Reflecting on REACH: Global Implications of the European Union's chemicals regulation

Nanotechnology Law and Business

Volumn 4, Issue 3, 2007, Pages 375-383

  Bowman, Diana ^a,b   Van Calster, Geert ^a,c,d  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b MONASH UNIVERSITY   (Australia)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d Brussels Bar of Counsel ^*

Author keywords

[No Author keywords available]

Indexed keywords

ACCIDENT PREVENTION; PRODUCT DEVELOPMENT; REGULATORY COMPLIANCE;

CHEMICAL SUBSTANCES; EUROPEAN UNION; GLOBAL IMPLICATIONS; NANOSCALE SUBSTANCES;

NANOSTRUCTURED MATERIALS;

EID: 34548048793     PISSN: 15462080     EISSN: 15462080     Source Type: Journal    
DOI: None     Document Type: Article

References (62)

1. Press Release, European Commission, REACH: Commission Welcomes European Parliament Vote on New EU Chemicals Legislation (Dec. 13, 2006) (IP/06/1799)
2. Commission Regulation 1907/2006, 2006 O.J. (L396/1), art. 141(1) [hereinafter " REACH Regulation"].
3. REACH Regulation, art. 139.
4. The new regulatory regime will not apply to a range of applications or preparations in their finished state which are regulated under a range of Regulations and Directives including for example, radioactive substances, non-isolated intermediates, the carriage of dangerous substances, waste, medicinal products for human or veterinary use, food or feedingstuffs (including food additives, flavorings, animal nutrition), and cosmetic products. See REACH Regulation, art. 2.
5. Henrik Selin & Stacy VanDeveer, Raising Global Standards, 48 ENV'T 6, 8-15 (2006), available with subscription at http://www.heldref.org/env.php (last visited July 17, 2007)
6. (in particular, using a concept coined by DAVID VOGEL, TRADING UP: CONSUMER AND ENVIRONMENTAL REGULATION IN A GLOBAL ECONOMY (1997)).
7. For discussion of an issue first raised by CEFIC, the E.U.'s foremost industry pressure group on chemicals, see Proposed New Chemicals Legislation and International Trade/WTO, CEFIC COMMENTS (July 8, 2003), available at www.cefic.be (last July 17, 2007).
8. Geert van Calster, Regulating Nanotechnology in the European Union, 3 NANOTECH. L. & BUS. 359, 364 (2006).
9. Council Regulation 793/93, Evaluation and Control of the Risks of Existing, 1993 O.J. (L84/1).
10. Eur. Chem. Bur., ESIS-European Chemical Substances Information System: EINECS Information System, http://ecb.jrc.it/esis/index.php?PGM-ein (last visited July 17, 2007).
11. See id.
12. See Council Directive 67/548/EEC (June 27, 1967) on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances (the Directive on Dangerous Substances), as amended.
13. See in particular the sixth amendment to the Directive (Council Directive 79/831/EEC (Sept. 18, 1979)) and the seventh amendment to the Directive (Council Directive 92/32/EEC (Apr. 30, 1992)).
14. It is important to note that as the volume of chemical substance per year per manufacturer increases, so, too, do the testing requirements.
15. This is equivalent to 22.046 pounds.
16. Under the Existing Substances Regulation, the "Commission, in consultation with Member States, shall regularly draw up lists of priority substances or groups of substances (hereinafter referred to as priority lists) requiring immediate attention because of their potential effects on man or the environment." Council Regulation (EEC) 793/93, art. 8(1), 1993 O.J. (L 84), available at http://ec.europa.eu/environment/chemicals/exist_subst/pdf/ 793_93_ec.pdf (last visited July 17, 2007).
17. A substance that is deemed to be a "priority substance" must undergo in-depth human and environmental risk assessments in accordance with Commission Regulation (EC) 1488/94, 1994 O.J. (L 161), available at http://ecb.jrc.it/legislation/1994R1488EC.pdf (last visited July 17, 2007). To date, four priority lists consisting of 141 chemical substances have been adopted under the Existing Substances Regulation.
18. See note 9, supra (Database containing ORATS available online).
19. Commission White Paper on Strategy for a Future Chemicals Policy, COM (2001) 88 final (Feb. 27, 2001), available at http://eur-lex.europa. eu/LexUriServ/site/en/com/2001/com2001_0088en01.pdf (last visited July 17, 2007).
20. Id. at 16-27.
21. REACH Regulation, art. 1(1) (entitled, "Aim and scope").
22. REACH Regulation, art. 5 (entitled, "No data, no market").
23. REACH Regulation, art. 6 (entitled, "General obligation to register substances on their own or in preparations").
24. REACH Regulation, art. 7 (entitled, "Registration and notification of substances in articles"). In addition to this mass requirement, a second condition must be met to require a producer or importer to submit a registration. Article 7(b) also requires that the "substance is intended to be released under normal or reasonably foreseeable conditions of use."
25. REACH Regulation, art. 10 (entitled, "Information to be submitted for general registration purposes");
26. See also REACH Regulation, art. 12 (entitled "Information to be submitted depending on tonnage in relation to the provision of physicochemical, toxicological and ecotoxicological information").
27. A chemical safety report will be required where the tonnage exceeds ten tonnes per year. See REACH Regulation, art. 10(b), 14.
