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Occupational Hygiene and the implementation of REACH IOSH Exhibition & Conference Hugh Wolfson

Occupational Hygiene and the implementation of REACH IOSH Exhibition & Conference Hugh Wolfson Thanks to Andy Gillies for format and some of the content. REACH Timetable. July 06: common position agreed between Parliament and Commission

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Occupational Hygiene and the implementation of REACH IOSH Exhibition & Conference Hugh Wolfson

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  1. Occupational Hygiene and the implementation of REACH IOSH Exhibition & Conference Hugh Wolfson Thanks to Andy Gillies for format and some of the content hw3/07

  2. REACH Timetable • July 06: common position agreed between Parliament and Commission • 18 Dec 06: adoption of Regulation by European parliament and EU Council • April 07: entry into force in Member States • 2007/08: European Chemical Agency start-up, Helsinki • 2008 – 2018: phase-in for existing substances hw3/07 BOHS

  3. Summary of Presentation • BOHS – an introduction • Substance information - existing situation • REACH - What’s new? • Format of REACH • Risk assessment under REACH • How does COSHH fit in? • Useful sources of information hw3/07 BOHS

  4. An introduction to BOHS • A multidisciplinary, learned and professional society established in 1953 & merged with the British Institute of Occupational Hygienists (BIOH) in 2003 • Faculty of Occupational Hygiene is its professional arm • The voice of the occupational hygiene community in the UK • An unrivalled source of information and expertise for members and non-members alike • An examining board, through the Faculty of Occupational Hygiene, awarding qualifications in occupational hygiene and allied subjects hw3/07 BOHS

  5. The BOHS The Society’s aim : To help to reduce work-related ill-health resulting in A healthy worker in a healthy working environment www.bohs.org hw3/07 BOHS

  6. “they wouldn’t be allowed to sell it if it wasn’t safe” • Industrial products • Commercial products • Sale to the public hw3/07 BOHS

  7. “they wouldn’t be allowed to sell it if it wasn’t safe” Objective since the 1960’s - ensure enough safety information is available with products. 40 years after Directive 67/548/EEC on classification, packaging & labelling In UK, HSWA 1974 section 6. CPL Regulations 1978 15 years after Directive 92/32/EEC (New Substances) In UK, NONS Regulations 1993 Regulation (EC) No 1907/2006 of the European Parliament & Council and Directive 2006/121/EC hw3/07 BOHS

  8. Why is a new policy needed? • The “old” system isn’t working • The 1992 Regulation excluded “existing substances” on the market before 1982 - 100,000+ substances, 99% (by volume) “sketchy” information on properties, uses & risks • NONS a drag on research and innovation • Information required for “new” substances far greater than for “existing” • Programme on Existing Chemicals (ESR) slow and costly – would take many years • REACH transfers main burden of proof from authorities to manufacturers and formulators hw3/07 BOHS

  9. REACHthe new EU chemicals policy • Information on all substances • Physicochemical properties relevant to safety and environmental risk • Sufficient toxicity by any relevant route • Typical exposure scenarios and exposure estimates • Risk management advice • Enhanced Safety Data Sheet hw3/07 BOHS

  10. Elements of REACH • Registration By industry • Document that human health & environmental risks are adequately controlled in all identified uses • EvaluationBy ECA or CA • Review of registration dossiers for compliance and animal testing proposals • AuthorisationBy ECA or CA • For substances of very high concern (CMR class 1 and 2, PBT, vPvB, others, e.g. endocrine disrupters) • RestrictionBy ECA or CA • for substances where risks are unacceptable ECA= new European Chemicals Agency, Helsinki CA= National Competent Authority (HSE in UK) hw3/07 BOHS

  11. Who has duties? Any company producing, importing, using or placing on to the EU market a substance, preparation or article. • Not just the Chemical Industry sector • Manufacturers, importers, formulators, suppliers • Estimated about 30,000 substances will be registered • Some exemptions: • e.g. radioactive substances, non-isolated intermediates, wastes, polymers, minerals, ores, LPG, biocides, medicinal products… Downstream users use the information for their local Risk Assessment hw3/07 BOHS

  12. REACH & downstream users Most of REACH is about manufacturers and importers to EU Downstream users • have rights & obligations • can join a Substance Information Exchange forum during the registration process • have a right to request that suppliers’ CSA covers their use(s) • are obliged to use risk reduction measuresin the CSA • may have to do a local risk assessment for their particular use of the chemical if they do not disclose to the forum hw3/07 BOHS

  13. Registration timetable All substances (approx 30,000) manufactured/imported over 1te/year (= existing substances, unless new registration pending) • For new substances, registration is essential before manufacture • For existing substances on EINECS and ELINCS, phase-in period over 11 years (to 2018) • Notify intention by 1/12/2008 (pre-registration) • Phase 1: >1000 tonnes/year + CMR, PBT (by 1/12/2010) • Phase 2: 100 – 1000 tonnes/year (by 1/6/2013) • Phase 3: 10 – 100 and 1 – 10 tonnes/year (by 1/6/2018) hw3/07 BOHS

  14. Registration “CMR, PBT” on previous slide means • Carcinogenic, mutagenic, or reproductive-toxic cat 1 or 2 above 1 tonne per year • Persistent bio-accumulative & toxic (Environmental risk) R 50-53 above 100 tonnes per year • Substances very persistent and very bio-accumulative (vPvB) included in above • Also substances of equivalent concern, eg endocrine disruptors hw3/07 BOHS

