Commission Implementing Regulation (EU) 2017/781 of 5 May 2017 withdrawing the approval of the active substance methyl nonyl ketone, 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 (Text with EEA relevance. )
Date: 2017-05-05
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_2017118EN.01000101.xml










6.5.2017   


EN


Official Journal of the European Union


L 118/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2017/781
of 5 May 2017
         
withdrawing the approval of the active substance methyl nonyl ketone, 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
(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 methyl nonyl ketone as an active substance in Annex I to Council Directive 91/414/EEC (3). Commission Implementing Regulation (EU) No 608/2012 (4) required that the notifier at whose request methyl nonyl ketone has been included provide further confirmatory information on (a) the specification of the material tested in mammalian toxicology and ecotoxicology studies, (b) the specification with supporting batch data and validated methods of analysis, (c) an appropriate assessment of the fate and behaviour of that substance and its potential transformation products in the environment and (d) the risk to aquatic and to soil living organisms. This information was due by 30 April 2013 for points (a) and (b) and by 31 December 2015 for points (c) and (d).












(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 failed to submit the confirmatory information on points (c) and (d) of recital (1) by 31 December 2015. The notifier also failed to reply to the letter from the Commission giving him the opportunity to explain his position before any decision to withdraw the substance would be taken.












(4)


Consequently, it is appropriate to withdraw the approval of methyl nonyl ketone.












(5)


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












(6)


Member States should be given time to withdraw authorisations for plant protection products containing that active substance. It is appropriate to limit the maximum duration of the grace period that may be granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 for plant protection products containing the active substance.












(7)


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 methyl nonyl ketone 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 238, methyl nonyl ketone, is deleted.


Article 3

Transitional measures

Member States shall withdraw authorisations for plant protection products containing methyl nonyl ketone as an active substance by 26 August 2017 at the latest.


Article 4

Grace period

A 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 26 August 2018.


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, 5 May 2017.


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) No 608/2012 of 6 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil (OJ L 177, 7.7.2012, p. 19).

(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).