Florasulam final RR 1107 Part B Section 8 Nat Saracen CHE DE

Transcription

CHA 5350
Saracen
Part A
National Assessment Germany
Registration Report –Central Zone
Page 1 of 27
REGISTRATION REPORT
Part A
Risk Management
Product code:
CHA 5350
Active Substance:
florasulam 50 g/L
COUNTRY: Germany
Central Zone
Zonal Rapporteur Member State: UK
NATIONAL ASSESSMENT
Applicant:
Cheminova
Applicant:
Cheminova
Date:
19/02/2015
Date:19/02/2015
CHA 5350
Saracen
Part A
Page 2 of 27
Table of Contents
PART A – Risk Management
4
1
Details of the application
4
1.1
Application background
4
1.2
Annex I inclusion
4
1.3
Regulatory approach
5
1.4
Data protection claims
5
1.5
Letters of Access
5
2
Details of the authorisation
5
2.1
Product identity
5
2.2
Classification and labelling
6
2.2.1
Classification and labelling under Directive 99/45/EC
6
2.2.2
Classification and labelling under Regulation (EC) No 1272/2008
6
2.2.3
Standard phrases under Regulation (EC) No 547/2011
7
2.3
Other phrases notified under Regulation (EC) No 547/2011
7
2.3.1
Restrictions linked to the PPP
7
2.3.2
Specific restrictions linked to the intended uses
8
2.4
Product uses
10
3
Risk management
12
3.1
Reasoned statement of the overall conclusions taken in accordance
with the Uniform Principles
12
3.1.1
Physical and chemical properties (Part B, Section 1, Points 2 and 4)
12
3.1.2
Methods of analysis (Part B, Section 2, Point 5)
12
3.1.2.1
Analytical method for the formulation (Part B, Section 2, Point 5.2)
12
3.1.2.2
Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
13
3.1.3
Mammalian Toxicology
13
3.1.3.1
Acute Toxicity
13
3.1.3.2
Operator Exposure
13
3.1.3.3
Bystander Exposure
13
3.1.3.4
Worker Exposure
13
3.1.3.5
Groundwater metabolites
14
3.1.4
Residues and Consumer Exposure
15
3.1.4.1
Residues
15
3.1.4.2
Consumer exposure (Part B, Section 4, Point 8.10)
15
3.1.5
Environmental fate and behaviour (Part B, Section 5, Point 9)
15
Applicant:
Cheminova
Date: 19/02/2015
Part A
CHA 5350
Saracen
Page 3 of 27
3.1.6
Ecotoxicology (Part B, Section 6, Point 10)
17
3.1.6.1
Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
17
3.1.6.2
Effects on Aquatic Species (Part B, Section 6, Point 10.2)
17
3.1.6.3
Effects on Bees and Other Arthropod Species
(Part B, Section 6, Points 10.4 and 10.5)
18
Effects on Earthworms and Other Soil Macro-organisms
(Part B, Section 6, Point 10.6)
20
3.1.6.5
Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
21
3.1.6.6
Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
21
3.1.6.7
Assessment of Potential for Effects on Other Non-target Organisms
(Flora and Fauna) (Part B, Section 6, Point 10.8)
21
3.1.7
Efficacy (Part B, Section 7, Point 8)
21
3.2
Conclusions
24
3.3
Further information to permit a decision to be made or to support
a review of the conditions and restrictions associated with the authorisation
24
3.1.6.4
Appendix 1 – Copy of the product authorisation
25
Appendix 2 – Copy of the product label
26
Appendix 3 – Letter of Access
27
Applicant:
Cheminova
Date: 19/02/2015
Part A
CHA 5350
Saracen
Page 4 of 27
PART A – Risk Management
This document describes the acceptable use conditions required for the registration of CHA5350
(Saracen) containing florasulam in Germany. This evaluation is required subsequent to the approval of
florasulam.
The risk assessment conclusions are based on the information, data and assessments provided in
CHA5350 Registration Report, Part B Sections 1-7 and Part C from UK and where appropriate the
addendum for Germany. The information, data and assessments provided in Registration Report, Parts B
includes assessment of further data or information as required at national registration by the EU review. It
also includes assessment of data and information relating to CHA5350 where that data has not been
considered in the EU review. Otherwise assessments for the safe use of CHA5350 have been made using
endpoints agreed in the EU review of florasulam.
This document describes the specific conditions of use and labelling required for Germany for the
registration of CHA5350.
Appendix 1 of this document provides a copy of the final product authorisation in Germany.
Appendix 2: The submitted draft product label has been checked by the competent authority. The
applicant is requested to amend the product label in accordance with the decisions made by the competent
authority. The final version of the label has to fulfil the requirements according to Article 16 of Directive
91/414/EEC.
Appendix 3: Letter(s) of access is/are classified as confidential and, thus, are not attached to this
document.
1
Details of the application
1.1
Application background
This application was submitted by Cheminova on 19 December 2012.
The aim of this registration application is to gain approval of Florasulam 50 g/L SC (CHA 5350) – a
suspension concentrate formulation containing 50 g/L Florasulam, 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.
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 amending Directive 91/414/EEC, and subsequently amended under
Directive 2010/77/EU on 10 November 2010 extending the expiry date on Annex I to 31 December 2015.
Document SANCO/1406/2001-final (18/09/2002) and associate DAR for florasulam are considered the
Applicant:
Cheminova
Date:19/02/2015
CHA 5350
Saracen
Part A
Page 5 of 27
most relevant sources to provide the relevant review information or reference on the EU endpoints/critical
EU agreed endpoints as well as justifications for any deviation from the 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.
These concerns have been addressed within the current submission.
1.3
Regulatory approach
To obtain approval the product CHA5350 must meet the conditions of Annex I inclusion and be
supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to
Uniform Principles, using Annex I agreed end-points.
This application was submitted in order to allow the first approval of this product/use in Germany in
accordance with the above.
1.4
Data protection claims
Where protection for data is being claimed for information supporting registration of Saracen, it is
indicated in the reference lists in Appendix 1 of the Registration Report, Part B, sections 1, 5, 6 and 7.
1.5
Letters of Access
Data access has been proven. Cheminova Deutschland provided a letter of access from Cheminova AS.
2
Details of the authorisation
2.1
Product identity
Product Name
Authorization Number
Function
Applicant
Composition
Formulation type
Applicant:
Cheminova
Saracen (CHA 5350)
007767-00/00
Herbicide
Cheminova Deutschland GmbH
50 g/L florasulam
Suspension concentrate [Code: SC]
Date: 19/02/2015
CHA 5350
Saracen
Part A
Packaging
Page 6 of 27
Bottle, fluorinated HDPE, 0.1 L– 3 L
Bottle, HDPE/PA, 0.1 L– 3 L
Jerry can, fluorinated HDPE, 0.25 L – 5 L
Jerry can, HDPE/PA, 0.25 L – 5 L
2.2
2.2.1
Classification and labelling under Directive 99/45/EC
The following labelling is proposed in accordance with Directive 1999/45/EC:
Symbol(s)/Indication(s) of danger:
None
N
Dangerous for the environment
Risk phrases:
None
R 50/53
Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic
environment
RA105
Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.
Safety phrases:
S36/37
Wear suitable protective clothing and gloves.
S2
Keep out of the reach of children
S24
Avoid contact with skin
S35
This material and its container must be disposed of in a safe way.
S46
If swallowed, seek medical advice immediately and show this container or label
S57
Use appropriate container to avoid environmental contamination.
SP001
To avoid riks to man and the environment, comply with the instructions for use.
Specific labelling requirement:
To avoid risks to man and the environment, comply with the instructions for use.
Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.
2.2.2
Classification and labelling under Regulation (EC) No 1272/2008
The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:
Applicant:
Cheminova
Date: 19/02/2015
CHA 5350
Saracen
Part A
Page 7 of 27
Hazard classes and categories:
None
Hazard pictograms:
None
GHS09
environment
Signal word:
Warning
Hazard statements:
None
H400
Very toxic to aquatic life.
H410
Very toxic to aquatic life with long lasting effects.
Precautionary statemtents:
Not proposed by zRMS Germany, to be decided by applicant
Special rule for labelling of PPP:
EUH401
To avoid risks to man and the environment, comply with the instructions for use.
Further labelling statements under Regulation (EC) No 1272/2008:
EUH 208-0098 - Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.
2.2.3
Standard phrases under Regulation (EC) No 547/2011
None
2.3
Other phrases notified under Regulation (EC) No 547/2011
2.3.1
Restrictions linked to the PPP
The authorization of the PPP is linked to the following conditions (mandatory labelling):
Human health protection
SB001
Avoid any unnecessary contact with the product. Misuse can lead to health
damage.
SB010
Keep out of the reach of children.
SB110
The directive concerning requirements for personal protective gear in plant
protection, "Personal protective gear for handling plant protection products" of
the Federal Office of Consumer Protection and Food Safety must be observed.
SF245-01
Treated areas/crops may not be entered until the spray coating has dried.
SS110
Wear standard protective gloves (plant protection) when handling the undiluted
Applicant:
Cheminova
Date: 19/02/2015
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Saracen
Part A
Page 8 of 27
product.
SS2101
Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots)
when handling the undiluted product.
SS530
Wear face protection when handling the undiluted product.
SS610
Wear a rubber apron when handling the undiluted product.
Integrated pest management (IPM)/sustainable use
WMB
Mode of action (HRAC-group): B
WH951
The risk of resistance has to be indicated on the package and in the instructions
for use. Particularly measures for an appropriate risk management have to be
declared.
NB6641
The product is classified as non-hazardous to bees, even when the maximum
application rate, or concentration if no application rate is stipulated, as stated for
authorisation is applied. (B4)
Ecosystem protection
NW 262
The product is toxic for algae.
NW 265
The product is toxic for higher aquatic plants.
NW 468
Fluids left over from application and their remains, products and their remains,
empty containers and packaging, and cleansing and rinsing fluids must not be
dumped in water. This also applies to indirect entry via the urban or agrarian
drainage system and to rain-water and sewage canals.
The authorization of the PPP is linked to the following conditions (voluntary labelling):
NN1001
The product is classified as non-harmful for populations of relevant beneficial insects.
NN1002
The product is classified as non-harmful for populations of relevant beneficial predatory
mites and spiders.
2.3.2
Specific restrictions linked to the intended uses
Some of the authorised uses are linked to the following conditions (mandatory labelling):
See 2.4 (Product uses)
WH9161
The instructions for use must include a summary of weeds which can be controlled well,
less well and insufficiently by the product, as well as a list of species and/or varieties
showing which crops are tolerant of the intended application rate and which are not.
WH960
The risk of replanting has to be indicated on the package and in the instructions of use.
Particularly, the endangered succeeding crops have to be declared and measures for a risk
management have to be described.
WP740
Take care of adjacent crops, since damage is possible.
Applicant:
Cheminova
Date: 19/02/2015
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CHA 5350
Saracen
Page 9 of 27
Ecosystem protection
NW 642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters.
Irrespective of this, the minimum buffer zone from surface waters stipulated by state law
must be observed. Violations may be punished by fines of up to 50 000 EUR.
NT 109
A buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or
horticulturally used areas, roads, paths and public places). In addition, in an adjoining strip
of at least 20 m, the product must be applied using loss reducing equipment which is
registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette
No 205, p. 9780) as amended, and be registered in at least drift reducing class 90 %.
Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the
product is applied with portable plant protection equipment or if adjacent areas (field
boundaries, hedges, groups of woody plants) are less than 3 m wide. A buffer zone of at
least 5 m is also unnecessary if the product is applied in an area which has been declared
by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of 7
February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian
landscape with a sufficient proportion of natural and semi-natural structures, or if evidence
can be shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants)
were planted on agriculturally or horticulturally used areas.
Human and animal health protection
VV447
Applicant:
Cheminova
Newly treated areas must not be used for fodder or grazing.
Date: 19/02/2015
CHA5350
Saracen
Part A
2.4
Page 10 of 27
Product uses
GAP rev.2, date: 2015-01-27
BVL-Reg.-No.:
007767-00/00
PPP (product name/code):
Active substance 1:
Saracen (CHA 5350)
Florasulam
Formulation Type:
Conc. of a.s. 1:
SC
50 g/l
Applicant:
Zone(s):
central/EU
Professional use:
Non-professional use:
Yes
No
Verified by MS:
1
UseNo.
2
Member
state(s)
yes
3
Crop and/
or situation
(crop destination /
purpose of crop)
001
002
DE
DE
Applicant:
Cheminova
4
F
G
or
I
5
Pests or Group of
pests controlled
(additionally:
developmental stages
of the pest or pest
group)
6
7
8
10
Application
Method /
Kind
F
winter soft wheat
(TRZAW), winter
barley (HORVW),
winter rye (SECCW),
winter triticale
(TTLWI)
annual dicotyledonous spraying
weeds (TTTDS)
F
winter soft wheat
(TRZAW), winter
barley (HORVW),
winter rye (SECCW),
winter triticale
weeds (TTTDS)
11
12
Application rate
Timing / Growth Max. number kg, L product /
stage of crop &
(min. interval ha
season
between
a) max. rate
applications) per appl.
a) per use
b) max. total
b) per crop/
rate per
season
crop/season
g, kg a.s./ha
Autumn
13 to 29
a) 0.00375
kg/ha
a) 1
a) 0.075 L/ha
b) 1
b) 0.075 L/ha
Water
L/ha
13
PHI Remarks:
(days
e.g. safener/synergist per ha
)
a) max. rate
min / max
per appl.
b) max. total
rate per
crop/season
e.g. recommended or mandatory
tank mixtures
200 – 400 -
WH9161
WH960
WP740
NW642-1
NT109
200 - 400
WH9161
WH960
WP740
NT109
b) 0.00375
kg/ha
Spring
13 to 29
a) 1
a) 0.1 L/ha
b) 1
b) 0.1 L/ha
a) 0.005
kg/ha
b) 0.005
kg/ha
14
-
Date: 19/02/2015
(TTLWI)
003
004
005*
DE
DE
DE
F
winter soft wheat
(TRZAW), winter
barley (HORVW),
winter rye (SECCW),
winter triticale
(TTLWI)
weeds (TTTDS)
spring soft wheat
(TRZAS), spring
barley (HORVS),
common oats
(AVESA)
F
weeds (TTTDS)
spelt (TRZSP)
F
Spring
30 to 39
a) 1
a) 0.15 L/ha
b) 1
b) 0.15 L/ha
a) 0.0075
kg/ha
200 - 400
-
WH9161
WH960
WP740
NW642-1
NT109
200 - 400
-
WH9161
WH960
WP740
NW642-1
NT109
200 - 400
-
200 - 400
-
b) 0.0075
kg/ha
Spring
13 to 29
a) 1
a) 0.1 L/ha
b) 1
b) 0.1 L/ha
a) 0.005
kg/ha
b) 0.005
kg/ha
weeds (TTTDS)
Spring
13 to 32
a) 1
a) 0.1 L/ha
b) 1
b) 0.1 L/ha
a) 0.005
kg/ha
b) 0.005
kg/ha
006** DE
grasses (GGGGG)
in crops for seed
production
F
weeds (TTTDS)
Spring
13 to 32
a) 1
a) 0.1 L/ha
b) 1
b) 0.1 L/ha
a) 0.005
kg/ha
No authorization granted!
b) 0.005
kg/ha
Withdrawn by applicant
** The evaluation of the zRMS UK following the application 006 rated “negative” due to the insufficient data base. Moreover effects on the yield were reported.
*
Remarks:
Applicant:
Cheminova
(1) Numeration of uses in accordance with the application/as verified by MS
(2) Member State(s) or zone for which use is applied for
(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
situation should be described (e.g. fumigation of a structure)
(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages
(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
equipment used must be indicated
(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of
application
(8) The maximum number of applications possible under practical conditions of use for each single
application and per year (permanent crops) or crop (annual crops) must be provided
(8) Min. interval between applications (days) were relevant
(10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season
must be given in metric units (e.g. kg or L product / ha)
(11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per
crop/season must be given in metric units (e.g. g or kg / ha)
(12) The range (min/max) of water volume under practical conditions of use must be given
(L/ha)
(13) PHI - minimum pre-harvest interval
(14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
Date: 19/02/2015
Part A
CHA5350
Saracen
Page 12 of 27
3
Risk management
3.1
Reasoned statement of the overall conclusions taken in accordance with the
Uniform Principles
3.1.1
Physical and chemical properties (Part B, Section 1, Points 2 and 4)
Overall Summary:
The product Saracen (CHA 5350) was not the representative formulation for the inclusion of florasulam
into Annex I of Directive 91/414/EEC. Therefore, physical, chemical and technical properties of Saracen
are provided and the results were considered acceptable.
Saracen (CHA 5350) is an opaque white liquid with a petrol-like odour. It is not explosive and not
considered to be oxidizing. For the formulation, no flash point was detected up to 66 °C, at which
temperature the flame was extinguished and no auto-ignition temperature was determined below 600 °C.
Saracen (CHA 5350) possesses a slightly acidic pH of 4.04 (undiluted product) or a pH of 4.38 (1 %
aqueous solution). Saracen (CHA 5350) and its commercial container materials have been shown to be
stable in an accelerated stability test (14 days at 54°C) and for two years at ambient temperature (in
HDPE). The technical properties are such that no problems are expected when the product is used
according to label recommendations under normal field conditions.
Implications for labelling: None
Compliance with FAO specifications:
There are no FAO specifications for florasulam.
Compliance with FAO guidelines:
The product Saracen (CHA 5350) complies with the general requirements for SC formulations according
to the FAO/WHO manual (2010).
Compatibility of mixtures:
No tank mixtures are recommended for Saracen (CHA 5350).
Nature and characteristics of the packaging:
Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,
leakproofness, resistance to normal transport and handling, resistance to and compatibility with the
contents of the packaging, have been submitted, evaluated and is considered to be acceptable.
Nature and characteristics of the protective clothing and equipment:
Information regarding the required protective clothing and equipment for the safe handling of CHA 5350
has been provided and is considered to be acceptable.
3.1.2
Methods of analysis (Part B, Section 2, Point 5)
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)
An analytical method (VAM 223-01) based on high performance liquid chromatography (HPLC) with
UV detection has been developed for the determination of the active substance florasulam in SC
Applicant:
Cheminova
Date: 19/02/2015
Part A
CHA5350
Saracen
Page 13 of 27
formulations including Saracen (CHA 5350). 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 (Part B, Section 2, Points 5.3 – 5.8)
Analytical methods for food of plant origin and air, and florasulam and 5-OH florasulam in soil and water
are active substance data and were provided in the EU review of florasulam and were considered
adequate.
MRLs are set for food of animal origin which are effective by July 2014. No methods were provided for
food of animal origin but no residues are expected from the use of Saracen.
3.1.3
Mammalian Toxicology
3.1.3.1 Acute Toxicity
Acute toxicity studies for Saracen were not evaluated as part of the EU review of florasulam. Therefore,
all relevant data were provided and are considered adequate.
Saracen, containing 50 g/L florasulam, is of low acute toxicity by the oral, dermal and inhalation route of
administration. Saracen 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 CHA 5350.
3.1.3.2 Operator Exposure
Operator exposure to Saracen was not evaluated as part of the EU review of florasulam for this submitted
rate/crops. 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 (florasulam 0.05 mg/kg
bw/day). Data on dermal absorption of Saracen was provided and considered acceptable. Operator
exposure was modelled using UK OPEX, German and Dutch models.
According to the model calculations, it can be concluded that the risk for the operator using Saracen on
cereals and grass for seed production in the field is acceptable even without the use of personal protective
equipment during mixing/loading and application.
3.1.3.3 Bystander Exposure
Bystander exposure to Saracen was not evaluated as part of the EU review of florasulam. Therefore, all
relevant data and risk assessments have been provided and are considered adequate. It is concluded that
there is no undue risk to any bystander after accidental short-term exposure to Saracen. This has no
labelling implications.
3.1.3.4 Worker Exposure
Worker exposure to Saracen was not evaluated as part of the EU review of florasulam. Therefore, all
relevant data and risk assessments have been provided and are considered adequate. It is concluded that
there is no unacceptable risk anticipated for the worker wearing adequate work clothing (but no PPE),
when re-entering crops treated with Saracen. As a standard rule, it should be mentioned on the label that
treated crops should not be re-entered before spray deposits on leaf surfaces have completely dried.
Applicant:
Cheminova
Date: 19/02/2015
Part A
CHA5350
Saracen
Page 14 of 27
Implications for labelling resulting from operator, worker, bystander assessments:
See 2.2
3.1.3.5 Groundwater metabolites
The two groundwater metabolites ASTCA and TSA are not genotoxic and are not defined as toxic.
Therefore a threshold of 0.75 µg/L can be considered acceptable for these two metabolites (please refer to
Section B Part 8 national addendum). Cheminova has no access to the studies that were used for the
evaluation of the metabolites TSA and ASTCA in section 8 of this RR. Subsequently Cheminova has
submitted their own studies on the genotoxicity of TSA and ASTCA. The studies were evaluated and lead
to the same conclusion that TSA and ASTCA a threshold of 0.75 µg/L can be considered acceptable for
these two metabolites. Section 8 has not been adapted.
Applicant:
Cheminova
Date: 19/02/2015
Part A
3.1.4
CHA5350
Saracen
Page 15 of 27
Residues and Consumer Exposure
3.1.4.1 Residues
Fundamental residue data on florasulam like metabolism are already evaluated previously and is
described in detail in the respective DARs.
A sufficient number of residue trials are available to demonstrate that the MRLs set in Regulation (EC)
No 396/2005 for florasulam will not be exceeded for the intended uses in cereals and grass.
The applicant does not have access to residues data supporting the use on grass for seed production. As
this use is primarily for the grass seed then authorisation is possible with the following restriction: Newly
treated areas must not be used for fodder or grazing.
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)
The EU MS and UK TMDIs are below the ADI (florasulam 0.05 mg/kg bw/d) and hence no chronic
health effects are expected from the consumption of treated commodities. The active is not acutely toxic
and hence an ARfD has not been allocated. Therefore an acute risk assessment has not been performed.
3.1.5
Environmental fate and behaviour (Part B, Section 5, Point 9)
The exposure assessment of the plant protection product Saracen in its intended uses in winter and spring
cereals is documented in detail in the core assessment, part B, section 5 of the plant protection product
Saracen dated from December 2013 by UK. However, zRMS UK refrained from a detailed evaluation of
the dossier submitted by the applicant with reference to the “risk envelopes set by either the evaluation of
the representative uses of the active substances at Annex I stage or in other existing single active products
approved in the UK in accordance with the Uniform Principles (to address UK specific requirements)”.
The following chapters summarize specific exposure assessment for soil and surface water and the
specific risk assessment for groundwater for the authorization of Saracen in Germany according to its
intended uses in winter and spring cereals (Use No. 00-001 to 00-006).
Florasulam
No new study on the fate and behaviour of florasulam or Saracen has been performed. Hence no
potentially new metabolites need to be considered.
The risk assessment for the soil metabolites 5-OH-XDE-570, DFP-ASTCA, ASTCA, and TSA of
florasulam has already been performed for EU approval (see SANCO/1406/2001-final). Therefore, no
new risk assessment hence no exposure assessment for these metabolites is necessary.
Potential ground water contaminations by the soil metabolites 5-OH-XDE-570, DFP-ASTCA, and
ASTCA was evaluated for EU approval of florasulam. PECgw modelled with FOCUS PELMO (version
3.0). The PECgw values were less than 0.1 µg/L for the metabolites 5-OH-XDE-570 and DFP-ASTCA
and higher than 0.1 µg/L for the metabolite ASTCA in scenario Hamburg based on an application of 7.5 g
as/ha (50 % crop interception) in winter wheat on 15th April.
However, the leaching potential into groundwater of the soil metabolites 5-OH-XDE-570, DFP-ASTCA,
ASTCA, and TSA will be assessed for the application of the plant protection product and its intended
uses.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points
9.4 and 9.5)
For the intended use of the plant protection product Saracen in Germany according to its intended uses in
winter and spring cereals (Use No. 00-001 to 00-006) PECsoil values were calculated for the active
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substance florasulam considering a soil depth of 2.5 cm. Due to the fast degradation of the active
substance florasulam in soil their accumulation potential was not considered.
