Regulatory aspects of nanomaterials in the EU

Nanotechnology is considered to be a key enabling technology (KET) by the European Commission, and nanomaterials are a subgroup of chemicals defined by their size. They are present in almost any industrial sector and are implicitly or explicitly addressed in legislation addressing chemicals and certain consumer products. This also requires legally clear terminology and therefore the EC has developed a recommendation of the term "nanomaterial" for regulatory purposes. Some regulations have already implemented that overarching definition, others use a dedicated and to some extent different definition of the term. Due to uncertainties regarding the safety of nanomaterials it is necessary to develop best practices and facilitate harmonisation of assessment practices for nanomaterials. These challenges are dealt with in the European Union by Agencies, expert groups and independent scientific committees, and on a more global level by the OECD and its Working Party on Manufactured Nanomaterials. However, more research with specific relevance for regulatory questions is still needed, in particular regarding the implementation of the definition of nanomaterials, the enforcement of product labelling for the presence of nanomaterials, the development of methods for the safety testing and risk assessment of nanomaterials and a better availability of quality data on nanomaterials for regulatory purposes.

RAUSCHER Hubert;  RASMUSSEN Kirsten;  SOKULL-KLUETTGEN Birgit; 

2017-03-01

WILEY-V C H VERLAG GMBH

JRC102195

0009-286X,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC102195,   

10.1002/cite.201600076,