REGISTRATION REPORT Part A. Risk Management. Folpet 500 g/kg. COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT

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1 Part A National Assessment Germany Sanvino Page 1 of 36 REGISTRATION REPORT Part A Risk Management Product code: Active Substance: Sanvino Amisulbrom 50 g/kg Folpet 500 g/kg COUNTRY: Germany Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: ADAMA Deutschland GmbH Applicant: ADAMA Deutschland GmbH Evaluator: DE

2 Part A National Assessment Germany Sanvino Page 2 of 36 Table of Contents PART A Risk Management 4 1 Details of the application Application background Annex I inclusion Regulatory approach Data protection claims Letters of Access 6 2 Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC R and S phrases under Directive 2003/82/EC (Annex IV and V) Fehler! Textmarke nicht definiert Other phrases Fehler! Textmarke nicht definiert. 2.3 Product uses 11 3 Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Methods of analysis Analytical method for the formulation Analytical methods for residues Mammalian Toxicology Acute Toxicity Operator Exposure Bystander Exposure Worker Exposure Residues and Consumer Exposure Residues Consumer exposure Environmental fate and behaviour Ecotoxicology Effects on Terrestrial Vertebrates Effects on Aquatic Species 23 Applicant: ADAMA Deutschland GmbH Evaluator: DE

3 Part A National Assessment Germany Sanvino Page 3 of Effects on Bees and Other Arthropod Species Effects on Earthworms and Other Soil Macro-organisms Effects on organic matter breakdown Effects on Soil Non-target Micro-organisms Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) Efficacy Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 32 Appendix 1 Copy of the product authorisation 33 Appendix 2 Copy of the product label 34 Appendix 3 Letter of Access 36 Appendix 4 Copy of the product authorisation 367 Applicant: ADAMA Deutschland GmbH Evaluator: DE

4 Part A National Assessment Germany Sanvino Page 4 of 36 PART A Risk Management This document describes the acceptable use conditions required for the re-registration of containing the active substances amisulbrom (50 g/kg) and folpet (500g/kg) in Germany. The risk assessment conclusions are based on the information, data and assessments provided in, Part B Sections 1-7 and Part C. The information, data and assessments provided in, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to where that data has not been considered in the EU review. Otherwise assessments for the safe use of have been made using endpoints agreed in the EU review of amisulbrom and folpet. This document describes the specific conditions of use and labelling required for Germany for the reregistration of. Appendix 1: due to technical reasons, the authorisation of the final product in Germany will be found under Appendix 4. Appendix 2: The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions drawn by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again. Appendix 3: Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. Appendix 4 of this document provides a copy of the final product authorisation Germany. It will be inserted in the final version. 1 Details of the application 1.1 Application background This application was submitted by ADAMA Deutschland GmbH on The application was for approval of, water dispersible granules (WG) containing 50 g/kg amisulbrom and 500 g/kg folpet for use as a fungicide in vine grapes. 1.2 Annex I inclusion The Annex I inclusion process of the active substance amisulbrom (Commission Implementing Regulation (EU) No 193/2014) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MA prior to granting an authorisation. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amisulbrom, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. Applicant: ADAMA Deutschland GmbH Evaluator: DE

5 Part A National Assessment Germany Sanvino Page 5 of 36 In this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1H- 1,2,4-triazol-3-ylsulfonyl)-1H-indole and 1- (dimethylsulfamoyl)-1h- 1,2,4-triazole-3-sulfonic acid to contaminate groundwater; (2) the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1- (dimethylsulfamoyl)-1h-1,2,4-triazole-3-sulfonic acid, 1H- 1,2,4-triazole-3-sulfonic acid, 1H-1,2,4- triazole, N,N-dimethyl-1H-1,2,4- triazole-3-sulfonamide, 2-acetamido-4-fluorobenzoic acid, 2-acetamido- 4-fluoro-hydroxybenzoic acid and 2,2 -oxybis(6-fluoro-2-methyl-1,2- dihydro-3h-indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff; (3) depending on the outcome of the assessment under (1) and (2), where there is considerable photodegradation in soil or where there is high potential for contamination or exposure, additional analytical methods to determine all compounds of the residue definition for monitoring in surface water; (4) the risk from secondary poisoning for birds and mammals by 3-bromo- 6-fluoro-2-methyl-1-(1H- 1,2,4-triazol-3-ylsulfonyl)-1H-indole; (5) the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4- triazol-3-ylsulfonyl)-1h-indole. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) to (4) by 30 June 2016 and under point (5) within two years after the adoption of pertinent OECD test guidelines on endocrine disruption. Folpet is included into Annex I of Directive 91/414 (Directive number 2007/5/EC). The Annex I Inclusion Directive for folpet (2007/5/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation. For the implementation of the Uniform Principles of Regulation (EU) 546/2011 the conclusions of the review report on the active substance folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 07/02/2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: - the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; - the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; - the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures. Applicant: ADAMA Deutschland GmbH Evaluator: DE

6 Part A National Assessment Germany Sanvino Page 6 of 36 These concerns have been addressed within the current submission. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval. 1.3 Regulatory approach To obtain approval the product must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Regulation (EU) 544/2011 and Regulation (EU) 545/2011, with an assessment to Uniform Principles, using Annex I (Regulation (EU) 540/2011) agreed end-points. This application was submitted in order to allow the re-registration of an already approved product/use in Germany in accordance with the above 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of, it is indicated in the reference lists in Appendix 1 of the, Part B, sections 1-7 and Part C. 1.5 Letters of Access Data access has been proven. ADAMA Deutschland GmbH provided own data as well as a letter of access from Nissan Chemical for the use of the annex II data of the active substance Amisulbrom. 2 Details of the authorisation 2.1 Product identity Product Name Authorization Number Function Fungicide Applicant ADAMA Deutschland GmbH Composition 50 g/kg amisulbrom and 500 g/kg folpet Formulation type Water dispersible granules [Code: WG] Packaging 1 or 5 kg sachets (composite HDPE/AL/paper), each within a cardboard box 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC Not proposed Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008: Applicant: ADAMA Deutschland GmbH Evaluator: DE

7 Part A National Assessment Germany Sanvino Page 7 of 36 Hazard classes and categories: Skin Irrit. 2, Skin Sens. 1A, Eye Irrit. 2, Acute Tox. 4, Carc. 2, Repr. 2 Hazard pictograms: GHS07 GHS08 GHS09 Signal word: Warning Hazard statements: H315 H317 H319 H332 H351 H400 H410 exclamation mark health hazard environment Causes skin irritation. May cause an allergic skin reaction. Causes serious eye irritation. Harmful if inhaled. Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>. Very toxic to aquatic life. Very toxic to aquatic life with long lasting effects. Precautionary statemtents: Not proposed by zrms Germany, to be decided by applicant P101 P102 P201 P261 P280 P302+P352 P305+P351+P338 P308+P313 P362+P364 P405 If medical advice is needed, have product container or label at hand. Keep out of reach of children. Obtain special instructions before use. Avoid breathing dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face protection. IF ON SKIN: Wash with plenty of water/... IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF exposed or concerned: Get medical advice/attention. Take off contaminated clothing and wash before reuse. Store locked up. 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: EUH Contains folpet. May produce allergic reactions. Applicant: ADAMA Deutschland GmbH Evaluator: DE

8 Part A National Assessment Germany Sanvino Page 8 of 36 Applicant: ADAMA Deutschland GmbH Evaluator: DE

9 Part A National Assessment Germany Sanvino Page 9 of Standard phrases under Regulation (EC) No 547/2011 None 2.3 Other phrases notified under Regulation (EC) No 547/ Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Human health protection SB001 SB110 SB166 SF1891 SS110 SS2101 SS2202 Avoid any unnecessary contact with the product. Misuse can lead to health damage. 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. Do not eat, drink or smoke when using this product. 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. Wear standard protective gloves (plant protection) when handling the undiluted product. Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. 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 WMFC4 WMFM4 NB6641 NN3001 Ecosystem protection NW 262 NW 264 NW 468 Mode of action (FRAC-Group): C4; target site: complex III cytochrome bc1 (ubiquinone reductase) at Qi site (for amisulbrom) Mode of action (FRAC-Group): M4; multi-site contact activity (for folpet) 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) The product is classified as harmful for populations of relevant beneficial insects. The product is toxic for algae. The product is toxic for fish and aquatic invertebrates. 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 Applicant: ADAMA Deutschland GmbH Evaluator: DE

10 Part A National Assessment Germany Sanvino Page 10 of 36 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 NN1002 The product is classified as non-harmful for populations of relevant beneficial predatory mites and spiders 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 WW762 WW750 WG734 NN134 Ecosystem protection Due to resistance management, do not apply the product (including other products with the same active substance, with an active substance from the same active substance group or with a cross-resistant active substance) more often than is stated in the instructions for use. If in doubt, consult extension services. The maximum number of applications is limited due to active substance-specific reasons. Sufficient control is therefore not expected in all cases. If necessary, use products containing other active substances afterwards or alternately. Use of the product for spontaneous fermentation can lead to a delay in fermentation. The product is classified as harmless for populations of the species Typhlodromus pyri (predatory mite). NW When applying the product on areas adjacent to surface waters - except only occasionally but including periodically water bearing surface waters - the product must be applied with equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 205, p. 9780) as amended. Depending on the drift reduction classes for the equipment stated below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times for drift reduction classes marked with "*". Drift reduction by 90% 5 m 75 % 10 m 50% 10 m NW 606 The only case in which the product may be applied without loss reducing equipment is when at least the buffer zone stated below is kept from surface waters - except only occasionally but including periodically water bearing surface waters. Violations may be punished by fines of up to Euro. Buffer zone of 15 m Applicant: ADAMA Deutschland GmbH Evaluator: DE

11 Part A National Assessment Germany Sanvino Page 11 of Product uses GAP rev. (No), date: PPP (product name/code): Active substance 1: Active substance 2: Sanvino Folpet Amisulbrom Formulation type: Conc. of as 1: Conc. of as 2: WG 500 g/kg 50 g/kg Applicant: Zone(s): ADAMA Deutschland GmbH Central EU Professional use: Non-professional use: Yes No Verified by MS: Yes Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Method / Kind Application Timing / Growth kg, L product / ha Application rate g, kg as/ha Water L/ha PHI (days) stage of crop & a) max. rate per appl. season min / max Max. number (min. interval between application s) a) per use b) per crop/ season b) max. total rate per crop/season a) max. rate per appl. b) max. total rate per crop/season Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 001 DE grape vine (utilisation as wine grape) VITVI F downy mildew of grapevine Plasmopara viticola PLASVI spraying or fine spraying (low volume spraying) in case of danger of infection and/or after warning service appeal BBCH a) 4 b) 4 (12 days) a) basic application: kg/ha BBCH 61: 0.75 kg/ha BBCH 71: kg/ha a) as1: g/ha as2: g/ha as1: 375 g/ha as2: 37.5 g/ha as1: g/ha as2: g/ha max. 400 max. 800 max WW762 WW750 WG734 NN134 NW605-1/606 (50 %/10 m, 75%/10m, Applicant: ADAMA Deutschland GmbH Evaluator: DE

12 Part A National Assessment Germany Sanvino Page 12 of 36 BBCH 75: 1.5 kg/ha as1: 750 g/ha as2: 75 g/ha max %/5 m und conv. 15 m) b) as1: 3000 g/ha b) 6 kg/ha as2: 300 g/ha Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (2) Member State(s) or zone for which use is applied for (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (8) The maximum number of applications possible under practical conditions of use for each single application and per year (permanent crops) or crop (annual crops) must be provided Min. interval between applications (days) where relevant (9) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. kg or L product / ha) (10) The application rate of the active substance a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. g or kg / ha) (11) The range (min/max) of water volume under practical conditions of use must be given (L/ha) (12) PHI - minimum pre-harvest interval (13) Remarks may include: Extent of use/economic importance/restrictions/minor use etc. Applicant: ADAMA Deutschland GmbH Evaluator: DE

13 Part A National Assessment Germany Sanvino Page 13 of 36 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties (Part B, Section 1, Points 2 and 4) Overall Summary: The appearance of the product is that of a pale brown, fine granulate that is water dispersible at room temperature, with a vanilla-like odour. It is not explosive, has no oxidising properties. It has a self ignition temperature of 366 C. In aqueous solution, it has a ph value around 6.4. The stability data indicate a shelf life of at least 2 years at ambient temperature. The technical characteristics are acceptable for a water dispersible granule formulation. Implications for labelling: None Compliance with FAO guidelines: The product Sanvino complies with the general requirements for WG formulations according to the FAO/WHO manual (2010). Compatibility of mixtures: A report regarding physical and chemical compatibility of the tank mixes with 8 formulations of the type WG, SC, SL, EW and SG has been submitted which has demonstrated compatibility. These tank mixes can therefore be mentioned on the product label for Sanvino. 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 has been provided and is considered to be acceptable Methods of analysis (Part B, Section 2, Point 5) Analytical method for the formulation (Part B, Section 2, Point 5.2) The active substances of (NC-225) can be quantified using the analytical HPLC method M The method was developed for quantifying amisulbrom and folpet in (NC-225). The active substances amisulbrom and folpet are dissolved in acetonitril, chromatographed on a HPLC reversed phase system with UV-detection and internal calibration. For amisulbrom there are currently no CIPAC methods published. There is a CIPAC method available for folpet TC, DP and WP formulations. The relevant impurities of folpet can be quantified using the GC/MS and the GC/FID method 11F VMFO. The relevant impurity IT-4 can be quantified using the submitted HPLC method. Applicant: ADAMA Deutschland GmbH Evaluator: DE

14 Part A National Assessment Germany Sanvino Page 14 of Analytical methods for residues (Part B, Section 2, Points ) Adequate analytical methods are available to monitor all compounds given in the respective residue definition of amisulbrom and folpet 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. Amisulbrom residues can be monitored in food of plant origin, soil, water and air by LC-MS/MS. Analytical methods for the determination of amisulbrom in animal matrices are missing. However, the intended use is not relevant for feeding stuff. Folpet residues can be monitored in food of plant origin and soil by GC-MS and GC-ECD and in water and air by HPLC-UV. Analytical methods for analysis of folpet in animal matrices are not needed, because no MRLs are set for food of animal origin. Methods for body fluids and tissues are not required, because amisulbrom and folpet are not considered to be toxic or very toxic (T / T+) nor are they classified according to GHS as follows: Acute toxicity (cat. 1-3), CMR (cat. 1) or STOT (cat. 1). However, the following minor data gaps have been identified according to the requirements of SANCO/825/00 rev. 8.1: Amisulbrom: A primary analytical method, an ILV and a confirmatory method for the determination of residues of amisulbrom in animal matrices are missing for the enforcement of the current legal residue definition (Regulation (EC) No. 897/2012, annex III part A) for food of animal origin. Folpet: An ILV and a confirmatory method for the determination of residues of folpet in dry crops are missing. However, the intended use is on grapes (commodity with high acid content). A confirmatory method for the determination of residues of folpet in plant commodities with high oil content is missing. However, the intended use is on grapes (commodity with high acid content). These data gaps can be addressed in the context of the next renewal of the approval of the active substances according to Reg. (EC) No 1107/2009 or in the context of the assessment of existing MRLs of according to Reg. (EC) No 396/ Mammalian Toxicology Acute Toxicity Sanvino, containing 50 g/l amisulbrom and 500 g/l folpet has a low toxicity in respect to oral and dermal toxicity. It is toxic by inhalation, irritating to rabbit eye and skin and is a skin sensitizer to the guinea pig Operator Exposure Operator exposure to Sanvino was not evaluated as part of the EU review of amisulbrom and folpet for this submitted rate/crop. Therefore all relevant data and risk assessments were provided and are considered adequate. Operator exposure was assessed against the AOEL-S agreed in the EU review (amisulbrom 0.15 mg/kg bw/d, folpet 0.1). According to the model calculations, it can be concluded that the risk for the operator Applicant: ADAMA Deutschland GmbH Evaluator: DE

15 Part A National Assessment Germany Sanvino Page 15 of 36 using Sanvino in grape vine is acceptable with the use of personal protective equipment described in Bystander Exposure The bystander and/or resident exposure estimations indicated that the acceptable operator exposure level (AOEL) for amisulbrom and folpet will not be exceeded under conditions of the intended use Worker Exposure The worker exposure was estimated using the model German model. Wearing adequate PPE the estimated consumption of AOEL was about 52% for folpet and 10% for amisulbrom. Implications for labelling resulting from operator, worker, bystander assessments: See Groundwater Metabolites For the amisulbrom-metabolite IT-4 a groundwater concentration of 0.1 µg/l can be excluded in all of the FOCUS groundwater scenarios. The folpet-metabolites phtalimide, phthalamic acid and phthalic acid are below 0.1 µg/l also. Therefore, the toxicological relevance of metabolites in groundwater in the groundwater is not been evaluated. Applicant: ADAMA Deutschland GmbH Evaluator: DE

16 Part A National Assessment Germany Sanvino Page 16 of Residues and Consumer Exposure Residues Fundamental residue data on amisulbrom and folpet like metabolism are already evaluated previously and is described in detail in the respective DARs. For all active substances a sufficient number of residue trials are available to demonstrate that the MRLs set in Regulation (EC) No 396/2005 (0.5 mg/kg for amisulbrom and of 10 mg/kg for folpet) will not be exceeded for the intended use in vine grapes Consumer exposure An estimation of dietary intake using EFSA PRIMo results in a maximum consumption of the respective ADIs/ARfDs below 100 %. Substance ADI/ARfD Model / Diet Amisulbrom ADI: 0.1 mg/kg bw TMDI, EFSA PRIMo, WHO Cluster diet B, 4 % ADI/ARfD Consumption ARfD: 0.3 mg/kg bw IESTI, EFSA PRIMo, UK adults < 1 % Folpet ADI: 0.1 mg/kg bw IEDI, EFSA PRIMo, French all population 22 % ARfD: 0.2 mg/kg bw IESTI, EFSA PRIMo, UK adults 6 % The chronic and the short-term intake of amisulbrom and folpet residues are unlikely to present a public health concern Environmental fate and behaviour (Part B, Section 5, Point 9) A full exposure assessment for the plant protection product Sanvino in its intended uses in grapes is documented in detail in the core assessment of the plant protection product Sanvino dated from April 2015 performed by zrms Germany. Applicant: ADAMA Deutschland GmbH Evaluator: DE

17 Part A National Assessment Germany Sanvino Page 17 of 36 Table: Overview of intended uses in Germany for Sanvino relevant for risk assessment Group/ use No A/ Crop/growth stage grapes/ BBCH Application method Drift scenario Number of applications, Minimum application interval, application time, interception spraying 4 x, 10 d, 1.) BBCH 14-61: 50 % 2.) BBCH >61: 70 % 3.) BBCH >71: 85 % 4.) BBCH >75: 85 % Application rate, cumulative (g as/ha) Amisulbrom: 1.) ) ) ) Folpet: 1.) ) ) ) Soil effective application rate (g as/ha) Amisulbrom: 1.) ) ) ) = Folpet: 1.) ) ) ) = Regarding the PEC calculations following worst case scenario in terms of soil load was considered by the applicant: four times per year with an application rate of 75 g amisulbrom/ha and 750 g folpet/ha, an application interval of 10 days, a crop interception of 70 %. The following chapters summarises specific exposure assessment for soil and surface water and the specific risk assessment for groundwater for the authorization of Sanvino in Germany according to its intended use in grapes (Use No ). Active substances Amisulbrom Under laboratory conditions amisulbrom degraded in soil with a geo.mean of 143 d. During degradation in soil two metabolites can be observed (IT-4, IT-14). For the metabolites only for IT-4 a geo.mean. of 88.9 days is presented. Under field conditions degradation was a lot quicker with DT 50 values between 1 and 13 days but showing in some studies a biphasic kinetic with slow phase half lifes of up to 83 days. In the Efsa conclusion it was recommended not to use this values for modelling. The active substance is well absorbed to soil with a median Kfoc value of This can also be contributed to metabolit IT-4 with an mean Kfoc of In water/sediment-systems dissipation from the water phase for amisulbrom is quick with a DissT 50 of 6.7 days whereby the persistence in the whole system including sediment is higher with an DegT50 geo.mean. of 100 days. In the water sediment studies also the metabolites IT-4 and IT-15 were investigated. Only for IT-4 valid data points could be derived with a DissT 50 of 28.7 from the water phase and a DegT 50 of 58.9 for the whole system. Folpet Folpet is quickly degraded in soil under laboratory conditions with a range of half lives between 0.1 and 22.3 days. During degradation in soil three metabolites (Phthalimide, Phthalamic acid, Phthalic acid) occur which show a similar quick degradation behavior. K OC of Folpet is not measurable due to rapid hydrolysis. Worst-case estimated K OC = 304 ml/g. for metabolite phthalimide a Kfoc of 209 was measured and for the other metabolites estimations using PCKOC exist indicating only a weak adsorption with values of 10 for phthalamic acid and 73.1 for phthalic acid. Folpet is in water/sediemt studies not satble with DT 50 values below 1 d. Five metabolites were detected with half lives up to 6 days for the whole system. Applicant: ADAMA Deutschland GmbH Evaluator: DE

18 Part A National Assessment Germany Sanvino Page 18 of 36 Metabolites Amisulbrom No new study on the fate and behaviour of amisulbrom or Sanvino has been performed. Hence no potentially new metabolites need to be considered for environmental risk assessment. The risk assessment for one of these metabolites (IT-4) has already been performed for EU approval (see EFSA Journal 2014; 12(4):3237). For the potential ground water contamination by the soil metabolite IT- 4 a data gap was identified for all representative uses by EFSA. Therefore, the leaching potential into groundwater of the soil metabolite IT-4 will be assessed for the application of the plant protection product and its intended uses. In the EU assessment (refers to EFSA Journal 2014; 12(4):3237) the risk to groundwater from metabolite IT-14 was considered to be low, although the metabolite was still increasing at study end (maximum observed formation of 6.4%). No PEC groundwater calculation was carried out. Therefore, the leaching potential into groundwater of the soil metabolite IT-14 will be assessed by zrms. Furthermore, the outcome of the peer-review was a data gap regarding the route of degradation of amisulbrom in soil based on the maximum label recommended rate of application in order to identify and address all potential degradation products formed in relevant amounts (see EFSA Journal 2014;12(4): 3237). However, in the specific groundwater risk assessment for Germany considering the entry path surface run-off and drainage with subsequent bank filtration the soil metabolite IT-4 of amisulbrom is included. Folpet From the national authorization of different formulations containing folpet an additional study on the degradation of folpet in soil is available. No new soil metabolite of folpet needs to be considered in the risk assessment. The risk assessment for the metabolites of folpet has already been performed for EU approval (see SANCO/10032/2006 rev. 5 11/07/2008). The leaching potential into groundwater of the soil metabolites phthalimide and phthalamic aicd and phthalic acic will be assessed for the application of the plant protection product and its intended uses. However, in the specific groundwater risk assessment for Germany considering the entry path surface run-off and drainage with subsequent bank filtration the soil metabolites of folpet are included Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) For german exposure assessment, the applied soil depth is based on experimental data 1 (Fent, 1999). Generally, for active substances with a K f,oc < 500 a soil depth of 2.5 cm is used whereas for active substances with a K f,oc > 500 a soil depth of 1.0 cm is applied. The initial PEC soil calculations according to the FOCUS guidance were performed with ESCAPE 2.0. For the intended use of the plant protection product Sanvino in grapes according to use No PECsoil was calculated for the active substance amisulbrom considering a soil depth of 1.0 cm. Due to the fast degradation of the active substance amisulbrom in soil the accumulation potential of amisulbrom was not considered. For the intended use of the plant protection product Sanvino in grapes according to use No PECsoil was calculated for the active substance folpet considering a soil depth of 2.5 cm. Due to the fast degradation of the active substance folpet in soil the accumulation potential of folpet was not considered. Table: Overview PECsoil values relevant for risk assessment active substance/ formulation soil relevant application rate (g/ha) soil depth act (cm) PEC act (mg/kg)* Amisulbrom 4 x , refined 1 Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ , UBA, Berlin 1999 Applicant: ADAMA Deutschland GmbH Evaluator: DE

19 Part A National Assessment Germany Sanvino Page 19 of (d 30) Folpet 4 x , refined (d 30) Sanvino , refined (85% interception): 6, refined (85 % interzeption and 2.5 cm): 2.4 *crop interception: 4 x 70 % 1) as Folpet is the main contributor to the product toxicity to earthworms The results for PECsoil for the active substances and its metabolites were used for the eco-toxicological risk assessment Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 1. Direct leaching into groundwater Amisulbrom Results of modelling with FOCUS PELMO show that the active substance amisulbrom is not expected to penetrate into groundwater at concentrations of 0.1 µg/l in the intended uses in grapes. For the metabolites IT-4 and IT-14 concentrations of 0.1 µg/l in groundwater can be excluded in all of the FOCUS groundwater scenarios in the intended uses. Folpet Results of modelling with FOCUS PELMO show that the active substance folpet is not expected to penetrate into groundwater at concentrations of 0.1 µg/l in the intended uses in grapes. For the metabolites phthalimide, phthalamic acid and phthalic acid concentrations of 0.1 µg/l in groundwater can be excluded in all of the FOCUS groundwater scenarios in the intended uses. 2. Ground water contamination by bank filtration due to surface water exposure via run-off and drainage Amisulbrom According modelling with EXPOSIT 3.01, groundwater contamination at concentrations 0.1 µg/l by the active substance amisulbrom due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded. According to modelling with EXPOSIT 3.01, groundwater contamination at concentrations 0.1 µg/l by the soil metabolite IT-4 of amisulbrom due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded. Folpet According modelling with EXPOSIT 3.01, groundwater contamination at concentrations 0.1 µg/l by the active substance folpet due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded. According to modelling with EXPOSIT 3.01, groundwater contamination at concentrations 0.1 µg/l by the soil metabolites phthalimide, phthalamic acid and phthalic acid of folpet due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded. Applicant: ADAMA Deutschland GmbH Evaluator: DE

20 Part A National Assessment Germany Sanvino Page 20 of 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 Sanvino in grapes according to use No PECsw was calculated for the active substances amisulbrom and folpet considering the two routes of entry (i) spraydrift and volatilisation 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 amisulbrom is < 10-5 Pa. Hence the active substance amisulbrom is regarded as non-volatile. Therefore, exposure of surface water by the active substance amisulbrom due to deposition following volatilization was not considered. 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 folpet is between 10-5 und 10-4 Pa. Hence the active substance folpet is regarded as semivolatile (volatilisation only from plant surfaces). Therefore, exposure of surface water by the active substance folpet due to deposition following volatilization was not considered. The concentration of the active substances amisulbrom and folpet in adjacent ditch due to surface runoff and drainage was calculated using the model EXPOSIT Table: Summary of PEC sw values for the intended use in vines used for German risk assessment active substance/ formulation PECsw Spray-Drift (incl. volatilisatio n) [µg/l] with 3 m default buffer - scenario vine PECsw run-off [µg/l] without buffer PECsw drainage [µg/l] scenario autumn/winter/ early spring PECsw drainage [µg/l] scenario spring/summ er Amisulbrom (74 Perc) Folpet (90 Perc) Sanvino (90 Perc) The results for PEC surface water for the active substance and its metabolites were used for the ecotoxicological risk assessment Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) The vapour pressure at 20 C of the active substance amisulbrom is < 10-5 Pa. Hence the active substance amisulbrom is regarded as non-volatile. Therefore exposure of surface water by the active substance amisulbrom due to deposition following volatilization should not be considered. The vapour pressure at 20 C of the active substance folpet is between 10-5 und 10-4 Pa. Hence the active Applicant: ADAMA Deutschland GmbH Evaluator: DE

21 Part A National Assessment Germany Sanvino Page 21 of 36 substance folpet is regarded as semivolatile (volatilisation only from plant surfaces). Therefore exposure of surface water by the active substance folpet due to deposition following volatilization should be considered. Implications for labelling resulting from environmental fate assessment: For the authorization of the plant protection product Sanvino following labeling and conditions of use are mandatory: Classification and labelling Based on the data on the active substances amisulbrom and folpet the plant protection product Sanvino is considered to be not readily degradable in the sense of the CLP regulation. The formulation Sanvino is regarded as a candidate for R 53. R and S phrases under Directive 2003/82/EC (Annex IV and V) none Other labels /conditions for use Labelling none Applicant: ADAMA Deutschland GmbH Evaluator: DE

22 Part A National Assessment Germany Sanvino Page 22 of Ecotoxicology (Part B, Section 6, Point 10) A full risk assessment according to Uniform Principles for the plant protection product in its intended uses in grapes is documented in detail in the core assessment of the plant protection product dated from April 2015 performed by zrms DE. The intended use of in Germany is generally covered by the uses evaluated in the course of the core assessment. The following chapters summarises specific risk assessment for non-target organisms and hence risk mitigation measures for the authorization of in Germany according to its intended use in grapes: Group/ use No Crop/growth stage Application method Drift scenario Number of applications, Minimum application interval, application time, interception Application rate, cumulative (g/ha) Soil effective application rate (g as/ha) A/ grapes/ BBCH spraying 4 x, 10 d, 1.) BBCH 14-61: 50 % 2.) BBCH >61: 70 % 3.) BBCH >71: 85 % 4.) BBCH >75: 85 % Product: 1.) ) ) ) 1500 Amisulbrom: 1.) ) ) ) Amisulbrom: 1.) ) ) ) = Folpet: 1.) ) ) ) = Folpet: 1.) ) ) ) Regarding the PEC calculations following worst case scenario in terms of soil load was considered by the applicant: four times per year with an application rate of 75 g amisulbrom/ha and 750 g folpet/ha, an application interval of 10 days, a crop interception of 70 % Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) Applicant: ADAMA Deutschland GmbH Evaluator: DE

23 Part A National Assessment Germany Sanvino Page 23 of 36 Table: Endpoints used for risk assessment for birds and mammals Test system Species Results Amisulbrom Acute toxicity Reproductive toxicity Colinus virginianus (Bobwhite quail) Colinus virginianus (Bobwhite quail) LD 50 > 2000 mg/kg bw NOEL 34.2 mg/kg bw/d Acute toxicity rat LD 50 > 5000 mg/kg bw/d Reproductive toxicity Folpet Acute toxicity Reproductive toxicity rat Colinus virginianus (Bobwhite quail) Colinus virginianus (Bobwhite quail) NOAEL = 48.5 mg/kg bw/d LD 50 > 2510 mg/kg bw NOEL 78.3 mg/kg bw/d Acute toxicity rat LD 50 > 2000 mg/kg bw Reproductive toxicity Sanvino rabbit NOAEL = 10 mg a.s./kg bw/d Acute toxicity rat LD 50 > 2000 mg/kg bw 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). Birds: Dietary risk assessment Based the Tier 1 assessment step, the calculated TER values for the long-term risk resulting from an exposure of birds to amisulbrom and folpet according to the GAP of the formulation achieve the acceptability criteria TER 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point for long-term effects. The results of the assessment indicate an acceptable risk for birds due to the intended use of in grape vine according to the label. Further refinement is not necessary. Risk assessment for exposure via drinking water The puddle scenario has been taken into account to calculate the exposure concentration of Amisulbrom and Folpet formed on a field after rainfall. The ratios do not exceed the value of 3000 for Amisulbrom (Koc = L/kg) and 50 for Folpet (Koc = 304 L/kg), thus it is not necessary to conduct a drinking water risk assessment for birds. Risk assessment for exposure via secondary poisoning Based on the calculation of the risk arising from secondary poisoning, the calculated TER values for birds exposed to the active substance Amisulbrom and Folpet according to the GAP of the formulation achieve the acceptability criteria TER 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point for long-term effects, further refinement is not necessary. Applicant: ADAMA Deutschland GmbH Evaluator: DE

24 Part A National Assessment Germany Sanvino Page 24 of 36 It has to be noted though that the risk assessment for the amisulbrom metabolite IT-4 has not been finalised in the EU-review on amisulbrom, thus for the product evaluation a worst case assessment has been conducted concluding an acceptable risk of secondary poisoning from IT-4. The general data gap concerning IT-4 has been described in EFSA Journal 2014;12(4):3237 and has to be addressed until June 30th 2016 according to COMMISSION IMPLEMENTING REGULATION (EU) No 193/2014 of 27 February Mammals: Dietary risk assessment Based on the Tier 1 assessment step, the calculated TER values for acute risk resulting from an exposure of mammals to amisulbrom, folpet and the amisulbrom metabolite IT-4 according to the GAP of the formulation achieve the acceptability criteria TER 10 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point for acute effects. The results of the assessment indicate an acceptable acute risk for mammals due to the intended use of in grapes according to the label. Based on the refined risk assessment, the calculated TER values for the long-term risk resulting from an exposure of mammals to Amisulbrom and Folpet according to the GAP of the formulation achieve the modified acceptability criteria TER 2 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point for long-term effects with respect to the active substance Folpet. The results of the assessment indicate an acceptable long-term risk for mammals due to the intended use of in grapes according to the label. Risk assessment for exposure via drinking water Based on the calculation of the risk arising from the uptake of amisulbrom and folpet via drinking water, the calculated TER values for mammals exposed to the active substances according to the GAP of the formulation achieve the acceptability criteria TER 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point for longterm effects, further refinement is not necessary. Risk assessment for exposure via secondary poisoning Based on the calculation of the risk arising from secondary poisoning, the calculated TER values for mammals exposed to the active substances amisulbrom and folpet according to the GAP of the formulation achieve the acceptability criteria TER 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point for longterm effects. It has to be noted though that the risk assessment for the amisulbrom metabolite IT-4 has not been finalised in the EU-review on amisulbrom, thus for the product evaluation a worst case assessment has been conducted concluding an acceptable risk of secondary poisoning from IT-4. The general data gap concerning IT-4 has been described in EFSA Journal 2014;12(4):3237 and has to be addressed until June 30th 2016 according to COMMISSION IMPLEMENTING REGULATION (EU) No 193/2014 of 27 February Consequences for authorization: None. It has to be noted though that the risk assessment for the amisulbrom metabolite IT-4 has not been finalised in the EU-review on amisulbrom, thus for the product evaluation a worst case assessment has been conducted concluding an acceptable risk of secondary poisoning from IT-4. The general data gap concerning IT-4 has been described in EFSA Journal 2014;12(4):3237 and has to be addressed until June 30th 2016 according to COMMISSION IMPLEMENTING REGULATION (EU) No 193/2014 of 27 February The issue is still pending. Applicant: ADAMA Deutschland GmbH Evaluator: DE

25 Part A National Assessment Germany Sanvino Page 25 of Effects on Aquatic Species (Part B, Section 6, Point 10.2) The risk assessment towards aquatic organisms is driven by the chronic toxicity of folpet towards fish (Oncorhynchus mykiss, 28d, semistatic; NOEC mortality/growth= 39 µg a.s. /L; NOEC sublethal effects, i.e. hyperventilation, darkening = 19.5 µg a.s. /L). Resulting in a regulatory acceptable concentration (RAC) of 1.9 µg/l by consideration of an assessment factor of 10. The relvant endpoint for risk assessment of the active substance amislulbrom is driven by the acute toxicity towards fish with a LC 50 of 22.9 µg/l. Resulting in a RAC of µg/l by consideration of an assessment factor of 100. 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. 1. Exposure by spraydrift and deposition following volatilization The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzelmeier. Amisulbrom has a vapour pressure of < 10-5 Pa and is therefore classified as non-volatile. Folpet has a vapour pressure between 10 5 and 10 4 Pa and is therefore classified as semi-volatile, yet according to the EFSA conclusion on the peer review for folpet (2009) volatilization from plant surfaces is negligible for folpet. Therefore, exposure of surface water by the active substances amisulbrom and folpet due to deposition following volatilization was not considered. The aquatic risk assessment of spray drift entries in surface water by the use of in oilseed rape according to use No is based on the chronic effects of folpet to fish. Based on the calculated concentrations of amisulbrom and folpet in surface water (EVA 3), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to amisulbrom and folpet due to spray drift according to the GAP of the formulation achieve the acceptability criteria TER 100 and TER 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point for long-term effects when buffer strips and/or drift reducing technique are applied. 2. Exposure by surface run-off and drainage The concentration of the active substances amisulbrom and folpet in adjacent ditch due to surface runoff and drainage was calculated using the model EXPOSIT The calculated TER values for the risk to aquatic organism resulting from an exposure of surface water by the active substances amisulbrom and folpet due to runoff an drainage according to the use No achieve the acceptability criteria of TER 100 or 10 respectivly, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point Risk mitigation measure do not need to be applied. Consequences for authorization: For the authorization of the plant protection product following labeling and conditions of use are mandatory: Required Labelling NW 262 NW 264 amisulbrom: Pseudokirchneriella subcapitata NOEC = mg/l (static) amisulbrom: Cyprinus carpio LC50= mg/l (flow- Applicant: ADAMA Deutschland GmbH Evaluator: DE

26 Part A National Assessment Germany Sanvino Page 26 of 36 through) amisulbrom: Daphnia magne EC50= mg/l (static) folpet: Salmo trutta LC50 = (static) folpet: Oncorhynchus mykiss LC50 = mg/l (flow-through) folpet: Daphnia magna EC50=0.020 mg/l (flow-through) folpet: Daphnias magna EC50=0.68 mg/l (static) : Oncorhynchus mykiss LC50 = 0.49 mg/l (static) Conditions for use All uses NW 468 NW 605-1/606 (common 15 m, 50 % 10 m, 75 % 10 m, 90 % 5 m buffer) Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Bees The recommended use pattern for Sanvino includes application in grapevine at a maximum application rate of up to 1.5 kg product/ha. Bee exposure Bees may be exposed to the product Sanvino 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 honeydew. Laboratory bee toxicity Laboratory bee toxicity studies provided acute oral and contact toxicity data as LD 50 after 48 h of bee exposure to the product Sanvino. The results are presented in the following table, which also shows results of laboratory bee toxicity studies with the active substances amisulbrom and folpet after 48 h of bee exposure. Table: Laboratory bee toxicity data Test substance Exposure route LD 50 Sanvino oral 48 h contact 48 h > µg product/bee > 200 µg product/bee amisulbrom tech. folpet tech. * EU agreed endpoint oral 48 h > 100 µg as/bee * contact 48 h > 100 µg as/bee * oral 48 h > 236 µg as/bee * contact 48 h > 200 µg as/bee * Applicant: ADAMA Deutschland GmbH Evaluator: DE

