Earlier this month, the European Commission (EC) released the “Communication on the Second Regulatory Review on Nanomaterials” report (the Review), along with a Working Paper on nanomaterial types and uses (the Working Paper). The Review highlighted the potential benefits of new nanomaterials and new uses, including electronics, solar panels, batteries and biomedical applications. Established uses of nanomaterials include rubber goods, fuel cells, paints and coatings, and cosmetics. According to a 2010 report by Forfás, Ireland’s policy advisory board for enterprise and science, the global market for nanotechnology-related products will soar 900% to €2 trillion ($2.7 trillion = €0.72 = $1) from 2009 to 2015. The Review also stated that nanotechnology is responsible for 300,000–400,000 jobs in the EU. The Working Paper touted the benefits of nanomaterials, which provide everything from targeted drug delivery to ways to reduce environmental harm. However, despite the potential benefits, some organizations, most notably the European Parliament, have expressed concern over the lack of regulations designed specifically for nanomaterials.

In October 2011, the EC defined a nanomaterial as “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 1–100 nm.” In certain nanomaterials that present potential environmental, health, safety or competitiveness concerns, that percentage may be as low as 1%.

The Review was prompted by a 2009 European Parliament paper that criticized the EC’s 2008 review on nanomaterials and by a 2010 request from the European Council to assess the need to implement regulation specifically for nanomaterials safety. Parliament is concerned that there is too little information on the use and safety of nanomaterials. As it currently stands, nanomaterials safety falls under the scope of Europe’s chemical legislation, REACH (Regulation, Evaluation and Authorization of Chemicals) (see IBO 12/15/06), which became effective in 2007 and will be fully implemented by 2018. Less than 2% of the 4,700 substances registered in REACH’s database are considered nanomaterials. As with all chemicals, REACH guidelines stipulate that nanomaterials imported or produced in the EU typically must be registered with the European Chemicals Agency (ECHA) to prove their safety. Under the EC Regulation 1272/2008 on classification, labeling and packaging, all substances that are classified as potentially hazardous, which include nanomaterials, must be reported to the ECHA before entering the market.

Although REACH does not specifically address nanomaterials, they qualify as “substances” under the legislation. Testing for potentially hazardous substances under REACH, however, is not done on a case-by-case basis. This has prompted concern from some organizations, such as the European Parliament, that believe that the current risk assessment procedures for nanomaterials are insufficient. There are several challenges involved with nanomaterials risk assessment described in the Review. Nanomaterials come in many forms, such as nanopowders, nanosuspensions, nano-aerosols, nano-emulsions and nanocomposite materials. Under REACH, these multiple forms all undergo the same type of testing. Also, nanomaterials are difficult to monitor because of their small particle size and low concentration levels. Detecting nanomaterials in cosmetics, food, waste, soil, water and sludge is particularly challenging. These issues are exacerbated by the fact that new kinds of nanomaterials are in early stages of development and are not addressed in recent EC reports. These nanomaterials are considered “second generation” and include targeted drug delivery systems and actuators; “third generation,” which include robotic devices and 3D networks; and “fourth generation,” defined as “molecule-by-molecule design and self-assembly capabilities.”

The Review concluded that REACH “sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures.” However, the Working Paper stated that more research should be done on risk assessment of nanomaterials on a case-by-case basis. It also stated that minimizing the risk of exposure to nanomaterials is the responsibility of an employer, in accordance with European Council Directive 89/391/EEC. Nanomaterials may have potential toxic implications, according to the Working Paper, but in experiments with nanomaterials at low doses, few effects were realized. Therefore, the Working Paper determined that no additional regulations are needed for nanomaterials at this time.

Despite not issuing nanomaterials guidelines in its Review, the EC has shown its intent to pursue research on the substances’ safety. The EU’s budget for nanosafety jumped a whopping 4650% to €30 million ($41.7 million) from 2004 to 2010. The EC has also not ruled out future possible action on nanomaterials. In its Review, the EC pledged that future legislation on nanomaterials must “ensure a high level of health, safety and environmental protection” while promoting innovation for new nanomaterials and uses. The EC’s Advisory Committee on Safety and Health at Work has established a specific Nano subgroup within its Chemicals Working Party that is drafting a paper on risk assessment and management of nanomaterials. The Review stated that the definition of nanomaterials will be incorporated into EU legislation as needed. It noted that the EC is working on ways to measure and analyze nanomaterials, adding that key challenges will be to develop validated methods and instrumentation and to assess hazards of and exposure to nanomaterials. The EC also anticipates altering some REACH annexes to accommodate nanomaterials and suggests that the ECHA establish new guidance for nanomaterials after 2013.

Nanotechnology is important to the EU economy. According to a 2011 report by the High-Level Expert Group on Key Enabling Technologies, the EU accounts for 27% of public nanomaterials funding, 33% of nanotechnology publications, 17% of nanomaterials patents and 15% of production of materials based on nanotechnology. The EC will continue to assess developments in nanomaterials safety research and will present its findings to Parliament, the European Council, and the European Economic and Social Committee by 2015.