Debate or regulate? – Europe’s Struggle with Nanomaterials

Nanotechnology, the science of controlling molecular structures comprised between 1 and 100 nanometres, has recently caused a number of difficulties to policy-makers and legislators in the European Union. Due to their size, which gives them specific properties or effects, nanomaterials are widely used in consumer products, such as sunscreen, textile or foodstuff. Nanomaterials are present in various industrial sectors such as construction, automobile, packaging, chemistry, energy, environment or health.

Concern about how to regulate the wide-ranging presence of this ‘new’ technology has spread over the EU institutions, reflecting the growing importance of the precautionary principle. The precautionary principle included in the EU Treaties as a foundation for environmental policy aims at launching action to prevent or minimize a high level of harm, even when the absence of scientific certainty makes it difficult to predict the likelihood or scale of harm occurring. For the moment, no specific regulatory action has been taken on nanomaterials. In the EU, nanoparticulate substances are regulated as any other form of chemical substances by the main chemicals legislation, REACH (Regulation EC/1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals). REACH addresses all types of substances, independently of their size, shape or physical state. However, nanomaterials often display different chemical, physical, and biological characteristics than the larger form of the same substance, highlighting the need for specific nano-policies.

To start the regulatory process for nanomaterials, and to accurately set requirements for their use, marketing and the occupational exposure of workers, the first step taken by the 

European institutions was to launch a definition process. Two parallel procedures have been started: one by the European Commission, which asked the Scientific Committee on Emerging and Newly Identified Risks (SCENIHR) to provide its scientific opinion for a definition of nanomaterials, and the other by the European Parliament, which requested a definition of nanomaterials from the European Commission’s Joint Research Centre.

The Scientific Committee and the Joint Research Centre have both insisted that the main element of definition of nanomaterials is the size of the material.  Nanoparticles are commonly defined as those with a size from 1 to 100 nanometres. While 1 nanometre has been acknowledged as an acceptable lower threshold, the upper threshold of 100 nanometres generates some controversy. The upper size-limit of 100 nm would certainly include all primary nanoparticles such as carbon nanotubes; leaving agglomerates of primary nanoparticles, complex nanomaterials or nanoparticles with coatings or long-chain organic compounds out of scope. The SCENIHR suggests a reference to the internal structure when mentioning the size in a definition. Both the Scientific Committee and the Joint Research Centre agree that a definition of nanomaterials should not solely be based on their sizes but further defined according to the specific policy issue being addressed taking into consideration the type and characteristics of the material, its origin or application and potential thresholds influencing the properties of the material. The Joint Research Centre also proposes the use of the term “particulate nanomaterial” instead of “nanomaterial”, as the term “material” is proposed to refer to a “single or closely bound ensemble of substances”. The definition of the SCENIHR is under consultation until 15 September 2010, before being submitted to the European Commission, which has so far adopted a very cautious approach to the issue of nanomaterials.

Meanwhile, two specific Regulations were drafted providing a definition of nanomaterials in policy fields where nanomaterials are strongly present. These are the new Cosmetics Regulation EC/1223/2009 and the proposed Novel Foods Regulation (COM [2007] 872 final). Cosmetics Regulation EC/1223/2009, for example, defines nanomaterials when referring to cosmetics as “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”.

While the European Union is in the process of defining what a nanomaterial is, France has adopted another approach by setting specific requirements applicable to nanomaterials. The long-awaited Grenelle 2 Law, which was presented as France’s environmental New Deal in 2007 and adopted in July 2010, introduced a Chapter into the Environment Code related to substances in a nanoparticulate state. According to these innovative provisions, manufacturers, importers, or persons that place on the market nanoparticulate substances, mixtures containing them or materials intended to release these substances in foreseeable conditions of use are required to periodically declare the identity, quantities and uses of these substances, as well as the identity of the professional users they supplied them to. They also will be required to submit, on request of the authority, any available data on the hazards of these substances and the type of exposure they are likely to generate. This also applies to various products containing nanoparticulates such as medicinal products, cosmetics, or plant protection products. France became the first country to require such compulsory declaration.

However, despite the uniqueness of this requirement, the issue is not yet picture-perfect. The legislative requirement will need to be implemented in a future text, which leaves the French Government the power to change the meaning of these unprecedented provisions. Time may pass before the French Government comes to an agreement on details such as substances included, thresholds, procedures, and enforcement. In addition, while the French legislation now requires manufacturers of nanomaterials to declare these substances, it does not define the term nanomaterial. Without a strict definition, manufacturers of nanomaterials could use legislative holes to avoid administrative burden.

Nanotechnology presents significant potential to provide innovative solutions for today’s world, but at the same time the health and environmental consequences of nanomaterials remain unknown. Therefore, policy responses appear to be hesitant about which stance to take on nanotechnology. The debate about the definition of nanomaterials illustrates that many steps are still needed in order to adequately regulate the specificity of nanomaterials, but rising awareness among policy-makers may allow regulatory authorities to respond quickly to any new information on the risks presented by nanotechnology.

Flore Cognat

EHS consultant

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