28. It is important to note that the testing requirements vary according to four tonnage trances, specifically substances registered in quantities of one tonne or more, ten tonnes or more, one hundred tonnes or more, and one thousand tonnes or more.
29. See note 1, supra.
30. ROYAL SOC'Y & ROYAL ACADEMY OF ENG'G, NANOSCIENCE AND NANOTECHNOLOGIES: OPPORTUNITIES AND UNCERTAINTIES (2004).
31. Press Release, Friends of the Earth Europe, REACH and Nanotechnology-Briefing (Oct. 5, 2006), at 1 (emphasis added).
32. These proposed Amendments included the following: 87, 115, 158, 160, 217, 228, 325 and 333.
33. SCENIHR, OPINION ON THE APPROPRIATENESS OF EXISTING METHODOLOGIES TO ASSESS THE POTENTIAL RISKS ASSOCIATED WITH ENGINEERED AND ADVENTITIOUS PRODUCTS OF NANOTECHNOLOGIES (Rep. No. 002/005, 2006), http://ec.europa.eu/health/ph_risk/committees/ 04_scenihr/docs/scenihr_o_003b.pdf (last visited July 17, 2007).
34. See id., art 81 (discussing Justification-Amendment 333) (emphasis added).
35. European Parliament, Recommendation for Second Reading, Oct. 13, 2006, Amendments 24, 56, 79, 87, 161 and 165.
36. REACH Regulation, art. 5.
37. Id., art. 3.
38. Note that under Article 7(b) of the REACH Regulation, the producer or importer will only be required to register the substance if the substance is intended to be released under normal or reasonably foreseeable conditions of use.
39. See note 25, supra.
40. EUR. ENVTL. BUREAU, REACH: ENVIRONMENTAL ISSUES FOR THE SECOND READING 10 (EEB Pub. No. 2006/007, 2006), http://www.eeb.org/activities/chemicals/ Publication-REACH-EEB-016-06.pdf (last visited July 17, 2007).
41. QASIM CHAUDHRY, JAMES BLACKBURN, PETER FLOYD, CAROLYN GEORGE, TOBE NWAOGU, ALISTAIR BOXALL & ROBERT AITKEN, FINAL REPORT: A SCOPING STUDY TO IDENTIFY GAPS IN ENVIRONMENTAL REGULATION FOR THE PRODUCTS AND APPLICATIONS OF NANOTECHNOLOGIES (2006), http://www.defra.gov.uk/science/project_data/ DocumentLibrary/CB01075/CB01075_3373_FRP.doc (last visited July 17, 2007).
42. Diana Bowman & Graeme Hodge, A Small Matter of Regulation: An International Review of Nanotechnology Regulation, 8 COLUM. SCI. & TECH. L. REV. 1 (2007).
43. See e.g., Chiu-wing Lam, John James, Richard McClusky, Sivaram Arepalli & Robert Hunter , A Review of Carbon Nanotube Toxicity and Assessment of Potential Occupational and Environmental Risks, 36 CRITICAL REVIEWS IN TOXICOLOGY 189 (2006);
44. Anna Shvedova, Vincent Castranova, Elena Kisin, Diane Schwegler-Berry, Ashley Murray, Vadim Gandelsman, Andrew Maynard & Paul Baron, Exposure to Carbon Nanotube Material-Assessment of Nanotube Cytotoxicity Using Human Keratinocyte Cells, 66 J. OF TOXICOLOGY & ENVTL. HEALTH 1909 (2003).
45. REACH Regulation, art. 5.
46. See note 28, supra.
47. Id. at 54.
48. The CAS Numbers for fullerenes / buckyballs are: 115383-22-7 (C60) and 7782-42-5 (C70).
49. See note 28, supra.
50. European Chemical Industry Council ("CEFIC"), Profile of the Chemical Industry: Facts and Figures, available at http://www.cefic.be/ activities/eco/ff99/01.htm (last visited July 17, 2007). CEFIC estimates that in 2005, global chemical sales amounted to €1476 billion.
51. Id. at 2.
52. Article 1(3) of the REACH Regulation states the following: "[t]his Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.'" The Regulation itself does not provide a definition of the precautionary principle, nor how it may be implemented. The principle is part of the general principles of the E.U.'s environmental policy, as set out in Article 174 of the E.C. Treaty, and the European Commission has issued a Communication on how it sees the implementation of the principle: see Commission Communication on the Precautionary Principle, at 1, COM (2000) 1, Bulletin E.C. 2000/1/-2, 1.4.60, available at http://europa.eu/bulletin/en/200001/p104060.htm (last visited July 17, 2007).
53. See Thomas Daemen, The EC's Evolving Precautionary Principle-Comparisons with the United States Ramifications for Doha Round Trade Negotiations, 12 EUR. ENVTL. L. REV. 6, 16 (2003).
54. See e.g., Damien Geradin, The Development of European Regulatory Agencies: What the E. U. Should Learn from American Experience, 11 COLUM. J. OF EUR. L. (2005).
55. See e.g., Int'l Ctr. for Tech. Assessment, Citizen Petition to the United States Food and Drug Administration (May 16, 2007);
56. MICHAEL R TAYLOR, REGULATING THE PRODUCTS OF NANOTECHNOLOGY: DOES FDA HAVE THE TOOLS IT NEEDS? (2006), available at http://www.nanotechproject. org/file_download/110 (last visited July 17, 2007);
57. George Kimbrell, Nanomaterial Consumer Products and FDA Regulation: Regulatory Challenges and Necessary Amendments, 3 NANOTECH. L. & BUS. 329 (2006).
58. Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH), Establishing a European Chemicals Agency and Amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants} - Extended Impact Assessment, (SEC 1171/3) (2003).
59. E.C., ENTERPRISE & INDUS. DIRECTORATE GENERAL, REACH IN BRIEF (2006), available at http://ec.europa.eu/enterprise/reach/docs/reach/ reach_in_brief_council_comm_pos_060905.pdf (last visited July 17, 2007).
60. See note 5, supra.
61. See note 28, supra, at 47.
62. See note 35, supra, at 4.