(Utkast) Kommisjonens gjennomføringsforordning om fastsettelse av gjennomføringsbestemmelser til forordning (EF) nr. 1907/2006 med hensyn til søknader om autorisasjon og evalueringsrapporter om bruk av stoffer i produksjon av eldre reservedeler og reparasjon av artikler og komplekse produkter som ikke lenger produseres, og endring av forordning (EF) nr. 340/2008
(Draft) Commission Implementing Regulation 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
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 16.3.2021
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Article 56(1) of Regulation (EC) No 1907/2006 sets out an authorisation requirement for the placing on the market and the use of substances of very high concern listed in Annex XIV to that Regulation. The compliance with that requirement, in certain cases, constitutes a significant administrative burden for undertakings. In its Communication of 18 June 2014 “Regulatory Fitness and Performance Programme (REFIT): State of Play and Outlook” the Commission announced that it was considering simplifying the authorisation process in some specific cases. Simplifying the applications for continued use of substances of very high concern in the production of legacy spare parts was identified as one of the actions in the Commission Communication of 5 March 2018 “Commission General Report on the operation of REACH and review of certain elements” .
(2) The Commission Communication of 2 December 2015 “Closing the loop – An EU action plan for the Circular Economy” describes that the extension of the lifetime of products by way of repair helps avoid wastage. The Council conclusions of 20 June 2016 on that action plan invite the Commission to investigate what initiatives can be taken at Union level in the interest of extending the lifetime of products, in particular by promoting the availability of spare parts.
(3) In order to avoid the premature obsolescence of articles or complex products that are no longer produced after the sunset dates referred to in Annex XIV to Regulation (EC) No 1907/2006, spare parts as well as substances and mixtures that are necessary for the repair of such articles or complex products need to continue to be made available on the market and used. If a substance listed in Annex XIV to Regulation (EC) No 1907/2006 has been used to produce such articles or complex products and, if after the sunset date the spare part cannot be produced or the product cannot be repaired without the use of that substance, the requirements as regards the content of the application for authorisation and of the review report of an authorisation for such uses should be clarified in order to simplify such applications for authorisation.
(4) As regards the analysis of alternatives referred to in Article 62(4)(e) of Regulation (EC) No 1907/2006, providing justification demonstrating that the article or complex product is no longer produced after the sunset date, that it cannot function as intended without the spare part and that such spare part cannot be produced without the substance, or that the article or complex product cannot be repaired otherwise than by using the substance, should be considered sufficient to conclude on the lack of suitable alternatives. As the use of the substance in the production of such spare parts or repair of such articles or complex products will gradually decrease since its intended use is for a product that is no longer produced, while the substitution costs for research and development, testing, qualification, and industrialisation of possible alternatives for such uses are likely to be high in view of the expected decreasing trend, such provision is deemed justified.
(5) Similarly, the justification demonstrating that the article or complex product is no longer produced after the sunset date, that it cannot function as intended without the spare part and that such spare part cannot be produced without the substance, or that the article or complex product cannot be repaired otherwise than by using the substance should be considered sufficient in order to demonstrate the socio-economic benefits of the use of the substance in the socio-economic analysis referred to in point (a) of Article 62(5) of Regulation (EC) No 1907/2006. The non-availability of spare parts or the impossibility to repair articles or complex products no longer produced without that substance would lead to the premature obsolescence of those articles or complex products before the end of their lifetime use and therefore to their premature disposal, likely causing high costs to operators, consumers or society. Moreover, the number of uses and quantities of the substance used for such spare parts are expected to decrease, leading to a diminishing impact on human health and the environment associated with the exposure to or emission of the substance used. It is therefore appropriate that contents of the socio-economic analysis referred to in point (a) of Article 62(5) of Regulation (EC) No 1907/2006 be provided by the applicant in a succinct form. This is without prejudice to the consideration of the risk posed by the use of the substance to human health or the environment and to the need for the applicant to demonstrate that socio-economic benefits outweigh that risk.
(6) The clarification of the content of applications for authorisation for the use of a substance in the production of spare parts for repair or in the repair of articles and complex products no longer produced should result in a reduction of the workload for the European Chemicals Agency (‘the Agency’) in assessing applications for authorisation in those specific cases. The fees levied for such applications should be proportionate to the expected workload of the Agency in such cases and, hence, be reduced when compared to the fee levied for the applications for other uses. For the same reasons, the charges applicable to the review of authorisations granted for those uses should be reduced by the same proportion.
(7) Commission Regulation (EC) No 340/2008 should therefore be amended accordingly.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133 of Regulation (EC) No 1907/2006
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