The results for PEC soil for the active substance and its metabolites were used for the ecotoxicological
risk assessment.
active substance/
formulation
soil relevant
application rate
(g/ha)
soil
depthact
(cm)
PECact
(mg/kg)
PECaccu =
PECact +
PECbkgd
(mg/kg)
PECbkgd
tillage
depth (cm) (mg/kg)
florasulam:
3.75
2.5
0.0100
-
-
-
metabolite 5-OHXDE-570:
2.54
2.5
0.0068
-
-
-
metabolite DFPASTCA:
0.53
2.5
0.0014
-
-
-
metabolite ASTCA:
0.80
2.5
0.0021
20
0.0002
0.0023
metabolite TSA:
0.27
2.5
0.0007
20
<0.0001
0.0007
formulation
Saracen (CHA
5350):
1040
2.5
2.7733
-
-
-
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,
Section 5, Point 9.6)
1. Direct leaching into groundwater
Results of modelling with FOCUSPELMO 5.5.3 show that the active substance florasulam is not
expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended uses of Saracen in
spring and winter cereals according to use No. 00-001 to 00-006.
For the metabolites 5-OH-XDE-570 and DFP-ASTCA of florasulam a groundwater concentration of
≥ 0.1 µg/L can be excluded for the intended uses of Saracen in spring and winter cereals according to use
No. 00-001 to 00-006. For the metabolites ASTCA and TSA of florasulam a groundwater concentration
of ≥ 0.1 µg/L cannot be excluded for the intended uses of Saracen in spring and winter cereals according
to use No. 00-001 to 00-006. According to the data in the recent DAR to florasulam, the metabolites are
not relevant for groundwater organisms.
2. Ground water contamination by bank filtration due to surface water exposure via run-off and drainage
According to modelling with EXPOSIT 3.01, a groundwater contamination at concentrations ≥ 0.1 µg/L
by the active substance florasulam and its soil metabolites due to surface run-off and drainage into the
adjacent ditch with subsequent bank filtration can be excluded.
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section
5, Points 9.7 and 9.8)
For the intended use of the plant protection product Saracen in Germany according to its intended uses in
winter and spring cereals (Use No. 00-001 to 00-006) PECsw was calculated for the active substance
florasulam considering the two routes of entry (i) spraydrift and volatilization with subsequent deposition
and (ii) run-off, drainage separately.
The vapour pressure at 20 °C of the active substance florasulam is < 10-5 Pa. Hence the active substance
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florasulam is regarded as non-volatile. Therefore exposure of surface water by the active substance
florasulam due to deposition following volatilization does not need to be considered.
The concentration of the active substance florasulam in adjacent ditch due to surface run-off and drainage
was calculated using the model EXPOSIT 3.01.
The results for PEC surface water for the active substance and its metabolites were used for the ecotoxicological risk assessment.
PECsw florasulam (drift and volatilisation): 0.069µg/L (no drift reduction technique)
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point
9.9)
florasulam is regarded as non-volatile.
Implications for labelling resulting from environmental fate assessment:
For the authorization of the plant protection product Saracen following labeling and conditions of use are
mandatory:
Based on the data on the active substances florasulam the plant protection product Saracen is considered
to be not readily degradable in the sense of the CLP regulation.
The formulation Saracen is regarded as a candidate for R 53.
3.1.6
Ecotoxicology (Part B, Section 6, Point 10)
A full risk assessment according to Uniform Principles for the plant protection product Saracen in its
intended uses in cereals is documented in detail in the core assessment of the plant protection product
Saracen dated from December 2013 performed by zRMS UK. The intended use of Saracen in Germany is
generally covered by the uses evaluated in the course of the core assessment by UK.
The following chapters summarizes specific risk assessment for non-target organisms and hence risk
mitigation measures for the authorization of Saracen in Germany according to its intended use in cereals
and grassland (use No. 00-001 – 00-006).
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
The risk assessment for effects on birds and other terrestrial vertebrates was carried out according to the
European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals on
request from EFSA (EFSA Journal 2009; 7(12): 1438).
Please refer to the core assessment of the UK.
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)
Results of aquatic risk assessment for the intended for uses of Saracen in cereals based on FOCUS
Surface Water PEC values is presented in the core assessment, Part B, Section 6, chapter 10.2.
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For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i)
spraydrift and volatilization with subsequent deposition and (ii) run-off, drainage separately in order to
allow risk mitigation measures separately for each entry route.
1. Exposure by spraydrift and deposition following volatilization
Based on the calculated concentrations of florasulam and its metabolites in surface water (EXPOSIT
3.0.1), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic
organisms to florasulam according to the GAP of the formulation Saracen achieve the acceptability
criteria TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C,
2. Specific principles, point 2.5.2. for long-term effects.
Relevant toxicity endpoint: EC50 = 0.001 mg a.i./L (Lemna gibba)
Relevant TER: 10
2. Exposure by surface run-off and drainage
The concentration of the active substances florasulam in adjacent ditch due to surface runoff and drainage
was calculated using the model EXPOSIT 3.01.
The calculated TER values for the risk to aquatic organisms resulting from an exposure of surface water
by the active substances florasulam due to run-off and drainage according to the use No 00-001 – 00-006
achieve the acceptability criteria of TER ≥ 10, according to commission implementing regulation (EU)
No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. Risk mitigation measures do not need to
be applied.
Relevant toxicity endpoint: EC50 = 1 µg a.s./L (Lemna gibba.)
Relevant TER: 10
Consequences for authorization:
For the authorization of the plant protection product Saracen the following labelling and conditions of use
are mandatory:
Required Labelling
NW 262
NW 265
Florasulam: N. pelliculosa NOEC < 0.000788 mg a.s./L
Saracen: P. subcapitata NOEC < 0.046 mg/L
Florasulam: L. gibba NOEC = 0.00062 mg a.s./L
Saracen : L. minor. NOEC = 0.007 mg/L
Safety precautions / Conditions of use
Saracen
NW 468
NW 642-1
NT 109
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and
10.5)
Bees
Toxicity
Effects on bees for CHA 5350 (Florasulam 50 g/L SC) were not evaluated as part of the EU review of
florasulam. Data on CHA 5350 is evaluated, and risk assessments with the proposed use pattern, are
provided here and are considered adequate.
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The EU agreed honeybee toxicity endpoints are presented in the following Table 3.1.6.3-1 for florasulam.
The toxicity of CHA 5350 to honeybees is given in Table 3.1.6.3-2.
Table 3.1.6.3-1: Toxicity of Florasulam to honeybees
EU agreed endpoints
Endpoints
used
in
risk
Active substance (SANCO/1406/2001 – final. 18
assessment
September 2002)
Oral LD50 > 100 µg a.s./bee
Oral LD50 > 100 µg a.s./bee
Florasulam
Contact LD50 > 100 µg a.s/bee
Contact LD50 > 100 µg a.s/bee
Table 3.1.6.3-2: Toxicity of CHA 5350 (Florasulam 50 g/L SC) to honeybees
Substance
Endpoint
Value
Reference
> 1.911µl product/bee
48-h oral LD50
>94.76 µg a.s./bee
Ansaloni T. (2012a)
CHA 5350
CHA
127 FOM
48-h
contact >2.016 µl product/bee
LD50
>100 µg a.s./bee
Hazard Quotients
The risk assessment for effects of CHA 5350 on honeybees has been conducted in accordance with the
Guidance document on terrestrial ecotoxicology, SANCO/10329/2002 rev 2 final, (2002)1.
The studies performed on bees provide the oral and contact LD50 values of the active substance expressed
as µg a.s./bee. Based on low toxicity, the submitted laboratory honeybee oral and contact toxicity tests
with CHA 5350 were conducted as limit tests.
The acute risk to honeybees from use of CHA 5350 was assessed using the worst-case maximum single
application rate for the proposed uses and the LD50 values (µg a.s./bee) to calculate hazard quotients
(EPPO 2003)2 as follows:
Hazard Quotient (QH)=
Maximum single application rate (g a.s./ha or g formulation/ha)
Acute LD50 (µg a.s./ha or µg formulation/ha)
Hazard quotients were calculated for oral exposure (QHO) and contact exposure (QHC) and were evaluated
against a trigger value of 50. Values below 50 are considered to indicate a low risk to bees in the field.
The calculated HQ values are presented in Table 3.1.6.3-3.
Table 3.1.6.3-3 Hazard quotients (QH) for honey bees
Test
substance
Use pattern
Exposure
route
Endpoint
LD50
(µg a.s./bee
Maximum
single
application
rate
(g a.s./ha)
Hazard
quotient
(HQ)
HQ
assessment
trigger
1
European Commission Working Document – SANCO/10329/2002 rev 2 Final. Guidance Document on Terrestrial Ecotoxicology under Council
Directive 91/414/EEC.
2
EPPO/OEPP (2003) Environmental risk assessment scheme for plant protection products, Chapter 10: Honeybees (PP 3/10(2)). Bulletin
OEPP/EPPO Bulletin 33: 141-145.
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Test
substance
Use pattern
Florasulam
1 × 7.5 g a.s./ha
CHA 5350
Exposure
route
Endpoint
LD50
(µg a.s./bee
Oral
>100
Page 20 of 27
Maximum
single
application
rate
(g a.s./ha)
Hazard
quotient
(HQ)
<0.075
7.5
Contact
>100
Oral
>94.76
1 × 7.5 g a.s./ha
50
<0.075
<0.079
7.5
Contact
>100
HQ
assessment
trigger
50
<0.075
Risk Assessment
Honeybees may be exposed to florasulam by direct contact from spray applications of florasulam
containing products while foraging in crops, flowers or weeds (in areas adjacent to the crops). Bees may
also be exposed through contact with fresh or dry residues or by oral uptake of contaminated pollen,
nectar and honey dew.
Florasulam is a herbicide used for control of broadleaf weeds in cereals and early growth stage grassland,
application is made at early growth stages BBCH 13- 39 maximum, therefore direct contact via the crop
will be minimal. However fields may contain flowering weeds in-field at the time of application or in the
area adjacent to the crop. The maximum single application rate for post-emergence use is 7.5 g a.s./ha.
Florasulam does not exhibit insect growth regulator activity.
Overall conclusion
The QH values for oral and contact exposure to florasulam are below the trigger value of 50. Therefore,
CHA 5350 is considered to pose a low acute oral and contact risk to honeybees following application in
accordance with the proposed uses.
Label NB6641 is assigned to the product.
Other non-target arthropods
The applicant has submitted data on the effect of Saracen on non-target arthropods. According to the
herbicidal effect of the formulation these effect values are substantially higher than those effects
determined for non-target terrestrial plants, which are therefore relevant for the risk assessment for
terrestrial biocoenosis. A quantitative risk assessment for non-target arthropods is for that reason not
conducted in this national addendum.
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point
10.6)
Based on the predicted concentrations of florasulam in soils, the TER values describing the acute and
longterm risk for earthworms and other non-target soil organisms following exposure to florasulam
according to the GAP of the formulation Saracen achieves the acceptability criteria TER ≥ 10 resp. TER
≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific
principles, point 2.5.2. The results of the assessment indicate an acceptable risk for soil organisms due to
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the intended use of florasulam in winter cereals according to the label. The used endpoint NOEC =
2.0965 mg Saracen/kg dw is based on the highest concentration tested.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
Not relevant
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
Based on the predicted concentrations of florasulam in soils, the risk to soil microbial processes following
exposure to florasulam according to the GAP of the formulation Saracen is considered to be acceptable
according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific
principles, point 2.5.2.
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and
Fauna) (Part B, Section 6, Point 10.8)
Terrestrial plants
Based on the predicted rates of florasulam in off-field areas, the TER values describing the risk for nontarget plants following exposure to florasulam according to the GAP of the formulation Saracen regarding
the indication 00-003 does is slightly below the acceptability criteria TER ≥ 5 according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. The
calculation is based on the most sensitive species Beta vulgaris with an ER50 = 0.019 g a.s./ha. The next
higher ER50 value = 0.25 g a.s./ha for the mung bean, followed by an ER50 = 0.29 g a.s./ha for the tomato.
Beta vulgaris turned out to be very sensitive towards the active substance florasulam. The factor between
Beta vulgaris and the next sensitive species mung bean is 10. From the 10 species tested, 5 turned out to
have an ER50 > 7.5 g a.s/ha, which is almost factor 400 towards the ER50 = 0.019 g a.s./ha for beta
vulgaris. Therefore, the slight shortfall of the acceptability criteria is negligible.
Based on the predicted rates of florasulam in off-field areas, the TER values describing the risk for nontarget plants following exposure to florasulam according to the GAP of the formulation Saracen regarding
the uses 00-001, 00-002, 00-004 and 00-006 achieve the acceptability criteria TER ≥ 5 according to
commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point
2.5.2. The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to the
intended use of Saracen in winter cereals and grassland according to the label.
For details please refer to the core assessment Part B, section 6, chapter 6.10.
Conditions for use
For the authorization of the plant protection product Saracen following labelling and conditions of use are
mandatory:
Safety precautions / Conditions of use
All uses
NT 109 (5 m distance; 90 % drift reduction technique)
3.1.7
Efficacy (Part B, Section 7, Point 8)
Information on the active substance
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Florasulam is a triazolopyrimidine herbicide (HRAC Group B) which acts by inhibiting acetolactate
synthesis (ALS inhibitor).
Label WMB is assigned to the product.
Preliminary range-finding tests
In the presented dRR the applicant did not provide details of preliminary range-finding tests as the
chemistry of the active ingredient is well understood.
Minimum effective dose
A number of the weed control trials included a range of doses of ‘CHA 5350’. Data were submitted on
individual weed species and also on ‘overall control’ of broad-leaved weeds from a range of situations
and doses.
The zonal RMS considers that the data are sufficient to address minimum effective dose. Member States
should, however, consider other target species in their locations on which to base their consideration of
the minimum effective dose and any existing knowledge of the active substance.
Requirement WH9161 is assigned to each of the uses.
Efficacy tests
Data were submitted from four situations:
Autumn application to winter cereals
Spring application to winter cereals
Spring application to spring cereals
Spring application to grass seed crops
ml/ha product
75
100-150
80-150
100
g as/ha
3.75
5.0-7.5
4.0-7.5
5.0
Data on autumn use in winter cereals are limited although on balance the zRMS considers that the data
are sufficient for authorisation of use in the autumn. 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 and the zRMS
does not consider these to be representative of the MS where authorisation is sought. Consequently use
006 was rated “negative” due to the insufficient data base.
Effects on yield and quality
No data regarding processing or transformation were submitted.
The applicant did not present a reasoned case based on the absence of residues in harvested grain (EPPO
PP 1/243 Effects of plant protection products on transformation processes) but did state that florasulam is
applied early in the season (up to BBCH 39; before inflorescence emergence and heading), and as the
active ingredient is not systemic it is unlikely to be transferred to the grain.
It is noted that florasulam is 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.
CHA 5350’ applied at the recommended rate or at twice that rate had no meaningful or consistent adverse
effect on either yield (t/ha) or quality of cereal grains. The trials were conducted across a wide range of
locations, including Maritime, South East and North East zones. Thus the trials are considered to be
representative of the area where authorization is sought.
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The data on seed yield of grass seed crops is very limited and yield reductions were seen in three of the
seven trials. For grass seed crops, the requirement to demonstrate safety to treated crops has therefore not
been adequately addressed in line with the Uniform Principles. Consequently use 006 was rated
“negative” due to the insufficient data base.
Adverse effects
Phytotoxicity to host crop
The trials were conducted across a wide range of locations, including Maritime, South East and North
East zones. Thus the trials are considered to be representative of the area where authorization is sought.
Cereals
No phytotoxicity was seen the vast majority of cereal trials. In the few trials where phytotoxicity was
seen it was maximum 2.5% at 100 ml/ha and maximum 5.5% at 200 ml/ha and symptoms were outgrown
in all cases with no yield reductions.
Crop vigour was assessed in some cereal trials (using a 1-10 scale where 10 is no reduction). Minor
reductions in crop vigour were seen in some trials (lowest score 9.0 but typically score >9.3) but the
effects were transient and recovery was complete.
Where adverse effects were seen from treatment with ‘CHA 5350’ they were fully comparable to the
standard florasulam product and crop recovery was complete.
The data are sufficient for authorisation of use of ‘CHA 5350’ in winter and spring wheat, winter and
spring barley, winter and spring oats, rye and triticale. It is noted that in some MS authorisation is being
requested in spelt and durum wheat. No case for extrapolation was provided by the applicant.
Grass seed crops
It is noted that all the grass trials were conducted in the Maritime zone (DK). No unacceptable
phytotoxicity was seen, but despite the absence of visible crop effects, reductions in yield of grass seed
were seen in trials on Poa and Festuca species. This is a matter of concern and for grass seed crops, the
requirement to demonstrate safety to treated crops has therefore not been adequately addressed in line
with the Uniform Principles. Consequently use 006 was rated “negative” due to the insufficient data base.
Adverse effects on beneficial organisms (other than bees)
On the basis of the results of laboratory tests using a comparable substance at the proposed maximum
application rate of 0.15 L/ha, Saracen can be considered as not harmful for the predatory mite
Typhlodromus pyri, the parasitoid wasp Aphidius rhopalosiphi and the ground beetle Poecilus cupreus.
On the basis of the results of an extended laboratory test, the test product can be classified as not harmful
for the lacewing Chrysoperla carnea. The results for these sensitive indicator species indicate that the test
product will not be harmful for other, relevant predatory mites and spiders or insects.
Labels NN1001 and NN1002 are assigned to the product.
Adverse effects on parts of plant used for propagating purposes
No meaningful reductions in germination of cereal seeds were seen. In two tests reductions were seen
following application of ‘CHA 5350’ at 150 ml/ha but not at double that dose. No restrictions on the use
of ‘CHA 5350’ 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, particularly as yield reductions were seen in some of the grass
trials.
Impact on succeeding crops
The applicant’s own BAD highlights a risk to succeeding crops but no data were submitted from specific
succeeding crop field trials to address this issue. Further consideration is therefore required.
Label warning WH960 is assigned to each of the uses.
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Page 24 of 27
Impact on other plants including adjacent crops
A risk to adjacent crops was identified from a screening study on 10 crop species. The most sensitive of
the tested crops was sugar beet with an ER50 for biomass of 0.019 g a.s./ha.
The label warning WP740 is considered appropriate.
Possible development of resistance or cross-resistance
The applicant provided a resistance risk assessment in line with EPPO PP1/213.
Florasulam is a triazolopyrimidine herbicide (HRAC Group B) which acts by inhibiting acetolactate
synthesis (ALS inhibitor). ALS herbicides have been widely used throughout Europe for over 30 years.
To date, worldwide, 126 different weed species, mostly dicotyledonous, have been reported as resistant
towards one or more HRAC group B herbicides (Heap, 2012). Resistance in a least one grass weed
species (ALOMY) has been reported in most MS in the EU Central zone but resistance has also been
reported in broad-leaved weeds (eg. STEME and PAPRH). Since all the ALS’s are active towards a
single target site, cross resistance is a well-known phenomenon in this group of chemicals. Due to the
length of time ALS herbicides have been in commercial use, no baseline sensitivity data were submitted.
However, data were submitted from Efficacy field trials conducted in 2011 and 2012 which provide an
indication of current sensitivity to this product of a range of weeds in a range of locations. Florasulam is
considered a high risk active for the development of resistance and an unrestricted use pattern is not
acceptable.
Consequently, requirement WH951is deemed appropriate.
3.2
Conclusions
With respect to identity, physical, chemical and technical properties, packaging and further information as
well as analytical methods (formulation and residues) an authorisation can be granted.
With respect to efficacy (IPM)/sustainable use incl. effects on honeybees an authorization can be granted,
except use No 006 which was rated “negative” due to an insufficient data base
With respect to toxicology, residues and consumer protection an authorisation can be granted.
With respect to fate and ecotoxicology assessment, authorisation can be granted.
The evaluation of the zRMS UK following the application 006 rated “negative” due to the insufficient
data base. Moreover, following the use of Saracen in crops for seed production of Poa and Festuca species
yield losses occurred. Unacceptable effects on the crop may thus not be ruled out.
Authorisation can be granted for the uses 001 – 004.
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
No further information required.
Applicant:
Cheminova
Date: 19/02/2015
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Appendix 1 – Copy of the product authorisation
See below.
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Cheminova
Date: 19/02/2015
Part A
National Assessment Federal Republic of Germany
CHA5350
Saracen
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Appendix 2 – Copy of the product label
The submitted draft product label has been checked by the competent authority. The applicant is
requested to amend the product label in accordance with the decisions made by the competent authority.
The final version of the label has to fulfil the requirements according to Article 16 of Directive
91/414/EEC.
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Date: 19/02/2015
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Appendix 3 – Letter of Access
Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
Applicant:
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Date: 19/02/2015
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig
Dr. Dietmar Gottschild
Referent
TELEFON +49 (0)531 299-3512
TELEFAX +49 (0)531 299-3002
E-MAIL dietmar.gottschild@bvl.bund.de
& Co. KG
Stader Elbstraße 26
21683 Stade
IHR ZEICHEN
IHRE NACHRICHT VOM
AKTENZEICHEN 200.22100.007767-00/00.74034
(bitte bei Antwort angeben)
DATUM 13. Februar 2015
ZV3 007767-00/00
Saracen
Zulassungsverfahren für Pflanzenschutzmittel
Bescheid
Das oben genannte Pflanzenschutzmittel
mit dem Wirkstoff:
50 g/l
Florasulam
Zulassungsnummer:
007767-00
Versuchsbezeichnungen:
CHD-05350-H-0-SC
Antrag vom:
19. Oktober 2012
wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen
Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates
(ABl. L 309 vom 24.11.2009, S. 1), wie folgt zugelassen:
Zulassungsende
BVL_FO_05_2437_200_V1.4
Die Zulassung endet am 31. Dezember 2016.
Festgesetzte Anwendungsgebiete bzw. Anwendungen
Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1):
Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de
SEITE 2 VON 21
Anwendungs-
Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck
nummer
Zweckbestimmung Objekte
007767-00/00-004 Einjährige zweikeim- Sommerweichweizen,
blättrige Unkräuter
Sommergerste, Sommerhafer
007767-00/00-001, Einjährige zweikeim- Winterweichweizen,
007767-00/00-002, blättrige Unkräuter
Wintergerste, Winter-
007767-00/00-003
roggen, Wintertriticale
Festgesetzte Anwendungsbestimmungen
Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum
Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I
S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 87 des Gesetzes vom 7. August 2013
(BGBl. I S. 3154) festgesetzt:
(NW468)
Anwendungsflüssigkeiten und deren Reste, Mittel und dessen Reste, entleerte Behältnisse
oder Packungen sowie Reinigungs- und Spülflüssigkeiten nicht in Gewässer gelangen lassen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe
sowie Regen- und Abwasserkanäle.
Begründung:
Aufgrund der Auswirkungen des Wirkstoffes Florasulam gegenüber aquatischen Organismen
(insbesondere Wasserpflanzen) besitzt das o.g. Pflanzenschutzmittel einen den Naturhaushalt schädigenden Charakter, so dass jeder weitergehende, d.h. den als Folge der sachgerechten und bestimmungsgemäßen Anwendung des Pflanzenschutzmittels "Saracen" übersteigende Eintrag von Rückständen in Gewässer zu einer erheblichen Gefährdung des
Naturhaushaltes führen würde. Angesichts der Umstände, dass ein erheblicher Anteil an
Pflanzenschutzmittelfrachten im einzelnen Gewässer auf Einträge aus kommunalen Kläranlagen zurückzuführen ist (vgl. Umweltpolitik - Wasserwirtschaft in Deutschland, 10.5.2 Pestizide, S. 156 ff., BMU, Februar 1998 und Fischer, Bach, Frede: Abschlussbericht zum DBUProjekt 09931, April 1998), ist es unverzichtbar, der Gefahr, die eine Verbringung von Pflanzenschutzmitteln in Gewässer mit sich bringt, durch die bußgeldbewehrte Anwendungsbestimmung im Sinne der Zweckbestimmung des Pflanzenschutzgesetzes durchsetzbar zu
begegnen.
