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Regulation of Nanomaterials in the EU: Proposed Measures to Fill in the Gap

Published online by Cambridge University Press:  20 January 2017

David Azoulay  and
Vito Buonsante
David Azoulay
Affiliation:
Center for International Environmental Law (Geneva)
Vito Buonsante
Affiliation:
ClientEarth (Brussels)
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Abstract

This report discusses a proposal fromthe Center for International Environmental Law(CIEL), ClientEarth and Friends of the Earth Germany (Bund) on the regulation of nanomaterials in the European Union. It discusses in particular, the proposal for a horizontal regulation on nanomaterials (also referred to as a nano-patch for existing legislation) that would fill in the regulatory gap on nanomaterials. The proposal goes beyond a review of the REACH text and encompasses all EU legislation relevant to nanomaterials. The proposed instrument would amend the REACH text with delimitation in scope to all areas relevant to nanomaterials (on the model of Regulation 1272/2008 on the classification, labelling and packaging of chemicals). The main aim of the regulation is to ensure that hazard, risk and exposure assessments for all forms and uses of such materials are adequately carried out and taken into consideration.

Type
Reports
Information
European Journal of Risk Regulation , Volume 5 , Issue 2 , June 2014 , pp. 228 - 235
Copyright
Copyright © Cambridge University Press 2014

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References

1 Buonsante Azoulay, “High time to act on nanomaterials: A proposal for a ‘nano patch’ for EU Regulation,” 2012 commissioned by Bund für Umwelt und Naturschutz Deutschland.

2 Regulation (EC) No 1272/2008, OJ L 353, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ 2006 L 396/1.

3 Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Regulatory Aspects of Nanomaterials, COM (2008) 366 final.

4 Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Second Regulatory Review on Nanomaterials, COM (2012) 572 final.

5 See Commission Staff Working Paper, “Types and uses of nanomaterials, including safety aspects,” accompanying the Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the Second Regulatory Review on Nanomaterials, SWD (2012) 288 final, at p. 26.

6 Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals, OJ 2006 L 396.

7 Council Directive 89/391/EEC, OJ 1989 L 183/1.

8 Council Directive 2008/1/EC concerning integrated pollution prevention and control, OJ 2008 L 24/8.

9 Directive 2010/75/EU on industrial emissions (integrated pollution prevention and control), OJ 2010 L 334/17.

10 Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances, OJ 2012 L 197/1.

11 Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for the Community Action in the field of water policy, OJ 2010 L 237/1.

12 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste, OJ 2008 L 312/3.

13 Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions in accordance with Article 117(4) of REACH and Article 46(2) of CLP, and a review of certain elements of REACH in line with Articles 75(2), 138(2), 138(3), and 138(6) of REACH, COM (2013) 49 final, at p. 13.

14 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012, concerning the making available on the market and use of biocidal products, OJ 2012 L 167/1, Article 19(1)(e).

15 “The scope of registered dossiers (i.e., whether and how many nanoforms are included) is currently often unclear and the level of nano-specific information provided (i.e., substance characterisation, hazards, exposure and risks) shows significant room for improvement.” ECHA, Evaluation under REACH 2012. Available on the Internet at <http://echa.europa.eu/documents/10162/13628/evaluation_report_2012_en.pdf>.

16 See David Azoulay, “Just out of REACH,” 2012; Milieu Ltd. and RPA Ltd., “Information from Industry on Applied Nanomaterials and their Safety: Final Report Proposal for an EU Reporting System for Nanomaterials”; European Parliament Resolution of 24 April 2009 on regulatory aspects of nanomaterials (2008/2208(INI)).

17 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, OJ 1967 L 196/1.

18 Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations OJ 1999 L 200.

19 REACH, supra note 6, recital 4.

20 See, for example, Nanowerk's Nanomaterials Database (of commercially available nanomaterials) available on the Internet at <http://www.nanowerk.com/phpscripts/n_dbsearch.php>; the Friends of the Earth Germany (BUND) nanoproduct database, available on the Internet at <http://www.nanowatch.de>; and the Danish Consumer Council and Technical University of Denmark database, available on the Internet at <http://www.nanotech-now.com/redir.cgi?dest=http%3A//nano.taenk.dk/welcome-to-the-database>.

21 A list of these can be found in section 6.1 of the Staff Working Paper accompanying the second regulatory review, available on the Internet at <http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0288:FIN:EN:PDF>.

