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Posted: Oct 20th, 2011
Adoption of the new definition of nanomaterials by the European Commission: first reactions and analyses
(Nanowerk News – Translation of the original article written in French available here) This Tuesday, October 18, the European Commission published its long-awaited definition of nanomaterials after a year of intense negotiations. The reactions were not long in coming, revealing power struggles so far mainly confined to Brussels area.
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.
Nanomaterial: the official definition of the European Commission
In a self-applauding press release1, 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."2.
A review of the definition is planned by December 2014 , in the light of experience and technical and scientific progress.
This definition has been awaited by industries, CSOs, and governments of member states: it will indeed serve as a reference for methods of measurement and testing of nanomaterials toxicity, and for EU (and possibly national) nano-specific regulations (especially a nano-specific Reach regulation).
At the end of March 2011, DG Environment of the Commission announced that the Commission would not provide definitive definition before several months, causing general dissatisfaction3 .
Antagonistic opinions between the various stakeholders explain the delay in the draft recommendation adoption. Several directions of the Commission were involved in the process, each subject to intense lobbying from actors with often conflicting interests: on one side DG Enterprise defending industrial interests, on the other DG Sanco and DG Environment defending positions of environmental and consumer health protection CSOs.
The definition adopted by the Commission is a trade-off between the expectations of the various stakeholders.
First reactions from civil society and chemical industry: three main points of controversy
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)4 - the federation of 140+ environmental organisations in 31 countries, Friends of the Earth Australia (FoE Australia)5, the Center for International Environmental Law (CIEL)6, the European Consumers' Organisation (BEUC)7 or the European consumer voice in standardisation (ANEC)8 ; on the industrial side, the European Chemical Industry Council (CEFIC)9.
– The 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 had argued for a threshold of 300 nm10.
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 SCENIHR11, 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%)13 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.
A supposedly scientific definition ... actually very political, resulting from power struggles between stakeholders supporting different interests
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.
CSOs regret the power imbalance between involved parties: industrial lobbies' human or financial resources are way higher than those of CSOs who can't get as much involved as industries in working groups or lobbying activities.
Within civil society though, differences in EC definition appreciations can be noted. Despite their reserves, CIEL, EEB and BEUC have welcomed the adoption of this definition, hoping it will pave the way for genuine regulation by the European Union in this field. But FoE Australia is much more critical, arguing that the text adopted by the Commission is a mockery of the democratic process of consultation and stakeholder involvement, that institutions pretend to implement. While it should encourage the consideration of environmental, health, social, and ethical issues, and guide public action according to public interest rather than the satisfaction of industrial interests, the Commission failed in its duty to give priority to the precautionary principle.
The beginning of a new adventure: problems of implementation are yet to come
David Azoulay from CIEL notes that this definition is not an end goal, but a tool for regulatory oversight of the manufacture and use of nanomaterials.
Now European institutions (and Member States if they want to) have a common definition that can be used as a reference for their potential regulations. And scientists will also be able to ensure terminology consistency for their risk assesment and management methods .
With some exceptions (notably that of Andrew Maynard14), this definition was seen by many as a prerequisite for any regulation or risk assessment process. Buonsante Vito, a lawyer for ClientEarth, says15 there should be no reason why specific data on their risks is not documented under REACH as separate substances; manufacturers and importers have no excuse not to register them and (ECHA) will be able to see more clearly which substances are nanomaterials according to this Recommendation. This definition should help to get things done.
Still, many pitfalls await the authorities responsible for implementing the regulations that will be based on this definition - including those posed by the thresholds, the inclusion in the definition of aggregates and agglomerates and of natural nanomaterials (i.e not just those manufactured), or the reliability of measurement methods16. The definition of nanomaterials is of course now stable until 2014, but the work and negotiations will go on...
Next important events on the European agenda on REACH and nanomaterials
On october 28, CARACAL will have a meeting, where these Competent Authorities for REACH and CLP will deal with nanospecific REACH implementation.
A month later, on November 22 and 23, CASG Nano (Competent Authorities Sub-Group on Nanomaterials) will in turn deepen the results of CARACAL meeting.
The French suspense: what definition for the upcoming decree on the annual declaration of "substances with nanoparticle status"?
As far as France is concerned, it is not clear at present whether he decree on the annual declaration of "substances with nanoparticle status"17 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.