(Utkast) Kommisjonens gjennomføringsforordning om ikke fornyet godkjenning av det aktive stoffet propineb, i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009 om markedsføring av plantevernmidler, og om endring av vedlegget til Kommisjonens gjennomføringsforordning (EU) nr. 540/2011
(Draft) Commission Implementing Regulation concerning the non-renewal of approval of the active substance propineb, 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
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 1.2.2018
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Directive 2003/39/EC included propineb 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 propineb, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2019.
(4) An application for the renewal of the approval of propineb 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 October 2015.
(7) The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.
(8) On 15 November 2016 the Authority communicated to the Commission its conclusion on whether propineb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that the consumer risk assessment through dietary intake cannot be conducted for the products of plant and animal origin. Based on the data available in the dossier it was not possible to complete the assessment of relevant metabolites of propineb.
(9) In addition, the Authority underlined a critical area of concern for propineb related to the endocrine disrupting properties of the relevant metabolite 4 methylimidazolidine-2-thione (PTU) which is classified as toxic for reproduction category 2 and has tyroid as a target organ for toxicity.
(10) Moreover, the Authority could not finalise the assessment of the risk to honeybee brood and concluded that a high risk to honeybee brood development could not be excluded for propineb.
(11) The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.
(12) However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.
(13) Based on these identified risks, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance propineb in accordance with Article 20(1)(b) of that Regulation.
(14) Commission Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(15) Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing propineb.
(16) For plant protection products containing propineb, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on [Office of Publications please insert date 15 months from the date of entry into force].
(17) Commission Implementing Regulation (EU) 2018/84 extended the expiry date of propineb to 31 January 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.
(18) This Regulation does not prejudice the submission of a further application for the approval of propineb pursuant to Article 7 of Regulation (EC) No 1107/2009.
(19) 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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