Archive – 2011: Adoption of the definition of nanomaterials by the European Commission

Adoption of the definition of nanomaterials by the European Commission: first reactions and analyses

By the AVICENN team – Last modification in October 2011

Nanomaterial: the official definition of the European Commission

In a self-congratulatory press release¹What is a “nanomaterial”? The European Commission is pioneering a common definition European Commission press release, 18 Oct. 2011, the European Commission announced yesterday that it has finally established “a clear definition (of nanomaterials) to ensure that all appropriate chemical safety rules are applied”.
The nanomaterial is thus defined as:

• “a natural, incidental or manufactured material,
• containing free particles, in an unbound state or as an aggregate or as an agglomerate,
• 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”²See the full text here: Commission Recommendation of 18 October 2011 on the definition of nanomaterial, European Commission, Oct. 2011; see the French version published in the OJEU here; see the questions and answers in English here.

The Commission’s text included a provision for a review of the definition by December 2014, based on initial feedback as well as technical and scientific progress. This definition has been long awaited by the industry, associations and public authorities in the Member States: it should serve as a reference for measurement methods and tests on the toxicity of nanomaterials, and for the drafting and promulgation of European regulations (and if applicable national regulations) specific to nanomaterials. It paves the way for a Reach-Nano regulatory framework. (As of mid-2019, this revision had still not been published).

The end of a long negotiation process

In October 2010, the European Commission submitted for public consultation a “Draft Recommendation on the Definition of Nanomaterials”. 200 responses to the consultation were provided by industrialists, academics, civil society associations, citizens, etc. At the end of March 2011, the Commission’s Directorate-General for Environment (DG ENV) announced the fact that the Commission would not provide a final definition for several months, causing widespread dissatisfaction³The Commission stumbles over the definition of nanotechnology, Euractiv, 1 April 2011.

The delay in adopting the draft recommendation was caused by differences of opinion among the various stakeholders. Several Commission directorates were involved in the process, each subject to intense lobbying from stakeholders with often incompatible interests: on the one hand, DG Enterprise defending industrial interests, and on the other hand, DG Environment and DG Sanco defending the positions of environmental and consumer health protection associations respectively.

The definition adopted by the Commission is the result of a trade-off between the expectations of the different parties.

Initial reactions from civil society and the chemical industry: three main points of controversy

The day after the publication of this new definition, the most active “stakeholders” have already reacted officially: among them, on the civil society side, the European Environmental Bureau (BEE)⁴Nano definition too narrow says EEB, European Environmental Bureau press release, 18 October 2011 – which brings together over 140 NGOs in 31 countries, Friends of the Earth Australia (FoE Australia)⁵European Commission caves to industry pressure on nano definition, leaves people and environment at risk, Friends of the Earth Australia, 19 Oct. 2011, the Center for International Environmental Law (CIEL)⁶CIEL welcomes new EU definition of nanomaterials as a necessary step towards assuring safety, CIEL, Oct. 2011, the European Consumers’ Organization (BEUC)⁷BEUC welcomes adoption of nano-definition but calls for proper regulation of safety risks, BEUC, 19 Oct. 2011 or the European Consumers’ Association on Standardization (ANEC)⁸Nanomaterials: a very small step on the long and bumpy road to consumer safety, ANEC, 19 Oct. 2011 and on the industrial side, the European Chemical Industry Council (CEFIC)⁹Practical nanomaterials definition needed to push forward next great innovation breakthroughs, CEFIC, Oct 18. 2011.

I – The 100 nm threshold

Friends of the Earth Australia, ANEC and BEUC denounced the adoption of the 100 nm threshold as too restrictive: these associations would have liked a higher threshold, which would have allowed to take into account more materials¹⁰The associations rely on the considerations of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), which stressed the lack of scientific basis for this 100 nm limit, as well as on the results oftoxicological studies reporting the toxicity of submicron particles exceeding 100 nm. As illustrated by Friends of the Earth, if this definition were to be applied to the regulation, it would imply that substances composed of 45% of 95nm particles and 55% of 105nm particles would escape the regulation applicable to nanomaterials and would not be subject to possible labeling or health assessment obligations. All this at the expense of consumers and workers exposed to these substances, who will continue to be threatened by a supposed but unassessed risk. In response to the Commission’s consultation on its first definition proposal in 2010, many associations had advocated for a threshold of 300 nm¹¹NGO recommendations for the European definition of nanomaterials, 23 Nov. 2010.
Friends of the Earth Australia pointed out that European cosmetic brands and US bioactive manufacturers are already modifying their products to exploit the novel optical, chemical and biological properties of nanomaterials larger than 100nm to avoid the labeling and safety assessment requirements anticipated for materials with a size between 1 and 100 nm.

II – The 50% threshold

Some organizations – including CIEL and ANEC – applauded the choice of the number of particles, rather than their mass, as the unit of measurement for nanomaterials while CEFIC fears that the adoption of this definition in regulations will result in a significant increase in costs for companies. The Commission followed here the recommendations of SCENIHR¹²Scientific Basis for the Definition of the Term nanomaterial, SCENIHR, December 8, 2010, backed by ANEC in 2010.

