(Utkast) Kommisjonens gjennomføringsforordning om fornyet av godkjenningen av det aktive stoffet propyzamid som substitusjonskandidat i samsvar med europaparlaments- og rådsforordning (EU) nr. 1107/2009 om markedsføring 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 propyzamide, 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 5.4.2018
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Directive 2003/39/EC included propyzamide 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 propyzamide, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 January 2019.
(4) An application for the renewal of the approval of propyzamide 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 31 July 2015.
(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 12 July 2016 the Authority communicated to the Commission its conclusion on whether propyzamide 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 propyzamide to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2018.
(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 propyzamide 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 propyzamide.
(11) The risk assessment for the renewal of the approval of propyzamide is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing propyzamide may be authorised. It is therefore appropriate to remove the restriction for use only as a herbicide.
(12) The Commission however considers that propyzamide is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Propyzamide is a persistent and toxic substance in accordance with points 22.214.171.124 and 126.96.36.199 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in freshwater is greater than 40 days and the long-term no-observed effect concentration for freshwater organisms is less than 0.01 mg/L. Propyzamide therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.
(13) It is therefore appropriate to renew the approval of propyzamide as a candidate for substitution.
(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 include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.
(15) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(16) Commission Implementing Regulation (EU) 2018/84 extended the approval period of propyzamide to 31 January 2019 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 this extended expiry date, this Regulation should apply from 1 July 2018.
(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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