1 Reach itself amends Directive 1999/45/EC and repeals Council Regulation (EEC) No 793/93 and Commission Regulation 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 European Parliament, Committee on the Environment, Public Health and Food Safety, Report on regulatory aspects of nanomaterials, 7 April 2009, (2008/2208(INI)), A6-0255/2009.

3 According to the European Commission, the word “nanotechnology” refers to science and technology at the nano-scale of atoms and molecules, and to the scientific principles and new properties that can be understood and mastered when operating in this domain. Such properties can then be observed and exploited at the micro- or macro-scale, for example, for the development of materials and devices with novel functions and performance”. European Commission, Communication, Towards a European Strategy for Nanotechnology, COM (2004) 338 final, at p. 4.

4 The National Nanotechnology Initiative in the United States defined nanotechnology as “the understanding and control of matter at dimensions of roughly 1 to 100 nanometres, where unique phenomena enable novel applications.” See Breggin, Falkner, Jaspers, Pendergrass and Porter, Securing the promises of Nanotechnologies Towards Transatlantic Regulatory Cooperation, September 2009, p. 10.

5 Helmut Kaiser Consultancy, Study: Nanotechnology in Food and Food Processing Industry Worldwide, 2004, at p. 1. Available on the Internet at http://www.hkc22.com/nanofood.html (last accessed on 15 February 2010).

6 See also European Economic and Social Committee, Opinion on the Communication Towards a European Strategy for Nanotechnology: “Taken as a whole, data on turnover suggest an increase from the current EUR 50 billion to approximately EUR 350 billion in 2010, reaching EUR 1,000 billion in 2015”, 28 June 2005, (COM (2004) 338 final), (2005/C 157/03).

7 Scenihr adopted this opinion at its 28th plenary, 19 January 2009.

8 Ibid, p. 10.

9 Reach, Article 1.

10 Phase-in substances are defined in Article 3.20 of Reach and cover mainly substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) which have been placed on the market in the EU before 1981 and reported to the European Commission at that time.

11 An “article” is defined under Reach as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition”, Reach, Article 3.3.

12 Regulation 1272/2008 of 16 December 2008 on classification, labelling and packaging of substances and mixtures, the amending and repealing Directives 67/548/EEC and 1999/45/EC, and the amending Regulation 1907/2006 (the CLP).

13 http://echa.europa.eu/reach_en.asp.

14 Reach, Article 3.1.

15 European Commission, Communication on regulatory aspects of nanomaterials, Brussels, 17 June 2008, COM (2008) 366 final.

16 PBT stands for “very persistent, bio-accumulative and toxic” while “vPvB” stands for very persistent and very bio-accumulative”.

17 In the conditions specified in Article 57.f of the Reach Regulation. See infra.

18 European Commission, Communication on regulatory aspects of nanomaterials. See supra note 15.

19 Ibid.

20 See above footnote 15, p. 10.

21 Reach, Article 5.

22 See footnote 10 above.

23 European Commission, “Nanomaterials in Reach”, Follow up to the 6^th Meeting of the Reach Competent Authorities for the Implementation of Regulation, 16 December 2008, CA/59/2008 rev.1, p. 7.

24 See European Commission document for the 4^th meeting of Reach Competent Authorities Subgroup on Nanomaterials of 9 December 2009, CASG Nano/05/2008, rev. 3, at p. 7.

25 European Commission, Nanomaterials in Reach, Follow up to the 6^th Meeting of the Reach Competent Authorities for the Implementation of Regulation, 16 December 2008, CA/59/2008 rev. 1, p. 6.

26 Ibid, rev. 1, p. 11.

27 Scientific Committee on emerging and newly identified health risks, modified Opinion on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies, adopted on 10 March 2006 and “Opinion on the appropriateness of the risk assessment methodology in accordance with the technical guidance documents for new and existing substances for assessing the risks of nanomaterials”, adopted on 29 March 2007.

28 See European Commission, document prepared for the 4^th meeting of Reach Competent Authorities Subgroup on Nanomaterials of 9 December 2009, CASG Nano/05/2008, rev. 3, OECD declaration at page 4

29 European Commission, Communication Towards a European strategy for nanotechnology, Brussels, 12 May 2004, COM(2004) 338 final.

30 European Commission Communication to the Council, the European Parliament and the Economic and Social Committee, Nanosciences and nanotechnologies: An action plan for Europe 2005–2009, Brussels, 7 June 2005, COM(2005) 243 final.

31 European Commission Communication to the Council, the European Parliament and the European Economic and Social Committee, Nanosciences and Nanotechnologies: An action plan for Europe 2005–2009. First Implementation Report 2005–2007, Brussels, 6 September 2007, COM(2007) 505 final and Nanosciences and Nanotechnologies: An action plan for Europe 2005–2009. Second Implementation Report 2007–2009, ﹛SEC(2009)1468﹜.

32 European Commission, Recommendation on a code of conduct for responsible nanosciences and nanotechnologies research, Brussels, 7 February 2008, (2008) 424 final.

33 4^th Meeting of the Competent Authorities Subgroup on Nanomaterials, RIP-No 1 on Substance Identification, Progress Report, CASG Nano/25/2009, Ispra, 23 November 2009.

34 European Commission, Towards a strategic nanotechnology action plan (SNAP) 2010–2015, Public Consultation see http://ec.europa.eu/research/consultations/snap/consultation_en.htm.

