Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (Text with EEA relevance)
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Article 1 Amendments to Regulation (EU) No 283/2013
The Annex to Regulation (EU) No 283/2013 is amended as follows: (1) the Introduction is replaced by the text set out in Annex I to this Regulation; (2) Part B is replaced by the text set out in Annex II to this Regulation.
Article 2 Transitional measures as regards certain procedures concerning active substances that are micro-organisms
1 Applicants may submit data in accordance with Part B of the Annex to Regulation (EU) No 283/2013 as it stood before being amended by this Regulation in the following cases: (a) procedures concerning the approval of an active substance that is a micro-organism or an amendment to the approval of such a substance for which the dossiers provided for in Article 8(1) and (2) of Regulation (EC) No 1107/2009 are submitted before 21 May 2023; (b) procedures concerning the renewal of approval of an active substance that is a micro-organism where the application for renewal referred to in Article 5 of Commission Implementing Regulation (EU) 2020/1740 is submitted before 21 May 2023.
2 Where applicants choose to apply the option provided for in paragraph 1, they shall specify that choice in writing when submitting the application concerned. Such choice shall be irrevocable for the procedure concerned.
Article 3 Transitional measures as regards certain procedures concerning plant protection products containing active substances that are micro-organisms
1 For authorisation of plant protection products, within the meaning of Regulation (EC) No 1107/2009, containing one or more active substances that are micro-organisms, where the dossiers have been submitted in accordance with Article 2 of this Regulation or a decision on the renewal of the approval has not been taken in accordance with Article 20 of Regulation (EC) No 1107/2009 on the basis of Part B of the Annex to Regulation (EU) No 283/2013 as amended by this Regulation, applicants: (a) shall submit data in accordance with Part B of the Annex to Regulation (EU) No 283/2013 as it stood before being amended by this Regulation, unless they act in accordance with point (b) of this paragraph; (b) may choose, from 21 November 2022 to submit data in accordance with Part B of the Annex to Regulation (EU) No 283/2013 as amended by this Regulation.
2 Where applicants choose to apply the option provided for in paragraph 1(b), they shall specify that choice in writing when submitting the application concerned. Such choice shall be irrevocable for the procedure concerned.
Article 4 Entry into force and application
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 from 21 November 2022.
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