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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 Commis-
sion 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,
13.6.2014 EN Official Journal of the European Union L 174/33
(
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 Euro-
pean Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1). 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
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