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REGISTRATION REPORT Part A
Risk Management
Product code: U 46 M-Fluid Active Substance: MCPA 500 g/L as DMA salt 612.35 g/L
COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany
NATIONAL ASSESSMENT
Applicant: Nufarm Date: 21/04/2017
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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 2 Details of the authorisation 5 2.1 Product identity 5 2.2 Classification and labelling 5 2.2.1 Classification and labelling under Directive 99/45/EC 5 2.2.2 Classification and labelling under Regulation (EC) No 1272/2008 5 2.2.3 Standard phrases under Regulation (EC) No 547/2011 6 2.3 Other phrases notified under Regulation (EC) No 547/2011 6 2.3.1 Restrictions linked to the PPP 6 2.3.2 Specific restrictions linked to the intended uses 8 2.4 Product uses 10 3 Risk management 13 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 13 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 13 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 13 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 13 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 13 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 14 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 14 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 14 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 14 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 14 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 16 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 16 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 16 3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 16
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) 17
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3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 17
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) 19
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) 19 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 20 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 20 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 21 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 22 3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) 23 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 23 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 23 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 23 3.1.7 Efficacy (Part B, Section 7, Point 8) 27 3.2 Conclusions 29 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 29 Appendix 1 – Copy of the product authorisation 30 Appendix 2 – Copy of the product label 31 Appendix 3 – Letter of Access 32
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PART A – Risk Management This document describes the acceptable use conditions required for the re-registration/registration of U 46 M-Fluid containing MCPA in Germany. This evaluation is required subsequent to the inclusion of MCPA on Annex 1.
The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-8 and Part C and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national re-registration/registration by the EU review. It also includes assessment of data and information relating to U 46 M-Fluid where that data has not been considered in the EU review. Otherwise assessments for the safe use of U 46 M-Fluid have been made using endpoints agreed in the EU review of MCPA.
This document describes the specific conditions of use and labelling required for Germany for the re- registration/registration of U 46 M-Fluid.
Appendix 1 of this document provides a copy of the final product authorisation for Germany. Will be inserted in the final version.
Appendix 2 of this document is a copy of the approved product label for Germany The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label has to fulfil the requirements according to Article 16 of Directive 91/414/EEC.
Appendix 3 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation. Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
1 Details of the application
1.1 Application background This application was submitted by Nufarm Deutschland GmbH on 21st December 2013.
The application was for approval of U 46 M-Fluid, a soluble concentrate (SL) containing 500 g/l MCPA for use as a herbicide in grassland, field crops, fruits and wine.
1.2 Annex I inclusion MCPA was included on Annex I of Directive 91/414/EEC on 01/05/2006 under Inclusion Directive 2005/57/EC. The approval period was extended by Commission Regulation (EU) No 762/2013 of 07/08/2013. Expiration of approval: 31/10/2017.
The Annex I Inclusion Directive for MCPA (2005/57/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.
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For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15/04/2005, 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 should include risk mitigation measures, where appropriate. Member States must 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 should include risk mitigation measures, where appropriate.
These concerns were all addressed in the submission.
1.3 Regulatory approach Where protection for data is being claimed for information supporting registration of U 46 M-Fluid (CA2643), it is indicated in the reference lists in Appendix 1 of the respective documents of the Registration Report.
1.4 Data protection claims Data access has been proven. Nufarm is the owner of all data. This point is not relevant.
2 Details of the authorisation
2.1 Product identity
Product Name U 46 M-Fluid (CA2643) Authorization Number 060939-00 (for re-registration) Function herbicide Applicant Nufarm Composition 500 g/L MCPA as DMA salt: 612.35 g/L Formulation type Soluble concentrate [Code: SL] Packaging 1-20 l jerry can HDPE 1-20 l jerry can PET
2.2 Classification and labelling
2.2.1 Classification and labelling under Directive 99/45/EC Not proposed anymore.
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:
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Hazard classes and categories: Eye Dam. 1, Acute Tox. 4 Hazard pictograms: GHS05 corrosion GHS07 exclamation mark GHS09 environment Signal word: Danger Hazard statements: H302 Harmful if swallowed. H318 Causes serious eye damage. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Precautionary statemtents: P101 If medical advice is needed, have product container or label at hand. P102 Keep out of reach of children. P264 Wash ... thoroughly after handling. P270 Do no eat, drink or smoke when using this product. P280 Wear protective gloves/protective clothing/eye protection/face protection. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P308+P310 IF exposed or concerned: Immediately call a POISON CENTER or a doctor/physician. P501 Dispose of contents/container to ...
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: -
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):
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Human health protection SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB110 The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. SB199 When applying the product with tractor-mounted, trailed or self-propelled application equipment, only vehicles with closed pressurized cabins (e.g. cabin category 3, if no respiratory protective equipment or particle-filtering masks are necessary or category 4, if gas-tight respiratory protective equipment is needed acc. to EN 15695-1 and -2) are suited to replace personal protective equipment during application. During all other activities outside of the cabin the prescribed personal protective equipment must be worn. In order to avoid contamination of the cabin, it is not permitted to enter the cabin with contaminated personal protective equipment (it should be deposited e.g. in an appropriate storage facility). Contaminated gloves should be washed before removing the gloves and hands should be washed before entering the cabin with pure water, respectively. SE110 Wear tight fitting eye protection when handling the undiluted product. SF1891 Re-entering the treated areas/crops are only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. SS110 Wear standard protective gloves (plant protection) when handling the undiluted product. SS206 Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. SS2202 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. Integrated pest management (IPM)/sustainable use WMO Mode of action (HRAC-group): O WH952 The indication identifying the mode of action must be assigned directly to each corresponding name of the active substance as supplementary information on the packaging and in the instructions for use. 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 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
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drainage system and to rain-water and sewage canals.
The authorization of the PPP is linked to the following conditions (voluntary labelling):
Integrated pest management (IPM)/sustainable use 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)
Integrated pest management (IPM)/sustainable use WH9161 The instructions for use must include a summary of weeds which can be controlled well, For uses less well and insufficiently by the product, as well as a list of species and/or varieties 001 – 005 showing which crops are tolerant of the intended application rate and which are not. WW742 The product has no sustainable effect in perennial weeds. For use 003 - 005 WP733 Damage is possible to the crop, including yield reduction. For use 003 Ecosystem protection NG404 Between treated areas with an incline of more than 2% and surface water - except only (Use No. occasionally but including periodically water-bearing surface water - there must be a 00-004) border under complete plant cover. The border's protective function must not be impaired by the use of implements. It must be at least 20 m wide. This border is not necessary if: - sufficient catching systems are available for the water and soil transported by run-off, which do not flow into surface water or are not connected with the urban drainage system or - the product is used for mulch or direct drilling methods. NW 642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters. (Use No. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law 00-001, must be observed. Violations may be punished by fines of up to 50 000 EUR. 00-002, 00-003 and 00-004 NT 108 A buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or (Use No. horticulturally used areas, roads, paths and public places). In addition, in an adjoining strip 00-001 and of at least 20 m, the product must be applied using loss reducing equipment which is 00-002) registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette
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No 205, p. 9780) as amended, and be registered in at least drift reducing class 75 %. 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 NT 109 A buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or (Use No. horticulturally used areas, roads, paths and public places). In addition, in an adjoining strip 00-003 and of at least 20 m, the product must be applied using loss reducing equipment which is 00-004) 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
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2.4 Product uses GAP rev. (No), date: 2016-07-22
PPP (product name/code): U 46 M-Fluid Formulation type: SL Active substance: MCPA Conc. of as: 500 g/L
Applicant: Nufarm Professional use: X Zone(s): central/EU Non-professional use:
Verified by MS: yes
1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Membe Crop and/ F Pests or Group of Application Application rate PHI Remarks: No. r or situation G pests controlled (days) state(s) or Method / Timing / Growth Max. number kg, L product / g, kg as/ha Water e.g. safener/synergist (crop destination / I (additionally: Kind stage of crop & (min. interval ha L/ha per ha purpose of crop) developmental stages of season between a) max. rate a) max. rate per the pest or pest group) applications) per appl. appl. min / max e.g. recommended or a) per use b) max. total b) max. total rate mandatory tank b) per crop/ rate per per crop/season mixtures season crop/season 001 DE Winter soft wheat F Dicotyledonous weeds Spraying After emergence a) 1 a) 1.4 L/ha a) 700 g as/ha 200 - 400 F NW 642-1, TRZAW TTTDD BBCH 13 – 39 b) 1 b) 1.4 L/ha b) 700 g as/ha NT108, winter durum wheat Annual dicotyledonous spring WH9161 TRZDW weeds Spelt TTTDS TRZSP Creeping thistle winter barley CIRAR HORVW winter rye SECCW winter triticale
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TTLWI 002 DE Spring soft wheat F Dicotyledonous weeds Spraying After emergence a) 1 a) 1.4 L/ha a) 700 g as/ha 200 - 400 F NW 642-1, TRZAS TTTDD BBCH 13 – 39 b) 1 b) 1.4 L/ha b) 700 g as/ha NT108, spring durum wheat Annual dicotyledonous spring WH9161 TRZDS weeds spring barley TTTDS HORVS Creeping thistle common oats CIRAR AVESA spring rye SECCS 003 DE Grassland, pasture, F Dicotyledonous weeds Spraying BBCH 13 – 35 a) 1 a) 2 L/ha a) 1000 g 200 - 400 14 d NW 642-1, meadow TTTDD spring b) 1 b) 2 L/ha as/ha NT109, NNNFW BBCH 25 – 35 b) 1000 g WH9161, as/ha May to August WP733, WW742 004 DE Pome fruit F Dicotyledonous weeds Spraying March to a) 1 a) 2 L/ha a) 1000 g 200 - 400 F NG404, NNNOK TTTDD with September b) 1 b) 2 L/ha as/ha NW 642-1, screen stone fruits b) 1000 g NT109, as/ha NNNOS WH9161, WW742 from 1st year after planting 005 DE Grape vine F Dicotyledonous weeds Spraying March to a) 1 a) 4 L/ha a) 2000 g 200 - 600 F No authorization due VITVI TTTDD September b) 1 b) 4 L/ha as/ha to contamination of groundwater due to utilisation as wine b) 2000 g as/ha surface runoff into the and table grape with adjacent ditch with up to 3rd year after screen subsequent bank planting of the vine filtration. WH9161, WW742
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Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (8) The maximum number of applications possible under practical conditions of use for each single (2) Member State(s) or zone for which use is applied for application and per year (permanent crops) or crop (annual crops) must be provided (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (8) Min. interval between applications (days) were relevant situation should be described (e.g. fumigation of a structure) (10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) must be given in metric units (e.g. kg or L product / ha) (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 (11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of crop/season must be given in metric units (e.g. g or kg / ha) equipment used must be indicated (12) The range (min/max) of water volume under practical conditions of use must be given (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, (L/ha) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of (13) PHI - minimum pre-harvest interval application (14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
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3 Risk management
3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles
3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) Overall Summary: The product CA2643 is a soluble concentrate formulation. All studies have been performed in accordance with the current requirements, the critical GAP and the results are deemed to be acceptable. The appearance of the product is that of a pale yellow liquid with an amine like odour. It is not explosive, has no oxidising properties and a self ignition temperature of 422 °C. The neat formulation has a pH of 7.6 to 9.2. The stability data indicate a shelf life of at least two years at ambient temperature in packaging of HDPE. The technical characteristics are acceptable for a soluble concentrate formulation.
Implications for labelling: none
Compliance with FAO specifications: The product U 46 M-Fluid complies with FAO specification 2.1+50.1/SL/ts/- (1983).
Compatibility of mixtures: Some tank mixes are mentioned on the label, but no experimental data were submitted to prove the compatibility, only a reference to the published literature.
Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.
Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of U 46 M- Fluid 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 adequate analytical method for the determination of the active substance MCPA in the formulation is available.
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) Adequate analytical methods are available to monitor all compounds given in the respective residue definition in food of plant origin, soil, water and air. Analytical methods used to meet the requirements of the Annex to Regulation (EU) No 544/2011, Part A, point 4.2 can be also applied for the product. MCPA residues can be monitored in food of plant origin and soil by GC-MS, in water by LC-MS and in air by HPLC-UV. Methods for body fluids and tissues are not required since MCPA is not considered to
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However, the following data gaps were noticed: • A validation of an analytical method for residues of MCPA (residue definition: MCPA, MCPB including their salts, esters and conjugates expressed as MCPA) according to SANCO/825/00 rev. 8.1 in plant commodities with high water content, high acid content and high fat content in an independent laboratory (ILV) is missing. The submitted study by Wasser, 2000 is not validated according to the requirements of SANCO/825/00 rev. 8.1. • An analytical method for residues of MCPA (residue definition: MCPA, MCPB and MCPA thioethyl expressed as MCPA) in foodstuff of animal origin is missing. • A validation of an analytical method for residues of MCPA (residue definition: MCPA, MCPB and MCPA thioethyl expressed as MCPA) in foodstuff of animal origin in an independent laboratory is missing. • A validated confirmatory method for residues of MCPA (residue definition: MCPA, MCPB and MCPA thioethyl expressed as MCPA) in foodstuff of animal origin is missing. • A study or statement regarding the efficiency of the extraction procedure used in methods for residues of MCPA (residue definition: MCPA, MCPB and MCPA thioethyl expressed as MCPA) in foodstuff of animal origin is missing.
These data gaps are considered being of minor relevance and it is sufficient to fill these gaps in the context of the next application for the approval of MCPA according to Reg. (EC) No 1107/2009 or in the context of the assessment of existing MRLs of MCPA according to Art. 12 of Reg. (EC) No 396/2005.
3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)
3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) U 46 M-Fluid, containing 500 g/L MCPA has to be categorized as acute toxic category 4 and eye damaging category 1. This results in a classification with H302 and H318.
3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) Operator exposure was assessed against the AOEL agreed in the EU review (MCPA 0.04 mg/kg bw/d). Dermal absorption data of studies conducted with different but comparable formulations with the single active substances have been used. The detailed evaluation is provided in Part B. According to the model calculations, it can be concluded that the risk for the operator using U 46 M-Fluid for the intended uses is acceptable with the use of personal protective equipment described in 2.3.1.
3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) The bystander and/or resident exposure estimations indicated that the acceptable operator exposure level (AOEL) for MCPA will not be exceeded under conditions of intended uses.
3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) The worker exposure was estimated using the model “German model”. Without any PPE the estimated consumption of AOEL would be 233 % for MCPA. With PPE the consumption of the AOEL will be 32.7 % (see SF1891 in 2.3.1).
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Implications for labelling resulting from operator, worker, bystander assessments:
See 2.2
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3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8)
3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) Fundamental residue data on MCPA like metabolism are already evaluated previously and is described in detail in the respective DAR.
The intended uses in pome fruits and stone fruits are not relevant in terms of consumer protection. The application is directed to the floor within an orchard but not to the trees. No residue trials are necessary.
For the use of U 46 M-Fluid in the intended crops (grapes, barley, oat, rye, wheat) a sufficient number of residue trials are available to demonstrate that the MRLs set in Regulation (EC) No 396/2005 for MCPA will not be exceeded. Residue trials in grass are also available.
The intended uses are in crops that can be used for animal feed (cereals and grass). The expected residues in those commodities will not lead to an exceedance of the MRLs in animal commodities.
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) An estimation of dietary intake using EFSA PRIMo results in a maximum consumption of the ADI and ARfD below 100 %.
Substance ADI Model / Diet ADI Consumption
MCPA 0.05 mg/kg bw TMDI, EFSA PRIMo, 10 % WHO cluster diet B
Max. ARfD Substance ARfD Model / Diet commodity Consumption
MCPA 0.15 mg/kg bw IESTI, EFSA Pome fruit 3.3 % (UK infants) PRIMo Stone fruit 2 % (German children) Grapes 2.2 % (German children) Cereals < 1 % (UK and German children) Poultry and swine < 1 % (Spanish, Dutch products and German children) Ruminant products < 1 % (UK and German children) Milk < 1 % (UK infants)
For the intake of residues of MCPA neither a long-term nor a short-term risk for consumers is to be expected.
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)
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A full exposure assessment for the plant protection product U 46 M Fluid in its intended uses in winter and spring cereals, grassland, pome and stone fruits and grape vine is documented in detail in the core assessment of the plant protection product U 46 M Fluid performed by Germany. The following chapters summarise specific exposure assessment for soil and surface water and the specific risk assessment for groundwater for the authorization of U 46 M Fluid in Germany according to its intended use in winter and spring cereals, grassland, pome and stone fruits and grape vine (Use No. 00- 001 to 00-005). No relevant metabolites of MCPA need to be considered for exposure assessment.
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 U 46 M Fluid in winter and spring cereals, grassland, pome and stone fruits and grape vine according to use No 00-001 to 00-005 PECsoil was calculated for the active substance MCPA considering a soil depth of 2.5 cm. Due to the fast degradation of the active substance MCPA in soil the accumulation potential of MCPA was not considered. Details are given in Part B National Addendum-Germany, Section 5, chapter 5.5. The results for PEC soil for the active substance were used for the eco-toxicological risk assessment.
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 FOCUS PELMO 5.5.3 show that the active substance MCPA is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended of U 46 M Fluid uses in winter and spring wheat, grassland, pome and stone fruits according to use No. 00-001 to 00-004. For the intended use in grape vine (use No. 00-005) groundwater contamination of the active substance MCPA in concentrations ≥ 0.1 µg/L cannot be excluded for applications after 15 August.
PECGW at 1 m soil depth of MCPA considered relevant for German exposure assessment (simulation run due to pH dependency)
th -1 80 Percentile PECGW at 1 m soil depth (µg L ) modeled by FOCUS PELMO 5.5.3 Use No. Scenario MCPA
00-001, Hamburg 0.000 00-002, 00-003, Kremsmünster 0.000 00-004 Application on
1 March 15 August 1 September 30 September 00-005 Hamburg 0.001 0.028 0.052 0.126 Kremsmünster 0.017 0.085 0.154 0.191
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For details see Part B, National Addendum-Germany, Section 5, chapter 5.7.1. Consequences for authorization: Use no. 00-005: to restrict application from March to 15 August
2. Ground water contamination by bank filtration due to surface water exposure via run-off and drainage Modelling with EXPOSIT 3.01 showed that for use No 00-001, 00-002 and 00-003 groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance MCPA due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded. For use 00-004 groundwater contamination can only be excluded if appropriate risk mitigation measures (vegetated buffer strip of 20 m) are applied. However, for use No 00-005 groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance MCPA due to drainage into the adjacent ditch with subsequent bank filtration cannot be excluded. No authorization is possible for use No 00-005 due to contamination of groundwater by MCPA at concentration > 0.1 µg/L due to surface runoff into the adjacent ditch with subsequent bank filtration.
PECgw for MCPA after surface run-off and drainage with subsequent bank filtration (modelled with EXPOSIT 3.01)
Active substance MCPA Use No. application PECgw due to rate run-off drainage interception vegetated buffer bank filtrate Time of bank filtrate strip (µg/L) application (µg/L) (m) 00-001, 00-002 1 x 700 g 0 0.077 spring/summer 0.032 a.s./ha, 5 - 25 % 10 - autumn/winter/ Not relevant 20 - early spring required labelling none 00-003 1 x 1000 g 0 0.073 spring/summer 0.030 a.s./ha, 5 - 50 % 10 - autumn/winter/ Not relevant 20 - early spring required labelling none 00-004 1 x 1000 g 0 0.146 spring/summer 0.060 a.s./ha, 5 0.126 0 % 10 0.108 autumn/winter/ Not relevant 20 0.076 early spring required labelling NG 404 (20 m vegetated buffer strip) 00-005 1 x 2000 g 0 0.292 spring/summer 0.120 a.s./ha, 5 0.253 0 % 10 0.217 autumn/winter/ Not relevant 20 0.152 early spring required labelling No authorization possible due to runoff., NG 405 For details see Part B, National Addendum-Germany, Section 5, chapter 5.7.2.
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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 U 46 M Fluid in winter and spring cereals, grassland, pome and stone fruits and grape vine according to use No 00-001 to 00-005 PECsw was calculated for the active substance MCPA considering the two routes of entry (i) spraydrift and volatilization with subsequent deposition and (ii) run-off, drainage separately. The calculation of concentrations in surface water was based on spray drift data by Rautmann and Ganzelmeier. The vapour pressure at 20 °C of the active substance MCPA is between 10-5 und 10-4 Pa. Hence the active substance MCPA is regarded as semivolatile (volatilisation only from plant surfaces). Therefore, exposure of surface water by the active substance MCPA due to deposition following volatilization was considered. The concentrations of the active substance MCPA in adjacent ditch due to surface run-off and drainage were calculated using the model EXPOSIT.
Details are given in Part B, National Addendum-Germany, Section5, chapter 5.6. The results for PEC surface water for the active substance and its metabolites were used for the eco- toxicological risk assessment.
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) The vapour pressure at 20 °C of the active substance MCPA is between 10-5 and 10-4 Pa. Hence the active substance MCPA is regarded as semivolatile (volatilisation only from plant surfaces). But MCPA is less volatile in the form of salts as it predominantly dissociated at pH 7. The anion is not volatile. Therefore exposure of adjacent surface waters and terrestrial ecosystems by the active substance MCPA due to volatilization with subsequent deposition does not need to be considered in the risk assessment. Due to the atmospheric half-life of 1.3 d (Atkinson calculation) the long-range transport does not need to be considered.
Implications for labelling resulting from environmental fate assessment: (Phrase Rxx should be added to the label) NG 404 Between treated areas with an incline of more than 2% and surface water - except (Use No. 00-004) only occasionally but including periodically water-bearing surface water - there must be a border under complete plant cover. The border's protective function must not be impaired by the use of implements. It must be at least 20 m wide. This border is not necessary if: - sufficient catching systems are available for the water and soil transported by run- off, which do not flow into surface water or are not connected with the urban drainage system or - the product is used for mulch or direct drilling methods.
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3.1.6 Ecotoxicology (Part B, Section 6, Point 10) A full risk assessment according to Uniform Principles for the plant protection product U 46 M Fluid in its intended uses in in winter and spring cereals, grassland, pome and stone fruits and grape vine (Use No. 00-001 to 00-005) is documented in detail in the core assessment of the plant protection product U 46 M Fluid performed by Germany. The intended use of U 46 M Fluid in Germany is generally covered by the uses evaluated in the course of the core assessment by Germany. The following chapters summarise specific risk assessment for non-target organisms and hence risk mitigation measures for the authorization of U 46 M Fluid in Germany according to its intended uses. For reasons of better readability, the intended uses in of the plant protection product U 46 M Fluid in Germany are summarised as follows:
Table 3.1.6-1: Critical use pattern of „U 46 M-Fluid“
Group Crop/growth Application Number of applications, Application rate, Soil effective (use stage method / Minimum application cumulative application rate No.) Drift scenario interval, interception, (g as/ha) (g as/ha) application time (season) A (001, Winter and spraying / 1 x, spring MCPA 1 x 700, MCPA 002) spring wheat arable crops 25 % interception 1 x 525 BBCH 13-39 6 April
B (003) grassland spraying / 1 x, May to August MCPA 1 x 1000 MCPA arable crops 90 % interception 1 x 100
C (004) Pome and stone spraying 1 x, March to September MCPA 1 x 1000 MCPA fruits 0 % interception 1 x 1000
D (005) grape vine spraying with 1 x, March to September MCPA 1 x 2000 MCPA screen , up to 0 % interception 1 x 2000 3rd year after planting of the vine
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).
Effects on birds: Based on tier 1 and higher tier assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of birds to MCPA (oral exposure and exposure via drinking water and secondary poisoning) according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C,
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2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable acute and long- term risk for birds due to the intended use of „U 46 M-Fluid“ in cereals, orchards, vineyards and on grassland according to the label.
Effects on terrestrial vertebrates other than birds Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ does achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the uses according to use No. 00-001 and 00-002 (use group A) Based on higher tier assessment step, the calculated TER values for the acute risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ does achieve the modified acceptability criteria TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the use group B and C (1000 g a.s./ha). Considering the results of the dietary toxicity studies as well as the characteristic of MCPA to rapidly assimilate and excrete the acute risk resulting from an exposure of mammals to MCPA at a rate of 2000 g as/ha according to use group D (use No 00-005) is considered to be acceptable. Based on higher tier assessment step, the calculated TER values for the long-term risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ does achieve the acceptability criteria TER ≥ 5 and the modified acceptability criteria TER ≥ 2, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the all intended for uses of the formulation “U 46 M Fluid”
For details see Part B, core assessment and National Addendum-Germany, Section 6.
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 U 46 M Fluid based on FOCUS Surface Water PEC values is presented in the core assessment, Part B, Section 6, chapter 6.5. 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 spray drift and deposition following volatilization Based on the intrinsic property of the active substance MCPA (Lemna gibba NOEC < 0.04 mg a.s. /L), the national labelling NW265 is assigned. Based on the relevant toxicity of the MCPA, the calculated TER values for the risk to aquatic organisms resulting from an exposure of surface water by spray drift to U 46 M Fluid according to the use No 00- 001 to 00-004 achieve the acceptability criteria of TER ≥ 10, according to commission regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. However, the application of PPP in the immediate vicinity of surface or coastal waters is not permitted in Germany, minimum buffer zones stipulated by state law must be observed and no additional entries as those according to the evaluated use pattern and good agricultural practice are acceptable. The conditions of use NW468 and NW642-1 are assigned. The calculated TER values for the risk to aquatic organisms resulting from an exposure of surface water by MCPA and as DMA salt due to run-off and drainage according to the use No 00-005 only achieve the acceptability criteria of TER ≥ 100 or 10 respectively, according to commission regulation (EU) No
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546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2 if appropriate risk mitigation measures (5 m buffer stripe or drift reducing technique) are applied.
For details see Part B, National Addendum-Germany, Section 6, chapters 6.5.3.
2. Exposure by surface run-off and drainage The concentrations of MCPA and as DMA salt in adjacent ditch due to surface runoff and drainage was calculated using the model EXPOSIT. The calculated TER values for the risk to aquatic organisms resulting from an exposure of surface water by MCPA and as DMA salt due to run-off and drainage according to the use No 00-001 to 00-005 achieve the acceptability criteria of TER ≥ 100 or 10 respectively, according to commission regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2 if appropriate risk mitigation measures are applied (vegetated buffer strip).
For details see Part B, National Addendum-Germany, Section 6, chapters 6.5.4.
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)
Bees Effects on bees of U 46 M-Fluid were not evaluated as part of EU review of MCPA dimethyla-min-salt and no toxicity data with the formulation were presented here. However, since U 46 M-Fluid is a well known product and has been approved for long time, studies with the active sub-stance are acceptable for the risk assessment.
Hazard quotients Table 3.1.6.3-1 presents the hazard quotients (HQ) for oral and contact exposure according to EPPO (2010) Environmental risk assessment scheme for plant protection products (Chapter 10: Honeybees (PP 3/10(3)). Bulletin OEPP/EPPO Bulletin 40: 323-331). HQ-values were calculated as follows:
Hazard Quotient = max. application rate [g a.s./ha] / LD50 [µg a.s./bee]
Table 3.1.6.3-1: Hazard quotients for honeybees
Max. single Hazard Exposure LD HQ Test substance application rate 50 quotient route [µg a.s./bee] trigger [g a.s./ha] (HQ) U 46 M-Fluid oral > 200 µg < 10 2000 50 (MCPA 500 g/L)* contact > 200 µg < 10 * tested as technical substance
Risk assessment Due to the results of laboratory tests according to OECD standard 213/214 and GLP, U 46 M-Fluid is considered to be practically non-toxic to bees. Furthermore, all hazard quotients according to EPPO Environmental risk assessment scheme are below the trigger of 50, indicating that the intended use poses low risk to bees.
Overall conclusion
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It is concluded that U 46 M-Fluid will not adversely affect bees or bee colonies when used as recommended. The product is classified as non-hazardous to bees, even when the maximum application rate as stated for authorisation is applied. Label NB6641 is assigned to the product.
Other non-target arthropods Based on the calculated rates of MCPA/“U 46 M-Fluid“ in off-field areas, the calculated HQ values describing the risk resulting from an exposure of non-target arthropods to MCPA /“U 46 M-Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria HQ ≤ 2, according to commission regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of „U 46 M-Fluid“ in cereals, grassland, orchards and vine according to the label.
For details please refer to the core assessment Part B, section 6, chapter 6.6.
3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) Based on the predicted concentrations of MCPA/“U 46 M-Fluid“ in soil, the TER values describing the acute risk for earthworms and other non-target soil organisms following exposure to MCPA /“U 46 M- Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria TER ≥ 10 according to commission 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 „U 46 M-Fluid“ in cereals, grassland, orchards and vineyards according to the label. For details please refer to the core assessment Part B, section 6, chapter 6.8.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) No data on the effects on organic matter breakdown (litterbag) are required since the active substance MCPA does not meet the trigger on degradation in soil.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) Based on the predicted concentrations of MCPA in soils, the risk to soil microbial processes following exposure to MCPA according to the GAP of the formulation „U 46 M-Fluid“ is considered to be acceptable according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. For details please refer to the core assessment Part B, section 6, chapter 6.9.
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 MCPA/“U 46 M-Fluid“ in off-field areas, the TER values describing the risk for non-target plants following exposure to MCPA /“U 46 M-Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria TER ≥ 5 according to commission regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. if appropriate risk mitigation measures are applied for all intended for uses. The results of the assessment indicate an
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Table 3.1.6-4: Risk assessment for MCPA for non-target plants for the entry route via spray drift and deposition following volatilization for use Group A (use No. 00-001 and 00-002, cereals) Compound: MCPA Intended use group: A (use No. 00-001 and 00-002) Crop/Application rate grassland, 1 x 700 g a.s./ha Crop interception 25 % Drift-Percentile: 90th / arable crops
Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 19.390 0.022% 0.155 19.545 9.850 5.003 2.094 5 0.57 3.990 0.018% 0.125 4.115 2.120 1.122 0.524
Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5
Buffer zone [m] TER 1 0.3 0.6 1.1 2.6 5 1.3 2.6 5.0 10.5 Risk mitigation measures NT 108
PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.
Table 3.1.6-5: Risk assessment for MCPA for non-target plants for the entry route via spray drift and deposition following volatilization for use Group B (use No. 00-003, grassland)
Compound: MCPA Intended use group: B (use No. 00-003) Crop/Application rate grassland, 1 x 1000 g a.s./ha Crop interception 50 % Drift-Percentile: 90th / arable crops
Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 27.700 0.045 0.444 28.144 14.294 7.369 3.214 5 0.57 5.700 0.036 0.357 6.057 3.207 1.782 0.927
Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5
Buffer zone [m] TER 1 0.2 0.4 0.7 1.7 5 0.9 1.7 3.1 5.9 Risk mitigation measures NT 109
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PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.
Table 3.1.6-6: Risk assessment for MCPA for non-target plants for the entry route via spray drift and deposition following volatilization for use Group C (use No. 00-004, orchards)
Compound: MCPA Intended use group: C (use No. 00-004) Crop/Application rate Orchards not crop directed, 1 x 1000 g a.s./ha Crop interception 0 % Drift-Percentile: 90th / arable crops
Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 27.700 0 0 27.700 13.850 6.925 2.770 5 0.57 5.700 0 0 5.700 2.850 1.425 0.570
Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5
Buffer zone [m] TER 1 0.2 0.4 0.8 2.0 5 1.0 1.9 3.8 9.6 Risk mitigation measures NT 109
PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.
Table 3.1.6-7: Risk assessment for MCPA for non-target plants for the entry route via spraydrift and deposition following volatilization for use Group D (use No. 00-005, vineyards)
Compound: MCPA Intended use group: D (use No. 00-005) Crop/Application rate Vineyards not crop directed, 1 x 2000 g a.s./ha Crop interception 0 % Drift-Percentile: 90th / arable crops
Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 55.4 0 0 55.400 27.700 13.850 5.540 5 0.57 11.4 0 0 11.400 5.700 2.850 1.140
Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5
Buffer zone [m] TER 1 0.1 0.2 0.4 1.0
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5 0.5 1.0 1.9 5.0 Risk mitigation measures NT 109
PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.
For details please refer to the National Addendum-Germany Part B, section 6, chapter 6.10.
Implications for labelling resulting from ecotoxicological assessment:
Classification and labelling Relevant toxicity Active substance: MCPA (content 50 %) EC50 = 0.124 mg/L (Lemna gibba) M-factor = 1 Classification and labelling according to Regulation 1272/2008 Hazard sysmbol GHS09 Signal word warning Hazard statement H400, H 410
Standard Phrases for special risks and safety precautions under Regulation (EU) 547/2011 Annex II and III / conditions of use : NW 468 (All uses) 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. NW 642-1 The product may not be applied in or in the immediate vicinity of (Use No. 00-001, 00-002, surface or coastal waters. Irrespective of this, the minimum buffer zone 00-003 and 00-00 from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to 50 000 EUR.
NW 609-1 When applying the product on areas adjacent to surface waters - except (Use No. 00-005) only occasionally but including periodically water-bearing surface waters - the product must be applied observing the minimum buffer zone stated below. It is not necessary to observe this buffer zone if the product is applied using equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended. Irrespective of this, in addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times. Violations may be punished by fines of up to 50 000 EUR.
NW 706 Between treated areas which have an incline of more than 2 % and (Use No. 00-005) surface waters - including periodically but excluding occasionally water-bearing surface waters- there must be a buffer zone under complete plant cover. The buffer zone's protective function must not be impaired by the use of implements. It must be at least 20 m wide. This buffer zone is not necessary if: -sufficient catching systems are available for the water and soil transported by run-off, which do not flow into surface water or are not connected with the urban drainage system or -the product is used for conservation or no-tillage methods.
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NT 108 A buffer zone of at least 5 m must be kept from adjacent areas (except (Use No. 00-001 and 00- agriculturally or horticulturally used areas, roads, paths and public 002) 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 75 %. 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. NT 109 A buffer zone of at least 5 m must be kept from adjacent areas (except (Use No. 00-003, 00-004 agriculturally or horticulturally used areas, roads, paths and public and 00-005) 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.
Other labels NW 265 The product is toxic for aquatic plants.
3.1.7 Efficacy (Part B, Section 7, Point 8)
Information to the active substance MCPA belongs to the chemical group of phenoxy carbonic acids. MCPA belongs to the group of auxin- herbicides and acts as a selective, systemic, hormone-type herbicide. MCPA will mainly be absorbed through green leaves. MCPA is translocated in the plant by both acropetal and basipetal action and concentrates in meristematic tissues of plants. MCPA influences levels of RNA and DNA polymerase and levels of enzymes involved in normal plant growth. MCPA acts by inducing abnormal cell division, abnormal growth, influence of respiration and influence of metabolic processes. Good growing conditions support the uptake of the active ingredient and the efficacy. Site of action (HRAC-group): O
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Preliminary range-finding tests The applicant does not provide results about range-finding tests, which is accepted as MCPA is a well- known active substance. Sufficient data for minimum effective dose tests were presented for the following uses: 001: annual dicotyledonous weeds and CIRAR 002: annual dicotyledonous weeds and CIRAR 003: dicotyledonous weeds 004: dicotyledonous weeds 005: dicotyledonous weeds Consequently the spectrum of target species was amended to annual dicotyledonous weeds and creeping thistle for uses 001 and 002.
Efficacy tests Sufficient efficacy data are presented for: 001: annual dicotyledonous weeds and CIRAR 002: annual dicotyledonous weeds and CIRAR 003: dicotyledonous weeds 004: dicotyledonous weeds 005: dicotyledonous weeds
Impact on the quality of plants and plant products No impact on the TGW was observed in cereals or on the dry matter in grasses. No data on quality were submitted for fruits and grape vine.
Effects on the processing procedure Neither from trial experience nor from practical use of the active ingredient MCPA was reported any case about negative influences on parameters influencing the processing procedure of win-ter cereals, spring cereals, grassland, orchard and grape vine.
Effects on the yield of treated plants and plant products In general, no impact on the yield was observed. However, for the use in grassland the label warning WP733 “Damage is possible to the crop, including yield reduction”, is assigned, because yield reductions had been observed.
Phytotoxicity to host crop In general, no phytotoxic symptoms were observed. However, for use in orchards a spray shield is required and phytotoxic symptoms in grapes were transient.
Adverse effects on beneficial organisms (other than bees) The product can be classified as not harmful for populations of relevant beneficial arthropods in general. Labels NN1001 and NN1002 are assigned to the product.
Impact on succeeding crops No risk for succeeding crops.
Impact on other plants including adjacent crops
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The comparison indicates that there is no theoretical risk of spray drift damage for the tested crops.
Possible development of resistance or cross-resistance The evaluation indicates a medium inherent and agronomic risk of resistance development for U 46 M- Fluid for use in cereals and a low risk for use in grassland and in orchards.
3.2 Conclusions
With respect to physical, chemical and technical properties of the formulation an authorisation can be granted.
Concerning analytical methods for the formulation an authorisation can be granted. With respect to analytical methods for residues an authorisation can be granted.
Regarding efficacy/IPM and sustainable use incl. effects on honeybees and beneficial arthropods an authorisation can be granted.
Concerning toxicology, residues and consumer protection an authorisation can be granted.
With respect to fate and ecotoxicology assessment, an authorisation can be granted for uses 00-001, 00- 002, 00-003 and 00-004. Considering an application in accordance with the evaluated use pattern and good agricultural practice as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. No authorization is possible for use No 00-005 due to contamination of groundwater by MCPA at concentration > 0.1 µg/L due to surface runoff into the adjacent ditch with subsequent bank filtration.
An authorisation can be granted except for use No 00-005.
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 is required.
Applicant Nufarm Evaluator DE Date 21/04/2017
Part A U 46 M-Fluid Registration Report –Central Zone National Assessment - 060939-00/00 Page 30 of 32 Federal Republic of Germany
Appendix 1 – Copy of the product authorisation See below.
Applicant Nufarm Evaluator DE Date 21/04/2017
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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.
Applicant Nufarm Evaluator DE Date 21/04/2017 Part A U 46 M-Fluid Registration Report –Central Zone National Assessment - 060939-00/00 Page 32 of 32 Federal Republic of Germany
Appendix 3 – Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
Applicant Nufarm Evaluator DE Date 21/04/2017
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dr. Dietmar Gottschild Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Referent
TELEFON +49 (0)531 299-3512 Nufarm Deutschland GmbH TELEFAX +49 (0)531 299-3002 Im MediaPark 4 e E-MAIL [email protected] 50670 Köln IHR ZEICHEN IHRE NACHRICHT VOM
AKTENZEICHEN 200.22100.060939-00/00.96976 (bitte bei Antwort angeben)
DATUM 2. Mai 2017
ZV1 060939-00/00 U 46 M-Fluid Zulassungsverfahren für Pflanzenschutzmittel Bescheid
Das oben genannte Pflanzenschutzmittel
mit dem Wirkstoff: 500 g/l MCPA (als Dimethylamin-Salz 612 g/l)
Zulassungsnummer: 060939-00
Versuchsbezeichnungen: NUD-01080-H-3-SL
Antrag vom: 21. Dezember 2013
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 Pflanzen- schutzmitteln 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
Die Zulassung endet am 31. Oktober 2018.
Festgesetzte Anwendungsgebiete bzw. Anwendungen
Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1): BVL_FO_05_2437_200_V1.8
Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de SEITE 2 VON 19
Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 060939-00/00-002 Einjährige zweikeim- Sommerweichweizen, blättrige Unkräuter, Sommerhartweizen, Acker-Kratzdistel Sommergerste, Som- merhafer, Sommerrog- gen 060939-00/00-001 Einjährige zweikeim- Winterweichweizen, blättrige Unkräuter, Winterhartweizen, Din- Acker-Kratzdistel kel, Wintergerste, Win- terroggen, Wintertriti- cale 060939-00/00-004 Zweikeimblättrige Kernobst, Steinobst Unkräuter 060939-00/00-003 Zweikeimblättrige Wiesen, Weiden Unkräuter
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 84 des Gesetzes vom 18. Juli 2016 (BGBl. I S. 1666), festgesetzt: (NW468) Anwendungsflüssigkeiten und deren Reste, Mittel und dessen Reste, entleerte Behältnisse oder Packungen sowie Reinigungs- und Spülflüssigkeiten nicht in Gewässer gelangen las- sen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle. Begründung: Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff MCPA weist aufgrund seiner Toxizität ein hohes Gefährdungspotenzial für aquatische Organismen auf. Jeder Eintrag von Rück- ständen in Oberflächengewässer, der den Eintrag als Folge der bestimmungsgemäßen und sachgerechten Anwendung des Mittels entsprechend der guten fachlichen Praxis übersteigt, würde daher zu einer Gefährdung des Naturhaushaltes aufgrund von nicht akzeptablen Aus- wirkungen auf Gewässerorganismen führen. Da ein erheblicher Anteil der in Oberflächenge- wässern nachzuweisenden Pflanzenschutzmittelfrachten auf Einträge aus kommunalen Klär- anlagen zurückzuführen ist, muss dieser Gefährdung durch die bußgeldbewehrte Anwen- dungsbestimmung durchsetzbar begegnet werden. BVL_FO_05_2437_200_V1.8 SEITE 3 VON 19
Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3.
Verpackungen
Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen:
Verpackungs- Verpackungs- Anzahl Inhalt art material von bis von bis Einheit Kanister HDPE 1 1,00 20,00 l Kanister PET 1 1,00 20,00 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: (NW265) Das Mittel ist giftig für höhere Wasserpflanzen.
(SB001) Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschä- den 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.
(SB199) Wenn das Produkt mittels an den Traktor angebauten, gezogenen oder selbstfahrenden Anwendungsgeräten ausgebracht wird, dann sind nur Fahrzeuge, die mit geschlossenen Überdruckkabinen (z. B. Kabinenkategorie 3, wenn keine Atemschutzgeräte oder partikelfil- trierenden Masken benötigt werden oder Kabinenkategorie 4, wenn gasdichter Atemschutz erforderlich ist (gemäß EN 15695-1 und -2)) ausgestattet sind, geeignet, um die persönliche Schutzausrüstung bei der Ausbringung zu ersetzen. Während aller anderen Tätigkeiten außerhalb der Kabine ist die vorgeschriebene persönliche Schutzausrüstung zu tragen. Um die Kontamination des Kabineninnenraumes zu vermeiden, ist es nicht erlaubt, die Kabine BVL_FO_05_2437_200_V1.8 SEITE 4 VON 19
mit kontaminierter persönlicher Schutzausrüstung zu betreten (diese sollte in einer entspre- chenden Vorrichtung aufbewahrt werden). Kontaminierte Handschuhe sollten vor dem Aus- ziehen abgewaschen werden, beziehungsweise sollten die Hände vor Wiederbetreten der Kabine mit klarem Wasser gereinigt werden.
(SE110) Dicht abschließende Schutzbrille tragen beim Umgang mit dem unverdünnten Mittel.
(SF1891) Das Wiederbetreten der behandelten Flächen/Kulturen ist am Tage der Applikation nur mit der persönlichen Schutzausrüstung möglich, die für das Ausbringen des Mittels vorgegeben ist. Nachfolgearbeiten auf/in behandelten Flächen/Kulturen dürfen grundsätzlich erst 24 Stunden nach der Ausbringung des Mittels durchgeführt werden. Innerhalb 48 Stunden sind dabei der Schutzanzug gegen Pflanzenschutzmittel und Universal-Schutzhandschuhe (Pflan- zenschutz) zu tragen.
(SS110) Universal-Schutzhandschuhe (Pflanzenschutz) tragen beim Umgang mit dem unverdünnten Mittel.
(SS206) Arbeitskleidung (wenn keine spezifische Schutzkleidung erforderlich ist) und festes Schuh- werk (z.B. Gummistiefel) tragen bei der Ausbringung/Handhabung von Pflanzenschutzmit- teln.
(SS2202) Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) tragen bei der Ausbringung/Handhabung des anwendungsfertigen Mittels.
(WMO) Wirkungsmechanismus (HRAC-Gruppe): O
Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2.
Sonstige Auflagen: (WH952) Auf der Verpackung und in der Gebrauchsanleitung ist die Angabe zur Kennzeichnung des Wirkungsmechanismus als zusätzliche Information direkt jedem entsprechenden Wirk- BVL_FO_05_2437_200_V1.8 SEITE 5 VON 19
stoff-namen zuzuordnen.
Vorbehalt
Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.
Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG) Nr. 1272/2008
Signalwort: (S2) Gefahr
Gefahrenpiktogramme: (GHS05) Ätzwirkung (GHS07) Ausrufezeichen (GHS09) Umwelt
Gefahrenhinweise (H-Sätze): (H302) Gesundheitsschädlich bei Verschlucken.
(H318) Verursacht schwere Augenschäden.
(H400) Sehr giftig für Wasserorganismen.
(H410) Sehr giftig für Wasserorganismen mit langfristiger Wirkung.
(EUH 401) Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.
Sicherheitshinweise (P-Sätze): (P101) Ist ärztlicher Rat erforderlich, Verpackung oder Kennzeichnungsetikett bereithalten.
(P102)
BVL_FO_05_2437_200_V1.8 Darf nicht in die Hände von Kindern gelangen. SEITE 6 VON 19
(P264) Nach Gebrauch ... gründlich waschen.
(P270) Bei Gebrauch nicht essen, trinken oder rauchen.
(P280) Schutzhandschuhe/Schutzkleidung/Augenschutz/Gesichtsschutz tragen.
(P305+P351+P338) BEI KONTAKT MIT DEN AUGEN: Einige Minuten lang behutsam mit Wasser spülen. Eventu- ell vorhandene Kontaktlinsen nach Möglichkeit entfernen. Weiter spülen.
(P308+P310) BEI Exposition oder falls betroffen: Sofort GIFTINFORMATIONSZENTRUM oder Arzt anru- fen.
(P501) Inhalt/Behälter ... zuführen.
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 060939-00/00-005 Zweikeimblättrige Weinrebe Nutzung als Kelter- Unkräuter und Tafeltraube ab 3. Standjahr der Wein- rebe
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 bienen- gefährlich eingestuft (B4). BVL_FO_05_2437_200_V1.8 SEITE 7 VON 19
(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 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 Zulas- sungsinhabers 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. Martin Streloke Abteilungsleiter
Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.
Anlage BVL_FO_05_2437_200_V1.8 SEITE 8 VON 19
Anlage 1 zugelassene Anwendung: 060939-00/00-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Einjährige zweikeimblättrige Unkräuter, Acker-Kratz- distel Pflanzen/-erzeugnisse/Objekte: Winterweichweizen, Winterhartweizen, Dinkel, Win- tergerste, 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 39 Anwendungszeitpunkt: Nach dem Auflaufen, Frühjahr Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: spritzen Aufwand: - 1,4 l/ha in 200 bis 400 l Wasser/ha
2.2 Sonstige Kennzeichnungsauflagen (NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstenge- wässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorge- gebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.
(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 Mittelauf- wand verträglich oder unverträglich ist.
(WW742) Das Mittel besitzt keine nachhaltige Wirkung gegen ausdauernde Unkräuter. BVL_FO_05_2437_200_V1.8 SEITE 9 VON 19
2.3 Wartezeiten (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: Winterhartweizen 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: Dinkel 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 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: Winterroggen 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: Wintertriticale 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.
3 Anwendungsbezogene Anwendungsbestimmungen (NT108) BVL_FO_05_2437_200_V1.8 SEITE 10 VON 19
Bei der Anwendung des Mittels muss ein Abstand von mindestens 5 m zu angrenzenden Flä- chen (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 Ver- zeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 75 % 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 trag- baren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B. Feldraine, Hecken, Gehölzinseln) weniger als 3 m breit sind. Bei der Anwendung des Mittels ist ferner die Einhal- tung eines Abstandes von mindestens 5 m nicht erforderlich, wenn die Anwendung des Mit- tels 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 MCPA weist ein hohes Gefährdungspotenzial für terrestrische Nichtzielpflanzen auf. Bewertungsbestimmend ist hier die ER50 von 5,48 g MCPA/ha für Lactuca sativa im Wachstumstest. Ausgehend von den geltenden Modellen zur Abdrift sowie zur Verflüchtigung von Zielflächen und anschließender Deposition (hier: EVA 3) und einem Sicherheitsfaktor von 5 ist nach dem Stand der wissen- schaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausrei- chenden Schutz von terrestrischen Nichtzielpflanzen in Saumbiotopen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registra- tion Report zu entnehmen. BVL_FO_05_2437_200_V1.8 SEITE 11 VON 19
Anlage 1 zugelassene Anwendung: 060939-00/00-002 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Einjährige zweikeimblättrige Unkräuter, Acker-Kratz- distel Pflanzen/-erzeugnisse/Objekte: Sommerweichweizen, Sommerhartweizen, Sommer- gerste, Sommerhafer, Sommerroggen Verwendungszweck:
2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung
Einsatzgebiet: Ackerbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 13 bis 39 Anwendungszeitpunkt: Nach dem Auflaufen, Frühjahr Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: spritzen Aufwand: - 1,4 l/ha in 200 bis 400 l Wasser/ha
2.2 Sonstige Kennzeichnungsauflagen (NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstenge- wässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorge- gebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.
(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 Mittelauf- wand verträglich oder unverträglich ist.
(WW742) Das Mittel besitzt keine nachhaltige Wirkung gegen ausdauernde Unkräuter. BVL_FO_05_2437_200_V1.8 SEITE 12 VON 19
2.3 Wartezeiten (F) Freiland: Sommerweichweizen 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: Sommerhartweizen 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: Sommergerste 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: Sommerhafer 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: Sommerroggen 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.
3 Anwendungsbezogene Anwendungsbestimmungen (NT108) Bei der Anwendung des Mittels muss ein Abstand von mindestens 5 m zu angrenzenden Flä- chen (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 Ver- zeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 75 % eingetragen ist. BVL_FO_05_2437_200_V1.8 SEITE 13 VON 19
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 trag- baren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B. Feldraine, Hecken, Gehölzinseln) weniger als 3 m breit sind. Bei der Anwendung des Mittels ist ferner die Einhal- tung eines Abstandes von mindestens 5 m nicht erforderlich, wenn die Anwendung des Mit- tels 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 MCPA weist ein hohes Gefährdungspotenzial für terrestrische Nichtzielpflanzen auf. Bewertungsbestimmend ist hier die ER50 von 5,48 g MCPA/ha für Lactuca sativa im Wachstumstest. Ausgehend von den geltenden Modellen zur Abdrift sowie zur Verflüchtigung von Zielflächen und anschließender Deposition (hier: EVA 3) und einem Sicherheitsfaktor von 5 ist nach dem Stand der wissen- schaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausrei- chenden Schutz von terrestrischen Nichtzielpflanzen in Saumbiotopen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registra- tion Report zu entnehmen. BVL_FO_05_2437_200_V1.8 SEITE 14 VON 19
Anlage 1 zugelassene Anwendung: 060939-00/00-003 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Zweikeimblättrige Unkräuter Pflanzen/-erzeugnisse/Objekte: Wiesen, Weiden Verwendungszweck:
2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung
Einsatzgebiet: Grünland Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Anwendungszeitpunkt: Mai bis August Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: spritzen Aufwand: - 2 l/ha in 200 bis 400 l Wasser/ha
2.2 Sonstige Kennzeichnungsauflagen (NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstenge- wässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorge- gebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.
(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 Mittelauf- wand verträglich oder unverträglich ist.
(WP733) Schäden, einschließlich Ertragsminderung an der Kulturpflanze möglich.
(WW742) Das Mittel besitzt keine nachhaltige Wirkung gegen ausdauernde Unkräuter.
2.3 Wartezeiten 14 Tage Freiland: Wiesen, Weiden BVL_FO_05_2437_200_V1.8 SEITE 15 VON 19
3 Anwendungsbezogene Anwendungsbestimmungen (NT109) Bei der Anwendung des Mittels muss ein Abstand von mindestens 5 m zu angrenzenden Flä- chen (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 Ver- zeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 90 % eingetragen ist. Bei der Anwendung des Mittels ist 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 MCPA weist ein hohes Gefährdungspotenzial für terrestrische Nichtzielpflanzen auf. Bewertungsbestimmend ist hier die ER50 von 5,48 g MCPA/ha für Lactuca sativa im Wachstumstest. Ausgehend von den geltenden Modellen zur Abdrift sowie zur Verflüchtigung von Zielflächen und anschließender Deposition (hier: EVA 3) und einem Sicherheitsfaktor von 5 ist nach dem Stand der wissen- schaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausrei- chenden Schutz von terrestrischen Nichtzielpflanzen in Saumbiotopen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registra- tion Report zu entnehmen. BVL_FO_05_2437_200_V1.8 SEITE 16 VON 19
Anlage 1 zugelassene Anwendung: 060939-00/00-004 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Zweikeimblättrige Unkräuter Pflanzen/-erzeugnisse/Objekte: Kernobst, Steinobst Verwendungszweck:
2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung
Einsatzgebiet: Obstbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Erläuterung zur Kultur: Ab 1. Standjahr Anwendungszeitpunkt: März bis September Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: spritzen - Erläuterungen: mit Spritzschirm
Aufwand: - 2 l/ha in 200 bis 400 l Wasser/ha
2.2 Sonstige Kennzeichnungsauflagen (NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstenge- wässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorge- gebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.
(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 Mittelauf- wand verträglich oder unverträglich ist.
(WW742) Das Mittel besitzt keine nachhaltige Wirkung gegen ausdauernde Unkräuter. BVL_FO_05_2437_200_V1.8 SEITE 17 VON 19
2.3 Wartezeiten (F) Freiland: Kernobst 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: Steinobst 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.
3 Anwendungsbezogene Anwendungsbestimmungen (NG404) Zwischen behandelten Flächen mit einer Hangneigung von über 2 % und Oberflächenge- wässern - ausgenommen nur gelegentlich wasserführender, aber einschließlich periodisch wasserführender - muss ein mit einer geschlossenen Pflanzendecke bewachsener Rand- streifen vorhanden sein. Dessen Schutzfunktion darf durch den Einsatz von Arbeitsgeräten nicht beeinträchtigt werden. Er muss eine Mindestbreite von 20 m haben. Dieser Randstrei- fen ist nicht erforderlich, wenn: - ausreichende Auffangsysteme für das abgeschwemmte Wasser bzw. den abgeschwemmten Boden vorhanden sind, die nicht in ein Oberflächenge- wässer münden bzw. mit der Kanalisation verbunden sind, oder - die Anwendung im Mulch - oder Direktsaatverfahren erfolgt. Begründung: Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff MCPA weist ein hohes Potenzial für Einträge in das Grundwasser über den Pfad Oberflächenabfluss mit anschließender inverser Uferfiltration auf. Ausgehend von einem Datensatz charakteristischer Eigenschaften des Wirkstoffs (Wasserlöslichkeit = 294000 mg/L; DT50 Boden = 26,7 d; KOC = 81) und einer Berechnung der zu erwartenden Einträge mit dem Modell Exposit 3.01 sind nach dem Stand der wissenschaftlichen Erkenntnisse die Vorgaben der o.g. Anwendungsbestimmung einzu- halten, um einen ausreichenden Schutz des Grundwassers vor Rückständen des Wirkstoffs MCPA (Konzentration im Grundwasser < 0,1 µg/L) zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entneh- men.
(NT109) Bei der Anwendung des Mittels muss ein Abstand von mindestens 5 m zu angrenzenden Flä- chen (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 Ver- zeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 90 % BVL_FO_05_2437_200_V1.8 SEITE 18 VON 19
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 MCPA weist ein hohes Gefährdungspotenzial für terrestrische Nichtzielpflanzen auf. Bewertungsbestimmend ist hier die ER50 von 5,48 g MCPA/ha für Lactuca sativa im Wachstumstest. Ausgehend von den geltenden Modellen zur Abdrift sowie zur Verflüchtigung von Zielflächen und anschließender Deposition (hier: EVA 3) und einem Sicherheitsfaktor von 5 ist nach dem Stand der wissen- schaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausrei- chenden Schutz von terrestrischen Nichtzielpflanzen in Saumbiotopen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registra- tion Report zu entnehmen. BVL_FO_05_2437_200_V1.8 SEITE 19 VON 19
Anlage 2 nicht zugelassene Anwendung: 060939-00/00-005 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Zweikeimblättrige Unkräuter Pflanzen/-erzeugnisse/Objekte: Weinrebe Verwendungszweck: Nutzung als Kelter- und Tafeltraube ab 3. Standjahr der Weinrebe
2 Angaben zur sachgerechten Anwendung
Einsatzgebiet: Weinbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Anwendungszeitpunkt: März bis September Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: spritzen - Erläuterungen: mit Spritzschirm
Aufwand: - 4 l/ha in 200 bis 600 l Wasser/ha
3 Begründung Naturhaushalt Die Prüfung der zum o.g. Antrag vorliegenden Untersuchungsergebnisse hat ergeben, dass die Zulassungsvoraussetzungen für die Anwendung 00-005 nicht erfüllt sind. Der im Pflanzenschutzmittel "U 46 M-Fluid" enthaltene Wirkstoff MCPA weist ein hohes Potenzial für Einträge in das Grundwasser über den Pfad Oberflächenabfluss mit anschlie- ßender inverser Uferfiltration auf. Ausgehend von einem Datensatz charakteristischer Eigen- schaften des Wirkstoffs (Wasserlöslichkeit = 294000 mg/L; DT50 Boden = 26,7 d; KOC = 81) und einer Berechnung der zu erwartenden Einträge mit dem Modell Exposit 3.01 können Konzentrationen im Grundwasser > 0,1 µg/L auch bei Ausschöpfung aller praktikablen Risi- kominderungsmaßnahmen nicht ausgeschlossen werden. Unannehmbare bzw. schädliche Auswirkungen auf das Grundwasser infolge der bestimmungsgemäßen und sachgerechten Anwendung von "U 46 M-Fluid" sind somit nicht auszuschließen. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entneh- men. BVL_FO_05_2437_200_V1.8 Part B – Section 1 CA2643 / T041A Registration Report – Central Zone Core Assessment – Germany U 46 M-Fluid Page 1 of 34
REGISTRATION REPORT Part B
Section 1: Identity, physical and chemical properties, other information Detailed summary of the risk assessment
Product code: CA2643 / T041A Active Substance: MCPA 500 g/L as DMA salt 612.35 g/L
Central Zone Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: Nufarm Submission Date: 21/12/2013 Date: February 2017
Applicant Nufarm Evaluator: DE Date: February 2017 Part B – Section 1 CA2643 / T041A Registration Report – Central Zone Core Assessment – Germany U 46 M-Fluid Page 2 of 34
Table of Contents
IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT ...... 7
IIIA 1.1 Applicant ...... 7
IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s) ...... 7
IIIA 1.2.1 Manufacturer(s) of the preparation ...... 7
IIIA 1.2.2 Manufacturer(s) of the active substance(s) ...... 7
IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s) ...... 7
IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation ...... 7
IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation ...... 7
IIIA 1.4.1 Content of active substance and formulants ...... 7
IIIA 1.4.2 Certified limits of each component ...... 8
IIIA 1.4.3 Common names and code numbers for the active substance(s) ...... 8
IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and function...... 8
IIIA 1.4.5 Formulation process ...... 9
IIIA 1.4.5.1 Description of formulation process ...... 9
IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern ...... 9
IIIA 1.5 Type of Preparation and Code ...... 9
IIIA 1.6 Function ...... 9
IIIA 1.7 Other/Special Studies ...... 9
IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT ...... 10
IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15 ...... 20
IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT ...... 20
IIIA 3.1 Field of Use ...... 20
IIIA 3.2 Nature of the Effects on Harmful Organisms ...... 20
Applicant Nufarm Evaluator: DE Date: February 2017 Part B – Section 1 CA2643 / T041A Registration Report – Central Zone Core Assessment – Germany U 46 M-Fluid Page 3 of 34
IIIA 3.3 Details of Intended Use ...... 20
IIIA 3.3.1 Details of existing and intended uses ...... 20
IIIA 3.3.2 Details of harmful organisms against which protection is afforded ...... 20
IIIA 3.3.3 Effects achieved ...... 20
IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) ...... 20
IIIA 3.5 Concentration of the Active Substance in the Material Used ...... 20
IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent ...... 21
IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection ...... 21
IIIA 3.7.1 Maximum number of applications and their timings ...... 21
IIIA 3.7.2 Growth stages of crops or plants to be protected ...... 21
IIIA 3.7.3 Development stages of the harmful organism concerned ...... 21
IIIA 3.7.4 Duration of protection afforded by each application ...... 21
IIIA 3.7.5 Duration of protection afforded by the maximum number of applications ...... 21
IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops ...... 21
IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops ...... 21
IIIA 3.8.2 Limitations on choice of succeeding crops ...... 21
IIIA 3.8.3 Description of damage to rotational crops ...... 21
IIIA 3.9 Proposed Instructions for Use as Printed on Labels ...... 21
IIIA 3.10 Other/Special Studies ...... 21
IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT ...... 22
IIIA 4.1 Packaging and Compatibility with the Preparation ...... 22
IIIA 4.1.1 Description and specification of the packaging ...... 22
IIIA 4.1.2 Suitability of the packaging and closures ...... 22
IIIA 4.1.3 Resistance of the packaging material to its contents ...... 22
IIIA 4.2 Procedures for Cleaning Application Equipment ...... 23
IIIA 4.2.1 Procedures for cleaning application equipment and protective clothing ...... 23
Applicant Nufarm Evaluator: DE Date: February 2017 Part B – Section 1 CA2643 / T041A Registration Report – Central Zone Core Assessment – Germany U 46 M-Fluid Page 4 of 34
IIIA 4.2.2 Effectiveness of the cleaning procedures ...... 23
IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment...... 23
IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop ...... 23
IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed ...... 23
IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces treated ...... 23
IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs ...... 23
IIIA 4.3.5 Waiting period (in days) between application and handling of treated products ...... 23
IIIA 4.3.6 Waiting period (in days) between last application and sowing or planting succeeding crops ...... 23
IIIA 4.3.7 Information on specific conditions under which the preparation may or may not be used ...... 23
IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks ...... 24
IIIA 4.4.1 Warehouse storage ...... 24
IIIA 4.4.2 User level storage ...... 24
IIIA 4.4.3 Transport ...... 24
IIIA 4.4.4 Fire ...... 24
IIIA 4.4.5 Nature of protective clothing proposed ...... 24
IIIA 4.4.6 Characteristics of protective clothing proposed ...... 24
IIIA 4.4.7 Suitability and effectiveness of protective clothing and equipment ...... 24
IIIA 4.4.8 Procedures to minimise the generation of waste ...... 24
IIIA 4.4.9 Combustion products likely to be generated in the event of fire ...... 24
IIIA 4.5 Detailed Procedures for Use in the Event of an Accident During Transport, Storage or Use ...... 25
IIIA 4.5.1 Containment of spillages ...... 25
IIIA 4.5.2 Decontamination of areas, vehicles and buildings ...... 25
IIIA 4.5.3 Disposal of damaged packaging, adsorbents and other materials ...... 25
IIIA 4.5.4 Protection of emergency workers and bystanders ...... 25
Applicant Nufarm Evaluator: DE Date: February 2017 Part B – Section 1 CA2643 / T041A Registration Report – Central Zone Core Assessment – Germany U 46 M-Fluid Page 5 of 34
IIIA 4.5.5 First aid measures ...... 25
IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage ...... 25
IIIA 4.6.1 Details of proposed procedures for small quantities ...... 25
IIIA 4.6.2 Evaluation of products of neutralization (small quantities) ...... 25
IIIA 4.6.3 Procedures for disposal of small quantities of neutralized waste ...... 25
IIIA 4.6.4 Details of proposed procedures for large quantities ...... 25
IIIA 4.6.5 Evaluation of products of neutralization (large quantities) ...... 26
IIIA 4.6.6 Procedures for disposal of large quantities of neutralized waste ...... 26
IIIA 4.7 Pyrolytic Behaviour of the Active Substance ...... 26
IIIA 4.8 Disposal Procedures for the Plant Protection Product ...... 26
IIIA 4.8.1 Detailed instructions for safe disposal of product and its packaging ...... 26
IIIA 4.8.2 Methods other than controlled incineration for disposal ...... 26
IIIA 4.9 Other/Special Studies ...... 26
IIIA 11 FURTHER INFORMATION ...... 26
IIIA 11.1 Information of Authorisations in Other Countries ...... 26
IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries ...... 26
IIIA 11.3 Justified Proposals for Classification and Labelling ...... 27
IIIA 11.4 Proposals for Risk and Safety Phrases ...... 27
IIIA 11.5 Proposed Label ...... 27
IIIA 11.6 Specimens of Proposed Packaging ...... 27
Appendix 1: List of data used in support of the evaluation ...... 28
Appendix 2: Critical Uses – Justification and GAP tables ...... 31
Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics: ...... 34
Applicant Nufarm Evaluator: DE Date: February 2017 Part B – Section 1 CA2643 / T041A Registration Report – Central Zone Core Assessment – Germany U 46 M-Fluid Page 6 of 34
Introduction This document summarises the information related to the identity, the physical and chemical properties, the data on application, further information and the classification for the product CA2643 containing the active substance MCPA. MCPA was listed in Annex 1 of EU inclusion Directive 91/414/EC on May 1st 2006 (Commission Inclusive Directive 2005/57/EC 21 September 2005)). The review Report for MCPA is detailed in commission working SANCO/4062/2001-final dated 15th April 2005, Amended 11 July 2008.
This product was not the representative formulation. The product has not been previously evaluated according to Uniform Principles.
The following table provides the EU endpoints to be used in the evaluation.
Agreed EU End-points
End-Point MCPA (Reg. (EU) No. 540/2011)
Purity of active substance min 930 g/kg
Appendix 1 of this document contains the list of references included in this document for support of the evaluation.
Information on the detailed composition of CA2643 can be found in the confidential dossier of this submission (Registration Report - Part C).
Applicant Nufarm Evaluator: DE Date: February 2017 Part B – Section 1 CA2643 / T041A Registration Report – Central Zone Core Assessment – Germany U 46 M-Fluid Page 7 of 34
IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT IIIA 1.1 Applicant
Nufarm Deutschland GmbH Im MediaPark 4e 50670 Köln Germany
Contact person: XXXXX Tel.No.: XXXXX Fax No: XXXXX e-mail: XXXXX
IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s) IIIA 1.2.1 Manufacturer(s) of the preparation Confidential information - data provided separately (Part C). IIIA 1.2.2 Manufacturer(s) of the active substance(s) Confidential information - data provided separately (Part C). IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s) MCPA: min 940 g/kg Further information/justification is provided in Part C.
IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation Trade name: AGROXONE 50 U46 M Fluid Agrichem MCPA 500 Agritox
Company code number: CA2643 / T041A
IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation IIIA 1.4.1 Content of active substance and formulants The formulation was not the representative formulation.
Applicant Nufarm Evaluator: DE Date: February 2017 Part B – Section 1 CA2643 / T041A Registration Report – Central Zone Core Assessment – Germany U 46 M-Fluid Page 8 of 34
Pure active substance: content of pure MCPA acid: 500 g/L content of pure MCPA DMA salt: 612.35 g/L limits MCPA acid: 480 - 520 g/L limits MCPA DMA salt: 587.35 - 637.35 g/L
Technical active substance: content of technical MCPA acid 531.9 g/l 47.07 % w/w at minimum purity (94 %): content of technical MCPA DMA salt 651.4 g/L 57.65 % w/w at minimum purity (94 %):
The active substance in the formulation is present in the form of the Dimethylamine salt. Further information on the active substances and on the certified limits of formulants is considered confidential and is provided separately (Part C).
IIIA 1.4.2 Certified limits of each component This is not an EC data requirement/ not required by regulation (EU) 2011/545.
IIIA 1.4.3 Common names and code numbers for the active substance(s)
Data Type Name/Code Number Point
1.4.3.1 ISO common name MCPA
1.4.3.2 CAS No. 94-74-6
1.4.3.2 EINECS No. 202-360-6
1.4.3.2 CIPAC No. 2
1.4.3.2 ELINCS –
1.4.3.3 Salt, ester anion or cation Dimethylammonium salt (DMA) present
IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and function. CONFIDENTIAL information - data provided separately (Part C).
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IIIA 1.4.5 Formulation process IIIA 1.4.5.1 Description of formulation process This is not an EC data requirement/ not required regulation (EU) 2011/545, but the applicant submitted information which are summarised in the confidential part C.
IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern The formulation process involves a simple neutralisation reaction to form the DMA salt of the MCPA active ingredient. No impurities of particular toxicological significance are present; however the manufacture of phenoxy acids presents a risk of dioxin and difuran formation. Analyses have been performed to determine that dioxin/difuran impurities are not present.
IIIA 1.5 Type of Preparation and Code Type : Soluble concentrate Code : SL
IIIA 1.6 Function The product will be used as herbicide.
IIIA 1.7 Other/Special Studies None.
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IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable.
Table 1: Summary of the physical, chemical and technical properties of the plant protection product
Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N
Colour, odour and Visual assessment and MCPA DMA 500 The preparation is a pale yellow Y Hutchinson, N., 1998, Acceptable physical state organoleptic sample purity = liquid (Munsell 5Y8/3) with a amine 97/0037 (IIIA 2.1) determination 502 g/l like odour.
MCPA DMA 500 The preparation is a pale yellow Y Mahmood, T., 2011, sample purity = liquid (Munsell 2.5Y8/3) with a 10/0591 500 g/l amine like odour.
MCPA DMA 500 The preparation is a yellow liquid Y Wilson, I., 2013, sample purity = (Munsell 5Y8/3) with a amine like 13/0820 516.9 g/l odour.
Explosive properties Theoretical - The components do not contain N Hutchinson, N., 2000, Acceptable. (IIIA 2.2.1) assessment functional groups which enhance 00/0132 explosivity. The formulation has no explosive properties
Oxidizing properties Theoretical - Theoretical assessment is only N Hutton, L., 2009, Acceptable (IIIA 2.2.2) assessment based on active ingredient and 09/LH/002 water, but does not take the other co-formulants into consideration.
Theoretical - The co-formulants in the MCPA Patel, S., 2016
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N assessment DMA formulation (CA2463) are not classified as oxidisers and hence will not impart any oxidising properties to the formulation.
Flash point EEC A 9 MCPA DMA 500 No flash point up to 200 °C. Y Bass, R. V., 2000, Acceptable. (IIIA 2.3.1) sample purity = 00/0112 500 g/l
Flammability not required for liquid formulations Acceptable. (IIIA 2.3.2)
Auto-flammability EEC A 15 MCPA DMA 500 Auto-ignition 422 °C Y Weaver, M. J., 2000, Acceptable. (IIIA 2.3.3) sample DG/345/73 27200 SOP No. 414 purity = 504 g/l
Acidity or alkalinity CIPAC MT 75 MCPA DMA 500 pH 9.2 (neat) at 20 °C Y Bass, R. V., 2000, Acceptable. and pH batch DG/345/73 00/0115 (IIIA 2.4.1) MCPA DMA 500 20 °C: 7.6 Y Mahmood, T., 2011, sample purity = 10/0591 500 g/l
MCPA DMA 500 20 °C: 8.1 Y Wilson, I., 2013, sample purity = 13/0820 516.9 g/l pH of a 1% aqueous CIPAC MT 75 MCPA DMA 500 water, 20 °C: 8.4 Y Bass, R. V., 2000, Acceptable. dilution, emulsion or sample purity = 00/0115 dispersion 504 g/l
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N (IIIA 2.4.2)
MCPA DMA 500 water, 20 °C: 5.8 Y Mahmood, T., 2011, sample purity = 10/0591 500 g/l
MCPA DMA 500 water, 20 °C: 6.9 Y Wilson, I., 2013, sample purity = 13/0820 516.9 g/l
Kinematic viscosity Not applicable, product not for ultra Acceptable (IIIA 2.5.1) low volume use
Dynamic viscosity OECD 114 MCPA DMA 500 20 °C: 15.7 mPa s Y Mahmood, T., 2011, Acceptable. (IIIA 2.5.2) sample purity = 10/0591 500 g/l 40 °C: 7.4 mPa s
MCPA DMA 500 20 °C: 15.4 mPa s Y Bass, R. V., 2000, batch DG/345/73 00/0115
Surface tension EEC A 5 MCPA DMA 500 0.1 %, 20 °C: 72.5 mN/m Y Bass, R. V., 2000, Acceptable. (IIIA 2.5.3) batch DG/345/73 00/0115
20 Relative density EEC A 3 MCPA DMA 500 d4 = 1.128 Y Bass, R. V., 2000, Acceptable. (IIIA 2.6.1) OECD 109 batch DG/345/73 00/0115
20 MCPA DMA 500 d4 = 1.126 Y Mahmood, T., 2011, sample purity = 10/0591 500 g/l
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N
20 MCPA DMA 500 d4 = 1.134 Y Wilson, I., 2013, sample purity = 13/0820 516.9 g/l
Bulk or tap density Not applicable as product is liquid Acceptable. (IIIA 2.6.2)
Storage Stability after CIPAC MT 46.3 MCPA DMA 500 Storage material: glass Y Hutchinson, , 1998, No determination of 14 days at 54º C sample purity = 98/0040 phys chem props after (IIIA 2.7.1) EPA Guidelines 40 502 g/l Content of MCPA: storage were CFR 158.190 before storage: 507 g/L conducted, but the batch DG/291/1 after storage: 506 g/L results submitted under 2.7.5 showed no significant changes, so this is acceptable.
Stability after storage storage conditions: MCPA DMA 500 Test results indicate that the Y Ackroyd, C., 2002, Acceptable. for other periods 3, 6 12, 18 months at sample purity = material is stable for at least 24 99/0095 and/or temperatures ambient temperature 513 g/l months (IIIA 2.7.2)
Minimum content - Not necessary, since the decrease of Acceptable. after heat stability the active substance did not exceed testing 5 %. (IIIA 2.7.3)
Effect of low CIPAC MT 39.3 MCPA DMA 500 No separated material, Y Bass, R. V., 2000, Acceptable. temperatures on batch DG/345/73 homogeneous liquid. 00/0115 stability
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N (IIIA 2.7.4)
Ambient temperature MCPA DMA 500 Storage material: HDPE bottle Y Ackroyd, C., 2002, Acceptable. shelf life sample purity = 99/0095 (IIIA 2.7.5) 513 g/l Average temperature: batch DG/345/49 The content of the active substance does not decrease > 5 %. Content of MCPA: before storage: 513 g/L after storage: 523 g/L The changes of the physical and chemical properties appearance, pH, density and dilution stability are negligible. the packaging showed no sign of corrosion.
MCPA DMA 500 g/l storage material: 1 L HDPE bottle Wilson, I. (2015) Acceptable To41A(CA2643) Content of MCPA: 13/0818 before storage: 512.6 g/L after storage: 520.1 g/L content of relevant impurity PCOC: before storage: 4.56 g/L after storage: 4.77 g/L The changes of the physical and chemical properties pH, density, dilution stability and persistent foam
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N are negligible. packaging shows no sign of corrosion.
MCPA DMA 500 g/l storage material: 1 L PET bottle Content of MCPA: before storage: 512.6 g/L after storage: 520.9 g/L content of relevant impurity PCOC: before storage: 4.56 g/L after storage: 4.95 g/L The changes of the physical and chemical properties pH, density, dilution stability and persistent foam are negligible. packaging shows no sign of corrosion.
Shelf life in months - Please refer to 2.7.5 Acceptable. (if less than 2 years) (IIIA 2.7.6)
Wettability Not applicable, product is a liquid. Acceptable. (IIIA 2.8.1)
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N
Persistence of CIPAC MT 47 MCPA DMA 500 2.6 %, CIPAC water D: Y Bass, R. V., 2000, Acceptable. foaming batch DG/345/73 00/0115 (IIIA 2.8.2) Before storage 10 s: 0 mL 15 min: 0 mL
Suspensibility not required for SL formulations Acceptable. (IIIA 2.8.3.1)
Spontaneity of not required for SL formulations Acceptable. dispersion (IIIA 2.8.3.2)
Dilution stability CIPAC MT 41 MCPA DMA 500 0.5% v/v/ 2% v/v/ 5% v/v , Y Bass, R. V., 2000, Acceptable. (IIIA 2.8.4) batch DG/345/73 CIPAC water D, 20 °C for 4 h: 00/0115 Solution clear and free from precipitates.
MCPA DMA 500 2.5 % v/v , CIPAC water D, 20 °C Y Mahmood, T., 2011, sample purity = for 4 h: 10/0591 500 g/l Solution clear and free from precipitates.
MCPA DMA 500 0.5 % v/v/ 2 % v/v/ 5 % v/v, Y Wilson, I., 2013, sample purity = CIPAC water D, 20 °C for 4 h: 13/0820 516.9 g/l Solution clear and free from precipitates.
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N
MCPA DMA 500 0.5%v/v/ 2%v/v/ 5%v/v, CIPAC Y Ackroyd, C., 2002, sample purity = water D, 20 °C for 4 h: 99/0095 513 g/l Before and after storage for 24 month at ambient temperature: Solution clear and free from precipitates. 5 % v/v, CIPAC water C, 20 °C for 1 h: Before and after storage for 24 month at ambient temperature: Solution clear and free from precipitates.
Dry sieve test not required for liquid formulations Acceptable. (IIIA 2.8.5.1)
Wet sieve test not required for SL formulations Acceptable. (IIIA 2.8.5.2)
Particle size not required for SL formulations Acceptable. distribution (IIIA 2.8.6.1)
Nominal size range of not required for liquid formulations Acceptable. granules (IIIA 2.8.6.2)
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N
Dust content not required for liquid formulations Acceptable. (IIIA 2.8.6.3)
Particle size of dust not required for liquid formulations Acceptable. (IIIA 2.8.6.4)
Friability and attrition not required for liquid formulations Acceptable. (IIIA 2.8.6.5)
Emulsifiability not required for SL formulations Acceptable. (IIIA 2.8.7.1)
Flowability not required for liquid formulations Acceptable. (IIIA 2.8.8.1)
Pourability (including not required for SL formulations Acceptable. rinsed residue) (IIIA 2.8.8.2)
Dustability following not required for liquid formulations Acceptable. accelerated storage (IIIA 2.8.8.3)
Physical applicant states: N Tomlin, C S additional compatibility of tank (November 2006) The information mixes tank mixes are well known Pesticides Manual, (IIIA 2.9.1) 14th Edition; tank mixtures should be evaluated at national level
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Test or study & Annex Method used / Test material purity Findings GLP Reference Acceptability / point deviations and specification comments Y/N
Chemical applicant states: N Tomlin, C S additional compatibility of tank (November 2006) The information mixes tank mixes are well known Pesticides Manual, (IIIA 2.9.2) 14th Edition; tank mixtures should be evaluated at national level
Distribution to seed Not applicable, product is not used Acceptable (IIIA 2.10.1) for seed treatment.
Adhesion to seeds Not applicable, product is not used Acceptable (IIIA 2.10.2) for seed treatment. %
Miscibility Not required by regulation (EU) Acceptable. (IIIA 2.11) 2011/545.
Dielectric breakdown Not required by regulation (EU) Acceptable. (IIIA 2.12) 2011/545.
Corrosion Not required by regulation (EU) Acceptable. characteristics 2011/545. (IIIA 2.13)
Container material Not required by regulation (EU) Acceptable. (IIIA 2.14) 2011/545.
Other/special studies Not required by regulation (EU) Acceptable. (IIIA 2.15) 2011/545.
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IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15 The product CA2643 is a soluble concentrate formulation. All studies have been performed in accordance with the current requirements, the critical GAP and the results are deemed to be acceptable. The appearance of the product is that of a pale yellow liquid with a amine like odour. It is not explosive, has no oxidising properties and a self ignition temperature of 422 °C. The neat formulation has a pH of 7.6 to 9.2. The stability data indicate a shelf life of at least two years at ambient temperature in packaging of HDPE. The technical characteristics are acceptable for a soluble concentrate formulation.
Experimental testing of the product's physico-chemical and technical characteristics: See Appendix 3
Implications for labelling: No labelling necessary due to physical or chemical properties described above.
IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT IIIA 3.1 Field of Use The data presented support the label claim for U 46 M-Fluid for the control of annual and perennial dicotyledonous weeds in spring and winter cereals, grassland, orchards and grape vine. IIIA 3.2 Nature of the Effects on Harmful Organisms MCPA belongs to the chemical group of phenoxy carbonic acids. MCPA belongs to the group of auxin- herbicides and acts as a selective, systemic, hormone-type herbicide. MCPA will mainly be absorbed through green leaves. MCPA is translocated in the plant by both acropetal and basipetal action and concentrates in meristematic tissues of plants. MCPA influences levels of RNA and DNA polymerase and levels of enzymes involved in normal plant growth. MCPA acts by inducing abnormal cell division, abnormal growth, influence of respiration and influence of metabolic processes. Good growing conditions support the uptake of the active ingredient and the efficacy. Site of action (HRAC-group): O IIIA 3.3 Details of Intended Use IIIA 3.3.1 Details of existing and intended uses Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 3.3.2 Details of harmful organisms against which protection is afforded Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 3.3.3 Effects achieved Please refer to Part B Section 7. IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 3.5 Concentration of the Active Substance in the Material Used
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Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection IIIA 3.7.1 Maximum number of applications and their timings Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 3.7.2 Growth stages of crops or plants to be protected Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 3.7.3 Development stages of the harmful organism concerned Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 3.7.4 Duration of protection afforded by each application Please refer to Part B Section 7. IIIA 3.7.5 Duration of protection afforded by the maximum number of applications Please refer to Part B Section 7. IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops Please refer to Part B Section 7. IIIA 3.8.2 Limitations on choice of succeeding crops Please refer to Part B Section 7. IIIA 3.8.3 Description of damage to rotational crops Please refer to Part B Section 7. IIIA 3.9 Proposed Instructions for Use as Printed on Labels Please refer to Registration Report – Part A, Appendix 2 for the relevant country. IIIA 3.10 Other/Special Studies This is not an EC data requirement/ not required by Directive 91/414/EEC.
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IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT IIIA 4.1 Packaging and Compatibility with the Preparation Packaging Summary Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.
IIIA 4.1.1 Description and specification of the packaging MCPA DMA 500 can be provided in containers of sizes 1-20 litres (HDPE or PET), depending upon requirements. Below is the specification for the containers used, including an example packaging description of a 10 L container.
10 litre bottle: material: High density polyethylene (HDPE) Polyethylene tetraphlalate (PET)
shape/size: 375 mm x 240 mm x 179 mm
opening: 63 mm inner diameter
closure: tamper evident cap
seal: compression or heat seal
IIIA 4.1.2 Suitability of the packaging and closures MCPA DMA 500 will be stored, packed and transported in UN approved packaging, which has been tested for suitability in terms of strength, leak proofness and resistance. Individual packaging displays a UN certification number with guidelines on its suitability.
IIIA 4.1.3 Resistance of the packaging material to its contents
Report: Ackroyd, C., 2002
Title: Agroxone: Two Year Storage Stability of 4-chloro-2-methylphenoxy acetic acid dimethylamine salt at 500 g l-1
Document No: 99/0095
Guidelines: Regulation (EU) No 545/2011.Annex III 2.7.1, EEC 94/37, Manual on Development and Use of FAO Specifications for Plant Protection Products (Jan. 1999) GLP Yes
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The containers are checked for corrosion and for weight loss during storage stability testing. The contents have no negative effect on package integrity after 24 months storage at room temperature. Package: HDPE bottle.
IIIA 4.2 Procedures for Cleaning Application Equipment IIIA 4.2.1 Procedures for cleaning application equipment and protective clothing Wash equipment thoroughly, immediately after use. Fill the tank with clean water and leave overnight, spray out before storage or using other products. Traces of product may cause damage to susceptible crops sprayed later.
IIIA 4.2.2 Effectiveness of the cleaning procedures MCPA DMA 500 has been used for the control of broad-leaved weeds in agricultural situations for many years. Many non target crops are highly susceptible to MCPA and would show phytotoxic effects from using spraying equipment that has not been cleaned in the appropriate manner described on the label and above in this section. Due to the fact that no reports of any crop damage caused in this way are received from year to year, it can be assumed that if the directions are followed correctly spray tanks are effectively cleaned.
IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop See section 4. IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed See section 4. IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces treated See section 4. IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs See section 4. IIIA 4.3.5 Waiting period (in days) between application and handling of treated products See section 4. IIIA 4.3.6 Waiting period (in days) between last application and sowing or planting succeeding crops See section 4. IIIA 4.3.7 Information on specific conditions under which the preparation may or may not be used
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See section 4.
IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks
Report: Anonymous, 2013
Title: Safety data sheet - MCPA DMA 500G/L AI
The safety data sheet complies with actual EEC regulations and is based on the present state of knowledge.
IIIA 4.4.1 Warehouse storage Keep containers tightly closed in a dry, cool and well-ventilated place. IIIA 4.4.2 User level storage Keep away from food, drink and animal feeding stuffs. Store in original container. Active substance minimum shelf life: 2 years. IIIA 4.4.3 Transport No transport stickers are required as MCPA is classed as a non hazardous material. IIIA 4.4.4 Fire MCPA DMA 500 is not classified as flammable. However if involved in a fire it may give off toxic fumes of carbon monoxide, carbon dioxide and hydrogen chloride gas. Extinguish with carbon dioxide, dry chemical and foam or water spray. IIIA 4.4.5 Nature of protective clothing proposed Avoid contact with skin, eyes, clothing and inhalation of vapours, aerosols or dusts. Wear suitable protective clothing, boots, pvc gloves, eye and face protection. Never wear contact lenses while working with this material. IIIA 4.4.6 Characteristics of protective clothing proposed Eye protection used should conform to EN166 and be suitable for liquid chemicals. PVC gloves used should conform to EN374 - protection against chemical hazards. IIIA 4.4.7 Suitability and effectiveness of protective clothing and equipment The European standards EN166 and EN374 are well established as being suitable and effective protection against chemical hazards. IIIA 4.4.8 Procedures to minimise the generation of waste MCPA DMA 500 is supplied in a wide range of container sizes, always buy the container to match needs. One large container should be used in preference to several small containers. Always determine accurately how much product is required to avoid excess concentrate remaining in the tank. IIIA 4.4.9 Combustion products likely to be generated in the event of fire
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MCPA DMA 500 is not classified as flammable. However if involved in a fire it may give off toxic fumes of carbon monoxide, carbon dioxide and hydrogen chloride gas. IIIA 4.5 Detailed Procedures for Use in the Event of an Accident During Transport, Storage or Use
IIIA 4.5.1 Containment of spillages If source of spillage is land based, soak up with inert absorbent material, place in suitable labelled containers and dispose of as hazardous waste. All containment materials may be disposed of by controlled incineration or activated sludge sewage treatment. In case of contamination of water, telephone the relevant Water Management Company or Government Bureau, Police and Emergency Services, The Pollution Inspectorate or Environmental Protection Agency. IIIA 4.5.2 Decontamination of areas, vehicles and buildings Refer to IIIA 4.5.1 for details. IIIA 4.5.3 Disposal of damaged packaging, adsorbents and other materials Refer to Point IIIA 4.8 for detailed instructions on disposal of packaging materials etc. IIIA 4.5.4 Protection of emergency workers and bystanders Use protective clothing as detailed in data point IIIA 4.4.5 IIIA 4.5.5 First aid measures
Inhalation Remove casualty from exposure ensuring one’s own safety whilst doing so. Consult a doctor.
Skin Contact Wash immediately with plenty of soap and water.
Eye Contact Bathe the eye(s) with running water for 15 minutes
Ingestion Wash out mouth with water. Do not induce vominting. If conscious, give half a litre of water to drink immediately. Transfer to hospital as soon as possible
IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage IIIA 4.6.1 Details of proposed procedures for small quantities Not applicable, MCPA DMA 500 is already present in a salt form. IIIA 4.6.2 Evaluation of products of neutralization (small quantities) Not applicable, MCPA DMA 500 is already present in a salt form. IIIA 4.6.3 Procedures for disposal of small quantities of neutralized waste Not applicable, MCPA DMA 500 is already present in a salt form. IIIA 4.6.4 Details of proposed procedures for large quantities
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Not applicable, MCPA DMA 500 is already present in a salt form. IIIA 4.6.5 Evaluation of products of neutralization (large quantities) Not applicable, MCPA DMA 500 is already present in a salt form. IIIA 4.6.6 Procedures for disposal of large quantities of neutralized waste Not applicable, MCPA DMA 500 is already present in a salt form. IIIA 4.7 Pyrolytic Behaviour of the Active Substance Unwanted amounts of MCPA may be disposed of by controlled combustion in a licensed incinerator. The halogen content of MCPA is less than 60 %. Complete degradation is possible at temperatures in excess of 900ºC. However a temperature of approximately 1100ºC is advised as an incineration temperature. The formation of hydrogen chloride gas (HCl) and chlorine gas (Cl2) should be noted. Incineration will also produce CO2, CO and H2O. IIIA 4.8 Disposal Procedures for the Plant Protection Product IIIA 4.8.1 Detailed instructions for safe disposal of product and its packaging Only sufficient product for the required treatment area should be prepared thereby no waste product should be present. However, in the event that disposal is required, follow national guidelines for the disposal of plant protection products and their packaging. Do not contaminate surface water or ground water with packaging or surplus product. Any person spraying plant protection products should be aware of the relevant regulations and codes of practice for disposal of plant protection products, which are applicable in their own country/region. IVA and BVL publishes various guidance documents and codes of practice relating to the use of plant protection products on its website and these are regularly updated to take account of legislative amendments. Similar considerations apply in all Member States and these should be adhered to by producers and users of plant protection products.
IIIA 4.8.2 Methods other than controlled incineration for disposal No other methods for disposal of CA2643 than those described in chapter 4.8.1 are available.
IIIA 4.9 Other/Special Studies No additional studies were performed.
IIIA 11 FURTHER INFORMATION IIIA 11.1 Information of Authorisations in Other Countries see EU pesticide data base (http://ec.europa.eu/sanco_pesticides/public/ )
IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries
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MRLs are set at European level, see Regulation (EC) No. 396/2005.
IIIA 11.3 Justified Proposals for Classification and Labelling Proposals for classification and labelling of BAS 512 16 F in accordance with the EC Directive on dangerous preparations 1999/45/EC and Directive 2001/59/EC (as amended) are presented below:
Physico-chemical properties
Table 11.3-1 Physico-chemical properties
Study Type Findings Reference (triggered risk phrase)
Explosivity Not explosive (-) Hutchinson, N., 2000, 00/0132
Oxidizing Not oxidizing (-) Hutton, L., 2009, 09/LH/002 properties
Flammability Auto-ignition temperature is 422 °C Weaver, M. J., 2000, 27200
Viscosity 20 °C: 15.7 mPa s Mahmood, T., 2011, 10/0591 (dynamic) 40 °C: 7.4 mPa s
Toxicology see section 3.
Ecotoxicology/Environment see section 6.
IIIA 11.4 Proposals for Risk and Safety Phrases Please refer to Registration Report – Part A.
IIIA 11.5 Proposed Label Please refer to Registration Report – Part A.
IIIA 11.6 Specimens of Proposed Packaging Specimens of the packaging were not provided as there was no request.
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Appendix 1: List of data used in support of the evaluation
Annex point/ Author(s) Year Title Data Owner How reference No Source (where different from company) protection considered Report-No. claimed in dRR GLP or GEP status (where relevant) Study- Status / Usage*
KIIIA 2.1 Hutchinson, 1997 Physical Chemical Properties of 4- N NUF 1 N. chloro-2-methylphenoxyacetic acid, dimethylamine salt solution at 500 g/l acid concentration A H Marks & Company Limited 97/0037 GLP, not published KIIIA 2.1 Mahmood, 2010 MCPA DMA 500 and MCPA Y NUF 1 KIIIA 2.4.1 T. DMA 250 Certificate of Analysis KIIIA 2.4.2 and Viscosity KIIIA 2.5.2 Nufarm UK Limited KIIIA 2.6.1 10/0591 KIIIA 2.8.4 GLP, not published KIIIA 2.1 Wilson, I. 2013 MCPA DMA 500 g/l – Certificate Y NUF 1 KIIIA 2.4.1 of Analysis KIIIA 2.4.2 Nufarm UK Limited KIIIA 2.6.1 13/0820 KIIIA 2.8.4 GLP, not published KIIIA 2.2.1 Hutchinson, 2000 Theoretical Assessment of the N NUF 1 N. D. Explosivity of Agroxone A H Marks & Company Limited 00/0132 GLP, not published KIIIA 2.2.2 Hutton, L. 2009 Oxidising Properties of MCPA N NUF 5 DMA Solutions (waiver) Nufarm UK Limited 09/LH/002 Not GLP, not published KIIIA 2.2.2 Patel, S. 2016 see Part C Y NUF 5 KIIIA 2.3.1 Bass, R. V. 2000 Determination of the Flash Points N NUF 1 of Agroxone, Agroxone 75 and Agroxone Combi A H Marks & Company Limited 00/0112
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Annex point/ Author(s) Year Title Data Owner How reference No Source (where different from company) protection considered Report-No. claimed in dRR GLP or GEP status (where relevant) Study- Status / Usage*
KIIIA 2.3.3 Weaver, M. 2000 To Determine the Auto-Ignition N NUF 1 J. F. Temperature on a Sample of MCPA DMA 500 g/l a.i Chilworth Technology Ltd, UK 272000 GLP, not published KIIIA 2.4.1 Bass, R. V. 2000 The Chemical and Physical N NUF 1 KIIIA 2.4.2 Properties of MCPA DMA salt KIIIA 2.5.2 solution at 500 g l-1 MCPA acid KIIIA 2.5.3 concentration KIIIA 2.6.1 A H Marks & Company Limited KIIIA 2.7.4 00/0115 KIIIA 2.8.2 GLP, not published KIIIA 2.8.4 KIIIA 2.7.1 Hutchinson, 1998 Determination of the thermal N NUF 5 N. D. stability of Agroxone Amine 500 A H Marks & Company Limited 98/0040 GLP, not published KIIIA 2.7.5 Ackroyd, C. 2002 Agroxone: Two Year Storage N NUF 1 KIIIA 2.8.4 Stability of 4-chloro-2- methylphenoxy acetic acid dimethylamine salt at 500 g l-1 A H Marks & Company Limited 99/0095 GLP, not published KIIIA1 2.7.5 Wilson, I 2015 MCPA DMA 500 g/l – Two years Y NUF 1 storage stability – Final report 13 October 2015 13/0818 GLP, unpublished KIIIA 2.9.1 Tomlin, C. 2006 A World Compendium: The N Public 5 KIIIA 2.9.2 D. S. Pesticides Manual, Fourteenth not Edition submitted Not GLP Published by: British Crop Protection Council ISBN 1 901396 14 2
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Annex point/ Author(s) Year Title Data Owner How reference No Source (where different from company) protection considered Report-No. claimed in dRR GLP or GEP status (where relevant) Study- Status / Usage*
KIIIA 4.4 Anonymous 2013 Safety data sheet - MCPA DMA N NUF 1 500G/L AI Not GLP
* 1 accepted (study valid and considered for evaluation) 2 not accepted (study not valid and not considered for evaluation) 3 not considered (study not relevant for evaluation) 4 not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)
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Appendix 2: Critical Uses – Justification and GAP tables GAP rev. (No), date: 2016-07-22
PPP (product name/code): U 46 M-Fluid Formulation type: SL Active substance: MCPA Conc. of as: 500 g/L
Applicant: Nufarm Professional use: X Zone(s): central/EU Non-professional use:
Verified by MS: yes
1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Membe Crop and/ F Pests or Group of Application Application rate PHI Remarks: No. r or situation G pests controlled (days state(s) or Method / Timing / Growth Max. number kg, L product / g, kg as/ha Water ) e.g. safener/synergist per (crop destination / I (additionally: Kind stage of crop & (min. interval ha L/ha ha purpose of crop) developmental stages of season between a) max. rate a) max. rate the pest or pest group) applications) per appl. per appl. min / max e.g. recommended or a) per use b) max. total b) max. total mandatory tank mixtures b) per crop/ rate per rate per season crop/season crop/season 001 DE Winter soft wheat F Annual dicotyledonous Spraying After emergence a) 1 a) 1.4 L/ha a) 700 g 200 - 400 F NW 642-1, TRZAW weeds BBCH 13 – 39 b) 1 b) 1.4 L/ha as/ha NT108,
winter durum wheat TTTDS spring b) 700 g WH9161 as/ha TRZDW Creeping thistle Spelt CIRAR TRZSP winter barley HORVW winter rye SECCW winter triticale
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TTLWI 002 DE Spring soft wheat F Annual dicotyledonous Spraying After emergence a) 1 a) 1.4 L7ha a) 700 g 200 - 400 F NW 642-1, TRZAS weeds BBCH 13 – 39 b) 1 b) 1.4 L/ha as/ha NT108,
spring durum wheat TTTDS spring b) 700 g WH9161 as/ha TRZDS Creeping thistle spring barley CIRAR HORVS common oats AVESA spring rye SECCS 003 DE Grassland, pasture, F Dicotyledonous weeds Spraying BBCH 25 – 35 a) 1 a) 2 L/ha a) 1000 g 200 - 400 14 d NW 642-1, meadow TTTDD May to August b) 1 b) 2 L/ha as/ha NT109,
NNNFW b) 1000 g WH9161, as/ha WP733, WW742 004 DE Pome fruit F Dicotyledonous weeds Spraying March to a) 1 a) 2 L/ha a) 1000 g 200 - 400 F NG404, NNNOK TTTDD with September b) 1 b) 2 L/ha as/ha NW 642-1, screen stone fruits b) 1000 g NT109, as/ha NNNOS WH9161, WW742 from 1st year after planting 005 DE Grape vine F Dicotyledonous weeds Spraying March to a) 1 a) 4 L/ha a) 2000 g 200 - 600 F No authorization due to VITVI TTTDD September b) 1 b) 4 L/ha as/ha contamination of groundwater due to utilisation as wine b) 2000 g as/ha surface runoff into the and table grape with adjacent ditch with up to 3rd year after screen subsequent bank planting of the vine filtration. WH9161, WW742
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Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (8) The maximum number of applications possible under practical conditions of use for each single (2) Member State(s) or zone for which use is applied for application and per year (permanent crops) or crop (annual crops) must be provided (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (8) Min. interval between applications (days) were relevant situation should be described (e.g. fumigation of a structure) (10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) must be given in metric units (e.g. kg or L product / ha) (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 (11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of crop/season must be given in metric units (e.g. g or kg / ha) equipment used must be indicated (12) The range (min/max) of water volume under practical conditions of use must be given (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, (L/ha) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of (13) PHI - minimum pre-harvest interval application (14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
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Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics: The following physical, chemical and technical properties of the plant protection product were experimentally tested: density, colour, pH, surface tension, storage stability at high temperatures (14 d at 54 °C) and persistent foaming. No significant deviations from the data submitted by the applicant were detected. The formulation complies with the FAO specification 2.1+50.1/SL/ts/- (1983).
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REGISTRATION REPORT Part B
Section 2: Analytical Methods Detailed summary of the risk assessment
Product code: CA2643 / T041A Active Substance: MCPA 500 g/L as DMA salt 612.35 g/L
Central Zone Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: Nufarm Submission Date: 21/12/2013 Date: February 2017
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Table of Contents
IIIA 5 METHODS OF ANALYSIS ...... 4
IIIA 5.1 Analytical Standards and Samples ...... 4
IIIA 5.1.1 Samples of the preparation...... 4
IIIA 5.1.2 Analytical standards for the pure active substance ...... 4
IIIA 5.1.3 Samples of the active substance as manufactured...... 4
IIIA 5.1.4 Analytical standards for relevant metabolites and all other components included in the residue definition ...... 4
IIIA 5.1.5 Samples of reference substances for relevant impurities ...... 4
IIIA 5.2 Methods for the Analysis of the Plant Protection Product ...... 4
IIIA 5.2.1 Description of the analytical methods for the determination of the active substance in the plant protection product ...... 4
IIIA 5.2.2 For preparations containing more than one active substance, description of method for determining each in the presence of the other ...... 5
IIIA 5.2.3 Applicability of existing CIPAC methods ...... 5
IIIA 5.2.4 Description of analytical methods for the determination of relevant impurities ...... 5
IIIA 5.2.5 Description of analytical methods for the determination of formulants ...... 5 IIIA 5.3 Description of Analytical Methods for the Determination of Residues ...... 6 IIIA 5.3.1 Evaluation of MCPA ...... 6 IIIA 5.3.1.1 Description of Analytical Methods for the Determination of Residues of MCPA in Plant Matrices (OECD KIII A 5.3.1) ...... 7 IIIA 5.3.1.2 Description of Analytical Methods for the Determination of Residues of MCPA in Animal Matrices (OECD KIII A 5.3.1) ...... 9 IIIA 5.3.1.3 Description of Methods for the Analysis of MCPA in Soil (OECD KIII A 5.4) ...... 9 IIIA 5.3.1.4 Description of Methods for the Analysis of MCPA in Water (OECD KIII A 5.6) ...... 10 IIIA 5.3.1.5 Description of Methods for the Analysis of MCPA in Air (OECD KIII A 5.7) ...... 10 IIIA 5.3.1.6 Description of Methods for the Analysis of MCPA in Body Fluids and Tissues (OECD KIII A 5.8) ...... 10
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IIIA 5.3.1.7 Other Studies/ Information ...... 10 IIIA 5.4 Conclusion on the availability of analytical methods for the determination of residues ...... 11
Appendix 1 – List of data submitted in support of the evaluation ...... 11
Appendix 2 – Detailed evaluation of the additional studies relied upon ...... 15 A 1.1 Analytical methods for MCPA ...... 15
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IIIA 5 METHODS OF ANALYSIS This document summarises the information related to the analytical methods for the product CA2643 (U 46 M-Fluid) containing the active substance MCPA which was approved according to Regulation (EC) No 1107/2009.
This product was not the representative formulation. The product has not been previously evaluated according to Uniform Principles.
Appendix 1 of this document contains the list of references included in this document for support of the evaluation.
Information on the detailed composition of CA2643 (U 46 M-Fluid) can be found in the confidential dossier of this submission (Registration Report - Part C).
IIIA 5.1 Analytical Standards and Samples
IIIA 5.1.1 Samples of the preparation A sample of the preparation was provided by the applicant but no analysis of the contents of the active substance was performed.
IIIA 5.1.2 Analytical standards for the pure active substance Analytical standards of MCPA were not provided because there was no request.
IIIA 5.1.3 Samples of the active substance as manufactured No samples were provided because there was no request.
IIIA 5.1.4 Analytical standards for relevant metabolites and all other components included in the residue definition No samples were provided because there was no request.
IIIA 5.1.5 Samples of reference substances for relevant impurities MCPA does not contain any impurity of toxicological or ecotoxicological concern.
IIIA 5.2 Methods for the Analysis of the Plant Protection Product
IIIA 5.2.1 Description of the analytical methods for the determination of the active substance in the plant protection product Report: 5.2.1, Wilson, I., 2013 Title: Validation of a Method for the Determination of MCPA in MCPA DMA 500 g/l Document No: 13/0816 Guidelines: SANCO/3030/99 rev. 4 GLP Yes
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Method description After homogenisation, the product is dissolved in a small amount of acetonitrile. After addition of 4- bromophenol (2% w/v in acetonitrile) as an internal standard and acetic acid, the solution is further diluted with mobile phase. MCPA is determined by HPLC-UV using external standard calibration. The ratio of the analyte and internal standard peak areas are used for quantification.
Column: ACE 5 C18 or equivalent, 250 mm x 4.6 mm, 5 µm Mobile phase: acetonitrile / 0.1 M acetic acid (35 / 65) (v/v) Detector wavelength: 280 nm
Method validation
Table B.5.2.1-1: Determination of MCPA in formulation MCPA DMA 500 g/l Analyte Specificity/ Linearity Accuracy Repeatability interferences (n = 5) (n = 2) (% RSD) (conc. range) fortification mean (n = 5) level (%) recovery (%) MCPA demonstrated / r = 1.0000 80 100.6 0.31 no interferences 1 – 5 mg/L 100 100.1 (at 516.5 g/L) (corresponding to 120 99.9 25 – 125 % of the nominal content)
Chromatograms of the formulation with and without MCPA present were submitted. The identity of the analyte was determined by retention time match with reference standard.
Conclusion The method is considered acceptably validated and allows the determination of MCPA in the formulation MCPA DMA 500 g/l.
IIIA 5.2.2 For preparations containing more than one active substance, description of method for determining each in the presence of the other Please refer to chapter 5.2.1 as CA2643 (U 46 M-Fluid) contains only one active substance.
IIIA 5.2.3 Applicability of existing CIPAC methods CIPAC Method 2.4/SL/M2/- (CIPAC Handbook 1C, page 2142) can be used for MCPA salt aqueous solutions. The applicability to MCPA DMA 500 g/l has not been demonstrated.
IIIA 5.2.4 Description of analytical methods for the determination of relevant impurities CA2643 (U 46 M-Fluid) does not contain any impurity of toxicological or ecotoxicological concern.
IIIA 5.2.5 Description of analytical methods for the determination of formulants No formulants with toxicological or ecotoxicological relevant compounds are present in the formulation. Therefore, no analytical methods for the determination of formulants are necessary.
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IIIA 5.3 Description of Analytical Methods for the Determination of Residues
IIIA 5.3.1 Evaluation of MCPA
The conclusions regarding the peer review of the analytical methods for residues of MCPA are summarized in SANCO/4062/2001-final, 2008-07-11.
Table 5.3-1: Information on the active substance MCPA
Name of component of residue definiton Structural formula Substance code IUPAC name Formula Molecular weight MCPA Cl (4-chloro-2-methylphenoxy)acetic acid C9H9ClO3 OH 200.62 g mol-1 O CH O 3 MCPB Cl 4-(4-chloro-2-methylphenoxy)butanoic acid C11H13ClO3 OH 228.67 g mol-1 O CH O 3
MCPA-thioethyl Cl CH3 S-ethyl (4-chloro-2-methylphenoxy)ethanethioate C11H13ClO2S S 244.74 g mol-1 O CH O 3
Overview of residue definitions and levels for which compliance is required
The current legal residue definition is not the same as the one proposed in the Draft Assessment Report incl. its addenda (see table below).
Table 5.3-2: Relevant residue definitions
Matrix Relevant residue Reference Remarks Plant material MCPA, MCPB including their salts, Regulation (EC) No 491/2014, annex esters and conjugates expressed as II, annex III part B MCPA MCPA1 DAR, list of endpoints, 08/2004 Foodstuff of animal origin MCPA, MCPB and MCPA thioethyl Regulation (EC) No 491/2014, annex expressed as MCPA II, annex III part B MCPA1 DAR, list of endpoints, 08/2004 Soil MCPA, potentially relevant: 2- DAR, list of endpoints, 08/2004 methyl-4-chlorphenol Surface water MCPA DAR, list of endpoints, 08/2004
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Matrix Relevant residue Reference Remarks Drinking/ground water MCPA Minimal requirement of the Drinking Water Act (Trinkwasser-VO) Air MCPA Classifed as Xn, DAR, list of endpoints, 08/2004 Body fluids/tissue Not residue relevant Not classified as T / T+ 1 This residue definition was not considered in the assessment.
Table 5.3-3: Levels for which compliance is required
Matrix MRL Reference for MRL/level Remarks Plant, high water content 0.05 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Plant, acidic commodities 0.05 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Plant, dry commodities 0.05 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Plant, high oil content 0.05 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Meat 0.1 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Milk 0.05 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Eggs 0.05 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Fat 0.1 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Liver, kidney 0.1 mg/kg Regulation (EC) No 491/2014, annex II, annex III part B Soil 0.05 mg/kg Common limit Drinking water 0.1 µg/L general limit for drinking water
Surface water 152 µg/L IC50 Lemna gibba, Review Report, SANCO/4062/2001-final, 2008-07-11 Air 12 µg/m3 AOEL sys: 0.04 mg/kg bw/d Review Report, SANCO/4062/2001- final, 2008-07-11 Tissue (meat or liver) Not required Not classified as T / T+ Body fluids Not required Not classified as T / T+
IIIA 5.3.1.1 Description of Analytical Methods for the Determination of Residues of MCPA in Plant Matrices (OECD KIII A 5.3.1)
An overview of the acceptable methods and the data gaps (if appropriate) for analysis of MCPA in plant
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matrices is given in the following tables. New studies were provided. For the detailed evaluation of new studies it is referred to Appendix 2. A further study (Wasser, 2000) was provided by the notifier as independent laboratory validation of the method by Harper, 2005a. The study by Wasser, 2000 is an EU agreed method (see Draft Assessment Report), but it is not validated according to SANCO/825/00 rev. 8.1. The number of fortified samples per level (n=3) is not sufficient. For grain samples the repeatability at LOQ is not sufficient (RSD > 20 %). Therefore, the study is not considered as a successful independent laboratory validation.
Table 5.3-4: Overview of independently validated methods and confirmatory methods for food and feed of plant origin (always required for first 4 matrix types)
Matrix type Primary method ILV Confirmatory method high water content Harper, 2005a Wasser, 2000* Pfarl, 1994* acidic Harper, 2005a Wasser, 2000* Harper, 2005a fatty Harper, 2005b missing Harper, 2005b dry Pfarl, 1994* Rawle, 2001 Harper, 2005a difficult not required for the not required for the not required for the intended GAP intended GAP intended GAP *EU agreed method (see Draft Assessment Report)
Table 5.3-5: Statement on extraction efficiency
Method for products of plant origin Required, available from: Sabourin, 1995*; RIP2002-1902 Not required, because: *EU agreed method (see Draft Assessment Report)
Table 5.3-6: Methods suitable for the determination of residues (enforcement) in products of plant origin
Author(s), year Matrix Method LOQ Principle of Comment Evaluated in group method Pfarl, 1994 High water 0.05 mg/kg GC-MS, HP5 MS- Confirmation not Vol. 3, section MET2002-174 content, dry column, m/z 214 sufficiently B.4.2.1 of the validated DAR; ASB2010- 10197 Wasser, 2000 High water 0.05 mg/kg GC-MS, HP5 MS- Method Vol. 3, section ASB2014-10253 content, also column, m/z 141 validation does B.4.2.1 of the MET2000-717 accepted for not meet the addendum acidic requirements of (Octobre 2003) to matrices SANCO/(25/oo the DAR; rev.8.1 No ASB2010-10197 confirmation Harper, 2005a High water 0.05 mg/kg GC-MS, HP5 MS- Confirmation Appendix 2 MET2005-427 content, dry, column, m/z 216, included also 214, 141 accepted for acidic matrices
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Author(s), year Matrix Method LOQ Principle of Comment Evaluated in group method Harper, 2005b Fatty 0.05 mg/kg GC-MS, HP5 MS- Confirmation Appendix 2 MET2005-428 column, m/z 216, included 214, 141 Rawle, 2001 Dry 0.05 mg/kg GC-MS, DB5 MS- No confirmation, Appendix 2 ASB2014-10236 column, m/z 214 ILV for Pfarl, 1994
IIIA 5.3.1.2 Description of Analytical Methods for the Determination of Residues of MCPA in Animal Matrices (OECD KIII A 5.3.1)
Acceptable methods for analysis of MCPA in animal matrices were not provided. This is detailed in the following tables. A new study was not provided. For its detailed evaluation it is referred to Appendix 2.
Table 5.3-7: Overview of independently validated methods and confirmatory methods for food and feed of animal origin (if appropriate)
Matrix type Primary method ILV Confirmatory method milk missing missing missing eggs missing missing missing meat missing missing missing fat missing missing missing kidney, liver missing missing missing
Table 5.3-8: Statement on extraction efficiency
Method for products of animal origin Required, available from: missing Not required, because:
IIIA 5.3.1.3 Description of Methods for the Analysis of MCPA in Soil (OECD KIII A 5.4)
An overview of the acceptable methods and the data gaps (if appropriate) for analysis of MCPA in soil is given in the following tables. A new study was provided. For its detailed evaluation it is referred to Appendix 2.
Table 5.3-9: Overview of suitable primary and confirmatory methods for soil
Component(s) of residue definition Primary method Confirmatory method MCPA Harper, 2005 Harper, 2005
Table 5.3-10: Methods for soil
Author(s), year Method LOQ Principle of method Comment Evaluated in Harper, 2005 0.01 mg/kg GC-MS using HP- Confirmation Appendix 2 MET2005-426 5MS column, m/z 214, included 216, 141
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IIIA 5.3.1.4 Description of Methods for the Analysis of MCPA in Water (OECD KIII A 5.6)
An overview of the acceptable methods and the data gaps (if appropriate) for analysis of MCPA in drinking and surface water is given in the following tables. A new study was provided. For its detailed evaluation it is referred to Appendix 2.
Table 5.3-11: Overview of suitable primary and confirmatory methods for water
Component(s) of residue Matrix Primary method Confirmatory method definition MCPA Drinking water/ surface Harper, 2005 Harper, 2005 water
Table 5.3-12: Methods for drinking water and surface water
Author(s), year Method LOQ Principle of method Comment Evaluated in Harper, 2005 0.01 µg/L LC-MS, Luna C8 Confirmation Appendix 2 MET2005-429 column included
IIIA 5.3.1.5 Description of Methods for the Analysis of MCPA in Air (OECD KIII A 5.7)
An overview of the acceptable methods and possible data gaps for analysis of MCPA in air is given in the following table. New studies were not provided.
Table 5.3-13: Overview of suitable primary and confirmatory methods for air
Component(s) of residue definition Primary method Confirmatory method MCPA Reichert, 1994* Not required *EU agreed method (see Draft Assessment Report)
Table 5.3-14: Methods for air
Author(s), year Method LOQ Principle of method Comment Evaluated in Reichert, 1994 0.6 µg/m3 HPLC-UV, No confirmation Vol. 3, section MET1999-814 LiChropsher 60 RP B.4.3.2 of DAR Select B, 280 nm ASB2010-10197
IIIA 5.3.1.6 Description of Methods for the Analysis of MCPA in Body Fluids and Tissues (OECD KIII A 5.8)
Methods for body fluids and tissues are not required, because MCPA is not considered to be toxic or very toxic (T / T+) nor is it classified according to GHS as follows: Acute toxicity (cat. 1 - 3), CMR (cat. 1) or STOT (cat. 1).
IIIA 5.3.1.7 Other Studies/ Information
None
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IIIA 5.4 Conclusion on the availability of analytical methods for the determination of residues
Sufficiently sensitive and selective analytical methods are not available for all analytes included in the residue definitions for MCPA.
The following data gaps were noticed: − A validation of an analytical method for residues of MCPA (residue definition: MCPA, MCPB including their salts, esters and conjugates expressed as MCPA) according to SANCO/825/00 rev. 8.1 in plant commodities with high water content, high acid content and high fat content in an independent laboratory (ILV) is missing. The submitted study by Wasser, 2000 is not validated according to the requirements of SANCO/825/00 rev. 8.1. − An analytical method for residues of MCPA (residue definition: MCPA, MCPB and MCPA thioethyl expressed as MCPA) in foodstuff of animal origin is missing. − A validation of an analytical method for residues of MCPA (residue definition: MCPA, MCPB and MCPA thioethyl expressed as MCPA) in foodstuff of animal origin in an independent laboratory is missing. − A validated confirmatory method for residues of MCPA (residue definition: MCPA, MCPB and MCPA thioethyl expressed as MCPA) in foodstuff of animal origin is missing. − A study or statement regarding the efficiency of the extraction procedure used in methods for residues of MCPA (residue definition: MCPA, MCPB and MCPA thioethyl expressed as MCPA) in foodstuff of animal origin is missing.
These data gaps are considered being of minor relevance and it is sufficient to fill these gaps in the context of the next application for the approval of MCPA according to Reg. (EC) No 1107/2009 or in the context of the assessment of existing MRLs of MCPA according to Art. 12 of Reg. (EC) No 396/2005.
Appendix 1 – List of data submitted in support of the evaluation Annex point/ Author(s) Year Title Data Owner How considered reference No Source (where different from protection in dRR company) claimed Study-Status / Report-No. Usage* GLP or GEP status (where relevant), Published or not KIIIA 5.2.1 Wilson, I. 2013 Validation of a Method for the Y NUF 1 Determination of MCPA in MCPA DMA 500 g/l Nufarm UK Limited 13/0816 GLP, not published BVL no. 2571962
* 1 accepted (study valid and considered for evaluation) 2 not accepted (study not valid and not considered for evaluation) 3 not considered (study not relevant for evaluation) 4 not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)
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Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * Italy 2001 MCPA (Monograph + Addendum Add August 2002) March 2001 GLP: Open Published: Yes ASB2010-10197 KIIA 4.3 Flynn, S. G. 1979 Determination of 2-Methyl-4- No AHM N chlorophenoxy Acetic Acid (MCPA) and 2,4-Dichlorophenoxy Propionic Acid (2,4-DP) residues in spring barley grain and straw; Oat Grain and Straw; Grass and Hay RR 0256 ! 1707-35/1/2 GLP: Open Published: Open BVL-2346385, MET2002-173 KIIA 4.3 Pfarl, C. 1994 Validation of an analytical method for Yes AHM Y determination of residues of MCPA in cereals and grass R93-86 ! 1172a GLP: Open Published: Open BVL-2346389, MET2002-174 KIIA 4.4 Sattar, M. A.; Paasivirta, J. 1900 Simultaneous determination of 4- No LIT N Chloro-2-methylphenoxyacetic Acid and its metabolites in soil by gas chromatography
GLP: Open Published: Open BVL-2346387, MET2002-175 KIIA 4.4 Tilting, N. 1988 Mecoprop, MCPA, Boden; GC-MS No BAS N Bestimmung über Phenoxyalkancarbonsäuremethylester; Methodenergänzung 173/2 88/10189 GLP: Open Published: Open BVL-2346553, MET1999-808 KIIA 4.5 Anon. 1985 The Determination of MCPA, MCPB No LIT N and MCPP Herbicides in River and Drinking Waters
GLP: Open Published: Open BVL-2346388, MET2002-176 KIIA 4.7 Reichert, N. 1994 Development and validation of a method Yes BAS Y for the determination of 2,4-D, MCPA, Dichlorprop-P and Mecoprop-P in air 94/10505 ! 439705 GLP: Open Published: Open BVL-2346386, MET1999-814 KIIA 6.2.1 Sabourin, P. J. 1995 Nature of the residue of 14C-2-Methyl- Yes Nufarm Y 4-Chlorophenoxyacetic acid (14C- MCPA) as the Dimethylamine Salt (14C-MCPA DMA) and the 2- Ethylhexyl Esther (14C-MCPA 2-EHE) in wheat SC930053 GLP: Open Published: Open BVL-2365919, RIP2002-1902 KIIA 6.3 Rawle, N. 2001 Validation of a GC/MS method of Yes Nufarm Y analysis of 2,4-D, MCPA and 2,4-D Ethylhexyl ester in cereal grain and straw CEMS-965 GLP: Yes Published: No BVL-2684980, ASB2014-10236 KIIA 6.3 Wasser, C. 2000 Validation of analysis for MCPA, Yes Nufarm N MCPB and HMCPA residues in cereals R9110 ! AHM R 99 134 GLP: Yes Published: No BVL-2685370, ASB2014-10253
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Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIA 6.3, KIIIA1 Wasser, C. 2001 Validation of analysis for MCPA, Yes AHM N 5.3.1 MCPB and HMCPA residues in grass Nufarm R9111 ! AHM R 99 234 GLP: Yes Published: No BVL-2681767, BVL-2685374, ASB2014-10233 KIIIA1 5.3.1 Cumberbatch, D. 2000 Analytical method for the determination No AHM N of MCPA, HMCPA and MCPB in cereals and grass ATM 592 GLP: No Published: No BVL-2681791, ASB2014-10270 KIIIA1 5.3.1 Harper, H. 2005 Independent laboratory validation of No AHM Y methodology for the determination of residues of MCPA in grain and straw and validation of the methodology for the determination of MCPA in apples TFT 002/052115 GLP: Yes Published: No BVL-2681697, MET2005-427 KIIIA1 5.3.1 Harper, H. 2005 Validation of methodology for the No AHM Y determination of residues of MCPA in rape seed TFT 004/052164 GLP: Yes Published: No BVL-2681698, MET2005-428 KIIIA1 5.3.1 Wasser, C 2000 Validation of analysis for MCPA, No AHM N MCPB and HMCPA residues in cereals R 9110 ! AHM R 99 134 GLP: Yes Published: No BVL-2681764, MET2000-717 KIIIA1 5.3.1 Wasser, C. 2001 Validation of analysis for MCPA, No AHM N MCPB and HMCPA residues in maize R9112 ! R 99 333 GLP: Yes Published: No BVL-2681768, ASB2014-10269 KIIIA1 5.4 Harper, H. 2005 Independent laboratory validation of Yes AHM Y methodology for the determination of residues of MCPA in two soil types TFT 003/052217 GLP: Open Published: No BVL-2681700, MET2005-426 KIIIA1 5.6 Anon. 1997 The determination of acidic herbicides, No LIT N Bromoxynil, Ioxynil and Pentachlorophenol in waters 1997; Methods for the examination of waters and associated materials 1997/1000528 GLP: No Published: Yes BVL-2681847, MET2000-373 KIIIA1 5.6 Harper, H. 2005 Validation of the methodology for the Yes NUF Y determination of residues in drinking and surface water TFT 005/052350 GLP: Yes Published: No BVL-2681701, MET2005-429 KIIIA1 5.7 Zangmeister, W. 1995 Recovery of 2,4-D-K, MCPA-DME, No AHM N Mecoprop-P-DMA and Dichlorprop-P- DMA after elution from TENAX - Supplement to analytical method RCC project 439 705 95/10939 ! 32202 GLP: Yes Published: No BVL-2681702, MET1999-813
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Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIIA1 5.8 Johnson, T.; King, D. L. 2001 Validated analytical method for the No NUF N determination of 4-Chloro-2- methylphenoxyacetic acid (MCPA), MCPA Glycine conjugate, 4-Chloro-2- hydroxymethylphenoxyacetic acid (HMCPA) and HMCPA Glucose conjugate in beef tissues, milk and cream 1042 ! 2117 GLP: Yes Published: No BVL-2681726, MET2002-180 MIIIA1 Sec 2 Applicant 2014 MCPA / U 46 M-Fluid (CA2643/ Open Nufarm N T041A): Analytical methods - Tier 2, IIIA-5 - Draft Registration Report - Part B - Core assessment MIII / Sec. 2 GLP: Open Published: No BVL-2570823, BVL-2571164, ASB2014-10230 * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation
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Appendix 2 – Detailed evaluation of the additional studies relied upon
A 1.1 Analytical methods for MCPA A 1.1.1 Methods for enforcement of residues in food and feed of plant origin A 1.1.1.1 Analytical method 1 Reference: OECD KIIIA1 5.3.1 Report Independent Laboratory Validation of Methodology for the Determination of Residues of MCPA in Grain and Straw and Validation of the Methodology for the Determination of MCPA in Apples, Harper, H., 2005, TFT 002/052115, MET2005-427 Guideline(s): Not mentioned, methods used comparable to guideline SANCO/825/00 Deviations: No GLP: Yes Acceptability: Yes Materials and methods Samples of commodities of high water content (apple) and of dry crops (cereal grain and straw) are extracted with 0.1 M potassium hydroxide/water (2/8, v/v). Esters of MCPA in the extract are converted to the free acid with potassium hydroxide. After addition of water, 0.1 M potassium hydroxide and saturated sodium chloride, the extract is washed with dichloromethane. The pH of the aqueous phase is adjusted to <2 with hydrochloric acid/water (1/1, v/v). The free MCPA is partitioned to dichloromethane and re-extracted with 0.1 M potassium hydroxide. The pH of the aqueous phase is adjusted to <2 with hydrochloric acid/water (1/1, v/v). A SPE clean-up on C18 cartridges is performed. Residues are eluted with methyl-tert-buthyl ether. The eluate is evaporated to dryness. MCPA in the dry residue is methylated with a mixture of methanol / sulfuric acid (1/1, v/v). The resulting MCPA methyl ester is extracted with hexane. Sample concentration in final extract is 0.25 g/mL for grain and apple, and 0.125 g/mL for straw. Final quantification of the MCPA methyl ester is done by GC-MS using a HP-5MS column, electron impact ionisation mode and monitoring m/z 214, 216, 141 and 155. Results and discussions
Table A 1: Recovery results from primary method validation of plant commodities using the analytical method. Standards were prepared in methanol.
No of samples Fortification Mean Matrix per fortifica- RSD (%) Comments level (mg/kg) recovery tion level Grain 0.05 5 90 4.5 m/z 214 0.5 5 75 4.1 Straw 0.05 5 98 3.5 m/z 214 0.5 5 80 5.0 Apple 0.05 5 97 2.6 m/z 214 0.5 5 74 2.2
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Table A 2: Recovery results from confirmatory method validation of plant commodities using the analytical method. Standards were prepared in methanol.
No of samples Fortification Mean Matrix per fortifica- RSD (%) Comments level (mg/kg) recovery tion level Grain 0.05 5 97 7.2 m/z 155 0.5 5 76 4.1 Straw 0.05 5 102 3.5 m/z 155 0.5 5 78 3.1 Apple 0.05 5 96 7.7 m/z 155 0.5 5 74 3.4 Grain 0.05 5 99 4.1 m/z 141 0.5 5 78 5.7 Straw 0.05 5 93 2.8 m/z 141 0.5 5 79 4.1 Apple 0.05 5 99 3.4 m/z 141 0.5 5 74 2.7 Grain 0.05 5 83 6.0 m/z 216 0.5 5 70 0.8 Straw 0.05 5 86 5.1 m/z 216 0.5 5 71 1.0 Apple 0.05 5 97 1.3 m/z 216 0.5 5 71 1.3
Table A 3: Characteristics for the analytical method used for the quantitation of MCPA residues in plant commodities
MCPA methyl ester MCPA methyl ester
m/z 214 m/z 155 Calibration function Y=0.100207*X²+55.1916*X Y=0.107139*X²+37.1150*X -114.212 -82.6073 R=0.9999 R=0.9999 Accepted calibration range in concentration units 2.5 – 250 ng/mL 2.5 – 250 ng/mL (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio 0.01 – 1 mg/kg (grain, 0.01 – 1 mg/kg (grain, units for the sample (e.g.in mg/kg or µg/L) apple) apple) 0.02 – 2 mg/kg (straw) 0.02 – 2 mg/kg (straw) Does the calibration consist of at least 3 levels yes yes (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented yes yes (yes/no) Interference >30% of LOQ in blank sample is yes no absent (yes/no)
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Table A 4: Characteristics for the analytical method used for the quantitation of MCPA residues in plant commodities
MCPA methyl ester MCPA methyl ester
m/z 141 m/z 216 Calibration function Y=0.141227*X²+63.3562*X Y=0.0529994*X²+37.1556*X -169.000 -111.224 R=0.9996 R=0.9991 Accepted calibration range in concentration 2.5 – 250 ng/mL 2.5 – 250 ng/mL units (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio 0.01 – 1 mg/kg (grain, 0.01 – 1 mg/kg (grain, apple) units for the sample (e.g.in mg/kg or µg/L) apple) 0.02 – 2 mg/kg (straw) 0.02 – 2 mg/kg (straw) Does the calibration consist of at least 3 levels yes yes (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented yes yes (yes/no) Interference >30% of LOQ in blank sample is yes( grain, apple) yes absent (yes/no)
Conclusion The method is sufficiently validated for the quantification of MCPA in commodities with high water content and in dry crops using GC-MS detection. Method is suitable also for commodities with high acid content, since extraction is performed under alkaline conditions. The validated limit of quantification is 0.05 mg/kg. A confirmation of the results is included by validation of the GC-MS method with three fragment ions (m/z 214, 216, 141). The selectivity at m/z 155 is not acceptable for all tested matrices (blank values 52 – 73 % of LOQ). No significant matrix effects are reported.
Comments of zRMS: Acceptable.
A 1.1.1.2 Analytical method 2 Appendix 1 Reference: OECD KIIIA1 5.3.1 Report Validation of Methodology for the Determination of Residues of MCPA in Rape Seed, Harper, H., 2005, TFT 004/052164, MET2005-428 Guideline(s): Not mentioned, methods used comparable to guideline SANCO/825/00 Deviations: No GLP: Yes Acceptability: Yes Materials and methods Samples of commodities of high oil content (rape seed) are extracted with 0.1 M potassium hydroxide/water (2/8, v/v). Esters of MCPA in the extract are converted to the free acid with potassium hydroxide. After addition of water, 0.1 M potassium hydroxide and saturated sodium chloride, the extract is washed with dichloromethane. The pH of the aqueous phase is adjusted to <2 with hydrochloric acid/water (1/1, v/v). The free MCPA is partitioned to dichloromethane and re-extracted with 0.1 M potassium hydroxide.
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The pH of the aqueous phase is adjusted to <2 with hydrochloric acid/water (1/1, v/v). A SPE clean-up on C18 cartridges is performed. Residues are eluted with methyl-tert-buthyl ether. The eluate is evaporated to dryness. MCPA in the dry residue is methylated with a mixture of methanol / sulfuric acid (1/1, v/v). The resulting MCPA methyl ester is extracted with hexane. Sample concentration in final extract is 0.25 g/mL. Final quantification of the MCPA methyl ester is done by GC-MS using a HP-5MS column, electron impact ionisation mode and monitoring m/z 214, 216, 141 and 155. Results and discussions
Table A 5: Recovery results from primary method validation of plant commodities using the analytical method. Standards were prepared in methanol.
No of samples Fortification Mean Matrix per fortifica- RSD (%) Comments level (mg/kg) recovery tion level Rape seed 0.05 5 84 9.1 m/z 214 0.5 5 77 6.2
Table A 6: Recovery results from confirmatory method validation of plant commodities using the analytical method. Standards were prepared in methanol.
No of samples Fortification Mean Matrix per fortifica- RSD (%) Comments level (mg/kg) recovery tion level Rape seed 0.05 5 87 9.7 m/z 155 0.5 5 91 6.6 Rape seed 0.05 5 100 4.9 m/z 141 0.5 5 80 6.6 Rape seed 0.05 5 105 5.7 m/z 216 0.5 5 86 7.2
Table A 7: Characteristics for the analytical method used for the quantitation of MCPA residues in plant commodities
MCPA methyl ester MCPA methyl ester
m/z 214 m/z 155 Calibration function Y=0.0779885*X²+84.1130*X Y=0.0655382*X²+62.1900*X -248.077 -185.838 R=0.9991 R=0.9987 Accepted calibration range in concentration 2.5 – 250 ng/mL 2.5 – 250 ng/mL units (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio 0.01 – 1 mg/kg 0.01 – 1 mg/kg units for the sample (e.g.in mg/kg or µg/L) Does the calibration consist of at least 3 levels yes yes (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented yes yes (yes/no) Interference >30% of LOQ in blank sample is yes no absent (yes/no)
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Table A 8: Characteristics for the analytical method used for the quantitation of MCPA residues in plant commodities
MCPA methyl ester MCPA methyl ester
m/z 141 m/z 216 Calibration function Y=0.106347*X²+99.5824*X Y=0.0194444*X²+19.6080*X -309.991 -33.2568 R=0.9989 R=0.9984 Accepted calibration range in concentration 2.5 – 250 ng/mL 2.5 – 250 ng/mL units (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio 0.01 – 1 mg/kg 0.01 – 1 mg/kg units for the sample (e.g.in mg/kg or µg/L) Does the calibration consist of at least 3 levels yes yes (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented yes yes (yes/no) Interference >30% of LOQ in blank sample is yes yes absent (yes/no)
Conclusion The method is sufficiently validated for the quantification of MCPA in commodities with high oil content using GC-MS detection. The validated limit of quantification is 0.05 mg/kg. A confirmation of the results is included by validation of the GC-MS method with three fragment ions (m/z 214, 216, 141). The selectivity at m/z 155 is not acceptable (blank values 61 % of LOQ). No significant matrix effects are reported.
Comments of zRMS: Acceptable.
A 1.1.1.3 Analytical method 3 Reference: OECD KIIA 6.3 Report Validation of a GC/MS method of analysis of 2,4-D, MCPA and 2,4-D Ethylhexyl ester in cereal grain and straw, Rawle, N., 2001, CEMS-965, ASB2014-10236 Guideline(s): Not mentioned, methods used comparable to guideline SANCO/825/00 Deviations: No GLP: Yes Acceptability: Yes Materials and methods The samples of dry crops (cereal grain and straw) are homogenized with methanol/water (80/20, v/v) and filtered. After addition of NaOH, an aliquot of the extract is evaporated to dryness and dissolved in sulphuric acid. The extract is shaken with cyclohexane/ethyl acetate (1/1, v/v) and centrifuged, Acetic acid is added to the organic phase and filtered through anhydrous sodium sulphate. Further clean-up is performed by GPC. The mobile phase is collected and evaporated to dryness. After addition of concentrated sulphuric acid and methanol (1+9, v/v), derivatisation of the cleaned extract is performed. Water and isooctane are
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added and centrifuged. To the organic phase sodium hydrogencarbonat is added and centrifuged. Anhydrous sodium sulphate is added to the organic phase and centrifuged. The sample concentration in the final extract is 1 g/mL for grain and 0.5 g/mL for straw. Final quantification of the MCPA methyl ester is done by GC-MS using a DB-5 column and monitoring m/z 214. Results and discussions
Table A 9: Recovery results from method validation of plant commodities using the analytical method. Standards were prepared in methanol.
No of samples Fortification Mean Matrix per fortifica- RSD (%) Comments level (mg/kg) recovery tion level Wheat grain 0.05 4 105 5.2 m/z 214 0.5 4 93 9.6 Barley grain 0.05 4 97 5.4 m/z 214 0.5 4 100 1.9 Wheat grain 0.05 4 98 4.9 m/z 214 0.5 4 106 1.2 Barley grain 0.05 4 85 9.2 m/z 214 0.5 4 82 11.7
Table A 10: Characteristics for the analytical method used for the quantitation of MCPA residues in plant commodities
MCPA methyl ester
m/z 141 Calibration function Y=111161*X+1591 R²=0.9987 Accepted calibration range in concentration units 10 – 1000 ng/mL (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio 0.01 – 1 mg/kg (grain) units for the sample (e.g.in mg/kg or µg/L) 0.02 – 2 mg/kg (straw) Does the calibration consist of at least 3 levels yes (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented (yes/no) no Interference >30% of LOQ in blank sample is yes absent (yes/no)
Conclusion The method is sufficiently validated for the quantification of MCPA in dry crops using GC-MS detection. The validated limit of quantification is 0.05 mg/kg. A confirmation of the results is not included. The method is also validated for residues of 2,4-D and of 2,4-D 2-hexyl ester. These data are not reported here. The number of fortified samples per level (n=4) is insufficient, but samples from wheat and barley could be combined respectively for grain and straw. The study is accepted as independent laboratory validation of the method by Pfarl, 1994.
Comments of zRMS: Accepted.
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A 1.1.2 Description of Methods for the Analysis of Soil A 1.1.2.1 Analytical method 1 Reference: OECD KII A, 4.4
Report Independent Laboratory Validation of Methodology for the Determination of Residues of MCPA in Two Soil Types, Harper, H., 2005, TFT 003/052217, MET2005-426
Guideline(s): Yes (SANCO/825/00 rev 6, SANCO/3029/99 rev 4, 91/414/EEC, 96/46/EC)
Deviations: No
GLP: Yes
Acceptability: Yes
Materials and methods Soil samples are extracted by shaking with methanol/water (8/2, v/v). Esters of MCPA in the extract are converted to the free acid with sodium hydroxide. Methanol is evaporated from the saponified extract and the remainder is washed with methylene chloride. The alkaline extract is acidified with sulfuric acid and the free MCPA is partitioned to dichloromethane. After evaporation of dichloromethane, MCPA in the dry residue is methylated with a mixture of methanol and concentrated sulfuric acid. The resulting MCPA methyl ester is extracted with hexane after addition of some water and further purified by SPE on silica with hexane/ethyl acetate (9/1, v/v) as eluent. Sample concentration in final extract is 1 g/mL. Final quantification is done by GC-MS using a HP-5MS column, electron impact ionisation mode and monitoring m/z 214, 216, 141. Results and discussions
Table A 11: Recovery results from method validation of clay soil using the analytical method. Standards were prepared in methanol.
No of samples Fortification Mean Matrix per fortifica- RSD (%) Comments level (mg/kg) recovery tion level Clay 0.01 5 95 3.0 m/z 214 0.1 5 99 2.1 0.01 5 97 3.6 m/z 216 0.1 5 100 1.4 0.01 5 98 5.5 m/z 141 0.1 5 100 2.3
Table A 12: Recovery results from method validation of sandy loam soil using the analytical method. Standards were prepared in methanol.
Matrix Fortification No of samples Mean RSD (%) Comments
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level (mg/kg) per fortifica- recovery tion level Sandy loam 0.01 5 82 5.3 m/z 214 0.1 5 81 4.0 0.01 5 83 5.5 m/z 216 0.1 5 82 3.6 0.01 5 78 6.0 m/z 141 0.1 5 80 3.9
Table A 13: Characteristics for the analytical method used for the quantitation of MCPA residues in soil
MCPA MCPA MCPA
m/z 216 m/z 214 m/z 141 Calibration function Y=0.026016*X²+ Y=0.0712245*X²+ Y=0.118723*X²+ 39.0106*X- 121.064*X- 129.281*X- 47.9606 91.1972 221.192 R²=0.9993 R²=0.9994 R²=0.9984 Accepted calibration range in concentration units 2.5 – 250 ng/mL 2.5 – 250 ng/mL 2.5 – 250 ng/mL (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio units 0.003 – 0.250 0.003 – 0.250 0.003 – 0.250 for the sample (e.g.in mg/kg or µg/L) mg/kg mg/kg mg/kg Does the calibration consist of at least 3 levels yes yes yes (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented (yes/no) yes yes yes Interference >30% of LOQ in blank sample is absent yes yes yes (yes/no)
Conclusion The method is sufficiently validated for the quantification of MCPA in soil using GC-MS detection. The validated limit of quantification for is 0.01 mg/kg. A confirmation of the results is included by validation of the GC-MS method with three fragment ions. Matrix effects are reported for clay soil 7 - 8 % enhancement, for sandy loam 6 - 8 % enhancement. Soil samples are characterized.
Comments of zRMS: Acceptable.
A 1.1.3 Description of Methods for the Analysis of Water A 1.1.3.1 Analytical method 1 Reference: OECD KIIA 4.5
Report Validation of the Methodology for the Determination of Residues in Drinking and Surface Water, Harper, H., 2005, TFT 005/052350, MET2005-429
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Guideline(s): Yes (SANCO/825/00 rev 6, SANCO/3029/99 rev 4, 91/414/EEC, 96/46/EC)
Deviations: No
GLP: Yes
Acceptability: Yes
Materials and methods The surface water samples are acidified by addition of formic acid. After addition of 10 % dibuthylamine in methanol to the drinking water samples they are acidified by addition of hydrochloric acid. Residues of MCPA are enriched on a C18 SPE column. The elution is performed by methyl tert butyl ether. The eluate is evaporated for removing solvent and dissolved in methanol/water (50/50, v/v). The sample concentration in the final extract is 0.2 L/mL. Final quantification is done by LC-MS using a Luna C8 column, electrospray ionization in negative mode and monitoring for MCPA in surface water m/z 199, 143, 141 and in drinking water m/z 199, 143, 201 respectively. Results and discussions
Table A 14: Recovery results from method validation of surface water using the analytical method. Standards were prepared in methanol.
No of samples Fortification Mean Matrix per fortifica- Comments level (µg/L) recovery RSD (%) tion level Surface 0.1 5 87 14.2 m/z 199 water 10 5 83 3.2 0.1 5 86 17.6 m/z 143 10 5 84 4.9 0.1 5 85 18.2 m/z 141 10 5 83 4.0
Table A 15: Recovery results from method validation of drinking water using the analytical method. Standards were prepared in methanol.
No of samples Fortification Mean Matrix per fortifica- RSD (%) Comments level (µg/L) recovery tion level Drinking 0.1 5 100 7.1 m/z 199 water 10 5 89 7.5 0.1 5 100 7.3 m/z 143 10 5 88 6.5 0.1 5 103 6.6 m/z 201 10 5 88 8.3
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Table A 16: Characteristics for the analytical method used for the quantitation of MCPA residues in water
MCPA MCPA
m/z 199 m/z 143 Calibration function Y=-0.00311236*X²+ Y=-0.00369417*X²+ 137.492*X+551.660 152.020*X+565.421 R²=0.9992 R²=0.9991 Accepted calibration range in concentration units 10 – 500 ng/mL 10 – 500 ng/mL (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio 0.05 – 2.5 µg/L 0.05 – 2.5 µg/L units for the sample (e.g.in mg/kg or µg/L) Does the calibration consist of at least 3 levels yes yes (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented (yes/no) yes yes Interference >30% of LOQ in blank sample is yes yes absent (yes/no)
Table A 17: Characteristics for the analytical method used for the quantitation of MCPA residues in water
MCPA MCPA
m/z 141 m/z 201 Calibration function Y=-0.0102759*X²+ Y=-0.00564146*X²+ 471.442*X+1482.28 35.6397*X-123.300 R²=0.9997 R²=0.9947 Accepted calibration range in concentration units 10 – 500 ng/mL 10 – 500 ng/mL (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio 0.05 – 2.5 µg/L 0.05 – 2.5 µg/L units for the sample (e.g.in mg/kg or µg/L) Does the calibration consist of at least 3 levels yes yes (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented (yes/no) yes yes Interference >30% of LOQ in blank sample is yes yes absent (yes/no)
Conclusion The method is sufficiently validated for the quantification of MCPA in drinking water and surface water using LC-MS detection. The validated limit of quantification for all matrices is 0.1 µg/L. A confirmation of the results is included by validation of the LC-MS method with three fragment ions. Surface water samples are characterized. Minor matrix effects are reported for drinking and surface water. Fortification at the 100*LOQ level was outside the calibration range. However, dilution of these samples was mentioned in the report. The method validation is also performed for MCPB, Mecoprop-P, Dichlorprop, 2,4-D and 2,4-DB. Validation data for these substances are not reported here.
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Comments of zRMS: Acceptable.
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version
REGISTRATION REPORT Part B
Section 3: Mammalian Toxicology Detailed summary of the risk assessment
Product code/name: U 46 M-Fluid Active Substance: MCPA (DMA salt); 500 g/L
Central Zone Zonal Rapporteur Member State: Germany
CORE ASSESSMENT Germany
Applicant: Nufarm Deutschland GmbH Date: May 2016
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version
Table of Contents
3 Mammalian Toxicology (IIIA 7) ...... 3 3.1 Summary ...... 3 3.2 Toxicological Information on MCPA ...... 6 3.3 Toxicological Evaluation of Plant Protection Product ...... 7 3.4 Toxicological evaluation of groundwater metabolites ...... 8 3.5 Dermal Absorption (IIIA 7.6) ...... 8 3.5.1 Justification for proposed values - MCPA...... 8 3.6 Exposure Assessment of Plant Protection Product ...... 9 3.6.1 Selection of critical use(s) and justification...... 9 3.6.2 Operator exposure (IIIA 7.3) ...... 9 3.6.2.1 Estimation of operator exposure ...... 9 3.6.2.2 Measurement of operator exposure ...... 10 3.6.3 Worker exposure (IIIA 7.5) ...... 10 3.6.3.1 Estimation of worker exposure ...... 11 3.6.3.2 Measurement of worker exposure ...... 11 3.6.4 Bystander and resident exposure (IIIA 7.4) ...... 11 3.6.4.1 Estimation of bystander and resident exposure ...... 11 3.6.4.2 Measurement of bystander and/or resident exposure ...... 12 3.6.5 Statement on combined exposure ...... 12
Appendix 1 Reference list ...... 13
Appendix 2 Detailed evaluation of the studies relied upon ...... 14 A 2.1 Statement on bridging possibilities ...... 14 A 2.2 Acute oral toxicity (IIIA1 7.1.1) ...... 14 A 2.3 Acute percutaneous (dermal) toxicity (IIIA1 7.1.2) ...... 15 A 2.4 Acute inhalation toxicity (IIIA1 7.1.3) ...... 16 A 2.5 Skin irritation (IIIA1 7.1.4) ...... 18 A 2.6 Eye irritation (IIIA1 7.1.5)...... 19 A 2.7 Skin sensitisation (IIIA1 7.1.6) ...... 20 A 2.8 Supplementary studies for combinations of plant protection products (IIIA1 7.1.7) ...... 24 A 2.9 Data on co-formulants (III1 7.9) ...... 24 A 2.9.1 Material safety data sheet for each co-formulant ...... 24 A 2.9.2 Available toxicological data for each co-formulant ...... 24
Appendix 3 Exposure calculations ...... 25 A 3.1 Operator exposure calculations (IIIA1 7.3.1) ...... 25 A 3.1.1 Calculations for MCPA ...... 25 A 3.2 Worker exposure calculations (IIIA1 7.5.1) ...... 29 A 3.2.1 Calculations for MCPA ...... 29 A 3.3 Bystander and resident exposure calculations (IIIA1 7.4.1)...... 30 A 3.3.1 Calculations for MCPA ...... 30
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version
3 Mammalian Toxicology (IIIA 7)
3.1 Summary
Table 3.1-1: Information on U 46 M-Fluid *
Product name and code U 46 M-Fluid (BVL code: NUD-01080-H-3-SL, company code: CA2643) Formulation type Soluble concentrate (SL) Active substance(s) (incl. content) MCPA (DMA salt); 500 g/L Function Herbicide Product already evaluated as the ‘representative No formulation’ during the Annex I inclusion Product previously evaluated in an other MS according No to Uniform Principles * Information on the detailed composition of U 46 M-Fluid can be found in the confidential dRR Part C.
Justified proposals for classification and labelling
In accordance with criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 the following classification and labelling with regard to toxicological data is proposed for the preparation:
Table 3.1-2: Justified proposals for classification and labelling
C&L according to Regulation (EC) No 1272/2008
Hazard classes, categories: Acute Tox. 4, Eye Dam. 1 Signal word: Danger Hazard statements: 302-318 Precautionary statements: 101-102-264-270-280-305+351+338-308+310-501 Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use. [EUH401]
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version
Table 3.1-3: Summary of risk assessment for operators, workers, bystanders and residents for U 46 M-Fluid
Result PPE / Risk mitigation measures Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to health damage. [SB001] - 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. [SB110] - When applying the product with tractor-mounted, trailed or self- propelled application equipment, only vehicles with closed pressurized cabins (e.g. cabin category 3, if no respiratory protective equipment or particle-filtering masks are necessary or category 4, if gas-tight respiratory protective equipment is needed acc. to EN 15695-1 and -2) are suited to replace personal protective equipment during application. During all other activities outside of the cabin the prescribed personal protective equipment must be worn. In order to avoid contamination of the cabin, it is not permitted to enter the cabin with contaminated personal protective equipment (it should be deposited e.g. in an appropriate storage facility). Contaminated gloves should be washed before removing the gloves and hands should be washed before entering the cabin with pure water, respectively. [SB199] - Wear tight fitting eye protection when handling the undiluted product. [SE110] - Wear standard protective gloves (plant protection) when handling the undiluted product. [SS110] - Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. [SS206] - Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. [SS2202]
Workers Acceptable Re-entering the treated areas/crops is only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. [SF1891] Bystanders Acceptable None Residents Acceptable None
No unacceptable risk for operators, workers, bystanders and residents was identified when the product is used as intended and provided that the PPE/ risk mitigation measures stated in Table 3.1-3 are applied.
The risk assessment according to the German model has shown that the estimated exposure towards MCPA in U 46 M-Fluid will not exceed the particular systemic AOEL for operators, workers, bystanders and residents. Operator and worker exposure will be below the systemic AOEL only, if prescribed PPE is worn. The risk assessment according to the UK-POEM has shown that the estimated exposure towards MCPA in U 46 M-Fluid does exceed the particular systemic AOEL for operators even if PPE is worn.
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and bystanders/residents is presented in Table 3.1-4.
Table 3.1-4 Critical uses and overall conclusion of exposure assessment 1 2 3 4 5 6 7 8 Crops 1) and F/G Application Application rate Remarks: Acceptability of situation or I 2) exposure (e.g. growth (e.g. surfactant (L /ha)) assessment stage of crop) Method / Kind Max. number kg as/ha Water (incl. (min. interval L/ha critical gap for operator, application between a) max. rate per worker, bystander or
technique 3)) applications) appl. min / max resident exposure based
a) per use b) max. total rate on [Exposure model] b) per crop/ per crop/season season Operator Worker Bystander Residents Grape vine F Spraying a) 1 a) 2 200-600 critical gap for operator, b) 1 b) 2 worker, bystander or resident exposure based on German Model critical gap for operator exposure based on UK- POEM
Exposure acceptable without PPE / risk mitigation measures Further refinement and/or risk mitigation measures required Exposure not acceptable/ Evaluation not possible 1) Pooled critical GAPS with the same max. application rate per application and using the same application technique 2) F: field or outdoor application, G: greenhouse application, I: indoor application 3) e.g. LC: low crops, HC: high crop, TM: tractor-mounted, HH: hand-held
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version 3.2 Toxicological Information on MCPA
Information regarding classification of the active substance and on EU endpoints is given in Table 3.2-1.
Table 3.2-1: Information on MCPA
Information on absorption rates of the active ingredient Value Source
oral 75 % SANCO/4062/2001-final (2005-04-15) inhalative 100 % (default)
Reference doses Value Source ADI 0.05 mg/kg bw SANCO/4062/2001-final (2008-07-11) AOEL-S 0.04 mg/kg bw/d SANCO/4062/2001-final (2005-04-15) ARfD 0.15 mg/kg bw SANCO/4062/2001-final (2005-04-15)
Classification and proposed labelling with regard to toxicological data Regulation (EC) No 1272/2008 (Table 3.1): (according to the criteria in Reg. 1272/2008) Acute toxicity, cat. 4 Skin corrosion/irritation, cat. 2 Serious eye damage, cat. 1 H302 - Harmful if swallowed H315 - Causes skin irritation H318 - Causes serious eye damage Salts and esters of MCPA: Acute toxicity, cat. 4 H302 - Harmful if swallowed H332 - Harmful if inhaled. H312 - Harmful in contact with skin. Proposal BfR: none additional
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version
3.3 Toxicological Evaluation of Plant Protection Product
A summary of the toxicological evaluation for U 46 M-Fluid is given in Table 3.3-1. Full summaries of studies on the product are presented in Appendix 2. MSDS on U 46 M-Fluid can be found in the confidential dRR Part C.
Table 3.3-1: Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for U 46 M-Fluid
Type of test, model Result Acceptability Classification Reference system (Guideline) (acc. to the criteria in Reg. (EC) No 1272/2008)
LD50 oral, rat = 1239 mg/kg bw Yes H302 xxxxxx (comparable with OECD 401)
LD50 dermal, rat > 2000 mg/kg bw Yes None xxxxx (comparable with OECD 402)
LC50 inhalation, rat > 5.9 mg/L Yes None xxxxx (comparable with 403)
Skin irritation, rabbit Non-irritant Yes None xxxxx (comparable with OECD 404)
Eye irritation, rabbit Irritant Yes H318 xxxxx (comparable with OECD 405)
Skin sensitisation Non-sensitising Yes None xxxxx
Supplementary studies No data – not for combinations of required plant protection products
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version
Table 3.3-2: Additional toxicological information relevant for classification/labelling of U 46 M-Fluid
Substance Classification of the Reference Classification of product (Concentration substance (acc. to the criteria in in product, (acc. to the criteria in Reg. (EC) No 1272/2008) % w/w) Reg. (EC) No 1272/2008)
Toxicological None properties of active substance(s) (relevant for classification of product) Toxicological None properties of non-active substance(s) (relevant for classification of product) Further toxicological No data – not information required
3.4 Toxicological evaluation of groundwater metabolites
No relevance assessment of groundwater metabolites is required – no data submitted.
3.5 Dermal Absorption (IIIA 7.6)
A summary of the dermal absorption endpoints for the active substances in U 46 M-Fluid are presented in Table 3.5-1.
Table 3.5-1: Dermal absorption endpoints for active substances in U 46 M-Fluid
MCPA
Value Reference
Concentrate 7 %
xxxxx Dilution 3.9 % (dilution factor 1:80)
3.5.1 Justification for proposed values - MCPA Proposed absorption values for MCPA is based on dermal absorption studies on a formulation similar in composition and formulation type (SL: soluble concentrate) to U 46 M-Fluid. The studies are summarized in Table 3.5-2. Both studies have been newly evaluated according to EFSA-Guidance on dermal absorption“ (EFSA Journal 2012: 10(4); 2665). However, no detailed summaries are provided since the studies have already been assessed and accepted at EU level. The comparative in vitro rat and human skin assessment of the xxxxx studies show that the dermal absorption decreases with increasing dilution, therefore the dermal absorption can be accepted even if the U 46 M-Fluid will be used with a higher dilution factor in some applications.
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Table 3.5-2: Summary of dermal absorption studies for MCPA Formulation in Concentrate Test/Reference Acceptability of study Spray dilution study (dilution factor 1:80) 750 g/l DMA salt 7 % for the concentrate (applied Xxxxx Yes, soluble formulation dose appr. 7.5 mg/cm2) and Rat in vivo and comparative in used for evaluation. (SL): 3.9 % for the dilution (applied vitro rat and human skin dose appr. 0.09 mg/cm2) [TOX2005-1297; TOX2006- 779]* 750 g/l MCPA DMA 750 g/l MCPA DMA Xxxxx Yes formulation formulation: In vitro human skin 4.6 % for the concentrate (752 [TOX2006-779]* g/L; applied dose appr. 7.5 mg/cm2) and 13.4 % for the dilution (9.43 g/L; applied dose appr. 0.09 mg/cm2) *indicates that a study was reviewed at EU level
3.6 Exposure Assessment of Plant Protection Product
Table 3.6-1: Product information and toxicological reference values used for exposure assessment Product name and code U 46 M-Fluid (BVL code: NUD-01080-H-3-SL, company code: CA2643) Formulation type Soluble concentrate (SL) Category Herbicide Container sizes, short Bottle 1.0 – 20.0 L High density polyethylene (HDPE), Polyethylene description tetraphthalate (PET) Active substance MCPA (DMA salt) (incl. content) 500 g/L AOEL systemic 0.04 mg/kg bw/d Inhalative absorption 100 % Oral absorption 100 % Dermal absorption Concentrate: 7 % Dilution: 3.9 % (Dilution rate: 1:80) (based on 750 g/L MCPA DMA solution)
3.6.1 Selection of critical use(s) and justification The critical GAP used for the exposure assessment of the plant protection product is shown in Table 3.1-4.
3.6.2 Operator exposure (IIIA 7.3) 3.6.2.1 Estimation of operator exposure A summary of the exposure models used for estimation of operator exposure to the active substance(s) during application of U 46 M-Fluid according to the critical use(s) is presented in Table 3.6-2. Outcome of the estimation is presented in Table 3.6-3. Detailed calculations are in Appendix 3.
Table 3.6-2: Exposure models for intended uses
Critical use Grape vine (max. 4 L product/ha) ‘worst case’ Models German model
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version [Uniform Principles for Safeguarding the Health of Applicators of Plant Protection Products (Uniform Principles for Operator Protection), Mitteilungen aus der Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277, 1992] Revised UK-POEM [Estimation of Exposure and Absorption of Pesticides by Spray Operators, Scientific subcommittee on Pesticides and British Agrochemical Association Joint Medical Panel Report (UK MAFF), 1986 and the Predictive Operator Exposure Model (POEM) V 1.0, (UK MAFF), 1992]
Table 3.6-3: Estimated operator exposure MCPA Model data Level of PPE Total absorbed dose % of systemic AOEL (mg/kg/day) High crop tractor mounted application outdoors (worst-case for herbicide application in high crops) Application rate: 2 kg a.s./ha German Model no PPE1) Body weight: 70 kg 0.14517 362.9
Protective gloves (m/l) and protective 0.02585 64.6 garment+sturdy footwear (appl.) High crop hand held application outdoors (worst-case for herbicide application in high crops) Application rate: 2 kg a.s./ha German Model no PPE1) Body weight: 70 kg 0.46502 1162.5
Protective gloves (m/l) and protective 0.03265 81.6 garment+sturdy footwear (appl.) Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level target Application rate: 2 kg a.s./ha UK POEM no PPE2) Application volume: 1.0910 2728.3 200 L/ha Container: 10 L, 63 mm opening Body + Gloves weight: 60 kg mixing/loading and 0.3622 905.4 application
1) no PPE: Operator wearing T-shirt and shorts 2) no PPE: Operator wearing long sleeved shirt, long trousers (“permeable”) but no gloves
3.6.2.2 Measurement of operator exposure Since the operator exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of operator exposure was not necessary and was therefore not performed.
3.6.3 Worker exposure (IIIA 7.5)
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version 3.6.3.1 Estimation of worker exposure Table 3.6-4 shows the exposure model(s) used for estimation of worker exposure after entry into a previously treated area or handling a crop treated with U 46 M-Fluid according to the critical use(s). Outcome of the estimation is presented in Table 3.6-5. Detailed calculations are in Appendix 3.
Table 3.6-4: Exposure models for intended uses
Critical use Grape vine (max. 1 x 4 L product/ha) ‘worst case’ Model German re-entry model, Krebs et al. (2000) [Uniform Principles for Safeguarding the Health of Workers Re-entering Crop Growing Areas after Application of Plant Protection Products, Nachrichtenbl. Deut. Pflanzenschutzdienst., 52(1), p. 5-9]
Table 3.6-5: Estimated worker exposure
MCPA Model data Level of PPE Total absorbed dose (mg/kg/day) % of systemic AOEL Number of applications and application rate: 1 x 2.0 kg a.s./ha, based on TC values for ornamentals used as a surrogate for herbicidal application in grape vine. 8 hours/day 1), no PPE 2) 0.09333 233.3 Body weight: 60 kg, 3) DFR: 1µg/cm2/kg a.s.4) with PPE 0.01307 32.7 1) 8 h/day for professional applications for harvesting, pruning, tying, thinning or weeding activities 2) no PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves (TC: 5000 cm2/person/h); acc to EFSA Journal 2014;12(10):3874. 3) with PPE : Worker wearing long sleeved shirt, long trousers (“permeable”) and gloves (TC: 14000 cm2/person/h; for gloves and workwear: 0.05 reduction); acc to EFSA Journal 2014;12(10):3874. 4) with DFR of 3µg/cm2/kg a.s. would result in 699.9 % of systemic AOEL without PPE and in 98.1 % of systemic AOEL with PPE.
3.6.3.2 Measurement of worker exposure Since the worker exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of worker exposure was not necessary and was therefore not performed.
3.6.4 Bystander and resident exposure (IIIA 7.4) 3.6.4.1 Estimation of bystander and resident exposure Table 3.6-6 shows the exposure model(s) used for estimation of bystander and resident exposure to MCPA. Outcome of the estimation is presented in Table 3.6-7. Detailed calculations are in Appendix 3.
Table 3.6-6: Exposure models for intended uses
Critical use Grape vine (max. 1 x 4 L product/ha) ‘worst case’ Model Martin, S. et al. (2008) [Guidance for Exposure and Risk Evaluation for Bystanders and Residents Exposed to Plant Protection Products During and After Application; J. Verbr. Lebensm. 3 (2008): 272-281 Birkhäuser Verlag Basel] and Bundesanzeiger (BAnz), 06 January 2012, Issue No. 4, pp. 75-76
Table 3.6-7: Estimated bystander and resident exposure
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version MCPA Model data Total absorbed dose (mg/kg/day) % of systemic AOEL Air-assisted spray application outdoors to high crops ('worst case') Application rate: 2 kg a.s./ha Drift of 2.77 % based on ornamentals < 50 cm, used as a surrogate for herbicidal application in grape vine Bystanders (adult) Drift rate: 2.77 % (1 m) 0.003740 9.35 Body weight: 60 kg Bystanders (children) Drift rate: 2.77 % (1 m) 0.003106 7.76 Body weight: 16.15 kg Residents (adult) Drift rate: 2.77 % (1 m) 0.000472 1.18 Body weight: 60 kg Residents (children) Drift rate: 2.77 % (1 m) 0.001268 3.70 Body weight: 16.15 kg
3.6.4.2 Measurement of bystander and/or resident exposure Since the bystander and/or resident exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) for MCPA will not be exceeded under conditions of intended uses, a study to provide measurements of bystander/resident exposure was not necessary and was therefore not performed.
3.6.5 Statement on combined exposure Not relevant. The product contains only one active substance.
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Appendix 1 Reference list
Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIIA1 7.1.1 xxxxx 1998 Acute oral toxicity to the rat of Marks Add MCPA DMA 500 g/l AHM 125/982487/AC TOX2002-521 KIIIA1 7.1.2 xxxxx 1998 Marks MCPA DMA 500 g/l: Acute Add dermal toxicity to rat AHM 126/982204/AC TOX2002-520 KIIIA1 7.1.3 xxxxx 1998 Marks MCPA DMA 500 g/l acute Add inhalation study in rats (4-hour exposure) AHM 139/974402 TOX2002-517 KIIIA1 7.1.4 xxxxx 1998 Marks MCPA DMA 500 g/l: Skin Add irritation to the rabbit AHM 127/982047/SE TOX2002-522 KIIIA1 7.1.5 xxxxx 1998 Marks MCPA DMA 500 g/l: Eye Add irritation to the rabbit AHM 128/982157/SE TOX2002-523 KIIIA1 7.1.6 xxxxx 2007 MCPA DMA 500 g/l: Sensitation tests - Yes Nufarm Y Evaluation and investigation ( incl. correspondence sent) BVL-2687786, ASB2014-10267 KIIIA1 7.6 xxxxx 2003 14C-MCPA - Study of the dermal Open NUD Y** absorption in rats 01B0209/026003 TOX2005-1297 KIIIA1 7.6 xxxxx 2002 MCPA.DMA 750g/l formulation: in No Nufarm Y Vitro absorption through human and rat epidermis JV1706 BVL-2685557, TOX2006-779 *Y, Yes/relied on; N, No/not relied on; Add, Additional, Relied on/study not submitted by applicant but necessary for evaluation, **submitted to the previous application of U 46 M-Fluid (050939-00/00)
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Appendix 2 Detailed evaluation of the studies relied upon
A 2.1 Statement on bridging possibilities The studies were performed on a formulation similar to the formulation applied for. The results of the studies can be used for U 46 M-Fluid. Comments of zRMS: Acceptable.
A 2.2 Acute oral toxicity (IIIA1 7.1.1) Comments of zRMS: Acceptable (no deviations from below mentioned test guideline), used for evaluation.
Reference: 7.1.1 Report Acute oral toxicity to the rat of Marks MCPA DMA 500g/L; xxxxx.; 1998; Study No. AHM 125/982487/AC; TOX2002-521 Guideline: U.S. EPA Health Effects Test Guidelines OPPTS 870.1100 Deviations: No GLP: Statement: “Compliance with Good Laboratory Practice Standards” Acceptability: Yes
Materials and methods
Test material (Lot/Batch No.) Marks MCPA DMA 500 g/L Species Rat, Sprague-Dawley (Hsd:Sprague-Dawley(CD)) No. of animals (group size) 15 rats/sex Dose(s) 800 mg/kg bw, 1000 mg/kg bw, 1600 mg/kg bw, 2000 mg/kg bw Exposure Once by gavage Vehicle/Dilution None Post exposure observation period 14 days Remarks None
Results and discussions
Table A 1: Results of acute oral toxicity study in rats of Marks MCPA DMA 500 g/L
1) Dose Toxicological results Duration of signs Time of death LD50 [mg/kg bw] [mg/kg bw] (14 days) Male rats 1000 0/5/5 14 days - 1600 4/5/5 15 days d 1 - d 2 = 1509 2000 5/5/5 3 days d 2 – d 3 Female rats 800 0/5/5 8 days - = 1015 1000 2/5/5 8 days d 3
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version 2000 5/5/5 3 days d 2 - d 3 1) Number of animals which died/number of animals with clinical signs/number of animals used
Table A 2: Summary of findings of acute oral toxicity study in rats of Marks MCPA DMA 500 g/L
Mortality: Yes, two females at 1000 mg/kg, four males at 1600 mg/kg and all rats at 2000 mg/kg died during the study. All deaths occurred within approximately three days of dosing. Clinical signs: Clinical sign of reaction to treatment included piloerection, hunched posture, waddling/unsteady gait, lethargy, abnormal respiration, partially closed eyelids, pallid extremities, walking on toes, increased lacrimation, increased sensitivity to touch, thin appearance, ungroomed appearance, postration and blue/cold extremities, seen in rats at all dosages. In addition, increased salivation, abnormal faeces, abnormal urine, hair loss on neck and shoulders and darkened pupils were all seen in rats at one or more dose levels. Recovery of surviving rats was complete in all instances, with the exception of piloerection in males at 1600 mg/kg, by Day 15. Body weight: A loss in bodyweight was recorded for one male on Day 8 and slightly low bodyweight gain was evident for one female on Day 15. All other surviving rats were considered to have achieved satisfactory bodyweight gains throughout the study. Macroscopic Macroscopic examination of animals surviving treatment and killed at study termination on examination: Day 15 revealed no abnormalities.
Conclusion
Under the experimental conditions, the oral LD50 of U 46 M-Fluid is 1239 mg/kg bw for both sexes in rats (1015 mg/kg bw for female rats and 1509 mg/kg bw for male rats). Thus classification/labelling with Acute Tox. 4, H302 is required according to Regulation (EC) No. 1272/2008.
A 2.3 Acute percutaneous (dermal) toxicity (IIIA1 7.1.2) Comments of zRMS: Acceptable (no deviations from below mentioned test guideline), used for evaluation.
Reference: 7.1.2 Report Marks MCPA DMA 500 g/L Acute dermal toxicity to the rat; xxxxx; 1998; Study No. AHM 126/982204/AC; TOX2002-520 Guideline: U.S. EPA Health Effects Test Guidelines OPPTS 870.1200 Deviations: No GLP: Statement: “Compliance with Good Laboratory Practice Standards” Acceptability: Yes
Materials and methods
Test material (Lot/Batch No.) Marks MCPA DMA 500 g/L Species Rat, Sprague-Dawley (Hsd:Sprague-Dawley(CD)) No. of animals (group size) 5 rats/sex Dose(s) 2000 mg/kg bw Exposure 24 hours (dermal, semi-occlusive) Vehicle/Dilution None
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Post exposure observation period 14 days Remarks None
Results and discussions
Table A 3: Results of acute dermal toxicity study in rats of Marks MCPA DMA 500 g/L
1) Dose Toxicological results Duration of signs Time of death LD50 [mg/kg bw] [mg/kg bw] (14 days) Male rats 2000 0/2/5 7 days - > 2000 Female rats 2000 0/4/5 12 days - > 2000 1) Number of animals which died/number of animals with clinical signs/number of animals used
Table A 4: Summary of findings of acute dermal toxicity study in rats of Marks MCPA DMA 500 g/L
Mortality: No mortality occurred. Clinical signs: No clinical signs of toxicity were observed. Body weight: A slight loss in bodyweight was evident in two females on Day 8. All remaining animals were considered to have achieved satisfactory bodyweight gains. Macroscopic The necropsies performed at the end of the study revealed no apparent findings. examination:
Conclusion
Under the experimental conditions, the dermal LD50 of U 46 M-Fluid is higher than 2000 mg/kg bw in rats. Thus, no classification/labelling is required according to Regulation (EC) No. 1272/2008.
A 2.4 Acute inhalation toxicity (IIIA1 7.1.3) Comments of zRMS: Acceptable (no deviations from below mentioned test guideline), used for evaluation.
Reference: 7.1.3 Report Marks MCPA DMA 500 g/L Acute inhalation study in rats (4-hour exposure); xxxxx.; 1998; Study No. AHM 139/974402; TOX2002-517 Guideline: EC Council Directive, 87/18 EEC (1986) Deviations: No GLP: Statement: “Compliance with Good Laboratory Practice Standards” Acceptability: Yes
Materials and methods
Test material (Lot/Batch No.) Marks MCPA DMA 500 g/L Species Rat, Sprague-Dawley
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version No. of animals (group size) One control group and one test group of 5 male and 5 female rats Concentration 5 mg/L air Exposure 4 hours (nose only) Vehicle/Dilution None Post exposure observation period 14 days Remarks None
Results and discussions
Table A 5: Concentration(s) and exposure conditions
Nominal conc. Actual conc. MMAD 1) GSD 2) [mg/L air] [mg/L air] [µm] [µm] 35 5.9 2.3 2.0 1) MMAD = Mass Median Aerodynamic Diameter 2) GSD = Geometric Standard Deviation
Table A 6: Results of acute inhalation toxicity study in rats of Marks MCPA DMA 500 g/L
1) Concentration Toxicological results Duration of signs Time of death LC50 [mg/L air] [mg/L air] (14 days) Male rats 5.9 0/5/5 2 days - > 5.9 Female rats 5.9 0/5/5 14 days - > 5.9 1) Number of animals which died/number of animals with clinical signs/number of animals used
Table A 7: Summary of findings of acute inhalation toxicity study in rats of Marks MCPA DMA 500 g/L
Mortality: No mortality occurred. Clinical signs: Clinical sign observed in rats immediately following exposure to Marks MCPA DMA 500 g/L were exaggerated respiratory movements, lethargy, matted fur, and brown staining around the snout and jaws and on the head. Brown staining on the head was also observed in control male and 2 control females immediately following exposure. Clinical signs recorded in test rats on Day 1 of the observation period were brown staining on the head in 2 males and 5 females and matted fur in 3 female rats. Hair loss from the body was observed in 3 female rats from Day 3 onwards. All male test rats were normal in appearance and behavior by Day 2 of the observation period. Recovery from the effects of exposure was evident in 1 of 5 female test rats from Day 3 of observation and, with the exception of hair loss, all female test rats had recovered by Day 5. Hair loss persisted in 1 test female until Day 7 of observation and in 2 other females until Day 14. Soiling of the fur with excreta, as a consequence of the method of restraint, was seen in all test and control rats during and immediately following exposure. Body weight: Bodyweight losses were evident in test rats on the day following exposure. The rate of bodyweight gain for test rats was otherwise similar to that of the control rats. Macroscopic The necropsies performed at the end of the study revealed no apparent findings.
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version examination:
Conclusion
Under the experimental conditions, the inhalation LC50 of U 46 M-Fluid is higher than 5.9 mg/L air in rats. Thus, no classification/labelling is required according to Regulation (EC) No. 1272/2008.
A 2.5 Skin irritation (IIIA1 7.1.4) Comments of zRMS: Acceptable (no deviations from below mentioned test guideline), used for evaluation.
Reference: 7.1.4 Report Marks MCPA DMA 500 g/L skin irritation to the rabbit; xxxxx.; 1998; Study No. AHM 127/98204/SE; TOX2002-522 Guideline: U.S. EPA Health Effects Test Guidelines OPPTS 870.2500 Deviations: No GLP: Statement: “Compliance with Good Laboratory Practice Standards” Acceptability: Yes
Materials and methods
Test material (Lot/Batch No.) Marks MCPA DMA 500 g/L Species Rabbit, New Zealand White No. of animals (group size) 6 males Initial test using one animal Yes Exposure 0.5 mL (4 hours, semi-occlusive) Vehicle/Dilution None Post exposure observation period 5 days Remarks None
Results and discussions
Table A 8: Skin irritation of Marks MCPA DMA 500 g/L
Animal Scores after treatment 1) Mean scores Reversible No. (24-72 h) [day] 1 h 24 h 48 h 72 h 1 Erythema 1 2 1 1 1.33 5 Oedema 1 1 1 0 0.67 2 Erythema 2 1 0 0 0.33 3 Oedema 0 0 0 0 0.00 3 Erythema 2 2 1 0 1.00 4 Oedema 1 1 0 0 0.33 4 Erythema 1 0 0 0 0.00 2 Oedema 0 0 0 0 0.00 5 Erythema 2 1 1 0 0.67 4 Oedema 1 0 0 0 0.00
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version 6 Erythema 2 1 1 0 0.66 4 Oedema 2 0 0 0 0.00 1) scores in the range of 0 to 4
Clinical signs: None
Conclusion Under the experimental conditions, U 46 M-Fluid is not a skin irritant. Thus, no classification/labelling is required according to Regulation (EC) No. 1272/2008.
A 2.6 Eye irritation (IIIA1 7.1.5) Comments of zRMS: Acceptable (no deviations from below mentioned test guideline), used for evaluation.
Reference: 7.1.5 Report Marks MCPA DMA 500 g/L eye irritation to the rabbit; xxxxx; 1998; Study No. AHM 128/982157/SE; TOX2002-523 Guideline: U.S. EPA Health Effects Test Guidelines OPPTS 870.2400 Deviations: No GLP: Statement: “Compliance with Good Laboratory Practice Standards” Acceptability: Yes
Materials and methods
Test material (Lot/Batch No.) Marks MCPA DMA 500 g/L Species Rabbit, New Zealand White No. of animals (group size) 1 male Initial test using one animal Yes Exposure 0.1 mL (single instillation into conjunctival sac) Irrigation (time point) Yes, eye was rinsed 30 seconds after installation Vehicle/Dilution None Post exposure observation period 2 days Remarks Due to the severity of the ocular reaction, on grounds of animal welfare the rabbit was sacrificed two days after treatment and no further animal were used.
Results and discussions
Table A 9: Eye irritation of Marks MCPA DMA 500 g/L
Animal Scores after treatment 1) Mean scores Reversible No. (24-72 h) [day] 1 h 24 h 48 h 72 h 1 Corneal opacity 3 2 A - - - Iritis 1 1 A - - - Redness conjunctivae 3 3 3 - - - Chemosis conjunctivae 2 4 4 - - -
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version 1) scores in the range of 0 to 4 for cornea opacity and chemosis, 0 to 3 for redness of conjunctivae and 0 to 2 for iritis A: Unable to assess due to severity of swelling
Clinical signs: None
Conclusion Under the experimental conditions, U 46 M-Fluid is an eye irritant. Thus, classification/labelling with Eye Dam. 1, H318 is required according to Regulation (EC) No. 1272/2008.
A 2.7 Skin sensitisation (IIIA1 7.1.6) Comments of zRMS: Acceptable (no deviations from below mentioned test guideline), used for evaluation.
Reference: 7.1.6 Report MCPA DMA 500 g/L Sensitisation test- Evaluation and Investigation; xxxxx.; 2007; ASB2014-10267
Summary An Open Epicutaneous (Buehler) sensitization study in the guinea pig has demonstrated that MCPA DMA 500 preparation is a weak potential contact sensitiser. This result is at variance with those from the technical acid (active ingredient), MCPA technical sodium salt, a 750 g/l DMA salt preparation, a 400 g/l potassium salt preparation and a 300 g/l sodium salt preparation. All the latter preparations use very similar co-formulants to the DMA 500 preparation. The murine Local Lymph Node Assay (LLNA) confirmed sensitization potential on this preparation of MCPA DMA 500. Further investigation in a second laboratory failed to duplicate the result in the LLNA with two separate preparations of MCPA DMA 500, the pure and technical grade active ingredient (MCPA) and with a “blank” formulation. However, a Buehler test, performed in the second laboratory with a new formulation of MCPA DMA 500 confirmed the test article to be a moderate sensitizer. In both Buehler tests the individual responses observed were generally weak. As both the active ingredient and other formulations of different strengths with identical or similar co- formulants are negative, the positive results from the Buehler tests are regarded as anomalous. No reason for the anomaly has been established. The conflict between the results of the Buehler test and those from the LLNA is unresolved. Nevertheless, given the long history of use of MCPA in various formulations, the lack of any reports of sensitization in the workforces handling this material and the known inert nature of the other components of the formulation, it is considered appropriate to accept the results from the LLNA (now regarded as the test of first choice) and thus NOT to label this preparation as a sensitizer.
Introduction This paper gives a brief overview of studies on the sensitization potential of an MCPA DMA 500 g/l formulation.
Experimental Results A study (xxxxx) performed on MCPA DMA 500 formulation showed this preparation to have moderate sensitization potential in the Buehler guinea pig test. This result was considered anomalous in view of the following negative results: 1. xxxxx (1984) Guinea pig maximization test (M&K). Purified MCPA was not a sensitizer in this test. 2. xxxxx (1984) Buehler Test. MCPA technical acid was not a sensitizer in this test . 3. xxxxx (1993) Buehler Test 750 g/l MCPA DMA concentrate (a more concentrated version of the DMA 500 formulation with very similar additives) was non-sensitizing 4. xxxxx (1998a) Buehler Test. MCPA Na 300g/l was non-sensitizing.
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version 5. xxxxx (1998b) Buehler Test MCPA K 400 g/l was non-sensitizing. 6. xxxxx (1998) Guinea pig maximization test (M&K). MCPA Na technical was non-sensitizing
The positive reaction from the Buehler test with MCPA DMA 500 was seen at challenge concentrations of 75-100%. A re-challenge at lower concentrations (5 and 10%) showed only minimal reactions, none of which persisted to the 48-hour assessment. The lack of any recorded response in control animals should be noted. Other investigations have established that MCPA formulations are non-irritant over the standard 4-hour test period but may be irritant following more prolonged exposures.
The preparation was also tested by the LLNA to establish whether this would be a suitable model system to investigate the effects further. A positive result was obtained (xxxxx). A second preparation of MCPA DMA 500 tested at this laboratory also gave a nominally positive response (xxxxx), but this study showed an inverse dose-relationship, a most unusual finding with the LLNA.
Expert guidance was sought from an internationally-established expert on immune reactions who is also one of the originators of the LLNA. The LLNA was repeated at his laboratory, with MCPA technical acid, analytical standard MCPA, the formulation excluding the MCPA component, and an MCPA DMA 500 preparation. All were negative (xxxxx). These results suggested possible contamination of the original sample. A further series of LLNA tested 3 formulations of MCPA DMA 500.
1. The test sample which gave the original positive result, recovered from the testing laboratory. 2. The A H Marks reference sample of the same preparation. 3. A new preparation to the same formulation.
All were negative (xxxxx).
A further Buehler study was performed on the new preparation, at the laboratory where the more recent LLNA investigations were performed. This study (xxxxx) showed moderate sensitizing potential under the conditions of the test, but individual responses were at a low level.
Discussion The initial positive result was inconsistent with previous experience with MCPA, both alone and in formulations of both higher and lower strength than MCPA DMA 500. The co-formulants (mainly dimethylamine with small quantities of EDTA and a dispersing agent) are themselves not sensitizing and are routinely included in other preparations which have not shown sensitizing potential.
A positive result with the LLNA proved not to be reproducible in another laboratory with considerable experience of the conduct of this test. Further investigations with the LLNA have consistently shown negative results with all the formulations tested as well as the various components. Nevertheless, a further Buehler test in a second laboratory also showed moderate sensitization potential for the formulation, with similar weak individual responses in those animals which reacted.
An expert review of the raw data from the latter study to revealed no reason to discount the results obtained.
The results from this formulation remain anomalous. It is unclear why:
a) This particular strength formulation should show an effect not seen at higher or lower strengths. b) The formulation consistently shows moderate sensitization potential in the Buehler test but not in the LLNA, although guinea–pig tests are widely regarded as oversensitive
It is not clear what further investigations could be conducted to determine whether the response in the Buehler study is indicative of a human sensitization potential. However, given the long history of use of MCPA in various formulations, the lack of any reports of sensitization in the workforces handling this material and the known inert nature of the other components of the formulation, it is considered
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version appropriate to accept the results from the LLNA (now regarded as the test of first choice) and thus NOT to label this preparation as a sensitizer. This is also in accord with the annex 1 listing for MCPA.
REFERENCES A. xxxxx; MCPA (2-methyl-4-chlorophenoxyacetic acid): Local Lymph Node Assay , unpublished report number CTL/P/6212. Zeneca CTL, Macclesfield
Bxxxxx; MCPA Analytical Standard (2-methyl-4-chlorophenoxyacetic acid): Local Lymph Node Assay, unpublished report number CTL/P/6213. Zeneca CTL, Macclesfield
C. xxxxxEDTA (0.25% w/w) DMA (0.16% w/w): Local Lymph Node Assay, unpublished report number CTL/P/6224. Zeneca CTL, Macclesfield
D. xxxxxMCPA. DMA 500 (2-methyl-4-chlorophenoxyacetic acid): Local Lymph Node Assay, unpublished report number CTL/P/6223. Zeneca CTL, Macclesfield
E. xxxxxMCPA DMA 500 (2-methyl-4-chlorophenoxyacetic acid, dimethylamine salt 500 g/l AI): Sample KMW/99/08: Local Lymph Node Assay, unpublished report number CTL/P/6324. Zeneca CTL, Macclesfield
F. xxxxx) MCPA DMA 500 (2-methyl-4-chlorophenoxyacetic acid, dimethylamine salt 500 g/l AI): Sample KMW/99/09: Local Lymph Node Assay, unpublished report number CTL/P/6325. Zeneca CTL, Macclesfield
G. xxxxxMCPA DMA 500 (2-methyl-4-chlorophenoxyacetic acid, dimethylamine salt 500 g/l AI): Sample KMW/99/07: Local Lymph Node Assay, unpublished report number CTL/P/6323. Zeneca CTL, Macclesfield
H. xxxxxMCPA DMA 500 (2-methyl-4-chlorophenoxyacetic acid, dimethylamine salt 500 g/l AI): Skin Sensitisation Study in Guinea Pigs, unpublished report number CTL/P/6322. Zeneca CTL, Macclesfield
I. xxxxxSensitising effect of MCPA in the guinea pig - Maximisation Test , unpublished report number 84/236- BASF Laboratories Limburgerhof
J. xxxxxSensitising effect of MCPA in the guinea pig – Open Epicutaneous Test (OET), unpublished report number 31H46/83-BASF Laboratories, Limburgerhof.
K. xxxxxSkin Sensitisation to the guinea pig of MCPA DMA , unpublished report number JEL 85/930153755- Huntingdon Research Centre.
L. xxxxxMCPA Na 300 Buehler delayed contact hypersensitivity study in the guinea pig. Unpublished report No. 1156/003 Safepharm Laboratories Derby.
M. xxxxxMCPA K 400 Buehler delayed contact hypersensitivity study in the guinea pig. Unpublished report No. 1156/004 Safepharm Laboratories Derby.
N. xxxxxMarks MCPA Technical Sodium Salt skin sensitisation in the guinea pig Unpublished report No. AHM 119/972258/AC Huntingdon Life Sciences.
O. xxxxx MCPA DMA 500 Buehler delayed contact hypersensitivity study in the guinea pig. Unpublished report No. 1156/005 Safepharm Laboratories Derby.
P. xxxxxThe local lymph node assay in the mouse: MCPA DMA 500 Formulation 1 Unpublished report No.1156/007 Safepharm Laboratories, Derby
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Q. xxxxxThe local lymph node assay in the mouse: MCPA DMA 500 Formulation 2 Unpublished report No.1156/008 Safepharm Laboratories, Derby
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version
A 2.8 Supplementary studies for combinations of plant protection products (IIIA1 7.1.7) None.
A 2.9 Data on co-formulants (III1 7.9)
A 2.9.1 Material safety data sheet for each co-formulant Material safety data sheets of the co-formulants can be found in the confidential dossier of this submission (Registration Report - Part C).
A 2.9.2 Available toxicological data for each co-formulant Available toxicological data for each co-formulant can be found in the confidential dossier of this submission (Registration Report - Part C).
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Appendix 3 Exposure calculations A 3.1 Operator exposure calculations (IIIA1 7.3.1) A 3.1.1 Calculations for MCPA
Table A 10: Input parameters considered for the estimation of operator exposure (HCTM)
Formulation type: SL High Crop Tractor Mounted Application technique: Application rate (AR): 2 kg a.s./ha (HCTM)
Area treated per day (A): 8 ha Dermal hands m/l (DM(H)): 2.4 mg/person/kg a.s.
7 % (concentr.) Dermal hands appl. (DA(H)): 0.7 mg/person/kg a.s. Dermal absorption (DA): 3.9 % (dilution) Dermal body appl. (DA(B)): 9.6 mg/person/kg a.s.
Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 1.2 mg/person/kg a.s.
Body weight (BW): 70 kg/person Inhalation m/l (IM): 0.0006 mg/person/kg a.s.
AOEL 0.04 mg/kg bw/d Inhalation appl. (IA): 0.018 mg/person/kg a.s.
Table A 11: Estimation of operator exposure towards MCPA using the German model (HCTM)
Without PPE With PPE Operators: Systemic dermal exposure after application in Grape vine Dermal exposure during mixing/loading Hands Hands 1) SDEOM(H) = (DM(H) x AR x A x DA) / BW SDEOM(H) = (DM(H) x AR x A x PPE x DA) / BW (2.4 x 2 x 8 x 7%) / 70 (2.4 x 2 x 8 x 0.01 x 7%) / 70 External dermal exposure 38.4 mg/person External dermal exposure 0.384 mg/person External dermal exposure 0.548571 mg/kg bw/d External dermal exposure 0.005486 mg/kg bw/d Systemic dermal exposure 0.0384 mg/kg bw/d Systemic dermal exposure 0.000384 mg/kg bw/d Dermal exposure during application Hands Hands
SDEOA(H) = (DA(H) x AR x A x DA) / BW SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW (0.7 x 2 x 8 x 3.9%) / 70 (0.7 x 2 x 8 x 1 x 3.9%) / 70 External dermal exposure 11.2 mg/person External dermal exposure 11.2 mg/person External dermal exposure 0.16 mg/kg bw/d External dermal exposure 0.16 mg/kg bw/d Systemic dermal exposure 0.00624 mg/kg bw/d Systemic dermal exposure 0.00624 mg/kg bw/d Body Body 2) SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE x DA) / BW (9.6 x 2 x 8 x 3.9%) / 70 (9.6 x 2 x 8 x 0.05 x 3.9%) / 70 External dermal exposure 153.6 mg/person External dermal exposure 7.68 mg/person External dermal exposure 2.194286 mg/kg bw/d External dermal exposure 0.109714 mg/kg bw/d Systemic dermal exposure 0.085577 mg/kg bw/d Systemic dermal exposure 0.004279 mg/kg bw/d Head Head
SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW (1.2 x 2 x 8 x 3.9%) / 70 (1.2 x 2 x 8 x 1 x 3.9%) / 70 External dermal exposure 19.2 mg/person External dermal exposure 19.2 mg/person External dermal exposure 0.274286 mg/kg bw/d External dermal exposure 0.274286 mg/kg bw/d Systemic dermal exposure 0.010697 mg/kg bw/d Systemic dermal exposure 0.010697 mg/kg bw/d
Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) + Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) + SDEOA(B) + SDEOA(C) SDEOA(B) + SDEOA(C) Total external dermal exposure 222.4 mg/person Total external dermal exposure 38.464 mg/person Total external dermal exposure 3.177143 mg/kg bw/d Total external dermal exposure 0.549486 mg/kg bw/d Total systemic dermal 0.140914 mg/kg bw/d Total systemic dermal exposure 0.0216 mg/kg bw/d exposure Operators: Systemic inhalation exposure after application in Grape vine Inhalation exposure during mixing/loading
SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW (0.0006 x 2 x 8 x 100%) / 70 (0.0006 x 2 x 8 x 1 x 100%) / 70 External inhalation exposure 0.0096 mg/person External inhalation exposure 0.0096 mg/person
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version External inhalation exposure 0.000137 mg/kg bw/d External inhalation exposure 0.000137 mg/kg bw/d Systemic inhalation exposure 0.000137 mg/kg bw/d Systemic inhalation exposure 0.000137 mg/kg bw/d Inhalation exposure during application
SIEOA = (IA x AR x A x IA) / BW SIEOA = (IA x AR x A x PPE x IA) / BW (0.018 x 2 x 8 x 100%) / 70 (0.018 x 2 x 8 x 1 x 100%) / 70 External inhalation exposure 0.288 mg/person External inhalation exposure 0.288 mg/person External inhalation exposure 0.004114 mg/kg bw/d External inhalation exposure 0.004114 mg/kg bw/d Systemic inhalation exposure 0.004114 mg/kg bw/d Systemic inhalation exposure 0.004114 mg/kg bw/d
Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total external inhalation Total external inhalation 0.2976 mg/person 0.2976 mg/person exposure exposure Total external inhalation Total external inhalation 0.004251 mg/kg bw/d 0.004251 mg/kg bw/d exposure exposure Total systemic inhalation Total systemic inhalation 0.004251 mg/kg bw/d 0.004251 mg/kg bw/d exposure exposure
Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure 10.1616 mg/person Total systemic exposure 1.8096 mg/person Total systemic exposure 0.145166 mg/kg bw/d Total systemic exposure 0.025851 mg/kg bw/d % of AOEL 362.9 % % of AOEL 64.6 % 1) reduction factor for gloves is 0.01 (professional appl.) 2) reduction factor for protective garment is 0.05 (professional appl.)
Table A 12: Input parameters considered for the estimation of operator exposure (HCHH)
Formulation type: SL High Crop Tractor Mounted Application technique: Application rate (AR): 2 kg a.s./ha (HCHH)
Area treated per day (A): 1 ha Dermal hands m/l (DM(H)): 205 mg/person/kg a.s.
7 % (concentr.) Dermal hands appl. (DA(H)): 10.6 mg/person/kg a.s. Dermal absorption (DA): 3.9 % (dilution) Dermal body appl. (DA(B)): 25 mg/person/kg a.s.
Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 4.8 mg/person/kg a.s.
Body weight (BW): 70 kg/person Inhalation m/l (IM): 0.05 mg/person/kg a.s.
AOEL 0.04 mg/kg bw/d Inhalation appl. (IA): 0.3 mg/person/kg a.s.
Table A 13: Estimation of operator exposure towards MCPA using the German model (HCHH)
Without PPE With PPE Operators: Systemic dermal exposure after application in Grape vine Dermal exposure during mixing/loading Hands Hands 1) SDEOM(H) = (DM(H) x AR x A x DA) / BW SDEOM(H) = (DM(H) x AR x A x PPE x DA) / BW (205 x 2 x 1 x 7%) / 70 (205 x 2 x 1 x 0.01 x 7%) / 70 External dermal exposure 410 mg/person External dermal exposure 4.1 mg/person External dermal exposure 5.857143 mg/kg bw/d External dermal exposure 0.058571 mg/kg bw/d Systemic dermal exposure 0.41 mg/kg bw/d Systemic dermal exposure 0.0041 mg/kg bw/d Dermal exposure during application Hands Hands
SDEOA(H) = (DA(H) x AR x A x DA) / BW SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW (10.6 x 2 x 1 x 3.9%) / 70 (10.6 x 2 x 1 x 1 x 3.9%) / 70 External dermal exposure 21.2 mg/person External dermal exposure 21.2 mg/person External dermal exposure 0.302857 mg/kg bw/d External dermal exposure 0.302857 mg/kg bw/d Systemic dermal exposure 0.011811 mg/kg bw/d Systemic dermal exposure 0.011811 mg/kg bw/d Body Body 2) SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE x DA) / BW (25 x 2 x 1 x 3.9%) / 70 (25 x 2 x 1 x 0.05 x 3.9%) / 70 External dermal exposure 50 mg/person External dermal exposure 2.5 mg/person External dermal exposure 0.714286 mg/kg bw/d External dermal exposure 0.035714 mg/kg bw/d Systemic dermal exposure 0.027857 mg/kg bw/d Systemic dermal exposure 0.001393 mg/kg bw/d
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Head Head
SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW (4.8 x 2 x 1 x 3.9%) / 70 (4.8 x 2 x 1 x 1 x 3.9%) / 70 External dermal exposure 9.6 mg/person External dermal exposure 9.6 mg/person External dermal exposure 0.137143 mg/kg bw/d External dermal exposure 0.137143 mg/kg bw/d Systemic dermal exposure 0.005349 mg/kg bw/d Systemic dermal exposure 0.005349 mg/kg bw/d
Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) + Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) + SDEOA(B) + SDEOA(C) SDEOA(B) + SDEOA(C) Total external dermal exposure 490.8 mg/person Total external dermal exposure 37.4 mg/person Total external dermal exposure 7.011429 mg/kg bw/d Total external dermal exposure 0.534286 mg/kg bw/d Total systemic dermal 0.455017 mg/kg bw/d Total systemic dermal exposure 0.022653 mg/kg bw/d exposure Operators: Systemic inhalation exposure after application in Grape vine Inhalation exposure during mixing/loading
SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW (0.05 x 2 x 1 x 100%) / 70 (0.05 x 2 x 1 x 1 x 100%) / 70 External inhalation exposure 0.1 mg/person External inhalation exposure 0.1 mg/person External inhalation exposure 0.001429 mg/kg bw/d External inhalation exposure 0.001429 mg/kg bw/d Systemic inhalation exposure 0.001429 mg/kg bw/d Systemic inhalation exposure 0.001429 mg/kg bw/d Inhalation exposure during application
SIEOA = (IA x AR x A x IA) / BW SIEOA = (IA x AR x A x PPE x IA) / BW (0.3 x 2 x 1 x 100%) / 70 (0.3 x 2 x 1 x 1 x 100%) / 70 External inhalation exposure 0.6 mg/person External inhalation exposure 0.6 mg/person External inhalation exposure 0.008571 mg/kg bw/d External inhalation exposure 0.008571 mg/kg bw/d Systemic inhalation exposure 0.008571 mg/kg bw/d Systemic inhalation exposure 0.008571 mg/kg bw/d
Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total external inhalation Total external inhalation 0.7 mg/person 0.7 mg/person exposure exposure Total external inhalation Total external inhalation 0.01 mg/kg bw/d 0.01 mg/kg bw/d exposure exposure Total systemic inhalation Total systemic inhalation 0.01 mg/kg bw/d 0.01 mg/kg bw/d exposure exposure
Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure 32.5512 mg/person Total systemic exposure 2.2857 mg/person Total systemic exposure 0.465017 mg/kg bw/d Total systemic exposure 0.032653 mg/kg bw/d % of AOEL 1162.5 % % of AOEL 81.6 % 1) reduction factor for gloves is 0.01 (professional appl.) 2) reduction factor for protective garment is 0.05 (professional appl.)
Table A 14: Estimation of operator exposure towards MCPA using the UK-POEM (without PPE)
Active substance MCPA Product U46 M-Fluid
Formulation type water-based
Concentration of a.s. 500 mg/mL
Dose 4 L preparation/ha (2 kg a.s./ha) Application volume 200 L/ha
Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level Application method target Container* 10 litres 63 mm closure
Work rate/day 1 ha
Duration of spraying 6 h
PPE during mix./loading None
PPE during application None
Dermal absorption from product 7 %
Dermal absorption from spray 3.9 %
EXPOSURE DURING MIXING AND LOADING Container size 10 Litres
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Hand contamination/operation 0,05 mL
Application dose 4 Litres product/ha
Work rate 1 ha/day
Number of operations 14 /day
Hand contamination 0.7 mL/day
Protective clothing None
Transmission to skin 100 %
Dermal exposure to formulation 0.7 mL/day DERMAL EXPOSURE DURING SPRAY APPLICATION Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level Application technique target Application volume 200 spray/ha
Volume of surface contamination 50 mL/h
Distribution Hands Trunk Legs 25% 25% 50% Clothing None Permeable Permeable Penetration 100% 20% 18% Dermal exposure 10 2.5 4.5 mL/h Duration of exposure 6 h
Total dermal exposure to spray 102 mL/day ABSORBED DERMAL DOSE Mix/load Application
Dermal exposure 0.7 mL/day 102 mL/day Concen. of a.s. product or spray 500 mg/mL 10 mg/mL Dermal exposure to a.s. 350 mg/day 1020 mg/day Percent absorbed 7 % 3.9 % Absorbed dose 24.5 mg/day 39.78 mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure 0.02 mL/h
Duration of exposure 6 h
Concentration of a.s. in spray 10 mg/mL
Inhalation exposure to a.s. 1.2 mg/day
Percent absorbed 100 %
Absorbed dose 1.2 mg/day PREDICTED EXPOSURE Total absorbed dose 65.48 mg/day
Operator body weight 60 kg
Operator exposure 1.091 mg/kg bw/day Amount of AOEL 2728.3 % *worst case, smaller container would result in lower exposure
Table A 15: Estimation of operator exposure towards MCPA using the UK-POEM (with PPE)
Active substance MCPA Product U46 M-Fluid
Formulation type water-based
Concentration of a.s. 500 mg/mL
Dose 4 L preparation/ha (2 kg a.s./ha) Application volume 200 L/ha
Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level Application method target Container 10 litres 63 mm closure
Work rate/day 1 ha
Duration of spraying 6 h
PPE during mix./loading Gloves
PPE during application Gloves
Dermal absorption from product 7 %
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version Dermal absorption from spray 3.9 %
EXPOSURE DURING MIXING AND LOADING Container size 10 Litres
Hand contamination/operation 0,05 mL
Application dose 4 Litres product/ha
Work rate 1 ha/day
Number of operations 14 /day
Hand contamination 0.7 mL/day
Protective clothing Gloves
Transmission to skin 5 %
Dermal exposure to formulation 0.035 mL/day DERMAL EXPOSURE DURING SPRAY APPLICATION Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level Application technique target Application volume 200 spray/ha
Volume of surface contamination 50 mL/h
Distribution Hands Trunk Legs 25% 25% 50% Clothing Gloves Permeable Permeable Penetration 10% 20% 18% Dermal exposure 1.25 2.5 4.5 mL/h Duration of exposure 6 h
Total dermal exposure to spray 49.5 mL/day ABSORBED DERMAL DOSE Mix/load Application
Dermal exposure 0.035 mL/day 49.5 mL/day Concen. of a.s. product or spray 500 mg/mL 10 mg/mL Dermal exposure to a.s. 17.5 mg/day 495 mg/day Percent absorbed 7 % 3.9 % Absorbed dose 1.225 mg/day 19.305 mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure 0.02 mL/h
Duration of exposure 6 h
Concentration of a.s. in spray 10 mg/mL
Inhalation exposure to a.s. 1.2 mg/day
Percent absorbed 100 %
Absorbed dose 1.2 mg/day PREDICTED EXPOSURE Total absorbed dose 21.73 mg/day
Operator body weight 60 kg
Operator exposure 0.362 mg/kg bw/day Amount of AOEL 905.4 % *worst case, smaller container would result in lower exposure
A 3.2 Worker exposure calculations (IIIA1 7.5.1) A 3.2.1 Calculations for MCPA
Table A 16: Input parameters considered for the estimation of worker exposure
Dislodgeable foliar residues Intended use(s): Grape vine (worst case) 1 µg/cm2/kg a.s. (DFR): Transfer coefficient potential Application rate (AR): 2 kg a.s./ha 14000 cm2/person/h (TC): Transfer coefficient with Number of applications (NA): 1 5000 cm2/person/h workwear (TC): Body weight (BW): 60 kg/person Work rate per day (WR): 8 h/d Dermal absorption (DA): 7 % ('worst case') PPE 5 % AOEL 0.04 mg/kg bw/d
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version
Table A 17: Estimation of worker exposure towards MCPA using the German re-entry model
Without PPE 1) With PPE 2) Worker (re-entry): Systemic dermal exposure after application
in Grassland Grape vine Grape vine
SDEW = (DFR x TC x WR x AR x NA x DA) / BW SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW (1 x 5000 x 8 x 2 x 1 x 7%) / 60 (1 x 14000 x 8 x 2 x 1 x 5% x 7%) / 60 External dermal exposure 80 mg/person External dermal exposure 11.2 mg/person External dermal exposure 1.333333 mg/kg bw/d External dermal exposure 0.186667 mg/kg bw/d Total systemic exposure 5.6 mg/person Total systemic exposure 0.784 mg/person Total systemic exposure 0.093333 mg/kg bw/d Total systemic exposure 0.013067 mg/kg bw/d % of AOEL 233.3 % % of AOEL 32.7 % 1) without PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves (TC: 5000 cm2/person/h); acc to EFSA Journal 2014;12(10):3874. 2) with PPE : Worker wearing long sleeved shirt, long trousers (“permeable”) and gloves (TC: 14000 cm2/person/h, reduction of 0.05 for gloves and workwear); acc to EFSA Journal 2014;12(10):3874.
A 3.3 Bystander and resident exposure calculations (IIIA1 7.4.1) A 3.3.1 Calculations for MCPA
Table A 18: Input parameters considered for the estimation of bystander exposure
Intended use(s): Grape vine (worst case) Drift (D): 2.77* % (HC, 1 m) 2 kg a.s./ha Exposed body surface area 1 m² (adults) Application rate (AR): 200 mg/m2 (BSA): 0.21 m² (children) mg/kg a.s. (6 hours, 60 kg/person (adults) 0.3 Specific Inhalation Exposure adults) Body weight (BW): (I* ): mg/kg a.s. (6 hours, 16.15 kg/person (children) A 0.172414 children) Dermal absorption (DA): 3.9 % Area Treated (A): 1 ha/d (based on HCHH) Inhalation absorption (IA): 100 % AOEL: 0.04 mg/kg bw/d Exposure duration (T): 5 min * Based on ornamentals < 50 cm, used as a surrogate for herbicidal application in grape vine.
Table A 19: Estimation of bystander exposure towards MCPA
Adults Children Bystander: Systemic dermal exposure during/after application (via spray drift)
SDEB = (AR x D x BSA x DA) / BW SDEB = (AR x D x BSA x DA) / BW (200 x 2.77% x 1 x 3.9%) / 60 (200 x 2.77% x 0.21 x 3.9%) / 16.15 External dermal exposure 5.54 mg/person External dermal exposure 1.1634 mg/person External dermal exposure 0.092333 mg/kg bw/d External dermal exposure 0.072037 mg/kg bw/d Systemic dermal exposure 0.003601 mg/kg bw/d Systemic dermal exposure 0.002809 mg/kg bw/d Bystander: Systemic inhalation exposure during/after application (via spray drift)
SIEB = (I*A x AR x A x T x IA) / BW SIEB = (I*A x AR x A x T x IA) / BW (0.3 / 360 x 2 x 1 x 5 x 100%) / 60 (0.172414 / 360 x 2 x 1 x 5 x 100%) / 16.15 External inhalation exposure 0.008333 mg/person External inhalation exposure 0.004789 mg/person External inhalation exposure 0.000139 mg/kg bw/d External inhalation exposure 0.000297 mg/kg bw/d Systemic inhalation exposure 0.000139 mg/kg bw/d Systemic inhalation exposure 0.000297 mg/kg bw/d
Total systemic exposure: SEB = SDEB + SIEB Total systemic exposure: SEB = SDEB + SIEB Total systemic exposure 0.224393 mg/person Total systemic exposure 0.050162 mg/person Total systemic exposure 0.00374 mg/kg bw/d Total systemic exposure 0.003106 mg/kg bw/d % of AOEL 9.35 % % of AOEL 7.76 %
Table A 20: Input parameters considered for the estimation of resident exposure
Intended use(s): Grape vine (worst case) Drift (D): 2.77* % (HC, 1 m)
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 3 - Core Assessment zRMS Version 2 kg a.s./ha 7300 cm2/h (adults) Application rate (AR): Transfer coefficient (TC): 0.02 mg/cm2 2600 cm2/h (children) Turf Transferable Residues Number of applications (NA): 1 5 % (TTR): 60 kg/person (adults) Exposure Duration (H): 2 h Body weight (BW): Airborne Concentration of 16.15 kg/person (children) 0 Vapour (ACV): mg/m3 Dermal absorption (DA): 7 % ('worst case') 16.57 m3/d (adults) Inhalation Rate (IR): Inhalation absorption (IA): 100 % 8.31 m3/d (children) Oral absorption (OA): 75 % Saliva Extraction Factor (SE): 50 % AOEL: 0.04 mg/kg bw/d Surface Area of Hands (SA): 20 cm2 Frequency of Hand to Mouth 20 events/h (Freq): Dislodgeable foliar residues 20 % (DFR): Ingestion Rate for Mouthing of 25 cm2/d Grass/Day (IgR): * Based on ornamentals < 50 cm, used as a surrogate for herbicidal application in grape vine.
Table A 21: Estimation of resident exposure towards MCPA
Adults Children Residents: Systemic dermal exposure after application (via deposits caused by spray drift)
SDER = (AR x NA x D x TTR x TC x H x DA) / BW SDER = (AR x NA x D x TTR x TC x H x DA) / BW (0.02 x 1 x 2.77% x 5% x 7300 x 2 x 7%) / 60 (0.02 x 1 x 2.77% x 5% x 2600 x 2 x 7%) / 16.15 External dermal exposure 0.40442 mg/person External dermal exposure 0.14404 mg/person External dermal exposure 0.00674 mg/kg bw/d External dermal exposure 0.008919 mg/kg bw/d Systemic dermal exposure 0.000472 mg/kg bw/d Systemic dermal exposure 0.000624 mg/kg bw/d Residents: Systemic inhalation exposure after application (via vapour)
SIER = (ACV x IR x IA) / BW SIER = (ACV x IR x IA) / BW (0 x 16.57 x 100%) / 60 (0 x 8.31 x 100%) / 16.15 External inhalation exposure none External inhalation exposure none
Systemic inhalation exposure none Systemic inhalation exposure none Residents: Systemic oral exposure (hand-to-mouth transfer)
SOER(H) = (AR x NA x D x TTR x SE x SA x Freq x H x OA) / BW (0.02 x 1 x % x 5% x 50% x 20 x 20 x 2 x 100%) / 16.15 External oral exposure 0.01108 mg/person External oral exposure 0.000686 mg/kg bw/d Systemic oral exposure 0.000686 mg/kg bw/d
Residents: Systemic oral exposure (object-to-mouth transfer)
SOER(O) = (AR x NA x D x DFR x IgR x OA) / BW (0.02 x 1 x % x 20% x 25 x 100%) / 16.15 External oral exposure 0.00277 mg/person External oral exposure 0.000172 mg/kg bw/d Systemic oral exposure 0.000172 mg/kg bw/d
Total systemic exposure: SER = SDER + SIER Total systemic exposure: SER = SDER + SIER + SOER(H) + SOER(O) Total systemic exposure 0.028309 mg/person Total systemic exposure 0.023933 mg/person Total systemic exposure 0.000472 mg/kg bw/d Total systemic exposure 0.001482 mg/kg bw/d % of AOEL 1.18 % % of AOEL 3.70 %
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U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version
REGISTRATION REPORT Part B
Section 4: Metabolism and Residues Detailed summary of the risk assessment
Product name: U 46 M-Fluid Active Substance: MCPA (DMA salt); 500 g/L
Central Zone Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: Nufarm Deutschland GmbH Date: February 2017
Page 1 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version Table of Contents
4 METABOLISM AND RESIDUES DATA ...... 4 4.1 Evaluation of the active substances ...... 4 4.1.1 MCPA ...... 4 4.1.1.1 Storage stability ...... 4 4.1.1.2 Metabolism in plants and plant residue definition(s) ...... 4 4.1.1.3 Metabolism in livestock and animal residue definition(s) ...... 6 4.1.1.4 Residues in rotational crops ...... 6 4.1.1.5 Residues in livestock...... 6 4.2 Evaluation of the intended use(s) ...... 8 4.2.1 Selection of critical use and justification ...... 8 4.2.2 Pome fruits, stone fruits ...... 11 4.2.2.1 Residues in primary crops ...... 11 4.2.2.2 Distribution of the residue in peel/pulp ...... 11 4.2.2.3 Residues in processed commodities...... 11 4.2.2.4 Proposed pre-harvest intervals, withholding periods ...... 11 4.2.3 Grapes ...... 11 4.2.3.1 Residues in primary crops ...... 11 4.2.3.2 Distribution of the residue in peel/pulp ...... 12 4.2.3.3 Residues in processed commodities...... 12 4.2.3.4 Proposed pre-harvest intervals, withholding periods ...... 12 4.2.4 Barley, oat, rye and wheat...... 12 4.2.4.1 Residues in primary crops ...... 12 4.2.4.2 Distribution of the residue in peel/pulp ...... 13 4.2.4.3 Residues in processed commodities...... 13 4.2.4.4 Proposed pre-harvest intervals, withholding periods ...... 13 4.2.5 Grassland, pasture, meadow ...... 13 4.2.5.1 Residues in primary crops ...... 13 4.2.5.2 Distribution of the residue in peel/pulp ...... 14 4.2.5.3 Residues in processed commodities...... 14 4.2.5.4 Proposed pre-harvest intervals, withholding periods ...... 14 4.3 Consumer intake and risk assessment ...... 14 4.4 Proposed maximum residue levels (MRLs) ...... 16 4.5 Conclusion ...... 16
Appendix 1 List of data submitted in support of the evaluation ...... 17
Appendix 2 Detailed evaluation of the additional studies relied upon ...... 20 A 2.1 Storage stability ...... 20 A 2.2 Residues in primary crops ...... 20 A 2.2.1 Nature of residues ...... 20 A 2.2.2 Magnitude of residues in pome fruit ...... 21 A 2.2.3 Magnitude of residues in table and wine grape ...... 25 A 2.2.4 Magnitude of residues in cereals...... 29 A 2.2.5 Magnitude of residues in grassland, pasture, meadow ...... 43 A 2.3 Residues in processed commodities...... 53
Page 2 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version A 2.4 Residues in rotational crops ...... 53 A 2.5 Residues in livestock...... 53 A 2.5.1 Nature of residues ...... 53 A 2.5.2 Magnitude of residues ...... 53 A 2.6 Other studies/information ...... 54
Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) ...... 55
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4 METABOLISM AND RESIDUES DATA
4.1 Evaluation of the active substances
4.1.1 MCPA
Table 4.1-1: Identity of the active substance
Structural formula Cl CH3
O COOH
Common Name MCPA CAS number 94-74-6
4.1.1.1 Storage stability A brief summary of the storage stability data on MCPA is given in the following table. Data has been previously evaluated at EU level and is described in detail in the Addendum to the DAR (2002, ASB2010-10197).
Table 4.1-2: Stability of residues (Annex IIA, point 6.1)
Stability of MCPA Residues of MCPA, MCPB and HMCPA were shown to be stable under deep freezer conditions (-18°C) for at least 18 months in samples of cereal plants, grain and straw (ASB2014-10254).
4.1.1.2 Metabolism in plants and plant residue definition(s) A brief summary of the metabolism of MCPA in plants is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB2010-10197).
Page 4 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version Table 4.1-3: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, 6.6.2 and 6.7.1)
Plant groups covered Wheat (RIP2002-1902): greenhouse, foliar application of 1x 1.68 kg as/ha applied at BBCH 45-47, [U-phenyl-14C] label, MCPA-DMA salt and MCPA-2-EHE (ethylhexylester) tested in parallel
TRR levels were 33.2 mg/kg in forage, 82.2 mg/kg in straw and 0.048 mg/kg in grain for 2-EHE-MCPA and 52.0 mg/kg in forage, 135 mg/kg in straw and 0.58 mg/kg in grain for DMA-MCPA. The residue profiles in grain were similar for either form of MCPA: MCPA was readily formed from both variants. The carboxyl group can bind to endogenous molecules or MCPA is oxidised at the methyl group forming 2-OH- MCPA and then further CCPA (2-carboxy-4-chloro phenoxy acetic acid). To a lower extent hydroxylation of the aromatic ring was seen. Either of these molecules can react with cellular macromolecules, with glucose being the primary acceptor molecule. MCPA, 2OH-MCPA-gluc and CCPA were the primary components of the residue in forage and straw. The residues in grain were not further identified due to both low extractability and low amounts present.
Similar results were obtained in a further study on wheat (RIP2002-1888): application of 1x 1.4 kg as/ha, [U- phenyl-14C] label. Rotational crops In a confined rotational crop study (RIP2002-1900) bare soil was treated with 14C-MCPA at a rate of 0.84 kg/ha. Following aging periods of 30, 120 and 365 days, lettuce, turnips, and barley were planted.
Levels of 14C in plant parts were all <0.05 mg/kg, with the highest level found in lettuce leaves at 0.042 mg/kg (120 day PBI). Due to the low residue levels, metabolite identification was not feasible. Metabolism in rotational crops similar to metabolism Unknown since residue pattern in rotated crops was not in primary crops? (yes/no) elucidated. Distribution of the residue in peel/ pulp Not applicable Processed commodities (nature of residue) No study was available and non is required due to low residue levels in RAC. Residue pattern in raw and processed commodities Not applicable similar? (yes/no) Plant residue definition for monitoring MCPA and MCPB (MCPA, MCPB including their salts, esters and conjugates expressed as MCPA) according to Reg. (EC) No 396/2005
The enforcement analytical method involves alkaline hydrolysis of various esters and re-esterification with MeOH/sulphuric acid. Hence it covers also MCPB. Plant residue definition for risk assessment MCPA according to the submitted PROFile (ASB2013-9605) Conversion factor(s) (monitoring to risk assessment) None
Page 5 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version 4.1.1.3 Metabolism in livestock and animal residue definition(s) A brief summary of the metabolism of MCPA in livestock is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB2010-10197).
Table 4.1-4: Metabolism in livestock (Annex IIA, point 6.2.2 to 6.2.5 and 6.7.1)
Animals covered Lactating goat (RIP2002-1903): [U-phenyl-14C] labelled MCPA, two goats were dosed with either 832 or 694 mg/kg feed for 3 consecutive days
>99 % of the dose were excreted via urine/feces as MCPA. Milk and tissues accounted for <0.1% of the dose each. MCPA was a major component in muscle, fat and milk (in milk mainly as the glycine conjugate). Triglyceride-like compounds with a “de-chlorinated MCPA-like structure” were major in fat, kidney and liver.
Laying hens (RIP2002-1898): [U-phenyl-14C] labelled MCPA, 100 mg/kg feed for 7 consecutive days
>99 % of the dose were excreted. Residues in eggs and tissues made up only 0.004% of the administered dose; unchanged MCPA was the major component of the residue in all tissues. Time needed to reach a plateau concentration in milk Not determined and eggs Animal residue definition for monitoring MCPA, MCPB and MCPA thioethyl expressed as MCPA according to Reg. (EC) No 396/2005 Animal residue definition for risk assessment MCPA according to the submitted PROFile (ASB2013-9605) Conversion factor(s) (monitoring to risk assessment) None Metabolism in rat and ruminant similar (yes/no) Yes
Fat soluble residue: (yes/no) Yes according to Reg. (EC) No 396/2005, but log Pow <0 at pH 7.
4.1.1.4 Residues in rotational crops A brief summary of the field rotational crop studies on MCPA is given in the following table.
Table 4.1-5: Residues in rotational crops (Annex IIA, point 6.6.3)
Field studies Field residue studies were not available and not required. Significant residues are not expected in food and feed commodities obtained from succeeding crops (consequent to uses in compliance with cGAP).
4.1.1.5 Residues in livestock An actual calculation of the dietary burden, based on all relevant uses authorized in Germany including the uses for which authorization is sought, is provided in Table 4.1-6.
Page 6 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version Table 4.1-6: Calculation of the dietary burden based on all relevant uses authorized in Germany
Feedstuff % Percent of daily livestock diet (dry feed basis) Residue Intake (mg/kg, dry feed basis) D (mg/kg) M Chicken Dairy cattle Beef cattle Pig Chicken Dairy Beef Pig 1.9 kg bw 550 kg bw 350 kg bw 75 kg bw cattle cattle daily daily daily daily maximum maximum maximum maximum feed (DM) feed (DM) feed (DM) feed (DM) 120 g 20 kg 15 kg 3 kg
Grass 20 -- 100 100 -- 5.6 a -- 28.000 28.000 --
Cereals grain 86 70 -- -- 80 0.05 b 0.041 -- -- 0.047
Cereals straw 86 ------0.49 b ------Intake (mg/kg dry weight feed) 0.041 28.000 28.000 0.047 Intake (mg/kg bw/d) 0.003 1.018 1.20 0.002 Intake (mg/animal/d) 0.005 560.0 420.0 0.140 a HR, based on the following cGAP: 1 x 1 kg as/ha, PHI: 14 d b STMR (cereals grain) and HR (cereals straw), based on the following cGAP: 1 x 0.7 kg as/ha (BBCH 13-39), PHI: F
Table 4.1-7: Conditions of requirement of livestock feeding studies (Annex IIA, point 6.4)
Ruminant: Poultry: Pig: Expected intakes by livestock ≥0.1 mg/kg diet (dry Yes No No weight basis) (yes/no – If yes, specify the level) 28 mg/kg feed Potential for accumulation (yes/no): No No No Metabolism studies indicate potential level of Yes No No residues ≥0.01 mg/kg in edible tissues (yes/no)
A brief summary of the available livestock feeding study is given in the following table. For the detailed evaluation of this livestock feeding study it is referred to Appendix 2.
Table 4.1-8: Results of livestock feeding studies (Annex IIA, point 6.4)
Ruminant: Poultry: Pig: Feeding studies Lactating cows: Not applicable Not applicable ASB2009-251 Feeding levels in mg/kg feed DM 50; 150; 500 Feeding levels in mg/kg bw 1.98; 5.89; 19.58 Relevant dosing levels in feeding study: 50 mg/kg feed Not applicable Not applicable (1.98 mg/kg bw) Expected residue levels in animal matrices at calculated dietary burden (mg/kg): Muscle <0.05 <0.01 <0.01 Liver <0.05 <0.01 <0.01 Kidney 0.22 – <0.01 Fat <0.05 <0.01 <0.01 Milk <0.01 – – Eggs – <0.01 –
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4.2.1 Selection of critical use and justification The GAP reported for the central zone (only Germany is involved) is presented in Table 4.2-1. It has been used for consumer intake and risk assessment.
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Table 4.2-1: Critical Uses (worst case) used for consumer intake and risk assessment
1 2 3 4 5 6 7 8 9 10 11 12 13 Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number L product / ha kg as/ha Water (i) e.g. safener/synergist per ha (crop destination / I (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) developmental stages of season between per appl. a) max. rate e.g. recommended or (b) the pest or pest group) (d-f) applications) b) max. total per appl. min / max mandatory tank mixtures (a) (g) a) per use rate per b) max. total (c) b) per crop/ crop/season rate per (j) season crop/season (h) 1 DE winter soft wheat, F dicotyledonous weeds spraying BBCH 13-39, a) 1 a) 1.4 a) 0.70 200/400 F winter durum wheat, post-emergence, b) 1 b) 1.4 b) 0.70 spelt, winter triticale spring (0500090), winter barley (0500010), winter rye (0500070) 2 DE spring soft wheat, F dicotyledonous weeds spraying BBCH 13-39, a) 1 a) 1.4 a) 0.70 200/400 F spring durum wheat, post-emergence, b) 1 b) 1.4 b) 0.70 spelt (0500090), spring spring barley (0500010), common oats (0500050), spring rye (0500070) 3 DE grassland, pasture, F dicotyledonous weeds spraying May to August a) 1 a) 2.0 a) 1.0 200/400 14 meadow b) 1 b) 2.0 b) 1.0 4 DE pome fruit (0130000), F dicotyledonous weeds spraying from 1st year after a) 1 a) 2.0 a) 1.0 200/400 F stone fruit (0140000) planting, b) 1 b) 2.0 b) 1.0 March to September 5 DE table and wine grapes F dicotyledonous weeds spraying up to 3rd year after a) 1 a) 4.0 a) 2.0 200/600 F (0151000) with screen planting of the vine, b) 1 b) 4.0 b) 2.0 March to September
Page 9 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, the use situation should be described (e.g. fumigation of a structure) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) at time of application (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (h) The minimum and maximum number of application possible under practical (d) All abbreviations used must be explained conditions of use must be provided (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, (i) PHI - minimum pre-harvest interval drench (j) Remarks may include: Extent of use/economic importance/restrictions (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated
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4.2.2 Pome fruits, stone fruits
4.2.2.1 Residues in primary crops The intended use is not relevant in terms of consumer health protection. Application of the product to orchards will be applied to the floor within an orchard but not to the trees. No significant residues are therefore expected in fruits. The submission of supervised residue trials is therefore not necessary. However, a residue study was submitted (ASB2014-10235) where a radio-labelled MCPA formulation was applied in spring to the bare soil surface surrounding apple trees at a rate of 2 kg/ha MCPA acid. At commercial harvest, mature apples were sampled and radioactive content was determined to investigate the possibility of the presence of residues in fruits. In ripe fruits harvested from the trees no radioactivity greater than that measured in fruit collected from untreated (control) trees was detected. This was calculated to be equivalent to less than 0.005µg MCPA/g fresh weights. From these results it is concluded that application of MCPA to the soil surface did not result in a residue level in the fruit above 0.01µg/g total radioactive residues. Further eight residue trials on pome fruits (three on apples and five on pears) were available confirming the above presented results. These trials were conducted in the 1980s, thus prior to GLP requirements, and with considerably higher application rates (1-2x 8 kg as/ha). However, the trials were used as supplementary information. Despite the high application rates at harvest no MCPA residues above the LOQ of 0.05 mg/kg were found in apples and pears.
4.2.2.2 Distribution of the residue in peel/pulp Not relevant.
4.2.2.3 Residues in processed commodities Not relevant. Due to low expected residues at harvest, no processing studies are required.
4.2.2.4 Proposed pre-harvest intervals, withholding periods The pre-harvest interval (PHI) is covered by the time interval between application and commercial harvest. Setting of a specific PHI in days is not required.
4.2.3 Grapes
4.2.3.1 Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of MCPA in grapes. Data has not been previously evaluated at EU level. For the detailed evaluation of the available residue trials, it is referred to Appendix 2.
Table 4.2-2: Overview of the selected supervised residue trials for MCPA
Individual trial results (mg/kg) Enforcement Risk assessment (MCPA and MCPB (MCPA and MCPB Existing Outdoor/ STMR HR Median Commodity Region (a) (MCPA, MCPB (MCPA, MCPB MRL Indoor (mg/kg) (b) (mg/kg) (c) CF (d) including their salts, including their salts, (mg/kg) esters and esters and conjugates conjugates expressed expressed as MCPA)) as MCPA)) Grapes NEU Outdoor <0.05 (8) <0.05 (8) 0.05 0.05 0.05* 1 (a): NEU, SEU, EU or Import (country code). (b): Median value of the individual trial results according to the risk assessment residue definition.
Page 11 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial.
A total of eight residue trials on grapes according to the critical GAP were available. In these trials no MCPA residues above the LOQ of 0.05 mg/kg were determined in grapes at harvest. It should be noted that these trials were conducted in the 1970s, thus prior to GLP requirements. Grapes belong to the group of commodities with a high acid content. No storage stability data were available for this crop group. However, the maximum sample storage time in the residue trials was only three to four months. With regard to the results of the storage stability study on cereals where MCPA residues were shown to be stable for at least 18 months in cereals grain (high starch content), straw and green plants (high water content), no significant decrease of MCPA residues is expected in grapes. In summary, the available residue data on grapes are considered sufficient for risk assessment.
4.2.3.2 Distribution of the residue in peel/pulp Not relevant.
4.2.3.3 Residues in processed commodities Not relevant. Due to low residues at harvest, no processing studies are required.
4.2.3.4 Proposed pre-harvest intervals, withholding periods The pre-harvest interval (PHI) is covered by the time interval between application and commercial harvest. Setting of a specific PHI in days is not required.
4.2.4 Barley, oat, rye and wheat
4.2.4.1 Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of MCPA in cereals. Data has been previously evaluated at EU level and is described in detail in the DAR and in the Addendum to the DAR (ASB2010-10197). For the detailed evaluation of these and additional residue trials, it is referred to Appendix 2.
Table 4.2-3: Overview of the selected supervised residue trials for MCPA
Individual trial results (mg/kg) Enforcement Risk assessment (MCPA and MCPB (MCPA and MCPB Existing Outdoor/ STMR HR Median Commodity Region (a) (MCPA, MCPB (MCPA, MCPB MRL Indoor (mg/kg) (b) (mg/kg) (c) CF (d) including their salts, including their salts, (mg/kg) esters and esters and conjugates conjugates expressed expressed as MCPA)) as MCPA)) Cereals grain NEU Outdoor <0.05 (10) <0.05 (10) 0.05 0.05 0.2 1 Cereals straw NEU Outdoor <0.05 (4), 0.05, 0.07, <0.05 (4), 0.05, 0.07, 0.07 0.49 n.n. 1 0.09, 0.15, 0.22, 0.34, 0.09, 0.15, 0.22, 0.34, 0.49 0.49 (a): NEU, SEU, EU or Import (country code). (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial.
A total of 12 trials on cereals (each 6 trials on barley and wheat) were available supporting the intended
Page 12 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version uses on cereals. These trials were performed with one application of 1.7-1.9 kg as/ha up to growth stage BBCH 39. The application rates were more than twice the intended rate. However, since they represent the worst case and no residues were detected in grain at harvest, the trials were included in risk assessment. Whilst MCPA residues in cereals grain were all below the LOQ of 0.05 mg/kg MCPA residues in straw were ranging between <0.05 and 0.49 mg/kg. Barley, oats, rye and wheat are major crops in Northern Europe. A minimum of eight trials representative of the proposed growing area are normally required for major crops. Due to applications early in the growing season (up to BBCH 39, before consumable part of the crop has started to form) a combination of residue data on barley and wheat and the extrapolation to the other cereal crops is possible (extrapolation guideline: SANCO 7525/VI/95 - rev.9, March 2011). In summary, sufficient residue data are available to support the intended uses on cereals.
4.2.4.2 Distribution of the residue in peel/pulp Not relevant.
4.2.4.3 Residues in processed commodities Not relevant. Due to low residues at harvest, no processing studies are required.
4.2.4.4 Proposed pre-harvest intervals, withholding periods The pre-harvest interval (PHI) is covered by the time elapsing between application and commercial harvest. Setting of a specific PHI in days is not required.
4.2.5 Grassland, pasture, meadow
4.2.5.1 Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of MCPA in grass. Data has been previously evaluated at EU level and is described in detail in the DAR and in the Addendum to the DAR (ASB2010-10197). For the detailed evaluation of these and additional residue trials, it is referred to Appendix 2.
Table 4.2-4: Overview of the selected supervised residue trials for MCPA
Individual trial results (mg/kg) Enforcement Risk assessment (MCPA and MCPB (MCPA and MCPB Existing Outdoor/ STMR HR Median Commodity Region (a) (MCPA, MCPB (MCPA, MCPB MRL Indoor (mg/kg) (b) (mg/kg) (c) CF (d) including their salts, including their salts, (mg/kg) esters and esters and conjugates conjugates expressed expressed as MCPA)) as MCPA)) Grass NEU Outdoor 0.7; 1.1; 1.3; 3.3; 4.6; 0.7; 1.1; 1.3; 3.3; 4.6; 2.3 5.6 n.a. 1 5.6 5.6 Grass NEU Outdoor 5.1; 5.6 (2) 5.1; 5.6 (2) -- -- n.a. 1 (supplemental trials) (a): NEU, SEU, EU or Import (country code). (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial.
A total of 9 trials on grassland were available supporting the intended uses. Six of these trials were
Page 13 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version performed with higher application rates compared to the intended rate (1.7-1.8 kg as/ha instead of 1 kg as/ha). However, MCPA residues in grass (5.1-5.6 kg as/ha) were not higher than in the other trials (0.7 up to 5.6 mg/kg). They were therefore included in the risk assessment. It should be noted that three trials were only used as supplementary information since the maximum sample storage time in these trials (20-23 months) is not validated since storage stability for MCPA residues in commodities with high water content was proved for 18 months only. In summary, sufficient residue data are available to support the intended uses on grassland and no further trials are deemed necessary.
4.2.5.2 Distribution of the residue in peel/pulp Not relevant.
4.2.5.3 Residues in processed commodities Not relevant.
4.2.5.4 Proposed pre-harvest intervals, withholding periods The proposed pre-harvest interval (PHI) of 14 days is not challenged.
4.3 Consumer intake and risk assessment
The key data for consumer intake assessment, which have been derived from residue studies for the intended uses, are summarized in Table 4.3-1.
Table 4.3-1: Key data for consumer intake assessment derived for the intended uses
Long-term intake Short-term intake Commodity Input value Comment Input value Comment (mg/kg) (mg/kg) Pome fruits 0.05* MRL (LOQ) 0.05* MRL (LOQ) Stone fruits Grapes 0.05* STMR (LOQ, MRL) 0.05* HR (LOQ, MRL) Barley, oat, rye and 0.05* STMR (LOQ) 0.05* HR (LOQ) wheat grain Poultry and pig products 0.01* No MCPA residues 0.01* No MCPA residues expected expected Ruminant muscle, fat 0.05* Expected residues 0.05* Expected residues (LOQ) liver (LOQ) Ruminant kidney 0.22 Expected residues 0.22 Expected residues Milk 0.01* Expected residues 0.01* Expected residues (LOQ) (LOQ) All other commodites MRL Reg. (EC) No Not applicable 396/2005 (last amendment Reg. (EU) No 491/2014)
The toxicological reference values and all input values used for consumer risk assessment are stated in Table 4.3-2. To illustrate the results of the chronic risk assessment, a screenshot of the TMDI results obtained with EFSA PRIMO is displayed in Appendix 3.
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Table 4.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)
Chronic risk assessment ADI 0.05 mg/kg bw TMDI (% ADI) according to EFSA PRIMo 10 % (based on WHO cluster diet B, mean body weight) NTMDI (% ADI) according to German NVS II 8.2 % (based on 2-4 years old German children, individual consumption/body weight ratio) IEDI (% ADI) according to EFSA PRIMo rev.2 Not necessary NEDI (% ADI) according to German NVS II Not necessary Factors included in IEDI and NEDI None Acute risk assessment ARfD 0.15 mg/kg bw IESTI (% ARfD) according to EFSA PRIMo rev.2 Pome fruits:max. 3.3 % (based on UK infants, mean body weight) Stone fruits: max. 2 % (based on 2-4 years old German children, mean body weight) Grapes: 2.2 % (based on 2-4 years old German children, mean body weight) Cereals: each <1 % (based on UK 4-6 years old children, UK infants and 2-4 years old German children, mean body weight)
Poultry and swine products:each <1 % (based on German, spanish or dutch children, mean body weight) Ruminant products: each <1 % (based on German children, UK infants or UK toddler, mean body weight) Milk: <1 % (based on UK infants, mean body weight) NESTI (% ARfD) according to German NVS II Pome fruits: max. 3 % (based on 2-4 years old German children, individual consumption/body weight ratio) Stone fruits: max. 3 % (based on 2-4 years old German children, individual consumption/body weight ratio) Grapes: max. 2 % (based on 2-4 years old German children, individual consumption/body weight ratio) Cereals: each <1 % (based on 2-4 years old German children, individual consumption/body weight ratio)
Poultry and swine products:each <1 % (based on 2-4 years old German children, individual consumption/body weight ratio) Ruminant products: each <1 % (based on 2-4 years old German children, individual consumption/body weight ratio) Milk: <1 % (based on 2-4 years old German children, individual consumption/body weight ratio) Factors included in IESTI and NESTI − pome fruits, stone fruits: 0.05* mg/kg (MRL=LOQ) − grapes, cereals: 0.05* mg/kg (HR=LOQ) − expected residue values in animal matrices at calculated dietary burden
Page 15 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version 4.4 Proposed maximum residue levels (MRLs)
No new MRLs are required. The existing EU MRLs for the crops applied for in this dossier are summarized in Table 4.4-1.
Table 4.4-1: Overview of the existing EC MRLs for MCPA
Result of Existing EC Proposed EC OECD Justification for the proposal/ Commodity (Code) MRL MRL calculator Comments (mg/kg) (mg/kg) (mg/kg) Pome fruits (0130000) 0.05* n.a. n.a. Data set sufficient. No MCPA Stone fruits (0140000) residues above 0.01 mg/kg expected. No consumer risk. Grapes (0151000) 0.05* n.a. n.a. Data set sufficient, HR below MRL, no consumer risk Barley (0500010) 0.2 n.a. n.a. Oat (0500050) Rye (0500070) Wheat (0500090) Swine, bovine, sheep, goat and 0.1 n.a. n.a. Expected residues below the equine muscle MRLs, no consumer risk Swine, bovine, sheep, goat and 0.2 n.a. n.a. equine fat Swine, bovine, sheep, goat and 3.0 n.a. n.a. equine offals Poultry muscle, fat, liver, 0.1* n.a. n.a. No residues above the LOQs kidney expected, no consumer risk Milk, Birds eggs 0.05* n.a. n.a.
4.5 Conclusion
The available data are sufficient for dietary risk assessment. No further residue trials are required. An exceedance of the current MRLs of 0.05* mg/kg for MCPA in pome fruits, stone fruits and grapes as well as of 0.2 mg/kg for MCPA in grain of barley, oat, rye and wheat as laid down in Reg. (EU) 396/2005 is not expected. Likewise, no exceedance of the current MRLs for MCPA in animal matrices as laid down in Reg. (EU) 396/2005 is expected due to residues arising from the intended uses.
The long-term and the short-term intake of MCPA residues are unlikely to present a public health concern.
As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the intended uses.
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Table A 1: List of data submitted in support of the evaluation Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * All Italy 2001 MCPA (Monograph + Addendum Add August 2002) March 2001 GLP: Open Published: Yes ASB2010-10197 All EFSA 2013 Scientific support for preparing an EU Add position for the 45th Session of the Codex Committee on Pesticide Residues (CCPR) EFSA Journal 2013;11(7):3312 ASB2013-9605 KIIA 6.1 Wasser, C. 2002 Storage stability of MCPA, MCPB and Yes Nufarm Y HMCPA residues in cereals AHM R 99 144 ! 9123 GLP: Yes Published: No BVL-2685010, ASB2014-10254 KIIA 6.2.1 Keller, W.; Otto, S. 1979 Investigations into the metabolism of Yes Nufarm Y MCPA in winter wheat 1611a GLP: Open Published: Open BVL-2360991, RIP2002-1888 KIIA 6.2.1 Sabourin, P. J. 1995 Nature of the residue of 14C-2-Methyl- Yes Nufarm Y 4-Chlorophenoxyacetic acid (14C- MCPA) as the Dimethylamine Salt (14C-MCPA DMA) and the 2- Ethylhexyl Esther (14C-MCPA 2-EHE) in wheat SC930053 GLP: Open Published: Open BVL-2365919, RIP2002-1902 KIIA 6.2.2 xxxxxx 1995 Nature of the residue study of 14C-2- Yes Nufarm Y Methyl-4-Chlorophenoxyacetic acid (14C-MCPA) using egg-laying white leghorn hens SC920100 GLP: Open Published: Open BVL-2365924, RIP2002-1898 KIIA 6.2.3 xxxxxxx 1995 Nature of the residue of 14C-2-Methyl- Yes Nufarm Y 4-Chlorophenoxyacetic acid (14C- MCPA) using lactating goats SC930051 GLP: Open Published: Open BVL-2365920, RIP2002-1903 KIIA 6.3 Anon. 1975 Abbaukurve in Weidegras Yes Nufarm Y 010 01 H 75/2A GLP: Open Published: Open BVL-2365905, RIP2002-1894 KIIA 6.3 Anon. 1975 Abbaukurve in Weidegras Yes Nufarm Y 010 01 H 75/3A GLP: Open Published: Open BVL-2365908, RIP2002-1895 KIIA 6.3 Anon. 1975 Berichtsbogen für Yes NUD Y Rückstandsuntersuchungen mit Pflanzenschutzmitteln - Gras/Heu 010 01 H 75/1 A GLP: No Published: No BVL-1802730, ASB2009-241 KIIA 6.3 Anon. 1975 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenschutzmitteln - Gras/Heu 010 01 H 75/2 A ASB2009-243
Page 17 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIA 6.3 Anon. 1975 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenschutzmitteln - Gräser/Heu 010 01 H 75/3 A ASB2009-244 KIIA 6.3 Anon. 1976 Berichtsbogen für Yes Nufarm Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln - Trauben Riesling 76/10449 ! 010 01 H 76/ 1 E GLP: No Published: No BVL-2688315, ASB2009-7712 KIIA 6.3 Anon. 1976 Berichtsbogen für Yes Nufarm Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln - Trauben Silvaner 76/10450 ! 010 01 H 76/ 2 E GLP: No Published: No BVL-2688316, ASB2009-7718 KIIA 6.3 Anon. 1976 Berichtsbogen für Yes Nufarm Y Rüchstandsuntersuchungen mit Pflanzenbehandlungsmitteln - Trauben Müller-Thurgau 76/10451 ! 010 01 H 76/ 3 E GLP: No Published: No BVL-2688317, ASB2009-7721 KIIA 6.3 Anon. 1976 Berichtsbogen für Yes Nufarm Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln - Trauben Portugieser 76/10452 ! 010 01 H 76/ 4 E GLP: No Published: No BVL-2688318, ASB2009-7722 KIIA 6.3 Anon. 1976 Berichtsbogen für Yes Nufarm Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln - Trauben Müller-Thurgau 76/10453 ! 010 01 H 76/ 5 E GLP: No Published: No BVL-2688319, ASB2009-7725 KIIA 6.3 Anon. 1979 Berichtsbogen für Yes Nufarm Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln - Trauben Müller-Thurgau 78/10552 ! 010 01 H 78/1 E GLP: No Published: No BVL-2688320, ASB2009-7726 KIIA 6.3 Anon. 1979 Berichtsbogen für Yes Nufarm Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln - Trauben Bacchus 78/10553 ! 010 01 H 78/2 E GLP: No Published: No BVL-2688321, ASB2009-7727 KIIA 6.3 Anon. 1979 Berichtsbogen für Yes Nufarm Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln - Trauben Müller-Thurgau 78/10554 ! 010 01 H 78/3 E GLP: No Published: No BVL-2688322, ASB2009-7728 KIIA 6.3 Anon. 1982 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln – Birne Spi 003235 ASB2015-10065
Page 18 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIA 6.3 Anon. 1982 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln – Birne Spi 003252 ASB2015-10066 KIIA 6.3 Anon. 1982 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln – Apfel URA 6581 ! 28963 ASB2015-10068 KIIA 6.3 Anon. 1982 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln – Apfel URA 6681 ! 28964 ASB2015-10069 KIIA 6.3 Anon. 1982 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln – Apfel URA 6681 ! 28965 ASB2015-10070 KIIA 6.3 Anon. 1983 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln – Birne Spi 003379 ASB2015-10073 KIIA 6.3 Anon. 1983 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln – Birne URA 003308 ASB2015-10071 KIIA 6.3 Anon. 1983 Berichtsbogen für Y Rückstandsuntersuchungen mit Pflanzenbehandlungsmitteln – Birne URA 003309 ASB2015-10072 KIIA 6.3 Klimmek, S.; Marzouki, 2008 Decline and magnitude of residues of Yes Nufarm Y M.; Gizler, A. MCPA in winter cereals following one application of MCPA 750 - Northern Europe (Denmark), season 2007 NUK-0701 GLP: Yes Published: No BVL-2684082, ASB2014-10234 KIIA 6.3 Old, J.; Duncan, P. 2001 MCPA Dimethylamine salt residue Yes Nufarm Y decline in cereals in Northern Europe: Field phase AHM R 00 103 ! 19522 GLP: Yes Published: No BVL-2684794, ASB2014-10238 KIIA 6.3 Old, J.; Duncan, P.; Perny, 2001 MCPA Dimethylamine salt residue Yes Nufarm Y A. decline in grassland in Northern Europe: Field Phase - incl. analytical report dated 10.10.2001 18558 ! AHM R 00 222 ! AHM R 00 202 ! R A0120 GLP: Yes Published: No BVL-2684939, ASB2009-250 KIIA 6.3 Old, J.; Venuti, J. 2001 MCPA Dimethylamine salt residue Yes Nufarm Y decline in cereals in Northern Europe: Field phase - Report amendment 1 AHM R 99 103 ! 18192 ! AHM R 99 123 ! R 9114 GLP: Yes Published: No BVL-2684951, ASB2014-10245
Page 19 / 55 U 46 M-Fluid – ZV1 060939-00/00 Part B – Section 4 - Core Assessment zRMS Version Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * KIIA 6.3 Old, J.; Venuti, J.; Gallais, 2001 MCPA Dimethylamine salt residue Yes Nufarm Y C. decline in grassland in Northern Europe: Field Phase - Report Amendment 1 - incl. analytical report dated 12.02.2001 18196 ! AHM R 99 222 ! R9117 ! AHM R 99 202 GLP: Yes Published: No BVL-2684959, ASB2009-249 KIIA 6.3 Parsons, R. 2007 MCPA: Residues in apples - Radio- Yes Nufarm Y labelled study ACE06-035 GLP: Yes Published: No BVL-2687728, ASB2014-10235 KIIA 6.3 Perny, A. 2001 Harvest residue of MCPA Yes Nufarm Y Dimethylamine salt in cereals in Northern Europe - Analytical phase report AHM R 00 122 ! A0116 GLP: Yes Published: No BVL-2684798, ASB2014-10240 KIIA 6.3 Pfarl, C. 1994 Residues of MCPA in cereals treated Yes Nufarm Y with 2.0 l Dicopur M/ha 1194 ! R 92-16 GLP: Open Published: Open BVL-2365873, RIP2002-1891 KIIA 6.3 Pfarl, C. 1994 Residues of MCPA in Grassland treated Yes Nufarm Y with 2.0 l Dicopur M/ha 1209 ! R 92 -17 ! R 93 - 86 GLP: Open Published: Open BVL-2365903, RIP2002-1893 KIIA 6.3 Wasser, C. 2000 Harvest residue of MCPA Yes Nufarm Y Dimethylamine salt in cereals in Northern Europe - Analytical phase report AHM R 99 123 ! R 9114 ! AHM R 99 103 ! 18192 GLP: Yes Published: No BVL-2684955, ASB2014-10247 KIIA 6.4.2 xxxxxxx 2007 Magnitude of the residues of MCPA in Yes Nufarm Y dairy cow milk and tissues 49737 ! 214-001-10 GLP: Yes Published: No BVL-2687756, ASB2009-251 KIIA 6.6 Ewing, D. D. 1988 MCPA confined accumulation study on Yes Nufarm Y rotational crops PAL-EF-86-31 GLP: Open Published: Open BVL-2360995, RIP2002-1900 * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation
Appendix 2 Detailed evaluation of the additional studies relied upon
A 2.1 Storage stability No further study on storage stability submitted.
A 2.2 Residues in primary crops
A 2.2.1 Nature of residues No further study on nature of residues submitted/needed.
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A 2.2.2 Magnitude of residues in pome fruit Reference: OECD KIIA 6.3 Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list) Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box Deviations: no relevant deviations unless stated otherwise in the commenting box GLP: see reference list Acceptability: acceptable unless stated otherwise in the commenting box
Table A 2: Residues of MCPA in apples RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Apple Crop Code : MABSD Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 1982-05-26
Content of a.i. (g/kg or g/l) : 40 g/kg (44.4 g/kg MCPA sodium salt) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : FG (fine granule) Other a.i. in formulation Commercial product (name) : Brennessel-Granulat-Neu Spiess-Urania (content and common name) : 42.4 g/kg mecoprop sodium salt Applicant : Urania Chemicals GmbH Residues calculated as : MCPA
Page 21 / 55
1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 28963, Gravensteiner 1) 1961 8.0 0.00 1981-05-294) BBCH fruit <0.050 18 4) spraying study URA 6581 (planting) 72-74 <0.050 44 2) 1981-05-10 <0.050 59 analytical method: Germany (DE) - 1981-05-22 <0.050 74 deutsche lebensmittel 3) 1981-09-10 <0.050 104 rundschau, 66 (11), 1970, 393 ff Drochtersen (GC-ECD), LOQ(s): 0.05 mg/kg 1982-01-21 max. sample storage time in month(s): 8
ASB2015-10068 report 28964, Cox Orange 1) 1964 8.0 0.00 1981-05-274) BBCH fruit <0.050 22 4) spraying study URA 6681 (planting) 72-74 <0.050 50 2) 1981-05-08 <0.050 58 analytical method: Germany (DE) - 1981-05-22 <0.050 65 Deutsche Lebensmittel 3) 1981-09-16 <0.050 78 Rundschau, 66 (11), 1970, 393 Neuendorf <0.050 112 ff (GC-ECD), LOQ(s): 0.05 mg/kg 1982-01-21 max. sample storage time in month(s): 8
ASB2015-10069 report 28965, James Grieve 1) 1964 8.0 0.00 1981-05-274) BBCH fruit <0.050 22 4) spraying study URA 6781 (planting) 72-74 <0.050 50 2) 1981-05-08 <0.050 58 analytical method: Germany (DE) - 1981-05-22 <0.050 65 Deutsche Lebensmittel 3) 1981-09-16 <0.050 78 Rundschau, 66 (11), 1970, 393 Neuendorf <0.050 112 ff (GC-ECD), LOQ(s): 0.05 mg/kg 1982-01-21 max. sample storage time in month(s): 8
ASB2015-10070
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Table A 3: Residues of MCPA in pears RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Pear Crop Code : PYUCO Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date :
Content of a.i. (g/kg or g/l) : 40 g/kg (44.4 g/kg MCPA sodium salt) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : FG (fine granule) Other a.i. in formulation Commercial product (name) : Brennessel-Granulat-Neu Spiess-Urania (content and common name) : 42.4 g/kg mecoprop sodium salt Applicant : Urania Chemicals GmbH Residues calculated as : MCPA
1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) study SPI No. William Christ 1) 1965 8.0 0.00 1982-05-274) BBCH 76 fruit <0.050 102 4) spraying 003253 (planting) 8.0 0.00 1982-06-164) 2) 1982-05-08 analytical method: Germany (DE) - 1982-05-22 Deutsche Lebensmittel 3) 1982-09-06 Rundschau, 66 (11), 1970, 393 ff Kleinkarlbach (GC-ECD), LOQ(s): 0.05 mg/kg 1982-10-11 max. sample storage time: 3 months
ASB2015-10065 study SPI No. William Christ 1) 1962 8.0 0.00 1982-07-204) BBCH 78 fruit <0.050 14 4) spraying 003252 (planting) 8.0 0.00 1982-08-134) <0.050 21 2) 1982-05-03 <0.050 35 analytical method: Germany (DE) - 1982-05-17 <0.050 57 Deutsche Lebensmittel 3) 1982-09-10 Rundschau, 66 (11), 1970, 393 ff Kleinkarlbach (GC-ECD), LOQ(s): 0.05 mg/kg 1982-10-14 max. sample storage time: 4 months
ASB2015-10066
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) study URA No. William Christ 1) 1972 8.0 0.00 1983-07-024) BBCH 76 fruit <0.050 30 4) spraying 003308 (planting) <0.050 45 2) 1983-04-25 <0.050 60 analytical method: Germany (DE) - 1983-05-09 <0.050 75 Deutsche Lebensmittel 3) 1983-08-31 Rundschau, 66 (11), 1970, 393 ff Immenstaad (GC-ECD), LOQ(s): 0.05 mg/kg 1983-10-12 max. sample storage time: 4 months
ASB2015-10071 study URA No. William Christ 1) 1965 8.0 0.00 1983-07-134) BBCH 78 fruit <0.050 30 4) spreading 003379 (planting) <0.050 44 2) 1983-04-20 <0.050 61 analytical method: Germany (DE) - 1983-05-06 <0.050 64 Deutsche Lebensmittel 3) Rundschau, 66 (11), 1970, 393 ff Immenstaad (GC-ECD), LOQ(s): 0.05 mg/kg 1983-10-25 max. sample storage time: 4 months
ASB2015-10073 study URA No. William Christ 1) 1960 8.0 0.00 1983-07-024) BBCH 78 fruit <0.050 30 4) spreading 003309 (planting) <0.050 45 2) 1983-04-25 <0.050 60 analytical method: Germany (DE) - 1983-05-09 <0.050 75 Deutsche Lebensmittel 3) 1983-08-31 Rundschau, 66 (11), 1970, 393 ff Überlingen (GC-ECD), LOQ(s): 0.05 mg/kg 1983-10-12 max. sample storage time: 4 months
ASB2015-10072
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate
Comments of zRMS: Used as supplemental information.
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A 2.2.3 Magnitude of residues in table and wine grape Reference: OECD KIIA 6.3 Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list) Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box Deviations: no relevant deviations unless stated otherwise in the commenting box GLP: see reference list Acceptability: acceptable unless stated otherwise in the commenting box
Table A 4: Residues of MCPA in table and wine grape RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Grape Vine Crop Code : VITVI Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 500 g/L (610 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : U 46 M-Fluid (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : MCPA
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) BASF 76/10449, Riesling 1) 2.0 1000 0.20 1976-08-204) BBCH bunch of <0.050 35 4) spraying 010 01 H 76/ 1 (white variety) 2) 79-81 grapes E, 3) 1976-09-24 analytical method: harvest trial not reported (GC-MS), LOQ(s): 0.05 mg/kg Germany (DE) max. sample storage time in 67117 month(s): 3 Limburgerhof ASB2009-7712
1976-11-23
76/10450, 010 Silvaner 1) 2.0 1000 0.20 1976-08-204) BBCH bunch of <0.050 35 4) spraying 01 H 76/ 2 E, (white variety) 2) 79-81 grapes harvest trial 3) 1976-09-24 analytical method: not reported (GC-MS), Germany (DE) LOQ(s): 0.05 mg/kg 67117 max. sample storage time in Limburgerhof month(s): 3 ASB2009-7718 1976-11-23
76/10451, 010 Müller 1) 2.0 1000 0.20 1976-08-204) BBCH bunch of <0.050 35 4) spraying 01 H 76/ 3 E, Thurgau 2) 79-81 grapes harvest trial (white variety) 3) 1976-09-24 analytical method: not reported (GC-MS), Germany (DE) LOQ(s): 0.05 mg/kg 67117 max. sample storage time in Limburgerhof month(s): 3 ASB2009-7721 1976-11-23
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) 76/10453, 010 Müller 1) 2.0 600 0.33 1976-08-234) BBCH bunch of <0.050 29 4) spraying 01 H 76/ 5 E, Thurgau 2) 79-81 grapes harvest trial (white variety) 3) 1976-09-21 analytical method: not reported (GC-MS), Germany (DE) LOQ(s): 0.05 mg/kg 76833 max. sample storage time in Siebeldingen month(s): 3 ASB2009-7725 1976-11-23
76/10452, 010 Portugieser 1) 2.0 600 0.33 1976-08-234) BBCH bunch of <0.050 29 4) spraying 01 H 76/ 4 E, (red variety) 2) 79-81 grapes harvest trial 3) 1976-09-21 analytical method: not reported (GC-MS), Germany (DE) LOQ(s): 76833 0.05 mg/kg Siebeldingen max. sample storage time in month(s): 3 1976-11-23 ASB2009-7722
78/10552, 010 Müller 1) 1965 1.9 1000 0.19 1978-08-314) BBCH 81 bunch of <0.050 28 4) spraying 01 H 78/1 E, Thurgau (planting) grapes harvest trial (white variety) 2) 1978-06-12 analytical method: - 1978-06-30 not reported (GC-MS), Germany (DE) 3) 1978-09-28 LOQ(s): 76835 0.05 mg/kg Flemlingen max. sample storage time in month(s): 4 1979-01-09 ASB2009-7726
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) 78/10553, 010 Bacchus 1) 1971 1.9 1000 0.19 1978-08-254) BBCH 79 bunch of <0.050 26 4) spraying 01 H 78/2 E, (white variety) (planting) grapes harvest trial 2) 1978-07-04 analytical method: - 1978-07-11 not reported (GC-MS), Germany (DE) 3) 1978-09-20 LOQ(s): 97355 0.05 mg/kg Abtswind max. sample storage time in month(s): 4 1979-01-09 ASB2009-7727
78/10554, 010 Müller 1) 1970 1.9 1000 0.19 1978-09-014) BBCH bunch of <0.050 31 4) spraying 01 H 78/3 E, Thurgau (planting) 79-81 grapes harvest trial (white variety) 2) 1978-06-22 analytical method: - 1978-07-25 not reported (GC-MS), Germany (DE) 3) 1978-10-02 LOQ(s): 0.05 mg/kg 71720 max. sample storage time in Oberstenfeld month(s): 3 ASB2009-7728 1979-01-09
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate
Comments of zRMS: Acceptable, but it should be noted that residue trials were conducted prior to GLP requirements. Furthermore, sample storage times were not validated for commodities wih high acid content. However, with regard to the storage stability data for cereal matrices trials were considered sufficient for risk assessment.
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A 2.2.4 Magnitude of residues in cereals Reference: OECD KIIA 6.3 Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list) Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box Deviations: no relevant deviations unless stated otherwise in the commenting box GLP: see reference list Acceptability: acceptable unless stated otherwise in the commenting box
Table A 5: Residues of MCPA in winter barley RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Winter Barley Crop Code : HORVW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 750 g/L (918.6 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : MCPA 750 D (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : MCPA
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) NUK-0701, trial Ohess 2006-09-17 1.7 290 0.60 2007-05-034) BBCH 39 whole plant 26.0 0 4) spraying no. 3, (sowing) without root 1.2 13 analytical method: decline trial 2007-05-28 0.38 27 R 9110 (GC-MS),
2007-06-01 rest of plant 0.71 42 LOQ(s): Denmark (DK) 2007-07-10 0.05 mg/kg ears of grain <0.050 42 4800 max. sample storage time in Nykobing grain <0.050 68 month(s): 16
straw 0.22 68 2008-11-17 ASB2014-10234
NUK-0701, trial Ohess 2006-09-17 1.8 300 0.60 2007-05-034) BBCH 39 grain <0.050 68 4) spraying no. 4, (sowing) straw 0.15 68 analytical method: harvest trial 2007-05-28 R 9110 (GC-MS), 2007-06-01 LOQ(s): Denmark (DK) 2007-07-10 0.05 mg/kg 4800 max. sample storage time in Nykobing month(s): 14
2008-11-17 ASB2014-10234
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Note: All entries to be filled in as appropriate
Comments of zRMS: Acceptable although the application rate was more than twice the intended rate. However, this was considered acceptable since it represents a worst case situation.
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Table A 6: Residues of MCPA in winter soft wheat RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Winter Soft Wheat Crop Code : TRZAW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 750 g/L (918.6 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : MCPA 750 D (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : MCPA
1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) NUK-0701, trial Smugler 1) 2006-09-25 1.8 290 0.60 2007-05-034) BBCH 37 whole plant 39.0 0 4) spraying no. 1, (sowing) without root 2.7 13 decline trial 2) 2007-05-30 0.43 27 analytical method:
- 2007-06-14 ears of grain <0.050 42 R 9110 (GC-MS), Denmark (DK) 3) 2007-08-01 LOQ(s): 0.05 mg/kg grain <0.050 90 67117 max. sample storage time in Toreby straw 0.34 90 month(s): 16
2008-11-17 ASB2014-10234
NUK-0701, trial Smugler 1) 2006-09-25 1.9 310 0.60 2007-05-034) BBCH 37 grain <0.050 90 4) spraying no. 2, (sowing) straw 0.49 90 harvest trial 2) 2007-05-30 analytical method: - 2007-06-14 R 9110 (GC-MS), Denmark (DK) 3) 2007-08-01 LOQ(s): 0.05 mg/kg 67117 max. sample storage time in Toreby month(s): 13
2008-11-17 ASB2014-10234
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Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate
Comments of zRMS: Acceptable although the application rate was more than twice the intended rate. However, this was considered acceptable since it represents a worst case situation.
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Table A 7: Residues of MCPA in winter barley RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Winter Barley Crop Code : HORVW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 750 g/L (917.7 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Agroxone 75 (T021A) (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : 8.1 HMCPA (2-hydroxymethyl-4- chlorophenoxyacetic acid) 8.2 MCPA
1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) Report Nr. Regina 1) 1999-09-10 1.8 250 0.71 2000-04-064) BBCH whole plant 0.25 113 0 4) spraying
19522; AHM R (sowing) 30-31 grain <0.050 <0.050 121 00 103, 2) analytical method: analytical report 3) straw <0.050 <0.050 121 ATM 592 (GC-MS), R A0116, AHM LOQ(s): R00 122, trial controls > LOQ: 8.1: 0.05 mg/kg 397273/2, whole plant 0.13 0 8.2: 0.05 mg/kg max. sample storage time United Kingdom in month(s): 14 (UK) ASB2014-10238 Pathhead, East ASB2014-10240 Lothian (analytical part)
2001-07-25
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1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) Report Nr. Majestic 1) 1999-10-13 1.8 260 0.70 2000-03-224) BBCH 30 whole plant <0.050 57.0 0 4) spraying
19522; AHM R (sowing) grain <0.050 0.16 99 00 103, 2) analytical method: analytical report 3) straw <0.050 <0.050 99 ATM 592 (GC-MS), R A0116, AHM LOQ(s): R00 122, trial 8.1: 0.05 mg/kg 397273/4, 8.2: 0.05 mg/kg max. sample storage time France (FR) in month(s): 15 21910 Noiron sous ASB2014-10238 Gevrey ASB2014-10240 (analytical part) 2001-07-25
Report Nr. Sonja 1) 1998-09-25 1.8 250 0.72 1999-03-244) BBCH 30 whole plant 0.51 53.0 0 4) spraying 18192; AHM R (sowing) 0.29 4.2 7 99 103, 2) 0.14 0.79 14 analytical method: analytical report 3) <0.050 0.090 28 ATM 592 (GC-MS),
R 9114, AHM grain <0.050 <0.050 106 LOQ(s): R99 123, trial 8.1: 0.05 mg/kg 394361/1, straw 0.050 <0.050 106 8.2: 0.05 mg/kg decline trial max. sample storage time controls > LOQ in month(s): 16 France (FR) whole plant 0.070 0 45360 ASB2014-10245 Chântillon sur ASB2014-10247 Loire (analytical part)
2001-10-15
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1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) Report Nr. Regina 1) 1998-09-27 1.9 260 0.72 1999-04-014) BBCH 30 whole plant 0.43 31.0 0 4) spraying 18192; AHM R (sowing) 0.24 4.3 7 99 103, 2) 0.050 1.8 14 analytical method: analytical report 3) <0.050 0.56 28 ATM 592 (GC-MS),
R 9114, AHM grain <0.050 <0.050 116 LOQ(s): R99 123, trial 8.1: 0.05 mg/kg 394361/3, straw <0.050 0.070 116 8.2: 0.05 mg/kg decline trial max. sample storage time in month(s): 15 United Kingdom (UK) ASB2014-10245 ASB2014-10247 Pencaitland, (analytical part) East Lothian
2001-10-15
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate
Comments of zRMS: Except one trial acceptable although the application rate was more than twice the intended rate. However, this was considered acceptable since it represents a worst case situation. One trial (397273/4) was not included in risk assessment since MCPA residues in barley grain were found to be extraordinary high (0.16 mg/kg) compared to all other trials on cereals where no MCPA residues above the LOQ of 0.05 mg/kg were determined. This value was therefore considered as outlier and not used. These trials were reported in the Addendum to the DAR.
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Table A 8: Residues of MCPA in winter soft wheat RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Winter Soft Wheat Crop Code : TRZAW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 750 g/L (917.7 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Agroxone 75 (T021A) (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : 8.1 HMCPA (2-hydroxymethyl-4- chlorophenoxyacetic acid) 8.2 MCPA
1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) Report Nr. Hereward 1) 1999-10-13 1.8 240 0.74 2000-04-064) BBCH 30 whole plant 0.10 69.0 0 4) spraying
19522; AHM R (sowing) grain <0.050 <0.050 127 00 103, 2) analytical method: analytical report 3) straw <0.050 <0.050 127 ATM 592 (GC-MS), R A0116, AHM LOQ(s): R00 122, trial 8.1: 0.05 mg/kg 397273/1, 8.2: 0.05 mg/kg decline trial max. sample storage time in month(s): 14 United Kingdom (UK) ASB2014-10238 ASB2014-10240 Tumblers (analytical part) Green, Essex
2001-07-25
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1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) Report Nr. Soissons 1) 1999-10-20 1.8 250 0.71 2000-04-024) BBCH 31 whole plant 0.26 46.0 0 4) spraying
19522; AHM R (sowing) grain <0.050 <0.050 109 00 103, 2) analytical method: analytical report 3) straw <0.050 <0.050 109 ATM 592 (GC-MS), R A0116, AHM LOQ(s): R00 122, trial controls > LOQ: 8.1: 0.05 mg/kg 397273/3, grain 0.10 109 8.2: 0.05 mg/kg decline trial max. sample storage time in month(s): 14 France (FR) 21130 ASB2014-10238 Poncey Ies ASB2014-10240 Athée (analytical part)
2001-07-25
Report Nr. Isengrain 1) 1998-10-28 1.8 250 0.73 1999-03-304) BBCH 30 whole plant 0.82 89.0 0 4) spraying 18192; AHM R (sowing) 0.45 7.5 7 99 103, 2) 0.45 0.99 14 analytical method: analytical report 3) 0.10 0.87 28 ATM 592 (GC-MS),
R 9114, AHM grain <0.050 <0.050 118 LOQ(s): R99 123, trial 8.1: 0.05 mg/kg 394361/2, straw <0.050 0.090 118 8.2: 0.05 mg/kg decline trial max. sample storage time controls > LOQ: in month(s): 15 France (FR) whole plant 0.080 14 41500 ASB2014-10245 Lestiou ASB2014-10247 (analytical part) 2001-10-15
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1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) Report Nr. Consort 1) 1998-12-17 1.8 250 0.72 1999-04-264) BBCH whole plant 1.2 66.0 0 4) spraying 18192; AHM R (sowing) 30-31 1.0 23.0 7 99 103, 2) 0.43 5.9 14 analytical method: analytical report 3) 0.19 1.4 28 ATM 592 (GC-MS),
R 9114, AHM grain <0.050 <0.050 109 LOQ(s): R99 123, trial 8.1: 0.05 mg/kg 394361/4, straw <0.050 0.050 109 8.2: 0.05 mg/kg decline trial max. sample storage time in month(s): 15 United Kingdom (UK) ASB2014-10245 ASB2014-10247 Thorpe Morieux, (analytical part) Suffolk
2001-10-15
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate
Comments of zRMS: Acceptable although the application rate was more than twice the intended rate. However, this was considered acceptable since it represents a worst case situation. One residue value for wheat grain was not included (trial 397273/3) due to determination of MCPA residues above the LOQ in the control sample (0.1 mg/kg). These trials were reported in the Addendum to the DAR.
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Table A 9: Residues of MCPA in spring soft wheat RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Spring Soft Wheat Crop Code : TRZAS Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 281 g/L (344.19 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Dicopur M (CL-23609-3) (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : MCPA
1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 1194, Star A3 1) 1992-03-04 0.56 300 0.19 1992-05-184) BBCH 31 plant 16.1 0 4) spraying project R 92-16, (sowing) 0.70 15 analytical report 2) rest of plant 0.093 28 analytical method: No. 1172, project 3) report No. 1172, R 93-86 (GC- ears of grain <0.050 28 R 93-86, trial 01, MSD), decline trial grain <0.050 70 LOQ(s): 0.05 mg/kg max. sample storage time in Austria (AT) straw <0.050 70 month(s): 21 4052 mean of two analyses, validated Ansfelden level in this study: 0.1 mg/kg RIP2002-1891 1994-07-01
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate
Comments of zRMS: This trial was reported in the DAR, but not included in the risk assessment for the present product since the sample storage time (21 months) is not validated. Storage stability for MCPA residues in cereal matrices was proved for 18 months (ASB2014-10254).
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Table A 10: Residues of MCPA in spring barley RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Spring Barley Crop Code : HORVS Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 281 g/L (344.19 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Dicopur M (CL-23609-3) (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : MCPA
1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 1194, Berta 1) 1992-03-13 0.56 300 0.19 1992-05-184) BBCH 31 plant 12.6 0 4) spraying project R 92-16, (sowing) rest of plant 0.17 15 analytical report 2) <0.050 28 analytical method: No. 1172, 3) report No. 1172, R 93-86 (GC- project R 93-86, ears of grain <0.050 15 MSD), <0.050 28 trial 02, LOQ(s): decline trial grain <0.050 63 0.05 mg/kg max. sample storage time in straw <0.050 63 Austria (AT) month(s): 21 4052 mean of two analyses, validated Ansfelden level in this study: 0.1 mg/kg
1994-07-01 RIP2002-1891
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 1194, Robin 1) 1992-04-22 0.56 300 0.19 1992-05-294) BBCH 31 plant 17.5 0 4) spraying project R 92-16, (sowing) 0.089 13 analytical report 2) rest of plant <0.050 26 analytical method: No. 1172, 3) report No. 1172, R 93-86 (GC- ears of grain <0.050 26 project R 93-86, MSD), trial 04, grain <0.050 60 LOQ(s): decline trial 0.05 mg/kg straw <0.050 60 max. sample storage time in Austria (AT) month(s): 20 4060 mean of two analyses, validated Leonding level in this study: 0.1 mg/kg
1994-07-01 RIP2002-1891
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Note: All entries to be filled in as appropriate
Comments of zRMS: These trials were reported in the DAR, but not included in the risk assessment for the present product since the sample storage time (20-21 months) is not validated. Storage stability for MCPA residues in cereal matrices was proved for 18 months (ASB2014-10254).
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Table A 11: Residues of MCPA in oats RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Oats Crop Code : AVESS Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 281 g/L (344.19 g/L MCPA dimethylamine salt) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (soluble concentrate) Other a.i. in formulation Commercial product (name) : Dicopur M (CL-23609-3) (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : MCPA
1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 1194, Lord 1) 1992-04-03 0.56 300 0.19 1992-05-184) BBCH 31 plant 22.1 5 4) spraying project R 92-16, (sowing) 0.15 23 analytical report 2) ears of grain <0.050 37 analytical method: No. 1172, project 3) report No. 1172, R 93-86 (GC- rest of plant <0.050 37 R 93-86, trial 03, MSD), decline trial grain <0.050 71 LOQ(s): 0.05 mg/kg Austria (AT) straw <0.050 71 max. sample storage time in 3353 month(s): 21 Seitenstetten mean of two analyses, validated level in this study: 0.1 mg/kg 1994-07-01 RIP2002-1891
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate
Comments of zRMS: This trial was reported in the DAR, but not included in the risk assessment for the present product since the sample storage time (21 months) is not validated. Storage stability for MCPA residues in cereal matrices was proved for 18 months (ASB2014-10254).
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A 2.2.5 Magnitude of residues in grassland, pasture, meadow Reference: OECD KIIA 6.3 Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list) Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box Deviations: no relevant deviations unless stated otherwise in the commenting box GLP: see reference list Acceptability: acceptable unless stated otherwise in the commenting box
Table A 12: Residues of MCPA in grassland, pasture, meadow RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Grassland, Pasture, Meadow Crop Code : NNNFW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2008-11-17
Content of a.i. (g/kg or g/l) : 750 g/L (917.7 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Agroxone 75 (T021A) (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : 8.1 HMCPA (2-hydroxymethyl-4- chlorophenoxyacetic acid) 8.2 MCPA
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1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report R 9117, tall fescue, 1) 1997-09 1.8 250 0.71 1999-05-054) BBCH plant 1.3 80.0 0 4) spraying study AHM R 99 cocksfoot, (sowing) 31-33 0.15 6.7 7 222, trial ryegrass, 2) <0.050 5.6 14 analytical method: 394445/1, Timothy 3) 1999-06-30 <0.050 1.4 28 ATM 592 (GC-MSD), decline trial <0.050 0.20 56 LOQ(s): 8.1: 0.05 mg/kg France (FR) 8.2: 0.05 mg/kg 37800 max. sample storage time Ports sur Vienne in month(s): 15
2001-10-15 ASB2009-249 report R 9117, rye, clover 1) 1998 1.7 240 0.70 1999-05-054) BBCH plant 0.050 98.0 0 4) spraying study AHM R 99 (sowing) 24-60 <0.050 4.9 7 222, trial 2) <0.050 1.1 14 analytical method: 394445/2, 3) 1999-06-30 <0.050 0.76 28 ATM 592 (GC-MSD), decline trial <0.050 0.38 56 LOQ(s): 8.1: 0.05 mg/kg United Kingdom 8.2: 0.05 mg/kg (UK) max. sample storage time in month(s): 15 Peaston, East BBCH: 4 tillers up to Lothian flowering
2001-10-15 ASB2009-249
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Note: All entries to be filled in as appropriate
Comments of zRMS: Acceptable although the application rate was higher than the intended rate. However, this was considered acceptable since it represents a worst case situation. These trials were reported in the Addendum to the DAR.
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Table A 13: Residues of MCPA in grassland, pasture, meadow RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Grassland, Pasture, Meadow Crop Code : NNNFW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 750 g/L (917.7 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Agroxone 75 (T021A) (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : 8.1 HMCPA (2-hydroxymethyl-4- chlorophenoxyacetic acid) 8.2 MCPA
1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report R A0120, Timothy 1) 1989 1.8 250 0.72 2000-04-074) BBCH plant 0.12 128 0 4) spraying study AHM R 00 (Phleum (sowing) 24-26 0.24 8.1 7 222, trial pratense) and 2) 0.12 4.6 14 analytical method: 397320/1, Ryegrass 3) 2000-06 <0.050 0.78 28 ATM 592 (GC-MSD), decline trial (Lolium spp) <0.050 <0.050 56 LOQ(s): 8.1: 0.05 mg/kg United Kingdom 8.2: 0.05 mg/kg (UK) max. sample storage time in month(s): 10 Underriver, near Sevenoaks, ASB2009-250 Kent
2001-06-29
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1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report R A0120, Meadowgrass 1) 1999-05 1.8 250 0.71 2000-03-264) BBCH plant <0.050 85.0 0 4) spraying study AHM R 00 (Poa spp) and (sowing) 25-30 0.12 9.5 7 222, trial Ryegrass 2) 0.080 5.1 14 analytical method: 397320/2, 3) 2000-05 <0.050 0.90 28 ATM 592 (GC-MSD), decline trial <0.050 0.080 56 LOQ(s): 8.1: 0.05 mg/kg United Kingdom controls > LOQ: 8.2: 0.05 mg/kg (UK) plant 0.070 28 max. sample storage time in month(s): 23 Pathhead, East ASB2009-250 Lothian
2001-06-29 report R A0120, Ryegrass 1) 1999-09 1.8 260 0.70 2000-05-154) BBCH plant 0.31 59.0 0 4) spraying study AHM R 00 (Lolium spp) (sowing) 24-49 0.20 13.0 7 222, trial 2) 0.16 5.6 14 analytical method: 397320/3, 3) 2000-07 0.080 3.2 28 ATM 592 (GC-MSD), decline trial 0.14 1.4 56 LOQ(s): 8.1: 0.05 mg/kg France (FR) 8.2: 0.05 mg/kg 71290 max. sample storage time La Genête in month(s): 21 ASB2009-250 2001-06-29
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1 2 3 4 5 6 7 8.1 8.2 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report R A0120, Fescue 1) 1998-10 1.8 260 0.70 2000-06-014) BBCH plant 0.28 10.0 0 4) spraying study AHM R 00 (Festuca (sowing) 32-61 0.56 40.0 7 222, trial spp), 2) 0.60 5.6 14 analytical method: 397320/4, Cocksfoot 3) 2000-07 0.36 1.7 28 ATM 592 (GC-MSD), decline trial (Dactylis spp) 0.16 0.62 55 LOQ(s): and Ryegrass 8.1: 0.05 mg/kg France (FR) (Lolium spp) 8.2: 0.05 mg/kg 21910 max. sample storage time Noiron sous in month(s): 20 Gevrey ASB2009-250
2001-06-29
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Note: All entries to be filled in as appropriate
Comments of zRMS: These trials were reported in the DAR, but three of them (397320/2, 397320/3, 397320/4) were only used as supplementary information for the present product since the sample storage time (20-23 months) is not validated. Storage stability for MCPA residues in commodities with high water content was proved for 18 months (ASB2014-10254).
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Table A 14: Residues of MCPA in grassland, pasture, meadow RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Grassland, Pasture, Meadow Crop Code : NNNFW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-10-02
Content of a.i. (g/kg or g/l) : 281 g/L (344.19 g/L MCPA dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Dicopur M (CL-23609-3) (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : MCPA
1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 1209, No data 1) 0.56 300 0.19 1992-06-244) BBCH plant 54.3 0 4) spraying project R 92-17, 2) 0.92 13 analytical report 3) 0.28 28 analytical method: No. 1172, 0.066 34 report No. 1172, R 93-86 (GC- project R 93-86, hay 0.61 28 MSD), trial 01, 0.32 34 LOQ(s): 0.05 mg/kg decline trial max. sample storage time in month(s): 24 Austria (AT) mean of two analyses, validated 3353 level in this study: 0.1 mg/kg, Seitenstetten growth stage at application 5-10 cm 1994-08-01 RIP2002-1893
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 1209, No data 1) 0.56 300 0.19 1992-06-294) BBCH plant 59.6 0 4) spraying project R 92-17, 2) 1.4 14 analytical report 3) 1.1 28 analytical method: No. 1172, 0.74 35 report No. 1172, R 93-86 (GC- project R 93-86, hay 2.2 28 MSD), trial 02, 1.7 35 LOQ(s): decline trial 0.1 mg/kg (plant), 1 mg/kg (hay), Austria (AT) max. sample storage time in 4040 month(s): 23 Linz/St. mean of two analyses, validated Magdalena level in this study: 0.1 mg/kg, growth stage at application 1994-08-01 5-10 cm RIP2002-1893 report 1209, No data 1) 0.56 300 0.19 1992-07-104) BBCH plant 57.3 0 4) spraying project R 92-17, 2) 1.4 12 analytical report 3) 1.1 28 analytical method: No. 1172, <0.10 34 report No. 1172, R 93-86 (GC- project R 93-86, hay 1.1 28 MSD), trial 03, <1.0 34 LOQ(s): decline trial 0.1 mg/kg (plant), 1 mg/kg (hay), Austria (AT) max. sample storage time in 4491 month(s): 23 Niederneukirche mean of two analyses, growth n stage at application 5-15 cm RIP2002-1893 1994-08-01
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 1209, No data 1) 0.56 300 0.19 1992-07-164) BBCH plant 50.0 0 4) spraying project R 92-17, 2) 1.8 12 analytical report 3) 1.4 28 analytical method: No. 1172, 1.2 34 report No. 1172, R 93-86 (GC- project R 93-86, hay 3.3 28 MSD), trial 04, 2.2 34 LOQ(s): decline trial 0.1 mg/kg (plant), 1 mg/kg (hay), Austria (AT) max. sample storage time in 4441 month(s): 23 Behamberg mean of two analyses, growth stage at application 5-15 cm 1994-08-01 RIP2002-1893
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Note: All entries to be filled in as appropriate
Comments of zRMS: These trials were reported in the DAR, but not included in risk assessment for the present product since the application rates were lower than the intended rates. Furthermore the sample storage time (23-24 months) is not validated. Storage stability for MCPA residues in commodities with high water content was proved for 18 months (ASB2014-10254).
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Table A 15: Residues of MCPA in grassland, pasture, meadow RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : MCPA (Application on agricultural and horticultural crops) Crop / crop group : Grassland, Pasture, Meadow Crop Code : NNNFW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2008-11-17
Content of a.i. (g/kg or g/l) : 500 g/L (610 g/L MCPA dimethylamine salt) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (soluble concentrate) Other a.i. in formulation Commercial product (name) : U 46 M-Fluid (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : MCPA
1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 010 01 H grassland 1) 1.0 800 0.13 1975-06-094) BBCH grass 30.7 0 4) spraying 75/1 A, 2) 1.5 7 decline trial 3) 1975 0.70 14 analytical method: 0.70 21 not reported (GC-MS),
Germany (DE) hay 0.55 24 LOQ(s): 0.05 mg/kg Uplengen/Olden max. sample storage time in burg month(s): 2
1975-12-03 ASB2009-241 report 010 01 H grassland 1) 1.0 800 0.13 1975-09-014) BBCH grass 290 0 4) spraying 75/2 A, 2) 62.4 7 analytical method: decline trial 3) 1975 1.3 14 not reported (GC-MS), 1.6 21 LOQ(s):
Germany (DE) hay 4.6 24 0.05 mg/kg max. sample storage time in Altenbuch b. month(s): 3 München ASB2009-243 RIP2002-1894 1975-12-03 (duplicate)
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1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) report 010 01 H grassland 1) 1.0 800 0.13 1975-06-044) BBCH grass 150 0 4) spraying 75/3 A, 2) 12.5 8 5) not analysed decline trial 3) 1975 3.3 14 n.a.5) 21 analytical method:
Germany (DE) hay 1.5 24 not reported (GC-MS), LOQ(s): Geinsheim , 0.05 mg/kg Pfalz max. sample storage time in month(s): 2 1975-12-02 ASB2009-244 RIP2002-1895 (duplicate)
Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Note: All entries to be filled in as appropriate
Comments of zRMS: Acceptable.
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A 2.3 Residues in processed commodities No new study on residues in processed commodities has been submitted and none is needed due to low residues at harvest.
A 2.4 Residues in rotational crops No new study on residues in rotational crops has been submitted.
A 2.5 Residues in livestock
A 2.5.1 Nature of residues No new studies on the nature of residues in livestock have been submitted.
A 2.5.2 Magnitude of residues
Reference: OECD KIIA 6.4.2 Report Magnitude of the residues of MCPA in dairy cow milk and tissues; xxxxxxx; ABC Study No. 49737, GML Study No. 214-001-10; ASB2009- 251 Guideline(s): Yes (US EPA Residue Chemistry Guidelines) Deviations: No GLP: Yes Acceptability: Yes
Materials and methods The purpose of this study was to determine MCPA residue levels in bovine milk and edible tissues after administration of MCPA with feeding stuff. Twelve lactating Holstein cows were orally dosed for 28 consecutive days with encapsulated MCPA [(4-chloro-2-methylphenoxy) acetic acid] via a balling gun. Each three cows were dosed at approximately 50 MCPA mg/kg diet (on a dry diet basis) and 150 MCPA mg/kg diet. Further six cows were dosed at approximately 500 MCPA mg/kg diet. These feeding levels correspond to 1.98, 5.89 and 19.59 mg MCPA/kg bw. In addition three cows served as controls and received empty placebo gelatin capsules daily during the dosing period. Within the study a 7-day withdrawal phase was conducted to investigate the decline of residues following completion of dosing period. For this phase, two animals from the control group and three animals from the high dose group were chosen.
Cows were milked twice daily. Milk samples were collected on Days 0 (pre-treatment), 1, 3, 7, 11, 14, 18, 21, 24 and 27. Additional milk samples were collected on days 29 and 30 for the depuration animals. Tissue samples (round, loin and flank muscle, omental, perirenal and subcutaneous fat, liver and kidney) were collected from each cow except depuration animals within 24 hours of the 28 days dose and frozen on dry ice for analysis. The depuration group animals were sacrificed on day 35. All samples were stored frozen at -20°C until extraction.
Milk and tissue samples were analyzed for MCPA by GC-MS after extraction with acetonitrile or hexane, acidification, partition on SPE columns and methylation with boron trifluoride in methanol. The LOQs for milk and tissues were 0.01 and 0.05 mg/kg.
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Results and discussions No significant effect on body weight, feed intake and milk production was observed at any feeding level.
Highest MCPA residues were found in kidney while residues in muscle were low for all dosing groups. MCPA residues for the low treatment group (50 mg/kg diet) were detectable, but In the two lower dose groups selected milk samples showed no MCPA residues above the LOQ of 0.01 mg/kg. Only in the highest dose group MCPA residues could be observed in milk ranging from 0.015 to 0.023 mg/kg. A plateau of residues in milk was reached already at day 1. Analysis of milk samples from the depuration group showed no residues above the LOQ. Aliquots of milk samples from the highest dose group were separated in cream and skim milk samples. Residues of MCPA were low and in the same range in both cream (0.017 mg/kg) and skim milk (0.019 mg/kg) indicating no concentration of MCPA in cream. Table A 16: Summary of residue data from ruminant feeding study with MCPA Feeding Residue levels (mg/kg) Matrix level n Single values Median Mean (mg/kg) Liver 50 3 <0.05; <0.05; <0.05 0.05 0.05 150 3 <0.05; 0.058; 0.095 0.058 0.068 500 3 0.16; 0.25; 0.28 0.25 0.23 Kidney 50 3 0.28, 0.40; 0.41 0.40 0.36 150 3 0.60; 0.63; 1.2 0.63 0.81 500 3 1.7, 1.7; 2.4 1.7 1.9 Muscle 50 3 <0.05; <0.05; <0.05 0.05 0.05 150 3 <0.05, <0.05; 0.077 0.05 0.059 500 3 <0.05, 0.051; 0.076 0.051 0.059 Fat 50 3 <0.05; <0.05; <0.05 0.05 0.05 150 3 <0.05; 0.12; 0.17 0.12 0.11 500 3 <0.05; 0.12; 0.13 0.12 0.10 Conclusion The results of the study indicate that residues of MCPA tend to pass quickly through the animals and do not persist in milk nor accumulate in tissues. Highest residues were found in kidney in all dosing groups while residues in milk and muscle samples were generally low. Comments of zRMS: Acceptable. A 2.6 Other studies/information None Page 54 / 55 Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) MCPA and MCPB (MCPA, MCPB including their salts, esters and conjugates expressed as MCPA) Prepare workbook for refined calculations (F) (R) Status of the active substance: Code no. LOQ (mg/kg bw): proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0,05 ARfD (mg/kg bw): 0,15 Undo refined calculations Source of ADI: SCoFCAH Source of ARfD: COM Year of evaluation: 2008 Year of evaluation: 2005 Explain choice of toxicological reference values. The risk assessment has been performed on the basis of the MRLs collected from Member States in April 2006. For each pesticide/commodity the highest national MRL was identified (proposed temporary MRL = pTMRL). The pTMRLs have been submitted to EFSA in September 2006. Chronic risk assessment TMDI (range) in % of ADI minimum - maximum 1 10 No of diets exceeding ADI: --- Highest calculated Highest contributor 2nd contributor to 3rd contributor to pTMRLs at TMDI values in % to MS diet Commodity / MS diet Commodity / MS diet Commodity / LOQ of ADI MS Diet (in % of ADI) group of commodities (in % of ADI) group of commodities (in % of ADI) group of commodities (in % of ADI) 10,1 WHO Cluster diet B 3,4 Wheat 0,9 Bovine: Edible offal 0,7 FRUIT (FRESH OR FROZEN) 9,6 NL child 2,9 Milk and cream, 1,9 Wheat 1,5 FRUIT (FRESH OR FROZEN) 9,0 FR toddler 4,0 Milk and cream, 1,2 FRUIT (FRESH OR FROZEN) 1,0 Wheat 8,7 UK Infant 3,9 Milk and cream, 1,0 Wheat 1,0 SUGAR PLANTS 8,3 UK Toddler 2,3 SUGAR PLANTS 2,1 Milk and cream, 1,6 Wheat 7,5 DK child 2,2 Wheat 1,8 Rye 1,3 Milk and cream, 7,1 DE child 2,3 FRUIT (FRESH OR FROZEN) 1,6 Wheat 1,4 Milk and cream, 6,9 IE adult 1,4 Sheep: Liver 1,1 FRUIT (FRESH OR FROZEN) 0,9 Wheat 6,7 WHO cluster diet D 2,6 Wheat 0,6 Bovine: Edible offal 0,5 Milk and cream, 6,4 WHO cluster diet E 1,6 Wheat 0,6 Swine: Edible offal 0,6 FRUIT (FRESH OR FROZEN) 6,0 FR infant 2,6 Milk and cream, 1,5 FRUIT (FRESH OR FROZEN) 0,7 Root and tuber vegetables 6,0 ES child 1,8 Wheat 1,3 Milk and cream, 0,6 FRUIT (FRESH OR FROZEN) 5,5 WHO regional European diet 1,2 Wheat 0,6 Bovine: Edible offal 0,5 Swine: Edible offal 5,4 WHO Cluster diet F 1,4 Wheat 0,4 Root and tuber vegetables 0,4 Bovine: Edible offal 4,4 SE general population 90th percentile 1,3 Wheat 1,2 Milk and cream, 0,6 FRUIT (FRESH OR FROZEN) 3,7 IT kids/toddler 2,7 Wheat 0,4 FRUIT (FRESH OR FROZEN) 0,2 Fruiting vegetables 3,6 NL general 0,8 Wheat 0,7 Milk and cream, 0,5 FRUIT (FRESH OR FROZEN) 3,4 ES adult 0,9 Wheat 0,5 Milk and cream, 0,4 FRUIT (FRESH OR FROZEN) 3,4 FR all population 1,3 Wheat 0,6 FRUIT (FRESH OR FROZEN) 0,4 Bovine: Edible offal 3,2 PT General population 1,6 Wheat 0,6 FRUIT (FRESH OR FROZEN) 0,3 Brassica vegetables 2,8 DK adult 0,8 Wheat 0,5 Milk and cream, 0,3 FRUIT (FRESH OR FROZEN) 2,7 LT adult 0,4 Rye 0,4 Wheat 0,4 Milk and cream, 2,5 IT adult 1,7 Wheat 0,3 FRUIT (FRESH OR FROZEN) 0,2 Fruiting vegetables 2,5 UK Adult 0,7 Wheat 0,4 SUGAR PLANTS 0,3 Milk and cream, 2,5 UK vegetarian 0,8 Wheat 0,4 SUGAR PLANTS 0,3 FRUIT (FRESH OR FROZEN) 1,9 FI adult 0,6 Milk and cream, 0,4 Wheat 0,3 Rye 1,0 PL general population 0,4 Root and tuber vegetables0,3 FRUIT (FRESH OR FROZEN) 0,1 Fruiting vegetables Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI. A long-term intake of residues of MCPA and MCPB (MCPA, MCPB including their salts, esters and conjugates expressed as MCPA) (F) (R) is unlikely to present a public health concern. Page 55 / 55 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 1 of 15 REGISTRATION REPORT Part B Section 5 Environmental Fate Detailed summary of the risk assessment Product code: U 46 M Fluid Active Substance: MCPA 500 g/L as DMA salt 612.35 g/L Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Nufarm Date: June 2016 Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 2 of 15 Table of Contents TABLE OF CONTENTS ...... 2 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 MCPA ...... 4 5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ...... 6 5.4.1 Rate of degradation in soil...... 6 5.4.2 Adsorption/desorption ...... 7 5.4.3 Rate of degradation in water and sediment ...... 8 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (PECSOIL) (KIIIA1 9.4) ...... 9 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (PECSW/PECSED) (KIIIA1 9.7) 10 5.7 RISK ASSESSMENT GROUND WATER (KIIIA1 9.6) ...... 12 5.7.1 Predicted environmental concentration in groundwater (PECGW) calculation for active substances and metabolites (Tier 1 and 2) ...... 12 5.7.2 Summary of risk assessment for ground water ...... Fehler! Textmarke nicht definiert. 5.8 POTENTIAL OF ACTIVE SUBSTANCE FOR AERIAL TRANSPORT ...... 13 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ...... 15 Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 3 of 15 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) This document comprises the risk assessment for groundwater and the exposure assessment of surface water and soil for the plant protection product U 46 M Fluid containing MCPA as DMA salt in its intended uses in winter and spring cereals, grassland, pome and stone fruits and grape vine. National Addenda are included containing country specific assessments for some annex points. 5.1 General Information on the formulation Table 5.1-1: General information on the formulation U 46 M Fluid Code CA2643 Plant protection product U 46 M Fluid Applicant Nufarm Date of application 21.12.2013 Formulation type SL, rel. density 1.128 (WP, EC, SC, …; density) Active substance (as) MCPA as DMA salt Concentration of as (g/L) 500 612.35 5.2 Proposed use pattern The critical GAPs used for exposure assessment is presented in Table 5.2-1. Table 5.2-1: Critical use pattern of U 46 M Fluid Group Crop/growth Application Number of applications, Application rate, Soil effective stage method / Minimum application cumulative application rate Drift scenario interval, interception, (g as/ha) (g as/ha) application time (season) A (001, Winter and spraying / 1 x, spring MCPA 1 x 700, MCPA 002) spring cereals arable crops 25 % interception 1 x 525 BBCH 13-39 6 April B (003) grassland/ spraying / 1 x, March to September MCPA 1 x 1000 MCPA BBCH 25-35 arable crops 90 % interception 1 x 100 C (004) Pome and stone spraying / 1 x, March to September MCPA 1 x 1000 MCPA fruits arable crops 0 % interception 1 x 1000 D (005) grape vine spraying with 1 x, March to September MCPA 1 x 2000 MCPA screen , up to 0 % interception 1 x 2000 3rd year after planting of the vine / arable crops* Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 4 of 15 *Although the use of formulation u 46 M-Fluid in vineyards (use No 00-005) should be undertaken by spraying with a shield this application technique is not generally available. Therefore exposure assessment is based on the drift values for arable crops. 5.3 Information on the active substances 5.3.1 MCPA 5.3.1.1 Identity, further information of MCPA Table 5.3-1: Identity, further information on MCPA Active substance (ISO common name) MCPA IUPAC 4-chloro-o-tolyoxyacetic acid Function (e.g. fungicide) herbicide Status under Reg. (EC) No 1107/2009 approved Date of approval 01/05/2006 Conditions of approval Only uses as herbicide may be authorised. Regulation (EC) No 1107/2009, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account. − 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 should include risk mitigation measures, where appropriate. − Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones Confirmatory data - RMS Italy Minimum purity of the active substance ≥ 920 g/kg as manufactured (g/kg) Molecular formula C9H9ClO3 Molecular mass 200.6 Structural formula Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 5 of 15 5.3.1.2 Physical and chemical properties of MCPA Physical and chemical properties of MCPA as agreed at EU level (see SANCO/4062/2001-final – 11/06/2008) and considered relevant for the exposure assessment are listed in Table 5.3-2. Table 5.3-2: EU agreed physical chemical properties of MCPA relevant for exposure assessment Value Reference Vapour pressure (at 20 °C) (Pa) 4 x 10-4 Pa at 32°C; SANCO/4062/2001-final – 4 x 10-3 Pa at 45°C. Purity 11/06/2008 99.4%. (extroplated to 20 °C: 8.64 x 10-5 Pa) Henry’s law constant (Pa × m³ × mol-1) 5.5 x 10-5 Pa.m3/mol at 25°C. Solubility in water (at 25 °C in mg/L) Unbuffered (pH1) 0.395g/l at 25°C. pH5: 26.22 g/l at 25°C pH7: 293.90 g/l at 25° pH9:320.09 g/l at 25°C Purity 99.4%. Partition co-efficient (at 25 °), log POW pH 7: -0.81 (0.001 mol/L) Dissociation constant, pKa pKa = 3.73 (s = 0.07) at 20°C. pKa = 3.73 (s = 0.00) at 25°C. Hydrolytic degradation 14C-MCPA acid was stable to hydrolytic degradation at pH 5, 7 and 9 at 25°C for 30 d. Photolytic degradation DT50 (aqueous): 25.4 d. Quantum yield of direct phototransformation Estimated Quantum in water > 290 nm efficiency Φ = ≤ 0.093. The wavelength applied in this test was 304 nm. Purity = 99.0 %. Photochemical oxidative degradation in air DT50 =1.271 d calculated by zRMS (calculation according to Atkinson) (AOP version: 1.91, 0.5 × 106 radicals/cm³, 24 h day)Purity 99.4%. 5.3.1.3 Metabolites of MCPA No relevant metabolites of MCPA need to be considered for exposure assessment. Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 6 of 15 5.4 Summary on input parameters for environmental exposure assessment 5.4.1 Rate of degradation in soil 5.4.1.1 Laboratory studies MCPA No new studies have been submitted regarding route and rate of degradation in soil of MCPA. The environmental exposure assessment is based on the EU agreed DT50 values from the laboratory as summarized in Table 5.4-1. DT50 values from literature (reviewed by Smith, 1989) are only used as additional information whereas the study by Matt (1990) is considered as DT50 endpoint. Following FOCUS for normalization a Q10 factor of 2.58 is applied instead of 2.2. Table 5.4-1: Summary of aerobic degradation rates for MCPA - laboratory studies Soil type pH T °C Moisture DT50 (d) DT50 (d) Kinetic, Reference 20 °C, pF2 Fit (Q10 = 2.58) Sandy loam 8.0 25 75% FC at 1/3 24 26.7 SFO Matt, F.J., 1990 bar („Route of degradation study“, SANCO/4062/2001- final – 11/06/2008 Sandy loam 8.0 23 12.7% FC 8.0 2.5 SFO SANCO/4062/2001- final – 11/06/2008 Sandy loam 7.2 26 100% FC 32.0 56.5 SFO Review from Smith, Clay loam 7.8 26 100% FC 41.0 72.4 SFO A. (1989) Clay loam 6.2 26 100% FC 15.0 26.5 SFO Loam 7.6 26 100% FC 14.0 24.7 SFO Loam 7.5 26 100% FC 22.0 38.9 SFO Clay 7.7 20 85% FC 7.0 6.2 SFO Clay loam 6.0 20 85% FC 7.0 6.2 SFO Sandy loam 7.6 20 85% FC 7.0 6.3 SFO Clay 7.7 20 85% FC 13.0 11.6 SFO Clay loam 6.0 20 85% FC 14.0 12.5 SFO Sandy loam 7.6 20 85% FC 14.0 12.5 SFO Sandy clay 5.2 23 100% FC 28.0 37.2 SFO Sandy clay 4.7 25 100% FC 40.0 64.2 SFO Matt, F.J., 1990 normalised (d) 26.7 For PECgw/sw/sed Aggregated DT50 (n=1) Smith, A. (1989) Maximum (d) 41 for PECsoil (not normalised) Aggregated DT50 (n=14) Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 7 of 15 5.4.1.2 Field studies MCPA Field studies are not available and not required based on the short-lives in the aerobic degradation studies. 5.4.2 Adsorption/desorption MCPA No new studies have been submitted regarding adsorption/desorption in soil of MCPA. The exposure modeling is based on the EU KFoc values as summarized in Table 5.4-2. Table 5.4-2: KF, KFoc and 1/n (Freundlich exponent) values for MCPA Soil Type OC pH Kf Kfoc 1/n Reference (%) (-) (mL g-1) (mL g-1) (-) Clay loam, California 1.20 7.80 0.460 38 0.720 Goodwin P A and Sand, Florida 0.52 5.00 0.816 157 0.710 Laskowski D A, Silt loam, Ohio 1.22 5.80 1.160 95 0.700 (1988) (SANCO/40 62/2001- Sandy loam, Ohio 0.81 7.30 0.490 60 0.700 final – 11/06/2008) Silt loam, Illinois 2.23 5.90 1.490 67 0.707 Fernando T R, (1992) Sandy loam, California 0.22 7.50 0.050 23 0.500 (SANCO/40 62/2001- Loam, North Dakota 3.08 6.80 1.990 65 0.721 final – 11/06/2008) Clay, Massachusetts 1.26 7.00 1.070 85 0.686 Arithmetic mean (EU agreed endpoint), (n=8) 74 0.68 The Kfoc values of MCPA shows pH dependency that is summarized in Table 5.4-3 Table 5.4-3: pH-dependency of Kfoc values of MCPA pH dependency (Kfoc ) Yes (see LoEP 2005) Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 8 of 15 5.4.3 Rate of degradation in water and sediment MCPA No new water/sediment study has been submitted. The exposure modeling is based on the results of the water/sediment study of MCPA (Cremers, R.K.H., 2003) reviewed in the addendum of MCPA (Vol. 3, part B7, Oct. 2003). The DT50 values of the water/sediment study are summarized in Table 5.4-4. Table 5.4-4: Degradation in water/sediment of MCPA Water/sediment DegT50 Method of DissT50/ Method of DissT50/ Method of Reference system / DegT90 calculation, DissT90 calculation, DissT90 calculation, whole Fit water Fit sed. Fit system I) Kromme Rijn, 16.9/56.2 SFO 0.889 13.6/- SFO n.a. - Cremers, R.K.H. Clay loam 0.962 (2003) II) TNO, Sandy 16.9/56.2 SFO 0.882 13.3/- SFO n.a. - (SANCO/40 clay loam 0.908 62/2001- final – 11/06/2008) Geometric mean 16.9 DT50 (n=2) Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 9 of 15 5.5 Estimation of concentrations in soil (PECsoil) (KIIIA1 9.4) PECsoil calculations are based on the recommendations of the FOCUS workgroup on degradation kinetics. A soil bulk density of 1.5 g/cm3, a soil depth of 5 cm and a tillage depth of 20 cm (arable crop)/5 cm (permanent crops) were assumed. The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented in tables below. Table 5.5-1: Application related input parameters for PECSoil calculations Plant protection product U 46 M Fluid Use No.: 001, 002 003 004 005 Crop: Winter and grassland Pome and stone Grape vine spring cereals fruits Application rate: 1.4 L/ha 2 L/ha 2 L/ha 4 L/ha 700 g a.s./ha 1000 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha Number of applications/interval: 1 x Crop interception: 25 % 50 % 0 % 0 % Table 5.5-2: Substance related input parameters for PECsoil calculation Active substance DT50 value in accordance to EU endpoint MCPA 41 d Yes Due to the fast degradation of MCPA in soil (DT90 < 365 d, laboratory data) the accumulation potential of MCPA does not need to be considered. Table 5.5-3: Results of PECsoil calculation for application of U 46 M Fluid in grape vine (soil bulk density 1.5 g/cm-3, soil depth 5 cm) according to use No 005 active substance/ soil relevant PECact PECtwa 21 tillage PECbkgd PECaccu = preparation application rate (mg/kg) d depth (cm) (mg/kg) PECact + (g/ha) (mg/kg) PECbkgd (mg/kg) U 46 M Fluid 4512 6.02 - - - - MCPA 2000 2.67 - - - - Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 10 of 15 5.6 Estimation of concentrations in surface water and sediment (PECsw/PECsed) (KIIIA1 9.7) PECsw and PECsed calculations are provided according to the recommendations of the FOCUS working group on surface water scenarios in a stepwise approach considering the pathways drainage and runoff. The relevant input parameters used for PEC calculation are summarized in the tables below. Table 5.6-1: Input parameters for MCPA for PECsw/sed calculations Parameter Endpoint used for Values in Remarks PECsw/sed calculation accordance to EU endpoint in LoEP Active substance MCPA - - Molecular weight (g/mol) 200.6 yes - Saturated vapour 4 x 10-4 Pa at 32°C yes see point 5.3.1.2 pressure (Pa) not required for Step 1+2 Water solubility (mg/L) pH7: 293.9 g/l at 25° yes see point 5.3.1.2 Diffusion coefficient in not required for Step 1+2 - default water (m²/d) Diffusion coefficient in not required for Step 1+2 - default air (m²/d) -1 KFoc (mL g ) 74 yes Arithmetic mean (see point 5.4.2) Freundlich Exponent not required for Step 1+2 - - 1/n Plant Uptake not required for Step 1+2 - - Wash-Off factor from not required for Step 1+2 - - Crop DT50,soil (d) 26.7 yes Single value (SFO, pF2,20°C), laboratory data (see point 5.4.1) DT50,water (d) 16.9 yes Geomean of whole system (1st order, 20°C) (see point 5.4.3) DT50,sed (d) 1000 - default DT50,whole system (d) 16.9 yes Geomean of whole system (1st order, 20°C) (see point 5.4.3) Table 5.6-2: Input parameters related to application for PECsw/sed calculations Plant protection product U 46 M Fluid Use No.: 001, 002 003 004 005 Crop: Winter and grassland Pome and stone Grape vine spring cereals fruits Application rate: 700 g a.s./ha 1000 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha Number of applications/interval: 1 x Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 11 of 15 crop (step 2) Winter cereals Grass/alfalfa See 003* Crop interception (step 2) Mimimal crop full canopy See 003* 0 % cover * It is a non-crop directed application, therefor scenario for Step 2 calaculation is comparable to those for application in grassland. Results of FOCUS SW calculations for the worst-case application scenario of U 46 M Fluid are summarized in the tables below. Table 5.6-3: Maximum FOCUS Step 1 and Step 2 PECsw and PECsed of MCPA for the application of U 46 M Fluid according to the intended uses use no. 001, FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg) 002 218.8 157.2 (minimal crop cover) FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg) North Europe, Mar- 43.3 31.9 May use no. 003 FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg) and 004 312.6 224.5 FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg) North Europe, Mar- 20.95 15.34 May , June-Sep. use no. 005 FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg) 625.2 449.0 FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg) North Europe, Mar- 58.3 42.8 May and June – Sep Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 12 of 15 5.7 Risk assessment ground water (KIIIA1 9.6) 5.7.1 Predicted environmental concentration in groundwater (PECGW) calculation for active substances and metabolites (Tier 1 and 2) Groundwater contamination by direct leaching of the active substance and its metabolites, degradation or reaction products through soil is generally assessed by groundwater model calculations. Table 5.7-1: Application related input parameters for PECGW modelling Plant protection product U 46 M Fluid Use No. 001, 002 003 004 005 Application rate 700 g a.s./ha 1000 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha Crop (crop rotation) winter spring grassland pome and stone grape vine cereals cereals fruits Application date(s) 5 d after 156 d after 1 March – 30 1 March – 30 1 March – emergence emergence September September 30 September Interception (%) 25 % 50 % 0 % 0 % Soil relevant application rate 525 g a.s./ha 500 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha Soil moisture 100 % FC Q10-factor 2.58 Moisture exponent 0.7 Simulation period (years) 26 MCPA The applicant has provided PECgw for Germany only. Please refer to the national addendum for Germany for details to the PECgw calculation for Germany. The endpoints used for groundwater modelling for MCPA according to LoEP are summarized in Table 5.7-2. Please note, that Kfoc of MCPA shows a pH- dependency (see LoEP). For risk assessment to groundwater in Germany pH-dependancy is considered as presented in the national addendum (chapter 5.7). Table 5.7-2: Input parameters related to MCPA for PECGW modelling Parameter Endpoint used for PECGW Remarks/Reference calculation Molecular weight (g/mol) 200.6 - DT50 in soil (d) 26.7 n = 1, normalized to pF2, 20°C (Q10 = 2.58), slightly different from EU endpoint (DT50 = 24 d, not normalized), (see point 5.4.1) KFoc 74 (arith. mean, n=8) EU agreed endpoint, Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report Core Assessment Central Zone Page 13 of 15 1/n 0.68 EU agreed endpoint, n=8 Plant uptake factor 0 default Table 5.7-3: PECGW at 1 m soil depth for MCPA for the application of U 46 M Fluid in grape vine (based on geom. mean for DT50 value and arithm. mean for Kfoc) th -1 Crop/ Scenario 80 percentile PECGW at 1 m soil depth (µg L ) Group/us groundwater model: FOCUS PELMO 5.5.3 e No. Name pH-H2O Application on (1st 1 March 30 September horizon) Grape Châteaudun 8.0 0.000 0.000 vine / Hamburg 6.4 0.000 0.011 005 / (covers all Kremsmünster 7.7 0.000 0.000 intended uses) Piacenza 7.0 0.007 0.226 Porto 4.9 0.000 0.041 Sevilla 7.3 0.000 0.000 Thiva 7.7 0.000 0.000 According to the PECGW modelling with FOCUS PELMO 5.5.3 a groundwater contamination of the active substance MCPA at a concentration of ≥ 0.1 µg/L is not expected for all of the FOCUS groundwater scenarios for the intended for uses of the product based on EU endpoints. Please note that pH-dependancy of Kfoc was note considered for PECgw in EU level. 5.8 Potential of active substance for aerial transport The vapour pressure at 20 °C of the active substance MCPA is between 10-5 and 10-4 Pa. Hence the active substance MCPA is regarded as semivolatile (volatilisation only from plant surfaces). But MCPA is less volatile in the form of salts as it predominantly dissociated at pH 7. The anion is not volatile. Therefore exposure of adjacent surface waters and terrestrial ecosystems by the active substance MCPA due to volatilization with subsequent deposition does not need to be considered in the risk assesment. Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 CA2643 Registration Report Core Assessment Central Zone Page 15 of 15 Appendix 1 List of data submitted in support of the evaluation No additional data have been submitted. Please refer to the national addendum for Germany. Nufarm Evaluator: Germany Date:June 2016 Part B – Section 5 U 46 M Fluid Registration Report National Addendum– Germany Central Zone zRMS: DE Page 1 of 20 REGISTRATION REPORT Part B Section 5 Environmental Fate Detailed summary of the risk assessment Product code: U 46 M Fluid Active Substance: MCPA 500 g/L as DMA salt 612.35 g/L Central Zone Zonal Rapporteur Member State: Germany NATIONAL ADDENDUM – Germany Applicant: Nufarm Date: June 2016 Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 U 46 M Fluid Registration Report National Addendum– Germany Central Zone zRMS: DE Page 2 of 20 Table of Contents TABLE OF CONTENTS ...... 2 SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ...... 3 5.1 GENERAL INFORMATION ON THE FORMULATION ...... 3 5.2 PROPOSED USE PATTERN ...... 3 5.3 INFORMATION ON THE ACTIVE SUBSTANCES ...... 5 5.3.1 MCPA ...... 5 5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ...... 6 5.4.1 Rate of degradation in soil...... 6 5.4.2 Adsorption/desorption ...... 7 5.4.3 Rate of degradation in water/sediment ...... 8 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4) ...... 9 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) ...... 11 5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition ...... 11 5.6.2 PECSW after exposure by surface run-off and drainage ...... 12 5.7 RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6) ...... 13 5.7.1 Direct leaching into groundwater ...... 13 5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and drainage ...... 17 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ...... 19 APPENDIX 2 DETAILED EVALUATION OF STUDIES RELIED UPON ...... 20 KIIIA1 9 FATE AND BEHAVIOUR IN THE ENVIRONMENT ...... 20 KIIIA1 9.6.1 and 9.7 Simmons, 2013a ...... 20 KIIIA1 9.6.1 and 9.7 Simmons, 2013b ...... 20 Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 3 of 20 Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) The exposure assessment of the plant protection product U 46 M Fluid in its intended uses in winter and spring cereals, grassland, pome and stone fruits and grape vine is documented in detail in the core assessment of the plant protection product U 46 M Fluid dated from June 2016 performed by DE. This document comprises the risk assessment for groundwater and the exposure assessment of surface water and soil for authorization of the plant protection product U 46 M Fluid in Germany. 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 U 46 M Fluid Code CA2643 Plant protection product U 46 M Fluid Applicant Nufarm Date of application 21.12.2013 Formulation type SL, rel. density 1.128 (WP, EC, SC, …; density) Active substances (as) MCPA as DMA salt Concentration of as (g/L) 500 612.35 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. Table 5.2-1: Classification of intended uses in Germany for U 46 M Fluid Group/ Crop/growth Application Number of applications, Application rate, Soil effective use No stage method Minimum application cumulative application rate Drift scenario interval, application (g as/ha) (g as/ha) time, interception A (001, Winter and spraying / 1 x, spring MCPA 1 x 700, MCPA 002) spring cereals arable crops 25 % interception 1 x 525 BBCH 13-39 6 April B (003) grassland/ spraying / 1 x, March to September MCPA 1 x 1000 MCPA BBCH 25-35 arable crops 90 % interception 1 x 100 Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 4 of 20 C (004) Pome and stone spraying / 1 x, March to September MCPA 1 x 1000 MCPA fruits arable crops 0 % interception 1 x 1000 D (005) grape vine spraying with 1 x, March to September MCPA 1 x 2000 MCPA screen , up to 0 % interception 1 x 2000 3rd year after planting of the vine /arabel crops* Although the use of formulation u 46 M-Fluid in vineyards (use No 00-005) should be undertaken by spraying with a shield this application technique is not generally available. Therefore exposure assessment is based on the drift values for arable crops. Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 5 of 20 5.3 Information on the active substances 5.3.1 MCPA Please refer to the core assessment part B, section 5, point 5.3.1 Metabolites of MCPA No relevant metabolites of MCPA need to be considered for exposure assessment. Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 6 of 20 5.4 Summary on input parameters for environmental exposure assessment 5.4.1 Rate of degradation in soil 5.4.1.1 Laboratory studies The DT50 value of 24 d used in the EU assessment is based on one soil out of a single study (Matt, F.J., 1990, “route of degradation”). This value of 24 d is a not normalized DT50 value. Further DT50 values (n=14) are received from a literature review by Smith (1989). Original data from the included reviewed studies were not submitted. Therefore uncertainties resulting from missing data/information on followed guideline (e.g. OECD 307), on kinetic evaluation (evaluation is not following recommendations according to FOCUS degradation kinetics, 2006), and on the quality of kinetic fit (statistical parameters, e.g. chi2) exist. Even information given in the addendum (Vol. 3, B7, 2003) on this review is limited and cannot serve to allay existing doubts and therefore does not match actual assessment criteria and regulations. Furthermore soils with an OC-content of up to 6.8% are not in line with recommendations of OECD 307 and may not be representative for agriculturally used soils in Germany. Based on existing regulations in Germany a formal data gap on degradation in soil of the active substance MCPA exists as only one instead of four valid DT50 values were submitted by the notifier. However, in the framework of mutual recognition an additional degradation study of MCPA performed by Kaczynska (2005) was presented to the German authority. Here 3 of 4 soils matched criteria according to recommendations of OECD 307. Although the original study was not available to the German authority, analysis of the presented data according to FOCUS (2006) showed that statistical parameters match FOCUS (2006) recommendations. The received DT50 values are in the range of DT50 values presented in the DAR. Furthermore in the context of the renewal assessment procedure of MCPA at EU level starting in 2015 new soil degradation studies of MCPA will be finished by then. Under this aspect we accept the EU-agreed endpoint for PEC calculations used in the core assessment (26.7 d, normalized to pF2 and 20°C) until new data are available because in our opinion and under consideration of the study by Kaczynska (2005) this value seems to reflect a realistic worst case. The study by Smith (1989) is used as additional information, only. The results are summarized in the table below. Table 5.4-1: Summary of aerobic degradation rates for MCPA - laboratory studies Soil type Temper Moisture OC pH DT50 DT50 (d) Kinetic, Reference ature °C (d) 20 °C, pF2 Fit (Q10=2.58) Sandy loam 25 75% FC at 1.65 8.0 24 26.7 SFO Matt, F.J., 1990 1/3 bar („Route of degradation study“ Sandy loam 23 12.7% FC 1.16 8.0 8.0 2.5 SFO SANCO/4062/2001 -final – 11/06/2008 Sandy loam 26 100% FC 1.102 7.2 32.0 56.5 SFO Review from Clay loam 26 100% FC 1.044 7.8 41.0 72.4 SFO Smith, A. (1989) Clay loam 26 100% FC 3.944 6.2 15.0 26.5 SFO Loam 26 100% FC 1.392 7.6 14.0 24.7 SFO Loam 26 100% FC 1.682 7.5 22.0 38.9 SFO Clay 20 85% FC 2.436 7.7 7.0 6.2 SFO Clay loam 20 85% FC 6.786 6.0 7.0 6.2 SFO Sandy loam 20 85% FC 2.32 7.6 7.0 6.3 SFO Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 7 of 20 Clay 20 85% FC 2.436 7.7 13.0 11.6 SFO Clay loam 20 85% FC 6.786 6.0 14.0 12.5 SFO Sandy loam 20 85% FC 2.32 7.6 14.0 12.5 SFO Sandy clay 23 100% FC 3.654 5.2 28.0 37.2 SFO Sandy clay 25 100% FC 4.872 4.7 40.0 64.2 SFO Matt, F.J., 1990 normalised (d) 26.7 For PECgw/sw/sed Aggregated DT50 (n=1) Smith, A. (1989) Maximum (d) 41 for PECsoil (not normalised) Aggregated DT50 (n=14) 5.4.2 Adsorption/desorption MCPA The KFoc values were analysed 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 5.4-2: KF, KFoc and 1/n (Freundlich exponent) values for MCPA Soil Type OC pH Kf Kfoc 1/n Reference (%) (-) (mL g-1) (mL g-1) (-) Clay loam, California 1.20 7.80 0.460 38 0.720 Goodwin P A and Sand, Florida 0.52 5.00 0.816 157 0.710 Laskowski D A, Silt loam, Ohio 1.22 5.80 1.160 95 0.700 (1988) (SANCO/40 62/2001- Sandy loam, Ohio 0.81 7.30 0.490 60 0.700 final – 11/06/2008) Silt loam, Illinois 2.23 5.90 1.490 67 0.707 Fernando T R, (1992) Sandy loam, California* 0.22 7.50 0.050 (23) (0.500) (SANCO/40 62/2001- Loam, North Dakota 3.08 6.80 1.990 65 0.721 final – 11/06/2008) Clay, Massachusetts 1.26 7.00 1.070 85 0.686 Arithmetic mean (n=7) 81 0.706 * not considered for further calculation as oc < 0.3 % (on EU level this soil has been considered) Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 8 of 20 Table 5.4-3: Statistical values according to INPUT DECISION 3.3 for MCPA for PECGW modelling Does the active substance dissociate ? yes, pKa = 3.73 LoEP correlation Kfoc and pH Kendall-τ: -0.810 significant ‰ use pH tool p-value: 0.016 correlation Kf and pH - not significant correlation Kf and oc Kendall-τ: 0.619 positiv significant p-value: 0.036 (p-Wert < significance level) coefficient of variation Kfoc 47 sufficiently low (≤ 60%) coefficient of variation Kf 51 sufficiently low (≤ 100%) Correlation Kf and other soil parameters - not significant (clay, CEC) Kfoc/Kf for PECGW 158.7 at pH 5 pH dependence result by Input 62.8 at pH 9 Decision 3.3 Kfoc/Kf for PECSW 81 arithmetic mean of 7 soils 1/n PECgw 0.706 arithmetic mean of 7 soils 5.4.3 Rate of degradation in water/sediment MCPA Please refer to the core assessment, part B, section 5, point 5.4.3. Accumulation of active substance and relevant metabolites in the sediment active substance MCPA accumulation potential in sediment no (DT90,whole system < 1 year, see core assessment, part B, section 5, chapter 5.4.3) accumulation factor (SFO) - -kt -kt faccu = e /(1 – e ) Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 9 of 20 5.5 Estimation of concentrations in soil (KIIIA1 9.4) Results of PECsoil calculation for U 46 M Fluid according to EU assessment considering 5 cm soil depth are given in the core assessment, part B, section 5, chapter 5.5. For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittel- wirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999). Generally for active substances with a KFoc < 500 a soil depth of 2.5 cm is applied whereas for active substances with a KFoc > 500 a soil depth of 1 cm is applied. As soil bulk density 1.5 g cm-3 is assumed. Due to the fast degradation of the active substance MCPA in soil (DT90 < 365 d, laboratory data) the accumulation potential of MCPA does not need to be considered. The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented in Table 5.5-1. Table 5.5-1: Input parameters for U 46 M Fluid for PECsoil calculation Active substance DT50 MCPA Not required for PECsoil Additional PECsoil,act was calculated for the formulation U 46 M Fluid 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 MCPA as well as for the formulation U 46 M Fluid are summarized in the table below. Table 5.5-2: Application related input parameters for PECSoil calculations Plant protection product U 46 M Fluid Use No.: 001, 002 003 004 005 Crop: Winter and grassland Pome and stone Grape vine spring cereals fruits Application rate: 1.4 L/ha 2 L/ha 2 L/ha 4 L/ha 700 g a.s./ha 1000 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha Number of applications/interval: 1 x Crop interception: 25 % 90 % 0 % 0 % To achieve a concise risk assessment, the risk envelope approach is applied. Here, the exposure assessment for the use group D also covers the exposure assessment for all other intended uses in groups A, B and C. Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 10 of 20 Table 5.5-3: Results of PECsoil calculation for the intended use in grape vine for German risk assessment (Group D, use No 00-005) active substance/ soil relevant soil depthact PECact tillage PECbkgd PECaccu = formulation application rate (cm) (mg/kg) depth (cm) (mg/kg) PECact + (g/ha) PECbkgd (mg/kg) U 46 M Fluid 4512 2.5 12.03 - - - MCPA 2000 2.5 5.33 - - - Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 11 of 20 5.6 Estimation of concentrations in surface water and sediment (KIIIA1 9.7) Results of PECsw calculation of MCPA for the intended uses of U 46 M Fluid in winter and spring cereals, grassland, pome and stone fruits and grape vine using FOCUS Surface Water are given in the core assessment , part B, section 5, chapter 5.6. For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to allow risk mitigation measures separately for each entry route. Surface water exposure via spray drift and volatilization with subsequent deposition is estimated with the model EVA 2.1. Surface water exposure via surface run-off and drainage is estimated using the model EXPOSIT 3.0. The German surface water exposure assessment is outlined in the following chapters. 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. The vapour pressure at 20 °C of the active substance MCPA is between 10-5 and 10-4 Pa. Hence the active substance MCPA is regarded semivolatile (volatilisation only from plant surfaces). Therefore exposure of surface water by the active substance MCPA due to volatilization with subsequent deposition needs to be considered. The calculation of PECsw after exposure via spray drift and volatilization 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. For multiple applications, lower percentiles of the drift values for each application are applied, resulting in an overall 90th percentile of drift probabilities. Only one volatilization event following the last use of pesticide is generally considered. The endpoints used for modelling of surface water exposure via spray drift and volatilization with subsequent deposition with EVA 3 are summarized below. Table 5.6-1: Endpoints of MCPA used for the PECSW calculations with EVA 3 Parameter MCPA Reference vapour pressure at 32 °C (Pa) 4 x 10-4 Pa, extrapolated to 20 °C = See core assessment, section 5, 8.64 x 10-5 Pa point 5.3.1.2 Solubility in water at 25 °C (mg/L) 293900 (at pH 7) See core assessment, section 5, point 5.3.1.2 DissT50 water (d) not required for single applications - DegT50 water/sediment study, total not required for single applications - system (d) The calculated PECsw values after exposure via spray drift and volatilization with subsequent deposition for MCPA for the intended use of U 46 M Fluid in winter and spring cereals, grassland, pome and stone fruits and grape vine according to use No. 00-001 to 00-005 are presented in the National addendum Germany, part B, section 6, chapter 6.5 considering the following input parameters related to the application. Table 5.6-2: Input parameters for U 46 M Fluid used for PECSW calculations with EVA 3 Use No.: 00-001, 00-002 00-003 00-004 00-005 Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 12 of 20 Number of applications/ interval: 1 x Application rate 700 g a.s./ha 1000 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha (g a.s./ha) Drift scenario: Arable crops Arable crops Arable crops Arable crops 5.6.2 PECSW after exposure by surface run-off and drainage The concentration of the active substance MCPA in adjacent ditch due to surface runoff and drainage is calculated using the model EXPOSIT 3.01. The substance specific input parameters used for modelling surface water exposure via run-off and drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in chapter 5.7.2 of this document. The calculated PECSW in an adjacent ditch due to surface run-off and drainage for the active substance MCPA for the intended use of U 46 M Fluid in winter and spring cereals, grassland, pome and stone fruits and grape vine according to use No. 00-001 to 00-005 are presented in the National addendum Germany, part B, section 6, chapter 6.5 considering the following input parameters related to the application. Table 5.6-3: Input parameters related to the application for PECsw calculations with Exposit 3.01 Use No.: 00-001, 00-002 00-003 00-004 00-005 Number of applications/ interval: 1 x Application rate 700 g a.s./ha 1000 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha (g a.s./ha) Crop interception: 25 % 90 % 0 % 0 % Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 13 of 20 5.7 Risk assessment for groundwater (KIIIA1 9.6) Results of the PECgw calculation of MCPA for the intended uses of U 46 M Fluid in winter and spring cereals, grassland, pome and stone fruits and grape vine according to EU assessment using FOCUS PELMO 5.5.3 are given in the core assessment, part B, section 5, chapter 5.7. For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and drainage of the active substance into an adjacent ditch with subsequent bank filtration into the groundwater. Direct leaching after soil passage is assessed following the recommendations of the publication of Holdt et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental concentrations of active substances of plant protection products and their metabolites in groundwater (PECGW) in the National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011) for tier 1 and tier 2 risk assessment. According to Holdt 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. 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 The worst case scenario used for PECgw modelling is summarized in Table 5.7-1. It covers the intended uses of U 46 M Fluid in winter and spring cereals, grassland, pome and stone fruits and grape vine according to Table 5.2-1 . Table 5.7-1: Input parameters related to application for PECGW modelling with FOCUS PELMO 5.5.3 Plant protection product U 46 M Fluid Use No. 001, 002 003 004 005 Application rate 700 g a.s./ha 1000 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha Crop (crop rotation) winter spring grassland pome and stone grape vine cereals cereals fruits Application date(s) 5 d after 156 d after 1 March – 30 1 March – 30 1 March – emergence emergence September September 30 September Interception (%) 25 % 50 % 0 % 0 % Soil relevant application rate 525 g a.s./ha 500 g a.s./ha 1000 g a.s./ha 2000 g a.s./ha Soil moisture 100 % FC Q10-factor 2.58 Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 14 of 20 Moisture exponent 0.7 Simulation period (years) 26 MCPA The endpoints used for groundwater modelling for MCPA according to INPUT DECISION 3.3 are summarized in Table 5.7-3. Due to pH dependency of Kfoc of MCPA two simulation runs with the relevant FOCUS scenarios are performed. For the first simulation runs the geometric mean DT50 and the arithmetic mean Kfoc of all soils are used as input parameters. PECgw are presented in the core assessment (see chapter 5.7) For the second simulation runs the pH-tool in FOCUS PELMO 5.5.3 is used, thereby the geometric mean DT50 of all soils is used as input parameter. To get appropriate Kfoc – values, the Kfoc – pH relationship is fitted according the sigmoidal function (1) by using the solver tool in the Microsoft EXCEL® software, which is implemented in the EXCEL tool Input Decision 3.3. The fitted Kfoc – pH curve is shown in Figure 5.7-1 and Figure 5.7-2 and shows an acceptable visual fit in the range of the measured Kfoc values. Figure 5.7-1: Fitted relationship between soil pH value and Kfoc KOC-pH water 2500 2000 1500 OC data points K 1000 correlation 500 pKa 0 0,0 5,0 10,0 15,0 pH H2O Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 15 of 20 Figure 5.7-2: Fitted relationship between soil pH value and Kfoc in the range of the measured Kfoc values KOC-pH water 200 150 OC 100 data points K correlation 50 pKa 0 0,0 5,0 10,0 15,0 pH H2O Therefore the calculated Kfoc values can be used for PECGW calculations with FOCUS models. The calculated Kfoc values are summarized in Table 5.7-2. Table 5.7-2: calculated pH dependent Kfoc values of MCPA pH KOC calc 1 1940.8 2 1909.9 3 1648.9 4 720.2 5 158.7 6 72.8 7 63.8 8 62.9 9 62.8 10 62.8 11 62.8 Table 5.7-3: Input parameters related to MCPA for PECGW modelling Parameter Endpoint used for PECGW Remarks/Reference calculation Molecular weight (g/mol) 200.6 - DT50 in soil (d) 26.7 n =1, normalized to pF2, 20°C (Q10 = 2.58), slightly different from EU endpoint (DT50 = 24 d, not normalized), (see point 5.4.1). Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 16 of 20 KFoc Calculated .KFoc -values for pH- pH – dependence tool: (see above) 158.7 at pH 5 62.8 at pH 9 1/n 0.706 arithm. mean, n=7 (see point 5.4.2) pKs 3.73 see LoEP Plant uptake factor 0 default The results of the groundwater simulation are presented in Table 5.7-4. Table 5.7-4: PECGW at 1 m soil depth of MCPA considered relevant for German exposure assessment (simulation run due to pH dependency) th -1 80 Percentile PECGW at 1 m soil depth (µg L ) modeled by FOCUS PELMO 5.5.3 Use No. Scenario MCPA 00-001, Hamburg 0.000 00-002, 00-003, Kremsmünster 0.000 00-004 Application on 1 March 15 August 1 September 30 September 00-005 Hamburg 0.001 0.028 0.052 0.126 Kremsmünster 0.017 0.085 0.154 0.191 According to the results of the groundwater simulation with FOCUS PELMO 5.5.3, a groundwater contamination of the active substance MCPA in concentrations ≥ 0.1 µg/L is not expected for the intended use in winter and spring cereals, grassland, pome and stone fruits (use No. 00-001 to 00-004), whereas for the intended use in grape vine (use No. 00-005) a groundwater contamination of the active substance MCPA in concentrations ≥ 0.1 µg/L cannot be excluded for applications after 15 August. 5.7.1.2 Summary on risk assessment for groundwater after direct leaching Results of modelling with FOCUS PELMO 5.5.3 show that the active substance MCPA is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended of U 46 M Fluid uses in winter and spring cereals, grassland, pome and stone fruits according to use No. 00-001 to 00-004, whereas for the intended use in grape vine (use No. 00-005) a groundwater contamination of the active substance MCPA in concentrations ≥ 0.1 µg/L cannot be excluded for applications after 15 August. Consequences for authorization: Use no. 00-005: to restrict application from March to 15 August Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 17 of 20 5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and drainage MCPA The input parameters for MCPA used for modelling surface water exposure via run-off and drainage in an adjacent ditch with subsequent bank filtration into the groundwater with EXPOSIT 3.0 are summarized in Table 5.7-5. Table 5.7-5: Input parameters for MCPA used for PECGW calculations with EXPOSIT 3.01 Parameter MCPA Reference K Foc, Runoff 81 arithm. Mean, n=7 (see point 5.4.2) slghtly different from EU endpoint (Koc = 74). Difference in endpoint does not change outcome of assessment. KFoc, mobility class 81 arithm. Mean, n=7 (see point 5.4.2) DT50 soil (d) 26.7 n=1, normalized to pF2, 20°C, (Q10 = 2.58), slightly different from EU endpoint (DT50 = 24, not normalized) Difference in endpoint does not change outcome of assessment. Solubility in water (mg/L) 294000 see core assessment, section 5, point 5.3.2 Mobility class - Reduction by bank filtration 74% measured values, see Schmidt, 2005 (TZW Karlsruhe) The calculated PECgw for MCPA after surface run-off and drainage with subsequent bank filtration are summarized in Table 5.7-6. Table 5.7-6: PECgw for MCPA after surface run-off and drainage with subsequent bank filtration (modelled with EXPOSIT 3.01) Active substance MCPA Use No. application PECgw due to rate run-off drainage interception vegetated buffer bank filtrate Time of bank filtrate strip (µg/L) application (µg/L) (m) 00-001, 00-002 1 x 700 g 0 0.077 spring/summer 0.032 a.s./ha, 5 - 25 % 10 - autumn/winter/ Not relevant 20 - early spring required labelling none 00-003 1 x 1000 g 0 0.073 spring/summer 0.030 a.s./ha, 5 - 50 % 10 - autumn/winter/ Not relevant 20 - early spring required labelling none Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 18 of 20 00-004 1 x 1000 g 0 0.146 spring/summer 0.060 a.s./ha, 5 0.126 0 % 10 0.108 autumn/winter/ Not relevant 20 0.076 early spring required labelling NG 404 (20 m vegetated buffer strip) 00-005 1 x 2000 g 0 0.292 spring/summer 0.120 a.s./ha, 5 0.253 0 % 10 0.217 autumn/winter/ Not relevant 20 0.152 early spring required labelling No authorization possible due to runoff., NG 405 According modelling with EXPOSIT 3.01 groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance MCPA due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded for the uses according to use No. 00-001, 00-002, 00-003 and 00-004 if approbriate risk mitigation measures (vegetated buffer strip of 20 m) are applied. For the intended use in grape vine (use No. 00-005) groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance MCPA due to surface run-off into the adjacent ditch with subsequent bank filtration can not be excluded. Consequences for authorization: No authorization is possible for the use No 00-005 due to contamination of groundwater by MCPA at concentration > 0.1 µg/L due to surface runoff into the adjacent ditch with subsequent bank filtration The authorization of the plant protection product U 46 M Fluid according to use No 00-001, 00-002, 00-003 and 00-004 is linked with following labeling: Use No. 00-004 NG 404 Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 19 of 20 Appendix 1 List of data submitted in support of the evaluation Table A 1: List of data submitted in support of the evaluation Annex Author(s) Year Title Data Owner How considered point/referenc Source (where different from protection in dRR e No company) claimed Study- Report-No. Status/Usage* GLP or GEP status (where relevant), Published or not Authority registration No OECD: Simmons, 2013a Calculation of Predicted Y Nufarm 1)** KIIIA1 9.6.1 K. Environmental and 9.7 Concentrations in Groundwater (PECgw) and Surface Water (PECsw) of the Active Substance MCPA Following Application to Spring and Winter Cereals using FOCUS PELMO 5.5.3, EXPOSIT 3.0 Beta and EVA 2.1 Report No. NUF2013-68 ! 2013a BVL No. 2587732 OECD: Simmons, 2013b Calculation of Predicted Y Nufarm 1)** KIIIA1 9.6.1 K. Environmental and 9.7 Concentrations in Groundwater (PECgw) and Surface Water (PECsw) of the Active Substance MCPA Following Application to Grassland and Orchard Floor using FOCUS PELMO 5.5.3, EXPOSIT 3.0 Beta and EVA 2.1 Report No. NUF2013-68 ! 2013b BVL No. 2587739 * 1) accepted (study valid and considered for evaluation) 2) not accepted (study not valid and not considered for evaluation) 3) not considered (study not relevant for evaluation) 4) not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5) supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation) ** partly accepted (study valid and partly considered for evaluation) Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 5 CA2643 Registration Report National Addendum– Germany Central Zone zRMS: DE Page 20 of 20 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). KIIIA1 9 Fate and Behaviour in the Environment KIIIA1 9.6.1 and 9.7 Simmons, 2013a Reference: OECD: KIIIA1 9.6.1 and 9.7 Author Simmons, K. Report: Calculation of Predicted Environmental Concentrations in Groundwater (PECgw) and Surface Water (PECsw) of the Active Substance MCPA Following Application to Spring and Winter Cereals using FOCUS PELMO 5.5.3, EXPOSIT 3.0 Beta and EVA 2.1 Date: 02.12.2013 Guideline(s): - Deviations: - GLP: Not relevant Acceptability: yes KIIIA1 9.6.1 and 9.7 Simmons, 2013b Reference: OECD: KIIIA1 9.6.1 and 9.7 Author Simmons, K. Report: Calculation of Predicted Environmental Concentrations in Groundwater (PECgw) and Surface Water (PECsw) of the Active Substance MCPA Following Application to Grassland and Orchard Floor using FOCUS PELMO 5.5.3, EXPOSIT 3.0 Beta and EVA 2.1 Date: 02.12.2013 Guideline(s): - Deviations: - GLP: Not relevant Acceptability: yes PEC calculations were performed by Germany. The studies by Simmons are used as information only. Nufarm Evaluator: Germany (UBA) June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 1 of 49 REGISTRATION REPORT Part B Section 6: Ecotoxicological studies Detailed summary of the risk assessment Product code: U 46 M-Fluid Active Substance: MCPA 500 g/L as DMA salt 612.35 g/L Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Nufarm Date: June 2016 Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 2 of 49 Table of Contents SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)...... 5 6.1 GAP AND OVERALL CONCLUSIONS ...... 6 6.1.1 Table of intended uses ...... 6 6.1.2 Grouping of intended uses for risk assessment ...... 8 6.1.3 Consideration of metabolites ...... 8 6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1) ...... 9 6.2.1 Justification for new endpoints ...... 9 6.2.2 Risk assessment (MIIIA 10.1.1, MIIIA 10.1.2) for spray applications ...... 9 6.2.3 Biomagnification in terrestrial food chains ...... 14 6.2.4 Risk assessment (MIIIA 10.1.3, MIIIA 10.1.4, MIIIA 10.1.5) for baits, pellets, granules, prills or treated seed ...... 14 6.2.5 Overall conclusions ...... 14 6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC 10.1.2) ...... 15 6.3.1 Justification for new endpoints ...... 15 6.3.2 Risk assessment (MIIIA 10.3.1) for spray applications ...... 15 6.3.3 Biomagnification in terrestrial food chains ...... 23 6.3.4 Risk assessment (MIIIA 10.3.1) for baits, pellets, granules, prills or treated seed ...... 23 6.3.5 Overall conclusions ...... 23 6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC 10.1.3) ...... 23 6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ...... 23 6.5.1 Justification for new endpoints ...... 25 6.5.2 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ...... 25 6.5.3 Overall conclusions ...... 27 6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) ...... 27 6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ...... 27 6.7.1 Justification for new endpoints ...... 30 6.7.2 Risk assessment ...... 30 6.7.3 Overall conclusions ...... 32 6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1, KPC 10.4.2) ...... 32 6.8.1 Justification for new endpoints ...... 32 6.8.2 Risk assessment (MIIIA 10.6.1) ...... 32 6.8.3 Overall conclusions ...... 33 6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) ...... 34 6.9.1 Justification for new endpoints ...... 34 6.9.2 Risk assessment ...... 34 6.9.3 Overall conclusions ...... 35 6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) ...... 35 6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) ...... 35 6.10.2 Justification for new endpoints ...... 35 6.10.3 Risk assessment ...... 35 6.11 EFFECTS ON OTHER TERRESTRIAL ORGANISMS (FLORA AND FAUNA) (KPC 10.7) ...... 38 6.12 MONITORING DATA (KPC 10.8) ...... 38 6.13 AVAILABLE PRELIMINARY DATA (IIIA 10.9) ...... 38 6.14 OTHER/SPECIAL STUDIES (IIIA 10.10) ...... 38 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ...... 39 APPENDIX 2 DETAILED EVALUATION OF THE NEW STUDIES ...... 43 Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 3 of 49 Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 5 of 49 ECOTOXICOLOGICAL STUDIES (MIIIA 10) This document reviews the ecotoxicological studies for the product „U 46 M-Fluid“ containing the active substance MCPA, which is currently approved under Reg. (EC) No 1107/2009 (repealing Directive 91/414/EEC) and fulfils the criteria according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. „U 46 M-Fluid“ was one of the representative formulation considered in the EU review process as part of the approval of the MCPA. The studies with the relevant endpoints for each non-target organism group were agreed during EU review process and are used for the risk assessment. Reference is made to the following documents, if not otherwise labelled with an asterisk: MCPA: Review Report SANCO/4062/2001-final, 11 July 2008 Full details of toxicity studies are provided in the respective EU DAR. The applicant provides further studies with the formulation „U 46 M-Fluid“ and for the active substance MCPA and its major metabolites. Detailed study summaries for the studies performed with the formulated product „U 46 M-Fluid“ and for other new studies are presented in Appendix 2. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 6 of 49 6.1 GAP and overall conclusions 6.1.1 Table of intended uses Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 7 of 49 Table 1: GAP and overall conclusions Max number Application per treatment Overall conclusions Timing Intended appl. Rate/season F/G (months, kg a.s./ha Aquatic Non-target Soil Non-target use (interval in [kg a.s./ha] Birds Mammals Bees BBCH) max organisms arthropods organisms plants days) max 001 F After 1 700 700 emergence A R R A A A R BBCH 13 – 39 spring 002 F After 1 700 700 emergence A R R A A A R BBCH 13 – 39 spring 003 F May to August 1 1000 1000 A R R A A A R 004 F March to 1 1000 1000 A R R A A A R September 005 F March to 1 2000 2000 A R R A A A R September F: Field use; G: Glasshouse use A Acceptable,Safe use identified Remarks: R Further refinement and/or risk mitigation measures are needed N No safe use identified and considered possible Explanations: The colours in the Table 6-1 are intended to reflect the outcome of the assessments including the available and valid refinement steps and risk mitigations measures. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 8 of 49 6.1.2 Grouping of intended uses for risk assessment 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 2: Critical use pattern of „U 46 M-Fluid“ Group Crop/growth Application Number of applications, Application rate, Soil effective (use stage method / Minimum application cumulative application rate No.) Drift scenario interval, interception, (g as/ha) (g as/ha) application time (season) A (001, Winter and spraying / 1 x, spring MCPA 1 x 700, MCPA 002) spring wheat arable crops 25 % interception 1 x 525 BBCH 13-39 6 April B (003) grassland spraying / 1 x, May to August MCPA 1 x 1000 MCPA arable crops 90 % interception 1 x 100 C (004) Pome and stone spraying 1 x, March to September MCPA 1 x 1000 MCPA fruits 0 % interception 1 x 1000 D (005) grape vine spraying with 1 x, March to September MCPA 1 x 2000 MCPA screen , up to 0 % interception 1 x 2000 3rd year after planting of the vine 6.1.3 Consideration of metabolites No relevant metabolites of MCPA need to be considered for exposure assessment (see also dRR, Part B, section 5) Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 9 of 49 6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1) Table 3: Endpoints used for risk assessment for birds Species Substance Exposure Results Reference Internal System code Colinus MCPA DMA-salt Acute LD50: 270 mg XXX 3943 virginianus a.s./kg bw 1986 222-102 EU-Review report MCPA (2008) Colinus MCPA-acid Long-term NOEC: 93.2 mg XXX 26728 virginianus a.s./kg bw 1994 (equivalent to 1000 364-102 ppm) EU-Review report MCPA (2008) 6.2.1 Justification for new endpoints Not applicable. 6.2.2 Risk assessment (MIIIA 10.1.1, MIIIA 10.1.2) for spray applications The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438; hereafter referred to as EFSA/2009/1438). 6.2.2.1 Tier 1 risk assessment The results of the acute and reproductive Tier 1 risk assessments are summarized in the following tables (TER values in bold fall below the trigger value). Since there is no crop scenario defined in EFSA/2009/1438for the intended use of “U46 M –Fluid” in vine (group D, use No 00-005) the risk assessment follows the risk assessment for group C in orchards (non crop directed use). Table 4: First-tier assessment of the acute and long-term/reproductive risk for birds due to the use of „U 46 M-Fluid“ in cereals (group A) Intended use Group A (00-001 and 00-002), cereals Active substance/product MCPA Application rate (g/ha) 1 x 700 g a.s./ha Acute toxicity (mg/kg bw) 270 mg/kg bw TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Cereals, BBCH 10- Small omnivorous bird "lark" 24 1.0 16.8 16.1 29 Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 10 of 49 Cereals, BBCH 30- Small omnivorous bird "lark" 12 1.0 8.4 32.1 39 Reprod. toxicity (mg/kg bw/d) 93.2 mg/kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Cereals, BBCH 10- Small omnivorous bird "lark" 10.9 0.53 4.02 23.2 29 Cereals, BBCH 30- Small omnivorous bird "lark" 5.4 0.53 1.99 46.8 39 Table 5: First-tier assessment of the acute and long-term/reproductive risk for birds due to the use of „U 46 M-Fluid“ on grassland (group B) Intended use Group B (00-003), grassland Active substance/product MCPA Application rate (g/ha) 1 x 1000 g a.s./ha Acute toxicity (mg/kg bw) 270 mg/kg bw TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Growing shoots Large herbivorous bird "goose" 30.5 1.0 30.5 8.9 Growing shoots Small insectivorous bird 26.8 1.0 26.8 10.1 "wagtail" Reprod. toxicity (mg/kg bw/d) 93.2 mg/kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Growing shoots Large herbivorous bird "goose" 16.2 0.53 8.53 10.9 Growing shoots Small insectivorous bird 11.3 0.53 5.95 15.7 "wagtail" Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 11 of 49 Table 6: First-tier assessment of the acute and long-term/reproductive risk for birds due to the use of „U 46 M-Fluid“ in orchards (not crop directed) (group C) Intended use Group C (00-004), orchards (not crop directed) Active substance/product MCPA Application rate (g/ha) 1 x 1000 g a.s./ha Acute toxicity (mg/kg bw) 270 mg/kg bw TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Not crop directed Small granivorous bird "finch" 27.4 1.0 27.4 10 applic. all season Not Crop directed Small insectivorous/vermivorous 7.4 1.0 7.4 36.5 applic. all season bird "thrush" Reprod. toxicity (mg/kg bw/d) 93.2 mg/kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Not crop directed Small granivorous bird "finch" 12.6 0.53 6.64 14 applic. all season Not Crop directed Small insectivorous/vermivorous 2.7 0.53 1.42 65.5 applic. all season bird "thrush" Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 12 of 49 Table 7: First-tier assessment of the acute and long-term/reproductive risk for birds due to the use of „U 46 M-Fluid“ in vineyards (not crop directed) (group D) Intended use Group D (00-005), vine not crop directed Active substance/product MCPA Application rate (g/ha) 1 x 2000 g a.s./ha Acute toxicity (mg/kg bw) 270 mg/kg bw TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Not crop directed Small granivorous bird "finch" 27.4 1.0 54.80 4.9 applic. all season Not Crop directed Small insectivorous/vermivorous 7.4 1.0 14.80 18.2 applic. all season bird "thrush" Reprod. toxicity (mg/kg bw/d) 93.2 mg/kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage* TWA (mg/kg bw/d) Not crop directed Small granivorous bird "finch" 12.6 0.53 13.274 7.0 applic. all season Not Crop directed Small insectivorous/vermivorous 2.7 0.53 2.844 32.8 applic. all season bird "thrush" 6.2.2.2 Refined acute risk assessment for „U 46 M-Fluid“/MCPA in grassland (group B) and vineyards (group D) Refined acute toxicity endpoint: The applicant proposes a refinement of the acute toxicity value considering results of the dietry toxicity. MCPA has been shown to be rapidly assimilated and excreted. Therefore, the dietary administration more accurately reflects the type of exposure to which wild birds may be subjected to when consuming treated vegetation or other food matter. (see also EU assessment, Addendum 3 to Volume 3 B.9, February 2009) For EU approval of MCPA two dietry studies are available. The dietry toxicity value of LD50 > 803 mg MCPA/ kg bw is used for refined risk assessment. Species Substance Exposure Results Reference Internal System code Anas MCPA-DMA-Salt 8 d LD50 > 4608 mg XXX 27610 platyrhynchos acid/kg (Futter) bzw. 12.02.1988 > 802 mg acid/kg bw Project No. 103- LD50 > 5620 mg 285 DMA salt (Futter) bzw. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 13 of 49 983 mg DMA salt/kg bw Colinus MCPA-DMA-Salt 8 d LD50 > 5620 mg XXX 27612 virginianus DMA salt/kg 12.02.1988 (Futter) bzw. Project No. 103- > 2415 mg acid/kg 284 bw Table 8: Refinement of acute risk assessment for Large herbivorous bird "goose"exposed to MCPA according to EFSA Journal (2009) in grassland (Group A). Intended use Group B (00-003), grassland Active substance/product MCPA Application rate (g/ha) 1 x 1000 g a.s./ha Acute toxicity (mg/kg bw) > 802 mg/kg bw (refined endpoint from dietry study) TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Growing shoots Large herbivorous bird "goose" 30.5 1.0 30.5 26.3 Table 9: Refinement of reproductive risk assessment for small granivorous bird "finch"exposed to MCPA according to EFSA Journal (2009) in vine (Group D). Intended use Group D (00-005), vine not crop directed Active substance/product MCPA Application rate (g/ha) 1 x 2000 g a.s./ha Acute toxicity (mg/kg bw) > 802 mg/kg bw (refined endpoint from dietry study) TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Not crop directed Small granivorous bird "finch" 27.4 1.0 54.80 14.6 applic. all season 6.2.2.3 Drinking water exposure Where necessary, the assessment of the risk for birds due to uptake of contaminated drinking water is conducted for a small granivorous bird with a body weight of 15.3 g (Carduelis cannabina) and a drinking water uptake rate of 0.46 L/kg bw/d (cf. Appendix K of EFSA/2009/1438). Puddle scenario Due to the characteristics of the exposure scenario in connection with the standard assumptions for water uptake by animals (see below), no specific calculations of exposure and TER are necessary when the ratio of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 14 of 49 of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg). A comparison of the relevant endpoints with the effective application rates for MCPA is presented below. Table 10: Application rate to endpoint ratios for birds exposed to MCPA Intended Exposure Effective Koc LD50/NOEL Ratio use Scenario application rate* Application Rate : endpoint [g a.s./ha]* [L/kg] [mg a.s./kg bw] MCPA Group D Acute 2000** 74 270 7.4 Long-term 93.2 21.5 * effective application rate = application rate multiplied by mean MAF ** maximum application rate cover ing the risk for birds from all other intended uses in groups A, B and C Leaf scenario Since „U 46 M-Fluid“ is not intended to be applied on leafy vegetables forming heads or other water collecting structures, the leaf scenario does not have to be considered. 