8.3.3 Nanotechnology

Documentgegevens:

Mr. T.E. Lambooy, datum 17-11-2010

Datum: 17-11-2010
Auteur: Mr. T.E. Lambooy
JCDI: JCDI:ADS370631:1
Vakgebied(en): Ondernemingsrecht (V)

Nanotechnology is used in a wide range of products such as IT products and cosmetics, and is expected to grow rapidly into a global, multi-billion euro market.1 Preliminary observations suggest that exposure to certain types of nanoparticles could be detrimental to human health, for example being a cause of numerous skin diseases.2 Another study suggests that there is a serious "concern that long-term exposure to some nanoparticles without protective measures may be related to serious damage to the lungs".3 Nonetheless, there are no provisions in REACH referring specifically to nanomaterials.4 Generally, REACH deals with substances, in whatever size, shape and physical state, including substances at nanoscale.5 Consequently, importers, manufactures and downstream users have to ensure that their nanomaterials do not adversely affect human health or the environment. Nevertheless, in April 009, the EP explicitly called for a more serious approach towards nanomaterials. The EP asked for the insertion of provisions in the REACH Regulation that will provide information to consumers on the use of nanomaterials in finished products. Concerns were expressed that nanomaterials need not be registered if manufactured or imported below 1 tonne.6 This is a valid concern, because, according to the newly-established REACH Competent Authorities Subgroup on Nanomaterials, "several nanomaterials are only produced at low tonnage level", which leads to a "lack of information on nanomaterials due to the present tonnage triggers for data requirement under REACH".7

In May 2009, during the Helsinki Chemicals Forum organised by the Commission and ECHA, the participants agreed that the handling of nanoscale substances should be reconsidered under REACH. Governmental spokespersons came to the conclusion that a specific regulation on nanomaterials might be adopted after the revision of REACH, which the EC is required to do by June 1, 2012.8 However, why wait? Protection at the national level can be instituted today. On 8 July 2009, the Norwegian Board9 of Technology announced that the Norwegian Pollution Control Authority had established a scheme to report their use of nanomaterials in chemical products.10

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Note 51, supra [EU-OSHA, 2009], p. 8.

Note 51, supra [EU-OSHA, 2009], p. 40.

Y. Song, X. Li, X. Du, Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma, in European Respiratory Journal, vol. 34, 2009, pp. 559-567.

Commission, Environment Directorate-General, Follow-up to the 6th Meeting of the REACH Competent Authorities for the implementation of Regulation (EC) 1907/2006 (REACH), December 2008, pp. 5, and 15-16. See: http://ec.europa.eu/environment/chemi-cals/reach/pdf/nanomaterials.pdf, accessed on 24 June.

There is a difference between 'nanomaterial' and 'nanoscale'. 'Nanomaterial' is manufactured or engineered nanosised and nanostructered materials, without specification as to whether these materials are substances or forms ofsubstances. Nanomaterials include metals or metal oxides, carbon black, carbon nanotubes, fullerenes, silicate, organic nanoparticles or nanocomposites. 'Substance at nanoscale' refers to substances with properties specific to nanomaterials. See: Commission, Follow-up to the 6th Meeting of the REACH Competent. Authorities for the implementation of Regulation (EC) 1907/2006, 2008.

European Parliament, Press Release: Nanomaterials: MEPs Calls for More Prudence, 24 April 2009. Available at: http://www.europarl.europa.eu/sides/getDoc.do7langua-ge=EN&type=IM-PRESS&reference=20090422IPR54260, accessed on 24 June 2010; WWF, 'First Improvements on nanoparticles under REACH chemical law', 2008, at: http://www.panda.org/about_our_earth/teacher_resources/webfieldtrips/toxics/news/? 136301/First-improvements-on-nanoparticles-under-REACH-chemicals-law, accessed on 24 June 2010.

Note 55 supra [Commission, 2008], p. 14.

L. Bergeson, 'EU Examining how REACH Applies to Nanomaterials',in Nanotechnology Law Blog, 2009, at: http://nanotech.lawbc.com/2009/06/articles/international/eu-examining-how-reach-applies-to-nanomaterials/, accessed on 24 June 2010.

After adoption the REACH Regulation entered into force in Norway on 30 May 2008. Norwegian Ministry of Environment, REACHadoptedinNorway,newsandstory 25.08.2005. Available at: http://www.regjeringen.no/en/dep/md/Whats-new/News/2008/ reach-adopted-in-norway-2.html?id=515102, accessed on 28 June 2010.

10.

Norwegian Board of Technology, 'Businesses Asked to Declare Use of Nanomaterials', Teknologiradet, 2009, at: http://www.teknologiradet.no/FullStory.aspx?m=3&amid=7830, accessed on 24 June 2010.