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(EU) No 629/2014:就活性物质甲基壬基酮(methyl nonyl ketone)的批准条件修订实施条例(EU) No 540/2011

   2014-06-13 411
核心提示:  COMMISSION IMPLEMENTING REGULATION (EU) No 629/2014  of 12 June 2014  amending Implementing Regulation (EU) No 5

  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  /confirm/iatory  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  /confirm/iatory  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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