Registration Report Part A

Transcription

14869 N
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1.
BESLUIT
Op 25 april 2013 is van
Cheminova A/S
P.O. Box 9
DK-7620 LEMVIG
DENEMARKEN
een aanvraag tot toelating ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009
(verder te noemen: de Verordening) voor het gewasbeschermingsmiddel
SARACEN DELTA
op basis van de werkzame stoffen diflufenican en florasulam. Nederland is in deze een
betrokken lidstaat, als bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is het Verenigd
Koninkrijk
HET COLLEGE BESLUIT tot toelating van bovenstaand middel.
Alle bijlagen, waaronder registratierapport deel A, vormen een onlosmakelijk onderdeel van dit
besluit.
1.1
Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.2
Gebruik
Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en
zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.
1.3
Classificatie en etikettering
Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende
aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te
worden vermeld:



De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder
“verpakkingsinformatie” in bijlage I.
Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in
deel A van het registratierapport, Appendix I.
Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
SARACEN DELTA, 20130557 NLTG
14869 N

De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de
voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in
paragraaf 2.2 van deel A van het registratierapport.
1.4
Aflever- en opgebruiktermijn (respijtperiode)
Niet van toepassing. Het betreft een nieuwe toelating.
2.
WETTELIJKE GRONDSLAG
Besluit
artikel 28 en artikel 36, derde lid, Verordening (EG)
1107/2009
Classificatie en etikettering
artikel 31 en artikel 65 van de Verordening (EG) 1107/2009
Gebruikt toetsingskader
Bgb en Rgb d.d. 16 december 2011, Evaluation Manual
Zonaal, GD Birds & Mammals 2012 en GD Dermal
Absorption 2012
3.
BEOORDELINGEN
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en
ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen
zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische
eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van
het middel aanvaardbaar geacht.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen
bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn,
volgend uit geoorloofd gebruik.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor de mens verwacht.
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht
dat het werkzaam is.
14869 N
Bezwaarmogelijkheid
Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van
Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet
bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een
bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen
en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de
mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.
Wageningen, 5 juni 2015
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. J.F. de Leeuw
Voorzitter
14869 N
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
2.1 Aanvraaginformatie
Aanvraagnummer:
Type aanvraag:
Middelnaam:
Verzenddatum aanvraag:
Formele registratiedatum: *
Datum in behandeling name:
Datum compliance check:
20130557 NLTG
Nederland is in deze een betrokken lidstaat, als
bedoeld in artikel 36, tweede lid; de beoordelend
lidstaat is het Verenigd Koninkrijk
SARACEN DELTA
23 april 2013
30 mei 2013
28 januari 2015
n.v.t.
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2.2 Stofinformatie
Werkzame stof
diflufenican
florasulam
Gehalte
500 g/L
50 g/L

De stof diflufenican is per 1 januari 2009 geplaatst op Annex I van Richtlijn 91/414/EEG
(Dir 2008/66/EC d.d. 30 juni 2008) en vervolgens bij Uitvoeringsverordening (EU)
540/2011 d.d. 25 mei 2011 goedgekeurd. De goedkeuring van deze werkzame stof
expireert op 31 december 2018.

De stof florasulam is per 1 oktober 2002 geplaatst op Annex I van Richtlijn 91/414/EEG
(Dir 2002/64/EC d.d. 15 juli 2002) en vervolgens bij Uitvoeringsverordening (EU)
540/2011 d.d. 25 mei 2011 goedgekeurd. De goedkeuring van deze werkzame stof
expireert op 31 december 2015.
2.3 Toelatingsinformatie
Toelatingsnummer:
Expiratiedatum:
Afgeleide parallel of origineel:
Biocide, gewasbeschermingsmiddel of
toevoegingsstof:
Gebruikers:
2.4 Verpakkingsinformatie
Aard van het preparaat:
Suspensie concentraat
14869 N
31 december 2016
n.v.t.
Gewasbeschermingsmiddel
Professioneel
14869 N
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE II Etikettering van het middel SARACEN DELTA
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
Pictogram
GHS09
Signaalwoord
WAARSCHUWING
Gevarenaanduidingen H410 Zeer giftig voor in het water levende organismen, met
langdurige gevolgen.
Voorzorgsmaatregelen P273 Voorkom lozing in het milieu.
P391 Gelekte/gemorste stof opruimen.
P501 Inhoud/verpakking afvoeren naar ....
SP 1 Zorg ervoor dat u met het product of zijn verpakking geen
water verontreinigt.
Aanvullende
EUH208
Bevat 1,2-benzisothiazolin-3-on. Kan een allergische
etiketelementen
reactie veroorzaken.
EUH401
Volg de gebruiksaanwijzing om gevaar voor de
menselijke gezondheid en het milieu te voorkomen.
Kinderveilige sluiting verplicht
Nee
Voelbare gevaarsaanduiding verplicht Nee
14869 N
REGISTRATION REPORT
Part A
Risk Management
Product code:
SARACEN DELTA
Active Substance:
Florasulam 50 g/L +
Diflufenican 500 g/L SC
COUNTRY: NETHERLANDS
Central Zone
Zonal Rapporteur Member State: UK
NATIONAL ASSESSMENT
Applicant:
Cheminova A/S
Date:
May 2015
Table of Contents
14869 N
PART A – Risk Management
9
1
Details of the application
9
1.1
Application background
9
1.2
Annex I inclusion
10
1.3
Regulatory approach
10
1.4
Data protection claims
11
1.5
Letters of Access
11
2
Details of the authorisation
11
2.1
Product identity
11
2.2
Classification and labelling
11
2.2.1
Classification and labelling under Directive 99/45/EC
11
2.2.2
R and S phrases under Directive 2003/82/EC (Annex IV and V)
Bladwijzer niet gedefinieerd.
Fout!
2.2.3
Other phrases
Bladwijzer niet gedefinieerd.
Fout!
2.3
Product uses
13
3
Risk management
15
3.1
Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles
15
3.1.1
Physical and chemical properties
15
3.1.2
Methods of analysis
15
3.1.2.1
Analytical method for the formulation
15
3.1.2.2
Analytical methods for residues
15
3.1.3
Mammalian Toxicology
16
3.1.3.1
Acute Toxicity
16
3.1.3.2
Operator Exposure
16
3.1.3.3
Bystander Exposure
17
3.1.3.4
Worker Exposure
17
3.1.3.5
Other studies
17
3.1.4
Residues and Consumer Exposure
17
3.1.4.1
Residues
17
3.1.4.2
Consumer exposure
18
3.1.5
Environmental fate and behaviour
19
3.1.6
Ecotoxicology
23
3.1.6.1
Effects on Terrestrial Vertebrates
23
3.1.6.2
Effects on Aquatic Species
24
3.1.6.3
Effects on Bees and Other Arthropod Species
24
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3.1.6.4
Effects on Earthworms and Other Soil Macro-organisms
25
3.1.6.5
Effects on organic matter breakdown
26
3.1.6.6
Effects on Soil Non-target Micro-organisms
26
3.1.6.7
Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna)
27
3.1.7
Efficacy
28
3.2
Conclusions
29
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
31
Appendix 1 – Copy of the product label
32
Appendix 2 – Reference listl
34
14869 N
Introduction
This document - Part A – for the product SARACEN DELTA (Florasulam 50 g/L + Diflufenican 500 g/L
SC) for The Netherlands is an updated version of the original document dated March 2013. The current
document reflects the revisions of the Part B requested by CTGB in October 2014 to address specific
Dutch requirements.
PART A – Risk Management
This document - Part A - of the application (draft Registration Report format) gives a general overview of
the product endpoints and of the overall assessment conditions and risk management related to the use
pattern (GAP) applied for the national registration as well as to the data protection and to the existing data
access agreements.
1
Details of the application
This evaluation is required subsequent to the inclusion of florasulam and diflufenican on Annex 1.
Risk assessment conclusions are based on the information, data and assessments provided in the
Registration Report, Part B, sections 1-7 and 8 and Part C – confidential. The information, data and
assessments provided in part B of the RR includes assessment of further data or information as required
for the national registration by the EU review. It also includes assessment of data and information relating
to the product SARACEN DELTA (Product code CHA 1225) where that data has not been considered in
the EU review. Otherwise the safe use assessments of SARACEN DELTA (CHA 1225) have been
prepared by using the endpoints agreed in the EU review.
This document describes the specific conditions of use and labelling required in the Netherlands for the
registration of SARACEN DELTA (CHA 1225).
Appendix 1 of this document provides a copy of the Dutch draft label.
Appendix 2 of this document provides a reference list.
1.1
Application background
The aim of this registration application is to gain approval of Florasulam 50 g/L + Diflufenican 500 g/L
SC (SARACEN DELTA) – a suspension concentrate formulation containing 50 g/L florasulam + 500 g/L
diflufenican in the Netherlands, for use as a post emergence herbicide for the control of annual broad
leaved weeds on cereals and grass for seed production in the field.
Florasulam 50 g/L + Diflufenican 500 g/L SC (SARACEN DELTA) is recommended for spring
application as a foliar spray on winter cereals (BBCH 20-32), spring cereals (BBCH 12-32) and grass for
seed production (BBCH 12-32). This product was not evaluated as the representative formulation of
florasulam or diflufenican in the EU evaluation process. The complete GAP for the national application in
the Netherlands is provided below, under point 2.3.
14869 N
1.2
Annex I inclusion
Florasulam is a herbicidal compound which was included on Annex I of Directive 91/414/EEC on 15 July
2002 under Directive 2002/64/EC. Document SANCO/1406/2001-final (18/09/2002) and the associated
DAR are considered the most relevant sources to provide the review information or reference on the EU
endpoints/critical EU agreed endpoints.
The Annex I Inclusion Directive for florasulam (2002/64/EC) provides 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.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
florasulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 19/04/2002, shall be taken into account. In this overall assessment,
Member States should pay particular attention to:
- the potential for groundwater contamination, when the active substance is applied in regions with
vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk
mitigation measures, where appropriate.
Diflufenican was included on Annex I of Directive 91/414/EEC under Directive 2008/66/EC. The EFSA
Scientific Report for diflufenican ((2007) 122, 1-84) is considered the most relevant sources to provide
the relevant review information or reference on the EU endpoints/critical EU agreed endpoints.
The Annex I Inclusion Directive for diflufenican (Dir. 2008/66/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.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on
diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment,
Member States must pay particular attention to:
- the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be
applied, where appropriate,
- the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer
zones shall be applied, where appropriate.
These concerns have been addressed within the current submission.
1.3
Regulatory approach
The application for the registration of product Florasulam 50 g/L + Diflufenican 500 g/L SC (SARACEN
DELTA) in the Netherlands was conducted in line with all Dutch national specific requirements.
To obtain approval of the product Florasulam 50 g/L + Diflufenican 500 g/L SC (SARACEN DELTA) in
the Netherlands, this application and the supporting dossier (RR) should meet and satisfy the
requirements of Annex II and Annex III - with an assessment done according to the Uniform Principles using the end-points agreed in Annex I, if appropriate.
14869 N
This application was submitted in order to allow the first approval of this product in the Netherlands in
accordance with the above.
1.4
Data protection claims
CHEMINOVA A/S hereby requests data protection for all information listed in Appendix 1, part B of
each dossier section, on the basis that this information is regarded as proprietary and it is the first
application for the product in the Netherlands. Furthermore, CHEMINOVA A/S requests data protection
and confidentiality for all information included in part C of this dRR application.
1.5
Letters of Access
Within the documents of this application we refer to the “Annex II data” submitted in support of the
inclusion of diflufenican on Annex I. The access to all referenced data is granted to CHEMINOVA A/S
through a Letter of Access issued by the data owner Bayer CropScience AG, Germany.
2
Details of the authorisation
2.1
Product identity
Product Name (Code)
SARACEN DELTA
Authorization Number (for re-registration) n.a.
Function
Herbicide
Applicant
CHEMINOVA A/S
Composition
50 g/L Florasulam + 500 g/l Diflufenican
Formulation type
Suspension concentrate [Code: SC]
Packaging
Bottles or cans (HDPE, COEX HDPE/PA, fluorinated HDPE)
Capacity:
0.1 - 5L
2.2
Classification and labelling
2.2.1
Classification and labelling under Regulation (EC) No 1272/2008
Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the
co-formulants, the method of application and the risk assessment for the operator, as mentioned above,
the following labeling of the preparation is proposed:
The identity of all substances in the mixture that contribute to the classification of the
mixture *:
Pictogram:
GHS09
Signal word:
Warning
H-statements:
H410
Very toxic to aquatic life with long lasting effects.
P-statements:
P273
Avoid release to the environment.
P391
Collect spillage.
P501
Dispose of contents/container to …
Supplemental Hazard
EUH208
Contains 1,2-benzisothiazolin-3-one. May produce
information:
an allergic reaction.
