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Movento SC 100 Productcode: 102000016538 Part A Product code Registration Report –Central Zone National Assessment - Movento SC 100 Page 1 of 28 Federal Republic of Germany 102000016538 REGISTRATION REPORT Part A Risk Management Product name: Movento SC 100 Productcode: 102000016538 Active Substance: Spirotetramat 100 g/L COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Austria NATIONAL ASSESSMENT Applicant: Bayer CropScience Date: 17/10/2018 Applicant: Bayer CropScience Evaluator: Germany Date 17/10/2018 Part A Product code Registration Report –Central Zone National Assessment - Movento SC 100 Page 2 of 28 Federal Republic of Germany 102000016538 Applicant: Bayer CropScience Evaluator: Germany Date 17/10/2018 Part A Product code Registration Report –Central Zone National Assessment - Movento SC 100 Page 3 of 28 Federal Republic of Germany 102000016538 Table of Contents PART A – Risk Management 5 1 Details of the application 5 1.1 Application background 5 1.2 Annex I inclusion 5 1.3 Regulatory approach 6 1.4 Data protection claims 6 1.5 Letters of Access 6 2 Details of the authorisation 6 2.1 Product identity 6 2.2 Classification and labelling 7 2.2.1 Classification and labelling under Regulation (EC) No 1272/2008 7 2.2.2 Standard phrases under Regulation (EU) No 547/2011 8 2.2.3 Other phrases notified under Regulation (EU) No 547/2011 8 2.2.3.1 Restrictions linked to the PPP 8 2.2.3.2 Specific restrictions linked to the intended uses 9 2.3 Product uses 11 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) 16 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 16 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 17 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 18 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 19 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 19 Applicant: Bayer CropScience Evaluator: Germany Date 17/10/2018 Part A Product code Registration Report –Central Zone National Assessment - Movento SC 100 Page 4 of 28 Federal Republic of Germany 102000016538 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 20 3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) 21 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) 22 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 22 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: Bayer CropScience Evaluator: Germany Date 17/10/2018 Part A Product code Registration Report –Central Zone National Assessment - Movento SC 100 Page 5 of 28 Federal Republic of Germany 102000016538 PART A – Risk Management This document describes the acceptable use conditions required for the registration of Movento SC 100 containing spirotetramat in Germany. This evaluation is required subsequent to the inclusion of spirotetramat 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 (new dRR format). 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 Movento SC 100 where that data has not been considered in the EU review. Otherwise assessments for the safe use of Movento SC 100 have been made using endpoints agreed in the EU review of Spirotetramat. This document describes the specific conditions of use and labelling required for Germany for the registration of Movento SC 100. Appendix 1 of this document provides a copy of the final product authorisation Germany. 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 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. 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 Bayer CropScience Deutschland GmbH on 01/07/2013. The application was for authorisation of Movento SC 100, a suspension concentrate containing 100 grams of spirotetramat per Litre for use as an insecticide in agriculture or horticulture. 1.2 Annex I inclusion Spirotetramat was included on Annex I of Directive 91/414/EEC on 01/05/2014 under Inclusion Directive 1177/2013/EC. The Annex I Inclusion Directive for Spirotetramat (1177/2013/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. Applicant: Bayer CropScience Evaluator: Germany Date 17/10/2018 Part A Product code Registration Report –Central Zone National Assessment - Movento SC 100 Page 6 of 28 Federal Republic of Germany 102000016538 For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the Spirotetramat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 03/10/2013, shall be taken into account. In this overall assessment: Member States should/must/may pay particular attention to the: • risk to insectivorous birds These concerns were all addressed in the submission. 1.3 Regulatory approach To obtain approval the product Movento SC 100 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/use in Germany in accordance with the above. 1.4 Data protection claims Where data protection is being claimed regarding information supporting registration of Movento SC 100/ Spirotetramat SC 100, it is indicated in the reference list in Appendix 1 of the respective documents of the registration report. 1.5 Letters of Access The applicant has access to any protected studies required for the evaluation of the product or has provided sufficient data to show that access is not required. 2 Details of the authorisation 2.1 Product identity Product Name Movento SC 100 Spirotetramat SC 100 Authorisation Number 008007-00/00 (for re-registration) Function Insecticide, acaricide Applicant Bayer CropScience Deutschland GmbH Composition 100 g/L spirotetramat Formulation type Suspension Concentrate [Code: SC] Packaging 1 L HDPE or HDPE/PA or HDPE/E-VAL bottles, 3 L and 5 L HDPE or HDPE/PA or HDPE/E-VAL jerry cans Applicant: Bayer CropScience Evaluator: Germany Date 17/10/2018 Part A Product code Registration Report –Central Zone National Assessment - Movento SC 100 Page 7 of 28 Federal Republic of Germany 102000016538 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 chronic 2 Hazard pictograms: GHS07 exclamation mark GHS08 health hazard GHS09 environment Signal word: S1 warning Hazard statements: H317 May cause an allergic skin reaction. H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. H411 Toxic to aquatic life with long lasting effects. Precautionary statemtents: P101 If medical advice is needed, have product container or label at hand. P102 Keep out of reach of children. P201 Obtain special instructions before use. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves/protective clothing/eye protection/face protection. P302 + P352 IF ON SKIN: Wash with plenty of water/... P308 + P313 IF exposed or concerned: Get medical advice/attention. P362 + P364 Take off contaminated clothing and wash it before reuse.
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