Amendments to Implementing Regulation (EU) 2021/1165
Article 1
Implementing Regulation (EU) 2021/1165 is amended as follows: (1) The following Article 10a is inserted: ‘Article 10a Procedure to grant specific authorisation for the use of products and substances in the outermost regions of the Union 1. Where a Member State considers that a product or substance should be granted a specific authorisation for use in an outermost region of the Union due to the specific conditions set out in Article 45(2) of Regulation (EU) 2018/848, it may request the Commission to carry out an assessment. For that purpose, it shall notify the Commission of a dossier describing the product or substance concerned, giving the reasons for such specific authorisation due to the specific conditions set out in Article 45(2) of Regulation (EU) 2018/848 and explaining why the products and substances authorised under this Regulation are not adequate to be used due to the specific conditions in the outermost region concerned. It shall ensure that the dossier is fit to be made publicly available subject to Union and national legislation of the Member States on data protection. 2. The Commission shall publish any requests referred to in paragraph 1. 3. The Commission shall analyse the dossier referred to in paragraph 1. The Commission shall authorise the product or substance in the light of the specific conditions referred to in the dossier only if its analysis concludes, as a whole that: (a) such specific authorisation is justified in the outermost region concerned; (b) the product or substance described in the dossier complies with the principles laid down in Chapter II, the criteria set out in Article 24(3) and the condition set out in Article 24(5) of Regulation (EU) 2018/848; and (c) the use of the product or substance is in accordance with the relevant provisions of Union law, in particular, for active substances contained in plant protection products, with Regulation (EC) No 396/2005. The authorised product or substance shall be included in Annex VI to this Regulation. 4. When the 2-year period referred to in Article 45(2) of Regulation (EU) 2018/848 expires, the authorisation shall be automatically renewed for another period of 2 years, provided that no new elements are available and no Member State or control authority or control body recognised under Article 46(1) of Regulation (EU) 2018/848 has objected, justifying that the conclusion by the Commission referred to in paragraph 3 needs to be reassessed.’ ; (2) Annex I is amended in accordance with Annex I to this Regulation; (3) Annex II is amended in accordance with Annex II to this Regulation; (4) Annex III is amended in accordance with Annex III to this Regulation; (5) Annex V is amended in accordance with Annex IV to this Regulation; (6) Annex VI is replaced by the text set out in Annex V to this Regulation.