Considerations on a Definition of Nanomaterial for Regulatory Purposes

The recent EU Cosmetic Products Regulation includes a labelling obligation for nanomaterials in the list of ingredients, in order to allow consumers to make a choice. Similar provisions are now being considered for other regulations/directives, e.g. the Novel Foods Regulation. Also the European chemicals legislation REACH may need adjustments to address and control the potential risk of nanomaterials. The introduction of these provisions specific to nanomaterials requires the adoption of a definition of the term ‘nanomaterial’. This need is also acknowledged by the European Parliament which has called for a comprehensive science-based definition in Community legislation. The report reviews and discusses issues related to a definition of the term ‘nanomaterial’. It gives a short overview about what may be considered as nanomaterials, their novel properties and applications. The need for a definition of nanomaterial is discussed, and the question of what should be achieved by a definition is addressed. The report gives an overview of definitions by international, national and European institutions, and lists approaches used in European legislation. It summarises the advantages and shortcomings of different elements typically used in available definitions, regarding their applicability in a regulatory context. The report concludes that a definition of the term ‘nanomaterial’ for regulatory purposes, only should concern ‘particulate nanomaterials’. The definition should ideally be broadly applicable in EU legislation and in line with other approaches worldwide. The following three key elements are identified as being crucial: (i) the term ‘material’, (ii) the nanoscale, and (iii) specific nanoscale properties. ‘Material’ and ‘nanoscale’ should both preferably be defined precisely in order to ease enforceability. This implies the introduction of precise nanoscale limits and instructions on how such limits can be applied to nanoscale materials with size distributions. For a basic and clear definition, which is broadly applicable and enforceable, it is recommended not to include properties other than size in a general definition. Shape and state of agglomeration/aggregation must be adequately dealt with either in the definition or in subsequent legislation. Other issues may need to be considered in specific regulations such as origin of the nanomaterial, properties other than size, and specific inclusion or exclusion of certain nanomaterials. The mission of the Joint Research Centre (JRC) is to provide customer-driven scientifi c and technical support for the conception, development, implementation and monitoring of European Union policies. As a service of the European Commission, the JRC functions as a reference centre of science and technology for the Union. Close to the policy-making process, it serves the common interest of the Member States, while being independent of special interests, whether private or national. LB -N A -2403-EN -C