EUH401
To avoid risks to human health and the
environment, comply with the instructions for use.
SP1
Do not contaminate water with the product or its
container.
Child-resistant fastening obligatory?
Not applicable
14869 N
Tactile warning of danger obligatory?
Explanation:
Pictogram:
H-statements:
Not applicable
Applicant proposed the highest classification H410: Very toxic
to aquatic life with long lasting effects. Proposal accepted.
P-statements:
P-statements as proposed by the applicant are accepted.
Other:
EUH208 is assigned based on the presence of 1,2benzisothiazolin-3-one above 10% of its SCL.
SP1 according to Reg. (EU) No 547/2011
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
14869 N
2.3
Product uses
Table 2.3a product uses applied for
1
UseNo.
2
Member
state(s)
3
Crop and/
or situation
4
F
G
or
I
5
Pests or Group of pests
controlled
6
7
8
10
Application
Method /
Kind
Timing / Growth
stage of crop &
season
11
12
Application rate per treatment
Number /
(min. Interval
between
applications)
L product
/ ha
g as/ha
Water L/ha
13
PHI
(days)
14
Remarks:
a) max. no. of applications per crop
and season
b) Maximum product rate per season
min / max
c) additional remarks
1
2
3
4
5
6
7
NL
NL
NL
NL
NL
NL
NL
Winter wheat
Spring wheat
Winter barley
Spring barley
Winter Rye
Winter Triticale
Grass (for seed
production)
F
F
F
F
F
F
F
Table 2.3b product uses authorised
Annual broad leaved
weeds
Foliar
spray
BBCH 20-32
Annual broad leaved
weeds
Foliar
spray
BBCH 12-32
Annual broad leaved
weeds
Foliar
spray
BBCH 20-32
Annual broad leaved
weeds
Foliar
spray
BBCH 12-32
Annual broad leaved
weeds
Foliar
spray
BBCH 20-32
Annual broad leaved
weeds
Foliar
spray
BBCH 20-32
Annual broad leaved
weeds
Foliar
spray
BBCH 12-32
1
0.1
1
0.1
1
0.1
1
0.1
1
0.1
1
0.1
1
0.1
March - June
March - June
March - June
March - June
March - June
March - June
March - June
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
150 - 300
-
Spring application
150 - 300
-
150 - 300
-
150 – 300
-
150 – 300
-
Spring application
150 – 300
-
Spring application
150 - 300
-
Spring application
Spring application
14869 N
1
UseNo.
2
Member
state(s)
3
Crop and/
or situation
4
F
G
or
I
5
Pests or Group of pests
controlled
6
7
8
10
Application
Method /
Kind
Timing / Growth
stage of crop &
season
11
12
Application rate per treatment
Number /
(min. Interval
between
applications)
L product
/ ha
g as/ha
Water L/ha
13
PHI
(days)
14
Remarks:
a)
max. no. of applications per
crop and season
b) Maximum product rate per season
min / max
c) additional remarks
1
2
3
4
5
6
NL
NL
NL
NL
NL
NL
Winter wheat
Spring wheat
Winter barley
Spring barley
Winter Rye
Winter Triticale
F
F
F
F
F
F
Annual broad leaved
weeds
Foliar
spray
BBCH 20-32
Annual broad leaved
weeds
Foliar
spray
BBCH 12-32
Annual broad leaved
weeds
Foliar
spray
BBCH 20-32
Annual broad leaved
weeds
Foliar
spray
BBCH 12-32
Annual broad leaved
weeds
Foliar
spray
BBCH 20-32
Annual broad leaved
weeds
Foliar
spray
BBCH 20-32
1
0.1
5.0
florasulam
50.0
diflufinican
1
0.1
1
0.1
1
0.1
1
0.1
1
0.1
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
5.0
florasulam
50.0
diflufinican
March - June
March - June
March - June
March - June
March - June
March - June
150 - 300
-
Spring application
150 - 300
-
150 - 300
-
150 – 300
-
150 – 300
-
Spring application
150 – 300
-
Spring application
Spring application
14869 N
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
The product SARACEN DELTA (CHA 1225) was not the representative formulation for the inclusion of
florasulam or diflufenican into Annex I of Directive 91/414/EEC. Therefore, physical, chemical and
technical properties of SARACEN DELTA are provided and the results were considered acceptable.
SARACEN DELTA is an off-white opaque homogeneous liquid with a weakly aromatic odour. It is not
explosive, oxidising or flammable. No flash point was detected up to 74°C, at which temperature the
flame was extinguished and no auto-ignition temperature was determined below 600°C. SARACEN
DELTA is slightly acidic (pH of 4.46 undiluted, pH of 4.53 as a 1 % aqueous solution). SARACEN
DELTA and its commercial container materials have been shown to be stable in an accelerated stability
test (14 days at 54°C in co-extruded HDPE) and at low temperature (0oC for 7 days). Its technical
properties are such that no problems are expected when the product is used according to label
recommendations under normal field conditions.
A 2 year storage stability study at 20oC has been submitted at national level. A final shelf-life study was
not included in the core assessment, but the study was evaluated in the northern zone by zonal rapporteur
Denmark. The study was performed in HDPE and showed the product has a shelf-life of at least 2 years at
ambient temperatures.
Implications for labelling: none
Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity,
size of opening, type of closure, strength, leak proofness, resistance to normal transport & handling,
resistance to & compatibility with the contents of the packaging, have been described and submitted in
Part B (RR). The intended packaging complies with all current UN and ADR requirements.
Nature and characteristics of the protective clothing and equipment: Information regarding the
required protective clothing and equipment for the safe handling of SARACEN DELTA has been
provided and is considered to be acceptable.
3.1.2
Methods of analysis
3.1.2.1 Analytical method for the formulation
One analytical method (VAM 228-01) based on high performance liquid chromatography (HPLC) with
UV detection has been developed for the determination of the active substances florasulam and
diflufenican in SC formulations including SARACEN DELTA. The method has been validated according
to specificity, linearity, sensitivity, recovery and precision and thus the method is considered adequate. A
CIPAC method is not currently available. Methods for determination of impurities and formulants of
toxicological, ecotoxicological or environmental concern are not required.
3.1.2.2 Analytical methods for residues
14869 N
All analytical methods for analysis of florasulam and diflufenican in plant and environmental
compartments are active substance data and were provided in the EU review of florasulam and
diflufenican. Details of the methodology are provided in Part B Section 2 of the dossier.
An analytical method for the determination of florasulam in water was submitted by the applicant and
evaluated in support of SARACEN (14653 N).
For florasulam and diflufenican the Dutch national requirements for residue analytical methods for
surface water with an LOQ of equal to or lower than 0.1µg/L are met. For florasulam the EU dossier
includes an adequate method. For diflufenican, the applicant has access to a method submitted at national
level.
3.1.3
Mammalian Toxicology
3.1.3.1 Acute Toxicity
Acute toxicity studies for Florasulam 50g/L + Diflufenican 500 g/L SC (SARACEN DELTA) were not
evaluated as part of the EU review of florasulam or diflufenican. Therefore, all relevant data have been
provided and are considered adequate.
Summary of acute toxicity studies
Study Type
Species
Result
Classification
according to Reg
(EC) No 1272/2008
No classification
No classification
No classification
Acute oral toxicity
Acute dermal toxicity
Acute inhalation
toxicity
Primary skin irritation
rat
rat
rat
LD50 > 5000 mg/kg bw
LD50 > 5000 mg/kg bw
LC50 > 3.98 mg/l (maximum attainable)
rabbit
Primary eye irritation
rabbit
Skin sensitisation;
(Lymph node)
mouse
Primary irritation index of 0.1 and thus
No classification
is classified as slightly irritant to the
rabbit skin according to the Draize
system. No corrosive effects were
noted.
Maximum group mean score of 8.0 and No classification
thus classified as minimally irritant to
the rabbit eye according to a modified
Kay and Calandra classification system.
Stimulation Index of 1.11, 1.38 and
No classification
1.50. The test item was considered to
be a non sensitiser.
SARACEN DELTA, containing 50 g/L Florasulam + 500 g/L Diflufenican, is of low acute toxicity by the
oral, dermal and inhalation route of administration. SARACEN DELTA is not irritating to the skin or
eyes and is not a sensitiser by skin contact. As a consequence of the acute toxicity data, no classification
is proposed for SARACEN DELTA.
3.1.3.2 Operator Exposure
Operator exposure to Florasulam 50g/L + Diflufenican 500 g/L SC (SARACEN DELTA) was not
evaluated as part of the EU review of florasulam for this submitted GAP. Therefore all relevant data and
risk assessments have been provided and are considered to be adequate.
Operator exposure was assessed against the AOEL agreed in the EU review, this is 0.05 mg/kg bw/day
for florasulam and 0.11 mg/kg bw/d for diflufenican.
ZRMS proposed default values for dermal absorption: 25% for the concentrate and 75% for the spray
dilution, for both active substances. Operator exposure was estimated in the Core dossier according to
EUROPOEM I for mechanical spray applications in low crops based on tractor mounted/trailed hydraulic
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boom sprayer applications in the field. The results show that there are no potential health risks to
operators applying SARACEN DELTA wearing normal work clothing but no PPE. This conclusion is
also valid for the simultaneous exposure to both active substances (total 54% of the AOEL)..
According to current endpoints
Model data
Level of PPE
Diflufenican
Total
absorbed
dose
(mg/kg/day)
Florasulam
% of AOEL
0.11 mg/kg
bw/d
Total
absorbed
dose
(mg/kg/day)
% of AOEL
0.05 mg/kg
bw/d
44
0.0048
10
Tractor boom sprayer application outdoors to low crops (winter cereals)
Application rate 0.05 kg/ha diflufenican +0.005 kg/ha florasulam
Dutch Model
 10 ha/day
 70 kg operator
no PPE
0.0481
3.1.3.3 Bystander Exposure
Bystander and resident exposure to SARACEN DELTA was not evaluated as part of the EU review of
florasulam or diflufenican for the proposed use. Therefore, all relevant data and risk assessments have
been provided and are considered adequate. Bystander and resident exposure was assessed in the Core
dossier using EUROPOEM II, the UK method and DE mode. It is concluded that neither bystanders, nor
residents are at risk due to the intended use of SARACEN DELTA.
3.1.3.4 Worker Exposure
Worker exposure to SARACEN DELTA was not evaluated as part of the EU review of florasulam nor
diflufenican for the proposed use. Therefore, all relevant data and risk assessments have been provided
and are considered adequate. Worker exposure was assessed in the Core dossier using EUROPOEM II. It
is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing
(but no PPE), when re-entering crops treated with SARACEN DELTA. No re-entry interval is required.
3.1.3.5 Other studies
In the National Addendum of Section B3, three genotoxicity studies with metabolite TSA were evaluated.
The studies demonstrated that TSA was negative in the Ames test, negative in a micronucleus test with
human lymphocytes and negative an a mammalian cell gene mutation assay. Therefore, TSA does not
show any genotoxic potential.
3.1.4
Residues and Consumer Exposure
3.1.4.1 Residues
The metabolism in plants and livestock assessed for the approval of both actives is sufficient to support
the proposed uses on cereals and grass for seed production.
No new residue trials data have been evaluated in this application. For florasulam the proposed
application rate to cereals is within the GAP considered supported for the approval of the active
substance. The proposed GAP for cereals for diflufenican is not within the GAP considered as supported
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for the approval of the active substance. However, sufficient residue trials supporting the proposed GAP
were evaluated in the DAR.
The use on grass (for seed production) is a use to obtain grass seeds. However, there is still the possibility
that the treated grass could be grazed by livestock or cut for fodder. As no residue trials data on grass
have been provided, the use of the product on grass is authorised in the UK with the following restriction
on the label:
‘The product must not be used on grass that will be grazed or cut for fodder’
According to the UK, other MS will need to decide if such a restriction is applicable for the authorisation
in their country. The authorisation should only be granted with the restrictions as no residues data on
grass has been provided. It should be noted, that an estimate of residues in grass using cereal forage data
was made to assess the potential impact of residues in grass if the restriction was not followed. Residues
of diflufenican would below the current default LOQ MRL of 0.05 mg/kg for products of animal origin.
For florasulam MRLs for products of animal origin are set at 0.01 mg/kg (Regulation (EU) No
1317/2013). On the basis of data from a lactating goat metabolism study it cannot be excluded that
grazing of treated grass or using treated grass for fodder will lead to residues above the current MRL in
liver and kidney.
It is unlikely that residues in animal commodities resulting from the use on grass would result in any
exceedances of the ADI and hence raise any chronic intake concerns. Neither active is acutely toxic.
However, since the MRL for florasulam might be exceeded in some matrices of animal origin, the feeding
restriction proposed by UK is considered appropriate.
For the proposed GAP, and following the label restrictions with respect to grass (for seed production)
residues in products of animal origin for either active are unlikely.
