1. hw3/071 Occupational Hygiene and the implementation of REACH IOSH Exhibition & Conference Hugh Wolfson Thanks to Andy Gillies for format and some of the content

2. hw3/07 BOHS 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. hw3/07 BOHS 9 REACH the 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

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

11. 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

12. 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 measures in 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

13. 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)

14. 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

15. 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

16. 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

17. 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 help SMEs 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

18. 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

19. 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

20. hw3/07 BOHS 20 Chemical Safety Assessment hazard 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)

21. hw3/07 BOHS 21 Chemical Safety Assessment exposure 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!

22. 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

23. 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 (downstream users) PRIMARY SUPPLIERS (manufacturers, importers) CUSTOMERS/SUPPLIERS (formulators)

24. hw3/07 BOHS 24 Exposure scenarios some 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?

25. 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

26. 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

27. 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

28. 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

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