27 Part A National Assessment Germany Sanvino Page 27 of 36 Risk assessment Risks were also assessed from hazard quotients (HQs). HQs are calculated from the ratio between the application rate of the product and the lowest laboratory LD 50-values. An HQ of less than 50 indicates a low risk to bees. In the present case, HQs are calculated based on the maximum single application rate of the product Sanvino resulting in HQs of <7.5 in case of bee oral and contact exposure. Hence, Sanvino is considered to be practically non-toxic to honey bees. All hazard quotients are clearly below the trigger of 50, indicating that the intended use poses a low risk to bees in the field. Conclusion It is concluded that the product Sanvino will not adversely affect bees or bee colonies when used as recommended. Other non-target arthropods For the formulation the standard laboratory tests with A. rhopalosiphi and T. pyri were performed. For both species also an extended laboratory study was performed and additionally the applicant provided an extended laboratory study with Orius insidiosus. A. rhopalosiphi and T. pyri are more sensitive than O. insidiosus. Therefor the endpoints for A. rhopalosiphi and T. pyri determined in extended laboratory studies were considered for the higher tier risk assessment considering a ER g product/ha. Based on the calculated rates of in off-field areas under the implementation of 3 m vegetated buffer strip (standard for vine), the calculated TER values describing the risk resulting from an exposure of non-target arthropods to according to the GAP of the formulation achieve the acceptability criteria of TER 10 (Tier 1) resp. 5 (Higher tier), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of in grapes according to the label Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) Table: Endpoints relevant for risk assessment Species Test item Time scale Endpoint [mg/kg soil dw] Eisenia fetida Amisulbrom Acute > 500 Chronic Folpet Acute > 500 Chronic 5.18 Acute > 500 Chronic 15 Based on the predicted concentrations of amisulbrom, folpet and in soils, the TER values describing the acute risk for earthworms and other non-target soil organisms following exposure to according to the GAP of the formulation achieve the acceptability criteria TER Applicant: ADAMA Deutschland GmbH Evaluator: DE

28 Part A National Assessment Germany Sanvino Page 28 of resp. TER 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point Based on the refined predicted concentrations of amisulbrom, folpet and in soils, the TER values describing the longterm risk for earthworms and other non-target soil organisms following exposure to folpet and according to the GAP of the formulation achieve the acceptability criteria TER 10 resp. TER 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point Effects on organic matter breakdown (Part B, Section 6, Point 10.6) Not applicable Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) Based on the predicted concentrations of amisulbrom, folpet and in soils, the risk to soil microbial processes following exposure to according to the GAP of the formulation is considered to be acceptable according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) Terrestrial plants Relevant for the risk assessment is a ER 50 of > 6000 g product/ha as shown in a vegetative vigor study on 6 plants. Based on the predicted rates of in off-field areas, the TER values describing the risk for nontarget plants following exposure to according to the GAP of the formulation achieve the acceptability criteria TER 10 resp. 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point Implications for labelling resulting from ecotoxicological assessment: For the authorization of the plant protection product following labeling and conditions of use are mandatory: Classification and labelling of the formulation Relevant toxicity Active substance: amisulbrom (content 5 %) LC50= mg/l (Cyprinus carpio), M-factor = 10, Acute category 1 NOEC=0.037 mg/l (Pimephales promelas), M-factor =1, chronic category 1 Active substance: folpet (content 50 %) LC50= mg/l (Oncorhynchus mykiss), M-factor =10, acute category 1 NOEC= mg/l (Pimephales promelas), M-factor= 1, chronic category 1 : LC50 = 0.49 mg/l (O.mykiss) Acute category 1 Classification and labelling according to Directive 67/548/EC, 78/631/EC and 1999/45/EC Applicant: ADAMA Deutschland GmbH Evaluator: DE

29 Part A National Assessment Germany Sanvino Page 29 of 36 Hazard symbol N, dangerours for the environment Risk phrases R 50/53 Classification and labelling according to Regulation 1272/2008 Hazard sysmbol GHS09 Signal word warning Hazard statement H400, H410 R and S phrases under Directive 2003/82/EC (Annex IV and V) None Other labels /conditions for use Labelling NW 262 NW 264 The product is toxic for algae. The product is toxic for fish and aquatic invertebrates. Conditions of use: All uses: NW 468 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. NW When applying the product on areas adjacent to surface waters - except only occasionally but including periodically water bearing surface waters - the product must be applied with equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 205, p. 9780) as amended. Depending on the drift reduction classes for the equipment stated below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times for drift reduction classes marked with "*". Drift reduction by 90% 5 m 75 % 10 m 50% 10 m NW 606 The only case in which the product may be applied without loss reducing equipment is when at least the buffer zone stated below is kept from surface waters - except only occasionally but including periodically water bearing surface waters. Violations may be punished by fines of up to Euro. Applicant: ADAMA Deutschland GmbH Evaluator: DE

30 Part A National Assessment Germany Sanvino Page 30 of 36 Buffer zone: 15 m Efficacy (Part B, Section 7, Point 8) Sanvino is a water dispersible granule formulation containing 50 g/kg amisulbrom and 500 g/kg folpet for use as a fungicide against downy mildew of grapevine. Information on the active substances Amisulbrom: The active substance amisulbrom belongs to the sulfonamide group. The mode of action is an inhibition of the cytochrome complex III in mitochondrial respiration. Because of the inhibition of the respiratory chain, various stages of development of the fungus can be affected. Amisulbrom is characterized by good activity against oomycetes. Mode of action (FRAC-Group): C4, target site: complex III cytochrome bc1 (ubiquinone reductase) at Qi site. Folpet: The active substance folpet belongs to the chemical group b-phthalimides and acts as a nonsystemic, non-translocated fungicide with protectant activity. Folpet enters treated conidia and reacts with many conidial constituents. The toxicity is attributed to the SCCl3 group. Folpet inhibits many oxidative enzymes, carboxylases and enzymes involved with phosphate metabolism and citrate synthesis. Folpet reacts with the sulphhydryl groups of the nuclear protein, leading to an inhibition of cell division. The reaction of folpet with thiols and the reaction of thiophosgen, its decomposition product, with thiols and other groups is a kind of metabolic inhibition. Mode of action (FRAC-Group): M4, multi-site contact activity. Effectiveness A total of 13 trials were carried out in 2004, 2005 and 2006 to evaluate the effect of Sanvino on the control of downy mildew disease (Plasmopara viticola) in grapevine. In addition, one laboratory trial was carried out to determine the potential of Sanvino for curative action on the target pathogen. All trials were carried out in Germany. Results from these trials show that Sanvino provides high potential for the control of Plasmopara viticola on grapevine and that its performance is comparable to the performance of relevant reference products. The effect of Sanvino on downy mildew is clearly suitable for the control of Plasmopara viticola on grapevine. Sanvino showed a clear potential for a curative action against Plasmopara viticola. It is comparable to superior to the reference product. The curative action allows an increased timing flexibility and an application interval of 10 days. Minimum effective dose An application rate of 0.25 kg/ha provides already a high level of control of downy mildew on grapevine. However, the intended target basis rate of kg/ha Sanvino is required to provide prevention of Plasmopara viticola infestation on a level being comparable to relevant reference products. Phytotoxicity and effects on yield and quality Phytotoxicity was assessed in all efficacy trials. No crop injury was observed in any trial and at any single rating. Thus, based on the results of 13 trials, it can be concluded that there is no risk for enduring crop injury. Sanvino is not expected to cause any negative effects on the yield of grapevine. In 4 trials carried out in France and Italy the wines produced from grapes treated with Sanvino and a reference product, respectively, could not be differentiated by taste or odour. However, the product might cause a clear but acceptable delay of the fermentation process and a marginally reduced alcohol yield. These effects are well known and determined by the folpet content of Sanvino. Therefore, a label is assigned stating that the use of the product for spontaneous fermentation can lead to a delay in fermentation. Applicant: ADAMA Deutschland GmbH Evaluator: DE

31 Part A National Assessment Germany Sanvino Page 31 of 36 Adverse effects on beneficial organisms other than bees The toxicity of Sanvino on beneficial organisms was assessed in different laboratory tests on Aphidius rhopalosiphi, Orius insidiosus and Typhlodromus pyri. With Orius insidiosus, unacceptable effects ( 25%) on survival or fertility were not observed, when Sanvino was applied up to 16 times the recommended basic application rate/ha and treatment in an extended laboratory test. Tests on the predatory mite Typhlodromus pyri showed that application rates of up to 6000 g/ha Sanvino (corresponding to 16 times the recommended basic application rate/ha and treatment) led to lethal effects < 11%. Effects on the reproduction were 25% at application rates 1500 g/ha Sanvino in two higher tier tests. However, in a field test, no decrease of the Typhlodromus pyri population was observed after 4 applications of Sanvino. Based on these results no effects 25% are expected for populations of Typhlodromus pyri when Sanvino is applied according to the recommended use pattern, i.e. four applications of 375 g/ha to 1,500 g/ha in grapevine. With Aphidius rhopalosiphi, effects > 50% are expected at the maximum total rate per crop/season of Sanvino (6 kg/ha). With today s level of knowledge, the results for Aphidius rhopalosiphi indicate that the application of Sanvino to vineyards might reduce populations of relevant beneficial insect species by > 50%. Based on the presented results, the product is classified as harmful for populations of relevant beneficial insects. The product is classified as non-harmful for populations of relevant beneficial predatory mites and spiders. Possible development of resistance or cross-resistance Plasmopara viticola has a high inherent risk to develop resistance towards amisulbrom and a low inherent risk to develop resistance towards folpet. If Sanvino is used unrestrictedly, a risk for the development of pathogen resistance against the product can be expected. Therefore, measures for a resistance management are necessary for Sanvino: With the reduction of the number of applications and the proposal of an alternation with products providing a mode of action different to amisulbrom, two different modifiers are proposed in addition. The recommendations will be clearly indicated in all documents distributed to technical advisors, dealers and users. The resistance risk of the target pathogen to develop resistance to amisulbrom is considered low to medium if Sanvino is applied according to the instructions of use following the proposed anti-resistance measures. The monitoring of the susceptibility of Plasmopara viticola populations to amisulbrom is followed up since the registration was granted and after the commercial launching of Sanvino in Germany. The results of these observations will be taken into account to adjust the strategy to any new condition. Effects on soil quality Unacceptable adverse effects on soil macro- or micro-organisms relevant for the maintenance of soil quality are not expected following the use of Sanvino according to the GAP. 3.2 Conclusions With respect to physical, chemical and technical properties of the formulation an authorisation can be granted. With respect to analytical methods (formulation) an authorisation can be granted. With respect to analytical methods for residues an authorisation can be granted. Applicant: ADAMA Deutschland GmbH Evaluator: DE

32 Part A National Assessment Germany Sanvino Page 32 of 36 With respect to toxicology, residues and consumer protection an authorisation can be granted. With respect to efficacy, an authorisation can be granted. It is concluded that the formulated product Sanvino will not adversely affect bees or bee colonies when used as recommended. With respect to fate and ecotoxicology assessment, an authorisation can be granted. 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. Summary: An authorisation can be granted 3.3 Further information to permit a decision to be made or to support a review of the No further information is required. Applicant: ADAMA Deutschland GmbH Evaluator: DE

33 Part A National Assessment Germany Sanvino Page 33 of 36 Appendix 1 Copy of the product authorisation It will be inserted in Appendix 4. Applicant: ADAMA Deutschland GmbH Evaluator: DE

34 Part A National Assessment Germany Sanvino Page 34 of 36 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 31 of Regulation (EU) No 1107/2009. PPP (product name/code): Active substance 1: Active substance 2: Sanvino Folpet Amisulbrom Formulation type: Conc. of as 1: Conc. of as 2: WG 500 g/kg 50 g/kg Applicant: Zone(s): ADAMA Deutschland GmbH Central EU Professional use: Non-professional use: Yes No Verified by MS: Yes Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Method / Kind Application Timing / Growth kg, L product / ha Application rate g, kg as/ha Water L/ha PHI (days) stage of crop & a) max. rate per appl. season min / max Max. number (min. interval between application s) a) per use b) per crop/ season b) max. total rate per crop/season a) max. rate per appl. b) max. total rate per crop/season Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 001 DE grape vine (utilisation as wine grape) VITVI F downy mildew of grapevine Plasmopara viticola PLASVI spraying or fine spraying (low volume spraying) in case of danger of infection and/or after warning service appeal BBCH c) 4 d) 4 (12 days) c) basic application: kg/ha BBCH 61: 0.75 kg/ha c) as1: g/ha as2: g/ha as1: 375 g/ha max. 400 max WW762 WW750 WG734 NN134 NW605-1/606 Applicant: ADAMA Deutschland GmbH Evaluator: DE

35 Part A National Assessment Germany Sanvino Page 35 of 36 BBCH 71: kg/ha as2: 37.5 g/ha as1: g/ha as2: g/ha max (90%/5m, 75%/10m, 50%/10m, conv. 15m) BBCH 75: 1.5 kg/ha as1: 750 g/ha as2: 75 g/ha max d) 6 kg/ha d) as1: 3000 g/ha as2: 300 g/ha Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (2) Member State(s) or zone for which use is applied for (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (8) The maximum number of applications possible under practical conditions of use for each single application and per year (permanent crops) or crop (annual crops) must be provided Min. interval between applications (days) where relevant (9) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. kg or L product / ha) (10) The application rate of the active substance a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. g or kg / ha) (11) The range (min/max) of water volume under practical conditions of use must be given (L/ha) (12) PHI - minimum pre-harvest interval (13) Remarks may include: Extent of use/economic importance/restrictions/minor use etc. Applicant: ADAMA Deutschland GmbH Evaluator: DE

36 Part A National Assessment Germany Sanvino Page 36 of 36 Appendix 3 Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. Appendix 4 Copy of the product authorisation See below Applicant: ADAMA Deutschland GmbH Evaluator: DE

37 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig ADAMA Deutschland GmbH Edmund-Rumpler-Straße Köln IHR ZEICHEN IHRE NACHRICHT VOM Dr. Claudia Bock Referentin TELEFON +49 (0) TELEFAX +49 (0) claudia.bock@bvl.bund.de AKTENZEICHEN / (bitte bei Antwort angeben) DATUM 30. Juni 2017 ZV /00 Sanvino Zulassungsverfahren für Pflanzenschutzmittel Bescheid Das oben genannte Pflanzenschutzmittel mit den Wirkstoffen: 500 g/kg Folpet 50 g/kg Amisulbrom Zulassungsnummer: Versuchsbezeichnungen: ADD F-0-WG Antrag vom: 29. Juni 2012 wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates (ABl. L 309 vom , S. 1), wie folgt zugelassen: Zulassungsende BVL_FO_05_2437_200_V1.8 Die Zulassung endet am 31. Juli Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet:

38 SEITE 2 VON 10 Festgesetzte Anwendungsgebiete bzw. Anwendungen Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1): Anwendungsnummer Zweckbestimmung Schadorganismus/ / Falscher Mehltau (Plasmopara viticola) Pflanzen/-erzeugnisse/ Objekte Weinrebe Verwendungszweck Nutzung als Keltertraube 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 lassen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle. Begründung: Die im o.g. Pflanzenschutzmittel enthaltenen Wirkstoffe Folpet und Amisulbrom weisen aufgrund ihrer Toxizität ein hohes Gefährdungspotenzial für aquatische Organismen auf. Jeder Eintrag von Rückständen 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 Auswirkungen auf Gewässerorganismen führen. Da ein erheblicher Anteil der in Oberflächengewässern nachzuweisenden Pflanzenschutzmittelfrachten auf Einträge aus kommunalen Kläranlagen zurückzuführen ist, muss dieser Gefährdung durch die bußgeldbewehrte Anwendungsbestimmung durchsetzbar begegnet werden. 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: BVL_FO_05_2437_200_V1.8

39 SEITE 3 VON 10 Verpackungsart Beutel Beutel Verpackungsmaterial Verbundmaterial Verbundmaterial Anzahl Inhalt von bis von bis Einheit 1 1,00 kg 1 5,00 kg 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: (NN3001) Das Mittel wird als schädigend für Populationen relevanter Nutzinsekten eingestuft. (NW262) Das Mittel ist giftig für Algen. (NW264) Das Mittel ist giftig für Fische und Fischnährtiere. (SB001) Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschäden führen. (SB110) Die Richtlinie für die Anforderungen an die persönliche Schutzausrüstung im Pflanzenschutz "Persönliche Schutzausrüstung beim Umgang mit Pflanzenschutzmitteln" des Bundesamtes für Verbraucherschutz und Lebensmittelsicherheit ist zu beachten. (SB166) Beim Umgang mit dem Produkt nicht essen, trinken oder rauchen. BVL_FO_05_2437_200_V1.8 (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

40 SEITE 4 VON 10 Stunden nach der Ausbringung des Mittels durchgeführt werden. Innerhalb 48 Stunden sind dabei der Schutzanzug gegen Pflanzenschutzmittel und Universal-Schutzhandschuhe (Pflanzenschutz) zu tragen. (SS110) Universal-Schutzhandschuhe (Pflanzenschutz) tragen beim Umgang mit dem unverdünnten Mittel. (SS2101) Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.b. Gummistiefel) tragen beim Umgang mit dem unverdünnten Mittel. (SS2202) Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.b. Gummistiefel) tragen bei der Ausbringung/Handhabung des anwendungsfertigen Mittels. (WMFC4) Wirkungsmechanismus (FRAC-Gruppe): C4 (WMFM4) Wirkungsmechanismus (FRAC-Gruppe): M4 Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2. Sonstige Auflagen: (VH383) Der Gehalt an Tetrachlorkohlenstoff und Perchlormethylmercaptan im technischen Wirkstoff Folpet darf 4 g/kg bzw. 3,5 g/kg nicht überschreiten. (VH384) Der Gehalt an Tetrachlorkohlenstoff im Pflanzenschutzmittel darf 0,1 % nicht überschreiten. BVL_FO_05_2437_200_V1.8 (WH952) Auf der Verpackung und in der Gebrauchsanleitung ist die Angabe zur Kennzeichnung des Wirkungsmechanismus als zusätzliche Information direkt jedem entsprechenden Wirkstoff-namen zuzuordnen.

41 SEITE 5 VON 10 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: (S1) Achtung Gefahrenpiktogramme: (GHS07) (GHS08) (GHS09) Ausrufezeichen Gesundheitsgefahr Umwelt Gefahrenhinweise (H-Sätze): (H315) Verursacht Hautreizungen. (H317) Kann allergische Hautreaktionen verursachen. (H319) Verursacht schwere Augenreizung. (H332) Gesundheitsschädlich bei Einatmen. (H351) Kann vermutlich Krebs erzeugen <Expositionsweg angeben, sofern schlüssig belegt ist, dass diese Gefahr bei keinem anderen Expositionsweg besteht>. (H400) Sehr giftig für Wasserorganismen. BVL_FO_05_2437_200_V1.8 (H410) Sehr giftig für Wasserorganismen mit langfristiger Wirkung. (EUH )

42 SEITE 6 VON 10 Enthält Folpet. Kann allergische Reaktionen hervorrufen. (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) Darf nicht in die Hände von Kindern gelangen. (P201) Vor Gebrauch besondere Anweisungen einholen. (P261) Einatmen von Staub/Rauch/Gas/Nebel/Dampf/Aerosol vermeiden. (P280) Schutzhandschuhe/Schutzkleidung/Augenschutz/Gesichtsschutz tragen. (P302+P352) BEI BERÜHRUNG MIT DER HAUT: Mit viel Wasser/... waschen. (P305+P351+P338) BEI KONTAKT MIT DEN AUGEN: Einige Minuten lang behutsam mit Wasser spülen. Eventuell vorhandene Kontaktlinsen nach Möglichkeit entfernen. Weiter spülen. (P308+P313) BEI Exposition oder falls betroffen: Ärztlichen Rat einholen/ärztliche Hilfe hinzuziehen. (P362+P364) Kontaminierte Kleidung ausziehen und vor erneutem Tragen waschen. BVL_FO_05_2437_200_V1.8 (P405) Unter Verschluss aufbewahren. (P501)

43 SEITE 7 VON 10 Inhalt/Behälter... zuführen. Abgelehnte Anwendungsgebiete bzw. Anwendungen Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): - keine - Hinweise Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden: (NB6641) Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienengefährlich eingestuft (B4). (NN1002) Das Mittel wird als nicht schädigend für Populationen relevanter Raubmilben und Spinnen eingestuft. Weitere Hinweise und Bemerkungen Auf dem Etikett ist zusätzlich zum Wirkstoffgehalt anzugeben: "Enthält ca. 280 g /kg Kaolin (Al.-silikat) als Füllstoff" Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben, soweit sie noch nicht erfüllt sind. Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulassungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen. Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid. BVL_FO_05_2437_200_V1.8

44 SEITE 8 VON 10 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, Braunschweig, schriftlich oder zur Niederschrift einzulegen. Mit freundlichen Grüßen im Auftrag gez. Dr. Karsten Hohgardt stellvertretender Abteilungsleiter Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. Anlage BVL_FO_05_2437_200_V1.8

45 SEITE 9 VON 10 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Falscher Mehltau (Plasmopara viticola) Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: Weinrebe Nutzung als Keltertraube 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Weinbau Freiland Nein Stadium der Kultur: 14 bis 83 Anwendungszeitpunkt: Bei Infektionsgefahr bzw. ab Warndiensthinweis Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Erläuterungen Anzahl Behandlungen: zeitlicher Abstand der Behandlungen mindestens 10 Tage Anwendungstechnik: spritzen oder sprühen Aufwand: - Basisaufwand: 0,375 kg/ha in maximal 400 l Wasser/ha - ES 61: 0,75 kg/ha in maximal 800 l Wasser/ha - ES 71: 1,125 kg/ha in maximal 1200 l Wasser/ha - ES 75: 1,5 kg/ha in maximal 1600 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen (NN134) Das Mittel wird als nichtschädigend für Populationen der Art Typhlodromus pyri (Raubmilbe) eingestuft. (WG734) Die Anwendung des Mittels kann bei Spontangärung zu Gärverzögerungen führen. BVL_FO_05_2437_200_V1.8 (WW750) Die maximale Anzahl der Anwendungen ist aus wirkstoffspezifischen Gründen eingeschränkt. Ausreichende Bekämpfung ist damit nicht in allen Fällen zu erwarten. Gegebenenfalls deshalb anschließend oder im Wechsel Mittel mit anderen Wirkstoffen verwenden.

46 SEITE 10 VON 10 (WW762) Aus Gründen des Resistenzmanagements das Mittel (einschließlich anderer Mittel mit gleichem Wirkstoff, mit einem Wirkstoff aus der gleichen Wirkstoffgruppe oder mit kreuzresistentem Wirkstoff) insgesamt nicht häufiger anwenden als in der Gebrauchsanleitung angegeben. Im Zweifel einen Beratungsdienst hinzuziehen. 2.3 Wartezeiten 28 Tage Freiland: Weinrebe (Keltertrauben) 3 Anwendungsbezogene Anwendungsbestimmungen (NW605-1) Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - muss mit einem Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung eingetragen ist. Dabei sind, in Abhängigkeit von den unten aufgeführten Abdriftminderungsklassen der verwendeten Geräte, die im Folgenden genannten Abstände zu Oberflächengewässern einzuhalten. Für die mit "*" gekennzeichneten Abdriftminderungsklassen ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in jedem Fall zu beachten. reduzierte Abstände: 50% 10 m, 75% 10 m, 90% 5 m Begründung: Das Pflanzenschutzmittel bzw. die darin enthaltenen Wirkstoffe Amisulbrom und Folpet weisen ein hohes Gefährdungspotential für aquatische Organsimen, insbesondere Fische auf. Bewertungsbestimmend sind hier die LC50 für C.carpio von 22,9 µg/l (Amisulbrom) und die NOEC für O.mykiss von 19,5 µg/l (Folpet). Ausgehend von den geltenden Modellen zur (hier: EVA 2.1) und einem Sicherheitsfaktor von 100 (Amisulbrom) bzw. 10 (Folpet) ist nach dem Stand der wissenschaftlichen Erkenntnisse die Anwendungsbestimmungen NW605-1/606 erforderlich, um einen ausreichenden Schutz von Gewässerorganismen vor Einträgen der Wirkstoffe Amisulbrom und Folpet in Oberflächengewässer zu gewährleisten. Weitere Infromatinen hierzu sind dem natinalen Addendum zum Part B des Registration Reports zu entnehmen (Sektion 6, Kapitel 6.5). BVL_FO_05_2437_200_V1.8 (NW606) Ein Verzicht auf den Einsatz verlustmindernder Technik ist nur möglich, wenn bei der Anwendung des Mittels mindestens unten genannter Abstand zu Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - eingehalten wird. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von Euro geahndet werden. 15 m Begründung: Siehe Anwendungsbestimmung NW605-1

47 Part B Section 1 Germany NC-225 WG Page 1 of 41 REGISTRATION REPORT Part B Section 1: Identity, physical and chemical properties, other information Detailed summary of the risk assessment Product code: NC-225 WG () Active Substance: Amisulbrom 50 g/kg Folpet 500 g/kg Rapporteur Member State: Germany CORE ASSESSMENT Applicant: ADAMA Deutschland GmbH Submission Date: 29/06/2012 Applicant ADAMA Deutschland GmbH Evaluator: DE

48 Part B Section 1 Germany NC-225 WG Page 2 of 41 Table of Contents IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT... 8 IIIA 1.1 Applicant... 8 IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s)... 8 IIIA Manufacturer(s) of the preparation... 8 IIIA Manufacturer(s) of the active substance(s)... 8 IIIA Statement of purity (and detailed information on impurities) of the active substance(s)... 8 IIIA 1.3 Trade Names and Manufacturer s Code Numbers for the Preparation... 8 IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation... 9 IIIA Content of active substance and formulants... 9 IIIA Certified limits of each component... 9 IIIA Common names and code numbers for the active substance(s) IIIA Co-formulant details: identity, structure, codes, trade name, specification and function IIIA Formulation process IIIA Description of formulation process IIIA Discussion of the formation of impurities of toxicological concern IIIA 1.5 Type of Preparation and Code IIIA 1.6 Function IIIA 1.7 Other/Special Studies IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT IIIA 3.1 Field of Use Applicant ADAMA Deutschland GmbH Evaluator: DE

49 Part B Section 1 Germany NC-225 WG Page 3 of 41 IIIA 3.2 Nature of the Effects on Harmful Organisms IIIA 3.3 Details of Intended Use IIIA Details of existing and intended uses IIIA Details of harmful organisms against which protection is afforded IIIA Effects achieved IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) IIIA 3.5 Concentration of the Active Substance in the Material Used IIIA 3.6 IIIA 3.7 Method of Application, Type of Equipment Used and Volume of Diluent Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection IIIA Maximum number of applications and their timings IIIA Growth stages of crops or plants to be protected IIIA Development stages of the harmful organism concerned IIIA Duration of protection afforded by each application IIIA IIIA 3.8 IIIA Duration of protection afforded by the maximum number of applications Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops IIIA Limitations on choice of succeeding crops IIIA Description of damage to rotational crops IIIA 3.9 Proposed Instructions for Use as Printed on Labels IIIA 3.10 Other/Special Studies IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT IIIA 4.1 Packaging and Compatibility with the Preparation IIIA Description and specification of the packaging Applicant ADAMA Deutschland GmbH Evaluator: DE

50 Part B Section 1 Germany NC-225 WG Page 4 of 41 IIIA Suitability of the packaging and closures IIIA Resistance of the packaging material to its contents IIIA 4.2 Procedures for Cleaning Application Equipment IIIA Procedures for cleaning application equipment and protective clothing IIIA Effectiveness of the cleaning procedures IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment IIIA Pre-harvest interval (in days) for each relevant crop IIIA Re-entry period (in days) for livestock, to areas to be grazed IIIA Re-entry period (in hours or days) for man to crops, buildings or spaces treated IIIA Withholding period (in days) for animal feeding stuffs IIIA IIIA IIIA IIIA 4.4 Waiting period (in days) between application and handling of treated products Waiting period (in days) between last application and sowing or planting succeeding crops Information on specific conditions under which the preparation may or may not be used Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks IIIA Warehouse storage IIIA User level storage IIIA Transport IIIA Fire IIIA Nature of protective clothing proposed IIIA Characteristics of protective clothing proposed IIIA Suitability and effectiveness of protective clothing and equipment IIIA Procedures to minimise the generation of waste IIIA Combustion products likely to be generated in the event of fire Applicant ADAMA Deutschland GmbH Evaluator: DE

51 Part B Section 1 Germany NC-225 WG Page 5 of 41 IIIA 4.5 Detailed Procedures for Use in the Event of an Accident During Transport, Storage or Use IIIA Containment of spillages IIIA Decontamination of areas, vehicles and buildings IIIA Disposal of damaged packaging, adsorbents and other materials IIIA Protection of emergency workers and bystanders IIIA First aid measures IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage IIIA Details of proposed procedures for small quantities IIIA Evaluation of products of neutralization (small quantities) IIIA Procedures for disposal of small quantities of neutralized waste IIIA Details of proposed procedures for large quantities IIIA Evaluation of products of neutralization (large quantities) IIIA Procedures for disposal of large quantities of neutralized waste IIIA 4.7 Pyrolytic Behaviour of the Active Substance IIIA 4.8 Disposal Procedures for the Plant Protection Product IIIA Detailed instructions for safe disposal of product and its packaging IIIA Methods other than controlled incineration for disposal IIIA 4.9 Other/Special Studies IIIA 11 FURTHER INFORMATION IIIA 11.1 Information of Authorisations in Other Countries IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries IIIA 11.3 Justified Proposals for Classification and Labelling IIIA 11.4 Proposals for Risk and Safety Phrases IIIA 11.5 Proposed Label IIIA 11.6 Specimens of Proposed Packaging Applicant ADAMA Deutschland GmbH Evaluator: DE

52 Part B Section 1 Germany NC-225 WG Page 6 of 41 Appendix 1: List of data used in support of the evaluation Appendix 2: Critical Uses justification and GAP tables... Fehler! Textmarke nicht definiert. Applicant ADAMA Deutschland GmbH Evaluator: DE

53 Part B Section 1 Germany NC-225 WG Page 7 of 41 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 containing the active substances amisulbrom and folpet which are approved according to Regulation (EC) No 1107/2009. This product was not the representative formulation. The product has not been previously evaluated according to Uniform Principles. The following table provides the EU endpoints to be used in the evaluation. Agreed EU End-points End-Point Amisulbrom (Reg. (EU) No 193/2014) Folpet (Reg. (EU) No 540/2011) Purity of active substance min 985 g/kg min 940 g/kg Relevant impurities 3-Bromo-6-fluoro-2-methyl- 1-(1H-1,2,4-triazol-3-ylsulfonyl)- 1H-indole: max 2 g/kg Perchloromethylmercaptan: max 3.5 g/kg Carbon tetrachloride: max 4 g/kg Appendix 1 of this document contains the list of references included in this document for support of the evaluation. Appendix 2 of this document is the table of intended uses for. Information on the detailed composition of can be found in the confidential dossier of this submission ( - Part C). Applicant ADAMA Deutschland GmbH Evaluator: DE

54 Part B Section 1 Germany NC-225 WG Page 8 of 41 IIIA 1 IIIA 1.1 IDENTITY OF THE PLANT PROTECTION PRODUCT Applicant ADAMA Deutschland GmbH Edmund Rumpler Str Köln Germany Contact person: Preciosa Conde Tel.No.: Fax No: Preciosa.Conde@fcs-feinchemie.com IIIA 1.2 IIIA Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s) Manufacturer(s) of the preparation Confidential information - data provided separately (Part C). IIIA Manufacturer(s) of the active substance(s) Confidential information - data provided separately (Part C). IIIA Amisulbrom Minimum purity: Relevant impurities: Folpet Minimum purity: Statement of purity (and detailed information on impurities) of the active substance(s) 985 g/kg 3-Bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole max 2 g/kg 940 g/kg Relevant impurities: Perchloromethylmercaptan max 2 g/kg Carbon tetrachloride max 0.5 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: Company code number: NC-225 WG; NC-225 WG 04 Applicant ADAMA Deutschland GmbH Evaluator: DE

55 Part B Section 1 Germany NC-225 WG Page 9 of 41 Synonyms: FSG F IIIA 1.4 IIIA Detailed Quantitative and Qualitative Information on the Composition of the Preparation Content of active substance and formulants The formulation was not the representative formulation. Pure active substance: content of pure amisulbrom: content of pure folpet: limits amisulbrom: limits folpet: Technical active substance: content of technical amisulbrom at minimum purity (96.5 %): content of technical folpet at minimum purity (94.0 %): 50 g/kg 500 g/kg g/kg g/kg 51.8 g/kg (5.18 % w/w) g/kg (53.19 % w/w) None of the active substances in the formulation are present in the form of a salt, ester, anion or cation. Further information on the active substances and on the certified limits of formulants is considered confidential and is provided separately (Part C). IIIA Certified limits of each component This is not an EC data requirement/ not required by regulation (EU) 2011/545. Applicant ADAMA Deutschland GmbH Evaluator: DE

56 Part B Section 1 Germany NC-225 WG Page 10 of 41 IIIA Common names and code numbers for the active substance(s) Data Point Type Name/Code Number ISO common name Amisulbrom Folpet CAS No EINECS No CIPAC No ELINCS Salt, ester anion or cation present IIIA Co-formulant details: identity, structure, codes, trade name, specification and function. CONFIDENTIAL information - data provided separately (Part C). IIIA Formulation process IIIA Description of formulation process This is not an EC data requirement/ not required regulation (EU) 2011/545. IIIA Discussion of the formation of impurities of toxicological concern Folpet contains < 3.5 g/kg perchloromercaptan and < 4 g/kg carbon tetrachloride. Amisulbrom contains 3-Bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole as relevant impurity (max 2 g/kg). IIIA 1.5 Type of Preparation and Code Type : Water dispersible granule Code : WG IIIA 1.6 Function The product will be used as fungicide. Applicant ADAMA Deutschland GmbH Evaluator: DE

57 Part B Section 1 Germany NC-225 WG Page 11 of 41 IIIA 1.7 None. Other/Special Studies Applicant ADAMA Deutschland GmbH Evaluator: DE

58 Part B Section 1 Germany NC-225 WG Page 12 of 41 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. Tabelle 1: Summary of the physical, chemical and technical properties of the plant protection product Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments Colour, odour and physical state (IIIA 2.1) Visual assessment and organoleptic determination NC-225 WG () Batch no. C content of a.s. (analysed) in g/kg: amisulbrom: 51.8 folpet: 508 The preparation is pale brown (10YR 7/2) fine granular solid with a vanilla-like odour. Y Comb, A.L., 2007a, NAS0799/ Acceptable Explosive properties (IIIA 2.2.1) EEC A 14 Batch no. C Formulation has no explosive properties. No thermal (flame) or mechanical (shock, friction) sensitivity was observed. Y Comb, A.L., 2007a, NAS0799/ Acceptable. Oxidizing properties (IIIA 2.2.2) EEC A 17 Batch no. C Formulation has no oxidising properties. Mixtures with cellulose at different ratios did not burn completely. Y Comb, A.L., 2007a, NAS0799/ Acceptable. Flash point (IIIA 2.3.1) not required for solid formulations Flammability (IIIA 2.3.2) EEC A 10 Batch no. C Formulation is not flammable. After removal of the burner, the flame did not propagate along the Y Comb, A.L., 2007a, NAS0799/ Acceptable. Applicant ADAMA Deutschland GmbH Evaluator: DE

59 Part B Section 1 Germany NC-225 WG Page 13 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments pile. Auto-flammability (IIIA 2.3.3) EEC A 16 Batch no. C Auto-ignition at 366 C. Y Comb, A.L., 2007a, NAS0799/ Acceptable. UN Test N.4 Test for self-heating substances Batch no. C Signs of self-heating when tested in 100 mm cubic wire mesh container at 140 ± 2 C, but insufficient to provide a positive result. Not classified as a self-heating substance of Division 4.2 Y Comb, A.L., 2009a, NAS1021 Acceptable. Acidity or alkalinity and ph (IIIA 2.4.1) - - The test was not conducted Acceptable. The ph of the 1 % aqueous dispersion was in the neutral region ph of a 1 % aqueous dilution, emulsion or dispersion (IIIA 2.4.2) CIPAC MT 75.3 Batch no. C Before storage: Destilled water, 20 C: 6.4 Batch no. C After 2 weeks, 54 C Destilled water, 20 C: 6.1 Y Comb, A.L., 2007a, NAS0799/ Y Comb, A.L., 2007b, NAS0800/ Acceptable. Batch no. C After 2 years, 20 C Destilled water, 20 C: 6.3 Y Comb, A.L., 2009c, NAS0801 Applicant ADAMA Deutschland GmbH Evaluator: DE

60 Part B Section 1 Germany NC-225 WG Page 14 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments Kinematic viscosity (IIIA 2.5.1) - - not required for solid formulations - - Acceptable Dynamic viscosity (IIIA 2.5.2) - - not required for solid formulations - - Acceptable Surface tension (IIIA 2.5.3) - - not required for solid formulations - - Acceptable Relative density (IIIA 2.6.1) - - not required for solid formulations - - Acceptable Bulk or tap density (IIIA 2.6.2) CIPAC MT 186 Batch no. C bulk: 0.66 g/ml Comb, A.L., 2009b, NAS1019 CIPAC MT 169 Batch no. C tapped: 0.77 g/ml Comb, A.L., 2007a, NAS0799/ Acceptable. Acceptable Storage Stability after 14 days at 54º C (IIIA 2.7.1) CIPAC MT 46.3 Batch no. C Storage material: laminated heat sealed sachet. The content of the active substance does not decrease > 5 %. Y Comb, A.L., 2007b, NAS0800/ Acceptable. Content of amisulbrom: Before storage: After 14 days, 54 C: 51.8 g/kg 51.1 g/kg Content of folpet: Before storage: g/kg Applicant ADAMA Deutschland GmbH Evaluator: DE

61 Part B Section 1 Germany NC-225 WG Page 15 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments After 14 days, 54 C: g/kg The changes of appearance, ph, wettability, persistent foaming, Suspensibility, dispersibility, wet sieving, dry sieve analysis, dustiness and attrition resistance are negligible Stability after storage for other periods and/or temperatures (IIIA 2.7.2) Minimum content after heat stability testing (IIIA 2.7.3) - - Not required by regulation (EU) 2011/ Not necessary, since the decrease of the active substance did not exceed 5 %. - - Acceptable - - Acceptable. Effect of low temperatures on stability (IIIA 2.7.4) - - not required for solid formulations - - Acceptable Ambient temperature shelf life (IIIA 2.7.5) Batch no. C Storage material: laminated heat sealed sachet. The content of the active substance does not decrease > 5 %. Y Comb, A.L., 2009c, NAS0801 Acceptable. Content of amisulbrom: Before storage: 51.8 g/kg Applicant ADAMA Deutschland GmbH Evaluator: DE

62 Part B Section 1 Germany NC-225 WG Page 16 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments After 2 years, 20 C: 51.9 g/kg Content of folpet: Before storage: g/kg After 2 years, 20 C: g/kg The changes of appearance, ph, wettability, persistent foam, Suspensibility, dispersibility, wet sieving, dry sieve anaylsis, dustiness and attrition resistance are negligible. Shelf life in months (if less than 2 years) (IIIA 2.7.6) - Please refer to Acceptable. Wettability (IIIA 2.8.1) CIPAC MT 53.3 without swirling Batch no. C s Y Comb, A.L., 2007a, NAS0799/ Acceptable. Batch no. C s Y Comb, A.L., 2009c, NAS0801 Acceptable. Persistence of foaming (IIIA 2.8.2) CIPAC MT 47.2 Batch no. C CIPAC water D, 1.5 %: Before storage 10s: 38 ml 1 min: 4 ml 3 min: 2 ml 12 min: 2 ml Y Comb, A.L., 2007a, NAS0799/ Acceptable. According to the GAP table the application concentrations are %. Applicant ADAMA Deutschland GmbH Evaluator: DE

63 Part B Section 1 Germany NC-225 WG Page 17 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments Batch no. C CIPAC water D, 1.5 %: After 2 years, 20 C: 10s: 46 ml 1 min: 8 ml 3 min: 0 ml 12 min: 0 ml Y Comb, A.L., 2009c, NAS0801 Acceptable. Suspensibility (IIIA ) CIPAC MT 168 Batch no. C Before storage: CIPAC water D, 0.04 %: amisulbrom: 73 % folpet: 75 % CIPAC water D, 1.5 %: amisulbrom: 80 % folpet: 82 % Y Comb, A.L., 2007a, NAS0799/ Acceptable. According to the GAP table the application concentrations are %. Batch no. C After 2 weeks, 54 C: CIPAC water D, 0.04 %: Amisulbrom: 70 % Folpet: 73 % Y Comb, A.L., 2007b, NAS0800/ Acceptable. CIPAC water D, 1.5 %: Amisulbrom: 84 % Folpet: 86 % Applicant ADAMA Deutschland GmbH Evaluator: DE

64 Part B Section 1 Germany NC-225 WG Page 18 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments Batch no. C After 2 years, 20 C: CIPAC water D, 0.04 %: Amisulbrom: 74 % Folpet: 75 % Y Comb, A.L., 2009c, NAS0801 Acceptable. CIPAC water D, 1.5 %: Amisulbrom: 82 % Folpet: 84 % Spontaneity of dispersion (IIIA ) CIPAC MT 174 Batch no. C Before storage amisulbrom: 97 % folpet: 97 % Y Comb, A.L., 2007a, NAS0799/ Acceptable. Batch no. C After 2 weeks, 54 C: Amisulbrom: 100 % Folpet: 100 % Y Comb, A.L., 2007b, NAS0800/ Acceptable. Batch no. C After 2 years, 20 C: Amisulbrom: 97 % Folpet: 97 % Y Comb, A.L., 2009c, NAS0801 Acceptable. Dilution stability (IIIA 2.8.4) - - not required for WG formulations - - Acceptable Dry sieve test (IIIA ) CIPAC MT 170 Batch no. C Before storage Size range µm: 93.6 % Y Comb, A.L., 2007a, NAS0799/ Acceptable. Batch no. C After 2 weeks, 54 C: Size range µm: 95 % Y Comb, A.L., 2007b, NAS0800/ Acceptable. Applicant ADAMA Deutschland GmbH Evaluator: DE

65 Part B Section 1 Germany NC-225 WG Page 19 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments Wet sieve test (IIIA ) Particle size distribution (IIIA ) Nominal size range of granules (IIIA ) CIPAC MT 185 CIPAC MT 170 CIPAC MT 58.3 Dust content CIPAC MT 171 Batch no. C Batch no. C Batch no. C Batch no. C Batch no. C Batch no. C Batch no. C Batch no. C Batch no. C After 2 years, 20 C: Size range µm: 95 % Before storage 0.05 % on 75 µm sieve After 2 weeks, 54 C 0.01 % on 75 µm sieve After 2 years, 20 C: 0.04 % on 75 µm sieve Before storage, after 2 weeks at 54 C and after 2 years at 20 C: < 10 %:1000 µm > 90 %: 125 µm Y Comb, A.L., 2009c, NAS0801 Y Comb, A.L., 2007a, NAS0799/ Y Comb, A.L., 2007b, NAS0800/ Y Comb, A.L., 2009c, NAS0801 Y Comb, A.L., 2007a, NAS0799/ Comb, A.L., 2007b, NAS0800/ Comb, A.L., 2009c, NAS0801 Before storage: 0.0 % < 50 µm: Y Comb, A.L., 2007a, NAS0799/ After 2 weeks, 54 C: 0.0 % < 50 µm: Y Comb, A.L., 2007b, NAS0800/ After 2 years, 20 C: 0.1 % < 50 µm Y Comb, A.L., 2009c, NAS0801 Acceptable. Acceptable. Acceptable. Acceptable. Acceptable. Acceptable. Before storage: 1.7 mg Y Comb, A.L., 2007a, Acceptable. Applicant ADAMA Deutschland GmbH Evaluator: DE

66 Part B Section 1 Germany NC-225 WG Page 20 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings (IIIA ) nearly dust-free NAS0799/ Batch no. C Batch no. C GLP Y/N After 2 weeks, 54 C: 2.2 mg Y Comb, A.L., 2007b, NAS0800/ After 2 years, 20 C: 0.7 mg Y Comb, A.L., 2009c, NAS0801 Reference Acceptability / comments Particle size of dust (IIIA ) Not required by regulation (EU) 2011/545. Friability and attrition (IIIA ) CIPAC MT Batch no. C Before storage: 99.9 % After 2 weeks, 54 C: 99.6 % After 2 years, 20 C: 99.5 % Y Comb, A.L., 2007a, NAS0799/ Comb, A.L., 2007b, NAS0800/ Comb, A.L., 2009c, NAS0801 Acceptable. Emulsifiability (IIIA ) - - not required for WG-formulations - - Acceptable Dispersibility (IIIA ) - - not required for WG formulations - - Acceptable Flowability (IIIA ) CIPAC MT 172 Batch no. C formulations flows spontaneously through a 4.75 mm sieve. Y Comb, A.L., 2007a, NAS0799/ Acceptable. Pourability (including rinsed residue) - - not required for solid formulations - - Acceptable Applicant ADAMA Deutschland GmbH Evaluator: DE

67 Part B Section 1 Germany NC-225 WG Page 21 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments (IIIA ) Dustability following accelerated storage (IIIA ) - - Not required by regulation (EU) 2011/ Acceptable Physical compatibility of tank mixes (IIIA 2.9.1) ASTM mixing by hand - evaluation after standing for different times - additional characterizations SMB0403 (NC 225) was tested for physical compatibility with 8 formulations of the types WG, SC, SL, EW, SG and MG. All mixtures were determined to be physically compatible and can be used in spray applications. In all mixtures no lumping, no flocculation occurred, but a running agitator should be used preparing some of them. N Schnell, R., 2007, FCS 15/2007 Acceptable. The mixtures appeared to be homogeneous. Chemical compatibility of tank mixes (IIIA 2.9.2) Statement SMB0403 Amisulbrom and folpet:, the active substances of (NC 225), are stable in diluted aqueous conditions. Therefore none of the functional groups are likely to react under normal tank mix conditions. (NC 225) was tested for physical compatibility with 8 formulations of the types WG, SC, SL, EW, SG and MG. No indication of any chemical reaction between the mixed products was observed. N Schnell, R., 2007, FCS 16/2007 Acceptable. Applicant ADAMA Deutschland GmbH Evaluator: DE

68 Part B Section 1 Germany NC-225 WG Page 22 of 41 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments Therefore (NC 225) is apparently chemically compatible with the tested products.- Distribution to seed (IIIA ) - - not intended for seed treatment - - Acceptable Adhesion to seeds (IIIA ) - - not intended for seed treatment - - Acceptable Miscibility (IIIA 2.11) Dielectric breakdown (IIIA 2.12) Corrosion characteristics (IIIA 2.13) Container material (IIIA 2.14) Other/special studies (IIIA 2.15) - - Not required by regulation (EU) 2011/ Not required by regulation (EU) 2011/ Not required by regulation (EU) 2011/ Not required by regulation (EU) 2011/ Not required by regulation (EU) 2011/ Acceptable. - - Acceptable. - - Acceptable. - - Acceptable. - - Acceptable. Applicant ADAMA Deutschland GmbH Evaluator: DE

69 Part B Section 1 Germany NC-225 WG Page 23 of 41 IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15 All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a pale brown, fine granulate that is water dispersible at room temperature, with a vanilla-like odour. It is not explosive, has no oxidising properties. It has a self ignition temperature of 366 C. In aqueous solution, it has a ph value around 6.4. The stability data indicate a shelf life of at least 2 years at ambient temperature. is chemically and physically compatible with other products under recommended use conditions. The technical characteristics are acceptable for a water dispersible granule formulation. Experimental testing of the product's physico-chemical and technical characteristics: No experimental testing of the formulation was conducted in the BVL laboratory. Implications for labelling: None. IIIA 3 IIIA 3.1 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT Field of Use Sanvino is a water dispersible granule formulation containing 50 g/kg amisulbrom and 500 g/kg folpet for use as a fungicide against downy mildew of grapevine. IIIA 3.2 Nature of the Effects on Harmful Organisms Amisulbrom: The active ingredient amisulbrom belongs to the sulfonamide group. The mode of action is inhibition of the cytochrome complex III during mitochondrial respiration. Because of the inhibition of the respiratory chain various stages of development of the fungus such as the spore release, germination and mobility of zoospores and the mycelial growth may be adversely affected. The risk of the formation of resistant strains is thus low. Amisulbrom is characterized by good activity against Oomycetes. Due to the non-systemic effect (contact fungicide) existing infestation is not combated. However, the further spread of the infection is stopped reliably. Mode of action (FRAC-Group): C4; target site: complex III cytochrome bc1 (ubiquinone reductase) at Qi site. Folpet: The active ingridient folpet belongs to the chemical group b-phthalimides and acts as a nonsystemic, non-translocated fungicide with protectant activity. Folpet enters treated conidia and reacts with many conidial constituents. The toxicity is attributed to the SCCl3 group. Folpet inhibits many oxidative enzymes, carboxylases and enzymes involved with phosphate metabolism and citrate synthesis. Folpet reacts with the sulphhydryl groups of the nuclear protein, leading to an inhibition of cell division. The reaction of folpet with thiols and the reaction of thiophosgen, its decomposition product, with thiols and other groups can be a means of metabolic inhibition. Since folpet is a general thiol reactant and thiophosgen a more general reactant than folpet, fungitoxicity is non-specific and not the result of a single mode of action at a specific site. Since coenzyme A is a very important thiol in cell metabolism, its inactivation affects many enzyme systems. Mode of action (FRAC-Group): M4; multi-site contact activity. Applicant ADAMA Deutschland GmbH Evaluator: DE

70 Part B Section 1 Germany NC-225 WG Page 24 of 41 IIIA 3.3 IIIA Details of Intended Use Details of existing and intended uses Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA Details of harmful organisms against which protection is afforded Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA 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 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 IIIA Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection Maximum number of applications and their timings Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA Growth stages of crops or plants to be protected Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA Development stages of the harmful organism concerned Please refer to Appendix 2 - Critical Uses - and Part B Section 7. IIIA Please refer to Part B Section 7. IIIA Please refer to Part B Section 7. IIIA 3.8 IIIA Duration of protection afforded by each application Duration of protection afforded by the maximum number of applications Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops Please refer to Part B Section 7. IIIA Please refer to Part B Section 7. IIIA Limitations on choice of succeeding crops Description of damage to rotational crops Applicant ADAMA Deutschland GmbH Evaluator: DE

71 Part B Section 1 Germany NC-225 WG Page 25 of 41 Please refer to Part B Section 7. IIIA 3.9 Proposed Instructions for Use as Printed on Labels Please refer to Part A, Appendix 2 for the relevant country. IIIA 3.10 Other/Special Studies This is not an EC data requirement/ not required by Regulation (EC) No. 1107/2009. Applicant ADAMA Deutschland GmbH Evaluator: DE

72 Part B Section 1 Germany NC-225 WG Page 26 of 41 IIIA 4 IIIA 4.1 Packaging Summary FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT Packaging and Compatibility with the Preparation 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 Description and specification of the packaging Sanvino is to be marketed in 1 kg thermally sealed sachets of polyethylene, which are glued to the base of an outer cardboard box and in 5 kg 3-layer sachets. 1 kg sachet: material: laminated heat sealed polyethylene sachets within a cardboard box shape/size: Outer package containing 20 cardboard boxes: 442 mm x 302 mm x 491 mm 5 kg sachet: material: laminated heat sealed 3-layer polyethylene, aluminium and paper sachets within a cardboard box shape/size: Outer cardboard box: 290 mm x 198 mm x 330 mm IIIA Suitability of the packaging and closures Report: Pique, B., 2007 Title: Mechanical tests on a type of packaging (1kg and 5 kg) Document No: LNE G ! LNE H Guidelines: GLP ADR No The packaging was assigned to the following UN marks which indicate that it corresponds to a successfully tested design type and complies with manufacturing requirements as detailed in Part 6 of Chapter 6 of UNECE Restructured ADR applicable as from 1 January No deterioration of the outer packaging in a stacking test. No leaks, no deterioration of the packaging IIIA Resistance of the packaging material to its contents Applicant ADAMA Deutschland GmbH Evaluator: DE

73 Part B Section 1 Germany NC-225 WG Page 27 of 41 Report: Comb, A.L., 2009 Title: Document No: Guidelines: GLP NCC-225 WG: Two year storage stabilty NAS0801 Visual inspection No The containers of NC-225 WG were weighed prior to, during and following storage in order to ascertain whether any volatile materials were lost. There were no significant changes in the weight. The containers used were seen not to swell, discolour or be permeated by the test substance Package: 1 kg and 5 kg laminated heat sealed sachet. Weight loss after 24 month: 0.01 %. IIIA 4.2 IIIA Procedures for Cleaning Application Equipment Procedures for cleaning application equipment and protective clothing After each day s work, all application equipment and contaminated clothing should be thoroughly washed/ cleaned with a water diluted detergent solution and rinsed with clean water three times. After each step of washing the drain sprayer should be sprayed out completely with clear water. It has to be ensured, that all liquid is removed from the sprayer tank, pump and hoses. The nozzles have to be removed and washed out. After the cleaning procedure the tank and drain pump should stay open to allow free access of air to all parts of the system. Care should be taken not to rinse contaminated washings from application equipment into waster water channels. Contaminated cleaning liquids should be disposed safely according to local regulations. In any case, all personal protective clothing must be washed weakly. Limited life coveralls may be washable, but must be discarded after a maximum of six days use. Operator should read the sprayer s manufacturer s instructions before beginning to clean the sprayer. IIIA Effectiveness of the cleaning procedures Report: Comb, A.L., 2006 Title: Document No: Guidelines: NC-255 WG: Determination of the efficiency of the normal procedures used for cleaning spray tanks after use NAS752/ The European Council Directive 91/414/EEC as amended by European Commission Directive 94/37EC Applicant ADAMA Deutschland GmbH Evaluator: DE

74 Part B Section 1 Germany NC-225 WG Page 28 of 41 GLP Yes Executive Summary A study was conducted using cleaning procedures representative of those carried out in the field. It used the maximum recommended application rate of and was conducted in both polypropylene and stainless steel spray tanks typical of those used in agriculture. Residual active substance (amisulbrom and folpet) remaining after the final rinse was negligible in both types of spray tank. Therefore, the washing procedure described on the product label will remove any residual amisulbrom and folpet from spray tanks and the associated equipment. Consequently, provided the equipment used to apply has been cleaned in accordance with the label recommendations, it should not pose a risk to crops. I. Materials and Methods A. Materials: 1.Test Material: NC-225 WG () Description: Fungicide / dark brown granular solid Lot/Batch: P Content of a.s. (analysed): 49.9 g amisulbrom/kg 494 g folpet/kg Stability: not recorded 2a. Reference Material: amisulbrom (NC-224) Description: not recorded Lot/Batch: 224S Purity: 99.8 % Stability: not recorded 2b. Reference Material: folpet Description: not recorded Lot/Batch: Purity: 99.4 % Stability: not recorded B. Study design and methods: The cleaning steps used for both types of tank were as follows: Step 1: Initial wash with purified water Step 2: Second wash with purified water Step 3: Wash with purified water containing commercial cleaning product Step 4: Second wash with purified water containing commercial cleaning product Step 5: Rinse with purified water Analysis of residual levels of amisulbrom and folpet in the sub-samples from the cleaning procedure was performed by high performance liquid chromatography (HPLC) using an octadecyl silica column with Applicant ADAMA Deutschland GmbH Evaluator: DE

75 Part B Section 1 Germany NC-225 WG Page 29 of 41 UV detection at 254 nm. Determination of amisulbrom and folpet was carried out using internal standard calibration. II. Results and discussion Results of analyses are summarised in Tables IIIA and IIIA Table IIIA : Efficiency of spray tank cleaning for amisulbrom Cleaning step Polypropylene tank Stainless steel tank mg/l a % b mg/l a % b Initial spray solution (calculated) Step 1 Initial wash with purified water Step 2 Second wash with purified water Step 3 Initial wash with purified water containing commercial cleaning product (½ of tank volume) Step 4 Second wash with purified water containing commercial cleaning product (½ of tank volume) ND ND ND ND ND ND ND ND Step 5 Rinse with purified water ND ND ND ND a b ND: Mean concentration of active substance in each wash solution Percentage of the active substance initially added to tank None detected; below the LOD (amisulbrom: 0.1 mg/l) Residual of the active substances (amisulbrom and folpet) remaining after the final rinse in both types of spray tank was negligible. Therefore, the washing procedure described on the product label is found to be appropriate to remove residual amisulbrom and folpet from spray tanks and the associated equipment. Table IIIA : Efficiency of spray tank cleaning for folpet Cleaning step Polypropylene tank Stainless steel tank mg/l a % b mg/l a % b Applicant ADAMA Deutschland GmbH Evaluator: DE

76 Part B Section 1 Germany NC-225 WG Page 30 of 41 Initial spray solution (calculated) Step 1 Initial wash with purified water Step 2 Second wash with purified water Step 3 Initial wash with purified water containing commercial cleaning product (½ of tank volume) Step 4 Second wash with purified water containing commercial cleaning product (½ of tank volume) ND ND ND ND ND ND ND ND Step 5 Rinse with purified water ND ND ND ND a : b : ND: Mean concentration of active substance in each wash solution Percentage of the active substance initially added to tank None detected; below the LOD (folpet: 10 mg/l) Residual of the active substances (amisulbrom and folpet) remaining after the final rinse in both types of spray tank was negligible. Therefore, the washing procedure described on the product label is found to be appropriate to remove residual amisulbrom and folpet from spray tanks and the associated equipment. III. Conclusions In this tank cleaning study the residual active substance (amisulbrom and folpet) remaining in both experimental spray tanks after the third cleaning step was below the limit of detection (amisulbrom: 0.1 mg/l and folpet: 10 mg/l). Consequently, if the spraying equipment is cleaned once with a dilution detergent and twice with water, the equipment can be regarded as clean. Moreover, no adverse effects on the target crop (like phytotoxicity, effects on yield, plant products) are expected if the cleaning solutions are sprayed on the already treated fields (please refer to IIIA, Section 6, Point 6.2 of the Biological Assessment Report). Nevertheless, it is generally recommended to dilute the cleaning solutions in the ratio 1:10 before application. IIIA 4.3 IIIA See section 4. IIIA Re-entry Periods to Protect Man, Livestock and the Environment Pre-harvest interval (in days) for each relevant crop Re-entry period (in days) for livestock, to areas to be grazed Applicant ADAMA Deutschland GmbH Evaluator: DE

77 Part B Section 1 Germany NC-225 WG Page 31 of 41 See section 4. IIIA See section 4. IIIA See section 4. IIIA See section 4. IIIA See section 4. IIIA See section 4. Re-entry period (in hours or days) for man to crops, buildings or spaces treated Withholding period (in days) for animal feeding stuffs Waiting period (in days) between application and handling of treated products Waiting period (in days) between last application and sowing or planting succeeding crops Information on specific conditions under which the preparation may or may not be used IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks The safety data sheet complies with actual EEC regulations and is based on the present state of knowledge. IIIA Warehouse storage Store in a cool and dry place in accordance with relevant specific regulations and guidelines. Please refer to Safety Data Sheet of IIIA User level storage Store in a cool and dry place. Avoid contact with water. Protect containers against physical damage. Prevent spillage from entering the drainage systems or watercourses. Please refer to Safety Data Sheet of IIIA Transport Please refer to Safety Data Sheet of ADR/RID: UN no Class: 6.1 Packaging group: III Proper shipping name: Pesticide, solid, toxic, n.o.s. (folpet) Applicant ADAMA Deutschland GmbH Evaluator: DE

78 Part B Section 1 Germany NC-225 WG Page 32 of 41 IMDG: UN no Class: 6.1 Packaging group: III Hazard label: Toxic (N) Marine pollutant label: Marine pollutant Proper shipping name: Pesticide, solid, toxic, n.o.s. (folpet) ICAO/IATA: UN no Class: 6.1 Packaging group: III Proper shipping name: Pesticide, solid, toxic, n.o.s. (folpet) ADN/ADNR: UN no Class: 6.1 Packaging group: III Proper shipping name: Pesticide, solid, toxic, n.o.s. (folpet) IIIA Fire Unusual fire and explosion hazards: the relative self ignition temperature is 366 ºC (for details see Comb (2007a), ref. KIIIA 4.4.4/01), therefore, avoid high temperatures. The product is stable under normal storage conditions. Extinguishing media: water, foam, dry chemicals or carbon dioxide (CO²). Fight fire in early stages if safe to do so. Wear protective breathing apparatus with independent air breath and full protective clothing for safety. Fight fire from upwind position. Use a water spray or fog nozzle to keep containers in surrounding area cool. Contain run-off to prevent entry into water or drainage systems. Please refer to Safety Data Sheet of IIIA Nature of protective clothing proposed Avoid contact with the product. Keep the place of work clean and working clothes separate from other clothing. Remove soiled or soaked clothing immediately and clean thoroughly before using again. Garments that cannot be cleaned must be destroyed by incineration. Wash thoroughly hands after work. Respiratory, hand, eye and skin protection: Please refer to the point below (IIIA 4.4.6). Other protective measures: Not required. Please refer to Safety Data Sheet of IIIA Characteristics of protective clothing proposed Applicant ADAMA Deutschland GmbH Evaluator: DE

79 Part B Section 1 Germany NC-225 WG Page 33 of 41 Respiratory protection: face mask with filter, in case of smoke Hand protection: Neopren/nitrile gloves (EN 374), barrier hand cream recommended Eye protection: Safety glasses (goggles) with tight fitting side-shields (EN 166), with danger of projection Skin protection: Please refer to Safety Data Sheet of IIIA Protective clothing (e.g. work/safety shoes EN 344, coverall with long sleeves) Suitability and effectiveness of protective clothing and equipment Respiratory protection: face mask with filter, in case of smoke Hand protection: Neopren/nitrile gloves (EN 374), barrier hand cream recommended Eye protection: Safety glasses (goggles) with tight fitting side-shields (EN 166), with danger of projection Skin protection: Please refer to Safety Data Sheet of IIIA Protective clothing (e.g. work/safety shoes EN 344, coverall with long sleeves) Procedures to minimise the generation of waste Only purchase and store quantities of product expected to be used in one season. Do not mix a volume of the spray mixture that is greater than the volume necessary for the area planned to be treated. Dilute the rinsing water of the spray equipment in the ratio 1:10 and apply it on the previously treated area. Use a pack size appropriate to the area to be treated and according to the label recommendations. Avoid residues of the product by rinsing the container thoroughly with water (if possible, using an integrated rinsing device) immediately after pouring. Always add the rinsing water to the spray tank. Leave the rinsed container open to allow any remaining water to evaporate. The packaging design follows the national system to optimise the removal of remainder of the product and its containers. For safety reasons only the controlled incineration of empty containers can be proposed. Please refer to Safety Data Sheet of IIIA Combustion products likely to be generated in the event of fire Carbon dioxide, carbon monoxide, hydrogen bromide, hydrogen chloride, hydrogen fluoride and oxides of nitrogen and sulfur are potential thermal decomposition products. Please refer to Safety Data Sheet of IIIA 4.5 Detailed Procedures for Use in the Event of an Accident During Transport, Storage or Use Please refer to recommendations of the Safety Data Sheet IIIA Containment of spillages Keep unauthorised persons, children and animals away from the affected area. Prevent spillage from entering the drainage systems or watercourses. If accidental entry occurs, inform responsible authorities. Applicant ADAMA Deutschland GmbH Evaluator: DE

80 Part B Section 1 Germany NC-225 WG Page 34 of 41 Take up spilled product with absorbent material (e.g. sand, earth or a proprietary absorbent material). Pack spilled material into closable containers for recovery or disposal. Clean contaminated floors and objects thoroughly, observing environmental regulations. IIIA Decontamination of areas, vehicles and buildings For a good decontamination absorb in sand or other inert material and dispose of in authorised waste collecting points. To clean the floor and all objects contaminated by this material, use damp cloth which should than be placed into closable receptacles. In case of contaminated soils, please collect the spillage and dispose according to the national respectively local recommendations. IIIA Product Disposal of damaged packaging, adsorbents and other materials Allocation of a waste code number, according to the European Waste Catalogue, should be carried out in agreement with the regional waste disposal company. Packaging Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste removal. Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer. IIIA Protection of emergency workers and bystanders Wear suitable protective clothing, shoes, gloves and goggles. In the event of fire use self-contained breathing apparatus and protective clothing. Avoid contact with spilled product or contaminated surfaces. Use personal protective equipment and keep away the unprotected persons. IIIA First aid measures Eye contact: Skin contact: Inhalation: Ingestion: Note to physician: Immediately rinse with plenty of water. Seed medical advise immediately. Remove all contaminated clothing, shoes and socks from the affected area. Wash material off the skin in running water or shower with soap. If irritation persists, seek medical advice immediately. If respiratory discomfort occurs, move the person to fresh air. If not breathing, give mouth-to-mouth resuscitation (or artificial respiration). Keep warm with blanket and keep at rest. Seek emergency medical advice. Do not induce vomiting. Wash out mouth with water. Do not give anything by mouth if person in unconscious. Seek medical advice immediately. No symptoms are known. Treat according to symptoms (decontamination, visual function). No specific antidotes are known. Applicant ADAMA Deutschland GmbH Evaluator: DE

81 Part B Section 1 Germany NC-225 WG Page 35 of 41 IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage Insert a general statement as to whether neutralisation is a suitable procedure for use in the case of accidental spillage.if neutralisation can be used then more detailed information should be provided under points to IIIA Details of proposed procedures for small quantities Neutralisation is not recommended. Follow procedures given in IIIA IIIA Evaluation of products of neutralization (small quantities) Not applicable. Refer to IIIA IIIA Procedures for disposal of small quantities of neutralized waste Not applicable. Refer to IIIA IIIA Details of proposed procedures for large quantities Neutralisation is not recommended. Follow procedures given in IIIA IIIA Evaluation of products of neutralization (large quantities) Not applicable. Refer to IIIA IIIA Procedures for disposal of large quantities of neutralized waste Not applicable. Refer to IIIA IIIA 4.7 Pyrolytic Behaviour of the Active Substance Due to halogen content in the active ingredient and the formulants of less than 60 %, combustion of BAS F in a waste incinerator plant does not raise concern about the formation of halogenated dibenzodioxins/-furans. IIIA 4.8 IIIA Disposal Procedures for the Plant Protection Product Detailed instructions for safe disposal of product and its packaging Small amounts of the product and unclean empty packaging should be packaged and sealed, labelled and transferred to a suitable incinerator in accordance with the local regulations. Collect spilled material. Wash away remainder with water and soap. Use appropriate containment to avoid environmental contamination. Contaminated soil layers have to be dug out. Dispose of in a pesticide approved landfill, or in a chemical incinerator, in accordance with national and regional regulations. Empty packaging rinsed with water should be disposed of in an authorised waste collecting point. Refer to the supplier for information regarding recovery/recycling or refer to the recommendations specified in the Safety Data Sheet (for details see Anonymous (2011), ref. KIIIA 4.4/01). IIIA Methods other than controlled incineration for disposal Applicant ADAMA Deutschland GmbH Evaluator: DE

82 Part B Section 1 Germany NC-225 WG Page 36 of 41 Applications that involve controlled incineration with energy recovery are considered to be the most environmentally-accepted means of disposal. However, where local recycling schemes exist, these should also be considered. Packages cleaned with water can be disposed of in an authorised waste collecting point. For information on recovery/recycling refer to manufacturer/supplier. 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 ( ) IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries MRLs set at European Level are stated in the Regulation (EC) No 396/2005 (see: EU Pesticides database, as published on June 8, 2010, Internet: index.cfm). IIIA 11.3 Justified Proposals for Classification and Labelling Proposals for classification and labelling of BAS 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 Study Type Physico-chemical properties Findings (triggered risk phrase) Reference Explosivity Not explosive (-) Comb, A.L., 2007a, NAS0799/ Oxidizing properties Not oxidizing (-) Comb, A.L., 2007a, NAS0799/ Applicant ADAMA Deutschland GmbH Evaluator: DE

83 Part B Section 1 Germany NC-225 WG Page 37 of 41 Table Study Type Physico-chemical properties Findings (triggered risk phrase) Reference Flammability Auto-ignition temperature is 366 C Comb, A.L., 2007a, NAS0799/ ) Signs of self-heating when tested in 100 mm Comb, A.L., 2009a, cubic wire mesh container at 140 ± 2 C, but NAS1021 insufficient to provide a positive result. 2) Not classified as a self-heating substance of Division 4.2 Toxicology Please refer to Part B Section 3. Ecotoxicology/Environment Please refer to Part B Section 6. IIIA 11.4 Proposals for Risk and Safety Phrases Please refer to Part B Section 3 und Section 6. IIIA 11.5 Proposed Label Please refer to Part A. IIIA 11.6 Specimens of Proposed Packaging Specimens of the packaging were not provided as there was no request.. Applicant ADAMA Deutschland GmbH Evaluator: DE

84 Part B Section 1 Germany NC-225 WG Page 38 of 41 Appendix 1: List of data used in support of the evaluation Annex point No. OECD KIIIA1 2.1, KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished Comb, A.L. Comb, A.L. 2007a 2009a Physico-chemical Properties, Huntingdon Life Sciences Ltd., Report-no. NAS0799/073685, GLP: yes, Published: no NC-225 WG: Auto-flammability Test N.4: Test for self-heating substances, Huntingdon Life Sciences Ltd., Report-no. NAS1021, GLP: yes, Published: no Data protection claimed Yes/No Owner Y NIS 1 Y NIS 1 How considere d in drr Study- Status / Usage * Applicant ADAMA Deutschland GmbH Evaluator: DE

85 Part B Section 1 Germany NC-225 WG Page 39 of 41 Annex point No. OECD KIIIA KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , KIIIA , Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished Comb, A.L. Comb, A.L. Comb, A. L. 2009b 2007b 2009c NC-225 WG: Bulk density, Huntingdon Life Sciences Ltd., Report-no. NAS1019, GLP: yes, Published: no Accelerated storage stability, Huntingdon Life Sciences Ltd., Report-no. NAS0800/073686, GLP: yes, Published: no NC-225 WG: two year storage stability, Huntingdon Life Sciences Ltd., Report-no.: NAS0801, GLP: yes, Published: no Data protection claimed Yes/No Owner Y NIS 1 Y NIS 1 Y NIS 1 How considere d in drr Study- Status / Usage * Applicant ADAMA Deutschland GmbH Evaluator: DE

86 Part B Section 1 Germany NC-225 WG Page 40 of 41 Annex point No. OECD KIIIA , KIIIA , KIIIA Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA Schnell, R. 2007a Evaluation of Physical Compatibility of Tank Mixtures of NC 225, Feinchemie Schwebda GmbH, Report-no. FCS 15/2007, GLP: no, Published: no KIIIA Schnell, R. 2007b Evaluation of Chemical Compatibility of Tank Mixtures of NC 225, Feinchemie Schwebda GmbH, Report-no. FCS 16/2007, GLP: no, Published: no KIIIA , KIIIA Pique, B Mechanical tests on a type of packaging, Laboratoire national de métrologie et d`essais, Report-no. G080278, GLP: no, Published: no Data protection claimed Yes/No Owner Y FSG 1 Y FSG 1 Y NIS 1 KIIIA , Pique, B Mechanical tests on a type of Y NIS 1 How considere d in drr Study- Status / Usage * Applicant ADAMA Deutschland GmbH Evaluator: DE

87 Part B Section 1 Germany NC-225 WG Page 41 of 41 Annex point No. OECD KIIIA KIIIA Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished Comb, A.L. packaging, Laboratoire national de métrologie et d`essais, Report-no. H061308, GLP: no, Published: no 2006 NC-255 WG: Determination of the efficiency of the normal producres used for cleaning spray tanks after use, Huntingdon Life Sciences Ltd., Report-no. NAS752/053469, GLP: yes, Published: no Data protection claimed Yes/No Owner Y NIS 1 How considere d in drr Study- Status / Usage * * 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) Applicant ADAMA Deutschland GmbH Evaluator: DE

88 Part B Section 2 Germany NC-225 WG Page 1 of 32 REGISTRATION REPORT Part B Section 2: Analytical Methods Detailed summary of the risk assessment Product code: NC-225 WG () Active Substance: Amisulbrom 50 g/kg Folpet 500 g/kg Rapporteur Member State: Germany CORE ASSESSMENT Applicant: ADAMA Deutschland GmbH Submission Date: 29/06/2012 Applicant ADAMA Deutschland GmbH Evaluator: DE

89 Part B Section 2 Germany NC-225 WG Page 2 of 32 Table of Contents IIIA 5 METHODS OF ANALYSIS... 4 IIIA 5.1 Analytical Standards and Samples... 4 IIIA Samples of the preparation... 4 IIIA Analytical standards for the pure active substance... 4 IIIA Samples of the active substance as manufactured... 4 IIIA Analytical standards for relevant metabolites and all other components included in the residue definition... 4 IIIA Samples of reference substances for relevant impurities... 4 IIIA 5.2 Methods for the Analysis of the Plant Protection Product... 4 IIIA IIIA Description of the analytical methods for the determination of the active substance in the plant protection product... 4 For preparations containing more than one active substance, description of method for determining each in the presence of the other... 5 IIIA Applicability of existing CIPAC methods... 6 IIIA Description of analytical methods for the determination of relevant impurities... 6 IIIA Description of analytical methods for the determination of formulants... 8 IIIA 5.3 Description of Analytical Methods for the Determination of Residues... 8 IIIA Evaluation of Amisulbrom... 8 IIIA IIIA IIIA IIIA IIIA IIIA Overview of residue definitions and levels for which compliance is required... 9 Description of Analytical Methods for the Determination of Residues of Amisulbrom in Plant Matrices (OECD KIII A 5.3.1) Description of Analytical Methods for the Determination of Residues of Amisulbrom in Animal Matrices (OECD KIII A 5.3.1) Description of Methods for the Analysis of Amisulbrom in Soil (OECD KIII A 5.4) Description of Methods for the Analysis of Amisulbrom in Water (OECD KIII A 5.6) Description of Methods for the Analysis of Amisulbrom in Air (OECD KIII A 5.7) Applicant ADAMA Deutschland GmbH Evaluator: DE

90 Part B Section 2 Germany NC-225 WG Page 3 of 32 IIIA Description of Methods for the Analysis of Amisulbrom in Body Fluids and Tissues (OECD KIII A 5.8) IIIA Other Studies/ Information IIIA Evaluation of Folpet IIIA IIIA IIIA IIIA Overview of residue definitions and levels for which compliance is required Description of Analytical Methods for the Determination of Residues of Folpet in Plant Matrices (OECD KIII A 5.3.1) Description of Analytical Methods for the Determination of Residues of Folpet in Animal Matrices (OECD KIII A 5.3.1) Description of Methods for the Analysis of Folpet in Soil (OECD KIII A 5.4) IIIA Description of Methods for the Analysis of Folpet in Water (OECD KIII A 5.6) IIIA IIIA Description of Methods for the Analysis of Folpet in Air (OECD KIII A 5.7) Description of Methods for the Analysis of Folpet in Body Fluids and Tissues (OECD KIII A 5.8) IIIA Other Studies/ Information IIIA 5.4 Conclusion on the availability of analytical methods for the determination of residues Appendix 1 List of data submitted in support of the evaluation Appendix 2 Detailed evaluation of the additional studies relied upon A 1.1 Analytical methods for Amisulbrom A 1.2 Analytical methods for Folpet Applicant ADAMA Deutschland GmbH Evaluator: DE

91 Part B Section 2 Germany NC-225 WG Page 4 of 32 IIIA 5 METHODS OF ANALYSIS This document summarises the information related to the analytical methods for the product NC-225 WG () containing amisulbrom and folpet which are approved under Reg. (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 NC-225 WG can be found in the confidential dossier of this submission ( - Part C). IIIA 5.1 Analytical Standards and Samples IIIA Samples of the preparation A sample of the preparation was not provided because there was no request. IIIA Analytical standards for the pure active substance Analytical standards of amisulbrom and folpet were not provided because there was no request. IIIA Samples of the active substance as manufactured No samples were provided because there was no request. IIIA Analytical standards for relevant metabolites and all other components included in the residue definition No samples were provided because there was no request. IIIA Samples of reference substances for relevant impurities No samples were provided because there was no request. IIIA 5.2 Methods for the Analysis of the Plant Protection Product Analytical methods for the determination of amisulbrom and folpet and their impurities and relevance of CIPAC methods were evaluated as part in the EU review. The respective data are considered adequate and are not included in this submission. Additional studies to support the registration of not previously assessed are given below. All relevant data are provided and are considered adequate. IIIA Description of the analytical methods for the determination of the active substance in the plant protection product Please refer to chapter as contains two active substances. Applicant ADAMA Deutschland GmbH Evaluator: DE

