REACH is a European Union regulation that addresses the production and use of chemical substances and their potential impacts on human health and the environment. It requires companies to register manufactured or imported chemical substances and provides authorities with powers to check companies are managing risks appropriately and substituting potentially dangerous chemicals. Substances of very high concern require authorization for use. REACH also updates chemical labeling and safety data sheet requirements. The key requirement is that companies must evaluate chemical hazards and demonstrate appropriate risk management measures are implemented across the supply chain.

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

12. Helsinki

13. What does REACH involve?

14. Registration
E
A
C
H

15. Registrants have to
provide a
 Technical dossier
 Chemical safety
report

16. Registrants have to
provide a
 Technical dossier
 Chemical safety
report
If more than 10 tonnes
produced or imported

17. Source: http://echa.europa.eu/clp/clp_regulation/transition_en.asp

18. R
Evaluation
A
C
H

19. R
E
Authorisation & restriction
C
H

20. Substances of Very High Concern
 Carcinogens, mutagens, toxic for reproduction

21. Substances of Very High Concern
 Carcinogens, mutagens, toxic for reproduction
 Persistent, bio-accumulative and toxic

22. Substances of Very High Concern
 Carcinogens, mutagens, toxic for reproduction
 Persistent, bio-accumulative and toxic
 Very persistent and very bio-accumulative

23. 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

24. REACH also repeals and replaces CHIP
requirements on safety data sheets

25. Extended safety data sheets must
contain information about risk
management measures for user
‘exposure scenarios’

26. Extended safety data sheets are
required for :
Substances
Mixtures

27. Extended safety data sheets are
NOT required for

28. Substances / mixtures
not classified as hazardous

29. Cosmetics

30. Medical products

31. Consumer products

32. Extended safety data sheets are
NOT required for:
Low hazard substances and mixtures
Cosmetics
Medical products
Consumer products

33. In parallel with REACH, new
requirements are being introduced on
the labelling of hazardous substances

34. European Regulation on
Classification, Labelling and Packaging
of chemical substances and mixtures

35. Source: http://echa.europa.eu/clp/clp_regulation/transition_en.asp

36. Source: http://echa.europa.eu/clp/clp_regulation/transition_en.asp

37. Old style label

38. New style label

39. New Pictograms
!

41. 116 Pages

42. http://guidance.echa.europa.eu/guidance_en.htm

43. The key to REACH is
the chemical safety report

45. Hazard
assessment
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
scenarios”
Assess risks for
exposure
scenarios
Establish risk
management
measures
Determine
o physio-chemical
o toxicological
o environmental
properties

48. Hazard
assessment
Establish all
“exposure
scenarios”
Assess risks for
exposure
scenarios
Establish risk
management
measures
Establish
“Derived no effect levels”
(DNELs)

49. Hazard
assessment
Establish all
“exposure
scenarios”
Assess risks for
exposure
scenarios
Establish risk
management
measures

50. Hazard
assessment
Establish all
“exposure
scenarios”
Assess risks for
exposure
scenarios
Establish risk
management
measures
Co-ordinate with
“downstream users”

51. Hazard
assessment
Establish all
“exposure
scenarios”
Assess risks for
exposure
scenarios
Establish risk
management
measures

52. Hazard
assessment
Establish all
“exposure
scenarios”
Assess risks for
exposure
scenarios
Establish risk
management
measures
Air sampling data
or
Modelling

53. Hazard
assessment
Establish all
“exposure
scenarios”
Assess risks for
exposure
scenarios
Establish risk
management
measures
Will the DNELs be exceeded?

54. Hazard
assessment
Establish all
“exposure
scenarios”
Assess risks for
exposure
scenarios
Establish risk
management
measures

55. What about “downstream users”?

56. “The downstream user
should follow his supplier’s
advice on measures to
control risks as provided in
the safety data sheets”

57. Other responsibilities of
“downstream users” are to:
Co-ordinate and co-operate with
suppliers
Pass information down the supply chain

58. What if there’s a
conflict between
COSHH and
REACH?

59. The most
rigorous
requirement
must take
precedence

60. (That will
probably be the
REACH
requirements!)

61. Registration
Evaluation
Authorisation & restriction of
CHemicals

62. www.diamondenv.co.uk
@diamondenv
http://diamondenv.wordpress.com/
Mike Slater