  15. Authorisation • Authorisation required for all uses of substances of very high concern (eg CMR, PBT vPvB substances) • Authorisation granted if risks are under “adequate control” • adequate control allows authorities to prioritise action to haz subst that cannot be so controlled • If adequate control not possible, authorisation may still be granted on socio-economic grounds (i.e. no suitable safer alternative) • Companies required to make efforts to find safer alternative as part of their application for authorisation • Any substitute must be “feasible” and deliver lower overall risks hw3/07 BOHS

  16. Registration documents • Technical dossier for all substances • Info. on properties, uses and classification • Animal test data or proposals for testing • Guidance on safe use • >10 tonnes/year Chemical Safety Report • Hazard classification • Chemical Safety Assessment (human health, safety & environmental risk assessment) • Exposure scenarios for all identified uses hw3/07 BOHS

  17. REACH and Small & Medium Establishments 20,000 of the 30,000 substances are supplied between 1 and 10 tonnes per year, mostly by SMEs • Special provisions in REACH to helpSMEs • Greatly reduced information requirement for 1 to 10 te/yr substances • 11 years (to June 2018) to register 1 to 10 te/yr substances • Reduced fees for SMEs in all areas of REACH • The Helsinki Chemical Safety Agency will take particular account of SMEs needs in preparing technical guidance and enforcement strategy hw3/07 BOHS

  18. Registration documents • Technical dossier and Chemical Safety Report • Direct to new European Chemical Agency in Helsinki • 100% check for completeness • 5% detailed verification • UK lead body in negotiation was DEFRA • UK Competent Authority is Health & Safety Executive • Enforcement in UK may lie with various authorities hw3/07 BOHS

  19. Substance Evaluation In addition, EU Member States & Commission can nominate and agree on annual list of substances for in-depth evaluation Competent Authorities carry out the evaluation May lead to new control measures or to no further action hw3/07 BOHS

  20. Chemical Safety Assessmenthazard assessment • Human health • Evaluate data (animal data, epidemiology) • Decide on classification and labelling • Establish Derived No-Effect Level (DNEL) • Safety (physico-chemical) • Explosivity, flammability, oxidising potential • Environmental • Evaluate data, including PBT and vPvB assessment • Decide on classification and labelling • Establish Predicted No-Effect Concentration (PNEC) hw3/07 BOHS

  21. Chemical Safety Assessmentexposure assessment Exposure scenarios • Cover manufacture and intended uses throughout substance life cycle, incl. waste disposal/recycling • Describe processes and tasks • Operational conditions • Risk management measures required • Included as an appendix to enhanced SDS This is where Occupational Hygiene input is really needed! hw3/07 BOHS

  22. Human health risk characterisation • For each exposure scenario; and • for each human population exposed (as workers, consumers, indirectly via the environment, or a combination) • Residual risk (after RMM implemented); and • comparison of exposure with relevant DNEL hw3/07 BOHS

  23. Communication up & down the supply chain • Multi-directional information flow • Enhanced Safety Data Sheets • Hazard data, exposure scenarios, approved uses, restrictions on supply CUSTOMERS/SUPPLIERS (formulators) PRIMARY SUPPLIERS (manufacturers, importers) CUSTOMERS (downstream users) hw3/07 BOHS

  24. Exposure scenariossome questions • Should ES be generic or specific? • Can COSHH Essentials help? And, based on the supplier’s scenarios……. • How does the ES fit with a COSHH risk  Downstream User assessment? What if the conclusions are different? • What if my use isn’t covered by an ES?  Downstream User • How can a supplier estimate the exposure levels at my site?  Downstream User Did the downstream user contribute to the forum? hw3/07 BOHS

  25. Risk Management Measures some questions • Will control banding schemes like COSHH Essentials help? • A different mix of control options may achieve the same result; are both options valid? • How effective are RMM? Do I need to measure exposure? Downstream User • Do I have to use the recommended RMM from my supplier? Downstream User • What if different suppliers give conflicting recommendations? Downstream User hw3/07 BOHS

  26. COSHH and REACH Did the downstream user contribute to the forum? And meanwhile….. • Until REACH deals with a product, COSHH is fully required, and downstream user contributes to forum • When REACH sheets established, am I using it exactly as described in the REACH sheet? • If not, full COSHH assessment needed (and possibly added to the data base for REACH) • The REACH sheets may specify quantity limits, or numerical ventilation provisions, so a use can easily be outside the exact specification hw3/07 BOHS

  27. REACH and Occupational Hygiene • REACH is about protecting human health and the environment. Major role for H&S professionals • Multi-disciplinary team to address all the issues (commercial, technical, PR) • Occupational hygiene at the heart of REACH: • Exposure Scenarios • Risk Management Measures • Exposure monitoring and modelling • Data interpretation and use of exposure limits • Risk communication hw3/07 BOHS

  28. BOHS and REACH • REACH Steering Group reporting to Council • REACH pages on website • Workshops/Seminars planned for 2007 • Statement of the value of OH hw3/07 BOHS

  29. Useful information sources Handy websites: European Chemical Bureau http://ecb.jrc.it/REACH/ CEFIC http://www.cefic.be/ DG Enterprise http://ec.europa.eu/enterprise/reach CIA “REACH Ready” http://www.reachready.co.uk/ British Occupational Hygiene Societyhttp://www.bohs.org.uk/ DEFRAhttp://www.defra.gov.uk/environment/chemicals/reach/ HSE (Competent Authority) or phone helpdesk http://www.hse.gov.uk/chemicals/reach/ hw3/07 BOHS

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