92 Part B Section 2 Germany NC-225 WG Page 5 of 32 IIIA For preparations containing more than one active substance, description of method for determining each in the presence of the other The following analytical method for the determination of the active substances in the plant protection product performed on has not previously been reviewed. Report: Comb, A.L Title: Document No: Guidelines: GLP NC-225 WG, two year storage stability NAS/0801 The European Council Directive 91/414/EEC as amended by European Commission Directive 96/46/EC, US EPA/OPPTS Fully GLP compliant - laboratory certified by the Japan Ministry of Agriculture, Forestry and Fisheries, Japan Report: Gyakushi, N., 2007 Title: Document No: Guidelines: GLP Validation of analytical method for determination of active ingredients in NC-225 WG NCI ! 0FC The European Council Directive 91/414/EEC as amended by European Commission Directive 96/46/EC, US EPA/OPPTS Fully GLP compliant - laboratory certified by the Japan Ministry of Agriculture, Forestry and Fisheries, Japan In the study Comb, 2009, a reference is given to a fully validated analytical method Huntington, No. NAS 741/052897, but the method is not submitted and no validation data are given. Nevertheless, from the description of the method it seems that it is identical to the analytical method M given in appendix 1 of the study Gyakushi, 2007, which is described below. Method description The analytes were determined by HPLC on an YMC Pack Pro C18 column (250 x 4.6 mm, dp= 5 µm), using internal calibration. Injection volume was 5 µl. Detection was performed by UV at 254 µm. The mobile phase consisted of acetonitrile : methanol : 0.01 % v/v aqueous phosphoric acid (50:25:25 v/v/v). Each active ingredient was quantified using a calibration curve prepared by plotting peak area ratio of the active ingredient to the internal standard against the corresponding weight ratio. Method validation The validation data of method NCI were determined for the formulation NC-225. The method is suitable for the determination of amisulbrom and folpet in the WG-formulation. This was proved with respect to precision, accuracy, linearity and specificity. Applicant ADAMA Deutschland GmbH Evaluator: DE

93 Part B Section 2 Germany NC-225 WG Page 6 of 32 Table containing the validation of the method Analyte Linearity n = 5 amisulbrom folpet mg/l r = mg/l r = Accuracy n = 3 Mean [%] Repeatability n = 5 [%RSD] Specificity/Interferences No interferences were noted. Chromatograms of formulation with and without active substances present were submitted. No interferences were noted. Chromatograms of formulation with and without active substances present were submitted. Summary The active substances of (NC-225) can be quantified using the analytical HPLC method M The method was developed for quantifying amisulbrom and folpet in (NC-225). The active substances amisulbrom and folpet are dissolved in acetonitrile, chromatographed on a HPLC reversed phase system with UV-detection and internal calibration. IIIA Applicability of existing CIPAC methods contains two active ingredients, amisulbrom and folpet. For amisulbrom there are currently no CIPAC methods published. There is a CIPAC method available for folpet TC, DP and WP formulations. IIIA Description of analytical methods for the determination of relevant impurities A Amisulbrom Commission implementing regulation (EU) No 193/2014 (applying from 1 July 2014) defines 3-bromo-6- fluoro-2-methyl-1-(1h-1,2,4-triazol-3-ylsulfonyl)-1h-indole (= IT-4) as relevant impurity. Report: Tsunemi, K., 2014 Title: Validation of Analytical Method for the Determination of IT-4 in NC-225 WG Document No: NCI Guidelines: Guidance document SANCO/3030/99 rev.4 GLP Yes Method description The sample is dissolved in acetonitrile. The analyte IT-4 is determined by HPLC with detection at 220 nm. The mobile phase consists of 0.01 % H 3PO 4 and acetonitrile (65:35 %). Method validation Applicant ADAMA Deutschland GmbH Evaluator: DE

94 Part B Section 2 Germany NC-225 WG Page 7 of 32 The validation data of the method were determined for the formulation (NC-225) It was with respect to precision, accuracy, linearity and specificity proved that the method is suitable for the determination of IT-4 in the WG-formulation. Table containing the validation of the method (formulation NC-225 WG) Analyte Linearity n = 5 Specificity/Interferences IT % w/w r = Accuracy n = 3 Mean [%] % at % (not acceptable) 97.5 % at %: % at 0.02 % The allocation of the recovery values to the fortification levels is not clear from the table. Repeatability n = 5 [%RSD] 2.17 % RSDr = 5.82 % No interferences were noted. Chromatograms of sample solution, reference solution and blank solution were submitted. The identity was confirmed by DAD. LOQ = % maximum tolerable content in formulation: 50 g/kg x = 0.1 g/kg B Folpet Folpet contains PCMM (perchloromethylmercaptan) and carbon tetrachloride CCl 4 as relevant impurities. The content must not exceed 3.5 g/kg for PCMM and 4 g/kg for CCl 4 in the technical material. Report: Witte, A., 2012 Title: Document No: Guidelines: GLP Development and Validation of an Analytical Method for the Determination of the Impurities PCMM and CCl 4, in Formulation Sanvino 11F VMFO Guidance document SANCO/ rev.4 of 11 July 2000, European Commission Yes Method description The analyte PCMM was determined by GC/MS GC 6890 A with MSD 5973 A) on a Zebron 7HG-C ZB-35 column (30m x 0.25 mm x 0.25 µm) at approximately 250 C (temperature program) and detector temp. 230 C, using external calibration. Injection volume was 1 µl. PCMM was quantified using three characteristic mass fragments with m/z > 100 (sum of m/z = 117, 119 and 149). The analyte CCl 4 was determined by GC/FID Perkin Elmer GC 8700 on a chromatographic column Zebron 624 (60m x 0.35 mm x 1.8µm) for qualification and on a Restek Rtx-VGC column (60m x 0.32mm x 1.8µm) for confirmation at approximately 160 C (temperature program) and detector temp. at 280 C with different polarities using external calibration. CCl 4 was verified by the specific retention times of the analyte and confirmatory analysis on a chromatographic column with different polarity. Applicant ADAMA Deutschland GmbH Evaluator: DE

95 Part B Section 2 Germany NC-225 WG Page 8 of 32 Method validation The validation data of the methods 11F VMFO were determined for the formulation (NC225) It was with respect to precision, accuracy, linearity and specificity proved that the method is suitable for the determination of PCMM and CCl 4in the WG-formulation. Table containing the methods and validation of the methods (formulation (NC225) Analyte Linearity n = 5 Specificity/Interferences PCMM CCl µg/ml r = µg/vial r = (quant.) r = (cnnfirm.) Accuracy n = 5 Mean [%] Repeatability n = 5 [%RSD] (mean= < 0.05 g/kg) (mean = <0.2 g/kg) No interferences were noted. Chromatograms of formulation with and without active substances present were submitted. No interferences were noted. Chromatograms of formulation with and without active substances present were submitted. Summary The relevant impurities of folpet can be quantified using the GC/MS and the GC/FID method 11F VMFO. The relevant impurity IT-4 can be quantified using the submitted HPLC method. IIIA Description of analytical methods for the determination of formulants No formulants with toxicological or ecotoxicological relevant compounds are present in the formulation. Therefore, no analytical methods for the determination of formulants are necessary. IIIA 5.3 IIIA Description of Analytical Methods for the Determination of Residues Evaluation of Amisulbrom The conclusions regarding the peer review of the analytical methods for residues of Amisulbrom are summarized in EFSA s Conclusion on the peer review of the pesticide risk assessment of the active substance amisulbrom (EFSA Journal 2014; 12(4):3237, ASB ). Table 3-1: Information on the active substance Amisulbrom Name of component of residue definition substance code IUPAC name formula Structural formula Applicant ADAMA Deutschland GmbH Evaluator: DE

96 Part B Section 2 Germany NC-225 WG Page 9 of 32 Amisulbrom NC224 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)- N,N-dimethyl-1,2,4-triazole-1-sulfonamide C 13 H 13 Br F N 5 O 4 S 2 F O 2 Br N S CH 3 N N N SO 2 N(CH 3 ) 2 IT-4 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3- ylsulfonyl)indole C 11 H 8 Br F N 4 O 2S F O Br N S O CH 3 N N NH IT-15 6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3- ylsulfonyl)indole C 11 H 9 N 4 F O 2 S F O N S O CH 3 N N NH IIIA Overview of residue definitions and levels for which compliance is required The current legal residue definition for food of plant origin is the same as the one proposed in the Draft Assessment Report (incl. its addenda) and in the respective EFSA conclusion. The current legal residue definition for food of animal origin differs from the one proposed in the Draft Assessment Report (incl. its addenda) and the respective EFSA conclusion. As a conclusion of the peer review of amisulbrom no residues in animal matrices are expected. Therefore, from the representative uses (grapes, potatoes) no residue definition and no MRLs are proposed for animal matrices. However, currently MRLs are nevertheless set for food of animal origin based on the residue definition amisulbrom. This current legal residue definition (Regulation (EC) No. 897/2012, annex III part A) is used for the evaluation. Table 3-2: Relevant residue definitions Matrix Relevant residue Reference Remarks plant material amisulbrom Regulation (EC) No. 897/2012, annex III part A foodstuff of animal origin amisulbrom Regulation (EC) No. 897/2012, annex III part A soil amisulbrom and IT-4 EFSA Journal 2014; 12(4):3237, ASB surface water amisulbrom, IT-4, IT-15 and the aqueous photodegradation products T-1, T-3, I-2, I-8, T-4, T-7 and I-9 EFSA Journal 2014; 12(4):3237, ASB drinking/ground water amisulbrom, IT-4 EFSA Journal 2014; 12(4):3237, Applicant ADAMA Deutschland GmbH Evaluator: DE

97 Part B Section 2 Germany NC-225 WG Page 10 of 32 Matrix Relevant residue Reference Remarks ASB air amisulbrom EFSA Journal 2014; 12(4):3237, ASB body fluids/tissue not residue relevant not classified as T / T+ Table 3-3: Levels for which compliance is required Matrix MRL Reference for MRL/level Remarks plant, high water content 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A plant, acidic commodities 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A plant, dry commodities 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A plant, high oil content 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A plant, difficult matrices (hops, spices, tea) 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A meat 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A milk 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A eggs 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A fat 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A liver, kidney 0.01 mg/kg Regulation (EC) No. 897/2012, annex III part A soil 0.05 mg/kg common limit drinking water 0.1 µg/l general limit for drinking water surface water 19.7 µg/l (amisulbrom) NOEC Daphnia magna 160 µg/l (IT-4) NOEC Pimephales promelas 8760 µg/l (IT-15) E bc 50 Pseudokirchneriella subcapitata EFSA Journal 2014; 12(4):3237, ASB air 45 µg/m 3 AOEL sys: 0.15 mg/kg bw/d tissue (meat or liver) not required not classified as T / T+ body fluids not required not classified as T / T+ Applicant ADAMA Deutschland GmbH Evaluator: DE

98 Part B Section 2 Germany NC-225 WG Page 11 of 32 IIIA Description of Analytical Methods for the Determination of Residues of Amisulbrom in Plant Matrices (OECD KIII A 5.3.1) An overview of the acceptable methods and the data gaps (if appropriate) for analysis of amisulbrom in plant matrices is given in the following tables. New studies were not provided. Table 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 Brewin, 2008* Peatman, 2005* Brewin, 2008* acidic Brewin, 2008* Peatman, 2005* Brewin, 2008* fatty Brewin, 2007* Peatman, 2008* Brewin, 2007* dry Brewin, 2007* Peatman, 2008* Brewin, 2007* difficult not required for the intended GAP *EU agreed method (see Draft Assessment Report) not required for the intended GAP not required for the intended GAP Table 3-5: Statement on extraction efficiency Method for products of plant origin Required, available from: Not required, because: Crowe, 2005*, RIP in Vol. 3 section B of the DAR 2008 Table 3-6: Methods suitable for the determination of residues (enforcement) in products of plant origin Author(s), year Brewin, 2008 ASB Peatman, 2005 MET Brewin, 2007 ASB Peatman, 2008 ASB Matrix group high water content, acidic high water content, acidic Method LOQ Principle of method 0.01 mg/kg LC-MS/MS, C18 column, APCI-, m/z , m/z mg/kg LC-MS/MS, C18 column, APCI-, m/z dry, fatty 0.01 mg/kg LC-MS/MS, C18 column, APCI-, m/z , m/z dry, fatty 0.01 mg/kg LC-MS/MS, C18 column, APCI-, m/z , m/z Comment confirmation included no confirmation, ILV for Brewin, 2008 confirmation included confirmation included, ILV for Brewin, 2007 Evaluated in section B of the DAR 2012 section B of the DAR 2008 section B of the DAR2012 section B of the DAR2012 Applicant ADAMA Deutschland GmbH Evaluator: DE

99 Part B Section 2 Germany NC-225 WG Page 12 of 32 IIIA Description of Analytical Methods for the Determination of Residues of Amisulbrom in Animal Matrices (OECD KIII A 5.3.1) Acceptable methods for analysis of amisulbrom in animal matrices were not provided. Table 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 3-8: Statement on extraction efficiency Required, available from: Not required, because: Method for products of animal origin no residues expected IIIA Description of Methods for the Analysis of Amisulbrom in Soil (OECD KIII A 5.4) An overview of the acceptable methods and the data gaps (if appropriate) for analysis of amisulbrom and metabolite IT-4 in soil is given in the following tables. New studies were not provided. Table 3-9: Overview of suitable primary and confirmatory methods for soil Component(s) of residue definition Primary method Confirmatory method Amisulbrom Tate, 2005* Tate, 2005* IT-4 Brewin, 2008* Brewin, 2008* *EU agreed method (see Draft Assessment Report) Table 3-10: Methods for soil Author(s), year Method LOQ Principle of method Comment Evaluated in Tate, 2005 MET mg/kg LC-MS/MS, Luna C8 column, APCI-, m/z , m/z confirmation included, only for amisulbrom section B of the DAR 2008 Brewin, mg/kg LC-MS/MS, C8, ESI-, confirmation section B of Applicant ADAMA Deutschland GmbH Evaluator: DE

100 Part B Section 2 Germany NC-225 WG Page 13 of 32 Author(s), year Method LOQ Principle of method Comment Evaluated in ASB m/z , included, only for the metabolite IT-4 the DAR 2012 IIIA Description of Methods for the Analysis of Amisulbrom in Water (OECD KIII A 5.6) An overview of the acceptable methods and the data gaps (if appropriate) for analysis of amisulbrom in surface and drinking water is given in the following table. A new study was provided. For the detailed evaluation of the new study it is referred to Appendix 2. Table 3-11: Overview of suitable primary and confirmatory methods for water Component(s) of residue definition amisulbrom IT-4 Matrix Primary method Confirmatory method drinking water surface water drinking water surface water Tate, 2005* Tate, 2005* Todd, 2007* Todd, 2007* IT-15 surface water Miller, 2015 Miller, 2015 *EU agreed method (see Draft Assessment Report) Table 3-12: Methods for surface water Author(s), year Method LOQ Principle of method Comment Evaluated in Tate, 2005 MET Todd, 2007 ASB Miller, 2015 ASB µg/l LC-MS/MS, Luna C8 column, APCI-, m/z , m/z confirmation included, for amisulbrom 160 µg/l see drinking water for metabolite IT µg/l LC-MS/MS, UPLC BEH C18 column, ESI-, m/z , m/z confirmation included, for metabolite IT- 15 section B of the DAR 2008 see drinking water Appendix 2 Table 3-13: Methods for drinking water Author(s), year Method LOQ Principle of method Comment Evaluated in Tate, 2005 MET µg/l LC-MS/MS, Luna C8 column, APCI-, m/z , m/z confirmation included, for amisulbrom section B of the DAR 2008 Todd, 2007 ASB µg/l LC-MS/MS, Luna C8 column, m/z , m/z confirmation included, for metabolite IT-4 also acceptable for monitoring of action level section B of the DAR 2008 Applicant ADAMA Deutschland GmbH Evaluator: DE

101 Part B Section 2 Germany NC-225 WG Page 14 of 32 Author(s), year Method LOQ Principle of method Comment Evaluated in of 160 µg/l in surface water IIIA Description of Methods for the Analysis of Amisulbrom in Air (OECD KIII A 5.7) An overview of the acceptable methods and the data gaps (if appropriate) for analysis of amisulbrom in air is given in the following table. Table 3-14: Overview of suitable primary and confirmatory methods for air Component(s) of residue definition Primary method Confirmatory method amisulbrom Tate, 2005* Tate, 2005* *EU agreed method (see Draft Assessment Report) Table 3-15: Methods for air Author(s), year Method LOQ Principle of method Comment Evaluated in Tate, 2005 ASB µg/m 3 LC-MS/MS, Luna C8 column, APCI-, m/z , m/z confirmation included section B of the DAR 2008 IIIA Description of Methods for the Analysis of Amisulbrom in Body Fluids and Tissues (OECD KIII A 5.8) Methods for body fluids and tissues are not required, because amisulbrom 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 Other Studies/ Information Anonymous, 2015; ASB The applicant responds to open points in the interim evaluation report from BVL on re-registration application for NC-225 WG submitted for ZV /00, namely to requirements for primary and confirmatory analytical methods for determination of the residues of amisulbrom metabolites IT-15, T-1, T-3, I-2, I-8, T-4, T-7 and I-9 in surface water. In this response, toxicity endpoints (fish, daphnia, algae) for metabolites IT-15, IT-4, T-1, T-3, I-2, I-8, T- 4, T-7 and I-9 estimated using US EPA model are compared with determined toxicity endpoints for IT-15 and IT-4 in fish, daphnia and algae. Generally, a good correlation was reported. Using the estimated toxicity endpoints and the PEC of the metabolites in surface water, TER values (toxicity exposure ratio) are calculated. The applicant concludes, that the large margin of safety shown by the calculated TER values (all >10 3 ) indicate an acceptable risk for aquatic organisms. Therefore it is concluded, that these metabolites do not need consideration in the surface water residue definition and primary and confirmatory analytical methods for determination of the residues of amisulbrom metabolites T-1, T-3, I- 2, I-8, T-4, T-7 and I-9 in surface water are not required. Furthermore, a summary of a validated analytical method for determination of the residues of the metabolite IT-15 in surface water (Miller, 2015; Applicant ADAMA Deutschland GmbH Evaluator: DE

102 Part B Section 2 Germany NC-225 WG Page 15 of 32 ASB ) is presented. IIIA Evaluation of Folpet The conclusions regarding the peer review of the analytical methods for residues of folpet are summarized in EFSA s Scientific report (2009), 297, 1-80, ASB Table 3-16: Information on the active substance folpet Name of component of residue definiton substance code IUPAC name formula folpet N-(trichloromethylthio) phthalimide C 9H 4Cl 3NO 2S Structural formula captan O N-(trichloromethylthio)cyclohex-4-ene-1,2- dicarboximide C 9H 8Cl 3NO 2S NSCCl 3 phthalimide phthalic acid imide C 8H 5NO 2 O IIIA Overview of residue definitions and levels for which compliance is required Compared to the residue definition proposed in the Draft Assessment Report (incl. its addenda, ASB ) the current legal residue definition differs for some plant materials. The residue definition for pome fruit, strawberries, blackberries, raspberries, currants, gooseberries, tomatoes and beans with and without pods as regulated in Regulation (EC) No 251/2013 includes also captan. Table 3-17: Relevant residue definitions Matrix Relevant residue Reference Remarks pome fruit, strawberries, blackberries, raspberries, currants, gooseberries, tomatoes, beans with and without pods all other plant materials foodstuff of animal origin sum of captan and folpet 1 folpet not defined Regulation (EU) No 251/2013, annex II, annex III part B soil folpet EFSA Scientific report (2009), 297, 1- Applicant ADAMA Deutschland GmbH Evaluator: DE

103 Part B Section 2 Germany NC-225 WG Page 16 of 32 Matrix Relevant residue Reference Remarks surface water drinking/ground water air For surface water no enforcement method is needed. (Adequate marker may need to be identified to monitor folpet in surface water.) 2 folpet EFSA note: folpet is the only ecotoxicologically relevant compound; folpet and phthalic acid are the only toxicologically relevant compounds. Folpet has a DT 90 well below 3d (maximum DT 90 = 9h in buffered ph 5 or 7) Adequate marker may need to be identified to monitor folpet in ground / drinking water. Folpet body fluids/tissue not residue relevant not classified as T / T+ 1 Captan was not considered in this assessment because it is not formed by degradation of folpet in plant material. 2 This statement reflects the fast degradation of folpet in water (DT90 < 3d) 80 Table 3-18: Levels for which compliance is required Matrix MRL Reference for MRL/level Remarks plant, high water content plant, acidic commodities plant, dry commodities plant, high oil content plant, difficult matrices (hops) meat milk eggs fat liver, kidney 0.02 mg/kg 0.02 mg/kg 0.02 mg/kg 0.02 mg/kg 150 mg/kg such MRLs do not exist such MRLs do not exist such MRLs do not exist such MRLs do not exist such MRLs do not exist soil 0.05 mg/kg common limit Regulation (EU) No 251/2013, annex II, annex III part B drinking water 0.1 µg/l general limit for drinking water surface water not required DT 90< 3 d, EFSA Scientific report (2009), 297, 1-80, ASB air 30 µg/m 3 AOEL sys: 0.1 mg/kg bw/d, EFSA Scientific report (2009), 297, 1-80, ASB tissue (meat or liver) not required not classified as T / T+ body fluids not required not classified as T / T+ Applicant ADAMA Deutschland GmbH Evaluator: DE

104 Part B Section 2 Germany NC-225 WG Page 17 of 32 IIIA Description of Analytical Methods for the Determination of Residues of Folpet in Plant Matrices (OECD KIII A 5.3.1) An overview of the acceptable methods and possible data gaps for analysis of folpet in plant matrices is given in the following tables. For the detailed evaluation of additional studies it is referred to Appendix 2. Table 3-19: 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 EN 12393:2014 EN 12393:2014 Munro, 2005 Acidic EN 12393:2014 Weeren, 1998 Munro, 2005 Fatty EN 12393:2014 Not necessary Missing Dry Simek, 2002 * Missing Missing Difficult Not required for the intended GAP *EU agreed method (see Draft Assessment Report) Not required for the intended GAP Not required for the intended GAP Table 3-20: Statement on extraction efficiency Method for products of plant origin Required, available from: Not required, because: O Connor, J., 1994 (RIP ) Edwin, 1991 (RIP ) For the detailed evaluation of studies it is referred to DAR, vol. 3, B.7.1. Table 3-21: Author(s), year EN 12393:2014 method N (identical with DFG S19) ASB Simek, 2002 ASB Weeren, 1998 MET Munro, 2005 ASB Methods suitable for the determination of residues (enforcement) in products of plant origin Matrix group high water content, acidic, fatty high water content, dry Method LOQ Principle of method Comment 0.02 mg/kg GC-ECD DFG S19 method, new data published in EURL data pool, for high water content matrix in 3 labs validated 0.02 mg/kg GC-ECD, DB-5 column no confirmation acidic 0.01 mg/kg GC-ECD no confirmation, DFG S19 method high water content, acidic 0.01 mg/kg GC-MS, HP-5MS column, m/z 260 Evaluated in Appendix 2 section B of the DAR Appendix 2 Appendix 2 Applicant ADAMA Deutschland GmbH Evaluator: DE

105 Part B Section 2 Germany NC-225 WG Page 18 of 32 IIIA Description of Analytical Methods for the Determination of Residues of Folpet in Animal Matrices (OECD KIII A 5.3.1) Analytical methods for analysis of folpet in animal matrices are not needed, because no MRLs are set for food of animal origin. IIIA Description of Methods for the Analysis of Folpet in Soil (OECD KIII A 5.4) An overview of the acceptable methods and possible data gaps for analysis of folpet in soil is given in the following tables. New studies were not provided. Table 3-22: Overview of suitable primary and confirmatory methods for soil Component(s) of residue definition Primary method Confirmatory method Folpet Rose & Kimmel, 2001 * Mende, 2002 * *EU agreed method (see Draft Assessment Report) Table 3-23: Methods for soil Author(s), year Method LOQ Principle of method Comment Evaluated in Mende, 2002 MET Rose & Kimmel, 2001 ASB mg/kg GC-MS, DB-5 column, m/z 104, 130, 147, 260, mg/kg GC-ECD, DB-1701 column section B of the DAR no confirmation section B of the DAR IIIA Description of Methods for the Analysis of Folpet in Water (OECD KIII A 5.6) An overview of the acceptable methods and possible data gaps for analysis of folpet in surface and drinking water is given in the following table. New studies were not provided. Table 3-24: Overview of suitable primary and confirmatory methods for water Component(s) of residue definition Matrix Primary method Confirmatory method folpet drinking water Mende, 1994 * missing ** folpet surface water not required not required *EU agreed method (see Draft Assessment Report) ** This data gap is not considered here, because the stability of folpet in water is very low. (maximum DT90 = 9 h in buffered ph 5 or 7). Table 3-25: Methods for drinking water Author(s), year Method LOQ Principle of method Comment Evaluated in Mende, 1994 MET µg/l HPLC-UV/DAD, C18 column no confirmation section B of the DAR It has to be noted that folpet has a DT 90 well below 3d (maximum DT 90 = 9h in buffered ph 5 or 7). Therefore, no method for surface water is required and a confirmatory method for drinking water is less Applicant ADAMA Deutschland GmbH Evaluator: DE

106 Part B Section 2 Germany NC-225 WG Page 19 of 32 important. IIIA Description of Methods for the Analysis of Folpet in Air (OECD KIII A 5.7) An overview of the acceptable methods and possible data gaps for analysis of folpet in air is given in the following table. New studies were not provided. Table 3-26: Overview of suitable primary and confirmatory methods for air Component(s) of residue definition Primary method Confirmatory method folpet Balluff, 1994 * not necessary *EU agreed method (see Draft Assessment Report) Table 3-27: Methods for air Author(s), year Method LOQ Principle of method Comment Evaluated in Balluff, 1994 MET µg/m 3 HPLC-DAD study design and extent of validation not sufficient according to SANCO/825/00 rev. 8.1 but EU agreed method section B of the DAR IIIA Description of Methods for the Analysis of Folpet in Body Fluids and Tissues (OECD KIII A 5.8) Methods for body fluids and tissues are not required, because folpet 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 Other Studies/ Information Not required 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 definition for amisulbrom. The following deficiencies were noted: A primary analytical method, an ILV and a confirmatory method for the determination of residues of amisulbrom in animal matrices are missing for the enforcement of the current legal residue definition (Regulation (EC) No. 897/2012, annex III part A) for food of animal origin. These data gaps are considered being of minor relevance since the intended use is on grapes only and no feeding stuffs are obtained from this use. It is sufficient to fill the data gaps in the context of the next application for the approval of amisulbrom according to Reg. (EC) No 1107/2009 or in the context of the Applicant ADAMA Deutschland GmbH Evaluator: DE

107 Part B Section 2 Germany NC-225 WG Page 20 of 32 assessment of existing MRLs of amisulbrom according to Reg. (EC) No 396/2005. Sufficiently sensitive and selective analytical methods are not available for all analytes included in the residue definition for folpet. The following deficiencies were noted: An ILV and a confirmatory method for the determination of residues of folpet in dry crops are missing. However, the intended use is on grapes (commodity with high acid content). A confirmatory method for the determination of residues of folpet in plant commodities with high oil content is missing. However, the intended use is on grapes (commodity with high acid content). 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 folpet according to Reg. (EC) No 1107/2009 or in the context of the assessment of existing MRLs of folpet according to Reg. (EC) No 396/2005. Applicant ADAMA Deutschland GmbH Evaluator: DE

108 Part B Section 2 Germany NC-225 WG Page 21 of 32 Appendix 1 List of data submitted in support of the evaluation Annex point/ reference No. OECD KIIIA KIIIA Author(s) Year Title Comb, A.L. Gyakushi, N. Source (where different from company) Report-No. GLP or GEP status (where relevant), Published or not 2009 NC-225 WG, two year storage stability, Huntingdon Life Sciences Ltd, NAS/0801, GLP: yes, Published: no 2007 Validation of analytical Method for determination of active ingredients on NC-225 WG, Tsukuba Laboratory, NCI , GLP: yes, Published: no KIIIA Witte, A Development and Validation of an Analytical Method for the Determination of the Impurities PCMM and CCl 4, in Formulation Sanvino, CIP Chemisches Institut Pforzheim GmbH, 11 F VMFO, GLP: yes, Published: no KIIIA Tsunemi, K Validation of Analytical Method for the Determination of IT-4 in NC- 225WG AN225WG203 NCI Not published, GLP Data protection claimed Y Owner Nissan Chemical Industries = NIS Y NIS 1 Y NIS 1 Y NIS 1 How considered in drr Study-Status / Usage * 5 * 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) Applicant ADAMA Deutschland GmbH Evaluator: DE

109 Part B Section 2 Germany NC-225 WG Page 22 of 32 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No All EFSA 2009 Conclusion regarding the peer review of the pesticide risk assessment of the active substance folpet EFSA Scientific Report (2009) 297, 1-80 ASB All EFSA 2013 Conclusion on the peer review of the pesticide risk assessment of the active substance Amisulbrom EFSA Journal 2014;12(4):3237 ASB All Italy 2004 Folpet: (Draft Assessment Report) Vol. 1-4 ASB KIIA Takehara, K Validation of the method for determination of the active ingredient in NC-224 technical product AN201! NCI Nissan Chemical Industries, Ltd. BVL , CHE KIIA 4.3 Anon EN 12393:2014: Foods of plant origin - Multiresidue methods for the determination of pesticide residues by GC or LC-MS/MS: Part 1: General Considerations; Part 2: Methods for extraction and cleanup; Part 3: Determination and confirmatory tests (Method N of this standard complies with German DFG S19, for validation results see EURL data pool) EN ! EN ! EN ! ! ! ! ICS ASB KIIA 4.3 Byast, M. G Determination of Folpet in decline samples of winter wheat treated with Folpan 80 WDG OA00344/R52855! R BVL , ASB KIIA 4.3 Cowlyn, T. C Validation of analytical method for the determination of residues of the fungicide Folpet on apples, melons, onions, lettuce tomatoes and stawberries 96/MAK387/1137! R-9172 BVL , ASB KIIA 4.3 Faessel, V Validation of the analytical method for the determination of Folpet and its metabolite Phthalimide residues in grapes R A8076! R BVL , ASB KIIA 4.3 Mende, P Analysis of Folpet in liver, kidney, muscle, fat, eggs and milk, method development and validation 96222/01-RAT! R-9651 BVL , MET KIIA 4.3 Mende, P Analysis of Folpet in flour - Method development and validation 96222/01-RWF! R-9653 BVL , MET KIIA 4.3 Munro, S Validation of a confirmatory method of analysis for the determination of concentrations of Folpet in grapes and tomatoes R-18330! MAK882/ BVL , ASB Data protection claimed Owner How considered in drr * Add Add Add Yes NCI N Add Yes MAC N Yes MAC N Yes ADAMA Deutschland N Yes MAC N Yes MAC N Yes MAC Y Applicant ADAMA Deutschland GmbH Evaluator: DE

110 Part B Section 2 Germany NC-225 WG Page 23 of 32 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No KIIA 4.3 Munro, S Validation of a confirmatory method of analysis for the determination of concentrations of phthalimide in grapes and tomatoes R-18331! MAK881/ BVL , ASB KIIA 4.3 Nishioka, L. T.; Rose, J. E.; Ruzo, L. O A method for the determination of Folpet residues in avocados and other oily crops 10146(part III)! 568W-1 BVL , ASB KIIA 4.3 Peatman, M. H Independent laboratory validation of NAS 490/042294, determination of residues of NC-224 in grapes and potatoes AN304! D2149 Nissan Chemical Industries, Ltd. BVL , MET KIIA 4.3 Peatman, M. H Amisulbrom: Independant laboratory validation of analytical method NAS 0968/074113; Determination of residues of amisulbrom in oilseed rape seed and dried peas AN306! 0306/153 Nissan Chemical Industries, Ltd BVL , ASB KIIA 4.3 Sato, T Amisulbrom: Statement on source of analytical reference standard BVL , ASB KIIA 4.3 Schlesinger, H. M A method for the determination of Folpan and Phthalimide residues in nonoily crops; FP/15/91! R-6255! 10146(Part II) BVL , MET KIIA 4.3 Simek, I Validation of the method of analysis of the residues of Folpet in cereals R A1044-1! R-13050b BVL , ASB KIIA 4.3 Simek, I Validation of the method of analysis of the residues of Phthalimide in cereals R-13050c! R A BVL , ASB KIIA 4.3 Tate, S NC Validation of methodology for the determination of residues of NC-224 in grapes, potatoes and tomatoes and twelve month storage stability at approximately -18 C incl. Amendment 1 vom AN302! NAS 490/ Nissan Chemical Industries, Ltd. BVL , ASB KIIA 4.3 Todd, M Amisulbrom: Validation of methodology for the determination of residues of Amisulbrom in oil seed rape seed and dry peas AN305! NAS 0968/ BVL , ASB KIIA 4.3 Todd, M Amisulbrom: Validation of methodology for the determination of residues of amisulbrom in grapes and potatoes AN307! HLS NAS/0980 BVL , BVL , ASB Data protection claimed Owner How considered in drr * Yes MAC N Yes MAC N Yes NCI Y Yes NCI Y Yes NIS N Yes MAC N Yes MAC Y Yes MAC N Yes NCI N Yes NCI Y Yes NIS Y Applicant ADAMA Deutschland GmbH Evaluator: DE

111 Part B Section 2 Germany NC-225 WG Page 24 of 32 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No KIIA 4.3 Weeren, R. D.; Pelz, S Determination of the residues of Folpet in/on grapes after application of SZX Folpet 43.5 WP in the normal manner usual for agricultural practice in Germany and France, 1997 RA-2129/97! BAY-9705! MO ! M ! BAY-9705! 60110/97! 00086/M024 BVL ; MET KIIA 4.3 Williams, M Independant laboratory confirmation of analytical methods for the determination of Folpet in plant tissues 10146(part I)! R-9008 BVL , ASB KIIA 4.3 Williams, M.; Howell, R. E. KIIA 4.3, KIIA 6.1.1, KIIA KIIA 4.3, KIIA 6.3, KIIA 6.5.4, KIIIA , KIIIA1 8.3, KIIIA KIIA 4.3, KIIIA General methods for the analysis of Folpet in oily and non-oily crops: Enforcements methods R-9559! Vers. 1.0 BVL , ASB Tate, S Validation of methodology for the determination of residues of NC-224 in processed fractions of grapes and six month storage stability at approximately -18 C AN303! NAS 648/ Nissan Chemical Industries, Ltd. BVL , BVL , BVL , MET Raufer, B Determination of residues of NC-224 and Folpet after four applications of NC-225 WG in grapevine and processed goods at 4 sites in Germany /G1-FPVI! R308 BVL , BVL , BVL , BVL , BVL , BVL , ASB Tate, S Validation of methodology for the determination of residues of folpet in grapes NAS/744/053186! OFC ! ! NC-224(FP) BVL , BVL , ASB KIIA 4.4 Brewin, S Validation of methodology for the determination of residues of IT-4 in two soil types NAS0997! AN403 BVL , ASB KIIA 4.4 Creeger, S. M Folpet field dissipation study in citrus groves in Polk County, Florida CO-002a! R-5450a BVL , ASB KIIA 4.4 Creeger, S. M Folpet field dissipation study in citrus groves in Seminole County, Florida CO-002b! R-5450b BVL , ASB KIIA 4.4 Mende, P Validation of an analytical method (confirmatory method) for the determination of Folpet in soil /01-RVS BVL , MET KIIA 4.4 Nolting, H.; Köhle, H.; Siebers, J.; Blacha-Puller, M DFG- Manual of pesticide residue analysis volume II R-10598! DFG S26 BVL , ASB Data protection claimed Yes Owner Bayer Crop Science How considered in drr * Y Yes MAC N Yes ADAMA Deutschland N Yes NCI N Yes FSG N Yes NIS N Yes NCI Y Yes MAC N Yes MAC N Yes MAC Y No LIT N Applicant ADAMA Deutschland GmbH Evaluator: DE

112 Part B Section 2 Germany NC-225 WG Page 25 of 32 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No KIIA 4.4 Rose, J. E.; Kimmel, E Field soil dissipation of Folpet in bare ground in Washington 915W-1! FLP 688! R BVL , ASB KIIA 4.4 Tate, S Validation of methodology for the determination of residues of NC-224 and metabolites IT-4 and IT-14 in soil and six month storage stability at approximately -18 C AN401! NAS/542/ Nissan Chemical Industries, Ltd. BVL , ASB KIIA 4.4 Tate, S NC-224 Validation of methodology for the determination of residues of NC-224 in two soil types AN402! NAS 0786/ Nissan Chemical Industries, Ltd. BVL , MET KIIA 4.5 Anon Response to open points in the interim evaluation report from BVL on reregistration application for NC-225 WG BVL , ASB KIIA 4.5 Mende, P Residue analysis of Folpet in water, method validation IFU94002/01-FOL! R-7736 BVL , MET KIIA 4.5 Mende, P Residue analysis of Folpet in water - Method validation amendment no /01-FOL Amend 1! BVL , MET KIIA 4.5 Tate, S Validation of methodology for the determination of residues of NC-224 in ground, drinking and surface water - incl. Amendment Date: AN501! NAS 0780/ Nissan Chemical Industries, Ltd. BVL , MET KIIA 4.5 Todd, M Validation of methodology for the determination of residues of IT-4 in ground water AN502! NAS/0924/ Nissan Chemical Industries, Ltd. BVL , ASB KIIA 4.5 Todd, M Validation of methodology for the determination of residues of Amisulbrom in surface water AN503! 0NE0035 BVL , ASB KIIA 4.5, KIIIA1 5.6 Miller, C IT-15: Validation of methodology for the determination of residues in surface water ONE0305! AN504 BVL , BVL , ASB KIIA 4.7 Balluff, M Monitoring low levels of Folpan in air 93092/01-MEL BVL , MET KIIA 4.7 Mende, P Monitoring low levels of Folpan in air - Amendment /01-MEL amendment 2 BVL , MET Data protection claimed Owner How considered in drr * Yes MAC Y Yes NCI N Yes NCI Y Open Nissan Chemical Y Yes MAC Y Yes MAC N Yes NCI Y Yes NCI Y Yes NCI N Yes Nissan Chemical Y Yes MAC Y Yes MAC N Applicant ADAMA Deutschland GmbH Evaluator: DE

113 Part B Section 2 Germany NC-225 WG Page 26 of 32 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No KIIA 4.7 Tate, S NC-224 Validation of methodology for the post registration monitoring of residues in air - incl. amendment date: AN701! NAS 764/053073! NC-224 Nissan Chemical Industries, Ltd. BVL , ASB KIIA 6.1.1, KIIA Tate, S Validation of methodology for the determination of residues of NC-224 in grapes, potatoes and tomatoes and twelve month storage stability at approximately -18 C AN302! NAS 490/ Nissan Chemical Industries, Ltd. BVL , BVL , MET KIIA O Connor, J.; Mester, T Folpet: Nature of residues on grapes. Final report - incl. field report 6091B vom /WLS019/0962! R-6403a! 93/0962! R329201! 6091B BVL , RIP KIIA Crowe, A NC-224: Metabolism in grapes + one report amendment R203! NAS 425/ BVL , RIP KIIA Edwin, A.; Woolson, Ph.D Folpet - Plant Metabolism on Avocado Fruits - Florida STUDY NO RIP * Y: Yes, relied on N: No, not relied on Add: Data protection claimed Relied on, study not submitted by applicant but necessary for evaluation; ( # study report was submitted to the first application for authorisation of the product Sanvino; /00) Owner How considered in drr * Yes NCI Y Yes NCI N Yes MAC Y Yes NCI Add # Yes DPB ISA MAC SPU Add Applicant ADAMA Deutschland GmbH Evaluator: DE

