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

Transcription

1 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 1 of 36 Art. 51 Extension of authorisation for minor uses REGISTRATION REPORT Part A Risk Management Product code: Ridomil Gold MZ Active Substances: Mancozeb 640 g/kg and Metalaxyl M 38,8 g/kg COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04 July 2016 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

2 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 2 of 36 Table of Contents PART A Risk Management Details of the application Application background... 3 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 Restrictions linked to the PPP under Regulation (EC) No 547/ 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_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

3 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 3 of 36 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of Ridomil Gold MZ containing Mancozeb and Metalaxyl M 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 Ridomil Gold MZ have been made using endpoints agreed in the EU reviews of Mancozeb and Metalaxyl M. Appendix 1 of this document provides a copy of the final product authorisation in Germany. 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 Ridomil Gold MZ Registration number /07 Applicant Authorisation holder Function Type of formulation Zonal application according to Article 51, ZRMS=DE, first application (GV1) Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen, Siebengebirgsstraße 200, Bonn, Deutschland Syngenta Agro GmbH, Am Technologiepark 1-5, Maintal Fungicide Expiration of authorisation Water dispersible granule (WG) BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

4 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 4 of 36 Annex I inclusion The active substances included in the plant protection product are approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Mancozeb (0010) Content in PPP 640 g/kg Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 30/06/2016 Metalaxyl M (0933) Content in PPP 38,8 g/kg Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/12/ 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 001 bulb crops (utilisation as common onion) downy mildew of onion (Peronospora destructor) Authorise 002 bulb crops (utilisation as bunch onions) downy mildew of onion (Peronospora destructor) Authorise 003 broad bean downy mildew of legumes (Peronospora viciae) Authorise 004 fresh herbs downy mildew, white rust of crucifers (Albugo candida) Authorise BVL_FO_05_2422_200_V leek downy mildew of leek (Phytophthora porri) Authorise Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

5 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 5 of head lettuce iceberg lettuce downy mildew of lettuce (Bremia lactucae) Authorise Public interest and minor use According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest. In Germany the cultivated area of bulb crops as common onion (001) is about 9442 ha, of which approx ha need to be controlled, the cultivated area of bulb crops as bunch onion (002) is about 1949 ha, of which approx. 780 ha need to be controlled, the cultivated area of broad bean is about 538 ha, of which approx. 215 ha need to be controlled, the cultivated area of fresh herbs is about 3566 ha, of which approx ha need to be controlled, the cultivated area of leek is about 2399 ha, of which approx. 960 ha need to be controlled and the cultivated area of endives and lettuce is about ha, of which approx ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested uses. All data concern to open field production. 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 Authorisation holder agrees to the current application to extend the authorisation. 2 Details of the authorisation 2.1 Product identity Product name Ridomil Gold MZ Authorisation number Composition Mancozeb 640 g/kg and Metalaxyl M 38,8 g/kg Type of formulation Water dispersible granule (WG) Function Fungicide Authorisation holder Syngenta Agro GmbH, Am Technologiepark 1-5, Maintal 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC Not proposed. BVL_FO_05_2422_200_V Classification and labelling under Regulation (EC) No 1272/2008 The product is not complete classified according Regulation (EC) No 1272/2008 yet. Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

6 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 6 of 36 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008: Hazard classes and categories: (kein Labelling-Requirement!) Aquatic Acute 1 H400 Very toxic to the aquatic environment Aquatic Chronic 1 H410 Very toxic to aquatic life with long lasting effects Hazard pictograms: GHS 09 Signal word: Warning Hazard statements: H400 Very toxic to the aquatic environment H410 Very toxic to aquatic life with long lasting effects Precautionary statements: 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: BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

