Art. 51 Extension of authorisation for minor uses. Risk Management

Transcription

1 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 1 of 12 Art. 51 Extension of authorisation for minor uses REGISTRATION REPORT Part A Risk Management Product code: Luna Experience Active Substances: Fluopyram 2 g/l and Tebuconazole 2 g/l COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: Bayer CropScience Deutschland GmbH Date: BVL_FO_5_2422_2_V1. Applicant Bayer CropScience Deutschland GmbH Date:

2 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 2 of 12 Table of Contents PART A Risk Management Details of the application Application background Annex I inclusion Regulatory approach Uses applied for and registration decision Public interest and minor use Data protection claims Letters of Access Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC R and S phrases under Directive 23/82/EC (Annex IV and V) Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses 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 Residues and Consumer Exposure Residues Consumer exposure Environmental fate and behaviour Ecotoxicology Efficacy Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Appendix 1 Copy of the product authorisation Appendix 2 Copy of the product label Appendix 3 Letter of Access BVL_FO_5_2422_2_V1. Applicant Bayer CropScience Deutschland GmbH Date:

3 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 3 of 12 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of Luna Experience containing fluopyram and tebuconazole in Germany. The risk assessment conclusions are based on the already existing registration of the PPP. The following sections of Registration Report, Part B were prepared on basis of new data: Section 4. Assessments for the safe use of Luna Experience have been made using endpoints agreed in the EU reviews of fluopyram and tebuconazole. Appendix 1 of this document provides a copy of the final product authorisation in Germany (will be inserted) 1 Details of the application Application to extend the authorisation of a plant protection product (PPP) already authorised in Germany to minor uses not yet covered by that authorisation. The application is intended for use in Germany only. 1.1 Application background Details on applicant and application Plant protection product Type of application Luna Experience Registration number /2 Applicant Authorisation holder Function Type of formulation Zonal application according to Article 51, ZRMS = DE, first application (GV1) Bayer CropScience Deutschland GmbH Registrierung & PGA, Elisabeth- Selbert-Straße 4 a, 464 Langenfeld, Deutschland Bayer CropScience Deutschland GmbH Registrierung & PGA, Elisabeth- Selbert-Straße 4 a, 464 Langenfeld, Deutschland Fungicide Suspension concentrate Expiration of authorisation BVL_FO_5_2422_2_V1. Applicant Bayer CropScience Deutschland GmbH Date:

4 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 4 of Annex I inclusion The active substances included in the plant protection product are approved according Regulation (EC) No 11/29. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Fluopyram (1134) Content in PPP 2 g/l Approval status Approved according Regulation (EC) No 11/29 Approval Regulation (EC) No 54/211, Reg. (EU) No 82/213 Expiration of approval 31/1/224 Tebuconazole (84) Content in PPP 2 g/l Approval status Approved according Regulation (EC) No 11/29 Approval Regulation (EC) No 54/211, Reg. (EU) No 28/125 Expiration of approval 31/8/ Regulatory approach The PPP is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. Therefore the evaluation of the current application is limited to the points not covered by the existing registration Uses applied for and registration decision Number of use Plant/commodity/object Harmful organism/purpose decision 1 plum Monilinia laxa, brown fruit rot of Japan (Monilinia fructigena), leaf spot of cherry (Blumeriella jaapii), leaf blotch of plum (Polystigma rubrum), gumspot of stone fruit (Stigmina carpophila) 2 peach Monilinia laxa, brown fruit rot of Japan (Monilinia fructigena), leaf spot of cherry (Blumeriella jaapii), gumspot of stone fruit (Stigmina carpophila) Authorise Authorise Public interest and minor use BVL_FO_5_2422_2_V1. According to Article 51 (2) a and c of the Regulation (EC) No 11/29 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest. Applicant Bayer CropScience Deutschland GmbH Date:

5 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 5 of 12 In Germany the cultivated area of plum is about 436 ha, of which approx. 144 ha need to be controlled, the cultivated area of peach is about 12 ha, of which approx. 41 ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested uses. Upon this calculation and the examination of available alternative measures for the applied uses it can be stated that the applied uses is minor in nature and the authorisation is in the public interest. 1.4 Data protection claims The applicant is owner of the new studies submitted and claims data protection. 1.5 Letters of Access The applicant is owner of the new studies submitted. Authorisation holder is the applicant. 2 Details of the authorisation 2.1 Product identity Product name Luna Experience Authorisation number Composition Type of formulation Function Authorisation holder Fluopyram 2 g/l; Tebuconazole 2 g/l Suspension concentrate (SC) Fungicide 2.2 Classification and labelling Bayer CropScience Deutschland GmbH Registrierung & PGA, Elisabeth- Selbert-Straße 4 a, 464 Langenfeld, Deutschland Classification and labelling under Directive 99/45/EC or Regulation (EC) No 122/28 BVL_FO_5_2422_2_V1. Xn RA15 R4 Harmful Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions. Limited evidence of a cancinogenic effect R52/53 Hazardous to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R63 S 36/3 S2 S13 S24 S35 S46 risk of harm to the unborn child Wear suitable protective clothing and gloves. Keep out of the reach of children Keep away from food, drink and animal feeding stuffs Avoid contact with skin This material and its container must be disposed of in a safe way. If swallowed, seek medical advice immediately and show this container or label Applicant Bayer CropScience Deutschland GmbH Date:

