Regulatory preparedness for multicomponent nanomaterials: Current state, gaps and challenges of REACH

NanoImpact, vol. 37, pp. 100538

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.

Authors 8

1. Vikram Kestens

   European Commission · Joint Research Center

   Affiliation as printed

   European Commission, Joint Research Centre (JRC), Geel, Belgium

2. Kirsten Rasmussen

   Joint Research Centre

   Affiliation as printed

   European Commission, Joint Research Centre (JRC), Ispra, Italy

3. Elena Badetti

   Ca' Foscari University of Venice

   Affiliation as printed

   Department of Environmental Sciences, Informatics and Statistics, Ca' Foscari University of Venice, Via Torino, 155, Venice Mestre (VE) 30172, Italy

4. Lya G. Soeteman‐Hernández

   National Institute for Public Health and the Environment

   Affiliation as printed

   National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands

5. Agnes G. Oomen

   National Institute for Public Health and the Environment · University of Amsterdam

   Affiliation as printed

   National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands; Institute for Biodiversity and Ecosystem Dynamics (IBED), University of Amsterdam, Amsterdam, the Netherlands

6. Willie J.G.M. Peijnenburg Aachen

   Leiden University · National Institute for Public Health and the Environment

   Affiliation as printed

   National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands; Institute of Environmental Sciences (CML), Leiden University, Leiden, the Netherlands

7. Danail Rumenov Hristozov
   Affiliation as printed

   EMERGE Ltd, 1303 Sofia, Bulgaria

   GreenDecision S.r.l., 30170 Venice Mestre, Italy

8. Hubert Rauscher

   Joint Research Centre

   Affiliation as printed

   European Commission, Joint Research Centre (JRC), Ispra, Italy