Exploring building blocks for amending EU regulation of nanomaterials
Verkenning van bouwstenen voor EU-wetgeving van nanomaterialen
30 August 2013, PDF |
59 pages |
Bleeker EAJ, Theodori D, Wijnhoven SWP
RIVM Report 601353003
In early 2013, the Netherlands Interdepartmental Working Group on Risks of Nanotechnology (IWR) defined six building blocks to amend regulatory frameworks and improve risk assessment of nanomaterials. Furthermore, the building blocks aim at improving knowledge on nanomaterials in products. RIVM has explored these building blocks for their effectiveness and provides further interpretation for them. The six building blocks are: (1) a uniform definition of nanomaterials, (2) specific information requirements under REACH for a substance in nanoform, (3) lowering the production volume for registering a substance in nanoform or requiring certain information under REACH, (4) separate assessment of exposure and risk of nanomaterials for workers, and (5) a European register and/or (6) labelling of products that contain nanomaterials. The first three building blocks are strongly related to the European REACH Regulation for chemical substances, while the other three relate to other frameworks. A horizontal definition should be solely aimed at identification of nanomaterials, i.e. distinguish between a nanoform and a 'conventional' non-nanoform of the substance. The recent recommendation by the European Commission is a good starting point for such a definition. The risk assessment of nanomaterials and the necessary (additional) information should be determined as a next step in the appropriate regulatory framework. The risk assessment of nanomaterials requires detailed information to characterise the materials. Additional information is needed on the toxic potential of the substances and on their behaviour in humans and the environment, as well as on their fate. The same holds for determining the exposure of humans and environment to nanomaterials and necessary risk management measures to limit the risk. REACH information requirements are related to the amount of chemical substance that is produced in or imported into the EU. This is in line with the idea that larger volumes produce a greater chance of exposure and risks. Nanomaterials are generally used in low volumes, thus requiring information on substance properties at low levels. In the event that substances are exempted from REACH registration because they are assessed under specific legislation, e.g. medicine, that legislation may need to be adapted accordingly. For workers the present study shows how such adaptation may include a specific risk analysis and separate exposure limits for each substance. To gain insight into the products in which nanomaterials are incorporated, a European registration and/or labelling of nanomaterials may be useful. The best approach to this, however, is not yet clear and should be further explored.