6 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 6 of 12 S5 SP1 Use appropriate container to avoid environmental contamination. To avoid riks to man and the environment, comply with the instructions for use R and S phrases under Regulation (EC) No 54/211 None Other phrases Restrictions linked to the PPP The authorisation of the PPP is linked to the following conditions (mandatory labelling): BVL_FO_5_2422_2_V1. Operator protection SB1 SB11 SE11 SF1891 SS11 SS12 SS211 SS222 SS61 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. Wear tight fitting eye protection when handling the undiluted product. Re-entering the treated areas/crops is only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. Wear standard protective gloves (plant protection) when handling the undiluted product. Wear standard protective gloves (plant protection) when handling/applying the product ready for application. 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. Wear a rubber apron when handling the undiluted product. Ecosystem protection NW262 NW264 NW265 NW468 The product is toxic for algae. The product is toxic for fish and aquatic invertebrates. The product is toxic for higher aquatic plants. 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. Integrated Pest Management (IPM) NN21 The product is classified as slightly harmful for populations of relevant beneficial insects. NN22 The product is classified as slightly harmful for populations of relevant predatory mites and Applicant Bayer CropScience Deutschland GmbH Date:

7 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page of 12 spiders. Mode of action (FRAC-Group): C2 Mode of action (FRAC-Group): G1 Active substance The authorisation of the PPP is linked to the following conditions (voluntary labelling): Honeybee NB6641 The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4) Specific restrictions linked to the intended uses Some of the authorised uses are linked to the following conditions (mandatory labelling): See 2.3 (Product uses) Ecosystem protection NW6-1 When applying the product on areas adjacent to surface waters - except only occasionally but including periodically water bearing surface waters - the product must be applied with equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 25, p. 98) 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 "*". Violations may be punished by fines of up to 5 EUR. 5 % - 2 m, 9 % - 15 m Uses: NT15 In a strip at least 2 m wide which is adjacent to other areas, the product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 25, p. 98) as amended, and be registered in at least drift reducing class 5 % (except agriculturally or horticulturally used areas, roads, paths and public places). If it is not possible to apply the product with loss reducing equipment, a buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally used areas, roads, paths and public places). Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the product is applied with portable plant protection equipment or if adjacent areas (e.g. field boundaries, hedges, groups of woody plants) are less than 3 m wide or if the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of February 22 (Federal Gazette no. a of 13 April 22), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural structures. Uses: BVL_FO_5_2422_2_V1. Applicant Bayer CropScience Deutschland GmbH Date:

8 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 8 of Product uses PPP (product name/code) Luna Experience (26861-) active substance 1 Fluopyram active substance 2 Tebuconazole active substance Formulation type: Conc. of as 1: Conc. of as 2: Conc. of as: SC 2 g/l 2 g/l safener - synergist - Conc. of safener: - Conc. of synergist: - Applicant: Zone(s): Verified by MS: j Bayer CropScience Deutschland GmbH Registrierung & PGA central zone professional use non professional use BVL_FO_5_2422_2_V1. 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) 1 DE Plum (PRNDO) F Monilinia laxa (MONILA), brown fruit rot of Japan (Monilinia fructigena) (MONIFG), leaf spot of cherry (Blumeriella jaapii) (BLUMJA), leaf blotch of plum (Polystigma rubrum) Method / Kind Application Application rate PHI Max. number kg, L product / g, kg as/ha Water L/ha (days) (min. interval ha between a) max. rate per a) max. rate min / max applications) appl. per appl. a) per use Timing / Growth stage of crop & season spraying BBCH 59-8; in case of risk of infection, at beginning of infestation and/or when first symptoms become visible b) per crop/ season a) 2 ( days) b) 2 b) max. total rate per crop/season a).6 L/ha b) 1.2L/ha b) max. total rate per crop/season a1).12 kg as/ha a2).12 kg as/ha b1).24 kg as/ha b2).24 kg as/ha Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 1-5 Restrictions (see ) NT15, NW6-1 (5 % - 2 m, 9 % - 15 m) Dose expression for DE:,2 L/ha and m crown height Applicant Bayer CropScience Deutschland GmbH Date:

9 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 9 of 12 (POLTRU), gumspot of stone fruit (Stigmina carpophila) STIGCA) 2 DE Peach (PRNPS) F Monilinia laxa (MONILA), brown fruit rot of Japan (Monilinia fructigena) (MONIFG), leaf spot of cherry (Blumeriella jaapii) (BLUMJA), gumspot of stone fruit (Stigmina carpophila) (STIGCA) spraying BBCH 59 8 in case of risk of infection, at beginning of infestation and/or when first symptoms become visible a) 2 ( days) b) 2 a).6 L/ha b) 1.2L/ha a1).12 kg as/ha a2).12 kg as/ha b1).24 kg as/ha b2).24 kg as/ha 1-5 Restrictions (see ) NT15, NW6-1 (5 % - 2 m, 9 % - 15 m) Dose expression for DE:,2 L/ha and m crown height BVL_FO_5_2422_2_V1. Applicant Bayer CropScience Deutschland GmbH Date:

