Commission Implementing Regulation (EU) 2021/876 of 31 May 2021 laying down rules for the application of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for the uses of substances in the production of legacy spare parts and in the repair of articles and complex products no longer produced and amending Regulation (EC) No 340/2008 (Text with EEA relevance)
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Article 1
This Regulation implements Articles 61(1), 62(4)(e) and 62(5)(a) of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for any of the following uses of a substance, on its own or in a mixture, listed in Annex XIV to that Regulation: (a) the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date for that substance specified in Annex XIV, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance (‘production of legacy spare parts’); (b) the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date for that substance specified in Annex XIV, where that substance was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance (‘repair of articles or complex products no longer produced’).
Article 2
1 An application for authorisation pursuant to Article 62 of Regulation (EC) No 1907/2006 for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced shall be considered to comply with point (e) of Article 62(4) of that Regulation when it includes the following: (a) a description and analysis of the function of the substance; and (b) a justification demonstrating that the conditions set out in points (a) or (b) of Article 1 of this Regulation as appropriate have been fulfilled.
2 An application for authorisation pursuant to Article 62 of Regulation (EC) No 1907/2006 for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced shall be considered to comply with point (a) of Article 62(5) of that Regulation when it includes the following: (a) a succinct description of the human health or environmental impacts in accordance with the information provided in the chemical safety report; (b) a succinct description of the socioeconomic benefits of the use applied for, including a justification demonstrating that the conditions set out in points (a) or (b) of Article 1 of this Regulation as appropriate have been fulfilled; (c) a conclusion based on a comparison of the risks and benefits of the use of the substance applied for, as described in points (a) and (b) of this paragraph.
3 Where the application for authorisation is submitted for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced, information referred to in paragraphs 1 and 2 of this Article, together with any third party contributions on possible alternatives submitted in accordance with Article 64(2) of Regulation (EC) No 1907/2006, shall suffice for the purpose of assessing the socioeconomic factors and the suitability of the alternatives associated with the use of the substance.
4 Paragraphs 1, 2 and 3 of this Article shall apply mutatis mutandis to review reports submitted pursuant to Article 61(1) of Regulation (EC) No 1907/2006 concerning an authorisation granted for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced.
5 By 5 July 2021 the European Chemicals Agency (‘the Agency’) shall make publicly available specific formats for the analysis of alternatives and the socioeconomic analysis to be used in applications for authorisation for uses of substances in the production of legacy spare parts or in the repair of articles or complex products no longer produced as well as in review reports concerning an authorisation granted for such uses, submitted in accordance with this Regulation, reflecting the elements referred to in paragraphs 1 and 2.
Article 3
Regulation (EC) No 340/2008 is amended as follows: (1) in Article 8(2), the following subparagraph is added after the fourth subparagraph: ‘The Agency shall levy a reduced fee as set out in point 2 of Annex VI to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Commission Implementing Regulation (EU) 2021/876 and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation. (2) in Article 9(2), the following subparagraph is inserted after the fourth subparagraph: ‘The Agency shall levy a reduced charge as set out in point 2 of Annex VII to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Implementing Regulation (EU) 2021/876 and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation’; (3) Annexes VI and VII are replaced by the text as set out in the Annex to this Regulation.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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