22 However, labelling is foreseen for certain categories of products.

23 Éléments issus des déclarations des substances à l’état nanoparticulaire, RAPPORT d’étude, November 2013, which provides a detailed report on the first experience from the French nano register, available on the Internet at <http://www.developpement-durable.gouv.fr/IMG/pdf/Rapport_public_format_final_20131125.pdf>.

24 See, for example: “Novel Material in the Environment: The Case of Nanotechnology,” UK Royal Commission on Environmental Pollution, November 2008, at p. 13, available on the Internet at <http://www.rcep.org.uk/novel%20materials/Novel%20materials%20summary.pdf>.

25 See Nano Support Project (Ref. Ares (2012) 314828 - 16/03/2012), in which a detailed analysis of 45 dossiers likely to include information on nanomaterials was performed by the JRC in cooperation with the ECHA staff.

26 See Article 2 of REACH.

27 Article 36 of REACH imposes on registrants the duty to gather and provide on request ‘all the information the registrant requires to carry out his duties under this Regulation'.

28 Commission Implementing Regulation (EU) No 408/2014 of 23 April 2014 approving synthetic amorphous silicon dioxide as an existing active substance for use in biocidal products for producttype 18, OJ 2014 L 121/17.

29 NANO SUPPORT Project Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information (Contract AA N° 07.0307/2010/581080/AA/D3).

30 REACH, Title II, Articles 5- 24.

31 Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, O.J. 2012 L 167/1.

32 Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial. O.J.2012 L 275/38, 2011.

33 The Biocides Directive was revised in May 2012 and includes specific provisions for nanomaterials, including a separate risk assessment for nanomaterials containing biocides. These provisions entered into force on 1 September 2013.

34 European Inventory of Existing Commercial chemical Substances, an inventory of substances that were deemed to be on the European Community market between 1 January 1971 and 18 September 1981. EINECS was drawn up by the European Commission in the application of Article 13 of Directive 67/548/EEC, as amended by Directive 79/831/EEC, and in accordance with the detailed provisions of Commission Decision 81/437/EEC.

35 REACH Article 3(20), phase-in substance: means a substance which meets at least one of the following criteria:

(a) it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);

(b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this;

(c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, by the manufacturer or importer before the entry into force of this Regulation, and it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC in the version of Article 8(1) resulting from the amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this, including proof that the substance was placed on the market by any manufacturer or importer between 18 September 1981 and 31 October 1993 inclusive.

36 See Article 12 and Annex III of REACH.

37 See “Exposure to nanomaterials in Germany, Results of the corporate survey of the Federal Institute for Health and Safety (BAuA) and the Association of the Chemicals Industry (VCI) using questionnaires,” Federal Institute for Health and Safety (BAuA), 24.04.2008, at p. 1.

38 Directive 92/32/EEC amending for the seventh time Directive 67/54/EEC on the classification, packaging and labelling of dangerous substances, Article 13.2.

39 See Julian Schenten, “Recht und Innovation bei Nanomaterialien: Zwischenergebnisse einer juristisch-empirischen Untersuchung,” in StoffR - Stoffrecht für Praktiker, 2/2012: pp. 79–87.

40 Available on the Internet at <http://webdominoI.oecd.org/comnet/env/wp-nano.nsf>.

41 Available on the Internet at <http://www.nanotechproject.org/inventories/consumer/updates/>.

42 Available on the Internet at <http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/Nanotechnology/pdf/survey.pdf>.

43 See the analysis in “Information from Industry on Applied Nanomaterials and their Safety: Final Report” prepared by Milieu Ltd. and RPA Ltd, under Contract NV.D.1/SER/2008/00105r. For example, in 2006, the German Institute for Occupational Health and Safety (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) jointly with the Chemical Industry Association (VCI) launched a voluntary survey with the aim of having a better understanding of activities involving nanomaterials. The questionnaire was sent to 656 companies, but only 217 companies responded (33%).

44 See supra note 23.

45 The European Commission foresees to launch a public consultation on the creation of a notification scheme for nanomaterials in 2014. An impact assessment is currently being carried out.

46 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. OJ 2009 L 342/59.Article 16(10)(a) of the Regulation also provides for the Commission to make available, by 11 January 2014, a catalogue of all nanomaterials used in cosmetic products placed on the market. However this catalogue was not yet published at the time this article was completed [2 June 2014].

47 See supra note 33, at p. 46.

48 W. Shane Journeay and Rose H. Goldman,Occupational Handling of Nickel Nanoparticles: A Case Report, American Journal of industrial medicine, Article first published online: 8 May 2014.