In support of documentary standards (CSA)

Topic description

Specific Challenge:

There is a general consensus that the implementation of nanotechnologies ought to be based on a clear science-based understanding of potential risks that might be associated to the manufacture, use and disposal of substances in the Nano form, as well as of products and articles containing nanomaterials. The scientific body of knowledge should be translated to a level of regulatory relevance, with support from regulatory research. A crucial element is the establishment, by consensus, of a set of scientifically reliable and regulatory relevant technical guidelines and good practices documents. Ideally such guidelines and documents should be aligned to the requirements for guidance and standards of international organisations such as OECD, ISO and CEN. Agreed standardised test guidelines and guidance documents are needed to allow reliable and relevant safety testing of nanomaterials regarding both human health and the environment. In particular, the OECD guidelines for chemicals' notification and registration under REACH need adaptation for nanomaterials from characterisation of materials and exposure, to potential for persistence, bioaccumulation and toxicity. Initial test guidelines and guidance documents are meant to be a basis that can be updated on a regular basis as well as expanded to keep pace with progress in science and regulatory needs and to ensure mutual acceptance of regulatory relevant data by the regulatory bodies of OECD member states.

• Outline specific research actions of regulatory research nature to cover existing gaps in OECD test guidelines and guidance documents development;
• Establish integration of other public and private resources (funding or labour) to develop and validate new OECD test guidelines and OECD guidance documents;
• Establish maximum synergy of actions across industrial sectors and international cooperation;
• Support the completion of the elaborated documents by the relevant international organisations involving OECD Member States and relevant EU agencies;
• Establish very close cooperation with Member States, OECD, BIAC, JRC, ECHA, EU and Member State agencies to act as leads and co-leads for the test guidelines and guidance documents to be developed.

The Commission considers that proposals requesting a contribution from the EU around EUR 3 million would be an important contribution to allow this specific challenge to be further addressed. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

• Filling the gaps that are currently blocking the way to international adoption of the running OECD projects with the aim to amend test guidelines and guidance documents for nanomaterials regarding both the environment and human health;
• Delivery of a consistent, complete and timely set of standardized technical guidelines and guidance documents, internationally harmonised and validated respecting the principles of good laboratory practice, to effectively implement the existing chemicals' legal frameworks of OECD- and EU-Member States (i.e. REACH regulation in Europe) and to ensure safe manufacturing and responsible use of nanomaterials;
• Establish seamless collaboration with the science layer (e.g. the EU Nano safety cluster), the relevant DGs and agencies of the EU, the OECD-WPMN, WNT, ISO and CEN.

International cooperation