The responses to the announcement of the nanomaterials definition for Europe are coming fast and furious now. A summary from L’Association de Veille et d’Information Civique sur les Enjeux des Nanosciences et des Nanotechnologies (L’Avicenn) is available in an Oct. 20, 2011 news item on Nanowerk (French language version is available here),

Avicenn offers a first insight into the politics hidden behind this supposedly neutral and “scientific” definition, the next obstacles and important meetings, and then concludes on the suspense surrounding the definition that France will finally adopt for the annual mandatory declaration of nanomaterials it is implementing.

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In a self-applauding press release, the European Commission announced yesterday that it finally published “a clear definition (of nanomaterials) to ensure that the appropriate chemical safety rules apply”. Nanomaterial is defined 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 nm – 100 nm.”

Here’s a list of the responding organizations (from the Oct. 20, 2011 news item on Nanowerk),

After the release of this new definition, the most active “stakeholders” have already formally responded: among them, on the side of CSOs, the European Environmental Bureau (BEE) – the federation of 140+ environmental organisations in 31 countries, Friends of the Earth Australia (FoE Australia), the Center for International Environmental Law (CIEL), the European Consumers’ Organisation (BEUC) or the European consumer voice in standardisation (ANEC); on the industrial side, the European Chemical Industry Council (CEFIC).

I posted European nanomaterials definition not good enough about the response from the European Environmental Bureau yesterday (Oct. 19, 2011). So this may seem mildly repetitive (from English language tranaslation on the Avicenn website),

• The new 100 nm upper limit

Friends of the Earth Australia, ANEC and BEUC denounce the adoption of the upper limit of 100 nm that they consider too restrictive: these CSOs would have preferred a higher threshold limit, that would have encompassed more materials. They refer to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)’s highlight of the lack of scientific basis for this 100nm limit, and to results of toxicology studies on toxicity of submicron particles over 100 nm.
As illustrated by Foe Australia, “if this definition were applied to regulation, it would mean that where 45% of particles are 95nm in size and 55% particles are 105nm in size, substances would not be regulated as nano”… at the expense of consumers and workers exposed to these substances and over whom will therefore keep hanging the threat of a risk that is assumed but not evaluated.
In response to EC consultation on its draft definition in 2010, many CSOs [civil society organizations] had argued for a threshold of 300 nm.
FoE Australia alerts to the fact that “some European cosmetics companies and North American bioactive manufacturers are reformulating their products to exploit the novel optical, chemical and biological properties of larger nanomaterials (ie >100nm) while escaping the labelling and safety assessment requirements that were anticipated for materials 1-100nm in size”.

• 50% threshold

Some organizations – including CIEL and ANEC – applaud the choice of particle number (i.e. the number of particles) rather than mass as a measuring unit for size distribution of a nanomaterial product ; in contrast, CEFIC (which had strongly advocated using weight concentration rather than particle number distribution to determine the cut-off criterion for nanomaterials) is concerned that the adoption of this definition will add unnecessary burden for companies, leading to added costs and less efficient use of resources. The Commission followed by the recommendations of SCENIHR, which had been particularly supported by ANEC in 2010.
The Commission, however, largely raised the proportion of nano-sized materials required to qualify as nanomaterial compared to what was expected: 50% or more of the particles in the number size distribution is 50 times higher than the one that was proposed by DG Environment and supported by civil society (1%) and 333 times greater than that recommended by SCENIHR (0.15%) and supported by DG Sanco.
CSOs have expressed their surprise, incomprehension and hostility to such a high threshold. For example CIEL pinpoints that even the German industry had not been so demanding: it had campaigned for a rate of 10% “only”. However, the Commission provided that “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 %”. While CIEL or ClientEarth welcome this opportunity, FoE Australia deplores that it puts a huge burden of proof on to the CSOs to demonstrate not only that certain nanomaterials can cause harm but that certain they do so as a specific proportion of particles in a sample. Showing that some nanomaterials can cause damage in itself is already very difficult by the uncertainties, the gaps in the safety science, the variability of nanomaterials and the lack of information about real life exposure. But making the same demonstration by identifying the fraction of nanoparticles in a sample that cause such harm is even more difficult, actually well beyond current scientific knowledge.

• The inclusion of aggregate and agglomerate

CIEL appreciates the inclusion of aggregate and agglomerate within the definition. CEFIC believes that this measure will make any European legislation on nanomaterials too restrictive.

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The apparent technical nature of these debates and, ultimately, the arbitrary selection of thresholds illustrate the strong political dimension at work behind the decisions made by the EC : granted, the European authorities have had to make a decision based on “sound science” – backed by consultation of scientific experts – but in the end, they mainly had to come up with a trade-off between conflicting interests of stakeholders.

Here’s how they hope the French government will respond to all of this (from the English translation on the Avicenn website),

As far as France is concerned, it is not clear at present whether the decree on the annual declaration of “substances with nanoparticle status” will use the new definition of the European Commission. In its decree, the French government might try to maintain a larger definition than the definition adopted by the Commission. CSOs are turning with hope towards French choice which will be determinant for the future: if the adopted definition is larger than that of the Commission and therefore more in line with the precautionary principle, it could serve as an example and be followed in other countries.

For anyone who may not be familiar with some recent French nanotechnology history, in the Spring of 2010 there were major nanotechnology protests in France during a series of public debates.  You can read more about them in my Jan. 26, 2011 posting, Feb. 26, 2010 posting, and followup March 10 , 2010 posting, which includes details about a French-language podcast with two Québec academics discussing the French protests.

This does clear up one question I had about European Commission (EC) jurisdictions and national jurisdictions. It seems that countries can choose to create their own definitions although I imagine they cannot be at cross-purposes with the EC definition.

On an almost final note, here’s Dexter Johnson (Nanoclast blog for the Institute of Electrical and Electronics Engineers [IEEE]) in his Oct. 19, 2011 posting,

The definition itself…well, I don’t see how it helps to narrow anything, which I understand to be one of the main purposes of definitions. It would seem that the nanoparticles that are given off when your car’s tires roll along the pavement are now up for regulatory policy (“Nanomaterial” means a natural, incidental or manufactured material containing particles…”). And due to the lack of distinction between “hard” and “soft” nanoparticles in the definition, Andrew Maynard points out that “someone needs to check the micelle size distribution in homogenized milk.”

So what is the fallout from this definition? It would seem to be somewhat less than had been anticipated earlier in the year when worries surrounded getting the definition just right because it would immediately dictate policy.

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So basically they have created a class of materials that at the moment are not known to be intrinsically hazardous, but if someday they are they now have a separate class for them. While some may see as this as making some sense, it eludes me.

As for me, I think much depends on future implementations. After all, you can have the best system possible but if it’s being run by fools, you have a big problem. That said, I take Dexter’s point about establishing a class of materials ‘just in case there could be a problem’. I really must take another look at the Health Canada nanomaterials definition.

Note: I removed footnotes from the Avicenn material; these can easily be found by viewing either the Oct. 20, 2011 news item on Nanowerk or the material on the Avicenn site.

ETA Oct. 20, 2011 1500 hours: I forgot to include a link to the ANEC response in this Oct. 20, 2011 news item on Nanowerk.