(Utkast) Kommisjonens gjennomføringsforordning om ikke fornyet godkjenning av det aktive stoffet bromoksynil 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 concerning the non-renewal of the approval of the active substance bromoxynil, 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 25.7.2020
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Directive 2004/58/EC included bromoxynil 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 bromoxynil, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2021.
(4) An application for the renewal of the approval of the active substance bromoxynil 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 21 March 2016.
(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the 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 10 April 2017, the Authority communicated to the Commission its conclusion on whether bromoxynil can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(9) The conclusion of the Authority indicates that, during the peer review, experts from Member States and the Authority suggested that bromoxynil, currently subject to harmonised classification and labelling in accordance with Regulation (EC) No 1272/2008 as toxic for reproduction category 2, should be classified as toxic for reproduction category 1B in accordance with the criteria laid down in that Regulation. The Commission therefore requested the Authority to consider whether negligible exposure in accordance with Point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 could be demonstrated. On 8 November 2018, the Authority communicated to the Commission its conclusion that, for the representative uses considered, non-dietary exposure to bromoxynil cannot be considered negligible. In that conclusion the Authority identified a risk to child residents from the representative uses of bromoxynil even when taking into account available mitigation measures.
(10) In its conclusion from 2017, the Authority also identified a high risk to wild mammals from dietary exposure to bromoxynil. Furthermore, the Authority concluded that the consumer risk assessment for products of animal origin and the risk assessment for aquatic organisms could not be finalised.
(11) In its Scientific Report , the Authority concluded that although for some uses of bromoxynil and in some Member States there may be an insufficient number of chemical alternatives available, a wide range of preventive and curative non-chemical methods are available, and that a combination of chemical and non-chemical methods appears often possible. Given the above-mentioned concerns, in particular the risk to child residents, and the existence of alternatives, which would allow the application of the principles of integrated pest management, as provided for in Article 55 of Regulation (EC) No 1107/2009, the conditions for the application of the derogation in Article 4(7) of Regulation (EC) No 1107/2009, which are cumulative, are not fulfilled.
(12) The Commission invited the applicant to submit its comments on the conclusions of the Authority. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the renewal report. The applicant submitted its comments, which have been carefully examined.
(13) However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.
(14) Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance bromoxynil in accordance with Article 20(1)(b) of that Regulation.
(15) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(16) Member States should be given sufficient time to withdraw authorisations for plant protection products containing bromoxynil.
(17) For plant protection products containing bromoxynil where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months from the date of entry into force of this Regulation.
(18) Commission Implementing Regulation (EU) 2020/869 extended the approval period of bromoxynil to 31 July 2021 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is being taken ahead of the expiry of that extended approval period, this Regulation should apply as soon as possible.
(19) This Regulation does not prevent the submission of a further application for the approval of bromoxynil pursuant to Article 7 of Regulation (EC) No 1107/2009.
(20) 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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