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Daminozide (ISO); 4-(2,2- Dimethylhydrazino)-4-Oxobutanoic Acid; N-Dimethylaminosuccinamic Acid

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Daminozide (ISO); 4-(2,2- Dimethylhydrazino)-4-Oxobutanoic Acid; N-Dimethylaminosuccinamic Acid European Commission Draft (Renewal) Assessment Report prepared according to the Commission Regulation (EC) No 1107/2009 and Proposal for Harmonised Classification and Labelling (CLH Report) according to Regulation (EC) N° 1272/2008 Daminozide (ISO); 4-(2,2- dimethylhydrazino)-4-oxobutanoic acid; N-dimethylaminosuccinamic acid Volume 1 Rapporteur Member State: Czech Republic Co-Rapporteur Member State: Hungary Version history page Date Version Reason for revision May 2018 Version 1 First draft October 2018 Version 2 Notifier’s and co-RMS comments January 2019 Version 3 Update to include CLH Report June 2019 Version 4 Update following the ECHA accordance check 2 TABLE OF CONTENTS 1 STATEMENT OF SUBJECT MATTER AND PURPOSE FOR WHICH THIS REPORT HAS BEEN PREPARED AND BACKGROUND INFORMATION ON THE APPLICATION ................................................. 5 1.1 Context in which the renewal assessment report was prepared ......................................................................... 5 1.2 Applicant(s) information ................................................................................................................................... 6 1.3 Identity of the active substance.......................................................................................................................... 7 1.4 Information on the plant protection products..................................................................................................... 8 1.5 Detailed uses of the plant protection product .................................................................................................. 10 2 SUMMARY OF ACTIVE SUBSTANCE HAZARD AND OF PRODUCT RISK ASSESSMENT ........... 19 2.1 Identity ............................................................................................................................................................. 19 2.2 Physical and chemical properties [Equivalent to Section 7 of the CLH report template] ................................ 20 2.3 Data on application and efficacy ..................................................................................................................... 29 2.4 Further information ......................................................................................................................................... 30 2.5 Methods of analysis ......................................................................................................................................... 30 2.6 Effects on human and animal health ................................................................................................................ 31 2.7 Residue .......................................................................................................................................................... 131 2.8 Fate and behaviour in the environment.......................................................................................................... 132 2.9 Effects on non-target species ......................................................................................................................... 142 2.10 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ACCORDING TO THE CLP CRITERIA [SECTIONS 1-6 OF THE CLH REPORT] ........................................................................................ 181 2.11 Relevance of metabolites in groundwater ...................................................................................................... 186 2.12 Consideration of isomeric composition in the risk assessment ...................................................................... 187 2.13 Residue Definitions ....................................................................................................................................... 187 3 PROPOSED DECISION WITH RESPECT TO THE APPLICATION ..................................................... 190 3.1 Background to the proposed decision ............................................................................................................ 190 3.2 Proposed decision .......................................................................................................................................... 202 3.3 Rationale for the conditions and restrictions to be associated with any approval or authorisation(s), as appropriate ............................................................................................................................................................. 202 Daminozide Volume 1 - Level 1 October, 2018 LEVEL 1 Daminozide Volume 1 - Level 1 October, 2018 1 STATEMENT OF SUBJECT MATTER AND PURPOSE FOR WHICH THIS REPORT HAS BEEN PREPARED AND BACKGROUND INFORMATION ON THE APPLICATION 1.1 Context in which the renewal assessment report was prepared 1.1.1 Purpose for which the renewal assessment report was prepared This renewal assessment report (RAR) has been prepared according to Regulation (EC) No 1107/2009 of the European parliament and of the council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC and Commission Implementing Regulation (EU) 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. Daminozide (ISO); 4-(2,2-dimethylhydrazino)-4-oxobutanoic acid; N-dimethylaminosuccinamic acid ('hereafter referred to as 'daminozide') was the existing active substance to be included in Annex I of Council Directive 91/414/EEC by Commission Directive 2005/53/EC of 16 September 2005. The active substance was subsequently deemed to be approved under Regulation (EC) 1107/2009 via Implementing Regulation (EU) 540/2011 of 25 May 2011. The approval expires on 30 October 2018. The present submission for Annex I Renewal (AIR3 program) is carried out in accordance to the Regulation EC/844/2012 and guidance document SANCO/2012/11251 rev. 1.2 – on the renewal of active substances included in Annex I of Drective 91/414. This Renewal Assessment Report (RAR) has been produced as a result of evaluation of the dossier submitted by EU Daminozide Task Force, consisting of Fine Agrochemicals Limited and Arysta LifeScience Great Britain Ltd (wholly owned subsidiary of Arysta LifeScience Inc., formerly known as MacDermid Agricultural Solutions Inc., and before that as Chemtura Corporation), as main applicant and owner of a complete data package in order to support the renewal of approval of daminozide according to Regulation (EC) No. 1107/2009. 1.1.2 Arrangements between Rapporteur Member State and Co-Rapporteur Member State In compliance with Commision Implementing Regulation (EU) No. 686/2012 the Czech Republic was appointed as the Rapporteur Member State and Hungary as the Co-Rapporteur Member State for the active substance daminozide. The Co-RMS conducted a peer-review of the RAR. 1.1.3 EU Regulatory history for use in Plant Protection Products Daminozide was included in Annex I to Directive 91/414/EEC and an existing active substance (EAS) by Commission Directive 2005/53/EC of 16 September 2005. Inclusion entered into force on 1 March 2006. The Rapporteur Member State was the Netherlands. Uniroyal Chemical (Crompton Europe Ltd.) and Fine Agrochemicals Ltd were considered to be the main data submitters. The final Commission Review Report (SANCO3043/99 final) was published on 15 February 2005 and provided endpoints agreed during the first inclusion evaluation (appendix I and II of the Review Report). Czech Republic and Hungary, being the designated Rapporteur Member State (RMS) and Co-Rapporteur Member State (Co-RMS) respectively, received an application for the renewal of daminozide submitted EU Daminozide Task Force within the 3-years deadline required by Regulation (EU) 844/2012 (art. 1). (Deadline: 28 February 2013, Date of Receipt: 27 February 2013). The completeness of application was confirmed by the RMS in communication to the applicant the co-RMS, the Commission and EFSA on 15 April 2013. 5 Daminozide Volume 1 - Level 1 October, 2018 A supplementary dossier carried out in accordance to the Regulation (EU) no. 844/2012 and guidance document SANCO/2012/11251 rev. 1.2 on the renewal of active substances was submitted to the RMS within the deadline of 30 months before expiry of the approval required by Regulation no. 844/2012 (art. 6.3) (Deadline 30 April 2015, Date of Receipt: 30 April 2015). The completeness of the supplementary dossier was confirmed by the RMS in communication to the applicant, co-RMS, the Commission and EFSA on 15 June 2015. 1.1.4 Evaluations carried out under other regulatory contexts None available. 1.2 Applicant(s) information 1.2.1 Name and address of applicant(s) for approval of the active substance The original notifiers supporting Daminozide for the first inclusion were Fine Agrochemicals Limited and Uniroyal Chemical Limited. The applicant for the renewal is the EU Daminozide Task Force. The EU Daminozide Task Force is an equal partnership between: 1) Arysta LifeScience Great Britain Limited (formerly: MacDermid Agricultural Solutions Incorporated, Chemtura Europe Limited and Uniroyal Chemical Limited) Registered company address: 3-5 Melville Street Edinburgh EH3 7 PE United Kingdom Correspondence address: Brooklands Farm Cheltenham Road Evesham Worcestershire WR11 2LS United Kingdom Contact: Telephone
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