114 Part B Section 2 Germany NC-225 WG Page 27 of 32 Appendix 2 Detailed evaluation of the additional studies relied upon A 1.1 Analytical methods for Amisulbrom A Description of Methods for the Analysis of Water A Analytical method 1 Reference: OECD KIIIA, 5.6 Report Guideline(s): Deviations: GLP: Acceptability: Materials and methods IT-15: Validation of methodology for the determination of residues in surface water, Miller, C., 2015, ONE0305! AN504, ASB Yes (SANCO/825/00 rev. 8.1; SANCO/3029/99 rev.4) No Yes Yes The analytical method involved no extraction and clean-up procedures. Samples of surface water are diluted with acetonitrile and acidified with acetic acid. The sample concentration in the final extract is 0.2 ml/ml. For any further dilution (if required) acetonitrile/water/ acetic acid (80/20/0.1; v/v/v) is used. Final determination of the metabolite IT-15 is made by LC-MS/MS using an Acquity UPLC BEH C18 column, electrospray ionization in negative mode and monitoring the MS/MS transitions m/z , Results and discussions Table A 1: Recovery results from method validation of surface water using the analytical method. Standards were prepared in acetonitrile Matrix Fortification level (mg/kg) No of samples per fortification level Mean recovery RSD (%) Comments surface water Metabolite IT-15 m/z Metabolite IT-15 m/z Table A 2: Characteristics for the analytical method used for the quantitation of Metabolite IT-15 residues in surface water Calibration function Accepted calibration range in concentration units (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio units for the sample (e.g.in mg/kg or µg/l) Metabolite IT-15 m/z Y=239831*X R= Metabolite IT-15 m/z Y=110952*X R= ng/ml ng/ml µg/l µg/l Does the calibration consist of at least 3 levels yes yes Applicant ADAMA Deutschland GmbH Evaluator: DE

115 Part B Section 2 Germany NC-225 WG Page 28 of 32 (duplicated points) or 5 levels (single points)? (yes/ no) Assessment of matrix effects is presented (yes/no) yes Interference >30% of LOQ in blank sample is absent (yes/no) yes yes yes Conclusion The analytical method is sufficiently validated for quantification of the metabolite IT-15 in surface water. The limit of quantification is 0.1 µg/l. Because of validation of two MS/MS transitions, an additional confirmatory method is not required. Comments of zrms: Acceptable. A 1.2 Analytical methods for Folpet A Methods for enforcement of residues in food and feed of plant origin A Analytical method 1 Reference: OECD KIIIA, Report Guideline(s): Deviations: GLP: Acceptability: Materials and methods EN 12393:2014: Foods of plant origin - Multiresidue methods for the determination of pesticide residues by GC or LC-MS/MS: Part 1: General Considerations; Part 2: Methods for extraction and cleanup; Part 3: Determination and confirmatory tests (Method N of this standard complies with German DFG S19, for validation results see EURL data pool), Anonymous, ASB Validation procedure was comparable to SANCO/825/00 rev. 7 guideline Calibration and selectivity not reported No (not required for monitoring methods) Yes After addition of some water and.ph adjustment to ph 7 (if below ph 4), cucumber and kiwi samples are homogenized in acetone/water (2/1, v/v)). Sodium chloride and ethyl acetate/cyclohexane (1/1; v/v) are added to the homogenate and mixed well. An aliquot of the organic phase is evaporated to the aqueous reminder. After dilution with ethyl acetate/cyclohexane (1/1; v/v) the mixture is dried with sodium sulfate. Hazelnut samples are homogenized in acetone/acetonitrile (1/9, v/v) in the presence of Calflo E and Celite. An aliquot of the extract is filtrated through Calflo E. After addition of isooctane, the aliquot is evaporated to dryness. The dry residue is reconstituted in ethyl acetate/cyclohexane (1/1, v/v). Aliquots of all extracts are further purified by GPC on BioBeads S-X3. Ethyl acetate/cyclohexane (1/1; v/v) is used as eluent. Residues of folpet in final extracts are quantified by GC-ECD. Results and discussions Table A 3: Recovery results from method validation in cucumber, kiwi and hazelnut using the analytical method. Matrix Fortification level (mg/kg) No of samples per fortifica- Mean recovery RSD (%) Comments Applicant ADAMA Deutschland GmbH Evaluator: DE

116 Part B Section 2 Germany NC-225 WG Page 29 of 32 Cucumber Kiwi Hazelnut High water content Conclusion tion level Data from EURL data pool Data from EURL data pool Data from EURL data pool Data from Germany proficiency test in 2 labs The internationally standardized method is suitable according to the number of levels and the fortified samples per level, the recovery and the repeatability to quantify residues of folpet in commodities with high water and high acid content and in oily crops. Calibration data and selectivity are not reported. However, the method is widely used in Europe for the determination of residues of folpet. For high water content matrix, the method is validated in 3 labs. Therefore, ILV is included for this matrix. Comments of zrms: The method is acceptable to quantify residues of folpet in plant commodities with high water, high acid and high oil content. A Analytical method 2 Reference: OECD; KIIIA, Report Guideline(s): Deviations: GLP: Acceptability: Materials and methods Weeren R.D., Pelz, S.; Determination of the residues of folpet in/on grapes after application of SZX 0722+folpet 43.5 WP in the normal manner usual for agricultural practice in germany and france, 1997; method no.00086/m024; study-no. RA-2130/97; performing lab: Dr. Specht & Partner, Hamburg, Germany; MET Not stated Not applicable Yes Yes Sample material is extracted according to modified DFG S19 method. For acidic matrix (grapes) according to the module E3 samples are extracted with acetone/water (2/1, v/v). A first cleanup is done by partition into ethyl acetate/cyclohexane (1/1, v/v). Further clean-up by GPC is performed on BioBeads S- X3. Ethyl acetate/cyclohexane (1/1; v/v) is used as eluent. Final cleanup was performed on mini silica gel chromatography using toluene/acetone (95/5, v/v) as eluent. Quantification is done by GC-ECD on DB-1 capillary column. Results and discussions Table A 4: Recovery results from method validation of grapes using the analytical method. Standards were prepared in toluene/acetone (95/5, v/v) Matrix Fortification level (mg/kg) No of samples per fortification level Mean recovery RSD (%) Comments Applicant ADAMA Deutschland GmbH Evaluator: DE

117 Part B Section 2 Germany NC-225 WG Page 30 of 32 Grapes Applicant ADAMA Deutschland GmbH Evaluator: DE

118 Part B Section 2 Germany NC-225 WG Page 31 of 32 Table A 5: Characteristics for the analytical method used for the quantitation of folpet residues in grapes Calibration function Accepted calibration range in concentration units (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio units for the sample (e.g.in mg/kg or µg/l) Does the calibration consist of at least 3 levels (duplicated points) or 5 levels (single points)? (yes/ no) Folpet Y=18132*X-29.3, R²= X: concentration in µg/ml; Y: peak area in counts ng/ml ,390 mg/kg (without dilution), but higher level were diluted 1:10 or 1:30 to fit in calibration range Yes Assessment of matrix effects is presented (yes/no) No Interference >30% of LOQ in blank sample is absent (yes/no) Yes Conclusion The method is acceptable for the quantification of folpet in grapes. The limit of quantification is 0.01 mg/kg. Comments of zrms: The study is intended to quantify residues of folpet in field trials. The number of samples for the higher fortification level is not sufficient according to SANCO/825/00 rev Nevertheless, the study demonstrated the suitability of DFG S19 method which is used for food monitoring as well as for residue trials in different labs. It is accepted as ILV of the DFG S19 multi-residue method. A Analytical method 3 Reference: OECD; KIIIA, Report Munro, S.; Validation of a confirmatory method of analysis for the determination of concentrations of Folpet in grapes and tomatoes; study no. MAK 882/052489, ASB Guideline(s): SANCO/825/00 rev. 7, SANCO/3029/99 rev. 4 Deviations: GLP: Acceptability: Materials and methods No Yes Yes The samples are extracted by homogenisation with ethyl acetate, sodium sulfate and o-phosphoric acid. After filtration the sample volume is adjusted to 250 ml with ethyl acetate. An aliquot is washed with 0.75 % o-phosphoric acid. The organic phase is evaporated to dryness and reconstituted in acetonitrile. A cleanup by SPE on C18 is performed using acetonitrile/water (60/40, v/v) for elution. After addition of water and sodium chloride, residues in the eluate are partitioned into hexane. Following evaporation to a smaller volume, column chromatography with florisil is performed. The residues are eluted with dichloromethane/methanol (99/1, v/v), evaporated to dryness and dissolved in toluene. The sample concentration in the final extract is 1 g/ml. Quantification is done by GC-MS using a HP-5MS column. Applicant ADAMA Deutschland GmbH Evaluator: DE

119 Part B Section 2 Germany NC-225 WG Page 32 of 32 The ion m/z 260 is used for quantification. Results and discussions Table A 6: Recovery results from method validation of grapes using the analytical method. Standards were prepared in toluene. Matrix Fortification level (mg/kg) No of samples per fortification level Mean recovery RSD (%) Comments Grapes Table A 7: Recovery results from method validation of tomato using the analytical method. Standards were prepared in toluene. Matrix Fortification level (mg/kg) No of samples per fortification level Mean recovery RSD (%) Comments Tomato Table A 8: Characteristics for the analytical method used for the quantitation of folpet residues in grapes and tomato Calibration function Accepted calibration range in concentration units (e.g. in µg/ml or ng/µl) Corresponding calibration range in mass ratio units for the sample (e.g.in mg/kg or µg/l) Does the calibration consist of at least 3 levels (duplicated points) or 5 levels (single points)? (yes/ no) Folpet Y= *X , R²=0.998, Y. Peak area in area units; X: concentration in ng/ml ng/ml mg/kg Yes Assessment of matrix effects is presented (yes/no) Yes (<10 %) Interference >30% of LOQ in blank sample is absent (yes/no) Conclusion Yes The method is sufficiently validated for folpet in commodities with high water content (tomato) and acidic crops (grapes). The limit of quantification is 0.01 mg/kg. Comments of zrms: Acceptable, because of different detection (GC-MS) also as confirmatory method. Applicant ADAMA Deutschland GmbH Evaluator: DE

120 Sanvino ZV /00 Part B Section 3 - zrms Version REGISTRATION REPORT Part B Section 3: Mammalian Toxicology Detailed summary of the risk assessment Product Name: Sanvino Active Substances: Amisulbrom 50 g/kg Folpet 500 g/kg Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: ADAMA Deutschland GmbH Page 1 / 47

121 Sanvino ZV /00 Part B Section 3 - zrms Version Table of Contents 3 Mammalian Toxicology (IIIA 7) Summary Toxicological Information on Active Substance(s) Toxicological Evaluation of Plant Protection Product Toxicological evaluation of groundwater metabolites Dermal Absorption (IIIA 7.6) Justification for proposed values - Amisulbrom Justification for proposed values - Folpet Exposure Assessment of Plant Protection Product Selection of critical use(s) and justification Operator exposure (IIIA 7.3) Estimation of operator exposure Measurement of operator exposure Worker exposure (IIIA 7.5) Estimation of worker exposure Measurement of worker exposure Bystander and resident exposure (IIIA 7.4) Estimation of bystander and resident exposure Measurement of bystander and/or resident exposure Statement on combined exposure Appendix 1 Reference list Appendix 2 Detailed evaluation of the studies relied upon A 2.1 Statement on bridging possibilities A 2.2 Acute oral toxicity (IIIA ) A 2.3 Acute percutaneous (dermal) toxicity (IIIA ) A 2.4 Acute inhalation toxicity (IIIA ) A 2.5 Skin irritation (IIIA ) A 2.6 Eye irritation (IIIA ) A 2.7 Skin sensitisation (IIIA ) A 2.8 Supplementary studies for combinations of plant protection products (IIIA ) A 2.9 Data on co-formulants (III1 7.9) A Material safety data sheet for each co-formulant A Available toxicological data for each co-formulant A 2.10 Studies on dermal absorption (IIIA 7.6) Appendix 3 Exposure calculations A 3.1 Operator exposure calculations (IIIA ) A Calculations for amisulbrom A Calculations for folpet A 3.2 Worker exposure calculations (IIIA ) A Calculations for amisulbrom Page 2 / 47

122 Sanvino ZV /00 Part B Section 3 - zrms Version A Calculations for folpet A 3.3 Bystander and resident exposure calculations (IIIA ) A Calculations for amisulbrom A Calculations for folpet Page 3 / 47

123 Sanvino ZV /00 Part B Section 3 - zrms Version 3 Mammalian Toxicology (IIIA 7) 3.1 Summary Table 3.1-1: Information on Sanvino (NC-225 WG 04)* Product name and code Formulation type Active substance(s) (incl. content) Function Product already evaluated as the representative formulation during the Annex I inclusion Sanvino (NC-225 WG) (ADD F-0-WG) Water dispersible granule (WG) Amisulbrom; 50 g/kg Folpet; 500 g/kg Fungicide No Product previously evaluated in an other MS according to Uniform Principles * Information on the detailed composition of Sanvino can be found in the confidential drr Part C. Justified proposals for classification and labelling No According to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 the following classification and labelling with regard to toxicological data is proposed for the preparation: Table 3.1-2: Justified proposals for classification and labelling C&L according to Regulation (EC) No 1272/2008 Hazard class(es), categories: Skin Irrit. 2, Skin Sens. 1A, Eye Irrit. 2, Acute Tox. 4, Carc. 2 Signal word: Warning Hazard statement(s): Precautionary statement(s): Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use. [EUH401] 'Contains folpet (CAS No ). May produce an allergic reaction.' [EUH208] Table 3.1-3: Summary of risk assessment for operators, workers, bystanders and residents for Sanvino 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] - Do not eat, drink or smoke when using this product.[sb166] - Wear standard protective gloves (plant protection) when handling the undiluted product. [SS110] - Wear a protective suit against pesticides and sturdy shoes (e.g. rubber Page 4 / 47

124 Sanvino ZV /00 Part B Section 3 - zrms Version boots) when handling the undiluted product. [SS2101] - Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. [SS2202] Workers Acceptable - Treated areas/crops may not be entered until the spray coating has dried. [SF1891] Bystanders Acceptable None Residents Acceptable None The risk assessment according to the German model has shown that the estimated exposure towards amisulbrom and folpet in Sanvino 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 folpet in Sanvino will exceed the particular systemic AOEL for operators even if gloves are worn during mixing/loading and application. Further reduction of exposure is to be expected due to necessary PPE allocated according to dangerous substances regulations. A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and bystanders/residents is presented in Table Table Critical uses and overall conclusion of exposure assessment Crops 1) and situation (e.g. growth stage of crop) F/G or I 2) Application Application rate kg as/ha Remarks: (e.g. surfactant (L /ha)) Method / Kind (incl. application technique 3) ) Max. number (min. interval between applications) a) per use b) per crop/ season Grapevine F HCTM, HCHH a) 4 b) 4 (12 days) a) max. rate per appl. b) max. total rate per crop/season a) amisulbrom: ; folpet: b) amisulbrom: 0.3; folpet: 3.0 Water L/ha min / max critical gap for operator, worker, bystander or resident exposure based on [Exposure model] 1600 German model UK POEM Acceptability of exposure assessment Operator Worker Bystander Residents 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) HC: high crop, TM: tractor-mounted, HH: hand-held Page 5 / 47

125 Sanvino ZV /00 Part B Section 3 - zrms Version 3.2 Toxicological Information on Active Substance(s) Information regarding classification of the active substances and on EU endpoints are given in Table Table 3.2-1: Amisulbrom Information on active substance(s) Reference doses Value Source ADI 0.1 mg/kg bw EFSA Journal 2014;12(4):3237 ( ) AOEL-S 0.15 mg/kg bw/d EFSA Journal 2014;12(4):3237 ( ) ARfD 0.3 mg/kg bw EFSA Journal 2014;12(4):3237 ( ) Classification and proposed labelling with regard to toxicological data (according to the criteria in Reg. (EC) No 1272/2008, as amended) Amisulbrom: Regulation (EC) No 1272/2008 (as amended): Substance not listed RAC-Opinion (CLH-O /F; 10 March 2016): Hazard classes (s), categories: Eye Irrit. 2 Code(s) for hazard pictogram(s): GHS07 Signal word: Warning Hazard statement(s): H319 Hazard classes (s), categories: Carc. 2 Code(s) for hazard pictogram(s): GHS08 Signal word: Warning Hazard statement(s): H351 zrms: none additional IT-4: Proposal EU Peer Review (EFSA Journal 2014;12(4):3237: Danger, Acute Tox. 3, H301: Toxic if swallowed no data provided or available (for other endpoints) Folpet Reference doses Value Source ADI 0.1 mg/kg bw EFSA Scientific Report (2009) 297, 1-80 ( ) AOEL-S 0.1 mg/kg bw/d EFSA Scientific Report (2009) 297, 1-80 ( ) ARfD 0.2 mg/kg bw EFSA Scientific Report (2009) 297, 1-80 ( ) Classification and proposed labelling with regard to toxicological data (according to the criteria in Reg. 1272/2008) Regulation (EC) No 1272/2008 (Table 3.1): Acute toxicity, cat. 4 Eye irritation, cat. 2 Skin sensitisation, cat. 1 Carcinogenicity, cat. 2 H317 - May cause an allergic skin reaction H319 - Causes serious eye irritation Page 6 / 47

126 Sanvino ZV /00 Part B Section 3 - zrms Version Reference doses Value Source ADI 0.1 mg/kg bw EFSA Scientific Report (2009) 297, 1-80 ( ) AOEL-S 0.1 mg/kg bw/d EFSA Scientific Report (2009) 297, 1-80 ( ) ARfD 0.2 mg/kg bw EFSA Scientific Report (2009) 297, 1-80 ( ) Classification and proposed labelling H332 - Harmful if inhaled H351 - Suspected of causing cancer zrms: none additional 3.3 Toxicological Evaluation of Plant Protection Product A summary of the toxicological evaluation for Sanvino is given in Table Full summaries of studies on the product are presented in Appendix 2. MSDS on Sanvino 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 Sanvino Type of test, model system (Guideline) Result Acceptability Classification (acc. to the criteria in Reg. 1272/2008) Reference LD 50 oral, rat (OECD 423) LD 50 dermal, rat (OECD 402) LC 50 inhalation, rat (OECD 403) Skin irritation, rabbit (OECD 404) Eye irritation, rabbit (OECD 405) Skin sensitisation, guinea pig (OECD 406, M&K) > 2000 mg/kg bw Yes None XXXXX; 2005a > 2000 mg/kg bw Yes None XXXXX; 2005b 1.4 mg/l air (male rats) Yes H332 XXXXX; 2005 Irritant Yes H315 XXXXX; 2005a Irritant Yes H319 XXXXX; 2005a Sensitising Yes H317 XXXXX; 2006 Supplementary studies for combinations of plant protection products No data not required Table 3.3-2: Additional toxicological information relevant for classification/labelling of Sanvino Substance (Concentration in product, % w/w) Classification of the substance (acc. to the criteria in Reg. 1272/2008) Reference Classification of product (acc. to the criteria in Reg. 1272/2008) Toxicological Amisulbrom H351 ( 1 % (w/w)) RAC-Opinion H351 Page 7 / 47

127 Sanvino ZV /00 Part B Section 3 - zrms Version properties of active substance(s) (relevant for classification of product) (5 % (w/w)) (CLH-O /F; 10 March 2016) Toxicological properties of non-active substance(s) (relevant for classification of product) Further toxicological information Folpet (50 % (w/w)) None No data not required H361fd ( 3 % (w/w)) H317; EUH208 ( 0.1 % (w/w)) H351 ( 1 % (w/w)) EFSA/BfR proposal 1 up to now no legal classification - not yet considered for classification of the product Reg. (EC) No 1272/2008 H361fd 1 EUH208 H 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 Sanvino are presented in Table Table 3.5-1: Dermal absorption endpoints for active substances in Sanvino Amisulbrom Folpet Value Reference Value Reference Concentrate 75 % default value (concentration 5 %) Dilution 75 % default value (concentration 5 %) 4 % XXXXX, 2014 [ASB ] 26 % XXXXX, 2014 [ASB ] Justification for proposed values - Amisulbrom No data on dermal absorption for amisulbrom in Sanvino is available. Justification for default values according to Guidance on Dermal Absorption (EFSA Journal 2012; 10(4):2665) are presented in Table Table 3.5-2: Default dermal absorption endpoints for Amisulbrom Value Justification for value Acceptability of justification Concentrate For default values, c.f., EFSA Journal 2012;10(4):2665 ( yes Dilution 18): 25 % or 75 % depending on the concentration and the physico-chemical properties Page 8 / 47

128 Sanvino ZV /00 Part B Section 3 - zrms Version Justification for proposed values - Folpet Proposed endpoint for folpet is based on a dermal absorption study on Sanvino. The study is summarized in Table A full summary of the study that has not previously been evaluated within an EU peer review process is presented in Appendix 2. Table 3.5-3: Formulation in study Sanvino (NC-225 WG) Summary of dermal absorption studies for Folpet Concentrate Spray dilution 4 % for the concentrate and 26 % for the dilution (0.159 g/l) Test Reference XXXXX, 2014 [ASB ]: in vitro dermal penetration study of folpet in NC-225 WG through human skin Acceptability of study Justification provided on representativ ity of study formulation for current product Acceptability of justification Yes Not required Endpoint can be used for current product. 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 Sanvino (NC-225 WG) (ADD F-0-WG) Formulation type WG Category Fungicide Container size(s), short 1 kg and 5 kg bags description Active substance(s) (incl. content) Amisulbrom 50 g/kg Folpet 500 g/kg AOEL systemic 0.15 mg/kg bw/d 0.1 mg/kg bw/d Inhalative absorption 100 % 100 % Oral absorption 50 % 100 % Dermal absorption Concentrate: 75 % Dilution: 75 % Default Selection of critical use(s) and justification Concentrate: 4 % Dilution: 26 % (Dilution: g/l) (NC-255 WG) The critical GAP used for the exposure assessment of the plant protection product is shown in Table Operator exposure (IIIA 7.3) Estimation of operator exposure A summary of the exposure models used for estimation of operator exposure to the active substance(s) during application of Sanvino according to the critical use is presented in Table Outcome of the estimation is presented in Table Detailed calculations are in Appendix 3. Page 9 / 47

129 Sanvino ZV /00 Part B Section 3 - zrms Version Table 3.6-2: Exposure models for intended uses Critical use(s) Model(s) Critical use(s) Model(s) Grapevine (max. 1.5 kg product/ha) German model [Uniform Principles for Safeguarding the Health of Applicators of Plant Protection Products (Uniform Principles for Operator Protection), Mitteilungen aus der Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277, 1992] Grapevine (max. 1.5 kg product/ha) Revised UK-POEM [Estimation of Exposure and Absorption of Pesticides by Spray Operators, Scientific subcommittee on Pesticides and British Agrochemical Association Joint Medical Panel Report (UK MAFF), 1986 and the Predictive Operator Exposure Model (POEM) V 1.0, (UK MAFF), 1992] Page 10 / 47

130 Sanvino ZV /00 Part B Section 3 - zrms Version Table 3.6-3: Estimated operator exposure Amisulbrom Model data Level of PPE Total absorbed dose (mg/kg/day) Air assisted spray application outdoors to high crops Application rate: kg amisulbrom/ha kg folpet/ha German Model Body weight: 70 kg gloves m/l + coverall appl. UK POEM Application volume: 1600 L/ha Container: n.r. Body weight: 60 kg % of systemic AOEL Folpet Total absorbed dose (mg/kg/day) % of systemic AOEL no PPE 1) no PPE 2) gloves m/l + gloves appl. Hand-held application outdoors to high crops Application rate: kg amisulbrom/ha kg folpet/ha German Model no PPE 1) Body weight: 70 kg gloves m/l + coverall appl. UK POEM no PPE 2) Application volume: 1600 L/ha Container: n.r. Body weight: 60 kg gloves m/l + gloves appl n.r. not relevant 1) no PPE: Operator wearing T-shirt and shorts 2) no PPE: Operator wearing long sleeved shirt, long trousers ( permeable ) but no gloves 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 Worker exposure (IIIA 7.5) Estimation of worker exposure Table shows the exposure model(s) used for estimation of worker exposure after entry into a previously treated area or handling a crop treated with Sanvino according to the critical use(s). Outcome of the estimation is presented in Table Detailed calculations are in Appendix 3. Table 3.6-4: Exposure models for intended uses Critical use(s) Grapevine (max. 4 x 1.5 kg product/ha) Model German re-entry model, Krebs et al. (2000) [Uniform Principles for Safeguarding the Health of Workers Re-entering Crop Growing Areas after Application of Plant Protection Products, Nachrichtenbl. Deut. Pflanzenschutzdienst., 52(1), p. 5-9] Page 11 / 47

131 Sanvino ZV /00 Part B Section 3 - zrms Version Table 3.6-5: Estimated worker exposure Model data Level of PPE Total absorbed dose (mg/kg/day) Amisulbrom % of systemic AOEL Total absorbed dose (mg/kg/day) Number of applications and application rate: 4 x kg amisulbrom/ha + 4 x kg folpet/ha 8 hours/day 1), DFR: 1 µg/cm 2 /kg a.s. TC: cm 2 /person/h 2) Body weight: 60 kg Folpet % of systemic AOEL no PPE 3) ) ) ) ) with PPE 4) ) ) ) ) 1) 8 h/day for professional applications for harvesting, pruning, tying, thinning or weeding activities etc. 2) US-EPA policy paper [EPA, Science Advisory Council for Exposure; 2000; Agricultural Default Transfer Coefficients, Policy # 003.1, May revised 7 August 2000]. 3) no PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves 4) with PPE: see 'Instructions for use' 5) for a DFR of 3 µg/cm 2 /kg a.s. worker exposure to amisulbrom would amount to 600 % of the AOEL without PPE and to 30 % of the AOEL with PPE, worker exposure to folpet would amount to 3120 % of the AOEL without PPE and to 156 % of the AOEL with PPE, with respect to the residue data the half life of folpet is considered to be low; hence, it seems appropriate to apply a multiple application factor of only 2, in that case exposure to folpet would amount to 78 % of the AOEL with PPE 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 Bystander and resident exposure (IIIA 7.4) Estimation of bystander and resident exposure Table shows the exposure model(s) used for estimation of bystander and resident exposure to amisulbrom and folpet. Outcome of the estimation is presented in Table Detailed calculations are in Appendix 3. Table 3.6-6: Critical use(s) Model Exposure models for intended uses Grapevine (max. 4 x 1.5 kg product/ha) 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): Birkhäuser Verlag Basel] and Bundesanzeiger (BAnz), 06 January 2012, Issue No. 4, pp Page 12 / 47

132 Sanvino ZV /00 Part B Section 3 - zrms Version Table 3.6-7: Estimated bystander and resident exposure Model data Total absorbed dose (mg/kg/day) Amisulbrom % of systemic AOEL Air assisted spray application outdoors to high crops Application rate: 4 x kg amisulbrom/ha + 4 x kg folpet/ha Bystanders (adult) Drift rate: 8.02 % (3 m) Body weight: 60 kg Bystanders (children) Drift rate: 8.02 % (3 m) Body weight: kg Residents (adult) Drift rate: 6.71 % (3 m, 4 appl.) Body weight: 60 kg Residents (children) Drift rate: 6.71 % (3 m, 4 appl.) Body weight: kg Total absorbed dose (mg/kg/day) Folpet % of systemic AOEL 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 amisulbrom and folpet 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 Statement on combined exposure From a scientific point of view it is regarded necessary to take into account potential combination effects. However, the evaluation of cumulative or synergistic effects as requested by 4 (3b) of Regulation (EC) No. 1107/2009 should only be performed, if harmonised scientific methods accepted by the authorities are available. Page 13 / 47

133 Sanvino ZV /00 Part B Section 3 - zrms Version Appendix 1 Reference list Annex point/ reference No Author(s) Year Title Report-No. Authority registration No KIIIA XXXXX 2005a NC-225 WG: Acute oral toxicity to the rat (Acute toxic class method) HLS/NAS/726! NAS726/053192/AC GLP: Yes Published: No BVL , ASB KIIIA XXXXX 2005b NC-225 WG: Acute dermal toxicity to the rat HLS/NAS/727! NAS727/053193/AC GLP: Yes Published: No BVL , ASB KIIIA XXXXX 2005 NC -225 WG: An acute (4-hour) inhlation toxicity study in the rat via nose-only exposure HLS GLP: Yes Published: No BVL , ASB KIIIA XXXXX 2005a NC -225 WG: Skin irritation to the rabbit HLS/NAS/728! NAS/728/ GLP: Yes Published: No BVL , ASB KIIIA XXXXX 2005b NC -225 WG: Eye irritation to the rabbit HLS/NAS/730! NAS/730/ GLP: Yes Published: No BVL , ASB KIIIA XXXXX 2006 NC- 225 WG: Delayed dermal sensitation study in guinea pigs (Magnusson and Klingman test) RTC GLP: Yes Published: No BVL , ASB KIIIA1 7.6 XXXXX 2014 In vitro dermal penetration study of [14C]-Folpet in NC-225 WG through human skin FNC/01! QBR116938! R GLP: Yes Published: No BVL , ASB Data protection claimed Owner Yes NIS Y Yes NIS Y Yes NIS Y Yes NIS Y Yes NIS Y Yes NIS Y Yes ADAMA Deutschland *Y, Yes/relied on; N, No/not relied on; Add, Additional, Relied on/study not submitted by applicant but necessary for evaluation How considered in drr * Y Page 14 / 47

134 Sanvino ZV /00 Part B Section 3 - zrms Version Appendix 2 Detailed evaluation of the studies relied upon A 2.1 Statement on bridging possibilities The tests on acute oral, acute dermal and acute inhalation toxicity as well as on skin irritation, eye irritation and skin sensitisation were performed on Sanvino (NC-225 WG). A 2.2 Acute oral toxicity (IIIA ) Comments of zrms: Acceptable; according to recent guidelines, used for evaluation. Reference: Report NC-225 WG: Acute oral toxicity to the rat (acute toxic class method), XXXXX, 2005a, NAS 726/053192/AC (T225WG101), ASB Guideline(s): OECD 423 (2001), 2004/73/EC method B.1, EPA OPPTS , JMPA 12 NohSan No. 8147, (2000) Deviations: No GLP: Yes Acceptability: Yes Materials and methods Test material (Lot/Batch No.) NC-225 WG (Lot No. P050411) Species Rat, Sprague-Dawley No. of animals (group size) 2 x 3 females Dose(s) 2000 mg/kg bw Exposure Once by gavage Vehicle/Dilution 1 % methylcellulose Post exposure observation period 14 days Remarks None Results and discussions Table A 1: Results of acute oral toxicity study in rats of NC-225 WG Dose [mg/kg bw] Toxicological results 1) Duration of signs Time of death LD50 [mg/kg bw] (14 days) Female rats /3/3 day 1 day 7 -- > /3/3 day 1 day 7 day 2 > ) Number of animals which died/number of animals with clinical signs/number of animals used Page 15 / 47

135 Sanvino ZV /00 Part B Section 3 - zrms Version Table A 2: Summary of findings of acute oral toxicity study in rats of NC-225 WG Mortality: One female was found death on day 2. Clinical signs: Body weight: Macroscopic examination: Clinical signs seen from about 30 minutes post-dosing included piloerection and loose faeces in all animals and hunched posture in two females, with decreased faecal pellets in three females from day 2 and brown staining observed in two animals from day 3. Recovery, as judged by external appearance and behavior, was complete by day 7. Body weight gain was considered to be normal. The necropsies performed at the end of the study revealed no apparent findings. Conclusion Under the experimental conditions, the oral LD 50 of Savino is higher than 2000 mg/kg bw in rats. Thus, no classification is required according to Regulation (EC) No. 1272/2008. A 2.3 Acute percutaneous (dermal) toxicity (IIIA ) Comments of zrms: Acceptable; according to recent guidelines, used for evaluation. Reference: Report NC-225 WG: Acute dermal toxicity in rats, XXXXX, 2005b, NAS 727/053193/AC ( T225WG102), ASB Guideline(s): OECD 402 (1987), 92/69/EEC method B.3 (1992), EPA OPPTS (1998), JMAFF 12 NohSan No. 8147, (2000) Deviations: No GLP: Yes Acceptability: Yes Materials and methods Test material (Lot/Batch No.) NC-225 WG (Lot No. P050411) Species Rat, Sprague-Dawley No. of animals (group size) 5 males and 5 females Dose(s) 2000 mg/kg bw Exposure 24 hours (dermal, semi-occlusive) Vehicle/Dilution 1 % methylcellulose Post exposure observation period 14 days Remarks None Page 16 / 47

136 Sanvino ZV /00 Part B Section 3 - zrms Version Results and discussions Table A 3: Dose [mg/kg bw] Results of acute dermal toxicity study in rats of NC-225 WG Toxicological results 1) Duration of signs Time of death LD50 [mg/kg bw] (14 days) Male rats /0/ > 2000 Female rats /0/ > ) Number of animals which died/number of animals with clinical signs/number of animals used Table A 4: Mortality: Clinical signs: Body weight: Macroscopic examination: Summary of findings of acute dermal toxicity study in rats of NC-225 WG No mortality occurred. No clinical signs of toxicity were observed. Body weight gain was reduced in three females on day 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study. The necropsies performed at the end of the study revealed no apparent findings. Conclusion Under the experimental conditions, the dermal LD 50 of Sanvino is higher than 2000 mg/kg bw in rats. Thus, no classification is required according to Regulation (EC) No. 1272/2008. A 2.4 Acute inhalation toxicity (IIIA ) Comments of zrms: Acceptable; according to recent guidelines, used for evaluation. Reference: Report NC-225 WG: An acute (4-hour) inhalation toxicity study in the rat via nose-only exposure, XXXXX, 2005, (T225WG103), ASB Guideline(s): OECD 403 (1981), 92/69/EC, B.2 (1992) EPA OPPTS (1998), JMAFF 12 NohSan No Deviations: No GLP: Yes Acceptability: Yes Materials and methods Test material (Lot/Batch No.) NC-225 WG (Lot No. P050411) Species No. of animals (group size) Concentration(s) Rat, Sprague-Dawley, Crl:CD (SD) IGS BR 3 x 5 males and 5 females (females were nulliparous and nonpregnant) 2.7, 1.2 and 0.52 mg/l Page 17 / 47

137 Sanvino ZV /00 Part B Section 3 - zrms Version Exposure Vehicle/Dilution Post exposure observation period Remarks 4 hours (nose only) None 14 days None Results and discussions Table A 5: Concentration(s) and exposure conditions Nominal conc. [mg/l air] Actual conc. [mg/l air] MMAD 1) [µm] GSD 2) [µm] ) MMAD = Mass Median Aerodynamic Diameter 2) GSD = Geometric Standard Deviation Table A 6: Concentration [mg/l air] Results of acute inhalation toxicity study in rats of NC-225 WG Toxicological results 1) Duration of signs Time of death LC50 [mg/l air] (14 days) Male rats 2.7 4/5/5 d 1 d 5 d 1 < /5/5 d 1 d 4 d 1 > /5/5 d 1 d 3 d 1 > 0.52 Female rats 2.7 2/5/5 d 1 d 7 d 1 > 2.7 1) Number of animals which died/number of animals with clinical signs/number of animals used Table A 7: Mortality: Clinical signs: Body weight: Summary of findings of acute inhalation toxicity study in rats of NC-225 WG Four males and two females exposed to 2.7 mg/l were euthanized in moribund condition within one day after exposure. Two males exposed to 1.2 mg/l were euthanized in moribund condition within one day after exposure. One males exposed to 0.52 mg/l were euthanized in moribund condition within one day after exposure. Immediately after exposure, excessive lacrimation or salivation, clear or red nasal discharge, laboured breathing or gasping and moist rales were observed. Frequently observed signs of matted coat, wet fur and tan/brown material on the fur were considered to be incidental and due to exposure conditions. During the first week of the 14 days post-exposure period a few responses similar to those seen immediately after exposure were noted. Most surviving animals gained weight in both weeks of the post-exposure observation period. Although some showed a minimal weight loss 7 days after exposure they gained weight during the 2 nd week. Page 18 / 47

138 Sanvino ZV /00 Part B Section 3 - zrms Version Macroscopic examination: Animals killed within 1 day post exposure showed discoloured lungs or dilated renal pelvis, or were within normal limits. Those surviving until study termination were within normal limits or were noted with minimal changes. Conclusion Under the experimental conditions, the inhalation LC 50 of Sanvino is 1.4 mg/l air in male rats (the more sensitive sex). Thus, classification is required with with Cat. 4; H332 according to Regulation (EC) No. 1272/2008. A 2.5 Skin irritation (IIIA ) Comments of zrms: Acceptable; according to recent guidelines, used for evaluation. Reference: Report NC-225 WG: Skin irritation to the rabbit, XXXXX, 2005a, NAS 728/ (T225WG104), ASB Guideline(s): OECD 404 (2002), 2004/73/EC, B.4 (2004), EPA OPPTS (1998), JMAFF 12 NohSan No. 8147, (2000) Deviations: No GLP: Yes Acceptability: Yes Materials and methods Test material (Lot/Batch No.) NC-225 WG (Batch No. P050411) Species Rabbit, New Zealand White No. of animals (group size) 3 males Initial test using one animal Yes Exposure 0.5 g (4 hours, semi-occlusive) Vehicle/Dilution None (treatment site wetted with 0.5 ml of reverse osmosis water) Post exposure observation period 15 days Remarks None Results and discussions Table A 8: Skin irritation of NC-225 WG Animal No. Scores after treatment 1) 1 h 24 h 48 h 72 h Mean scores (24-72 h) Reversible [day] 1 Erythema Oedema > 15-2 Erythema Oedema > 15-3 Erythema Oedema 1) scores in the range of 0 to Page 19 / 47

