REACH: A step change in the management of chemicals

Review of European Community and International Environmental Law

Volumn 15, Issue 3, 2006, Pages 270-280

  Hansen, Bjorn G ^a   Blainey, Mark ^b  

^a Chemicals Unit

^b HEALTH AND SAFETY EXECUTIVE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CHEMICAL SUBSTANCE; ENVIRONMENTAL LEGISLATION; EUROPEAN UNION; MANAGEMENT;

EURASIA; EUROPE;

EID: 33751581603     PISSN: 09628797     EISSN: 14679388     Source Type: Journal    
DOI: 10.1111/j.1467-9388.2006.00527.x     Document Type: Article

References (62)

1. Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, [1967] OJ 196/1.
2. Council Directive 1999/45/EC of 31 May 1999 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations, [1999] OJ L200/1.
3. Council Regulation (EEC) 793/93 of 23 March 1993 on the evaluation and control of existing chemical substances, [1993] OJ L84/1.
4. Council Directive 76/769/EEC of 27 July 1976 on the approximation of laws, regulations and administrative provisions relating to restrictions on the marketing and use of certain dangerous substances and preparations, [1976] OJ L262/201.
5. Treaty establishing the European Community (consolidated text), 2002] OJ C225/33.
6. Treaty of Amsterdam, [1997] OJ C340/1.
7. The distinction, introduced under Regulation (EEC) 793/93, n. 3 above, between so-called 'existing' and 'new' chemicals is based on the cut-off date of 1981. All chemicals that were put on the market before 1981 are called 'existing' chemicals. In 1981, they numbered more than 100,000 different substances. Chemicals introduced to the market after 1981 (more than 3800) are termed 'new' chemicals; see R. Allanou, B. Hansen and Y. van der Bilt, Public Availability of Data on EU High Production Volume Chemicals European Chemicals Bureau, 1999), available at .
8. See Report on the Operation of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations, Directive 88/397/EEC of the European Parliament and of the Council of 7 June 1988 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations and Council Regulation (EEC) No 793/ 93 of 23 March 1993 on the evaluation and control of the risks of existing substances, SEC (1998) 1986 final.
9. Other issues identified included that, while new chemicals have to be tested before they are placed on the market, there are no such provisions for 'existing' chemicals; the current allocation of responsibilities between authorities and enterprises is not appropriate; current legislation requires the manufacturers and importers of chemicals to provide information, but does not impose similar obligations on downstream users (industrial users and formulators); new chemicals having to be notified and tested starting from volumes as low as 10 kg per year have been a barrier to innovation within the EU by discouraging research and invention of new substances and favouring the development and use of existing substances over new ones; see ibid.
10. European Commission, White Paper on the Strategy for a Future Chemicals Policy, COM (2001) 88, available at "http://ec.europa.eu/ environment/chemicals/pdf/0188_en.pdf".
11. Ibid., Introduction.
12. Conclusions of the Environment Council of 8 June 2001 on the White Paper (Council Document 9857/01, 8 June 2001), available at "http://register.consilium.eu.int/pdf/en/01/st09/ 09857en1.pdf".
13. European Parliament Resolution on the Commission White Paper on Stratgy for a Future Chemicals Policy (COM (2001) 88), [2002] OJ C140E.
14. This policy supports the greater use of general principles and minimum standards for consultation, impact assessment to support policy-making decisions and simplification of legislation. For a general overview, see the website available at "http://ec.europa.eu/enterprise/regulation/ better_regulation/simplification.htm".
15. 'Comitology' is defined by the EU in the following manner: 'Under the Treaty establishing the European Community, it is for the Commission to implement legislation at Community level. In practice, each legislative instrument specifies the scope of the implementing powers granted to the Commission and how the Commission is to use them. Frequently, the treaty will also make provision for the Commission to be assisted by a committee in accordance with a procedure known as "comitology". The committees, which are forums for discussion, consist of representatives from Member States and are chaired by the Commission. They enable the Commission to establish a dialogue with national administrations before adopting implementing measures. The Commission ensures that they reflect as far as possible the situation in each country in question'. See Europa Glossory (EU, undated), available at "http://europa.eu/scadplus/glossary/comitology_en.htm".
16. REACH is expected to enter into force in early 2007.
17. European Parliament, First Reading Opinion on REACH (P6_TAPROV(2005)0434, 17 November 2005), available at "http://www.europarl.europa.eu/oeil/file.jsp?id=237952".
18. See European Council, Common Position on REACH (27 June 2006), available at "http://register.consilium.europa.eu/pdf/en/06/st07/ st07524-re08.en06.pdf".
19. Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control, [1996] OJ L257/26.
20. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, [1991] OJ 230/1.
21. See n. 1 above.
22. See n. 3 above.
23. Directive 98/8/EC of the European Parliament and of the Council 16 February 1998 concerning the placing of biocidal products on the market, [1998] OJ L123/1.
24. See n. 4 above.
25. Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy, [2000] OJ L327/1.
26. European Commission, Green Paper on Integrated Product Policy, COM (2001) 68.
27. Commission Communication of 2 February 2000 on the Precautionary Principle, COM (2000) 1 final.
28. See Common Position on REACH, n. 18 above, Annex I, para. 6.4, which introduces the key concept of the 'dequate control' of chemicals under REACH. A substance is defined, in Annex I, as being adequately controlled when the estimated or measured exposure is less than the derived no-effect level (DNEL) or the predicted noeffect concentration (PNEC). These levels are developed from the no-effect level(s) obtained from analysis of the information on the substance and an appropriate safety factor. There can be a DNEL PNEC for each route of exposure (inhalation, ingestion, dermal) and even for each sub-population (i.e. workers, consumers or specific vulnerable sub-populations such as children).
29. Ibid., Article 10(a).
30. Ibid., Articles 10(b) and 14.
31. 'Read across' means the interpolation of a property of a substance from other related substances as set out in ibid., Annex XI, para. 1.5.
32. Ibid., Article 25.
33. The principles of good laboratory practice (GLP) define a set of rules and criteria for a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. They are set out in Directive 2004/10/ EC of the European Parliament and of the Council 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles good laboratory practice and the verification of their application for tests on chemical substances, [2004] OJ L50/44.
34. Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC, [1991] OJ L76/35. This Directive was last amended by Commission Directive 2001/58/EC amending for the second time Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC, [2001] OJ L212/24.
35. See Common Position on REACH, n. 18 above, Article 33.
36. Ibid., Title VI, Chapter 2.
37. Ibid., Title VI, Chapter 3.
38. Ibid., Article 51.
39. The criteria are set out in ibid., Annex VI and in Directive 67/548/ EEC, n. 1 above.
40. The criteria are set out in Common Position on REACH, n. 18 above, Annex XII.
41. The guidance will be available before this element of REACH enters into force (probably in early 2008).
42. See Common Position on REACH, n. 18 above, Article 58.
43. Ibid., Article 57(2).
44. Ibid., Article 61.
45. Ibid., Article 59.
46. Ibid., Article 59(3).
47. Ibid., Article 63.
48. Ibid., Article 60.
49. Ibid., Article 65.
50. Ibid., Article 59(10).
51. Ibid., Article 66.
52. Ibid., Article 68.
53. Ibid., Articles 69-72.
54. Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC, [2004] OJ L158/7.
55. Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC, [2003] OJ L275/32.
56. See D. Roe, 'A National Proposition', 3:3 Economic Development Quarterly (August 1989), 179, at 179.
57. Safe Drinking Water and Toxic Enforcement Act of 1986, Assembly Bill 1756 (Committee on Budget), Chapter 228, Statutes of 2003, available at "http://www.oehha.ca.gov/prop65/law/pdf_zip/P65LAW72003.pdf".
58. See P. Cerin and L. Karlson, 'Business Incentives for Sustainability: A Property Rights Approach', 40:1 Ecological Economics (January 2002), 13.
59. See Common Position on REACH, n. 18 above, Recital 7.
60. REACH significantly lowers the requirements for new substances compared to today. Directive 67/548/EEC, n. 1 above, requires information on new substances to be submitted if the substance placed on the market in quantities of 10 kg or more. REACH will only require information to be registered if the substance is manufactured or imported at 1 tonne or more. The information requirements at 1 tonne today are equivalent to what is required at tonnes under REACH. Compare Directive 67/548/EEC, ibid., Annex VII.A with Common Position on REACH, n. 18 above, Annex VIII.
61. Manufacturers, importers, producers of articles can apply for a 5-year exemption from REACH, extendable to 10 years, for the purposes of product and process-oriented research and development (PPORD). PPORD means any scientific research related to product development, on a substance, on its own, in preparations or in articles, where a pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance. Downstream users undertaking PPORD are exempted from carrying out a chemical safety assessment, if their use is not covered by their supplier
62. see Common Position on REACH, ibid., Article 36(4)(f).