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ECHA Scientific Report for Evaluation of Limit Values for Lead and Its Compounds at the Workplace

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ECHA Scientific Report for Evaluation of Limit Values for Lead and Its Compounds at the Workplace ECHA Scientific report for evaluation of limit values for lead and its compounds at the workplace Prepared by the European Chemicals Agency 17 October2019 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ECHA SCIENTIFIC REPORT on Lead and its compounds II Preamble The Commission, in view of the preparation of the proposals for its amendment of Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (CAD), and in line with the 2017 Commission Communication ‘Safer and Healthier Work for All’ - Modernisation of the EU Occupational Safety and Health Legislation and Policy1, asked the advice of RAC to assess the scientific relevance of occupational exposure limits for some chemical agents. Therefore, the Commission made a request on 26 March 2019 to ECHA in accordance with the Service Level Agreement (SLA) (Ares(2019)18725), to evaluate, in accordance with the Directive (98/24/EC), the following chemical agent: lead and its compounds. In support of the Commission’s request, ECHA has prepared a scientific report concerning occupational limit values for lead and its compounds at the workplace. In support of the Commission’s request, ECHA has prepared a scientific report concerning occupational limit values for lead and its compounds at the workplace. In the preparatory phase of making this report, a call for evidence was started on 17/04/2019 to invite interested parties to submit comments and evidence on the subject by 30/06/2019. The scientific report was made publicly available at ECHA’s website on 17/10/2019 and interested parties were invited to submit comments by 16/12/2019. The Committee for Risk Assessment (RAC) will develop its opinion on the basis of the scientific report submitted by ECHA. During the preparation of the opinion on occupational limit values for lead and its compounds, the scientific report will be further developed as the Background Document (Annex I). Following adoption of an opinion on [date], recommending an Occupational Exposure Limit for lead and its compounds by RAC, the Background Document will be amended to align it appropriately with the view of RAC. It supports the opinion of the RAC and gives the detailed grounds for the opinion2. 1 http://ec.europa.eu/social/main.jsp?langId=en&catId=148&newsId=2709&furtherNews=yes 2 https://echa.europa.eu/documents/10162/13579/interim_wponevaluation_oel_agreed_rac_42_en. pdf/021bc290-e26c-532f-eb3f-52527700e375 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ECHA SCIENTIFIC REPORT ON LEAD AND ITS COMPOUNDS III Table of Contents LITERATURE ...................................................................................................... 11 ECHA RECOMMENDATION ................................................................................... 11 1. CHEMICAL AGENT IDENTIFICATION AND PHYSICO-CHEMICAL PROPERTIES .......... 12 LEAD ....................................................................................................... 12 LEAD COMPOUNDS ................................................................................... 12 1.2.1 Inorganic compounds ....................................................................... 13 1.2.2 Organic compounds .......................................................................... 13 2. EU HARMONISED CLASSIFICATION AND LABELLING – CLP: REGULATION (EC) 1272/2008 ........................................................................................................ 14 INORGANIC COMPOUNDS .......................................................................... 15 ORGANIC COMPOUNDS ............................................................................. 15 3. CHEMICAL AGENTS AND SCOPE OF LEGISLATION - REGULATED USES OF LEAD AND ITS COMPOUNDS IN THE EU ................................................................................ 16 DIRECTIVE 98/24/EC AND DIRECTIVE 2004/37/EC ....................................... 16 REACH REGISTRATIONS ............................................................................ 17 3.2.1 Inorganic compound ......................................................................... 17 3.2.2 Organic compounds .......................................................................... 17 AUTHORISED USES UNDER ANNEX XIV OF REACH ........................................ 17 RESTRICTED USES UNDER ANNEX XVII OF REACH ....................................... 18 REGULATION (EC) 98/70 ON PETROL .......................................................... 18 PLANT PROTECTION PRODUCTS REGULATION (EC) 1107/2009 ...................... 18 HUMAN AND VETERINARY MEDICINAL PRODUCTS DIRECTIVES 2001/83/EC AND 2004/28/EC RESPECTIVELY ................................................................... 18 BIOCIDAL PRODUCTS REGULATION (EU) 528/2012 ...................................... 18 COSMETICS PRODUCTS REGULATION (EC) 1123/2009 .................................. 19 DRINKING WATER DIRECTIVE 98/83/EC .................................................... 19 CERAMICS DIRECTIVE 84/500/EEC ........................................................... 19 SAFETY OF TOYS DIRECTIVE 2009/49/EC .................................................. 19 FOOD CONTAMINANTS REGULATION LEAD (EC) 1881/2006/EC .................... 19 DIRECTIVE 2008/50/EC ON AMBIENT AIR QUALITY AND CLEANER AIR FOR EUROPE .............................................................................................. 19 DIRECTIVE 86/278/EEC ON THE PROTECTION OF THE ENVIRONMENT, AND IN PARTICULAR OF THE SOIL, WHEN SEWAGE SLUDGE IS USED IN AGRICULTURE 19 DIRECTIVE 2003/40/EC ON NATURAL MINERAL WATERS ............................. 19 4. EXISTING OCCUPATIONAL EXPOSURE LIMITS .................................................... 20 IV ECHA SCIENTIFIC REPORT ON LEAD AND ITS COMPOUNDS INORGANIC COMPOUNDS .......................................................................... 20 ORGANIC COMPOUNDS ............................................................................. 21 5. OCCURRENCE, USE AND OCCUPATIONAL EXPOSURE .......................................... 24 OCCURRENCE ........................................................................................... 24 PRODUCTION AND USE INFORMATION ........................................................ 25 5.2.1 Production ....................................................................................... 25 5.2.1.1 Primary Lead - Mining ............................................................ 25 5.2.1.2 Secondary lead – recycling/recovery from lead containing (used) material ................................................................................ 26 5.2.2 Uses ............................................................................................... 27 5.2.2.1 Lead-acid battery production .................................................. 27 5.2.2.2 Lead Stabilisers in PVC ........................................................... 29 5.2.2.3 Use of lead oxides in speciality and crystal glass production ........ 30 5.2.2.4 Lead Alloys ........................................................................... 30 5.2.2.5 Lead sheet............................................................................ 31 5.2.2.6 Ammunition .......................................................................... 32 5.2.2.7 Fuel additives ....................................................................... 32 OCCUPATIONAL EXPOSURE ........................................................................ 32 ROUTES OF EXPOSURE AND UPTAKE ........................................................... 34 5.4.1 Worker exposure .............................................................................. 34 5.4.2 General population ........................................................................... 34 6. MONITORING EXPOSURE ................................................................................. 35 EXTERNAL EXPOSURE ............................................................................... 35 6.1.1 Airmonitoring methods ..................................................................... 35 BIOMONITORING OF EXPOSURE (INTERNAL EXPOSURE) ............................... 36 6.2.1 Biomarkers ...................................................................................... 36 6.2.1.1 Biomarkers of exposure ......................................................... 36 6.2.1.2 Biomarkers of effect .............................................................. 36 6.2.2 Background levels ............................................................................ 36 6.2.3 Biological monitoring and occupational exposure .................................. 39 6.2.4 Biomonitoring analytical methods ....................................................... 40 7. HEALTH EFFECTS ........................................................................................... 41 TOXICOKINETICS (ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION - ADME) ................................................................................................ 42 7.1.1 Human data .................................................................................... 42 7.1.1.1 Inorganic compounds ............................................................. 42 7.1.1.2 Organic compounds ............................................................... 44 ECHA SCIENTIFIC REPORT ON LEAD AND ITS COMPOUNDS V 7.1.2
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