Risks feature in EU nanotech plan

The first glimmerings of an EU strategy for addressing the health and environmental risks of nanotechnology appeared in a four-year action plan on nanotechnology published by the European Commission in June.1 But details of how existing EU chemicals regulations may be adapted to address potential risks from nanoparticles remain hazy in the extreme.

The Commission regards nanotechnology as one of the engines of wealth creation in the coming decades, and is spending hundreds of millions of euros annually to support R&D in the sector. Europe, it says, "must avoid a repeat of the 'European paradox' witnessed for other technologies and transform its world class R&D in [nanosciences and nanotechnologies] into useful wealth-generating products."

The action plan outlines a series of measures to help realise that aspiration, including a proposed doubling of EU research expenditure on nanotechnology, initiatives to promote interdisciplinary "poles of excellence" in nanotechnology, and support for the commercialisation of nanotechnology innovations.

This strong and growing momentum behind nanotechnology has raised increasing concern that humans and the environment may be exposed to products whose risks remain poorly understood. While billions of euros and dollars have supported the development and commercialisation of nanotechnology, funding for toxicological and ecotoxicological studies of nanoparticles has been limited in the extreme - though some of the few studies carried out have sounded warning bells (ENDS Report 357, pp 30-35 ).

The funding situation has lately been easing. Last winter, the US Environmental Protection Agency awarded $4 million for studies into the health and environmental risks posed by engineered nanomaterials (ENDS Report 358, p 6 ).

This April saw the launch of Europe's largest study in the field. The €12.4 million Nanonsafe2 project involves 23 partners from seven countries, including major manufacturers such as BASF and Procter & Gamble. Its goals include the development of novel detection and characterisation methods for engineered nanoparticles, measurement of exposures to nanoparticles at each stage of their life-cycles, and development of technologies for minimising both releases and exposures at industrial sites.

Looking ahead, the Commission's action plan says that risk assessment "should be responsibly integrated" into all stages of nanotechnology's life-cycle, with risk management procedures in place before mass production of engineered nanomaterials begins.

That, though, is only the aspiration. The paper is thin on specifics. It concedes that the incoming REACH regime for chemicals management may only cover "some aspects on nanoparticles produced in very high quantities". Until REACH is in place, the existing regime for regulating new substances will apply - though this has just as many loopholes allowing nanoparticles to slip through the regulatory net.

The Commission goes on to pledge that it will:

  • Identify and address safety concerns arising from the use of nanotechnologies "at the earliest possible stage".

  • Promote measures to minimise exposure of workers, consumers and the environment to "manufactured nanoscale entities", backed up by a "wide range" of studies on exposures and control methods.

  • Develop with stakeholders guidelines and standards for risk assessment of nanotechnology products throughout their life-cycles.

  • On the regulatory front, "examine and, where appropriate, propose adaptations of EU regulations in relevant sectors", paying particular attention to tonnage and other thresholds below which substances are normally exempt from regulation.

    The Commission also wants Member States to play a part in assuring the safety of nanotechnology - for example, by making inventories of uses of and exposures to nanotechnologies.

    It is also urging them to modify national laws to take into account the specific characteristics of nanotechnologies and "take nanoparticles into account" in enforcing the EU's new substances regime. These may be important statements of principle for the future, but for the moment their practical implications are far from clear.

    The action plan also emphasises the importance of "integrating the social dimension" into the development and commercialisation of nanotechnology - through "effective dialogue with all stakeholders, informing about progress and expected benefits, and taking into account expectations and concerns." Critics are likely to view the Commission's approach as skewed towards more effective communication about nanotechnology to the public, with little trace of the "upstream engagement" model which has begun to get a purchase in the UK (ENDS Report 354, p 18 ).