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.
The EC’s Environment and Enterprise Directorate-Generals (DG) issued separate statements in response to the NGOs’ proposal. DG Environment stated: “We regard the NGO proposal . . . as a reaction to the Commission’s recent regulatory review on nanomaterials. We are looking forward to discussing our review with all the stakeholders.” DG Enterprise released a more detailed statement, noting that the EC “does not consider appropriate at present to change the basic registration rules under REACH and the rules for when a chemical safety assessment is required under REACH.” In addition, DG Enterprise stated: “[T]he highest volume substances such as carbon black and synthetic amorphous silica, as well as the most debated substances such as titanium dioxide, zinc oxide and carbon nanotubes, have already been registered under REACH. Together, they represent the vast majority of nanomaterials on the market in terms of tonnage and sales value.”