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Annex Xv Investigation Report Public 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 consumer articles as well as the availability of alternatives to these materials and to certain articles exempted by paragraph 8 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 P.O. Box 400, FI-00121 Helsinki, Finland VERSION NUMBER: 1.0 DATE: 26/06/2020 P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu ANNEX XV INVESTIGATION REPORT – LEAD IN CONSUMER ARTICLES CONTENTS Summary ................................................................................................................ 1 1. Problem identification ........................................................................................ 6 1.1. Introduction .................................................................................................................. 6 1.2. Hazard, exposure/emissions, and risk .............................................................................. 7 1.3. Justification for an EU wide restriction measure ................................................................. 8 1.4. Baseline ....................................................................................................................... 8 1.5. Context of this review - recap from the Background Document ........................................... 8 2. Keys and locks, including padlocks ................................................................... 10 2.1. Rationale for the derogation ......................................................................................... 10 2.2. Information received on alternatives .............................................................................. 10 2.2.1. Quantity and technical functions of lead .................................................................. 11 2.2.2. Market for keys and locks ...................................................................................... 14 2.2.3. Assessment of alternatives .................................................................................... 17 2.2.4. Removing derogation scenario ............................................................................... 21 2.2.4.1. Affected actors ................................................................................ 22 2.2.4.2. Most likely response to removing the derogation ................................. 22 2.2.4.3. Costs of removing the derogation ...................................................... 23 2.2.4.4. Total costs ...................................................................................... 26 2.3. Conclusions ................................................................................................................ 28 3. Musical instruments ......................................................................................... 29 3.1. Rationale for the derogation ......................................................................................... 29 3.2. Information received .................................................................................................... 30 3.2.1. Quantity and technical functions of lead .................................................................. 31 3.2.2. Market for musical instruments .............................................................................. 34 3.2.3. Assessment of alternatives .................................................................................... 35 3.2.4. Removing derogation scenario ............................................................................... 37 3.2.4.1. Affected actors ................................................................................ 37 3.2.4.2. Most likely response to removing the derogation ................................. 38 3.2.4.3. Costs of removing the derogation ...................................................... 39 3.3. Conclusions ................................................................................................................ 41 4. Religious articles .............................................................................................. 41 4.1. Rationale for the derogation ......................................................................................... 41 4.2. Information received .................................................................................................... 42 4.2.1. Quantity and technical function of lead.................................................................... 42 i ANNEX XV INVESTIGATION REPORT – LEAD IN CONSUMER ARTICLES 4.2.2. Market for religious articles ................................................................................... 42 4.2.3. Assessment of alternatives .................................................................................... 42 4.2.4. Removing derogation scenario ............................................................................... 42 4.2.4.1. Most likely response to removing derogation ....................................... 43 4.2.4.2. Cost of removing the derogation ........................................................ 43 4.3. Conclusions ................................................................................................................ 43 5. Portable zinc-carbon batteries and button cell batteries .................................. 44 5.1. Rationale for the derogation ......................................................................................... 44 5.2. Information received .................................................................................................... 44 5.2.1. Quantity and technical function .............................................................................. 44 5.2.2. Market for portable zinc-carbon and button cell batteries .......................................... 45 5.2.3. Assessment of alternatives .................................................................................... 46 5.2.4. Removing derogation scenario ............................................................................... 47 5.2.4.1. Actors affected ................................................................................ 47 5.2.4.2. Most likely response to removing derogation ....................................... 48 5.2.4.3. Economic costs of removing derogation .............................................. 48 5.3. Conclusions ................................................................................................................ 50 6. Availability of lead migration testing methods and their ability to meet the requirements in the legislation ....................................................................... 51 6.1. Hazard/exposure/emissions and risk .............................................................................. 51 6.2. Approach for evaluating suitability, availability and enforceability of the methods ................ 53 6.2.1. Test methods for corrosion and wear ...................................................................... 54 6.2.2. Lead migration testing methods and requirements ................................................... 55 6.2.2.1. Migration testing within the framework of toys .................................... 60 6.2.3. Method accuracy .................................................................................................. 62 6.3. Overview of the feedback provided in consultations ......................................................... 65 6.3.1. Feedback provided by the Forum ............................................................................ 65 6.3.2. The feedback submitted to the call for evidence ....................................................... 66 6.3.3. Feedback from other expert consultations ............................................................... 68 6.3.4. Conclusions from the feedback ............................................................................... 69 6.4. Conclusions ................................................................................................................ 70 6.4.1. Migration methods for lead release ......................................................................... 70 6.4.2. Corrosion and wear test methods ........................................................................... 72 6.5. Recommendations ....................................................................................................... 73 6.5.1. Migration test method EN 16711-3 ......................................................................... 73 6.5.2. Wear test method EN 12472 .................................................................................. 75 ii ANNEX XV INVESTIGATION REPORT – LEAD IN CONSUMER ARTICLES 7. Conclusions & Recommendations ..................................................................... 76 7.1. Derogations ................................................................................................................ 76 7.2. Migration test methods ................................................................................................ 77 7.3. Wear test methods .....................................................................................................
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