10 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 1 of 12 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Not relevant for extension of authorisation according article Methods of analysis Analytical method for the formulation Not relevant for extension of authorisation according article Analytical methods for residues Peaches and plums belong to the group of high water content commodities. Sufficiently validated analytical methods for enforcing residues of fluopyram and tebuconazole are available Mammalian Toxicology The PPP is already registered in Germany according to Directive 91/414/EEC. If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected Residues and Consumer Exposure The residue behaviour of the active substances fluopyram and tebuconazole have been evaluated within the EU review process. Information about metabolism is sufficient to evaluate the intended use in peaches and plums Residues The available residue information is sufficient to perform an adequate assessment. Residues that are expected from the intended use of the plant protection product will not exceed the MRL set in Regulation (EC) No 396/25 for tebuconazole. For fluopyram new MRLs were necessary which are covered by a MRL proposal prepared by Germany (Evaluation report on the setting/modification of MRLs for fluopyram in plant commodities, , EFSA Question Number EFSA-Q ). New MRLs are in force since July 215 (COMMISSION REGULATION (EU) 215/111 of 8 July 215: 1.5 mg/kg in peaches and.5 mg/kg in plums). BVL_FO_5_2422_2_V Consumer exposure An assessment of residue uptake by consumers (IEDI calculation, EFSA PRIMo) results in the following maximum ADI consumptions: Fluopyram (.12 mg/kg bw/d) 58 % (DE child) Tebuconazole (.3 mg/kg bw/d) 26 % (DE child) Long-term dietary intake of residues of fluopyram and tebuconazole is unlikely to present a public health concern for European consumers. An assessment of residue uptake by consumers (IESTI calculation, EFSA PRIMo) results in the following ARfD consumptions: Applicant Bayer CropScience Deutschland GmbH Date:

11 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 11 of 12 Fluopyram (.5 mg/kg bw/d) plums 2 % (NL child); peaches 5 % (DE child) Tebuconazole (.3 mg/kg bw/d) plums 24 % (NL child); peaches 59 % (DE child) No acute risk is expected from the consumption of peaches and plums treated according to the intended use Environmental fate and behaviour No new studies were presented; all data were reviewed within the EU review for the active substances fluopyram and tebuconazole and the national authorisation procedure for the product Luna Experience (26861-), respectively, and assessed according to the uniform principles of Regulation (EU) No 546/211. The environmental exposure due to the minor use extension applied for (spraying of plums and peaches) is covered by the uses already authorised in cherries. Neither accumulation in soil nor leaching to groundwater of the active substance or relevant metabolites in concentrations above.1 µg/l have to be expected. Specific additional risk mitigation measures are not required Ecotoxicology No new studies were presented; all data were reviewed within the EU review for the active substances fluopyram and tebuconazole and the national authorisation procedure for the product Luna Experience (26861-), respectively, and assessed according to the uniform principles of Regulation (EU) No 546/211. The risk for non-target organisms as a consequence of the minor use extension applied for is considered acceptable since exposure due to the intended uses (spraying of plums and peaches) is covered by the uses already authorised in cherries. Toxicity exposure ratios (TER) calculated for the exposure of aquatic organisms due to entry into adjacent surface waters via spray drift show for the field spray uses an acceptable risk only considering specific additional risk mitigation measures (relevant ecotoxicological endpoint: tebuconazole: Pimephales promelas - NOEC =.58 mg/l, fluopyram: Pimephales promelas - NOEC = 5 mg/l). Both an untreated buffer zone and use of spray drift reducing application technique are necessary for risk mitigation (label restriction NW6-1: 5 % drift reduction + 2 m buffer zone; 9 % drift reduction and 15 m buffer zone). For the protection of terrestrial arthropods in adjacent non-target areas the use of spray drift reducing application technique (5 % reduction) is necessary (label restriction NT15). The product Luna Experience as well as the active substances fluopyram and tebuconazole are toxic to the aquatic environment. Therefore, additional labelling with risk phrases (NW262, NW264, NW265) and safety phrases (NW468) is assigned, particularly to enforce prevention of any point source entry into surface waters; see also chapter 2.2. BVL_FO_5_2422_2_V1. Risk Assessment for Honeybees The honeybee risk assessment for the main application covers the use(s) in accordance with Article 51 of regulation (EC) No 11/29 (see also point 2.2) Efficacy Applicant Bayer CropScience Deutschland GmbH Date:

12 Part A National Assessment Luna Experience Art. 51 Extension of authorisation for minor uses BVL Registration Number:26861-/2 Registration Report Central Zone Country Germany Page 12 of 12 Labelling in accordance with the requirements of ANNEX III General principles of integrated pest management under directive 29/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the uses applied for under the terms of Article 51 of regulation (EC) No 11/29. -The categories and labelling for mode of action for the main application cover the uses applied for under the terms of Article 51 of regulation (EC) No 11/29. According to Article 51 of the regulation (EC) No 11/29 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products not need to be checked. 3.2 Conclusions Luna Experience is already registered in Germany according to Regulation (EU) The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are anticipated because of the extension of uses. The indended uses in plum and peach will not result in residues above the MRLs set in for tebuconazole or proposed for fluopyram in Regulation (EC) No 396/25. A risk for consumers through the consumption of food with these residues of tebuconazole and fluopyram is not expected. There is no special risk mitigation necessary which deviates from the existing registration. An authorisation is granted after a change of the MRLs (COMMISSION REGULATION (EU) 215/111 of 8 July 215. Considering the minor use extension applied for neither harmful effects on groundwater nor unacceptable effects on the environment have to be apprehended as a consequence of proper use consistent with good plant protection practice. Specific additional risk mitigation measures are required for the protection of aquatic organisms and terrestrial non-target arthropods. 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation None Appendix 1 Copy of the product authorisation An authorisation could not be granted Appendix 2 Copy of the product label No product label available. Not mandatory according to Article 51 (5) Appendix 3 Letter of Access No letter of access necessary. The applicant is owner of the new studies submitted. Authorisation holder agrees to the current application to extend the authorisation. BVL_FO_5_2422_2_V1. Applicant Bayer CropScience Deutschland GmbH Date:

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23 REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: Luna Experience Active Substance: 2 g/l Fluopyram 2 g/l Tebuconazole Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Bayer CropScience Deutschland GmbH Date: Page 1 / 2

