The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH. Nanoforms of substances are those that fulfil the European Commission’s recommendation for a definition of a nanomaterial. The revised REACH annexes addressing nanoforms introduce clarifications and new provisions for:
- characterisation of nanoforms or sets of nanoforms covered by the registration (Annex VI);
- the chemical safety assessment (Annex I);
- registration information requirements (Annexes III and VII-XI); and
- downstream user obligations (Annex XII).
The purpose is to make sure companies provide enough information to demonstrate the safe use of their nanoforms for human health and the environment. The amendments apply to all the new and existing registrations covering nanoforms. This means that registrants are expected to update their existing dossiers with nanoform-specific information by 1 January 2020.
Available guidance and test guidelines
ECHA’s new nano-specific guidance helps companies to comply with the changes in Annex VI. In addition, the guidance on read-across between nanoforms or sets of nanoforms is being updated to reflect the changes. Both documents are expected to be ready by the end of 2019. The draft documents are published on the ongoing guidance consultation page…