16 th Meeting of Competent Authorities for REACH and CLP (CARACAL) November 2014 CCAB, Brussels, Belgium

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1 EUROPEAN COMMISSION ENVIRONMENT DIRECTORATE-GENERAL Green Economy Chemicals ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Resources Based, Manufacturing and Consumer Goods Industries REACH Chemicals Industry Brussels, 27 October 2014 Doc. CA/95/ th Meeting of Competent Authorities for REACH and CLP (CARACAL) November 2014 CCAB, Brussels, Belgium Concerns: REACH authorisation and legacy spare parts Agenda Point: 6.1 Action Requested: The CARACAL are invited to take note of this document.

2 At CARACAL 13 COM drew the attention of MSCAs to a number of issues concerning the use of Annex XIV substances in the production of spare parts intended for repair and maintenance of long life-time durable articles that were put on the market before the respective sunset dates ( legacy spare parts ). According to information provided by several industry sectors, the REACH authorisation requirement appears to raise difficulties for operators, namely the economic and technical difficulties that effectively prevent substitution of the substances and the cost of applying for authorisation that may sometimes be disproportionate due to the limited volumes of spare parts or substances involved. All this is contributing to the risk (already coming from the socio-economic climate) that production of the legacy parts might be moved outside the EU or the legacy parts may no longer be available on the market. COM emphasised in particular that the specific situation for legacy spare parts had been recognised in Directive 2000/53/EC on end-of-life vehicles (which provides for an exemption for this type of spare parts from the ban on four heavy metals) and in Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS). The solution found in these two legal frameworks is commonly referred to as the repair as produced principle. In a note for CARACAL 14 (CA/30/2014), COM acknowledged that in REACH there is no legal basis for providing for an exemption for legacy spare parts as it was done in the ELV and RoHS Directives. It has therefore proposed to address this matter within the REACH authorisation system by providing for a longer transitional period (i.e. later sunset date and latest application date) for the use of Annex XIV substances in the production of this type of spare parts for long life-time durable articles. At the CARACAL meeting and afterwards COM received comments from 12 CAs, as well as from a number of stakeholders (UEAPME, Client Earth, CEFIC, EEB, ACEA-JAMA-CLEPA, ASD, AEA, ORGALIME, FIVA, EGMF and CECE). Summary of comments received from MSCAs and stakeholders and COM response This note replies to the comments received and proposes a possible way forward. The paper is structured around the main elements of the proposal, i.e. the justification for specific measures for legacy spare parts, the nature of those measures, their scope and their main content. 1) Justification for specific measures for legacy spare parts Most MSCAs and stakeholders agree that the use of Annex XIV substances in legacy spare parts (at least for certain articles) deserves specific measures so that the authorisation requirement is not disproportionate and does not lead to unavailability of these parts (which in turn would shorten the useful life of the articles concerned, as they would have to be disposed of if repair was no longer possible). COM welcomes the support of the justification, which is the same that motivated the exemption of legacy spare parts from the ban of certain substances in motor vehicles (End-of life Directive) and in electric and electronic equipment (EEE) (RoHS Directive). It should nevertheless be pointed out that these two pieces of legislation have a much narrower scope. As to their objectives, REACH aims to ensure that the risks presented by substances are