For both actives residues in cereal grain at harvest were <0.1 mg/kg and hence processing data are not
required.
Residues in rotational crops are unlikely for both actives.
The proposed GAP in CEU will not result in residues of diflufenican exceeding the current EU MRL of
0.05* mg/kg or florasulam exceeding the current EU MRL of 0.01* mg/kg for cereal grains No new
MRLs are required.
3.1.4.2 Consumer exposure
Using the current EFSA PRIMO acute and chronic model for consumer risk assessment it is demonstrated
that using current EU MRLs for the selected crops would not cause concerns over human health when the
product Saracen Delta containing diflufenican and florasulam is used according to the proposed GAP for
CEU, with chronic exposure being significantly below the currently agreed toxicological endpoints. No
acute reference dose was required to be set for diflufenican or florasulam.
The following label restriction is required for use on grass for seed production:
‘The product must not be used on grass that will be grazed or cut for fodder’
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3.1.5
Environmental fate and behaviour
No new studies are presented; all data were reviewed in the EU reviews of florasulam and diflufenican.
Appropriate endpoints from the EU review were used to calculate PECs for Saracen Delta, florasulam,
diflufenican and their metabolites in soil, surface water, sediment, ground water and air for the intended
use patterns.
Predicted Environmental Concentration in Soil (PECsoil)
The PECsoil of diflufenican, florasulam and the relevant soil metabolites have been assessed with the
FOCUS model and the FOCUS groundwater interception values and the DT50 values established in the
EU review. Values were determined using a critical GAP (risk envelope) to cover all proposed uses in the
central zone, this represents the highest exposure for soil organisms. The GAP applied in the assessment
was 1 x 0.1 L Saracen Delta/ha, equivalent to 5 g florasulam/ha and 50 g diflufenican/ha in cereals as a
spring application at BBCH 12-32. Crop interception was 25% therefore rates to soil were 3.75 g/ha and
37.5 g/ha, equivalent to 75% of applied dose.
The maximum PECsoil over a 5 cm depth for florasulam was 0.005 mg/kg.
The maximum PECsoil over a 5 cm depth for diflufenican was 0.1265 mg/k g.
The maximum PECsoil over a 5 cm depth for the florasulam metabolite 5-OH was 0.00344 mg/kg.
The maximum PECsoil over a 5 cm depth for the florasulam metabolite DFP-ASTCA was 0.00075 mg/kg.
The maximum PECsoil over a 5 cm depth for the florasulam metabolite ASTCA was 0.00107 mg/kg.
The maximum PECsoil over a 5 cm depth for the florasulam metabolite TSA was 0.00033 mg/kg.
The maximum PECsoil over a 5 cm depth for the diflufenican metabolite AEB107137was 0.00603 mg/kg.
The maximum PECsoil over a 5 cm depth for the diflufenican metabolite AE 0542291 was 0.00942 mg/kg.
PECsoil values for the formulation have also been calculated for the critical GAP assuming a maximum
application rate of 0.1 L/ha and a formulation density of 1.22 g/mL. Other assumptions were the same as
for the active substance PECsoil calculations: Initial PECsoil for Saracen Delta = 0.122 mg Saracen
Delta/kg.
Predicted Environmental Concentration in Ground Water (PECgw)
PECgw values were calculated using a critical GAP (risk envelope) approach to cover all uses in The
Netherlands. The critical GAPs for PECgw were determined to be:
-
Winter cereals (Spring application): 1 × 5 g Florasulam/ha at BBCH 12 – 32
Winter cereals (Spring application): 1 × 50 g Diflufenican/ha at BBCH 12 – 32
Spring cereals (Spring application): 1 × 5 g Florasulam/ha at BBCH 12 – 32
Spring cereals (Spring application): 1 × 50 g Diflufenican/ha at BBCH 12 – 32
Grass (Spring application): 1 × 5 g Florasulam/ha at BBCH 12 – 32
Grass (Spring application): 1 × 50 g Diflufenican/ha at BBCH 12 – 32
The PECs in groundwater were assessed with standard FOCUS scenario Kremsmünster to obtain outputs
from the FOCUS PEARL (v.4.4.4) model. Date of yearly application was set at May 25th (default).
Results are summarised in the following tables:
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PECgw [µg L-1] at 1 m soil depth for Florasulam and its metabolites. Values ≥0.1 µg/L are indicated
in bold, values ≥0.01-<0.1 µg/L are underlined
Crop
Scenario
Application
timing
80th Percentile PECgw at 1m Soil Depth [µg L-1]
Florasulam
5-OH
DFPASTCA
ASTCA
TSA
Winter cereals
(Spring application)
Kremsmünster
25-May
< 0.001
0.009
< 0.001
0.153
0.050
Spring cereals
Kremsmünster
25-May
< 0.001
0.009
< 0.001
0.169
0.053
Grass
Kremsmünster
25-May
< 0.001
0.005
< 0.001
0.130
0.035
PECgw [µg L-1] at 1 m soil depth for Diflufenican and its metabolites
Crop
Scenario
80th Percentile PECgw at 1m Soil Depth [µg L-1]
Application
timing
Diflufenican
AEB017137
AE0542291
25-May
< 0.001
< 0.001
< 0.001
Kremsmünster
25-May
< 0.001
< 0.001
< 0.001
Kremsmünster
25-May
< 0.001
< 0.001
< 0.001
Winter cereals
Kremsmünster
Spring cereals
Grass
The PECgw for Florasulam, metabolites 5-OH and DFP-ASTCA and the PECgw for Diflufenican,
AEB017137 and AE0542291 are below the regulatory threshold of 0.01 µg/L.
PECgw for ASTCA and TSA are above the Dutch regulatory threshold of 0.01 µg/L.
The metabolites ASTCA and TSA were assessed with Tier 2 GeoPEARL modelling. The leaching
potential of substances to the shallow groundwater in the potential area of use within The Netherlands is
calculated using the GeoPEARL model. The same input data as used in the first tier with Pearl 3.3.3 is
employed. Additional input is the crop and the number of plots (minimum 250). For results see the table
below
Leaching of a.s. florasulam and metabolites 5-OH, DFP-ASTCA, ASTCA and TSA as predicted by
GeoPEARL 3.3.3, spring scenario. Values ≥0.1 µg/L are indicated in bold, values ≥0.01-<0.1 µg/L are
underlined.
Use
Substance
Cereals Florasulam
5-OH
DFP-ASTCA
ASTCA
TSA
Rate a.s. Frequency
[kg/ha]
0.005
**
**
**
**
1
Interval Fraction
[days]
intercepted*
-
0.25
PEC
groundwater
[g/L]
< 0.001
0.002
< 0.001
0.032
0.112
GeoPEARL calculations show that the predicted leachate concentrations for Florasulam and its
metabolites 5-OH and DFP-ASTCA are smaller than 0.1 µg/L. Florasulam metabolites ASTCA and TSA
have predicted leaching concentrations above 0.01 µg/L and 0.1 µg/L respectively.
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The relevance of the metabolites ASTCA and TSA were assessed in accordance with SANCO/221/2000
rev.10 – 25/02/2003 (Leslie, 2012 – CHA Doc No. 218 FOM, submitted to zRMS). The metabolites
could not be excluded as degradation products of no concern. However, a hazard assessment involving (i)
biological activity screening, (ii) genotoxicity screening, and (iii) toxicity hazard screening, did not
identify ASTCA or TSA as hazardous. As the predicted levels of these metabolites in groundwater is <
0.75 μg/L for all scenarios, no further consideration is required.
Predicted Environmental Concentration in Surface Water (PECsw)
The PECsw values for florasulam and its metabolites 5-OH, TPSA, ASTCA, ASTP and 5-OH ASTP as
well as diflufenican and the metabolite AE B107137 following spray drift exposure, were calculated
using TOXSWA v 1.2 for the Dutch standard spring and autumn scenarios for the edge of field ditch
concentrations. The drift simulations were based on application at 1 × 0.1 L Saracen Delta/ha (equivalent
to 5.0 g florasulam and 50.0 g diflufenican).
PECsw values are presented below based on the maximum PECsw value at time 0 from the Dutch standard
scenarios.
Based on spray drift exposure the PECsw initial (Day 0) values were;
Florasulam: 50% reduction PECsw = 0.0238 µg a.s./L
Metabolite 5-OH: 50% drift reduction PECsw = 0.019µg/L
Metabolite TPSA: 50% drift reduction PECsw = 0.010 µg/L
Metabolite ASTCA: 50% drift reduction PECsw = 0.007 µg/L
Metabolite ASTP: 50% drift reduction PECsw = 0.003 µg/L
Metabolite 5-OH ASTP: 50% drift reduction PECsw = 0.004 µg/L
Diflufenican: 50% drift reduction PECsw = 0.234 µg a.s./L
Metabolite AE B107137: 50% drift reduction PECsw = 0.0786 µg/L
Monitoring data surface water
The Pesticide Atlas (Version 3.1) (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) was used
to evaluate measured concentrations of Florasulam in Dutch surface water, and to assess whether the
observed concentrations exceed threshold values.
The active substance Florasulam was observed in the surface water (most recent data from 2013).
In Table 9.8-5 the number of observations in the surface water is presented. In the Pesticide Atlas, surface
water concentrations are compared to the authorisation threshold value of 0.118 µg L-1 (05/02/2010,
consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant
safety factors, which is used for risk assessment, in this case 0.1*EC50 Lemna) and to the indicative
Maximum Permissible Concentration (MPC) of 0.0089 µg L-1 as presented in the Pesticide Atlas.
Currently, this MPC value is not harmonised, which means that not all available ecotoxicological data for
this substance are included in the threshold value. In the near future and in the framework of the Water
Framework Directive, new quality criteria will be developed which will include both MPC data as well as
authorisation data. The currently available MPC value is reported here for information purposes. Pending
this policy development, however, no consequences can be drawn for the proposed application(s).
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Table 9.8-6: Monitoring data for Florasulam in Dutch surface water
Total no of locations
(2012)
100
n > authorisation
threshold
n > MPC indicative
threshold
0
0
n > MPC-INS
threshold*
n.a.
* n.a.: no MPC-INS available
The active substance Diflufenican was observed in the surface water (most recent data from 2013).
In Table 9.8-6 the number of observations in the surface water is presented. In the Pesticide Atlas, surface
water concentrations are compared to the authorisation threshold value of 0.25 µg L-1 (10/02/2013,
consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant
safety factors, which is used for risk assessment, in this case 2 nd tier NOEAEC mesocosm with a safety
factor of 2) and to the indicative Maximum Permissible Concentration (MPC) of 9 µg L -1 as presented in
the Pesticide Atlas. Currently, this MPC value is not harmonised, which means that not all available
ecotoxicological data for this substance are included in the threshold value. In the near future and in the
framework of the Water Framework Directive, new quality criteria will be developed which will include
both MPC data as well as authorisation data. The currently available MPC value is reported here for
information purposes. Pending this policy development, however, no consequences can be drawn for the
proposed application(s).
Table 9.8-7: Monitoring data for Diflufenican in Dutch surface water
Total no of locations
(2012)
100
n > authorisation
threshold
0
n > MPC indicative
threshold
0
n > MPC-INS
threshold*
n.a.
* n.a.: no MPC-INS available
Drinking water criterion
Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or
existing substances on the Dutch market (authorised for more than 3 years).
 For new substances, a pre-registration calculation is performed.
 For existing substances, the assessment is based on monitoring data of VEWIN (drinking water
board).
o If for an existing substance based on monitoring data no problems are expected by
VEWIN, Ctgb follows this VEWIN assessment.
o If for an existing substance based on monitoring data a potential problem is identified by
VEWIN, Ctgb assesses whether the 90th percentile of the monitoring data meet the
drinking water criterion at each individual drinking water abstraction point.
Florasulam has been on the Dutch market for > 3 years (authorised since 05-01-2001). This period is
sufficiently large to consider the market share to be established. From the general scientific knowledge
about the product and its active substance, it is concluded that there are in this case no concrete
indications for concern about the consequences of this product for surface water from which drinking
water is produced, when used in compliance with the directions for use. Under this approach no
exceeding of the drinking water criterion are expected. The standards for surface water destined for the
production of drinking water are met.
Diflufenican has been on the Dutch market for > 3 years (authorised since 10-10-1991). This period is
sufficiently large to consider the market share to be established. From the general scientific knowledge
about the product and its active substance, it is concluded that there are in this case no concrete
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indications for concern about the consequences of this product for surface water from which drinking
water is produced, when used in compliance with the directions for use. Under this approach no
exceeding of the drinking water criterion are expected. The standards for surface water destined for the
production of drinking water are met.
Predicted Environmental Concentration in Air (PECair)
The fate and behavior in air of florasulam and diflufenican were evaluated during the Annex I inclusion.
No additional studies have been submitted.
3.1.6
Ecotoxicology
3.1.6.1 Effects on Terrestrial Vertebrates
Birds and Mammals.
The bird and mammal risk assessments for Saracen Delta have been conducted in accordance with the
EFSA Guidance document (EFSA 2009) for the proposed critical uses.
The acute and long-term (reproductive) dietary exposure risks to birds and mammals were demonstrated
to be acceptable based on the worst-case screening phase performed for small omnivorous bird in cereals
and large herbivorous bird in grass, and small herbivorous mammal in both crops. Florasulam and
diflufenican were each assessed based on respective exposure following application of Saracen Delta at, 1
× 0.1 L/ha, equivalent to 1 x 0.005 kg florasulam/ha and 1 × 0.05 kg diflufenican/ha. The TER values for
acute and long-term exposure to birds and mammals based on the worst-case indicator species were in
excess of the Annex VI triggers of 10 and 5, respectively, for both active ingredients indicating a low risk.
Further assessment of the dietary exposure risk was not required (See Core Assessment).
To assess the acute combined toxicity an evaluation of combination toxicity was conducted based on the
EFSA 2009 Guidance document. The TER values to birds and mammals based on worst-case
assumptions were in excess of the trigger values indicating a low risk.
The secondary poisoning risk from florasulam exposure was considered to be low as this active has a logP
value of <3 (actual = -1.22 at pH 7.0, range 1.00 to -2.06, PH 4.0 and pH 10.0, respectively).
Additionally the risk from florasulam following consumption of drinking water is considered to be low.
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Diflufenican has a LogP value of 4.2 therefore the secondary poisoning risk and the potential for
biomagnification were evaluated. The risks were determined to be low following the proposed
application of Saracen Delta. Additionally the risk from diflufenican following consumption of drinking
water is considered to be low.
The dietary and secondary poisoning risk to birds from the soil and water metabolites of both actives are
considered to be low.
3.1.6.2 Effects on Aquatic Species
Aquatic toxicity
Effects on aquatic organisms for Saracen Delta were not evaluated as part of the EU review of florasulam
and diflufenican. Data on Saracen Delta, florasulam and diflufenican were evaluated based on specific
Dutch PEC surface water values. The PECsw values were determined for drift exposure following a worstcase application of 1 × 0.1 L Saracen Delta/ha in cereals or grass.
As expected with herbicides, algae and Lemna were the most sensitive species tested. The risk
assessments for effects of florasulam, diflufencan, Saracen Delta and associated surface water metabolite
AE B107137, on aquatic organisms, performed in accordance with SANCO 3268 2001/rev 4 –final1 ,
demonstrate a low acute and chronic exposure risk for all indicator groups based on the PEC sw values for
spray drift exposure following application of Saracen Delta based on 90% drift reduction mitigation.
Therefore, Saracen Delta applied in accordance with the proposed uses poses a low risk to the aquatic
environment following spray drift where 90% spray drift reduction is implemented as application
mitigation.
The diflufenican metabolite AE B107137 and the florasulam metabolites TPSA and 5-OH are considered
to pose a low risk in the aquatic environment based on the worst-case proposed use of Saracen Delta.
The following restriction sentence must be placed on the label:
Om in het water levende organismen te beschermen is de toepassing van het middel in percelen die
grenzen aan watergangen uitsluitend toegestaan wanneer gebruikt wordt gemaakt van minimaal 90%
driftreducerende spuitdoppen.
3.1.6.3 Effects on Bees and Other Arthropod Species
Effects on Honeybees
The risks to honeybees were determined based on the Working Document for terrestrial ecotoxicology,
SANCO 10329/2002 rev 2 final. The risk to honeybees following application of Saracen Delta is
considered to be low, both the contact and oral hazard quotients were below the trigger value of 50 based
on the worst-case proposed uses (See Core Assessment).
Arthropods other than bees
The risk to non-target arthropods following exposure to Saracen Delta was addressed based on Tier I data
for the indicator species Aphidius rhopalosiphi and Typhlodromus pyri in accordance with the ESCORT 2
Guidance document (Candolfi et al 2000). The in-field, foliar and soil, hazard quotients were all below
the trigger value of <2 for all proposed uses, indication a low risk (See Core Assessment).
1
SANCO 3268/2001-rev 4-final. Working Document: Guidance document on aquatic ecotoxicity in the context of Directive 91/414/EC. 17
October 2002
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Additionally, extended laboratory data on the green lacewing Chrysoperla carnea was generated with
CHA 5350, a straight formulation containing 50 g/L of florasulam. This species was shown to be
sensitive to florasulam in a Tier I study listed in the review report (SANCO 1406/2001 final). The Tier II
HQ value for exposure of C. carnea to fresh residues of CHA 5350 in a dose response study was <1
indicating a low risk.
The off-field HQ values for non-target arthropods based on the Dutch specific drift values were below the
trigger values of 2 and 1 for Tier I and Tier II data, respectively. Therefore, Saracen Delta poses a low
off-field risk to non-target arthropods following application in accordance with the proposed uses. No
further assessment of the off-field risk was required and no application mitigation is required for the offfield protection of non-target arthropods.
The risks to non-target arthropods were demonstrated to be low based on the proposed uses of Saracen
Delta.
No additional application mitigation is required for the protection of non-target arthropods.
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms
Earthworms
The risks to earthworms were determined based on the Working Document for terrestrial ecotoxicology,
SANCO 10329/2002 rev 2 final. Exposure was based on maximum initial PECs values for florasulam,
diflufenican and Saracen Delta along with the relevant soil metabolites following application at 0.1 L
Saracen Delta/ha in cereals with 25% crop interception.
The acute earthworm TER values for Saracen Delta and the relevant soil metabolite, 5-OH, AE B107137
and AE 0542291 were above the Annex VI trigger value of 10. A worst-case assumption that the three
additional florasulam soil metabolites, DFP-ASTCA, ASTCA and TSA are 10-times more toxic than
parent was made, the TER values determined based on the respective PECs values were far in excess of
the Annex VI trigger, indicating a low acute risk to earthworms.
The chronic earthworm toxicity TER value for Saracen Delta was above the Annex VI trigger value of 5.
Therefore Saracen Delta and associated soil metabolites are considered to pose a low acute and chronic
risk to earthworms following application in accordance with the proposed uses (See Core Assessment).
Other Soil macro-organisms
In accordance with the Working document on terrestrial ecotoxicology (SANCO 10329/2002 rev 4 final),
effects on other soil macro-organisms are required if persistence in soil is expected, e.g. DT90 field >365
days or >100 days and >3 applications. As the DT90 of diflufenican is >365 days toxicity data for Saracen
Delta was generated with Collembola. The TER value exceeded the trigger value of 5 indicating a low
risk to other soil microarthropods. Additionally for diflufenican effects on non-target macro-organisms
(soil arthropods) were investigated as an objective within a litter bag test submitted during the EU review.
Cheminova have a Letter of Access to all Annex II data for diflufenican from the owner Bayer
CropScience and therefore, these data can be referred to for assessment of the risk to non-target soil
macro-organisms from exposure to diflufenican following application of Saracen Delta. The measured
exposure concentration in the field trial was in excess of the diflufenican PECs following application of
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Saracen Delta and the data confirmed that diflufenican had no long-term impact on Collembola
communities (See Core Assessment).
3.1.6.5 Effects on organic matter breakdown
In accordance with the Working document on terrestrial ecotoxicology (SANCO 10329/2002 rev 4 final),
effects on organic matter breakdown are required if persistence in soil is expected, e.g. DT 90 field >365
days. For long-term exposure in soil it is appropriate to consider the active ingredient opposed to the
formulated product, therefore florasulam and diflufenican were considered separately in regards to the
risk for long term effects on soil function and a field litterbag study with Saracen Delta has not been
conducted and was not triggered by the chronic soil tests.
Effects on soil organic matter breakdown from exposure to diflufenican were investigated in a field litter
bag test (Meister A., Schwiening S 2001, EU DAR (Oct. 2003) and Addendum to DAR, (April 2007))
and were evaluated under the EU review. Cheminova have a Letter of Access to all Annex II data for
diflufenican from the owner Bayer CropScience, therefore the data from the litterbag test with
diflufenican (497 g/L SC) is referenced in order to assess the risk from diflufenican following application
of Saracen Delta.
The measured exposure concentration in the field trial was in excess of the
diflufenican PECs following application of Saracen Delta, it was concluded that the risks from
diflufenican to organic matter breakdown were sufficiently addressed by the litterbag study (see Core
Assessment).
3.1.6.6 Effects on Soil Non-target Micro-organisms
Comparison of the NOEC concentrations, based on <25% effects compared to the control, with the worstcase PECsoil initial values for Saracen Delta, were made. Comparisons were performed based on exposure in
soil following application at 1 × 0.1 L Saracen Delta/ha in cereals with 25% crop interception.
The 28-d NOEC for both nitrogen and carbon respiration was 2.42 mg Saracen Delta/ha, based on < 25%
effects compared to the control. This is >19 times higher than the predicted exposure in soil following It
is concluded that Saracen Delta, poses a low risk to soil micro-organisms following application in
accordance with the proposed uses.
The florasulam metabolites are not considered to be of greater toxicity then parent and PEC soil values
are all below those of florasulam therefore they are considered to pose a low risk to soil micro-organisms.
Endpoint for the diflufenican metabolites AE B107137 and AE 0542291 were available from the EU
review with NOECs of 0.36 mg/kg. Based on PECs values following application of Saracen Delta these
are >50 to >30 times in excess of the predicted, respective, soil concentrations and indicate a low risk to
soil micro-organisms (see Core Assessment).
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3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and
Fauna)
Effects on Non-target Plants
The risks to non-target terrestrial plants were determined based on the Working Document for terrestrial
ecotoxicology, SANCO 10329/2002 rev 2 final. Saracen Delta was tested in both a seedling emergence
study and vegetative vigour study with ten species of plants (four monocots and six dicots). The ER50
estimates determined based on dry biomass (and emergence) ranged from 1.012 to 1601.36 g product/ha
for post-emergence exposure and 12.96 to 1548 g product/ha for pre-emergence exposure.
Based on CTGB specific spray drift reduction mitigation options an acceptable use was possible using the
most sensitive endpoint (ER50) for pre-emergence exposure (Allium cepa (Onion) 12.96 g Saracen Delta
/ha) for all drift reduction application mitigation options except standard flat fan at 4.7% drift.
For post-emergence exposure based on the sensitive endpoint (ER50) for Beta vulgaris, Sugar beet of
1.012 g Saracen Delta/ha) none of the drift reduction mitigation options resulted in a TER above the
trigger value and further refinement was required.
Therefore the risk from post-emergence exposure was refined using a probabilistic approach also
recommended in the Terrestrial Working Document. This method is used as standard by ecotoxicologists
and is acceptable to regulatory authorities. Statistical analysis of the ER50 values was conducted in order
to construct SSD’s and derive the HC5 value.
The HC5 value, 0.6299 g Saracen Delta/ha was below all the drift rates based on the CTGB drift
mitigation application options and further refinement of the risk was necessary by including additional
crop free zones. A safe use for Saracen Delta based on the proposed GAP in cereals is possible when
appropriate drift reduction measures are implemented in order to achieve a deposition of <0.51%; these
include both drift reduction nozzles and additional crop-free buffer zones. The required levels of
mitigation, nozzle class and crop-free zone are presented in the table below.
Summary of mitigation options for Saracen Delta required in order to protect non-target plants
DRT
Sprayer type
Nozzle type
Nozzle spray
drift
reduction
class
Distance from the last nozzle below
threshold value (% of spray drift
deposition) of 0.51% (m)
Bare soil/low
crops (<20cm,
BBCH ≤30)
Developed crop
(>20 cm; BBCH
≥31)
Reference
conventional
XR11004
0
6.25-7.25
8.75-9.75
DRT50
Conventional
DG11004+ end nozzle
50
1.75-2.75
2.75-3.75
DRT75
Conventional
ID12002 + end nozzle
75
1.75-2.75
2.75-3.75
DRT90
Air assisted
DG11004 + end nozzle
50
1.75-2.75
2.00-3.00
DRT95
Air assisted
XLTD04-110 + end nozzle
90
1.5-2.5
1.75-2.75
Based on what is realistic and applicable in practice, no additional crop free zones > 3 m are accepted in
arable crops in The Netherlands (many small parcels on which larger crop-free zones are not realistic (not
accepted by the farmers)). This means that at maximum a crop-free zone of 3.0 m, measured from the
middle of the last crop row to the border of the parcel (off-field evaluation zone distance (1m wide) is
then 3.5 – 4.5 m) is accepted. Hence, in the case of Saracen delta the first option (conventional,
XR11004) is not accepted. The other measures can be applied. The following drift reduction measures are
appropriate:
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- at least 50% drift reducing nozzles and an end nozzle in combination with a crop-free zone of at least
2.25 m (measured from the middle of the last crop row till the border of the parcel);
- at least 50% drift reducing nozzles and an end nozzle in combination with air assistance and a crop-free
zone of at least 1.5 m (measured from the middle of the last crop row till the border of the parcel).
The following restriction sentence must be placed on the label:
Om niet tot de doelsoorten behorende planten te beschermen is toepassing uitsluitend toegestaan indien
gebruik wordt gemaakt van één van de volgende driftreducerende maatregelen:
- minimaal 50% driftreducerende spuitdoppen en een kantdop in combinatie met een teeltvrije
zone van tenminste 2,25 meter (gemeten vanaf het midden van de laatste gewasrij tot aan de
perceelsgrens);
- minimaal 50% driftreducerende spuitdoppen in combinatie met luchtondersteuning en een
kantdop met inachtneming van een teeltvrije zone van tenminste 1,50 meter (gemeten vanaf het
midden van de laatste gewasrij tot aan de perceelsgrens).
Since sentences are necessary for aquatic organisms as well as non-target terrestrial plants the restriction
sentences on the final label should be written as follows:
Om in het water levende organismen te beschermen is toepassing van het middel uitsluitend toegestaan
wanneer in perceelsstroken die grenzen aan oppervlaktewater in de eerste 14 m vanaf de insteek van de
sloot gebruik wordt gemaakt van minimaal 90% driftreducerende spuitdoppen.
Om niet tot de doelsoorten behorende planten te beschermen is toepassing van het middel uitsluitend
toegestaan wanneer in perceelsstroken die niet grenzen aan oppervlaktewater in de eerste 14 m van het
gewas, gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij, gebruik wordt
gemaakt van één van de volgende driftreducerende maatregelen:
- minimaal 50% driftreducerende spuitdoppen en een kantdop in combinatie met een teeltvrije
zone van tenminste 2,25 meter (gemeten vanaf het midden van de laatste gewasrij tot aan de
perceelsgrens);
- minimaal 50% driftreducerende spuitdoppen in combinatie met luchtondersteuning en een
kantdop met inachtneming van een teeltvrije zone van tenminste 1,50 meter (gemeten vanaf het
midden van de laatste gewasrij tot aan de perceelsgrens).
3.1.7
Efficacy
Minimum effective dose
The applicant provided some background to the activity of both active substances and the rationale for the
co-formulation which is considered in more detail under ‘minimum effective dose’. A number of the
weed control trials included a range of doses of ‘CHA1225’. To determine the minimum effective dose,
39 trials from the Maritime zone (17 spring cereals, 19 winter cereals with spring applications and 3
grass-seed crops with spring applications) and 10 trials from the North-East zone (5 spring cereals and 5
winter cereals) are included.
EPPO PP1/225 (2) states that in the case of multiple target pests ‘Information is required for a range of
targets which are considered to be the most important, and for which control provides the major
agricultural benefit. It should be noted that where the proposed use is across a substantive geographical
area such as an authorization zone (as defined in PP 1/278 Principles of zonal data production and
evaluation), the major target species and/or the major crop may vary and there may be differences in
population pressures. Therefore particular consideration should be given to trials location.’
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GALAP has been considered by the zRMs as a major target in the member states where authorisation is
being requested.
Winter cereals - In the Maritime zone trials there was a trend to increased control from 100 ml/ha
compared to 50 ml/ha but less of a distinction between 75 and 100 ml. The only clear dose response
between 75 and 100 ml was in the control of LAMPU, MATMA, THLAR, VERAR, BRSNN and
VIOTR. This was a pattern that was reflected in the NE trials. In the NE trials, however, the most
pronounced dose response between 75 and 100 ml was in the control of CNSRE, MATIN and VIOAR.
Spring cereals – In the Maritime zone trials there was increased control from 100 ml/ha compared to 50
ml/ha but less of a distinction between 75 and 100 ml. The only clear dose response between 75 and 100
ml was in the control of GALAP, LAMPU, POLSS, VERPE and VIOAR. In the NE trials, however, the
most pronounced dose response between 75 and 100 ml was in the control of CENCY and GALAP.
Grass seed crops – In GALAP there was little evidence of a dose response, although higher doses did give
improved control of MATIN.
The zonal RMS considers that the data are sufficient to address minimum effective dose.
Efficacy tests
Data on spring use in winter cereals and spring cereals are sufficient for authorisation of claims of control
of a range of specific weeds. Data on spring use in grass seed crops are very limited in terms of number
and location (DK only). In accordance with EPPO extrapolation table 11-16629 it may be acceptable to
extrapolate weed control claims from cereals to grass seed crops but this can only be determined at a MS
level. The location of the trials is not considered by the zRMS to be representative of the MS where
authorisation is sought although they are relevant to MS in the Maritime zone.
In The Netherlands products based on diflufenican and florasulam are authorised against annual
broadleaved weeds for many years. Based on the trial results, extrapolation possibilities and experiences
with the active ingredients, the control against annual broadleaved weeds in winter and spring wheat,
winter and spring barley, winter rye, triticale and grass seed crops as spring application can be accepted.
Effects on yield and quality
Impact on the quality of plants and plant products
Saracen Delta’ applied at the recommended rate or at twice that rate had no meaningful or consistent
adverse effect on quality of cereal grains
Effects on the processing procedure.
No data regarding processing or transformation was submitted.
The applicant presented a reasoned case based on the absence of residues in harvested grain (EPPO PP
1/243 Effects of plant protection products on transformation processes) and stated that the product is
applied early in the season (up to BBCH 32; before inflorescence emergence and heading), and as the
active ingredients are not systemic it is unlikely to be transferred to the grain.
It is noted that florasulam and diflufenican are accepted in the UK by the brewer’s organisation (BBPA)
for use on crops intended for use in brewing, which indicates that an effect on fermentation is very
unlikely. Member states should consider whether this case is sufficient under their circumstances.
Based on the argumentations an effect on the processing procedure is not expected.
Effects on the yield of treated plants and plant products
See Phytotoxicity to host crop. If no negative effects are found in the crop safety trials, an effect on the
yield of treated plants and plant products is not expected.
14869 N
Adverse effects
Phytotoxity to the host crop
Taking the advice provided in EPPO PP1/226 it is the conclusion of the zRMS that sufficient specific
crop safety trials have been submitted in winter wheat (MAR & NE zone), winter barley (MAR) and
spring barley (MAR& NE zone). In spring barley the earliest time of application will need to be amended
to the beginning of tillering to reflect the data submitted. Although the results from trials conducted in
spring wheat (TRZAS), winter rye and winter triticale do not suggest any impact on yield these are major
crops in certain MS in the Maritime and North East zone and the results submitted are significantly fewer
than suggested in EPPO PP1/226. In addition for the most part trials did not cover the range of growth
stages proposed. Nonetheless MS may wish to consider the submitted results in spring wheat (TRZAS),
winter rye and winter triticale in view of their own knowledge of these active substances and whether
these crops are major/minor.
In The Netherlands products based on diflufenican and florasulam are authorised for many years. Based
on the trial results, extrapolation possibilities and experiences with the active ingredients, the application
in winter and spring wheat, winter and spring barley, winter rye and triticale is expected to be safe.
Seven specific crop safety trials were submitted in grass seed crops in the Maritime zone only. These are
not considered to be representative of the NE or SE zones. Of the 7 trials submitted no trials were
conducted at BBCH 12 and 2 trials included grass seed crops which were greater than BBCH 32 at
application. For grass seed crops, the requirement to demonstrate safety to treated crops at BBCH 12-32
has therefore not been adequately addressed for the MS where authorisation is being sought. Individual
CMS should consider the trials submitted in the light of whether grass seed crops are major or minor in
their MS.
We agree with the conclusions of the zRMS: crop safety is not demonstrated for grass seed crops at
BBCH 12-32.
Adverse effects on parts of plant used for propagating purposes
No meaningful reductions in germination of cereal seeds were seen. In some tests the germination % in
the untreated was low, however. In two tests reductions were seen following application of ‘Saracen
Delta’ at 100 ml/ha but not at double that dose. No restrictions on the use of ‘Saracen Delta’ on cereal
crops grown for seed production are required.
No data were submitted on germination of grass seed. Although the likelihood of adverse effects on
germination of grass seed is considered low, the zRMS considers that some seed germination data are
required to support use on grass seed crops.
We agree with the conclusions of the zRMS.
Impact on succeeding crops
The zRMS (UK) is not aware of the specific recommendations for sowing succeeding crops in other MS,
but the proposed UK label for ‘Saracen Delta’ states the following regarding succeeding crops:
Restrictions/Warnings
Crop failure
In the event of crop failure in the spring after an application of Saracen Delta, only the following crops
may be planted following cultivation to 20 cm: Spring wheat (TRZAS), spring barley or spring oats.
Following crops
Crops that can be sown in the same year as a crop treated with Saracen Delta is harvested: Cereals,
oilseed rape, field beans and vegetable brassicas as transplants.
(Vigour reductions may be seen in following crops of oilseed rape after a dry summer. This will be
outgrown and will not result in yield loss).
Crops that can be sown in the calendar year following treatment with Saracen Delta:
Cereals, oilseed rape, field beans, grass, peas, sugar beet, potatoes, maize and vegetable brassicas as
transplants
14869 N
Member States may consider this wording in light of existing authorisations under national conditions.
The following sentences are placed on the label:
Vervanggewassen
Bij het mislukken van de teelt kunnen na ploegen (20 cm) zomer tarwe, zomer gerst en haver worden
gezaaid.
Volggewassen
Na de oogst kunnen in het zelfde jaar granen, koolzaad en veldboon gezaaid en koolgewassen geplant
worden. In het volgende jaar kunnen granen, koolzaad, veldboon, gras, erwten, suikerbiet en mais
gezaaid, aardappels gepoot en groentegewassen geplant worden.
Impact on other plants including adjacent crops
The proposed label wording of ‘Take extreme care to avoid drift onto crops and non-target plants outside
the target area.’ is appropriate.
If used according to Good Agricultural Practice, a warning sentence is not necessary.
Possible development of resistance or cross-resistance
Overall the risk of resistance development from an application of Saracen Delta is considered to be
moderate. This is on the basis that the high inherent risk posed by florasulam is modified by the inclusion
of diflufenican in the formulation since the latter is effective on STEME particularly.
The following sentence is placed on the label:
Resistentiemanagement
Dit middel bevat de werkzame stoffen diflufenican en florasulam. Diflufenican behoort tot de
pyridinecarboxamiden. De HRAC code is F1. Florasulam behoort tot de groep van acetolactate synthase
(ALS) remmers. De HRAC code is B. Bij dit product bestaat er kans op resistentieontwikkeling. In het
kader van resistentiemanagement dient u de adviezen die gegeven worden in de
voorlichtingsboodschappen, op te volgen.
3.2
Conclusions
The assessment conducted for SARACEN DELTA was in accordance with Uniform Principles and
demonstrates an acceptable risk to human health and the environment. An authorisation can be granted
for the use in winter wheat, spring wheat, winter barley, spring barley, winter rye and winter triticale.
Crop safety is not demonstrated for grass seed crops at BBCH 12-32 and therefore grass (for seed
production) cannot be authorised.
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.
14869 N
Appendix 1 – Copy of the product label
Wettelijk Gebruiksvoorschrift
Toegestaan is uitsluitend het professionele gebruik als onkruidbestrijdingsmiddel door middel van een na-opkomst toepassing in de volgende
toepassingsgebieden onder de vermelde toepassingsvoorwaarden.
Toepassing
Te bestrijden organisme
Maximale dosering (middel) per toepassing Maximaal aantal toepassingen per teeltcyclus
eenjarige breedbladige onkruiden
0,1 l/ha
0,1 l/ha
0,1 l/ha
0,1 l/ha
0,1 l/ha
0,1 l/ha
sgebied
Wintertarwe
Wintergerst
Winterrogge
Triticale
Zomertarwe
Zomergerst
1
1
1
1
1
1
Toepassingsvoorwaarden
Saracen Delta alleen van maart tot en met juni toepassen.
Saracen Delta toepassen in150-300 liter water per ha.
Om in het water levende organismen te beschermen is toepassing van het middel uitsluitend toegestaan wanneer in perceelsstroken die
grenzen aan oppervlaktewater in de eerste 14 m vanaf de insteek van de sloot gebruik wordt gemaakt van minimaal 90% driftreducerende
spuitdoppen.
Om niet tot de doelsoorten behorende planten te beschermen is toepassing van het middel uitsluitend toegestaan wanneer in perceelsstroken
die niet grenzen aan oppervlaktewater in de eerste 14 m van het gewas, gemeten vanaf het midden van de laatste gewasrij of de laatste plant
in de rij, gebruik wordt gemaakt van één van de volgende driftreducerende maatregelen:
- minimaal 50% driftreducerende spuitdoppen en een kantdop in combinatie met een teeltvrije zone van tenminste 2,25 meter (gemeten
vanaf het midden van de laatste gewasrij tot aan de perceelsgrens);
14869 N
-
minimaal 50% driftreducerende spuitdoppen in combinatie met luchtondersteuning en een kantdop met inachtneming van een teeltvrije
zone van tenminste 1,50 meter (gemeten vanaf het midden van de laatste gewasrij tot aan de perceelsgrens).
