The new definition of nanomaterials adopted by the European Commission will leave products that pose nano-risks effectively unregulated and people and the environment at risk.

After many months of consultations the European Commission has released its definition of nanomaterials. The definition reflects intense industry lobbying and rejects scientific advice. It uses a threshold for nano-content – 50% of the number of particles in a sample – that is 333 times greater than that recommended by the Commission’s own Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR recommended 0.15%). It also entrenches 100nm as an upper limit for nanomaterials, despite SCENIHR warning that there is no scientific basis for this limit, and early toxicological studies finding nano-specific toxicity in particles larger than this.

The Commission recommends that its definition underpin future regulation of nanomaterials, including in decision making about whether or not a given product should trigger nano-specific health or environmental assessment.

If this definition were applied to regulation, it would mean that where 45% of particles are 95nm in size and 55% particles are 105nm in size, substances would not be regulated as nano. To put that another way, despite senior scientists recognising that nanoparticles pose new risks that are not seen in larger particles of the same substance, even if nearly half a sample is in nano-form, it will trigger no new safety assessment or labelling.

Manufacturers of sunscreen, cosmetic, foods, paints, cleaning products, textile additives and others that use ingredients with these particle sizes would not have to conduct any new safety assessment where the substance had a history of use in bulk (larger particle) form, nor to label ingredients as ‘nano’.  In the workplace, there would be no expectation that Material Safety Data Sheets would give nano-specific information.

The ‘loophole’ in the European Commission definition that says “where warranted by concerns for the environment, health, safety or competitiveness a threshold below 50% may be set” will be ineffective in practice. It puts a huge burden of proof on to the community to demonstrate not only that certain nanomaterials can cause harm but that certain nanomaterials can cause harm as a specific proportion of particles in a sample.

Given the uncertainties, the gaps in the safety science, the variability of nanomaterials and the lack of information about real life exposure, demonstrating harm associated with a particular nanomaterial is already extremely difficult. Identifying the fraction of nanoparticles in a sample that cause such harm is well beyond current scientific knowledge.

Friends of the Earth Australia (FoEA) is also very concerned that the Commission has backed an upper size limit of 100nm in its definition. Recognising that particles greater than 100nm in size still display nano-specific toxicity (see studies cited here and here), NGOs including FoEA have called for the definition to include particles up to 300nm in size. Senior toxicologists have also made clear that larger nanoparticles pose nano-specific risks, for example see evidence from Professor Ken Donaldson to the UK House of Lords Inquiry in 2009.

It appears likely that manufacturers of nano-products will reformulate their products to take advantage of the narrow 1-100nm regulatory definition of nanomaterials. We have already heard that some European cosmetics companies and North American bioactive manufacturers are reformulating their products to exploit the novel optical, chemical and biological properties of larger nanomaterials (ie >100nm) while escaping the labelling and safety assessment requirements that were anticipated for materials 1-100nm in size.

Given the extraordinary decision by the European Commission to support this definition, we now question whether nano-specific regulations in development can credibly protect people and the environment from new nano risks.

In the wake of the worldwide backlash against biotechnology, low levels of public trust in science and technology governance appeared to prompt a rethink of governments’ approach to emerging technologies. A seemingly endless series of workshops and conferences was dedicated to examining ‘what went wrong’.

To avoid a repeat of the experience with genetic engineering, governments made unprecedented commitments to ‘upstream’ public engagement on nanotechnology, to early management of health and environmental risks, and to addressing social and ethical dimensions alongside basic safety risks. This time, we were assured, technology development would not just reflect industry interests, but be guided by public preferences and priorities, and a commitment to ‘get the balance right’.

Senior scientists from the United Kingdom’s Royal Society and risk assessors from global reinsurance agent Swiss Re added their voices to calls for strong, precautionary action on nanotechnology back in 2004. The Royal Society called for nanomaterials to be regulated as new chemicals, to face safety assessment prior to being used in products, for mandatory labelling, and for factories and research laboratories to treat nanomaterials as if they were hazardous.

Swiss Re warned that nanotechnology could repeat the asbestos tragedy, where serious harm to health manifested decades after exposure. Swiss Re called explicitly for precaution “In view of the dangers to society that could arise out of the establishment of nanotechnology, and given the uncertainty currently prevailing in scientific circles, the precautionary principle should be applied whatever the difficulties”.

The European Commission’s definition makes a mockery of claims to precautionary management of nanotechnology risks. Countries that wish to avoid being seen as selling out science to industry interests would do well to avoid adopting it.


A press release from the European Environment Bureau, the peak environmental NGO in Europe, can be read at: