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Opposing Reactions on the European Definition of Nanomaterials

In response to the European Commission's Recommendation on a Definition of Nanomaterials, the European Chemical Industry Council (CEFIC) stated that the definition is too broad, saying it would add 'unnecessary burden' as well as legal uncertainty for companies. In addition fears were expressed that too many products would fall under the scope of the definition as, for example, mineral pigments used in paints and others that have already been on the market for decades. While the chemical industry agrees with the Commission that the definition should not be swayed by hazard or risk but be used in a 'neutral' manner, CEFIC points out that the definition should focus on solid particulate substances 'using weight concentration rather than particle number distribution to determine the cut-off criterion' for nanomaterials. According to CEFIC, industry is also worried that the lack of standardised measurement techniques would further add to legal uncertainty.

By contrast the European Environmental Bureau (EEB), a federation of environmental citizens organizations, condemned the definition as 'too narrow', indicating that industry has been favored over the scientific advisors of the Commission itself. According to EBB's officer on nanotechnology, Louise Duprez, the Commission has taken too long for coming up with the definition, creating an impasse for risk assessment and control, which has in turn prompted France to develop its own initiative. More member states may follow France's example, which could lead to even more uncertainty for industry and consumers. A major sticking point for the EEB in the definition remains the threshold; according to the EEB's statement on its website, it had advocated a '1% threshold of the particle number size distribution'.

Even greater criticism was voiced by the Australian Friends of the Earth (FoE); the NGO expressed that the new definition would 'leave products that pose nano-risks effectively unregulated and people and the environment at risk' primarily because the 50% threshold for nano-content in the definition appears to be 333 times greater than the one the Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) had recommended in December 2010; the 100 nm upper limit for nanomaterials. FoE furthermore sees a 'loophole' in the definition that would allow companies to 'reformulate their products [containing nanomaterials greater than 100nm], thus escaping labeling and safety assessment requirements'. FoE Australia perceives the new definition as a blow to the scientific and consumer community and concludes that the definition 'makes a mockery of claims to precautionary management of nanotechnology risks. Countries that wish to avoid being seen as selling out to science to industry interests would do well to avoid adopting it'.

From across the Atlantic, Professor Andrew Maynard, Director of the Risk Science Center at the University of Michigan in the United States, notes the definition may be too indiscriminating in regards to covering both incidental and natural nanomaterials, as well as soft and hard nanoparticles, such as nanoscale micelles in milk. Maynard maintains that only risk assessment is capable of determining whether a nanomaterial is hazardous and in the current state of the definition, the costs to industry that would be incurred from the requirement to provide more information might very well outweigh the benefits consumers would gain from it.

Nanoclast's Dexter Johnson blogs about the presumable inutility of the released definition and questions whether its outcome is based on PR or real regulatory policy. Having singled out nanomaterials as 'not intrinsically hazardous' in the definition, the blogger contends the Commission may have defined a separate class of nanomaterials on the premise that should they test for hazardous properties, then they should eventually come under regulatory scrutiny. Johnson views this precautionary approach as ambiguous and similar to Maynard, pokes fun at the inclusion of 'incidental' nanoparticles in the nanomaterials definition.

The Nanotechnology Industries Association (NIA) welcomes the publication of the definition for the clarity it finally provides to companies which have long been in a limbo between proactive nano-specific safety tests and the exposure to an increasing (and sometimes uninformed) criticism of nanomaterials. The NIA applauds the European Commission for its decision to significantly raise the threshold compare to the initially suggested 1%, which the NIA had warned against in its submission to the Commission's public consultation in November 2010. Given the European Commission's aim to create an overarching definition of the term 'nanomaterial', it was expected that the resulting text would raise (even diametrically opposing) criticism; appropriate exclusion and inclusion criteria based on this overarching definition will now need to be set in the vertical regulation of separate individual sectors.


Follow these link to read CEFIC's press release, to read the EEB's press release, to read the full statement of FoE Australia, to read the blog entry of Andrew Maynard, or to read Dexter Johnson's blog entry.

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