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The European Commission Requests Input on Revision of Recommendation on the Definition of Nanomaterial

October 5, 2017

The European Commission (EC) is planning to revise its Recommendation 2011/698/EU on the definition of nanomaterial dated October 18, 2011 and, in this context, it has published a roadmap, titled, “Review and potential revision of the EU Recommendation on the definition of nanomaterial (No. 2011/696).”  The roadmap is open for public consultation until October 13, 2017.  

   

Point 6 of the Recommendation states that the definition should be reviewed by December 2014 “in the light of experience and of scientific and technological developments.” The EC launched a review of EU Recommendation 2011/696/EU in 2013. Work to date on the review has shown the need for additional technical guidance for users. The EC explained that while there is general acceptance of the main elements of the definition (such as a particle size range of 1-100nm), some other elements need to be amended or clarified.  For example, the EC outlined that the language regarding the number size distribution threshold needs revision while the meaning of a particle’s “external dimension” and the concept of “constituent particle” need to be clarified with respect to agglomerates and aggregates. The EC added that implementation remains challenging given that there is no single universally applicable measurement method and existing measurement methods needs to be improved.  As a result, no easy routes are presently provided to quickly determine for certain when a material is or is not a nanomaterial.  

   

For further information on the issues arising with the current EC’s Recommendation on the definition of nanomaterial, please refer to the roadmap in the first paragraph.  For background information on the EC’s recommendation on the definition of nanomaterial, see the PackagingLaw.com article, Nanotechnology Regulation of Food Packaging.