BVL_FO_05_2437_200_V1.4
Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3.
SEITE 3 VON 21
Verpackungen
Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend
näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen:
Verpackungs-
Verpackungs-
Anzahl
Inhalt
art
material
von
bis
von
bis
Einheit
Flasche
Coex
1
10
100,00
3000,00
ml
Flasche
HDPE, fluoriert
1
10
100,00
3000,00
ml
Kanister
Coex
1
10
250,00
Kanister
Coex
1
4
0,50
Kanister
HDPE, fluoriert
1
10
250,00
Kanister
HDPE, fluoriert
1
4
0,50
ml
5,00
l
ml
5,00
l
Die Verpackungen für den beruflichen Anwender sind wie folgt zu kennzeichnen:
Anwendung nur durch berufliche Anwender zulässig.
Auflagen
Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden:
Kennzeichnungsauflagen:
(NW262)
Das Mittel ist giftig für Algen.
(NW265)
Das Mittel ist giftig für höhere Wasserpflanzen.
(SB001)
Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschäden führen.
(SB110)
Die Richtlinie für die Anforderungen an die persönliche Schutzausrüstung im Pflanzenschutz
"Persönliche Schutzausrüstung beim Umgang mit Pflanzenschutzmitteln" des Bundesamtes
für Verbraucherschutz und Lebensmittelsicherheit ist zu beachten.
BVL_FO_05_2437_200_V1.4
(SF245-01)
Behandelte Flächen/Kulturen erst nach dem Abtrocknen des Spritzbelages wieder betreten.
(SS110)
SEITE 4 VON 21
Universal-Schutzhandschuhe (Pflanzenschutz) tragen beim Umgang mit dem unverdünnten
Mittel.
(SS2101)
Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) tragen
beim Umgang mit dem unverdünnten Mittel.
(SS530)
Gesichtsschutz tragen beim Umgang mit dem unverdünnten Mittel.
(SS610)
Gummischürze tragen beim Umgang mit dem unverdünnten Mittel.
(WMB)
Wirkungsmechanismus (HRAC-Gruppe): B
Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2.
Sonstige Auflagen:
(WH951)
Auf der Verpackung und in der Gebrauchsanleitung ist auf das Resistenzrisiko hinzuweisen.
Insbesondere sind Maßnahmen für ein geeignetes Resistenzmanagement anzugeben.
Vorbehalt
Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder
Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.
Angaben zur Einstufung und Kennzeichnung gemäß § 4 Gefahrstoffverordnung
Gefahrensymbole:
N
Gefahrenbezeichnungen: Umweltgefährlich
Gefahrenhinweise (R-Sätze):
R 50/53: Sehr giftig für Wasserorganismen, kann in Gewässern längerfristig schädliche Wir-
BVL_FO_05_2437_200_V1.4
kungen haben.
Sicherheitshinweise (S-Sätze):
S 36/37 : Bei der Arbeit geeignete Schutzkleidung und Schutzhandschuhe tragen
SEITE 5 VON 21
S 2 : Darf nicht in die Hände von Kindern gelangen
S 24 : Berührung mit der Haut vermeiden
S 35 : Abfälle und Behälter müssen in gesicherter Weise beseitigt werden
S 46 : Bei Verschlucken sofort ärztlichen Rat einholen und Verpackung oder Etikett vorzeigen
S 57 : Zur Vermeidung einer Kontamination der Umwelt geeigneten Behälter verwenden
Enthält 1,2-Benzisothiazol-3(2H)-on. Kann allergische Reaktionen hervorrufen.
Zur Vermeidung von Risiken für Mensch und Umwelt ist die Gebrauchsanleitung einzuhalten.
Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG)
Nr. 1272/2008
Signalwort:
(S1)
Achtung
Gefahrenpiktogramme:
(GHS09)
Umwelt
Gefahrenhinweise (H-Sätze):
(EUH 208-0098)
Enthält 1,2-Benzisothiazol-3(2H)-on. Kann allergische Reaktionen hervorrufen.
(EUH 401)
Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.
(H400)
Sehr giftig für Wasserorganismen.
(H410)
Sehr giftig für Wasserorganismen mit langfristiger Wirkung.
BVL_FO_05_2437_200_V1.4
Sicherheitshinweise (P-Sätze):
- keine -
SEITE 6 VON 21
Abgelehnte Anwendungsgebiete bzw. Anwendungen
Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe
Anlage 2):
Anwendungs-
Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck
nummer
Zweckbestimmung Objekte
007767-00/00-006 Einjährige zweikeim- Gräser
blättrige Unkräuter
Hinweise
Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden:
(NB6641)
Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder
Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienengefährlich eingestuft (B4).
(NN1001)
Das Mittel wird als nicht schädigend für Populationen relevanter Nutzinsekten eingestuft.
(NN1002)
Das Mittel wird als nicht schädigend für Populationen relevanter Raubmilben und Spinnen
eingestuft.
Weitere Hinweise und Bemerkungen
Zu KIIIA1 6.2.8:
Hinweis und Begründung für die Kennzeichnungsauflage zum Wirkungsmechanismus
(WMB: Florasulam):
Die HRAC-Klassifizierung ist als neutrale Information direkt dem Wirkstoff zuzuordnen. Die
Kennzeichnung erleichtert der Praxis die Bestimmung des Wirkungsmechanismus von Herbiziden und ermöglicht so ein gezieltes Wirkstoffmanagement.
Zu der Fassung der Anwendungen
Das JKI ist zu dem Ergebnis gekommen, dass der Wasseraufwand in allen Anwendungen
(00/00-001 bis 00/00-004) an die in Deutschland praxisübliche Wasseraufwandmenge 200
bis 400 l/ha angepasst werden sollte (beantragt waren 150 - 300 l/ha). Dieser Änderung
BVL_FO_05_2437_200_V1.4
wurde mit Nachlieferung vom 21. Januar 2015 zugestimmt. Die Änderung wurde vorgenommen.
SEITE 7 VON 21
Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben,
soweit sie noch nicht erfüllt sind.
Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu
schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulassungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen.
Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid.
Rechtsbehelfsbelehrung
Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch
erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und
Lebensmittelsicherheit, Messeweg 11/12, 38104 Braunschweig, schriftlich oder zur
Niederschrift einzulegen.
Mit freundlichen Grüßen
im Auftrag
gez. Dr. Gerhard Joermann
Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.
BVL_FO_05_2437_200_V1.4
Anlage
SEITE 8 VON 21
Anlage 1 zugelassene Anwendung: 007767-00/00-001
1
Anwendungsgebiet
Schadorganismus/Zweckbestimmung: Einjährige zweikeimblättrige Unkräuter
Pflanzen/-erzeugnisse/Objekte:
Winterweichweizen, Wintergerste, Winterroggen,
Wintertriticale
Verwendungszweck:
2
Kennzeichnungsauflagen
2.1
Angaben zur sachgerechten Anwendung
Einsatzgebiet:
Ackerbau
Anwendungsbereich:
Freiland
Anwendung im Haus- und
Kleingartenbereich:
Nein
Stadium der Kultur:
13 bis 29
Anwendungszeitpunkt:
Herbst
Maximale Zahl der Behandlungen
- in dieser Anwendung:
1
- für die Kultur bzw. je Jahr:
1
Anwendungstechnik:
spritzen
Aufwand:
2.2
0,075 l/ha in 200 bis 400 l Wasser/ha
Sonstige Kennzeichnungsauflagen
(NW642-1)
Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstengewässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorgegebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können
mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.
BVL_FO_05_2437_200_V1.4
(WH9161)
In die Gebrauchsanleitung ist eine Zusammenstellung der Unkräuter aufzunehmen, die
durch die Anwendung des Mittels gut, weniger gut und nicht ausreichend bekämpft werden,
sowie eine Arten- und/oder Sortenliste der Kulturpflanzen, für die der vorgesehene Mittelaufwand verträglich oder unverträglich ist.
(WH960)
Auf der Verpackung und in der Gebrauchsanleitung ist auf das hohe Nachbaurisiko hinzuweisen. Insbesondere sind gefährdete Folgekulturen zu benennen und Möglichkeiten für das
Risikomanagement zu beschreiben.
(WP740)
SEITE 9 VON 21
Vorsicht bei benachbart wachsenden Kulturpflanzen, da Schäden möglich.
2.3
(F)
Freiland: Winterweichweizen
Die Wartezeit ist durch die Anwendungsbedingungen
und/oder die Vegetationszeit abgedeckt, die zwischen
Anwendung und Nutzung (z. B. Ernte) verbleibt bzw.
die Festsetzung einer Wartezeit in Tagen ist nicht
erforderlich.
(F)
Freiland: Wintergerste
erforderlich.
(F)
Freiland: Winterroggen
erforderlich.
(F)
Freiland: Wintertriticale
erforderlich.
(F)
Freiland: Winterhafer
erforderlich.
3
BVL_FO_05_2437_200_V1.4
Wartezeiten
Anwendungsbezogene Anwendungsbestimmungen
(NT109)
Bei der Anwendung des Mittels muss ein Abstand von mindestens 5 m zu angrenzenden Flächen (ausgenommen landwirtschaftlich oder gärtnerisch genutzte Flächen, Straßen, Wege
und Plätze) eingehalten werden. Zusätzlich muss die Anwendung in einer darauf folgenden
Breite von mindestens 20 m mit einem verlustmindernden Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S.
SEITE 10 VON 21
BVL_FO_05_2437_200_V1.4
9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 90 %
eingetragen ist. Bei der Anwendung des Mittels ist weder der Einsatz verlustmindernder
Technik noch die Einhaltung eines Abstandes von mindestens 5 m erforderlich, wenn die
Anwendung mit tragbaren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B.
Feldraine, Hecken, Gehölzinseln) weniger als 3 m breit sind. Bei der Anwendung des Mittels
ist ferner die Einhaltung eines Abstandes von mindestens 5 m nicht erforderlich, wenn die
Anwendung des Mittels in einem Gebiet erfolgt, das von der Biologischen Bundesanstalt im
"Verzeichnis der regionalisierten Kleinstrukturanteile" vom 7. Februar 2002 (Bundesanzeiger
Nr. 70a vom 13. April 2002) in der jeweils geltenden Fassung, als Agrarlandschaft mit einem
ausreichenden Anteil an Kleinstrukturen ausgewiesen worden ist oder angrenzende Flächen
(z. B. Feldraine, Hecken, Gehölzinseln) nachweislich auf landwirtschaftlich oder gärtnerisch
genutzten Flächen angelegt worden sind.
Begründung:
Das o.g. Pflanzenschutzmittel bzw. der darin enthaltene Wirkstoff Florasulam weist ein hohes
Gefährdungspotenzial für terrestrische Nichtzielpflanzen auf. Bewertungsbestimmend ist hier
die EC50 von 0,019 g a.i./ha für Beta vulgaris. Ausgehend von den geltenden Modellen zur
Abdrift und einem Sicherheitsfaktor von 5 ist nach dem Stand der wissenschaftlichen
Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausreichenden Schutz
von terrestrischen Nichtzielpflanzen in Saumbiotopen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen.
SEITE 11 VON 21
1
Anwendungsgebiet
Wintertriticale
Verwendungszweck:
2
2.1
Einsatzgebiet:
Ackerbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
13 bis 29
Frühjahr
1
1
Anwendungstechnik:
spritzen
Aufwand:
2.2
(NW642-1)
BVL_FO_05_2437_200_V1.4
(WH9161)
(WH960)
(WP740)
SEITE 12 VON 21
2.3
(F)
erforderlich.
(F)
erforderlich.
(F)
erforderlich.
(F)
erforderlich.
(F)
erforderlich.
3
BVL_FO_05_2437_200_V1.4
Wartezeiten
(NT109)
SEITE 13 VON 21
BVL_FO_05_2437_200_V1.4
Begründung:
SEITE 14 VON 21
1
Anwendungsgebiet
Wintertriticale
Verwendungszweck:
2
2.1
Einsatzgebiet:
Ackerbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
30 bis 39
Frühjahr
1
1
Anwendungstechnik:
spritzen
Aufwand:
2.2
(NW642-1)
BVL_FO_05_2437_200_V1.4
(WH9161)
(WH960)
(WP740)
SEITE 15 VON 21
2.3
(F)
erforderlich.
(F)
erforderlich.
(F)
erforderlich.
(F)
erforderlich.
(F)
erforderlich.
3
BVL_FO_05_2437_200_V1.4
Wartezeiten
(NT109)
SEITE 16 VON 21
BVL_FO_05_2437_200_V1.4
Begründung:
SEITE 17 VON 21
1
Anwendungsgebiet
Sommerweichweizen, Sommergerste, Sommerhafer
Verwendungszweck:
2
2.1
Einsatzgebiet:
Ackerbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Stadium der Kultur:
13 bis 29
Frühjahr
1
1
Anwendungstechnik:
spritzen
Aufwand:
2.2
(NW642-1)
(WH9161)
BVL_FO_05_2437_200_V1.4
(WH960)
(WP740)
SEITE 18 VON 21
2.3
(F)
Freiland: Sommerweichweizen
erforderlich.
(F)
Freiland: Sommergerste
erforderlich.
(F)
Freiland: Sommerhafer
erforderlich.
3
BVL_FO_05_2437_200_V1.4
Wartezeiten
(NT109)
Begründung:
SEITE 19 VON 21
BVL_FO_05_2437_200_V1.4
SEITE 20 VON 21
Anlage 2 nicht zugelassene Anwendung: 007767-00/00-006
1
Anwendungsgebiet
Gräser
Verwendungszweck:
2
Einsatzgebiet:
Ackerbau
Anwendungsbereich:
Freiland
Kleingartenbereich:
Nein
Erläuterung zur Kultur:
In Beständen zur Saatguterzeugung
Stadium der Kultur:
13 bis 32
Frühjahr
1
1
Anwendungstechnik:
spritzen
Aufwand:
-
BVL_FO_05_2437_200_V1.4
3
Begründung
Wirksamkeit
Die Anwendung 00/00-006 wurde aufgrund einer unzureichenden Datengrundlage negativ
bewertet. Folgende Unterlagen fehlen:
Gemäß VERORDNUNG (EU) Nr. 284/2013 Teil A Abschnitt 6 sind u.a. zu Punkt 6.2 Wirksamkeitsversuche sowie zu Punkt 6.4 Untersuchungen bzgl. der möglichen schädlichen Auswirkungen auf behandelte Kulturen vorzulegen. Versuchskonzeption, -analyse, -verhalten
und -berichte müssen den vorhandenen spezifischen Leitlinien der Europäischen und Mediterranen Pflanzenschutzorganisation (EPPO) entsprechen.
Punkt 6.2 Wirksamkeitstests
EPPO Leitlinie PP 1/214 definiert die Anforderungen zum Beleg der hinreichenden Wirksamkeit wie folgt: Die Studien sollen an Standorten durchgeführt werden, die die Bereiche der
Landwirtschaft, des Pflanzenschutzes und die Umweltbedingungen (einschließlich der klimatischen Bedingungen), die bei den vorgeschlagenen Anwendungen des Mittels wahrscheinlich sind, widerspiegeln. EPPO Leitlinie PP 1/226 (2) beziffert die Anzahl der einzureichenden
Wirksamkeitsstudien in einem Gebiet, in dem ähnliche Bedingungen vorliegen, mit 10
(Spanne 6-15).
Laut zRMS ist die Anzahl der Studien, die eine hinreichende Wirksamkeit für die Bekämpfung von Zweikeimblättrigen Unkräutern im Frühjahr in Gräsern unzureichend. Zudem
bewertet der zRMS diese als nicht repräsentativ für die MS in denen eine Zulassung bean-
SEITE 21 VON 21
BVL_FO_05_2437_200_V1.4
tragt wurde.
Punkt 6.4 Kulturpflanzenverträglichkeit
Untersuchungen zur Kulturpflanzenverträglichkeit sind gemäß EPPO Leitlinie PP 1/135
durchzuführen. Laut EPPO Leitlinie PP 1/226 (2) sind regelmäßig mindestens acht Versuche
je Kultur durchzuführen, die die Bereiche der Landwirtschaft, des Pflanzenschutzes und die
Umweltbedingungen (einschließlich der klimatischen Bedingungen), die bei den vorgeschlagenen Anwendungen des Mittels wahrscheinlich sind, widerspiegeln.
Aufgrund der Bewertung durch den zRMS sind die Daten zum Ertrag von Grassamen unzureichend und Minderungen wurden in drei von sieben Studien beobachtet. So traten nach
der Anwendung des Mittels in Vermehrungsbeständen von Poa- und Festuca-Arten trotz ausbleibender visueller phytotoxischer Effekte Ertragsverluste auf. Unvertretbare Auswirkungen
auf die Kulturpflanze können somit nicht ausgeschlossen werden. Es wurden außerdem
keine Daten zur Wirkung des Mittels auf die Keimung von Grassamen eingereicht.
Part B – Section 5
National Addendum– Germany
Saracen (CHA 5350)
Registration Report
Central Zone
zRMS: UK
Page 1 of 38
REGISTRATION REPORT
Part B
Section 5 Environmental Fate
Detailed summary of the risk assessment
Product code:
Saracen (CHA 5350)
Active Substance(s): 50 g/L Florasulam
Central Zone
NATIONAL ADDENDUM – Germany
Applicant: Cheminova A/S
Date:
August 2014
Evaluator: Germany
August 2014
Saracen (CHA 5350)
Registration Report
Central Zone
zRMS: UK
Page 2 of 38
Table of Contents
TABLE OF CONTENTS .......................................................................................................................................2
SEC 5
FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ........................................3
5.1
GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3
5.2
PROPOSED USE PATTERN ........................................................................................................................ 3
5.3
INFORMATION ON THE ACTIVE SUBSTANCES........................................................................................... 4
5.3.1 Florasulam ......................................................................................................................................... 4
5.4
SUMMARY ON INPUT PARAMETER FOR ENVIRONMENTAL EXPOSURE ASSESSMENT - FLORASULAM ........ 8
5.4.1 Rate of degradation in soil................................................................................................................. 8
5.4.2 Adsorption/desorption ..................................................................................................................... 14
5.4.3 Rate of degradation in water and sediment ..................................................................................... 20
5.5
ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4) ...................................................................... 22
5.6
ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) .......................... 23
5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition ........................ 24
5.6.2 PECSW after exposure by surface run-off and drainage ................................................................... 25
5.7
RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6)........................................................................... 30
5.7.1 Direct leaching into groundwater .................................................................................................... 30
5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and
drainage ........................................................................................................................................................ 35
APPENDIX 1
LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION .......................... 37
APPENDIX 2
DETAILED EVALUATION OF STUDIES RELIED UPON .............................................. 38
KIIA 7
FATE AND BEHAVIOUR IN THE ENVIRONMENT – FLORASULAM ........................................................ 38
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Sec 5
FATE AND BEHAVIOUR IN THE ENVIRONMENT
(KIIIA 9)
The exposure assessment of the plant protection product Saracen (CHA 5350) in its intended uses in
winter and spring cereals is documented in detail in the core assessment, part B, section 5 of the plant
protection product Saracen (CHA 5350) dated from October 2012 performed by UK.
This document comprises the risk assessment for groundwater and the exposure assessment of surface
water and soil for authorization of the plant protection product Saracen (CHA 5350) in Germany
according to uses listed in Appendix 3.
Regarding PECgw relevant risk mitigation measures, if necessary, are documented in this document.
PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary
(see National addendum Germany, part B, section 6 and part A).
5.1
General Information on the formulation
Table 5.1-1:
General information on the formulation Saracen (CHA 5350)
Code
CHA 5350
plant protection product
Saracen
applicant
Cheminova A/S
date of application
Formulation type
(WP, EC, SC, …; density)
SC
active substances (as)
florasulam
Concentration of as (g L-1)
50
5.2
Proposed use pattern
The intended uses in Germany classified according the soil effective application rate (cumulative,
disregarding degradation in soil) is presented in Table 5.2-1.
The intended uses in Germany (use No. 00-001 to 00-013) are covered by the core assessment
(December 2013), part B, section 5 by zRMS Austria performed by Austria.
Table 5.2-1: Classification of intended uses in Germany for Saracen (CHA 5350)
Group/
Use No.
Crop/
growth stage
A
Winter cereals
00-001
Application
method,
Drift scenario
Number of
applications,
application time,
interception
spraying, arable 1 x,
farming
autumn application,
winter wheat, winter
15th of november,
barley, winter rye,
25 % (BBCH 13)
winter triticale
Application
rate,
cumulative
(g as/ha)
Soil effective
application
rate
(g as/ha)
florasulam:
3.75 g as/ha
florasulam:
2.8125 g as/ha
BBCH 13-29
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00-002
farming
spring application,
6th of april,
barley, winter rye,
50 % (BBCH 29)
winter triticale
Winter cereals
florasulam:
5.0 g as/ha
florasulam:
2.5 g as/ha
florasulam:
7.5 g as/ha
florasulam:
2.25 g as/ha
BBCH 13-29
00-003
farming
spring application,
27th of april,
barley, winter rye,
70 % (BBCH 35)
winter triticale
Winter cereals
BBCH 30-39
B
00-006
Grass
farming
spring application,
27th of april,
90 %
florasulam:
5.0 g as/ha
florasulam:
0.5 g as/ha
00-004
Spring cereals
farming
spring application,
6th of april,
25 % (BBCH 13)
florasulam:
5.0 g as/ha
florasulam:
3.75 g as/ha
farming
spring application,
6th of april,
25 % (BBCH 13)
florasulam:
5.0 g as/ha
florasulam:
3.75 g as/ha
spring wheat, spring
barley, spring oats
BBCH 13-29
00-005
Spring cereals
spelt
BBCH 13-32
5.3
Information on the active substances
5.3.1
Florasulam
5.3.1.1
Identity, further information of florasulam
Table 5.3-1:
Identity, further information on florasulam
Active substance (ISO common name)
florasulam
IUPAC
2’,6’,8’-Trifluor-5-methoxy-[1,2,4]-triazolo[1,5-c]pyrimidin-2sulfonanilid
Function (e.g. fungicide)
herbicide
Status under Reg. (EC) No 1107/2009
approved
Date of approval
01/10/2002
Conditions of approval
Only uses as herbicide may be authorised.
For the implementation of the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions
of the review report on florasulam, and in particular Appendices I
and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health on 19 April 2002 shall be taken into
account. In this overall assessment Member States:
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should pay particular attention to the potential for ground water
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.
Confirmatory data
None
RMS
Belgium
Minimum purity of the active substance
as manufactured (g/kg)
970
Molecular formula
C12H8F3N5O3S
Molecular mass
359.3
Structural formula
MeO
N
N N
F
NH
SO 2
N
F
F
5.3.1.2
Physical and chemical properties of florasulam
Physical and chemical properties of florasulam as agreed at EU level (see SANCO/1406/2001-final) and
considered relevant for the exposure assessment are listed in Table 5.3-2.
