(Utkast) Kommisjonens gjennomføringsforordning om fornyet godkjenning av det aktive stoffet alfacypermetrin som substitusjonskandidat 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 renewing the approval of the active substance alpha-cypermethrin, as a candidate for substitution, 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 2004/58/EC included alpha-cypermethrin 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 alpha-cypermethrin, 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 alpha-cypermethrin 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 7 May 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 7 August 2018, the Authority communicated to the Commission its conclusion on whether alpha-cypermethrin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the renewal report for alpha-cypermethrin to the Standing Committee on Plants, Animals, Food and Feed on 24 and 25 January 2019.
(9) The applicant was given the opportunity to submit comments on the draft renewal report.
(10) As regards the new criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 , the conclusion of the Authority indicates that it is highly unlikely that alpha-cypermethrin is an endocrine disrupter via the estrogenic, steroidogenic and thyroid modalities. Furthermore, the available evidence indicates that alpha-cypermethrin is unlikely to be an endocrine disruptor via the androgenic modality. Thus, the Commission considers that alpha-cypermethrin is not to be considered as having endocrine disrupting properties.
(11) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(12) The risk assessment for the renewal of the approval of alpha-cypermethrin is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing alpha-cypermethrin may be authorised. It is therefore appropriate not to maintain the restriction to use as an insecticide only.
(13) The Commission, however, considers that alpha-cypermethrin is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Some of its toxicological reference values are significantly lower than those of the majority of the approved active substances within groups of substances. Alpha-cypermethrin, therefore fulfils the condition set in the first indent of point 4 of Annex II to Regulation (EC) No 1107/2009.
(14) It is therefore appropriate to renew the approval of alpha-cypermethrin as a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009.
(15) 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. It is, in particular, appropriate to require further confirmatory information.
(16) The Commission considers that alpha-cypermethrin does not have endocrine disrupting properties based on the available scientific information summarised in the conclusion of the Authority. However, in order to increase the confidence in this conclusion, the applicant should provide an updated assessment for the androgenic modality, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 and in accordance with the guidance for the identification of endocrine disruptors .
(17) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(18) Commission Implementing Regulation (EU) 2019/707 extended the expiry date of alpha-cypermethrin 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 renewal has been taken ahead of that extended expiry date, this Regulation should start to apply earlier than that date.
(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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