139 Sanvino ZV /00 Part B Section 3 - zrms Version Clinical signs: None Conclusion Under the experimental conditions, Sanvino is a skin irritant (due to persistency of irritation in two animals). Thus, classification is required with Cat.2; H315 according to Regulation (EC) No. 1272/2008. A 2.6 Eye irritation (IIIA ) Comments of zrms: Acceptable; according to recent guidelines, used for evaluation. Reference: Report NC-225 WG: Eye irritation to the rabbit, XXXXX, 2005b, NAS 730/ (T225WG106), ASB Guideline(s): OECD 405 (2002), 2004/73/EC, B.5 (2004), 2004/73/EC, EPA OPPTS (1998), JMAFF 12 NohSan No. 8147, (2000) Deviations: No GLP: Yes Acceptability: Yes Materials and methods Test material (Lot/Batch No.) NC-225 WG (Batch No. P050411) Species Rabbit, New Zealand White No. of animals (group size) 3 females Initial test using one animal Yes Exposure Corresponding to 0.1 ml (single instillation into conjunctival sac) Irrigation (time point) No Vehicle/Dilution None Post exposure observation period 15 days Remarks None Results and discussions Table A 9: Eye irritation of NC-225 WG Animal No. Scores after treatment 1) 1 h 24 h 48 h 72 h Mean scores (24-72 h) Reversible [day] 1 Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Page 20 / 47

140 Sanvino ZV /00 Part B Section 3 - zrms Version 3 Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae ) scores in the range of 0 to 4 for cornea opacity and chemosis, 0 to3 for redness of conjunctivae and 0 to 2 for iritis Clinical signs: None Conclusion Under the experimental conditions, Sanvino is an eye irritant. Thus, classification according to Regulation (EC) No. 1272/2008 is required with Cat. 2; H319. A 2.7 Skin sensitisation (IIIA ) Comments of zrms: Acceptable; according to recent guidelines, used for evaluation. Reference: Report NC-225 WG: Delayed dermal sensitisation study in guinea pigs (Magnusson and Kligman test), XXXXX, 2006, (T225WG107), ASB Guideline(s): OECD 406 (1992), 92/69/EEC method B.6 Deviations: No GLP: Yes Acceptability: Yes Materials and methods Test material (Lot/Batch No.) NC-225 WG (Batch No. P050411) Species No. of animals (group size) Range finding: Exposure (concentration(s), no. of applications) Vehicle Pretreatment prior to topical application Reliability check Remarks Guinea pig, Hartley albino Test substance group: 20 females (nulliparous and non-pregnant) Vehicle control goup: 10 females (nulliparous and non-pregnant) Yes Intradermal induction: 0.25 % Topical induction: 50 % Challenge: 50 % Sterile water Yes (sodium lauryl sulfate) Alpha-Hexylcinnamaldehyde (20 % in corn oil for intradermal induction, 50 % in corn oil for topical induction and 10 % in acetone for challenge) None Page 21 / 47

141 Sanvino ZV /00 Part B Section 3 - zrms Version Results and discussions Table A 10: Skin sensitisation of NC-225 WG 24 hours 48 hours After challenge Test group 14/20 14/20 Test Vehicle Control Group Positive control 0/10 0/10 60 % response in the test group and 0 % in the control group at challenge 1) Number of animals with positive dermal response (scores of 1-3) /number of animals in dose group Clinical signs: None Conclusion Under the experimental conditions, Sanvino is a skin sensitiser. Thus, classification is required with Cat. 1A; H317 according to Regulation (EC) No. 1272/2008. A 2.8 Supplementary studies for combinations of plant protection products (IIIA ) Sanvino is not intended to be registered in combination with other plant protection products. Therefore, no supplementary studies are necessary for the combination of plant protection products. A 2.9 Data on co-formulants (III1 7.9) A 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 ( - Part C). A Available toxicological data for each co-formulant Available toxicological data for each co-formulant can be found in the confidential dossier of this submission ( - Part C). A 2.10 Studies on dermal absorption (IIIA 7.6) Folpet Report: KIIIA /01, XXXXX, 2014 [ASB ] Title: In Vitro Dermal Penetration Study of 14 C-folpet in NC-225 WG Through Human Skin Document No: FNC/01 Guidelines: OECD 428, April 2004, EC No. 440/2008. Method B.45 GLP: Yes (certified laboratory) Page 22 / 47

142 Sanvino ZV /00 Part B Section 3 - zrms Version Executive summary The dermal penetration of Folpet has been investigated using the static cells (Franz cells) and [14C]- Folpet through dermatomed human skin. Experiments were conducted after administration of concentrate and aqueous dilution. The [14C]-Folpet formulations were applied to skin from four donors in duplicate at target concentrations of 500 g Folpet/kg of NC-225 WG concentrate and 0.23 g Folpet/L aqueous dilution of NC-225 WG. Based on the EFSA guidance document (EFSA Journal 2012; 10(4):2665) the directly absorbed values, 1.93% and 13.77% for the concentrate and aqueous dilution respectively, can be used for risk assessment as greater than 75% of the total absorption into the receptor fluid occurred within the first 12 hours of the experiment. Materials and methods A. Materials Labelled material (Batch A): Lot/Batch #: Radiochemical Purity: Specific Activity Labelled material (Batch B): Lot/Batch #: Radiochemical Purity: Specific Activity Folpet N-(trichloromethylthio)phthalimide XXI/23/A 99.47% 5.05 MBq/mg 136 µci/mg Folpet N-(trichloromethylthio)phthalimide XXI/28/A/ % MBq/mg NC-225 WG non-radiolabelled concentrate Name: Sanvino Development Code: NC-225 WG Batch number: B Concentration: Folpet 505 g/kg Amisulbrom 50.9 g/kg NC-225 WG blank formulation Name: Sanvino blank formulation Batch number: B Concentration: Folpet 0 g/kg Amisulbrom 0 g/kg Amisulbrom Technical Name: Amisulbrom Technical Batch number: Purity: 99.8% Test System Dermatomed human skin (typically µm, obtained from Biopredic International) was used in this study. Skin was taken by surgery from a total of six donors, each test formulation was applied to skin from four donors in duplicate. The experiment was conducted using Franz cells, representing a static cell design, with a nominal 12 ml receptor chamber volume and 1.77 cm2 exposed skin area for dosing. B. Study design and methods Preparation of dosing formulations The test formulations were prepared as described below. The undiluted concentrate represented the Page 23 / 47

143 Sanvino ZV /00 Part B Section 3 - zrms Version highest concentration possible when applying the formulation, while the aqueous dilution reflected the concentration recommended for use in the field. Table A 11: Dose formulation data The dose formulation for the concentrate comprised NC-225 WG non-radiolabelled concentrate and [14C]-Folpet. The [14C]-Folpet solution in acetonitrile was reduced to dryness under N2 and mixed with the NC-225 WG non-radiolabelled concentrate using a mortar and pestle followed by stirring the materials together overnight. The aqueous dilution comprised blank formulation, amisulbrom, Evian water and [14C]-Folpet. The radiolabelled Folpet and non-radiolabelled amisulbrom were dissolved in acetonitrile and the solution reduced to dryness under N2 to obtain material at the required specific activity. The radiodiluted material were mixed with the blank formulation using a mortar and pestle followed by stirring the materials together overnight. Evian water was added on the morning of dose administration. Radioactive concentrations (homogeneity) and radiochemical purities of the dose formulations were determined both before and after dose administration. Aliquots of each dose formulation were diluted in acetonitrile prior to LSC, to be considered acceptable the percentage variance (CV%) between the aliquots should be less than 10%. Aliquots of each dose formulation were also diluted in acetonitrile prior to determination of radiochemical purity by chromatographic analysis (HPLCRAD). Testosterone was used as a reference compound to check the operation of the system and was applied at approximately 0.1 mg/cm2. The radiolabelled testosterone was prepared at a specific activity suitable for administration and was diluted with non-radiolabelled reference compound to meet the required specific activity. In vitro dermal penetration experiment Application to the skin The receptor fluid was replaced fresh 0.9% saline + 5% Bovine serum albumin (BSA) prior to application of the test material formulations. A set amount of approximately 8 mg (4.52 mg/cm2) of the concentrate or 15µL (8.47 µl/cm2) of the aqueous dilution was applied to the skin from four donors in duplicate. The formulations were as far as reasonably possible evenly distributed across the surface of the skin and the application weigh boat or pipette tip retained for possible analysis. Cells to which the concentrate was added were moisturized with 10 µl of water to mimic sweat. In order to assess the experimental set-up the reference compound (testosterone) was applied as a solution in ethanol/water (1/1 v/v) at a set volume of 15µL to selected skin samples (total of 2 Franz cells dosed during the conduct of this study). Following Page 24 / 47

144 Sanvino ZV /00 Part B Section 3 - zrms Version dosing each cell was covered with a permeable (non-occlusive) nylon gauze to mimic the exposure condition under clothing. Exposure and sampling Skin was exposed to the test compound and testosterone for 8 hours. After the 8 hour sampling the dose formulation was removed from the test skin by washing the area with a 3% aqueous solution of Quotient Bioresearch (Rushden) Study Number: FNC/01 Final Report Page 18 of 81 liquid Dove (a commercially available soap) followed by a rinsing with water. The site was then washed with at least 1 natural sponge pre-wetted with a 3% aqueous solution of liquid Dove and at least 1 natural sponge pre-wetted with water, followed by at least 1 dry natural sponge to remove residual water. All washings, sponges and pipette tips were retained together for quantitative radiochemical analysis. Samples were taken from the receptor fluid at 10 sampling points over a 24 hour period: 0, 0.5, 1, 2, 4, 6, 8 (taken prior to removal of the dose formulation), 10, 12 and 24 hours after application. Duplicate aliquots (2 x 50µl) were removed for sampling and replaced with an equal volume of receptor fluid (0.9% saline + 5% Bovine serum albumin (BSA)). The receptor fluid was aliquoted into LSC vials containing 10% formic acid and mixed with scintillant prior to LSC. Terminal procedures Following collection of the 24 hour sample all components of the test system were analysed to determine a recovery for the system. The residual receptor fluid was transferred into an appropriate container and stored at c.a. -20 C. The skin was removed and skin fractionation was performed on the skin samples at the termination of the study. Tape strips (Standard D-Squame, CuDerm Corporation), were used to attempt to remove stratum corneum layer of the skin samples from each test cell. Twenty individual strips were used and the first ten strips analysed separately. The remaining skin was solubilised using Soluene 350 (Perkin Elmer) and analysed by liquid scintillation counting. The remaining Franz cell which consisted of the donor chamber, receptor chamber, stirrer bar, the cell clamp and nylon gauze were placed in an appropriate pre-weighed container, to which an appropriate volume of acetonitrile was added. The container was left to stand for at least 2 hours and then the cell components and gauze removed. The solution and container were then weighed. Duplicate aliquots were taken for QRA, this has been reported as cell wash. The residual extracted and solubilised samples were stored at room temperature. Results and discussion Solubility test The solubility of [14C]-Folpet in the receptor fluid 0.9% saline (w/v) + 5% Bovine serum albumin (BSA) (w/v) was determined. The measured concentrations of [14C]-Folpet before and after centrifugation are presented in Table 2 of the report. The percentage variation in concentration before and after centrifugation was less than or equal to 5.9% and therefore the solubility of [14C]-Folpet in the receptor fluid was considered acceptable. Integrity check To determine the skin preparation integrity, tritiated water was applied to the test vessels. Skin samples were deemed viable if the rate of penetration was not greater than 2.5 x10-3 cm/h. The observed rate of penetration was in the range of x10-3 to 2.49 x10-3 cm/h and was considered an acceptable rate for each skin confirming the suitability for use in this study. Dermal penetration Reference compound During this study the reference standard ([14C]-testosterone) produced a mean penetration rate of µg/cm2/h (Table 4). Radioactivity recovered was greater than 88%. These results indicate the test system was functional throughout the duration of the study. Test compound Page 25 / 47

145 Sanvino ZV /00 Part B Section 3 - zrms Version The dermal penetration of Folpet has been investigated using the static cells (Franz cells) and [14C]- Folpet through dermatomed human skin. Experiments were conducted after administration of concentrate and aqueous dilution. The [14C]-Folpet formulations were applied to skin from four donors in duplicate at target concentrations of 500 g Folpet/kg of NC-225 WG concentrate and 0.23 g Folpet/L aqueous dilution of NC-225 WG. The calculated dose concentration for the concentrate was 507 mg/g. The amount of [14C]- Folpet added to the NC-225 WG concentrate was considered negligible compared to the total amount of folpet required in the formulation. The percentage variance between dose check aliquots was 8.65% and therefore the dose was considered acceptable for use. The radiochemical purity of the concentrate was greater than 99% both before and after dose administration. Actual dose concentrations as determined by LSC for the aqueous dilution were g/l of [14C]-Folpet in water (0.312 g/l Sanvino formulation in water. The variance between dose check aliquots was 2.93% and therefore the dose was considered acceptable for use. There was a reduction in radiochemical purity of [14C]-Folpet following addition of water to the aqueous dilution formulation. The radiochemical purity of the aqueous dilution was 91.94% and 90.43% before and after dosing respectively. As Folpet is known to hydrolyse under aqueous conditions the radiochemical purity of the test compound alone was taken to indicate suitability of the test compound for use. Quotient Bioresearch (Rushden) Study Number: FNC/01 Final Report Page 22 of 81 The mean total recovery for the concentrate cells was 94.16%. The percentage dose absorbed and potential dose absorbed were 1.93% and 2.53%, respectively. Following 8 hour exposure to the concentrate, very little radioactivity was detected in the receptor fluid and skin removed 24 hours after dose administration. The majority of radioactivity (mean of 88.82%) was recovered in the 8 hour skin wash. The overall recovery of radioactivity following administration of the concentrate to donor 1 replicate 1 was atypically low and therefore the data obtained from this cell was excluded from mean calculations. The mean total recovery for the aqueous dilution cells was 98.38%. The percentage dose absorbed and potential dose absorbed were and 24.47% respectively. Following 8 hour exposure to the aqueous dilution a greater proportion of the administered dose was detected in the receptor fluid (10.75%) and skin (2.21%) removed 24 hours after dose administration. A high proportion of radioactivity (mean of 58.41%) was recovered in the 8 hour skin wash and Tape strip 1 (mean of 12.34%). The overall recovery of radioactivity following administration of the aqueous dilution to donor 1 replicate 2 was atypically high and therefore the data obtained from this cell was excluded from mean calculations. Conclusion Following exclusion of donor 1 replicate 1 the mean total recovery for the concentrate cells was 94.16%. Although this is slightly lower than the 95% recommended by the EFSA the recovery of radioactivity across the cells appears consistent and the mean is considered notably close enough to the 95% to be considered acceptable. Following exclusion of donor 1 replicate 2 the mean total recovery for the aqueous dilution cells was 98.38%. As the recovery was greater than the 95% recommended by the EFSA the recovery data obtained from these cells was considered acceptable. Based on the EFSA guidance document (EFSA Journal 2012; 10(4):2665) the directly absorbed values, 1.93% and 13.77% for the concentrate and aqueous dilution respectively, can be used for risk assessment as greater than 75% of the total absorption into the receptor fluid occurred within the first 12 hours of the experiment. Study Comments: Study acceptable Agreed endpoint: Taking into account the EFSA guidance (EFSA Journal 2012;10(4):2665) on dermal absorption the results are 4 % dermal absorption for the concentrate and 26 % for the dilution. Justification: The results for the concentrate are: Receptor fluid: 0.14±0.13; Skin: 0.32±0.26; Cell wash: 1.46±1.65. The standard deviations are 25 %, therefore, the SD is added to the mean values. The result of dermal absorption of the concentrate is 3.96%, rounded to 4%. Page 26 / 47

146 Sanvino ZV /00 Part B Section 3 - zrms Version The results for the aqueous dilution are: Receptor fluid: 10.75±7.35; Skin: 2.21±3.27; Cell wash: 0.81±1.77. The standard deviations are 25 %, therefore, the SD is added to the mean values. The result of dermal absorption of the concentrate is 26.16%, rounded to 26%. Page 27 / 47

147 Sanvino ZV /00 Part B Section 3 - zrms Version Appendix 3 Exposure calculations A 3.1 Operator exposure calculations (IIIA ) A Calculations for amisulbrom Table A 12: Input parameters considered for the estimation of operator exposure Formulation type: WG High Crop Tractor Mounted Application technique: Application rate (AR): kg a.s./ha (HCTM) Area treated per day (A): 8 ha Dermal hands m/l (D M(H)): 2 mg/person/kg a.s. 75 % (concentr.) Dermal hands appl. (D A(H)): 0.7 mg/person/kg a.s. Dermal absorption (DA): 75 % (dilution) Dermal body appl. (D A(B)): 9.6 mg/person/kg a.s. Inhalation absorption (IA): 100 % Dermal head appl. (D A(C)): 1.2 mg/person/kg a.s. Body weight (BW): 70 kg/person Inhalation m/l (I M): mg/person/kg a.s. AOEL 0.15 mg/kg bw/d Inhalation appl. (I A): mg/person/kg a.s. Table A 13: Estimation of operator exposure towards amisulbrom using the German model (HCTM) Without PPE Operators: Systemic dermal exposure after application in grapevine Dermal exposure during mixing/loading Hands With PPE Hands SDE OM(H) = (D M(H) x AR x A x DA) / BW SDE OM(H) = (D M(H) x AR x A x PPE 1) x DA) / BW (2 x x 8 x 75%) / 70 (2 x x 8 x 0.01 x 75%) / 70 External dermal exposure 1.2 mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Dermal exposure during application Hands SDE OA(H) = (D A(H) x AR x A x DA) / BW Hands SDE OA(H) = (D A(H) x AR x A x PPE x DA) / BW (0.7 x x 8 x 75%) / 70 (0.7 x x 8 x 1 x 75%) / 70 External dermal exposure 0.42 mg/person External dermal exposure 0.42 mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Body Body SDE OA(B) = (D A(B) x AR x A x DA) / BW SDE OA(B) = (D A(B) x AR x A x PPE 2) x DA) / BW (9.6 x x 8 x 75%) / 70 (9.6 x x 8 x 0.05 x 75%) / 70 External dermal exposure 5.76 mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Head Head SDE OA(C) = (D A(C) x AR x A x DA) / BW SDE OA(C) = (D A(C) x AR x A x PPE x DA) / BW (1.2 x x 8 x 75%) / 70 (1.2 x x 8 x 1 x 75%) / 70 External dermal exposure 0.72 mg/person External dermal exposure 0.72 mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Total systemic dermal exposure: SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total systemic dermal exposure: SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total external dermal exposure 8.1 mg/person Total external dermal exposure 1.44 mg/person Total external dermal exposure mg/kg bw/d Total external dermal exposure mg/kg bw/d Total systemic dermal exposure mg/kg bw/d Total systemic dermal exposure mg/kg bw/d Operators: Systemic inhalation exposure after application in grapevine Inhalation exposure during mixing/loading SIE OM = (I M x AR x A x IA) / BW SIE OM = (I M x AR x A x PPE x IA) / BW (0.008 x x 8 x 100%) / 70 (0.008 x x 8 x 1 x 100%) / 70 External inhalation exposure mg/person External inhalation exposure mg/person Page 28 / 47

148 Sanvino ZV /00 Part B Section 3 - zrms Version External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Inhalation exposure during application SIE OA = (I A x AR x A x IA) / BW SIE OA = (I A x AR x A x PPE x IA) / BW (0.018 x x 8 x 100%) / 70 (0.018 x x 8 x 1 x 100%) / 70 External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Total systemic inhalation exposure: SIE O = SIE OM + SIE OA Total systemic inhalation exposure: SIE O = SIE OM + SIE OA Total external inhalation Total external inhalation mg/person exposure exposure mg/person Total external inhalation Total external inhalation mg/kg bw/d exposure exposure mg/kg bw/d Total systemic inhalation Total systemic inhalation mg/kg bw/d exposure exposure mg/kg bw/d Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure mg/person Total systemic exposure mg/person Total systemic exposure mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL 58.0 % % of AOEL 10.4 % 1) reduction factor for gloves is ) reduction factor for protective garment is 0.05 Table A 14: Input parameters considered for the estimation of operator exposure Formulation type: WG Application rate (AR): kg a.s./ha Application technique: High Crop Hand Held (HCHH) Area treated per day (A): 1 ha Dermal hands m/l (D M(H)): 21 mg/person/kg a.s. Dermal absorption (DA): 75 % (concentr.) Dermal hands appl. (D A(H)): 10.6 mg/person/kg a.s. 75 % (dilution) Dermal body appl. (D A(B)): 25 mg/person/kg a.s. Inhalation absorption (IA): 100 % Dermal head appl. (D A(C)): 4.8 mg/person/kg a.s. Body weight (BW): 70 kg/person Inhalation m/l (I M): 0.02 mg/person/kg a.s. AOEL 0.15 mg/kg bw/d Inhalation appl. (I A): 0.3 mg/person/kg a.s. Table A 15: Estimation of operator exposure towards amisulbrom using the German model (HCHH) Without PPE With PPE Operators: Systemic dermal exposure after application in grapevine Dermal exposure during mixing/loading Hands Hands SDE OM(H) = (D M(H) x AR x A x DA) / BW SDE OM(H) = (D M(H) x AR x A x PPE 1) x DA) / BW (21 x x 1 x 75%) / 70 (21 x x 1 x 0.01 x 75%) / 70 External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Dermal exposure during application Hands SDE OA(H) = (D A(H) x AR x A x DA) / BW Hands SDE OA(H) = (D A(H) x AR x A x PPE x DA) / BW (10.6 x x 1 x 75%) / 70 (10.6 x x 1 x 1 x 75%) / 70 External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Body Body SDE OA(B) = (D A(B) x AR x A x DA) / BW SDE OA(B) = (D A(B) x AR x A x PPE 2) x DA) / BW (25 x x 1 x 75%) / 70 (25 x x 1 x 0.05 x 75%) / 70 External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Head Head SDE OA(C) = (D A(C) x AR x A x DA) / BW SDE OA(C) = (D A(C) x AR x A x PPE x DA) / BW (4.8 x x 1 x 75%) / 70 (4.8 x x 1 x 1 x 75%) / 70 Page 29 / 47

149 Sanvino ZV /00 Part B Section 3 - zrms Version External dermal exposure 0.36 mg/person External dermal exposure 0.36 mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Total systemic dermal exposure: SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total systemic dermal exposure: SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total external dermal exposure mg/person Total external dermal exposure mg/person Total external dermal exposure mg/kg bw/d Total external dermal exposure mg/kg bw/d Total systemic dermal exposure mg/kg bw/d Total systemic dermal exposure mg/kg bw/d Operators: Systemic inhalation exposure after application in grapevine Inhalation exposure during mixing/loading SIE OM = (I M x AR x A x IA) / BW SIE OM = (I M x AR x A x PPE x IA) / BW (0.02 x x 1 x 100%) / 70 (0.02 x x 1 x 1 x 100%) / 70 External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Inhalation exposure during application SIE OA = (I A x AR x A x IA) / BW SIE OA = (I A x AR x A x PPE x IA) / BW (0.3 x x 1 x 100%) / 70 (0.3 x x 1 x 1 x 100%) / 70 External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Total systemic inhalation exposure: SIE O = SIE OM + SIE OA Total systemic inhalation exposure: SIE O = SIE OM + SIE OA Total external inhalation Total external inhalation mg/person exposure exposure mg/person Total external inhalation Total external inhalation mg/kg bw/d exposure exposure mg/kg bw/d Total systemic inhalation Total systemic inhalation mg/kg bw/d exposure exposure mg/kg bw/d Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure mg/person Total systemic exposure mg/person Total systemic exposure mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL 33.1 % % of AOEL 9.3 % 1) reduction factor for gloves is ) reduction factor for protective garment is 0.05 Table A 16: Estimation of operator exposure towards amisulbrom using the UK-POEM (tractor-mounted/trailed equipment; no PPE) Active substance Amisulbrom Product Sanvino Formulation type WG or SG Concentration of a.s. 50 mg/g Dose 1.5 kg preparation/ha Application volume 1600 L/ha Application method Tractor-mounted/trailed broadcast airassisted sprayer: 500 L/ha Work rate/day 15 ha Duration of spraying 6 h PPE during mix./loading None PPE during application None Dermal absorption from product 75 % Dermal absorption from spray 75 % DERMAL EXPOSURE DURING MIXING AND LOADING Hand contamination/kg a.s mg/kg a.s. Hand contamination/day mg/day Protective clothing None Transmission to skin 100 % (0.075 kg a.s./ha) Page 30 / 47

150 Sanvino ZV /00 Part B Section 3 - zrms Version Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING MIXING AND LOADING Inhalation exposure/kg a.s mg/kg a.s. Inhalation exposure/day 0.04 mg/day RPE None Transmission through RPE 100 % Inhalation exposure to a.s mg/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed broadcast airassisted sprayer: 500 L/ha Application volume 1600 spray/ha Volume of surface contamination 400 ml/h Distribution Hands Trunk Legs 10% 65% 25% Clothing None Permeable Permeable Penetration 100% 2% 5% Dermal exposure ml/h Duration of exposure 6 h Total dermal exposure to spray ml/day Concentration of a.s. in spray solution mg/ml Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure to spray 0.05 ml/h Duration of exposure 6 h Concentration of a.s. in spray mg/ml Inhalation exposure to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day ABSORBED DOSE Mix/load Application Dermal exposure to a.s mg/day mg/day Percent absorbed 75 % 75 % Absorbed dose (dermal route) mg/day mg/day Inhalation exposure to a.s mg/day mg/day Absorbed dose mg/day mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator exposure mg/kg bw/day Amount of AOEL % Table A 17: Estimation of operator exposure towards amisulbrom using the UK- POEM (tractor-mounted/trailed equipment; with PPE) Active substance Amisulbrom Product Sanvino Formulation type WG or SG Concentration of a.s. 50 mg/g Dose 1.5 kg (0.075 kg a.s./ha) Page 31 / 47

151 Sanvino ZV /00 Part B Section 3 - zrms Version preparation/ha Application volume 1600 L/ha Application method Tractor-mounted/trailed broadcast airassisted sprayer: 500 L/ha Work rate/day 15 ha Duration of spraying 6 h PPE during mix./loading Gloves PPE during application Gloves Dermal absorption from product 75 % Dermal absorption from spray 75 % DERMAL EXPOSURE DURING MIXING AND LOADING Hand contamination/kg a.s mg/kg a.s. Hand contamination/day mg/day Protective clothing Gloves Transmission to skin 1 % Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING MIXING AND LOADING Inhalation exposure/kg a.s mg/kg a.s. Inhalation exposure/day 0.04 mg/day RPE None Transmission through RPE 100 % Inhalation exposure to a.s mg/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed broadcast airassisted sprayer: 500 L/ha Application volume 1600 spray/ha Volume of surface contamination 400 ml/h Distribution Hands Trunk Legs 10% 65% 25% Clothing Gloves Permeable Permeable Penetration 10% 2% 5% Dermal exposure ml/h Duration of exposure 6 h Total dermal exposure to spray 85.2 ml/day Concentration of a.s. in spray solution mg/ml Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure to spray 0.05 ml/h Duration of exposure 6 h Concentration of a.s. in spray mg/ml Inhalation exposure to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day ABSORBED DOSE Mix/load Application Dermal exposure to a.s mg/day mg/day Percent absorbed 75 % 75 % Absorbed dose (dermal route) mg/day mg/day Page 32 / 47

152 Sanvino ZV /00 Part B Section 3 - zrms Version Inhalation exposure to a.s mg/day mg/day Absorbed dose mg/day mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator exposure mg/kg bw/day Amount of AOEL 34.4 % Table A 18: Estimation of operator exposure towards amisulbrom using the UK-POEM (hand-held equipment; no PPE) Active substance Amisulbrom Product Sanvino Formulation type WG or SG Concentration of a.s. 50 mg/g Dose 1.5 kg (0.075 kg a.s./ha) preparation/ha Application volume 1600 L/ha Application method Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, high level target Work rate/day 1 ha Duration of spraying 6 h PPE during mix./loading None PPE during application None Dermal absorption from product 75 % Dermal absorption from spray 75 % DERMAL EXPOSURE DURING MIXING AND LOADING Hand contamination/kg a.s mg/kg a.s. Hand contamination/day mg/day Protective clothing None Transmission to skin 100 % Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING MIXING AND LOADING Inhalation exposure/kg a.s mg/kg a.s. Inhalation exposure/day mg/day RPE None Transmission through RPE 100 % Inhalation exposure to a.s mg/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, high level target Application volume 1600 spray/ha Volume of surface contamination 50 ml/h Distribution Hands Trunk Legs 10% 65% 25% Clothing None Permeable Permeable Penetration 100% 15% 20% Dermal exposure ml/h Duration of exposure 6 h Total dermal exposure ml/day Page 33 / 47

153 Sanvino ZV /00 Part B Section 3 - zrms Version to spray Concentration of a.s. in spray solution mg/ml Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure to spray 0.01 ml/h Duration of exposure 6 h Concentration of a.s. in spray mg/ml Inhalation exposure to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day ABSORBED DOSE Mix/load Application Dermal exposure to a.s mg/day 3.48 mg/day Percent absorbed 75 % 75 % Absorbed dose (dermal route) mg/day 2.61 mg/day Inhalation exposure to a.s mg/day mg/day Absorbed dose mg/day mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator exposure mg/kg bw/day Amount of AOEL % Table A 19: Estimation of operator exposure towards amisulbrom using the UK-POEM (hand-held equipment; with PPE) Active substance Amisulbrom Product Sanvino Formulation type WG or SG Concentration of a.s. 50 mg/g Dose 1.5 kg preparation/ha Application volume 1600 L/ha Application method Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, high level target Work rate/day 1 ha Duration of spraying 6 h PPE during mix./loading Gloves PPE during application Gloves Dermal absorption from product 75 % Dermal absorption from spray 75 % DERMAL EXPOSURE DURING MIXING AND LOADING Hand contamination/kg a.s mg/kg a.s. Hand contamination/day mg/day Protective clothing Gloves Transmission to skin 1 % Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING MIXING AND LOADING Inhalation exposure/kg a.s mg/kg a.s. (0.075 kg a.s./ha) Page 34 / 47

154 Sanvino ZV /00 Part B Section 3 - zrms Version Inhalation exposure/day mg/day RPE None Transmission through RPE 100 % Inhalation exposure to a.s mg/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, high level target Application volume 1600 spray/ha Volume of surface contamination 50 ml/h Distribution Hands Trunk Legs 10% 65% 25% Clothing Gloves Permeable Permeable Penetration 10% 15% 20% Dermal exposure ml/h Duration of exposure 6 h Total dermal exposure to spray ml/day Concentration of a.s. in spray solution mg/ml Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure to spray 0.01 ml/h Duration of exposure 6 h Concentration of a.s. in spray mg/ml Inhalation exposure to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day ABSORBED DOSE Mix/load Application Dermal exposure to a.s mg/day mg/day Percent absorbed 75 % 75 % Absorbed dose (dermal route) mg/day mg/day Inhalation exposure to a.s mg/day mg/day Absorbed dose mg/day mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator exposure mg/kg bw/day Amount of AOEL 19.6 % A Table A 20: Calculations for folpet Input parameters considered for the estimation of operator exposure Formulation type: WG High Crop Tractor Mounted Application technique: Application rate (AR): 0.75 kg a.s./ha (HCTM) Area treated per day (A): 8 ha Dermal hands m/l (D M(H)): 2 mg/person/kg a.s. 4 % (concentr.) Dermal hands appl. (D A(H)): 0.7 mg/person/kg a.s. Dermal absorption (DA): 26 % (dilution) Dermal body appl. (D A(B)): 9.6 mg/person/kg a.s. Inhalation absorption (IA): 100 % Dermal head appl. (D A(C)): 1.2 mg/person/kg a.s. Body weight (BW): 70 kg/person Inhalation m/l (I M): mg/person/kg a.s. AOEL 0.1 mg/kg bw/d Inhalation appl. (I A): mg/person/kg a.s. Page 35 / 47

155 Sanvino ZV /00 Part B Section 3 - zrms Version Table A 21: Estimation of operator exposure towards folpet using the German model (HCTM) Without PPE With PPE Operators: Systemic dermal exposure after application in grapevine Dermal exposure during mixing/loading Hands Hands SDE OM(H) = (D M(H) x AR x A x DA) / BW SDE OM(H) = (D M(H) x AR x A x PPE 1) x DA) / BW (2 x 0.75 x 8 x 4%) / 70 (2 x 0.75 x 8 x 0.01 x 4%) / 70 External dermal exposure 12 mg/person External dermal exposure 0.12 mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Dermal exposure during application Hands SDE OA(H) = (D A(H) x AR x A x DA) / BW Hands SDE OA(H) = (D A(H) x AR x A x PPE x DA) / BW (0.7 x 0.75 x 8 x 26%) / 70 (0.7 x 0.75 x 8 x 1 x 26%) / 70 External dermal exposure 4.2 mg/person External dermal exposure 4.2 mg/person External dermal exposure 0.06 mg/kg bw/d External dermal exposure 0.06 mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Body Body SDE OA(B) = (D A(B) x AR x A x DA) / BW SDE OA(B) = (D A(B) x AR x A x PPE 2) x DA) / BW (9.6 x 0.75 x 8 x 26%) / 70 (9.6 x 0.75 x 8 x 0.05 x 26%) / 70 External dermal exposure 57.6 mg/person External dermal exposure 2.88 mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Head Head SDE OA(C) = (D A(C) x AR x A x DA) / BW SDE OA(C) = (D A(C) x AR x A x PPE x DA) / BW (1.2 x 0.75 x 8 x 26%) / 70 (1.2 x 0.75 x 8 x 1 x 26%) / 70 External dermal exposure 7.2 mg/person External dermal exposure 7.2 mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Total systemic dermal exposure: SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total systemic dermal exposure: SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total external dermal exposure 81 mg/person Total external dermal exposure 14.4 mg/person Total external dermal exposure mg/kg bw/d Total external dermal exposure mg/kg bw/d Total systemic dermal exposure mg/kg bw/d Total systemic dermal exposure mg/kg bw/d Operators: Systemic inhalation exposure after application in grapevine Inhalation exposure during mixing/loading SIE OM = (I M x AR x A x IA) / BW SIE OM = (I M x AR x A x PPE x IA) / BW (0.008 x 0.75 x 8 x 100%) / 70 (0.008 x 0.75 x 8 x 1 x 100%) / 70 External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Inhalation exposure during application SIE OA = (I A x AR x A x IA) / BW SIE OA = (I A x AR x A x PPE x IA) / BW (0.018 x 0.75 x 8 x 100%) / 70 (0.018 x 0.75 x 8 x 1 x 100%) / 70 External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Total systemic inhalation exposure: SIE O = SIE OM + SIE OA Total systemic inhalation exposure: SIE O = SIE OM + SIE OA Total external inhalation Total external inhalation mg/person exposure exposure mg/person Total external inhalation Total external inhalation mg/kg bw/d exposure exposure mg/kg bw/d Total systemic inhalation Total systemic inhalation mg/kg bw/d exposure exposure mg/kg bw/d Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure mg/person Total systemic exposure mg/person Total systemic exposure mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL % % of AOEL 55.3 % 1) reduction factor for gloves is ) reduction factor for protective garment is 0.05 Page 36 / 47

156 Sanvino ZV /00 Part B Section 3 - zrms Version Table A 22: Input parameters considered for the estimation of operator exposure Formulation type: WG Application technique: High Crop Hand Held (HCHH) Application rate (AR): 0.75 kg a.s./ha Area treated per day (A): 1 ha Dermal hands m/l (D M(H)): 21 mg/person/kg a.s. 4 % (concentr.) Dermal hands appl. (D A(H)): 10.6 mg/person/kg a.s. Dermal absorption (DA): 26 % (dilution) Dermal body appl. (D A(B)): 25 mg/person/kg a.s. Inhalation absorption (IA): 100 % Dermal head appl. (D A(C)): 4.8 mg/person/kg a.s. Body weight (BW): 70 kg/person Inhalation m/l (I M): 0.02 mg/person/kg a.s. AOEL 0.1 mg/kg bw/d Inhalation appl. (I A): 0.3 mg/person/kg a.s. Table A 23: Estimation of operator exposure towards folpet using the German model (HCHH) Without PPE Operators: Systemic dermal exposure after application in grapevine Dermal exposure during mixing/loading Hands SDE OM(H) = (D M(H) x AR x A x DA) / BW With PPE Hands SDE OM(H) = (D M(H) x AR x A x PPE 1) x DA) / BW (21 x 0.75 x 1 x 4%) / 70 (21 x 0.75 x 1 x 0.01 x 4%) / 70 External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Dermal exposure during application Hands SDE OA(H) = (D A(H) x AR x A x DA) / BW Hands SDE OA(H) = (D A(H) x AR x A x PPE x DA) / BW (10.6 x 0.75 x 1 x 26%) / 70 (10.6 x 0.75 x 1 x 1 x 26%) / 70 External dermal exposure 7.95 mg/person External dermal exposure 7.95 mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Body Body SDE OA(B) = (D A(B) x AR x A x DA) / BW SDE OA(B) = (D A(B) x AR x A x PPE 2) x DA) / BW (25 x 0.75 x 1 x 26%) / 70 (25 x 0.75 x 1 x 0.05 x 26%) / 70 External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Head Head SDE OA(C) = (D A(C) x AR x A x DA) / BW SDE OA(C) = (D A(C) x AR x A x PPE x DA) / BW (4.8 x 0.75 x 1 x 26%) / 70 (4.8 x 0.75 x 1 x 1 x 26%) / 70 External dermal exposure 3.6 mg/person External dermal exposure 3.6 mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Total systemic dermal exposure: SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total systemic dermal exposure: SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total external dermal exposure mg/person Total external dermal exposure mg/person Total external dermal exposure mg/kg bw/d Total external dermal exposure mg/kg bw/d Total systemic dermal exposure mg/kg bw/d Total systemic dermal exposure mg/kg bw/d Operators: Systemic inhalation exposure after application in grapevine Inhalation exposure during mixing/loading SIE OM = (I M x AR x A x IA) / BW SIE OM = (I M x AR x A x PPE x IA) / BW (0.02 x 0.75 x 1 x 100%) / 70 (0.02 x 0.75 x 1 x 1 x 100%) / 70 External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Inhalation exposure during application SIE OA = (I A x AR x A x IA) / BW SIE OA = (I A x AR x A x PPE x IA) / BW (0.3 x 0.75 x 1 x 100%) / 70 (0.3 x 0.75 x 1 x 1 x 100%) / 70 External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Page 37 / 47

