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EU Health & Safety Legislation Now and Tomorrow The European Cement Industry: a Health Perspective CEMBUREAU General Assembly Stockholm June 13, 2006 Ursula Schliessner McKenna Long & Aldridge LLP I. Introduction Health related regulation is scattered in different areas: Workers Safety Chemicals* Products** * REACH; Classification, packaging and labeling of substances & preparations (Dir. 67/548, 1999/45: safety data sheets, chromium VI labeling); Marketing & Use Restrictions Directive 76/769 ( example: Chromium VI) ** Construction Products Directive 89/106 (Products must be safe for occupants, neighbors and other users, Annex I); Dir. 85/374 product liability; Dir. 2001/95 product safety) 2 II. Workers Safety Legislation There is a large number of Directives* setting minimum requirements all based on the same principles. * Dir. 89/391 (base); Dir. 98/24 chemicals at work; Dir. 2004/37 carcinogens/mutagens at work (Binding limit values for benzene, vinylchloride monomer, hardwood dusts); Others (Dir. 83/477 asbestos at work; Dir. 2003/10 physical agents (noise); Dir. 89/655 work equipment; Dir. 2000/54 biological agents; Dir. 1999/92 explosive atmospheres; Dir. 94/33 on protection of young people at work; Dir. 92/104 workers in surface and underground mineral-extracting industries; and drilling 92/91; Dir. 92/85 pregnant, recently given birth, and breastfeeding workers; Dir. 92/58 safety & health signs at work; Dir. 92/57 temporary and mobile construction sites; Dir. 91/322 indicative limit values; Dir. 90/270 display screen equipment; Dir. 90/269 manual handling of loads (risk of back injury); Dir. 2006/15; Dir. 89/656 personal protective equipment; Dir. 89/654 workplace; and Recommendation 66/464 medical control) 3 Principles of Workers Protection Legislation Avoid Risk Assessment of specific risks work place (on the basis of Combat risks safety data sheet, other at source available info, measuring) Adapt work to individual Risk management if risk identified Replace dangerous by non or less dangerous Training & consultation Develop coherent overall prevention Evaluation policy Collective measures take priority over individual measures (e.g. PPE) 4 Examples of Risk Assessment and Risk Management (Negative) 5 Examples of Risk Assessment and Risk Management (Positive) Cables routed under the walkway 6 Example of Risk Assessment and Risk Management (Negative) 7 Example of Risk Assessment and Risk Management (Positive) 8 Self-regulation may also be used in the workers safety area: so-called Social Dialogue Member States may entrust Social Partners, at their joint request, with the implementation of Directives Conclusion of Social Dialogue Agreements upon joint request (9 months suspension of legislative process)* Experience:** Currently 31 sectoral Social Dialogue committees incl. construction, mining and chemicals. CEMBUREAU not member. Indirectly CEMBUREAU may be impacted because of its suppliers/customers. Very few Social Dialogue Agreements. * Implementation possible by a) procedures/practices social partners and Member States, or b) Council Decision/Directive upo n Commission proposal ** At earlier stages, agreements at horizontal level implemented by Council Directives (part-time work, parental leave , fixed-term work, etc.); now “autonomous” horizontal or sectoral agreements, e.g. stress at work (horizontal); telework (sectoral); vocat ional 9 training in agriculture, working time in civil aviation; age diversity in commerce; telework in telecommunications sector Silica CEMBUREAU participated along 14 other industry associations and two employee organizations (EMCEF, EMF) in negotiation of Social Dialogue Agreement on “Workers health protection through the good handling and use of crystalline silica and products containing it” Novel because: • First Agreement on a substance • First multi-sector Agreement • First Agreement with parties not members of existing SD sector committees • First Agreement directly applicable • Very detailed (compared to existing SDAs) • Extensive monitoring and reporting scheme • Self-initiated (not in response to First or Second Stage consultation) 10 11 III. Chemical Legislation REACH will impact health protection, but changes will not be dramatic. Increased supply of information Less divergences More record keeping 12 Existing Requirements REACH Requirements • Classification, packaging, labeling under Dir. 67/548 and • Same 1999/45 of dangerous* substances and preparations – plus PBT and vPvB (Council); – plus substances eligible for authorization (EP) – plus annex with exposure scenarios (with related use and exposure categories, EP) • Provision of safety data sheets (SDS) for dangerous • Same substances and preparations and some non-dangerous preparations to professional users before or at first delivery • Obligation to revise SDS and inform customers, and to • Obligation to notify and update Agency