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July 12, 2013

Belgium Notifies EC of Draft Decree Creating Nanomaterials Register

Lynn L. Bergeson

On July 4, 2013, the Belgian Federal Public Service for Health, Food Chain Safety, and Environment notified the European Commission (EC) of a draft decree that would create a register of substances manufactured at the nanoscale based on declarations of products containing such substances by the parties placing these products on the market. Under the draft decree, substances manufactured at the nanoscale, and preparations containing them, would be declared if more than 100 grams of these substances are placed on the market per year. If Belgium believes that a substance could present a risk to human health or the environment, it could ask registrants to provide information on potential dangers, exposure, and risks. The draft decree would apply to: substances manufactured at the nanoscale; preparations containing such substances; and articles incorporating these substances. Substances manufactured at the nanoscale included within the scope of the draft decree would encompass nanomaterials as defined in the EC’s October 2011 recommendation on the definition of nanomaterials, “including the assimilation of fullerenes, graphene flakes and carbon nanotubes, but with the exception of non-chemically-modified natural substances, substances produced accidentally and substances whose fraction between one nanometer and one hundred nanomet[er]s is a by-product of human activity.” Pigments and — concerning the declaration of articles — carbon black, synthetic amorphous silica, and precipitated calcium carbonate used as fillers would be excluded from the scope of the draft decree. Products already subject to regulations concerning nanomaterials, such as biocides, would also be excluded. The draft decree would apply from January 1, 2015, for nanomaterials and substances containing nanomaterials, and from January 1, 2016, for articles or complex objects that contain a substance in a nanoparticle state. European Union (EU) Member States have until October 7, 2013, to submit comments on the draft decree. Belgium could then pass the draft decree, revising it as necessary based on any comments received.