Vervanggewassen
Bij het mislukken van de teelt kunnen na ploegen (20 cm) zomer tarwe, zomer gerst en haver worden gezaaid.
Volggewassen
Na de oogst kunnen in het zelfde jaar granen, koolzaad en veldboon gezaaid en koolgewassen geplant worden. In het volgende jaar kunnen
granen, koolzaad, veldboon, gras, erwten, suikerbiet en mais gezaaid, aardappels gepoot en groentegewassen geplant worden.
Resistentiemanagement
Dit middel bevat de werkzame stoffen diflufenican en florasulam. Diflufenican behoort tot de pyridinecarboxamiden. De HRAC code is F1.
Florasulam behoort tot de groep van acetolactate synthase (ALS) remmers. De HRAC code is B. Bij dit product bestaat er kans op
resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op
te volgen.
14869 N
Appendix 2 – Reference list
Identity, physico-chemical properties and analytical methods
Annex point
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
IIIA 2.1/01
IIIA 2.4.1/01
IIIA 2.4.2/01
IIIA 2.7.1/01
IIIA 2.8.2/01
IIIA 2.8.3.1/01
IIIA 2.8.3.2/01
IIIA 2.8.5.2/01
IIIA 2.8.8.2/01
IIIA 2.2.1/01
2012a
Determination of the storage stability for 14 days at
54°C of Diflufenican 500 g/L + Florasulam 50 g/l SC
formulation in commercial packaging
Cheminova A/S, Study No.: PYC 540
Cheminova A/S Report No.: 273 DFF
GLP, Unpublished
Y
Y
Y
CHE
2012a
Y
Y
Y
CHE
IIIA 2.2.2/01
2012b
Y
Y
Y
CHE
IIIA 2.3.1/01
IIIA 2.3.3/01
2012
Expert Statement on the Explosive Properties of
Diflufenican 500 g/L + Florasulam 50 g/l SC (CHA
1225)
Cheminova A/S, Study No.: CHA100238
Not GLP, Unpublished
Expert Statement on the Oxidizing Properties of
Diflufenican 500 g/L + Florasulam 50 g/l SC (CHA
1225)
Cheminova A/S, Study No.: CHA100237
Flash point and auto-ignition temperature (liquid and
gases) on the sample Diflufenican 500 g/L +
Florasulam 50 g/l SC
Stazione Sperimentale per i Combustibili, ITA
Report No.: 201200135
GLP, Unpublished
Y
Y
Y
CHE
Data protection
claimed
Y/N
Data protection
granted
Y/N
Relied on
Y/N
Owner
14869 N
Annex point
Year
Title
Company, Report No.
IIIA 2.5.2/01
IIIA 2.6.1/01
2012b
IIIA 2.5.3/01
2012
IIIA 2.7.4/01
IIIA 2.8.3.1/02
IIIA 2.8.5.2/02
2012c
IIIA 2.7.5/01
2014
IIIA 2.8.6.1/01
2012
Determination of the viscosity and the relative density
of Diflufenican 500 g/L + Florasulam 50 g/l SC
formulation
GLP, Unpublished
Determination fo the surface tension of the
Diflufenican 500 g/L + Florasulam 50 g/l SC Renolab
S.r.l., ITA, Study No.: 12011-01C
GLP, Unpublished
Determination of the cold stability (7 days at 0°C) of
Diflufenican 500 g/L + Florasulam 50 g/l SC
formulation
GLP, Unpublished
Christensen, H. S. (2014)
Determination of the long term storage stability at 20°C
of Diflufenican 500 g/l + Florasulam 50 g/l SC
formulation in commercial packaging
Cheminova A/S
Study No.: PYC 541
Unpublished report, CHA Doc. No.: 333 DFF
GLP, Unpublished
Particle Size Distribution determination of sample
Diflufenican 500 g/L + Florasulam 50 g/l SC (Batch
No. 1135-SG-55)
REDOX s.n.c , ITA, Report No.: 177/12
GLP, Unpublished
Data protection
claimed
Y/N
Data protection
granted
Y/N
Relied on
Y/N
Owner
Y
Y
Y
CHE
Y
Y
Y
CHE
Y
Y
Y
CHE
Y
Y
Y
CHE
Y
Y
Y
CHE
14869 N
Annex point
Year
Title
Company, Report No.
Data protection
claimed
Y/N
Data protection
granted
Y/N
Relied on
Y/N
Owner
IIIA 5.2.1/01
2012a
Analytical Method VAM 228-01 : Determination of of
Diflufenican (CAS No. 83164-33-4) and Florasulam
(CAS No. 145701-23-1) in Diflufenican 500 g/l +
Florasulam 50 g/l SC Formulation
Cheminova A/S, Study No.: VAM 228-01
Cheminova A/S Report No.: VAM 228-01
Y
Y
Y
CHE
IIIA 5.2.1/02
2012b
Validation of Analytical Method VAM 228-01 for
Determination of Diflufenican (CAS No. 83164-33-4)
and Florasulam (CAS No. 145701-23-1) in Diflufenican
500 g/l + Florasulam 50 g/l SC Formulation
Cheminova A/S, Study No.: VAL 228-01
Cheminova A/S Report No.: VAL 228-01
GLP, Unpublished
Y
Y
Y
CHE
Owner
Data
protection
granted Y/N
Mammalian tox:
Annex point
Year
IIIA,
7.1.1/01
2013a
IIIA,
7.1.2/01
2013b
Title
Company, Report No.
Diflufenican 500 g/l + Florasulam 50 g/l SC: Acute Oral Toxicity
Up And Down Procedure In Rats
Study No.: 35240
GLP, Unpublished
Diflufenican 500 g/l + Florasulam 50 g/l SC: Acute Dermal
Toxicity Study In Rats - Limit test
Study No.: 35241
GLP, Unpublished
Data
protection
claimed Y/N
Studies
relied on Y/N
Y
CHE
Y
Y
Y
CHE
Y
Y
14869 N
Annex point
Year
IIIA,
7.1.3/01
2013c
IIIA,
7.1.4/01
2013d
IIIA,
7.1.5/01
2013e
IIIA,
7.1.6/01
2013f
IIIA,
7.11/05
2014
IIIA,
7.11/06
2014
IIIA,
7.11/07
2013
Title
Company, Report No.
Amended Final Report: Diflufenican 500 g/l + Florasulam 50 g/l
SC: Acute Inhalation Toxicity Study In Rats - Limit test
Study No.: 35242 Amendment No. 1
Cheminova A/S Report No.: 293 DFF amdt-1
GLP, Unpublished
Diflufenican 500 g/l + Florasulam 50 g/l SC: Primary Skin
Irritation Study in Rabbits
Study No.: 35244
GLP, Unpublished
Diflufenican 500 g/l + Florasulam 50 g/l SC: Primary Eye
Irritation Study in Rabbits
Study No.: 35243
GLP, Unpublished
Diflufenican 500 g/l + Florasulam 50 g/l SC: Local Lymph Node
Assay (LLNA) in Mice
Study No.: 35245
GLP, Unpublished
Metabolite I: TSA: Reverse Mutation Assay 'Ames Test' using
Salmonella typhimurium and Escherichia coli
Harlan Laboratories Ltd.
Unpublished report, Study No.: 41303677
Cheminova A/S Report No: 324 FOM
GLP, Unpublished
Metabolite I: TSA: Micronucleus Test in Human Lymphocytes in
vitro
Harlan Laboratories Ltd., GBR
Study No.: 41303679
Cheminova A/S Report No.: 314 FOM
GLP, Unpublished
Metabolite I: TSA: L5178Y TK +/- Mouse Lymphoma Assay
Harlan Laboratories Ltd., GBR
Study No.: 41303678
Cheminova A/S Report No.: 313 FOM
GLP, Unpublished
Data
protection
claimed Y/N
Owner
Data
protection
granted Y/N
Studies
relied on Y/N
Y
CHE
Y
Y
Y
CHE
Y
Y
Y
CHE
Y
Y
Y
CHE
Y
Y
Y
CHE
Y
Y
Y
CHE
Y
Y
Y
CHE
Y
Y
14869 N
Section 4. Metabolism and Residues:
The Registration Report refers to the conclusions of the EU review of diflufenican and florasulam. No additional studies were submitted.
Section 5. Fate and behaviour
No additional studies were submitted
Section 6: Ecotoxicology
Annex
point
Year
Title
Company, Report No.
IIIA 10.8.1/01
2014
IIIA 10.8.1/02
2014
Probabilistic assessment of
the effect of CHA 1225 (Diflufenican 500 g/L +
Florasulam 50 g/L SC) on terrestrial plants
Cheminova A/S
Report No.: 100531
Cheminova Report No.: 336 DFF
Non-GLP, Unpublished
Spray drift deposition on the evaluation zone for
non-target plants when spraying a cereal crop
with different Drift Reducing Technologies in the
Netherlands
Plant research Internation B.V., Wageningen
Report No.: 598
Cheminova Report No.: 424 FOM
CHE: Cheminova A/S
Data protection
claimed Y/N
Data
protection
granted
Owner
Studies
relied on
Y
Y
CHE
Y
Y
Y
CHE
Y
14869 N
Section 7 Efficacy
Annex
point
Year
Title
Data
protection
claimed Y/N
Owner
Included in EU
submission/
review
Company, Report No.
Y/N
6.0/001
2012
Biological Assessment Dossier CHA 1225, Central zone
Y
CHA
Y
Cheminova A/S
-, No
Unpublished
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.1-001
Cook, S., Martin,
J.
KIIIA 6.1.1-002
Jørgensen, S.
Title
Company, Report No.
AS/6233/CN Field Study to evaluate the Herbicidal Efficacy of
CHA 1250 for the Control of Annual Weeds in Winter Cereals
in the Autumn/Winter, in Europe
Laboratory: Agrisearch UK Limited, UK
GEP, Unpublished report
Cheminova A/S Report No.: DFF 38
DK02H01 Field Study to evaluate the Efficacy of CHA1250 for
the Control of Annual Weed Species in Winter Cereals
Laboratory: Research Company Ytteborg, DK
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
Title
Company, Report No.
480201, 480202 Test of Efficacy and Crop Safety of CHA1250
in Winter Wheat
Laboratory: Agrolab A/S, Denmark
Final trial report on FOM11BLW-06 Sheridan: Field study to
evaluate the efficacy of CHA 5350 when applied postemergence for the control of Galium aparine and broadleaf
weeds in winter wheat in Ireland
Laboratory: Gerry Bird
GEP, Unpublished
Cheminova A/S Report No.: FOM 033
Final report on SUATRUH11/05:Trial report on Plant
Protection Products
Laboratory: ZS Trutnov
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
KIIIA 6.1.1-003
Møller, S.
Y
CHA
Y
Y
KIIIA 6.1.1-004
Also cited in:
6.1.2
6.1.3
6.2.1
Bird, G.
Y
CHA
Y
Y
KIIIA 6.1.1-005
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-006
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-007
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
Lastovickova, H.
Y
CHA
Y
Y
Koutecky, V.
Final report on SUMI DOM H 07 11: Trial report on Plant
Protection Products
Laboratory: Zemservis
GEP, Unpublished
Y
CHA
Y
Y
Stancl, J.
Final report on SUMIOPHSA11:Trial report on Plant
Protection Products
Laboratory: ZS Nechanice
GEP, Unpublished
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.1-008
Also cited in:
6.1.2
6.1.3
6.2.1
Bjergskov, S.
KIIIA 6.1.1-009
Also cited in:
6.1.2
6.1.3
6.2.1
Bjergskov, S.
KIIIA 6.1.1-010
Also cited in:
6.1.2
6.1.3
6.2.1
KIIIA 6.1.1-011
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-012
Also cited in:
6.1.2
6.1.3
6.2.1
Lydie, P.
Lastovickova, H.
Heinfelt, R.B.
Title
Company, Report No.
Final report on FOM-DK-11-BLW-01: Field study to evaluate
the efficacy of CHA 5350 and CHA 1225 when applied post
emergence for the control of Galium aparine and broadleaved
weeds in cereal crops in Denmark
Laboratory: Agrolab
GEP, Unpublished
Laboratory: Agrolab
GEP, Unpublished
Final report on 12SUM-KUD-CHA5350-PO-U: Trial report of
Plant Protection Products
Laboratory: ZS Krasne Udoli
GEP, Unpublished
Final report on CHNTRUH12/10: Trial Report of Plant
Protection Products
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Final report on FOM-DK-12-BLW: Field study to evaluate the
efficacy of CHA 5350 and CHA 1225 when applied post
weeds to cereals in Denmark
Laboratory: Agronova
GEP, Unpublished
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.1-013
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-014
Also cited in:
6.1.2
6.1.3
6.2.1
Koutecky, V.