on changes to notify new information on previously notified substances to – hazard classification MS – hazard label “Classification and Labeling Inventory” If information supplied results in different entries of the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the Inventory (Art. 110 REACH)** Information in the Supply Chain (see following slides) * 15 danger categories: explosive, oxidizing, extremely flammable, highly flammable, flammable, very toxic, toxic, harmful, corrosive, irritant, sensitizing, carcinogenic, mutagenic, toxic for reproduction, dangerous for the environment ** Art. 112 REACH: harmonized classification & labeling under Dir. 67/548 will continue only for carcinogenic, mutagenic or reprotox, cat. 1, 2 and 3, and respiratory sensitizers. 13 Safety Data Sheets under REACH (current Dir. 2001/58) 1. Identification of the 7. Handling and Storage substance/preparation and of the 7.1 Handling company/undertaking 7.2 Storage 1.1 Identification of the substance or 7.3 Specific Uses preparation 8. Exposure Controls/personal 1.2 Use of the S/P Protection 1.3 Company/undertaking identification 8.1 Exposure limit values 1.4 Emergency telephone 8.2 Exposure controls 2. Hazards Identification 9. Physical and chemical properties 3. Composition/Information or 9.1 General information Ingredients 9.2 Important health, safety and (= all hazard information) environmental information 9.3 Other information 4. First Aid Measures 10. Stability and Reactivity 5. Fire Fighting measures 10.1 Conditions to avoid 10.2 Materials to avoid 6. Accidental Release Measures 10.3 Other information 14 11. Toxicological information ANNEX (NEW!): 12. Ecological information Exposure scenarios (based on 12.1 Ecotoxicity chemical safety report, i.e. above 10 12.2 Mobility tons and subject to registration and 12.3 Persistence and degradability dangerous/PBT/vPvB = Article 13 12.4 Bioaccumulative potential REACH) 12.5 Results of PBT assessment 12.6 Other adverse effects 13. Disposal Considerations 14. Transport information 15. Regulatory information 16. Other information (e.g. key data, training, recommendations on use restrictions) 15 NOTE: SDS • TO BE PROVIDED IN NATIONAL LANGUAGES • TO BE UPDATED (and sent even to previous customers of last year) • TO BE DATED • PERSONS in charge MUST BE REGULARLY TRAINED • To be made available to workers 16 Information in supply chain when SDS not required Registration number Details on authorization Details on restrictions “Any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied” Info to be made available to workers To be updated Also to previous (12 months) customers 17 Record Keeping* Assembly and keeping of all information required to carry out duties under REACH for at least 10 years after last manufacture, import, supply or use This obligation is transferred in case of company transfer/cessation upon successor Obligation upon manufacturers, importers, downstream users and distributors Conclusion/consequence: Install a procedure and a system ! * Article 33 18 Conclusions REACH: Not so many changes for cement industry Communicate in the supply chain Change SDS Install record-keeping system 19 Legal Consequences from Failure to Comply with Information Requirements under REACH National administrative / criminal law penalties/fines Criminal law sanctions in case failure can be considered a negligent/intentional wrong-doing / omission leading to e.g. an injury / fatality Damage claims under national toxic tort law if damage caused negligently by inaccurate / incomplete / lacking information that caused damage Strict product liability if failure amounts to “defect” of a product Contractual liability in case supply contract provides for “compliance with all applicable laws” Product recall under product safety legislation only in case of “consumer products” 20 IV. Product Regulation Business as usual except for revision of Construction Products Directive 21 V. Tomorrow Legislative/Regulatory Program Adoption of REACH will lead to increased flow of information up and down supply chain, increased availability of information on substances and will therefore necessitate updating of work place risk assessments Adoption of new Community program 2007-2012 on H&S at work will increase focus on multisource agents and risks, facilitate setting of limit values. Revision of Construction Products Directive and standards may increase health and environmental standards of products 22 Other Sectoral Social Dialogue as self-starter creating pressure on human resources of associations Empty national health budgets to increase focus on employer responsibility/liability for occupational diseases and accidents and more prevention Aging workforce will create challenges also in terms of risk assessment and risk management at the work place Large disparity in national H&S protection levels and within sectors. No level-playing field 23
"The European Cement Industrya Health Perspective"