CELEX: 
Language: en
Date: 2020-01-17 00:00:00
Title: COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Implementing Regulation (EU) No 844/2012 as regards the harmonised classification of active substances

EUROPEAN
                      COMMISSION
                                                Brussels, 17.1.2020
                                                C(2020) 93 final
          COMMISSION IMPLEMENTING REGULATION (EU) …/...
                                    of 17.1.2020
   amending Implementing Regulation (EU) No 844/2012 as regards the harmonised
                        classification of active substances
                            (Text with EEA relevance)
EN                                                                             EN
 ---pagebreak---                   COMMISSION IMPLEMENTING REGULATION (EU) …/...
                                                   of 17.1.2020
       amending Implementing Regulation (EU) No 844/2012 as regards the harmonised
                                     classification of active substances
                                          (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/EEC1, and in particular Article 19
   and Article 78(2) thereof,
   Whereas:
   (1)    Commission Implementing Regulation (EU) No 844/20122 sets out the provisions
          necessary for the implementation of the renewal procedure for active substances under
          Regulation (EC) No 1107/2009.
   (2)    In accordance with Article 36(2) of Regulation (EC) No 1272/2008 of the European
          Parliament and of the Council3, active substances within the meaning of Regulation
          (EC) No 1107/2009 are normally to be subject to harmonised classification and
          labelling. It is therefore appropriate to set detailed rules of procedure regarding the
          submission of proposals to the European Chemicals Agency (‘the Agency’) in
          accordance with Article 37(1) of Regulation (EC) No 1272/2008 by the rapporteur
          Member State during the renewal of approval of active substances pursuant to
          Article 14 of Regulation (EC) No 1107/2009.
   (3)    Additional time in the framework of the procedure for renewal should be made
          available to the rapporteur Member State for preparing the draft renewal assessment
          report and the dossier submitted to the Agency, and to the European Food Safety
          Authority ('the Authority') for preparing its conclusion. The period available to the
          applicants between the submission of the application for renewal and the submission
          of the supplementary dossiers should therefore be reduced by three months and that
          period of three months should be reallocated to the periods available to the rapporteur
          Member State and the Authority.
   1
          OJ L 309, 24.11.2009, p. 1.
   2
          Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the
          provisions necessary for the implementation of the renewal procedure for active substances, as provided
          for in Regulation (EC) No 1107/2009 of the European Parliament and the Council concerning the
          placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).
   3
          Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
          classification, labelling and packaging of substances and mixtures, amending and repealing
          Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353,
          31.12.2008, p. 1).
EN                                                       1                                                        EN
 ---pagebreak---    (4)     It is appropriate that, in general, the rapporteur Member State submits a dossier in
           accordance with Article 37(1) of Regulation (EC) No 1272/2008 for at least those
           hazard classes that are relevant to identify whether an active substance can be
           considered as a low-risk active substance according to Article 22 of Regulation (EC)
           No 1107/2009 in conjunction with point 5.1.1 of Annex II to that Regulation, which
           also include the hazard classes relevant for the cut-off criteria set in points 3.6.2 to
           3.6.4 and 3.7 of Annex II to Regulation (EC) No 1107/2009. The rapporteur Member
           State should duly justify why no harmonised classification and labelling is warranted
           for hazard classes for which it considers that the criteria for harmonised classification
           and labelling set by Regulation (EC) No 1272/2008 are not fulfilled.
   (5)     However, where a proposal has already been submitted to the Agency and its
           assessment is ongoing, the rapporteur Member State should limit the proposal to any
           of those hazard classes that are not covered by the pending proposal, unless it
           considers that new information is available that was not part of the pending dossier.
   (6)     Moreover, for those of the hazard classes listed in point 5.1.1 of Annex II to
           Regulation (EC) No 1107/2009, which are already covered by an existing opinion of
           the Committee for Risk Assessment of the Agency, it is sufficient that the rapporteur
           Member State duly justifies that the existing opinion of the Committee for Risk
           Assessment remains valid. The Agency may provide its views regarding the rapporteur
           Member State’s submission.
   (7)     Indicative timelines should be defined to ensure that the opinion of the Committee for
           Risk Assessment of the Agency is available to the Authority prior to the adoption of
           its conclusion under Article 13 of Regulation (EU) No 844/2012.
   (8)     A transitional period should be provided for so that applicants can take account of the
           reduced period for dossier preparation between the application for renewal and the
           submission of the supplementary dossiers. Procedures for which supplementary
           dossiers have already been submitted should not be affected.
   (9)     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
   Regulation (EU) No 844/2012 is amended as follows:
   (1)       in Article 6, paragraph 3 is replaced by the following:
   ‘3.     The supplementary dossiers shall be submitted no later than 33 months before the
   expiry of the approval.’
   (2)       in Article 7(1), point (j) is replaced by the following:
   ‘(j) a proposal for classification where it is considered that the substance has to be classified
   or reclassified in accordance with Regulation (EC) No 1272/2008 of the European Parliament
   and of the Council4;’
   (3)       Article 11 is amended as follows:
   (a)       in paragraph 1, ’12 months’ is replaced by ’13 months’.
   4
           OJ L 353, 31.12.2008, p. 1.
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 ---pagebreak---    (b)       in paragraph 2, point (e) is replaced by the following:
   ‘(e)    a suggestion for the classification, or its confirmation, where applicable, or
   reclassification of the active substance in accordance with the criteria of Regulation (EC)
   No 1272/2008, as specified in and consistent with the dossier to be submitted pursuant to
   paragraph 9; ’
   (c)       in paragraph 5, second sentence,’12 months’ is replaced by ’13 months’.
   (d)       in paragraph 6, second sentence,’12 months’ is replaced by ’13 months’.
   (e)       the following paragraph 9 is added:
   ‘9. The rapporteur Member State shall at the latest at the time of submission of the draft
   renewal assessment report submit a proposal to the European Chemicals Agency (‘the
   Agency’) pursuant to Article 37(1) of Regulation (EC) No 1272/2008 and in accordance with
   the Agency’s requirements to obtain an opinion on a harmonised classification of the active
   substance at least for the following hazard classes:
   –         explosives;
   –         acute toxicity;
   –         skin corrosion/irritation;
   –         serious eye damage/eye irritation;
   –         respiratory or skin sensitisation;
   –         germ cell mutagenicity;
   –         carcinogenicity;
   –         reproductive toxicity;
   –         specific target organ toxicity - single exposure;
   –         specific target organ toxicity - repeated exposure;
   –         hazardous to the aquatic environment.
   The rapporteur Member State shall duly justify its view that the criteria for classification for
   one or more of these hazard classes are not fulfilled.
   Where a proposal for classification of an active substance has already been submitted to the
   Agency and its assessment is ongoing, the rapporteur Member State shall submit an additional
   proposal for classification, limited to any hazard classes listed above that are not covered by
   the pending proposal unless new information has become available that was not part of the
   pending dossier as regards the hazard classes listed above.
   For the hazard classes, which are already covered by an existing opinion of the Committee for
   Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC)
   No 1907/2006, whether or not this opinion has formed the basis of a decision concerning an
   entry for harmonised classification and labelling of a substance in Annex VI of Regulation
   (EC) No 1272/2008, it is sufficient that the rapporteur Member State duly justifies in its
   submission to the Agency that the existing opinion, or where it has already formed the basis
   of a decision concerning the inclusion in Annex VI, the existing classification remains valid
   as regards the hazard classes listed in the first subparagraph. The Agency may provide its
   views regarding the rapporteur Member State’s submission.’
   (4)       the following Article 11b is inserted after Article 11a:
EN                                                   3                                              EN
 ---pagebreak---                                                 'Article 11b
   The Committee for Risk Assessment shall endeavour to adopt the opinion referred to in
   Article 37(4) of Regulation (EC) No 1272/2008 within 13 months from the submission
   referred to in Article 11(9).’
   (5)       in Article 12, paragraph 1 is replaced by the following:
   ‘1.      The Authority shall examine whether the draft renewal assessment report received
   from the rapporteur Member State contains all the relevant information in the agreed format
   and circulate it to the applicant and to the other Member States at the latest three months after
   its receipt.’
   (6)       in Article 13(1), the first sentence is replaced by the following:
   ‘Within five months from the expiry of the period referred to in Article 12(3), or within two
   weeks from the adoption of the opinion of the Committee for Risk Assessment referred to in
   Article 37(4) of Regulation (EC) No 1272/2008, if any adopted, whichever occurs later, the
   Authority shall adopt a conclusion in the light of current scientific and technical knowledge
   using guidance documents applicable at the date of the submission of the supplementary
   dossiers and in the light of the opinion of the Committee for Risk Assessment on whether the
   active substance can be expected to meet the approval criteria provided for in Article 4 of
   Regulation (EC) No 1107/2009.’
   (7)       in Article 14(1), the second subparagraph is replaced by the following:
   ‘The renewal report and the draft Regulation shall take into account the draft renewal
   assessment report of the rapporteur Member State, the comments referred to in Article 12(3)
   of this Regulation and the conclusion of the Authority, where such a conclusion has been
   submitted, and the opinion of the Committee for Risk Assessment, if any, referred to in
   Article 37(4) of Regulation (EC) No 1272/2008.’
                                                  Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in
   the Official Journal of the European Union.
   It shall apply to renewal procedures of those active substances for which the approval period
   expires on or after [Office of Publication please insert date corresponding to the date of entry
   into force + 39 months].
   It shall, however, not apply to renewal procedures of such active substances for which
   supplementary dossiers have already been submitted before the date of adoption of this
   Regulation.
   This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels, 17.1.2020
                                                   For the Commission
                                                   The President
                                                   Ursula von der LEYEN
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