New amendments to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation clarify what information companies placing nanoform substances on the market must provide in their registration dossiers. The new rules apply as of 1 January 2020.
Nanomaterials are chemicals substances with specialized features at the nanoscale, between 1 nm and 100nm. They have a wide variety of applications such as in catalysts, electronics, and medicine. The features of a nanomaterial can influence the hazards associated with it. Scientific evidence demonstrates that the toxicity and environmental effects of nanomaterials may differ from that conventional form of the substance.
Since REACH came in to force, nanomaterials have been subject to the regulation. However, until recently it did not contain any specific requirements pertaining to these unique chemical substances. Now, companies will have to determine whether the new information requirements apply to their compounds. This is relevant for companies manufacturing or importing into Europe nanoforms of substances which fall within the scope of REACH. Nanomaterials are defined in the European Commission’s recommendation for a definition of a nanomaterial.1
ECHA has stated that it “strongly encourages” registrants of nanomaterials to become familiar with the new provisions and assess what steps must be taken in order to comply. ECHA is currently evaluating whether to update existing guidance or issue new guidance to help registrants comply with the new requirements.
In June 2017 ECHA launched its EU observatory for nanomaterials (EUON).2 This public website aims to improve availability of information about nanomaterials on the EU market.