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|Lynn L. Bergeson
Bergeson & Campbell, P.C.
On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee.
October 3rd, 2012
EC Adopts Communication on Second Regulatory Review on Nanomaterials
On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee. See http://ec.europa.eu/nanotechnology/pdf/second_regulatory_review_on_nanomaterials_-_com(2012)_572.pdf The Communication concludes that "nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not." Since possible risks are related to specific nanomaterials and specific uses, nanomaterials should be assessed on a case-by-case basis. The Communication states: "Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required." According to the Communication, the EC "remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013." To improve the availability of information, the EC states that it "will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist. In parallel, the Commission will launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes."
The Communication is accompanied by an EC Staff Working Paper on Types and Uses of Nanomaterials, Including Safety Aspects, which responds to the EP's concern that the EC's approach to nanomaterials is jeopardized by a lack of information on the use and safety of nanomaterials that are already on the market. See http://ec.europa.eu/nanotechnology/pdf/second_regulatory_review_on_nanomaterials_-_staff_working_paper_accompanying_com(2012)_572.pdf The Staff Working Paper provides detailed information on the definition of nanomaterials, nanomaterial markets, uses, benefits, health and safety aspects, risk assessment, and information and databases on nanomaterials. According to the Staff Working Paper, in response to the EP's call on the EC to compile a public inventory of the different types and uses of nanomaterials on the European market, the EC has compiled information on existing databases and intends to create an EC web platform on nanomaterial types and uses, including safety aspects.