7 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 7 of R and S phrases under Directive 2003/82/EC (Annex IV and V) None Other phrases Restrictions linked to the PPP under Regulation (EC) No 547/2011 The authorization of the PPP is linked to the following conditions (mandatory labelling): Human health protection BVL_FO_05_2422_200_V1.0 SB001 SB110 SE120 SS SS110 SS120 SS2101 SS2202 ST1203 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 applying/handling the product ready for application. Treated areas/crops may not be entered until the spray coating has dried. 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 particle-filtering half mask FFP2 or half mask with particle filter P2 (identification colour: white) according to the BVL guideline "Personal protective equipment for handling plant protection products", current version, when applying/handling the product ready for application. Integrated pest management (IPM)/sustainable use NN234 NN260 NN265 NN2842 The product is classified as slightly harmful for populations of the species Typhlodromus pyri (predatory mite) The product is classified as slightly harmful for populations of the species Aleochara bilineata (staphylinid beetle) The product is classified as slightly harmful for populations of the species Poecilus cupreus (ground beetle) Das Mittel wird als schwachschädigend für Populationen der Art Aphidius rhopalosiphi (Brackwespe) eingestuft Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

8 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 8 of 36 Mode of action (FRAC-Group): A1 (Mancozeb), M3 (Metalaxyl-M) Ecosystem protection NW262 NW264 NW468 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 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 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) Integrated pest management (IPM)/sustainable use Ecosystem protection NW605-1 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 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 "*". Driftreduction 90%: 5 m 75%: 5 m 50%: 10 m BVL_FO_05_2422_200_V1.0 NW606 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. Conventionell: 15 m Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

9 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 9 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

10 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 10 of Product uses PPP (product name/code) Ridomil Gold MZ ( ) active substance 1 Mancozeb active substance 2 Metalaxyl M Formulation type: Conc. of as 1: Conc. of as 2: WG 640 g/kg 38,8 g/kg safener - synergist - Conc. of safener: - Conc. of synergist: - Applicant: Zone(s): Verified by MS: yes Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen central EU professional use non professional use 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 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 b) per crop/ season b) max. total rate per crop/season b) max. total rate per crop/season Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures BVL_FO_05_2422_200_V1.0 1 DE bulb crops (utilisation as common onion) 002 DE bulb crops (utilisation as bunch F F downy mildew of onion (Peronospora destructor) PERODE downy mildew of onion spraying from BBCH 41; In case of danger of infection and/or after warning service appeal a) 1 b) 1 a) 2 kg/ha b) 2 kg/ha a.s.1: a) 80 kg as/ha b) 80 kg as/ha a.s. 2: a) kg as/ha b) kg as/ha spraying from BBCH 41; a) 1 a) 2 kg/ha a.s.1: a) 80 kg Restrictions (see ) NW %: 5; 75%: 5; 50%: 10 m NW606: 15 m NW605-1 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

11 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 11 of 36 onions) (Peronospora destructor) PERODE In case of danger of infection and/or after warning service appeal b) 1 b) 2 kg/ha as/ha b) 80 kg as/ha a.s. 2: a) kg as/ha b) kg as/ha 90%: 5; 75%: 5; 50%: 10 m NW606: 15 m 003 DE broad bean VICFJ F downy mildew of legumes (Peronospora viciae) PEROVI spraying from BBCH 29; In case of danger of infection and/or after warning service appeal a) 2 (8-14 days) b) 2 a) 2 kg/ha b) 4 kg/ha a.s.1: a) 80 kg as/ha b) 2560 kg as/ha a.s. 2: a) kg as/ha b) kg as/ha NW %: 5; 75%: 5; 50%: 10 m NW606: 15 m 004 DE fresh herbs F downy mildew, white rust of crucifers (Albugo candida) ALBUCA spraying from BBCH 21; In case of danger of infection and/or after warning service appeal a) 1 b) 1 a) 2 kg/ha b) 2 kg/ha a.s.1: a) 80 kg as/ha b) 80 kg as/ha a.s. 2: a) kg as/ha b) kg as/ha NW %: 5; 75%: 5; 50%: 10 m NW606: 15 m BVL_FO_05_2422_200_V DE leek ALLPO F downy mildew of leek (Phytophthora porri) PHYTPO spraying from BBCH 41, at beginning of infestation and/or when first symptoms become visible a) 1 b) 1 a) 2 kg/ha b) 2 kg/ha a.s.1: a) 80 kg as/ha b) 80 kg as/ha a.s. 2: a) kg NW %: 5; 75%: 5; 50%: 10 m NW606: 15 m Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

