The Center for International Environmental Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released on November 13, 2012, a proposal for European Union (EU) legislation to address the risks of nanomaterials. CIEL states that the non-governmental organizations’ (NGO) proposal was prompted by the European Commission’s (EC) October 3, 2012, Communication on the Second Regulatory Review on Nanomaterials. The Communication describes the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program as “the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures” and notes that “more specific requirements for nanomaterials within the framework have proven necessary.” The NGOs maintain that further regulatory action is necessary, and recommend a “nano patch” for REACH, including an obligation for all nanomaterials to be considered distinct from their non-nanoscale counterparts and substantially lower volume thresholds for registration of nanoscale substances. The NGOs also call for an EU-wide registry for all nanomaterials and products on the market.


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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. 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.”


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The Center for International Environmental Law (CIEL) published a report on February 6, 2012, entitled Just Out of REACH: How REACH Is Failing to Regulate Nanomaterials and How It Can Be Fixed. According to CIEL, there are four key gaps in the registration phase of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation:

  • REACH

The European Parliament (EP) passed a resolution on December 15, 2011, stating that nanomaterials must be covered by current European Union (EU) health and safety rules, based on a mid-term review of the EU’s 2007-2012 health and safety at work strategy. The resolution, which was adopted with 371 votes in favor, 47 against, and 15

On November 23, 2011, the European Union (EU) Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for “problematic” substances. The proposed legislation states that there is “scientific uncertainty” about the safety of nanomaterials, and “to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.” The proposed legislation calls on the European Commission (EC) to “regularly review the provisions on nanomaterials in the light of scientific progress.”


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The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled “Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of ‘Nanomaterials.’” The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the

The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”:

2.         “Nanomaterial” means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm.

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

3.         By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.


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The National Nanotechnology Initiative (NNI) has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:

  • Significant discussion about environmental, health,

The European Commission (EC) announced on July 13, 2011, that European Union (EU)-funded scientists have developed risk assessment criteria for engineered nanomaterials “that will help support experts in making innovation and policy decisions.” According to the EC, findings reveal that product design can affect the unintentional release of engineered nanomaterials. The scientists suggest that the risk

The recast of the Directive on the Restriction of Hazardous Substances (RoHS) was published in the July 1, 2011, Official Journal of the European Union. The notice calls for the restriction of other hazardous substances and their substitution by more “environmentally friendly alternatives” as soon as scientific evidence is available, and taking into account the