Commission Implementing Regulation (EU) 2020/103
of 17 January 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/EEC, and in particular Article 19 and Article 78(2) thereof,
OJ L 309, 24.11.2009, p. 1.
Whereas:
(1) Commission Implementing Regulation (EU) No 844/2012 sets out the provisions necessary for the implementation of the renewal procedure for active substances under Regulation (EC) No 1107/2009.
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).
(2) In accordance with Article 36(2) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council, 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.
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).
(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.
(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: