A specific revision of the REACH information requirements for nanomaterials has now been adopted by the European Commission. The amendments clarify what information companies placing substances in nanoform on the market need to provide in their registration dossiers. The new rules apply as of 1 January 2020. The new requirements will enable both companies and authorities to systematically assess the hazardous properties of nanomaterials, how they are used safely, and what risks they may pose to our health and the environment. This information will help authorities in the EU to identify if further risk management measures are needed. Companies now have to assess whether the new information requirements apply to their substances. The changes are relevant for companies manufacturing or importing nanoforms of substances that fall within the scope of REACH. Nanoforms of substances are those covered by the European Commissions recommendation for a definition of a nanomaterial. The European Chemicals Agency (ECHA) strongly encourages registrants of nanoform substances to familiarise themselves with the amendments and assess what action they need to take to comply. ECHA is also currently assessing the need to update existing guidance or issue new guidance to help registrants comply with the new requirements.
Nanomaterials are chemical substances in a particular form with special features at the nanoscale, between 1 nm and 100 nm. They can be used in many different ways, for example, in catalysts, electronics, solar panels and batteries, and in materials science and biomedical applications. Similar to conventional forms of substances, some nanomaterials are hazardous and others are not. Scientific evidence shows that the toxicity of nanoforms as well as their effects on the environment may differ from the conventional substance.
The European Union Observatory for Nanomaterials (EUON) provides information about the safety, innovation, research and uses of nanomaterials on the EU market. It is funded by the European Commission and hosted and maintained by ECHA. Further information is available at:
- Draft Commission Regulation
- European Commission: Definition of a nanomaterial
ECHA, 3 December 2018 ; http://echa.europa.eu