Prováděcí nařízení Komise (EU) č. 993/2011 ze dne 6. října 2011, kterým se v souladu s nařízením Evropského parlamentu a Rady (ES) č. 1107/2009 o uvádění přípravků na ochranu rostlin na trh schvaluje účinná látka 8-hydroxychinolin a mění příloha prováděcího nařízení Komise (EU) č. 540/2011 (Text s významem pro EHP)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EECOJ L 309, 24.11.2009, p. 1 . , and in particular Article 13(2) and Article 78(2) thereof,

The active substance 8-hydroxyquinoline, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

OJ L 309, 24.11.2009, p. 1 .

(1) In accordance with Article 80(1)(c) of Regulation (EC) No 1107/2009, Council Directive 91/414/EECOJ L 230, 19.8.1991, p. 1 . is to apply, with respect to the procedure and the conditions for approval, to active substances for which completeness has been established in accordance with Article 6 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex IOJ L 15, 18.1.2008, p. 5 . . 8-hydroxyquinoline is an active substance for which completeness has been established in accordance with that Regulation.

(2) Commission Regulations (EC) No 451/2000OJ L 55, 29.2.2000, p. 25 . and (EC) No 1490/2002OJ L 224, 21.8.2002, p. 23 . lay down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish lists of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. These lists included 8-hydroxyquinoline.

(3) For 8-hydroxyquinoline no complete dossier was submitted within the prescribed time limit. Consequently, Commission Decision 2006/797/EC of 22 November 2006 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substancesOJ L 324, 23.11.2006, p. 8 . was adopted on the non-inclusion of 8-hydroxyquinoline.

(4) Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter the applicant) submitted a new application requesting the regular procedure to be applied, as provided for in Articles 3 to 12 of Regulation (EC) No 33/2008.

(5) The application was submitted to Spain, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. That application complies with the substantive and procedural requirements of Articles 3 and 4 of Regulation (EC) No 33/2008.

(6) Spain evaluated the information submitted and prepared a draft assessment report. It communicated that report to the European Food Safety Authority (hereinafter the Authority) and to the Commission on 3 August 2009 . The Authority communicated the draft assessment report to the other Member States and the applicant for comments and forwarded the comments received to the17 December 2010 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance 8-hydroxyquinoline. EFSA Journal 2011;9(1):1964 [49pp.] doi:10.2903/j.efsa.2011.1964. Available online: www.efsa.europa.eu/efsajournal.htm . The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 15 July 2011 in the format of the Commission review report for 8-hydroxyquinoline.

(7) It has appeared from the various examinations made that plant protection products containing 8-hydroxyquinoline may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve 8-hydroxyquinoline in accordance with Regulation (EC) No 1107/2009.

(8) In accordance with Article 13(2) 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.

(9) Without prejudice to the conclusion that 8-hydroxyquinoline should be approved, it is, in particular, appropriate to require further confirmatory information.

(10) In accordance with Article 13(4) of Regulation (EC) No 1107/2009 the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substancesOJ L 153, 11.6.2011, p. 1 . should be amended accordingly.

(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

OJ L 230, 19.8.1991, p. 1 .

Article 1 Article 1 Approval of active substance

Article 2 Article 2 Amendments to Implementing Regulation (EU) No 540/2011

Article 3 Article 3 Entry into force and date of application

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .

It shall apply from 1 January 2012 .

OJ L 15, 18.1.2008, p. 5 .

OJ L 55, 29.2.2000, p. 25 .

OJ L 224, 21.8.2002, p. 23 .

OJ L 324, 23.11.2006, p. 8 .

European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance 8-hydroxyquinoline. EFSA Journal 2011;9(1):1964 [49pp.] doi:10.2903/j.efsa.2011.1964. Available online: www.efsa.europa.eu/efsajournal.htm

OJ L 153, 11.6.2011, p. 1 .

HAS ADOPTED THIS REGULATION: