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  • 1. REACH Regulating Chemicals in Europe
  • 2. R E A C H
  • 3. Registration E A C H
  • 4. Registration Evaluation A C H
  • 5. Registration Evaluation Authorisation & restriction C H
  • 6. Registration Evaluation Authorisation & restriction of CHemicals
  • 7. S I E F
  • 8. Substance Information Exchange Forum
  • 9. E C H A
  • 10. European CHemicals Agency
  • 11. Helsinki
  • 12. What does REACH involve?
  • 13. Registration E A C H
  • 14. Registrants have to provide a  Technical dossier  Chemical safety report
  • 15. Registrants have to provide a  Technical dossier  Chemical safety report If more than 10 tonnes produced or imported
  • 16. Source: http://echa.europa.eu/clp/clp_regulation/transition_en.asp
  • 17. R Evaluation A C H
  • 18. R E Authorisation & restriction C H
  • 19. Substances of Very High Concern  Carcinogens, mutagens, toxic for reproduction
  • 20. Substances of Very High Concern  Carcinogens, mutagens, toxic for reproduction  Persistent, bio-accumulative and toxic
  • 21. Substances of Very High Concern  Carcinogens, mutagens, toxic for reproduction  Persistent, bio-accumulative and toxic  Very persistent and very bio-accumulative
  • 22. Substances of Very High Concern  Carcinogens, mutagens, toxic for reproduction  Persistent, bio-accumulative and toxic  Very persistent and very bio-accumulative  Substances giving rise to an equivalent level of concern
  • 23. REACH also repeals and replaces CHIP requirements on safety data sheets
  • 24. Extended safety data sheets must contain information about risk management measures for user ‘exposure scenarios’
  • 25. Extended safety data sheets are required for :  Substances  Mixtures
  • 26. Extended safety data sheets are NOT required for
  • 27. Substances / mixtures not classified as hazardous
  • 28. Cosmetics
  • 29. Medical products
  • 30. Consumer products
  • 31. Extended safety data sheets are NOT required for:  Low hazard substances and mixtures  Cosmetics  Medical products  Consumer products
  • 32. In parallel with REACH, new requirements are being introduced on the labelling of hazardous substances
  • 33. European Regulation on Classification, Labelling and Packaging of chemical substances and mixtures
  • 34. Source: http://echa.europa.eu/clp/clp_regulation/transition_en.asp
  • 35. Source: http://echa.europa.eu/clp/clp_regulation/transition_en.asp
  • 36. Old style label
  • 37. New style label
  • 38. New Pictograms !
  • 39. 116 Pages
  • 40. http://guidance.echa.europa.eu/guidance_en.htm
  • 41. The key to REACH is the chemical safety report
  • 42. Hazard assessment Establish all “exposure scenarios” Assess risks for exposure scenarios Establish risk management measures
  • 43. Hazard assessment Establish all “exposure scenarios” Assess risks for exposure scenarios Establish risk management measures
  • 44. Hazard assessment Determine o physio-chemical o toxicological o environmental Establish all “exposure properties scenarios” Assess risks for exposure scenarios Establish risk management measures
  • 45. Hazard assessment Establish “Derived no effect levels” (DNELs) Establish all “exposure scenarios” Assess risks for exposure scenarios Establish risk management measures
  • 46. Hazard assessment Establish all “exposure scenarios” Assess risks for exposure scenarios Establish risk management measures
  • 47. Hazard assessment Establish all “exposure Co-ordinate with scenarios” “downstream users” Assess risks for exposure scenarios Establish risk management measures
  • 48. Hazard assessment Establish all “exposure scenarios” Assess risks for exposure scenarios Establish risk management measures
  • 49. Hazard assessment Establish all “exposure scenarios” Air sampling data Assess risks for exposure or scenarios Modelling Establish risk management measures
  • 50. Hazard assessment Establish all “exposure scenarios” Assess risks for exposure Will the DNELs be exceeded? scenarios Establish risk management measures
  • 51. Hazard assessment Establish all “exposure scenarios” Assess risks for exposure scenarios Establish risk management measures
  • 52. What about “downstream users”?
  • 53. “The downstream user should follow his supplier’s advice on measures to control risks as provided in the safety data sheets”
  • 54. Other responsibilities of “downstream users” are to:  Co-ordinate and co-operate with suppliers  Pass information down the supply chain
  • 55. What if there’s a conflict between COSHH and REACH?
  • 56. The most rigorous requirement must take precedence
  • 57. (That will probably be the REACH requirements!)
  • 58. Registration Evaluation Authorisation & restriction of CHemicals
  • 59. Mike Slater www.diamondenv.co.uk @diamondenv http://diamondenv.wordpress.com/