EC Explains Nanomaterials-as-Chemicals View

The European Commission October 3 asserted that nanomaterials should be regulated in a similar manner as chemical substances in its Communication on the Second Regulatory Review on Nanomaterials. Noting that risk assessment should be performed on a case-by-case basis, the Commission proposed that REACH (Registration, Evaluation, Authorisation, and Restriction of Chemical Substances) would serve as the best framework for the future risk management of nanomaterials. REACH, which went into force in June 2007, currently acts as the overarching framework for the regulation of all chemical substances in the EU.

In order to help facilitate the future regulation of nanomaterials, the Commission announced that it will create a web platform “with references to all relevant information sources, including registries on a national or sector level.” This platform is intended to help policymakers in future legislation involving nanomaterials. In addition, the Commission will be launching an impact assessment initiative in order to increase transparency and ensure regulatory oversight of all nanomaterials, including those that are not addressed by current regulations.

The EC’s conclusions are based on the knowledge and opinions of the EU Scientific and Advisory Committees, which concluded that nanomaterials are similar to normal chemical substances in that some may be toxic while others are not. Therefore, the challenge facing the Commission is to establish reliable methods for the detection, categorization, and analysis of toxic and nontoxic nanomaterials.

The EC Communication noted that the total quantity of nanomaterials on global markets is currently estimated at 11 million tons, with a market value of approximately €20 billion. The global market volume of products based on nanomaterial technologies is expected to grow from €200 billion in 2009 to €2 trillion by 2014. In addition, the study found that there are approximately 300,000-400,000 jobs in the EU that can be directly attributed to nanotechnologies.

The staff working paper accompanying the discussion identified a broad number of nanomaterials currently on the EU market, and its detailed explanations on their properties and uses can be found in Annex 2. The working paper also notes that about 99.9% of nanomaterials on the market are identified as “traditional” high-volume types, produced in quantities exceeding 1 ton per year. These “traditional” nanomaterials include substances such as carbon black which is used in rubber production and synthetic amorphous silica which is used as an anticoagulant in foodstuffs.

The Commission is planning to review legislation for consumer products with which nanomaterial exposure may be particularly high, such as cosmetics, biocides, and novel foods. As well, the EC launched a study on nanomaterials in the workplace, which is expected to produce a final assessment by 2014. The Commission expects that if new risks are identified, they can be sufficiently handled through current EU product safety tools, including the RAPEX system or the General Product Safety Regulation.

The full text of the communication is available online at ec.europa.eu/nanotechnology/pdf/second_regulatory_review_on_nanomaterials_-_com(2012)_572.pdf.

The full text of the staff working paper is at ec.europa.eu/nanotechnology/pdf/second_regulatory_review_on_nanomaterials_-_staff_working_paper_accompanying_com(2012)_572.pdf.