KIIIA 6.1.1-015
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-016
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-017
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
van Harinxma, W. Final report on ARI-12-S-033-04: Field study to evaluate the
efficacy of CHA 5350 and CHA 1225 when applied postemergence for the control of Galium aparine and broadleaved
weeds to cereals in the Netherlands
Laboratory: Agro Research International B.V.
GEP, Unpublished
Lydie, P.
Final report on 11SUM-KUD-CHA5350-PO-U:
Trial report on Plant Protection Products
GEP, Unpublished
Y
CHA
Y
Y
Y
CHA
Y
Y
Lastovickova, H.
Final report on SUATRUH11/08:
GEP, Unpublished
Y
CHA
Y
Y
Koutecky, V.
Final report on SUMI DOM H 08 11:
GEP, Unpublished
Y
CHA
Y
Y
Title
Company, Report No.
Final report on SUMI DOM H 04 12: Trial Report of Plant
Protection Products
GEP, Unpublished
14869 N
Ref. ID no.
and
Annex point
Author
Title
Company, Report No.
Final report on 11-SA-JJ-CHA5350-1225-E:
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
KIIIA 6.1.1-018
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-019
Also cited in:
6.1.2
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-020
Also cited in:
6.1.2
6.1.3
6.2.1
Cap, J.
Y
CHA
Y
Y
Lydie, P.
Final report on 11SUM-KUD-CHA5350-JJ-U:Trial report on
GEP, Unpublished
Y
CHA
Y
Y
Bjergskov, S.
Laboratory: Agrolab
GEP, Unpublished
Laboratory: Agrolab
GEP, Unpublished
Laboratory: Agrolab
GEP, Unpublished
Y
CHA
Y
Y
KIIIA 6.1.1-021
Also cited in:
6.1.2
6.1.3
6.2.1
Bjergskov, S.
Y
CHA
Y
Y
KIIIA 6.1.1-022
Also cited in:
6.1.2
6.1.3
6.2.1
Bjergskov, S.
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.1-023
Also cited in:
6.1.2
6.1.3
6.2.1
Bjergskov, S.
KIIIA 6.1.1-024
Also cited in:
6.1.2
6.1.3
6.2.1
Bjergskov, S.
KIIIA 6.1.1-025
Also cited in:
6.1.3
6.2.1
Lydie, P.
KIIIA 6.1.1-026
Also cited in:
6.1.3
6.1.4
6.2.1
KIIIA 6.1.1-027
Also cited in:
6.1.3
6.1.4
6.2.1
Lastovickova, H.
Koutecky, V.
Title
Company, Report No.
Laboratory: Agrolab
GEP, Unpublished
Final report on FOM-SW-11-BLW-02: Field study to evaluate
weeds in cereal crops in Sweden
Laboratory: Agrolab
GEP, Unpublished
Final report on 12SUM-KUD-CHA5350-JJ-U: Trial report of
GEP, Unpublished
Final report on CHNTRUH12/11: Trial Report of Plant
Protection Products
GEP, Unpublished
Final report on SUMI DOM H 05 12: Trial Report of Plant
Protection Products
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.2-001
Also cited in:
6.1.3
6.2.1
Bird, G.
KIIIA 6.1.2-002
Also cited in:
6.1.3
6.2.1
Bird, G.
KIIIA 6.1.2-003
Also cited in:
6.1.3
6.2.1
Bird, G.
KIIIA 6.1.2-004
Also cited in:
6.1.3
6.2.1
Bjergskov, S.
Title
Company, Report No.
Final trial report on FOM11BLW-04 McGuinness: Field study
to evaluate the efficacy of CHA 5350 when applied postemergence for the control of Galium aparine and broadleaf
weeds in winter barley in
GEP, Unpublished
Final trial report on FOM11BLW-05 McGuinness: Field study
GEP, Unpublished
Final trial report on FOM-IRE-11-BLW-07 Brady: Field study
GEP, Unpublished
Laboratory: Agrolab
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.2-005
Also cited in:
6.1.3
6.2.1
Bjergskov, S.
KIIIA 6.1.2-006
Also cited in:
6.1.3
6.1.4
6.2.1
KIIIA 6.1.2-007
Also cited in:
6.1.3
6.2.1
Nierobca, P.
KIIIA 6.1.2-008
Also cited in:
6.1.3
6.2.1
Pszczola, J.
KIIIA 6.1.2-09
Also cited in:
6.1.3
6.2.1
Jakubiak, E.
Potocka, E.
Title
Company, Report No.
Final report on FOM-SW-11-BLW-0: Field study to evaluate
weeds in cereal crops in Sweden
Laboratory: Agrolab
GEP, Unpublished
Final report on NUZ 08/11: Research on the effectiveness of
the preparations CHA 5350 and CHA 1225 in cereals
Laboratory: IUNG-PIB, Pulawy
GEP, Unpublished
Final report on ZBS 14, 15/11: The estimation of efficacy of
CHA 5350 and CHA 1225 in weeds control in winter wheat
Laboratory: University of life sciences, Lublin
GEP, Unpublished
Final report on FRS 022/11 PL: Efficacy and Crop selectivity
evaluation of CHA 5350 and CHA 1225 applied to control
cleavers (Galium aparine) and other broadleaved weeds in
winter wheat
Laboratory: Field Research Support
GEP, Unpublished
Final report on SH11PZ116W: Biological evaluation of
herbicides CHA 5350 and CHA 1225 applied against
dicotyledonous weeds in winter wheat
Laboratory: Institute of plant protection, Roslin
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.2-010
Also cited in:
6.1.3
6.2.1
Bird, G.
KIIIA 6.1.2-011
Also cited in:
6.1.3
6.2.1
Bird, G.
KIIIA 6.1.2-012
Also cited in:
6.1.3
6.2.1
Bird, G.
KIIIA 6.1.2-013
Also cited in:
6.1.3
6.2.1
Heinfelt, R.B.
Title
Company, Report No.
Final report on FOM+TBM-IR-12-BLW-001: Evaluate the
efficacy of FOM+TBM when applied post-emergence for the
control of Galium aparine and broadleaved weeds in cereals
in Ireland
GEP, Unpublished
in Ireland
GEP, Unpublished
in Ireland
GEP, Unpublished
Final report on FOM-FIN-12-BLW: Field study to evaluate the
weeds to cereals in Finland
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
KIIIA 6.1.2-014
Also cited in:
6.1.3
6.2.1
KIIIA 6.1.2-015
Also cited in:
6.1.3
6.2.1
KIIIA 6.1.2-016
Also cited in:
6.1.3
6.2.1
KIIIA 6.1.2-017
Also cited in:
6.1.3
6.2.1
KIIIA 6.1.2-018
Also cited in:
6.1.3
6.2.1
Author
Title
Company, Report No.
GEP, Unpublished
GEP, Unpublished
GEP, Unpublished
Bird, G.
Final trial report on FOM11BLW-01 SB Nangle: Cheminova
Spring barley herbicide trial 2011
GEP, Unpublished
Bird, G.
Final trial report on FOM11BLW-02 SB Rodgers: Cheminova
Spring barley herbicide trial
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.2-019
Also cited in:
6.1.3
6.2.1
Bird, G.
KIIIA 6.1.2-020
Also cited in:
6.1.3
6.1.4
6.2.1
KIIIA 6.1.2-021
Also cited in:
6.1.3
6.2.1
Potocka, E.
KIIIA 6.1.2-022
Also cited in:
6.1.3
6.2.1
Jakubiak, E.
KIIIA 6.1.2-023
Also cited in:
6.1.3
6.2.1
Heinfelt, R.B.
Pszczola, J.
Title
Company, Report No.
Final trial report on FOM11BLW-03 SW Hemercyk:
Cleaver herbicide trial on Spring wheat
GEP, Unpublished
Final report on ZBS 14, 15/11: The estimation of efficacy of
CHA 5350 and CHA 1225 in weeds control in spring barley
GEP, Unpublished
Final report on FRS 024/11 PL: Efficacy and Crop selectivity
evaluation of CHA 5350 and CHA 1225 applied to control
cleavers (Galium aparine) and other broadleaved weeds in
spring barley
GEP, Unpublished
Final report on SH11JJ105W: Biological evaluation of
herbicides CHA 5350 and CHA 1225 applied against
dicotyledonous weeds in spring barley
GEP, Unpublished
Final report on FOM-DK-12-BLW-Grass: Field study to
evaluate the efficacy of CHA 5350 and CHA 1225 when
applied post-emergence for the control of broadleaved weeds
to grass-seed crops in Denmark
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.3-001
Also cited in:
6.2.1
Vanaga, I, et al
KIIIA 6.1.3-002
Also cited in:
6.2.1
Vanaga, I, et al
KIIIA 6.1.3-003
Also cited in:
6.2.1
Vanaga, I, et al
KIIIA 6.1.3-004
Also cited in:
6.2.1
Vanaga, I, et al
KIIIA 6.1.3-005
Also cited in:
6.1.4
6.2.1
Seibutis, V.
KIIIA 6.1.3-006
Also cited in:
6.1.4
6.2.1
Seibutis, V.
Title
Company, Report No.
Final trial report on H-11-1-01-IV-1228: Efficacy evaluation of
herbicides CHA 5350 and CHA 1225 SC in winter wheat
Laboratory: Latvian Plant Protection Research Centre
GEP, Unpublished
herbicides CHA 5350 and CHA 1225 SC in winter wheat
GEP, Unpublished
herbicides CHA 5350 and CHA 1225 SC in spring wheat
GEP, Unpublished
herbicides CHA 5350 and CHA 1225 SC in spring wheat
GEP, Unpublished
Final trial report on 11384032: Report on the efficacy
evaluation of herbicides CHA 5350 and CHA 1225 in winter
wheat
Laboratory: Lithuanian institute of Agriculture
GEP, Unpublished
evaluation of herbicides CHA 5350 and CHA 1225 in spring
barley
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.3-007
Also cited in:
6.1.4
6.2.1
Seibutis, V.
KIIIA 6.1.3-008
Also cited in:
6.1.4
6.2.1
Seibutis, V.
KIIIA 6.1.3-009
Also cited in:
6.2.1
Kieloch, R.
KIIIA 6.1.3-010
Also cited in:
6.2.1
Kieloch, R.
KIIIA 6.1.3-011
Also cited in:
6.2.1
Kieloch, R.
Title
Company, Report No.
barley
GEP, Unpublished
wheat
GEP, Unpublished
Final report on 12-jj-23-Cs: Report no. 03/12 from trial 12-jj23-Cs on biological evaluation of herbicide CHA 5350, CHA
1225, FOM+TBM
Laboratory: IUNG, Wroclaw
GEP, Unpublished
Final report on 12-to-06-Fs: Report no. 01/12 from trial 12-to06-Fs on biological evaluation of herbicide CHA 5350, CHA
1225, FOM+TBM
GEP, Unpublished
Final report on 12-po-18-Ds: Report no. 02/12 from trial 12po-18-Ds on biological evaluation of herbicide CHA 5350,
CHA 1225, FOM+TBM
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
KIIIA 6.1.3-012
Also cited in:
6.2.1
KIIIA 6.1.3-013
Also cited in:
6.2.1
KIIIA 6.1.3-014
Also cited in:
6.2.1
KIIIA 6.1.3-015
Also cited in:
6.2.1
Author
Title
Company, Report No.
Jatczak, J.
Final report on PL 12 023 PL: Efficacy of CHA 5350, CHA
1225 and FOM+TBM when applied post-emergence for the
control of Galium aparine and broadleaved weeds in winter
wheat.
Laboratory: Anadiag Polska
GEP, Unpublished
Jatczak, J.
Final report on PL 12 024 PL: Efficacy of CHA 5350, CHA
1225 and FOM+TBM when applied post-emergence for the
control of Galium aparine and broadleaved weeds in spring
barley.
Laboratory: Anadiag Polska
GEP, Unpublished
GEP, Unpublished
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
KIIIA 6.1.3-016
Also cited in:
6.2.1
KIIIA 6.1.3-017
Also cited in:
6.2.1
KIIIA 6.1.3-018
Also cited in:
6.2.1
KIIIA 6.1.3-019
Also cited in:
6.2.1
Author
Title
Company, Report No.
GEP, Unpublished
Toth, M.
Final report on GEP12/23-SZA_2 : Field study to evaluate the
efficacy of CHA 5350, CHA 1225 and FOM+TBM when
applied post emergence for the control of Galium aparine and
broadleaved weeds to winter wheat in Hungary.
Laboratory: Biotek Agriculture Hungary Kft.