24 Table of Contents 4 METABOLISM AND RESIDUES DATA Evaluation of the active substances Evaluation of the intended uses Selection of critical use and justification Plums Residues in primary crops Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Peaches 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 Fluopyram Tebuconazole Proposed maximum residue levels (MRLs) Conclusion... 1 Appendix 1 List of data submitted in support of the evaluation... 1 Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability A 2.2 Residues in primary crops A Nature of residues A Magnitude of residues 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) Page 2 / 2

25 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances For an evaluation of the active substance fluopyram please refer to the DAR (ASB ; ASB ) and EFSA s Conclusion on the peer review of the pesticide risk assessment of the active substance (ASB ). For an evaluation of the active substance tebuconazole please refer to the DAR (ASB ), EFSA s Conclusion on the peer review of the pesticide risk assessment of the active substance (ASB214-23) and the outcome of the review of existing MRLs (ASB ). 4.2 Evaluation of the intended uses Selection of critical use and justification The GAPs reported for the central zone are presented in Table They have been used for consumer intake and risk assessment. Page 3 / 2

26 Table 4.2-1: Critical Uses (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) L 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 Plums (144) F Monilinia laxa, Brown fruit rot of Japan (Monilinia fructigena), Leaf spot of cherry (Blumeriella jaapii), Leaf blotch of plum (Polystigma rubrum), Gumspot of stone fruit (Stigmina carpophila) spraying BBCH 59-8, in case of risk of infection, at beginning of infestation and/or when first symptoms become visible a) 2 b) 2 (interval days) a).2 L/ha and per m crown height b).4 L/ha and per m crown height a) fluopyram:.4 kg/ha and per m crown height tebuconazole:.4 kg/ha and per m crown height b) fluopyram:.8 kg/ha and per m crown height tebuconazole:.8 kg/ha and per m crown height 1-5 L/ha and per meter crown height 2 DE Peaches (143) F Monilinia laxa, Brown fruit rot of Japan (Monilinia fructigena), Gumspot of stone fruit (Stigmina carpophila) spraying BBCH 59-8, in case of risk of infection, at beginning of infestation and/or when first symptoms become visible a) 2 b) 2 (interval days) a).2 L/ha and per m crown height b).4 L/ha and per m crown height a) fluopyram:.4 kg/ha and per m crown height tebuconazole:.4 kg/ha and per m crown height b) fluopyram:.8 kg/ha and per m crown height tebuconazole:.8 kg/ha and per m crown height 1-5 L/ha and per meter crown height 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, 199, 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 Page 4 / 2

27 4.2.2 Plums Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of fluopyram in/on plums. 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 fluopyram in plums Commodity Region (a) Outdoor/ Indoor Individual trial results Enforcement (Fluopyram) Plums NEU Outdoor.1; ;.14;.18;.19;.2;.22;.24;.2 Risk assessment (Sum fluopyram and fluopyram-benzamide (M25) expressed as fluopyram).11;.14;.15;.19;.2;.21;.23;.25;.28 STMR (b) HR (c) Existing MRL Median CF (d) * 1.5 (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. Table 4.2-3: Overview of the selected supervised residue trials for tebuconazole in plums Commodity Region (a) Outdoor/ Indoor Individual trial results Enforcement (Tebuconazole) plums NEU Outdoor.8; 2 x.1; ;.14;.16;.1;.2;.22 Risk assessment (Tebuconazole).8; 2 x.1; ;.14;.16;.1;.2;.22 STMR (b) HR (c) Existing MRL Median CF (d) (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. Plums are categorized as a major crop in the northern zone and a minimum of eight trials are required for assessment of the use. The number of trials is therefore sufficient. In all of the supervised trials plots received triple treatments whereas the intended use foresees a maximum of only two applications. Noting that significant residues were detected just before the last treatment, the first application may contribute to the final residue level. According to EFSA s Conclusion on the peer review of the pesticide risk assessment of the active substance fluoropyram (ASB ) analytical methods for commodities of high water content such as plums are available and considered acceptable for enforcing all compounds given in the residue definition. According to a Reasoned Opinion of EFSA on the review of the existing MRLs for tebuconazole (ASB ) validated analytical methods for enforcement of tebuconazole (provisional due to open questions regarding TDM) are available with an LOQ of at least.2 mg/kg in high water content matrices Distribution of the residue in peel/pulp Not relevant for plums. Page 5 / 2

28 Residues in processed commodities Fluopyram and its main metabolite fluopyram-benzamide were found to be hydrolytically stable under the standard processing conditions. No specific processing trials were available on the magnitude of residue in plums. Only one study was available on drying of plums showing a processing factor of only slightly higher than 1. Tebuconazole was shown to be stable during pasteurisation, cooking, boiling/brewing/baking and sterilization. Only one study was available on drying of plums showing a processing factor of only slightly higher than Proposed pre-harvest intervals, withholding periods The proposed pre-harvest interval of days is deemed acceptable Peaches Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of fluopyram in/on peaches. For the detailed evaluation of residue trials it is referred to Appendix 2. Table 4.2-4: Overview of the selected supervised residue trials for fluopyram in peaches Commodity Region (a) Outdoor/ Indoor Individual trial results Enforcement (Fluopyram) Risk assessment (Sum fluopyram and fluopyrambenzamide (M25) expressed as fluopyram) STMR (b) HR (c) Existing MRL Median CF (d) peaches NEU Outdoor.4;.14;.16;.39.5;.15;.1; (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. Table 4.2-5: Overview of the selected supervised residue trials for tebuconazole in peaches Commodity Region (a) Outdoor/ Indoor Individual trial results Enforcement (Tebuconazole) peaches NEU Outdoor.2;.8;.11;.3 Risk assessment (Tebuconazole).2;.8;.11;.3 STMR (b) HR (c) Existing MRL Median CF (d) (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. Peaches are categorized as a minor crop in the northern zone and a minimum of four trials are required for assessment of the use. The number of four trials is therefore sufficient. In all of the supervised trials plots received triple treatments whereas the intended use foresees a maximum of only two applications. Noting that significant residues were detected just before the last treatment, the third application may contribute to the final residue level. According to EFSA s Conclusion on the peer review of the pesticide risk assessment of the active substance fluopyram (ASB ) analytical methods for commodities of high water content such as peaches are available and considered acceptable for enforcing all compounds given in the residue Page 6 / 2

