Nanotechnology has huge potential to provide solutions to society's challenges, but it is the scientific community's responsibility to understand the potential environmental and health effects, writes Joint Research Centre director
Nanotechnology, and more particularly nanotechnology-based products and materials, have a huge potential for providing novel solutions to many of the current challenges facing society. Tapping into this potential is likely to play a major contributory role in realising the collective targets of the European Union's Europe 2020 strategy and the associated research and innovation goals.
Notwithstanding such benefits, or the fact that engineered nanomaterials are already in use in a variety of applications, their associated health and environmental effects are not yet clearly understood. To avoid a situation in which the initial advantages may be counterbalanced by longer-term drawbacks, it is important to have prior means for evaluating any possible associated hazards and for modifying the existing regulations accordingly.
Whereas it is widely acknowledged that safety assessments of nanomaterials should follow the same principles as for other products, any identified hazards – an important element in risk assessment – need to be balanced against the overall set of risks. If there is no or insignificant exposure, at least to the general population, there are generally fewer safety concerns – hazards relating solely to the industrial manufacture of nanomaterials can be addressed by the appropriate and enforceable safety measures. An important exception perhaps concerns products coming into direct bodily contact – for instance, food, cosmetics and clothing – which should be assessed thoroughly for all potential risks.
It is the scientific community's collective responsibility to better advise European policy-makers on the opportunities of nanotechnology in order to nurture the appropriate environment for fostering innovation and allowing flexibility in risk assessment. This will require investment in the science of safety assessment to avoid unnecessary prescriptive legislation that may otherwise needlessly prevent the optimisation of the innovative exploitation of the technology.
A recent joint initiative between the European Commission's Joint Research Centre and the European Academies Science Advisory Council led to a report on the safety aspects of engineered nanomaterials and identified the priorities for further scientific investigation. Whereas the report is not aiming at establishing the actual formal guidelines themselves, it describes the key principles and issues to be taken into consideration in laying out such a framework.
One of the pivotal recommendations of the report is to ensure greater cooperation between regulatory bodies and the scientific community for agreeing the most pressing priorities. Even in the absence of definitive or sufficiently specific data, the deployment of scientifically sound and internationally recognised safety assessment methodologies is essential for managing the potentially envisaged risks, including the principle of 'safety-by-design'. The report also highlights the need to ensure that decision-making is founded on evidence-based science – one important element of which is as precise a definition as possible of what is actually meant by a 'nanomaterial'.
In relation to such a definition, the commission has recently adopted a recommendation based on advice from the Scientific Committee on Emerging and Newly Identified Health Risks and the JRC. The definition provides EU legislators with a legal reference for nanomaterials that will be axiomatic in the adoption or implementation of legislation. The definition states that nanomaterials' main constituents – 50 per cent or more of the particles in the number-size distribution – have a dimension of between one and 100 billionth of a metre. In specific cases, the threshold of 50 per cent may be replaced by one between 1 per cent and 50 per cent. The definition further states that nanomaterials can be a natural, incidental or manufactured (engineered) material that contains particles in either an unbound state or an aggregate or agglomerate.
Now that we have the new EU definition at hand, it is important for risk assessment procedures to distinguish between embedded and free nanoparticles – also recognising that the composition of the nanomaterials themselves may vary during their lifetime. It should be noted that the authors of the joint JRC-EASAC report also felt that it was important to differentiate more precisely between the unintended exposure to environmental nanoparticles – for example, from combustion or other natural processes – and the unintended and intended exposure to engineered nanomaterials.
Issues requiring urgent attention in the further exploitation of nanotechnologies include not only sustained resources for research and training, but also appropriate research governance and integrity. Product regulation has to address aspects related to sustainable disposal, degradation and recycling of engineered nanomaterials. Of similar importance is the international harmonisation of ethical, legal and societal issues, as well as quality assurance measures for correct implementation of labelling nanomaterials. Without this harmonisation, consumers are likely to mistrust nanotechnology and be less prone to consider the benefits and advantages it brings.
In conclusion, to reap the promised benefits of nanotechnology, products should be subject to the same regulatory principles and sector specific practices that exist for other commodities. The guiding principles should be safety-by-design, together with effective communication on the associated hazards, risks and uncertainties. Current knowledge on engineered nanomaterials suggests that there is only a limited amount of scientific evidence to indicate that nanomaterials present a risk for human health. However, a careful balance of risks against benefits is necessary as a precautionary measure for products that come into direct contact with the body. There is consequently a need for screening approaches to help advise policy and decision-makers on when and which nanomaterials require more in-depth testing.Elke Anklam is director of the European Commission's Joint Research Centre's Institute for Health and Consumer Protection. This article first appeared in PublicServiceEurope.com's sister publication Public Service Europe: European Union