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How are nanomaterials regulated in the EU? Could GUIDEnano project help?

From the EU Science Hub of the European Commission: JRC scientists reviewed the legislation of nanomaterials in the EU and identified key needs for better implementation thereof including safety assessment. Today, nanomaterials can be found in almost any industrial sector including consumer products.


The EU’s regulatory framework generally covers nanomaterials. Legislation on specific products (Cosmetic Products, Novel Foods, Biocidal Products, Medical Devices) address nanomaterials, including requirements for information on nanomaterials (labelling) and assessment of the safety of these materials. Other regulations implicitly apply to nanomaterials, e.g. the chemicals regulation REACH, as the regulations addresses all chemicals including nanomaterials. However, due to their novel and/or nanospecific properties and often different behaviour as compared to “ordinary” chemicals, there are uncertainties about the safety of nanomaterials and how to assess it properly.


As a basis for a harmonised regulatory approach, the European Commission has developed a recommendation for a definition of the term nanomaterial for regulatory purposes, but other sector-specific definitions are used as well in legislation, partly because these regulations were adopted before the recommendation. Currently it is still a challenge to identify nanomaterials, in particular when integrated in products, i.e. to measure particle size and size distribution. The identification is relevant for finding out whether the nano-specific provisions apply. Furthermore, since several regulations require hazard testing of nanomaterials, e.g. before authorising them for the use in consumer products, there is the need to confirm that available test methods and guidance are suitable for nanomaterials and, where relevant, to develop nano-specific tests. Moreover, to facilitate the testing of a potentially huge variety of different nanomaterials, a sound approach to group them is necessary. More specific data on nanomaterials are required to address regulatory needs, to account for the specifities of nanomaterials, and to assess their safety.


In order to reduce uncertainties regarding the safety of nanomaterials, best practices, guidelines and assessment practices, and methods for the safety testing of nanomaterials are being developed, e.g. by ECHA and within the OECD test guidelines programme. Still, more research with specific relevance for regulatory questions is needed, in particular regarding the implementation of the definition of nanomaterials, the enforcement of product labelling for the presence of nanomaterials and the development of methods for the safety testing of nanomaterials.


In this regard, LEITAT is coordinating the GUIDEnano project that is developing an interactive risk assessment tool for nanomaterials. This is a concrete example of a measure financed by the European Commission to increase safety around the use and disposal of nanomaterials. The tool is already working and is being presented in various conferences around the continent. More information on the project’s website.


Read more in: H. Rauscher et al. “Regulatory Aspects of Nanomaterials in the EU”, Chemie Ingenieur Technik 89 (2017) (225:231), doi:10.1002/cite.201600076


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