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Annex XV Reporting Format 040615 ANNEX XV INVESTIGATION REPORT Investigation into the state of the art of scientific information in terms of available analytical methodologies to determine migration of lead from the different materials used in jewellery as well as the availability of alternatives to these materials and to those exempted by paragraph 4 of entry 63 of Annex XVII of REACH to enable the Commission to conduct the required review of the restriction. SUBSTANCE NAME: Lead and its compounds IUPAC NAME: - EC NUMBER: - CAS NUMBER: - CONTACT DETAILS OF THE REPORT AUTHOR: EUROPEAN CHEMICALS AGENCY VERSION NUMBER: 1.1 DATE: 15 January 2018 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ANNEX XV REST RICT ION REPORT – LEAD IN JEWELLERY TABLE OF CONTENTS S umma ry ....................................................................................................... 1 Report .......................................................................................................... 2 1. The problem identified ................................................................................... 2 1.1. Int roduct ion .......................................................................................... 2 1.2. Hazard, exposure/emissions and risk ........................................................... 3 1.3. Justification for an EU wide restriction measure .............................................. 3 1.4. Baseline ............................................................................................... 4 2. Impact assessment ....................................................................................... 4 2.1. Int roduct ion .......................................................................................... 4 2.2. Economic impacts ................................................................................... 5 2.2.1. Background information ....................................................................... 5 2.2.1.1. Crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Council Directive 69/493/EEC ...............................................................................5 2.2.1.2. Internal components of watch timepieces inaccessible to consumers..........6 2.2.1.3. Non-synthetic or reconstructed precious and semiprecious stones .............6 2.2.1.4. Enamels.....................................................................................6 2.2.2. Information received in the Call for evidence and through other sources........... 7 2.2.2.1. Crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Council Directive 69/493/EEC ...............................................................................7 2.2.2.2. Int ernal c omponent s of watc h pieces inaccessible to consumers ............. 13 2.2.2.3. Non-synthetic or reconstructed precious and semiprecious stones ........... 16 2.2.2.4. Enamels................................................................................... 17 2.3. Practicability and monitorability................................................................ 21 2.3.1. Background information ..................................................................... 21 2.3.2. Information received in the call for evidence and via consultation of ECHA Forum Members ..................................................................................... 22 2.3.2.1. Overview of the feedback provided by industry .................................. 22 2.3.2.2. Overview of the feedback provided by Member States (NEAs) ................ 25 2.3.2.3. Preliminary results from REF-4 (REACH-EN-FORCE project) ................... 29 2.3.3. Discussion on the implementation of a migration limit for the lead in Jewellery restriction .................................................................................... 29 2.4. Assumptions, uncertainties and sensitivities ................................................ 32 2.4.1. Assumptions ................................................................................... 32 i ANNEX XV REST RICT ION REPORT – LEAD IN JEWELLERY 2.4.2. Uncertainties................................................................................... 33 3. Conc lusions............................................................................................... 34 3.1. Availability of alternatives ....................................................................... 34 3.2. Migration limit ..................................................................................... 36 4. References................................................................................................ 37 TABLE OF TABLES Table 1 - lead-free glass composition, adapted from information in patent no.EP1725502B1 ................................................................................................................. 10 Table 2 - Overview of lead-containing prec ious stones and t heir lead content . ............... 17 ii ANNEX XV REST RICT ION REPORT – LEAD IN JEWELLERY Summary The Commission has requested ECHA to prepare an evaluation report to assist the Commission with the conduct of the required review of entry 63 of Annex XVII to REACH. Based on ECHA’s report, the Commission will c onsider whether to request the Agency to prepare an Annex XV dossier in accordance with Article 69(1) to launch the procedure to amend the c urrent restriction. To enable the Commission to conduct the required review of the restriction, the Agency has investigated the analytical methodologies available to determine migration of lead from the different materials used in jewellery and the availability of alternatives to the materials exempted by paragraph 4. In relation to the alternatives to the exempted materials, no significant new information about availability and feasibility of alternatives has been identified compared to the situation described in the Bac kground Document to the opinions on the lead in jewellery restric tion proposal. Therefore no changes are c urrently recommended for the following derogations: i. Crystal glass as defined in Annex I (c ategories 1, 2, 3 and 4) to Counc il Direc tive 69/493/EEC; ii. Internal components of watch timepieces inaccessible to consumers; iii. Non-synthetic or reconstructed precious and semiprecious stones (CN code 7103, as established by Regulation (EEC) No 2658/87), unless they have been treated with lead or its c ompounds or mixtures containing these substances; iv. Enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of minerals melted at a temperature of at least 500 °C. However, the need for the derogations i) and iv) could be revisited in the future, in light of the evolving market situation and possible R&D1 innovation. In relation to a possible introduc tion of a migration limit, based on the information gathered and discussed in the report (inc luding implementation issues), no change is recommended at the current t ime . However, it is recommended to reassess the need and the suitability of adding a migration limit in the future when further experience and evidence will be available. 1 Research and development. 1 ANNEX XV REST RICT ION REPORT – LEAD IN JEWELLERY Report 1. The problem identified 1.1. Introduction T he Co mmis sion has requested ECHA to prepare an evaluation report to enable the Commission to conduct the required review of entry 63 of Annex XVII to REACH: https://echa.europa.eu/documents/10162/13641/echa_lead_pah_commission_request_en. pdf/248461e1-cab2-9d23-9d54-42df72d26505. Paragraph 6 of entry 63 of Annex XVII to REACH, requires the Commission to review the current restriction for lead in jewellery articles by 9 October 2017. Based on this report the Commission will c onsider whether to request ECHA to prepare an Annex XV dossier in accordance with Article 69(1) to launch the proc edure to amend the c urrent restric tion. Based on the opinions of the Committee for Risk Assessment (RAC) and the Committee for Soc io-economic Analysis (SEAC) on a restric tion proposal made by France, Co mmis s io n Regulation (EU) No 836/2012 of 18 September 2012 was adopted (http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:252:0004:0006:EN:PDF). To enable the Commission to conduct the required review of the restriction, the Agency has investigated the analytical methodologies available to determine migration of lead from the different materials used in jewellery and the availability of alternatives to the materials exempted by paragraph 4. Lead and its compounds w e re c o mmo nly used in jewellery for its spec ific properties and for economic reasons. Children may be exposed to lead when they suck or unintentionally ingest jewellery. In general, the adverse health effects of lead are severe and children are more vulnerable than adults to the effects it can have on the central nervous system. To protect children from exposure to lead, France proposed that the use of lead and its compounds in the production of jewellery and the placing of such articles on the EU market should be restricted. ECHA has gathered information through a c all for evidenc e2 and f ro m other sourc es3 to assess whether a lead migration limit should be established4 and whether there are suitable and available alternatives for the following four derogations: • Crystal glass as defined in Annex I (c ategories 1, 2, 3 and 4) to Counc il Direc tive 69/493/EEC; • Internal components of watch timepieces inaccessible to consumers; 2 https://echa.europa.eu/documents/10162/588104b3-65cc-ac42-ed79-05f7fd09d0bf
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