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|Lynn L. Bergeson
Bergeson & Campbell, P.C.
As part of the Communication on the Second Regulatory Review on Nanomaterials, the European Commission (EC) announced the launch of an impact assessment intended to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials.
May 19th, 2014
EC Begins Public Consultation on Transparency Measures for Nanomaterials on the Market
As part of the Communication on the Second Regulatory Review on Nanomaterials, the European Commission (EC) announced the launch of an impact assessment intended to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials. The EC has provided a working document, which contains a draft problem definition, policy objectives, and a description of the preliminary policy options that are under consideration. The EC will update the working document over the course of the impact assessment. In support of the impact assessment, the EC is conducting a public consultation to obtain stakeholder views on the currently available information on nanomaterials on the market, the problem definition that forms the basis of the impact assessment, as well as the potential positive and/or negative impacts of the aforementioned policy options. According to the working document, the preliminary policy options are:
0. Baseline scenario;
1. Recommendation on how to implement a "best practice model" for Member States wishing to establish a national system (soft law approach);
2. Structured approach to collect information ("Nanomaterials Observatory");
3. Regulation creating a European Union (EU) nanomaterial registry with one annual registration per substance for each manufacturer/importer/downstream user/distributor; and
4. Regulation creating an EU nanomaterial registry with one annual registration per use (including substances, mixtures and articles with intended release).
For options 3 and 4, a number of variants, taking into account specific substances, mixtures or articles, shall be considered. Some policy options may be combined. The EC states that it will organize a validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials with interested stakeholders. The workshop will take place on June 30, 2014, in Brussels. See http://ec.europa.eu/enterprise/sectors/chemicals/reach/events/index_en.htm#h2-2 The public consultation will close August 5, 2014. See http://ec.europa.eu/enterprise/sectors/chemicals/reach/nanomaterials/public-consultation_en.htm