29 definition. According to EFSA s Reasoned Opinion on the review of the existing MRLs for tebuconazole (ASB ) validated analytical methods for enforcement of tebuconazole (provisional due to open questions regarding TDM) are available with an LOQ of at least.2 mg/kg in high water content matrices Distribution of the residue in peel/pulp Not relevant for peaches Residues in processed commodities No specific studies on the effect of processing on the magnitude of residues were submitted Proposed pre-harvest intervals, withholding periods The proposed pre-harvest interval of days is acceptable. 4.3 Consumer intake and risk assessment Fluopyram 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 4.3-1: Key data for consumer intake assessment derived for the intended uses Commodity Long-term intake Input value Comment Short-term intake Input value plums.2 STMR.28 HR peaches.16 STMR.4 HR Comment 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 and IEDI 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 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.12 mg/kg bw 2 % (based on WHO cluster diet B and MRLs as established in Regulation (EU) No 14/213). No conversion factors were considered to account for the deviating residue definition for risk assessment. 19 % (based on DE child, individual consumption/body weight ratio, and MRLs as established in Regulation (EU) No 14/213). No conversion factors were considered to account for the deviating residue definition for risk assessment. 58 % (based on DE child, mean body weight) 65 % (based on DE child, individual consumption/body weight ratio) Page / 2

30 Factors included in IEDI and NEDI STMR, STMR-P, CF, YF according to EFSA (ASB ) Acute risk assessment ARfD IESTI (% ARfD) according to EFSA PRIMo rev.2 NESTI (% ARfD) according to German NVS II.5 mg/kg bw plums: 2 % (based on NL child, mean body weight) peaches: 5 % (based on DE child, mean body weight) plums: 2 % (based on DE child, individual consumption/body weight ratio) peaches: 6 % (based on DE child, individual consumption/body weight ratio) Factors included in IESTI and NESTI HR (plums):.28 mg/kg HR (peaches):.4 mg/kg Tebuconazole 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 Long-term intake Input value Comment Short-term intake Input value plums.14 STMR.22 HR peaches.95 STMR.3 HR Comment 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 and IEDI results 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.3 mg/kg bw 115 % (based on DE child, mean body weight, and MRLs as established in Regulation (EU) No 5/213) 118 % (based on DE child, individual consumption/body weight ratio, and MRL as established in Regulation (EU) No 5/213) 26 % (based on DE child, mean body weight) 26 % (based on DE child, individual consumption/body weight ratio) STMR and STMR-P as outlined in the review of existing MRLs for tebuconazole in the context of Art. 12(1) (ASB ) and from EFSA RO in the context of MRL modification for citrus fruit (except orange), lettuce and other salad plants, parsley and chives (ASB ) Page 8 / 2

31 Acute risk assessment ARfD IESTI (% ARfD) according to EFSA PRIMo rev.2 NESTI (% ARfD) according to German NVS II.3 mg/kg bw plums: 24 % (based on NL child, mean body weight) peaches: 59 % (based on DE child, mean body weight) plums: 28 % (based on DE child, individual consumption/body weight ratio) peaches: 9 % (based on DE child, individual consumption/body weight ratio) Factors included in IESTI and NESTI HR (plums):.22 mg/kg HR (peaches):.3 mg/kg 4.4 Proposed maximum residue levels (MRLs) The existing EU MRLs and proposals for new MRLs for the crops applied for in this dossier are summarized in Table Table 4.4-1: Overview of the existing EU MRLs and new MRL proposals for fluopyram Commodity (Code) peaches (143) plums (144) Existing EC MRL Proposed EC MRL Result of OECD calculator *.6.55 Justification for the proposal/ Comments The data from supervised residue trials are sufficient for an MRL proposal which is higher than that one currently laid down in EU residue legislation. The new MRL would pose no unacceptable consumer risk. The data from supervised residue trials are sufficient for an MRL proposal which is higher than that one currently laid down in EU residue legislation. The new MRL would pose no unacceptable consumer risk. The proposed new MRLs have already been applied for by the applicant (plums), or are covered by a higher MRL already applied for by the applicant for a GAP from SEU (peaches). The Evaluating Member State (Germany) has provided an Evaluation Report by 24 January 214 which is currently being processed. Table 4.4-2: Overview of the existing EC MRL and new MRL proposal for tebuconazole Commodity (Code) peaches 1 Existing EC MRL Proposed EC MRL no new MRL is requested Result of OECD calculator.661 Justification for the proposal/ Comments The data from supervised residue trials are sufficient for concluding that no new MRL is needed. No unacceptable consumer risk is identified from the intended use. Page 9 / 2

