European Observatory for Nanomaterials

Companies to provide more information on nanomaterials

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.

Helsinki, 3 December 2018 – 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 Commission’s 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.

Background

Under REACH, the EU’s manufacturers and importers of chemicals have a general obligation to register in the European Chemicals Agency each substance manufactured or imported in quantities of 1 tonne or more per year per company. In the registration dossier, they must identify the risks linked to the substances they produce and market, and indicate how these risks are managed.

Ensuring that this safety assessment for substances in nanoform effectively captures and documents also the potential differences between the forms covered by the registration has been the principal objective of the modifications of the REACH annexes.

The Regulation supports and will generate information for the European Union Observatory for Nanomaterials (EUON) hosted by the European Chemicals Agency.