Report: “Regulation under uncertainty raises fundamental questions”
By Ophélie Spanneut | Tuesday 24 July 2012
Is it possible to regulate nanotechnology? It seems extremely doubtful given the results of a study
(1) carried out by the European Parliament’s Science and Technology Options Assessment (STOA) unit and entitled ‘NanoSafety - Risk governance of manufactured nanoparticles’. For now, disagreement reigns over the definition, the methodology for risk assessment, even the appropriate regulatory framework.
The study was requested in 2009 by Malcolm Harbour (ECR, UK), a member of STOA. It was fuelled by discussions between experts and MEPs and was presented on 10 July, giving them food for thought on the impact of nanotechnology.
The study presents the state of play of research and the risks posed by nanomaterials for the environment, health and security. It notes the “still unsolved scientific problems and uncertainties as well as technical challenges”. At the forefront of which is the absence of a definition for ‘nanomaterial’.
Scientific committees and standardisation bodies have proposed definitions, but they often contradict each other, and are generally written from a scientific rather than a legal point of view. The Joint Research Centre (JRC) recently proposed defining them between one and 100 nm (nanometre). This definition is contested, namely by the European Consumers’ Organisation BEUC, which worries that particles of over 100 nm will escape all regulation. They are therefore asking to refer to functionality, rather than size. The definition was called a lawyer’s paradise by the Advisory Committee on Hazardous Substances (ACHS), in reference to the fact that it would be extremely difficult to apply.
RISK ASSESSMENT “NOT FEASIBLE”
If insoluble particles are deposited in a certain area of the lung, they can accumulate in particular areas where they may even pass membrane barriers and enter individual cells, causing biological or toxicological effects. At high doses, carbon nanotubes or nanosilver particles, for example, may lead to pathological conditions and can cause toxic effects.
“The assumption that the move to the nanoscale implies not only novel material properties but also entails novel environmental and health risks was confirmed on a scientific basis”.
But the assessment of the toxicity is limited by the methodology. There is a lack of assessments in realistic conditions of exposure. We still do not know the potential effects of nanoparticle delivery to products during their life cycle. Thus, risk assessment is “at this time (and most probably in short and medium-term) not feasible or certainly not scientifically reasonable and only preliminary”.
Nanomaterials are increasingly appearing in consumer products, and are regulated on a case per case basis, according to the legislative revisions. From July 2013, their use in cosmetics will have to be specified. In 2014, this will also be the case for food products and biocides.
The Commission is intent on promoting their industrial production. With the strategy on new technologies, presented on 26 June, Commissioner Antonio Tajani (enterprise and industry) wants to exploit the growth and employment potential they represent.
So how to regulate? By adapting existing legislations and namely Regulation 1907/2006 on the registration, evaluation, authorisation and restriction of chemical substances (REACH)? Or should a specific framework be developed? Most of the political stakeholders are in favour of the former. Yet, “this approach has a number of challenges, limitations and potential gaps, since existing legislation is not designed to accommodate some specific aspects of nanomaterials”.
Many points need to be resolved as a matter of urgency: definition, identification and resolution of undesirable effects, adjustment of test methods, etc.
One nanometre is 10,000 times smaller than the width of a human hair. At this scale, materials acquire new physical properties. Nanosilver particles, for example, are used for anti-bacterial purposes and come in various forms: in anti-odour socks, in bandages, baby changing facilities or refrigerators.(1) The study is available at europarl.europa.eu/stoa