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23 Dec, 2011
The SKEP Nanomaterials in REACH Report provides a useful guide to authorities and EU member states in their future work on regulation and standardisation of nanomaterials. It provides a comprehensive overview of the known toxicity of nanomaterials to human health and the environment. The project Nanomaterials in REACH concerned the assessment, based on currently available scientific evidence, of the applicability of the EU regulation on industrial chemicals REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), and its associated guidelines for ensuring the safety of products containing Nanoparticles (NPs) and Nanomaterials (NMs).
The project team: KTH (Stockholm), UB (Birmingham), UCD (Dublin), UH (Helsinki) responded to the SKEP call ”Impacts of converging technologies for environmental regulation” and the project addressed a topic under ”Reviewing the sustainability of existing legal frameworks with respect to the challenges posed by converging technologies, theme 3: Human health and environmental impacts”.
Critical differences between the nanoforms and the bulk forms of substances necessitating specific regulatory considerations were analyzed and internally discussed. This was accompanied by regular exchanges of information and opinions with the national Competent Authorities within REACH involved in the Implementation Projects on NMs.
As a result the key recommendations for specific consideration of NMs in REACH were developed and described in the final report under the following headings: (I) definitions and naming of NMs for regulation, (II) characterization of NMs, (III) mandatory reporting system for substances in nano form on their own, in preparations and incorporated into products, (IV) systems of triggers for registration and subsequent data obligations, (V) obligations for NMs in articles, (VI) testing and information requirements for NMs, (VII) assessment of potential novel risks from NMs, (VIII) validation of test methods and test conditions, (IX) hazard classification and authorization.
Outcomes of this work were presented at national and international meetings where feedback from stakeholders from academia, government and Industry was received, including presentation at: Eurotox Barcelona 2010; the Nordic Workshops on regulatory issues on NMs Copenhagen, November 2010; Swedish Toxicological Council seminar on NMs Stockholm, March 2011; graduate course on Sustainable development with nano-perspective Lund, March 2011; Eurotox Paris, August 2011; Nordic NanoNet Workshop for researchers and regulators on safety evaluation of NMs, Helsinki, September 2011, Toxicological Risk Assessment Training workshop, December 2011; UK CA on REACH/NMs (DEFRA, HSE, Environment Agency) and ECHA.
The report has undergone external review and is intended to inform Member States’ position in activities within REACH Competent Authorities, and involvement within OECD Working Party on Manufactured Nanomaterials.
The SKEP Network – December 2011
Katarzyna Malkiewicz 1, Michala Pettitt 2, Kenneth A. Dawson 3, Arho Toikka 4, Sven Ove Hansson 1, Janne Hukkinen 4, Iseult Lynch 3, Jamie Lead
