(Utkast) Kommisjonens gjennomføringsforordning om fornyet godkjenning av det aktive lovrisikostoffet Streptomyces stamme K61 i samsvar med 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 renewing the approval of the low risk active substance Streptomyces strain K61 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 8.4.2021
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Directive 2008/113/EC included Streptomyces K61 (formerly ‘S. griseoviridis’) as an active substance in Annex I to Council Directive 91/414/EEC .
(2) The concerned active substance is a bacterium, that was first named ‘Streptomyces griseoviridis’. Subsequently, for scientific reasons, that name was changed into Streptomyces K61. More recently, it was changed again into its current name Streptomyces strain K61.
(3) 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 .
(4) The approval of the active substance Streptomyces strain K61, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2022.
(5) An application for the renewal of the approval of the active substance Streptomyces strain K61 was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.
(6) 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.
(7) The rapporteur Member State prepared a draft 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 15 January 2019.
(8) The Authority communicated the draft 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.
(9) On 19 June 2020, the Authority communicated to the Commission its conclusion on whether Streptomyces strain K61 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented a renewal report on the 3 December 2020 and a draft Regulation regarding Streptomyces strain K61 to the Standing Committee on Plants, Animals, Food and Feed on 25 January 2021.
(10) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14 (1) of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined.
(11) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance Streptomyces strain K61 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of Streptomyces strain K61.
(12) The risk assessment for the renewal of the approval of the active substance Streptomyces strain K61 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Streptomyces strain K61 may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide only.
(13) In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(14) Commission Implementing Regulation (EU) (…) extended the approval period of Streptomyces strain K61 to 30 April 2022 in order to allow the renewal process to be completed before the expiry of that period. However, given that a decision on renewal is being taken ahead of the expiry of that extended approval period, this Regulation should start to apply earlier than than date.
(15) 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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