(Utkast) Kommisjonens gjennomføringsforordning om fornyet godkjenning av det aktive stoffet Verticillium alboatrum stamme WCS850 som et lavrisikostoff, 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 active substance Verticillium albo-atrum strain WCS850 as a low-risk substance 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 2008/113/EC included Verticillium albo-atrum (formerly Verticillium dahlia) strain WCS850 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 Verticillium albo-atrum strain WCS850, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 30 April 2020.
(4) An application for the renewal of the approval of Verticillium albo-atrum strain WCS850 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 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 1 November 2017.
(7) 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.
(8) On 19 December 2018, the Authority communicated to the Commission its conclusion on whether Verticillium albo-atrum strain WCS850 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented an initial draft renewal report for Verticillium albo-atrum strain WCS850 to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2019.
(9) The applicant was given the opportunity to submit comments on the draft renewal report.
(10) It has been established with respect to one or more representative uses of at least one plant protection product containing Verticillium albo-atrum strain WCS850 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(11) The risk assessment for the renewal of the approval of Verticillium albo-atrum strain WCS850 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Verticillium albo-atrum strain WCS850 may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide.
(12) The Commission considers that Verticillium albo-atrum strain WCS850 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Verticillium albo-atrum strain WCS850 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Verticillium albo-atrum strain WCS850 is a micro-organism. Following the assessment by the rapporteur Member State and the Authority and taking into account the intended uses it is expected to pose a low-risk for humans, animals and the environment. In particular, the potential transfer or acquisition of resistance to antimicrobials in fungi such as Verticillium albo-atrum strain WCS850 is multifactorial and is not coded by a single gene, thus horizontal transfer of anti-microbial resistance genes between fungal species appears to be very rare and is not associated with specific mechanisms, as described for bacteria. Therefore, the Commission considers that multiple resistance to anti-microbials used in human and veterinary medicine is not demonstrated.
(13) It is therefore appropriate to renew the approval of Verticillium albo-atrum WCS850 as a low-risk active substance.
(14) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions.
(15) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(16) Commission Implementing Regulation (EU) 2019/168 extended the expiry date of Verticillium albo-atrum strain WCS850 to 30 April 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 renewal has been taken ahead of that extended expiry date, this Regulation should start to apply earlier than that date.
(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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