Pendimethalin final RR 1107 Art 51 Part A STOMP AQUA BASF DE

Transcription

Part A
Core Assessment
Stomp Aqua
Art. 51
Extension of authorisation for minor uses
BVL Registration Number:005958-00/28
Registration Report –Central Zone
Country – Germany
Page 1 of 14
Art. 51
REGISTRATION REPORT
Part A
Risk Management
Product code: Stomp Aqua
Active Substance:
Pendimethalin 455 g/L
COUNTRY: Germany
Central Zone
Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: BASF
BVL_FO_05_2422_200_V1.0
Date: 03/12/2012
Applicant
BASF SE E-APE/DT, Li 556
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 2 of 14
Table of Contents
BVL_FO_05_2422_200_V1.0
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
1.3.1
Uses applied for and registration decision............................................................................................. 5
1.3.2
Public interest and minor use ................................................................................................................. 5
1.4
Data protection claims............................................................................................................................. 6
1.5
Letters of Access ...................................................................................................................................... 6
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 or Regulation (EC) No 1272/2008................ 6
2.2.2
R and S phrases under Regulation (EC) No 547/2011 .......................................................................... 7
2.2.3
Other phrases ........................................................................................................................................... 7
2.2.3.1
Restrictions linked to the PPP ................................................................................................................ 7
2.2.3.2
Specific restrictions linked to the intended uses.................................................................................... 8
2.3
Product uses ........................................................................................................................................... 10
3
Risk management................................................................................................................................... 12
3.1
Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 12
3.1.1
Physical and chemical properties ......................................................................................................... 12
3.1.2
Methods of analysis................................................................................................................................ 12
3.1.2.1
Analytical method for the formulation ................................................................................................ 12
3.1.2.2
Analytical methods for residues ........................................................................................................... 12
3.1.3
Mammalian Toxicology......................................................................................................................... 12
3.1.4
Residues and Consumer Exposure ....................................................................................................... 12
3.1.4.1
Residues .................................................................................................................................................. 12
3.1.4.2
Consumer exposure ............................................................................................................................... 12
Applicant
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 3 of 14
3.1.5
Environmental fate and behaviour ...................................................................................................... 13
3.1.6
Ecotoxicology ......................................................................................................................................... 13
3.1.7
Efficacy ................................................................................................................................................... 13
3.2
Conclusions............................................................................................................................................. 13
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......................................................................................................... 14
Appendix 1 – Copy of the product authorisation ................................................................................................... 14
Appendix 2 – Copy of the product label.................................................................................................................. 14
BVL_FO_05_2422_200_V1.0
Appendix 3 – Letter of Access.................................................................................................................................. 14
Applicant
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 4 of 14
PART A – Risk Management
This document describes the acceptable use conditions required for extension of the registration of Stomp
Aqua containing Pendimethalin in Germany.
The risk assessment conclusions are based on the already existing registration of Stomp Aqua. The
following sections of Registration Report, Part B were prepared on basis of new data:
• Section 4.
Assessments for the safe use of Stomp Aqua have been made using endpoints agreed in the EU reviews of
Pendimethalin.
Appendix 1 of this document provides a copy of the final product authorisation in Germany.
Details of the application
1
Application to extend the authorisation of a plant protection product Stomp Aqua already authorised in
Germany to minor uses not yet covered by that authorisation.
The application is intended for use in Germany only.
1.1
Application background
Details on applicant and application
Stomp Aqua
Type of application
Zonal application according to Article 51, ZRMS=DE, first application
(GV1)
Registration number
005958-00/28
Applicant
BASF SE E-APE/DT, Li 556 , Speyerer Straße 2, 67117 Limburgerhof,
Deutschland
Authorisation holder
Deutschland
Function
Herbicide
Type of formulation
Capsule suspension
Expiration of authorisation
2017-12-31
BVL_FO_05_2422_200_V1.0
Plant protection product
Applicant
Date: 03/12/2012
Part A
Core Assessment
1.2
Stomp Aqua
Art. 51
Country – Germany
Page 5 of 14
Annex I inclusion
The active substances included in the plant protection product are approved according Regulation (EC)
No 1107/2009. The present application is in line with the provisions of the approvals.
Active substance (BVL Number)
Pendimethalin (0404)
1.3
Content in PPP
455 g/L
Approval status
Approved according Regulation (EC) No 1107/2009
Approval
Regulation (EC) No 540/2011
Expiration of approval
31/12/2013
Regulatory approach
The PPP is already registered in Germany according to Directive 91/414/EEC taking into account the
uniform principles of Annex VI. Therefore the evaluation of the current application is limited to the
points not covered by the existing registration.
1.3.1
Uses applied for and registration decision
Number of
use
Plant/commodity/object
Harmful organism/purpose
decision
001
Sorghum
(SORSS)
annual dicotyledonous weeds
(TTTDS)
(excluding
field chamomile
(ANTAR)
catchweed bedstraw
(GALAP)
chamomille spec.
(MATSS)
Birdseed
(SENVU)
galinsoga spec.
Authorise
(GASSS))
BVL_FO_05_2422_200_V1.0
1.3.2
Public interest and minor use
According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are
only possible if the intended use applied for is minor in nature and in public interest.
Applicant
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 6 of 14
In Germany the cultivated area of Sorghum is about 12350 ha, of which approx. 9880 ha need to be
controlled. Calculation shows that authorisation holder will not profit from an authorisation of the
requested use(s). All data are valid for open field.
Upon this calculation and the examination of available alternative measures for the applied use(s) it can
be stated that the applied use(s) is minor in nature and the authorisation is in the public interest.
1.4
Data protection claims
Non new studies have been submitted.
1.5
Letters of Access
Not applicable.
Details of the authorisation
2
BVL_FO_05_2422_200_V1.0
2.1
Product identity
Product name
Stomp Aqua
Authorisation number
005958-00
Composition
Pendimethalin 455 g/L
Type of formulation
Capsule suspension (CS)
Function
Herbicide
Authorisation holder
Deutschland
2.2
Classification and labelling
2.2.1
Classification and labelling under Directive 99/45/EC or Regulation (EC) No
1272/2008
N
Dangerous for the environment
Xn
Harmful
RA121
Contains polymeric methylene diisocyanate. May produce allergic reactions.
RK050
R 50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the
aquatic environment
RX042
R 42: May cuse sensitiation by inhalation
SK012
S 36/37: Wear suitable protective clothing and gloves.
SP001
To avoid riks to man and the environment, comply with the instructions for use.
SX002
S 2: Keep out of the reach of children.
SX013
S 13: Keep away from food, drink and animal feeding stuffs.
SX022
S 22: Do not inhale dust.
SX023
S 23: Do not inhale gas/fumes/vapour/spray (appropriate wording to be specified by the
manufacturer).
Applicant
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 7 of 14
SX024
S 24: Avoid contact with skin.
SX035
S 35: This material and its container must be disposed of in a safe way.
SX045
S 45: In case of an accident, or if you feel unwell, seek medical advice immediately
(where possible, show this label)
SX057
S 57: Use appropriate container to avoid environmental contamination.
2.2.2
R and S phrases under Regulation (EC) No 547/2011
None.
2.2.3
Other phrases
2.2.3.1 Restrictions linked to the PPP
The authorization of the PPP is linked to the following conditions (mandatory labelling):
Operator protection
SB001
Avoid any unnecessary contact with the product. Misuse can lead to health damage.
SB110
The directive concerning requirements for personal protective gear in plant protection,
"Personal protective gear for handling plant protection products" of the Federal Office of
Consumer Protection and Food Safety must be observed.
SE110
Wear tight fitting eye protection when handling the undiluted product.
SF245-01 Treated areas/crops may not be entered until the spray coating has dried.
SS110
Wear standard protective gloves (plant protection) when handling the undiluted product.
SS2101
Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling
the undiluted product.
SS610
Wear a rubber apron when handling the undiluted product.
Ecosystem protection
NW262 The product is toxic for algae.
NW264 The product is toxic for fish and aquatic invertebrates
NW265 The product is toxic for higher aquatic plants.
NW468 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 rain-water and sewage canals
Honeybee
Integrated Pest Management (IPM)
WH951
The risk of resistence has t be indicated on the package and in the instructions of use.
Particularly measures for an appropriate risk management have to be declared.
BVL_FO_05_2422_200_V1.0
Mode of action (FRAC/HRAC/IRAC-Group): K1
Active substance
Applicant
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 8 of 14
The authorization of the PPP is linked to the following conditions (voluntary labelling):
Honeybee
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)
Integrated Pest Management (IPM)
NN 130
The product is classified as harmless for populations of the species Pardosa amentata and
palustris (lycosid spiders).
NN 160
The product is classified as harmless for populations of the species Aleochara bilineata
(staphylinid beetle).
NN 165
The product is classified as harmless for populations of the species Poecilus cupreus (ground
beetle).
NN 1842 The product is classified as harmless for populations of the species Aphidius rhopalosiphi
(braconid wasp).
2.2.3.2 Specific restrictions linked to the intended uses
Some of the authorized uses are linked to the following conditions (mandatory labelling):
See 2.3 (Product uses)
Ecosystem protection
NW 605-1
When applying the product on areas adjacent to surface waters - except only occasionally but including
periodically water bearing surface waters - the product must be applied with equipment which is
registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal
Gazette] No 205, p. 9780) as amended. Depending on the drift reduction classes for the equipment stated
below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer
zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of
waters must be observed at all times for drift reduction classes marked with "*".
50 % 10 m
75 % 5 m
90 % 5 m
BVL_FO_05_2422_200_V1.0
NW606
The only case in which the product may be applied without loss reducing equipment is when at least the
buffer zone stated below is kept from surface waters - except only occasionally but including periodically
water bearing surface waters. Violations may be punished by fines of up to 50 000 Euro.
Buffer: 20m
NT 107
A buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally
used areas, roads, paths and public places). In addition, in an adjoining strip of at least 20 m, 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 50 %. Neither loss reducing equipment nor a buffer zone of at least 5 m are
required if the product is applied with portable plant protection equipment or if adjacent areas (field
boundaries, hedges, groups of woody plants) are less than 3 m wide. A buffer zone of at least 5 m is also
unnecessary if 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
Applicant
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 9 of 14
BVL_FO_05_2422_200_V1.0
April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural
structures, or if evidence can be shown that adjacent areas (e.g. field boundaries, hedges, groups of woody
plants) were planted on agriculturally or horticulturally used areas.
