Regulatory preparedness for multicomponent nanomaterials: Current state, gaps and challenges of REACH
Neil Hunt, Vikram Kestens, Kirsten Rasmussen, Elena Badetti, Lya G. Soeteman‐Hernández, Agnes G. Oomen, Willie J.G.M. Peijnenburg, Danail Hristozov, Hubert Rauscher
Abstract
In 2018 the European Commission adopted revisions to the Annexes of Regulation (EC) No 1907/2006 concerning registration, evaluation, authorisation and restriction of chemicals (REACH) to introduce nanomaterial-specific clarifications and provisions. Multicomponent nanomaterial (MCNM) is a non-regulatory term that has been used in recent EU-funded projects to describe nanomaterials with a complex structure and/or composition and which are expected to be increasingly used in products in the near future. This paper examines the regulatory preparedness of REACH, and its revised Annexes, for MCNMs. Several situations have been identified where there is potential confusion and uncertainty around how regulatory definitions used in REACH should be applied to MCNMs. If a MCNM cannot be identified as falling within a specific definition, understanding the regulatory obligations that apply to it is very difficult. Examples of these grey areas include how the term “surface functionalisation or modification” applies when a chemical is physisorbed to the surface of a nanoform, and the identity of the substance that should be registered when the modification takes it outside the definition of a nanoform. We conclude that the regulatory preparedness can be improved by amending the REACH guidance on information requirements for nanoforms and revising the definition of “nanoform” in line with the updated EC Recommendation on the definition of nanomaterial. • Regulatory preparedness (RP) improves the anticipation capabilities of regulators facilitates an agile adaptation of legislation and regulatory guidance. • Increasing use of multicomponent anomaterials (MCNMs) means that it is imnportant to understand if adaptations to EU legislation are needed. • Based on analysis of REACH, challenges and uncertainties from imprecise terminology and the variety of structures that MCNMs display are discussed.