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Table 5.3-2:
EU agreed physical chemical properties of florasulam relevant for exposure
assessment
Vapour pressure (at 20 °C) (Pa)
Value
Reference
1 x 10-5 Pa at 25°C
Appendix 1 (LoEP) of
SANCO/1406/2001
extrapolated from ZRMS
1 x 10-6 Pa at 20°C
Henry’s law constant (Pa × m³ × mol-1)
3.29 x 10-5 Pa. m3/mol (pH 5)
at 20°C
4.35 x 10-7 Pa. m3/mol (pH 7)
at 20°C
2.94 x 10-8 Pa. m3/mol (pH 9)
at 20°C
SANCO/1406/2001
Solubility in water (at 25 °C in mg/L)
solubility in:
purified water (pH 5.6-5.8) :
0.121 g/L
pH 5.0 buffer : 0.084 g/L
SANCO/1406/2001
Partition co-efficient (at 25 °), log POW
pH 4.0: log Pow = 1.00
pH 7.0: log Pow = -1.22
pH 10.0: log Pow = -2.06
SANCO/1406/2001
Dissociation constant, pKa
pKa = 4.54 (determined at 2223°C)
SANCO/1406/2001
Hydrolytic degradation
50°C: pH 4 and 7: less than 5% Appendix 1 (LoEP) of
degradation after 7d
SANCO/1406/2001
50°C: pH 9: k = 0.378 d-1; t 1/2 =
2 d (triazole-label)
25°C: pH 5: no degradation
observed after 30 d
25°C: pH 7: no degradation
observed after 30 d
25°C: pH 9: k = 0.00692 d-1; t1/2
= 100 d (phenyllabel)
k = 0.00706 d-1; t 1/2 = 98 d
(triazole-label)
Direct photolysis in water
pH 5, 25 °C, natural sunlight
40°N, June and May;
t1/2 = 88-223 d
SANCO/1406/2001
Quantum yield of direct phototransformation
in water > 290 nm
Φ = 0.074
SANCO/1406/2001
Photochemical oxidative degradation in air
(calculation according to Atkinson)
DT50 =1.82 d
k = 70.4 x 10-12 cm3 s-1
(1.5 × 106 radicals/cm³, 12 h
day)
SANCO/1406/2001
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5.3.1.3
Metabolites of florasulam
Environmental occurring metabolites of florasulam requiring further assessment according to the results
of the assessment of florasulam for EU approval are summarized in Table 5.3-3.
No new study on the fate and behaviour of florasulam or Saracen has been performed. Hence no
potentially new metabolites need to be considered.
The risk assessment for the soil metabolites 5-OH-XDE-570, DFP-ASTCA, ASTCA, and TSA of
florasulam has already been performed for EU approval (see SANCO/1406/2001-final). Therefore no
new risk assessment hence no exposure assessment for these metabolites is necessary.
Potential ground water contamination by the soil metabolites 5-OH-XDE-570, DFP-ASTCA, and
ASTCA was evaluated for EU approval of florasulam. PECgw modelled with FOCUS PELMO (version
3.0) was less than 0.1 µg/L for the metabolites 5-OH-XDE-570 and DFP-ASTCA and higher than 0.1
µg/L for the metabolite ASTCA in scenario Hamburg based on an application of 7.5 g as/ha (50 % crop
interception) in winter wheat on 15th April.
However, the leaching potential into groundwater of the soil metabolites 5-OH-XDE-570, DFPASTCA, ASTCA, and TSA will be assessed for the application of the plant protection product and its
intended uses.
Table 5.3-3:
Metabolites of florasulam potentially relevant for exposure assessment
(> 10 % of as or > 5 % of as in 2 sequential measurements or > 5 % of as and
maximum of formation not yet reached at the end of the study)
Metabolite
Structural formula/
Molecular formula
XDE-570 5hydroxy,
N-(2,6difluorophenyl)-8fluoro-5-hydroxyl
(1,2,4)
triazolo(1,5c)
pyrimidine-2sulphonamide
O
N S
O
N N
N
N
F
F
M = 345.26 g/mol
Status of Relevance
(SANCO/1406/2001-final,
18 September 2002)
Soil, aerob:
max. 71.6 % at d 3
Water:
max. 64 % at d 60
Sediment:
max. 35 % at d 60
(Soil photolysis: 60 %)
Aquatic organism:
Water: not relevant
Sediment: not relevant
Terrestrial organism: not
assessed
Groundwater: not relevant
(Step 2)1)
DFP-ASTCA
M3
F
N-(2,6difluorophenyl)-5aminosulphonyl1H-1,2,4)triazole3-carboxylic acid
F
ASTCA
M4
OH
F
5-OH-XDE-570
occurrence in
compartments
(Max. at day/ 2 x > 5 %)
H
N
O
N S
H
O
N
N
COOH
M = 304.20 g/mol
Soil, aerob:
max. 17.8 % at d 28
Water:
max. 15 % at d 100
Sediment:
max. 9.15 % at d 182
Aquatic organism:
Water: not assessed
Sediment: not assessed
assessed
(Step 2)1)
O
H2N S
O
H
N
N
Soil, aerob:
max. 40.0 % at d 59
N
COOH
Aquatic organism:
Water: not assessed
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5(aminosulphonyl)1H-1,2,4-triazole3-carboxylic acid
(Step 3-4)1)
O
H2N S
O
TSA
M6
1H-1,2,4-triazole3-sulphonamide
assessed
M = 192.13 g/mol
N
NH
Soil, aerob:
max. 15.9 % at d 100
Aquatic organism:
Water: not assessed
N
M = 148.14 g/mol
assessed
Groundwater: not assessed
According to Guidance Document on the assessment of the relevance of metabolites in groundwater of
substances regulated under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February 2003)
1)
5.4
Summary on input parameter for environmental exposure assessment Florasulam
5.4.1
Rate of degradation in soil
5.4.1.1
Laboratory studies
Florasulam
No new studies have been submitted regarding route and rate of degradation in soil of Florasulam and
its soil metabolites 5-OH-XDE-570, DFP-ASTCA, and ASTCA. However, a new study containing reevalulations of the degradation kinetics of florasulam for the study Jackson and Gosh, 1997 already
evaluated in the EU assessment together with temperature and moisture normalizations for the
recalculated DT50 values has been submitted (Jackson, 2010). The study was evaluated by the RMS in
the new DRAR submitted for renewal of EU approval, where the study summary can be found. The
study was considered only partly acceptable by the RMS and a new kinetic evaluation was performed
according to FOCUS guidance (2006). The recalculated and/or normalized DT50 and DT90 values for
florasulam are summarized in Table 5.4-1. The recalculated and/or normalized DT50 and DT90 values
for 5-OH-XDE-570, DFP-ASTCA, and ASTCA are presented in Table 5.4-2, Table 5.4-3 and Table
5.4-4. A new study (Simmonds, 2012) on the soil degradation of the florasulam soil metabolite TSA has
been submitted for renewal of EU approval and is summarized in the new DRAR for Florasulam. The
DT50 and DT90 values for TSA are summarized and Table 5.4-5.
The DT50 values of Florasulam and its soil metabolites 5-OH-XDE-570, DFP-ASTCA, ASTCA and
TSA listed in the core assessment, part B, section 5, point 5.4.1 were analyzed according to Holdt et al.
2011 (Holdt et al: Recommendations for simulations to predict environmental concentrations of active
substances of plant protection products and their metabolites in groundwater (PECGW) in the national
assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011). The recommendations of
the Excel tool Input Decision 3.3 are used for the national groundwater assessment.
The degradation of Florasulam in soil is not pH-dependent and the coefficient of variation is ≤ 100 %.
Thus, the geometric mean of all DT50 values can be used for groundwater risk assessment.
The degradation of the metabolites 5-OH-XDE-570, DFP-ASTCA and TSA in soil is not pH-dependent
and the coefficient of variations are ≤ 100 %. Thus, the geometric mean of all DT50 values can be used
for groundwater risk assessment.
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Table 5.4-1:
Summary of aerobic degradation rates for Florasulam - laboratory studies
Soil type
Andover, silt
loam
pH
T
moisture
o
(H2O)
( C)
7.6
20
40 %
MWHC
(d)
DT90
(d)
1.01
3.94
-
0.91
-
0.82
DT50
DT50 (d)
20 °C
pF2/10kPa
Method of Reference
calculation
DFOP, chi2: Jackson &
2.07%
Gosh (1997),
DRAR
DFOP, fast
(2013)
phase
Marcham
8.0
20
sandy clay loam
1.92
16.59
-
DFOP,
chi2: 5.64%
8.27
-
6.94
DFOP, slow
phase
SFO; chi2:
4.94%
Kenslow, humus 6.3
silt loam
20
40 %
MWHC
0.57
1.88
0.57
Speyer 2.2,
7.7
loamy sand, TPlabelled
20
40 %
MWHC
0.46
5.68
2.29
Speyer 2.2,
loamy sand,
Phenyl- labelled
7.7
20
40 %
MWHC
0.72
5.12
2.21
Marcham, Sandy 8.8
clay loam
25
40 %
MWHC
1.16
13.38
-
0.92
-
1.38
Cuckney, sand
8.0
Aggregated DT50 (n=6)
*
40 %
MWHC
2.25
*
DFOP, chi2:
4.84%
DFOP, chi2:
4.39%
2.43
*
DFOP, chi2: Pillar,
15.74%
(1997a),
DRAR
DFOP, fast
(2013)
phase
SFO, chi2:
12.78%
Pillar,
(1997b),
DRAR
(2013)
SFO, chi2:
12.78
Pillar,
(1997a),
DRAR
(2013)
2.86
SFO, chi2:
15.28
Pillar,
(1997b),
DRAR
(2013)
Coefficient of variation (%)
85
Geomean (d)
2.0
90th percentile (d)
5.2
No pH-dependency of
degradation according to
non-parametrical Kendall
test
20
pF2
4.29
14.24
4.29
25
40 %
MWHC
4.29
14.24
4.29
20
pF2
2.86
9.49
3.39
*
geomean
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Table 5.4-2
Soil type
Summary of aerobic degradation rates for metabolite 5-OH-XDE-570 laboratory studies
pH
T
o
(H2O) ( C)
Moisture
DT50/
DT90
f.f.
DT50 (d)
20 °C
pF2/10kPa
(d)
Andover,
7.9
20
silt loam
Marcham,
MWHC
8.0
20
sandy clay
loam
Kenslow,
40 %
MWHC
6.3
20
humous silt
loam
Speyer 2.2,
loamy sand,
TP-labelled
40 %
40 %
MWHC
7.7
20
40 %
MWHC
Speyer 2.2,
loamy sand,
phenyl-labelled
Marcham,
sandy clay
loam
Cuckney,
6.99/
23.22
0.786
6.27
DFOPSFO, chi2:
5.34%
14.73/ 0.795
48.93
12.36
DFOPSFO, chi2:
10.85
18.03/ 0.871
59.89
18.03
SFO- SFO,
chi2: 9.18%
13.72/ 0.902
45.58
0.92
**
13.12/ 0.939
43.58
7.6
8.0
25
40 %
MWHC
11.59/ 0.885
38.49
20
FC
14.24 / 1.000
98.63
25
40 %
MWHC
12.97/ 0.933
43.09
20
pF2 (=
0.05
bar)
24.77/ 1.000
82.30
13.7
2
13.4
2*
13.1
2
0.94
**
17.8
9
Jackson &
Gosh (1997),
DRAR
(2013)
DFOPSFO, chi2:
10.4%
DFOPSFO, chi2:
7.05%
SFO- SFO,
chi2:
18.37%
Pillar,
(1997a),
DRAR
(2013)
SFO- SFO,
chi2:
14.62%
Pillar,
(1997b),
DRAR
(2013)
SFO- SFO,
chi2: 16.52
Pillar,
(1997a),
DRAR
(2013)
24.7
7
SFO- SFO,
chi2:
21.07%
Pillar,
(1997b),
DRAR
(2013)
33
Geomean (d)
13.4
90th percentile
18.7
No pH-dependency of
test
sand
Aggregated DT50 (n =
6)
Kinetic, Fit Reference
15.9
6*
14.2
4
0.97
**
15.0
2
19.2
9*
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Formation Fraction
ai → 5-OH-XDE-570
(n = 6)
0.88
Arithmetic mean
* geomean
** arithmetic mean
Table 5.4-3
Soil type
Summary of aerobic degradation rates for metabolite DFP-ASTCA - laboratory
studies
pH
T
o
(H2O) ( C)
Moistur DT50/
e
DT90
f.f.**
DT50 (d)
20 °C
pF2/10kPa
(d)
Andover, silt
loam,
treated with
TP-labelled
XDE-570
7.6
Marcham,
sandy clay
loam,
treated with
TP-labelled
XDE-570
8.0
Kenslow,
humus silt
loam, treated
with TPlabelled XDE570
6.3
Speyer 2.2,
loamy sand,
treated with
TP-labelled
XDE-570
7.7
20
40 %
MWHC
20
40 %
MWHC
20
40 %
MWHC
20
40 %
MWHC
Speyer 2.2,
loamy sand,
treated with
phenyl-labelled
XDE-570
Cuckney, sand, 7.2
treated with
TP- labelled
DFP-ASTCA
20
40 %
MWHC
(2.46/ 0.743
8.18)*
-
DFOPSFO , chi2:
46.33%
(4.29/ 0.851
14.24)
*
-
DFOPSFO , chi2:
30.91%
(2.71/ 0.777
9.00)*
-
SFO- SFO ,
chi2:
32.03%
37.33
DFOPSFO , chi2:
11.9%
61.89/ 0.36
205.59 9
61.89
SFO-SFO,
chi2: 9.89
15.82/ n.a.
52.55
15.27
SFO, chi2:
9.95%
37.33/ 0.43
124.01 9
0.404
***
Jackson &
Gosh (1997),
DRAR
(2013)
Jackson and
Massart,
(1998),
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Marcham,
sandy clay
loam, treated
with TPlabelled DFPASTCA
7.9
Aggregated DT50 (n = 3)
Formation Fraction 5OH-XDE-570 → DFPASTCA (n = 4)
*
**
***
SFO, chi2:
7.51%
89
Geomean (d)
13.4
90th percentile
32.9
No pH-dependency of
test
Arithmetic mean
0.69
40 %
MWHC
4.23/
14.06
n.a.
no statistically reliable fit could be obtained
formation fractiion from 5-OH-XDE-570 to DFP-ASTCA
arithmetic mean
Table 5.4-4
Soil type
Summary of aerobic degradation rates for metabolite ASTCA - laboratory
studies
pH
T
Moisture
o
(H2O) ( C)
DT50/
DT90
f.f.**
Cuckney, Sand, 7.2
treated with
DFP-ASTCA
20
40%
MWHC
Cuckney, Sand,
treated with
ASTCA
Marcham,
sandy clay
loam, treated
with DFPASTCA
7.9
20
40%
MWHC
Marcham,
sandy clay
loam, treated
with ASTCA
Aggregated DT50 (n = 2)
Maximum
Formation Fraction
Maximum
DFP-ASTCA → ASTCA
(n = 2)
DT50 (d)
20 °C
pF2/10kPa
(d)
*
DRAR
(2013)
4.23
20
(170.7/
567)
0.571
-*
SFO, chi2:
18.84%
268.5/
892
-
259
SFO, chi2:
Jackson and
Massart
(1998),
DRAR
(2013)
4.25%
214/ 711 0.781
214
254
SFO, chi2:
***
4.40%
158.5/
863
-
-
DFOP,
chi2:
2.19%
301.4
-
301.4
DFOP, slow
phase
259
0.781
the fit after direct application of ASTCA is more robust, thus only the formation fraction after direct application
of DFP-ASTCA was used
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**
***
Formation Fraction from DFP-ASTCA to ASTCA
geomean
Table 5.4-5
Soil type
Summary of aerobic degradation rates for metabolite TSA - laboratory studies
pH
Calke, Sandy 5.9
Loam
S-Witham,
Clay Loam
7.6
T
DT90
DT50 (d)
(oC)
Moistur DT50
e
(d)
(d)
20 °C
pF2/10kP
a
20
pF2-2.5
8.1
166.9
78.77
20
pF2-2.5
10.6
Fit,
Kinetic
Reference
-
DFOP,
chi2: 2.2
Simmonds (2012)/
DRAR (2013)
-
71.44
DFOP,
slow
phase
155.3
-
101.93 -
Lufa 5M,
Sandy Loam
7.7
20
pF2-2.5
230
765
RefeSol 06A, Clay
Loam
7.6
20
pF2-2.5
24.87
622.9
6
187.64 -
Aggregated DT50 (n =
Geomean (d)
4)
90th percentile
94.39
DFOP,
slow
phase
172
SFO, chi2:
4.4
-
FOMC,
chi2: 1.99
172.44
41
118.9
No pH-dependency of degradation
according to non-parametrical
Kendall test
172.2
Formation Fraction
ASTCA→ TSA
Default
1.0
Formation Fraction
DFP-ASTCA→ TSA
Calculated by the difference of
1.000 – the mean ff value for the
formation of ASTCA from DFPASTCA (0.781)
0.219
5.4.1.2
DFOP,
chi2: 2.1
Field studies
Florasulam
No new studies have been submitted on the soil degradation of florasulam and its metabolite 5-OHXDE-570 under field conditions. However, a new kinetic evaluation according to FOCUS guidance
(2006) of the field studies with FLorasulam was performed in the DRAR of Florasulam submitted for
renewal of EU assessment. The recalculated DT50 and DT90 values for florasulam are summarized in
Table 5.4-6.
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Table 5.4-6:
Field degradation studies of Florasulam
depth
(cm)
DT50
(d)
DT90
(d)
Fit, Kinetic
DT50 Fit,
(d)
Kinetic
20 °C,
pF2
Reference
silty clay loam , 7.4
Tours, NorthFrance
0-50
12.20
40.54
SFO, chi2:
30.88
-
-
Maycock
(1997a–f)/
DRAR (2013)
silty loam ,
Wetterfeld,
Germany
6.1
0-50
17.66
58.67
SFO, chi2:
20.42%
-
-
sandy clay loam 7.7
, Marcham, UK
0-50
16.25
53.99
SFO, chi2:
26.42
-
-
Sand, Elvedon,
UK
7.6
0-50
25.48
84.65
SFO, chi2:
17.03
-
-
clay loam, St.
Livrade, SouthFrance
8.2
0-50
8.93
29.68
SFO, chi2:
23.06
-
-
sandy silt loam , 8.5
Valtohori,
Greece
0-50
5.84
19.41
SFO, chi2:
19.56
-
-
soil / location
5.4.2
pH
Adsorption/desorption
Florasulam
New studies on the adsorption of florasulam and its soil metabolites 5-OH-XDE-570, DFP-ASTCA,
ASTCA, and TSA have been submitted for the renewal of the EU approval of florasulam. The studies
are summarized in the new DRAR of florasulam from July 2013. The Kfoc values of the new studies
together with those values from the previous EU assessment are summarized in Table 5.4-7, Table 5.4-9,
Table 5.4-11, Table 5.4-13 and Table 5.4-15.
The Kfoc values of florasulam and of its soil metabolites were analyzed according to Holdt et al. 2011
(Holdt et al: Recommendations for simulations to predict environmental concentrations of active
substances of plant protection products and their metabolites in groundwater (PECGW) in the National
assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011).
Table 5.4-7
Kf, Kfoc and 1/n (Freundlich exponent) values for Florasulam
Soil Type
OC
(%)
pH
(-)
Kf
(mL g-1)
Kfoc
(mL g-1)
1/n
(-)
Reference
Catlin, Silty clay loam
2.2
7.0
0.89
40.45
0.88
Ostrander,
1996
Hanford, Sandy loam
1.0
7.4
0.22
22
0.86
Pewamo, clay
2.4
5.7
1.88
78.33
0.92
Fuquay, sand
0.64
4.7
0.35
54.69
1.00
Kenslow, Silt loam
6.8
6.1
1.47
21.62
0.94
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Speyer, Sandy loam
3.9
7.3
0.13
3.33
0.95
Calke, Sandy Loam
3.6
5.9
0.30
8.3
0.949
S-Witham, Clay Loam
3.8
7.6
0.10
2.7
0.983
Longwoods, Sandy Loam
1.5
7.7
0.03
1.7
0.885
Kenslow, Loam
3.8
5.3
0.47
12.3
0.914
Lufa 6S, Clay
1.8
7.3
0.04
2.5
1.041
Lufa 5M, Sandy Loam
1.0
7.7
0.03
2.6
0.947
RefeSol 06-A, Clay Loam
1.9
7.6
0.08
4.2
0.938
RefeSol 01-A, Sandy Loam
1.0
6.0
0.30
29.9
1.018
Arithmetic mean (n=14)
20.37
0.945
10th percentile
2
-
Arithm. mean (pH ≥7)
2.7
0.936
Arithm. mean (pH <7)
16.8
0.957
Simmonds,
2011 a
For the dissociating active substance florasulam a significant correlation was found between the Kfoc
values and pH of the soils (n=14). Since no realistic results could be obtained when using the pH-tool
implemted in FOCUS PELMO 5.5.3, the arithmetic mean of the Kfoc values and the Freundlich
exponents of the soils with pH<7 was used together with the scenario Hamburg and the arithmetic mean
of the Kfoc values and the Freundlich exponents of the soils with pH≥7. The results are summarized in
Table 5.4-8.
Table 5.4-8:
Statistic values according to INPUT DECISION 3.3 for Florasulam for PECGW
modelling
Does the active substance dissociate ?
yes, pKs = 4.54
correlation Kfoc and pH
Kendall-τ: -0.421
p-value: 0.046
positiv significant
correlation Kf and pH
Kendall-τ: -0.529
p-value: 0.012
negativ significant (expected for acid)
correlation Kf and oc
Kendall-τ: 0.261
p-value: 0.112
not positive significant
(p-Wert > significance level)
coefficient of variation Kfoc
117 %
not relevant
coefficient of variation Kf
127 %
not relevant
use pH-Tool
correlation Kf and other soil parameters (clay, CEC)
not relevant
Kfoc for PECGW
Arithmetic mean of Kfoc in acidic and
alkaline soils
At pH ≥7: 2.7
At pH<7: 16.8
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1/n PECgw
At pH ≥7: 0.936
At pH<7:0.957
Arithmetic mean of 1/n values in acidic
and alkaline soils
Table 5.4-9
Kf, Kfoc and 1/n (Freundlich exponent) values for the metabolite 5-OH-XDE-570
Soil Type
OC
(%)
pH
(-)
Kf
(mL g-1)
Kfoc
(mL g-1)
1/n
(-)
Reference
Catlin, Silty clay loam
2.2
7.0
0.69
31.36
0.88
Ostrander,
1996
Hanford, Sandy loam
1.0
7.4
0.21
21.00
0.95
Pewamo, clay
2.4
5.7
1.73
72.08
0.90
Fuquay, sand
0.64
4.7
0.24
37.50
0.98
Kenslow, Silt loam
6.8
6.1
1.55
22.79
0.90
Speyer, Sandy loam
3.9
7.3
0.07
1.79
1.10
Calke, Sandy Loam
3.6
5.9
0.29
8.06
0.832
S-Witham, Clay Loam
3.8
7.6
0.16
4.21
0.792
Lufa 5M, Sandy Loam
1.0
7.7
0.06
6.00
0.864
RefeSol 06-A, Clay Loam
1.9
7.6
0.12
6.32
0.866
Arithmetic mean
21.00
0.906
Arithm. mean (pH ≥7)
0.22
11.78
0.909
Arithm. mean (pH <7)
0.93
35.11
0.903
Simmonds,
2011 b
For the metabolite 5-OH-XDE-570, a significant correlation was found between the Kfoc values and pH
of the soils (n=14). Since no realistic results could be obtained when using the pH-Tool in FOCUS
PELMO 5.5.3, the arithmetic mean of the Kfoc values and the Freundlich exponents of the soils with
pH<7 was used together with the scenario Hamburg and the arithmetic mean of the Kfoc values and the
Freundlich exponents of the soils with pH≥7. The results are summarized in Table 5.4-10.
Table 5.4-10: Statistic values according to INPUT DECISION 3.3 for metabolite 5-OH-XDE570 for PECGW modelling
yes, pKs = 4.54
Kendall-τ: 0.135
p-value: 0.327
not positiv significant
103%
too high (> 60%)
Kendall-τ: -0.629
p-value: 0.018
significant
(p-Wert < significance level)
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not relevant
Kf for PECGW
At pH ≥7: 11.78
At pH<7: 35.11
Arithmetic mean of Kfoc in acidic and
alkaline soils
1/n PECGW
At pH ≥7: 0.909
At pH<7: 0.903
Arithmetic mean of 1/n values in acidic
and alkaline soils
Table 5.4-11
Kf, Kfoc and 1/n (Freundlich exponent) values for the metabolite DFP-ASTCA
Soil Type
OC
(%)
pH
(-)
Kd
Kd,OC
Kf (mL
g-1)
Kfoc
(mL g-1)
1/n
(-)
Reference
Marcham, Sandy clay
loam
3.40
7.90
0.940
28
n.a.
n.a.
n.a.