GEP, Unpublished
Toth, M.
Final report on GEP12/23-SZA3: Field study to evaluate of
CHA 5350, CHA 1225 and FOM+TBM when applied post
weeds to spring barley in Hungary.
GEP, Unpublished
Toth, M.
Final report on GEP12/23-SZA1: Field study to evaluate the
efficacy of CHA 5350, CHA 1225 and FOM+TBM when
applied post emergence for the control of Galium aparine and
broadleaved weeds to winter wheat in Hungary.
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.3-020
Also cited in:
6.2.1
Toth, M.
KIIIA 6.1.3-021
Also cited in:
6.2.1
Toth, M.
KIIIA 6.1.3-022
Also cited in:
6.2.1
Toth, M.
KIIIA 6.1.4-001
Also cited in:
6.2.1
van Tilburg, F.
KIIIA 6.1.4-002
Also cited in:
6.2.1
Vanaga, I, et al
Title
Company, Report No.
GEP, Unpublished
GEP, Unpublished
GEP, Unpublished
Final report on H-11-6402-1, H-11-6402-2, H-11-6402-3, H11-6402-4: Selectivity in winter cereals
Laboratory: De Bredelaar
GEP, Unpublished
Final trial report on H-11-1-01-IV-1232: Selectivity evaluation
of herbicides CHA 5350 and CHA 1225 SC in winter wheat
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.4-003
Also cited in:
6.2.1
Seibutis, V.
KIIIA 6.1.4-004
Also cited in:
6.2.1
Lydie, P.
KIIIA 6.1.4-005
Also cited in:
6.2.1
Lastovickova, H.
KIIIA 6.1.4-006
Also cited in:
6.2.1
Koutecky, V.
KIIIA 6.1.4-007
Also cited in:
6.2.1
6.2.5
Stancl, J.
KIIIA 6.1.4-008
Also cited in:
6.2.1
Bjergskov, S.
Title
Company, Report No.
wheat
GEP, Unpublished
Final report on 11SUM-KUD-CHA5350-PO-S
:Trial report on Plant Protection Products
GEP, Unpublished
Final report on SUATRUH11/06:
GEP, Unpublished
Final report on SUMI DOM S 09 11:
GEP, Unpublished
Final report on SUMIOPSNE11:
GEP, Unpublished
Final report on FOM-SW-11-CS-01, FOM-SW-11-CS-02,
FOM-SW-11-CS-03, FOM-SW-11-CS-04 and FOM-SW-11CS-05: Field study to evaluate the crop safety of CHA 5350
and CHA 1225 when applied post emergence in cereals
Laboratory: Agrolab
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.4-009
Also cited in:
6.2.1
6.2.5
Bjergskov, S.
KIIIA 6.1.4-010
Also cited in:
6.2.1
Potocka, E.
KIIIA 6.1.4-011
Also cited in:
6.2.1
Pszczola, J.
KIIIA 6.1.4-012
Also cited in:
6.2.1
Jakubiak, E.
KIIIA 6.1.4-013
Also cited in:
6.2.1
Lydie, P.
Title
Company, Report No.
Final report on FOM-DK-11-CS-01, FOM-DK-11-CS-02, FOMDK-11-CS-03, FOM-DK-11-CS-04, FOM-DK-11-CS-05,
FOM-DK-11-CS-06, FOM-DK-11-CS-07, FOM-DK-11-CS-08,
FOM-DK-11-CS-15: Field study to evaluate the crop safety of
CHA 5350 and CHA 1225 when applied post emergence in
cereals
Laboratory: Agrolab
GEP, Unpublished
Final report on ZBS 14, 15/11-WW_S: The estimation of
phytotoxicity of CHA 5350 and CHA 1225 for winter wheat
Laboratory: University of Life sciences, Lublin
GEP, Unpublished
Final report on FRS 023/11 PL: Evaluation of Crop selectivity
of herbicides CHA 5350 and CHA 1225 applied to winter
wheat
GEP, Unpublished
Final report on FH11PZ117W: Phytotoxic evaluation of CHA
5350 and CHA 1225 in winter wheat
GEP, Unpublished
Final report on 12SUM-KUD-CHA5350-PO-S: Trial report of
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
KIIIA 6.1.4-014
Also cited in:
6.2.1
KIIIA 6.1.4-015
Also cited in:
6.2.1
KIIIA 6.1.4-016
Also cited in:
6.2.1
KIIIA 6.1.4-017
Also cited in:
6.2.1
KIIIA 6.1.4-018
Also cited in:
6.2.1
Author
Title
Company, Report No.
Heinfelt, R.B.
Final report on FOM-FIN-12-CS-01, FOM-FIN-12-CS-02: Field
study to evaluate the crop safety of CHA 5350 and CHA 1225
when applied post-emergence to cereals in Finland, winter
wheat/spring barley
GEP, Unpublished
Jakubiak, E.
Final report on FH12PZ108W: Phytotoxic evaluation of CHA
5350 and CHA 1225 in winter wheat
GEP, Unpublished
Zöllner, H.
Final report on FRS 039/12: Field study to evaluate the crop
safety of CHA 5350, CHA 1225 and FOM+TBM when applied
post emergence to winter wheat in Poland
GEP, Unpublished
crop safety of CHA 5350, CHA 1225 and FOM+TBM when
applied post-emergence to cereals in the Netherlands
GEP, Unpublished
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.4-019
Also cited in:
6.2.1
Potocka, E.
KIIIA 6.1.4-020
Also cited in:
6.2.1
Nierobca, P.
KIIIA 6.1.4-021
Also cited in:
6.2.1
Zöllner, H.
KIIIA 6.1.4-022
Also cited in:
6.2.1
Vanaga, I, et al
KIIIA 6.1.4-023
Also cited in:
6.2.1
Koutecky, V.
KIIIA 6.1.4-024
Also cited in:
6.2.1
6.2.5
Cap, J.
Title
Company, Report No.
Final report on ZBS 19, 20, 21/12: The estimation of crop
safety of CHA 5350, CHA 1225 and FOM+TBM for winter
triticale
Laboratory: University of Life Sciences, Lublin
GEP, Unpublished
Final report on NUZ 05/12, Report I: Research on the
selectivity of action of the preparations CHA 5350 and CHA
1225 in the cultivation of winter triticale
GEP, Unpublished
post emergence to winter triticale in Poland
GEP, Unpublished
Final trial report on H-11-1-06-IV-1233: Selectivity evaluation
of herbicides CHA 5350 and CHA 1225 SC in spring barley
GEP, Unpublished
Final report on SUMI DOM S 10 11: Trial report on Plant
Protection Products
GEP, Unpublished
Final report on 11-SA-JJ-CHA5350-1225-S:Trial report on
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.1.4-025
Also cited in:
6.2.1
Lydie, P.
KIIIA 6.1.4-026
Also cited in:
6.2.1
Potocka, E.
KIIIA 6.1.4-027
Also cited in:
6.2.1
Pszczola, J.
KIIIA 6.1.4-031
Also cited in:
6.2.1
Jakubiak, E.
KIIIA 6.1.4-028
Also cited in:
6.2.1
Lydie, P.
KIIIA 6.1.4-029
Also cited in:
6.2.1
Nierobca, P.
Title
Company, Report No.
Final report on 11SUM-KUD-CHA5350-JJ-S:Trial report on
GEP, Unpublished
Final report on ZBS 14, 15/11-SB_S: The estimation of CHA
5350 and CHA 1225 phytotoxicity for spring barley
GEP, Unpublished
Final report on FRS 025/11 PL: Evaluation of Crop selectivity
of herbicides CHA 5350 and CHA 1225 applied to spring
barley
GEP, Unpublished
Final report on FH11JJ106W: Phytotoxic evaluation of CHA
5350 and CHA 1225 in spring barley
GEP, Unpublished
Final report on 12SUM-KUD-CHA5350-JJ-S: Trial report of
GEP, Unpublished
Final report on NUZ 05/12 SB, Report I: Research on the
selectivity of action of the preparations CHA 5350 and CHA
1225 in the cultivation of Spring barley
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
KIIIA 6.1.4-030
Also cited in:
6.2.1
KIIIA 6.1.4-031
Also cited in:
6.2.1
KIIIA 6.1.4-032
Also cited in:
6.2.1
KIIIA 6.1.4-033
Also cited in:
6.2.1
KIIIA 6.1.4-034
Also cited in:
6.2.1
Author
Title
Company, Report No.
Zöllner, H.
post emergence to spring barley in Poland
GEP, Unpublished
GEP, Unpublished
Seibutis, V.
wheat
Laboratory: Lithuanian Institute of Agriculture
GEP, Unpublished
Bird, G.
Final trial report on FOM11BLW-08 SO McGuinness:
Crop safety of CHA 5350 and CHA 1225 SC on oats
GEP, Unpublished
Bird, G.
Final trial report on FOM11BLW-09 SO Sheridan (FOM 027):
Crop safety of CHA 5350 and CHA 1225 SC on oats
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
KIIIA 6.1.4-035
Also cited in:
6.2.1
KIIIA 6.2.1-001
KIIIA 6.2.1-002
KIIIA 6.2.1-003
KIIIA 6.2.1-004
Author
Title
Company, Report No.
Heinfelt, R.B.
Final report on FOM-DK-12-CS-GRASS-01, FOM-DK-12-CSGRASS-02, FOM-DK-12-CS-GRASS-03, FOM-DK-12-CSGRASS-04, FOM-DK-12-CS-GRASS-05, FOM-DK-12-CSGRASS-06, FOM-DK-12-CS-GRASS-07, FOM-DK-12-CSGRASS-08: Field study to evaluate the crop safety of CHA
5350 and CHA 1225 when applied post emergence to grassseed crops in Denmark and Sweden
GEP, Unpublished
GEP, Unpublished
Zappata, A.
Final trial report on HD11CHE01AS02: Field study to evaluate
the crop safety of CHA 5350 and CHA 1225 in Common
wheat (Triticum aestivum L.)
Laboratory: Agroservice R&S
GEP, Unpublished
Zappata, A.
Final trial report on HD11CHE01AS03: Field study to evaluate
the crop safety of CHA 5350 and CHA 1225 in Common
barley (Hordeum vulgare L.)
Laboratory: Agroservice R&S
GEP, Unpublished
Annonymous
Final report on "Spanish Variety screen 1 & 2": Photoxicity
evaluation of CHA 5350 on cereal varieties 2010-2011
Laboratory: Uni. De Malherbologia i Fitoreguladors
GEP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.2.6-001
Martin, J
KIIIA 6.2.6-002
North, A
KIIIA 6.2.6-003
North, A
KIIIA 6.2.6-004
Peterek, S.
KIIIA 6.2.6-005
Peterek, S.
KIIIA 6.2.6-006
Siemoneit S.
Title
Company, Report No.
Final report on S09-00251: Determination of the effects of
ALS herbicides on various succeeding crops following
application to winter wheat crop, 4sites in the UK 2009
Laboratory: Eurofins AgroScience Services
GEP, Unpublished
Cheminova A/S Report No.: MEM 271
Final report on S10-00916: Determination of the effects of
ALS herbicides on various succeeding crops following
application to winter wheat crop, 3sites in the UK 2010
GEP, Unpublished
Final report on S11-02057: Field study to evaluate the effect
of various ALS herbicides applied in sequence or mixture to
winter wheat on a succeeding crop of oilseed rape
GEP, Unpublished
Final report on S12-01772: Diflufenican 500 g/L + Florasulam
50 g/L SC: Seedling emergence test for non-target plants on
ten plant species
GLP, Unpublished
Final report on S12-00107: Florasulam 50 g/l SC: Seedling
emergence test for non-target plants on ten plant species.
GLP, Unpublished
Final report on CHE-A: Biotest to determine the effects of
CHA 1250 (Diflufenican 500 g/L SC) on following crops.
Laboratory: DLR-Rheinpfalz.
GLP, Unpublished
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y
14869 N
Ref. ID no.
and
Annex point
Author
KIIIA 6.2.7-001
Peterek, S.
KIIIA 6.2.7-01
Peterek, S.
KIIIA 6.5.1-001
Teicher, H.B.
Title
Company, Report No.
Final report on S12-0173: Diflufenican 500 g/L + Florasulam
50 g/L SC: Vegetative vigour test for non-target plants on ten
plant species
GLP, Unpublished
Final report on S12-00108: Florasulam 50 g/l SC: Vegetative
vigour test for non-target plants on ten plant species
GEP, Unpublished
GLP, Unpublished
Final report on AH00347: Florasulam and
Florasulam+diflufenican tank cleaning - small scale jar test
Laboratory: Cheminova A/S
Data protection
claimed Y/N
Owner
Data
protection
granted
Y/N
Studies
relied on
Y/N
Y
CHA
Y
Y
Y
CHA
Y
Y
Y
CHA
Y
Y

Registration Report Part A

Transcription

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