Companies need to provide more data on nanoforms
ECHA has so far received a low number of registration dossiers for nanomaterials. By 1 January 2020, only 36 substances covering nanoforms have been registered according to the updated REACH requirements – 10 % of what the Agency expected.
Helsinki, 24 February 2020 – ECHA has received 95 unique submissions for 36 substances covering nanoforms according to the updated REACH requirements. The Agency expected to receive updated registrations for approximately 300 substances, based on data from the Belgian and French national inventories and the European Commission’s catalogue of nanomaterials used in cosmetic products.
With the submission rate so low and half of the incoming dossiers failing the technical completeness check, a webinar is available with practical advice for companies on how to prepare their registration dossiers for nanoforms.
The Agency is working closely with key industry associations and Member States to better understand the additional actions needed to raise awareness on the legal obligations. ECHA is also engaged in several short-term actions to help improve compliance, for example, by revising the Nanomaterials Expert Group’s mandate to allow more support for decision making and updating manuals, instructions and guidance for human health and environmental endpoints.
Where validated test methods for meeting REACH Annex VII and VIII information requirements are not yet available, ECHA has published a template to support registrants in documenting practical constraints and to help ensure they can show they have made all possible efforts to meet the information requirements.
ECHA reminds companies that without a valid registration, nanomaterials that fall within the scope of REACH are currently illegally on the market.
The European Union Observatory for Nanomaterials (EUON) allows you to search for nanomaterials on the EU market. The data is collected from publicly available information from REACH registrations, the Cosmetics Regulation as well as the French and Belgian national inventories. The results are linked to ECHA’s chemicals database.
Updated REACH information requirements for nanoforms of substances have applied since 1 January 2020. Beyond this date, companies must have a REACH registration compliant with these requirements to manufacture or import nanoforms of substances. The purpose of the new requirements is to make sure companies provide adequate data to show the safe use of their nanoforms for human health and the environment.
Webinar: Registering nanoforms - practical advice
- Support for companies registering nanomaterials
- EU nanomaterials observatory (EUON): search for nanomaterials
- EU nanomaterials observatory (EUON): Overview of REACH Annex modifications and available methods
- Template to document practical constraints for fulfilling REACH Annex VII and VIII information requirements [PDF][EN]
- Information on manual verification at completeness check (recently updated with advice for registering nanomaterials) [PDF][EN]
- Contact ECHA’s regulatory support