Kommisjonens gjennomføringsforordning (EU) 2020/1498 av 15. oktober 2020 om ikke å fornye godkjenningen av aktive stoffet tiofanatmetyl, i samsvar med europaparlamentets- og rådsforordning (EF) nr. 1107/2009 om omsetning av plantevernmidler og om endring av vedlegget til gjennomføringsforordning (EU) nr. 540/2011
Commission Implementing Regulation (EU) 2020/1498 of 15 October 2020 concerning the non-renewal of approval of the active substance thiophanate methyl, 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
Kommisjonsforordning publisert i EU-tidende 16.10.2020
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Directive 2005/53/EC included thiophanate-methyl as an active substance in Annex I to Council Directive 91/414/EEC .
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 .
(3) The approval of the active substance thiophanate-methyl, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2020.
(4) An application for the renewal of the approval of thiophanate-methyl was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.
(5) The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.
(6) The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 1 November 2016.
(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.
(8) On 17 January 2018, the Authority communicated to the Commission its conclusion on whether thiophanate-methyl can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The conclusion identified a number of concerns and data gaps.
(9) On 24 October 2018, the Commission presented the draft renewal report for thiophanate-methyl to the Standing Committee on Plants, Animal, Food and Feed, which discussed it during several meetings.
(10) By letter of 10 July 2020, the applicant informed the Commission of its decision to withdraw the application for the renewal of approval of thiophanate-methyl.
(11) The approval of thiophanate-methyl therefore should not be renewed.
(12) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(13) Member States should be given sufficient time to withdraw authorisations for plant protection products containing thiophanate-methyl.
(14) For plant protection products containing thiophanate-methyl, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months from the date of entry into force of this Regulation.
(15) This Regulation does not prevent the submission of a further application for the active substance thiophanate-methyl pursuant to Article 7 of Regulation (EC) No 1107/2009.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed
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