32 Commodity (Code) plums 1 Existing EC MRL Proposed EC MRL no new MRL is requested Result of OECD calculator.433 Justification for the proposal/ Comments The data from supervised residue trials are sufficient for concluding that no new MRL is needed. No unacceptable consumer risk is identified from the intended use. As the commodities under consideration are normally not fed to livestock, the intended uses are not anticipated to affect MRLs in commodities of animal origin. 4.5 Conclusion The available data are sufficient for dietary risk assessment. An exceedance of the current MRL as established in EU residue legislation of fluopyram in peaches (. mg/kg) and plums (.1 mg/kg) cannot be excluded. The existing MRLs for tebuconazole are sufficient. Long-term and short-term intake of fluopyram and tebuconazole residues is unlikely to present a public health concern. As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the intended uses. Prior to authorization of the intended uses the MRLs need to be amended for fluopyram in/on peaches and plums. 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 Canada; 211 Fluopyram: Draft Assessment Report, Vol. 1-3 Germany; USA; ASB Denmark 213 Tebuconazole: Draft Assessment Report; Addendum B5-B9, B5-B ASB EFSA 211 Reasoned opinion: Review of the existing maximum residue levels (MRLs) for Tebuconazole according to Article 12 of Regulation (EC) No 396/25 EFSA Journal 211;9(8):2339, 1-96 ASB EFSA 211 Reasoned opinion: Setting of new MRLs and import tolerances for Fluopyram in various crops EFSA Journal 211;9(9):2388, 1-68 ASB EFSA 212 Reasoned opinion on the modification of the existing MRLs for Tebuconazole in citrus (except oranges), lettuce and other salad plants, parsley and chives EFSA Journal 212;1(9):2898 ASB Data protection claimed no no no no no Owner How considered in drr * Add Add Add Add Add Page 1 / 2

33 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No EFSA 212 Conclusion on the peer review of the pesticide risk assessment of the active substance Fluopyram EFSA Journal 213;11(4):352 ASB EFSA 213 Conclusion on the peer review of the pesticide risk assessment of the active substance Tebuconazole EFSA Journal 214;12(1):3485 ASB Germany 212 Fluopyram: Draft Assessment Report, Vol. 3, B. Residue data ASB Harbin, A. M. 21 ELITE 45 DF - Magnitude of the residue on plum processed commodity [USA] 1962; MO GLP: Yes Published: No BVL , ASB Mackie, S. J. W. 28 AE C SC - Magnitude of the residue on plum processed commodities RAGMP49; M GLP: Yes Published: No BVL , ASB Noss, G. 211 Determination of the residues of AE C and Tebuconazole in/on plum after spraying of Fluopyram & Tebuconazole SC 4 in the field in France (North) and Germany 9-2; M ; RAGML152 GLP: Yes Published: No BVL , ASB Noss, G.; Bauer, J. Noss, G.; Krusell, L. Noss, G.; Krusell, L. 211 Determination of the residues of AE C and Tebuconazole in/on plum after spraying of Fluopyram & Tebuconazole SC 4 in the field in France (North) and Poland 1-226; M ; RAGML182 GLP: Yes Published: No BVL-2254, BVL-23912, ASB Determination of the residues of AE C and Tebuconazole in/on peach after spraying of fluopyram & tebuconazole SC 4 in the field in Germany 8-254; M GLP: Yes Published: No BVL , ASB Determination of the residues of AE C and Tebuconazole in/on plum after spraying of Fluopyram & Tebuconazole SC 4 in the field in Germany and Netherlands - Amendment No. 1 - incl. report dated ; M ; M ; RAGML88 GLP: Yes Published: No BVL , BVL-2398, ASB Data protection claimed no no no Owner How considered in drr * Add Add Add Yes BAY Yes Yes BAY Yes Yes BAY Yes Yes BAY Yes Yes BAY Yes Yes BAY Yes Page 11 / 2

34 Annex point/ reference No Author(s) Year Title Report-No. Authority registration No Noss, G.; Reineke, A. 211 Determination of the residues of AE C and Tebuconazole in/on peach after spraying of Fluopyram & Tebuconazole SC 4 in the field in France (North) and Germany - Amendment no. 1 - incl. report dated ; M ; M GLP: Yes Published: No BVL , ASB * Y yes, relied on N No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation Data protection claimed Owner Yes BAY Yes How considered in drr * Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability No further study on storage stability submitted/needed. A 2.2 Residues in primary crops A Nature of residues No further study on nature of residues submitted/needed. Page 12 / 2

35 A Magnitude of residues Reference: OECD KIIA 6.3 Report Guideline(s): Deviations: GLP: Acceptability: Table A 1: 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 acceptable unless stated otherwise in the commenting box Residues of Fluopyram in Plums RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Fluopyram (Application on agricultural and horticultural crops) Crop / crop group : Plums Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 2 g/l Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : AE C TBZ SC 2 + 2A G (content and common name) : 2 g/l Tebuconazole Applicant : Bayer CropScience Deutschland GmbH All residues were calculated as fluopyram equivalents : 8.1 Fluopyram 8.2 BCS-AA1139 ([3-chloro-5-(trifluoromethyl)pyridin-2-yl] acetic acid) 8.3 AE F (2-trifluoromethylbenzamide) 8.4 AE C65188 (3-chloro-5-trifluoromethylpyridine-2-carboxylic acid) Page 13 / 2