6.2.2.4 Effects of secondary poisoning (MIIIA 10.1.9) The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6 "Bioaccumulation and food chain behaviour"). Since the log Kow values of MCPA is -0.81 (pH=7), the active substance is deemed to have a negligible potential to bioaccumulate in animal tissues. No formal risk assessment from secondary poisoning is therefore required. 6.2.3 Biomagnification in terrestrial food chains Not relevant. 6.2.4 Risk assessment (MIIIA 10.1.3, MIIIA 10.1.4, MIIIA 10.1.5) for baits, pellets, granules, prills or treated seed Not relevant. 6.2.5 Overall conclusions Dietary risk assessment Based on tier 1 and higher tier assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of birds to MCPA (oral exposure and exposure via drinking water and secondary poisoning) according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable acute and long-term risk for Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 15 of 49 birds due to the intended use of „U 46 M-Fluid“ in cereals , on grassland and in orchards and vineyards according to the label. 6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1, KPC 10.1.2) Table 11: EU agreed endpoints and new endpoints Species Substance Exposure Results Reference Internal System code Rat MCPA DMA- Acute oral LD50 = 962 mg a.s/kg XXX -- salt toxicity bw/d 1983 84/108 EU-Review report MCPA (2008) Rat MCPA acid Long- term NOEL = 37.8 mg a.s/kg XXX -- bw/d 1986 (90 d rat study at 450 EU-Review report ppm) MCPA (2008) 6.3.1 Justification for new endpoints Not necessary. 6.3.2 Risk assessment (MIIIA 10.3.1) for spray applications The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438; hereafter referred to as EFSA/2009/1438). 6.3.2.1 Tier-1 risk assessment The results of the acute and reproductive Tier 1 risk assessments are summarized in the following tables. Table 12: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of „U 46 M-Fluid“ in cereals (group A) Intended use Group A (00-001 and 00-002), cereals Active substance/product MCPA Application rate (g/ha) 1 x 700 g a.s./ha Acute toxicity (mg/kg bw) 962 mg/kg bw TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Cereals Large herbivorous mammal 42.1 1 29.47 32.6 Early (shoots) "lagomorph"* Cereals Small omnivorous mammal 17.2 1 12.04 79.9 BBCH 10-29 "mouse"* Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 16 of 49 Reprod. toxicity (mg/kg bw/d) 37.8 mg /kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Cereals Large herbivorous mammal 22.3 0.53 8.223 5 Early (shoots) "lagomorph"* Cereals Small omnivorous mammal 7.8 0.53 2.876 13.1 BBCH 10-29 "mouse"* * generic focal species with highest shortcut values, generic focal species with smallest shortcut values hence TER value above the acceptability criteria are omitted. Table 13: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of „U 46 M-Fluid“ on grassland (group B) Intended use Group B (00-003), grassland Active substance/product MCPA Application rate (g/ha) 1 x 1000 g a.s./ha Acute toxicity (mg/kg bw) 962 mg/kg bw TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Grassland Large herbivorous mammal 32.6 1.0 32.6 29.5 All season "lagomorph" Grassland Small herbivorous mammal 136.4 1.0 136.4 7.1 All season "vole" Reprod. toxicity (mg/kg bw/d) 37.8 mg /kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Grassland Large herbivorous mammal 32.6 0.53 9.11 4.1 All season "lagomorph" Grassland Small herbivorous mammal 136.4 0.53 38.08 1.0 All season "vole" Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 17 of 49 Table 14: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of „U 46 M-Fluid“in orchards (not crop directed) (group C) Intended use Group C (00-004), orchards (not crop directed) Active substance/product MCPA Application rate (g/ha) 1 x 1000 g a.s./ha Acute toxicity (mg/kg bw) 962 mg/kg bw TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Orchard, Applic. Small insectivorous mammal 5.4 1.0 5.4 178 crop dir. BBCH <10 "shrew" or not crop dir. Orchard, Applic. Small herbivorous mammal 136.4 1.0 136.4 7.1 crop dir. BBCH <10 "vole" or not crop dir. Orchard, Applic. Large herbivorous mammal 35.1 1.0 35.1 27.4 crop dir. BBCH <10 "lagomorph" or not crop dir. Orchard, Applic. Small omnivorous mammal 17.2 1.0 17.2 55.9 crop dir. BBCH <10 "mouse" or not crop dir. Reprod. toxicity (mg/kg bw/d) 37.8 mg /kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Orchard, Applic. Small insectivorous mammal 1.9 0.53 1.0 37.8 crop dir. BBCH <10 "shrew" or not crop dir. Orchard, Applic. Small herbivorous mammal 72.3 0.53 38.08 1.0 crop dir. BBCH <10 "vole" or not crop dir. Orchard, Applic. Large herbivorous mammal 14.3 0.53 7.533 5.0 crop dir. BBCH <10 "lagomorph" or not crop dir. Orchard, Applic. Small omnivorous mammal 7.8 0.53 4.109 9.2 crop dir. BBCH <10 "mouse" or not crop dir. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 18 of 49 Table 15: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of „U 46 M-Fluid“in vine (not crop directed) (group D) Intended use Group D (00-005), vine not crop directed Active substance/product MCPA Application rate (g/ha) 1 x 2000 g a.s./ha Acute toxicity (mg/kg bw) 962 mg/kg bw TER criterion 10 Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Orchard, Applic. Small insectivorous mammal 5.4 1.0 10.8 89.1 crop dir. BBCH <10 "shrew" or not crop dir. Orchard, Applic. Small herbivorous mammal 136.4 1.0 272.8 3.5 crop dir. BBCH <10 "vole" or not crop dir. Orchard, Applic. Large herbivorous mammal 35.1 1.0 70.2 13.7 crop dir. BBCH <10 "lagomorph" or not crop dir. Orchard, Applic. Small omnivorous mammal 17.2 1.0 34.4 28.0 crop dir. BBCH <10 "mouse" or not crop dir. Reprod. toxicity (mg/kg bw/d) 37.8 mg /kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Orchard, Applic. Small insectivorous mammal 1.9 0.53 2.00 18.9 crop dir. BBCH <10 "shrew" or not crop dir. Orchard, Applic. Small herbivorous mammal 72.3 0.53 76.168 0.5 crop dir. BBCH <10 "vole" or not crop dir. Orchard, Applic. Large herbivorous mammal 14.3 0.53 15.065 2.5 crop dir. BBCH <10 "lagomorph" or not crop dir. Orchard, Applic. Small omnivorous mammal 7.8 0.53 8.217 4.6 crop dir. BBCH <10 "mouse" or not crop dir. Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ does achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the uses according to use No. 00-001 and 00-002. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 19 of 49 Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ do not achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the following uses: - Group B (grassland): acute risk for small herbivorous mammals and long-term risk for large and small herbivorous mammals - Group C (orchard): acute risk and and long-term risk for small herbivorous mammals - Group D (vineyards): acute risk for small herbivorous mammals and long-term risk for large and small herbivorous mammals and small omnivorous mammal A refined riks assessment is required. 6.3.2.2 Higher tier acute risk assessment for „U 46 M-Fluid“ The following refinement options are applied for risk assessment. Refined acute toxicity: Acute toxicity endpoint given in LoEP is based on the acute toxicity of female rats. The mean toxicity in the test (male an female rats) is 1160 mg/kg bw (XXX, 1983). Table 16: Refined acute risk assessment for mammals due to the use of „U 46 M-Fluid“ Acute toxicity (mg/kg bw) 1160 mg/kg bw TER criterion 10 Use Indicator/generic focal species SV90 MAF90 DDD90 TERa Application rate (mg/kg bw/d) Group B (00-003) Small herbivorous mammal 136.4 1.0 136.4 8.5 Group C (00-004) "vole" 1000 g a.s./ha Group D (00-005) Small herbivorous mammal 136.4 1.0 272.8 4.3 2000 g a.s./ha "vole" The applicant provided two additional dietry toxicity studies on female mice (Lowe, 2008; Lowe, 2009). The test anmimals were feeded for 24 hour with test diet containing MCPA –DMA salt. In study 1 by XXX (2008) a mean acute dietry intake of 2393 mg MCPA acid equivalent/kg bw did not cause any mortality or evoke any detectable toxic response in mice. Foodconsumption was slightly reducued compared to the intake estimated prior treatment. The LDD50 is > 2393 mg MCPA/kg bw. In study 2 (XXX, 2009) a mean acute dietary (24 hour) intake of 1429 mg MCPA acid equivalent/kg in female mice did not cause any mortality or evoke any detectable toxic response. Food consumption was 1.7 g per mouse and bodyweight was 23.8g. It can be seen that despite being starved for 4 hours prior to being offered the diet, there was a significant reduction in diet consumption. This indicates that there is a clear Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 20 of 49 avoidance of treated diet. Nevertheless food was consumed and the intake could be calculated. The LDD50 is > 1429 mg/kg bw. MCPA has been shown to be rapidly assimilated and excreted. Therefore, the dietary administration more accurately reflects the type of exposure to which mammals may be subjected to when consuming treated vegetation or other food matter. Considering this aspect the acute risk for mammals exposed to MCPA at application rates of 1000 g a.s./ha is acceptable. Please note that at an application rate of 2000 g a.s./ha (use No. 00-005, vineyards, not crop directed) even the use of the LDD50 > 2393 does not meet the acceptability criteria of TER >= 10. Table 17: Refined acute risk assessment for mammals due to the use of „U 46 M-Fluid“ Acute toxicity (mg/kg bw) > 2393 mg/kg bw TER criterion 10 Use Indicator/generic focal species SV90 MAF90 DDD90 TERa Application rate (mg/kg bw/d) Group D (00-005) Small herbivorous mammal 136.4 1.0 272.8 8.8 2000 g a.s./ha "vole" 6.3.2.3 Higher tier reproductive risk assessment for „U 46 M-Fluid“ Refined long-term toxicity: The refined risk assessment ist based on the toxicological endpoint of NOAEL = 60 mg/kg bw/d (for details see Addendum 3 to Volume 3 B.9, February 2009). Residue decline rate: The applicant proposes a refinement based on a DT50 of MCPA on grass of 2.3 days resulting in a ftwa value of 0.16 (see Bond and Pigott, 2012 in Appendix 2). This is a mean value derived of 9 field trials on grassland in Northern Europe. The residue trials were submitted for EU approval of MCPA. Residues trials in cereals (12 trials) resulted in a DT50 value of 3.1 days corresponding to fwta of 0,21). Considering all residue values (grass and cereals) a mean DT50 of 2.8 days (ftwa = 0.19) is to be applied. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 21 of 49 Table 18: Refined risk assessment of the long-term/reproductive risk for mammals due to the use of „U 46 M-Fluid“ on grassland (group B) and orchards (group C) Intended use Group B (00-003), grassland /group C (00-004), orchards (not crop directed) Active substance/product MCPA Application rate (g/ha) 1 x 1000 g a.s./ha Reprod. toxicity (mg/kg bw/d) 60 mg /kg bw/d (refined toxicity) TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Grassland Large herbivorous mammal 32.6 0.53 9.11 6.6 All season "lagomorph" Grassland Small herbivorous mammal 136.4 0.19 25.92 2.3 All season "vole" Table 19: First-tier assessment of the long-term/reproductive risk for mammals due to the use of „U 46 M-Fluid“in vine (not crop directed) (group D) Intended use Group D (00-005), vine not crop directed Active substance/product MCPA Application rate (g/ha) 1 x 2000 g a.s./ha Reprod. toxicity (mg/kg bw/d) 60 mg /kg bw/d TER criterion 5 Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Orchard, Applic. Small herbivorous mammal 72.3 0.19 27.474 2.2 crop dir. BBCH <10 "vole" or not crop dir. Orchard, Applic. Large herbivorous mammal 14.3 0.19 5.43 11.0 crop dir. BBCH <10 "lagomorph" or not crop dir. Orchard, Applic. Small omnivorous mammal 7.8 0.19 2.96 20.3 crop dir. BBCH <10 "mouse" or not crop dir. Based on tier higher tier assessment step, the calculated TER values for the long-term risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ do not achieve the acceptability criteria TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for all uses. Further refinement needs to be considered on Member state level. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 22 of 49 6.3.2.4 Drinking water exposure Where necessary, the assessment of the risk for mammals due to uptake of contaminated drinking water is conducted for a small omnivorous mammal with a body weight of 21.7 g (Apodemus sylvaticus) and a drinking water uptake rate of 0.24 L/kg bw/d (cf. Appendix K of EFSA/2009/1438). Puddle scenario Due to the characteristics of the exposure scenario in connection with the standard assumptions for water uptake by animals (see below), no specific calculations of exposure and TER are necessary when the ratio of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg). A comparison of the relevant endpoints with the effective application rates for MCPA is presented below. Table 20: Application rate to endpoint ratios for mammals exposed to MCPA Intended Exposure Soil relevant Koc LD50/NOEL Ratio use Scenario Application Rate Application Rate : endpoint [g a.s./ha]* [L/kg] [mg a.s./kg bw] MCPA Group D Acute 2000 74 962 2.1 Long-term 37.8 52.9 Group C Acute 1000** 74 962 1.0 Long-term 37.8 26.5 * effective application rate = application rate multiplied by mean MAF ** application rate covering the risk for birds from other intended uses in groups A and B With a K(f)oc of 74, MCPA belongs to the group of less sorptive substances. Since the ratio of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) exceeds the critical value of 50 for at least one use scenario, a quantitative risk assessment (calculation of TER values) is necessary. Intended use Group D, vine (not crop directed) Active substance MCPA Application rate (g/ha) 1 x 2000 g a.s./ha Acute toxicity (mg/kg bw) 932 TER criterion 10 Reprod. toxicity (mg/kg bw/d) 37.5 TER criterion 5 Soil-relevant Koc PECpuddle DW uptake Daily dose TERa applic. rate (L/kg) (mg/L) (L/kg bw/d) (mg/kg bw/d) (g/ha) TERlt Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 23 of 49 2626 2000 74 1.53 0.24 0.366 102 6.3.2.5 Effects of secondary poisoning (MIIIA 10.3.2.3) The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6 "Bioaccumulation and food chain behaviour"). Since the log Kow values of MCPA is -0.81(pH=7), the active substance is deemed to have a negligible potential to bioaccumulate in animal tissues. No formal risk assessment from secondary poisoning is therefore required. 6.3.3 Biomagnification in terrestrial food chains Not relevant. 6.3.4 Risk assessment (MIIIA 10.3.1) for baits, pellets, granules, prills or treated seed Not relevant. 6.3.5 Overall conclusions Dietary risk assessment Based on higher tier assessment step, the calculated TER values for the acute risk resulting from an exposure of mammals to MCPA (oral exposure and exposure via drinking water and secondary poisoning) according to the GAP of the formulation „U 46 M-Fluid“ achieve/do not achieve the acceptability criteria TER ≥ 10, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. For the long term effects the higher tier assessment did not achieve the acceptability criteria TER ≥ 5 according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the generic foval species “lagomorph”. Further refinement is required on Member State level (see also national addendum Germany). 6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC 10.1.3) Not yet considered. 6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1) Studies on the toxicity to aquatic organisms have been carried out with MCPA as DMA salt. Full details of these studies are provided in the respective EU DAR and related documents. Effects on aquatic organisms of “U 46 M Fluid”were evaluated as part of the EU assessment of MCPA. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 24 of 49 Table 21: Endpoints used for risk assessment for aquatic organisms for MCPA (see SANCO/4062/2001-final (11 July 2008)) Species Substance Exposure Results Reference Internal System code Oncorhynchus MCPA (Herbizid Acute, flow- LC50 (96h) = 50 XXX 40977 mykiss Marks M) through mg MCPA- 1993 DMA/L RCC 409015 LC50 = 41 mg Addendum Vol. 3 B8 ae/L* Pimephales MCPA-DMA-salt Chronic, flow- NOEC = 15 mg XXX 47274 promelas through, 28 d MCPA-DMA/L 10.10.1997 NOEC = 12.2 364A-102 mg/L ae/L* LoEP Daphnia magna MCPA-DMA-salt Acute, 2 d EC50 > 190 mg Putt, A.E. 40781 ae/L* 1992 92-4-4235 DAR Daphnia magna MCPA-DMA-salt 21 d, Durchfluss NOEC = 10.6 mg Drottar, K. 47281 ae/L, real* 10.10.1997 NOEC = 13 mg Report 364A-101 MCPA DMA/L, LoEP real** Navicula MCPA-DMA-salt 120 h EbC50 = 32.9 mg Palmer, S.; Kendall, 47286 pelliculosa MCPA-DMA/L T. and Krueger, H. real 1999 EbC50 = 26.9 mg 364A-106A ae/L* LoEP ErC50 = 117 mg MCPA DMA/L real NOEC 10.3 mg MCPA DMA/L Lemna gibba MCPA -DMA 14 d EC50 = 0.152 mg Drottar and Krueger 40790 MCPA-DMA/L 07.01.1999 EC50 = 0.124 mg 364A-103 ae/L LoEP NOEC < 0.04 mg ae/L Lemna gibba MCPA DMA 14 d EbC50: 1.52 mg Jenkins 88394 MCPA/L 2006 ErC50: 6.29 mg TFT 006/062180*** MCPA/L NOEC: <0.253 mg MCPA/L Lemna gibba MCPA DMA 14 d recovery NOEC < 2 mg/L Jenkins 88395 MCPA 2006 TFT 006/062236*** Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 25 of 49 Myriophyllum MCPA-DMA Salz 14 d static EyC50 = 0.09 mg Gonsior, G. 85952 spic W/S-System MCPA/L (nom) 22.04.2014 fresh weight S13-05079*** ErC50 = 0.13 mg MCPA/L (nom) fresh weight NOEyC = 0.01395 mg MCPA/L (nom) fresh weight * ae ... MCPA (acid) ** result from LoEP (NOEC = 50 mg/L study by Müllerschön et al, 1990, study code 167804) is regarded as not valid by zRMS (UBA) *** newly submitted by Applicant Table 22: Endpoints used for risk assessment for aquatic organisms for „U 46 M-Fluid“ Species Substance Exposure Results Reference Internal System code [mg a.s./L] Oncorhynchus MCPA-DMA-salt Chronic, flow- NOEC = 80 XXX 27609 mykiss (U 46 M-Fluid – 610 through, 28 d mg/L 42F0878/895259 g/L MCPA-DMA- NOEC = 50 mg DAR salt) MCPA /L Pseudo- U 46 M-Fluid 4 d, stat EC50 = 928 mg/L Hanstveit, A. O. 43946 kirchneriella bzw. 464 mg 31.12.1988 subcapitata MCPA/L Report No.R 88/421 DAR 6.5.1 Justification for new endpoints Not necessary. 6.5.2 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). The relevant global maximum FOCUS Step 1, 2 PECSW for risk assessments covering the proposed use pattern and the resulting TER values are presented in the following table. To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group D (2000 g a.i./ha in vine, not crop directed, no crop interception) also covers the risk for aquatic organisms from all other intended uses in groups A, B and C (see also core assessment Part B section 5 chapter 5.6.) Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 26 of 49 6.5.2.1 Toxicity to exposure ratio for the active substances In the following table the TER values for FOCUS Surface water Step 1 and Step 2 PECvalues for each organisms group are given. Table 23: Risk assessment for MCPA for each organism’ group for use group D (2000 g a.i./ha) Scenario PECSW Fish Fish Invertebrate Invertebrates Algae Aquatic Mesocosm xx d- Fish PECSed Sed. global max acute prolonged s acute prolonged plants PECtwa prolonged global dweller (use group max prolonged D, use No 00-005) O. mykiss O. mykiss D. magna D. magna Navicula Myriophyllu -- - O. mykiss - -- pelliculosa m spic FOCUS LC50 NOEC EC50 NOEC EbC50 EyC50 NOEC NOEC - NOEC 41 x 10³ 12x10³ > 190x10³ 10.6x10³ 26.9x10³ 90 --- 12x10³ -- [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/kg] [µg/kg] Step 1 625 65.6 19.2 304.1 17.0 43.1 0.14 - - - - - Step 2 N.Europe 58.3 703 206 3259 182 461 1.5 - - - - - Mar-may, June-Sep TER 100 10 100 10 10 10 10 100 10 criterion TER values shown in bold fall below the relevant trigger. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 27 of 49 Calculated TER values for the effects of MCPA on aquatic plants fall below the trigger value for use of the formulation U 46 M-Fluid at an application rate of 2000 g a.s./ha. For refined exposure assessment please refer to the National Addendum Germnay, Part B, Section 6. 6.5.2.2 Risk assessment for the product, valid for run-off and not run-off endangered areas (based on drift only) The risk assessment for formulations containing only one active substance is based on PECSW values including drift, drainage and run-off (FOCUS) and can be included in the tables above. 6.5.3 Overall conclusions Based on the calculated concentrations of MCPA in surface water (PECSW FOCUS Step 2), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to MCPA according to the GAP of the formulation „U 46 M-Fluid“ do not achieve the acceptability criteria TER ≥ 10, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate that a refined exposure assessment is required such FOCUS Step 3 calculations. Refined exposure assessment for Germany ist presented in the National Addendum. 6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1) Effects on bees of U 46 M-Fluid were not evaluated as part of EU review of MCPA dimethylamin-salt and no toxicity data with the formulation were presented here. However, since U 46 M-Fluid is a well known product and has been approved for long time, studies with the active substance are acceptable for the risk assessment. Toxicity Table 6.6-1 presents the results of laboratory bee toxicity studies with the active substance. Further details regarding the tests with the active substance are provided in section 10.4.2. Table 6.6-1: Results of laboratory bee toxicity studies Test Exposure LD Reference substance route 50 MCPA oral 48 h > 200 µg a.s./bee * EU Review report for the active dimethylamin- substance MCPA (2008) salt contact 48 h > 200 µg a.s./bee * SANCO/4062/2001-final * EU agreed endpoint Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 28 of 49 Exposure The recommended use pattern for U 46 M-Fluid includes application in agriculture (cereals, pome and stone fruits), grassland (pasture, meadow) and wine-growing at a maximum application rate of up to 4 L product/ha. This maximum single application rate is equivalent to 2000 g a.s./ha (4512 g product/ha). Bees may be exposed to U 46 M-Fluid by direct spraying while bees are foraging on flowers and weeds, through contact with fresh or dried residues or by oral uptake of contaminated pollen, nectar and honey dew. Hazard quotients Table 6.6-2 presents Hazard quotients for oral and contact exposure according to EPPO (2010) Environmental risk assessment scheme for plant protection products (Chapter 10: Honeybees (PP 3/10(3)). Bulletin OEPP/EPPO Bulletin 40: 323-331). The HQs were calculated as follows: Hazard Quotient = max. application rate [g a.s./ha] / LD50 [µg a.s./bee] Table 6.6-2: Hazard quotients for honeybees Max. single Hazard Exposure LD50 HQ Test substance application rate quotient route [µg a.s./bee] trigger [g a.s./ha] (HQ) oral > 200 µg < 10 U 46 M-Fluid 2000 50 (MCPA 500 g/L)* contact > 200 µg < 10 * tested as technical substance Risk assessment Due to the results of laboratory tests according to OECD standard 213/214 and GLP, U 46 M-Fluid is considered to be practically non-toxic to bees. Furthermore, all hazard quotients according to EPPO Environmental risk assessment scheme are below the trigger of 50, indicating that the intended use poses low risk to bees. Bee brood testing is not required since the test item is not an IGR. Overall conclusion It is concluded that U 46 M-Fluid will not adversely affect bees or bee colonies when used as recommended. The product is classified as non-hazardous to bees, even when the maximum application rate as stated for authorisation is applied. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 29 of 49 IIIA 10.4.1 Hazard quotients for bees Refer to table 6.6-2. IIIA 10.4.1.1 Oral exposure QHO Refer to table 6.6-2. IIIA 10.4.1.2 Contact exposure QHC Refer to table 6.6-2. IIIA 10.4.2 Acute toxicity of the formulation to bees No acute toxicity studies were generated in accordance with OECD 213/214, EPPO 170 or other appropriate test guidelines and GLP requirements were presented. IIIA 10.4.2.1 Oral Refer to table 6.6-1. IIIA 10.4.2.2 Contact Refer to table 6.6-1. IIIA 10.4.3 Effects on bees of residues on crops Not required. IIIA 10.4.4 Cage tests Not required. IIIA 10.4.5 Field tests Not required. IIIA 10.4.6 Investigation into special effects Not required. IIIA 10.4.6.1 Larval toxicity Not required since the test item is not an IGR. IIIA 10.4.6.2 Long residual effects Not required. IIIA 10.4.6.3 Disorienting effects on bees Not required. IIIA 10.4.7 Tunnel tests Not required. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 30 of 49 6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2) Table 24: Toxicity of MCPA to non-target arthropods (see SANCO/4062/2001-final (11 July 2008)) Species Substance Exposure Results Reference Internal System code Typhlodromus pyri MCPA (acid) laboratory, LR50 > 2000 Adelberger, I. 43676 (protonymphs) residues g as/ha 08.10.1999 on glass, 2D ER50 > 2000 99038/01-NLTp g as/ha LoEP* Aphidius rhopalosiphi MCPA DMA Extend. Lab, 3D: LR50 > 2000 Schuld, M. 43679 barley seedlings g as/ha 1999 ER50 > 2000 99038/01-NEAp g as/ha LoEP* Chrysoperla carnea MCPA DMA 2 d LR50 > 2000 Kemmeter, F. 43683 glass plate g as/ha 1999 ER50 > 2000 99038/02-NLCc g as/ha LoEP* Pardosa sp. MCPA DMA 2 d LR50 > 2000 Kemmeter, F. 43684 sand g as/ha 1999 ER50 > 2000 99038/02-NLPa g as/ha LoEP* *Reference is also cited in Appendix IIIA (5 April 2005) of Review Report for MCPA (SANCO/4062/2001-final, 11 July 2008) 6.7.1 Justification for new endpoints Not necessary. 6.7.2 Risk assessment The evaluation of the risk for non-target arthropods 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), and in consideration of the recommendations of the guidance document ESCORT 2. 6.7.2.1 Risk assessment for in-field exposure To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group D also covers the risk for non-target arthropods from all other intended uses in groups A, B and C. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 31 of 49 Table 25: First- tier assessment of the in-field risk for non-target arthropods due to the use of U 46 M-Fluid in vine (not crop directed) (Group D) Intended use Group D (use No 00-005) Active substance/product MCPA Application rate (g/ha) 1 × 2000 g a.s./ha MAF 1 Test species LR50 (lab.) PERin-field HQin-field Tier I (g/ha) (g/ha) criterion: HQ ≤ 2 Typhlodromus pyri > 2000 < 1 2000 Aphidius rhopalosiphi > 2000 < 1 6.7.2.2 Risk assessment for off-field exposure To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group D also covers the risk for non-target arthropods from all other intended uses in groups A, B and C. Table 26: First- tier assessment of the off-field risk for non-target arthropods due to the use of U 46 M-Fluid in vine (not crop directed) (Group D) Intended use Group D (use No. 00-005) Active substance/product MCPA Application rate (g/ha) 1 × 2000 MAF 1 Vdf 10 Test species LR50 (lab.) Drift rate PERoff-field CF HQoff-field Tier I (g/ha) (g/ha) criterion: HQ ≤ 2 Typhlodromus pyri > 2000 2.77% 5.54 10 < 0.03 Test species Rate with ≤ 50 % Drift rate PERoff-field CF corr. PERoff-field Higher-tier effect* (g/ha) below rate with (g/ha) ≤ 50 % effect? Aphidius rhopalosiphi 2000 2.77 % 5.54 5 yes MAF: Multiple application factor; vdf: Vegetation distribution factor; (corr.) PER: (corrected) Predicted environmental rate; CF: Correction factor; HQ: Hazard quotient. Criteria values shown in bold breach the relevant trigger. * If an LR50 or ER50 from a relevant extended laboratory test is available, it should be considered in place of the rate with ≤ 50 % effect. 6.7.2.3 Additional higher-tier risk assessment Not relevant. 6.7.2.4 Risk mitigation measures No risk mitigation needed. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 32 of 49 6.7.3 Overall conclusions In-field Based on the calculated rates of MCPA/“U 46 M-Fluid“ in in-field areas, the calculated HQ values describing the risk resulting from an exposure of non-target arthropods to MCPA /“U 46 M-Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria HQ ≤ 2, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of „U 46 M-Fluid“ in cereals, grassland, orchards and vine according to the label. Off-field Based on the calculated rates of MCPA/“U 46 M-Fluid“ in off-field areas, the calculated HQ values describing the risk resulting from an exposure of non-target arthropods to MCPA /“U 46 M-Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria HQ ≤ 2, according to commission regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of „U 46 M-Fluid“ in in cereals, grassland, orchards and vine according to the label. 6.8 Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC 10.4.1, KPC 10.4.2) Table 27: EU agreed endpoints and new endpoints for earthworms and other soil macro- and mesofauna (see SANCO/4062/2001-final (11 July 2008)) Species Substance Exposure Results Reference Internal System code Eisenia foetida U 46 M-Fluid acute LC50 = 325 mg Adema, D. and Roza, P. 43943 MCPA/kg 10.05.1988 R 89/152 DAR, LoEP 6.8.1 Justification for new endpoints Not necessary. 6.8.2 Risk assessment (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). Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 33 of 49 6.8.2.1 First-tier risk assessment The relevant PECsoil for risk assessments covering the proposed use pattern are taken from Section B.5 (Environmental Fate), Chapter 5.5. According to the assessment of environmental-fate data, multi-annual accumulation in soil does not need to be considered for MCPA. To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group D also covers the risk for earthworms and other non-target soil organisms from all other intended uses in groups A, B and C. The results of the risk assessment are summarized in the following table. Table 28: First-tier assessment of the acute and chronic risk for earthworms and other non- target soil organisms (meso- and macrofauna) due to the use of “U-46 M-Fluid” in vine (not crop directed) (Group D, use No 00-005) Intended use Group D (Use No 00-005), vine (not crop directed) Acute effects on earthworms Product/active substance LC50 PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) MCPA 325 2.67 122 Chronic effects on earthworms Product/active substance NOEC PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) --- Chronic effects on other soil macro- and mesofauna Product/active substance NOEC PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) --- TER values shown in bold fall below the relevant trigger. 6.8.2.2 Higher tier risk assessment Not relevant. 6.8.3 Overall conclusions Based on the predicted concentrations of MCPA/“U 46 M-Fluid“ in soils, the TER values describing the acute risk for earthworms and other non-target soil organisms following exposure to MCPA /“U 46 M- Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria TER ≥ 10 according to commission 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 „U 46 M-Fluid“ in cereals, grassland, orchards and vine according to the label. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 34 of 49 6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5) Table 29: EU agreed endpoints and new endpoints for soil microorganisms (see SANCO/4062/2001-final (11 July 2008)) Substance Test design Results Source Internal code „U 46 M-Fluid“ C-mineralisation < 25 % inhibition at 26.7 mg Zohner, A. 69999 28 d MCPA/kg soil dw, 19.04.1989 sandy loam and silty loam equivalent to 40 L formulation/ha TPH Report No: 984 DAR, LoEP „U 46 M-Fluid“ N-mineralisation < 25 % inhibition at 26.7 mg Zohner , A. 70000 28 d MCPA/kg soil dw, 06.03.1989 sandy loam and silty loam equivalent to 40 L formulation/ha TPH Report No: 970 DAR, LoEP 6.9.1 Justification for new endpoints Not necessary. 6.9.2 Risk assessment The evaluation of the risk for soil microorganisms 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). The relevant PECsoil for risk assessments covering the proposed use pattern are taken from Section B.5 (Environmental Fate), chapter 5.5 and were already used in the risk assessment for earthworms and other non-target soil organisms (meso- and macrofauna)). To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group D also covers the risk for effects on soil micro-organisms from all other intended uses in groups A, B and C. The results of the risk assessment are summarized in the following table. Table 30: Assessment of the risk for effects on soil micro-organisms due to the use of “U 46 M- Fluid” in vine (not crop directed) (Group D, use No. 00-005) Intended use Group D, use No. 00-005, vine (not crop directed) N-mineralisation Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) MCPA 26.7 (at 28 d) 2.67 yes C-mineralisation Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) MCPA 26.7 (at 28 d) 2.67 yes Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 35 of 49 6.9.3 Overall conclusions Based on the predicted concentrations of MCPA in soils, the risk to soil microbial processes following exposure to MCPA according to the GAP of the formulation „U 46 M-Fluid“ is considered to be acceptable according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. 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) Table 31: EU-agreed endpoints and new endpoints for non-target terrestrial plants Species Substance Exposure Results Reference Internal System code Lactuca sativa MCPA-DMA salt Vegetative vigour ER50 = 5.48 g Maggi, V. L. 40908 21 d MCPA 04.02.1993 40907 10 species were (acid)/ha CAR 146-91C tested LoEP* Lactuca sativa MCPA-DMA salt Seedling ER50 = 5.48 g Maggi, V. L. 40864 emergence MCPA (acid) 11.03.1993 40861 21 d /ha CAR 146-91F 10 species were LoEP* tested *LoEP: reference is given in Appendix IIIA (5 April 2005) of Review Report for MCPA (SANCO/4062/2001-final, 11 July 2008) The risk assessment is based on the results of the vegetative vigour test. 6.10.2 Justification for new endpoints Not necessary. 6.10.3 Risk assessment 6.10.3.1 Tier-2 risk assessment (based on dose-response data) 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 non- crop plants located outside the treated area. Spray drift from the treated areas may lead to residues of a product in off-crop areas. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 36 of 49 Table 32: Assessment of the risk for non-target plants due to the use of “U 46 M-Fluid” in vine (Group D, use No 00-005) Intended use Group D (use No. 00-005), vine (not crop directed) Active substance/product MCPA Application rate (g/ha) 1 × 2000 MAF 1 Test species ER50 Drift rate PERoff-field TER (g/ha) (g/ha) criterion: TER ≥ 5 Lactuca sativa 5.48 2.77* 55.4 0.1 * Although the product should be applied by spraying using a screen the calclulation is based on the drift values for arable crops as there are no spray drift values are available for this application technique (pers. communication D. Rautmann, JKI). Table 33: Assessment of the risk for non-target plants due to the use of “U 46 M-Fluid” in vine (Group B, C, use No 00-003 and 00-004) Intended use Group B, C (use No. 00-003 and 00-004), grassland and orchard (not crop directed) Active substance/product MCPA Application rate (g/ha) 1 × 1000 MAF 1 Test species ER50 Drift rate PERoff-field TER (g/ha) (g/ha) criterion: TER ≥ 5 Lactuca sativa 5.48 2.77 27.7 0.2 Table 34: Assessment of the risk for non-target plants due to the use of “U 46 M-Fluid” in vine (Group A, use No 00-001 and 00-002) Intended use Group A (use No. 00-001 and 00-002), cereals Active substance/product MCPA Application rate (g/ha) 1 × 700 MAF 1 Test species ER50 Drift rate PERoff-field TER (g/ha) (g/ha) criterion: TER ≥ 5 Lactuca sativa 5.48 2.77 19.39 0.3 MAF: Multiple application factor; PER: Predicted environmental rate; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger. 6.10.3.2 Higher-tier risk assessment Not relevant. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 37 of 49 6.10.3.3 Risk mitigation measures In order to reduce the off-field exposure, risk mitigation measures can be implemented. These correspond to unsprayed in-field buffer strips of a given width and/or the usage of drift reducing nozzles. The results of the risk assessment using typical mitigation measures (no-spray buffer zones of 5 or 10 m; drift-reducing nozzles with reduction by 50 %, 75 %, or 90 %) are summarised in the following table. Table 35: Risk assessment for non-target terrestrial plants due to the use of “U 46 M-Fluid” in vine (Group D, use No. 00-005) considering risk mitigation (in-field no-spray buffer zones, and drift-reducing nozzles) Intended use Group D (use No. 00-005), vine (not crop directed) Active substance/product MCPA Application rate (g/ha) 1 × 2000 MAF 1 Buffer strip Drift rate PERoff-field PERoff-field PERoff-field PERoff-field (m) (%) (g/ha) 50 % drift red. 75 % drift red. 90 % drift red. (g/ha) (g/ha) (g/ha) 1 2.77 55.4 27.7 13.85 5.54 5 0.57 11.4 5.7 2.85 1.14 10 0.29 5.8 2.9 1.45 0.58 Toxicity value TER ER50 = 5.48 g/ha criterion: TER ≥ 5 1 0.1 0.2 0.4 1 5 0.5 1 2 5 10 0.9 2 4 9 Table 36: Risk assessment for non-target terrestrial plants due to the use of “U 46 M-Fluid” in cereals (Group A, use No. 00-001 and 00-002) considering risk mitigation (in-field no-spray buffer zones, and drift-reducing nozzles) Intended use Group A (use No. 00-001 and 00-002), cereals Active substance/product MCPA Application rate (g/ha) 1 × 700 MAF 1 Buffer strip Drift rate PERoff-field PERoff-field PERoff-field PERoff-field (m) (%) (g/ha) 50 % drift red. 75 % drift red. 90 % drift red. (g/ha) (g/ha) (g/ha) 1 2.77 19.39 9.695 4.8475 1.939 5 0.57 3.99 1.995 0.9975 0.399 10 0.29 2.03 1.015 0.5075 0.203 Toxicity value TER ER50 = 5.48 g/ha criterion: TER ≥ 5 Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 38 of 49 1 0.3 0.6 1.1 2.8 5 1.4 2.7 5.5 13.7 10 2.7 5.4 10.8 27.0 TER values shown in bold fall below the relevant trigger. 6.10.3.4 Overall conclusions Based on the predicted rates of MCPA/“U 46 M-Fluid“ in off-field areas, the TER values describing the risk for non-target plants following exposure to MCPA /“U 46 M-Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria TER ≥ 10 resp. ≥ 5 according to commission regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. when appropriate risk mitigation measures are applied for all intended for uses. The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to the intended use of „U 46 M-Fluid“ according to the label. 6.11 Effects on other terrestrial organisms (flora and fauna) (KPC 10.7) 6.12 Monitoring data (KPC 10.8) 6.13 Available preliminary data (IIIA 10.9) 6.14 Other/special studies (IIIA 10.10) Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 39 of 49 Appendix 1 List of data submitted in support of the evaluation Table A 1: List of data submitted by the applicant and relied on Annex point/ Author(s) Year Title Data Owner Evaluated reference No Source (where different from protection in EU company) claimed Report-No. [Y/N] GLP or GEP status (where relevant), Published or not Authority registration No KIIIA1 XXX 1993 Acute Toxicity of Herbizid Y Nufarm Y 10.2.2.1 Marks M to Rainbow Trout Oncorhynchus mykiss in a 96 hour Flow-Through Test XXX 409015 GLP Not published KIIIA1 XXX 1993 Toxicity of Herbizid Marks M to Y Nufarm Y 10.2.2.3 Pseudokirchnieriella subcapitata in a 72-hour Algal Growth Inhibition test XXX 409050 GLP Not published KIIIA1 10.3 XXX 2008 MCPA DMA 500g/L: Acute Y Nufarm N Dietary Toxicity in Mice, XXX 23077 GLP Not published KIIIA1 10.3 XXX 2008 MCPA DMA 600g/L: Acute Y Nufarm N Dietary Toxicity in Mice XXX 25406 GLP Not published KIIIA1 Bond, A., 2012 MCPA: Birds & Mammals risk Y Nufarm N 10.3.1.3 Pigott , assessments according to G.H. EFSA (2009) AND Pirimicarb (2005) Wild Birds Risk Assessment/ Wild Mammals Risk Assessment, Appendix 4 Residue Decline Data Wyke_2012_017G Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 40 of 49 Not GLP Not published KIIIA1 10.5.1 Adelberger, 1999 MCPA DMA: Toxicity to the Y Nufarm Y I. Predatory Mite, Typhlodromus pyri SCHEUTEN (Acari, Phytoseiidae) in the Laboratory GAB Biotechnologie, Germany 99038/01-NLTp GLP Not published KIIIA1 10.5.1 Kemmeter, 1999 MCPA DMA: Toxicity to the Y Nufarm Y F. Green Lacewing, Chrysoperla carnea Steph. (Neuroptera, Chrysopidae) in the Laboratory GAB Biotechnologie, Germany 99038/02-NLCc GLP Not published KIIIA1 10.5.1 Kemmeter, 1999 MCPA DMA: Toxicity to the Y Nufarm Y F. Wolf Spider, Pardosa spp. (Araneae, Lycosidae) in the Laboratory GAB Biotechnologie, Germany 99038/01-NLPa GLP Not published KIIIA1 10.5.2 Schuld, M. 1999 MCPA DMA: Toxicity to the Y Nufarm Y Aphid Parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae) Using an Extended Laboratory Test GAB Biotechnologie, Germany 99038/01-NEAp GLP Not published KIIIA1 10.6.2 Adema, 1989 The acute toxicity of U 46-M- Y Nufarm Y D.M.M., Fluid (500g MCPA acid as Roza, dimethylsalt/l) to Eisenia fetida P. TNO division of technology for society Report No. R 89/152 GLP Not published KIIIA1 Maggi, 1993 The effects of MCPA DMAS on Y Nufarm Y 10.8.1.3 V.L. Nontarget Plants: Seed Germination/Seedling Emergence California Agricultural Research CAR 146-91F Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 41 of 49 GLP Not published KIIIA1 Drottar, 1999 MCPA DMAS: A 14-Day Y Nufarm Y 10.8.2.1 K.R., Toxicity Test with Duckweed Krueger, (Lemna gibba G3) Wildlife H.O. International Ltd, USA 364A-103 GLP Not published KIIIA1 Jenkins, 2006 MCPA (DMA Salt) Higher Plant Y Nufarm N 10.8.2.1 C.A. (Lemna Gibba) Growth Inhibition Test. Huntingdon Life Sciences, UK TFT 0006/062180 GLP Not published KIIIA1 Jenkins, C. 2006 MCPA (DMA Salt) Recovery of Y Nufarm N 10.8.2.1 A. Lemna gibba following Exposure to the Test substance for three days Huntingdon Life Sciences, UK TFT 0008/062236 GLP Not published KIIIA1 10.8.2 Gonisor 2014 MCPA DMA 500 g/L - Growth Y Nufarm N Inhibition of Myriophyllum spicatum in a Water/Sediment System. S13-05079 GLP, not published Table A 2: List of data submitted by the applicant but not used for assessment Annex point/ Author(s) Year Title Data Owner Evaluated reference No Source (where different from protection in EU company) claimed Report-No. [Y/N] GLP or GEP status (where relevant), Published or not Authority registration No KIIIA1 10.3 XXX 2004 4-chloro-2-methylphenoxyacetic Y Nufarm N acid (MCPA): One Generation Study in the Rat, XXX, CTL/RR1007 GLP Not published Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 42 of 49 Table A 3: List of data relied on not submitted by applicant but necessary for evaluation Annex Author(s) Year Title Data Owner Evelauted in point/ Source (where different from protection EU reference company) claimed No Report-No. [Y/N] GLP or GEP status (where relevant), Published or not Authority registration No KIIIA1 Maggi, 1993 The Effects of MCPA DMAS on Y 10.8.1.3 V.L. Nontarget Plants: Vegetative Vigour MCPA DPWG California Agricultural Research Inc 146-91c GLP, Not published Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 43 of 49 Appendix 2 Detailed evaluation of the new studies In this appendix all studies submitted by applicant and not yet described for EU assessment are summarised. Please note that only studies are described in detail for those a summary was provided by the applicant.Other studies are only listed. Lowe, 2008 (23077) Comments of zRMS: Study only used as additional information for refined risk assessment. No summary provided. Reference: KIIIA1 10.3. Report Lowe, C.. (2008) MCPA DMA 500g/L: Acute Dietary Toxicity in Mice, Eurofins, USA, 23077 Guideline(s): U.S. EPA OPPTS 870.1100 (2002); OECD 425 (2006) Deviations: Not applicable GLP: yes Acceptability: Not relevant Duplication No (if vertebrate study) No study summary provided by applicant. Lowe, 2008 (25406) Comments of zRMS: Study only used as additional information for refined risk assessment. No summary provided. Reference: KIIIA1 10.3. Report Lowe, C.. (2008) MCPA DMA 600g/L: Acute Dietary Toxicity in Mice Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 44 of 49 Eurofins, USA 25406 Guideline(s): U.S. EPA OPPTS 870.1100 (2002); OECD 425 (2006) Deviations: Not applicable GLP: yes Acceptability: Not relevant Duplication No (if vertebrate study) No study summary provided by applicant. Bond, Pigott, 2012 Comments of zRMS: This study does only provide a list of tests results no further information. However , the results were used for refined risk assessment. Reference: KIIIA1 10.3.1.3 Report Bond, A., Pigott , G.H. (2012) MCPA: Birds & Mammals risk assessments according to EFSA (2009) AND Pirimicarb (2005). Wild Birds Risk Assessment/ Wild Mammals Risk Assessment, Appendix 4 Residue Decline Data. Wyke_2012_017G/019G Guideline(s): Not applicable Deviations: Not applicable GLP: no Acceptability: Yes Duplication No (if vertebrate study) Materials and methods The report summarise results of several residue studies to determine residue decline. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 45 of 49 Results and discussions Residue decline of MCPA is reported in 12 Northern European cereals trials and 9 trials in grassland in Northern Europe (see table below). rate No. Crop (kg/ha) region country RUD DT50 (days) 1 spring wheat 0,58 N-EU AU 27,8 2,1 2 spring barley 0,58 N-EU AU 21,7 1,6 3 spring oat 0,58 N-EU AU 38,1 2,1 4 spring barley 0,58 N-EU AU 30,2 2 5 spring wheat 0,8 N-EU DE 66,4 3,3 6 spring barley 0,8 N-EU DE 46,8 4,2 7 winter barley 0,8 N-EU DE 74,5 6,6 8 spring oat 0,8 N-EU DE 27,4 4,6 9 winter wheat 1,8 N-EU FR 49,4 2 10 winter wheat 1,8 N-EU UK 36,7 4,4 11 winter barley 1,8 N-EU FR 29,4 1,9 12 winter barley 1,8 N-EU UK 17,2 2,6 1 Grass 0,58 N-EU AU 93,6 2 2 Grass 0,58 N-EU AU 102,6 2,6 3 Grass 0,58 N-EU AU 98,8 2,3 4 Grass 0,58 N-EU AU 86,2 2,6 5 Grass 1,8 N-EU FR 44,4 2,1 6 Grass 1,8 N-EU UK 54,4 1,6 7 Grass 1,8 N-EU UK 71,1 1,8 8 Grass 1,8 N-EU UK 47,2 2,3 9 Grass 1,8 N-EU FR 32,8 3,4 cereals mean 38,8 3,1 Grass mean 70,1 2,3 grass+cereals mean 52,2 2,8 Conclusion The residue trials were submitted for EU approval of MCPA. Residues trials in cereals (12 trials) resulted in a DT50 value of 3.1 days corresponding to fwta of 0,21). Considering all residue values (grass and cereals) a mean DT50 of 2.8 days (ftwa = 0.19) is to be applied. Jenkins, 2006 (TFT 0006/062180) Comments of zRMS: Study is acceptable. Following endpoints are derived for Lemna gibba EbC50: 1.52 mg MCPA/L ErC50: 6.29 mg MCPA/L NOEC: <0.253 mg MCPA/L Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 46 of 49 Reference: KIIIA1 10.3.1.3 Report Jenkins, C.A. (2006) MCPA (DMA Salt) Higher Plant (Lemna Gibba) Growth Inhibition Test. Huntingdon Life Sciences, UK TFT 0006/062180 Guideline(s): Yes Deviations: No GLP: Yes Acceptability: Yes Duplication No (if vertebrate study) Materials and methods 1. Test materials: MCPA (DMA salt) Description: Clear yellow liquid Lot/Batch: 05/75 Purity: MCPA 779.3g/l Stability of compound: Shown to be stable at ambient conditions for at least 2 years, but will degrade in the presence of micro-organisms or strong sunlight 2. Vehicle and/or positive Approximately 12.2mg/l of MCPA was added to sterile nutrient control: medium. This solution was serially diluted to the required concentration. 3. Test plants Source: AstraZeneca, Brixham Laboratory, Brixham, UK Temperature: 24 ± 2°C Humidity: N/A Photoperiod: Continuously illuminated 4. In life dates: Start of experiment 23 November 2005 End of experiment 13 December 2005 5. Plant assignment and The definitive test was conducted on six test concentrations plus a nutrient treatment medium control. An aliquot of control or test medium was added to the flask, following the addition of the plant, each flask was placed in a temperature-controlled environment. Results and discussions The intended exposure concentrations were maintained within the range 88% and 114% of nominal (fresh medium and 87 and 118% (two or three day old “expired “medium) throughout the test. The EC50 and “no observed effect concentration” (NOEC) for each parameter were: Mean measured concentration (mg/l as MCPA) Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 47 of 49 EC50 NOEC 1.52 Area under the growth curve (0-14 Days) < 0.253 (0.99-2,37) 6.29 Average specific growth rate (0-14 Days) < 0.253 (5.45-7.34) 4.2 Final biomass as dry weight (14 Days) 1.00 (3.17-5.72) Values in parenthesis are 95% confidence limits. Morphological change (shortened roots, gibbosity and chlorotic fronds) were seen at all concentrations except the lowest tested (0.253mg MCPA/ l) where observations were confined to a few chlorotic fronds. Conclusion After fourteen days of exposure to MCPA formulation, the EbC50 for inhibition was1.52 mg/l expressed as MCPA acid. The EC50“based on biomass (based on dry weight) was 6.3 mg/l. The no observed effect concentration” (NOEC) for area under the growth curve was < 0.253 mg/l and for final biomass was 1.00 mg/l. Jenkins, 2006 (TFT 0008/062236) Comments of zRMS: Study is acceptable resulting in an endpoint of NOEC < 2 mg/L MCPA for Lmena gibba. The endpoint is not used in the risk assessment. Reference: KIIIA1 10.3.1.3 Report Jenkins, C.A. (2006) MCPA (DMA Salt) Recovery of Lemna gibba following Exposure to the Test substance for three days. Huntingdon Life Sciences, UK TFT 0008/062236 Guideline(s): Not applicable Deviations: Not applicable GLP: Yes Acceptability: Yes Duplication No (if vertebrate study) Materials and methods 1. Test materials: MCPA (DMA salt) Description: Clear yellow liquid Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 48 of 49 Lot/Batch: 05/75 Purity: MCPA 779.3g/l Stability of compound: Shown to be stable at ambient conditions for at least 2 years, but will degrade in the presence of micro-organisms or strong sunlight 2. Vehicle and/or positive Approximately 12.2mg/l of MCPA was added to sterile nutrient control: medium. This solution was serially diluted to the required concentration. 3. Test plants Source: AstraZeneca, Brixham Laboratory, Brixham, UK Temperature: 22.3 – 24.4ºC Humidity: N/A Photoperiod: Continuously illuminated 4. In life dates: Start of experiment 12 December 2005 End of experiment 28 December 2005 5. Plant assignment and The test employed two exposure concentrations plus a nutrient treatment medium control. Three replicate vessels were prepared for the control and for each test group; each contained 12 fronds of Lemna at the start. Results and discussions After 3 days of exposure, the means number of fronds had increased to 41 in the control compared to 37 at 2mg/l MCPA/l and 39 at 4mg/l MCPA/l. Following the transfer of plants to untreated culture medium for a period of 9 days, frond numbers increased to 223 and 225 respectively, in cultures previously exposed to the test substance at 2 and 4mg/l as MCPA compared with 319 in the control. NOEC (mg/l) Exposure : Area under curve (0-3 days) 4 Exposure: Growth rate (0-3 days) 4 Recovery : Growth rate (3-6 days) < 2 Recovery : Growth rate (6-9 days) < 2 Recovery : Growth rate (9-12 days) 4 During the initial 6 days of the recovery phase (Day 3-9 of the test); growth of the cultures previously exposed to the test substance at 2 and 4mg/l MCPA was significantly reduced compared to the control, with a reduction in growth rate of up to 28% between days 3 and 6. However, between Day 6 and 9 recovery (Day 9 and 12 of the test), no statistical differences in growth rate were identified, indicating that the viability of the plants had not been affected by a three day exposure to MCPA (DMA salt). Since growth rates were reduced compared to the control during the initial six days of the recovery phase, reductions in final biomass were expected. Conclusion After 3 days of exposure to the test substance at 2 and 4mg MCPA/l, both the area under the growth curve and growth rate were significantly reduced (at most 13%) compared to the control although this was not statistically different. During the subsequent recovery period, plants previously exposed to the test substance at 2 and 4mg MCPA/l continued to grow, albeit at a significantly lower rate (up to 28%) than the control during the initial 6 days. During the latter 3 days, no significant reductions in growth rate were observed. These Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report Core Assessment Central Zone Page 49 of 49 results indicate that after a short exposure to MCPA (DMA salt), the viability of the Lemna culture had not been affected. Gonisor, 2014 Comments of zRMS: Study is valid and acceptable. The results are used for risk assessment. EyC50 = 0.09 mg MCPA/L (nom) fresh weight ErC50 = 0.13 mg MCPA/L (nom) fresh weight NOEyC = 0.01395 mg MCPA/L (nom) fresh weight Reference: KIIIA1 10.8.2 Report Gonisor (2014) MCPA DMA 500 g/L - Growth Inhibition of Myriophyllum spicatum in a Water/Sediment System. S13-05079 Guideline(s): Not applicable Deviations: No GLP: Yes Acceptability: Yes Duplication No (if vertebrate study) Materials and methods Results and discussions Conclusion No study summary provided by applicant. Applicant: Nufarm Evaluator: zRMS DE Date: June 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 1 of 18 REGISTRATION REPORT Part B Section 6: Ecotoxicological studies Detailed summary of the risk assessment Product code: U 46 M-Fluid Active Substance: MCPA 500 g/L as DMA salt 612.35 g/L Central Zone Zonal Rapporteur Member State: Germany NATIONAL ADDENDUM Applicant: Nufarm Date: June 2016 Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 2 of 18 Table of Contents SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)...... 3 6.1 GAP AND OVERALL CONCLUSIONS ...... 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) ...... 4 6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC 10.1.2) ...... 5 6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC 10.1.3) ...... 7 6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ...... 8 6.5.1 Overview ...... 8 6.5.2 Toxicity ...... 8 6.5.3 Justification for new endpoints ...... 8 6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ...... 8 6.5.5 Overall conclusions ...... 12 6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) ...... 12 6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ...... 12 6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1, KPC 10.4.2) ...... 12 6.8.1 Justification for new endpoints ...... 12 6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna ...... 13 6.8.3 Overall conclusions ...... 13 6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) ...... 14 6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) ...... 14 6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) ...... 14 6.10.2 Justification for new endpoints ...... 14 6.10.3 Risk assessment ...... 14 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ...... 18 Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 3 of 18 Sec 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10) A full risk assessment according to Uniform Principles for the plant protection product U 46 M-Fluid in its intended uses in wheat, grassland, pome and stone fruits and vine is documented in detail in the core assessment of the plant pro-tection product U46 M Fluid dated from June 2016 performed by zRMS Germany. This document comprises specific risk assessment for some annex points for authorization of the plant protection product U 46 M Fluid in Germany. Applicant: Nufarm Evaluator: zRMS DE Date June 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 4 of 18 6.1 GAP and overall conclusions Grouping of intended uses for risk assessment The following table lists the grouping of the intended uses of the formulation U 46 M Fluid in Germany. The intended uses in Germany are covered by the core assessment. Table 6.1-1: Critical use pattern of „U 46 M-Fluid“ Group Crop/growth Application Number of applications, Application rate, Soil effective (use stage method / Minimum application cumulative application rate No.) Drift scenario interval, interception, (g as/ha) (g as/ha) application time (season) A (001, Winter and spraying / 1 x, spring MCPA 1 x 700, MCPA 002) spring wheat arable crops 25 % interception 1 x 525 BBCH 13-39 6 April B (003) grassland spraying / 1 x, May to August MCPA 1 x 1000 MCPA arable crops 90 % interception 1 x 100 C (004) Pome and stone spraying 1 x, March to September MCPA 1 x 1000 MCPA fruits 0 % interception 1 x 1000 D (005) grape vine spraying with 1 x, March to September MCPA 1 x 2000 MCPA screen , up to 0 % interception 1 x 2000 3rd year after planting of the vine Consideration of metabolites Please refer to the core assessment. 6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1) Please refer to the core assessment. Consequences for authorization: none Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 5 of 18 6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1, KPC 10.1.2) Please refer to the core assessment. Use group A (use No 00-001 and 00-002): Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ does achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the uses according to use No. 00-001 and 00-002. Consequences for authorization: none Use group B (use No. 00-003), C (use No. 00-004) and C (use No. 00-005): In the core assessment acute and reproductive risk assessment for mammals showed that further refinement ist necessary on Member state level. Following refinement options are applied in Germany for the risk assessment for mammals: In cases where the relevant model species for assessment of the risk from the intended uses of MCPA is a mouse or a vole, the TER acceptability criterion may be modified. In terms of size and potential exposure, mice and voles already represent the ‘worst case’ for agricultural areas in Europes' central zone. Furthermore, the toxicological endpoints and effect values for the assessment are determined on phylogenetically closely related species. Hence, a TER ≥ 5 in the acute exposure scenario and a TER ≥ 2 in the long-term exposure scenario may be accepted as sufficient. It should additionally be noted that there are currently no indications for a significant impact of pesticides on the population dynamics of mice or voles in the agricultural landscape, which are apparently determined by other biological factors (e.g. periodical increases in vole populations creating the necessity for control measures). Refined acute risk assessment: Acute toxicity endpoint given in LoEP is based on the acute toxicity of female rats. The mean toxicity in the test (male an female rats) is 1160 mg/kg bw (XXX, 1983). Table 6.3-1: Refined acute risk assessment risk for mammals due to the use of „U 46 M-Fluid“ Acute toxicity (mg/kg bw) 1160 mg/kg bw (see core assessment) TER criterion 10/5 (for mouse and vole) Use Indicator/generic focal species SV90 MAF90 DDD90 TERa Application rate (mg/kg bw/d) Group B (00-003) Small herbivorous mammal 136.4 1.0 136.4 8.5 Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 6 of 18 Group C (00-004) "vole" 1000 g a.s./ha Group D (00-005) Small herbivorous mammal 136.4 1.0 272.8 4.3 2000 g a.s./ha "vole" TER values in bold fall below the relevant trigger. Based on higher tier assessment step, the calculated TER values for the acute risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ does achieve the modified acceptability criteria TER ≥ 5, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the use group B and C (1000 g a.s./ha). Considering the results of the dietry toxicity studies by XXX (2008, 2009; see core assessment) as well as the characteristic of MCPA to rapidly assimilate and excrete the acute risk resulting from an exposure of mammals to MCPA at a rate of 2000 g as/ha according to use group D (use No 00-005) is considered to be acceptable. Refined reproductive risk assessment: Table 6.3-2: Refined risk assessment of the long-term/reproductive risk for mammals due to the use of „U 46 M-Fluid“ on grassland (group B) and orchards (group C) Intended use Group B (00-003), grassland /group C (00-004), orchards (not crop directed) Active substance/product MCPA Application rate (g/ha) 1 x 1000 g a.s./ha Reprod. toxicity (mg/kg bw/d) 60 mg /kg bw/d (refined toxicity) TER criterion 5/2(vole and mouse) Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Grassland Large herbivorous mammal 32.6 0.53 9.11 6.6 All season “lagomorph” Grassland Small herbivorous mammal 136.4 0.19 25.92 2.3* All season “vole” * modified acceptability criteria; TER values in bold fall below the relevant trigger. Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 7 of 18 Table 6.3-3: First-tier assessment of the long-term/reproductive risk for mammals due to the use of „U 46 M-Fluid“in vine (not crop directed) (group D) Intended use Group D (00-005), vine not crop directed Active substance/product MCPA Application rate (g/ha) 1 x 2000 g a.s./ha Reprod. toxicity (mg/kg bw/d) 60 mg /kg bw/d TER criterion 5/2 (vole and mouse) Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Orchard, Applic. crop Small herbivorous mammal 72.3 0.19 27.474 2.2* dir. BBCH <10 or not "vole" crop dir. Orchard, Applic. crop Large herbivorous mammal 14.3 0.19 5.43 11.0 dir. BBCH <10 or not "lagomorph" crop dir. Orchard, Applic. crop Small omnivorous mammal 7.8 0.19 2.96 20.3 dir. BBCH <10 or not "mouse" crop dir. * modified acceptability criteria; TER values in bold fall below the relevant trigger. Based on higher tier assessment step, the calculated TER values for the long-term risk resulting from an exposure of mammals to MCPA according to the GAP of the formulation „U 46 M-Fluid“ does achieve the acceptability criteria TER ≥ 5 and the modified acceptability criteria TER ≥ 2, according to commission regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for the all intended for uses of the formulation “U 46 M Fluid” Consequences for authorization: none 6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC 10.1.3) Please refer to the core assessment. Consequences for authorization: none Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 8 of 18 6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1) Overview Results of aquatic risk assessment for the intended for uses of U 46 M-Fluid based on FOCUS Surface Water PEC values is presented in the Core assessment. 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 U 46 M-Fluid is outlined in the following chapters. Toxicity Please refer to the core assessment. Justification for new endpoints Please refer to the core assessment. Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) 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. MCPA has a vapour pressure of 10-5-10-4 Pa and is therefore classified as semivolatile. Hence, deposition following volatilization has been considered. The input parameters for MCPA are given in National Addendum Germany, Part B, Section 5.6.1. Table 6.5-1: Risk assessment for MCPA for aquatic organisms for the entry route via spraydrift and deposition following volatilization under the implementation of different risk mitigation measures (Group A, use No. 00-001 and 00-002) Compound MCPA Use group/use No. Group A, 00-001 and 00-002 Crop/Application rate Cereals, 1 x 700 g a.s./ha Crop interception 25 % DT50 water (SFO) Not relevant PEC-selection actual Drift-Percentile 90th Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 9 of 18 Buffer Entry via spraydrift Entry via deposition PECsw; conventional and drift reducing technique zone following volatilization 0% conv. 50% red. 75% red. 90% red. [m] [%] [µg/L] [%] [µg/L] [µg /L] 1 2.77 6.463 0.022 0.052 6.515 3.283 1.668 0.698 Relevant toxicity endpoint: EyC50 = 90 µg a.i./L (Myriophyllum spic) Relevant TER: 10 Buffer zone [m] TER 1 13.8 Risk mitigation measures none PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. Table 6.5-2: Risk assessment for MCPA for aquatic organisms for the entry route via spraydrift and deposition following volatilization under the implementation of different risk mitigation measures (Group B, use No. 00-003 and Group D, 00-004) Compound MCPA Use group/use No. Group B (00-003) covering also Group D (00-004) Crop/Application rate grassland, 1 x 1000 g a.s./ha Crop interception 90 % (0% für 00-004 ‰ no entry via volatisation/deposition) DT50 water (SFO) Not relevant PEC-selection actual Drift-Percentile 90th Buffer Entry via spraydrift Entry via deposition PECsw; conventional and drift reducing technique zone following volatilization 0% conv. 50% red. 75% red. 90% red. [m] [%] [µg/L] [%] [µg/L] [µg /L] 1 2.77 9.233 0.08 0.266 9.500 4.883 2.575 1.190 Relevant toxicity endpoint: EyC50 = 90 µg a.i./L (Myriophyllum spic) Relevant TER: 10 Buffer zone [m] TER 1 10 Risk mitigation measures none PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. Table 6.5-3: Risk assessment for MCPA for aquatic organisms for the entry route via spraydrift and deposition following volatilization under the implementation of different risk mitigation measures (Group D, use No. 00-005) Compound MCPA Use group/use No. Group D, 00-005 Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 10 of 18 Crop/Application rate Vineyards not crop directed, 1 x 2000 g a.s./ha Crop interception 0 % DT50 water (SFO) Not relevant PEC-selection: actual Drift-Percentile: 90th Buffer Entry via spraydrift Entry via deposition PECsw; conventional and drift reducing technique zone following volatilization 0% conv. 50% red. 75% red. 90% red. [m] [%] [µg/L] [%] [µg/L] [µg /L] 1 2.77 18.467 0 0 18.467 9.233 4.617 1.847 5 0.57 3.800 0 0 3.800 1.900 0.950 0.380 Relevant toxicity endpoint: EyC50 = 90 µg a.i./L (Myriophyllum spic) Relevant TER: 10 Buffer zone [m] TER 1 4.9 10 19.5 48.7 5 23.7 Risk mitigation measures NW 609-1 PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. 6.5.4.2 TER values for the entry into surface water via run-off and drainage The concentration of the active substance MCPA in adjacent ditch due to surface runoff and drainage is calculated using the model EXPOSIT 3.01. The input parameters for MCPA for exposure modelling with EXPOSIT 3.01 are given in the German National Addendum, Part B, Section 5, chapter 5.6.2. Table 6.5-4: Risk assessment for MCPA for aquatic organisms for the entry via run-off and drainage for use group D (use No. 00-005; vineyards not crop directed) Compound MCPA Use group/use No. Group D/00-005 Application rate 2000 g a.s./ha Crop interception 0 % Relevant toxicity endpoint EyC50 = 90 µg a.s./L (Myriophyllum spic) Relevant TER 10 Run-off Buffer zone PEC TER [m] [µg/L] 0 14.02 6.4 5 12.15 7.4 10 10.41 8.6 Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 11 of 18 20 7.29 12.4 Drainage Time of application PEC TER [µg/L] Autumn/winter/early spring Not relevant Not relevant Spring/summer 5.78 15.6 Risk mitigation measures NW 706 PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. Table 6.5-5: Risk assessment for MCPA for aquatic organisms for the entry via run-off and drainage for use group C (use No. 00-004; pome and stone fruits) Compound MCPA Use group/use No. Group C /00-004 Application rate 1000 g a.s./ha Crop interception 0 % Relevant toxicity endpoint EyC50 = 90 µg a.s./L (Myriophyllum spic) Relevant TER 10 Run-off Buffer zone PEC TER [m] [µg/L] 0 7.01 12.8 Drainage Time of application PEC TER [µg/L] Autumn/winter/early spring Not relevant Not relevant Spring/summer 2.89 31.1 Risk mitigation measures none PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. Use Group B (use No. 00-003) and A ( use No. 00-001 and 00-002): Risk assessment for aquatic organismen due to exposure of surface water by Runoff or drainage is covered by the risk assessment for use Group C (use No. 00-004) resulting in an acceptable risk. No risk mitigation measures are needed. Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 12 of 18 Overall conclusions Based on the calculated concentrations of MCPA in surface water (EVA 3, EXPOSIT 3), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to MCPA according to the GAP of the formulation U 46 M-Fluid achieve the acceptability criteria TER ≥ 100 and TER ≥ 10, according to commission 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 aquatic organisms due to the intended for uses of U 46 M-Fluid in Germany according to the label. Consequences for authorization: For the authorization of the plant protection product U 46 M-Fluid following labeling and conditions of use are mandatory: Required Labelling NW 265 MCPA: Lemna gibba NOEC < 0.04 mg/L NW 642-1 For use No. 00-001, 00-002, 00-003 and 00-004 Conditions for use All uses NW 468 use No. 00-005 NW 609-1 (common: 5 m), NW 706 (vegetated buffer strip: 20 m) 6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1) Please refer to the risk assessment outcome as provided in the core assessment. 6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2) Please refer to the core assessment. Consequences for authorization: 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) Please refer to the core assessment. Justification for new endpoints Not necessary. Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 13 of 18 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittel- wirkstoffe 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 the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the environmental fate section (Part B, Section 5) of this National Addendum. The results of the risk assessment are summarized in the following table. Table 6.8-1: First-tier assessment of the acute and chronic risk for earthworms and other non- target soil organisms (meso- and macrofauna) due to the use of “U-46 M-Fluid” in vine (not crop directed) (Group D, use No 00-005) Intended use Group D (Use No 00-005), vineyards (not crop directed) (2000 g a.s./ha, 0 % crop interception, 2.5 cm soil depth) Acute effects on earthworms Product/active substance LC50 PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) MCPA 325 5.34 61 Chronic effects on earthworms Product/active substance NOEC PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) --- Chronic effects on other soil macro- and mesofauna Product/active substance NOEC PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) --- TER values shown in bold fall below the relevant trigger. The risk assessment for the use group D also covers the risk for earthworms and other non-target soil organisms from all other intended uses in groups A, B and C. Overall conclusions Based on the predicted concentrations of MCPA/“U 46 M-Fluid“ in soils, the TER values describing the acute risk for earthworms and other non-target soil organisms following exposure to MCPA /“U 46 M- Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria TER ≥ 10 according to commission 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 „U 46 M-Fluid“ in cereals, grassland, orchards and vineyards according to the label. Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 14 of 18 Consequences for authorization: none 6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5) Please refer to the core assessment. Consequences for authorization: none 6.10 Effects on non-target plants (MIIIA 10.8, KPC 10.6) Effects on non-target terrestrial plants (MIIIA 10.8.1) Please refer to the core assessment. Justification for new endpoints Please refer to the core assessment. 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 non-crop 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. MCPA has a vapour pressure of 10-5-10-4 Pa and is therefore classified as semivolatile. Hence, deposition following volatilization has been considered. The input parameters for MCPA are given in National Addendum Germany, Part B, Section 5.6.1. In the vegetative vigour test 10 plant species were tested. Therefore the assessment factor is reduced from 10 to 5. The results of the risk assessment are summarized in the following table. Table 6.10-1: Risk assessment for MCPA for non-target plants for the entry route via spraydrift and deposition following volatilization for use Group D (use No. 00-005, vineyards) Compound: MCPA Intended use group: D (use No. 00-005) Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 15 of 18 Crop/Application rate Vineyards not crop directed, 1 x 2000 g a.s./ha Crop interception 0 % Drift-Percentile: 90th / arable crops Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 55.4 0 0 55.400 27.700 13.850 5.540 5 0.57 11.4 0 0 11.400 5.700 2.850 1.140 Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5 Buffer zone [m] TER 1 0.1 0.2 0.4 1.0 5 0.5 1.0 1.9 5.0 Risk mitigation measures NT 109 PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. Table 6.10-2: Risk assessment for MCPA for non-target plants for the entry route via spraydrift and deposition following volatilization for use Group C (use No. 00-005, orchards) Compound: MCPA Intended use group: C (use No. 00-004) Crop/Application rate Orchards not crop directed, 1 x 1000 g a.s./ha Crop interception 0 % Drift-Percentile: 90th / arable crops Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 27.700 0 0 27.700 13.850 6.925 2.770 5 0.57 5.700 0 0 5.700 2.850 1.425 0.570 Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5 Buffer zone [m] TER 1 0.2 0.4 0.8 2.0 5 1.0 1.9 3.8 9.6 Risk mitigation measures NT 109 PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. Table 6.10-3: Risk assessment for MCPA for non-target plants for the entry route via spraydrift and deposition following volatilization for use Group C (use No. 00-005, orchards) Compound: MCPA Intended use group: C (use No. 00-004) Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 16 of 18 Crop/Application rate Orchards not crop directed, 1 x 1000 g a.s./ha Crop interception 0 % Drift-Percentile: 90th / arable crops Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 27.700 0 0 27.700 13.850 6.925 2.770 5 0.57 5.700 0 0 5.700 2.850 1.425 0.570 Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5 Buffer zone [m] TER 1 0.2 0.4 0.8 2.0 5 1.0 1.9 3.8 9.6 Risk mitigation measures NT 109 PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. Table 6.10-4: Risk assessment for MCPA for non-target plants for the entry route via spraydrift and deposition following volatilization for use Group B (use No. 00-003, grassland) Compound: MCPA Intended use group: B (use No. 00-003) Crop/Application rate grassland, 1 x 1000 g a.s./ha Crop interception 50 % Drift-Percentile: 90th / arable crops Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 27.700 0.045 0.444 28.144 14.294 7.369 3.214 5 0.57 5.700 0.036 0.357 6.057 3.207 1.782 0.927 Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5 Buffer zone [m] TER 1 0.2 0.4 0.7 1.7 5 0.9 1.7 3.1 5.9 Risk mitigation measures NT 109 PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Registration Report National Addendum Germany Central Zone Page 17 of 18 Table 6.10-5: Risk assessment for MCPA for non-target plants for the entry route via spraydrift and deposition following volatilization for use Group A (use No. 00-001 and 00- 002,cereals) Compound: MCPA Intended use group: A (use No. 00-001 and 00-002) Crop/Application rate grassland, 1 x 700 g a.s./ha Crop interception 25 % Drift-Percentile: 90th / arable crops Buffer Entry via spraydrift Entry via deposition PERoff-field; conventional and drift reducing technique zone following volatilization 0% conv. 90% red. 75% red. 50% red. [m] [%] [g/ha] [%] [g/ha] [g/ha] 1 2.77 19.390 0.022% 0.155 19.545 9.850 5.003 2.094 5 0.57 3.990 0.018% 0.125 4.115 2.120 1.122 0.524 Relevant toxicity endpoint: Lactuca sativa ER50 = 5.48 g a.s./ha (vegetative vigour) Relevant TER: 5 Buffer zone [m] TER 1 0.3 0.6 1.1 2.6 5 1.3 2.6 5.0 10.5 Risk mitigation measures NT 108 PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger. 6.10.3.1 Overall conclusions Based on the predicted rates of MCPA/“U 46 M-Fluid“ in off-field areas, the TER values describing the risk for non-target plants following exposure to MCPA /“U 46 M-Fluid“ according to the GAP of the formulation „U 46 M-Fluid“ achieve the acceptability criteria TER ≥ 5 according to commission regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. when appropriate risk mitigation measures are applied for all intended for uses. The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to the intended use of „U 46 M-Fluid“ according to the label. Consequences for authorization: Conditions for use use No. 00-001 and 00-002 NT 108 (5 m: 75 %) use No. 00-003, 00-004 and 00-005 NT 109 (5m: 90 %) Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 6 U 46 M-Fluid Draft Registration Report National Addendum Germany Central Zone Page 18 of 18 Appendix 1 List of data submitted in support of the evaluation Not relevant. Applicant: Nufarm Evaluator: zRMS DE Date: Mai 2016 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 1 of 76 REGISTRATION REPORT Part B Section 7: Efficacy Data and Information Detailed Summary Product Code: U 46 M-Fluid Reg. No.: ZV1 060939-00/00 Active Substance: 500 g/L MCPA Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Nufarm Deutschland GmbH Date: 2013-12-31 (rev. June 2015) Evaluator: Julius Kühn-Institut Date: 2017-02-14 - Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 2 of 76 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) ...... 7 Information on crops and pests ...... 7 Information on the intended uses for Germany ...... 8 IIIA1 6.1 Efficacy data...... 11 IIIA1 6.1.1 Preliminary range-finding tests ...... 12 IIIA1 6.1.2 Minimum effective dose tests ...... 12 IIIA1 6.1.3 Efficacy tests ...... 21 IIIA1 6.1.4 Effects on yield and quality ...... 28 IIIA1 6.1.4.1 Impact on the quality of plants and plant products ...... 28 IIIA1 6.1.4.2 Effects on the processing procedure ...... 31 IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products ...... 32 IIIA1 6.2 Adverse effects ...... 38 IIIA1 6.2.1 Phytotoxicity to host crop...... 38 IIIA1 6.2.2 Adverse effects on health of host animals ...... 43 IIIA1 6.2.3 Adverse effects on site of application ...... 43 IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) ...... 43 IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ...... 44 IIIA1 6.2.6 Impact on succeeding crops ...... 45 IIIA1 6.2.7 Impact on other plants including adjacent crops ...... 46 IIIA1 6.2.8 Possible development of resistance or cross-resistance ...... 47 IIIA1 6.3 Economics ...... 48 IIIA1 6.4 Benefits ...... 48 IIIA1 6.4.1 Survey of alternative pest control measures ...... 48 IIIA1 6.4.2 Compatibility with current management practices including IPM...... 48 IIIA1 6.4.3 Contribution to risk reduction ...... 48 IIIA1 6.5 Other/special studies ...... 48 IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ...... 48 IIIA1 6.7 List of test facilities including the corresponding certificates ...... 51 Appendix 1: List of data submitted in support of the evaluation 13.08.2015 ...... 52 Appendix 2: GAP table ...... 74 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 3 of 76 IIIA1 6 Efficacy Data and Information on the Plant Protection Product The following data and information was mainly provided by the applicant and was submitted as dRR and BAD. Text in italics is written by the zRMS DE, all other parts are taken from the dRR of the applicant. The zRMS DE deleted parts of the dRR of the applicant in cases where information was sought to be irrelevant. Additional comments and the final evaluation by the zRMS in this Registration Report are marked by green boxes. Typographical errors have been corrected. Not all appendices mentioned by the applicant are shown. In these cases, the references to the appendices have been deleted. General information This document summarizes the information related to the efficacy data of the plant protection product U 46 M-Fluid containing 500 g/L MCPA [(4-chloro-2-methylphenoxy) acetic acid] which was included into Annex I of Council Directive 91/414/EEC (COMMISSION DIRECTIVE 2005/57/EC of 21 September 2005). For the implementation of the uniform principles of Annex VI, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof (the Appendices I and II did not contain any information but another reference and therefore have been deleted) as finalised in the Stand- ing Committee on the Food Chain and Animal Health on 15/04/2005 shall be taken into account. In this overall assessment: Member States must pay particular attention: - to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, - to the protection of aquatic organisms and must ensure that the conditions of authorisation in- clude risk mitigation measures, where appropriate, such as buffer zones. This Registration Report summarises the biological data for application of re-registration of U 46 M-Fluid in Germany. It presents the efficacy trial program of the seasons 2003 to 2013 in the maritime EPPO zone, in which U 46 M-Fluid was compared with similar products. Germany is the zonal Rapporteur member state; there are no concerned member states. Table 6.0-1: Zonal Rapporteur member state (zRMS). zRMS Germany DE Recent registration situation/history of the PPP U 46 M-Fluid is marketed in Germany since 1952. The first application for registration of U 46 M- Fluid was submitted on 28.04.1969 (Kenn-Nr 00939 00/00), applications for re-registration were submitted on 31.10.1986 (Kenn-Nr 020939 00/00), on 06.02.1989 and 03.08.1990, respectively (Kenn-Nr 030939 00/00), and on 06.03.2002 and 20.01.2003 (Kenn-Nr 050393 00/00), respec- tively. Table 6.0-2 shows the registration of products based on MCPA in Austria, Germany and UK as typical examples for MCPA registrations in the maritime EPPO Zone. Table 6.0-2: Existing registrations in the maritime EPPO zone Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 4 of 76 Formula- Regis- Coun- tion Authorisa- Product tered rate Use(s) try Type / tion No. L/ha Conc. Austria Dicopur M SL 500 3052-0 1.5 Winter wheat, winter triti- cale, winter barley, winter rye, spring wheat, spring barley, oat, spring rye Ger- U 46 M- SL / 050939-00 1.0 Hops many Fluid 500 g/L 1.5 Winter wheat, winter triti- cale, winter barley, winter rye, spring wheat, spring barley, oat, spring rye 2.0 Coniferous trees and pas- ture 4.0 Grapes 2 x 2.0 Pome fruit and stone fruit / creeping thistle, field bind- weed Agroxone SL / 004367-00 1.5 Winter wheat, winter triti- 500 g/L cale, winter barley, winter rye, spring wheat, spring barley, oat, spring rye 2.0 Pasture Ger- Ceridor SL / 050939-67 1.0 Hops many MCPA 500 g/L 1.5 Winter wheat, winter triti- cale, winter barley, winter rye, spring wheat, spring barley, oat, spring rye. 2 Coniferous trees and pas- ture 4.0 Grapes 2 x 2.0 Pome fruit and stone fruit / creeping thistle, field bind- weed Dicopur M SL / 050939-62 1.0 Hops / Dicotyledonous 500 g/L weeds 1.5 Winter wheat, winter triti- cale, winter barley, winter rye, spring wheat, spring barley, oat, spring rye 2 Coniferous trees and pas- ture 4.0 Grapes 2 x 2.0 Pome fruit and stone fruit / creeping thistle, field bind- weed MCPA - SL / 007176-00 1.5 Winter wheat, winter triti- DMA 500 500 g/L cale, winter barley, winter SL rye MCPA SL / 050939-68 1.0 Hops 500 500 g/L 1.5 Winter wheat, winter triti- cale, winter barley, winter Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 5 of 76 Formula- Regis- Coun- tion Authorisa- Product tered rate Use(s) try Type / tion No. L/ha Conc. rye, spring wheat, spring barley, oat, spring rye 2 Coniferous trees and pas- ture 4.0 Grapes 2 x 2.0 Pome fruit and stone fruit / creeping thistle, field bind- weed Formula- Regis- Coun- tion Authorisa- Product tered rate Use(s) try Type / tion No. L/ha Conc. Ger- MCPA SL / 050939-60 1.0 Hops many Berghoff 500 g/L 1.5 Winter wheat, winter triti- cale, winter barley, winter rye, spring wheat, spring barley, oat, spring rye / 2.0 Coniferous trees and pas- ture 4.0 Grapes 2 x 2.0 Pome fruit and stone fruit / creeping thistle, field bind- weed UK Agrichem 15836 3.3 1 application: Barley MCPA (spring), barley (winter), 500 oats (spring), oats (winter), rye (spring), rye (winter), wheat (spring), wheat (win- ter) 1.4 1 application: Barley (un- dersown with red clover), oats (undersown with red clover), rye (undersown with red clover), wheat (un- dersown with red clover) 2.7 1 application: Barley (un- dersown with grassland), oats (undersown with grassland), rye (undersown with grassland), wheat (un- dersown with grassland) 3.3 2 applications: Grassland 3.2 1 application: Grassland (seed crop) Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 6 of 76 Formula- Regis- Coun- tion Authorisa- Product tered rate Use(s) try Type / tion No. L/ha Conc. UK Agritox 500 SL 14894 3.3 /crop Barley (spring), barley (winter), oats (spring), oats (winter), rye (spring), rye (winter), wheat (spring), wheat (winter) 1.4 /crop Barley (undersown with red clover), oats (undersown with red clover), rye (un- dersown with red clover), wheat (undersown with red clover) 2.7 /crop 1 application: Barley (un- dersown with grassland), oats (undersown with grassland), rye (undersown with grassland), wheat (un- dersown with grassland) 6.6 /year Grassland 3.2 /crop Grassland (seed crop) Agritox 50 500 SL 3.3 /crop Barley (spring), barley (winter), oats (spring), oats (winter), rye (spring), rye (winter), wheat (spring), wheat (winter) 1.4 /crop Barley (undersown with red clover), oats (undersown with red clover), rye (un- dersown with red clover), wheat (undersown with red clover) 2.7 /crop 1 application: Barley (un- dersown with grassland), oats (undersown with grassland), rye (undersown with grassland), wheat (un- dersown with grassland) 6.6 /year Grassland 3.2 /crop Grassland (seed crop) Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 7 of 76 Formula- Regis- Coun- tion Authorisa- Product tered rate Use(s) try Type / tion No. L/ha Conc. UK Agroxone 500 SL 08940 3.3 /crop Barley (spring), barley (winter), oats (spring), oats (winter), rye (spring), rye (winter), wheat (spring), wheat (winter) 1.4 /crop Barley (undersown with red clover), oats (undersown with red clover), rye (un- dersown with red clover), wheat (undersown with red clover) 2.7 /crop 1 application: Barley (un- dersown with grassland), oats (undersown with grassland), rye (undersown with grassland), wheat (un- dersown with grassland) 6.6 /year Grassland 3.2 /crop Grassland (seed crop) Information on the active ingredients (Uptake and mode of action) MCPA belongs to the chemical group of phenoxy carbonic acids. MCPA belongs to the group of auxin-herbicides and produces phytohormone action. MCPA acts as a selective, systemic, hor- mone-type herbicide. MCPA will mainly be absorbed through green leaves. MCPA is translocated in the plant by both acropetal and basipetal action and concentrates in meristematic region of plants. MCPA inhibits growth in a similar manner to the natural auxin. MCPA influences levels of RNA and DNA polymerase and levels of enzymes involved in normal plant growth. MCPA acts by inducing abnormal cell division, abnormal growth, influence of respiration and influence of met- abolic processes. The effect is mainly based on auxin activity. Good growing conditions support the uptake of the active ingredient and the efficacy. In winter wheat, MCPA is hydroxylated at the methyl group with formation of 2-hydroxymethyl-4- chlorphenoxyacetic acid. Other metabolites are 2-carboxy-4-chlorphenoxyacetic acid and hy- droxy-2-methyl-4-chlorphenoxyacetic acid. This may be further degraded to the benzoic, prior to ring opening. Conjugation of 2-hydroxymethyl-4-chlorphenoxyacetic acid leads to the creation of glycosides. Site of action (HRAC-group): O Information on crops and pests The data presented in this dossier support the label claim for U 46 M-Fluid for the control of annual and perennial dicotyledonous weeds in spring and winter cereals, grassland, orchards and grape vine. Table 6.0-3 shows the classification of crops for which registration is requested. Table 6.0-3: Classification of crop/situation for Germany (zRMS) Classification EPPO-Code major minor Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 8 of 76 crop/situation winter soft wheat TRZAW DE - winter barley HORVW DE - winter rye SECCW DE - winter triticale TTLWI DE - winter durum wheat TRZDW DE spelt TRZSP DE spring soft wheat TRZAS DE spring durum wheat TRZDS DE spring barley HORVS DE - spring rye SECCS - DE oat AVESA DE - grassland, pasture, NNNFW DE - meadow grape vine VITVI DE - pome fruit, stone fruit NNNOK, NNNOS DE - weed/pest/disease dicotyledonous weeds TTTDD DE - Information on the intended uses for Germany Date: 2017-01-17 Product: U 46 M-Fluid Use No. 060939-00/00-001 Field of use Agriculture (field crops) Crop(s)/object(s) winter soft wheat (TRZAW), winter durum wheat (TRZDW), spelt (TRZSP), winter barley (HORVW), winter rye (SECCW), winter trit- icale (TTLWI) Crop stage(s) (BBCH) 13 to 39 Pest(s)/target(s) annual dicotyledonous weeds (TTTDS), Cirsium arvensis (CIRAR) Area of application Outdoors Timing of application After emergence, spring Max. number of treat- 1 ments for the use Max. number of treat- 1 ments per crop or sea- son Application spraying method/kind of treat- ment Application rate(s) 1.4 L/ha in 200 to 400 L water/ha ------Use No. 060939-00/00-002 Field of use Agriculture (field crops) Crop(s)/object(s) spring soft wheat (TRZAS), spring durum wheat (TRZDS), spring barley (HORVS), common oats (AVESA), spring rye (SECCS) Crop stage(s) (BBCH) 13 to 39 Pest(s)/target(s) annual dicotyledonous weeds (TTTDS), Cirsium arvensis (CIRAR) Area of application Outdoors Timing of application After emergence, spring Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 9 of 76 Max. number of treat- 1 ments for the use Max. number of treat- 1 ments per crop or sea- son Application spraying method/kind of treat- ment Application rate(s) 1.4 L/ha in 200 to 400 L water/ha ------Use No. 060939-00/00-003 Field of use Grassland Crop(s)/object(s) grassland, pasture, meadow (NNNFW) Pest(s)/target(s) dicotyledonous weeds (TTTDD) Area of application Outdoors Timing of application May to August Max. number of treat- 1 ments for the use Max. number of treat- 1 ments per crop or sea- son Application spraying method/kind of treat- ment Application rate(s) 2 L/ha in 200 to 400 L water/ha ------Use No. 060939-00/00-004 Field of use Fruit growing Crop(s)/object(s) pome fruit (NNNOK), stone fruits (NNNOS) Notes on crop from 1st year after planting Pest(s)/target(s) dicotyledonous weeds (TTTDD) Area of application Outdoors Timing of application March to September Max. number of treat- 1 ments for the use Max. number of treat- 1 ments per crop or sea- son Application spraying method/kind of treat- ment Remarks on application with screen method Application rate(s) 2 L/ha in 200 to 400 L water/ha ------Use No. 060939-00/00-005 Field of use Viticulture Crop(s)/object(s) grape vine (VITVI) designated use utilisation as wine and table grape up to 3rd year after planting of the vine Pest(s)/target(s) dicotyledonous weeds (TTTDD) Area of application Outdoors Timing of application March to September Max. number of treat- 1 ments for the use Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 10 of 76 Max. number of treat- 1 ments per crop or sea- son Application spraying method/kind of treat- ment Remarks on application with screen method Application rate(s) 4 L/ha in 200 to 600 L water/ha ------ Description of the plant protection product U 46 M-Fluid is a SL formulation containing 500 g/L MCPA, in UK the product name is Agritox 50. The product is present as dimethylamine salt (611.8 g/L), containing the equivalent of 500 g/L of MCPA. The purpose of the salt is to maintain the active ingredient in solution, since the acid is not freely soluble in water. Table 6.0-4: Details of the active substances Product code: U 46 M-FLUID A.S. content: 500 g/L MCPA Formulation type: Soluble concentrate, SL Synonyms: None MCPA IUPAC name: 4-chloro-o-tolyoxyacetic acid Chemical group: Chlorophenoxy acid Mode of action: Synthetic auxins Plant translocation: Translocated throughout the plant Biological action: Post emergence Proposed uses for this product are supplied in Appendix 2. In the trials presented in this report the following 60 weed species were monitored: ACHMI, Gemeine Schafgarbe, Achillea millefolium; AGRRE, Acker-Quecke, Elymus repens; AMARE, Acker-Fuchsschwanz, Amaranthus retroflexus; ANRSY, Wiesen-Kerbel, Anthriscus syl- vestris; ANTAR, Acker-Hundskamille, Anthemis arvensis; APESV, Gemeiner Windhalm, Apera spica-venti; ATXPA, Gemeine Melde, Atriplex patula; BRSNN, Raps (Ausfallraps), Brassica na- pus; BRSNW, Winterraps (Ausfallraps), Brassica napus; CAPBP, Gemeines Hirtentäschel, Capsella bursa-pastoris; CHEAL, Weißer Gänsefuß, Chenopodium album; CIRAR, Acker- Kratzdistel, Chenopodium album; CONAR, Acker-Winde, Convolvulus arvensis; CENCY, Korn- blume, Cyanus segetum; CERFO, Gewöhnliches Hornkraut, Cerastium fontanum; ECHCG, Ge- meine Hühnerhirse, Echinochloa crus-galli; FUMOF, Gemeiner Erdrauch, Fumaria officinalis; GALAP, Kletten-Labkraut, Galium aparine; GASPA, Kleinblütiges Franzosenkraut, Galinsoga parviflora; GERSS, Storchschnabel-Arten, Geranium species; HELAN, Sonnenblume, Helianthus annuus; LAMAM, Stengelumfassende Taubnessel, Lamium amplexicaule; LAMPU, Acker-Taub- nessel, Lamium purpureum; LEBAU, Herbstlöwenzahn, Scorzoneroides autumnalis; MATCH, Echte Kamille, Matricaria chamomilla; MATIN, Geruchlose Kamille, Matricaria inodora; MATSS, Kamille-Arten, Matricaria species; MYOAR, Acker-Vergißmeinnicht, Myosotis arvensis; PLALA, Spitzwegerich, Plantago lanceolata; PLAMA, Breitwegerich, Plantago major; PAPRH, Klatschmohn, Papaver rhoeas; POAAN, Einjähriges Rispengras, Poa annua; POLLA, Ampfer- knöterich, Persicaria lapathifolia; OLAV, Acker-Vogelknöterich, Polygonum arvense; POLCO, Gemeiner Windenknötrich, Polygonum convolvulus; POLPE, Flohknöterich, Persicaria maculosa; Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 11 of 76 RANAC, Scharfer Hahnenfuß, Ranunculus acris; RANRE, Kriechender Hahnenfuß, Ranunculus repens; RAPRA, Acker-Rettich, Raphanus raphanistrum; RUMOB, Stumpfblättriger Ampfer, Ru- mex obtusifolia; SINAR, Acker-Senf, Sinapis arvensis; SOLNI, Schwarzer Nachtschatten, Sola- num nigrum; SONOL, Kohl-Gänsedistel, Sonchus oleraceus; SOLTU, Kartoffel, Solanum tu- berosum; STEME, Vogel-Sternmiere, Stellaria media; TAROF, Gemeiner Löwenzahn, Taraxa- cum officinale; TARSS, Löwenzahnarten, Taraxacum sp.; THLAL, Lauch-Hellerkraut, Thlaspi al- liacum; THLAR, Acker-Hellerkraut, Thlaspi arvensis; TRFPR, Rotklee, Trifolium pratense; TRFRE, Weißklee, Trifolium repens; TRFDU, Fadenklee, Trifolium dubium; URTDI, Große Bren- nessel, Urtica dioica; URTUR, Kleine Brennessel, Urtica urens; VERHE, Efeublättriger Ehren- preis, Veronica hederaefolia; VERAG, Acker-Ehrenpreis, Veronica agrestis; VEROF, Echter Eh- renpreis, Veronica officinale; VERPE, Persischer Ehrenpreis, Veronica persica; VERSS, Ehren- preis-Arten, Veronica species; VIOAR, Acker-Stiefmütterchen, Viola arvensis. . Conclusion – Information on the Plant Protection Product Information about the active ingredient is given by the zRMS and information about the registra- tion situation in the EU is given by the applicant. IIIA1 6.1 Efficacy data Trials in this Registration Report were organized, conducted and reported by different GEP certi- fied contract research organizations, all of which followed in general the relevant EPPO stand- ards. The involved organizations were, at the time of conduct of the studies officially recognized by the competent authorities to carry out field registration trials in accordance with the principles of Good Experimental Practice (GEP). Table 6.1-1: Efficacy in minimum effective dose trials in winter cereals – in the maritime EPPO zone Country Year 2007 2011 2012 2013 2014 Total Germany ------5 8 13 United Kingdom 5 ------5 Total 5 -- -- 5 8 18 Table 6.1-2: Efficacy in minimum effective dose trials in spring cereals – in the maritime EPPO zone Country Year 2007 2011 2012 2013 2014 Total Germany ------5 10 15 United Kingdom 5 ------5 Total 5 -- -- 5 10 20 Table 6.1-3: Efficacy in minimum effective dose trials in grassland – in the maritime EPPO zone Country Year 2003 2011 2012 2013 Total Germany ------4 4 United Kingdom 4 ------4 Total 4 -- -- 4 8 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 12 of 76 Table 6.1-4: Efficacy in minimum effective dose trials in grape vine – in the maritime EPPO zone Country Year 2008 2009 2012 2013 Total Germany 3 4 -- -- 7 Accordingly this draft registration report is based on a total of 53 outdoor trials (18 trials in winter cereals, 20 trials in spring cereals and 8 trials in grassland and 7 trials in grape vine). All trials were performed in the maritime EPPO zone. IIIA1 6.1.1 Preliminary range-finding tests As MCPA is a well-known herbicidal active ingredient, range finding tests (laboratory or glass- house and small scale field trials) are not required. Therefore, further preliminary range finding tests have not been conducted. Conclusion – Preliminary range-finding tests The applicant does not provide results about range-finding tests, which is accepted as MCPA is a well-known active substance. IIIA1 6.1.2 Minimum effective dose tests IIIA1 6.1.2.1 Minimum effective dose tests – winter cereals A total of 18 GEP trials were conducted in the field in order to prove the required dose rate of U 46 M-FLUID (500 g/L MCPA) against annual and perennial dicotyledonous weeds as a post-weed emergence herbicide for spring application in winter cereals. 10 trials were carried out in winter wheat, 3 trials in winter barley, 3 trials in winter triticale, 1 trial in winter oats and 1 trial in winter rye. The trials were set up in Germany (13) and in the UK (5). All trials from UK were conducted in 2007 and all trials from Germany were conducted in 2013 and 2014. The trials are presented in detail in the following document: BAD of U 46 M-Fluid containing 500 g/L MCPA DMA (December 2013), Doc. No. 381-004, KIIIA1 6/02. All trials were conducted by officially recognized organizations in accordance with the Principles of Good Experimental Practice (GEP) according to EPPO standards PP 1/93(2/3), PP 1/135(2/3), PP 1/152(2/3) and PP 1/181(2/3). No deviations have been reported or were observed. In 18 winter cereal trials, performed in 2007, 2013 and 2014, different weed species were moni- tored and assessed. The efficacy value at last assessment timing was described. In these trials 20 annual and 2 perennial weeds (CIRAR and VEROF) were determined. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 13 of 76 Table 6.1.2.1-1: Efficacy of U 46 M-Fluid in winter cereal, minimum effective dose trials in the maritime EPPO zone, 18 trials, Germany (2013, 2014), UK (2007) % Efficacy U 46 M-Fluid U 46 M-Fluid U 46 M-Fluid Reference product 0.8 - 0.9 L/ha 1.2 L/ha 1.5 - 1.6 L/ha No. No. No. No. Weed Spe- EPPO Tri- Mean Min Max Tri- Mean Min Max Tri- Mean Min Max Tri- Mean Min Max cies Code als als als als Broad- leaved BBBBB 1 63.3 63.3 63.3 - - - - 1 71.5 71.5 71.5 1 92.3 92.3 92.3 weeds Brassica na- BRSNN 1 98.8 98.8 98.8 1 100.0 100.0 100.0 1 100.0 100.0 100.0 1 100.0 100.0 100.0 pus Brassica na- BRSNW 4 92.7 88.8 97.0 4 97.6 91.3 100.0 4 100.0 100.0 100.0 4 100.0 100.0 100.0 pus Capsella bursa pas- CAPBP 4 66.6 27.5 91.3 4 83.3 45.0 97.5 4 87.1 55.0 100.0 4 98.9 96.3 100.0 toris Chenopo- dium CHEAL 4 74.7 25.0 96.3 4 99.6 98.8 100.0 4 100.0 100.0 100.0 4 66.6 23.8 100.0 album Cirsium arv- CIRAR 2 74.4 72.5 76.3 2 88.8 85.0 92.5 2 97.8 97.3 98.3 2 98.6 98.5 98.8 ense Fumaria of- FUMOF 1 83.8 83.8 83.8 - - - - 1 94.0 94.0 94.0 1 92.3 92.3 92.3 ficinalis Galium apa- GALAP 4 7.81 0.0 13.3 4 13.8 11.1 25.0 4 33.8 0.0 82.5 4 75.0 0.0 100.0 rine Lamium am- LAMAM 1 35.0 35.0 35.0 1 51.3 51.3 51.3 1 56.3 56.3 56.3 1 75.0 75.0 75.0 plexicaule Lamium LAMPU 3 61.3 32.5 88.3 1 51.3 51.3 51.3 3 75.0 62.5 91.3 3 80.8 62.5 92.3 purpureum Matricaria MATCH 3 22.0 0.0 50.0 3 24.0 0.0 50.0 3 27.0 0.0 50.0 3 100.0 100.0 100.0 chamomilla Matricaria MATIN 2 71.3 68.8 73.8 - - - - 2 76.9 73.8 80.0 2 67.5 60.0 75.0 inodora Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 14 of 76 % Efficacy U 46 M-Fluid U 46 M-Fluid U 46 M-Fluid Reference product 0.8 - 0.9 L/ha 1.2 L/ha 1.5 - 1.6 L/ha Matricaria MATSS 1 50.0 50.0 50.0 - - - - 1 52.5 52.5 52.5 1 61.3 61.3 61.3 species Myosotis MYOAR 2 70.5 52.5 88.5 1 77.5 77.5 77.5 2 86.3 77.5 95.0 2 85.0 70.0 100.0 arvensis Papaver PAPRH 2 67.1 45.0 89.3 1 97.8 97.8 97.8 2 83.1 66.3 99.8 2 81.7 63.8 99.5 rhoeas Poa POAAN 1 68.8 68.8 68.8 - - - - 1 83.8 83.8 83.8 1 72.5 72.5 72.5 annua Polygonum POLCO 1 0.0 0.0 0.0 1 0.0 0.0 0.0 1 12.5 12.5 12.5 1 0.0 0.0 0.0 convolvulus Raphanus raphan- RAPRA 1 37.5 37.5 37.5 - - - - 1 86.8 86.8 86.8 1 99.0 99.0 99.0 istrum Sinapis SINAR 1 81.3 81.3 81.3 - - - - 1 85.0 85.0 85.0 1 85.0 85.0 85.0 arvensis Stellaria STEME 9 40.5 0.0 92.0 6 25.5 0.0 87.5 9 53.8 0.0 98.3 9 93.3 35.0 100.0 media Thlaspi al- THLAL 1 100.0 100.0 100.0 1 100.0 100.0 100.0 1 100.0 100.0 100.0 1 100.0 100.0 100.0 liaceum Thlaspi THLAR 5 81.5 25.0 98.8 5 95.0 75.0 100.0 5 99.8 98.8 100.0 5 97.9 89.5 100.0 arvensis Veronica VERAG 2 8.8 0.0 17.5 2 10.0 0.0 20.0 2 15.0 0.0 30.0 2 37.5 5.0 70.0 agrestis Veronica of- VEROF 1 72.5 72.5 72.5 - - - - 1 81.3 81.3 81.3 1 87.5 87.5 87.5 ficinalis Veronica VERPE 4 62.5 16.3 95.0 1 21.3 21.3 21.3 4 72.4 37.5 95.8 4 85.1 65.8 99.3 persica Viola arven- VIOAR 5 27.0 0.0 52.5 4 41.3 0.0 95.0 5 42.5 0.0 72.5 5 63.2 0.0 100.0 sis Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 15 of 76 The dose rate applied for, has been reduced from the dose rate which was tested in all efficacy and minimum effective dose trials in winter and spring cereals of 1.5 L/ha to 1.4 L/ha in order to comply with results of e-fate modelling to avoid the restriction NG 405 (no application on drained fields). IIIA 6.1.2.2 Minimum effective dose tests – spring cereals A total of 20 GEP trials were conducted in the field in order to prove the required dose rate of U 46 M-Fluid (500 g/L MCPA) against annual and perennial dicotyledonous weeds as a post-weed emergence herbicide in spring cereals (TRZSS, HORVS, SECCS and AVESS). 5 trials were car- ried out in spring wheat, 11 trials in spring barley, 3 trials in spring oat and 1 trial in spring rye. The trials were set up in Germany (15) and in the UK (5). All trials from UK were conducted in 2007 and all trials from Germany were conducted in 2013 and 2014. All trials were conducted by officially recognized organizations in accordance with the Principles of Good Experimental Practice (GEP). The trials were conducted under field conditions according to EPPO standards PP 1/93(2/3), PP 1/135(2/3), PP 1/152(2/3), PP 1/181(2/3). No deviations have been repeated or were observed. In 20 spring cereal trials, performed in 2007, 2013 and 2014, different weed species were moni- tored and assessment. The efficacy value at last assessment timing was described. A summary of the results is shown in Table 6.1.2.2-1. In these trials 26 annual and 2 perennial weeds (CIRAR and URTDI) were determined. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 16 of 76 Table 6.1.2.2-1: Efficacy of U 46 M-Fluid in spring cereal minimum effective dose trials in the maritime EPPO zone, 10 trials, Germany (2013), UK (2007) % Efficacy U 46 M-Fluid U 46 M-Fluid U 46 M-Fluid Reference product 0.8 - 0.9 L/ha 1.2 L/ha 1.5 - 1.6 L/ha No. No. No. No. Weed Spe- EPPO Tri- Mean Min Max Tri- Mean Min Max Tri- Mean Min Max Tri- Mean Min Max cies Code als als als als Anthemis ANTAR 1 8.8 8.8 8.8 1 75.0 75.0 75.0 1 88.8 88.8 88.8 1 77.5 77.5 77.5 arvensis Atriplex pat- ATXPA 1 83.8 83.8 83.8 - - - - 1 93.5 93.5 93.5 1 92.5 92.5 92.5 ula Brassica na- BRSNN 1 100.0 100.0 100.0 1 100.0 100.0 100.0 1 100.0 100.0 100.0 1 100.0 100.0 100.0 pus Capsella bursa pas- CAPBP 3 62.4 45.0 82.5 3 83.8 72.5 93.8 3 99.8 88.8 100.0 3 96.1 88.8 100.0 toris Chenopo- dium CHEAL 9 74.9 0.0 96.3 9 83.2 12.5 100.0 9 88.8 27.5 100.0 9 55.2 25.0 100.0 album Fumaria of- FUMOF 1 83.8 83.8 83.8 - - - - 1 94.0 94.0 94.0 1 92.3 92.3 92.3 ficinalis Cyanus CENCY 1 78.3 78.3 78.3 1 81.5 81.5 81.5 1 90.0 90.0 90.0 1 80.8 80.0 80.0 segetum Cirsium arv- CIRAR 5 71.1 35.0 87.8 5 82.4 55.0 96.8 5 94.9 85.0 98.5 5 85.8 75.0 98.8 ense Galium apa- GALAP 1 14.3 14.3 14.3 - - - - 1 21.3 21.3 21.3 1 98.8 98.8 98.8 rine Galinsoga GASPA 1 30.0 30.0 30.0 1 60.0 60.0 60.0 1 32.5 32.5 32.5 1 12.5 12.5 12.5 parviflora Helianthus HELAN 1 35.0 35.0 35.0 1 42.5 42.5 42.5 1 88.8 88.8 88.8 1 85.0 85.0 85.0 annuus Matricaria MATCH 3 30.4 0.0 53.7 3 33.8 5.0 56.3 3 52.5 7.5 95.0 3 76.5 45.0 97.5 chamomilla Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 17 of 76 % Efficacy U 46 M-Fluid U 46 M-Fluid U 46 M-Fluid Reference product 0.8 - 0.9 L/ha 1.2 L/ha 1.5 - 1.6 L/ha Matricaria MATIN 1 94.5 94.5 94.5 - - - - 1 95.0 95.0 95.0 1 96.3 96.3 96.3 inodora Matricaria MATSS 1 1 96.0 96.0 - - - - 1 97.0 97.0 97.0 1 98.0 98.0 98.0 species Polygonum POLCO 1 35.0 35.0 35.0 1 85.0 85.0 85.0 1 98.8 98.8 98.8 1 37.5 37.5 37.5 convolvulus Persicaria POLLA 1 0.0 0.0 0.0 1 0.0 0.0 0.0 1 2.5 2.5 2.5 1 95.0 95.0 95.0 lapathifolia Persicaria POLPE 2 96.4 94.3 95.8 - - - - 1 96.9 97.5 96.3 1 97.1 96.3 97.8 maculosa Solanum SOLNI 1 99.3 99.3 99.3 - - - - 1 100.0 100.0 100.0 1 100.0 100.0 100.0 nigrum Solanum tu- SOLTU 1 97.5 97.5 97.5 - - - - 1 99.0 99.0 99.0 1 99.0 99.0 99.0 berosum Stellaria STEME 5 76.6 23.3 97.5 2 56.3 36.5 76.0 5 86.0 47.5 99.0 5 91.0 97.0 98.8 media Sinapis SINAR 1 99.0 99.0 99.0 - - - - 1 99.0 99.0 99.0 1 98.0 98.00 98.0 arvensis Thlaspi arv- THLAR 4 78.3 53.8 97.5 4 92.3 77.5 98.8 4 98.1 96.3 100.0 4 95.6 90.0 100.0 ense Urtica dioica URTDI 1 100.0 100.0 100.0 - - - - 1 100.0 100.0 100.0 1 100.0 100.0 100.0 Urtica urens URTUR 1 99.5 99.5 99.5 1 98.5 98.5 98.5 1 95.0 95.0 95.0 1 70.0 70.0 70.0 Veronica VERAG 1 5.0 5.0 5.0 1 0.0 0.0 0.0 1 20.0 20.0 20.0 1 70.0 70.0 70.0 agrestis Veronica VERHE 1 0.0 0.0 0.0 1 0.0 0.0 0.0 1 0.0 0.0 0.0 1 89.5 89.5 89.5 hederifolia Veronica VERPE 2 75.0 70.0 80.0 2 72.5 70.0 75.0 2 82.5 80.0 85.0 2 67.5 55.0 80.0 persica Viola arven- VIOAR 7 56.4 0.0 96.3 4 30.9 0.0 65.0 7 63.9 0.0 98.0 7 98.1 0.0 99.0 sis Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 18 of 76 The dose rate applied for, has been reduced from the dose rate which was tested in all efficacy and minimum effective dose trials in winter and spring cereals of 1.5 L/ha to 1.4 L/ha in order to comply with results of e-fate modelling to avoid the restriction NG 405 (no application on drained fields). IIIA1 6.1.2.3 Minimum effective dose tests – grassland A total of 8 GEP trials were conducted in the field in order to prove the required dose rate of U 46 M-Fluid (containing 500 g/L MCPA) against dicotyledonous weeds in Germany 2013 (4 trials) and the United Kingdom 2002 (4 trials). All trials were conducted by officially recognized organizations in accordance with the Principles of Good Experimental Practice (GEP) according to EPPO standards PP 1/61(2/3), PP 1/135(2/3), PP 1/152(2/3) and PP 1/181(2/3). No deviations have been repeated or were observed. In 8 grassland trials, performed in 2002 and 2013, different weed species were monitored and assessed. The efficacy value at last assessment timing was described. A summary of the results is shown in Table 6.1.2.3-1. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 19 of 76 Table 6.1.2.3-1: Efficacy of U 46 M-Fluid in grassland minimum effective dose trials in the Maritime EPPO zone, 8 trials, Germany (2013) and United Kingdom (2002) % Efficacy U 46 M-Fluid U 46 M-Fluid U 46 M-Fluid 1.0 - 1.2 L/ha (0.5 - 0.6 N) 1.6 L/ha (0.8 N) 2.0 L/ha (1 N) EPPO Scientific name N Mean Min Max N Mean Min Max N Mean Min Max Code Achillea millefolium ACHMI 1 15.0 15.0 15.0 1 25.8 25.8 25.8 1 36.5 36.5 36.5 Anthriscus sylvestris ANRSY 1 0.0 0.0 0.0 1 0.0 0.0 0.0 1 0.0 0.0 0.0 Capsella bursa pas- CAPBP 1 97.5 97.5 97.5 1 97.5 97.5 97.5 1 96.3 96.3 96.3 toris Cerastium fontanum CERFO 1 40.0 40.0 40.0 - - - - 1 55.0 55.0 55.0 Cirsium arvense CIRAR 4 66.2 0.0 99.0 1 0.0 0.0 0.0 4 68.4 0.0 100.0 Geranium sp. GERSS 1 100.0 100.0 100.0 - - - - 1 66.7 66.7 66.7 Matricaria chamomilla MATCH 1 70.0 70.0 70.0 1 70.0 70.0 70.0 1 75.0 75.0 75.0 Scorzoneroides au- LEBAU 2 66.3 53.3 79.3 - - - - 2 89.2 86.7 91.7 tumnalis Plantago lanceolata PLALA 4 66.7 22.5 93.8 3 75.5 30.8 98.0 4 77.3 47.5 99.3 Plantago major PLAMA 1 100.0 100.0 100.0 1 100.0 100.0 100.0 1 100.0 100.0 100.0 Polygonum aviculare POLAV 1 86.3 86.3 86.3 1 97.5 97.5 97.5 1 98.8 98.8 98.8 Ranunculus acris RANAC 2 56.3 18.8 93.8 2 67.0 35.3 98.9 2 74.9 49.8 100 Ranunculus repens RANRE 2 75.3 56.7 94.0 - - - - 2 85.8 78.0 93.7 Rumex obtusifolius RUMOB 1 96.0 96.0 96.0 - - - - 1 99.0 99.0 99.0 Stellaria media STEME 1 85.0 85.0 85.0 1 83.8 83.8 83.8 1 77.5 77.5 77.5 Taraxacum officinale TAROF 4 47.1 8.8 83.3 2 29.1 15.0 43.3 4 65.6 27.8 100.0 Thlaspi arvense THLAR 1 100.0 100.0 100.0 1 100.0 100.0 100.0 1 100.0 100.0 100.0 Trifolium dubium TRFDU 1 74.3 74.3 74.3 - - - - 1 86.0 86.0 86.0 Trifolium pratense TRFPR 3 31.3 0.0 93.8 3 32.9 0.0 98.8 3 33.3 0.0 100.0 Trifolium repens TRFRE 2 11.9 11.3 12.5 2 20.4 15.0 25.8 2 33.0 27.8 38.3 Veronica persica VERPE 1 86.7 86.7 86.7 - - - - 1 86.7 86.7 86.7 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 20 of 76 IIIA1 6.1.2.4 Minimum effective dose tests – orchards No new trials to support the dose response of U 46 M-Fluid against dicotyledonous weeds in orchards are submitted. As the spectrum of weeds present in orchards often is similar to that of grape vine or grassland, reference is made to the trial results reported for these crops. IIIA1 6.1.2.5 Minimum effective dose tests – grape vine No new trials to support the dose response of U 46 M-Fluid against dicotyledonous weeds in grape are submitted. Table 6.1.2.5-1: Summary results of trials at 2.0 L/ha, 3.0 L/ha and 4.0 L/ha U 46 M-Fluid for control of weeds in grape vine (22-29 days after application), 7 trials, Germany (2008 and 2009) Median efficacy [%] Weed species N Dose rates 2.0 L/ha 3.0 L/ha 4.0 L/ha AMARE Amaranthus retroflexus 1 70.0 88.3 98.8 CHEAL Chenopodium album 2 87.5 90.0 92.5 CIRAR Cirsium arvense 1 72.5 85.0 80.0 CONAR Convolvulus arvensis 5 87.0 95.0 96.5 GERSS Geranium species 1 100.0 100.0 100.0 LAMPU Lamium purpureum 1 100.0 100.0 100.0 SONOL Sonchus oleraceus 1 56.7 76.7 80.0 STEME Stellaria media 1 100.0 100.0 100.0 TARSS / Taraxacum species 4 87.5 84.5 88.8 TAROF &Taraxacum officinale THLAR Thlaspi arvense 1 87.5 100.0 84.7 VERSS Veronica species 1 100.0 100.0 100.0 Conclusion – Minimum effective dose tests 001: Winter cereals: acceptable dose-response-relationship (in the range of 0.8-0.9, 1.2, and 1.5-1.6 L/ha) with 3 or more trial results and 90% or more efficacy are shown for BRSNW and CHEAL. With the provided data an increase of efficacy over all trials and annual dicotyledonous weeds can be calculated from 0.8-0.9 to 1.5-1.6 L/ha as well as for CIRAR, the only perennial dicotyledonous weed. 002: Spring cereals: acceptable dose-response-relationship (in the range of 0.8-0.9, 1.2, and 1.5-1.6 L/ha) with 3 or more trial results and 90% or more efficacy are shown for BRSNW. With the provided data an increase of efficacy over all trials and annual dicotyledonous weeds can be calculated from 0.8-0.9 to 1.5-1.6 L/ha as well as for CIRAR, the only perennial dicotyledonous weed species. 003: Grassland: With the provided data an increase of efficacy over all trials and dicotyledonous weeds can be calculated in the range of 1.0-1.2, 1.6 and 2.0 L/ha. 004: Orchards: no data are submitted. The applicant wants to transfer results from grassland and grape vine to orchards. This is possible in case of the presented data in grassland. Results of minimum effective dose tests of grape vine cannot be transferred, because the applied dose rate is not the same in grape vine (4 L/ha) like in orchards (2 L/ha). 005: Grape vine: acceptable dose-response-relationship (in the range of 2.0, 3.0 and 4.0 L/ha) with 3 or more trial results and 90% or more efficacy are shown for CONAR. With the provided data an increase of efficacy over all trials and weeds can be calculated from 2.0 to 4.0 L/ha for dicotyledonous weeds. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 21 of 76 Overall Conclusion Sufficient data for minimum effective dose tests are presented for: 001: annual dicotyledonous weeds and CIRAR 002: annual dicotyledonous weeds and CIRAR 003: dicotyledonous weeds 004: dicotyledonous weeds 005: dicotyledonous weeds IIIA1 6.1.3 Efficacy tests 55 field trials are reported to demonstrate the efficacy of U 46 M-Fluid against dicotyledonous weeds in winter cereals, spring cereals and grassland. For trials in grape vine and orchards ref- erence is made to trials submitted in previous years for the registration of the product. Materials and Methods Table 6.1.3-1: Number of efficacy trials 1995 2002 2007 2013 2014 total Germany -- 1 -- 18 18 37 United Kingdom 4 4 10 -- -- 18 total 4 5 10 18 18 55 Table 6.1.3-2: Location of efficacy trials in the EPPO climatic zones EPPO zone Maritime Germany 37 United Kingdom 18 total 55 Table 6.1.3-3: Standards and trial design GEP Yes (51), No (4) standards EPPO PP 1/61(2/3), PP 1/93(2/3), PP 1/135(2/3), PP 1/152(2/3/4), PP 1/181(2/3/4) number of replications 4 (55) plot design, plot size RCBD (55), plot size: 11 m2 - 24 m2 (55) trials per crop winter wheat (11) winter barley (3) winter rye (1) winter triticale (2) winter oat (1) spring wheat (5) spring barley (11) spring rye (1) spring oat (3) grassland (17) varieties per crop winter wheat: Alchemy, Einstein, JG Asano, Cubus, Winnetou, Akteur, Tobak, Schamane, Tommi (2) winter barley: Sequel, Carrot, Campanile winter rye: Visello winter triticale: Tulus, Agostino winter oat: Dalguise Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 22 of 76 spring wheat: Tybalt (2) , Kadrilj, Chasmin, Triso spring barley: Optic (2), Catamaran, Quench (3), Propino (1), Grace (3) spring oat: Firth, Max, KWS Contender spring rye: Arates grassland: not relevant sowing date winter wheat: 17.10.2006, 28.10.2006, 05.10. - 10.10.2012, 30.09.-25.10.2013 winter barley: 21.08.2006, 12.10.2006, 19.09.2013 winter rye: 19.10.2012 winter triticale: 07.11.2012, 24.10.2013 winter oat: 4.10.2006, 01.04.2014 spring wheat: 20.02.2007, 27.02.2007, 20.03. – 27.03 2014 spring barley: 09.03.2007, 09.04.2007, 09.04. - 17.04.2013, 23.03. – 25.03.2014 spring oat: 22.03.2007, 13.03. – 01.04.2014 spring rye: 03.04.2013 grassland: not relevant crop stage (BBCH) at winter wheat: 24 - 37 application winter barley: 22 - 30 winter rye: 27 winter triticale: 29 - 31 winter oat: 31 spring wheat: 23 - 39 spring barley: 23 - 37 spring oat: 24 - 31 spring rye: 29 grassland: not relevant reference product(s) Duplosan KV (2,3 l/ha), 600 g/L Mecoprop-P (dosage), act. subst. U 46 D-Fluid (2.0 L/ha), 500 g/L 2,4-D ARIANE C (1.5 L/ha), 80 g/L Clopyralid, 100 g/L Fluroxypyr, 2.5 g/L Florasulam Biathlon (0.07 kg/ha), 714 g/kg Tritosulfuron Biathlon 4D (0.07 kg/ha), 3.8 g a.s./ha Florasulam and 50 g a.s./ha Tritosulfuron soil type * Not relevant IIIA 6.1.3.1 Efficacy tests – winter cereals Proposed label claim: U 46 M-Fluid (SL formulation containing 500 g/L MCPA) is a se- lective systemic herbicide for post-weed emergence application. For control of dicotyledonous weeds, apply once by foliar applica- tion in spring at BBCH crop 13 - 39, under consideration that the threshold is reached. U 46 M-Fluid should be applied at 1.4 L/ha equivalent to 700 g a.s./ha in 200 to 400 litres of water/ha by foliar application equipment. A summary of the efficacy in winter cereals is presented in Table 6.1.3.1-1 across the target winter cereal crops (TRZSW, HORVW, SECCW and TTLSW). Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 23 of 76 The evaluation is based on the results of 18 GEP compliant field tests performed in 2007 in UK and 2013 and 2014 in Germany. All results were obtained after application of 1.5 L/ha U 46 M- Fluid. All reported trials were conducted by officially recognized organizations in accordance with the Principles of Good Experimental Practice (GEP) in the year 2013. The trials were performed under field conditions according to EPPO Standards PP 1/93(3), PP 1/135(3), PP 1/152(4), PP 1/181(4). No deviations have been repeated or were observed. Table 6.1.3.1-1: Summary of efficacy of 1.5 - 1.6 L/ha U 46 M-Fluid at the last assessment timing (20-51 days after application) in winter cereals in spring - results reported from 18 trials in Germany (13) and UK (5) - maritime EPPO Zone U 46 M-Fluid Reference products* weed EPPO n mean/ mean/ code min max min max median median 1 2 3 4 5 Broadleaved weeds BBBBB 1 71.5 71.5 71.5 92.3 92.3 92.3 Brassica napus BRSNN 1 100.0 100.0 100.0 100.0 100.0 100.0 Brassica napus BRSNW 4 100.0 100.0 100.0 100.0 100.0 100.0 Capsella bursa pas- CAPBP 5 89.3 55.0 100.0 98.9 96.2 100.0 toris Chenopodium album CHEAL 4 100.0 100.0 100.0 66.6 28.3 100.0 Cirsium arvense CIRAR 2 98.1 97.3 98.3 98.6 98.5 98.8 Fumaria officinalis FUMOF 1 94.0 94.0 94.0 92.3 92.3 92.3 Galium aparine GALAP 4 33.8 0.0 82.5 75.0 0.0 100.0 Lamium amplexicaule LAMAM 1 56.3 56.3 56.3 75.0 75.0 75.0 Lamium purpureum LAMPU 3 75.0 62.5 91.3 80.8 62.5 92.3 Matricaria chamomilla MATCH 4 11.3 0.0 37.5 100.0 100.0 100.0 Matricaria inodora MATIN 2 76.9 73.8 80.0 67.5 60.0 75.0 Matricaria species MATSS 1 52.5 52.5 52.5 61.3 61.3 61.3 Myosotis arvensis MYOAR 2 86.3 77.5 95.0 85.0 70.0 100.0 Papaver rhoeas PAPRH 2 83.0 66.3 99.8 81.6 63.8 99.5 Poa annua POAAN 1 83.8 83.8 83.8 72.5 72.5 72.5 Polygonum convolvu- POLCO 1 12.5 12.5 12.5 0.0 0.0 0.0 lus Raphanus raphan- RAPRA 1 86.8 86.8 86.8 99.0 99.0 99.0 istrum Sinapis arvensis SINAR 1 85.0 85.0 85.0 85.0 85.0 85.0 Stellaria media STEME 9 53.8 0.0 98.3 93.3 35.0 100.0 Thlaspi alliaceum THLAL 1 100.0 100.0 100.0 100.0 100.0 100.0 Thlaspi arvensis THLAR 5 99.8 98.8 100.0 97.9 89.5 100.0 Veronica agrestis VERAG 2 15.0 0.0 30.0 37.5 5.0 70.0 Veronica officinale VEROF 1 81.3 81.3 81.3 87.5 87.5 87.5 Veronica persica VERPE 4 72.4 37.5 95.8 72.9 42.5 99.3 Viola arvensis VIOAR 4 53.2 31.3 72.5 81.3 56.3 100.0 1 scientific name (lat.) 2 EPPO-Code 3 number of results (test/reference product) 4 mean (median), minimum, maximum test product 5 mean (median), minimum, maximum reference * Reference product in Germany: ARIANE C; in UK: Duplosan KV Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 24 of 76 The dose rate applied for has been reduced from the dose rate which was tested in all efficacy and minimum effective dose trials in winter and spring cereals of 1.5 L/ha to 1.4 L/ha in order to comply with results of e-fate modeling to avoid the restriction NG 405 (no application on drained fields). IIIA 6.1.3.2 Efficacy tests – spring cereals Proposed label claim: U 46 M-Fluid (SL formulation containing 500 g/L MCPA) is a se- lective systemic herbicide for post emergence application. For control of dicotyledonous weeds, apply once by foliar applica- tion in spring at BBCH crop 13 - 39, under consideration that the threshold is reached. U 46 M-Fluid should be applied at 1.4 L/ha equivalent to 700 g a.s./ha in 200 to 400 litres of water/ha by foliar application equipment. The evaluation is based on the results of 20 GEP compliant field tests performed in 2007 in UK and 2013 and 2014 in Germany. All results were obtained after application of 1.5 L/ha U 46 M- Fluid. All reported trials were conducted by officially recognized organizations in accordance with the Principles of Good Experimental Practice (GEP) in the years 2007, 2013 and 2014. The trials were performed under field conditions according to EPPO standards PP 1/93(2/3), PP 1/135(2/3), PP 1/152(2/3/4), PP 1/181(2/3/4). No deviations have been repeated or were observed. A summary of the efficacy in spring cereals is presented in Table 6.1.3.2-1 across the target spring cereal crops. Table 6.1.3.2-1: Summary of efficacy of 1.5 - 1.6 L/ha U 46 M-Fluid at the last assessment timing (20-51 days after application) in spring cereals - results reported from 20 trials in Germany (15) and UK (5) - maritime EPPO Zone U 46 M-Fluid Reference products* weed/pest/ EPPO n mean/ mean/ disease code min max min max median median 1 2 3 4 5 Anthemis arvensis ANTAR 1 88.8 88.88 88.8 77.5 77.5 77.5 Atriplex patula ATXPA 1 93.5 93.5 93.5 92.5 92.5 92.5 Brassica napus BRSNN 1 100.0 100.0 100.0 95.0 95.0 95.0 Capsella bursa pastoris CAPBP 3 99.8 88.8 100.0 96.1 88.8 100.0 Chenopodium album CHEAL 12 90.5 27.5 100.0 64.9 25.0 100.0 Cyanus segetum CENCY 1 90.0 90.0 90.0 80.8 80.8 80.8 Cirsium arvense CIRAR 5 94.9 85.0 98.5 85.8 75.0 98.8 Galium aparine GALAP 1 21.3 21.3 21.3 98.8 98.8 98.8 Galinsoga parviflora GASPA 1 32.5 32.5 32.5 12.5 12.5 12.5 Helianthus annuus HELAN 1 88.8 88.8 88.8 85.0 85.0 85.0 Matricaria chamomilla MATCH 3 52.5 7.5 95.0 76.5 45.0 97.5 Matricaria inodora MATIN 1 95.0 95.0 95.0 96.3 96.3 96.3 Matricaria species MATSS 1 97.0 97.0 97.0 98.0 98 98 Polygonum convolvulus POLCO 2 98.4 98.0 98.8 68.3 37.5 98.8 Persicaria lapathifolia POLLA 1 2.5 2.5 2.5 95.0 95.0 95.0 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 25 of 76 U 46 M-Fluid Reference products* weed/pest/ EPPO n mean/ mean/ disease code min max min max median median Polygonum persicaria POLPE 2 96.4 96.4 96.4 96.8 96.8 96.8 Solanum nigrum SOLNI 1 100.0 100.0 100.0 100.0 100.0 100.0 Solanum tuberosum SOLTU 1 99.0 99.0 99.0 99.0 99.0 99.0 Stellaria media STEME 6 82 52.5 99.0 93.6 70.5 100.0 Sinapis arvensis SINAR 1 99.0 99.0 99.0 98.0 98 98 Thlaspi arvensis THLAR 5 98.2 96.3 100.0 96.2 90.0 100.0 Urtica dioica URTDI 1 100.0 100.0 100.0 100.0 100.0 100.0 Urtica urens URTUR 1 95 95 95 70.0 70.0 70.0 Veronica agrestis VERAG 1 20.0 20.0 20.0 70.0 70.0 70.0 Veronica hederifolia VERHE 1 0.0 0.0 0.0 89.5 89.5 89.5 Veronica persica VERPE 2 82.5 80.0 85.0 67.5 55.0 80.0 Viola arvensis VIOAR 7 63.9 0.0 98.0 98.7 0.0 99.0 1 scientific name (lat.) 2 EPPO-Code 3 number of results (test/reference product) 4 mean (median), minimum, maximum test product 5 mean (median), minimum, maximum reference product *Reference product in Germany: ARIANE C; in UK: Duplosan KV The dose rate applied for, has been reduced from the dose rate which was tested in all efficacy and minimum effective dose trials in winter and spring cereals of 1.5 L/ha to 1.4 L/ha in order to comply with results of e-fate modeling to avoid the restriction NG 405 (no application on drained fields). IIIA 6.1.3.3 Efficacy tests – grassland Proposed label claim: U 46 M-Fluid (SL formulation containing 500 g/L MCPA) is a se- lective systemic herbicide for post emergence application. For control of dicotyledonous weeds, apply once by foliar applica- tion during vegetative vigour (May – August), under consideration that the threshold is reached. U 46 M-Fluid should be applied at 2.0 L/ha equivalent to 1000 g a.s./ha in 200 to 400 litres of water/ha by foliar application equipment. In 13 GEP compliant field tests, the efficacy of U 46 M-FLUID against dicotyledonous weeds was tested in grassland. 4 trials were carried out 2002 in UK and 9 trials were performed in 2013 in Germany. Additionally, 4 supportive trials from UK (1995) are reported. All trials were conducted by officially recognized organizations in accordance with the Principles of Good Experimental Practice (GEP). The trials conducted in Germany were performed accord- ing to EPPO Standards PP 1/61(3), PP 1/135(3), PP 1/152(3) and PP 1/181(3). No deviations have been repeated or were observed. A summary of the results is in Table 6.1.3.3-1. Table 6.1.3.3-1: Summary efficacy of 2.0 L/ha U 46 M-Fluid at the last assessment timing (15 - 88 days after application) in grassland - results reported from 9 trials in Germany and 4 trials in the United Kingdom - maritime EPPO zone Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 26 of 76 % ground cover % efficacy % efficacy Scientific EPPO N Untreated control U 46 M-Fluid reference product(s)* name code Mean Min Max Mean Min Max Mean Min Max Achillea ACHMI 1 9 9 9 37 37 37 90 90 90 millefolium Anthriscus ANRSY 2 2 2 3 0 0 0 0 0 0 sylvestris Capsella CAPBP 2 5 1 8 98 96 100 99 98 100 bursa-pastoris Cerastium fon- CERFO 1 8 8 8 64 64 64 68 68 68 tanum Cirsium CIRAR 4 8 5 20 68 0 100 64 0 99 arvense Geranium sp. GERSS 1 5 5 5 67 67 67 83 83 83 Scorzoneroides LEBAU 2 9 3 15 89 87 92 74 72 77 autumnalis Matricaria MATCH 2 13 13 13 75 75 75 75 73 78 chamomilla Plantago PLALA 7 6 3 11 80 48 100 92 60 100 lanceolata Plantago PLAMA 2 3 3 3 100 100 100 100 100 100 major Polygonum POLAV 1 7 7 7 99 99 99 89 89 89 aviculare Polygonum POLLA 2 2 1 3 83 73 94 94 94 95 lapathifolium Ranunculus ac- RANAC 4 3 1 4 75 50 100 70 46 100 ris Ranunculus re- RANRE 3 7 4 10 91 78 100 87 63 100 pens Rumex RUMAC 1 1 1 100 100 100 100 100 100 acris 1 Rumex obtusi- RUMOB - - - 62 62 62 69 69 69 folius 1 Stellaria STEME 3 8 2 12 88 78 98 84 70 98 media Taraxacum of- TAROF 10 8 1 24 71 25 100 76 25 100 ficinale Thlaspi THLAR 2 6 5 6 100 100 100 100 100 100 arvense Trifolium du- TRFDU 1 15 15 15 86 86 86 68 68 68 bium Trifolium TRFPR 5 8 3 13 20 0 100 59 42 94 pratense Trifolium TRFRE 5 10 2 23 46 21 100 43 23 94 repens Urtica URTDI 1 7 7 7 0 0 0 0 0 0 dioica Veronica per- VERPE 1 4 4 4 87 87 87 93 93 93 sica *Reference products: Germany: NUFARM`s MCPA 750 and D-Fluid IIIA 6.1.3.4 Efficacy tests – orchard floor of pome fruit and stone fruit Proposed label claim: U 46 M-Fluid (SL formulation containing 500 g/L MCPA) is a se- lective systemic herbicide for post emergence application. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 27 of 76 For control of dicotyledonous weeds, apply once per year by foliar application during vegetative vigour (March – September), under consideration that the threshold is reached. U 46 M-Fluid should be applied at 2.0 L/ha equivalent to 1000 g a.s./ha in 200 to 400 litres of water/ha by foliar application equipment. No new trials to support the efficacy of U 46 M-Fluid against dicotyledonous weeds in orchards are submitted. The spectrum of weeds present in orchards often is similar to that of grassland; therefore refer- ence is made to the trial results reported for this crop. IIIA 6.1.3.5 Efficacy tests – grape vine Proposed label claim: U 46 M-Fluid (SL formulation containing 500 g/L MCPA) is a se- lective systemic herbicide for post emergence application. For control of dicotyledonous weeds, apply once by foliar applica- tion during vegetative vigour (March – September), under consid- eration that the threshold is reached. U 46 M-Fluid should be applied at 4.0 L/ha equivalent to 2000 g a.s./ha in 200 to 600 litres of water/ha by foliar application equipment. No new trials to support the efficacy of 4.0 L/ha U 46 M-Fluid against dicotyledonous weeds in grape vine are submitted. Table 6.1.3.4-1: Summary results of trials at 4.0 L/ha U 46 M-Fluid and reference product for control of weeds in grape vine (22 - 31 days after application), Germany 2008 and 2009 Efficacy [%] Weed species U 46 M-Fluid Reference product N (EPPO code) Me- Me- Mean Min Max Mean Min Max dian dian AMARE 1 98.8 98.8 -- -- 100.0 100.0 -- -- CHEAL 2 92.5 92.5 85.0 100.0 100.0 100.0 100.0 100.0 CIRAR 1 80.0 80.0 -- -- 97.5 97.5 -- -- CONAR 6 97.4 97.9 92.5 100.0 82.9 85.0 52.5 100.0 GERSS 1 100.0 100.0 -- -- 100.0 100.0 -- -- LAMPU 1 100.0 100.0 -- -- 100.0 100.0 -- -- SONOL 1 80.0 80.0 -- -- 100.0 100.0 -- -- STEME 1 100.0 100.0 -- -- 100.0 100.0 -- -- TARSS / TAROF 4 81.9 93.8 40.0 100.0 85.9 100.0 43.8 100.0 THLAR 1 84.7 84.7 -- -- 100.0 100.0 -- -- VERSS 1 100.0 100.0 -- -- 100.0 100.0 -- -- Conclusion – Efficacy tests Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 28 of 76 001: winter cereals: Efficacy data of 1.5-1.6 L/ha application rate are submitted for the group of annual dicotyledonous weeds. For CIRAR data of 2 trials are submitted, according to EPPO standard PP1/226 6-15 trials for major weeds in major crops are required. But data of summer cereals for CIRAR can be transferred to winter cereals in the consequence, that CIRAR can be applied for registration. 002: spring cereals: Efficacy data of 1.5-1.6 L/ha application rate are submitted for the group of annual dicotyledonous weeds. 5 trials with CIRAR are submitted, these are enough data to reg- ister for the single weed CIRAR. 003: grassland: Efficacy data of 2 L/ha application rate are submitted to meet the group of di- cotyledonous weeds. 004: orchards (pome and stone fruit): efficacy of 2 L/ha application rate: no results are submit- ted. The applicant wants to transfer efficacy results from cereals, grape vine or grassland. This is not possible for cereals, because the species spectra are different. It is also not possible for grape vine, because the application rate is much higher (4 L/ha) than for orchards. Efficacy re- sults from grassland can be transferred. 005: grape vine: Efficacy data of 4 L/ha application rate are submitted to meet the group of di- cotyledonous weeds. 003-005 A sustained assessment for perennial weeds in the following year could not be carried out. Overall Conclusion Sufficient efficacy data are presented for: 001: annual dicotyledonous weeds and CIRAR 002: annual dicotyledonous weeds and CIRAR 003: dicotyledonous weeds 004: dicotyledonous weeds 005: dicotyledonous weeds 003-005 A sustained assessment for perennial weeds in the following year could not be carried out. There- fore the label warning: The product has no sustainable effect in perennial weeds 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 6.1.4.1.1 Winter cereals Results on the thousand grain weight are reported from 4 efficacy trials in winter wheat at 1.5 L/ha and from 7 selectivity trials in winter wheat (3 trials), winter barley (2 trials), winter rye (1 trial) and winter triticale (1 trial) at 1.5 L/ha and 3.0 L/ha. The efficacy trials were performed 1984 - 1994 with the following varieties: Herzog, Disponent and Bussard. The selectivity trials were performed 2002 with the following varieties: winter wheat varieties Bussard and Batis, winter barley variety Theresa, winter rye variety Avent and winter triticale variety Modus. The results are shown in Table 6.1.4.1.1-1 for the efficacy trials and Table 6.1.4.1.1-2 for the selectivity trials. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 29 of 76 Table 6.1.4.1.1-1: Thousand grain weight (TGW) of winter cereals after application of 1.5 L/ha U 46 M-Fluid in efficacy trials 1994 Thousand grain weight [g] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha Winter wheat 4 36.0 37.2 40.0 Table 6.1.4.1.1-2: Thousand grain weight (TGW) of winter cereals after application of 1.5 and 3.0 L/ha U 46 M-Fluid in selectivity trials 2002 Thousand grain weight [g] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 3.0 L/ha Winter wheat 3 41.2 42.8 43.2 41.3 42.2 Winter barley 2 40.0 41.1 40.8 40.6 39.6 Winter rye 1 36.3 34.9 32.1 34.9 33.7 Winter triticale 1 47.2 51.6 49.1 52.1 49.9 IIIA1 6.1.4.1.2 Spring cereals The assessment is based on a total of 13 selectivity trials against dicotyledonous weeds in spring cereals. The selectivity trials were performed 2014 in Germany with the following varieties: Miradoux, Max, Grace, Arantes, Tybald and Chasmin. Results on the thousand grain weight and the hectolitre weight are reported from trials in durum wheat (4 trials), spring barley (2 trials), spring oat (3 trials), spring rye (2 trials) and spring wheat (2 trials). In the addendum "Antrag auf die erneute Zulassung des Pflanzenschutzmittels U 46 M-Fluid (BAS 010 01 H)" dated January 2003 (Doc. No. 391-002, KIIIA1 6/01) results on the thousand grain weight are reported from 2 efficacy trials in spring wheat and 3 efficacy trials in spring barley at 1.5 L/ha and from 10 selectivity trials 2002 in spring wheat (4 trials), spring barley (4 trials) and oat (2 trials) at 1.5 L/ha and 3.0 L/ha. The efficacy trials were performed 1993 and 1994 with the following varieties: spring wheat variety Hanno and spring barley variety Alexis. The selectivity trials were performed 2002 with the following varieties: spring wheat varieties Triso and Thasos, spring barley variety Scarlet, oat varieties Flipper and Flämingskrone. The results are shown in Table 6.1.4.1.2-1 for the efficacy trials and Tables 6.1.4.1.2-2, 6.1.4.1.2- 3, 6.1.4.1.2-4 for the selectivity trials. Table 6.1.4.1.2-1: Thousand grain weight (TGW) of spring cereals after application of 1.5 L/ha U 46 M-Fluid in 5 efficacy trials 1993-1994 Thousand grain weight [g] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha Spring wheat 2 34.4 32.3 34.7 Spring barley 3 41.7 42.5 41.0 Table 6.1.4.1.2-2: Thousand grain weight (TGW) of spring cereals after application of 1.5 and 3.0 L/ha U 46 M-Fluid in 10 selectivity trials 2002 Thousand grain weight [g] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 3.0 L/ha Spring wheat 4 38.6 39.6 40.1 39.8 39.4 Spring barley 4 43.8 44.5 44.8 44.7 45.1 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 30 of 76 Thousand grain weight [g] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 3.0 L/ha Spring oat 2 28.9 31.7 31.3 32.3 31.7 Tab. 6.1.4.1.2-3: Thousand grain weight (g) of spring cereals after application of 1.5 and 3.0 L/ha U 46 M-Fluid in 13 selectivity trials 2014 Thousand grain weight [g] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 3.0 L/ha Spring oat 2 37.3 37.5 37.3 36.6 Spring barley 3 51.9 52.5 52.7 52.2 Spring rye 2 35.2 36.2 35.5 33.2 Spring wheat 2 47.1 46.7 47.9 47.1 Durum wheat 4 52.6 52.5 53.1 53.2 Tab. 6.1.4.1.2-4: Hectolitre weight (kg) of spring cereals after application of 1.5 and 3.0 L/ha U 46 M-Fluid in 13 selectivity trials 2014 Hectolitre weight [kg] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 3.0 L/ha Spring oat 2 45.4 47.6 47 46.9 Spring barley 3 60.9 61.6 61.2 61.1 Spring rye 2 69.5 70.5 70.0 69.6 Spring wheat 2 73.4 73.3 72.3 72.5 Durum wheat 4 73 73.3 73.4 73.1 IIIA1 6.1.4.1.3 Grassland The assessment is based on a total of 1 selectivity trial in Germany against dicotyledonous weeds in grassland. The results are shown in Table 6.1.4.1.3-1. Tab. 6.1.4.1.3-3 Dry matter content of grassland after application of 2.0 L/ha and 4.0 L/ha U 46 M-Fluid in a selectivity trial in 2003 (Germany) Dry matter content [%] Crop N Untreated U 46 M-Fluid Reference product Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 31 of 76 2.0 L/ha 4.0 L/ha grassland 1 22.5 23.8 25.6 24.9 IIIA 6.1.4.1.4 Orchard floor of pome fruit and stone fruit No data are submitted for the impact of U 46 M-Fluid on the quality of plants and plant products. The applicant gives the explanation that the orchard ground is treated and not the pome or stone fruit. IIIA1 6.1.4.1.5 Grape vine No data are submitted for the impact of U 46 M-Fluid on the quality of plants and plant products. Reference is made to "Second Amendment to Biological Dossier U 46 M-Fluid" dated March 2010 (Doc. No. 381-002, KIIIA1 6/01). Conclusion - Impact on the quality of plants and plant products 001: winter cereals: data are presented on the thousand grain weight from 4 efficacy trials (1994) in winter wheat at 1.5 L/ha and from 7 selectivity trials (2002) in winter wheat (3 trials), winter barley (2 trials), winter rye (1 trial) and winter triticale (1 trial) at 1.5 L/ha and 3.0 L/ha. No impact on the TGW was observed. 002: spring cereals: data are presented on the thousand grain weight and hectolitre weight from 5 efficacy trials (1993, 1994) in spring wheat (2 trials) and spring barley (3 trials) at 1.5 L/ha and from 23 selectivity trials (2002, 2014) in durum wheat (4 trials), spring barley (7 trials), spring oat (4 trials), spring rye (2 trials) and spring wheat (6 trials) at 1.5 L/ha and 3.0 L/ha. No impact on the TGW was observed. 003: grassland: data on the dry matter content from 1 selectivity trial are submitted. No impact on the dry matter was observed. 004: orchards (pome and stone fruit): No data are submitted. The applicant gives the explanation that the orchard ground is treated and not the pome or stone fruit. The zRMS can follow that argumentation, because the application is made with a screen. 