June 22, 2021

Volume XI, Number 173

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June 21, 2021

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The EU and the Definition of “Nanomaterial”

The EU Commission has not decided to harmonize the definition of nanomaterial yet, just to slightly update it. Considering that the issues identified in the current definition in the Recommendation 2011/696/EU might be addressed through minor changes of it, the EU Commission organizes only a second survey to targeted stakeholders (economic operators implementing all relevant EU sectoral regulation and their federations, Member States competent authorities and other regulatory stakeholders, research organisations supporting implementation, academia and NGOs).

Previous consultations and the JRC reports highlighted the following interim findings:

  1. The definition is fit for purpose, its main elements are generally accepted;

  2. Uptake of the definition in EU regulation to date has not been as comprehensive as anticipated. While some delay in the uptake can be attributed to the anticipation of the results of the review of the definition, direct uptake has been hindered by the lack of clarity of some of the definition’s elements in particular in relation to the term particle and to particle properties;

  3. Limiting the default inclusion of a number of materials to only carbon-based materials (fullerenes, graphene flakes and single wall carbon nanotubes) may be outdated;

  4. Implementation of the definition remains challenging. Because of the high diversity among nanomaterials, a single universally applicable and affordable particle size measurement method is unlikely to become available.

In this context, it should be noted that other nanomaterial definitions are still valid in specific legislation, where the definition from the Recommendation has not yet been taken up (e.g., the definition of ‘engineered nanomaterial’ in the Novel Foods Regulation (EU) 2015/2283 or the nanomaterial as “insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm” under Regulation of cosmetic products (EC) No 1223/2009) are outside the remit of this consultation.

 

See for further information: https://ec.europa.eu/eusurvey/runner/797488bd-3f43-ce96-4dc7-f93a2b4992b4#page0

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 138
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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