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TRINET P) + BAS 321 00 I (Pheroprax Dispenser) Active Substance: Alpha-Cypermethrin 1.57 G/Kg (Or 100 Mg Per M2 Net

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TRINET P) + BAS 321 00 I (Pheroprax Dispenser) Active Substance: Alpha-Cypermethrin 1.57 G/Kg (Or 100 Mg Per M2 Net Part A TRINET P Registration Report – Central Zone National Assessment – Page 1 of 21 Germany REGISTRATION REPORT Part A Risk Management Product code: BAS 310 62 I (TRINET P) + BAS 321 00 I (Pheroprax dispenser) Active Substance: Alpha-cypermethrin 1.57 g/kg (or 100 mg per m2 net) COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: BASF Date: 2014-08-20 Applicant: BASF Date: 2014-08-20 Part A TRINET P Registration Report –Central Zone National Assessment - Germany Page 2 of 21 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 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 10 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 10 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 10 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) 11 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 11 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 11 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 11 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 12 Applicant: BASF Date: 2014-08-20 Part A TRINET P Registration Report –Central Zone National Assessment - Germany Page 3 of 21 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 12 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 13 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 13 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 13 3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 14 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 15 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 16 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 16 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 16 3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) 18 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 18 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 18 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 18 3.1.7 Efficacy (Part B, Section 7, Point 8) 19 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 20 Appendix 1 – Copy of the product authorisation 21 Appendix 2 – Copy of the product label 21 Appendix 3 – Letter of Access 211 Applicant: BASF Date: 2014-08-20 Part A TRINET P Registration Report – Central Zone National Assessment – Page 4 of 21 Germany PART A – Risk Management This document describes the acceptable use conditions required for the registration of TRINET P containing alpha-cypermethrin 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 TRINET P where that data has not been considered in the EU review. Otherwise assessments for the safe use of TRINET P 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 TRINET P. 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 drawn 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. Data access has been proven. BASF SE provided only own data. BASF is the owner for the active substance alpha-cypermethrin. 1 Details of the application 1.1 Application background This application was submitted by BASF SE. The application was for approval of TRINET P, a LN- formulation containing 1.57 g/kg alpha- cypermethrin or 100 mg per m2 net used to prevent or reduce infestation of standing trees by European spruce bark beetle (Ips typographus). 1.2 Annex I inclusion Alpha-cypermethrin is approved under Regulation (EC) No 1107/2009 (repealing Directive 91/414/EEC) on 01/03/2005 under Inclusion Directive 2004/58/EC amended by Commission Implementing Regulation (EU) No 1197/2012 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period. Applicant: BASF Date: 2014-08-20 Part A TRINET P Registration Report –Central Zone National Assessment - Germany Page 5 of 21 The approval of alpha-cypermethrin (Inclusion Directive 2004/58/EC from 23 April 2004) 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 alpha-Cypermethrin, and in particular Appendices I and II thereof, as finalized 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. Expiration of approval: 31/07/2017. 1.3 Regulatory approach To obtain authorisation the product TRINET P 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 TRINET P in Germany in accordance with the above. 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of TRINET P, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B, section 1, 2, 4 – 7 and Part C. 1.5 Letters of Access Data access has been proven. BASF SE provided only own data. BASF is the owner for the active substance alpha-cypermethrin. Applicant: BASF Date: 2014-08-20 Part A TRINET P Registration Report –Central Zone National Assessment - Germany Page 6 of 21 2 Details of the authorisation 2.1 Product identity Product Name TriNet P Authorization Number 007691-00 (for re-registration) Function insecticide Applicant BASF Composition 1.57 g/kg or 100 mg per m2 net alpha-cypermethrin Formulation type long lasting insecticidal net [Code: LN] in combination with a pheromone dispenser Packaging Insecticide net: Polyethylene bags, 120 µm thickness; Pheromone dispensers: Aluminium composite bags; Overall packaging: UN-approved cartons. 2.2 Classification and labelling 2.2.1 Classification and labelling under Directive 99/45/EC and Regulation (EC) No 1272/2008 For TRINET P (BAS 310 62 I (TriNet) + BAS 321 00 I (Pheroprax)), 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: Xi, N Indications of danger: Irritant Dangerous for the environment Risk phrases: 36-38-50/53 Safety phrases: 2-24-26-29-35-36-37-39-46-56-57 Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use. [SP001] Applicant: BASF Date: 2014-08-20 Part A TRINET P Registration Report –Central Zone National Assessment - Germany Page 7 of 21 C&L according to Regulation (EC) No 1272/2008 Hazard classes, categories: Skin Irrit.
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