In accordance with the updated annex of REACH, companies had to provide updated data and information in their REACH dossiers for substances in the nanoform by a deadline of 1st January 2020 to remain compliant to REACH. The updated REACH requirements require registrants to identify substances meeting the definition of a nanoform and the safe use through their lifecycle. This obligation applies to both new and existing registrations. Companies placing such substance on the market that cannot demonstrate a valid registration for their nanomaterials are illegally placing substances on the market under the scope of REACH.

Based on data from national inventories and the EU catalogue of nanomaterials in cosmetics, ECHA expected updated registrations dossiers for almost 300 substances, a number that is much higher than the actually received 95 unique submissions for 36 substances covering nanoforms.

Although ECHA has been providing some support with new guidance documents and webinars, many registrants have found it difficult to understand and interpret their obligations. Multiple reasons, including confidentiality issues within the SIEF, the lack of validated test methods or difficulties with the characterisation of the nanoforms have been mentioned as playing a role in the low number of received registration dossiers and half of these submissions failing the completeness check.

How can we help?

Expert opinion

We have played an active role in a number of EU funded projects investigating the hazards and risks arising from nanomaterials (MARINA, SUN, NanoMONITOR) and have acted as an active stakeholder in a number of other projects and the EU NanoSafetyCluster. As well playing an active role in these cutting-edge research projects, we have supported clients in the REACH registration of nanomaterials and have taken roles in the Partner Expert Groups supporting the drafting of the nano specific annexes to the REACH guidance documents. This gives us unique expertise across all aspects of hazard and risk assessment for nanomaterials and their associated regulatory obligations.

Characterisation

Particle characterisation of powders to investigate whether they meet the definition of a nanomaterial and to distinguish different nanoforms

Testing Strategies

Design and commissioning of integrated testing strategies tailored to the requirements for nanomaterials stated in annexes VII – X of REACH. Exposure and risk assessment of nanomaterials throughout their lifecycle based on the latest research methods.

Regulatory Advice

Global regulatory advice on identifying and meeting any obligations unique to nanomaterials.

Safety by Design

Support for companies to achieve their “Safety by Design” goals to produce products that are as safe as possible and avoid product failure in late stage development.

Authors:

Eva Penssler, Associate Regulatory Consultant, Yordas Group
Dr Neil Hunt, Managing Regulatory Scientist, Yordas Group