Applicant
Date: 03/12/2012
Part A
Core Assessment
2.3
Country – Germany
Stomp Aqua
Art. 51
Page 10 of 14
Product uses
PPP (product name/code)
active substance
Stomp Aqua (005958-00/28)
Pendimethalin
Formulation type:
Conc. of as :
Applicant:
Zone(s):
central EU
professional use
non professional use
CS
455 g/L
Verified by MS: yes
1
UseNo.
2
Member
state(s)
3
Crop and/
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
Application
Method /
Kind
Timing / Growth
stage of crop &
season
Sorghum
(Sorghum spec.)
(SORSS)
BVL_FO_05_2422_200_V1.0
DE
Applicant
F
annual
spraying
dicotyledonous
weeds
(excluding
(TTTDS)
field chamomile
(ANTAR)
catchweed bedstraw
(GALAP)
chamomille spec.
(MATSS)
Birdseed
(SENVU)
11
12
Application rate
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
001
10
To BBCH 16; a) 1
after emergence b) 1
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
Remarks:
PHI
(days)
e.g. safener/synergist per ha
e.g. recommended or mandatory tank
mixtures
b) max. total rate b) max. total
per crop/season rate per
crop/season
a) 2,5 L/ha
b) 2,5 L/ha
a) 1,138 L
as/ha
b) 1.138 L
as/ha
150 – 400
L/ha
F
Restrictions (see 2.2.3.2)
NW 605-1 (50 % drift
reduction: 10 m buffer; 75 %
and 90 % drift reduction: 5 m
buffer)
NW606 (20 m buffer without
drift reducing technique)
NT 107 (5 m buffer and 50 %
drift reduction)
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 11 of 14
BVL_FO_05_2422_200_V1.0
galinsoga spec.
(GASSS))
Applicant
Date: 03/12/2012
Part A
Core Assessment
3
Stomp Aqua
Art. 51
Country – Germany
Page 12 of 14
Risk management
3.1
Reasoned statement of the overall conclusions taken in accordance with the
Uniform Principles
3.1.1
Physical and chemical properties
Not relevant for extension of authorisation according article 51.
3.1.2
Methods of analysis
3.1.2.1 Analytical method for the formulation
Not relevant for extension of authorisation according article 51.
3.1.2.2 Analytical methods for residues
Sorghum belongs to the group of dry commodities. Sufficiently validated analytical methods based on GC
and LC-MS/MS are available for enforcing Pendimethalin in sorghum seeds.
3.1.3
Mammalian Toxicology
The PPP is already registered in Germany according to Directive 91/414/EEC.
If used properly and according to the intended conditions of use, adverse health effects for operators,
workers, bystanders and residents will not be expected.
3.1.4
Residues and Consumer Exposure
The residue behaviour of the active substance pendimethalin has been evaluated within the EU review
process. Information about metabolism is sufficient to evaluate the intended use in sorghum.
3.1.4.1 Residues
No results of supervised residue trials in sorghum are available. Based on the available residue
information on maize which according to guideline 7525/VI/95 can be extrapolated to sorghum is
sufficient to perform an adequate assessment. Residues that are expected from the intended use of the
plant protection product will not exceed the MRL of 0.05* mg/kg for pendimethalin established under
Regulation (EC) No 396/2005.
3.1.4.2 Consumer exposure
BVL_FO_05_2422_200_V1.0
Uptake assessments of residues of by consumers result in the following maximum ADI (0.125 mg/kg
bw/d) consumptions:
TMDI (EFSA PRIMo): 3.4 % (FR toddlers)
NTMDI (DE NVS II): 2.8 % (DE children of 2-4 years)
Long-term dietary intake of residues of pendimethalin is unlikely to present a public health concern for
European consumers.
Since pendimethalin is found to be of low acute toxicity no ARfD has been allocated. Therefore, no acute
risk is expected from the consumption of sorghum treated according to the intended use.
Applicant
Date: 03/12/2012
Part A
Core Assessment
3.1.5
Stomp Aqua
Art. 51
Country – Germany
Page 13 of 14
Environmental fate and behaviour
No new studies are presented; all data were reviewed within the EU review and approval of the national
authorisation 005958-00/00 according the uniform principles of directive 91/414/EEC. No effect on
groundwater and the environment are to be expected.
3.1.6
Ecotoxicology
No new studies are presented; all data were reviewed within the EU review and approval of the national
authorisation 005958-00/00 according the uniform principles of directive 91/414/EEC.
The PPP Stomp Aqua and the active substance pendimethalin are toxic to the aquatic environment
(NOEAEC microcosm-study 1.1 µg pendimethalin/l, TER 1). Concerning PEC calculation results of a
field volatilisation study are available and are included (PEC drift and volatilisation for conventional
technique: 5 m 2,66 µg/l,10 m 1,603 µg/l, 15 m 1,262 µg/l and 20 m 0,769µg/l). Subsequently no
additional entries as those according to the evaluated use pattern and good agricultural practise are
acceptable. Therefore the safety phrases and conditions of use NW262, NW264, NW265 NW468, NW
605-1 (50 % 10 m, 75 % 5 m, 90 % 5 m buffer) NW 606 (20 m buffer) are assigned, see also 2.2.3.1 and
2.2.3.2.
Considering use patterns as laid down in 2.3 entries of the product Stomp Aqua on terrestrial non-target
areas cannot be excluded (HC 6,4 g as/ha with a TER of 2). Risk mitigation (NT107) is therefore
necessary to avoid harmful effects on terrestrial non-target plants.
Risk Assessment for Honeybees
The honeybee risk assessment for the main application covers the use(s) in accordance with Article 51 of
regulation (EC) No 1107/2009 (see also point 2.2).
3.1.7
Efficacy
Labelling in accordance with the requirements of ANNEX III General principles of integrated pest
management under directive 2009/128/EC (see also point 2.2):
-The classification of effects on beneficial arthropods for the main application covers the use(s) applied
for under the terms of Article 51 of regulation (EC) No 1107/2009.
-The categories and labelling for mode of action for the main application cover the use(s) applied for
under the terms of Article 51 of regulation (EC) No 1107/2009.
According to Article 51 of the regulation (EC) No 1107/2009 the requirements for approval concerning
the sufficient effect and any unacceptable effects on plants and plant products not need to be checked.
BVL_FO_05_2422_200_V1.0
3.2
Conclusions
PPP Stomp Aqua is already registered in Germany according to Directive 91/414/EEC taking into
account the uniform principles of Annex VI.
The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees
and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are
anticipated because of the extension of uses(s).
Applicant
Date: 03/12/2012
Part A
Core Assessment
Stomp Aqua
Art. 51
Country – Germany
Page 14 of 14
The indended use in sorghum will not result in residues above the MRLs set for pendimethalin according
to Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these
residues of pendimethalin is not expected. There is no special risk mitigation necessary which deviate
from the existing registration.
Considering an application in accordance with the evaluated use pattern and good agricultural practise as
well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on
the ecosystem are to be apprehended.
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
None
Appendix 1 – Copy of the product authorisation
See below.
Appendix 2 – Copy of the product label
No product label available. Not mandatory according to Article 51 (5)
Appendix 3 – Letter of Access
BVL_FO_05_2422_200_V1.0
No letter of access necessary. The applicant is owner of the data submitted for evaluation.
Applicant
Date: 03/12/2012
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig
Dr. Dietmar Gottschild
Referent
TELEFON
TELEFAX
E-MAIL
INTERNET
Mit Zustellungsurkunde
BASF SE
E-APE/DT, Li 556
Speyerer Straße 2
67117 Limburgerhof
+49 (0)531 299-3512
+49 (0)531 299-3002
[email protected]
www.bvl.bund.de
IHR ZEICHEN
IHRE NACHRICHT VOM
AKTENZEICHEN 200.22200.005958-00/28.64295
(bitte bei Antwort angeben)
DATUM 12. Dezember 2012
GV1 005958-00/28
Stomp Aqua
Verfahren zur Erweiterung einer Zulassung nach Artikel 51 Abs. 1 der Verordnung (EG)
Nr. 1107/2009
Bescheid
Die Zulassung des oben genannten Pflanzenschutzmittels
mit dem Wirkstoff:
455 g/l
Pendimethalin
Zulassungsnummer:
005958-00
Versuchsbezeichnung:
BAS-45538-H-1-CS
Antrag vom:
8. Februar 2012
wird wie in Anlage 1 beschrieben auf der Grundlage von Art. 51 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) um folgende Anwendungsge-
BVL_FO_05_2468_200_V1.0
biete bzw. Anwendungen erweitert:
Dienstsitz Braunschweig
Bundesallee 50, Geb. 247
38116 Braunschweig
Tel: +49 (0)531 21497-0
Fax: +49 (0)531 21497-299
Abt. Pflanzenschutzmittel
Messeweg 11/12
38104 Braunschweig
Tel: +49 (0)531 299-5
Fax: +49 (0)531 299-3002
Dienststelle Berlin
Mauerstraße 39-42
10117 Berlin
Tel: +49 (0)30 18444-000
Fax: +49 (0)30 18444-89999
Referatsgr. Untersuchungen
Diedersdorfer Weg 1
12277 Berlin
Tel: +49 (0)30 18412-0
Fax: +49 (0)30 18412-2955
SEITE 2 VON 8
Anwendungs-
Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck
nummer
Zweckbestimmung Objekte
005958-00/28-001 Einjährige zweikeim- Sorghum-Hirse
blättrige Unkräuter
(ausgenommen:
Acker-Hundskamille,
Kletten-Labkraut,
Kamille-Arten,
Gemeines Kreuzkraut, Franzosenkraut-Arten)
Festgesetzte Anwendungsbestimmungen
Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum
Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBI. I
S. 148, 1281) festgesetzt:
Für die Anwendungen 005958-00/28-001:
(NT107)
Bei der Anwendung des Mittels muss ein Abstand von mindestens 5 m zu angrenzenden Flächen (ausgenommen landwirtschaftlich oder gärtnerisch genutzte Flächen, Straßen, Wege
und Plätze) eingehalten werden. Zusätzlich muss die Anwendung in einer darauf folgenden
Breite von mindestens 20 m 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 50 %
eingetragen ist.