36 Report-No. Location incl. postal code and date study 8-262, trial Germany 8869 Tettnang / Bernau Commodity/ Variety plums / Presenta Date of 1) Planting 2) Flowering 3) Harvest Application rate per treatment kg Water kg a.i./ha l/ha a.i./hl Dates of treatments Growth stage at last treatment Portion analysed Residues Residues Residues Residues (a) (b) (c) (a) (d) (e) 1) BBCH 85 fruit.12-2) ) PHI (days) Remarks height of trees: meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage: 12 months study 8-262, trial Germany 5334 Meckenheim plums / Hauszwetsche 1) ) ) BBCH 85 fruit ASB height of trees: meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage: 12 months study 8-262, trial Netherlands 1684 Zwaadijk study 8-262, trial Netherlands 99 KA Sint Jacobiparochie plums / Reine Victoria plums / Reine Victoria 1) ) ) ) ) ) BBCH 85 fruit BBCH 85 fruit ASB height of trees: meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage: 12 months ASB height of trees: meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage: 12 months study 9-2, trial France 616 Steinseltz plums / Quetches d'alsace 1) 2 2) 3) BBCH 8 fruit ASB height of trees: 3.5 meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage: months ASB Page 14 / 2

37 Report-No. Location incl. postal code and date study 9-2, trial Germany Jork study 9-2, trial Germany 6229 Laumersheim study 1-226, trial France 688 Innenheim study 1-226, trial Poland Witoldzin Remarks: (a) (b) (c) (d) (e) Commodity/ Variety plums / Fellenberger plums / Elena Date of 1) Planting 2) Flowering 3) Harvest Application rate per treatment kg Water kg a.i./ha l/ha a.i./hl Dates of treatments Growth stage at last treatment Portion analysed Residues Residues Residues Residues (a) (b) (c) (a) (d) (e) 1) ) ) plums / Quetches d'alsace plums / Wagrowicra 1) 21 2) ) ) 22 2) 3) ) ) ) BBCH 85 fruit BBCH 81 fruit BBCH 8 fruit BBCH 8 fruit 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 PHI (days) Remarks height of trees: 3.2 meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage: months ASB height of trees: 3.2 meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage: months ASB height of trees: 3. meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage: 4 months ASB height of trees: 3. meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg (each analyte) max. sample storage: 4 months ASB Comments of zrms: The studies were conducted under acceptable conditions and the results are deemed valid. Though 3 treatments were made instead of the notified maximum of 2, the trials are acceptable for supporting the intended use. Page 15 / 2

38 Table A 2: Residues of Fluopyram in plums, dried RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Fluopyram (Application on agricultural and horticultural crops) Crop / crop group : Plums Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 5 g/l Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : AE C SC (content and common name) : 2 g/l Tebuconazole Applicant : Bayer CropScience Deutschland GmbH Portion analysed :.1 Fluopyram RAC.2 Fluopyram in washed fruit.3 Fluopyram in dried fruit Commodity/ Application rate per treatment Dates of Residues Residues Residues PHI Remarks Variety treatments (days) Report-No. Location incl. postal code and date RAGMP49, trial GM144-6PA USA Live Oak, California plums / French Date of 1) Planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Growth stage at last treatment (a) (b) (c) (d) (e) 1) ) ) BBCH analytical method: GM-1-P-1 (HPLC-MS/MS), 2 field sub-samples LOQ:.1 mg/kg (fruit, dried fruit, washed fruit), max. sample storage time 1 months 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. Page 16 / 2

39 Table A 3: Residues of Tebuconazole in plums RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Tebuconazole (Application on agricultural and horticultural crops) Crop / crop group : Plums Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 2 g/l Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : AE C TBZ SC 2 + 2A G SC (content and common name) : 2 g/l Fluopyram Applicant : Bayer CropScience Deutschland GmbH Residues calculated as : Tebuconazole Report-No. Location Commodity/ Variety Date of 1) Planting Application rate per treatment Dates of treatments Growth stage Portion analysed Residues PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl at last treatment (a) (b) (c) (a) (d) (e) study 8-262, trial plums / Presenta Germany 8869 Tettnang Bernau study 8-262, trial Germany 5334 Meckenheim plums / Hauszwetsche 1) ) ) ) ) ) BBCH 85 fruit BBCH 85 fruit height of trees: meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage: 12 months ASB height of trees: meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage: 12 months study 8-262, trial The Netherlands 1684 Zwaadijk plums / Reine Victoria 1) ) ) BBCH 85 fruit ASB height of trees: meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage: 12 months ASB Page 1 / 2

40 Report-No. Location incl. postal code and date study 8-262, trial The Netherlands 99 KA Sint Jacobiparochie study 9-2, trial France 616 Steinseltz study 9-2, trial Germany Jork study 9-2, trial Germany 6229 Laumersheim study 1-226, trial France 688 Innenheim Commodity/ Variety Date of 1) Planting Application rate per treatment Dates of treatments Growth stage Portion analysed Residues PHI (days) Remarks 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl at last treatment (a) (b) (c) (a) (d) (e) plums / Reine Victoria plums / Quetches d'alsace plums / Fellenberger plums / Elena plums / Quetches d'alsace 1) ) ) ) 2 2) 3) ) 2 2) 3) ) 21 2) ) ) 22 2) 3) BBCH 85 fruit BBCH 8 fruit BBCH 85 fruit BBCH 81 fruit BBCH 8 fruit height of trees: meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage: 12 months ASB height of trees: 3.5 meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage: months ASB height of tree s:3.2 meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage: months ASB height of trees: 3.2 meters analytical method: 984 (HPLC-MS/MS) all LOQ's.1 mg/kg, max. sample storage: months ASB height of trees: 3. meters analytic. method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg max. sample storage: 4 months ASB Page 18 / 2

41 Report-No. Location incl. postal code and date study 1-226, trial Poland Witoldzin Commodity/ Variety Date of 1) Planting Application rate per treatment Dates of treatments Growth stage Portion analysed Residues PHI (days) Remarks 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl at last treatment (a) (b) (c) (a) (d) (e) plums / Wagrowicra 1) ) ) BBCH 8 fruit height of trees: 3. meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage: 4 months 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: The studies were conducted under acceptable conditions and the results are deemed valid. Though 3 treatments were made instead of the notified maximum of 2, the trials are acceptable for supporting the intended use. Page 19 / 2