3 adequately controlled throughout their life-cycle, including those occurring in the waste stream. In addition, RoHS contributes to the sound management of waste EEE. 2) Nature of the specific measures: longer transitional periods, simplified authorisation The proposal of providing for longer transitional periods (latest application dates and sunset dates) for legacy spare parts as presented in document CA/30/2014 was welcomed by a majority of MSCAs, with some reservations concerning the scope (e.g., what concrete spare parts for what concrete categories of articles) and too long duration of the transitional periods (that would be contradictory to the aim of SVHC substitution in REACH). Industry associations also welcomed the idea. Two MSCAs did not support longer transitional periods, as in their view this is not possible under REACH. Some MSCAs appear to consider keeping the legacy spare parts under the authorisation requirement and providing for them a streamlined authorisation application, with a simplified analysis of alternatives and socio-economic analysis. One MSCA has also suggested providing for longer review periods for use in spare parts as an option. From the stakeholders side, EEB and Client Earth did not support longer transitional periods either. Concerning the basis in REACH: In COM s view Article 58(1)(c) REACH provides for a legal basis for transitional periods. This paragraph does not exclude the possibility of more than one latest application date and more than one sunset date being set for the same substance, and it provides that the dates should take into account, where appropriate, the production cycle specified for that use. In the specific case of legacy spare parts, the rationale for proposing longer transitional arrangements is related to the production cycle of those parts, since the purpose of the repair as produced principle is to ensure that legacy spare parts for the articles already placed on the market remain available during the lifetime of the articles for which they are intended, which exceeds the time period during which the articles themselves are produced and placed on the market. Concerning the simplified authorisation procedure: COM is not excluding that simplification could be developed, e.g. for certain special cases of Annex XIV substances being used in production of both original equipment and spare parts of articles/equipment that are being placed on the market after the sunset date. In some cases however, even a simplified procedure may appear to be too burdensome compared to the expected benefits in terms of protection of human health or the environment. This is because legacy spare parts, which are intended for articles that are no longer produced, are manufactured in decreasing volumes. Therefore, in the specific case of legacy spare parts, the search for substitutes can be too costly and, in some cases, their testing even physically impossible, while potentially resulting only into a limited benefit to human health and the environment as the number of articles in service for which the legacy spare parts will be required will anyway decrease over time. This has been recognised in the RoHS and ELV Directives, which ban certain substances from all EEE and from certain motor vehicle categories, respectively. COM is of the view that the same rationale can be applied to the case of REACH authorisation, however, given a much broader scope of the REACH authorisation as compared to that of the ELV and RoHS Directives, limited to (long life-time) durable articles. This should be acknowledged in the form of longer transitional periods allowing specific Annex XIV

4 substances being used in the production of legacy spare parts for long life-time and durable articles for a period beyond the otherwise applicable general sunset date. 3) Length of additional transitional period, legacy spare parts covered and Annex XIV substances concerned 3.1) Length of additional transitional period and legacy spare parts covered: A number of MSCAs who supported longer transitional periods for uses in legacy spare parts production, noted that providing for extremely long transitional periods (i.e. in the range of years) would be contradictory with the aim of substitution of SVHCs and was not justified. Some MSCAs suggested assigning different transitional periods per category of article or of spare parts, depending on the duration of the life of the article. Another suggestion favoured the transitional arrangements being based on detailed information from industry as to how long it would be expected that the articles need to be repaired with the original parts. It was also suggested to couple any motivation for longer transitional periods with safety demands and/or certificates, implications on risks and costs as compared to a normal sunset date, possibility to enforce, etc. The "repair as produced" principle today is applied to passenger cars and light commercial vehicles, in the case of the ELV Directive, and to all EEE (which also covers a wide variety of articles, with very different lifetimes) in the case of the RoHS Directive. Neither from this EU legislation nor from the information received from industry, concrete criteria can be identified to establish whether the repair as produced principle should apply only to certain legacy spare parts and not to others. Considering the general recognition in other EU legislation targeting the protection of human health and the environment of the principle that legacy spare parts should continue to be allowed on the market unchanged, it could also be implemented in REACH authorisation. However, a question needs to be considered as to whether in the REACH authorisation the "repair as produced" principle could also be applied in a general way for all products as it is in the RoHS Directive applied for all EEE. The Commission would invite Member States views on this question. Furthermore, when a substance is included in Annex XIV, the authorisation requirement is to cover all uses of the substance (unless they are exempted or fall out of the scope of authorisation) even if, at that stage, they may not be known to authorities. Longer transitional periods could be considered in the light of specific requests during the future public consultation on draft ECHA recommendations for future inclusion of substances in Annex XIV. 3.2) Annex XIV substances concerned: Similarly to the question of the articles concerned, MSCAs supporting a case-by-case approach also supported to limit the application of longer transitional periods to those substances actually used in legacy spare parts production. COM agrees.

5 Proposed way forward In light of the above, COM proposes the following when applying the "repair as produced" principle in REACH authorisation: Spare parts concerned (legacy spare parts): As outlined above, a question on which the Commission would like to get the MS and stakeholder's views is whether: (i) any spare part necessary for the repair or maintenance of all articles placed on the market before the sunset date could be covered ; or (ii) whether a further specification of the articles to be covered (for example, long lifetime durable articles in general or a specific time-figure determining the life-time such as a figure based on a guarantee provided by the article producer) is considered necessary. It is proposed to link the sunset date to the placing on the market of the [long life-time durable] article, and not to the date of its production, because in REACH there is no definition of production and from an enforcement point of view it may be easier to follow the same approach as in the ELV and RoHS Directives. It should be noted that in practice the legacy spare parts benefitting from a longer transitional period would be only those which are intended for [long life-time durable] articles which are no longer produced after the sunset date. The use of the Annex XIV substances in the production of spare parts intended for [long life-time durable] articles which are still being produced after the sunset date would require an authorisation, as the use of the substance in the production of the [long life-time durable] article itself would require authorisation anyway. Substances concerned: when considering providing for a longer transitional period for use in legacy spare parts production, it needs to be considered whether to apply it to all substances listed in Annex XIV, or to limit it to those substances for which COM and MS are aware or have indications that they may be used in complex articles: o blanket coverage of all Annex XIV substances: a blanket coverage would ensure that all possible uses of Annex XIV substances in legacy spare parts, including those of which COM and MS are not aware at the time of updating Annex XIV, are covered by the longer transitional periods; o only specific substances: knowledge on which substances are concerned could be gathered via the public consultation on ECHA s draft recommendation for priority substances to be included in Annex in the same way that information is gathered with regard to the applicability of possible exemptions. As the case of legacy spare parts is an exceptional case, it is proposed to limit the longer transitional periods to the substances for COM and MS are aware or have indications of their possible use in the production of long life-time durable articles. Such information could be specifically requested during the public consultations on draft ECHA recommendations for inclusion of substances in Annex XIV. Length of transitional periods: the length of the transitional periods appears difficult to establish on a case-by-case basis, as COM and MS may not be aware of all possible uses of an Annex XIV substance in legacy spare parts production, nor of the duration of life of different articles that may be concerned. As there may be durable articles with very different life-times, a possible way forward could be to propose the same transitional

6 period length. By means of illustration, 10 or 15 years after the latest application date and sunset date is proposed for discussion. The transitional period could be extended at a later stage if necessary, on a substance-by-substance basis and taking into account any requests made by manufacturers of complex articles and/or legacy spare parts. Any further developments with regard to the setting up of simplified authorisation procedures for specific cases (e.g. low volumes, articles subject to type approval or certification) etc. would also have to be taken into account. The Commission intends to prepare a draft amendment of Annex XIV based on the discussion and feedback received after the meeting an initial draft of how this could look like is attached. Further issues related to long life-time durable articles with type approval and ensuing long production times A separate matter is the case of spare parts intended for long life-time durable articles which continue to be in production after the sunset date and which correspond to a model or type which was approved or certified before the sunset date (e.g. aviation sector). The original equipment parts and spare parts of articles produced after the sunset date do not fall under the "repair as produced" principle which, by its own nature, only concerns legacy spare parts for articles that were actually placed on the market before the sunset date. In those cases, where the use of an Annex XIV substance is imposed via the product typeapproval or certification process, it may be more appropriate to develop a simplified authorisation procedure, with lighter requirements concerning some elements of the application, such as the analysis of alternatives. This is the case, for example, of the production of both original equipment and spare parts for aircrafts that are of a type approved by the European Aviation Safety Authority (EASA) before the sunset date (but still remaining in production in the future) and where, any changes in production (including those necessitated by substitution of an Annex XIV substance in the supply chain for spare parts) require the airworthiness re-certification or re-approval. However, given that the agreement on such a simplified process will take some time, while the sunset date for some substances in Annex XIV is approaching rapidly and although this would go beyond the "repair as produced" principle explained above, COM would welcome the MSCAs views about whether, in this particular case, both original equipment and spare parts of aircraft articles could for the moment be treated in the same way as legacy spare parts until such time that a simplified procedure will be in place.

7 Appendix Proposed amendment of Annex XIV REACH in order to address the specific case of legacy spare parts Next to the dates indicated under the columns Latest application date and Sunset date in entries 4 to 31, the following footnote (3) is inserted: (3) This date shall be extended by [10 or 15] years with regard to the use of the substance in the production of spare parts for the repair of [long life-time durable] articles placed on the market before the otherwise applicable sunset date.