations were estimated considering the maximum use rate of 3.6 kg a.s./ha.
With modern nozzle types (low pressure nozzles, anti-drift nozzles, air-assisted spraying systems), drift reductions are observed. PECs resulting from use of these technologies were also
considered. For this assessment, a value of 75% drift reduction was considered.
Initial PEC values are summarised in Table 6.2.7-2.
Table 6.2.7-2: Initial predicted environmental concentrations (PECi) of glyphosate following
spray drift into off-crop areas during application of MON 78708 at the maximum use rate
Distance from the treated field edge
No drift reduction
1m
5m
PECi (kg a.s./ha)
0.0997
1
0.0205
75% drift reduction
1m
5m
PECi (kg a.s./ha)
0.0249
0.0051
Application rate = 10 L MON 78708/ha, equivalent to 3.6 kg a.s/ha.
Based on the PEC values presented above for MON 78708, toxicity-exposure ratios were calculated using the EC50 for survival, plant height and plant dry weight of the two most sensitive
species tested in the vegetative vigour study (radish and tomato). Results are given in Table
6.2.7-3.
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Table 6.2.7-3: TER values for the most sensitive non-target plants exposed to glyphosate following spray drift into off-crop areas during application of MON 78708 at the maximum use rate
Species
(study type) Paramemter
Distance from the treated field edge
21-d EC501
No drift reduction
1m
5m
75% drift reduction
1m
5m
Toxicity/Exposure Ratio (TER) 2
Radish (vegetative vigour)
Survival
0.918
9.2
45
39
180
Plant height
0.358
3.6
17
14
70
Plant dry weight
0.246
2.5
12
10
48
Tomato (vegetative vigour)
Survival
0.515
5.2
25
21
101
Plant height
0.336
3.4
16
14
66
Plant dry weight
0.146
1.5
7
6
29
1
2
For most sensitive species tested, from Table 10.8.1-2
TER = 21-day EC50 (kg a.s./ha) / PECi (kg a.s./ha).
Table 6.2.7-3 indicates that, for sensitive plant species, TER values are greater than the trigger
of 5 at a distance of 5 m from treated field edges. The use of drift reduction measures raises the
TER to greater than 5 at 1 m from the treated field edge. This is considered to be a worst-case
assessment since the plants were treated at a susceptible growth stage.
Conclusions
MON 78708 is not expected to cause unacceptable risk to non-target plants when recommended use instructions and Good Agricultural Practices are respected. The use of anti-drift
application methods can be encouraged to further reduce the probability of any transient effects
in the area immediately surrounding treated fields.
IIIA1 6.2.8
Possible development of resistance or cross-resistance
Mechanism of resistance
The herbicide Tender GB Ultra contains the active substance glyphosate. The mode of action of
this active substance is to inhibit an enzyme involved in the synthesis of basic aromatic amino
acids. Glyphosate has been classified by the Herbicide Resistance Action Committee (HRAC)
as a herbicide inhibiting the enzyme EPSP synthase (HRAC group G).
Since most mutations of the EPSPS enzyme prevent its proper function and result in the death
of the plant, such mutations were regarded as unlikely to give rise to glyphosate-resistant weed
populations. A number of experiments with different active substances have shown a low frequency of glyphosate resistance compared to resistance to imidazoline and a sulfonlyurea. This
difference in frequency seems to be “related to the number and frequency of potential changes
in the target enzyme, which affect the binding potential of the herbicide. Accordingly many
changes are possible in the ALS enzyme; meanwhile only two specific changes in glyphosate
binding to plant EPSPS are known to confer resistance.” For example glyphosate resistance in
Eleusine indica is due to an altered target site, whereas the mechanism of resistance in the
other weed species is currently under investigation. Three different resistance mechanisms
were shown to be relevant for glyphosate resistance in weed species: target site mutation, limJulius Kühn-Institut
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ited or reduced glyphosate translocation and gene amplification. As a conclusion, the mechanisms for glyphosate “resistance seem to be complex and have not been fully elucidated.”
Evidence of resistance and cross resistance
Whereas glyphosate was first introduced as a commercial herbicide in 1974 under the trade
name of Roundup, the first documented case of glyphosate resistance was reported 22 years
later in the case of a Lolium species from an Australian orchard in 1996, based on an intensive
selection pressure over 15 years with two or three applications per year. Since 1996 several
additional resistant weed populations have been identified, encompassing cased from all over
the world, including Europe. Most cases of glyphosate resistance have been recorded from the
USA with considerable numbers also for South America and Australia where glyphosate is frequently applied throughout the year in both perennial and annual cropping systems. Such high
application frequencies are so far not common in arable systems of central Europe. However,
two or more applications per year are not uncommon on railways or in non crop situations.
Several weed species belonging to different botanical families have become resistant to glyphosate in the last 15 years. Currently (April 2012) the online database of Ian Heap
(www.weedscience.org) lists 22 plant species for which resistance has been documented, including 10 monocotyledonous and 12 dicotyledonous. In the following table, the applicant has
summarized the documented cases of weed resistance against glyphosate (Table 6.2.8-1). Biotypes indicated with a ‘*’ show multiple resistance mechanisms. Recent resistance cases not
mentioned by the applicant but listed under www.weedscience.org have been added to the table.
Table 6.2.8-1: Glycines (G/9) resistant weeds by species and country
Weed species
Country
Years with documented
cases till Apr 2012
Amaranthus palmeri
USA
2005, 2006, 2007, 2008*,
2009*, 2010, 2011, 2012
Amaranthus tuberculatus (Syn. rudis)
USA
2005*, 2006*, 2007,
2009, 2010, 2011*
Ambrosia artemisiifolia
USA
2004, 2006*, 2007, 2008
Ambrosia trifida
USA
2004, 2005, 2006*, 2007,
2008*, 2009, 2010
Canada
2008
Bromus diandrus
Australia
2011
Chloris truncata
Australia
2010
Conyza bonariensis
South Africa
2003
Spain
2004
Brazil
2005
Israel
2005
Colombia
2006
USA
2007, 2009*
Greece
2010
Portugal
2010
Australia
2010, 2011
USA
2000, 2001, 2002, 2003*,
2005, 2006, 2007*, 2009,
2011
2005
Conyza canadensis
Brazil
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2006
Spain
2007
Czech Republic
2007
Spain
2009
Brazil
2010
Brazil
2008, 2010
Paraguay
2006, 2008
Australia
2007, 2009, 2010
Argentina
2008
USA
2008
Malaysia
1997*
Colombia
2006
USA
2010, 2011
USA
2007, 2011
Canada
2012*
USA
2004, 2005, 2008, 2010*
Chile
2001*, 2002*, 2006*,
2007*
Brazil
2003, 2006, 2010*
Spain
2006
Argentina
2007, 2010
Lolium perenne
Argentina
2008
Lolium rigidum
Australia
1996, 1997, 1999*, 2003,
2008*, 2010*
USA
1998
South Africa
2001, 2003*
France
2005
Israel
2007*
Italy
2007
Spain
2006
Parthenium hysterophorus
Colombia
2004
Plantago lanceolata
South Africa
2003
Conyza sumatrensis
Digitaria insularis
Echinochloa colona
Eleusine indica
Kochia scoparia
Lolium multiflorum
Country
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Weed species
Country
Poa annua
USA
cases till Apr 2012
2010, 2011
Sorghum halepense
Argentina
2005, 2006
USA
2007, 2008, 2010
Australia
2008
Urochloa panicoides
Looking more in detail on the situation in Europe, currently 10 cases of resistance are known,
encompassing five different weed species, the dicotyledonous Conyza bonariensis,
C. canadensis and C. sumatrensis, as well as the monocotyledonous Lolium multiflorum and
L. rigidum. Spain is currently the most affected European country with five known glyphosate
resistant weed species. The other countries with cases of glyphosate resistance are Portugal,
France, Italy and the Czech Republic. So far, resistant biotypes have exclusively been found in
orchards, vineyards or olives groves (Italy, Spain and France) or on railways (Czech Republic).
All cases have been reported from the last seven years, indicating a growing impact of glyphosate resistance. The most serious problem seems to be L. rigidum with reported cases from
four different countries including a high number of affected sites. Besides one case
(C. canadensis) in the Czech Republic, Northern and Central Europe are not affected by glyphosate resistance up to now.
For all glyphosate-resistant weeds species from Europe, research has shown that these particular biotypes may also be cross-resistant to other HRAC Group G herbicides. Multiple resistances seems to be a serious issue in the case of some glyphosate-resistant weeds outside
Europe where resistance against up to four different herbicide groups (different modes of action)
has been detected.
Analysis of the inherent risk
Also the above listed cases of glyphosate resistance show clearly that a high resistance risk for
glyphosate has to be considered, the impact in Central Europe is still comparatively low. However, the increasing numbers of resistant populations worldwide including populations with multiple resistances to other MoA indicate a considerable and increasing resistance risk for glyphosate. The fact that all resistant biotypes in Europe have been found in perennial systems
indicates that a high risk applies especially for situations in which glyphosate is applied several
times a year e.g. on railways or in non crop situations.
The herbicide Tender GB Ultra aims at controlling both grasses and dicot weed species. A high
risk situation is evident for some of the weed species controlled by Tender GB Ultra like Lolium
spp. and Conyza spp. which have already evolved resistance in Europe. Those target species
can be considered as being high risk species as they have evolved resistance to many different
MoA. Lolium rigidum has developed resistance to the following MoA: ACCase Inhibitors (Fops
and Dims), ALS Inhibitors (Sulfonylureas), Photosystem-II-Inhibitors (Triazine and Ureas),
„bleachers“ (Triazoles) and Mitoses-Inhibitors (Carbamates). In Central Europe, resistance is so
far only evident in Conyza canadensis in the Czech Republic. The applicant claims that there “is
no history of reported or confirmed resistance to glyphosate developing in weed species commonly found on railway tracks in the Netherlands, Belgium, UK, Spain or France.” However, the
applicant does not list any of those species typically found on railways. Most likely, weed communities of railways will consist mainly of perennial and some annual species. In Germany, the
high risk species Conyza canadensis is also frequently found on railways. The same applies for
Lolium perenne, another high risk species. However, resistance to glyphosate has not yet been
found in these two species in Germany. According to the applicant, the inherent resistance risk
of glyphosate can be considered as low when good agricultural practice is followed. This conclusion cannot be completely followed. In consideration of the increasing number of resistance
cases worldwide and also in Europe, the inherent risk has to be assessed as being medium.
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No sensitivity data are provided. The applicant claims that glyphosate has been used commercially for almost 40 years. Therefore it may be difficult to find a still unexposed weed population.
EPPO (2001) recommends the establishment of sensitivity data by comparing the sensitivity of
resistant biotypes with that of populations showing no resistance and by undertaking greenhouse screening of many species over many years. This reference setting would also be possible for the new herbicide Tender GB Ultra. The applicant claims that the available data from
efficacy field trials can be used “to check for changes in susceptibility” and that there “are a
number of studies which have evaluated the variability of sensitivity to glyphosate in a weed
species.” However, no explicit data are presented by the applicant. He claims that “the available
data from efficacy field trials in Europe show no evidence of a change in weed susceptibility,
with the exception of the cases in perennial crops and Italy, Spain and France.”
Analysis of the agronomic risk
Glyphosate formulated as 360 g/L formulation (product name Tender GB Ultra) is intended to be
used against monocotyledonous and dicotyledonous weeds on railways as well as in non crop
situations with an application frequency of up to two applications per year.
As Tender GB Ultra is a broad spectrum herbicide, an unrestricted use pattern would mean use
against all weed species and frequent applications throughout the growing period/season. Annual weeds are mostly susceptible throughout their life cycle. However, for perennial weeds the
timing of application during their growth cycle can be critical to obtain good control. In annual
cropping systems, the use of glyphosate may be combined with other, non-chemical, weed
management techniques. Such agricultural cultivation measurements can be considered to reduce selection pressure by destroying annual weeds and suppressing perennial weeds but are
normally not used on railways or in non crop situations. Under Central European conditions, the
agronomic risk therefore has to be considered higher for the intended uses of Tender GB Ultra
compared to uses in arable systems. For Germany, the applicant has provided an assessment
of the agronomic risk for the following cropping systems: Arable crops, orchards and railways.
Since the herbicide is only indented to be used in non crop situations and on railways, only
those two systems will be considered in this resistance assessment.
The applicant claims that in non crop situations glyphosate is usually “applied for the control of
perennial weeds and may be completed by a range of herbicides used primarily for the control
of annual weeds. These herbicides often have different mode of action to glyphosate.” Therefore, application of glyphosate in alternation with other herbicides can be considered to reduce
the selection pressure for resistance. On railways, the applicant claims that “perennial weeds
are treated at their most susceptible growth stage every second year and that glyphosate treatment may be complemented by a herbicide with a different mode of action.” In addition, “tracks
are treated at different times each year so that perennial species are treated at their most susceptible growth stage every second year.” Although this may hold partially true for some situations, it seems unlikely that perennial species on railways are always treated at their most susceptible growth stage. This means that some species such as Conyza spp. will not be fully controlled and may therefore develop an increased potential for herbicide resistance. The applicant
claims that resistant bioytpes of can be controlled by a ready-mixed formulation of MCPA and
glyphosate especially when applied at early growth stages of the weed. For the control of resistant Lolium spp., tank mixtures with flazasulfuron, cycloxydim, clethodim and amitrole are recommended by the applicant.
The design of the respective crop rotations and the associated frequency of application of Tender GB Ultra may differ in the various Member States in the Central Zone and a national-specific
assessment of the agronomic risk is therefore recommended. The applicant has only provided
information on the individual agronomic risk in Germany but not for other Member States in the
Central Zone. Compared to arable crops, there therefore seems to be a higher risk for resistance development under non crop situations or on railways as glyphosate may be used as the
only herbicide.
It is concluded by the applicant that the overall agronomic resistance risk implemented by glyphosate can still be regarded as “low to moderate” under current normal European agricultural
practice although the resistance risk of some of the parameters might be considerable.
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Page 29 of 35
Summary and conclusion
According to the applicant, the risk of glyphosate resistance development in Europe appears to
be “still comparatively low and should be relatively easy to manage according to the procedures
and methods established successfully in France, Spain and other parts of the world.” The applicant suggests the following modifiers: non-chemical control measures, e.g. cultivation, mechanical weed control, a modified use of glyphosate, e.g. frequency, timing, dose rate, tank mixtures, the application of herbicides from different mode of action classes or adaptations in agricultural practices, e.g. crop rotation, use of cover crops, ploughing or conservation tillage. This
conclusion can be generally followed. However, the increasing use of glyphosate in many cropping and non crop systems in the Central registration zone of Europe constitutes an increasing
risk of resistance evolution in a number of weed species. Especially for uses on railways and in
non crop situations, the resistance risk is elevated. The general resistance risk of Tender GB
Ultra is therefore assessed as being low to medium. Besides the national-specific assessment
for Germany, the applicant has not provided any information on the individual resistance risk
within the different Member States in the central registration zone.
Management strategy
The applicant has provided specific management strategies for the following cropping systems:
Arable crops, orchards and railways. Those management strategies include: consideration of
GAP, use of herbicide with alternate mode of action and use of non-chemical control options.
No particular official restrictions on resistance management strategies are recommended for the
use of glyphosate containing products at the moment as the risk is only low to medium. However, the general recommendations of HRAC and further institutions for the prevention and delimitation of herbicide resistance should always be taken into account by the users of Tender
GB Ultra.
IIIA1 6.3
Economics
IIIA1 6.4
Benefits
IIIA1 6.4.1
Survey of alternative pest control measures
IIIA1 6.4.2
Compatibility with current management practices including IPM
IIIA1 6.4.3
Contribution to risk reduction
IIIA1 6.5
Other/special studies
There were no other or special studies conducted with MON78708
IIIA1 6.6
Summary and assessment of data according to points 6.1 to 6.5
The submission of the present draft Registration Report (dRR) serves the core registration of
MON78708 (glyphosate) in the central registration zone (B) of the European Union. Germany is
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Page 30 of 35
zRMS. The national label for Germany is available. A master label for the central zone (B) is
missing.
The applicant applies for a herbicide containing the active substance glyphosate. The evaluation
of the test compound is based on results of field trials conducted in Germany. Essentially the
trials satisfy the requirements for registration with regard to comprehension and quality of the
studies. In many cases the GEP-requirement is taken care of. The applicant refers to documents of other registered glyphosate herbicides in Germany.
Minimum effective dose tests were conducted regarding the control of mono- and dicotyledonous weeds. For all intended uses the requested dose rate is needed. A limited number of trials
were submitted. But overall the effectiveness of herbicides containing glyphosate and the required spray rate is well known.
Efficacy tests (spray and wiping application) were conducted regarding the control of mono- and
dicotyledonous weeds. MON78708 was tested in comparison to commercial standard reference
products. In the trials MON78708 demonstrated a level of efficacy against the different weed
species present in the trials similar to that of the commercial standard reference products. No
usable data were submitted for the intended use 003, 004 and for some intended uses only oneyear result were submitted. Results can be transferred from other indications. The spectrum of
weed species and dates of application are sufficiently comparable through the indications. A
limited number of trials were submitted. Overall the effectiveness of herbicides containing glyphosate is well known.
As MON78708 is non-selective herbicide the product should be used with care and in line with
good plant protection practice. Directions for use for example in regard to uncontrolled spay drift
to neighbouring fields, weather conditions or water volumes have to be observed. If requirements of good plant protection practice are observed it can be assumed that there are no negative impacts on other plants, including adjacent crops.
MON78708 is intended to be used as non-selective herbicide against monocotyledonous and
dicotyledonous weeds in on a number of field crops as well as in vineyards and orchards (pome
fruit) for desiccation and on non cropped areas. The active substance glyphosate is a commonly
used herbicide in agriculture worldwide. Despite the intensive use of glyphosate in many important crops on a worldwide scale, the number of documented cases of resistance is still comparatively low. However, the increasing use of glyphosate in many cropping systems in the Central
Zone of Europe constitutes an increasing risk of resistance. The general resistance risk of
MON78708 is therefore assessed as being low to medium.
IIIA1 6.7
List of test facilities including the corresponding certificates
No. Trial organisation
Address
1
agro-check
Dorfstr. 15
16833 Lentzke
Germany
agro-check
GEP
yes/no
yes
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Page 31 of 35
Appendix 1: List of data submitted in support of the evaluation
Annex
Point
Author
Title
Year
Document C
Anonymous
Gebrauchsanleitung Tender GB Ultra
2011
Ref. App.
Ref. JKI
253384
MIIIA1 Sec 6
MIIIA1 Sec 6
MIIIA1 Sec 7
Monsanto
Monsanto
Monsanto
Draft Registration Report - Part B - Tender GB
Ultra - DE -Section 6 - Ecotoxicology - Core
assessment
2011
Ultra - DE -Section 6 - Ecotoxicology - National
Addendum
2011
Ultra - DE -Section 7 - Efficacy Data and Information - Core assessment
2011
253388
253392
253394
KIIA 8.10
Todt, K.
Effect of the herbicide Roundup on the activity
of microflora of soil
1991
NA
90
9151
253405
KIIA 8.9.2
Hayward, J. C.
and Mallett, M.
J.
A laboratory investigation of the effects of glyphosate and its breakdown product AMPA on
reproduction in the earthworm Eisenia fetida
2000
Rep.-No.:
CEMR1173
253449
KIIA 8.9.1
Thun, S.
Acute toxicity in earthworms according to
OECD 207, test article: "Technical isopropylamin salt of glyphosate = Mon 0319"
1991
80-912078-00-90
253455
KIIA 8.9.1
Wüthrich, V.
Acute toxicity (LC50) of glyphosate to earthworms
1990
250784
253458
KIIA 8.9.1
Thun, S.
First amendment final report acute toxicity in
earthworms according to OECD 207, test article: "Mon 0319"
1995
80-912078-06-91
253464
KIIA 8.10
Trevors, J.T.
Bacterial biodiversity in soil with an emphasis
on chemically-contaminated soils
1900
k.A.
253473
KIIIA1 10.6.2
Hoxter, K. A.,
Smith, G. J.
MON 52276: An acute toxicity study with the
earthworm in an artificial soil substrate
1992
139-306 !
WL-91-272
253489
KIIIA1 10.7.1
Carter, J.N.
MON 52276 - Effects on soil non-target microorganisms: Nitrogen transformation, carbon
transformation
2001
HR-2000244 ! MON
256/00434
6
253492
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Page 32 of 35
Annex
Point
Author
Title
Year
Ref. App.
Ref. JKI
KIIIA1 10.6.3
Friedrich, S.
MON 0139 - Sublethal toxicity to the earthworm Eisenia fetida.
2009
T00193409 ! 09 10
48 056 S
253497
KIIIA1 10.6.2
Hayward, J.C.
MON 79351: Acute toxicity to the earthworm
Eisenia fetida
2003
CEMR2011
253500
MIIIA1 Sec 6
Monsanto
Ultra - DE -Section 6 - Ecotoxicology - Core
assessment
2011
Ultra - DE -Section 6 - Ecotoxicology - National
Addendum
2011
Ultra - DE -Section 7 - Efficacy Data and Information - Core assessment (word)
2011
MIIIA1 Sec 6
MIIIA1 Sec 7
Monsanto
Monsanto
253512
253513
253516
KIIIA1 6.1.2
Teresiak, H.
Railway bridging program TENDER GB ULTRA vs. MON 79351 - plot sprayer application
2010
200922093
4
253520
KIIIA1 6.1.3
Teresiak, H.
Railway bridging program TENDER GB ULTRA vs. MON 79351 - plot sprayer application
2010
200922093
4
253521
KIIIA1 6.1.2
Teresiak, H.
Railway bridging program TENDER GB ULTRA vs. MON 79351 - UNIMOG application
2010
200922093
6
253522
KIIIA1 6.1.3
Teresiak, H.
Railway bridging program TENDER GB ULTRA vs. MON 79351 - UNIMOG application
2010
200922093
6
253523
KIIIA1 6.1.2
Teresiak, H.
Railway bridging program TENDER GB ULTRA vs. MON 79351 - wiper application
2010
200922093
5
253525
KIIIA1 6.1.3
Teresiak, H.
Railway bridging program TENDER GB ULTRA vs. MON 79351 - wiper application
2010
200922093
5
253526
KIIIA1 6.2.8
Monsanto
Information on the possible Occurrence of the
Development of Resistance or CrossResistance (OECD: AIIIA-6.2.8) - Central Zone
(Germany; Austria)
2011
Ergebnisse der Zulassungsprüfung 1981 Herbizide - Unkraut- und Schosserrüben sowie
CHEAL, ATXPA u. CIRAR in Zucker- und Futterrüben
1981
KIIIA1 6.1.3
Anonymous
253527
H54/1 bis
H54/9
253528
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Page 33 of 35
Annex
Point
Author
Title
Year
Ref. App.