42 Table A 4: Residues of Tebuconazole in plums, dried RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : tebuconazole (Application on agricultural and horticultural crops) Crop / crop group : Plums Crop Code : PRNDO Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 45 g/kg Indoors / Outdoors : Outdoors (NAFTA) Formulation (e.g. WP) : DF (Dry flowable) Other a.i. in formulation Commercial product (name) : ELITE 45DF (content and common name) : Applicant : Bayer CropScience Residues calculated as : tebuconazole Report-No. Location Commodity/ Variety Date of 1) Planting Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) report 1962, study FR19PM3, trial FCA-FR-98H plums / French 1) 2) 3) 1998 BBCH 8 fruit USA Fresno, California dried fruit analytical method: Bayer report No (HPLC-MS/MS), LOQ:.1 mg/kg (fruit, dried fruit), max. sample storage time 5 months 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. Page 2 / 2

43 Table A 2: Residues of Fluopyram in peaches RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Fluopyram (AE C656948) (Application on agricultural and horticultural crops) Crop / crop group : Peaches Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 2 g/l Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : LUNA(R) experience (content and common name) : 2 g/l Tebuconazole (HWG 168) Applicant : Bayer CropScience Deutschland GmbH All residues were calculated as fluopyram equivalents Report-No. Location incl. postal code and date : 8.1 Fluopyram 8.2 BCS-AA1139 ([3-chloro-5-(trifluoromethyl)pyridin-2-yl] acetic acid) 8.3 AE F (2-trifluoromethylbenzamide) 8.4 AE C65188 (3-chloro-5-trifluoromethylpyridine-2-carboxylic acid) Commodity/ Application rate per treatment Dates of Portion Residues Residues Residues Residues PHI Remarks Variety treatments analysed (days) study 8-254, trial Germany 884 Meckenbeuren peaches / Red Haven Date of 1) Planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Growth stage at last treatment (a) (b) (c) (a) (d) (e) 1) BBCH 8 fruit - 2) ) height of crown: 2.5 meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage:16 months study 8-254, trial Germany 8351 Bodman- Ludwigshafen peaches / Edelstädter 1) ) ) BBCH 8 fruit ASB height of crown: 2.5 meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg (each analyte) max. sample storage:16 months ASB Page 21 / 2

44 Report-No. Location incl. postal code and date study , trial France 319 Valleres study , trial Germany 6433 Neustadt Commodity/ Variety peaches / Pavie Sanguine peaches / Benedikt Date of 1) Planting 2) Flowering 3) Harvest Application rate per treatment kg Water kg a.i./ha l/ha a.i./hl Dates of treatments Growth stage at last treatment Portion analysed (a) (b) (c) (a) (d) (e) 1) ) ) ) 199 2) ) Residues BBCH 8 fruit BBCH 83 fruit Residues Residues Residues PHI (days) Remarks height of crown: 2.6 meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg (each analyte) max. sample storage:3 months ASB height of crown: 2.6 meters analytical method: 984 (HPLC-MS/MS), LOQ:.1 mg/kg (each analyte) max. sample storage:5 months 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: The studies were conducted under acceptable conditions and the results are deemed valid. Though 3 treatments were made instead of the notified maximum of 2, the trials are acceptable for supporting the intended use. Page 22 / 2

45 Table A 3: Residues of Tebuconazole in peaches RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Tebuconazole (HWG 168) (Application on agricultural and horticultural crops) Crop / crop group : Peaches (PRNPS) Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 2 g/l Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : LUNA(R) experience (content and common name) : 2 g/l Fluopyram (AE C656948) Applicant : Bayer CropScience Deutschland GmbH Residues calculated as : Tebuconazole (HWG 168) Report-No. Location Commodity/ Variety Date of 1Planting Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) study 8-254, trial peaches / Red Haven Germany 884 Meckenbeuren 1) ) ) BBCH 8 fruit height of crown: 2.5 meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage:16 months study 8-254, trial Germany 8351 Bodman- Ludwigshafen study , trial France 319 Valleres peaches / Edelstädter peaches / Pavie Sanguine 1) ) ) ) ) ) BBCH 8 fruit BBCH 8 fruit ASB height of crown: 2.5 meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage:16 months ASB height of crown: 2.6 meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage:3 months ASB Page 23 / 2

46 Report-No. Location incl. postal code and date study , trial Germany 6433 Neustadt Commodity/ Variety Date of 1Planting Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues PHI (days) Remarks 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) 1) ) ) peaches / Benedikt BBCH 83 fruit height of crown: 2.6 meters analytical method: 984 (HPLC-MS/MS) LOQ:.1 mg/kg max. sample storage:5 months 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: The studies were conducted under acceptable conditions and the results are deemed valid. Though 3 treatments were made instead of the notified maximum of 2, the trials are acceptable for supporting the intended use. Page 24 / 2

47 A 2.3 Residues in processed commodities No new study on residues in processed commodities has been submitted/(and) none is needed due to low residues at harvest. A 2.4 Residues in rotational crops No new study on residues in rotational crops has been submitted. A 2.5 Residues in livestock No new study on residues in livestock has been submitted. A 2.6 None Other studies/information Page 25 / 2

48 Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) Tebuconazole (TMDI) Tebuconazole (NEDI) Page 26 / 2

49 Fluopyram (TMDI) Fluopyram (IEDI) Page 2 / 2