12 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 12 of 36 as/ha b) kg as/ha 006 DE head lettuce LACSC iceberg lettuce LACSA F downy mildew of lettuce (Bremia lactucae) BREMLA spraying from BBCH 41; In case of danger of infection and/or after warning service appeal a) 1 b) 1 a) 2 kg/ha b) 2 kg/ha a.s.1: a) 80 kg as/ha b) 80 kg as/ha a.s. 2: a) kg as/ha b) kg as/ha (21) NW %: 5; 75%: 5; 50%: 10 m NW606: 15 m Use changed to head lettuce and iceberg lettuce due to insufficient residue data with endives/open lettuce varieties. BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

13 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany 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 Not relevant for extension of authorisation according article Methods of analysis 3..1 Analytical method for the formulation Not relevant for extension of authorisation according article Analytical methods for residues The intended commodities belong to the group of high water content commodities. Sufficiently validated analytical methods are available for enforcing metalaxyl-m, mancozeb and dithiocarbamates 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 Metalaxyl-M and Mancozeb have been evaluated within the EU review process. Information about metabolism is sufficient to evaluate the intended uses 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 396/2005 for metalaxyl-m and mancozeb except for endives and other open lettuce varieties. For these crops additional residue data are asked for. Before authorisation the intended use (006) has been changed to head lettuce and iceberg lettuce Consumer exposure An assessment of residue uptake by consumers (TMDI calculation, EFSA PRIMo) results in the following maximum ADI consumptions: Dithiocarbamates (Mancozeb: 0.05 mg/kg bw/d) 72 % (DE children) Metalaxyl-M (0.08 mg/kg bw/d) 26 % (DE children) Long-term dietary intake of residues of Metalaxyl-M and Mancozeb is unlikely to present a public health concern for European consumers. No acute risk is expected from the consumption of the intended commodities treated according to the intended use. BVL_FO_05_2422_200_V Environmental fate and behaviour No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

14 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 14 of Ecotoxicology No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. The PPP Ridomil Gold MZ and the active substance mancozeb are toxic to the aquatic environment (mesocosm: NOEC 3.2 µg a.i./l). Subsequently no additional entries as those according to the evaluated use pattern and good agricultural practise are acceptable. Therefore the safety phrases and conditions of use NW262, NW264, NW468 and NW 605-1/NW606 are assigned, see also 2.2. The risk assessment with regard to effects on birds is based on a NOEL of 18.8 mg as/kg bw/d (Anas platyrhynchus tested with Dithane M 45 80,1 % Mancozeb). Together with the relevant focal species according to the EFSA guidance document EFSA/2009/1438 the acceptability criteria of a TER of 5 is reached for all scenarios relevant. 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 1107/2009 (see also point 2.2) Efficacy Labelling in accordance with the requirements of ANNEX III General principles of integrated pest management under directive 2009/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the use(s) applied for under the terms of Article 51 of regulation (EC) No 1107/ The categories and labelling for mode of action for the main application cover the use(s) applied for under the terms of Article 51 of regulation (EC) No 1107/2009. According to Article 51 of the regulation (EC) No 1107/2009 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products not need to be checked. BVL_FO_05_2422_200_V Conclusions PPP Ridomil Gold MZ is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. 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 intended use in bulb vegetables, beans, leeks, head lettuce, iceberg lettuce and fresh herbs, will not result in residues above the MRLs set in Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these residues is not expected. There is no special risk mitigation necessary which deviate from the existing registration. 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. An authorisation is foreseen for all uses. Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

15 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 15 of Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation - Two additional trials residue results with lettuce (open varieties) for Mancozeb - Four additional trials residue results with lettuce (open varieties) for Metalaxyl-M Justification: According to extrapolation guideline (SANCO 7525/VI/95 rev. 9, March 2011) residue trials on open lettuce varieties are necessary. The results can be extrapolated to endives. As endive is a minor crop four trials are necessary for each active substance. For Mancozeb two suitable results are available. BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

16 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 16 of 36 Appendix 1 Copy of the product authorization BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

17 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 17 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

18 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 18 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

19 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 19 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

20 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 20 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

21 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 21 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

22 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 22 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

23 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 23 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

24 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 24 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

25 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 25 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