Bei der Anwendung des Mittels ist weder der Einsatz verlustmindernder Technik noch die
Einhaltung eines Abstandes von mindestens 5 m erforderlich, wenn die Anwendung mit tragbaren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B. Feldraine, Hecken,
Gehölzinseln) weniger als 3 m breit sind. Bei der Anwendung des Mittels ist ferner die Einhaltung eines Abstandes von mindestens 5 m nicht erforderlich, wenn 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 oder angrenzende Flächen (z. B.
BVL_FO_05_2468_200_V1.0
Feldraine, Hecken, Gehölzinseln) nachweislich auf landwirtschaftlich oder gärtnerisch
genutzten Flächen angelegt worden sind.
Begründung:
Das o.g. Pflanzenschutzmittel bzw. der darin enthaltene Wirkstoff Pendimethalin besitzt ein
SEITE 3 VON 8
hohes Gefährdungspotenzial für terrestrische Pflanzen auf Nichtzielflächen.
Unter Berücksichtigung aller zu den Auswirkungen von Pendimethalin auf Pflanzen vorgelegten Daten wird die HC5 (Labor) von 6.4 g a.i./ha als bewertungsrelevante Toxizität angesehen. Aufgrund der Vielzahl geprüfter Arten (z.T. empfindliche Wildpflanzen) und der zusätzlich zu einigen Spezies vorliegenden Ergebnisse aus Freilandstudien wird eine Reduzierung
des Sicherheitsfaktors auf 2 für vertretbar erachtet. Da allerdings nur Monospeziestests
durchgeführt wurden und indirekte Effekte wie Konkurrenz unberücksichtigt bleiben, kann auf
einen Sicherheitsfaktor nicht ganz verzichtet werden.
Die Aufnahme von Pendimethalin erfolgt über die Wurzel, die Koleoptile und das Hypokotyl,
d.h. hauptsächlich über den Boden und nur im geringen Umfang über das Blatt. Daher kann
in die Berechnung der PECini eine Interzeption von 50% eingestellt werden. Pendimethalin
wird über die Pfade Abdrift und Verflüchtigung/Deposition auf die Nichtzielfläche eingetragen.
Grundlage der Einträge über Abdrift sind die tabellierten Driftwerte nach Rautmann und Ganzelmeier.
Die Einhaltung der in der o.g. Anwendungsbestimmung aufgeführten Maßnahmen ist bei Einsatz des Mittels aufgrund der beschriebenen Effekte gegenüber terrestrischen Pflanzen
durchsetzbar vorzuschreiben, da andernfalls das unter Berücksichtigung der bestehenden
Unsicherheiten zum Schutz terrestrischer Biozönosen festgelegte Toxizitäts-/Expositionsverhältnis (hier: TER = 2) unterschritten wird, schädliche Auswirkungen auf den Naturhaushalt
nicht auszuschließen sind und somit der Schutz der terrestrischen Biozönosen nicht gewährleistet ist.
(NW605-1)
Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender
Oberflächengewässer - muss mit einem Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung eingetragen ist. Dabei sind, in Abhängigkeit von den unten aufgeführten
Abdriftminderungsklassen der verwendeten Geräte, die im Folgenden genannten Abstände
zu Oberflächengewässern einzuhalten. Für die mit "*" gekennzeichneten Abdriftminderungsklassen ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu
Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in
jedem Fall zu beachten.
reduzierte Abstände: 50 % 10 m, 75 % 5 m, 90 % 5 m
BVL_FO_05_2468_200_V1.0
Begründung:
Das o.g. Pflanzenschutzmittel bzw. der darin enthaltene Wirkstoff Pendimethalin besitzt ein
hohes Gefährdungspotenzial für aquatische Organismen.
Für das beantragte Mittel sind die Auswirkungen auf Grünalgen bewertungsrelevant. Anhand
SEITE 4 VON 8
der Labortests weist das Mittel gegenüber Algen eine geringere Toxizität auf als der Wirkstoff-Gehalt es erwarten lässt. Die Risikobewertung basiert daher auf Ergebnissen zum Wirkstoff Pendimethalin. Die bewertungsrelevante Toxizität gegenüber aquatischen Organismen
für den Wirkstoff Pendimethalin ist der Endpunkt aus der Mikrokosmos-Studie mit einer
NOEAEC von 1,1 µg/L in Verbindung mit einem Sicherheitsfaktor von 1.
Die Kalkulation der abstandsabhängigen Konzentrationen in Oberflächengewässern basiert
zunächst auf den tabellierten Driftwerten nach Rautmann und Ganzelmeier. Verflüchtigungsbedingte Depositionen des Wirkstoffs Pendimethalin in Oberflächengewässern sind grundsätzlich zu erwarten, da der Wirkstoff mit einem Dampfdruck bei 20 °C von > 10"4 Pa als
semivolatil bis volatil (Verflüchtigung von Pflanzen und Boden) einzustufen ist.
Für die Berechnung der PEC werden Ergebnisse aus Freilandverflüchtigungsversuchen mit
dem Mittel Stomp SC (AWM: 4 L/ha = 1600 g Pendimethalin/ha) herangezogen.
Bei Nichteinhaltung der in Zusammenhang mit der o.g. Anwendungsbestimmung definierten
Maßgaben führen die Einträge des Mittels in Oberflächengewässer und die hieraus resultierenden Konzentrationen auch bei sachgerechter und bestimmungsgemäßer Anwendung zu
einer Unterschreitung des erforderlichen Toxizitäts-/Expositionsverhältnisses (hier: TER = 1).
(NW606)
Ein Verzicht auf den Einsatz verlustmindernder Technik ist nur möglich, wenn bei der Anwendung des Mittels mindestens unten genannter Abstand zu Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender
Oberflächengewässer - eingehalten wird. Zuwiderhandlungen können mit einem Bußgeld bis
zu einer Höhe von 50.000 Euro geahndet werden.
20 m
Begründung:
Siehe NW605-1.
Auflagen
Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden:
Siehe Anlage 1, jeweils unter Nr. 2.
Vorbehalt
Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder
BVL_FO_05_2468_200_V1.0
Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.
SEITE 5 VON 8
Abgelehnte Anwendungsgebiete bzw. Anwendungen
Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe
Anlage 2):
- keine -
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. Hans-Gerd Nolting
Abteilungsleiter
Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.
BVL_FO_05_2468_200_V1.0
Anlage
SEITE 6 VON 8
Anlage 1 zugelassene Anwendung: 005958-00/28-001
1
Anwendungsgebiet
Schadorganismus/Zweckbestimmung: Einjährige zweikeimblättrige Unkräuter (ausgenommen: Acker-Hundskamille, Kletten-Labkraut, KamilleArten, Gemeines Kreuzkraut, Franzosenkraut-Arten)
Pflanzen/-erzeugnisse/Objekte:
Sorghum-Hirse
Verwendungszweck:
2
Kennzeichnungsauflagen
2.1
Angaben zur sachgerechten Anwendung
Einsatzgebiet:
Ackerbau
Anwendungsbereich:
Freiland
- Erläuterungen:
Anwendung im Haus- und
Kleingartenbereich:
Nein
Erläuterung zum Schadorganismus:
Stadium des Schadorganismus:
bis 16
- Erläuterungen:
Erläuterung zur Kultur:
Stadium der Kultur:
ab 13
- Erläuterungen:
Anwendungszeitpunkt:
Nach dem Auflaufen
- Erläuterungen:
Maximale Zahl der Behandlungen
- in dieser Anwendung:
1
- für die Kultur bzw. je Jahr:
1
- Abstand:
- Erläuterungen Anzahl
Behandlungen:
Mischungspartner:
- Erläuterungen:
Anwendungstechnik:
spritzen
- Erläuterungen:
Aufwand:
-
2,5 l/ha in 150 bis 400 l Wasser/ha
BVL_FO_05_2468_200_V1.0
- Erläuterungen:
Sonstige Ergänzungen und Hinweise: - keine 2.2
Sonstige Kennzeichnungsauflagen
- keine -
SEITE 7 VON 8
2.3
Wartezeiten
(F)
3
Freiland: Sorghum-Hirse
Die Wartezeit ist durch die Anwendungsbedingungen
und/oder die Vegetationszeit abgedeckt, die zwischen
Anwendung und Nutzung (z. B. Ernte) verbleibt bzw.
die Festsetzung einer Wartezeit in Tagen ist nicht
erforderlich.
Anwendungsbezogene Anwendungsbestimmungen
BVL_FO_05_2468_200_V1.0
(NT107)
Bei der Anwendung des Mittels muss ein Abstand von mindestens 5 m zu angrenzenden Flächen (ausgenommen landwirtschaftlich oder gärtnerisch genutzte Flächen, Straßen, Wege
und Plätze) eingehalten werden. Zusätzlich muss die Anwendung in einer darauf folgenden
Breite von mindestens 20 m 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 50 %
eingetragen ist.
Bei der Anwendung des Mittels ist weder der Einsatz verlustmindernder Technik noch die
Einhaltung eines Abstandes von mindestens 5 m erforderlich, wenn die Anwendung mit tragbaren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B. Feldraine, Hecken,
Gehölzinseln) weniger als 3 m breit sind. Bei der Anwendung des Mittels ist ferner die Einhaltung eines Abstandes von mindestens 5 m nicht erforderlich, wenn 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 oder angrenzende Flächen (z. B.
Feldraine, Hecken, Gehölzinseln) nachweislich auf landwirtschaftlich oder gärtnerisch
genutzten Flächen angelegt worden sind.
(NW605-1)
Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender
Oberflächengewässer - muss mit einem Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung eingetragen ist. Dabei sind, in Abhängigkeit von den unten aufgeführten
Abdriftminderungsklassen der verwendeten Geräte, die im Folgenden genannten Abstände
zu Oberflächengewässern einzuhalten. Für die mit "*" gekennzeichneten Abdriftminderungsklassen ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu
Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in
jedem Fall zu beachten.
reduzierte Abstände: 50 % 10 m, 75 % 5 m, 90 % 5 m
(NW606)
SEITE 8 VON 8
BVL_FO_05_2468_200_V1.0
Ein Verzicht auf den Einsatz verlustmindernder Technik ist nur möglich, wenn bei der Anwendung des Mittels mindestens unten genannter Abstand zu Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender
Oberflächengewässer - eingehalten wird. Zuwiderhandlungen können mit einem Bußgeld bis
zu einer Höhe von 50.000 Euro geahndet werden.
