November 29, 2021

Volume XI, Number 333

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November 29, 2021

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EU Opens Public Consultation on Nanomaterial Definition

The European Commission (EC) announced an online targeted stakeholder consultation as part of a review of the definition of “nanomaterial” for use across all EU regulations.  The introductory note for the consultation emphasizes that the “common definition of the term ‘nanomaterial’ across EU regulation supports a harmonised approach, facilitates implementation and enforcement, and can serve as the technical and scientific basis for EU legislation and policies that set provisions specific to nanomaterials. Member States are also invited to consider the definition in the Recommendation in their national legislation.” 

Noteworthy, the Union legislation currently includes a few different legal definitions of the term.  These definitions are also different from ‘nanomaterial’ definition set out in Recommendation 2011/696/EU that for the sake of completeness, we recall below:

“a natural, incidental, or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %”

The consultation is part of the EC’s review of the ‘nanomaterial’ definition under the Recommendation 2011/696/EU.  The review has already involved:

  • Consultation such as targeted stakeholders survey, workshop, etc.

  • Publication of EC’s Joint Research Centre (JRC) three Technical Reports

The evidence gathered until now suggest that:

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

  2. Uptake of the definition in EU regulation to date has not been as comprehensive as anticipated and had 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of materials to only carbon-based materials (fullerenes, graphene flakes and single-wall carbon nanotubes) may be outdated 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 since, due to the high diversity among nanomaterials, a single universally applicable and affordable particle size measurement method is unlikely to become available.

The EC determined that the issues identified might be addressed through minor changes to the current definition and through implementation support. This consultation seeks stakeholders' views on the EC's interim findings and potential changes. Comments are being accepted until June 30, 2021.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 168
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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

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