26 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 26 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

27 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 27 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

28 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 28 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

29 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 29 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

30 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 30 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

31 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 31 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

32 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 32 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

33 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 33 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

34 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 34 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

35 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 35 of 36 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

36 Part A Core Assessment Ridomil Gold MZ Art. 51 Extension of authorisation for minor uses BVL Registration Number: /07 Draft Registration Report Central Zone Country Germany Page 36 of 36 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. Authorisation holder agrees to the current application to extend the authorisation. BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/07/2016

37 REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: Ridomil Gold MZ Active Substances: 640 g/kg Mancozeb 38.8 g/kg Metalaxyl-M Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04 July 2016 Page 1 / 68

38 Table of Contents 4 METABOLISM AND RESIDUES DATA Evaluation of the active substances Mancozeb Storage stability Metabolism in plants and plant residue definitions Metabolism in livestock and animal residue definitions Residues in rotational crops Residues in livestock Metalaxyl-M Storage stability Metabolism in plants and plant residue definitions Metabolism in livestock and animal residue definitions Residues in rotational crops Residues in livestock Evaluation of the intended uses Selection of critical uses and justification Bulb vegetables Residues in primary crops Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Broad beans Residues in primary crops Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Fresh herbs Residues in primary crops Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Leek Residues in primary crops Distribution of the residue in peel/pulp Page 2 / 68

39 Residues in processed commodities Proposed pre-harvest intervals, withholding periods Lettuce, scarole 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 Mancozeb Metalaxyl-M 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 Nature of residues A Magnitude of residues in bulb vegetables A Magnitude of residues in lettuce A Magnitude of residues in fresh herbs A Magnitude of residues in broad beans A Magnitude of residues in leek 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) Page 3 / 68

40 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances Mancozeb Table 4.1-1: Identity of the active substance mancozeb Structural formula Mn S H N H N S Zn y S S x Common Name Mancozeb (polymeric complex of the monomer illustrated above which contains 20 % manganese and 2.5 % zinc) CAS number Storage stability A brief summary of the storage stability data on mancozeb is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB ) and in EFSA s Reasoned Opinions on the Modification of the existing MRL for mancozeb in radishes (EFSA Journal 2011;9(3):2108; ASB ) and on the Modification of the existing MRL for mancozeb in fresh peas without pods (EFSA Journal 2010; 8(1):1451; ASB ). Table 4.1-2: Stability of residues (Annex IIA, point 6.1) Stability of mancozeb and ETU Residues of mancozeb are stable in apples, tomatoes and wheat under deep freezer conditions (-20 C) for up to two years (RIP ). Residues of ETU are moderately stable under conditions of frozen storage: for up to 12 months in tomatoes and wheat and for up to 6 months in apples (RIP ) Metabolism in plants and plant residue definitions A brief summary of the metabolism of mancozeb in plants is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB ) and in EFSA s Reasoned Opinions on the Modification of the existing MRL for mancozeb in radishes (EFSA Journal 2011;9(3):2108; ASB ) and on the Modification of the existing MRL for mancozeb in fresh peas without pods (EFSA Journal 2010; 8(1):1451; ASB ). Page 4 / 68