20 m
Stomp Aqua - 005958-00/00
Part B – Section 4 - Core Assessment
REGISTRATION REPORT
Part B
Section 4: Metabolism and Residues
Detailed summary of the risk assessment
Product code: Stomp Aqua
Active Substance:
455 g/L Pendimethalin
Central Zone
Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: BASF SE
Date:
03/12/2012
Page 1 / 32
Stomp Aqua - 005958-00/00
Table of Contents
IIIA 8
METABOLISM AND RESIDUES DATA .........................................................................3
IIIA 8.1
Evaluation of the active substances .....................................................................................3
IIIA 8.1.1
Pendimethalin ......................................................................................................................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)...................................................4
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) ........................................................................................6
IIIA 8.2.1
Selection of critical use and justification.............................................................................6
IIIA 8.2.2
Sorghum...............................................................................................................................8
IIIA 8.2.2.1
Residues in primary crops ...................................................................................................8
IIIA 8.2.2.2
Distribution of the residue in peel/pulp ...............................................................................8
IIIA 8.2.2.3
Residues in processed commodities ....................................................................................8
IIIA 8.2.2.4
Proposed pre-harvest intervals, withholding periods...........................................................8
IIIA 8.3
Consumer intake and risk assessment..................................................................................8
IIIA 8.4
Proposed maximum residue levels (MRLs) ........................................................................9
IIIA 8.5
Conclusion...........................................................................................................................9
Appendix 1
List of data submitted in support of the evaluation ...........................................................10
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 2.2.1
Nature of residues..............................................................................................................12
A 2.2.2
Magnitude of residues in maize.........................................................................................13
A 2.3
Residues in processed commodities ..................................................................................31
A 2.4
Residues in rotational crops...............................................................................................31
A 2.5
Residues in livestock .........................................................................................................31
A 2.6
Other studies/information ..................................................................................................31
Appendix 3
Pesticide Residue Intake Model (PRIMo) .........................................................................32
Page 2 / 32
Stomp Aqua - 005958-00/00
IIIA 8
METABOLISM AND RESIDUES DATA
IIIA 8.1
Evaluation of the active substances
IIIA 8.1.1
Pendimethalin
Table IIIA 8.1-1:
Information on the active substance pendimethalin
Structural formula
H3C
NO2
H3C
N
NO2
Common Name
IIIA 8.1.1.1
H
CH3
CH3
Pendimethalin
Storage stability
A brief summary of the storage stability data on pendimethalin is given in the following table. Data,
which has been previously evaluated on EU level is described in detail in the corresponding DAR (Spain,
1998, ASB2010-10301) and in the reasoned opinion on the modification of the existing MRLs for
pendimethalin in various crops (EFSA Journal 2011;9(10):2400, ASB2012-1117). There are further
studies on storage stability in plant products (cereals) available. However, none of them is needed for the
present evaluation, since the available data on storage stability is sufficient.
Table IIIA 8.1-2:
Stability of residues (Annex IIA, point 6 Introduction, Annex IIIA, point 8
Introduction)
Stability of pendimethalin
IIIA 8.1.1.2
Pendimethalin residues were stable for 24 months when
stored at -20 °C in commodities with high water content
(onions and potatoes), high acid content (grapes), high
oil content (soybean seeds, almond kernels) as well as in
dry commodities (almond hulls).
Metabolism in plants and plant residue definition(s)
A brief summary of the metabolism of pendimethalin in plants is given in the following table. Data,
pendimethalin in various crops (EFSA Journal 2011;9(10):2400, ASB2012-1117). There are further
studies on the metabolism in succeeding/rotational crops available. However, none of them is needed for
the present evaluation, since the available data on rotational crop metabolism is sufficient.
Table IIIA 8.1-3:
Plant groups covered
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and
8.6)
The metabolism was investigated in onions, soybeans,
potatoes and maize with 14C-labelled pendimethalin.
Pendimethalin was hardly translocated within the plants.
The metabolism appeared to be similar in all crops
investigated. Pendimethalin was extensively metabolised
to a variety of natural, water soluble-components and
was incorporated into macromolecular plant constituents,
none of which exceeded 10 % of the total radioactive
residue.
Page 3 / 32
Stomp Aqua - 005958-00/00
Rotational crops
Lettuce, carrots, radish, red beets, beans, wheat, soya
bean and cotton seed with 14C-labelled pendimethalin,
soil treatment.
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
Only small amounts of the total residue were identified
as parent compound and its alcohol metabolite
CL 202,347. The largest part of the radioactive residues
was either incorporated into natural plant components
(cellulose, lignin) or was polar in nature, thus indicating
an intensive metabolism. Metabolism in rotational crops
was found to be similar to that in primary crops.
yes
no data
no data
not applicable
pendimethalin
pendimethalin
none
Metabolism in livestock and animal residue definition(s)
A brief summary of the metabolism of pendimethalin in livestock is given in the following table. Data,
pendimethalin in various crops (EFSA Journal 2011;9(10):2400, ASB2012-1117).
Table IIIA 8.1-4:
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1
and 8.6)
Animals covered
Lactating goats and laying hens with [14C]-4-methyl- or
uniformly [14C]-ring-labelled pendimethalin.
In lactating goats, doses of 0.5 to 20 mg/kg feed were
studied. The largest part of the administered dose was
eliminated via urine (8-15 %) and faeces (69-94 %).
Liver was the target organ with total radioactive residues
of up to 0.25 mg/kg (at the 20 mg/kg dose level).
Residues in milk were <0.01 mg/kg at all dose levels
except the highest dose (0.02 mg/kg).
In laying hens, doses of 0.5 and 10 mg/kg were studied,
and resulted in no detectable residues (<0.01 mg/kg) in
tissues and eggs at the low dose, and residues of 0.205,
0.035 and <0.01 mg/kg, in liver, skin with adhering fat
and muscle, respectively, at the high dose.
Time needed to reach a plateau concentration in
milk and eggs
Pendimethalin was extensively metabolised to a
complex, unresolvable mixture of polar components each
minor relative to the total radioactive residue.
Metabolites in significant amounts were not observed.
A plateau was not reached.
Page 4 / 32
Stomp Aqua - 005958-00/00
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
pendimethalin
pendimethalin
none
yes
yes (log Pow = 5.2 at pH 7)
Residues in rotational crops
A brief summary of the field rotational crop studies on pendimethalin is given in the following table.
Data, which has been previously evaluated at EU level is described in detail in the corresponding DAR
(Spain, 1998, ASB2010-10301) and in the reasoned opinion on the modification of the existing MRLs for
pendimethalin in various crops (EFSA Journal 2011;9(10):2400, ASB2012-1117).
Table IIIA 8.1-5:
Residues in rotational crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
Field studies
IIIA 8.1.1.5
Experiments showed that pendimethalin persisted for a
long time in soil (more than one year). However,
numerous rotational crop studies are available and
showed that under practical conditions of use residues of
pendimethalin are below the LOQ (0.01 mg/kg) in
mature plant parts of crops belonging to the groups leafy
vegetables, root and tuber vegetables, oilseeds and pulses
as well as cereals.
Residues in livestock
An actual calculation of the dietary burden (based on all relevant uses authorized in Germany) is provided
in Table IIIA 8.1-6.
Table IIIA 8.1-6:
Feedstuff
%
DM
Calculation of the dietary burden (based on all relevant uses authorized in DE
Percent of daily livestock diet (dry feed basis)
Chicken
Dairy cattle
Beef cattle
Pig
1,9 kg bw
550 kg bw
350 kg bw
75 kg bw
daily max.
feed (DM)
120 g
daily max.
feed (DM)
20 kg
daily max.
feed (DM)
15 kg
daily max.
feed (DM)
3 kg
Intake (mg/kg, dry feed basis)
Residue
(mg/kg)
Chicken
Dairy
cattle
Pig
Beef
cattle
Kale/Cabbage
14
5
35
35
15
0.250 a
0.089
0.625
0.625
0.268
Silage
20
–
–
–
–
0.11 b)
–
–
–
–
Grains except
Maize
86
45
–
–
–
0.050 c
0.026
–
–
–
–
0.140
d
–
0.033
0.008
–
e
0.024
0.012
–
0.020
0.067
0.100
0.200
0.200
Straw (Cereals)
86
–
20
5
Pulses
86
30
15
–
25
0.070
Root + Tubers
(e.g. Potatoes)
15
20
30
60
60
0.050 f
Rape seed
86
–
–
–
–
0.05 g)
–
–
–
–
Intake (mg/kg dry weight feed)
0.207
0.770
0.833
0.488
Intake (mg/kg bw/d)
0.013
0.028
0.036
0.020
Intake (mg/animal/d)
0.025
15.395
12.497
1.465
a
HR, based on the following cGAP: 1x 1.6 kg as/ha, PHI: 56 d
b
HR, based on the following cGAP: 1x 1.6 kg as/ha, post-emergence, PHI: F
c
STMR, based on the following cGAP: 1x 1.6 kg as/ha, post-emergence, PHI: F
D
HR, based on the following cGAP: 1x 1.6 kg as/ha, post-emergence, PHI: F
E
STMR, based on the following cGAP: 1x 1.6 kg as/ha, pre-emergence, PHI: F
f
HR, based on the following cGAP: 2x 0.8 kg as/ha, PHI: 49 d
g
HR, based on the following cGAP: 1 x 0.9 kg as/ha, PHI: F
Page 5 / 32
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Table IIIA 8.1-7:
Conditions of requirement of livestock feeding studies on pendimethalin
Ruminant:
Poultry:
Pig:
Expected intakes by livestock ≥0.1 mg/kg diet (dry yes
0.77 (cow), 0.83
weight basis) (yes/no – If yes, specify the level)
(beef)
yes
0.21
yes
0.49
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
Table IIIA 8.1-8:
Results of livestock feeding or metabolism studies (Annex IIA, point 6.4)
Ruminant:
Poultry:
Pig:
Feeding levels (mg/kg feed dry matter) in feeding
studies
goat (metab. study): hen (metab.
0.5, 1.5, 20
study): 0.5, 10
See ruminant
Relevant dosing levels in feeding study:
1.5
See ruminant
0.5
Expected residue levels in animal matrices (mg/kg):
Muscle
<0.01
<0.01
<0.01
Liver
0.02 (referring to
TRR, % as most
likely also <0.01)
<0.01
<0.01
Kidney
0.02 (referring to
TRR, % as most
likely also <0.01)
<0.01
<0.01
Fat
<0.01
<0.01
<0.01
Milk
<0.01
–
–
Eggs
–
<0.01
–
IIIA 8.2
Evaluation of the intended use(s)
IIIA 8.2.1
Selection of critical use and justification
The critical GAP used for consumer intake and risk assessment is presented in Table IIIA 8.2-1.
Page 6 / 32
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Table IIIA 8.2-1:
Critical Use (worst case) used for consumer intake and risk assessment
1
2
3
4
5
6
UseNo.
Member
state(s)
Crop and/
or situation
F
G
or
I
Pests or Group of pests
controlled
Application
(crop destination /
purpose of crop)
(b)
(additionally:
developmental stages of
the pest or pest group)
Method /
Kind
7
8
Timing / Growth
stage of crop &
season
(g)
(c)
1
DE
Remarks:
sorghum
(a)
(b)
(c)
(d)
(e)
(f)
F
annual dicotyledonous
weeds (except field
chamomile, catchweed
bedstraw, chamomille
spec., birdseed, galinsoga
spec.)
BBCH 16
spraying
10
11
Application rate
(d-f)
(a)
9
after emergence,
from BBCH 13
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 7 / 32
Max. number
(min. interval
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
g as/ha
a) 1
b) 1
a) 2.5
b) 2.5
a) 1140
b) 1140
(g)
(h)
(i)
(j)
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water
L/ha
12
13
PHI
(days)
(i)
Remarks:
e.g. safener/synergist per ha
e.g. recommended or
mandatory tank mixtures
min / max
(j)
150 - 400
F
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
Stomp Aqua - 005958-00/00
IIIA 8.2.2
Sorghum
IIIA 8.2.2.1
Residues in primary crops
For the evaluation of the intended use 29 residue trials with pendimethalin on maize were submitted. The
trial data can be extrapolated to sorghum. All trials were conducted with higher application rates than
intended (1.5 to 2.0 kg as/ha instead of 1.1 kg as/ha) except for one trial where only 1 kg as/ha was
applied. Mature grain samples were taken in only 17 trials and only those were considered for the
assessment. The following table gives a brief overview of the supervised residue trials selected for the
assessment of pendimethalin in sorghum. For the detailed evaluation of new/additional residue trials, it is
referred to Appendix 2.
Table IIIA 8.2-2:
Overview of the selected supervised residue trials for pendimethalin in maize
Commodity
Region (a)
Outdoor/
Indoor
maize (grain)
sorghum
NEU
Outdoor
(a):
(b):
(c):
(d):
Individual trial results (mg/kg)
Enforcement
(pendimethalin)
Risk assessment
(pendimethalin)
<0.05 (17)
<0.05 (17)
STMR
(mg/kg) (b)
HR
(mg/kg) (c)
Median CF (d)
0.05
0.05
none
NEU, SEU, EU or Import (country code).
Median value of the individual trial results according to the risk assessment residue definition.
Highest value of the individual trial results according to the risk assessment residue definition.
The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual
conversion factors for each residue trial.
Analytical methods for commodities of dry content such as cereals are available and acceptable for
enforcing all compounds given in the residue definition.
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. Due to low residues at harvest, no processing studies are required.
IIIA 8.2.2.4
Proposed pre-harvest intervals, withholding periods
PHI: F
IIIA 8.3
Consumer intake and risk assessment
The consumer intake and risk assessment is based on the appropriate input values given in
Table IIIA 8.3-1 and the toxicological reference values stated in Table IIIA 8.3-2. For the detailed
calculation results it is referred to Appendix 3.
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)
Comment
Sorghum
0.05
MRL
--
not necessary (no ARfD
allocated)
All other commodities of various
MRL
Page 8 / 32
Stomp Aqua - 005958-00/00
plant and animal origin
Table IIIA 8.3-2:
Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)
ADI
0.125 mg/kg bw
TMDI (% ADI) according to EFSA PRIMo
3.4 % (based on FR toddler)
NTMDI (% ADI) according to DE NVS II
2.8 % (based on 2- 4 years old German children)
IEDI (% ADI) according to EFSA PRIMo
Not calculated
NEDI (% ADI) according to DE NVS II
Not calculated
Factors included in IEDI and NEDI
None
ARfD
n.n.
IESTI (% ARfD) according to EFSA PRIMo
Not calculated
NESTI (% ARfD) according to DE NVS II
Not calculated
Factors included in IESTI and NESTI
None
IIIA 8.4
Proposed maximum residue levels (MRLs)
No new MRLs are required.
IIIA 8.5
Conclusion
In supervised field trials involving the application of pendimethalin to maize at early growth stages, no
residues were found in maize grain. The trial data can be extrapolated to sorghum. It is concluded that the
MRL of 0.05 mg/kg as established under Reg. (EC) No 396/2005 for pendimethalin in sorghum is
sufficient to cover residues arising after treatment according to the intended use.
The chronic and the short-term intake of pendimethalin residues is unlikely to present a public health
concern.
As far as consumer health protection is concerned, the BfR/Germany agrees with the authorization of the
intended use.
Page 9 / 32
Stomp Aqua - 005958-00/00
Appendix 1 List of data submitted in support of the evaluation
Table A 1:
List of data submitted in support of the evaluation
Annex point/
reference No
Author(s)
Year
OECD: KIIA 6.3
Clemson, A.D. 1978
OECD: KIIA 6.3
Clemson, A.D. 1978
OECD: KIIA 6.3
Nicholson, M.
1976
OECD: KIIA 6.3
Anon.
2012
OECD: KIIA 6.3
Clemson, A.
D.
1981
OECD: KIIA 6.3
Eckel, M.;
Mertz, M.
1982
OECD: KIIA 6.3
Nicholson, M.
1975
OECD: KIIA 6.3
Nicholson, M.
G.
1975
OECD: KIIA 6.3
Clemson, A.
D.
1982
OECD: KIIA 6.3
Anon.
1982
OECD: KIIA 6.3
Eckel, M.;
Mertz, M.
1982
OECD: KIIA 6.3
Eckel, M.;
Mertz, M.
1982
OECD: KIIA 6.3
Trewhitt, J.
2000
Title
Source (where different from
company)
Report-No.
GLP or GEP status (where relevant),
Published or not
Authority registration No
STOMP* Residues in maize (grain and
straw)
PN-730-076 ! 9218/25865/82(GER) !
894
ASB2012-5657
STOMP* Residues in maize
9218/25866/82/ (GER) ! 898
ASB2012-5658
09218/18934/82 (GER) ! 611
ASB2012-5659
Residue summary from supervised field
trials, Pendimethalin in maize / cereals 2001
ASB2012-5660
STOMP* residues in maize
PN-730-077 ! 1415 !
9463/80151/82(GER)
RIP2003-985
Berichtsbogen für
Rückstandsuntersuchungen mit
Pflanzenbehandlungsmitteln – Mais
CYA 002770
RIP2003-1335
STOMP residues in maize
PN-730-037 ! 483 ! 09218/14894/82
(UK)
RIP2003-980
STOMP* residues in maize (France)
PN-730-074 ! 491 ! 09218/15937/82
(FR)
RIP2003-996
STOMP* residues in maize
PN-730-078 ! 1471 !
9465/81097/82(GER)
RIP2003-987
Berichtsbogen für
CYA No 000769 ! RLG 1471
ASB2010-2633
Berichtsbogen für
CYA 002768
RIP2003-1336
Berichtsbogen für
CYA 002767
RIP2003-1334
Pendimethalin (AC 92553) 400 g a.s./L
SC (RLM 11074) and 455 g a.s./L CS
(DF 10166): At harvest residue study on
Pendimethalin in maize - Germany,
1999.
PN-730-096 ! 4561 ! PN-FE-99-514
RIP2003-1020
Page 10 / 32
Data
protection
claimed
Owner
How considered in
dRR
Study-Status / Usage*
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
BASF
1
Stomp Aqua - 005958-00/00
Annex point/
reference No
Author(s)
Year
Title
Data
Owner
Source (where different from
protection
company)
claimed
Report-No.
GLP or GEP status (where relevant),
Published or not
Authority registration No
OECD: KIIA 6.3
Young, H.
2000
Pendimethalin (AC 92553) 400 g a.s./L
BASF
SC (RLM 11074) and 455 g a.s./L CS
(DF 10166): At harvest residue study on
Pendimethalin in maize - North France,
1999
PN-730-097 ! 4567 ! PN-FR-99-613
RIP2003-1021
BASF
OECD: KIIA 6.3
Trewhitt, J.;
2002
Study on the residue behaviour of BAS
Lehmann, A.;
455 H in maize after treatment with
Mackenroth,
BAS 455 21 H, BAS 455 24 H and BAS
C.
455 31 H under field conditions in
France (N and S), Germany and Spain,
2001.
2002/1004112 ! 82547
RIP2003-1022
OECD: KIIA 6.3
Anon.
1975
Berichtsbogen für
BASF
No 3083
ASB2010-2593
BASF
OECD: KIIA 6.3
Nicholson, M. 1976
09218/18934/82 (GER) ! 611
ASB2012-5659
OECD: KIIA 6.3
Anon.
1975
Berichtsbogen für
BASF
No 3086
ASB2010-2628
OECD: KIIA 6.3
Anon.
1976
Berichtsbogen für
BASF
No 3095
ASB2010-2626
BASF
OECD: KIIA 6.3
Anon.
1976
Berichtsbogen für
No 3101
ASB2010-2625
OECD: KIIA 6.3
Anon.
1975
Berichtsbogen für
BASF
No 3092
ASB2010-2627
BASF
OECD: KIIA 6.3
Anon.
1975
Berichtsbogen für
No 3094
ASB2010-2629
All
Spain
1998
DAR
ASB2010-10301
All
EFSA
2011
Reasoned Opinion: Modification of the
existing MRLs for pendimethalin in
various crops
EFSA Journal 2011;9(10):2400
ASB2012-1117
* 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 fulfil a data requirement, considered for evaluation)
Page 11 / 32
How considered in
dRR
Study-Status / Usage*
1
1
1
1
1
1
1
1
1
used
used
Stomp Aqua - 005958-00/00
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
A 2.2.1
Nature of residues
No further study on nature of residues submitted/needed.
Page 12 / 32
Stomp Aqua - 005958-00/00
A 2.2.2
Magnitude of residues in maize
Reference:
KII6.3
Report
ASB2012-5660, RIP2003-985, RIP2003-1335 (please refer to reference list for details)
Guideline(s):
Yes (Guidance 91/4141/EEC)
Deviations:
No
GLP:
No
Acceptability:
Yes
Table A 2:
Residues of pendimethalin in maize
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Federal Institute for Risk Assessment, Berlin
Federal Republic of Germany
Submission date
: 1982-06-21
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
Other a. i. in formulation
(common name and content)
Residues calculated as
: Outdoors (European North)
RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY)
(Application on agricultural and horticultural crops)
1
Report-No.
Location
incl.
Postal code
and date
CYA No 002770
No. 1415
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity /
Variety
(a)
Inracorn
Mutterlinie
:
:
:
:
330 g/l
EC
Stomp 330 EX (submitted to 003430-00)
BASF Aktiengesellschaft (BAS)
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 30.04.1980
2)
3) 25.08.1980
4
Application
rate per treatment
kg
a.i. / ha
1.7
Water
l / ha
400
kg
a.i. / hl
0.41
5
Dates of
treatments
or no. of
treatments
and last date
(c)
28.05.1980
D-7812
Schlatt
6
Growth
stage
at last
treatment
or date
post
emergence
7
Portion
analysed
(a)
foliage
cob
grain
06.10.1981
Page 13 / 32
8
Residues
(mg/kg)
<0.05
<0.05
<0.05
<0.05
<0.05
<0.05
:
: Pendimethalin
9
PHI
(days)
(d)
89
113
145
89
113
145
10
Remarks
(e)
analytical method: BASFmethod RLA 10841 V
(GC), LOQ: 0.05 mg/kg
ASB2012-5660
RIP2003-985
RIP2003-1335
Stomp Aqua - 005958-00/00
1
Report-No.
Location
incl.
Postal code
and date
CYA No 002769
No. 1415
2
Commodity /
Variety
(a)
Limac
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 04.05.1980
2)
3) 18.09.1980
4
Application
rate per treatment
kg
a.i. / ha
1.7
Water
l / ha
400
kg
a.i. / hl
0.41
5
Dates of
treatments
or no. of
treatments
and last date
(c)
28.05.1980
6
Growth
stage
at last
treatment
or date
post
emergence
D-7801 Umkirch
06.10.1981
CYA No 002771
No. 1415
7
Portion
analysed
(a)
foliage
cob
Limac
1) 02.05.1980
2)
3) 20.10.1980
1.7
400
0.41
29.05.1980
D-7585
Lichtenau
post
emergence
grain
foliage
cob
grain
06.10.1981
Comments of zRMS:
Acceptable.
Page 14 / 32
8
Residues
(mg/kg)
<0.05
<0.05
<0.05
<0.05
0.14
<0.05
<0.05
<0.05
<0.05
<0.05
<0.05
<0.05
9
PHI
(days)
(d)
89
113
145
89
113
145
88
112
144
88
112
144
10
Remarks
(e)
analytical method:
RLA 10841 V (GC)
RIP2003-985
RIP2003-1337
ASB2012-5660
analytical method:
RLA 10841 V (GC)
RIP2003-985
ASB2010-2631
ASB2012-5660
Stomp Aqua - 005958-00/00
Reference:
KII6.3
Report
RIP2003-980, RIP2003-996, ASB2012-5660 (please refer to reference list for details)
Guideline(s):
Deviations:
No
GLP:
No
Acceptability:
Yes
Table A 3:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 2003-08-22
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
1
Report-No.
Location
incl.
Postal code
and date
No. 483
GBWitchford,
Cambridgeshire
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity /
Variety
(a)
Atou 210
:
:
:
:
330 g/l
EC
Stomp 330 E (submitted to Stomp SC 033907-00)
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1)
2)
3) 13.10.1974
4
Application
rate per treatment
kg
a.i. / ha
1.0
Water
l / ha
330
kg
a.i. / hl
0.30
5
Dates of
treatments
or no. of
treatments
and last date
(c)
10.06.1974
6
Growth
stage
at last
treatment
or date
pre
emergence
7
Portion
analysed
(a)
whole plant
8
Residues
(mg/kg)
<0.05
:
: Pendimethalin
9
PHI
(days)
10
Remarks
(d)
125
(e)
RIP2003-980
ASB2012-5660
21.08.1975
Page 15 / 32
Stomp Aqua - 005958-00/00
1
Report-No.
Location
incl.
Postal code
and date
No. 483
2
Commodity /
Variety
(a)
Atou 210
GBWitchford,
Cambridgeshire
21.08.1975
No. 483
4
Application
rate per treatment
kg
a.i. / ha
1.5
Water
l / ha
330
kg
a.i. / hl
0.45
5
Dates of
treatments
or no. of
treatments
and last date
(c)
10.06.1974
6
Growth
stage
at last
treatment
or date
pre
emergence
7
Portion
analysed
(a)
whole plant
8
Residues
(mg/kg)
<0.05
9
PHI
(days)
10
Remarks
(d)
125
(e)
RIP2003-980
ASB2012-5660
Atou 210
GBWitchford,
Cambridgeshire
21.08.1975
PN-730-074
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1)
2)
3) 13.10.1974
1)
2)
3) 13.10.1974
2.0
330
0.61
10.06.1974
pre
emergence
whole plant
<0.05
125
RIP2003-980
ASB2012-5660
Inra 240
N-France
F-78
Orgeval
1)
2)
3)
1.5
600
0.25
30.04.1974
grain
<0.05
168
RIP2003-996
ASB2012-5660
1975-08-26
Comments of zRMS:
pre
emergence
Acceptable.
Page 16 / 32
Stomp Aqua - 005958-00/00
Reference:
KII6.3
Report
RIP2003-987, ASB2010-2633, RIP2003-1336, RIP2003-1334, ASB2012-5660 (please refer to reference list for
details)
Guideline(s):
Deviations:
No
GLP:
No
Acceptability:
Yes
Table A 4:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 1982-06-21
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
1
Report-No.
Location
incl.
Postal code
and date
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity /
Variety
(a)
CYA No 000769
No. 1471
Forla
:
:
:
:
330 g/l
EC
Stomp 330 E (submitted to 003430-00)
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1)15.05.1981
2)
3) 01.10.1981
4
Application
rate per treatment
kg
a.i. / ha
1.7
Water
l / ha
400
kg
a.i. / hl
0.42
5
Dates of
treatments
or no. of
treatments
and last date
(c)
20.05.1981
6
Growth
stage
at last
treatment
or date
pre
emergence
7
Portion
analysed
(a)
foliage
8
Residues
(mg/kg)
:
: Pendimethalin
9
PHI
(days)
10
Remarks
<0.05
<0.05
<0.05
(d)
90
120
137
(e)
xylene formulation,
analytical method:
RLA 10841 V (GC)
<0.05
<0.05
120
137
RIP2003-987
ASB2010-2633
ASB2012-5660
D- Limburgerhof
cob
grain
01.04.1982
Page 17 / 32
Stomp Aqua - 005958-00/00
1
Report-No.
Location
incl.
Postal code
and date
2
Commodity /
Variety
(a)
CYA No 002768
No. 1471
Forla
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1)15.05.1981
2)
3) 01.10.1981
4
Application
rate per treatment
kg
a.i. / ha
1.7
Water
l / ha
400
kg
a.i. / hl
0.42
5
Dates of
treatments
or no. of
treatments
and last date
(c)
20.05.1981
6
Growth
stage
at last
treatment
or date
pre
emergence
7
Portion
analysed
(a)
foliage
8
Residues
(mg/kg)
9
PHI
(days)
10
Remarks
<0.05
<0.05
0.06
(d)
90
120
137
(e)
solvesso formulation,
analytical method:
RLA 10841 V (GC)
cob
grain
<0.05
<0.05
120
137
foliage
<0.05
<0.05
<0.05
84
111
146
RIP2003-987
RIP2003-1336
ASB2012-5660
xylene formulation,
analytical method:
RLA 10841 V (GC)
cob
grain
<0.05
<0.05
111
146
foliage
0.11
0.05
0.06
84
111
146
cob
grain
<0.05
<0.05
111
146
D- Limburgerhof
01.04.1982
CYA No 000770
No. 1471
Tau
D-TuttendorfGettorf
01.04.1982
CYA No 002767
No. 1471
Tau
D- TuttendorfGettorf
1) 01.05.1981
2)25.07.1981
-05.08.1981
3)29.09.1981
1)01.05.1981
2)25.07.1981
-05.08.1981
3) 29.09.1981
1.7
1.7
400
400
0.42
0.42
06.05.1981
06.05.1981
01.04.1982
Comments of zRMS:
Acceptable.
Page 18 / 32
pre
emergence
pre
emergence
RIP2003-987
ASB2010-2632
ASB2012-5660
solvesso formulation,
analytical method:
RLA 10841 V (GC)
RIP2003-987
RIP2003-1334
ASB2012-5660
Stomp Aqua - 005958-00/00
Reference:
KII6.3
Report
RIP2003-1020, RIP2003-1021, RIP2003-1022, ASB2012-5660 (please refer to reference list for details)
Guideline(s):
Deviations:
No
GLP:
Yes
Acceptability:
Yes
Table A 5:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 2003-08-22
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
1
Report-No.
Location
incl.
