(Utkast) Kommisjonens gjennomføringsforordning om avslag på fornyet godkjenning av det aktive stoffet metiokarb i henhold til europaparlaments- og rådsforordning (EF) nr. 1107/2009 om omsetning av plantevernmidler, og om endring av vedlegget til Kommisjonens gjennomføringsforordning (EU) nr. 540/2011
(Draft) Commission Implementing Regulation concerning the non-renewal of the approval of the active substance methiocarb, 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 31.7.2019
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Directive 2007/5/EC included methiocarb 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 methiocarb, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2020.
(4) An application for the renewal of the approval of methiocarb 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 13 July 2017.
(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 24 September 2018 the Authority communicated to the Commission its conclusion on whether methiocarb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for methiocarb to the Standing Committee on Plants, Animals, Food and Feed on 24 January 2019.
(9) The Authority identified an unacceptable risk to workers, even when taking into account the use of personal protective equipment and a high risk to birds, mammals and earthworms. Furthermore, the Authority could not conduct the consumer risk assessment because the residue definition for risk assessment in plant commodities could not been finalised since the genotoxic potential of metabolite M01 could not be ruled out based on the available data.
(10) The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third subparagraph 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.
(11) However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.
(12) Consequently, 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 methiocarb in accordance with Article 20(1)(b) of that Regulation.
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(14) Member States should be provided with sufficient time to withdraw authorisations for plant protection products containing methiocarb. Taking into account the risk identified for workers from loading and sowing the treated seeds and for birds, wild mammals, earthworms from treated seeds, for plant protection products containing methiocarb, 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 6 months from the date of entry into force].
(15) Commission Implementing Regulation (EU) 2019/707 extended the approval period of methiocarb to 31 July 2020 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.
(16) This Regulation does not prejudice the submission of a further application for the approval of methiocarb in accordance with Article 7 of Regulation (EC) No 1107/2009.
(17) 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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