EU Nanomaterial Stakeholder Session

The European Fee (EC) announced an on the web qualified stakeholder consultation as element of a overview…

The European Fee (EC) announced an on the web qualified stakeholder consultation as element of a overview of the definition of “nanomaterial” for use across all EU restrictions.  The introductory take note for the session emphasizes that the “common definition of the phrase ‘nanomaterial’ across EU regulation supports a harmonised method, facilitates implementation and enforcement, and can provide as the specialized and scientific foundation for EU laws and procedures that set provisions certain to nanomaterials. Member States are also invited to take into consideration the definition in the Suggestion in their nationwide laws.” 

Noteworthy, the Union laws currently includes a number of unique legal definitions of the expression.  These definitions are also unique from ‘nanomaterial’ definition set out in Recommendation 2011/696/EU that for the sake of completeness, we remember under:

“a pure, incidental, or made substance that contains particles, in an unbound condition or as an mixture or as an agglomerate and in which, for 50% or much more of the particles in the selection dimensions distribution, just one or additional exterior proportions is in the sizing variety 1 nm – 100 nm. In precise circumstances and in which warranted by concerns for the setting, health and fitness, basic safety or competitiveness the amount size distribution threshold of 50 % may well be replaced by a threshold concerning 1 and 50 %”

The consultation is part of the EC’s evaluate of the ‘nanomaterial’ definition below the Recommendation 2011/696/EU.  The evaluate has currently included:

  • Consultation these kinds of as specific stakeholders study, workshop, and so forth.

  • Publication of EC’s Joint Analysis Centre (JRC) three Technical Stories

The evidence gathered until eventually now counsel that:

  1. The definition is fit for purpose and its main things are usually accepted

  2. Uptake of the definition in EU regulation to day has not been as in depth as expected and experienced been hindered by the deficiency of clarity of some of the definition’s features, in particular in relation to the phrase particle and to particle properties

  3. Restricting the default inclusion of a variety of elements to only carbon-dependent supplies (fullerenes, graphene flakes and one-wall carbon nanotubes) might be outdated 

  4. Implementation of the definition stays tough considering that, owing to the higher variety amid nanomaterials, a single universally applicable and affordable particle measurement measurement system is not likely to develop into accessible.

The EC established that the issues recognized may well be tackled as a result of small variations to the latest definition and through implementation assist. This session seeks stakeholders’ sights on the EC’s interim results and prospective variations. Comments are staying recognized until June 30, 2021.


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Countrywide Legislation Evaluation, Quantity XI, Variety 168