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Nanomaterials, EU Commission provides a new definition

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14 June 2022

Photo credit: EFSA websiteThe European Commission has adopted a recommendation for a new definition of nanomaterial, the group of chemical particles of different shapes no larger than one hundred nanometers, or about one thousand times smaller than the thickness of a human hair, that due to their specific properties can be exploited by industry and in products.

Calling for the new definition to be used in EU and national legislation, policies or research programs, the Commission adopted a review of existing definitions from 2011 in light of "new scientific evidence" with the aim of supporting a coherent EU regulatory framework. Fragmentation among national legislation due to the different approaches used to address material toxicity and correspond to safer use prompted the EU executive body to advise states on a new definition of nanomaterials to improve the enforcement of European laws in terms of data collection, risk assessment and, in selected cases, product labeling to inform consumers about the presence of nanomaterials.

The new definition proposed by the Commission qualifies nanomaterials as natural, incidental or manufactured materials consisting of solid particles that are present, alone or as identifiable constituent particles, in aggregates or agglomerates and whose size between 1nm-100nm exceeds a threshold. The new definition, however, is more precise about the size of the particles of which the material is composed.

The European Commission calls for other factors to be considered, proposing that chemicals whose 50% or more solid particles in the number-based size distribution qualify as nanomaterials if they meet at least one of the following conditions: one or more of the particle's external dimensions is in the size range of 1 nm to 100 nm; the particle has an elongated shape, such as a rod, fiber or tube, where two external dimensions are less than 1 nm and the other dimension is greater than 100 nm; the particle has a plate-like shape, where one external dimension is less than 1 nm and the other dimensions are greater than 100 nm.

With the new recommendation, the European Commission expects individual sectors to replace the old definition by making the new one legally binding in specific legislation. This is the first step toward a review of cosmetics legislation with a public consultation including questions related to the definition of nanomaterial and a proposal to revise the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, as announced in the Chemicals Strategy for Sustainability, by the end of 2022, with an updated definition of nanoform as part of the proposed revision. The European Commission stated that "due to the limited changes to the definition, almost all existing guidelines continue to be applicable to the new definition". By fall 2022, the JRC will develop new guidelines on the implementation of the nanomaterial definition in the Commission's recommendation.

Commission Recommendation on the definition of nanomaterial

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