Tilbaketrekking av godkjenning av midler med lukten av dyr eller planter (kvae) i plantevernmidler
(Utkast) Kommisjonens gjennomføringsforordning om tilbaketrekking av godkjenningen til det virkesomme stoffet midler med lukten av dyr eller planter (kvae), i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009 om markedsføring av plantevernmidler, og om endring av vedlegget til gjnnomføringsforordning (EU) nr. 540/2011
(Draft) Commission Implementing Regulation withdrawing the approval of the active substance repellents by smell of animal or plant origin/tall oil pitch, 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 Commission Implementing Regulation (EU) No 540/2011
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 24.5.2017
Nærmere omtale
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Directive 2008/127/EC included repellents by smell of animal or plant origin/tall oil pitch as active substance in Annex I to Council Directive 91/414/EEC . Commission Implementing Regulation 637/2012 required that Member States concerned ensure that the notifier at whose request repellents by smell of animal or plant origin/tall oil pitch has been included provide further confirmatory information on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers and on the toxicological profile of the substance by 1 May 2013 and 31 May 2014 respectively.
(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) On 29 April 2013 and 6 May 2014, the notifier submitted information with a view to complying with the obligation to submit further information as referred to in recital 1, to the rapporteur Member State, Greece.
(4) Greece assessed the information submitted by the notifier including some further information related to the initial submission that was submitted during the evaluation process. It submitted its assessment, in the form of addenda to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter 'the Authority' in October 2013 and November 2015.
(5) The Member States, the applicant and the Authority were consulted and asked to provide comments on the assessment of the rapporteur Member State.
(6) In the light of the information provided by the notifier, the evaluation of this information by the rapporteur Member State and the comments submitted on the evaluation by Member States and EFSA, the Commission considers that the confirmatory information has not been provided as the information submitted by the notifier is not sufficient to conclude on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers nor on the toxicological profile of the substance.
(7) The Commission invited the notifier to submit its comments on the considerations of the Commission.
(8) However, despite the arguments put forward by the notifier, the Commission has come to the conclusion that the information submitted is incomplete and does not allow a conclusion on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers nor on the toxicological profile of the substance to be made.
(9) Consequently, it is appropriate to withdraw the approval of that active substance.
(10) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(11) Member States should be provided with time to withdraw authorisations for plant protection products containing that active substance.
(12) For plant protection products containing that active substance, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on [Office of Publications please insert date 15 months from the date of entry into force].
(13) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed -
(1) Commission Directive 2008/127/EC included repellents by smell of animal or plant origin/tall oil pitch as active substance in Annex I to Council Directive 91/414/EEC . Commission Implementing Regulation 637/2012 required that Member States concerned ensure that the notifier at whose request repellents by smell of animal or plant origin/tall oil pitch has been included provide further confirmatory information on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers and on the toxicological profile of the substance by 1 May 2013 and 31 May 2014 respectively.
(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) On 29 April 2013 and 6 May 2014, the notifier submitted information with a view to complying with the obligation to submit further information as referred to in recital 1, to the rapporteur Member State, Greece.
(4) Greece assessed the information submitted by the notifier including some further information related to the initial submission that was submitted during the evaluation process. It submitted its assessment, in the form of addenda to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter 'the Authority' in October 2013 and November 2015.
(5) The Member States, the applicant and the Authority were consulted and asked to provide comments on the assessment of the rapporteur Member State.
(6) In the light of the information provided by the notifier, the evaluation of this information by the rapporteur Member State and the comments submitted on the evaluation by Member States and EFSA, the Commission considers that the confirmatory information has not been provided as the information submitted by the notifier is not sufficient to conclude on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers nor on the toxicological profile of the substance.
(7) The Commission invited the notifier to submit its comments on the considerations of the Commission.
(8) However, despite the arguments put forward by the notifier, the Commission has come to the conclusion that the information submitted is incomplete and does not allow a conclusion on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers nor on the toxicological profile of the substance to be made.
(9) Consequently, it is appropriate to withdraw the approval of that active substance.
(10) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(11) Member States should be provided with time to withdraw authorisations for plant protection products containing that active substance.
(12) For plant protection products containing that active substance, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on [Office of Publications please insert date 15 months from the date of entry into force].
(13) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed -