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Risk Management Part A BAS 310 62 I Registration Report –Central Zone National Assessment – STORANET Germany Page 1 of 22 REGISTRATION REPORT Part A Risk Management Product code: BAS 310 62 I (STORANET) Active Substance: Alpha-cypermethrin 1.57 g/kg or 100 mg per net m2 COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: BASF SE Date: June 2014 Applicant: BASF SE Evaluator: DE Date: 12/06/2014 Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 2 of 22 Table of Contents PART A – Risk Management 4 1 Details of the application 4 1.1 Application background 4 1.2 Annex I inclusion 5 1.3 Regulatory approach 5 1.4 Data protection claims 5 1.5 Letters of Access 5 2 Details of the authorisation 6 2.1 Product identity 6 2.2 Classification and labelling 6 2.2.1 Classification and labelling under Directive 99/45/EC and Regulation (EC) No 1272/2008 6 2.2.2 R and S phrases under Regulation (EU) No 547/2011 7 2.2.3 Other phrases 7 2.2.3.1 Restrictions linked to the PPP 7 2.3 Product uses 9 3 Risk management 11 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 11 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 11 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 11 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 11 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 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) 12 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 13 Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 3 of 22 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) 17 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 18 3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) 19 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 19 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 19 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 19 3.1.7 Efficacy (Part B, Section 7, Point 8) 20 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 21 Appendix 1 – Copy of the product authorisation 22 Appendix 2 – Copy of the product label 22 Appendix 3 – Letter of Access 22 Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Registration Report –Central Zone National Assessment – STORANET Germany Page 4 of 22 PART A – Risk Management This document describes the acceptable use conditions required for the registration of BAS 310 62 I (STORANET) containing alpha cypermethrin in Germany. This evaluation is required subsequent to the inclusion of alpha cypermethrin on Annex 1. 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 BAS 310 62 I (STORANET) where that data has not been considered in the EU review. Otherwise assessments for the safe use of BAS 310 62 I (STORANET) have been made using endpoints agreed in the EU review of alpha cypermethrin. This document describes the specific conditions of use and labelling required for Germany for the registration of BAS 310 62 I (STORANET). 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 has to fulfil the requirements according to Article 16 of Directive 91/414/EEC. 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 BASF SE on 27 February 2012. The application was for approval of BAS 310 62 I (STORANET), a long lasting insecticide net containing 1.57 g/kg or 100 mg per m2 net alpha-cypermethrin for use as an insecticide (net) against bark beetles, longhorn beetles and jewel beetles in hard- and softwood logs stored in forestry. Applicant: BASF SE Evaluator: DE Date: 12/06/2014 Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 5 of 22 1.2 Annex I inclusion Alpha-cypermethrin Alpha-cypermethrin was included on Annex I of Directive 91/414/EEC on 1 March 2005 under Inclusion Directive 2004/58/EC and is approved according to Regulation (EC) No 1107/2009 and implemented under Regulation (EU) No 540/2011. Only uses as insecticide may be authorised. The Annex I Inclusion Directive for alpha-cypermethrin (2004/58/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the alpha-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004, shall be taken into account. In this overall assessment: - Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. - Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures. These concerns were all addressed in the submission. 1.3 Regulatory approach To obtain approval the product BAS 310 62 I (STORANET) 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 first approval of this product in Germany in accordance with the above. 1.4 Data protection claims Where protection of data is being claimed for information supporting registration of STORANET, it is indicated in the reference lists in Appendix 1 of the Registration Report, part B, sections 1, 2, 4 – 7 and Part C. 1.5 Letters of Access Data access has been proven. BASF provided own data. So a letter of access is not necessary. Applicant: BASF SE Evaluator: Germany Date12/06/2014 Part A BAS 310 62 I Draft Registration Report – Central Zone National Assessment - Germany Page 6 of 22 2 Details of the authorisation 2.1 Product identity Product Name BAS 310 62 I; STORANET Authorization Number 007598-00/00 (for registration) Function insecticide (net) Applicant BASF SE Composition alpha-cypermethrin 1.57 g/kg or 100 mg per m2 net Formulation type Long lasting insecticide net [Code: LN] Packaging PE-bag (thickness 120 µm) net dimensions: 8 x 12,5 m, 0,8 x 20 m and 10 x 20 m, roll (8 x 100 m) 2.2 Classification and labelling 2.2.1 Classification and labelling under Directive 99/45/EC and Regulation (EC) No 1272/2008 The following is proposed in accordance with Directive 99/45/EC in combination with the latest classification and labelling guidance under Directive 67/548/EEC and according to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008: C&L according to Directives 67/548/EEC and 1999/45/EC Hazard symbols: N Indications of danger: Dangerous for the environment Risk phrases: R50/53 Safety phrases: S24, S35, S57 Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use.
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