Cuckney, Sand
1.50
7.20
0.390
26
n.a.
n.a.
n.a.
Jackson und
Massart,
1999
Sutton, Sandy clay
loam
2.10
7.50
0.680
32
n.a.
n.a.
n.a.
Thessaloniki, Sandy
silt loam
0.90
8.50
0.900
100
n.a.
n.a.
n.a.
Elvedon, Sand
1.10
7.60
0.260
24
n.a.
n.a.
n.a.
Toulouse, Clay
1.20
8.20
0.640
53
n.a.
n.a.
n.a.
Tours, Silty clay
1.20
7.40
0.650
54
n.a.
n.a.
n.a.
Wetterfeld, Silty clay
loam
1.20
6.10
0.630
53
n.a.
n.a.
n.a.
Catlin, Silty loam
1.70
6.50
0.880
52
n.a.
n.a.
n.a.
Hanford, Sandy loam
1.00
7.40
1.100
110
n.a.
n.a.
n.a.
Calke, Sandy Loam
3.6
5.9
n.a.
n.a.
0.88
24.4
0.84
S-Witham, Clay Loam 3.8
7.6
n.a.
n.a.
0.63
16.6
0.80
Lufa 5M, Sandy Loam 1.0
7.7
n.a.
n.a.
2.36
236.0
0.91
RefeSol 06-A, Clay
Loam
7.6
n.a.
n.a.
0.45
23.6
0.88
1.08
75.00
0.858
Arithmetic mean
n.a.
1.9
Burgess und
Simmonds,
2011a
not available
For the metabolite DFP-ASTCA, no siginificant correlation was found with the oc-content or the pH of
the soils. Besides, the coefficient of variation of the Kfoc values was >60%. However, the coefficient of
variation of the Kf values was with <100% sufficiently low. Thus, horizon-specific Kf values were used
together with the scenarios Hamburg and Kremsmünster. The results are summarized in Table 5.4-12.
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Table 5.4-12: Statistic values according to INPUT DECISION 3.3 for metabolite DFP-ASTCA
for PECGW modelling
yes, pKs = 4.54
Kendall-τ: -0.333
p-value: 0.367
143%
too high (> 60%)
81%
Sufficiently low (<60%)
Kendall-τ: 0.183
p-value: 1.000
Not significant
not relevant
Hamburg scenario with Kf = 1.08 (arithmetic mean) for 1st-3rd
horizon and Kf=0 (default) for 4th- 6th horizon
Kf for PECGW
Kremsmünster scenario with Kf = 1.08 (arithmetic mean) for1st – 5th
horizon
1/n PECGW
Table 5.4-13
0.858
Arithmetic mean
Kf, Kfoc and 1/n (Freundlich exponent) values for the metabolite ASTCA
Soil Type
OC
(%)
pH
(-)
Kd
Kd,OC
Kf (mL
g-1)
Kfoc
(mL g-1)
1/n
(-)
Reference
Marcham, Sandy clay
loam
3.40
7.90
1,65
49
n.a.
n.a.
n.a.
Cuckney, Sand
1.50
7.20
0,42
28
n.a.
n.a.
n.a.
Jackson und
Massart,
1999
Sutton, Sandy clay
loam
2.10
7.50
1,87
89
n.a.
n.a.
n.a.
Thessaloniki, Sandy
silt loam
0.90
8.50
1,00
111
n.a.
n.a.
n.a.
Elvedon, Sand
1.10
7.60
0,30
27
n.a.
n.a.
n.a.
Toulouse, Clay
1.20
8.20
0,89
74
n.a.
n.a.
n.a.
Tours, Silty clay
1.20
7.40
1,78
148
n.a.
n.a.
n.a.
Wetterfeld, Silty clay
loam
1.20
6.10
0,60
50
n.a.
n.a.
n.a.
Catlin, Silty loam
1.70
6.50
1,62
95
n.a.
n.a.
n.a.
Hanford, Sandy loam
1.00
7.40
1,59
159
n.a.
n.a.
n.a.
Calke, Sandy Loam
3.6
5.9
n.a.
n.a.
1.34
37.2
0.91
7.6
n.a.
n.a.
1.27
33.4
0.94
Burgess und
Simmonds,
2011a
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7.7
n.a.
n.a.
2.97
297.1
0.95
RefeSol 06-A, Clay
Loam
7.6
n.a.
n.a.
0.98
51.8
0.94
1.64
105
0.935
1.9
Arithmetic mean
n.a.
not available
For the metabolite ASTCA, no siginificant correlation was found with the oc-content or the pH of the
soils. Besides, the coefficient of variation of the Kfoc values was >60%. However, the coefficient of
variation of the Kf values was with <100% sufficiently low. Thus, horizon-specific Kf values were used
together with the scenarios Hamburg and Kremsmünster. The results are summarized in Table 5.4-14.
Table 5.4-14: Statistic values according to INPUT DECISION 3.3 for metabolite ASTCA for
PECGW modelling
yes, pKs = 4.54
Kendall-τ: -0.333
p-value: 1.000
122%
too high (> 60%)
55%
Kendall-τ: 0.183
p-value: 1.000
Not significant
not relevant
Kf for PECGW
horizon
1/n PECGW
Table 5.4-15
0.935
Arithmetic mean
Kf, Kfoc and 1/n (Freundlich exponent) values for the metabolite TSA
Soil Type
OC
(%)
pH
(-)
Kd
Kd,OC
Kf (mL
g-1)
Kfoc
(mL g-1)
1/n
(-)
Reference
Calke, Sandy Loam
3.6
5.9
n.a.
n.a.
0.26
7.3
0.98
7.6
n.a.
n.a.
0.36
9.5
0.94
Burgess und
Simmonds,
2011c
7.7
n.a.
n.a.
0.64
63.6
0.87
RefeSol 06-A, Clay
Loam
7.6
n.a.
n.a.
0.25
13.1
0.98
0.38
23.0
0.943
Arithmetic mean
n.a.
1.9
not available
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For the metabolite TSA, no siginificant correlation was found with the oc-content or the pH of the soils.
Besides, the coefficient of variation of the Kfoc values was >60%. However, the coefficient of variation
of the Kf values was with <100% sufficiently low. Thus, horizon-specific Kf values were used together
with the scenarios Hamburg and Kremsmünster. The results are summarized in
Table 5.4-16: Statistic values according to INPUT DECISION 3.3 for metabolite TSA for
PECGW modelling
yes, pKs = 4.54
Kendall-τ: 0.000
p-value: 0.500
118%
too high (> 60%)
47%
Kendall-τ: 0.548
p-value: 0.470
Not significant
not relevant
Kf for PECGW
horizon
1/n PECGW
5.4.3
0.943
Arithmetic mean
Rate of degradation in water and sediment
Florasulam
A new water/sediment study with florasulam has been submitted for the renewal of the EU approval of
Florasulam (Lewis & Gilbert, 2011). The study is summarized in the new DRAR of Florasulam from
July 2013. Besides, a new kinetic evaluation according to FOCUS guidance (2006) of the
water/sediment study with Florasulam already evaluated for the previous EU approval was performed
for the DRAR of Florasulam. The DT50 and DT90 values for florasulam of the two water/ sediment
studies are summarized in Table 5.4-17 and Table 5.4-18.
Table 5.4-17: Degradation in water/sediment of florasulam
Water /
sediment
system
DegT50/
DegT90
Brown
Carrick Hill,
phenyllabelled
6.74/ 22.38
Kinetic/
Fit
DissT50/
DissT90
water
Kinetic/
Fit
DissT50/
DissT90
sed.
Kinetic
/ Fit
Reference
SFO,
chi2: 4.45
6.12/ 20.3
SFO, chi2:
5.27
-
-
Phillips,
(1997)/
DRAR
(2013)
whole
system
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Brown
Carrick Hill,
TP-labelled
811.3/ 39.5
SFO,
chi2: 5.44
10.51/ 34.9
SFO, chi2:
5.65
-
-
Auchingilsie
system,
phenyllabelled
26.89/ 89.34
SFO,
chi2: 9.58
23.29/ 77.4
SFO, chi2:
7.97
-
-
Auchingilsie
system, TPlabelled
24.42/ 81.13
SFO,
chi2: 5.46
22.07/ 73.3
SFO, chi2:
4.28
-
-
Calwich
Abbey lake,
phenyllabelled
8.25/ 27.41
SFO,
chi2: 4.76
7.98/ 26.53
SFO, chi2:
3.28
-
-
Calwich
Abbey lake,
TP-labelled
9.89/ 32.85
SFO,
chi2: 4.5
9.98/ 33.15
SFO, chi2:
4.08
-
-
Swiss Lake,
phenyllabelled
25.05/ 89.19
SFO,
chi2: 4.71
24.01/.79.8
SFO, chi2:
3.97
-
-
Swiss Lake,
TP-labelled
25.49/ 84.66
SFO,
chi2: 5.45
24.30/ 80.7
SFO, chi2:
4.3
-
-
Geomean
DT50 values
(n=4)
15.03
Lewis &
Gilbert
(2011)
14.07
Table 5.4-18: Degradation in water/sediment of the metabolite 5-OH-XDE 570
Water /
sediment
system
Brown
Carrick Hill,
phenyllabelled
Brown
Carrick Hill,
TP-labelled
Table 5.4-19
DegT50/
DegT90
whole
system
117.5/
390
Kinetic/ Fit
DegT50
water
Kinetic/ Fit
DegT50
sed.
Kinetic/
Fit
Reference
SFO, chi2:
15.38
-
-
-
-
Phillips,
(1997),
DRAR
(2013)
332.0/
1097
SFO, chi2:
7.71
-
-
-
-
Accumulation of active substance and relevant metabolites in the sediment
active substance
Florasulam
accumulation potential in sediment
no (DT90,whole system < 1 year, see core assessment, part B, section 5,
chapter 5.4.3)
accumulation factor (SFO)
faccu = e-kt/(1 – e-kt)
-
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5.5
Estimation of concentrations in soil (KIIIA1 9.4)
Results of PECsoil calculation for Saracen (CHA 5350) according to EU assessment considering 5 cm
soil depth are given in the core assessment, part B, section 5 by zRMS UK (10/2012), part B, section 5,
chapter 5.5. However, zRMS UK refrained from a detailed evaluation of the dossier submitted by the
applicant with reference to the “risk envelopes set by either the evaluation of the representative uses of
the active substances at Annex I stage or in other existing single active products approved in the UK in
accordance with the Uniform Principles (to address UK specific requirements)”.
For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler,
Kubiak:
Ermittlung
der
Eindringtiefe
und
Konzentrationsverteilung
gesprühter
Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum
Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc
< 500 a soil depth of 2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of 1
cm is applied. As soil bulk density 1.5 g cm-3is assumed.
Due to the fast degradation of florasulam and its soil metabolites 5-OH-XDE-570 and DFP-ASTCA in
soil (DT90 < 365 d, SFO, laboratory data) their accumulation potential does not need to be considered.
Due to the slow degradation of metabolites ASTCA and TSA in soil (DT90> 365 d, Kinetic, laboratory
data) their accumulation potential needs to be considered. Therefore, for ASTCA and TSA an
accumulated soil concentration (PECaccu) is used for risk assessment that comprises background
concentration in soil (PECbkgd) considering a tillage depth of 20 cm (arable crop) or 5 cm (permanent
crops) and the maximum annual soil concentration PECact for a soil depth of 2.5 cm.
The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented
in Table 5.5-1, Table 5.5-2 and Fehler! Verweisquelle konnte nicht gefunden werden..
Table 5.5-1:
Input parameters related to application for PECSoil calculations
Plant protection product
Saracen (CHA 5350)
Use No.:
00-004 and 00-005 (worst case)
Crop:
Spring cereals
Application rate:
Active substance florasulam: 5 g as/ha
Formulation Saracen:
Number of application/interval:
1
Crop interception:
25 %
*formulation density: 1.04 g/mL
Table 5.5-2:
DT50 values of florasulam and its metabolites for PECsoil calculation
active substance/ metabolite
DT50
florasulam
25.48 d (SFO, maximum field studies
No
representative for German climate conditions,
see Table 5.4-6)
metabolite 5-OH-XDE-570
22.4 d (SFO, 90th percentile, laboratory study, No
see Table 5.4-2 )
value in accordance to
EU endpoint
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metabolite DFP-ASTCA
32.9 d (SFO, 90th percentile, laboratory study, No
see Table 5.4-3)
metabolite ASTCA
259 d (SFO, Maximum, laboratory study, see
Table 5.4-4)
No
metabolite TSA
172.2 d (SFO, 90th percentile, laboratory
study, see Table 5.4-5)
No
Additional PECsoil,act was calculated for the formulation Saracen (CHA 5350) for a soil depth of 2.5 cm.
No short-term and long-term PECsoil were calculated since PECsoil,act is considered sufficient for German
risk assessment.
The calculated PECsoil used for German risk assessment for florasulam, its metabolites and the
formulation Saracen (CHA 5350) are summarized in Table 5.5-3.
Table 5.5-3:
Results of PECsoil calculation for the intended use in spring cereals (use No. 00004 to 00-005, worst case) used for German risk assessment
active substance/
formulation
soil relevant
application rate
(g/ha)
tillage
depth (cm)
PECbkgd
(mg/kg)
PECaccu =
PECact +
PECbkgd
(mg/kg)
florasulam:
3.75
2.5
0.0100
-
-
-
metabolite 5-OHXDE-570:
2.54 a)
2.5
0.0068
-
-
-
metabolite DFPASTCA:
0.53 b)
2.5
0.0014
-
-
-
metabolite ASTCA:
0.80 c)
2.5
0.0021
20
0.0002
0.0023
metabolite TSA:
0.27 d)
2.5
0.0007
20
<0.0001
0.0007
formulation
Saracen (CHA
5350):
1040
2.5
2.7733
-
-
-
soil depthact PECact
(mg/kg)
(cm)
a)
maximum occurrence: 71.6 %, molecular correction: 0.961
c)
d)
b)
5.6
Estimation of concentrations in surface water and sediment (KIIIA1 9.7)
For authorization in Germany, exposure assessment of surface water considers the two routes of entry
(i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order
to allow risk mitigation measures separately for each entry route.
Surface water exposure via spray drift and volatilization with subsequent deposition is estimated with
the models EVA 2.1. Surface water exposure via surface run-off and drainage is estimated using the
model EXPOSIT 3.01.
The German surface water exposure assessment is outlined in the following chapters.
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5.6.1
PECSW after exposure by spraydrift and volatilization with subsequent
deposition
The calculation of concentrations in surface water is based on spray drift data by Rautmann and
Ganzelmeier.
florasulam is regarded as non-volatile. Therefore exposure of surface water by the active substance
florasulam due to deposition following volatilization does not need to be considered.
The calculation of PECsw after exposure via spray drift with subsequent deposition is performed using
the model EVA 3. For a single application, the exposure assessment via spray drift is based on the
application rate in conjunction with the 90th percentile of the drift values.
The endpoints used for modelling of surface water exposure via spray drift and volatilization with
subsequent deposition with EVA 3 are summarized in Table 5.6-1.
Table 5.6-1
Endpoints of florasulam used for the PECSW calculations with EVA 3
Parameter
Florasulam
Reference
-6
vapour pressure at 20 °C (Pa)
1 x 10
See chapter 5.3.1.2
Solubility in water (mg/L)
6360
See chapter 5.3.1.2
DT50 hydrolysis/photolysis (d)
1000
Default
The calculated PECsw values after exposure via spray drift for the active substance fluroxypyr-meptyl
for the intended use in spring cereals (use No. 00-003, worst case) are summarized in Table 5.6-2.
Table 5.6-2
PECSW for the active substance florasulam after exposure via spray drift and
volatilization with subsequent deposition modelled with EVA 3
active substance
florasulam
use pattern/gap:
spring cereals, use No. 00-003 (worst case)
application rate/number of
applications / interval
1 x 7.5 g as ha-1
scenario/percentile:
field crops/90. percentile
distance
(m)
PECsw via drift
PECsw via
volatilisation
PECsw (via drift and volatilisation) (µg/L)
depending on application technique (drift reduction)
(%)
(µg/L)
(%)
(µg/L)
1
2.77
0.069
-
-
no drift
reduction
0.069
50% drift
reduction
0.035
75% drift
reduction
0.017
90% drift
reduction
0.007
5
0.57
0.014
-
-
0.014
0.007
0.004
0.001
10
0.29
0.007
-
-
0.007
0.004
0.002
0.001
15
0.20
0.005
-
-
0.005
0.003
0.001
0.001
20
0.15
0.004
-
-
0.004
0.002
0.001
0.000
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5.6.2
PECSW after exposure by surface run-off and drainage
Florasulam
The concentration of the active substances florasulam in adjacent ditch due to surface runoff and
drainage is calculated using the model EXPOSIT 3.01.
The parameters for florasulam used for modelling surface water exposure via run-off and drainage in an
adjacent ditch with EXPOSIT 3.01 are summarized inTable 5.6-3.
Table 5.6-3
Input parameters for florasulam used for PECSW calculations with EXPOSIT
3.01
Parameter
Florasulam
Reference
Kfoc, Runoff
20
arithm. mean (see Table 5.4-7)
Kfoc, mobility class
2
10th percentile (see Table 5.4-7)
DT50 soil (d)
5.2
90th percentile (see Table 5.4-1)
6360
see chapter 5.3.1.2
Reduction by bank filtration (only
relevant for PECgw)
100 %
default
The calculated PECSW in an adjacent ditch due to surface run-off and drainage for the active substance
florasulam for the intended for use in winter cereals (worst case application rate) are summarized in
Table 5.6-4.
Table 5.6-4
PECSW of florasulam in an adjacent ditch due to surface run-off and drainage
Active substance:
florasulam
Use pattern/GAP:
Application rate:
5.0 g as/ha (25 % interception)
Exposure by surface runoff
vegetated buffer strip (m)
PECsw in adjacent ditch
(PECini Runoff)
(µg/L)
(PECini Gesamtaustrag)
(µg/L)
0
0.01
0.01
5
-
-
10
-
-
20
-
-
Exposure by drainage
time of application
PECsw in adjacent ditch (µg/L)
autuum/winter/early spring
0.02
Spring/summer
0.01
The parameters for metabolite 5-OH-XDE-570 of florasulam used for modelling surface water exposure
via run-off and drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in Table 5.6-5.
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Table 5.6-5
Input parameters for metabolite 5-OH-XDE-570 of florasulam used for PECSW
calculations with EXPOSIT 3.01
Parameter
Reference
Molecular correction factor
0.961
LoEP
Maximum occurrence in soil (%)
71.6
LoEP
K foc, Runoff
21
arithm. mean (see core assessment,
section 5, chapter 5.4.2)
3
10th percentile (see core assessment,
DT50 soil (d)
30.5
1000
estimated by the applicant
relevant for PECgw see 5.7.2)
90 %
default
The calculated PECSW in an adjacent ditch due to surface run-off and drainage for metabolite 5-OHXDE-570 of florasulam for the intended uses in winter cereals (worst case application rate) are
summarized in Table 5.6-6.
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Table 5.6-6
PECSW for metabolite 5-OH-XDE-570 of florasulam in an adjacent ditch due to
surface run-off and drainage
Active substance:
Use pattern/GAP:
Application rate:
(PECini Runoff)
(µg/L)
(µg/L)
0
0.02
0.02
5
0.01
0.01
10
0.01
0.01
20
0.01
0.01
time of application
0.03
Spring/summer
0.01
The parameters for metabolite DFP-ASTCA of florasulam used for modelling surface water exposure
via run-off and drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in Table 5.6-7.
Table 5.6-7
Input parameters for metabolite DFP-ASTCA of florasulam used for PECSW
Parameter
Reference
0.847
LoEP
17.8
LoEP
K foc, Runoff
22
22
DT50 soil (d)
33.0
1000
90 %
default
The calculated PECSW in an adjacent ditch due to surface run-off and drainage for metabolite DFPASTCA of florasulam for the intended for use in winter cereals (worst case application rate) are
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Table 5.6-8
PECSW for metabolite DFP-ASTCA of florasulam in an adjacent ditch due to
surface run-off and drainage
Active substance:
Use pattern/GAP:
Application rate:
(PECini Runoff)
(µg/L)
(µg/L)
0
<0.001
<0.001
5
<0.001
<0.001
10
<0.001
<0.001
20
<0.001
<0.001
time of application
0.01
Spring/summer
<0.001
The parameters for metabolite ASTCA of florasulam used for modelling surface water exposure via runoff and drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in Table 5.6-9.
Table 5.6-9
Input parameters for metabolite ASTCA of florasulam used for PECSW
Parameter
metabolite ASTCA
Reference
0.535
LoEP
40.0
LoEP
K foc, Runoff
41
41
DT50 soil (d)
234
maximum (see core assessment, section
5, chapter 5.4.1)
1000
75 %
default
The calculated PECSW in an adjacent ditch due to surface run-off and drainage for metabolite ASTCA
of florasulam for the intended for use in winter cereals (worst case application rate) are summarized in
Table 5.6-10.
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Table 5.6-10
PECSW for metabolite ASTCA of florasulam in an adjacent ditch due to surface
run-off and drainage
Active substance:
metabolite ASTCA
Use pattern/GAP:
Application rate:
(PECini Runoff)
(µg/L)
(µg/L)
0
< 0.01
< 0.01
5
< 0.01
< 0.01
10
< 0.01
< 0.01
20
< 0.01
< 0.01
time of application
0.01
Spring/summer
<0.01
The parameters for metabolite TSA of florasulam used for modelling surface water exposure via runoff and drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in Table 5.6-11.
Table 5.6-11
Input parameters for metabolite TSA of florasulam used for PECSW calculations
with EXPOSIT 3.01
Parameter
metabolite TSA
Reference
0.412
LoEP
15.9
LoEP
K foc, Runoff
10
10
DT50 soil (d)
157
1000
75 %
default
The calculated PECSW in an adjacent ditch due to surface run-off and drainage for metabolite TSA of
florasulam for the intended for use in winter cereals (worst case application rate) are summarized in
Table 5.6-12.
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Table 5.6-12
PECSW for metabolite TSA of florasulam in an adjacent ditch due to surface runoff and drainage
Active substance:
metabolite TSA
Use pattern/GAP:
Application rate:
(PECini Runoff)
(µg/L)
(µg/L)
0
<0.01
<0.01
5
<0.01
<0.01
10
<0.01
<0.01
20
<0.01
<0.01
time of application
<0.01
Spring/summer
<0.01
5.7
Risk assessment for groundwater (KIIIA1 9.6)
For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct
leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and
drainage of the active substance into an adjacent ditch with subsequent bank filtration into the
groundwater.
Direct leaching after soil passage is assessed following the recommendations of the publication of Holdt
et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental concentrations of
active substances of plant protection products and their metabolites in groundwater (PECGW) in the
National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011) for tier 1 and tier
2 risk assessment. According to Hold et al, 2011, endpoints for groundwater modelling are derived with
the program INPUT DECISION 3.1 and subsequent simulations are performed for the groundwater
scenarios “Hamburg” or with the scenarios “Hamburg” and “Kremsmünster” of FOCUS PELMO 4.4.3.
In tier 3 risk assessment, results of experimental studies (lysimeter studies and/or field leaching studies)
can also be considered in German groundwater risk assessment.
Surface run-off and drainage into an adjacent ditch with subsequent bank filtration into the groundwater
are estimated using the model EXPOSIT 3.
The German risk assessment for groundwater is given in the following chapters.
5.7.1
Direct leaching into groundwater
5.7.1.1
PECGW modelling
Table 5.7-1
Input parameters related to application for PECGW modelling with FOCUS
PELMO 5.5.3
use evaluated
A/00-001 autumn application
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A/00-002 spring application (covers also use No. 00-003)
B/00-004 spring application (covers also use No. 00-005)
application rate (kg as/ha)
A/00-001
A/00-002
B/00-004
0.00375 kg as ha-1
0.005 kg as ha-1
0.005 kg as ha-1
crop (crop rotation) and
date of application
A/00-001
A/00-002
B/00-004
winter cereals
winter cereals
spring cereals
interception (%)
A/00-001
A/00-002
B/00-004
25%
50%
25%
soil effective application rate
(kg as/ha)
A/00-001
A/00-002
B/00-004
0.0028125 kg as ha-1
0.0025 kg as ha-1
0.00375 kg as ha-1
soil moisture
100 % FC
Q10-factor
2.58
moisture exponent
0.7
plant uptake
0
simulation period (years)
26
15th of november
6th of april
6th of april
Florasulam
The endpoints used for groundwater modelling for florasulam and its metabolites 5-OH-XDE-570, DFPASTCA, ASTCA and TSA according to INPUT DECISION 3.3 are summarized in Table 5.7-2.
Table 5.7-2
Input parameters related to Florasulam for PECGW modelling
Substance
Value used for PECgw
simulations
Remarks/Reference to core assessment,
part B, section 5
molecular weight (g/mol)
359.3
See Table 5.3-1
DT50 in soil (d)
2.0
Geomean, all soils for scenario Hamburg and
Kremsmünster
Active substance florasulam
0.3050
Transformation rate
(Florasulam → 5-OH-XDE-570)
-
Transformation rate
(Florasulam→ CO2)
0.0416
-
Kfoc
pH ≥7: 2.7
pH <7: 16.8
Arithmetic mean of Kfoc in acidic soils for
scenario Hamburg and arithmetic mean of
Kfoc in alkaline soils for Kremsmünster
1/n
At pH ≥7: 0.936
At pH<7:0.957
Arithmetic mean of 1/n values in acidic acidic
soils for scenario Hamburg and arithmetic
mean of 1/n values in alkaline soils for
Kremsmünster
Plant Uptake
0
default
Metabolite 5-OH-XDE-570
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molecular weight (g/mol)
345.26
-
Formation fraction
(florasulam→5-OH-XDE-570)
0.88
Arithmetic mean
0.69
Transformation rate
(5-OH-XDE-570→DFP-ASTCA)
-
Transformation rate
(5-OH-XDE-570→ CO2)
0.31
-
DT50 in soil (d)
13.4
Geomean, laboratory studies at pF2 and 20°C
Kfoc
At pH ≥7: 11.78
At pH<7: 35.11
Arithmetic mean of Kfoc in acidic soils for
scenario Hamburg and arithmetic mean of
Kfoc in alkaline soils for Kremsmünster
1/n
At pH ≥7: 0.909
At pH<7: 0.903
Arithmetic mean of 1/n values in acidic acidic
soils for scenario Hamburg and arithmetic
mean of 1/n values in alkaline soils for
Kremsmünster
Plant Uptake
0
default
molecular mass
304.23
-
DT50 in soil (d)
13.4
Metabolite DFP-ASTCA
0.69
Formation fraction
(5-OH-XDE-570→ DFP-ASTCA)
Arithmetic mean, laboratory studies at pF2
and 20°C
Transformation rate
(DFP-ASTCA → ASTCA)
0.0404
-
Transformation rate
(DFP-ASTCA → TSA)
0.0113
-
Kfoc
Hamburg scenario with Kf = 1.08 (arithmetic mean) for 1st - 3rd horizon
and Kf=0 (default) for 4th- 6th horizon
Kremsmünster scenario with Kf = 1.08 (arithmetic mean) for 1st – 5th
horizon
1/n
0.858
Arithmetic mean
Metabolite ASTCA
molecular mass
192.15
DT50 in soil (d)
259
Maximum, laboratory studies at pF2 and 20°C
Formation fraction
(DFP-ASTCA→ASTCA)
0.781
Maximum, laboratory studies at pF2 and 20°C
Transformation rate
(ASTCA → TSA)
0.002676
-
Kfoc
Hamburg scenario with Kf = 1.64 (arithmetic mean) for 1st-3rd horizon and
Kf=0 (default) for 4th- 6th horizon
horizon
1/n
0.935
Arithmetic mean
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plant uptake factor
0
default
Metabolite TSA
molecular mass
148.14
DT50 in soil (d)
118.9
Formation fraction
ASTCA → TSA
1.0
default
Formation Fraction
DFP-ASTCA→ TSA
0.219
Calculated by the difference of 1.000 – the
mean ff value for the formation of ASTCA
from DFP-ASTCA (0.781)
Kfoc
Hamburg scenario with Kf = 0.38 (arithmetic mean) for 1st-3rd horizon and
Kf=0 (default) for 4th- 6th horizon
horizon
1/n
0.943
Arithmetic mean
plant uptake factor
0
default
Figure 1: Metabolization scheme for florasulam used in calculations with FOCUSPELMO 5.5.3
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The results of the groundwater simulation are presented in Table 5.7-3.
Table 5.7-3
PECGW at 1 m soil depth of Florasulam and its metabolites considered relevant
for German exposure assessment
80th Percentile PECGW at 1 m Soil Depth (µg L-1)
modeled by FOCUS PELMO 5.5.3
Use No.
A/00-001
winter
cereals,
autumn
applic.
A/00-002
winter
cereals,
spring
applic.
B/00-004
winter
cereals,
spring
applic.
Szenario
florasulam
metabolite
5-OH
metabolite
DFP-ASTCA
metabolite
ASTCA
metabolite
TSA
Hamburg
0.001
<0.001
<0.001
0.063
0.118
Kremsmünster
0.005
0.001
0.093
0.219
0.058
Hamburg
<0.001
<0.001
<0.001
0.47
0.103
Kremsmünster
<0.001
<0.001
0.026
0.215
0.062
Hamburg
<0.001
<0.001
<0.001
0.066
0.151
Kremsmünster
<0.001
<0.001
0.029
0.349
0.105
According to the results of the groundwater simulation with FOCUS-PELMO 5.5.3, a groundwater
contamination of the active substance florasulam in concentrations of ≥ 0.1 µg/L is not expected for the
intended uses in winter and spring cereals.
≥ 0.1 µg/L can be excluded for the application in winter and spring cereals according to the results of
the groundwater simulation with FOCUS-PELMO 5.5.3. For the metabolites ASTCA and TSA of
florasulam a groundwater concentration of ≥ 0.1 µg/L cannot be excluded for the intended uses
according to the results of the groundwater simulation with FOCUS-PELMO 5.5.3.
In addition to the PECgw modelling experimental data from lysimeter studies are used to assess the
leaching behaviour of the active substance florasulam.
5.7.1.2
Experimental data on the leaching behaviour of the active substances
Florasulam
In case of the active substance florasulam exposure assessment is based additionally on results of a
lysimeter study.
active substance:
Florasulam
author:
Jackson, R. and Paterson, G.
report:
The dissipation of XDE-570 in soil and crops using field
lysimeters
study date:
17/12/1997
study code:
GHE-P-6751
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see DAR for a detailed description of the study
reference:
The experimental data on the leaching behaviour of the active substance florasulam show that florasulam
and its metabolite 5-OH are not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L
in the intended for uses in winter and spring cereals after application in spring at locations for which the
climate conditions of the UK (51.5°N latitude) are considered a worst case scenario.
However, the duration of the lysimeter study is not considered long enough to estimate groundwater
entries of the relatively late occurring secondary and tertiary soil metabolites DFP-ASTCA and ASTCA.
5.7.1.3 Summary on risk assessment for groundwater after direct leaching
Results of modelling with FOCUSPELMO 5.5.3 show that the active substance florasulam is not
expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended uses of Saracen
(CHA 5350) in spring and winter cereals according to use No. 00-001 to 00-005.
≥ 0.1 µg/L can be excluded for the intended uses of Saracen (CHA 5350) in spring and winter cereals
according to use No. 00-001 to 00-006. For the metabolites ASTCA and TSA of florasulam a
groundwater concentration of ≥ 0.1 µg/L cannot be excluded for the intended uses of Saracen (CHA
5350) in spring and winter cereals according to use No. 00-001 to 00-006.
However the metabolites ASTCA and TSA are classified as not relevant for groundwater (see part B,
section 8, national addendum).
none
5.7.2
Ground water contamination by bank filtration due to surface water
exposure via run-off and drainage
Florasulam
The input parameters for florasulam used for modelling surface water exposure via run-off and drainage
in an adjacent ditch with subsequent bank filtration into the groundwater with EXPOSIT 3.01 are
Table 5.7-4
Input parameters of florasulam used for PECGW calculations with EXPOSIT 3.01
Parameter
florasulam
Reference
K foc, Runoff
20
2
DT50 soil (d)
5.2
6360
see core assessment, section 5, point
5.3.1.2
Mobility class
Reduction by bank filtration
4
100 %
Default
The soil metabolites 5-OH, DFP-ASTCA, ASTCA and TSA of florasulam (see Table 5.3-3) are
potentially relevant. Therefore potential ground water contamination due to bank filtration via surface
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water exposure by run-off and drainage needs to be assessed using EXPOSIT 3.01. However, EXPOSIT
3.01 calculations for the active substance florasulam resulted in concentrations <0.001 ug/L in the
groundwater due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration.
Since the metabolites are expected in even lower concentrations in the surface water than the active
substance, no groundwater contamination due to surface run-off and drainage into the adjacent ditch
with subsequent bank filtration of the metabolites is expected. Calculations with EXPOSIT 3.01 are
therefore not considered necessary for these metabolites.
The calculated PECgw for florasulam after surface run-off and drainage with subsequent bank filtration
are summarized in Table 5.7-5.
Table 5.7-5
PECgw for florasulam after surface run-off and drainage with subsequent bank
filtration (modelled with EXPOSIT 3.01 )
Active substance
Use No.
application
rate
interception
00-004 and
00-005
(worst case)
1x
5.0 g as/ha
25 %
required labelling
Florasulam
PECgw due to
run-off
vegetated buffer
strip
(m)
0
5
10
20
None
Drainage
bank filtrate
(µg/L)
Time of
application
bank filtrate
(µg/L)
< 0.001
< 0.001
< 0.001
< 0.001
autumn/winter/
early spring
< 0.001
spring/summer
< 0.001
According modelling with EXPOSIT 3.01, a groundwater contamination at concentrations ≥ 0.1 µg/L
by the active substance florasulam due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded.
None.
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Appendix 1 List of data submitted in support of the evaluation
Table A 1:
List of data submitted in support of the evaluation
none
Evaluator: Germany
August 2014
Saracen (CHA 5350)
Registration Report
Central Zone
zRMS: UK
Page 38 of 38
Appendix 2 Detailed evaluation of studies relied upon
Report only studies, which have not previously been evaluated within a peer reviewed process at EU level
(Annex I inclusion of active substance).
KIIA 7
Fate and Behaviour in the Environment – florasulam
All new studies on the fate and behavior in the environment of florasulam are summarized in the DRAR
from July 2013 submitted for the renewal of the EU approval of florasulam.
Evaluator: Germany
August 2014
Saracen
Draft Registration Report
Central Zone
National Addendum – DE
Page 1 of 17
DRAFT REGISTRATION REPORT
Part B
Section 6: Ecotoxicological studies
Product code:
Saracen
Active Substance:
Florasulam 50 g/L
Central Zone
Zonal Rapporteur Member State: United Kingdom
NATIONAL ADDENDUM
Germany
Applicant:
Cheminova
Date:
August 2014
Applicant: Cheminova
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 2 of 17
Table of Contents
SEC 6
ECOTOXICOLOGICAL STUDIES (MIIIA 10)............................................................ 3
6.1 PROPOSED USE PATTERN AND CONSIDERED METABOLITES .............................................................. 4
6.1.1 Grouping of intended uses for risk assessment ...................................................................... 4
6.1.2 Consideration of metabolites .................................................................................................. 4
6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1)................................................................. 6
6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC
10.1.2) ...................................................................................................................................................... 6
6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC
10.1.3) ...................................................................................................................................................... 6
6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1)........................................ 6
6.5.1 Overview ................................................................................................................................ 6
6.5.2 Toxicity .................................................................................................................................. 6
6.5.3 Justification for new endpoints .............................................................................................. 7
6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ............................................. 7
6.5.5 Overall conclusions ................................................................................................................ 8
6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1).................................................................................... 9
6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ....................................... 9
6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1,
KPC 10.4.2) .............................................................................................................................................. 9
6.8.1 Toxicity .................................................................................................................................. 9
6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) .... FEHLER! TEXTMARKE NICHT
DEFINIERT.
6.9.1 Toxicity ......................................................................... Fehler! Textmarke nicht definiert.
6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) .......................................................... 13
6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) ........................................................ 13
6.10.2 Toxicity ................................................................................................................................ 13
6.10.3 Justification for new endpoints ............................................................................................ 14
6.10.4 Risk assessment .................................................................................................................... 14
6.10.5 Conclusion............................................................................................................................ 16
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 3 of 17
Sec 6
ECOTOXICOLOGICAL STUDIES (MIIIA 10)
A full risk assessment according to Uniform Principles for the plant protection product Saracen in its
intended uses in winter cereals (wheat, barley, rye and triticale), summer cereals (wheat, barley and oat)
and grass is documented in detail in the core assessment of the plant protection product Saracen dated from
March 2014 performed by zRMS United Kingdom.
This document comprises specific risk assessment for some annex points for authorization of the plant
protection product Saracen in Germany according to the uses listed in Appendix 2.
General information on the formulation Saracen can be found in Table 5.1-1 of Section 5 of the National
addendum Germany (April 2013).
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 4 of 17
6.1
Proposed use pattern and considered metabolites
6.1.1
Grouping of intended uses for risk assessment
Full details of the proposed use pattern of the formulation Saracen that will be assessed are summarized in
the table below. The intended uses in Germany are covered by the core assessment performed by zRMS
United Kingdom.
The following table lists the grouping of the intended uses in order to perform a risk envelope approach.
Intended uses may be grouped according to soil relevant application rate, drift rate and maximum daily
dose for birds and mammals. The soil relevant application rate is based on the effective cumulative application rate including interception. For drift rate, the intended uses are grouped according to the application
rate and the relevant drift scenario. For birds and mammals the application rate, minimum interval, number
of applications and the relevant crop scenario are considered.
Table 6.1-1:
Critical use pattern of Saracen grouped according to soil relevance, drift scenario
and crop scenario
Groups – Soil relevance
Group
Intended uses
B01
00-002
00-004
00-006
B02
00-001
B03
00-003
Groups – Drift szenario
Group
Intended uses
D01
D02
00-003
00-002
00-004
00-006
D03
00-001
Groups – Birds and mammals
Group
Intended uses
V01S01
V02S03
V03S04
V04S02
6.1.2
00-003
00-002
00-004
00-001
00-006
Application rate (Interception) Soil relevant effective appl.
rate, cumulative
[g/ha]
[g/ha]
1 x 5 g ai/ha (25 %)
1 x 3.75 g ai/ha
1 x 3.75 g ai/ha (25 %)
1 x 7.5 g ai/ha (70 %)
1 x 2.813 g ai/ha
1 x 2.25 g ai/ha)
Application rate
[g/ha]
1 x 7.5 g ai/ha
1 x 5 g ai/ha
Drift scenario
agriculture
agriculture
1 x 3.75 g ai/ha
agriculture
Application rate
[g/ha]
1 x 7.5 g ai/ha
1 x 5 g ai/ha
Crop scenario
cereals
Cereals
1 x 3.75 g ai/ha
1 x 5 g ai/ha
cereals
grassland
Consideration of metabolites
Please refer to the core assessment.
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 5 of 17
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 6 of 17
6.2
Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1)
none
6.3
Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1,
KPC 10.1.2)
none
6.4
Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC
10.1.3)
none
6.5
Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1)
6.5.1
Overview
Results of aquatic risk assessment for the intended for uses of Saracen in cereals and grassland based on
FOCUS Surface Water PEC values is presented in the Core assessment, Part B, Section 6, chapter 10.2.
For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i)
spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to
allow risk mitigation measures separately for each entry route. Hence, aquatic risk assessment differs from
those in the core assessment.
The risk assessment for aquatic organism for authorization of Saracen is outlined in the following chapters.
6.5.2
Toxicity
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 7 of 17
6.5.3
Justification for new endpoints
6.5.4
Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1)
The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with
the recommendations of the “Guidance Document on Aquatic Ecotoxicology”, as provided by the Commission Services (SANCO/3268/2001 rev.4 (final), 17 October 2002).
For risk assessment purposes, a risk envelope approach was used. Hence, intended use group D01, D02 and
D03 cover the risk for aquatic organisms from intended uses 00-001 until 00-006 (see table 6.1.1).
6.5.4.1
TER values for the entry into surface water via spraydrift and deposition
following volatilization
The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzelmeier. Florasulam has a vapour pressure of 1 x < 10-5 Pa and is therefore classified as non-volatile. Hence,
deposition following volatilization has been considered. The input parameters for Florasulam are given in
Section 5.3.
Lemna gibba provides for Florasulam the lowest crucial endpoint and is therefore the relevant scenario for
risk assessment.
Table 6.5-1:
Risk assessment for Florasulam for aquatic organisms for the entry route via spraydrift and deposition following volatilization under the implementation of different
risk mitigation measures
Florasulam
Agriculture, 1 x 7.5 g ai/ha (worst case)
BBCH 30 – 39, spring
D01 (worst case)
24.3 d
actual
90th
Entry via
PECsw; conventional and drift reducing technique
deposition
following
volatilization
0% conv.
50% red.
75% red.
90% red.
[%]
[g/ha]
[%]
[µg/L]
[µg /L]
[m]
1
2.77
0.069
-/-/0.069
0.035
0.017
0.007
Relevant toxicity endpoint: EC50 = 0.001 mg a.i./L (Lemna gibba)
Relevant TER: 10
Compound:
Crop/Application rate:
Growth stage and season
Intended use group:
DT50 water (SFO):
PEC-selection:
Drift-Percentile:
Buffer Entry via
zone
spraydrift
Buffer zone [m]
1
Risk mitigation measures
TER
14.4
28.9
57.8
144.4
Not necessary
PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 8 of 17
6.5.4.2
TER values for the entry into surface water via run-off and drainage
The concentration of the active substance Florasulam in adjacent ditch due to surface runoff and drainage
is calculated using the model EXPOSIT 3.01. The input parameters for Florasulam for exposure modelling
with EXPOSIT 3.01 are given in the German National Addendum Section 5, chapter 5.6.2.
Table 6.5-2:
Risk assessment for Florasulam for aquatic organisms for the entry route via runoff and drainage under the implementation of different risk mitigation measures
Compound:
Florasulam
Application rate:
1 x 5 g ai/ha
Intended use
B01 (worst case)
Relevant toxicity endpoint:
EC50 = 1 µg a.s./L (Lemna gibba.)
Relevant TER:
10
Run-off
Buffer zone
PEC
TER
[m]
[µg/L]
0
0.01
94.02
PEC
TER
Drainage
Time of application
[µg/L]
Autumn/winter/early spring
0.02
41.4
Spring/summer
0.01
127.29
Not necessary
PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.
6.5.4.3
Consideration of Metabolites
6.5.5
Overall conclusions
Based on the calculated concentrations of Florasulam and its metabolites in surface water (EVA 2.1, EXPOSIT 3.0.1), the calculated TER values for the acute and long-term risk resulting from an exposure of
aquatic organisms to Florasulam according to the GAP of the formulation Saracen achieve the acceptability
criteria TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C
, 2. Specific principles, point 2.5.2. for long-term effects. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of Saracen in cereals and grassland according to the
label.
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 9 of 17
For the authorization of the plant protection product Saracen following labeling and conditions of use are
mandatory:
Required Labelling
NW 262
Florasulam: N. pelliculosa NOEC < 0.000788 mg a.s./L
Saracen: P. subcapitata NOEC < 0.046 mg/L
NW 265
Florasulam: L. gibba NOEC = 0.00062 mg a.s./L
Saracen : L. minor. NOEC = 0.007 mg/L
Conditions for use
Saracen
6.6
NW 468
NW 642
Effects on bees (MIIIA 10.4, KPC 10.3.1)
Please refer to the core assessment and the risk assessment outcome as provided by JKI.
none
6.7
Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2)
The applicant has submitted data on the effect of Saracen on non-target arthropods. According to the herbicidal effect of the formulation these effect values are substantially higher than those effects determined
for non-target terrestrial plants, which are therefore relevant for the risk assessment for terrestrial biocoenosis. A quantitative risk assessment for non-target arthropods is for that reason not conducted in this national addendum.
None
6.8
Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC
10.4.1, KPC 10.4.2)
6.8.1
Toxicity
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 10 of 17
Moreover following studies were submitted for EU-evaluation and are listed in the DRAR to florasulam
from June 2014:
Species
Substance
Exposure
System
Results
Reference
Internal
code
Eisenia foetida
DFP-ASTCA
Chronic
5 % peat
NOEC =
0.0304
mg/kg dw
Witte, B
2011
101341
72977
Eisenia foetida
ASTCA
Chronic
NOEC = 1.0
mg/kg dw
Lührs, U.
2008
080038
77672
Eisenia foetida
TSA
Chronic
NOEC =
10.0 mg/kg
dw
Witte, B
2011
110132
72974
Folsomia candida
DFP-ASTCA
Chronic
5 % peat
NOEC = 10
mg/kg dw
Lührs, U.
2011
101345
79760
Folsomia candida
ASTCA
Chronic
NOEC 12.5
mg/kg dw
Witte, B.
2010
101346
79761
Folsomia candida
TSA
Chronic
NOEC = 50
mg/kg dw
Lührs, U. 2011
110133
72976
6.8.2
Toxicity exposure ratios for earthworms and other soil macro- and mesofauna,
TERA and TERLT (MIIIA 10.6.1)
The evaluation of the risk for earthworms and other soil macro-organisms was performed in accordance
with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the
Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).
For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the
environmental fate section (Part B, Section 5) of this submission. The resulting maximum PECsoil values
for the active substance Florasulam and the major soil degradation products are presented in the table below.
For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ
360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of 2.5 cm is
applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As soil bulk density
1.5 g cm-3is assumed.
For risk assessment purposes, a risk envelope approach was used. Hence, intended use groups B01 until
B03 cover the risk for earthworms and other soil macro- and mesofauna from intended uses 00-001 until
00-006 (see Fehler! Verweisquelle konnte nicht gefunden werden.).
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 11 of 17
The acute risk for earthworms and other non-target soil macro- and mesofauna resulting from an exposure
to Saracen as well as the major soil degradation products of florasulam was assessed by comparing the
maximum PECSOIL with the 14-day LC50 value to generate acute TER values. The TERA was calculated as
follows:
TER A =
LC50 (mg/kg)
PECsoil (mg/kg)
The chronic risk for earthworms, other non-target soil macro- and mesofauna and organic matter breackdown resulting from an exposure to Saracen as well as the major soil degradation products of florasulam
was assessed by comparing the maximum PECSOIL with the NOEC value to generate chronic TER values.
The TERLT was calculated as follows:
TER LT =
NOEC (mg/kg)
PEC soil (mg/kg)
The results of the risk assessment are summarized in the following table.
Table 6.8-1:
Species
TER values for earthworms and other soil macro- and mesofauna (Tier-1) for the
use according to use group B01 (worst case)
Test item
Endpoint
Max. PECSOIL
[mg/kg soil dw]
[mg/kg soil dw]
Acute
>13201
0.0100
132000
DFP-Astca
Chronic
0.0304
0.0014
21.71
Astca
Chronic
1.0
0.0021
476.19
Tsa
chronic
10.0
0.0007
14285.71
Saracen
Acute
>5001
>23.851
2.7733
0.0100
180.29
2385
Saracen
Chronic
2.09651
0.11
2.7733
0.0100
0.756
10
DFP-Astca
Chronic
10
0.0014
7142.86
Astca
Chronic
12.5
0.0021
5952.38
Tsa
Chronic
50
0.0007
71428.58
Eisenia fetida Florasulam
Folsomia
candida
Time scale
TER
TER values shown in bold fall below the relevant trigger.