However, the Commission has significantly increased the proportion of nanosized materials required to qualify a substance as a nanomaterial compared to what was previously planned: the rate retained – 50% of nanosized particles by number in the material considered¹³Schematically, the particles of which the nanomaterial is composed have one or more dimensions between 1 and 100 nm for at least x% of the distribution of their number according to their size; the debate concerned the x%: 0,15, 1… then 50 – is 50 times higher than the one proposed by DG Environment and advocated by civil society (1%), and more than 333 times higher than the one defended by SCENIHR (0.15%)¹⁴ see note 4 and supported by DG Sanco.
Associations have expressed their surprise, incomprehension and hostility to such a high threshold. CIEL notes, for example, that even the German industry had not asked for so much: it had argued for a rate of about 10% “only”.

To mitigate, the Commission stated that in case of concerns about environmental or health risks, this rate could be lowered below 50% – but not raised – at least before 2014. While this measure is welcomed by CIEL or ClientEarth, Friends of the Earth Australia denounced the fact that the burden of proof of the toxicity of the materials on which this concern is based will then fall on the associations. Demonstrating that certain nanomaterials can cause damage is already very difficult because of the many scientific uncertainties, the lack of reliable methods and instruments for risk assessment, the variability of nanomaterials and the lack of information on actual exposure to these materials. To do this same demonstration on a determined proportion of nanoparticles in a sample, is therefore a near impossible task.

III – The inclusion of agglomerates and aggregates

While CIEL welcomed the inclusion of agglomerates and aggregates in the definition, CEFIC considered that this measure would make European legislation on nanomaterials too restrictive.

A scientific definition… but mostly political

The apparent technicality of the debates and the ultimately arbitrary nature of the selection of thresholds illustrate the strong political dimension at work behind the decisions taken. The European authorities had to make a decision on scientific grounds – thanks to the scientific insight of the experts called upon – but above all to arbitrate between the interests of divergent stakeholders.
The associations regret the imbalance between the forces at work – Industrial lobbies have disproportionate means compared to those of civil society, which does not have the human or financial resources to take as active a part as industry in working groups or lobbying activities with the Commission.
It should be noted that, within civil society itself, there are nuances in the assessment of the definition adopted by the European Commission. CIEL, EEB and BEUC have, despite their reservations, welcomed the adoption of this definition, hoping that it will pave the way for real regulation by the European Union in this area. On the other hand, Friends of the Earth Australia was much more critical: it believed that the text adopted by the Commission is an insult to the democratic process of consultation and involvement of stakeholders, which the institutions claim to have. The Commission, which was supposed to take into account environmental, health, social and ethical considerations, and to guide public action by considerations of general interest rather than by the satisfaction of industrial interests alone, failed in its duty to give priority to the precautionary principle.

The beginning of a new adventure: implementation problems to be expected

David Azoulay of CIEL reminded us that this definition is not an end in itself, but a necessary tool for regulating the manufacture and use of nanomaterials.
From now on, the European institutions (and the Member States if they so wish) will have a common definition to which they can refer for their possible regulations. Scientists will also be able to align the terminology of their risk assessment and management methods.
With some exceptions (notably that of Andrew Maynard¹⁵Don’t define nanomaterials, Nature, 475, 31, July 7, 2011, and Define nanomaterials for regulatory purposes? EU JRC says yes, 2020Science.org, Sept. 6. 2011), this definition was seen by many as a prerequisite for any regulatory or risk assessment approach. Vito Buonsante, a lawyer for ClientEarth, emphasized¹⁶Industry, NGOs comment on EU Commission’s nanomaterial definition, Chemical Watch, 18 Oct. 2011 that there is no longer any reason why specific data on the risks of nanomaterials should not be documented in REACH as separate substances; manufacturers and importers no longer have an excuse not to register them and the task of the European Chemicals Agency (ECHA) will be facilitated. This definition should therefore help to move things forward.
The fact remains that many pitfalls await the authorities in charge of implementing the regulations that will be based on this definition – particularly those posed by thresholds, the inclusion in the definition of aggregates and agglomerates and nanomaterials of natural origin (and not only those that are manufactured), or the reliability of measurement methods¹⁷EC adopts cross-cutting definition of nanomaterials to be used for all regulatory purposes, 2020Science.org, Oct 18. 2011.
Since 2014, the definition of nanomaterials has been under review, with work and negotiations continuing…

The next important meetings on the European agenda

A meeting of CARACAL, the competent authorities for the implementation of REACH and the CLP regulation on classification, labeling and packaging of chemical substances and mixtures, took place on October 28, 2011. The application of REACH to nanomaterials was be on the agenda.
The issue should have been further explored a month later, on November 22 and 23, at the meeting of the CARACAL sub-group specifically dedicated to nanomaterials, the CASG Nano (for Competent Authorities Sub-Group on Nanomaterials).

What will be the definition for R-Nano in France?

In France, it is not clear at this time whether the decree on the annual declaration of nanoparticulate substances would be based on the European Commission’s new definition. The French government could try to maintain a definition that allows for more nanomaterials to be included in its regulations than the definition adopted by the Commission. All of civil society’s hopes are therefore focused on the current French decision, which will be decisive for the future: if the definition chosen is broader 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.