41 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 Rotational crops 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) Plant residue definition for monitoring Soybeans (oilseeds, RIP ,RIP ), tomatoes (fruiting vegetables,rip ), potatoes and sugar beets (root and tuber vegetables, RIP and RIP ) and wheat (cereals, RIP , RIP ), all as foliar applications, 14 C- ethylene label. Metabolism studies in four different crop groups indicate extensive degradation in plants and incorporation of the majority of radioactivity into naturally occurring molecules such as sugars (up to 41 % TRR), starch (up to 27 % TRR), proteins and amino acids (up to 45 % TRR), oil or lipids (up to 14 % TRR) and lignin (up to 23 % TRR). Residues of the toxicologically significant metabolite ETU were mostly below the LOQ except for potatoes ( mg/kg). Incorporation into natural products proceeds either through glycine or through enzyme-catalysed, oxidative cleavage into single carbon units derived from the radiolabelled ethylene backbone of mancozeb. It was concluded that metabolism was similar in all crops and that mancozeb is the only relevant residue in unprocessed primary crops. Barley (cereals), potatoes and radishes (root and tuber vegetables), Swiss chard (leafy vegetables): soil application at a rate of 6.7 kg as/ha, 14 C- ethylene label (RIP ) Only low residues were determined at harvest in rotational crops: mg/kg after PBI of 30 days and mg/kg after PBI of 60 days. Residues of the metabolite ETU were not detected in rotational crops. Due to the low residues no further characterisation was performed. Not concluded, since only low residues were determined in rotational crop study. Not applicable Studies on the effects of processing on the nature of mancozeb residues showed that the only degradation product of toxicological significance is ethylenethiourea (ETU). It particularly occurs after heating. For processed commodities a consumer risk assessment has to be performed regarding the potential consumer health risk related to ETU (see DAR, ASB ). No Since no specific analytical methods are available for the individual active substances belonging to the dithiocarbamate group, a common residue definition was established for dithiocarbamates: Dithiocarbamates expressed as CS 2, including maneb, mancozeb, metiram, propineb, thiram and ziram. This is in line with Reg. (EC) No 396/2005. Page 5 / 68

42 Plant residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Not applicable Dithiocarbamates expressed as CS 2, including maneb, mancozeb, metiram, propineb, thiram and ziram, and ETU Metabolism in livestock and animal residue definitions A brief summary of the metabolism of mancozeb in livestock is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB ). Table 4.1-4: Metabolism in livestock (Annex IIA, point to and 6.7.1) Animals covered Lactating goats (RIP , RIP ), laying hens (RIP , RIP ), 14 C-ethylene label, 7 days, three feeding levels: 4, 20 and 50 mg/kg feed In goats mancozeb is extensively metabolised and excreted fast via feces and urine with only minor amounts remaining in milk and tissues. The carbon atoms are incorporated to a significant extent into natural components (fat, protein, and carbohydrates) of milk and tissues. Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring The metabolism of mancozeb in hens is not significantly different from its metabolism in goats. Most of the radioactivity was excreted and only low residues were determined in tissues and eggs with highest levels in kidney and liver. Residues declined immediately after cessation of administration. 14 C was present in natural substances, as well as in metabolites. Ethylene urea (EU) was the most abundant metabolite in eggs or tissues, while ETU was detected only in traces. Milk: 3 days Eggs: plateau concentration was not achieved during dosing period of 7 days Since no specific analytical methods are available for the individual active substances belonging to the dithiocarbamate group, a common residue definition was established for dithiocarbamates: Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Not applicable Metabolism in rat and ruminant similar (yes/no) Dithiocarbamates expressed as CS 2, including maneb, mancozeb, metiram, propineb, thiram and ziram. This is in line with Reg. (EC) No 396/2005. Dithiocarbamates expressed as CS 2, including maneb, mancozeb, metiram, propineb, thiram and ziram, and ETU. Yes Fat soluble residue: (yes/no) No, log P O/W = Residues in rotational crops Field rotational crop studies on mancozeb are not required. This is explained in the following table. Page 6 / 68

43 Table 4.1-5: Residues in rotational crops (Annex IIA, point 6.6.3) Field studies Based on the metabolism study on rotational crops and on the DT 90 of mancozeb in soil of approximately one day, no significant residues are expected to occur in rotational or succeeding crops grown in areas previously treated with mancozeb Residues in livestock Residues of mancozeb in commodities of animal origin were not assessed, since crops under consideration are normally not fed to livestock. 4. Metalaxyl-M Table 4.1-6: Identity of the active substance metalaxyl-m Structural formula Me Me N H R CO 2 Me Me Common Name Metalaxyl-M CAS number O OMe 4..1 Storage stability A brief summary of the storage stability data on metalaxyl-m is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB ) and EFSA s Reasoned Opinion regarding the review of the existing MRLs for metalaxyl-m (ASB ). Table 4.1-7: Stability of residues (Annex IIA, point 6.1) Stability of metalaxyl-m Storage stability of metalaxyl-m was demonstrated for a period of 30 months at -20 C in commodities with high water and high acid content, and for a period of 24 months in high oil content commodities and dry commodities (ASB ). Further studies on metalaxyl were available also demonstrating stability over the tested storage periods Metabolism in plants and plant residue definitions A brief summary of the metabolism of metalaxyl(-m) in plants is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB ) and EFSA s Reasoned Opinion regarding the review of the existing MRLs for metalaxyl-m (ASB ). All plant metabolism studies (primary and rotational crop studies) were conducted with [ 14 C-phenyl]- metalaxyl. One study comparing the metabolism of metalaxyl-m and metalaxyl was performed on lettuce, showing a similar pattern for the R-enantiomer and the racemic mixture. Page 7 / 68