157 Sanvino ZV /00 Part B Section 3 - zrms Version Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Total systemic inhalation exposure: SIE O = SIE OM + SIE OA Total systemic inhalation exposure: SIE O = SIE OM + SIE OA Total external inhalation Total external inhalation 0.24 mg/person exposure exposure 0.24 mg/person Total external inhalation Total external inhalation mg/kg bw/d exposure exposure mg/kg bw/d Total systemic inhalation Total systemic inhalation mg/kg bw/d exposure exposure mg/kg bw/d Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure mg/person Total systemic exposure mg/person Total systemic exposure mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL % % of AOEL 49.9 % 1) reduction factor for gloves is ) reduction factor for protective garment is 0.05 Table A 24: Estimation of operator exposure towards folpet using the UK-POEM (tractormounted/trailed equipment; no PPE) Active substance Folpet Product Sanvino Formulation type WG or SG Concentration of a.s. 500 mg/g Dose 1.5 kg preparation/ha (0.75 kg a.s./ha) Application volume 1600 L/ha Application method Tractor-mounted/trailed broadcast airassisted sprayer: 500 L/ha Work rate/day 15 ha Duration of spraying 6 h PPE during mix./loading None PPE during application None Dermal absorption from product 4 % Dermal absorption from spray 26 % DERMAL EXPOSURE DURING MIXING AND LOADING Hand contamination/kg a.s mg/kg a.s. Hand contamination/day mg/day Protective clothing None Transmission to skin 100 % Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING MIXING AND LOADING Inhalation exposure/kg a.s mg/kg a.s. Inhalation exposure/day mg/day RPE None Transmission through RPE 100 % Inhalation exposure to a.s mg/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed broadcast airassisted sprayer: 500 L/ha Application volume 1600 spray/ha Volume of surface contamination 400 ml/h Distribution Hands Trunk Legs 10% 65% 25% Clothing None Permeable Permeable Penetration 100% 2% 5% Dermal exposure ml/h Page 38 / 47

158 Sanvino ZV /00 Part B Section 3 - zrms Version Duration of exposure 6 h Total dermal exposure to spray ml/day Concentration of a.s. in spray solution mg/ml Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure to spray 0.05 ml/h Duration of exposure 6 h Concentration of a.s. in spray mg/ml Inhalation exposure to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day ABSORBED DOSE Mix/load Application Dermal exposure to a.s mg/day mg/day Percent absorbed 4 % 26 % Absorbed dose (dermal route) mg/day mg/day Inhalation exposure to a.s mg/day mg/day Absorbed dose mg/day mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator exposure mg/kg bw/day Amount of AOEL % Table A 25: Estimation of operator exposure towards folpet using the UK-POEM (tractormounted/trailed equipment; with PPE) Active substance Folpet Product Sanvino Formulation type WG or SG Concentration of a.s. 500 mg/g Dose 1.5 kg preparation/ha Application volume 1600 L/ha Application method Tractor-mounted/trailed broadcast airassisted sprayer: 500 L/ha Work rate/day 15 ha Duration of spraying 6 h PPE during mix./loading Gloves PPE during application Gloves Dermal absorption from product 4 % Dermal absorption from spray 26 % DERMAL EXPOSURE DURING MIXING AND LOADING Hand contamination/kg a.s mg/kg a.s. Hand contamination/day mg/day Protective clothing Gloves Transmission to skin 1 % Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING MIXING AND LOADING Inhalation exposure/kg mg/kg a.s. (0.75 kg a.s./ha) Page 39 / 47

159 Sanvino ZV /00 Part B Section 3 - zrms Version a.s. Inhalation exposure/day mg/day RPE None Transmission through RPE 100 % Inhalation exposure to a.s mg/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed broadcast airassisted sprayer: 500 L/ha Application volume 1600 spray/ha Volume of surface contamination 400 ml/h Distribution Hands Trunk Legs 10% 65% 25% Clothing Gloves Permeable Permeable Penetration 10% 2% 5% Dermal exposure ml/h Duration of exposure 6 h Total dermal exposure to spray 85.2 ml/day Concentration of a.s. in spray solution mg/ml Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure to spray 0.05 ml/h Duration of exposure 6 h Concentration of a.s. in spray mg/ml Inhalation exposure to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day ABSORBED DOSE Mix/load Application Dermal exposure to a.s mg/day mg/day Percent absorbed 4 % 26 % Absorbed dose (dermal route) mg/day mg/day Inhalation exposure to a.s mg/day mg/day Absorbed dose mg/day mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator exposure mg/kg bw/day Amount of AOEL % Table A 26: Estimation of operator exposure towards folpet using the UK-POEM (handheld equipment; no PPE) Active substance Folpet Product Sanvino Formulation type WG or SG Concentration of a.s. 500 mg/g Dose 1.5 kg preparation/ha Application volume 1600 L/ha Application method Hand-held rotary atomiser equipment (2.5 L (0.75 kg a.s./ha) Page 40 / 47

160 Sanvino ZV /00 Part B Section 3 - zrms Version tank). Outdoor, high level target Work rate/day 1 ha Duration of spraying 6 h PPE during mix./loading None PPE during application None Dermal absorption from product 4 % Dermal absorption from spray 26 % DERMAL EXPOSURE DURING MIXING AND LOADING Hand contamination/kg a.s mg/kg a.s. Hand contamination/day mg/day Protective clothing None Transmission to skin 100 % Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING MIXING AND LOADING Inhalation exposure/kg a.s mg/kg a.s. Inhalation exposure/day mg/day RPE None Transmission through RPE 100 % Inhalation exposure to a.s mg/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, high level target Application volume 1600 spray/ha Volume of surface contamination 50 ml/h Distribution Hands Trunk Legs 10% 65% 25% Clothing None Permeable Permeable Penetration 100% 15% 20% Dermal exposure ml/h Duration of exposure 6 h Total dermal exposure to spray ml/day Concentration of a.s. in spray solution mg/ml Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure to spray 0.01 ml/h Duration of exposure 6 h Concentration of a.s. in spray mg/ml Inhalation exposure to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day ABSORBED DOSE Mix/load Application Dermal exposure to a.s mg/day mg/day Percent absorbed 4 % 26 % Absorbed dose (dermal route) mg/day mg/day Inhalation exposure to a.s mg/day mg/day Page 41 / 47

161 Sanvino ZV /00 Part B Section 3 - zrms Version Absorbed dose mg/day mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator exposure mg/kg bw/day Amount of AOEL % Table A 27: Estimation of operator exposure towards folpet using the UK-POEM (handheld equipment; with PPE) Active substance Folpet Product Sanvino Formulation type WG or SG Concentration of a.s. 500 mg/g Dose 1.5 kg preparation/ha (0.75 kg a.s./ha) Application volume 1600 L/ha Application method Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, high level target Work rate/day 1 ha Duration of spraying 6 h PPE during mix./loading Gloves PPE during application Gloves Dermal absorption from product 4 % Dermal absorption from spray 26 % DERMAL EXPOSURE DURING MIXING AND LOADING Hand contamination/kg a.s mg/kg a.s. Hand contamination/day mg/day Protective clothing Gloves Transmission to skin 1 % Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING MIXING AND LOADING Inhalation exposure/kg a.s mg/kg a.s. Inhalation exposure/day mg/day RPE None Transmission through RPE 100 % Inhalation exposure to a.s mg/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, high level target Application volume 1600 spray/ha Volume of surface contamination 50 ml/h Distribution Hands Trunk Legs 10% 65% 25% Clothing Gloves Permeable Permeable Penetration 10% 15% 20% Dermal exposure ml/h Duration of exposure 6 h Total dermal exposure to spray ml/day Concentration of a.s. in spray solution mg/ml Page 42 / 47

162 Sanvino ZV /00 Part B Section 3 - zrms Version Dermal exposure to a.s mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure to spray 0.01 ml/h Duration of exposure 6 h Concentration of a.s. in spray mg/ml Inhalation exposure to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day ABSORBED DOSE Mix/load Application Dermal exposure to a.s mg/day mg/day Percent absorbed 4 % 26 % Absorbed dose (dermal route) mg/day mg/day Inhalation exposure to a.s mg/day mg/day Absorbed dose mg/day mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator exposure mg/kg bw/day Amount of AOEL 98.1 % A 3.2 Worker exposure calculations (IIIA ) A Table A 28: Calculations for amisulbrom Input parameters considered for the estimation of worker exposure Intended use(s): Grapevine Dislodgeable foliar residues (DFR): 1 µg/cm 2 /kg a.s. Application rate (AR): kg a.s./ha Transfer coefficient (TC): cm 2 /person/h Number of applications (NA): 4 Work rate per day (WR): 8 h/d Body weight (BW): 60 kg/person PPE 5 % Dermal absorption (DA): 75 % AOEL 0.15 mg/kg bw/d Table A 29: Estimation of worker exposure towards amisulbrom using the German reentry model Without PPE 1) With PPE 2) Worker (re-entry): Systemic dermal exposure after application in grapevine SDE W = (DFR x TC x WR x AR x NA x DA) / BW SDE W = (DFR x TC x WR x AR x NA x PPE x DA) / BW (1 x x 8 x x 4 x 75%) / 60 (1 x x 8 x x 4 x 5% x 75%) / 60 External dermal exposure 24 mg/person External dermal exposure 1.2 mg/person External dermal exposure 0.4 mg/kg bw/d External dermal exposure 0.02 mg/kg bw/d Total systemic exposure 18 mg/person Total systemic exposure 0.9 mg/person Total systemic exposure 0.3 mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL % % of AOEL 10.0 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves (allocation of BVL code SF for spray applications) 2) acceptable only with PPE: see 'Instructions for use' (allocation of BVL code SF1891) Page 43 / 47

163 Sanvino ZV /00 Part B Section 3 - zrms Version A Calculations for folpet Table A 30: Input parameters considered for the estimation of worker exposure Intended use(s): Grapevine Dislodgeable foliar residues (DFR): 1 µg/cm 2 /kg a.s. Application rate (AR): 0.75 kg a.s./ha Transfer coefficient (TC): cm 2 /person/h Number of applications (NA): 4 Work rate per day (WR): 8 h/d Body weight (BW): 60 kg/person PPE 5 % Dermal absorption (DA): 26 % ('worst case') AOEL 0.1 mg/kg bw/d Table A 31: Estimation of worker exposure towards folpet using the German re-entry model Without PPE 1) With PPE 2) Worker (re-entry): Systemic dermal exposure after application in grapevine SDE W = (DFR x TC x WR x AR x NA x DA) / BW SDE W = (DFR x TC x WR x AR x NA x PPE x DA) / BW (1 x x 8 x 0.75 x 4 x 26%) / 60 (1 x x 8 x 0.75 x 4 x 5% x 26%) / 60 External dermal exposure 240 mg/person External dermal exposure 12 mg/person External dermal exposure 4 mg/kg bw/d External dermal exposure 0.2 mg/kg bw/d Total systemic exposure 62.4 mg/person Total systemic exposure 3.12 mg/person Total systemic exposure 1.04 mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL % % of AOEL 52.0 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves (allocation of BVL code SF for spray applications) 2) acceptable only with PPE: see 'Instructions for use' (allocation of BVL code SF1891) A 3.3 Bystander and resident exposure calculations (IIIA ) A Calculations for amisulbrom Table A 32: Input parameters considered for the estimation of bystander exposure Intended use(s): Grapevine Drift (D): 8.02 % (HC, 3 m) Application rate (AR): kg a.s./ha Exposed body surface area 1 m² (adults) 7.5 mg/m 2 (BSA): 0.21 m² (children) Body weight (BW): 60 kg/person (adults) mg/kg a.s. (6 hours, 0.3 Specific Inhalation Exposure adults) kg/person (children) (I* A): mg/kg a.s. (6 hours, children) Dermal absorption (DA): 75 % Inhalation absorption (IA): 100 % Area Treated (A): 1 ha/d (based on HCHH) AOEL: 0.15 mg/kg bw/d Exposure duration (T): 5 min Table A 33: Estimation of bystander exposure towards amisulbrom Adults Children Bystander: Systemic dermal exposure during/after application (via spray drift) SDE B = (AR x D x BSA x DA) / BW SDE B = (AR x D x BSA x DA) / BW (7.5 x 8.02% x 1 x 75%) / 60 (7.5 x 8.02% x 0.21 x 75%) / External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Bystander: Systemic inhalation exposure during/after application (via spray drift) SIE B = (I* A x AR x A x T x IA) / BW SIE B = (I* A x AR x A x T x IA) / BW (0.3 / 360 x x 1 x 5 x 100%) / 60 ( / 360 x x 1 x 5 x 100%) / External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Page 44 / 47

164 Sanvino ZV /00 Part B Section 3 - zrms Version Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Total systemic exposure: SE B = SDE B + SIE B Total systemic exposure: SE B = SDE B + SIE B Total systemic exposure mg/person Total systemic exposure mg/person Total systemic exposure mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL 5.0 % % of AOEL 3.9 % Table A 34: Input parameters considered for the estimation of resident exposure Intended use(s): Grapevine Drift (D): 6.71 % (HC, 3 m, 4 appl.) Application rate (AR): kg a.s./ha 7300 cm 2 /h (adults) Transfer coefficient (TC): mg/cm cm 2 /h (children) Number of applications (NA): 4 Turf Transferable Residues (TTR): 5 % 60 kg/person (adults) Exposure Duration (H): 2 h Body weight (BW): Airborne Concentration of kg/person (children) 0 Vapour (ACV): mg/m 3 Dermal absorption (DA): 75 % m 3 /d (adults) Inhalation Rate (IR): Inhalation absorption (IA): 100 % 8.31 m 3 /d (children) Oral absorption (OA): 50 % Saliva Extraction Factor (SE): 50 % AOEL: 0.15 mg/kg bw/d Surface Area of Hands (SA): 20 cm 2 Frequency of Hand to Mouth (Freq): Dislodgeable foliar residues (DFR): Ingestion Rate for Mouthing of Grass/Day (IgR): 20 events/h 20 % 25 cm 2 /d Table A 35: Estimation of resident exposure towards amisulbrom Adults Children Residents: Systemic dermal exposure after application (via deposits caused by spray drift) SDE R = (AR x NA x D x TTR x TC x H x DA) / BW SDE R = (AR x NA x D x TTR x TC x H x DA) / BW ( x 4 x 6.71% x 5% x 7300 x 2 x 75%) / 60 ( x 4 x 6.71% x 5% x 2600 x 2 x 75%) / External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Residents: Systemic inhalation exposure after application (via vapour) SIE R = (AC V x IR x IA) / BW SIE R = (AC V x IR x IA) / BW (0 x x 100%) / 60 (0 x 8.31 x 100%) / External inhalation exposure none External inhalation exposure none Systemic inhalation exposure none Systemic inhalation exposure none Residents: Systemic oral exposure (hand-to-mouth transfer) SOE R(H) = (AR x NA x D x TTR x SE x SA x Freq x H x OA) / BW ( x 4 x % x 5% x 50% x 20 x 20 x 2 x 50%) / External oral exposure External oral exposure Systemic oral exposure mg/person mg/kg bw/d mg/kg bw/d Residents: Systemic oral exposure (object-to-mouth transfer) SOE R(O) = (AR x NA x D x DFR x IgR x OA) / BW ( x 4 x % x 20% x 25 x 50%) / External oral exposure External oral exposure Systemic oral exposure mg/person mg/kg bw/d mg/kg bw/d Total systemic exposure: SE R = SDE R + SIE R Total systemic exposure: SE R = SDE R + SIE R + SOE R(H) + SOE R(O) Total systemic exposure mg/person Total systemic exposure mg/person Total systemic exposure mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL 1.2 % % of AOEL 1.7 % Page 45 / 47

165 Sanvino ZV /00 Part B Section 3 - zrms Version A Table A 36: Calculations for folpet Input parameters considered for the estimation of bystander exposure Intended use(s): Grapevine Drift (D): 8.02 % (HC, 3 m) Application rate (AR): 0.75 kg a.s./ha Exposed body surface area 1 m² (adults) 75 mg/m 2 (BSA): 0.21 m² (children) Body weight (BW): 60 kg/person (adults) mg/kg a.s. (6 hours, 0.3 Specific Inhalation Exposure adults) kg/person (children) (I* A): mg/kg a.s. (6 hours, children) Dermal absorption (DA): 26 % ('worst case') Inhalation absorption (IA): 100 % Area Treated (A): 1 ha/d (based on HCHH) AOEL: 0.1 mg/kg bw/d Exposure duration (T): 5 min Table A 37: Estimation of bystander exposure towards folpet Adults Children Bystander: Systemic dermal exposure during/after application (via spray drift) SDE B = (AR x D x BSA x DA) / BW SDE B = (AR x D x BSA x DA) / BW (75 x 8.02% x 1 x 26%) / 60 (75 x 8.02% x 0.21 x 26%) / External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Bystander: Systemic inhalation exposure during/after application (via spray drift) SIE B = (I* A x AR x A x T x IA) / BW SIE B = (I* A x AR x A x T x IA) / BW (0.3 / 360 x 0.75 x 1 x 5 x 100%) / 60 ( / 360 x 0.75 x 1 x 5 x 100%) / External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Total systemic exposure: SE B = SDE B + SIE B Total systemic exposure: SE B = SDE B + SIE B Total systemic exposure mg/person Total systemic exposure mg/person Total systemic exposure mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL 26.1 % % of AOEL 20.4 % Table A 38: Input parameters considered for the estimation of resident exposure Intended use(s): Grapevine Drift (D): 6.71 % (HC, 3 m, 4 appl.) Application rate (AR): 0.75 kg a.s./ha 7300 cm 2 /h (adults) Transfer coefficient (TC): mg/cm cm 2 /h (children) Number of applications (NA): 4 Turf Transferable Residues (TTR): 5 % 60 kg/person (adults) Exposure Duration (H): 2 h Body weight (BW): Airborne Concentration of kg/person (children) Vapour (ACV): mg/m 3 Dermal absorption (DA): 26 % ('worst case') m 3 /d (adults) Inhalation Rate (IR): Inhalation absorption (IA): 100 % 8.31 m 3 /d (children) Oral absorption (OA): 100 % Saliva Extraction Factor (SE): 50 % AOEL: 0.1 mg/kg bw/d Surface Area of Hands (SA): 20 cm 2 Table A 39: Adults Frequency of Hand to Mouth (Freq): Dislodgeable foliar residues (DFR): Ingestion Rate for Mouthing of Grass/Day (IgR): Estimation of resident exposure towards folpet Children 20 events/h 20 % 25 cm 2 /d Residents: Systemic dermal exposure after application (via deposits caused by spray drift) SDE R = (AR x NA x D x TTR x TC x H x DA) / BW SDE R = (AR x NA x D x TTR x TC x H x DA) / BW ( x 4 x 6.71% x 5% x 7300 x 2 x 26%) / 60 ( x 4 x 6.71% x 5% x 2600 x 2 x 26%) / Page 46 / 47

166 Sanvino ZV /00 Part B Section 3 - zrms Version External dermal exposure mg/person External dermal exposure mg/person External dermal exposure mg/kg bw/d External dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Systemic dermal exposure mg/kg bw/d Residents: Systemic inhalation exposure after application (via vapour) SIE R = (AC V x IR x IA) / BW SIE R = (AC V x IR x IA) / BW (0.001 x x 100%) / 60 (0.001 x 8.31 x 100%) / External inhalation exposure mg/person External inhalation exposure mg/person External inhalation exposure mg/kg bw/d External inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Systemic inhalation exposure mg/kg bw/d Residents: Systemic oral exposure (hand-to-mouth transfer) SOE R(H) = (AR x NA x D x TTR x SE x SA x Freq x H x OA) / BW ( x 4 x % x 5% x 50% x 20 x 20 x 2 x 100%) / External oral exposure External oral exposure Systemic oral exposure mg/person mg/kg bw/d mg/kg bw/d Residents: Systemic oral exposure (object-to-mouth transfer) SOE R(O) = (AR x NA x D x DFR x IgR x OA) / BW ( x 4 x % x 20% x 25 x 100%) / External oral exposure External oral exposure Systemic oral exposure mg/person mg/kg bw/d mg/kg bw/d Total systemic exposure: SE R = SDE R + SIE R Total systemic exposure: SE R = SDE R + SIE R + SOE R(H) + SOE R(O) Total systemic exposure mg/person Total systemic exposure mg/person Total systemic exposure mg/kg bw/d Total systemic exposure mg/kg bw/d % of AOEL 6.6 % % of AOEL 12.1 % Page 47 / 47

167 Part B4 Germany Sanvino Page 1 of 39 REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product Name: Sanvino Active Substance: Amisulbrom 50 g/kg Folpet 500 g/kg Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: ADAMA Deutschland GmbH Applicant: ADAMA Deutschland GmbH Evaluator: DE

168 Part B4 Germany Sanvino Page 2 of 39 Table of Contents 4 METABOLISM AND RESIDUES DATA Evaluation of the active substances Amisulbrom Storage stability Metabolism in plants and plant residue definition(s) Metabolism in livestock and animal residue definition(s) Residues in rotational crops Residues in livestock Folpet Storage stability Metabolism in plants and plant residue definition(s) Metabolism in livestock and animal residue definition(s) Residues in rotational crops Residues in livestock Evaluation of the intended use Selection of critical use and justification Wine grapes Residues in primary crops Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Consumer intake and risk assessment Amisulbrom Folpet Proposed maximum residue levels (MRLs) Conclusion Appendix 1 List of data submitted in support of the evaluation Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability A 2.2 Residues in primary crops A Magnitude of residues in grapes A 2.3 Residues in processed commodities A 2.4 Residues in rotational crops A 2.5 Residues in livestock A 2.6 Other studies/information Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) Applicant: ADAMA Deutschland GmbH Evaluator: DE

169 Part B4 Germany Sanvino Page 3 of 39 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances Amisulbrom Table 4.1-1: Identity of the active substance Structural formula O O O O H S N 3 C S N N N CH 3 Br CH 3 N F Common Name Amisulbrom CAS number Storage stability A brief summary of the storage stability data on amisulbrom is given in the following table. Data has been previously evaluated at EU level and is described in detail in EFSA s Conclusion on the peer review (ASB ) and the DAR of 2012 (ASB ). Table 4.1-2: Stability of residues (Annex IIA, point 6.1) Stability of amisulbrom Grapes, potatoes, tomatoes (MET ): spiking level 0.1 mg/kg, -18 C, stable for at least 12 months Grape products pomace, juice and wine (MET ): spiking level 0.1 mg/kg, -18 C, stable for at least 6 months Metabolism in plants and plant residue definition(s) A brief summary of the metabolism of amisulbrom in plants is given in the following table. Data has been previously evaluated at EU level and is described in detail in EFSA s Conclusion on the peer review (ASB ) and the DAR of 2012 (ASB ). Applicant: ADAMA Deutschland GmbH Evaluator: DE

170 Part B4 Germany Sanvino Page 4 of 39 Table 4.1-3: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, and 6.7.1) Plant groups covered Grapes (RIP , Add. RIP ): 14 C indole and triazole labels, foliar application, 3x 100 g as/ha, 10 day intervals (at day 34, 24 and 14 before harvest), PHI 14 days The majority of radioactivity was recovered in the acetonitrile surface washes, which at harvest accounted for 89.1% TRR (0.258 mg/kg) and 92.8% TRR (0.498 mg/kg) in grapes and 70.1% TRR (4.314 mg/kg) and 60.6% TRR (5.565 mg/kg) in foliage treated with [indole- 14 C]- and [triazole- 14 C]-amisulbrom, respectively. The proportion of radiolabelled residue in surface washes declined between last treatment and harvest whilst that in the subsequent grape and foliage extracts increased, indicating penetration of amisulbrom into the plant matrices. Parent was the major radioactive residue at harvest (84.3% TRR and 83.4% TRR in grapes). The maximum level of the individual metabolites in grapes was 1.2% TRR ( mg/kg). Grapes (ASB ): 14 C indole and triazole labels, foliar application, 4x 75 g as/ha, 10 day intervals (at day 58, 48, 38 and 28 before harvest), PHI 28 days TRR at harvest (28 DALA) was up to 0.32 mg/kg in grapes and up to 3.58 mg/kg in foliage. The majority of the radioactivity was in the acetonitrile surface washes, which at harvest accounted for 81.9% TRR (0.261 mg/kg) and 81.1% TRR (0.187 mg/kg) in grapes and 60.9% TRR (1.837 mg/kg) and 75.6% TRR (2.702 mg/kg) in foliage treated with [indole- 14 C]- and [triazole- 14 C]-amisulbrom, respectively. The proportion of radiolabelled residue in surface washes declined between last treatment and harvest whilst that in the subsequent grape and foliage extracts increased, indicating penetration of amisulbrom into the plant matrices. The parent was the major radioactive residue at harvest (67.3% TRR and 69.8% TRR in grapes). The maximum level of the individual metabolites in grapes was 5.1% TRR ( mg/kg). Rotational crops Conclusion from all metabolism studies: The route of metabolism involves a series of reactions, including cleavage of the sulfonamide side chain on the triazole ring, debromination, oxidation/hydroxylation, cleavage of the sulfonyl bridge between the indole and triazole moieties and indole ring opening. This resulted in the production of low levels of numerous primary and secondary, polar and non-polar metabolites (e.g. non bridge cleaved metabolites: IT-2, IT-3, IT-4, IT-5, IT-6, IT-9, IT-10, IT-11, IT-12; bridge cleaved metabolites: I-2, I-3, T-2). In addition, there was evidence for some conjugation and natural incorporation into plant matrices. Confined study (RIP ): application of 0.6 kg as/ha to bare soil, indole and triazole labels, PBI 30 and 120 and 365 days (samples of the latter interval not analyzed), rotational crops lettuce (leafy vegetable), wheat (cereal), carrots (root and tuber vegetable) Amisulbrom was not found in rotational crop matrices. Major metabolites in wheat were the triazole metabolites Applicant: ADAMA Deutschland GmbH Evaluator: DE

171 Part B4 Germany Sanvino Page 5 of 39 Metabolism in rotational crops similar to metabolism in primary crops? (yes/no) Distribution of the residue in peel/ pulp Processed commodities (nature of residue) Residue pattern in raw and processed commodities similar? (yes/no) T-3 (triazole sulfonic acid), T-5 (triazole alanine) and T-6 (triazole acetic acid); all were 11.6 % TRR (0.009 mg/kg) and in carrots T-5 and T-6 (maximum 18.3% TRR, mg/kg). In lettuce all residues were 0.01 mg/kg. All metabolites in all crops studied are likely to be present at levels less than 0.01 mg/kg. Yes, but higher share of triazole metabolites. Not applicable Standard hydrolysis study (RIP ): ph4/90 C/20 min (pasteurization), ph5/100 C/60 min (boiling) and ph6/120 C/20 min (sterilisation); indole and triazole labels Amisulbrom is extensively degraded to IT-4 under all hydrolysis conditions tested and to I-1 and T-1 under sterilisation conditions. IT-4 accounted for a high proportion of the recovered radioactive residue especially under boiling and sterilisation conditions (44-62 %). Yes: Metabolites observed in the hydrolysis study are also present in plant metabolism, but higher shares of IT-4 and I-1 are observed under processing conditions. Plant residue definition for monitoring Amisulbrom (according to Reg. (EC) No. 396/2005) Plant residue definition for risk assessment Amisulbrom (fruiting and root/tuber crops) Amisulbrom and metabolites IT-4 and I-1 for processed commodities (EFSA Conclusion 2013, ASB ) Conversion factor(s) (monitoring to risk assessment) Not necessary for fruiting and root/tuber crops; not yet concluded for processed commodities Metabolism in livestock and animal residue definition(s) A brief summary of the metabolism of amisulbrom in livestock is given in the following table. Data has been previously evaluated at EU level and is described in detail in EFSA s Conclusion on the peer review (ASB ) and the DAR of 2012 (ASB ). Table 4.1-4: Metabolism in livestock (Annex IIA, point to and 6.7.1) Animals covered Ruminants Lactating goats (RIP ): indole label at 8.85 mg/kg and triazole label at mg/kg on 5 consecutive days % of applied dose was eliminated in urine, % in faeces. Only in liver and kidney were TRRs above mg/kg. IT-4-N-glucuronide was the major metabolite, accounting for 18 % TRR in liver and for % TRR in kidney. Other components were IT-4 and IT-5, which together with IT-4-N-glucuronide accounted for up to 50 % TRR in kidney (0.15 mg/kg) and 20 % TRR in liver (0.06 mg/kg). The route of metabolism involved cleavage of the sulfonamide side chain on the triazole ring, oxidation/hydroxylation and N-glucuronidation. Time needed to reach a plateau concentration in milk and eggs 3 days Applicant: ADAMA Deutschland GmbH Evaluator: DE

172 Part B4 Germany Sanvino Page 6 of 39 Animal residue definition for monitoring According to Reg. 396/2005: Amisulbrom Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Not concluded Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) Provisionally proposed by EFSA: IT-4 and IT-4-Nglucuronide (EFSA Conclusion 2013, ASB ) Provisional: IT-4 and IT-4-N-glucuronide (EFSA Conclusion 2013, ASB ) Yes log P O/W = 4.4 (ph 6.4 and 40 C), fat solubility not yet concluded (EFSA Conclusion 2013, ASB ) Residues in rotational crops Field rotational crop studies on amisulbrom are not available and not required. See EFSA s Conclusion on the peer review (ASB ) and the DAR of 2012 (ASB ) for further reasoning. Table 4.1-5: Residues in rotational crops (Annex IIA, point 6.6.3) Field studies Significant residues are not expected in food and feed commodities obtained from succeeding crops (consequent to uses in compliance with cgap) Residues in livestock No significant residues of amisulbrom are likely to be present in the total diet as received by livestock (i.e. <0.1 mg/kg). Table 4.1-6: Conditions of requirement of livestock feeding studies (Annex IIA, point 6.4) Expected intakes by livestock 0.1 mg/kg diet (dry weight basis) (yes/no If yes, specify the level) Ruminant: Poultry: Pig: No No No Potential for accumulation (yes/no): No No data See ruminant Metabolism studies indicate potential level of residues 0.01 mg/kg in edible tissues (yes/no) No No data See ruminant Livestock feeding studies are not available and not required. See EFSA s Conclusion on the peer review (ASB ) and the DAR of 2012 (ASB ) for further reasoning. Applicant: ADAMA Deutschland GmbH Evaluator: DE

173 Part B4 Germany Sanvino Page 7 of 39 Table 4.1-7: Results of livestock feeding studies (Annex IIA, point 6.4) Ruminant: Poultry: Pig: Feeding studies No data No data No data Feeding levels in mg/kg feed DM No data No data No data Feeding levels in mg/kg bw No data No data No data Relevant dosing levels in feeding study: Not applicable Not applicable Not applicable Expected residue levels in animal matrices at calculated dietary burden (mg/kg): Muscle <0.01 <0.01 <0.01 Liver <0.01 <0.01 <0.01 Kidney <0.01 <0.01 Fat <0.01 <0.01 <0.01 Milk <0.01 Eggs < Folpet Table 4.1-8: Identity of the active substance Structural formula Common Name Folpet CAS number Storage stability A brief summary of the storage stability data on folpet is given in the following table. Data, which has been previously evaluated at EU level is described in detail in EFSA s Conclusion on the Peer review of the pesticide risk assessment (ASB ) and EFSA s Reasoned opinion on the review of the existing MRLs for folpet according to Article 12 of Reg (EC) No 396/2005 (ASB ). Applicant: ADAMA Deutschland GmbH Evaluator: DE

174 Part B4 Germany Sanvino Page 8 of 39 Table 4.1-9: Stability of residues (Annex IIA, point 6.1) Stability of folpet - Grapes: 12 months (RIP ) - Grape products: at least 1 month in grape juice (ASB ) - Tomatoes: 18 months (ASB ) - Onions: at least 1 month (ASB ), 12 months (EFSA, ASB ) - Tomato products: puree and paste at least 1 month (ASB ) - Apples: at least 5 months (ASB ) - Apple pomace and apple juice: at least 1 month (ASB ) - Wheat grain, straw: 12 months (EFSA, ASB ) - Cranberries: 6 months (ASB ) - Cucumbers: at least 1 month (ASB ) - Lettuce: at least 3 months (ASB ) Stability of phthalimide - Grapes: 13 months according to EFSA (ASB ) - Tomatoes: 13 months according to EFSA (ASB ) - Onions: 18 months according to EFSA (ASB ) Metabolism in plants and plant residue definition(s) A brief summary of the metabolism of folpet in plants is given in the following table. Data, which has been previously evaluated at EU level is described in detail in EFSA s Conclusion on the Peer review of the pesticide risk assessment (ASB ) and EFSA s Reasoned opinion on the review of the existing MRLs for folpet according to Article 12 of Reg (EC) No 396/2005 (ASB ). Table : Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, and 6.7.1) Plant groups covered Rotational crops Metabolism in rotational crops similar to metabolism in primary crops? (yes/no) Distribution of the residue in peel/ pulp grapes (RIP ): foliar spray application, [Uphenyl- 14 C] label, 3 x 1.5 kg as/ha at BBCH 71 (berry set stage), BBCH (mid-berry stage) and BBCH 89 (late-berry stage) The TRR at harvest was 7.59 mg/kg in grapes and mg/kg in leaves, respectively. The residue contained folpet (grapes: 2.02 mg/kg, leaves: mg/kg), phtalimide, phtalic acid and phtalic acid conjugates. Not required due to a very short DT 50 in soil. Not applicable Not applicable Processed commodities (nature of residue) ASB : test conditions were 90 C/20 min/ph 4 (representative of pasteurization); 100 C/60 min/ph 5 (representative of baking, boiling, brewing) and 120 C/20 min/ph 6 (representative of sterilization) Conditions of pasteurization lead to 91.9 % phtalimide and 8.2 % phtalic acid. Conditions of baking/boiling/brewing lead to 42.2 % phtalic acid and 57.9 % phtalimide. Conditions of sterilization lead to phtalic acid (>80 %) and an additional compound that could not be assigned to one of the reference compounds, but could be related to phtalic anhydride. Applicant: ADAMA Deutschland GmbH Evaluator: DE

175 Part B4 Germany Sanvino Page 9 of 39 Residue pattern in raw and processed commodities similar? (yes/no) No Plant residue definition for monitoring Reg. (EC) No 396/2005: Folpet* EFSA proposal: Sum of folpet and phthalimide, expressed as folpet (ASB ) Plant residue definition for risk assessment Sum of folpet and phthalimide, expressed as folpet (EFSA, ASB ) Conversion factor(s) (monitoring to risk assessment) 1.6 for wine grapes (EFSA, ASB ) Phthalimide is mainly formed during processing. No conversion factors were derived for other commodities yet * The enforcement residue definition for the following commodities is "the sum of captan and folpet": (pome fruit); (strawberries); (blackberries); (raspberries); (currants); (gooseberries); (tomatoes); (beans with pods); (beans without pods) Metabolism in livestock and animal residue definition(s) A brief summary of the metabolism of folpet in livestock is given in the following table. Data has been previously evaluated at EU level and is described in detail in EFSA s Conclusion on the Peer review of the pesticide risk assessment (ASB ) and EFSA s Reasoned opinion on the review of the existing MRLs for folpet according to Article 12 of Reg (EC) No 396/2005 (ASB ). Table : Metabolism in livestock (Annex IIA, point to and 6.7.1) Animals covered Lactating goat (Part A TOX , Part B ASB ): trichloromethyl- 14 C label, 3 days, 20 mg/kg feed trichloromethyl, 6 days, 24 mg/kg feed phenyl- 14 C label, 6 days, 14 mg/kg feed Folpet is extensively metabolised and excreted and was not found in any edible tissue. Total residues in animal tissues were also very low and no accumulation was observed. Only in liver and kidney TRRs were above 0.01 mg as-eq/kg (0.02 and 0.05 mg as-eq/kg, respectively). The metabolism was found to be similar to that observed in rats proceeding via hydrolysis of the nitrogen-sulphur bond leading to thiophosgen and phthalimide which is then further metabolised to phthalamic acid and phthalic acid. According to the guidance recommendations, goats should have been fed with both folpet and phthalimide since the residue definition for risk assessment in plant commodities includes the metabolite phthalimide. Nevertheless, considering the above results, this deviation is not of concern because phthalimide is rapidly generated in vivo following exposure to folpet (EFSA, ASB ). EFSA identified a data gap concerning the investigation on the nature and magnitude of residues in poultry (ASB ). This is however not of importance in the context of the present evaluation of applications on wine grapes. Applicant: ADAMA Deutschland GmbH Evaluator: DE

176 Part B4 Germany Sanvino Page 10 of 39 Time needed to reach a plateau concentration in milk and eggs Milk: 4-5 days Animal residue definition for monitoring Reg. (EC) No 396/2005: residue not defined (no MRLs set for animal products yet) Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Not applicable Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) EFSA proposal: Phthalimide expressed as folpet (ASB ) Phthalimide expressed as folpet (EFSA, ASB ) Yes No Residues in rotational crops No field rotational crop studies on folpet were available or required. This was already concluded by EFSA after the peer review (ASB ) and in the Reasoned Opinion on the review of the existing MRLs for folpet according to Article 12 of Reg (EC) No 396/2005 (ASB ). Table : Residues in rotational crops (Annex IIA, point 6.6.3) Field studies No studies required due to a very short DT 50 in soil (low persistence of both folpet and phthalimide) Residues in livestock An actual calculation of the dietary burden, based on all relevant uses authorized in the EU (EFSA, ASB ), is provided in the following table. Table : Calculation of the dietary burden (based on all relevant uses authorized in the EU Feedstuff % DM Percent of daily livestock diet (dry feed basis) Chicken 1,9 kg bw daily maximum feed (DM) 120 g Dairy cattle 550 kg bw daily maximum feed (DM) 20 kg Beef cattle 350 kg bw daily maximum feed (DM) 15 kg Pig 75 kg bw daily maximum feed (DM) 3 kg Residue (mg/kg) Intake (mg/kg, dry feed basis) Chicken Grain a Bran (Wheat and Rye) Dairy cattle Beef cattle a Straw (Cereals) a Potatoes b Intake (mg/kg dry weight feed) Intake (mg/kg bw/d) Intake (mg/animal/d) a STMR (grain), STMR-P (bran, PF =8), HR (straw), based on the following cgap: 2 x 0.75 kg as/ha, BBCH 30-65, PHI: 42 d b HR, based on the following cgap (SEU-GAP): 3 x 1.25 kg as/ha, up to BBCH 48, PHI: 7 d Pig Applicant: ADAMA Deutschland GmbH Evaluator: DE

177 Part B4 Germany Sanvino Page 11 of 39 Table : Conditions of requirement of livestock feeding studies on folpet Expected intakes by livestock 0.1 mg/kg diet (dry weight basis) (yes/no If yes, specify the level) Ruminant: Poultry: Pig: yes 2.53 (dairy) 5.71 (beef) yes 0.30 Potential for accumulation (yes/no): no no no Metabolism studies indicate potential level of residues 0.01 mg/kg in edible tissues (yes/no) yes 0.62 no no no Livestock feeding studies were not available and are not considered necessary. Ruminant: Poultry: Pig: Feeding studies Lactating goat No data available. EFSA identified a data gap concerning investigations on nature and magnitude of residues in poultry (ASB ). This is however not of importance in the context of the present evaluation. Feeding levels in mg/kg feed DM 14 or 20 (metab. study) Relevant dosing levels in feeding study: see ruminants see ruminants Feeding levels in mg/kg bw 14 or 20 (metab. study) see ruminants Expected residue levels in animal matrices at calculated dietary burden (mg/kg): Muscle <0.01 <0.01 <0.01 Liver <0.01 <0.01 <0.01 Kidney <0.01 <0.01 Fat <0.01 <0.01 <0.01 Milk <0.01 Eggs < Evaluation of the intended use Selection of critical use and justification The GAP reported for the central zone is presented in Table It has been used for consumer intake and risk assessment. Applicant: ADAMA Deutschland GmbH Evaluator: DE

