Commission Implementing Regulation (EU) 2016/638 of 22 April 2016 withdrawing the approval of the active substance Z-13-hexadecen-11-yn-1-yl acetate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)
Date: 2016-04-22
Institutions: European Commission
Subjects: market approval, organic acid, plant health control, plant health product, withdrawal from the market








L_2016108EN.01002801.xml










23.4.2016   


EN


Official Journal of the European Union


L 108/28








            COMMISSION IMPLEMENTING REGULATION (EU) 2016/638
of 22 April 2016
         
withdrawing the approval of the active substance Z-13-hexadecen-11-yn-1-yl acetate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)


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/EEC (1), and in particular the second alternative of Article 21(3) and Article 78(2) thereof,

Whereas:







(1)


Commission Directive 2008/127/EC (2) included Z-13-hexadecen-11-yn-1-yl acetate as active substance in Annex I to Council Directive 91/414/EEC (3). Commission Implementing Regulation (EU) 2015/418 (4) requested the notifier to submit confirmatory information on the specification of the technical material, as commercially manufactured including information on any relevant impurities by 30 June 2015.












(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 (5).












(3)


The notifier did not submit the confirmatory information requested by the deadline of 30 June 2015. By email of 10 September 2015 it confirmed to the Commission its intention not to submit such information.












(4)


Consequently, it is appropriate to withdraw the approval of Z-13-hexadecen-11-yn-1-yl acetate.












(5)


The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.












(6)


Member States should be provided with time to withdraw authorisations for plant protection products containing Z-13-hexadecen-11-yn-1-yl acetate.












(7)


For plant protection products containing Z-13-hexadecen-11-yn-1-yl acetate, 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 18 months after entry into force of this Regulation.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1

Withdrawal of approval

The approval of the active substance Z-13-hexadecen-11-yn-1-yl acetate is withdrawn.


Article 2

Amendment to Implementing Regulation (EU) No 540/2011

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 258, Z-13-hexadecen-11-yn-1-yl acetate, is deleted.


Article 3

Transitional measures

Member States shall withdraw authorisations for plant protection products containing Z-13-hexadecen-11-yn-1-yl acetate as active substance by 13 November 2016.


Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire on 13 November 2017 at the latest.


Article 5

Entry into force

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




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 April 2016.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 309, 24.11.2009, p. 1.

(2)  Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(4)  Commission Implementing Regulation (EU) 2015/418 of 12 March 2015 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Z-13-hexadecen-11-yn-1-yl acetate (OJ L 68, 13.3.2015, p. 36).

(5)  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 substances (OJ L 153, 11.6.2011, p. 1).