Postal code
and date
PN-730-096
4561
99-514-01
D-67112
Dannstadt
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity /
Variety
(a)
Attribut
:
:
:
:
400 g/l
SC
Stomp 400 SC (RLM 11074) 033907-00
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1)26.04.1999
(sowing)
2) 02.07. 20.07.1999
3)11.10.1999
4
Application
rate per treatment
kg
a.i. / ha
2.0
Water
l / ha
490
kg
a.i. / hl
0.40
5
Dates of
treatments
or no. of
treatments
and last date
(c)
27.05.1999
6
Growth
stage
at last
treatment
or date
BBCH 16
7
Portion
analysed
(a)
whole plant
grain
8
Residues
(mg/kg)
<0.05
<0.05
:
: Pendimethalin
9
PHI
(days)
10
Remarks
(d)
78
140
(e)
RIP2003-1020
ASB2012-5660
07.06.2000
Page 19 / 32
Stomp Aqua - 005958-00/00
1
Report-No.
Location
incl.
Postal code
and date
PN-730-096
4561
99-613-353
2
Commodity /
Variety
(a)
Anjou 256
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1)29.04.1999
(sowing)
2) July 1999
3) 10.1999
4
Application
rate per treatment
kg
a.i. / ha
Water
l / ha
2.0
364
kg
a.i. / hl
0.55
5
Dates of
treatments
or no. of
treatments
and last date
(c)
01.06.1999
6
Growth
stage
at last
treatment
or date
BBCH 16
7
Portion
analysed
(a)
whole plant
grain
8
Residues
(mg/kg)
<0.05
<0.05
9
PHI
(days)
10
Remarks
(d)
73
122
(e)
F-28500 Cherisy
17.07.2000
2002/1004112
ACK/05/01
Lenz
D-16845 Manker
27.09.2002
2002/1004112
FAN/10/01
Kuxxar
F-67160
Seebach
1) 28.04.2001
(sowing)
2) 11.07 29.07.2001
3) 11.09. 17.09.2001
1) 11.05.2001
(sowin
g)
2) 17.07. 27.07.2001
3) 25.10.2001
2.0
2.0
300
300
0.66
0.67
30.05.2001
13.06.2001
BBCH 16
plant without
roots
cobs with
husks
rest of plant
without roots
plant without
roots
cobs with
husks
rest of plant
without roots
grain
straw with
husks
2003-06-04
Comments of zRMS:
BBCH 16
Acceptable.
Page 20 / 32
97.5
0.88
0
30
<0.05
104
<0.05
94.6
0.87
104
RIP2003-1021
ASB2012-5660
method: BASF 991/0
RIP2003-1022
ASB2012-5660
0 method: BASF 991/0
34
<0.05
75
<0.05
75
<0.05
118
<0.05
RIP2003-1022
118 ASB2012-5660
Stomp Aqua - 005958-00/00
Table A 6:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 2003-08-22
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
1
Report-No.
Location
incl.
Postal code
and date
PN-730-096
4561
99-514-01
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity /
Variety
(a)
Attribut
D-67112
Dannstadt
2000-07-06
PN-730-096
4561
99-613-353
:
:
:
:
455 g/l
SC
Stomp 455 CS [DF 10166] (submitted to Stomp SC 033907-00)
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 26.04.1999
(sowing)
2) 02.07. 20.07.1999
3) 11.10.1999
4
Application
rate per treatment
kg
a.i. / ha
Water
l / ha
kg
a.i. / hl
2.0
505
0.40
5
Dates of
treatments
or no. of
treatments
and last date
(c)
27.05.1999
6
Growth
stage
at last
treatment
or date
BBCH 16
7
Portion
analysed
(a)
whole plant
grain
8
Residues
(mg/kg)
<0.05
<0.05
:
: Pendimethalin
9
PHI
(days)
10
Remarks
(d)
(e)
78
140
RIP2003-1020
ASB2012-5660
Anjou 256
1) 29.04.1999
(sowing)
2) July 1999
3) 10.1999
2.0
364
0.55
01.06.1999
BBCH 16
whole plant
grain
<0.05
<0.05
73
122
F-28500 Cherisy
2000-07-17
RIP2003-1021
ASB2012-5660
Page 21 / 32
Stomp Aqua - 005958-00/00
1
Report-No.
Location
incl.
Postal code
and date
2
Commodity /
Variety
2002/1004112
ACK/05/01
(a)
Lenz
D-16845 Manker
2002-09-27
2002/1004112
FAN/10/01
F-67160
Seebach
Kuxxar
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 28.04.2001
(sowing)
2) 11.07 29.07.2001
3) 11.09. 17.09.2001
1) 11.05.2001
(sowing)
2) 17.07. 27.07.2001
3) 25.10.2001
4
Application
rate per treatment
kg
a.i. / ha
Water
l / ha
kg
a.i. / hl
2.0
300
0.66
2.0
300
0.67
5
Dates of
treatments
or no. of
treatments
and last date
(c)
30.05.2001
13.06.2001
2002-09-27
Comments of zRMS:
Acceptable.
Page 22 / 32
6
Growth
stage
at last
treatment
or date
BBCH 16
BBCH 16
7
Portion
analysed
(a)
plant without
roots
cobs with
husks
rest of plant
without roots
plant without
roots
cobs with
husks
rest of plant
without roots
grain
straw with
husks
8
Residues
(mg/kg)
9
PHI
(days)
(d)
38.7
0.54
<0.05
<0.05
85.0
0.77
<0.05
<0.05
<0.05
<0.05
10
Remarks
(e)
0
30 method used: BASF 991/0
104 RIP2003-1022
ASB2012-5660
104
0 method used: BASF 991/0
34
75
75
118 RIP2003-1022
ASB2012-5660
118
Stomp Aqua - 005958-00/00
Table A 7:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 22.08.2003
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
1
Report-No.
Location
incl.
Postal code
and date
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity /
Variety
(a)
2002/1004112
ACK/05/01
Lenz
D-16845
Manker
2003-06-04
2002/1004112
FAN/10/01
Kuxxar
F-67160
Seebach
:
:
:
:
330 g/l
EC
BAS 455 31 H (submitted to Stomp SC 033907-00)
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 28.04.2001
(sowing)
2) 11.07 29.07.2001
3) 11.09. 17.09.2001
1) 11.05.2001
(sowing)
2) 17.07. 27.07.2001
3) 25.10.2001
4
Application
rate per treatment
kg
a.i. / ha
2.0
2.0
Water
l / ha
300
300
kg
a.i. / hl
0.67
0.67
5
Dates of
treatments
or no. of
treatments
and last date
(c)
30.05.2001
13.06.2001
BBCH 16
BBCH 16
7
Portion
analysed
(a)
plant without
roots
cobs with
husks
rest of plant
without roots
plant without
roots
cobs with
husks
rest of plant
without roots
grain
corn straw
with husks
2003-06-04
Comments of zRMS:
6
Growth
stage
at last
treatment
or date
Acceptable.
Page 23 / 32
8
Residues
(mg/kg)
:
: Pendimethalin
9
PHI
(days)
10
Remarks
(d)
0
30
(e)
129
1.9
<0.05
104
<0.05
104
93.5
1.7
0
34
<0.05
75
<0.05
75
<0.05
118
<0.05
118
method: BASF 991/0
RIP2003-1022
ASB2012-5660
method: BASF 991/0
RIP2003-1022
ASB2012-5660
Stomp Aqua - 005958-00/00
Reference:
KII6.3
Report
ASB2010-2593, ASB2012-5659, ASB2012-5660 (please refer to reference list for details)
Guideline(s):
Deviations:
No
GLP:
Yes
Acceptability:
Yes
Table A 8:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 1977-04-28
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
Other a.i. in formulation
(content and common name)
1
Report-No.
Location
incl.
Postal code
and date
No 3083
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity/
Variety
(a)
Perdux
Germany
8301
Mitterhaid,
Landshut
:
:
:
:
330 g/l
EC
STOMP 023014-00 (submitted to 002396-00/03)
CYANAMID AGRAR GmbH & Co. KG
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 1975-05-01
(sowing)
2) 1975-07-20
- 1975-08-03
3) 1975-09-15
4
Application
rate per treatment
kg
a.i./ha
2.0
Water
l/ha
400
kg
a.i./hl
0.50
5
Dates of
treatments
or no. of
treatments
and last date
(c)
1975-05-064)
1975-11-01
Comments of zRMS:
Acceptable.
Page 24 / 32
6
Growth
stage
at last
treatment
or date
BBCH 07
7
Portion
analysed
8
Residues
(mg/kg)
(a)
maize cob with <0.05
husks
<0.05
:
: Pendimethalin
9
PHI
(days)
(d)
60
120
10
Remarks
(e)
4) spraying
analytical method:
M-458 (GC-ECD),
max. sample storage:
5 months
ASB2010-2593
ASB2012-5659
ASB2012-5660
Stomp Aqua - 005958-00/00
Reference:
KII6.3
Report
ASB2010-2628, ASB2010-2626, ASB2010-2625, ASB2012-5660 (please refer to reference list for details)
Guideline(s):
Deviations:
No
GLP:
Yes
Acceptability:
Yes
Table A 9:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 1977-04-28
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
1
Report-No.
Location
incl.
Postal code
and date
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity/
Variety
(a)
No 3086
Germany
7801
Hartheim
Limac
:
:
:
:
330 g/l
EC
tankmix STOMP and Atrazin 500 flüssig (submitted to 002396-00/03)
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 1975-04-24
(sowing)
2)
3) 1975-09-11
4
Application
rate per treatment
kg
a.i./ha
2.0
Water
l/ha
400
kg
a.i./hl
0.50
5
Dates of
treatments
or no. of
treatments
and last date
(c)
1975-04-304)
1975-11-01
Page 25 / 32
6
Growth
stage
at last
treatment
or date
BBCH 07
7
Portion
analysed
8
Residues
(mg/kg)
(a)
husks
<0.05
<0.05
: 480 g/l Atrazin
: Pendimethalin
9
PHI
(days)
(d)
79
114
134
10
Remarks
(e)
4) spraying
analytical method:
M-458 (GC-ECD),
5 months
ASB2010-2628
ASB2012-5659
ASB2012-5660
Stomp Aqua - 005958-00/00
1
Report-No.
Location
incl.
