(Utkast) Kommisjonens gjennomføringsforordning om fornyet godkjenning av det aktive stoffet cyazofamid 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 cyazofamid, 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 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 2003/23/EC included cyazofamid 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 cyazofamid, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011, expires on 31 July 2021.
(4) An application for the renewal of the approval of cyazofamid 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 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 23 June 2015.
(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.
(8) On 23 May 2016, the Authority communicated to the Commission its conclusion on whether cyazofamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. Following a mandate from the Commission due to uncertainties related to non-target arthropods, the Authority updated its conclusion on 28 July 2020 . The Commission presented a renewal report regarding cyazofamid to the Standing Committee on Plants, Animals, Food and Feed on 3 December 2020 and a draft Regulation on 26 January 2021.
(9) As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 , the conclusion of the Authority indicates that, based on the scientific evidence, it is highly unlikely that cyazofamid is an endocrine disrupter via the estrogenic, androgenic, thyroidogenic or steroidogenic modalities. Based on the available data and current knowledge summarised in the conclusion of the Authority no adverse effects that could be related to an endocrine disruptor mode of action were observed. Therefore, the Commission concludes that cyazofamid is not to be considered as having endocrine disrupting properties.
(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 reports. 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 cyazofamid 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 cyazofamid is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing cyazofamid may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide.
(13) It is therefore appropriate to renew the approval of cyazofamid.
(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. It is, in particular, appropriate to require further confirmatory information.
(15) In order to increase the confidence in the conclusion that cyazofamid does not have endocrine disrupting properties, the applicant should provide an updated assessment, 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 .
(16) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(17) Commission Implementing Regulation (EU) 2020/869 extended the approval period of cyazofamid to 31 July 2021 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. As the date of entry into force of this Regulation would be close to the date of expiry of the approval of cyazofamid this Regulation should apply from the day after the date of expiry of the approval of cyazofamid.
(18) 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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