44 Table 4.1-8: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, and 6.7.1) Plant groups covered Fruits and fruiting vegetables: wine grapes, outdoor, foliar application, 7 x 0.05 kg as/hl; PHI 52 d. (RIP , RIP ) Leafy vegetables: - lettuce, outdoor, foliar, 2 x 0.25 kg as/ha; PHI 14 d (RIP , RIP , RIP ) - tobacco, indoor, soil treatment at transplanting / preplanting soil incorporation treatment, application rates between 0.28 and 7.1 kg as/ha, sampling 3 to 20 weeks after transplanting. (RIP , RIP , RIP ) Root and tuber vegetables: potatoes, outdoor, foliar application, 4 x kg as/ha, PHI 47 d; 6 x 0.43 resp. 1.3 kg as/ha, PHI: 7 d. (RIP , RIP , RIP , RIP ) Rotational crops The metabolism data on metalaxyl can also be applied to metalaxyl-m. Uptake following root, stem or leaf application is fast and translocation primarily occurs acropetally. Metalaxyl(-M) was intensively metabolised in all investigated crops with up to 8 identified metabolites. At harvest, parent metalaxyl accounted for 64 % TRR in grapes, 20 % TRR in lettuce, and 3 % TRR in potato leaves. Metabolite CGA 94689, free and conjugated, accounted for 20 % TRR in grapes and 25 % TRR in lettuce. In potato leaves CGA amounted to 47 % TRR. All other metabolites were seen at <10 % TRR. Metabolites mainly consisted of hydroxylated or demethylated parent, which are considered as less toxic than the parent. Uptake following root, stem or leaf application is fast, translocation primarily occurs acropetally. [phenyl-u- 14 C]-metalaxyl, several rotational crops, planted at different PBIs either after treated crops or after bare soil treatment Leafy vegetables - Lettuce, after soil treatment at 3.4 kg as/ha, PBI 232 days, indoors (RIP ) - Lettuce following 6 over-the-top treatments of potatoes at 0.45 kg as/ha, 14-d-intervals, outdoors (RIP ) Root and tubers - Sugar beet, after soil treatment at 3.4 kg as/ha, PBI 232 days, indoors (RIP ) - Sugar beet following 6 over-the-top treatments of potatoes at 0.45 kg as/ha, 14-d-intervals, outdoors (RIP ) Cereals - Wheat, after soil treatment at 3.4 kg as/ha, PBI of 232 days), indoors (RIP ) - Wheat following 6 over-the-top treatments of potatoes at 0.45 kg as/ha, 14-d-intervals, outdoors (RIP ) - Oats following 6 over-the-top treatments of potatoes at 0.45 kg as/ha, 14-d-intervals, outdoors (RIP ) Page 8 / 68