Postal code
and date
2
Commodity/
Variety
(a)
No 3095
Limac
Germany
7601
Schutterwald
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 1975-04-28
(sowing)
2)
3) 1975-09-12
4
Application
rate per treatment
kg
a.i./ha
2.0
Water
l/ha
600
kg
a.i./hl
0.33
5
Dates of
treatments
or no. of
treatments
and last date
(c)
1975-04-304)
6
Growth
stage
at last
treatment
or date
BBCH 07
7
Portion
analysed
8
Residues
(mg/kg)
(a)
husks
<0.05
<0.05
9
PHI
(days)
(d)
79
114
135
10
Remarks
(e)
4) spraying
analytical method:
M-458 (GC-ECD),
10 months
1976-04-01
ASB2010-2626
ASB2012-5659
ASB2012-5660
No 3101
Perdux
Germany
2211
Christinenthal
1) 1975-05-02
(sowing)
2)
3)
2.0
400
0.50
1975-05-054)
no data
husks
<0.05
90
120
4) spraying
analytical method:
M-458 (GC-ECD),
8 months
1976-03-01
ASB2010-2625
Comments of zRMS:
Acceptable.
Page 26 / 32
Stomp Aqua - 005958-00/00
Reference:
KII6.3
Report
ASB2010-2627, ASB2010-2629, ASB2012-5660 (please refer to reference list for details)
Guideline(s):
Deviations:
No
GLP:
Yes
Acceptability:
Yes
Table A 10:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 1977-04-28
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
1
Report-No.
Location
incl.
Postal code
and date
No 3092
Germany
7521
Langenbrücken
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity/
Variety
(a)
Inra 258
:
:
:
:
330 g/l
EC
Tankmix STOMP and Atrazin 50 (submitted to 002396-00/03)
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 1975-05-10
(sowing)
2)
3) 1975-08-26
4
Application
rate per treatment
kg
a.i./ha
2.0
Water
l/ha
400
kg
a.i./hl
0.50
5
Dates of
treatments
or no. of
treatments
and last date
(c)
1975-05-124)
6
Growth
stage
at last
treatment
or date
BBCH 07
7
Portion
analysed
8
Residues
(mg/kg)
(a)
husks
<0.05
: 480 g/l Atrazin
: Pendimethalin
9
PHI
(days)
(d)
67
106
10
Remarks
(e)
4) spraying
analytical method: M-458
(GC-ECD), max. sample
storage: 5 months
1975-11-01
ASB2010-2627
ASB2012-5660
Page 27 / 32
Stomp Aqua - 005958-00/00
1
Report-No.
Location
incl.
Postal code
and date
No 3094
2
Commodity/
Variety
(a)
Inra 258
Germany
7521
Langenbrücken
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 1975-05-12
(sowing)
2)
3) 1975-08-26
4
Application
rate per treatment
kg
a.i./ha
2.0
Water
l/ha
400
kg
a.i./hl
0.50
5
Dates of
treatments
or no. of
treatments
and last date
(c)
1975-05-124)
BBCH 07
7
Portion
analysed
8
Residues
(mg/kg)
(a)
husks
<0.05
9
PHI
(days)
(d)
67
106
10
Remarks
(e)
4) spraying
analytical method: M-458
(GC-ECD), max. sample
storage: 5 months
1975-11-01
Comments of zRMS:
6
Growth
stage
at last
treatment
or date
ASB2010-2629
ASB2012-5659
Acceptable.
Page 28 / 32
Stomp Aqua - 005958-00/00
Reference:
KII6.3
Report
ASB2012-5657, ASB2012-5658 (please refer to reference list for details)
Guideline(s):
Deviations:
No
GLP:
Yes
Acceptability:
Yes
Table A 11:
Active ingredient
Crop / crop group
: Pendimethalin
: Maize
Submission date
: 2012-05-23
Content of a.i.
Formulation
Commercial product
Applicant
Indoors / outdoors
1
Report-No.
Location
incl.
Postal code
and date
(g/kg or g/l)
(e.g. WP)
(name)
2
Commodity/
Variety
330 g/l
CS
STOMP 330E (submitted to Stomp Aqua 002396-00)
BASF (SE)
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 1977-04
(sowing)
2)
3) 1977-10-24
4
Application
rate per treatment
kg
a.i./ha
Water
l/ha
kg
a.i./hl
5
Dates of
treatments
or no. of
treatments
and last date
(c)
1977-04-264)
6
Growth
stage
at last
treatment
or date
7
Portion
analysed
9
PHI
(days)
1978-06-29
ASB2012-5657
400
0.50
grain
Page 29 / 32
<0.05
(d)
181
<0.05
181
10
Remarks
Germany
94459
Deggendorf
2.0
(a)
BBCH 05-07 green forage
8
Residues
(mg/kg)
:
: Pendimethalin
(e)
4) spraying
analytical method: RLA
10355 V (straw), RLA
10467 V (grain), (GCECD), LOQ: 0.05 mg/kg,
max. sample storage: 6
months
PN-730-076,
9218/25865/82
(GER), trial 894
(a)
Inra-Korn
:
:
:
:
Stomp Aqua - 005958-00/00
1
Report-No.
Location
incl.
Postal code
and date
2
Commodity/
Variety
(a)
9218/25866/82
(GER), trial 898
Inra-Korn
Germany
94459
Deggendorf
3
Date of
1) Sowing or
planting
2) Flowering
3) Harvest
(b)
1) 1977-04
(sowing)
2)
3)
4
Application
rate per treatment
kg
a.i./ha
2.0
Water
l/ha
400
kg
a.i./hl
0.50
5
Dates of
treatments
or no. of
treatments
and last date
(c)
1977-04-26
4)
6
Growth
stage
at last
treatment
or date
7
Portion
analysed
8
Residues
(mg/kg)
9
PHI
(days)
10
Remarks
(d)
(e)
<0.05
<0.05
120
169
maize cob
without husks
<0.05
120
grain
<0.05
169
4) spraying
analytical method: RLA
10355 V (straw), RLA
10467 V (grain), RLA
10472 V (whole cobs) (GCECD), LOQ: 0.05 mg/kg,
max. sample storage: 8
months
(a)
BBCH 05-07 green forage
1978-08-02
ASB2012-5658
Remarks:
(a)
(b)
(c)
(d)
(e)
According to CODEX Classification / Guide
Only if relevant
Year must be indicated
Days after last application (Label pre-harvest interval, PHI, underline)
Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Note: All entries to be filled in as appropriate
Comments of zRMS:
Acceptable.
Page 30 / 32
Stomp Aqua - 005958-00/00
A 2.3
Residues in processed commodities
No new study on residues in processed commodities has been submitted and none is needed due to low
residues at harvest.
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 31 / 32
Stomp Aqua - 005958-00/00
Appendix 3 Pesticide Residue Intake Model (PRIMo)
Pendimethalin (F)
Status of the active substance:
LOQ (mg/kg bw):
Code no.
proposed LOQ:
Toxicological end points
ADI (mg/kg bw/day):
0,125
ARfD (mg/kg bw):
n.n.
Source of ADI:
Year of evaluation:
COM
2003
Source of ARfD:
Year of evaluation:
COM
2003
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
3,4
3,2
3,0
2,9
2,7
2,3
2,2
1,9
1,8
1,8
1,6
1,5
1,5
1,3
1,2
1,0
1,0
0,9
0,9
0,8
0,8
0,8
0,8
0,7
0,6
0,6
0,5
MS Diet
FR toddler
UK Infant
UK Toddler
NL child
FR infant
DE child
WHO Cluster diet B
IE adult
SE general population 90th percentile
DK child
ES child
WHO cluster diet E
WHO cluster diet D
WHO regional European diet
WHO Cluster diet F
PT General population
NL general
ES adult
UK Adult
UK vegetarian
FR all population
DK adult
IT kids/toddler
LT adult
FI adult
IT adult
PL general population
Highest contributor
to MS diet
(in % of ADI)
1,6
1,5
0,9
1,2
1,0
0,9
0,5
0,4
0,5
0,5
0,5
0,2
0,3
0,2
0,2
0,3
0,3
0,2
0,2
0,2
0,2
0,2
0,3
0,2
0,2
0,2
0,1
TMDI (range) in % of ADI
minimum - maximum
1
3
---
Commodity /
group of commodities
Milk and cream,
Milk and cream,
SUGAR PLANTS
Milk and cream,
Milk and cream,
FRUIT (FRESH OR FROZEN)
CEREALS
Milk and cream,
Milk and cream,
Milk and cream,
CEREALS
CEREALS
Milk and cream,
CEREALS
Milk and cream,
Milk and cream,
SUGAR PLANTS
SUGAR PLANTS
Milk and cream,
CEREALS
Milk and cream,
Milk and cream,
CEREALS
Potatoes
2nd contributor to
MS diet
(in % of ADI)
0,5
0,4
0,8
0,6
0,6
0,6
0,3
0,3
0,2
0,4
0,2
0,2
0,2
0,2
0,2
0,2
0,2
0,2
0,1
0,1
0,1
0,1
0,1
0,1
0,1
0,1
0,1
Commodity /
SUGAR PLANTS
Milk and cream,
Milk and cream,
CEREALS
CEREALS
Milk and cream,
Potatoes
Milk and cream,
CEREALS
Milk and cream,
CEREALS
Potatoes
Conclusion:
The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI.
A long-term intake of residues of Pendimethalin (F) is unlikely to present a public health concern.
Page 32 / 32
3rd contributor to
MS diet
(in % of ADI)
0,4
0,2
0,3
0,2
0,4
0,2
0,2
0,1
0,2
0,2
0,2
0,2
0,2
0,2
0,2
0,2
0,1
0,1
0,1
0,1
0,1
0,1
0,1
0,1
0,1
0,1
0,0
pTMRLs at
Commodity /
LOQ
(in % of ADI)
Carrots
Potatoes
Carrots
CEREALS
Fruiting vegetables
Tropical root and tuber vegetables
CEREALS
Carrots
CEREALS
Potatoes
Potatoes
Meat, preparations of meat, offals,
Potatoes
CEREALS
CEREALS
Milk and cream,
Milk and cream,
CEREALS
Fruiting vegetables
CEREALS
CEREALS
Fruiting vegetables
Carrots

Pendimethalin final RR 1107 Art 51 Part A STOMP AQUA BASF DE

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