005: grape vine: Reference is made to "Second Amendment to Biological Dossier U 46 M-Fluid dated March 2010 (Doc. No. 381-002, KIIIA1 6/01)”. This Dossier provides no data on quality for grape vine, therefore: no data are submitted. IIIA1 6.1.4.2 Effects on the processing procedure IIIA1 6.1.4.2.1 Winter cereals Neither from trial experience nor from practical use of the active ingredient MCPA was reported any case about negative influences on parameters influencing the processing procedure of winter cereals. Thus no special trials were carried out for the assessment of these criteria. IIIA1 6.1.4.2.2 Spring cereals Neither from trial experience nor from practical use of the active ingredient MCPA was reported any case about negative influences on parameters influencing the processing procedure of spring cereals. Thus no special trials were carried out for the assessment of these criteria. IIIA1 6.1.4.2.3 Grassland Not relevant for grassland. IIIA1 6.1.4.2.5 Orchard floor of pome fruit and stone fruit Neither from trial experience nor from practical use of the active ingredient MCPA was reported any case about negative influences on parameters influencing the processing procedure of pome fruit or stone fruit. Thus no special trials were carried out for the assessment of these criteria. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 32 of 76 IIIA1 6.1.4.2.4 Grape vine Neither from trial experience nor from practical use of the active ingredient MCPA was reported any case about negative influences on parameters influencing the processing procedure of grape vine. Thus no special trials were carried out for the assessment of these criteria. The product complies with the Uniform principles. Conclusion - Effects on the processing procedure Neither from trial experience nor from practical use of the active ingredient MCPA was reported any case about negative influences on parameters influencing the processing procedure of winter cereals, spring cereals, grassland, orchard and grape vine. IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products Tab. 6.1.4.3-1: Number of selectivity and efficacy trials 1984- 2002 2003 2006 2007 2009 2013 2014 total 1996 Germany 36 10+7 10+13 76 United Kingdom - 4 1 - 5 total 36 21 1 23 81 Tab. 6.1.4.3-2: Location of efficacy trials in the EPPO climatic zones EPPO zone Maritime Germany 76 United Kingdom 5 total 81 Tab. 6.1.4.3-3: Standards and trial design GEP Yes (44); No (37) standards EPPO PP 1/61(2/3), PP 1/93(2/3), PP 1/135(2/3), PP 1/152(2/3), PP 1/181(2/3) number of replications 4 (81) plot design. plot size RCBD (81), plot size: 9 m2 - 30 m2 (81) trials per crop winter wheat (12) winter barley (9) winter rye (2) winter triticale (2) spelt (4) spring wheat (8) spring barley (25) spring rye (2) spring oat (6) durum wheat (4) grassland (5) varieties per crop winter wheat: Astron, Batis, Bussard (3), Disponent (3), Herzog (2), JB ASano, Ritmo, winter barley: Doris (3), Gerbel (2), Lomerit (2),Theresa (2) winter rye: Avanti, Palazzo winter triticale: Dinaro, Modus spelt: Frankenkorn (4) Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 33 of 76 spring wheat: Hanno (2), KWS Chasmin, Thasos (2), Triso (2), Tybalt spring barley: Alexis (8), Baronesse (3), Grace (3), Scarlett (8), Thuringia (3), spring oat: Flipper, Flämmingstern, Max (2) spring rye: Arantes (2) durum wheat: Miradoux (4) grassland: not relevant crop stage (BBCH) at winter wheat: 25 - 37 application winter barley: 29 - 31 winter rye: 29 - 31 winter triticale: 25 - 31 spelt:25 - 39 spring wheat: 25 - 45 spring barley: 12-45 spring oat: 21 - 31 spring rye: 29 – 34 durum wheat: 29 - 37 grassland: not relevant reference product(s) Duplosan KV (2.3 L/ha), 600 g/L Mecoprop-P (dosage). act. subst. U 46 D-Fluid (2.0 L/ha), 500 g/L 2.4-D ARIANE C (1.5 L/ha), 80 g/L Clopyralid, 100 g/L Fluroxypyr. 2.5 g/L Florasulam Biathlon (0.07 kg/ha), 714 g/kg Tritosulfuron Basagran DP (4 L/ha) Pointer (0.02 – 0.025 kg/ha) soil type * Not relevant IIIA 6.1.4.3.1 Winter cereals The assessment is based on a total of 10 new selectivity trials in winter cereals. In addition, results submitted by BASF for the registration of U 46 M-Fluid in January 2003 (Antrag auf erneute Zu- lassung für das Pflanzenschutzmittel U 46 M-Fluid (BAS 010 01 H), (Doc. No. 381-002, KIIIA1 6/01) are considered, too. The 10 selectivity trials were performed 2014 in Germany with the following varieties: Lomerit, Palazzo, Dinaro, JB ASano, Ritmo and Frankenkorn. Results on the yield are reported from trials in winter wheat (2 trials), winter barley (2 trials), winter triticale (1 trial), winter rye (1 trial) and spelt (4 trials). In the Biological Assessment Dossier "Antrag auf die erneute Zulassung des Pflanzenschutzmit- tels U 46 M-Fluid (BAS 010 01 H)" dated January 2003 (Doc. No. 381-002, KIIIA1 6/01) results on the yield are reported from 8 efficacy trials in winter wheat, 4 efficacy trials in winter barley at 1.5 L/ha. From 1 selectivity trial in winter wheat and 4 selectivity trials in winter barley 1984 - 1996 and from 7 selectivity trials 2002 in winter wheat (3 trials), winter barley (2 trials), winter rye (1 trial) and winter triticale (1 trial) at 1.5 L/ha and 3.0 L/ha. The results are shown in Table 6.1.4.3.1-1 for the efficacy trials, Table 6.1.4.3.1-2 and Table 6.1.4.3.1-3; -4 for the selectivity trials. Table 6.1.4.3.1-1: Yield effect in 12 efficacy trials in the maritime EPPO zone, 1984 - 1996 Untreated Yield rel. [%] Crop BBCH N U 46 M-Fluid Reference prod- dt/ha 1.5 L/ha uct Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 34 of 76 13 - 29 2 32.4 102.3 103.1 Winter barley 30 - 39 2 77.3 104.5 103.3 13 - 29 5 55.1 108.3 103.8 Winter wheat 30 - 39 3 58.2 138.2 124.8 Table 6.1.4.3.1-2: Yield effect in 5 selectivity trials (weed-free) in the maritime EPPO zone, 1986 - 1996 Untreated Yield rel. [%] Crop N U 46 M-Fluid Reference dt/ha 1.5 L/ha 3.0 L/ha product Winter barley 3 63.6 97.3 97.3 101.1 Winter barley 1 55.3 101.4 102.2 Winter wheat 1 55.0 104.0 104.5 Table 6.1.4.3.1-3: Yield effect in 7 selectivity trials (weed-free) in the maritime EPPO zone, 2002 Untreated Yield rel. [%] Crop N U 46 M-Fluid Reference product dt/ha 1.5 L/ha 3.0 L/ha 1 N 2 N Winter wheat 3 65.5 106 108 102 99 Winter barley 2 88.7 97 101 100 99 Winter rye 1 87.4 104 114 113 110 Winter triticale 1 80.1 116 107 109 108 Tab. 6.1.4.3.1-4: Yield effect in 10 selectivity trials (weed-free) in the maritime EPPO zone, 2014 Untreated Yield rel. [%] Crop N U 46 M-Fluid Reference product dt/ha 1.5 L/ha 3.0 L/ha 1 N Winter barley 1 108.8 99.7 97.0 97.9 Winter rye 2 90.9 97.6 108.5 100.2 Winter wheat 2 93.2 99.0 99.5 101.6 Spelt 4 60 101.4 99.9 101.3 Winter triticale 1 77.0 103.7 103 103.8 No impact of application of 1.5 L/ha or 3.0 L/ha U 46 M Fluid on the yield of winter cereals (TRZSW, HORVW, SECCW and TTLSS and TRZSP) was found. It therefore is concluded that application of 1.4 L/ha U 46 M-Fluid will not have an impact on the yield of winter cereals. The product complies with the Uniform principles. IIIA 6.1.4.3.2 Spring cereals The assessment is based on a total of 13 new selectivity trials in spring cereals. In addition, results submitted by BASF for the registration of U 46 M-Fluid in January 2003 (Antrag auf erneute Zu- lassung für das Pflanzenschutzmittel U 46 M-Fluid (BAS 010 01 H), ( Doc. No. 381-002, KIIIA1 6/01) are considered, too. The 13 selectivity trials were performed 2014 in Germany with the following varieties: Miradoux, Max, Grace, Arantes, Tybald and Chasmin. Results on the yield are reported from trials in durum Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 35 of 76 wheat (4 trials), spring barley (2 trials), spring oat (3 trials), spring rye (2 trials) and spring wheat (2 trials). In previous submissions results on the yield are reported from 12 efficacy trials in spring wheat (2), in oat (2) and in spring barley (8) at 1.5 L/ha, from 12 selectivity trials in spring barley 1996 and from 10 selectivity trials 2002 in spring wheat (4 trials), spring barley (4 trials) and oat (2 trials) at 1.5 L/ha and 3.0 L/ha. The results are shown in Table 6.1.4.3.2-1 for the efficacy trials and Table 6.1.4.3.2-2/3 for the selectivity trials. Table 6.1.4.3.2-1: Yield effect in 12 efficacy trials in the maritime EPPO zone, 1994 Un- Yield rel. [%] treated Crop BBCH N U 46 M-Fluid dt/ha Reference product 1.5 L/ha 13 - 29 3 63.3 99.1 96.5 Spring barley 30 - 39 5 56.5 105.0 103.6 Spring wheat 13 - 29 2 39.2 96.4 108.7 Oat 30 - 39 2 38.4 102.5 - Table 6.1.4.3.2-2: Yield effect in 12 selectivity trials in the maritime EPPO zone, 1986 - 1996 Yield rel. [%] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 4.5 L/ha Spring barley 8 56.2 102.8 94.9 99.5 (ES 13 - 29) Spring barley 4 56.2 104.5 94.1 98.8 (ES 30 - 39) Table 6.1.4.3.2-3: Yield effect in 10 selectivity trials in the maritime EPPO zone, 2002 Yield rel. [%] Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 3.0 L/ha Spring wheat 4 45.6 107 102 106 103 Spring barley 4 42.9 106 108 106 104 Spring oat 2 62.7 102 104 87 83 Tab. 6.1.4.3.2-4: Yield effect in 13 selectivity trials in the maritime EPPO zone, 2014 Yield dt/ha Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 3.0 L/ha Spring oat 2 76.7 76.5 75.4 74.1 Spring barley 3 79.2 79.8 78.3 79.8 Spring rye 2 32.8 33.5 33.3 32.2 Spring wheat 2 70.9 71.2 70.1 70.9 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 36 of 76 Yield dt/ha Crop N U 46 M-Fluid Untreated Reference product 1.5 L/ha 3.0 L/ha Durum wheat 4 63.1 62.9 63.1 63 No impact of application of 1.5 L/ha or 3.0 L/ha U 46 M Fluid on the yield of spring cereals (TRZSS, HORVS, SECCS and AVESS) was found. Selectivity trials with barley (1986-1996) are not considered for evaluation because of a not rele- vant application rate (4.5 L/ha). The product complies with the Uniform principles. IIIA 6.1.4.3.3 Grassland The assessment is based on a total of 1 selectivity trial in Germany against dicotyledonous weeds in grassland. Tab. 6.1.4.3.3-4: Yield effect in selectivity trials in the Maritime EPPO zone, 2003 Fresh weight [dt/ha] Crop N U 46 M-Fluid Untreated Reference product 2.0 L/ha 4.0 L/ha grassland 1 158.0 127.3 107.8 139.8 As shown in the BAD and the individual trial report, the differences in fresh weight between the four variants are not statistically significant. IIIA 6.1.4.3.4 Pome and stone fruits No data are submitted. Based on the fact that the product is applied on the ground of the orchards - and not on the plants - it is concluded that 1 application of 2.0 L/ha U 46 M-Fluid will not influence the yield of pome fruit or stone fruit. IIIA 6.1.4.3.5 Grape vine No data are submitted. In previous submissions results (Doc. No. 381-002, KIIIA1 6/01) from 2 crop safety trials per- formed in Germany are reported. The trials were carried out in 2008 in the varieties Dornfelder and Ruländer, U 46 M-Fluid was tested at 4.0 L/ha (N) and 8.0 L/ha (2 N). Table 6.1.4.3.4-1: Effect of 4.0 L/ha U 46 M-Fluid on yield of grape vine Test Prod- Yield brutto Trial uct/ Appl. Rate No. of Rating Date DAT* ID Reference (L/ha) fruits/plot kg/plot Rel. [%] Product Reference Number 06 Dornfelder 6 Control 0 26.09.2008 102 164.8 44.4 100 6 U 46 M-Fluid 4 26.09.2008 102 155.3 41.7 94 6 U 46 M-Fluid 8 26.09.2008 102 168.8 47.3 107 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 37 of 76 Test Prod- Yield brutto Trial uct/ Appl. Rate No. of Rating Date DAT* ID Reference (L/ha) fruits/plot kg/plot Rel. [%] Product 6 Clinic 10 26.09.2008 102 171.3 46.4 105 Reference Number 07 Ruländer 7 Control 0 26.09.2008 102 193.5 23.6** 100 7 U 46 M-Fluid 4 26.09.2008 102 134.8 14.7** 62 7 U 46 M-Fluid 8 26.09.2008 102 125.0 13.6** 58 7 Clinic 10 26.09.2008 102 198.8 22.8** 97 *DAT= days after treatment; **reduced yield due to appearance of Pseudopezicula tracheiphila Table 6.1.4.3.4-1 shows the results of the trials. 201 days after application yield/plot in trial 6 was highest after application of the double dose rate of U 46 M-Fluid and lowest after application of 4 kg/ha U 46 M-Fluid. In trial 7 both dose rates of U 46 M-Fluid showed the lowest yield. No single sign of phytotoxicity (assessed parameters: brightening, necroses, growth deformation, growth inhibition) was observed on the grapevine in any variant. However, the fungal disease “Roter Brenner”, Pseudopezicula tracheiphila occurred in this trial. As no sign of phytotoxicity was ob- served on the grape vine and only the ground - not the plants - was sprayed it can be assumed, that these differences were not caused by the product but by other factors. The product complies with the Uniform principles. Conclusion - Effect on yield of plants and plant products 001: winter cereals: data is presented on yield from 12 efficacy trials in winter wheat (8), winter barley (8) at 1.5 L/ha and from 22 selectivity trials in winter wheat (6), winter barley (7), winter rye (3) and winter triticale (2) and spelt (4) at 1.5 L/ha and 3.0 L/ha. No impact on the yield was observed. 002: spring cereals: data is presented on yield from 12 efficacy trials in spring wheat (2), spring oat (2) and spring barley (8) at 1.5 L/ha. Yield data is submitted for 23 selectivity trials in spring barley (7), spring wheat (6), durum wheat (4), spring rye (2) and oat (4) at 1.5 L/ha and 3.0 L/ha. No impact on the yield was observed. 003: grassland: data is presented on yield from 1 selectivity trial. A yield reduction about 19% at 2 L/ha and 50% at 4 L/ha was recorded without giving an explanation. Therefore the label warning: Damage is possible to the crop, including yield reduction, is proposed. 004: orchards (pome and stone fruit): No data are submitted. The applicant gives the explanation that the orchard ground is treated and not the pome or stone fruit. The zRMS can follow that argumentation, because the application is made with a screen. 005: grape vine: data is presented on yield from 2 crop safety trials with two varieties performed in Germany (2008). The variety Ruländer had a yield reduction about 40% (1N) and more (2N) compared to the untreated control. This yield reduction was caused due to the fungal disease Pseudopezicula tracheiphila and is not considered for evaluation. No impact on the yield was observed. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 38 of 76 IIIA1 6.2 Adverse effects IIIA1 6.2.1 Phytotoxicity to host crop For phytotoxicity in efficacy trials see IIIA1 6.1.3 (Table 6.1.3-3: Standards and trial design) and in selectivity trials see IIIA1 6.1.4.3 (Tab. 6.1.4.3-3: Standards and trial design). All reported trials were conducted by officially recognized organizations in accordance with the Principles of Good Experimental Practice (GEP) in the years 2007, 2013 and 2014. The trials were performed under field conditions according to EPPO Standards PP 1/93(2/3), PP 1/135(2/3), PP 1/152(2/4), PP 1/181(2/4). No deviations have been reported or were observed. Table 6.2.1-1: Overview of tests carried out with U 46 M-Fluid providing information on crop safety Use Year Country EPPO Short description Zone Trials: 2; GEP (2); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (2); 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (2) Varieties: JB Asano. Ritmo Trials: 6; GEP (6); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (6); 2014 Germany Maritime Purpose: phytotoxicity in efficacy trials (6) Varieties: Akteur (2), Tommi (2), Schamane, To- Winter Wheat bak Trials: 3; GEP (3); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (3); 2013 Germany Maritime Purpose: phytotoxicity in efficacy trials (3) Varieties: JB Asano, Cubus, Winnetou Trials: 2; GEP (2); Formulation: Agritox 50; Rate(s): 1.0; 1.6; 3.3 L/ha (2); 2007 UK Maritime Purpose: phytotoxicity in efficacy trials (2) Varieties: Alchemy, Einstein Trials: 2; GEP (2); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (2); 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (2) Varieties: Lomerit (2) Trials: 1; GEP (1); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (1); Winter barley 2014 Germany Maritime Purpose: phytotoxicity in efficacy trials (1) Varieties: Campanile Trials: 2; GEP (2); Formulation: Agritox 50; Rate(s): 1.0; 1.6; 3.3 L/ha(2); 2007 UK Maritime Purpose: phytotoxicity in efficacy trials (2) Varieties: Sequel, Carrot Trials: 1; GEP (1); Formulation: Agritox 50; Rate(s): 1.0; 1.6; 3.3 L/ha (1); Winter oat 2007 UK Maritime Purpose: phytotoxicity in efficacy trials (1) Varieties: Dalguise Trials: 1; GEP (1); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (1); Winter triticale 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (1) Varieties: Dinaro Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 39 of 76 Use Year Country EPPO Short description Zone Trials: 1; GEP (1); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (1); 2014 Germany Maritime Purpose: phytotoxicity in efficacy trials (1) Varieties: Agostino Trials: 1; GEP (1); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (1); 2013 Germany Maritime Purpose: phytotoxicity in efficacy trials (1) Varieties: Tulus Trials: 1; GEP (1); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (1); 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (1) Varieties: Palazzo Winter rye Trials: 1; GEP (1); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (1); 2013 Germany Maritime Purpose: phytotoxicity in efficacy trials (1) Varieties: Visello Trials: 4; GEP (4); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (4); Winter Spelt 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (4) Varieties: Frankenkorn (4) Trials: 4; GEP (4); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (4); Durum wheat 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (4) Varieties: Miradox (4) Trials: 3; GEP (3); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (3); 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (3) Varieties: Grace (3) Trials: 5; GEP (5); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (5); 2014 Germany Maritime Purpose: phytotoxicity in efficacy trials (5) Varieties: Grace (4), Quench Spring barley Trials: 4; GEP (4); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (4); 2013 Germany Maritime Purpose: phytotoxicity in efficacy trials (4) Varieties: Catamaran., Quench (2), Propino Trials: 2; GEP (2); Formulation: Agritox 50; Rate(s): 1.0; 1.6; 3.3 L/ha (2); 2007 UK Maritime Purpose: phytotoxicity in efficacy trials (2) Varieties: Optic (2) Trials: 2; GEP (2); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (2); 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (2) Varieties: Tybalt, KWS Chasmin Spring wheat Trials: 3; GEP (3); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (3); 2014 Germany Maritime Purpose: phytotoxicity in efficacy trials (3) Varieties: Chasmin, Kadrilj, Triso Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 40 of 76 Use Year Country EPPO Short description Zone Trials: 2; GEP (2); Formulation: Agritox 50; Rate(s): 1.0; 1.6; 3.3 L/ha (2); 2007 UK Maritime Purpose: phytotoxicity in efficacy trials (2) Varieties: Tybalt (2) Trials: 2; GEP (2); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha (2); 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (2) Varieties: Max (2) Trials: 2; GEP (2); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha (2); Spring oat 2014 Germany Maritime Purpose: phytotoxicity in efficacy trials (2) Varieties: Max, KWS Contender Trials: 1; GEP (1); Formulation: Agritox 50; Rate(s): 1.0; 1.6; 3.3 L/ha (1); Purpose: phyto- 2007 UK Maritime toxicity in efficacy trials (1) Varieties: Firth Trials: 2; GEP (2); Formulation: U 46 M-Fluid; Rate(s): 1.5; 3.0 L/ha(2); 2014 Germany Maritime Purpose: phytotoxicity in selectivity trials (2) Varieties: Arantes (2) Spring rye Trials: 1; GEP (1); Formulation: U 46 M-Fluid; Rate(s): 0.9; 1.2; 1.5 L/ha(1); 2013 Germany Maritime Purpose: phytotoxicity in efficacy trials (1) Varieties: Arates Trials: 1; GEP (1); Formulation: U 46 M-Fluid; Rate(s): 2.0, 4.0 L/ha(1); 2003 Germany Maritime Purpose: phytotoxicity in selectivity trials (1) Varieties: not relevant Trials: 8; GEP (8); Formulation: U 46 M-Fluid; Rate(s): 1.2; 1.6; 2.0 L/ha(8); Grassland 2013 Germany Maritime Purpose: phytotoxicity in efficacy trials (8) Varieties: not relevant Trials: 4; GEP (4); Formulation: U 46 M-Fluid; Rate(s): 1.2; 1.6; 2.0 L/ha(8); 2002 UK Maritime Purpose: phytotoxicity in selectivity trials (8) Varieties: not relevant Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 41 of 76 Evaluations carried out for phytotoxicity assessments are described below: Evaluations • Method(s) Visual estimation of crop injury and crop stand reduction (thinning) compared to 'untreated' ('untreated' = 0% crop injury; 100% crop injury = total crop destruction). Where appropriate this overall score was substituted or supple- mented by assessments of individual symptoms. • Frequency of ratings 2 (UK), 4 (UK 2004; Germany 2003, 2007 and 2013) or 5 (Germany 2014) crop injury ratings • Statistics No statistical analysis was applied IIIA 6.2.1.1 Phytotoxicity to host crop - Target dose IIIA 6.2.1.1.1 Winter cereals In 13 efficacy trials from Germany, 10 selectivity trials from Germany and 5 efficacy trials from UK no symptoms of phytotoxicity after application of 1.5 L/ha U 46 M-Fluid or 1.6 L/ha Agritox 50 in winter cereals were observed. The trials were carried out in winter wheat (13), winter barley (5), winter triticale (3), winter oats (2), winter rye (2), and winter spelt (4). Selectivity trials according to EPPO Standard PP1/226 were carried out in: winter wheat (2), winter barley (2), winter triticale (1), winter rye (1), and winter spelt (4) Details on trial sites, varieties, applications and assessments are reported in Table 6.2.1-1 and in chapter IIIA1 6.1.2. Winter durum wheat is also sought for registration in Germany. Because winter durum wheat is a minor crop in Germany, extrapolation is made from winter wheat. IIIA 6.2.1.1.2 Spring cereals In 15 efficacy trials from Germany, 13 selectivity trials from Germany and 5 efficacy trials from UK no symptoms of phytotoxicity after application of 1.5 L/ha U 46 M-Fluid or 1.6 L/ha Agritox 50 in spring cereals were observed. The trials were carried out in durum wheat (4), spring wheat (7), spring barley (14), spring oats (5) and spring rye (3). Selectivity trials according to EPPO Standard PP1/226 and PP1/135 were carried out in: spring durum wheat (4), spring wheat (2), spring barley (3), spring oats, (2), spring rye (2) Details on trial sites, varieties, applications and assessments are reported in Table 6.2.1-1 and in chapter IIIA1 6.1.2. IIIA 6.2.1.1.3 Grassland In 9 efficacy trials from Germany and 4 selectivity/efficacy trials from The United Kingdom no symptoms of phytotoxicity after application of 2.0 L/ha U 46 M-Fluid in grassland were observed. Selectivity trials according to EPPO Standard PP1/226 and PP1/135 were carried out in one trial. IIIA 6.2.1.1.4 Pome fruit and stone fruit No new data are submitted. In previous submissions no signs of phytotoxicity in trials performed in pome fruit and stone fruit orchards are reported. Furthermore, no negative effects were reported from various selectivity trials in cereals, grassland and grapevine. According to the experience of official agricultural extension services, no negative effects were observed when used with spray shield and when the product is used according to the good agricultural practice. No selectivity trials according to EPPO Standard PP1/226 and PP1/135 were carried out. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 42 of 76 IIIA 6.2.1.1.5 Grape vine No new data are submitted. In previous submissions phytotoxicity assessments from 8 efficacy and 2 phytotoxicity trials are reported. The trials were carried out in 1981, 2008 and 2009. The following varieties were in- cluded: Riesling (3), Cab. Dorsa, Ruländer (2), Müller Thurgau, Dornfelder (2). The methods used in these trials are in accordance with the principles of the EPPO method n PP 1/135(2) Phytotox- icity assessment. Of all trials, only in one trial (Riesling), conducted in 1981, phytotoxic effects were observed. In the trial report, it is not reported whether a spray shield was used for application or not. One month after treatment 12% phytotoxic symptoms occurred. After nearly three months the symptoms de- creased to 10% and after 10 months to 5%. Thus the phytotoxic damage disappeared in time. No permanent damage remained. In none of the other trials phytotoxic symptoms occurred. IIIA 6.2.1.2 Phytotoxicity to host crop - Double dose IIIA 6.2.1.2.1 Winter cereals In 10 selectivity trials from Germany and 5 efficacy trials from UK no symptoms of phytotoxicity after application of 3.0 L/ha U 46 M-Fluid or 3.3 L/ha Agritox 50 in winter cereals were observed. Selectivity trials according to EPPO Standard PP1/226 and PP1/135 were carried out in: winter wheat (2), winter barley (2), winter triticale (1), winter rye (1), and winter spelt (4). Details on trial sites, varieties, applications and assessments are reported in Table 6.2.1-1 and in chapter IIIA1 6.1.2. Detailed results are provided in the individual trial reports. IIIA 6.2.1.2.2 Spring cereals In 13 selectivity trials from Germany and 5 efficacy trials from UK no symptoms of phytotoxicity after application of 3.0 L/ha U 46 M-Fluid or 3.3 L/ha Agritox 50 in winter cereals were observed. Selectivity trials according to EPPO Standard PP1/226 and PP1/135 were carried out in: spring durum wheat (4), spring wheat (2), spring barley (3), spring oats, (2), spring rye (2). Details on trial sites, varieties, applications and assessments are reported in Table 6.2.1-1 and in chapter IIIA1 6.1.2. Detailed results are provided in the individual trial reports. IIIA 6.2.1.2.3 Grassland In 4 selectivity/efficacy trials conducted in UK in 2002 and one selectivity trial conducted in Ger- many in 2003, no symptoms of phytotoxicity were observed. Selectivity trials according to EPPO Standard PP1/226 and PP1/135 were carried out in one trial. Additionally, the excellent selectivity of U 46 M-Fluid in grassland is well known after decades of use under practical conditions. The trials reported from spring and winter cereals may be taken as an additional proof. IIIA 6.2.1.2.4 Orchards No new data are submitted. In previous submissions no signs of phytotoxicity in trials performed in pome fruit and stone fruit orchards are reported. Furthermore, no negative effects were reported from various selectivity trials in cereals, grassland and grapevine. According to the experience of official agricultural extension services, no negative effects were observed when used with spray shield. No selectivity trials according to EPPO Standard PP1/226 and PP1/135 were carried out. IIIA 6.2.1.2.5 Grape vine No new trial results are reported. In the amendment to the Biological Assessment Dossier of U 46 M-Fluid from 2010 (Doc. No. 381-002, KIIIA1 6/02), 2 trials in grape vine at 4.0 L/ha and 8.0 L/ha U 46 M-Fluid are reported from Germany. The methods used in these trials are in accordance with the principles of the EPPO method PP 1/135(2) Phytotoxicity assessment. Both tests were determined under GEP conditions. In one of the two phytotoxicity trials, deformations of the leaves were observed. This Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 43 of 76 effect can be ignored, grape vine leaves have to be cut frequently so symptoms in that range are of no importance. Conclusion - Phytotoxicity to host crop 001: winter cereals: A written summary of selectivity and efficacy trial results (28 trials 1N and 15 trials 2N) are mentioned for winter cereals. No phytotoxic symptoms were observed. 002: spring cereals: A written summary of selectivity and efficacy trial results (33 trials 1N and 18 trials 2N) are mentioned for summer cereals. No phytotoxic symptoms were observed. 003: grassland: A written summary of selectivity and efficacy trial results (13 trials 1N and 4 tri- als 2N) are mentioned for grassland. No phytotoxic symptoms were observed. 004: orchards (pome and stone fruit): No data are submitted. In previous submissions no signs of phytotoxicity in trials performed in pome fruit and stone fruit orchards are reported. The appli- cant gives the argument that “according to the experience of official agricultural extension ser- vices, no negative effects were observed when used with spray shield”. 005: grape vine: phytotoxic symptoms occurred in one of 8 efficacy and 2 phytotoxicity trials after application of the target dose. The phytotoxic damage disappeared in time. IIIA1 6.2.2 Adverse effects on health of host animals This is not an EC data requirement. IIIA1 6.2.3 Adverse effects on site of application This is not an EC data requirement. IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) The herbicide U 46 M-Fluid (500 g/L MCPA, 633.8 g/L a.s. MCPA DMA, SL) is proposed for one application in cereals, grassland, pome and stone fruit and grape vine with a field rate of 1.4 - 4 L/ha, corresponding to 700 - 2000 g/ha MCPA. No specific assessments of beneficial organisms were carried out in the efficacy and crop safety trials. However, no adverse effects were noted when visual observations were made within these field trial sites. For the assessment of the toxicity of the test product (NUD-01080-H-3-SL) to beneficial organ- isms, studies for the inclusion of MCPA in Annex I were submitted. The toxicity on beneficial organisms has been investigated by carrying out tests with the two in- dicator species Typhlodromus pyri and Aphidius rhopalosiphi, the green lacewing Chrysoperla carnea and spiders of the genus Pardosa using the formulation MCPA DMA (500 g/L MCPA) (BAS 010 01 H, SL) (Table 6.2.4-1). The laboratory tests on artificial substrates showed no mortality and only marginal sublethal ef- fects on Typhlodromus pyri, Chrysoperla carnea and spiders of the genus Pardosa at the maximal proposed field rate. From a laboratory test on an artificial substrate submitted for an earlier national assessment in Germany (050939-00/00), the toxicity of MCPA DMA to Aphidius rhopalosiphi was known to be 100%. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 44 of 76 On a natural substrate the substance caused no mortality and only a sublethal effect < 25%. (The presentation in Registration Report Part B, Section 6, Annex Point IIIA 10.5 was partly incorrect, as this study was not a tier I study, and the sublethal effect at the maximal proposed rate was not 0.8% but 20%.) Table 6.2.4-1: Effects of MCPA DMA (493.1 g/L MCPA, SL) on beneficial arthropods Species Substrate Rate Prod- Corrected Sublethal Reference (Exposed Stage) uct [L/ha] Mortality Effect [%] [%] T. pyri (PN) Glass 0.4 -2 -20 (Re) 99038/01-NLTp 4 0 4 (Re) C. carnea (La) Glass 4 0 -4 (Re) 99038/02-NLCc Pardosa spp. (SA/A) Quartz sand 4 0 3 (F) 99038/01-NLPa A. rhopalosiphi (A) Barley 0.1 -3 7 (Re) 99038/01- NEAp 2 3 11 (Re) 4 0 20 (Re) PN = protonymphs, A = adults, SA = subadults, La = larvae Re = reproduction, F = feeding rate Conclusion - Adverse effects on beneficial organisms (other than bees) On the basis of results to a comparable formulation of MCPA DMA, the maximal proposed rate of U 46 M-Fluid can be considered as not harmful for the predatory mite Typhlodromus pyri, the parasitic wasp Aphidius rhopalosiphi, the lacewing Chrysoperla carnea and spiders of the genus Pardosa. Classification of effects: Laboratory tests on artificial substrates < 30% = harmless 30 – 79% = slightly harmful ≥ 80% = harmful Extended laboratory tests on natural substrates < 25% = not harmful 25 - 50% = slightly harmful > 50% = 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 Neither from the agricultural use of MCPA during the past years, nor from field trials there is any indication that the application of products containing this active ingredient has any influence on the propagation behaviour of cereal crops, grassland, stone fruit, pome fruit or grape vine. Conclusion - Adverse effects on parts of plant used for propagating purposes Special investigations on possible effects on the propagation behaviour of cereal crops, grass- land, stone fruit, pome fruit or grape vine are not provided by the applicant. It is concluded that there are no adverse effects on parts used for propagating purposes. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 45 of 76 IIIA1 6.2.6 Impact on succeeding crops Referring to EPPO standard PP 1/207(2), the risk for succeeding crops is determined by the cal- culation of TERs for U 46 M-Fluid for different potential succeeding crops and for different time intervals after application (Doc. No. 721-002, KIIIA1 6.2/03). The trials are presented in detail in the following document: BAD (December 2013), Doc. No. 381-004, KIIIAI 6/02 MCPA is degraded rapidly in soil. The DT50 values for MCPA range between 7 and 41 days and the DT50 is determined to be 24 days (SANCO). Table 6.2.6-1: EC10-values (mg/kg soil) EPPO- EC test plant 10 Code (mg/kg soil) 1 2 3 4 test product Spring barley Hordeum vulgare HORVS 239 Oat Avena sativa AVESA 333 Maize Zea mays ZEAMX 1774 Rape Brassica napus BRSNS 118 Sugar beet Beta vulgaris BEAVA 118 Pea Pisum sativum PIBSA 29 1 common name 2 scientific name (lat.) 3 EPPO-Code 4 EC10-values (mg/kg soil): test product, active substance A, active substance X, ... (in case of more than one a.s.). Table 6.2.6-2: PEC-values (mg/kg soil) of test product (active substance) in soil PEC days after application soil depth DT50 30 90 120 240 1 2 3 24 mean 0.3925 0.1650 0.0292 0.0009 5 cm 41 max 24 mean 0.0981 0.0173 0.0073 0.0002 20 cm max 1 soil depth (5 cm/20 cm) 2 DT50 max, mean test product/active substance 3 PEC values (mg test product, active substance/kg soil) 30, 90, 180, 360 days after application The calculation of TER values on 3 broad-leaved crops and 3 grasses show that the critical TER of ‘1’ is reached after shallow tillage (5 cm) by maize already on the day of application. By winter barley and spring oats this value is reached after 60 days, by spring rape and sugar beet it is reached after 90 days and by pea after 150 days. After deep tillage (20 cm) the critical TER of 1 is already reached on the day of application by maize and oat, after 10 days by winter barley, after 30 days by rape and sugar beet and after 90 days by pea. These results show that pea is the most sensitive succeeding crop, followed by sugar beet and rape. After deep tillage, rape and sugar beet may be re-sown 30 days after application, pea, however, only 90 days after application. The monocotyledonous crops barley, oat and maize are far less sensitive and may be replanted already 10 days after application if deep tillage is done. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 46 of 76 According to EPPO standard PP 1/207(2) no additional field trials are required to determine the carry over risk. Conclusion - Impact on succeeding crops No risk for succeeding crops. IIIA1 6.2.7 Impact on other plants including adjacent crops The impact on adjacent crops was assessed following the EPPO standard 1/256(1) ‘effects on adjacent crops’. In the Non-Target-Plant studies ED50 values were determined for different spe- cies. Predicted exposure rates by spray drift were calculated considering the possible spray drift deposition rate (Table 6.2.7-1) Based on these parameters, a theoretical risk assessment was made by comparing the calculated drift values to the ED50 values of possible adjacent crops (Table 6.2.7-2) and calculating Toxicity Exposure Ratio (TER) values for adjacent crops. TER-values are calculated as a quotient of the ED50- and PEC-values. TER-values >1 indicate a risk for the adjacent crop. The results (not pre- sented) show that there is no unacceptable risk for adjacent crops. Table 6.2.7-1: PEC-values at application rate of 4 L/ha U 46 M-Fluid Distance (m) % drift (kg a.s./ha ) 1 2.77 0.0554 3 0.95 0.0190 5 0.57 0.0114 10 0.29 0.0058 15 0.20 0.0040 Table 6.2.7-2: ED50-values (kg a.s./ha) of different mono- and dicotyledonous plant species based on plant dry weight Species ED50 Cabbage 0.11 Corn > 3.37 Cucumber 0.11 Lettuce 0.11 Oat > 3.37 Ryegrass > 3.37 Soybean 0.11 Radish 0.11 Onion 0.013 Tomato 1.21 Conclusion - Impact on other plants including adjacent crop The comparison indicates that there is no theoretical risk of spray drift damage for the tested crops. Following no effects on adjacent crops are expected. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 47 of 76 IIIA1 6.2.8 Possible development of resistance or cross-resistance Mechanism of resistance The herbicide U 46 M-Fluid contains the active substance MCPA. MCPA works as such as synthetic auxins. Due to its primary target site and its chemical family, MCPA is classified as group O herbicide in the HRAC mode of action classification. Although the mechanism of resistance of group O herbicides has not been determined, resistance may be due to an insensitive target site. Evidence of resistance and cross resistance Against group O herbicides, 34 weed species have developed resistance as demonstrated by the international survey of herbicide resistant weeds (www.weedscience.org, January 2017). For 14 biotypes, resistance against MCPA has been detected. Due to the higher impact of MCPA and other synthetic auxins on the metabolism of dicotyledonous plants, more cases of resistance have been observed for this group of actives. Among the species resistant to synthetic auxins and MCPA herbicides in Europe are: Centaurea cyanus [dicamba; Poland], , Cirsium arvense [MCPA and 2,4-D; Sweden, Hungary], Stellaria media [Mecoprop; UK] and Papaver rhoeas [MCPA and 2,4-D; Spain, Italy, France]. Weed species resistant to one active ingredient from HRAC group O may also be resistant to other actives from this group as indicated by several weed species with resistance to multiple actives from group O. In Europe, cases of multiple resistance including HRAC group O and group B herbicides are reported for biotypes of Papaver rhoeas in Spain, France and Italy. Analysis of the inherent risk As some cases of resistance to MCPA are reported on Europe, the inherent risk of MCPA can be classified as medium. The key target organisms of U 46 M-Fluid are annual dicotyledonous weeds in cereals, grassland and on orchard floors. The target species in cereals include some species against which resistance has already been detected in Europe (Stellaria media and Papaver rhoeas). Regarding the target species in grassland, only Cirsium arvense can be regarded as a high risk species. The applicant has not provided any baseline sensitivity data because the active substance has been used commercially in Europe for many years without any reported cases of reduced activity in field trials. Agronomic risk The herbicide is intended to be used in against dicotyledonous species post-emergent in winter and spring cereals, in grassland and on orchard floors. In a typical crop rotation scheme in Central Europe, cereals can be rotated with dicotyledonous crops in which MCPA cannot be applied. However, crop rotations consisting solely of cereal crops are also not uncommon. In these rota- tions, the application frequency of U 46 M-Fluid or other active substances from the HRAC group O and therefore the selection pressure might be enhanced. The same applies for the intended use in grassland. MCPA is usually applied in addition to other herbicides to close effectiveness gaps. However, the design of the respective crop rotations and the associated frequency of ap- plication of U 46 M-Fluid may differ in the various Member States in the Central Zone and a national-specific assessment of the agronomic risk is therefore recommended. Within one year, the number of treatments applied of U 46 M-Fluid is limited to one. This limits selection pressure and the risk of resistance development. There are other active substances available with alternative MoA controlling key target weeds (ALS inhibitors, bifenox, IPU, CTU, pendimethalin, picolinafen). Summary and Conclusions - Possible development of resistance or cross-resistance Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 48 of 76 The evaluation indicates a medium inherent and agronomic risk of resistance development for U 46 M-Fluid for use in cereals and a low risk for use in grassland and on orchard floors. The appli- cant has not provided any information on the individual inherent and agronomic resistance risk within the different Member States in the Central zone. Management strategy The applicant has provided a management strategy that is based on upon Good Agricultural Prac- tices (GAP). IIIA1 6.3 Economics This is not an EC data requirement. 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 This is not an EC data requirement. IIIA1 6.4.3 Contribution to risk reduction This is not an EC data requirement. IIIA1 6.5 Other/special studies IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 Preliminary range-finding tests The applicant does not provide results about range-finding tests, which is accepted as MCPA is a well-known active substance. Minimum effective dose tests 001: Winter cereals: acceptable dose-response-relationship (in the range of 0.8-0.9, 1.2, and 1.5-1.6 L/ha) with 3 or more trial results and 90% or more efficacy are shown for BRSNW and CHEAL. With the provided data an increase of efficacy over all trials and annual dicotyledonous weeds can be calculated from 0.8-0.9 to 1.5-1.6 L/ha as well as for CIRAR, is the only perennial dicotyledonous weed species. 002: Spring cereals: acceptable dose-response-relationship (in the range of 0.8-0.9, 1.2, and 1.5-1.6 L/ha) with 3 or more trial results and 90% or more efficacy are shown for BRSNW. With the provided data an increase of efficacy over all trials and annual dicotyledonous weeds can be calculated from 0.8-0.9 to 1.5-1.6 L/ha as well as for CIRAR, the only perennial dicotyledonous weed species. 003: Grassland: With the provided data an increase of efficacy over all trials and dicotyledonous weeds can be calculated in the range of 1.0-1.2, 1.6 and 2.0 L/ha. 004: Orchards: no data are submitted. The applicant wants to transfer results from grassland and grape vine to orchards. This is possible in case of the presented data in grassland. Results Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 49 of 76 of minimum effective dose tests of grape vine cannot be transferred, because the applied dose rate is not the same in grape vine (4 L/ha) like in orchards (2 L/ha). 005: Grape vine: acceptable dose-response-relationship (in the range of 2.0, 3.0 and 4.0 L/ha) with 3 or more trial results and 90% or more efficacy are shown for CONAR. With the provided data an increase of efficacy over all trials and weeds can be calculated from 2.0 to 4.0 L/ha for dicotyledonous weeds. Overall Conclusion Sufficient data for minimum effective dose tests are presented for: 001: annual dicotyledonous weeds and CIRAR 002: annual dicotyledonous weeds and CIRAR 003: dicotyledonous weeds 004: dicotyledonous weeds 005: dicotyledonous weeds Efficacy tests 001: winter cereals: Efficacy data of 1.5-1.6 L/ha application rate are submitted for the group of annual dicotyledonous weeds. For CIRAR data of 2 trails are submitted, according to EPPO standard PP1/226 6-15 trials for major weeds in major crops are required. But data of summer cereals for CIRAR can be transferred to winter cereals in the consequence, that CIRAR can be applied for registration. 002: spring cereals: Efficacy data of 1.5-1.6 L/ha application rate are submitted for the group of annual dicotyledonous weeds. 5 trials with CIRAR are submitted, these are enough data to reg- ister for the single weed CIRAR. 003: grassland: Efficacy data of 2 L/ha application rate are submitted to meet the group of di- cotyledonous weeds. 004: orchards (pome and stone fruit): efficacy of 2 L/ha application rate: no results are submit- ted. The applicant wants to transfer efficacy results from cereals, grape vine or grassland. This is not possible for cereals, because the species spectra are different. It is also not possible for grape vine, because the application rate is much higher (4 L/ha) than for orchards. Efficacy re- sults from grassland can be transferred. 005: grape vine: Efficacy data of 4 L/ha application rate are submitted to meet the group of di- cotyledonous weeds. 003-005 A sustained assessment for perennial weeds in the following year could not be carried out. Overall Conclusion Sufficient efficacy data are presented for: 001: annual dicotyledonous weeds and CIRAR 002: annual dicotyledonous weeds and CIRAR 003: dicotyledonous weeds 004: dicotyledonous weeds 005: dicotyledonous weeds 003-005 A sustained assessment for perennial weeds in the following year could not be carried out. There- fore the label warning: The product has no sustainable effect in perennial weeds is proposed. Impact on the quality of plants and plant products Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 50 of 76 001: winter cereals: data are presented on the thousand grain weight from 4 efficacy trials (1994) in winter wheat at 1.5 L/ha and from 7 selectivity trials (2002) in winter wheat (3 trials), winter barley (2 trials), winter rye (1 trial) and winter triticale (1 trial) at 1.5 L/ha and 3.0 L/ha. No impact on the TGW was observed. 002: spring cereals: data are presented on the thousand grain weight and hectolitre weight from 5 efficacy trials (1993, 1994) in spring wheat (2 trials) and spring barley (3 trials) at 1.5 L/ha and from 23 selectivity trials (2002, 2014) in durum wheat (4 trials), spring barley (7 trials), spring oat (4 trials), spring rye (2 trials) and spring wheat (6 trials) at 1.5 L/ha and 3.0 L/ha. No impact on the TGW was observed. 003: grassland: data on the dry matter content from 1 selectivity trial are submitted. No impact on the dry matter was observed. 004: orchards (pome and stone fruit): No data are submitted. The applicant gives the explanation that the orchard ground is treated and not the pome or stone fruit. The zRMS can follow that argumentation, because the application is made with a screen. 005: grape vine: Reference is made to "Second Amendment to Biological Dossier U 46 M-Fluid dated March 2010 (Doc. No. 381-002, KIIIA1 6/01)”. This Dossier provides no data on quality for grape vine, therefore: no data are submitted. Effects on the processing procedure Neither from trial experience nor from practical use of the active ingredient MCPA was reported any case about negative influences on parameters influencing the processing procedure of winter cereals, spring cereals, grassland, orchard and grape vine. Effects on the yield of treated plants and plant products 001: winter cereals: data is presented on yield from 12 efficacy trials in winter wheat (8), winter barley (8) at 1.5 L/ha and from 22 selectivity trials in winter wheat (6), winter barley (7), winter rye (3) and winter triticale (2) and spelt (4) at 1.5 L/ha and 3.0 L/ha. No impact on the yield was observed. 002: spring cereals: data is presented on yield from 12 efficacy trials in spring wheat (2), spring oat (2) and spring barley (8) at 1.5 L/ha. Yield data is submitted for 23 selectivity trials in spring barley (7), spring wheat (6), durum wheat (4), spring rye (2) and oat (4) at 1.5 L/ha and 3.0 L/ha. No impact on the yield was observed. 003: grassland: data is presented on yield from 1 selectivity trial. A yield reduction about 19% at 2 L/ha and 50% at 4 L/ha was recorded without giving an explanation. Therefore the label warning: Damage is possible to the crop, including yield reduction, is proposed. 004: orchards (pome and stone fruit): No data are submitted. The applicant gives the explanation that the orchard ground is treated and not the pome or stone fruit. The zRMS cannot follow that argumentation, because the application is made with a screen. 005: grape vine: data is presented on yield from 2 crop safety trials with two varieties performed in Germany (2008). The variety Ruländer had a yield reduction about 40% (1N) and more (2N) compared to the untreated control. This yield reduction was caused due to the fungal disease Pseudopezicula tracheiphila and is not considered for evaluation. No impact on the yield was observed. Phytotoxicity to host crop 001: winter cereals: A written summary of selectivity and efficacy trial results (28 trials 1N and 15 trials 2N) are mentioned for winter cereals. No phytotoxic symptoms were observed. 002: spring cereals: A written summary of selectivity and efficacy trial results (33 trials 1N and 18 trials 2N) are mentioned for summer cereals. No phytotoxic symptoms were observed. 003: grassland: A written summary of selectivity and efficacy trial results (13 trials 1N and 4 tri- als 2N) are mentioned for grassland. No phytotoxic symptoms were observed. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 51 of 76 004: orchards (pome and stone fruit): No data are submitted. In previous submissions no signs of phytotoxicity in trials performed in pome fruit and stone fruit orchards are reported. The appli- cant gives the argument that “according to the experience of official agricultural extension ser- vices, no negative effects were observed when used with spray shield”. 005: grape vine: phytotoxic symptoms occurred in one of 8 efficacy and 2 phytotoxicity trials after application of the target dose. The phytotoxic damage disappeared in time. Adverse effects on beneficial organisms (other than bees) The test product can be classified as not harmful for populations of the predatory mite Typhlodro- mus pyri, the parasitic wasp Aphidius rhopalosiphi, the lacewing Chrysoperla carnea, spiders of the genus Pardosa. Summarizing the test product can be classified as not harmful for populations of relevant beneficial arthropods in general. The product can be recommended for the integrated pest management. Impact on succeeding crops No risk for succeeding crops. Impact on other plants including adjacent crops The comparison indicates that there is no theoretical risk of spray drift damage for the tested crops. Following no effects on adjacent crops are expected. Possible development of resistance or cross-resistance The evaluation indicates a medium inherent and agronomic risk of resistance development for U 46 M-Fluid for use in cereals and a low risk for use in grassland and on orchard floors. The appli- cant has not provided any information on the individual inherent and agronomic resistance risk within the different Member States in the Central zone. IIIA1 6.7 List of test facilities including the corresponding certificates Trial organisation Address GEP/GLP yes/no Versuchswesen Pflanzenschutz Wallstr. 6 yes Dr. Paul Reh D-30938 Burgwedel Germany BioChem agrar GmbH Kupferstraße 6 yes D-04827 Machern OT Gerichs- hain Germany Oxford Agricultural trials West Farm Barns yes Launton Road Stratton Audley Bicester Oxfordshire UK AgroChemex Ltd. Aldhams Farm yes Dead Lane Manningtree Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 52 of 76 Exxex CO112NF UK Appendix 1: List of data submitted in support of the evaluation 13.08.2015 List of data submitted by the applicant and relied on Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) MIIIA1 Sec 1 Nufarm 2013 dRR - B1 - core N O Nufarm assess. - DE - 060939- 00/00 - U 46 M-Fluid O/O N 2570819/361944 MIIIA1 Sec 1 Nufarm 2013 dRR - B1 - core N O Nufarm assess. - DE - 060939- 00/00 - U 46 M-Fluid O/O N 2570822/361945 MIIIA1 Sec 6 Nufarm 2013 dRR - B6 - core N O Nufarm assess. - DE - 060939- 00/00 - U 46 M-Fluid O/O N 2570826/361949 MIIIA1 Sec 7 Nufarm 2013 dRR - B7 - core N O Nufarm assess. - DE - 060939- 00/00 - U 46 M-Fluid O/O N 2570831/361951 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 53 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) Document N Nufarm 2013 dRR - A - DE - N O Nufarm 060939-00/00 - U 46- Fluid O/O N 2570834/361956 Document N Nufarm 2013 dRR - A - DE - N O Nufarm 060939-00/00 - U 46- Fluid O/O N 2571072/361960 MIIIA1 Sec 6 Nufarm 2013 dRR - B6 - core N O Nufarm assess. - DE - 060939- 00/00 - U 46 M-Fluid O/O N 2571256/361964 MIIIA1 Sec 7 Nufarm 2013 dRR - B7 - core N O Nufarm assess. - DE - 060939- 00/00 - U 46 M-Fluid O/O N 2571266/361966 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in winter cereals 1310671616 N/J N 2574061/361973 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 54 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.1 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in winter cereals 1310661637 N/J N 2574072/361975 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in winter cereals 1310471921 N/J N 2574075/361976 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in winter cereals 1310695058 N/J N 2574077/361978 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in winter cereals 1310695059 N/J N 2574101/361980 KIIIA1 6.1.2 Burgess, 2008 The efficacy of N J Nufarm J.P., Allan, phenoxy herbicides A.R. applied in the spring to winter cereals 242-07-NUF-PHE N/J N 2574105/361982 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 55 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in spring cereals 1310601898 N/J N 2574108/361984 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in spring cereals 1310621890 N/J N 2574111/361985 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in spring cereals 1310611891 N/J N 2574112/361987 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in spring cereals 1310695088 N/J N 2574114/361989 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in spring cereals 1310601888 N/J N 2574115/361991 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 56 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.2 Burgess, 2008 The efficacy of N J Nufarm J.P., Carr, phenoxy herbicides D.E. applied to spring cereals 244-07-NUF-SPR N/J N 2574117/361993 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in grassland 1310471921 N/J N 2574120/361995 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in grassland 1310695106 N/J N 2574122/361997 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in grassland 1310471922 N/J N 2574124/361999 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in grassland 1310471923 N/J N 2574126/362001 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 57 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.3 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in grassland 1310471918 N/J N 2574128/362003 KIIIA1 6.1.3 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in grassland 1310471919 N/J N 2574137/362005 KIIIA1 6.1.3 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in grassland 1310471920 N/J N 2574141/362007 KIIIA1 6.1.3 Zickart, U. 2013 Efficacy of U 46 M- N J Nufarm Fluid against dicotyledonous weeds in grassland 1310695105 N/J N 2574152/362009 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 58 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.3 Reh, P. 2003 Determination of the N J Nufarm efficacy and the lowest effective dose rate of AGRITOX and the efficacy of Nufams MCPA 750 vs. broadleaf weeds in grassland in Germany 2003 VP3-4-9 N/J N 2574154/362010 KIIIA1 6.2.6 Eley, R. 2007 Nufarm Rhomene N J Nufarm (MCPA Dimethylamine Salt, 479,4 g ae/litre) evaluation of the phytotoxicity and effect on seeding emergence and growth of terrestrial non target plants ACE-06-009 N/J N 2574160/362011 KIIIA1 6.2.6 Eley, R. 2007 Nufarm Rhomene N J Nufarm (MCPA Dimethylamine Salt, 479,4 g ae/litre) evaluation of the phytotoxicity and effect on seeding emergence and growth of terrestrial non target plants ACE-06-010 N/J N 2574162/362012 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 59 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.2.6 Schmidt, O. 2002 U 46 M-Fluid (BAS N J Nufarm 141 07 H) Bioassay mit ausgewählten Nachbaukulturen zur Ermittlung von EC 10 (NOEL) und EC10- Werten für Wirkstoff im Boden 2002/1004426 ! A011002 N/J N 2574168/362013 KIIIA1 6 Schönhamm 2002 Antrag auf erneute N J Nufarm er, A. Zulassung Für das Pflanzenschutzmittel U 46 M-Fluid (BAS 010 01 H U46M-Fluid- Wirksamkeit1.doc N/N N 2574173/362014 KIIIA1 6 Anonymous 2013 Biological Assessment N J Nufarm Dossier Section 7: Efficacy Data and Information N/N N 2574176/362015 KIIIA1 3.9 Anonymous 1900 Vorläufige N J Nufarm Gebrauchsanleitung N/N N 2574338/362016 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 60 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 10.5.1 Adelberger, I. 1999 MCPA DMA - Toxicity N J Nufarm to the predatory mite, Typhlodromus pyri Scheuten (Acari, Phytoseiidae) in the laboratory 99038/01-NLTp ! BASF1999/11423 J/O N 2588714/362017 KIIIA1 10.5.2 Schuld, M. 1999 MCPA DMA - Toxicity N J Nufarm to the aphid parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae) using an extended laboratory test 99038/01-NEAp ! BASF1999/12036 J/O N 2588715/362018 KIIIA1 10.5.1 Kemmeter, 1999 MCPA DMA - Toxicity N J Nufarm F. to the green lacewing, Chrysoperla carnea Steph. (Neuroptera, Chrysopidae) in the laboratory 99038/02-NLCc ! BASF1999/11949 J/O N 2588716/362019 KIIIA1 10.5.1 Kemmeter, 1999 MCPA DMA - Toxicity N J Nufarm F. to the wolf spider, Pardosa spp. (Araneae, Lycosidae) in the laboratory 99038/01-NLPa ! BASF1999/11997 J/O N 2588717/362020 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 61 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 Maggi, V.L. 1993 The effects of MCPA N J Nufarm 10.8.1.3 DMAS on nontarget plants - Seed germination / seedling emergence CAR 146-91F ! 1145 J/O N 2588719/362021 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in spring wheat NUDR140504HET09 N/J N 2869444/402785 KIIIA1 6.1.2 Foster, A., 2003 Efficacy of MCPA N J Nufarm Davidson, J. Formulations against weeds in grasland 22163 N/N N 2869445/402786 KIIIA1 6.1.2 Burgess, J. 2008 The efficacy of N J Nufarm P. phenoxy herbicides applied to spring cereals 244-07-NUF-SPR N/J N 2869446/402787 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 62 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.3 Gray, S. J. 1995 AN EVALUATION OF N J Nufarm THE EFFICACY OF AGRITOX 50 AND MCPA-DMA 800 SG FOR THE CONTROL OF PERENNIAL AND ANNUAL BROAD- LEAVED WEEDS IN GRASSLAND - UNITED KINGDOM 1995 OAC/033/NUF N/N N 2869447/402788 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in durum wheat - Germany 2014 NUDR140502HET01 N/J N 2869448/402789 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in durum wheat - GERMANY 2014 NUDR140502HET02 N/J N 2869449/402790 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in durum wheat - GERMANY 2014 NUDR140502HET03 N/J N 2869450/402791 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 63 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in durum wheat - GERMANY 2014 NUDR140502HET04 N/J N 2869451/402792 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in oats - GERMANY 2014 NUDR140502HET05 N/J N 2869452/402793 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in oats - GERMANY 2014 NUDR140502HET06 N/J N 2869453/402794 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in spring barley - GERMANY 2014 NUDR140502HET08 N/J N 2869454/402795 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in spring barley - GERMANY 2014 NUDR140502HET09 N/J N 2869455/402796 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 64 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in spring barley - GERMANY 2014 NUDR140502HET10 N/J N 2869456/402797 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in spring rye - GERMANY 2014 NUDR140502HET11 N/J N 2869457/402798 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in spring rye - GERMANY 2014 NUDR140502HET12 N/J N 2869458/402799 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in spring barley - GERMANY 2014 NUDR140502HET14 N/J N 2869459/402800 KIIIA1 6.1.4 Hetterich, A. 2015 Selectivity of U46 M- N J Nufarm Fluid in spring wheat - GERMANY 2014 NUDR140502HET16 N/J N 2869460/402801 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 65 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC01 N/J N 2869461/402802 KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC03 N/J N 2869462/402803 KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC04 N/J N 2869463/402804 KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC07 N/J N 2869464/402805 KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC10 N/J N 2869465/402806 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 66 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC12 N/J N 2869466/402807 KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC13 N/J N 2869467/402808 KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC14 N/J N 2869468/402809 KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC15 N/J N 2869469/402810 KIIIA1 6.1.4 Zickart, U. 2014 Selectivity of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140502BIC16 N/J N 2869470/402811 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 67 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.4 Reh, P. 2003 An Evaluation of the N J Nufarm Selectivity of AGRITOX and NUFARM¿s MCPA 750 toPasture in Germany 2003 VP03-4-3 N/J N 2869471/402812 KIIIA1 6 Anonymous 2015 BAD U46 M Fluid N J Nufarm Nufarm revised final_2015-06-01 N/N N 2869472/402813 KIIIA1 6 Anonymous 2015 BAD U46 M Fluid N J Nufarm Nufarm revised final_2015-06-01 N/N N 2869473/402814 KIIIA1 6.1.2 Zickart, U. 2013 EFFICACY OF U 46 N J Nufarm M-FLUID AGAINST DICOTYLEDONOUS WEEDS IN WINTER CEREALS - GERMANY 2013 (TRIAL NO: 13 1061 1751) NUDR13006BIC03 N/J N 2869474/402815 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 68 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.2 Zickart, U. 2014 Efficacy of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140501BIC01 N/J N 2869475/402816 KIIIA1 6.1.2 Zickart, U. 2014 Efficacy of U46 M- N J Nufarm Fluid in winter cereals - GERMANY 2014 NUDR140501BIC02 N/J N 2869476/402817 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in winter wheat - GERMANY 2014 NUDR140501HET03 N/J N 2869477/402818 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in winter barley - GERMANY 2014 NUDR140501HET05 N/J N 2869478/402819 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in winter wheat - GERMANY 2014 NUDR140501HET06 N/J N 2869479/402821 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 69 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in winter wheat - GERMANY 2014 NUDR140501HET07 N/J N 2869480/402822 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in winter triticale - GERMANY 2014 NUDR140501HET08 N/J N 2869481/402823 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in winter wheat - GERMANY 2014 NUDR140501HET10 N/J N 2869482/402824 KIIIA1 6.1.2 Rohr, J. 2015 Efficacy of U46 M- N J Nufarm Fluid against CIRAR in Spring Barley - GERMANY 2014 NUDR140501_AGT01 _SG N/J N 2869483/402825 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 70 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.2 Rohr, J. 2015 Efficacy of U46 M- N J Nufarm Fluid against CIRAR in Spring Barley - GERMANY 2014 NUDR140501_AGT02 _SG N/J N 2869484/402826 KIIIA1 6.1.2 Rohr, J. 2015 Efficacy of U46 M- N J Nufarm Fluid against CIRAR and CENCY in Spring Wheat - GERMANY 2014 NUDR140501_AGT03 _SW N/J N 2869485/402827 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in spring wheat - GERMANY 2014 NUDR140504HET10 N/J N 2869486/402828 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in oats - GERMANY 2014 NUDR140504HET02 N/J N 2869487/402829 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 71 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in oats - GERMANY 2014 NUDR140504HET03 N/J N 2869488/402830 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in spring barley - GERMANY 2014 NUDR140504HET05 N/J N 2869489/402831 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in spring barley - GERMANY 2014 NUDR140504HET06 N/J N 2869490/402832 KIIIA1 6.1.2 Hetterich, A. 2015 Efficacy of U46 M- N J Nufarm Fluid against annual weeds in spring barley - GERMANY 2014 NUDR140504HET07 N/J N 2869491/402833 KIIIA1 6 Anonymous 2015 GAP-Table (BAD N J Nufarm extract) N/N N 2869523/402835 Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 72 of 76 Data Point Author(s) Year Title Verte- Data Justifi- Owner Report-No. brate protec- cation Source study tion if data claimed protec- GLP/GEP (J=Yes O=Open (J=Yes tion is Published claime N=No) O=Open Authority registration d No./JKI-No. N=No) MIIIA1 Sec 7 Nufarm 2015 dRR Part B Section 7 N J Nufarm Deutschland U 46 M-Fluid revised final_2015-06-01 N/N N 2869533/402840 MIIIA1 Sec 7 Nufarm 2015 dRR Part B Section 7 N J Nufarm Deutschland U 46 M-Fluid revised final_2015-06-01 N/N N 2869534/402841 List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review Data Au- Year Title Vertebrate Data protec- Justification if Owner Point thor(s) Report-No. study tion claimed data protection is Source (J=Yes (J=Yes claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority regis- tration No./JKI- No. List of data submitted by the applicant and not relied on Data Au- Year Title Vertebrate Data protec- Justification if Owner Point thor(s) Report-No. study tion claimed data protection is Source (J=Yes (J=Yes claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority regis- tration No./JKI- No. List of data relied on and not submitted by the applicant but necessary for evaluation Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 73 of 76 Data Au- Year Title Vertebrate Data protec- Justification if Owner Point thor(s) Report-No. study tion claimed data protection is Source (J=Yes (J=Yes claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority regis- tration No./JKI- No. Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 74 of 76 Appendix 2: GAP table GAP-Table of intended uses for Germany GAP rev. (No), date: 2014-02-25 2017-01-17 PPP (product name/code) U 46 M-Fluid Formulation type: SL active substance 1 MCPA Conc. of as 1: 500 g/L Applicant: Nufarm professional use X Zone(s): central non professional use Verified by MS: yes 1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Mem- Crop and/ F Pests or Group of Application Application rate PHI Remarks: No. ber or situation G pests controlled (days) state(s) or Method / Timing / Growth Max. num- kg, L product g, kg a.s./ha Water e.g. safener/synergist (crop destination / I (additionally: devel- Kind stage of crop & ber (min. in- / ha L/ha per ha purpose of crop) opmental stages of season terval be- a) max. rate a) max. rate the pest or pest tween appli- per appl. per appl. min / max e.g. recommended or cations) group) b) max. total b) max. total mandatory tank mix- a) per use rate per rate per tures b) per crop/ crop/season crop/season season 001 DE Winter soft wheat F annual dicotyle- Spraying After emer- a) 1 a) 1.4 L/ha a) 700 g 200 - 400 F TRZAW donous weeds gence b) 1 b) 1.4 L/ha a.s./ha (TTTDS), winter durum wheat BBCH 13 – 39 b) 700 g Cirsium arvensis (CI- spring a.s./ha TRZDW RAR) Spelt Dicotyledonous TRZSP weeds winter barley TTTDD HORVW winter rye SECCW Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 75 of 76 winter triticale TTLWI 002 DE Spring soft wheat F annual dicotyle- Spraying After emer- a) 1 a) 1.4 L/ha a) 700 g 200 - 400 F TRZAS donous weeds gence b) 1 b) 1.4 L/ha a.s./ha (TTTDS), spring durum wheat BBCH 11 13 – b) 700 g Cirsium arvensis (CI- 39 a.s./ha TRZDS RAR) spring spring barley Dicotyledonous HORVS weeds common oats TTTDD AVESA spring rye SECCS 003 DE Grassland, pasture, F Dicotyledonous Spraying March to Sep- a) 1 a) 2 L/ha a) 1000 g 200 - 400 14 d meadow weeds tember b) 1 b) 2 L/ha a.s./ha NNNFW TTTDD May to August b) 1000 g a.s./ha BBCH 25 - 35 004 DE Pome fruit F Dicotyledonous Spraying March to Sep- a) 1 a) 2 L/ha a) 1000 g 200 - 400 F NNNOK weeds tember b) 1 b) 2 L/ha a.s./ha stone fruits TTTDD b) 1000 g a.s./ha NNNOS from 1st year after with planting screen 005 DE Grape vine F Dicotyledonous Spraying March to Sep- a) 1 a) 4 L/ha a) 2000 g 200 - 600 F VITVI weeds tember b) 1 b) 4 L/ha a.s./ha utilisation as wine TTTDD b) 2000 g a.s./ha and table grape with up to 3rd year after screen planting of the vine Julius Kühn-Institut 2017-02-14 Part B – Section 7 U 46 M-Fluid Registration Report Core Assessment ZV1 060939-00/00 Central Zone Page 76 of 76 Julius Kühn-Institut 2017-02-14