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FURY 10 EW Active Substance: Zeta-Cypermethrin 100 G/L COUNTRY

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FURY 10 EW Active Substance: Zeta-Cypermethrin 100 G/L COUNTRY Part A Product name Registration Report –Central Zone National Assessment - FURY 10 EW Page 1 of 27 Federal Republic of Germany 024222-00/01 REGISTRATION REPORT Part A Risk Management Product name: FURY 10 EW Active Substance: zeta-cypermethrin 100 g/L COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: Cheminova Deutschland GmbH & Co. KG Submission Date: 02/01/2014 Date: 17/08/2018 Applicant (Cheminova Deutschland GmbH) Evaluator BVL / DE Date: 17/09/ 2018 Part A Product name Registration Report –Central Zone National Assessment - FURY 10 EW Page 2 of 27 Federal Republic of Germany 024222-00/01 Table of Contents PART A – Risk Management 4 1 Details of the application 4 1.1 Application background 4 1.2 Annex I inclusion 4 1.3 Regulatory approach 5 2 Details of the authorisation 6 2.1 Product identity 6 2.2 Classification and labelling 6 2.3.2.2 Specific restrictions linked to the intended uses 9 2.3 Product uses 10 3 Risk management 12 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 12 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 12 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 12 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 12 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 12 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 12 The PPP is already registered in Germany according to Regulation (EU) No 1107/2009. 12 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 12 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 13 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 13 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 13 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 14 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 14 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 14 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 17 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 17 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 18 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 19 3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) 20 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 21 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 21 Applicant (Cheminova Deutschland GmbH) Evaluator BVL / DE Date: August 2018 Part A Product name Registration Report –Central Zone National Assessment - FURY 10 EW Page 3 of 27 Federal Republic of Germany 024222-00/01 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 21 3.1.7 Efficacy (Part B, Section 7, Point 8) 23 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 24 Appendix 1 – Copy of the product authorisation 25 Appendix 2 – Copy of the product label 26 Appendix 3 – Letter of Access 27 Applicant (Cheminova Deutschland GmbH) Evaluator BVL / DE Date: August 2018 Part A Product name Registration Report –Central Zone National Assessment - FURY 10 EW Page 4 of 27 Federal Republic of Germany 024222-00/01 PART A – Risk Management This document describes the acceptable use conditions required for the registration of additional uses of FURY 10 EW containing zeta-cypermethrin in Germany. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 (except Section 2, 3 and 4) and where appropriate the addendum for Germany. There were no significant differences to the original product authorization from 2017. For this reason, no specific Part B, Section 2, 3 and 4 were drafted. Instead, it is referred to the original German assessment report of BfR. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to FURY 10 EW where that data has not been considered in the EU review. Otherwise assessments for the safe use of FURY 10 EW have been made using endpoints agreed in the EU review of zeta-cypermethrin. This document describes the specific conditions of use and labelling required for Germany for the registration of FURY 10 EW. Appendix 1 of this document provides a copy of the final product authorisation Germany. Appendix 2 of this document is a copy of the approved product label for Germany The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again. Appendix 3 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation. Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. 1 Details of the application 1.1 Application background This application was submitted by FMC Chemical on 2 January 2014. Afterwards the application was transferred to Cheminova Deutschland GmbH & Co. KG. The application was for extension of approval of FURY 10 EW, an emulsion, oil in water [EW] containing zeta-cypermethrin 100 g/L for use as an insecticide 1.2 Annex I inclusion Zeta-cypermethrin (CAS No 52315-07-8, CIPAC No 733) is included in the Annex to Commission Implementing Regulation (EU) No 540/2011 containing the active substances approved for use in plant protection products under Regulation (EC) No 1107/2009 with the expiration of approval on 30 November 2019. Applicant (Cheminova Deutschland GmbH) Evaluator BVL / DE Date: 17/09/ 2018 Part A Product name Registration Report –Central Zone National Assessment - FURY 10 EW Page 5 of 27 Federal Republic of Germany 024222-00/01 According to general provisions applying to all substances listed in the Annex to Commission Implementing Regulation (EU) No 540/2011: — for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account; — Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request. According to specific provisions in the parts A and B Annex to Regulation No 540/2011 on Zeta- cypermethrin (CAS No 52315-07-8): PART A Only uses as insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing zeta- cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate, — the protection of birds, aquatic organisms, bees, non-target arthropods and non- target soil macro- organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. 1.3 Regulatory approach To obtain approval of additional uses the product FURY 10 EW must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed end-points. This application was submitted in order to allow the registration of further uses of an already approved product in Germany in accordance with the above. 1.4 Data protection claims Where data protection is being claimed regarding information supporting registration of Fury 10 EW, it is indicated in the reference list in Appendix 1 of the respective documents of the Registration Report. Applicant (Cheminova Deutschland GmbH) Evaluator BVL / DE Date: August 2018 Part A Product name Registration Report –Central Zone National Assessment - FURY 10 EW Page 6 of 27 Federal Republic of Germany 024222-00/01 1.5 Letters of Access The data not provided by the applicant and necessary to conduct the evaluation is out of protection, no access authorization is needed.
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