COMMISSION IMPLEMENTING REGULATION (EU) No 629/2014

of 12 June 2014

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance methyl nonyl ketone

(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 Implementing Regulation (EU) No 608/2012(2) amended Implementing Regulation (EU) No 540/2011(3) as regards the conditions of approval of the active substance methyl nonyl ketone setting the condition that the notifier provides further confirmatory information in the form of studies on the specification with supporting batch data and validated methods of analysis.

(2) The notifier submitted additional information taking the form of studies on the specification with supporting batch data and validated methods of analysis to the rapporteur Member State Belgium within the time period provided for its submission.

(3) Belgium assessed the additional information submitted by the notifier. It submitted its assessment, in the form of a revised draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 25 November 2013.

(4) The revised draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 May 2014 in the format of the Commission review report for methyl nonyl ketone.

(5) The Commission invited the notifier to submit its comments on the review report for methyl nonyl ketone.

(6) The Commission has come to the conclusion that the further confirmatory information showed that the minimum purity of the active substance should be set at 985 g/kg.

(7) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. Member States should be provided with time to amend or withdraw authorisations for plant protection products containing methyl nonyl ketone where necessary.

(8) For plant protection products containing methyl nonyl ketone, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest eighteen months after the entry into force of this Regulation.

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

HAS ADOPTED THIS REGULATION:

Article 1

Amendment to Implementing Regulation (EU) No 540/2011

In the column ‘Purity’ of row 238, methyl nonyl ketone, of Part A of the Annex to Implementing Regulation (EU) No 540/2011, the purity is replaced by ‘≥ 985 g/kg’.

Article 2

Transitional measures

Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing methyl nonyl ketone as active substance by 3 January 2015.

Article 3

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 3 January 2016 at the latest.

Article 4

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, 12 June 2014.

For the Commission

The President

José Manuel BARROSO

(1)

OJ L 309, 24.11.2009, p. 1

(2) 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

(3) 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