35 See footnote 15 above

36 Dimas, Stavros (then European Commissioner for the environment), Speech Nanotechnologies … challenges for the future, Stakeholder Conference on Nanomaterials on the market, Brussels, 9 October 2009, Speech/09/460.

37 Ibid.

38 Dimas, Stavros (European Commissioner for the environment), “The Commission has not made up its mind on how precisely to get the information needed”, Speech Nanotechnologies … challenges for the future, Stakeholder Conference on Nanomaterials on the market, Brussels, 9 October 2009, Speech/09/460.

39 Mayer Brown, Brussels Client Alert: France might take the lead on nanotechnology regulation, 5 March 2009.

40 French Parliament, Loi n° 2009–967 du 3 août 2009 de programmation relative à la mise en œuvre du Grenelle de l’environnement, JORF n° 0179 du 5 août 2009, p. 13031.

41 Ibid, Non-official translation.

42 Ibid, Non-official translation.

43 Amendments are also proposed to the French “Public Health Code” and the “Rural Code” to the effect that the rules contained in the Environmental Code relating to nanoparticle substances also apply to the use of such substances as components in medicinal products for human or veterinary use and cosmetics covered by the Public Health Code, and as components in phytopharmaceutical products (preparations and products containing genetically modified organisms for use on plants) covered by the Rural Code.

44 See, Case C-5/94 Hedley Lomas [1996] ECR I-2553, paragraph 18.

45 European Commission, White paper on a Strategy for a future Chemicals Policy, 2 February 2001, COM (2001) 88 final.

46 Ibid, p. 8–9.

47 Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ No 196 of 16 August 1967, which was based on the then applicable Article 100a of the EC Treaty.

48 Reach, Article 128.1.

49 Reach, Article 128.2. Article 128.2 did not exist in the original European Commission Proposal but was added by the European Council (European Council Common position of 12 June 2006).

50 Oral questions during the hearing of the Commissioner designate for Environment. See, for instance, EU Food Law, 15 January 2010, issue 421.

51 Senat, Rapport législatif, Projet de loi portant engagement national pour l'environnement “Dans ce contexte, il est apparu nécessaire de créer une obligation de déclaration pour les fabricants et les importateurs, au plan national comme le permet l’article 128.2 du règlement Reach”, available on the Internet at http:///www.senat.fr/rap/l08-552-1/l08-552-1103.html.

52 Non-official translation.

53 Ibid.

54 In this opinion, the Scenihr indicated that “current risk assessment methodologies require some modification in order to deal with the hazards associated with nanotechnology and in particular that existing toxicological and ecotoxicological methods may not be sufficient to address all of the issues arising with nanoparticles”, Scientific Committee on emerging and newly identified health risks modified Opinion (after public consultation) on The appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, adopted during the 10th plenary meeting of 10 March 2006 after public consultation.

55 European Parliament, Committee on the Environment, Public Health and Food Safety, Amendment 24, Article 57, paragraph 3, point (B A) (new), Recommendation for second reading on the Council common position for adopting a regulation of Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing a European Chemicals Agency, amending Directive 1999/45/EC of the European Parliament and of the Council and repealing Council Regulation (EEC) No 793/93 and Commission Regulation 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” (7524/8/2006 – C6-0267/2006 – 2003/0256(COD)), Final A6-0352/2006,13 October 2006.

56 Bowman, and Calster, , “Reflecting on Reach: Global implications of the European Union's Chemical Regulation”, Nanotechnology Law and Business, 4, pp. 375–384 Google Scholar.

57 European Parliament, Amendment 87, Article 57, Paragraph 3, Point (B A) (new), Recommendation for second reading, supra note 55, Committee on the Environment, Public Health and Food Safety.

58 European Commission, Nanomaterials in Reach, Follow up to the 6^th Meeting of the REACH Competent Authorities for the Implementation of Regulation, supra note 25.

59 Council of the European Union, Working Document 29/04, 26 April 2004 on the Swedish note containing questions to the Council legal Service concerning Article 125 and attached note from the Swedish Ministry of the Environment dated 21 April 2004.

60 Now Articles 114 (4) to (6) of the TFEU.

61 Now Article 129 of Reach.

62 European Commission Communication to the Council dated 2 December 2005, Working Document 324/05.

63 European Commission Communication to the European Parliament pursuant to the second subparagraph of Article 251(2) of the EC Treaty Commission Statement on free movement (Article 125(2)), Brussels, 12 July 2006, COM(2006)375 final.

64 Reach, Article 57.f.

65 Reach, Article 69.4.

66 Reach, Article 129.1.

67 Ibid.

68 Reach, Article 129.2 and 3.

69 The precautionary principle is expressly contained in Article 191 of the TFEU (ex Article 174 of the Treaty Establishing the European Community). Reach is also based on this principle as stated in its Article 1.3. It is also one of the stated policy reasoning behind the French Grenelle proposals on nanomaterials.

70 The precautionary principle is also one of the justification of the French Grenelle proposals on nanomaterials.

71 See European Commission, Communication on the precautionary principle, COM(2000)1, 2 February 2000, p. 14.

72 Case C-236/01, Monsanto Agricultira Italia SpA and Others v Presidenza del Consiglio dei Ministri and Others.

73 Op. cit. at No 110.

74 See supra note 72.