In December 2018, the European Commission adopted Regulation (EU) 2018/1881. This amended the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation to directly address nanoforms of substances. 

Nanomaterials are microscopic particles that range in size from 1nm to 100nm. They are manufactured or processed for use in a range of industries including healthcare, information technology, cosmetics and engineering. Compared with materials present in larger forms, the very small size, high specific surface area and reactivity of nanomaterials may lead to altered environmental mobility, and subsequent toxicology and environmental impact. This, together with the influence of environmental conditions, may lead to altered environmental fate and behaviour. 

Regulation 2018/1881 mandated the effective characterisation and requirements of new and registered substances, and those that may contain nanomaterials. In particular:

• Particle size, shape and number size distribution.
• Surface chemistry.
• Sets of similar nanoforms.
• Physiochemical endpoints.
• Environmental fate and behaviour endpoints.

As of 1 January 2020, businesses manufacturing and importing nanoforms of substances must have a REACH registration that complies with the new requirements.

However, as of 24 February 2020, the European Chemicals Agency (ECHA) had received only 10% of the registration dossiers for nanomaterials that had been expected.

Organisations with nanomaterials placed on the market that fall under REACH and who do not have a valid registration dossier are considered to be non-compliant by the ECHA. Also, it is vital that the correct test methods are used to classify and test nanomaterials in accordance with the updated REACH requirements. For example, this may include the use of dispersion stability and rate of dissolution in aqueous environments to identify which further environmental fate studies may be necessary. 

How we can help

NCEC’s Environmental chemistry and toxicology team specialises in determining the environmental fate of chemicals for REACH purposes, which includes the use of standard and non-standard test methods. We have a proven track record of helping clients to address the challenges of REACH – including understanding the regulatory status of substances and developing strategies; to mitigate the associated business risks and engaging in technical discussions with regulatory authorities. 

If your business has any concerns regarding the characterisation of nanomaterials, appropriate test methods or you would like to discuss how the new nanoform regulations may affect your products and the wider business strategy, please feel free to contact us and discuss how we can help support your continued compliance. 

References:
ECHA’s news on nanoforms