Ref. JKI
KIIIA1 6.1.3
Lindner, K.
Wiper application of different GLY formulations
to control tough weeds / trees
2004
2004511G
S1
253529
KIIIA1 6.1.3
Lindner, K.
2004
2004511G
S2
253531
KIIIA1 6.1.3
Lindner, K.
2004
2004511G
S3
253532
KIIIA1 6.1.3
Lindner, K.
to control tough weeds
2005
2005511G
D1
253533
KIIIA1 6.1.3
Lindner, K.
2005
2005511G
D2
253534
KIIIA1 6.1.3
Lindner, K.
2005
2005511G
D3
253536
KIIIA1 6.1.3
Anonymous
Ergebnisse der Prüfung 1987 - gegen Unkräuter (allgemein) - Wege und Plätze mit Baumbewuchs
1987
87/..
253537
KIIIA1 10.6.3
Friedrich, S.
MON0139 - Sublethal toxicity to the earthworm
Eisenia fetida
2009
T00193409 ! 09 10
48 056 S
298750
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Page 34 of 35
Appendix 2: GAP table
glyphosate
1
2
Use- Member
No.
state(s)
3
4
5
6
7
8
10
11
12
14
and/ F
situation G
or
(crop destination / I
purpose of crop)
Pests or Group of Application
pests
controlled
Application rate
Method
(additionally: develop- Kind
mental stages of the
pest or pest group)
kg, L product /
ha
a) max. rate
per appl.
[b) max. total
rate
per
crop/season]
PHI
Remarks:
(days
e.g. safener/synergist per
kg
a.s./ha Water L/ha )
ha
a) max. rate min / max
e.g. recommended or
per appl.
[b) max. total
rate
per
crop/season]
Crop
or
/ Timing / Growth Max. number
stage of crop & (min. interval
season
between
applications)
a) per use
b) per crop/
season
1
DE,
AT
YGLES
Railway tracks
F
TTTMM
monocotyledonous
weeds,
TTTDD
spraying
During growing
season
a) 1
b) 1
a) 10,0
b) 10,0
a) 3.6
b) 3,6
500 - 1000
2
DE,
AT
YGLES
Railway tracks
F
TTTMM
monocotyledonous
weeds,
TTTDD
spraying
During growing
season
a) 2
b) 2
(3 month(s))
a) 5,0
b) 10,0
a) 1.8
b) 3,6
500 - 1000
3
DE,
AT
YGLES
Railway tracks
F
TTTMM
monocotyledonous
weeds,
TTTDD
wiping
During growing
season
a) 1
b) 1
DE,
AT
YNKOB
Non-cultivated land
F
TTTMM
monocotyledonous
spraying
During growing
season
a) 1
b) 1
4
13
b) 3,6
a) 10,0
b) 10,0
a) 3.6
b) 3,6
500 1000*)
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Page 35 of 35
weeds,
TTTDD
5
DE,
AT
YNKOB
Non-cultivated land
F
TTTMM
monocotyledonous
weeds,
TTTDD
spraying
During growing
season
a) 2
b) 2
(3 month(s))
6
DE,
AT
YNKOB
Non-cultivated land
F
TTTMM
monocotyledonous
weeds,
TTTDD
wiping
During growing
season
a) 1
b) 1
a) 5,0
b) 10,0
a) 1.8
b) 3,6
500 1000*)
b) 3,6
*) Remark: 500 to 1000 l water/ha are unusual in Germany
2013-11-05

Tender GB Ultra (MON 78708) - Bundesamt für Verbraucherschutz

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