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GF-2626 Active Substance: Sulfoxaflor 120 G/L

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GF-2626 Active Substance: Sulfoxaflor 120 G/L Part A Product code Draft Registration Report – All Zones National Assessment - GF 2626 Page 1 of 28 Federal Republic of Germany 008447-00/00 REGISTRATION REPORT Part A Risk Management Product name: Closer Product code: GF-2626 Active Substance: Sulfoxaflor 120 g/L COUNTRY: Germany All Zones Zonal Rapporteur Member State: France NATIONAL ASSESSMENT Applicant: Dow AgroSciences GmbH München Submission date: 06/05/2015 Finalisation date: 05/12/2018 Applicant (Dow AgroSciences GmbH München) Evaluator BVL Date .06/12/2018 Part A Product code Draft Registration Report – All Zones National Assessment - GF 2626 Page 2 of 28 Federal Republic of Germany 008447-00/00 Table of Contents PART A – Risk Management 4 1 Details of the application 4 1.1 Application background 4 1.2 Annex I inclusion 4 1.3 Regulatory approach 5 1.4 Data protection claims 5 1.5 Letters of Access 5 2 Details of the authorisation 5 2.1 Product identity 5 2.2 Classification and labelling 6 2.2.1 Classification and labelling under Directive 99/45/EC Fehler! Textmarke nicht definiert. 2.2.2 Classification and labelling under Regulation (EC) No 1272/2008 6 2.2.3 Standard phrases under Regulation (EC) No 547/2011 6 2.3 Other phrases notified under Regulation (EC) No 547/2011 6 2.3.1 Restrictions linked to the PPP 6 2.3.2 Specific restrictions linked to the intended uses 8 2.4 Product uses 9 3 Risk management 15 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 15 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 15 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 15 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 15 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 15 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 16 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 16 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 16 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 16 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 16 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 17 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 17 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 17 3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 18 Applicant (Dow AgroSciences GmbH München) Evaluator BVL Date .06/12/2018 Part A Product code Draft Registration Report – All Zones National Assessment - GF 2626 Page 3 of 28 Federal Republic of Germany 008447-00/00 3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) 18 3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 18 3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) 19 3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) 19 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 20 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 20 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 21 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 21 3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) 22 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 23 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 23 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 23 3.1.7 Efficacy (Part B, Section 7, Point 8) 24 3.2 Conclusions 25 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 25 Appendix 1 – Copy of the product authorisation (see Appendix 4) 26 Appendix 2 – Copy of the product label 27 Appendix 3 – Letter of Access 28 Appendix 4 – Copy of the product authorisation 28 Applicant (Dow AgroSciences GmbH München) Evaluator BVL Date .06/12/2018 Part A Product code Draft Registration Report – All Zones National Assessment - GF 2626 Page 4 of 28 Federal Republic of Germany 008447-00/00 PART A – Risk Management This document describes the acceptable use conditions required for the registration of Closer containing sulfoxaflor in Germany. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to Closer where that data has not been considered in the EU review. Otherwise assessments for the safe use of Closer have been made using endpoints agreed in the EU review of sulfoxaflor. This document describes the specific conditions of use and labelling required for Germany> for the re- registration/registration of Closer. Appendix 1 should include the authorisation of the final product in Germany. Due to technical reasons, the authorisation of the final product in Germany is inserted under Appendix 4. Appendix 2: The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label has to fulfil the requirements according to Article 31 of Regulation (EC9 No 1107/2009. Appendix 3: Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. Appendix 4 of this document provides a copy of the final product authorisation Germany. 1 Details of the application 1.1 Application background This application was submitted by Dow AgroSciences GmbH München on 6 May 2015. The application was for authorisation of Closer, a suspension concentrate (SC) containing 120 g/L sulfoxaflor for use as an insecticide in various vegetable cultures and ornamentals in greenhouses. 1.2 Annex I inclusion Sulfoxaflor was approved in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 with Commission Implementing regulation (EU) 2015/1295 on 18 August 2015. Applicant (Dow AgroSciences GmbH München) Evaluator BVL Date .06/12/2018 Part A Product code Draft Registration Report – All Zones National Assessment - GF 2626 Page 5 of 28 Federal Republic of Germany 008447-00/00 The approval for sulfoxaflor (2015/1295 /EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to bees and other non-target arthropods; (b)the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses. Conditions of use shall include risk mitigation measures, where appropriate. These concerns were all addressed in the submission. 1.3 Regulatory approach To obtain authorisation the product Closer must meet the conditions of EU active approval and be supported by dossiers satisfying the requirements of Commission Regulation (EU) 545/2011 with an assessment to Uniform Principles, using approved end-points. This application was submitted in order to allow the first authorisation of this product in Germany in accordance with the above. 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of CLOSER (GF-2626), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7. 1.5 Letters of Access Not necessary: the applicant has provided sufficient data to show that access is not required. 2 Details of the authorisation 2.1 Product identity Product Name Closer GF-2626 Authorisation Number 008447-00/00 (for re-registration) Function insecticide Applicant (Dow AgroSciences GmbH München) Evaluator BVL Date .06/12/2018 Part A Product code Draft Registration Report – All Zones National Assessment - GF 2626 Page 6 of 28 Federal Republic of Germany 008447-00/00 Applicant Dow AgroSciences Composition 120 g/L sulfoxaflor Formulation type Suspension concentrate [Code: SC] Packaging Bottle, HDPE or PET 0,25 - 20 L 2.2 Classification and labelling 2.2.1 Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008: Hazard classes and categories: Aquatic acute 1, Aquatic chronic 1 Hazard pictograms: GHS09 environment Signal word: Warning Hazard statements: H400 Very toxic to aquatic life.
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