1 Correction of the endpoint because of log Pow > 2.
The TER-value of the chronic risk assessment for earthworms for the formulation Saracen underlines the
trigger of 5. The used endpoint NOEC = 2.0965 mg Saracen/kg dw is based on the highest concentration
tested. No effects on mortality, biomass and reproduction were observed at this test concentration. Comparing the content of the active substance with the PEC of the active substance for the same test, the trigger
is well above the trigger of 5. As Saracen contains only one active substance which relieves the formulation
and the endpoint is the highest concentration tested without effects, the risk can be considered as acceptable.
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 12 of 17
6.8.3
Higher tier risk assessment
Not relevant.
6.8.4
Overall conclusions
Based on the predicted concentrations of florasulam in soils, the TER values describing the acute and longterm risk for earthworms and other non-target soil organisms following exposure to florasulam according
to the GAP of the formulation Saracen achieves the acceptability criteria TER ≥ 10 resp. TER ≥ 5 according
to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point
2.5.2. The results of the assessment indicate an acceptable risk for soil organisms due to the intended use
of florasulam in winter cereals according to the label.
none
6.9
Effects on soil microbial activity (MIIIA 10.7, KPC 10.5)
6.9.1
Moreover following studies were submitted for EU-evaluation and are listed in the DRAR to florasulam
from June 2014:
Species
Substance
Exposure
System
Results
Reference
Internal
code
C- & NMineralisation
DFP-ASTCA
28 d, aerob
< 25 %
Effect at
0.00760
mg/kg dw
Feil. N.
2011
101343
80512
ASTCA
28 d, aerob
< 25 %
Effect at 1.0
mg/kg dw
Feil, N.
2008
080039
77673
TSA
28 d, aerob
Feil, N.
< 25 %
Effect at 0.05 2011
110143
mg/kg dw
80511
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 13 of 17
6.9.2
Risk assessment
The evaluation of the risk for earthworms was performed in accordance with the recommendations of the
“Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services
(SANCO/10329/2002 rev 2 (final), October 17, 2002).
Please refer to above for the predicted environmental concentrations in soil (PECSOIL) of florasulam and
Saracen.
Table 6.9-1:
Risk assessment for effects on soil micro-organisms
Test substance
Test concentration
(adverse effects < 25%)
PECSOIL
Risk acceptable
[mg/kg]
[mg/kg]
[yes/no]
Florasulam
0.05
0.01
Yes
DFP-ASTCA
0.00760
0.0014
Yes
ASTCA
1.0
0.0021
Yes
TSA
0.05
0.0007
Yes
Saracen
0.1 a.s.
0.01
Yes
6.9.3
Overall conclusions
Based on the predicted concentrations of florasulam in soils, the risk to soil microbial processes following
exposure to florasulam according to the GAP of the formulation Saracen is considered to be acceptable/ not
acceptable according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2.
None.
6.10
Effects on non-target plants (MIIIA 10.8, KPC 10.6)
6.10.1
Effects on non-target terrestrial plants (MIIIA 10.8.1)
6.10.2
Toxicity
Please refer to the core assessment. The zRMS calculated a HC5, based on the ER50 of ten species. This
approach is not suitable for the vegetative vigour tests. Out of 10 species the ER50 values for five species
turned out to be “greater than” values. Therefore, they can not be used for the calculation of an HC5. The
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 14 of 17
five remaining ER50 values are insufficient for the calculation of a HC5. The most sensitive EC50 = 0.019 g
as/ha on Beta vulgaris is used for the risk assessment.
6.10.3
6.10.4
Risk assessment
The risk assessment is based on the “Guidance Document on Terrestrial Ecotoxicology”,
(SANCO/10329/2002 rev.2 final, 2002). It is restricted to off-field situations, as non-target plants are noncrop plants located outside the treated area. Spray drift from the treated areas may lead to residues of a
product in off-crop areas.
Exposure
Effects on non-target plants are of concern in the off-field environment, where they may be exposed to
spray drift. The amount of spray drift reaching off-crop habitats is calculated using the 90th percentile
estimates derived by the BBA (2000) from the spray-drift predictions of Ganzelmeier & Rautmann (2000).
Any dilution over the 3-dimensional vegetation surface is accounted for in the study design. Therefore, in
contrast to the assessment of risks to arthropods from standard laboratory tests, no vegetation distribution
factor is considered here.
PERoff-field= Maximum PERin-field (including MAF) x %drift
Florasulam has a vapour pressure of 10-5 Pa and is therefore classified as non-volatile. Hence, deposition
following volatilization has to be considered. The input parameters for Florasulam are given in Section 5.3.
For risk assessment purposes, a risk envelope approach was used. Hence, intended use groups D01, D02
and D03 cover the risk for non-target terrestrial plants from intended uses 00-001 until 00-006 (see Fehler!
Verweisquelle konnte nicht gefunden werden. 6.1.1).
Tier 1 assessment
The assessment of the risk to non-target arthropods due to an exposure to Saracen is performed on basis of
the calculation of toxicity-exposure ratios (TER values) according the following formula:
TER =
ER50 ( L product / ha)
Off − field PER ( L product / ha)
Table 6.10-1: Risk assessment for Florasulam for non-target arthropods for the entry route via
spraydrift and deposition following volatilization under the implementation of different risk mitigation measures – use group D01
Compound:
Intended use group:
Drift-Percentile:
Florasulam
D01
90th, agriculture
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 15 of 17
PERoff-field; conventional and drift reducing technique
Entry via
deposition
following
volatilization
0% conv.
50% red.
75% red.
90% red.
[%]
[g/ha]
[%]
[g/ha]
[g/ha]
[m]
1
2.77
0.208
-/-/0.208
0.104
0.052
0.021
5
0.57
0.043
-/-/0.043
0.021
0.011
0.004
Relevant toxicity endpoint: EC50 = 0.019 g a.s./ha (Beta vulgaris)
Relevant TER: 5
Buffer
zone
Entry via spraydrift
Buffer zone [m]
1
5
TER
0.1
0.2
0.4
0.9
Authorization is not possible – NT 109
0.4
1.8
0.9
4.4
PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold are above the relevant trigger.
Compound:
Intended use group:
Drift-Percentile:
Buffer
Entry via spraydrift
zone
Florasulam
D02
90th, agriculture
Entry via
deposition
following
volatilization
0% conv.
50% red.
75% red.
90% red.
[%]
[g/ha]
[%]
[g/ha]
[g/ha]
[m]
1
2.77
0.139
-/-/0.139
0.069
0.035
0.014
5
0.57
0.029
-/-/0.029
0.014
0.007
0.003
Relevant TER: 5
Buffer zone [m]
1
5
TER
0.1
0.7
0.3
1.3
0.5
2.7
1.4
6.7
NT 109
Compound:
Intended use group:
Drift-Percentile:
Buffer Entry via
zone
spraydrift
[m]
[%]
[g/ha]
Florasulam
D03
90th, agriculture
Entry via
deposition
following
volatilization
[%]
[g/ha]
0% conv.
50% red.
75% red.
[g/ha]
90% red.
Evaluator: zRMS DE
Date August 2014
Saracen
Central Zone
Page 16 of 17
1
2.77
0.104
-/-/0.104
5
0.57
0.021
-/-/0.021
Relevant TER: 5
Buffer zone [m]
1
5
TER
0.2
0.9
0.052
0.011
0.026
0.005
0.010
0.002
0.4
1.8
0.7
3.6
1.8
8.9
NT 109
The applicant provided tests with 10 plant species, including the sensitive species Beta vulgaris. Therefore,
the assessment factor can be lowered from 10 to 5.
6.10.5
Conclusion
Based on the predicted rates of Florasulam in off-field areas, the TER values describing the risk for nontarget plants following exposure to Florasulam according to the GAP of the formulation Saracen regarding
the indication 00-003 does is slightly below the acceptability criteria TER ≥ 5 according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. The calculation is based on the most sensitive species Beta vulgaris with an ER50 = 0.019 g a.s./ha. The next higher
ER50 value = 0.25 g a.s./ha for the mung bean, followed by an ER50 = 0.29 g a.s./ha for the tomato. Beta
vulgaris turned out to be very sensitive towards the active substance Florasulam. The factor between Beta
vulgaris and the next sensitive species mung bean is 10. From the 10 species tested, 5 turned out to have an
ER50 > 7.5 g a.s/ha, which is almost factor 400 towards the ER50 = 0.019 g a.s./ha for beta vulgaris. Therefore, the slight shortfall of the acceptability criteria is negligible.
Based on the predicted rates of Florasulam in off-field areas, the TER values describing the risk for nontarget plants following exposure to Florasulam according to the GAP of the formulation Saracen regarding
the indications 00-001, 00-002, 00-004, 00-005 and 00-006 achieve the acceptability criteria TER ≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles,
point 2.5.2. The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to
the intended use of Saracen in wintercereals and grassland according to the label.
Conditions for use
All indications
NT 109 (5 m distance; 90 %)
Evaluator: zRMS DE
Date August 2014
<formulation>
Central Zone
Page 17 of 17
Applicant: Insert company name
Evaluator: zRMS DE
Date July 2013
National Addendum
Germany
Saracen (CHA 5350)
ZV3 007767-00/00
Registration Report
Central Zone
Page 1 of 11
REGISTRATION REPORT
Part B
Section 7: Efficacy Data and Information
Detailed Summary
Product Code: Saracen (CHA 5350)
Reg. No.: ZV3 007767-00/00
Active Substance: 50 g/L florasulam
Central Zone
Zonal Rapporteur Member State: The United Kingdom
National Addendum Germany
Evaluator: Julius Kühn-Institut
Date: 2014-09-03
Julius Kühn-Institut
2014-09-03
Saracen (CHA 5350)
ZV3 007767-00/00
National Addendum
Germany
Registration Report
Central Zone
Page 2 of 11
Table of Contents
IIIA1 6
Efficacy Data and Information on the Plant Protection Product ............................ 3
General information ............................................................................................. 3
Recent registration situation/history of the PPP ................................................... 3
Information on the active ingredients (Uptake and mode of action) ..................... 3
Information on crops and pests ........................................................................... 3
Information on the intended uses for Germany .................................................... 3
IIIA1 6.1
Efficacy data........................................................................................................ 5
IIIA1 6.1.1
Preliminary range-finding tests ............................................................................ 5
IIIA1 6.1.2
Minimum effective dose tests .............................................................................. 5
IIIA1 6.1.3
Efficacy tests ....................................................................................................... 5
IIIA1 6.1.4
Effects on yield and quality .................................................................................. 5
IIIA1 6.1.4.1
Impact on the quality of plants and plant products ............................................... 5
IIIA1 6.1.4.2
Effects on the processing procedure ................................................................... 5
IIIA1 6.1.4.3
Effects on the yield of treated plants and plant products ...................................... 5
IIIA1 6.2
Adverse effects ................................................................................................... 5
IIIA1 6.2.1
Phytotoxicity to host crop..................................................................................... 5
IIIA1 6.2.2
Adverse effects on health of host animals ........................................................... 5
IIIA1 6.2.3
Adverse effects on site of application .................................................................. 6
IIIA1 6.2.4
Adverse effects on beneficial organisms (other than bees).................................. 6
IIIA1 6.2.5
Adverse effects on parts of plant used for propagating purposes ........................ 8
IIIA1 6.2.6
Impact on succeeding crops ................................................................................ 8
IIIA1 6.2.7
Impact on other plants including adjacent crops .................................................. 8
IIIA1 6.2.8
Possible development of resistance or cross-resistance ..................................... 8
IIIA1 6.3
Economics .......................................................................................................... 8
IIIA1 6.4
Benefits ............................................................................................................... 8
IIIA1 6.4.1
Survey of alternative pest control measures ........................................................ 8
IIIA1 6.4.2
Compatibility with current management practices including IPM.......................... 8
IIIA1 6.4.3
Contribution to risk reduction ............................................................................... 8
IIIA1 6.5
Other/special studies ........................................................................................... 8
IIIA1 6.6
Summary and assessment of data according to points 6.1 to 6.5 ........................ 9
IIIA1 6.7
List of test facilities including the corresponding certificates ................................ 9
Appendix 1:
List of data submitted in support of the evaluation ............................................... 9
Appendix 2:
GAP table.......................................................................................................... 10
2014-09-03
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ZV3 007767-00/00
National Addendum
Germany
IIIA1 6
Registration Report
Central Zone
Page 3 of 11
Efficacy Data and Information on the Plant Protection Product
General information
Refer to Registration Report for further information.
Recent registration situation/history of the PPP
Information on the active ingredients (Uptake and mode of action)
Information on crops and pests
Information on the intended uses for Germany
2014-07-01
Use No.
Field of use
Crop(s)/object(s)
007767-00/00-001
Agriculture (field crops)
winter soft wheat (TRZAW), winter barley (HORVW), winter rye
(SECCW), winter triticale (TTLWI)
Crop stage(s) (BBCH)
13 to 29
Pest(s)/target(s)
annual dicotyledonous weeds (TTTDS)
Area of application
Outdoors
Timing of application
Autumn
Max. number of treat- 1
ments for the use
ments per crop or season
Application
meth- spraying
od/kind of treatment
Application rate(s)
0.075 L/ha in 150 to 300 L water/ha
------------------------------------------------------Use No.
007767-00/00-002
Field of use
Crop(s)/object(s)
13 to 29
Pest(s)/target(s)
Area of application
Outdoors
Spring
ments for the use
Application
meth- spraying
Application rate(s)
2014-09-03
National Addendum
Germany
Saracen (CHA 5350)
ZV3 007767-00/00
Registration Report
Central Zone
Page 4 of 11
---------------------------Use No.
Field of use
Crop(s)/object(s)
---------------------------007767-00/00-003
30 to 39
Pest(s)/target(s)
Area of application
Outdoors
Spring
ments for the use
Application
meth- spraying
Application rate(s)
------------------------------------------------------Use No.
007767-00/00-004
Field of use
Crop(s)/object(s)
spring soft wheat (TRZAS), spring barley (HORVS), common oats
(AVESA)
13 to 29
Pest(s)/target(s)
Area of application
Outdoors
Spring
ments for the use
Application
meth- spraying
Application rate(s)
------------------------------------------------------Use No.
007767-00/00-006
Field of use
Crop(s)/object(s)
grasses (GGGGG)
13 to 32
Notes on crop
in crops for seed production
Pest(s)/target(s)
Area of application
Outdoors
Spring
ments for the use
Application
meth- spraying
Application rate(s)
Use 005 has been withdrawn by applicant
2014-09-03
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ZV3 007767-00/00
National Addendum
Germany
IIIA1 6.1
Registration Report
Central Zone
Page 5 of 11
Efficacy data
IIIA1 6.1.1
Preliminary range-finding tests
IIIA1 6.1.2
Minimum effective dose tests
IIIA1 6.1.3
Efficacy tests
According to the application form, the use of Saracen is intended for the control of annual dicotyledonous weeds (TTTDS). For some annual dicotyledonous weeds only a few or no efficacy
results have been submitted, which entails that a reliable evaluation of these weed species is
not possible.
Therefore and due to the fact that some cereals/varieties respond sensitively to herbicides, the
label warning WH9161 (The instructions for use must include a summary of weeds which can
be controlled well, less well and insufficiently by the product, as well as a list of species and/or
varieties showing which crops are tolerant of the intended application rate and which are not.) is
proposed.
IIIA1 6.1.4
Effects on yield and quality
IIIA1 6.1.4.1 Impact on the quality of plants and plant products
IIIA1 6.1.4.2 Effects on the processing procedure
IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products
IIIA1 6.2
Adverse effects
IIIA1 6.2.1
Phytotoxicity to host crop
IIIA1 6.2.2
Adverse effects on health of host animals
2014-09-03
National Addendum
Germany
IIIA1 6.2.3
Saracen (CHA 5350)
ZV3 007767-00/00
Registration Report
Central Zone
Page 6 of 11
Adverse effects on site of application
IIIA1 6.2.4
Adverse effects on beneficial organisms (other than bees)
Refer to Registration Report for further information. The herbicide Saracen (50 g/L Florasulam,
SC) has been proposed for one post emergence treatment per crop and season in cereals at a
maximum application rate of 0.15 L/ha, corresponding to 7.5 g/ha Florasulam.
During the course of the trials on effectiveness and selectivity observations indicating any effects whatsoever on beneficial organisms were not reported.
Appropriate studies on the potential adverse effects of the test product on beneficial arthropods
were available from Registration Report Part B, Section 6, Annex Point IIIA 10.5 (Effects on
Arthropods Other Than Bees), Core Assessment.
Summarized results from the EU assessment of the active ingredient florasulam (SANCO/1406/2001-final 18 September 2002) were referred to in Registration Report Part B, Section 6, Annex Point IIIA 10.5. (See Table 6.2.4-1; references and validity of the known studies
have been added):
In laboratory studies with the predatory mite Typhlodromus pyri, the parasitoid wasp Aphidius
rhopalosiphi and the ground beetle Poecilus cupreus, no effects > 30% on the beneficial capacity E (overall effect) were observed at the proposed rate (The study with Typhlodromus pyri was
known to be not valid).
In a laboratory test with the lacewing Chrysoperla carnea, the beneficial capacity was reduced
by 77.6% at the proposed rate.
In an extended laboratory test no effect occurred, but the study was known to be not valid.
Table 6.2.4-1: Effects of EF-1343 (50 g/L Florasulam)
Species
Substrate
Rate FlorasuBeneficial caReference
(Exposed Stage)
lam
pacity
[g/ha]
[%]
T. pyri (PN)
Glass
7.5
12.3
GHE-P-6706#
15
43.6
A. rhopalosiphi (A) Glass
7.5
25.2
GHE-P-6707
15
49.7
P. cupreus (A)
Quartz sand
7.5
0
GHE-P-6709
15
0
C. carnea (La)
Glass
7.5
77.6
GHE-P-6708
15
100
Natural substrate
7,5
0
EA97D5A061#
PN = protonymphs, A = adults, La = larvae, Re = reproduction, FC = food consumption
# studies GHE-P-6706 and EA97D5A061: not valid
Further detailed results on the toxicity were available from laboratory tests and extended laboratory tests, respectively, with the two indicator species Typhlodromus pyri and Aphidius
rhopalosiphi and with a further leaf dwelling species using the formulation Florasulam 50 SC
(Table 6.2.4-2):
2014-09-03
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Germany
Saracen (CHA 5350)
ZV3 007767-00/00
Registration Report
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Page 7 of 11
In a laboratory study with the predatory mite Typhlodromus pyri, no lethal or sublethal effects >
30% were observed up to 8fold the proposed rate.
In a laboratory study with the parasitoid wasp Aphidius rhopalosiphi, no lethal or sublethal effects > 30% were observed up to 16fold the proposed rate.
In an extended laboratory study with the lacewing Chrysoperla carnea, no lethal or sublethal
effects > 30% were observed up to 4fold the proposed rate.
Table 6.2.4-2: Effects of Florasulam 50 SC (=XDE-570 SC = EF-1343, 50-51 g/L Florasulam)
Species
Substrate
Rate FloCorrected
Sublethal
Reference
(Exposed Stage)
rasulam
Mortality
Effect
[g/ha]
[%]
[%]
T. pyri (PN)
Glass
7.5
7
TRC12-054BA
2
15
3
4
30
-4
0
60
25
8
120
35
28
A. rhopalosiphi (A) Glass
7.5
-6
TRC12-053BA
3
15
4
5
30
-2
8
60
1
8
120
-17
3
C. carnea (La)
Maize leaves
1.9
-41
TRC12-115BA
-4
3.7
-7
-4
7.5
19
-16
15
-57
4
30
-36
4
PN = protonymphs, A = adults, La = larvae, Re = reproduction
Conclusion
On the basis of the results of laboratory tests using a comparable substance at the proposed
maximum application rate of 0.15 L/ha, Saracen can be considered as not harmful for the
predatory mite Typhlodromus pyri, the parasitoid wasp Aphidius rhopalosiphi and the ground
beetle Poecilus cupreus.
As Typhlodromus pyri is not a relevant antagonist for the proposed crops, no classification is
necessary for this species. However the results for this sensitive indicator species indicate that
the test product will not be harmful for other, relevant predatory mites and spiders.
On the basis of the results of an extended laboratory test, the test product can be classified as
not harmful for the lacewing Chrysoperla carnea.
Classification according to IOBC:
Laboratory tests on inert substrates
< 30%
= not harmful
30 – 79%
= slightly harmful
≥ 80%
= harmful
Extended laboratory tests on natural substrates
< 25%
= not harmful
25 - 50%
= slightly harmful
2014-09-03
Saracen (CHA 5350)
ZV3 007767-00/00
National Addendum
Germany
> 50%
Registration Report
Central Zone
Page 8 of 11
= harmful
Adverse effects on soil quality indicators (e.g. microorganisms, earthworms) are considered in
Section 6 Ecotoxicological Studies in the Registration Report
IIIA1 6.2.5
Adverse effects on parts of plant used for propagating purposes
IIIA1 6.2.6
Impact on succeeding crops
IIIA1 6.2.7
Impact on other plants including adjacent crops
IIIA1 6.2.8
Possible development of resistance or cross-resistance
The increasing occurrence of dicotyledonous biotypes with ALS resistance in Europe emphasizes an increasing risk of resistance evolution for ALS active substances. In some major target
weed species such as Papaver rhoeas and Stellaria media resistance to florasulam has already
been detected in Germany. In addition, ALS inhibitors are frequently used in other main crop
species in Germany such as corn. The general resistance risk of Saracen under German conditions is therefore assessed as being high. The label warning WH951 (The risk of resistance has
to be indicated on the package and in the instructions of use. Particularly measures for an appropriate risk management have to be declared.) is proposed.
IIIA1 6.3
Economics
IIIA1 6.4
Benefits
IIIA1 6.4.1
Survey of alternative pest control measures
This is not an EC data requirement.
IIIA1 6.4.2
Compatibility with current management practices including IPM
IIIA1 6.4.3
Contribution to risk reduction
IIIA1 6.5
Other/special studies
2014-09-03
Saracen (CHA 5350)
ZV3 007767-00/00
National Addendum
Germany
IIIA1 6.6
Registration Report
Central Zone
Page 9 of 11
Summary and assessment of data according to points 6.1 to 6.5
IIIA1 6.7
List of test facilities including the corresponding certificates
Appendix 1: List of data submitted in support of the evaluation
No additional studies submitted.
2014-09-03
Saracen (CHA 5350)
ZV3 007767-00/00
National Addendum
Germany
Registration Report
Central Zone
Page 10 of 11
Appendix 2: GAP table
Reg.-No.
007767-00/00
GAP rev.1, date: 2014-09-02
PPP (product name/code)
active substance 1
active substance 2
active substance 3
active substance 4
active substance 5
Saracen
Florasulam
0
0
0
0
Formulation Type:
Conc. of a.s. 1:
Conc. of a.s. 2:
Conc. of a.s. 3:
Conc. of a.s. 4:
Conc. of a.s. 5:
SC
50 g/l
0
0
0
0
Applicant:
Zone(s):
central/EU
professional use
non professional use
Yes
No
Verified by MS:
yes
1
2
3
Use MemCrop and/
-No. ber
or situation
state(s)
(crop destination /
purpose of crop)
001
DE
4
5
6
7
F Pests or Group of
Application
G pests controlled
Method / Timing
/
or
Growth stage
I
(additionally: devel- Kind
of crop & seaopmental stages of
son
the pest or pest
group)
winter soft wheat F
(TRZAW),
winter
barley
(HORVW),
winter rye (SECCW),
winter
triticale
(TTLWI)
annual
donous
(TTTDS)
dicotyle- spraying
weeds
Autumn
13 to 29
8
9
10
11
12
Application rate
Max. number
(min.
interval between applications)
a) per use
b) per crop/
season
a)
b) 1
kg, L product
/ ha
a) max. rate
per appl.
b) max. total
rate
per
crop/season
g,
a.s./ha
PHI
(day
s)
kg Water
L/ha
a)
max. min
rate
per max
appl.
b)
max.
total
rate
per
crop/seaso
n
/
13
Remarks:
e.g. safener/synergist per ha
e.g. recommended or mandatory tank mixtures
1 a) 0.075 L/ha a) 0.00375 150 - 300 kg/ha
b) 0.075 L/ha
b) 0.00375
kg/ha
2014-09-03
Saracen (CHA 5350)
ZV3 007767-00/00
National Addendum
Germany
002
003
004
DE
DE
DE
005* DE
winter soft wheat F
(TRZAW),
winter
barley
(HORVW),
winter rye (SECCW),
winter
triticale
(TTLWI)
annual
donous
(TTTDS)
winter soft wheat F
(TRZAW),
winter
barley
(HORVW),
winter rye (SECCW),
winter
triticale
(TTLWI)
annual
donous
(TTTDS)
spring soft wheat F
(TRZAS),
spring
barley
(HORVS),
common
oats
(AVESA)
annual
donous
(TTTDS)
spelt (TRZSP)
annual
donous
(TTTDS)
F
dicotyle- spraying
weeds
Spring
13 to 29
Registration Report
Central Zone
Page 11 of 11
a)
b) 1
1 a) 0.1 L/ha a)
0.005 150 - 300 kg/ha
b) 0.10 L/ha
b)
0.005
kg/ha
dicotyle- spraying
weeds
Spring
30 to 39
a)
b) 1
1 a) 0.15 L/ha a) 0.0075 150 - 300 kg/ha
b) 0.15 L/ha
b) 0.0075
kg/ha
dicotyle- spraying
weeds
Spring
13 to 29
a)
b) 1
1 a) 0.1 L/ha a)
0.005 150 - 300 kg/ha
b) 0.10 L/ha
b)
0.005
kg/ha
dicotyle- spraying
weeds
Spring
13 to 32
a)
b) 1
1 a) 0.1 L/ha a)
0.005 200 - 400 kg/ha
b) 0.10 L/ha
b)
0.005
kg/ha
006
DE
grasses (GGGGG) F
in crops for seed
production
annual
donous
(TTTDS)
dicotyle- spraying
weeds
Spring
13 to 32
a)
b) 1
1 a) 0.1 L/ha a)
0.005 200 - 400 kg/ha
b) 0.10 L/ha
b)
0.005
kg/ha
*Withdrawn by applicant
2014-09-03
Saracen (CHA 5350)
National Addendum – Germany
Registration Report
Central Zone
zRMS: UK
Page 1 of 11
REGISTRATION REPORT
Part B
Section 8 Assessment of the relevance of
metabolites in groundwater
Product code:
Saracen (CHA 5350)
Active Substance(s): 50 g/L Florasulam
Central Zone
NATIONAL ADDENDUM – Germany
Applicant:
Date:
Cheminova A/S
August 2014
Evaluator: Germany
Date: August 2014
National Addendum – Germany
Saracen (CHA 5350)
Registration Report
Central Zone
zRMS: UK
Page 2 of 11
Table of Contents
Sec 8
ASSESSMENT OF THE RELEVANCE OF METABOLITES IN
GROUNDWATER....................................................................................... 3
8.1
8.1.1
8.2
8.3
8.3.1
8.3.1.1
8.3.1.2
8.4
8.4.1
8.4.1.1
8.4.2
8.4.3
8.5
8.6
8.6.1
8.6.2
Appendix 1.
Introduction .................................................................................................... 3
Florasulam...................................................................................................... 3
Exclusion of degradation products of no concern.......................................... 5
Quantification of potential groundwater contamination (Step 2) .................. 5
Florasulam...................................................................................................... 5
Exposure assessment for Germany ................................................................ 5
Conclusions .................................................................................................... 6
Hazard Assessment: Identification of relevant metabolites (Step 3) ............. 7
Screening for biological activity .................................................................... 7
Florasulam-metabolites .................................................................................. 7
Screening for genotoxicity ............................................................................. 7
Screening for toxicity..................................................................................... 8
Exposure assessment – threshold of concern approach (Step 4) ................... 8
Refined risk assessment for non-relevant metabolites (Step 5) ..................... 8
Refined toxicological risk assessment for non-relevant metabolites ............. 8
Refined ecotoxicological risk assessment for non-relevant metabolites ....... 9
Reference list ................................................................................................. 9
Evaluator: Germany
Date: August 2014
Core Assessment & National
Addendum – Germany
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 3 of 11
Sec 8
ASSESSMENT OF THE RELEVANCE OF METABOLITES IN
GROUNDWATER
8.1
Introduction
The applicant Cheminova has no access to the toxicology data that was evaluated in this Section 8 (see
Appendix I). Cheminova has submitted genotoxicity data on the metabolites TSA and ASTCA: This data
was evaluated after the Section 8 has been written. The evaluation of this data leads to the same
conclusions. Section 8 has only been adapted in Appendix I.
8.1.1
Florasulam
The active substance florasulam has been approved according to Regulation (EC) No 1107/2009.
Table 8.1-1:
Identity, further information on florasulam
Active substance (ISO common name)
florasulam
IUPAC
2', 6', 8-Trifluoro-5-methoxy-[1,2,4]-triazolo [1,5-c]
pyrimidine-2-sulfonanilide
Function (e.g. fungicide)
Herbizide
Status under Reg. (EC) No 1107/2009
Approved
Date of approval
01.10.2002
Conditions of approval
Only uses as herbicide may be authorised. For the implementation
of the uniform principles of Annex VI, the conclusions of the
review report on florasulam, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain
and Animal Health on 19 April 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.
Confirmatory data
None
RMS
Belgium
Minimum purity of the active substance as
manufactured (g/kg)
970
Molecular formula
C12H8O3N5F3S
Molecular mass
359.3
Structural formula
MeO
N
N N
F
NH
SO 2
N
F
F
Evaluator: Germany
Date: August 2014
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 4 of 11
Environmental occurring metabolites of florasulam are summarized in Part B, National Addendum,
Section 5, Table 5.3-3.
The soil metabolites of Florasulam for wich the leaching potentials into groundwater was assessed are
summarised in Table 8.1-2.
Table 8.1-2:
Metabolite
5-OH-XDE-570
XDE-570 5hydroxy,
N-(2,6difluorophenyl)8-fluoro-5hydroxyl (1,2,4)
triazolo(1,5c)
pyrimidine-2sulphonamide
Metabolites of florasulam relevant for groundwater exposure assessment
Structural formula/
Molecular weight
Maximum occurence in
compartements
OH
F
Soil, aerob:
N N
N max. 71.6 % at d 3
Water:
N
max. 64 % at d 60
F
F
Sediment:
max. 35 % at d 60
M = 345.26 g/mol
(Soil photolysis: 60 %)
O
N S
O
Aquatic organism:
Water: not relevant
Sediment: not relevant
assessed
(Step 2)1)
F
DFP-ASTCA
M3
Soil, aerob:
max. 17.8 % at d 28
N
Water:
N
COOH max. 15 % at d 100
Sediment:
max. 9.15 % at d 182
H
N
O
N S
H
O
N-(2,6F
difluorophenyl)5aminosulphonyl- M = 274.25 g/mol
1H-1,2,4)triazole3-carboxylic acid
ASTCA
M4
Status of relevance
(see SANCO/1406/2001 - 18
September 2002)
O
H2 N S
O
H
N
N
assessed
(Step 2)1)
Soil, aerob:
max. 40.0 % at d 59
N
Aquatic organism:
Water: not assessed
COOH
Aquatic organism:
Water: not assessed
5(aminosulphonyl) M = 162.17g/mol
-1H-1,2,4triazole-3carboxylic acid
assessed
(Step 3-4)1)
TSA
M6
O
H2N S
O
N
NH
Soil, aerob:
max. 15.9 % at d 100
Aquatic organism:
Water: not assessed
N
1H-1,2,4-triazole3-sulphonamide M = 148.14 g/mol
assessed
Groundwater: not assessed
Evaluator: Germany
Date: August 2014
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 5 of 11
1)
According to Guidance Document on the assessment of the relevance of metabolites in groundwater of substances regulated
under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February 2003)
8.2
Exclusion of degradation products of no concern
According to Part 4, Step 1 of SANCO/221/2000 –rev.10, 25 February 2003 – Guidance Document on the
Assessment of the Relevance of Metabolites in Groundwater of Substances Regulated Under Council
Directive 91/414/EEC, metabolites of no concern are:
- CO2 or an inorganic compound not containing a heavy metal
- an organic compound of aliphatic structure (chain length < 4) which consist only C, H, N, or O
atoms
- a substance, which is naturally occurring and of no toxicological and ecotoxicological concern
None of these criteria are met for metabolites of florasulam relevant for groundwater exposure assessment
(see table 8.1 2). Therefore, further assessment at Step 2 of this guidance document is required.
8.3
Quantification of potential groundwater contamination (Step 2)
8.3.1
Florasulam
8.3.1.1
Exposure assessment for Germany
PECGW calculations after leaching from soil for florasulam and its metabolites (see Table 8.1-2) were
performed using the simulation model FOCUS PELMO 5.5.3 (see Part B, National Addendum, Section
5.7.1).
The following uses of Saracen were considered.
Input parameters related to application for PECGW modelling with FOCUS PELMO 5.5.3
use evaluated
A/00-001 autumn application
A/00-002 spring application (covers also use No. 00-003)
B/00-004 spring application (covers also use No. 00-005)
application rate (kg as/ha)
A/00-001
A/00-002
B/00-004
0.00375 kg as ha-1
0.005 kg as ha-1
0.005 kg as ha-1
crop (crop rotation) and
date of application
A/00-001
A/00-002
B/00-004
winter cereals
winter cereals
spring cereals
interception (%)
A/00-001
A/00-002
B/00-004
25%
50%
25%
soil effective application rate
(g as/ha)
A/00-001
A/00-002
B/00-004
0.0028125 kg as ha-1
0.0025 kg as ha-1
0.00375 kg as ha-1
soil moisture
100 % FC
Q10-factor
2.58
moisture exponent
0.7
plant uptake
0
15th of november
6th of april
6th of april
Evaluator: Germany
Date: August 2014
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 6 of 11
26
simulation period (years)
The result of the PECgw calculation with FOCUS PELMO 5.5.3 for the intended use of for the intended
use of Saracen in spring and winter cereals in Germany are summarised in Table 8.3-1.
Table 8.3-1
PECGW at 1 m soil depth of Florasulam and its metabolites considered relevant for
German exposure assessment
80th Percentile PECGW at 1 m Soil Depth (µg L-1)
modeled by FOCUS PELMO 5.5.3
Use No.
Szenario
florasulam
metabolite
5-OH
metabolite
DFP-ASTCA
metabolite
ASTCA
metabolite
TSA
A/00-001
winter
cereals,
autumn
applic.
Hamburg
0.001
<0.001
<0.001
0.063
0.118
Kremsmünster
0.005
0.001
0.093
0.219
0.058
A/00-002
winter
cereals,
spring
applic.
Hamburg
<0.001
<0.001
<0.001
0.47
0.103
Kremsmünster
<0.001
<0.001
0.026
0.215
0.062
B/00-004
winter
cereals,
spring
applic.
Hamburg
<0.001
<0.001
<0.001
0.066
0.151
Kremsmünster
<0.001
<0.001
0.029
0.349
0.105
≥ 0.1 µg/L can be excluded. For the metabolites ASTCA and TSA of florasulam a groundwater
concentration of ≥ 0.1 µg/L cannot be excluded.
8.3.1.2
Conclusions
The metabolites that are relevant according to Step 2 of this assessment are summarized in Table 8.3-2.
Table 8.3-2:
Summary of PECgw of the soil metabolites of Florasulam for the intended uses
Saracen in spring and winter cereals (simulation with FOCUS PELMO 5.5.3)
Metabolite
PEC gw
Maximum concentration in
ground water
Status of relevance
(see SANCO/1406/2001 - 18
September 2002)
ASTCA
National Addendum
National Addendum Germany: Groundwater: not relevant
(Step 3-4)
Germany:
0.349 µg/L
> 0.1 µg/L in the scenario
Kremsmünster
TSA
National Addendum
National Addendum Germany: Not assessed
Germany:
0.151 µg/L
> 0.1 µg/L in the scenario
Evaluator: Germany
Date: August 2014
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 7 of 11
Hamburg
A relevance assessment for the metabolite TSA is required.
8.4
Hazard Assessment: Identification of relevant metabolites (Step 3)
8.4.1
Screening for biological activity
8.4.1.1
Florasulam-metabolites
The comparison of the aquatic plants and algae study results and QSAR modellings for the metabolites
with the results of studies performed with florasulam show that florasulam is several orders of magnitude
more toxic to aquatic organisms than the metabolites.
8.4.2
Screening for genotoxicity
ASTCA
ASTCA has been subjected to genotoxicity screening in the following tests: in vitro mutagenicity in
bacteria, gene mutation assays, in vitro chromosomal aberration assay (DRAR Florasulam - Volume 3,
Annex B.6: Toxicology and Metabolism, Poland, June 2014).
Summary of toxicity studies on ASTCA
l
e
R
Table 8.4-1:
Type of test
Salmonella Escherichia coli/MammalianMicrosome Reverse Mutation Assay
Preincubation Method with a
Confirmatory Assay (strains TA98,
TA100, TA1535, and TA1537; WP2uvrA)
Chinese Hamster Ovary
Cell/Hypoxanthine-GuaninePhosphoribosyl Transferase
(CHO/HGPRT) Forward Mutation Assay
negative
Purity,
batch n°
Test Substance No.
TSN106485, Purity:
100%
References
M. S. Mecchi
2008*
ASB2011-1365
M. R. Schisler
Test Substance No.
TSN106485,
2008*
5-(Aminosulfonyl)-1HASB2011-1366
1,2,4-triazole-3carboxylic acid
compound with N,N,diethylethanamine (1:1)
(100%).
M. R. Schisler
In Vitro Chromosomal Aberration Assay
Test Substance No.
negativ
TSN106485,
2008*
Utilizing Rat Lymphocytes
5-(aminosulfonyl)-1HASB2011-1367
1,2,4-triazole-3carboxylic acid
compound with N,N,diethylethanamine (1:1)
(100 %)
* Test is reported in the DRAR Florasulam - Volume 3, Annex B.6: Toxicology and Metabolism, Poland, June 2014
negative
In summary ASTCA is regarded as non-genotoxic, therefore ASTCA has successfully passed the
genotoxicity screening criteria.
TSA
Evaluator: Germany
Date: August 2014
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 8 of 11
TSA has been subjected to genotoxicity screening in the following tests: in vitro mutagenicity in bacteria,
gene mutation assay, in vitro chromosomal aberration assay (DRAR Florasulam - Volume 3, Annex B.6:
Toxicology and Metabolism, Poland, June 2014).
Summary of toxicity studies on TSA
l
e
R
Table 8.4-2:
Type of test
Bacterial Reverse Mutation Test using
Salmonella typhimurium (strains: TA1537,
TA1535, TA98, TA100 and TA102)
negative
In vitro Mammalian Cell Gene Forward
Mutation Test at the HGPRT Locus of the
Chinese Hamster Ovary (CHO)-K1 Cell
Line
In vitro Mammalian Chromosome
Aberration Test in Human Peripheral
Blood Lymphocytes
negative
Purity,
batch n°
Test Substance No.
GLCDAG-070211
99%
Test Substance No.
GLCDAG-070211
99%
References
Nagane, R.M.
(2011) *
ASB2013-1486
Nagane, R.M.
(2011) *
ASB2013-1487
Nagane, R. M.
(2011) *
ASB2013-1488
* Test is reported in the DRAR Florasulam - Volume 3, Annex B.6: Toxicology and Metabolism, Poland, June 2014
negative
99%
In summary TSA is regarded as non-genotoxic, therefore TSA has successfully passed the genotoxicity
screening criteria.
8.4.3
Screening for toxicity
This screening stage is designed to determine whether metabolites have certain toxicological properties
which would qualify them as being considered ‘relevant’ according to EC guidance document
SANCO/221/2000 –rev.10 (SANCO, 2003). The starting point for this assessment involves considering
the classification of the parent active substance, florasulam, under Regulation (EC) 1272/2008 (or earlier
directives, e.g., Directive 67/548/EEC). The active substance, florasulam, is not classified as “toxic” or
“very toxic” (symbols T and T+, respectively), nor is it classified as a carcinogen, genotoxic, or a
developmental/ reproductive toxin.
Independent of the classification of the parent active substance, there is no reason to expect that the
groundwater metabolites ASTCA or TSA may be toxic or highly toxic. Therefore no targeted testing is
necessary.
8.5
Exposure assessment – threshold of concern approach (Step 4)
The metabolites ASTCA and TSA have a lower biological activity than the parent, are not genotoxic, and
are not defined as toxic. Therefore, ASTCA and TSA have not been identified as being relevant according
to the hazard screening outlined in Step 3 according to EC guidance document SANCO/221/2000 –rev.10
(SANCO, 2003). A threshold of 0.75 µg/L can be considered acceptable for the groundwater metabolites
ASTCA and TSA, respectively.
8.6
Refined risk assessment for non-relevant metabolites (Step 5)
8.6.1
Refined toxicological risk assessment for non-relevant metabolites
No further consideration of its potential risk is required in step 5 because the groundwater metabolites
ASTCA and TSA do not exceed groundwater concentrations of 0.75 µg/L (threshold of concern).
Evaluator: Germany
Date: August 2014
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 9 of 11
8.6.2
Refined ecotoxicological risk assessment for non-relevant metabolites
8.6.2.1
Florasulam-metabolites
The refined risk assessment is presented in the following tables:
Table 8.6-1:
Refined risk assessment for non-relevant florasulam metabolites for Germany
Substance
PECGW
[µg/L]
ASTCA
TSA
0.349
0.151
Acute toxicity
endpoint
crustacean
[µg/L]*
>30
>30
TERcrustacean
PECGW/10
(“PEC(SW)”)
[µg/L]
86
199
0.349
0.151
Most sensitive
aquatic toxicity
endpoint
[µg/L]
>10200
>100000
TER(SW)
29226
662252
(SW) : ground water becoming surface water
* Endpoint from the DAR June 2013 (Kirk and Marino 1998)
TER values well achieve the acceptability criterium of TER ≥ 100 respectively TER ≥ 10.
8.6.2.2
Conclusion
The metabolites ASTCA and TSA are ecotoxicologically not relevant for groundwater (crustacean) and
not relevant for aquatic organisms if groundwater becomes surface water again. All TER values were well
above the acceptability criterium of TER ≥ 100 (acute data) respectively TER ≥ 10 (chronic data).
Appendix 1.
Reference list
Annex
point/
reference
No
Author(s)
Year Title
Report-No.
Authority registration No
IIA 5.8
Mecchi, M. S.
2008
IIA 5.8
Nagane, R. M.
2011
Salmonella-escherichia coli/mammalian-microsome
reverse mutation assay preincubation method with a
confirmatory assay with ASTCA metabolite of
Florasulam
071120 ! 6736-192
GLP: Yes
Published: No
BVL-2052092, BVL-2147242, BVL-2147573,
BVL-2184741, BVL-2199778, BVL-2199778,
BVL-2199778, BVL-2199778, BVL-2209513,
BVL-2546290,
ASB2011-1365
In vitro mammalian cell gene forward mutation test
at the hgprt locus of the chinese hamster ovary
(CHO)-K1 cell line using TSA metabolite of
Florasulam
110430
GLP: Yes
Published: No
BVL-2382321, BVL-2382321,
ASB2013-1487
Data
protection
claimed
Owner How
considered in
dRR *
Yes (7) Open
(3)
DOW
DPB
Add N
Yes (1) Open
(1)
DOW
Add N
Evaluator: Germany
Date: August 2014
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 10 of 11
Annex
point/
reference
No
Author(s)
Year Title
Report-No.
IIA 5.8
Nagane, R. M.
2011
IIA 5.8
Nagane, R. M.
2011
IIA 5.8
Schisler, M. R.,
Geter, D. R.
2008
IIA 5.8
Schisler, M. R.,
Kleinert, K. M.,
Geter, D. R.
2008
IIA 5.8
Thompson, P.W.
2014
IIA 5.8
Brown, R.
2013
In vitro mammalian chromosome aberration test of
TSA metabolite of Florasulam in human peripheral
blood lymphocytes
110431
GLP: Yes
Published: No)
BVL-2382355, BVL-2382355,
ASB2013-1488
Bacterial reverse mutation test of TSA metabolite of
Florasulam using Salmonella Typhimurium
110432 ! 481-1-06-2308
GLP: Yes
Published: No
BVL-2382320, BVL-2382320,
ASB2013-1486
Evaluation of Florasulam ASTCA metabolite in the
chinese hamster ovary cell/hypoxanthine-guaninephosphoribosyl transferase (CHO/HGPRT) forward
mutation assay
10000797-297-1 ! 071133 ! DECO HET DR-04173277-003
GLP: Yes
Published: No
BVL-2052093, BVL-2147244, BVL-2147575,
BVL-2184740, BVL-2199777, BVL-2199777,
BVL-2199777, BVL-2199777, BVL-2209515,
BVL-2546288,
ASB2011-1366
Evaluation of Florasulam Astca Metabolite in an in
vitro chromosomal aberration assay utilizing rat
lymphocytes
10000797-303-1 ! 071132 ! DECO HET DR-04170277-002
GLP: Yes
Published: No
BVL-2052094, BVL-2147243, BVL-2147574,
BVL-2184739, BVL-2199776, BVL-2199776,
BVL-2199776, BVL-2199776, BVL-2209514,
BVL-2546286,
ASB2011-1367
Metabolite I: TSA: Reverse Mutation Assay 'Ames
Test' using Salmonella typhimurium and
Escherichia coli
41303677 (324 FOM)
GLP: Yes
Published: No
BVL-2762286
Metabolite I: TSA: L5178Y TK +/- Mouse
Lymphoma Assay
41303678 (313 FOM)
GLP: Yes
Published: No
BVL-2762287
Data
protection
claimed
Owner How
considered in
dRR *
Yes (1) Open
(1)
DOW
Add N
Yes (1) Open
(1)
DOW
Add N
Yes (7) Open
(3)
DOW
DPB
Add N
Yes (7) Open
(3)
DOW
DPB
Add N
Yes
CHE
Add
Yes
CHE
Add
Evaluator: Germany
Date: August 2014
Saracen (CHA 5350)
Registration Report
– Central Zone
Page 11 of 11
Author(s)
Year Title
Report-No.
IIA 5.8
Morris, A.
2014
Metabolite I: TSA: Micronucleus Test in Human
Lymphocytes in vitro
41303679 (314 FOM)
GLP: Yes
Published: No
BVL-2762288
Yes
CHE
Add
IIA 5.8
Flügge, C.
2013
Mutagenicity study of ASTCA in the Salmonella
typhimurium Reverse Mutation Assay (in vitro)
29409 (227 FOM)
GLP: Yes
Published: No
BVL-2762294
Yes
CHE
Add
IIA 5.8
Brown, R.
2014
Metabolite II: ASTCA: L5178Y TK +/- Mouse
Lymphoma Assay
41303680 (325 FOM)
GLP: Yes
Published: No
BVL-2762295
Yes
CHE
Add
IIA 5.8
Flügge, C.
2013
In vitro assessment of the micronucleus test of
ASTCA in cultured CHO cells
29410 (234 FOM)
GLP: Yes
Published: No
BVL-2762296
Yes
CHE
Add
IIA 5.8
Poland
2014
Renewal Draft Assessment Report and Proposed
Decision of the Poland prepared in the context of
the re-authorisation procedures of florasulam in
Annex I of Regulation (EC) No 1107/2009
(Reviewed)
Rapporteur Member State: Poland
Florasulam - Volume 3, Annex B.6: Toxicology and
Metabolism
* Y:
N:
Add:
Data
protection
claimed
Owner How
considered in
dRR *
Annex
point/
reference
No
Add
Yes, relied on
No, not relied on
Relied on, study not submitted by applicant but necessary for evaluation
Evaluator: Germany
Date: August 2014

Florasulam final RR 1107 Part B Section 8 Nat Saracen CHE DE

Transcription

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