45 - Maize following 6 over-the-top treatments of potatoes at 0.45 kg as/ha, 14-d-intervals, outdoors (RIP ) Pulses and oilseeds - Soybean, after soil treatment at 3.4 kg as/ha, PBI 232 days, indoors (RIP ) - Soybean, following 6 over-the-top treatments of potatoes at 0.45 kg as/ha, 14-d-intervals, outdoors (RIP ) 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) Plant residue definition for monitoring Plant residue definition for risk assessment In crops planted immediately after harvest of treated potatoes, TRR levels at harvest were >0.1 mg/kg in wheat (0.11 mg/kg in grain, 0.56 in straw), soybean (0.17 mg/kg in beans, 0.59 in leaves), lettuce (0.11 mg/kg) and oats (0.19 mg/kg in straw). In corn, oat grain and sugar beet, TRR was below 0.1 mg/kg. In crops planted after tobacco which had received a soil treatment, 79% TRR in mature wheat stalks, 57% TRR in 50 % mature lettuce and 57 % TRR in mature sugar beet root had been charactewrised and/or identified. Seven glycosides were isolated and identified. Parent was extensively metabolized but still remained an important compound of the residue in the 50% mature lettuce foliage (15% TRR). The metabolite CGA present in wheat stalks (6.8% TRR) and lettuce foliage (15.5% TRR) was neither detected in plants nor in the rat metabolism. yes No information available. Simulated processing studies on the nature of metalaxyl residues demonstrated that under standard processing conditions (ph 4, 90 C, 20 min; ph 5, 100 C, 60 min; ph 6, 120 C, 20 min) the compound is hydrolytically stable (RIP ). yes metalaxyl including other mixtures of constituent isomers including metalaxyl-m (sum of isomers) This is in line with Reg. (EC) No 396/2005 and with EFSA s Reasoned Opinion (ASB ). metalaxyl including other mixtures of constituent isomers including metalaxyl-m (sum of isomers) Conversion factor(s) (monitoring to risk assessment) none This is in line with EFSA s Reasoned Opinion (ASB ) Metabolism in livestock and animal residue definitions A brief summary of the metabolism of metalaxyl in livestock is given in the following table. The data may be used also for metalaxyl-m. Data has been previously evaluated at EU level and is described in the DAR on metalaxyl (ASB ) and EFSA s Reasoned Opinion regarding the review of the existing MRLs for metalaxyl-m (ASB ). Page 9 / 68

46 Table 4.1-9: Metabolism in livestock (Annex IIA, point to and 6.7.1) Animals covered Lactating goats: [phenyl-u- 14 C]-metalaxyl, 77 mg/kg diet (3.9 mg/kg bw/d), 4 days (RIP , RIP , RIP ) Time needed to reach a plateau concentration in milk and eggs Lactating goats excreted 67 % of the administered dose via urine. Metalaxyl was intensively metabolised. The metabolic transformation involves oxidation and demethylation of the parent compound. In milk and edible tissues unchanged parent was not found. CGA (N- (2,6 dimethylphenyl)-n-(hydroxyacetyl)-alanine) was the major metabolite in liver (13.5 %; 0.22 mg/kg), kidney (31.5 %; 0.33 mg/kg), fat (29.6 %; 0.12 mg/kg), and muscle (18.4 %; 0.01 mg/kg). The glucorinic conjugate of CGA67869 (N-(2,6 dimethylphenyl)-n-(hydroxyacetyl)- alanine methylester) represented 67.5 % of the milk residues (0.28 mg/kg). Laying hens: [phenyl-u- 14 C]-metalaxyl, 100 mg/kg diet (6 mg/kg bw/d), 4 days (RIP , RIP ) With the majority of the radioactivity recovered in the excreta (91 %) transfer of radioactivity to eggs/tissues was relatively low. Highest levels were found in kidneys (1.47 mg/kg) and liver (1.39mg/kg). The parent compound was almost completely degraded and, if present, only at low levels (< % TRR). The remaining residue comprised a large number of distinct metabolites, out of which CGA was the major one (40.3 % TRR in fat, 17.1 % in liver, 14.5 % in egg yolk). An accumulation has not been observed in any tissue. 1 day Animal residue definition for monitoring Current definition according to Reg. (EC) No 396/2005: metalaxyl including other mixtures of constituent isomers including metalaxyl-m (sum of isomers) Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Not derived Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) no (log P OW = 1.71) Tentative proposal by EFSA in its Reasoned Opinion (ASB ): sum of metalaxyl (sum of isomers) and its metabolites containing the 2,6-dimethylaniline moiety, expressed as metalaxyl. EFSA concedes that it would be more appropriate if the definition could be simplified to include only one metabolite (CGA in animal tissues and CGA in milk); however no method was available for enforcing the compounds individually. The simplified DoR is supported by BfR. sum of metalaxyl (sum of isomers) and its metabolites containing the 2,6-dimethylaniline moiety, expressed as metalaxyl yes Page 10 / 68