The long arm of REACH: How to navigate through the compliance process

European Energy and Environmental Law Review

Volumn 18, Issue 1, 2009, Pages 34-50

  Forbes, Reshad ^a  

^a Van Bael and Bellis   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

COMPLIANCE; ENVIRONMENTAL LEGISLATION; EUROPEAN UNION; POLICY IMPLEMENTATION; REGULATORY FRAMEWORK; WORLD TRADE ORGANIZATION;

EID: 66649126078     PISSN: 18793886     EISSN: 25890387     Source Type: Journal    
DOI: 10.54648/eelr2009003     Document Type: Article

References (75)

1. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
2. OJ 30.12.2006 L396/1.
3. The REACH Regulation, Art. 6(1).
4. The REACH Regulation, Art. 23
5. The REACH Regulation, Art. 28.
6. The REACH Regulation, Art. 8.
7. OJ 29.6.1996 L159/1.
8. The REACH Regulation, Art. 3(15)(a).
9. Ibid.
10. Ibid.
11. Art. 1(1)(a) and Annex I of European Parliament and Council Directive 2006/12/EC of 5 April 2006 on waste, OJ 24.4.2006 L114/9.
12. Art. 1(2) of European Parliament and Council Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products, OJ 28.11.2001 L311/1, and Art. 1(2) of the European Parliament and Council Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use.
13. European Parliament and Council Regulation No 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ 1.2.2002 L31/1.
14. Art. 1(1) of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
15. An on-site isolated intermediate is "an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities" (the REACH Regulation, Art. 3(15)(b))
16. A transported isolated intermediate is "an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites".
17. The REACH Regulation, Art. 3(5).
18. European Parliament and Council Directive 98/8/EC of 16 February 1998 concerning the placing of biocidal products on the market, OJ 24.4.1998 L123/1.
19. "An active substance in the context of biocides is a substance of micro-organism including a virus or a fungus having general or specific action on or against harmful organisms. A biocidal product may be composed of only one active substance, without co-formulants, or it may be a preparation including one or more active substances" (ECHA, Guidance on registration, May 2008, p. 42).
20. Commission Regulation 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Art. 16(2) of Directive 98/ 8/EC of the European Parliament and Council of 16 February concerning the placing of biocidal products on the market, OJ 11.12.2008 L325/3. This Regulation replaces the Regulation 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Art. 16(2) of Directive 98/8/EC of the European Parliament and Council of 16 February concerning the placing of biocidal products on the market, OJ 24.11.2003 L307/1.
21. "A co-formulant in the context of plant protection products is a non-active substance in a plant protection product which is a preparation" (ECHA, Guidance on registration, May 2008, p. 44).
22. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, OJ 19.8.1991 L230/1.
23. Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Art. 8(2) of Council Directive 91/414/ EEC concerning the placing pf plant protection products on the market (OJ 13.10.2000 L259/27).
24. Commission Regulation (EC) No703/2001 of 6 April 2001 laying down the active substances of plant protection products to be assessed in the second stage of the work programme referred to in Art. 8(2) of Council Directive 91/414/EC and revising the list of Member States designated as rapporteurs for those substances, OJ 7.4.2001 L98/6.
25. Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Art. 8(2) of Council Directive 91/414/ EEC, OJ 8.10.2004 L311/23.
26. Commission Decision 2003/365/EC of 25 July 2003 extending the time period provided for in Art. 8(2) of Council Directive 91/414/EEC (OJ 31.7.2003 L192/40).
27. Council Directive 67/548/EEC of 6 November 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ 16.8.1967 L196/1.
28. European Parliament and Council Directive 1999/45/EC of 31 May 1999 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous substances, OJ 30.7.1999 L200/1.
29. "(...) in an individual concentration of ≥1% by weight for non-gaseous preparations and ≥0.2% by volume for gaseous preparations" (Art. 31(3)(a)).
30. "(...) in an individual concentration of ≥0.1% by weight for non-gaseous preparations" (Art. 31(3)(a)).
31. An exposure scenario is "the set of conditions (...) that describe how the substance how the substance is manufactures or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment" (Art. 3(37)).
32. ECHA guidance on requirements for substances in articles, May 2008, sections 2.3 and 8.1.
33. In this case, however, the downstream user is still under an obligation to "consider the use(s) of the substance and identify and apply any appropriate risk management measures needed to ensure that the risks to human health and the environment are adequately controlled. Where necessary, this information shall be included in any safety data sheet prepared by him" (Art. 37(6)).
34. The REACH Regulation, Art. 3(3).
35. ECHA Guidance on requirements for substances in articles, May 2008.
36. The REACH Regulation, Art. 7(1).
37. The REACH Regulation, Art. 7(2).
38. ECHA guidance on requirements for substances in articles, May 2008, section 3.3.
39. ECHA Frequently Asked Questions on REACH by Industry, Version 2.3, November 2008, section 8.5.
40. ECHA Frequently Asked Questions on REACH by Industry, Version 2.3, November 2008, section 8.5.
41. ECHA guidance on requirements for substances in articles, May 2008, Appendices 2 and 3.
42. ECHA guidance on requirements for substances in articles, May 2008, Appendix 2.
43. ECHA press release ECHA/PR/08/34 of 9 October 2008 "ECHA Member State committee agrees on the identification of 14 substances of very high concern".
44. ECHA guidance on requirements for substances in articles, May 2008, sections 5.2 and 8.2.
45. The Reach Regulation, Art. 10.
46. The REACH Regulation, recital 54.
47. The Reach Regulation, Art. 29(2).
48. ECHA Guidance on Substance Identification and Naming of Substances under REACH (2007).
49. The REACH Regulation, Art. 11(1).
50. ECHA Guidance on data sharing, p. 38.
51. The REACH Regulation, Art. 29(3).
52. ECHA Guidance on Data Sharing (2007), p. 47.
53. ECHA Guidance on Data Sharing (2007), p. 49.
54. The Reach Regulation, Art. 30.
55. ECHA Guidance on Data Sharing (2007), p. 52.
56. The REACH Regulation, Art. 29(3).
57. It should also be noted that the competition law of any number of non-EU jurisdictions may also be applicable insofar as any actions taken have effects in those jurisdictions.
58. This article will not discuss other forms of competition law, namely state aid law and merger control.
59. Bayer v. Commission, [2000] ECR II-3383, para. 69.
60. See, e.g., Commission and Others v. Bayer AG, [2004] ECR I-23, paras 101-102.
61. See, e.g., Vereniging van Cementhandelaren v. Commission, [1972] ECR 977.
62. ICI v. Commission, [1972] ECR 619, para. 66.
63. United Brands v. Commission, [1978] ECR 207, para. 65.
64. France and others v. Commission, [1998] ECR I-1375, para. 221.
65. Hoffmann-La Roche v. Commission, [1979] ECR 461, para. 91.
66. REACH issues have now been discussed in as many as 18 meetings of the TBT Committee, see the WTO TBT website at http://www.wto.org/english/ news_e/news08_e/tbt_6no-v08_e.htm (accessed December 18, 2008).
67. See, e.g., the comments submitted by the representative of the United States in the context of recent meetings held in the TBT Committee (March and July 2008).
68. See the comments submitted by the representative of the European Communities in the context of the March 2008 meeting of the TBT Committee in: WTO Committee on Technical Barriers to Trade, Minutes of the Meeting of 20 March 2008, G/TBT/M/44, June 10, 2008, para. 41.
69. In the EC-Asbestos case, the Appellate Body clarified that the products concerned need not be named or otherwise expressly identified in a "technical regulation"; instead, it suffices that a "technical regulation" targets an identifiable product, or group of products. See Report of the Appellate Body, European Communities - Measures Affecting Asbestos and Asbestos-Containing Products, WT/DS135/AB/R, para.
70. In that case, the Appellate Body reached the conclusion that a French decree imposing a prohibition on asbestos fibres constituted a "technical regulation" within the meaning of the TBT Agreement.
71. See REACH Regulation, recitals (1), (3), (4), (7), (9), (70), (71), (73), (87) together with Art. 1 setting out the underlying objective: "The purpose of this Regulation is to ensure a high level of protection of human health and the environment...". Art. 1.3 explicitly states that the provisions of REACH are "underpinned by the precautionary principle".
72. The Appellate Body has ruled that WTO Members are free to determine the level of protection of health and the environment they consider appropriate and that other Members may only challenge the "necessity" of such a measure to achieve the desired level of protection. See Report of the Appellate Body in EC-Asbestos, supra, para. 168.
73. In simple terms, the less restrictive the impact of the measure in question is on international trade, the more easily the measure may be considered to be "necessary".
74. "Conformity assessment procedures" are defined in Annex 1.3 to the TBT Agreement as "any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled".
75. For instance, the Appellate Body has consistently held that in justifying a measure under Art. XX(b) of the GATT or on the basis of the SPS Agreement, a WTO Member is not required to solely rely on the "preponderant" scientific evidence or the majority scientific opinion available at a given time but, may equally premise its regulatory choices on a "divergent, but qualified and respected, opinion". See in this respect, EC-Asbestos, supra, para. 178.