178 Part B4 Germany Sanvino Page 12 of 39 Table 4.2-1: Critical Use (worst case) used for consumer intake and risk assessment Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) (a) F G or I (b) Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) (c) Application Application rate PHI Method / Kind (d-f) Timing / Growth stage of crop & season (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) kg product / ha a) max. rate per appl. b) max. total rate per crop/season kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha min / max (days) (i) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures (j) 1 DE wine grapes ( ) F downy mildew of grapevine (Plasmopara viticola) spraying or fine spraying (low volume spraying) BBCH a) 4 b) 4 (12 days) a) basic application: BBCH 61: 0.75 a) as1: amisulbrom as2: folpet as1: as2: as1: as2: max. 400 max BBCH 71: BBCH 75: 1.5 b) 6.0 as1: as2: as1: as2: 0.75 b) as1: 0.3 as2: 3.0 max max Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (d) All abbreviations used must be explained (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (h) The minimum and maximum number of application possible under practical conditions of use must be provided (i) PHI - minimum pre-harvest interval (j) Remarks may include: Extent of use/economic importance/restrictions Applicant: ADAMA Deutschland GmbH Evaluator: DE

179 Part B4 Germany Sanvino Page 13 of Wine grapes Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of amisulbrom in wine grapes. For the detailed evaluation of residue trials it is referred to Appendix 2. Table 4.2-2: Overview of the selected supervised residue trials for amisulbrom Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (amisulbrom) Wine grapes NEU Outdoor 0.03 (2); <0.05; 0.05; (3), 0.10 (3), 0.11 (2), 0.12, 0.13, 0.15, 0.16, 0.18; 0.21; 0.24; 0.28 Risk assessment (amisulbrom) 0.03 (2); <0.05; 0.05; (3), 0.10 (3), 0.11 (2), 0.12, 0.13, 0.15, 0.16, 0.18; 0.21; 0.24; 0.28 STMR (mg/kg) (b) HR (mg/kg) (c) Existing MRL (mg/kg) (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. Median CF (d) The following table gives a brief overview of the supervised residue trials selected for the assessment of folpet in wine grapes. For the detailed evaluation of residue trials it is referred to Appendix 2. Table 4.2-3: Overview of the selected supervised residue trials for folpet Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (folpet) Wine grapes NEU Outdoor 0.060, 0.11, 0.15, 0.23, 0.64, 0.83, 1.3, 1.6, 1.7 Risk assessment (sum of folpet and phthalimide, expressed as folpet e ) 0.096, 0.18, 0.24, 0.37, 1.02, 1.33, 2.1, 2.6, 2.7 STMR (mg/kg) (b) HR (mg/kg) (c) Existing MRL (mg/kg) Median CF (d) (e) (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. (e) Use of median CF of available residue trials data in EFSA s RO on the review of existing MRLs (ASB ) since submitted residue trials which were analyzed for folpet and phthalimide were not conducted according to the intended GAP (8 to 10 applications instead of 4 as proposed) Distribution of the residue in peel/pulp Not relevant Residues in processed commodities Amisulbrom The following table gives a brief overview of the results of processing studies for amisulbrom in wine grapes, which have already been described in detail in the DAR (ASB ) and EFSA s Conclusion on the peer review (ASB ). It has to be noted that no information on the concentration of amisulbrom metabolites was available. Applicant: ADAMA Deutschland GmbH Evaluator: DE

180 Part B4 Germany Sanvino Page 14 of 39 Table 4.2-4: Overview of the available processing studies for amisulbrom in wine grapes Processed commodity Number of studies Individual PFs Grape/ wet pomace 5 1.9, 2.4, 2.7, 3.9, 4.0 Grape/ dry pomace 5 0.7, 4.9, 7.0, 7.1, 10.3 Grape/ red wine (must heated at 60 C) , 0.04, 0.20 Median PF (a) Median CF (b) Comments EFSA, 2013 (ASB ) Grape/ red wine , Raisins 5 1.4, 2.1, 2.3, 2.6, (a): The median processing factor (PF) is obtained by calculating the median of the individual PFs of each processing study. (b): The median conversion factor (CF) for enforcement to risk assessment is obtained by calculating the median of the individual CFs of each processing study. Folpet The following table gives a brief overview of the results of processing studies for folpet in wine grape, which have already been described in detail in EFSA s Reasoned opinion on the modification of the existing MRL for folpet in wine grapes (ASB ) and EFSA s Reasoned opinion on the review of the existing MRLs for folpet according to Article 12 of Reg (EC) No 396/2005 (ASB ). Table 4.2-5: Overview of the available processing studies for folpet in wine grapes Processed commodity Number of studies Range of individual PFs Median PF (a) Median CF (b) Comments Juice to Merged dataset for juice and must, PF is based on sum of folpet and phthalimide, expressed as folpet Wine to PF is based on sum of folpet and phthalimide, expressed as folpet (a): The median processing factor (PF) is obtained by calculating the median of the individual PFs of each processing study. (b): The median conversion factor (CF) for enforcement to risk assessment is obtained by calculating the median of the individual CFs of each processing study Proposed pre-harvest intervals, withholding periods The proposed pre-harvest interval (PHI) of 28 days is appropriate. 4.3 Consumer intake and risk assessment Amisulbrom The key data for consumer intake assessment, which have been derived from residue and/or processing studies for the intended uses, are summarized in Table Applicant: ADAMA Deutschland GmbH Evaluator: DE

181 Part B4 Germany Sanvino Page 15 of 39 Table 4.3-1: Key data for consumer intake assessment derived for the intended uses Commodity Long-term intake Input value (mg/kg) Comment Wine grapes STMR-P (STMR: mg/kg PF 0.08) Short-term intake Input value (mg/kg) Comment STMR-P (STMR: mg/kg PF 0.08) The toxicological reference values and all input values used for consumer risk assessment are stated in Table To illustrate the results of the chronic risk assessment, a screenshot of the TMDI results obtained with EFSA PRIMO is displayed in Appendix 3. Table 4.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) Chronic risk assessment ADI 0.1 mg/kg bw (EFSA 2013) TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS II IEDI (% ADI) according to EFSA PRIMo rev.2 NEDI (% ADI) according to German NVS II Factors included in IEDI and NEDI Acute risk assessment ARfD IESTI (% ARfD) according to EFSA PRIMo rev.2 4 % (based on WHO Cluster diet B, mean body weight) 2 % (based on German children aged 2-4 years, individual consumption/body weight ratio) Not necessary Not necessary None 0.3 mg/kg bw Wine grapes: <1 % (based on UK adults, mean body weight) NESTI (% ARfD) according to German NVS II Wine grapes: <1 % (based on DE general popuation years, individual consumption/body weight ratio) Factors included in IESTI and NESTI None Folpet The key data for consumer intake assessment, which have been derived from residue and/or processing studies for the intended uses, are summarized in Table Table 4.3-3: Key data for consumer intake assessment derived for the intended uses Commodity Wine grapes Long-term intake Input value (mg/kg) 0.46 (wine) 0.84 (juice) Comment STMR-P (STMR: 1.02 mg/kg PF 0.45) STMR-P (STMR: 1.02 mg/kg PF 0.82) Short-term intake Input value (mg/kg) 0.46 (wine) 0.84 (juice) Comment STMR-P (STMR: 1.02 mg/kg PF 0.45) STMR-P (STMR: 1.02 mg/kg PF 0.82) The toxicological reference values and all input values used for consumer risk assessment are stated in Table To illustrate the results of the chronic risk assessment, a screenshot of the TMDI results Applicant: ADAMA Deutschland GmbH Evaluator: DE

182 Part B4 Germany Sanvino Page 16 of 39 obtained with EFSA PRIMO is displayed in Appendix 3. Table 4.3-4: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) Chronic risk assessment ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS II IEDI (% ADI) according to EFSA PRIMo rev.2 NEDI (% ADI) according to German NVS II Factors included in IEDI and NEDI Acute risk assessment ARfD IESTI (% ARfD) according to EFSA PRIMo rev mg/kg bw Not conducted since MRLs are currently set for DoR folpet only Not conducted since MRLs are currently set for DoR folpet only 22 % (French all population, see EFSA, ASB ) Not conducted STMR and PF values as reported by EFSA (ASB ) 0.2 mg/kg bw Wine: 6 % (based on UK adults, mean body weight) Juice: 14 % (based on DE children, mean body weight) NESTI (% ARfD) according to German NVS II Wine: 2 % (based on German general population, years, individual consumption/body weight ratio) Juice: 13 % (based on DE children, individual consumption/body weight ratio) Factors included in IESTI and NESTI STMR grapes: 1.02 PFs: wine 0.45; grape juice 0.82 (EFSA, ASB ) 4.4 Proposed maximum residue levels (MRLs) No new MRLs are required. 4.5 Conclusion Amisulbrom The following data gap was noticed: Studies on the magnitude of residues in processed grape commodities including analysis of amisulbrom metabolites IT-4 and I-1 are missing. Amisulbrom was significantly degraded under standard hydrolysis conditions (pasteurization, boiling and sterilization) forming the metabolite IT-4. In addition, metabolite I-1 was detected in significant amounts under sterilization conditions. Since sufficient information was not available to address the toxicity of the metabolites formed under hydrolysis conditions, the residue definition for risk assessment for processed commodities was provisionally set as amisulbrom and metabolites IT-4 and I-1. Submitted processing studies on grapes were analyzed for amisulbrom only and no information on IT-4 and I-1 was provided. Due to the low percentage of utilization of ADI and ARfD, it is considered sufficient to fill the data gap in the context of the next application for the approval of amisulbrom according to Reg. (EC) No 1107/2009 or in the context of the assessment of existing MRLs of amisulbrom according to article 12 of Reg. (EC) No 396/2005. For the time being, the available data are sufficient for dietary risk assessment. An exceedance of the current MRL of 0.5 mg/kg for amisulbrom in wine grapes as laid down in Applicant: ADAMA Deutschland GmbH Evaluator: DE

183 Part B4 Germany Sanvino Page 17 of 39 Reg. (EU) 396/2005 is not expected. The long-term and the short-term intake of amisulbrom residues are unlikely to present a public health concern. Folpet The available data are sufficient for dietary risk assessment. An exceedance of the current MRL of 10 mg/kg for folpet in wine grapes as laid down in Reg. (EU) 396/2005 is not expected. The long-term and the short-term intake of folpet and phthalimide 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 use. Appendix 1 List of data submitted in support of the evaluation Table A 1: List of data submitted in support of the evaluation Annex point/ reference No Author(s) Year Title Report-No. Authority registration No All United Kingdom 2008 Amisulbrom: (Draft Assessment Report) Vol. 1-3 GLP: Open Published: Yes ASB All United Kingdom 2012 Amisulbrom; Draft Assessment Report; Vol. 1-3 ASB All EFSA 2012 Reasoned opinion on the modification of the existing MRL for Folpet in wine grapes EFSA Journal 2012;10(6):2769 ASB All EFSA 2013 Conclusion on the peer review of the pesticide risk assessment of the active substance Amisulbrom EFSA Journal 2013;11(6):3237 ASB All EFSA 2009 Conclusion regarding the peer review of the pesticide risk assessment of the active substance folpet EFSA Scientific Report (2009) 297, 1-80 ASB All EFSA 2011 Reasoned Opinion - Modification of the existing MRLs for Folpet in wine grapes, garlic and tomatoes EFSA Journal 2011;9(9):2391, 1-40 ASB All EFSA 2014 Reasoned opinion on the review of the existing maximum residue levels (MRLs) for Folpet according to Article 12 of Regulation (EC) No 396/2005 EFSA Journal 2014;12(5):3700 ASB Data protection claimed Owner How considered in drr * Add Add Add Add Add Add Add Applicant: ADAMA Deutschland GmbH Evaluator: DE

184 Part B4 Germany Sanvino Page 18 of 39 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No OECD KIIA 6.1 Tate, S Validation of methodology for the determination of residues of NC-224 in grapes, potatoes and tomatoes and twelve month storage stability at approximately -18 C AN302! NAS 490/ BVL , BVL , MET OECD KIIA 6.1 Tate, S Validation of methodology for the determination of residues of NC-224 in processed fractions of grapes and six month storage stability at approximately -18 C AN303! NAS 648/ BVL , MET OECD KIIA 6.1 Fuchsbichler, G Folpet, investigation of the storage stability in white and red grapes HVA 12/94! R-8096 BVL , RIP OECD KIIA 6.1 Singer, G. M Summery of storage stability studies of Folpet on various raw Agricultural Commodities R-9142 BVL , ASB OECD KIIA Crowe, A NC-224: Metabolism in grapes R202! NAS 425/ BVL , RIP OECD KIIA Crowe, A NC-224: Metabolism in grapes + one report amendment R203! NAS 425/ BVL , RIP OECD KIIA Crowe, A Metabolism in grapes (incl. amendment no. 1 dated ) R203! NAS 631/ BVL , BVL , ASB OECD KIIA O Connor, J.; Mester, T Folpet: Nature of residues on grapes. Final report - incl. field report 6091B vom /WLS019/0962! R-6403a! 93/0962! R329201! 6091B BVL , RIP OECD KIIA XXXXX C-Folpet metabolism in the lactating goat (part A). 14C- trichloromethyl Folpet: material balance of dosed radioactivity. MBS 72a/972856! R-9137a BVL , TOX OECD KIIA XXXXX C-Folpet metabolism in the lactating goat (part B). MBS 72b/972856! R-9137b GLP: Yes (8) Open (3) Published: Open (3) No (8) BVL , ASB OECD KIIA XXXXX 2005 NC-224: Metabolism in the lactating goat R204! NAS 649/ BVL , RIP OECD KIIA 6.3 Blaschke, U Residue study (at harvest and decline) with NC g as/l SC applied to grapes in Germany, North France, South France and Spain in one report amendment R301! NAS 519/ BVL , RIP Data protection claimed Owner How considered in drr * Yes NCI Y Yes NCI Y Yes MAC Y Yes MAC Y Yes NCI Y Yes NCI Add # Yes NCI Y Yes MAC Y Yes MAC Y Yes MAC Y Yes NCI Y Yes NCI Y Applicant: ADAMA Deutschland GmbH Evaluator: DE

185 Part B4 Germany Sanvino Page 19 of 39 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No OECD KIIA 6.3 Blaschke, U Residue study (at harvest and decline) with NC g as/l SC applied to grapes in Germany, North France, South France, Italy and Spain in 2004 R303! NAS 636/ BVL , RIP OECD KIIA 6.3 Jenkins, W. R Residue study (decline) with NC-225 WG applied to grapes in Germany, North France, Italy and Spain, 2005 NAS 708/053421! OFC ! R307 BVL , ASB OECD KIIA 6.3 Raufer, B Determination of residues of NC-224 and Folpet after four applications of NC-225 WG in grapevine and processed goods at 4 sites in Germany /G1-FPVI! R308 BVL , ASB OECD KIIA 6.3 Raufer, B Determination of residues of NC 224 and Folpet after four apllications of NC- 225 WG 03 in grapevine and processed goods at 4 sites in Germany /G1-FPVI! OFC BVL , ASB OECD KIIA 6.3 Fuchsbichler, G Analysis of residues of Folpet and its metabolite phthalimide in grapes, must and wine in (3) HVA 7/94! R-7993! HVA 7/94 OECD KIIA 6.3 BVL , ASB Grolleau, G Magnitude of the residue of Folpet in grape raw agricultural commodity EA950170! R-9146 F OECD KIIA 6.3 BVL , ASB Grolleau, G Magnitude of the residue of Phthalimide in grape raw agricultural commodity EA PH! R-9146 P OECD KIIA 6.3 BVL , ASB Grolleau, G Magnitude of the residue of Folpet in grape processed fractions (must and wine) V/EA950170! R-9146a! 9500AAA! R 5095 OECD KIIA 6.3 BVL , ASB Grolleau, G Folpet: Magnitude of the residue of Phtalimide in grape processed fractions (must and wine) V/EA PH! R-9146b OECD KIIA 6.3 BVL , ASB Simek, I Determination of Folpet residues in grapes following treatments with the preparations Folpan 80 WDG or Folpan 50 SC under field conditions in Europe in 2001 R A1043 ANA1! R-13051! R A1043 ANA2! A1043 OECD KIIA 6.3 BVL , ASB Wasser, C Folpet - Magnitude of the residues in grapes raw agricultural commodity R 6149! R-9098! BKA/628/96/RES BVL , ASB OECD KIIA 6.5 Morlock, G Abiotic degradation (hydrolysis) of Folpet under typical conditions (ph, temperature and time) of processing /01-PCHP! R BVL , ASB Data protection claimed Owner How considered in drr * Yes NCI Y Yes NIS Y Yes FSG Y Yes FSG Y Yes MAC N Yes MAC N Yes MAC N Yes MAC N Yes MAC N Yes MAC N Yes MAC N Yes MAC Y Applicant: ADAMA Deutschland GmbH Evaluator: DE

186 Part B4 Germany Sanvino Page 20 of 39 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No OECD KIIA 6.5 Blaschke, U Processing study with NC g as/l SC applied to grapes in Germany and Italy in 2004 R502! NAS 638/ BVL , RIP OECD KIIA 6.5 Wicks, R NC-224: Hydrolysis under simulated processing conditions R501! NAS 603/ BVL , RIP OECD KIIA 6.6 Crowe, A NC-224: Accumulation in confined rotational crops R601! NAS 589/ BVL , RIP * Y: Yes, relied on N: No, not relied on Add: Data protection claimed Relied on, study not submitted by applicant but necessary for evaluation ( # study report was submitted to the first application for authorisation of the product Sanvino, /00) Owner How considered in drr * Yes NCI Y Yes NCI Y Yes NCI Y Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability No further study on storage stability submitted/needed. A 2.2 Residues in primary crops No further study on primary crops submitted/needed. Applicant: ADAMA Deutschland GmbH Evaluator: DE

187 Part B4 Germany Sanvino Page 21 of 39 A Magnitude of residues in grapes Reference: OECD KIIA 6.3 Report Guideline(s): Deviations: GLP: Acceptability: Table A 2: see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list) in accordance with agreed guidance unless stated otherwise in the commenting box no relevant deviations unless stated otherwise in the commenting box see reference list Residues of amisulbrom in grapes acceptable unless stated otherwise in the commenting box RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Amisulbrom (Application on agricultural and horticultural crops) Crop / crop group : Grape Vine Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 50 g/kg Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : WG (Water dispersible granule) Other a.i. in formulation Commercial product (name) : NC-225 (content and common name) : 500 g/kg Folpet Applicant : Feinchemie Schwebda GmbH Residues calculated as : Amisulbrom Applicant: ADAMA Deutschland GmbH Evaluator: DE

188 Part B4 Germany Sanvino Page 22 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date NAS 708/053421, OFC , R307, trial NAS/ Germany (DE) Kirrweiler Scheurebe (white variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) ) BBCH 78 bunch of (planting) ) grapes ) ) ) ) ) spraying analytical method: NAS/490 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg (bunch of grapes), max. sample storage time 6 months validated level in this study 0.1 mg/kg ASB NAS 708/053421, OFC , R307, trial NAS/ France (FR) Reims Pinot Noir (red variety) 1) 1990 (planting) 2) 3) ) ) ) ) BBCH 83 bunch of grapes ) spraying analytical method: NAS/490 (HPLC-MS/MS),,LOQ(s): 0.01 mg/kg (bunch of grapes), max. sample storage time in month(s): 6 validated level in this study 0.1 mg/kg ASB /G1- FPVI, R308, trial G05N026R Processing trial Germany (DE) Diedesfeld Dornfelder (red variety) 1) 1996 (planting) 2) 3) ) ) ) ) BBCH 83 bunch of grapes bunch of grapes, RAC ) must, cloudy pomace, wet wine, young wine, bottled < ) spraying 5) before last treatment analytical method: NAS 490 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg, max. sample storage time in month(s): 12 sample storage time not validated for processed grape commodities ASB Applicant: ADAMA Deutschland GmbH Evaluator: DE

189 Part B4 Germany Sanvino Page 23 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date /G1- FPVI, R308, trial G05N027R Processing trial Germany (DE) Königsbach /G1- FPVI, R308, trial G05N028R Processing trial Germany (DE) Kleinfischlingen Spätburgunder (red variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) ) BBCH 83 bunch of ) (planting) ) grapes ) ) ) ) Müller- Thurgau (white variety) 1) 1988 (planting) 2) 3) ) ) ) ) BBCH 83 bunch of grapes, RAC must, cloudy pomace, wet wine, young wine, bottled < bunch of grapes bunch of grapes, RAC ) must, cloudy < pomace, wet wine, young < wine, bottled < ) spraying 5) before last treatment analytical method: NAS 490 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg, max. sample storage time in month(s): 11 sample storage time not validated for processed grape commodities ASB ) spraying 5) before last treatment analytical method: NAS 490 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg, max. sample storage time in month(s): 12 sample storage time not validated for processed grape commodities ASB Applicant: ADAMA Deutschland GmbH Evaluator: DE

190 Part B4 Germany Sanvino Page 24 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date /G1- FPVI, R308, trial G05N029R Processing trial Germany (DE) Mußbach /G1- FPVI, OFC , trial G06N023R Processing trial Germany (DE) Mußbach- Neustadt Riesling (white variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) ) BBCH 83 bunch of ) (planting) ) grapes ) ) ) ) Portugieser (red variety) 1) 1997 (planting) 2) 3) ) ) ) ) BBCH 83 bunch of grapes, RAC must, cloudy < pomace, wet wine, young wine, bottled < bunch of grapes bunch of grapes, RAC 4) spraying 5) before last treatment analytical method: NAS 490 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg, max. sample storage time in month(s): 12 sample storage time not validated for processed grape commodities ASB ) spraying must, cloudy < pomace, wet wine, young < wine, stored < analytical method: NAS/490 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg, max. sample storage time in month(s): 9 sample storage time not validated for processed grape commodities ASB Applicant: ADAMA Deutschland GmbH Evaluator: DE

191 Part B4 Germany Sanvino Page 25 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date /G1- FPVI, OFC , trial G06N024R Germany (DE) Diedesfeld- Neustadt Dornfelder (red variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) ) BBCH bunch of ) spraying (planting) ) grapes 2) ) bunch of 3) ) grapes, RAC analytical method: NAS/490 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg, max. sample storage time in month(s): 9 processing samples could not be generated ASB /G1- FPVI, OFC , trial G06N025R Processing trial Germany (DE) Kleinfischlingen Müller- Thurgau (white variety) 1) 1988 (planting) 2) 3) ) ) ) ) BBCH 83 bunch of grapes bunch of grapes, RAC ) spraying must, cloudy < pomace, wet wine, young < wine, stored < analytical method: NAS/490 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg, max. sample storage time in month(s): 9 sample storage time not validated for processed grape commodities ASB Remarks: (a) (b) (c) (d) (e) According to CODEX Classification / Guide Only if relevant Year must be indicated Days after last application (Label pre-harvest interval, PHI, underline) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Comments of zrms: Acceptable and conducted under conditions comparable to the intended use (±25 % tolerable deviation). Applicant: ADAMA Deutschland GmbH Evaluator: DE

192 Part B4 Germany Sanvino Page 26 of 39 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Amisulbrom (Application on agricultural and horticultural crops) Crop / crop group : Grape Vine Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 200 g/l Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : Canvas (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : Amisulbrom Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date R301, NAS/519/033985, 01 Germany Hainfeld R301, NAS/519/033985, 02 Germany Hainfeld Müller Thurgau (white variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) BBCH 85 grapes ) spraying (planting) ) ) ) Portugieser (red variety) 1) 1987 (planting) 2) 3) ) BBCH 85 grapes analytical method: HPLC-MS/MS, LOQ: 0.02 mg/kg, max. sample storage: 4 months RIP ) spraying analytical method: HPLC- MS/MS, LOQ: 0.02 mg/kg, max. sample storage: 4 months RIP Applicant: ADAMA Deutschland GmbH Evaluator: DE

193 Part B4 Germany Sanvino Page 27 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date R301, NAS/519/033985, 03 France Ambillou Chateau R301, NAS/519/033985, 04 France Tournus R303, NAS 636/043428, NAS/ Germany Radebeul Cabernet franc (red variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) BBCH 85 grapes ) spraying (planting) ) ) ) Chardonnay (white variety) Kerner (white variety) 1) 1982 (planting) 2) 3) ) 1988 (planting) 2) 3) ) ) BBCH 85 grapes BBCH 85 grapes analytical method: HPLC-MS/MS, LOQ: 0.02 mg/kg, max. sample storage: 3 months RIP ) spraying analytical method: HPLC-MS/MS, LOQ: 0.02 mg/kg, max. sample storage: 4 months RIP ) spraying analytical method: HPLC- MS/MS, LOQ: 0.05 mg/kg max. sample storage: 4 months, 2 replicate field samples RIP Applicant: ADAMA Deutschland GmbH Evaluator: DE

194 Part B4 Germany Sanvino Page 28 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date R303, NAS 636/043428, NAS/ Germany Eisleben R303, NAS 636/043428, NAS/ France Chinon R303, NAS 636/043428, NAS/ France Noizay R303, NAS 636/043428, NAS/ France Verzy Portugieser (red variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) BBCH 79 grapes ) spraying (planting) ) ) ) Grolleau (red variety) Chenin (white variety) Chardonnay (white variety) 1) 1982 (planting) 2) 3) ) 1989 (planting) 2) 3) ) 1982 (planting) 2) 3) ) ) ) BBCH 83 grapes BBCH 85 grapes BBCH 81 grapes <0.05 < analytical method: HPLC-MS/MS, LOQ: 0.05 mg/kg, max. sample storage: 5 months, 2 replicate field samples RIP ) spraying analytical method: HPLC-MS/MS, LOQ: 0.05 mg/kg, max. sample storage: 5 months, 2 replicate field samples RIP ) spraying analytical method: HPLC-MS/MS, LOQ: 0.05 mg/kg, max. sample storage: 5 months, 2 replicate field samples RIP ) spraying analytical method: HPLC-MS/MS, LOQ: 0.05 mg/kg, max. sample storage: 5 months, 2 replicate field sample RIP Applicant: ADAMA Deutschland GmbH Evaluator: DE

195 Part B4 Germany Sanvino Page 29 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) Applicant: ADAMA Deutschland GmbH Evaluator: DE

196 Part B4 Germany Sanvino Page 30 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date R502, NAS 638/ NAS/ plot 2 -balance processing- Germany Radebeul Portugieser (red variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) BBCH 79 grapes, RAC ) spraying (planting) ) grapes, washed ) ) grapes, rinsed juice juice, pasteurized < must press cake meal, wet press cake meal, dry wine, stored <0.01 < wine, young < raisin waste raisin sediment, sediment, sediment, sediment, 4. < dipping water washing water < replicate field samples (juice, stored wine, raisins) analytical method: HPLC- MS/MS, LOQ: 0.01 mg/kg, no recoveries reported in this study max. sample storage: 12 months RIP Applicant: ADAMA Deutschland GmbH Evaluator: DE

197 Part B4 Germany Sanvino Page 31 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date R502, NAS 638/ NAS/ plot 3 -balance processing- Germany Radebeul Portugieser (red variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) BBCH 79 grapes, RAC ) spraying (planting) ) grapes, washed ) ) grapes, rinsed juice juice, pasteurized must press cake meal, wet press cake meal, dry wine, stored <0.01 < wine, young < raisin waste raisin sediment, sediment, sediment, sediment, dipping water washing water replicate field samples (juice, stored wine, raisins) analytical method: HPLC- MS/MS, LOQ: 0.01 mg/kg no recoveries reported in this study max. sample storage: 12 months RIP Applicant: ADAMA Deutschland GmbH Evaluator: DE

198 Part B4 Germany Sanvino Page 32 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date R502, NAS 638/ NAS/ plot 2 -follow-up processing- Germany Eisleben Kerner (white variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) BBCH 85 grapes, RAC ) spraying (planting) ) juice ) ) juice, pasteurized press cake meal, wet press cake meal, dry wine, stored < wine, young < raisin waste raisin analytical method: HPLC- MS/MS, LOQ: 0.01 mg/kg no recoveries reported in this study max. sample storage: 12 months RIP Remarks: (a) (b) (c) (d) (e) According to CODEX Classification / Guide Only if relevant Year must be indicated Days after last application (Label pre-harvest interval, PHI, underline) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Comments of zrms: Allmost all trials are acceptable and were conducted under conditions comparable to the intended use (±25 % tolerable deviation). Results from one overdosed processing study were not considered for the assessment of the intended use. Applicant: ADAMA Deutschland GmbH Evaluator: DE

199 Part B4 Germany Sanvino Page 33 of 39 Table A 3: Residues of folpet in grapes RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : folpet (Application on agricultural and horticultural crops) Crop / crop group : Grape Vine Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 500 g/kg Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : WG (Water dispersible granule) Other a.i. in formulation Commercial product (name) : NC-225 (content and common name) : 50 g/kg amisulbrom Applicant : Feinchemie Schwebda GmbH Residues calculated as : folpet Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date NAS 708/053421, OFC , R307, trial NAS/ Germany (DE) Kirrweiler NAS 708/053421, OFC , R307, trial NAS/ France (FR) Reims Scheurebe (white variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) ) BBCH 78 bunch of ) spraying (planting) ) grapes ) ) ) ) Pinot Noir (red variety) 1) 1990 (planting) 2) 3) ) ) ) ) BBCH 83 bunch of grapes analytical method: NAS/744 (GC- MS), LOQ(s): 0.01 mg/kg, max. sample storage time 6 months validated level in this study 0.1 mg/kg ASB ) spraying analytical method: NAS/744 (GC- MS), LOQ(s): 0.01 mg/kg, max. sample storage time 6 months validated level in this study 0.1 mg/kg ASB Applicant: ADAMA Deutschland GmbH Evaluator: DE

200 Part B4 Germany Sanvino Page 34 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date /G1- FPVI, R308, trial G05N026R Processing trial Germany (DE) Diedesfeld /G1- FPVI, R308, trial G05N027R Processing trial Germany (DE) Königsbach Dornfelder (red variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) ) BBCH 83 bunch of ) 4) spraying (planting) ) grapes ) before last treatment 2) ) ) ) Spätburgunder (red variety) 1) 1995 (planting) 2) 3) ) ) ) ) BBCH 83 bunch of grapes, RAC must, cloudy < pomace, wet < wine, young < wine, bottled < bunch of grapes bunch of grapes, RAC ) must, cloudy < pomace, wet < wine, young < wine, bottled < analytical method: FP/15/91 (GC- ECD), LOQ(s): 0.05 mg/kg, max. sample storage time in month(s): 12 ASB ) spraying 5) before last treatment analytical method: FP/15/91 (GC- ECD), LOQ(s): 0.05 mg/kg, max. sample storage time in month(s): 11 ASB Applicant: ADAMA Deutschland GmbH Evaluator: DE

201 Part B4 Germany Sanvino Page 35 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date /G1- FPVI, R308, trial G05N028R Processing trial Germany (DE) Kleinfischlingen /G1- FPVI, R308, trial G05N029R Processing trial Germany (DE) Mußbach Müller-Thurgau (white variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) ) BBCH 83 bunch of ) 4) spraying (planting) ) grapes ) before last treatment 2) ) ) ) Riesling (white variety) 1) 1994 (planting) 2) 3) ) ) ) ) BBCH 83 bunch of grapes, RAC must, cloudy < pomace, wet wine, young < wine, bottled < bunch of grapes bunch of grapes, RAC ) must, cloudy pomace, wet wine, young < wine, bottled < Controls > LOQ pomace, wet analytical method: FP/15/91 (GC- ECD), LOQ(s): 0.05 mg/kg, max. sample storage time in month(s): 12 ASB ) spraying 5) before last treatment analytical method: FP/15/91 (GC- ECD), LOQ(s): 0.05 mg/kg, max. sample storage time in month(s): 12 ASB Applicant: ADAMA Deutschland GmbH Evaluator: DE

202 Part B4 Germany Sanvino Page 36 of Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date /G1- FPVI, OFC , trial G06N023R Processing trial Germany (DE) Mußbach- Neustadt /G1- FPVI, OFC , trial G06N024R Germany (DE) Diedesfeld- Neustadt /G1- FPVI, OFC , trial G06N025R Processing trial Germany (DE) Kleinfischlingen Portugieser (red variety) Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) 1) ) BBCH 83 bunch of ) spraying (planting) ) grapes 2) ) bunch of 3) ) grapes, RAC Dornfelder (red variety) Müller-Thurgau (white variety) 1) 1996 (planting) 2) 3) 1) 1988 (planting) 2) 3) ) ) ) ) ) ) ) ) BBCH BBCH 83 must, cloudy < pomace, wet wine, young < wine, stored < bunch of grapes bunch of grapes, RAC bunch of grapes bunch of grapes, RAC analytical method: FP/15/91 (GC- ECD), LOQ(s): 0.05 mg/kg, max. sample storage time 9 months ASB ) spraying ) spraying must, cloudy < pomace, wet < wine, young < wine, stored < analytical method: FP/15/91 (GC- ECD), LOQ(s): 0.05 mg/kg, max. sample storage time 9 months processing samples could not be generated ASB analytical method: FP/15/91 (GC- ECD), LOQ(s): 0.05 mg/kg, max. sample storage time 9 months ASB Remarks: (a) (b) (c) (d) According to CODEX Classification / Guide Only if relevant Year must be indicated Days after last application (Label pre-harvest interval, PHI, underline) Applicant: ADAMA Deutschland GmbH Evaluator: DE

203 Part B4 Germany Sanvino Page 37 of 39 (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Comments of zrms: The studies are acceptable and were conducted under conditions comparable to the intended use (±25 % tolerable deviation). Applicant: ADAMA Deutschland GmbH Evaluator: DE

204 Part B4 Germany Sanvino Page 38 of 39 A 2.3 Residues in processed commodities No new study on residues in processed commodities has been submitted. A 2.4 Residues in rotational crops No new study on residues in rotational crops has been submitted. A 2.5 Residues in livestock No new study on residues in livestock has been submitted. A 2.6 Other studies/information None Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) Highest calculated TMDI values in % of ADI Amisulbrom Status of the active substance: Code no LOQ (mg/kg bw): proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0,1 ARfD (mg/kg bw): 0,3 Source of ADI: EU Comm. Source of ARfD: EU Comm. Year of evaluation: 2013 Year of evaluation: 2013 Explain choice of toxicological reference values. The risk assessment has been performed on the basis of the MRLs collected from Member States in April For each pesticide/commodity the highest national MRL was identified (proposed temporary MRL = ptmrl). The ptmrls have been submitted to EFSA in September Chronic risk assessment TMDI (range) in % of ADI minimum - maximum 1 4 No of diets exceeding ADI: --- MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities 3,8 WHO Cluster diet B 1,4 Lettuce 1,2 Tomatoes 0,6 Table and wine grapes 2,8 ES adult 2,1 Lettuce 0,3 Tomatoes 0,1 Table and wine grapes 2,4 ES child 1,7 Lettuce 0,4 Tomatoes 0,2 PRODUCTS OF ANIMAL ORIGIN 2,3 WHO regional European diet 1,5 Lettuce 0,4 Tomatoes 0,1 Table and wine grapes 2,2 IT adult 1,5 Lettuce 0,5 Tomatoes 0,1 CEREALS 1,9 IT kids/toddler 1,2 Lettuce 0,6 Tomatoes 0,1 CEREALS 1,9 WHO Cluster diet F 1,2 Lettuce 0,3 Tomatoes 0,2 Table and wine grapes 1,9 FR all population 1,2 Table and wine grapes 0,4 Lettuce 0,2 Tomatoes 1,6 DE child 0,4 Tomatoes 0,4 Table and wine grapes 0,2 Lettuce 1,5 NL child 0,4 Lettuce 0,3 PRODUCTS OF ANIMAL ORIGIN 0,2 Tomatoes 1,4 WHO cluster diet E 0,5 Table and wine grapes 0,4 Lettuce 0,2 Tomatoes 1,3 PT General population 0,8 Table and wine grapes 0,4 Tomatoes 0,1 CEREALS 1,3 IE adult 0,3 Table and wine grapes 0,3 Lettuce 0,2 Tomatoes 1,3 DK child 0,6 Lettuce 0,2 PRODUCTS OF ANIMAL ORIGIN 0,2 Tomatoes 1,3 UK vegetarian 0,6 Lettuce 0,3 Table and wine grapes 0,2 Tomatoes 1,1 UK Adult 0,5 Lettuce 0,3 Table and wine grapes 0,2 Tomatoes 1,1 NL general 0,5 Lettuce 0,3 Table and wine grapes 0,2 Tomatoes 1,1 UK Toddler 0,2 Tomatoes 0,2 PRODUCTS OF ANIMAL ORIGIN 0,2 SUGAR PLANTS 1,0 FR toddler 0,4 PRODUCTS OF ANIMAL ORIGIN 0,3 Tomatoes 0,1 Root and tuber vegetables 0,9 WHO cluster diet D 0,4 Tomatoes 0,2 Table and wine grapes 0,1 CEREALS 0,9 UK Infant 0,4 PRODUCTS OF ANIMAL ORIGIN 0,1 Tomatoes 0,1 SUGAR PLANTS 0,8 SE general population 90th percentile 0,3 Tomatoes 0,2 PRODUCTS OF ANIMAL ORIGIN 0,1 Table and wine grapes 0,8 DK adult 0,4 Table and wine grapes 0,2 Tomatoes 0,1 PRODUCTS OF ANIMAL ORIGIN 0,7 FI adult 0,3 Lettuce 0,2 Tomatoes 0,1 Table and wine grapes 0,7 LT adult 0,3 Lettuce 0,2 Tomatoes 0,1 PRODUCTS OF ANIMAL ORIGIN 0,6 PL general population 0,4 Tomatoes 0,1 Table and wine grapes 0,1 Lettuce 0,5 FR infant 0,3 PRODUCTS OF ANIMAL ORIGIN 0,1 Root and tuber vegetables 0,1 Tomatoes Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake of residues of Amisulbrom is unlikely to present a public health concern. ptmrls at LOQ (in % of ADI) Applicant: ADAMA Deutschland GmbH Evaluator: DE

205 Part B4 Germany Sanvino Page 39 of 39 Applicant: ADAMA Deutschland GmbH Evaluator: DE