Lobbyists 'fuelling confusion' on nanotech, EU warns

Rasmus Kjeldahl, executive director of the Danish Consumer Council, said it is not a question of being "for or against" nanotechnology, but rather debating how it can be used. He said that in terms of communicating risk, the nanotech situation has parallels with genetically modified foods. 

The question of regulating nanotech was central to the TACD conference, which was run in conjunction with European consumers' organisation BEUC.

Dr Robert Falkner  of the London School of Economics said the EU and US had decided to work within existing regulations rather than draft nano-specific legislation. He said authorities on both sides of the Atlantic are moving in the same direction in terms of international cooperation, and are working to fill gaps in current regulations. 

Falkner, who will publish a book in September on regulating nanotechnology in the EU and US, said that despite some similarities, there are also differences which will continue to grow as systems develop. 

"In Europe, there is a greater acknowledgement of the need to adapt legislation, as can be seen from the discussion on REACH and the Cosmetics Directive," said Falkner, noting that the US has no such plans. 

He cited labelling as the biggest area of divergence, saying the EU is leaning towards nano-specific labelling of food and cosmetics, while the US appears to be steering clear of going down this road. 

Jean-Francois Roche, who has responsibility for novel foods at the health and consumer arm of the European Commission, said current EU food legislation covers nanotech even if it is not explicitly mentioned. Nanomaterials represent a significant change and therefore require pre-market authorisation. "If it is a new substance, a new evaluation is required," he said. 

His colleague Juergen Vogelgesang, who is responsible for non-food applications of nanotechnology at the Commission, said the general requirement that products on the European market should be safe applies to all products. 

Dr Jennifer Sass, senior scientist at the Natural Resources Defence Council, said she does not subscribe to the definition of nanotechnology which limits its scope to substances smaller than 100 nanometres. She said toxicological properties rather than size is the most important factor. 

Sass said that the lack of information on how nanomaterials behave does not mean that educated assumptions cannot be made as to their likely safety. She said it is known that very small materials are more likely to penetrate biological tissue, and that a large surface area to mass ratio increases the potential for chemical reactivity. 

"If you know nothing about toxicology you can at least presume nanomaterials are more bioavailable and chemically active. I don't think you need a full suite of toxicology tests to wonder whether something that feels and looks like asbestos might behave like asbestos," she said. 

Regulators should review nanomaterials as if they were new, according to Sass, who noted that the Environmental Protection Agency in the US now considers nanosilver to be a new substance. She also pointed out that nanosilver is regulated by the authority in charge of pesticides whereas other nanomaterials are not. 

Linda Tollefon of the US Food and Drug Administration said the size of particles can affect biological interactions but it does not always do so, and nanomaterials do not always behave in predictable ways. 

"Current knowledge does not support the contention that nano-containing products are necessarily more dangerous than those without."

She said the public health benefits of nanotechnology are not given enough attention, particularly the potential applications to drug delivery. A taskforce report in 2008 said the FDA already has the tools to assess nanotechnology and no additional legislation is necessary. 

"We believe no new regulations are needed at this time and we not in the process of preparing any." However, Tollefon noted that the administration is reviewing whether existing industry guidelines are adequate. 

Laurent Selles, of the European Commission's directorate-general for enterprise, said manufacturers would be given three-and-a-half years to adapt to the recast Cosmetics Diretive which covers nanomaterials. 

The emphasis has been on in-market surveillance as no pre-market authorisation is needed for cosmetics, he said. However, he said every effort would be made to apply current legislation to nanotechnology. 

"Before creating new tools, we should see if existing tools can be used and, of course, we can adapt existing regulation if necessary," Selles said. 

Henrik Laursen of the Commission's environment department said the REACH directive on chemicals requires manufacturers, importers and downstream users to ensure substances do not adversely affect human health or the environment. This applies to nanomaterials even if they are not explicitly mentioned. "Nanotechnology is so new that there were no real concerns expressed when REACH was being drafted," Laursen noted. 

For practical and cost reasons, there is a grace period which gives a longer adjuatment time for REACH compliance, depending on the amount each material that is produced. This has caused some consternation amongst consumer groups, who point out that the small quantities of some nanomaterials being produced means they will be exempted from REACH for most of the coming decade. 

"We may have some problems in terms of nanomaterials produced in very small volumes," Laursen acknowledged. "The phase-in deadline means low-volume nanomaterials will only be covered by 2018." 

He said the Commission would review the situation and, if necessary, adapt legislation, including REACH. "We may at some stage need to revise REACH to take account of technological developments." He suggested that the chemicals industry should be proactive and may be interested in registering substances produced below the one tonne cut-off point, just to demonstrate goodwill and control. 

Steffi Freidrichs, director of the Nanotechnologies Industries Association, said nanotechnology was not a single industry and never would be. She said nanotechnologies add value across almost every industry. 

Freidrichs said companies go to great lengths to ensure products are safe and this is essential to protecting corporate reputations. 

However, the inherent difficulties in risk assessment for nanotechnologies have proved challenging and have practical implications for insurance firms, according to Thomas Epprecht, director of underwriting products at the Swiss Reinsurance Company. 

He said insurers need to assess risk but the technological leap that nanotechnology has brought means a major knowledge gap has opened. "Novelty and complexity creates uncertainty, and uncertainty limits our appetite for risk," he said. 

Epprecht said nanotechnology risks are currently insured and will continue to be, but insurers will try to limit their exposure by careful selection. He said one company had refused to insure nanotechnology, but this was not a practical way forward. Workplace exposure, rather than the risk to consumer, remains a major issue in the insurance sector, he added. 

Professor James Bridges,  chair of the EU Scientific Committee on Emerging and Newly Identified Health Risks, said work is ongoing to determine any potential risks from nanotechnologies used in consumer goods. He said very few nanoparticles may be more hazardous than in other physico-chemical forms. 

"There is some indication that as well as local effects, smaller particles may be able to penetrate the lung and thereby reach body organs including the brain. But it cannot be assumed that around 100nm marked changes in hazardous properties occur." 

However, he said data for asbestos can be extrapolated to nanomaterials with comparable physical properties. 

Bridges also said there is not yet enough information for full life-cycle risk assessment. "We suggest a tiered approach based on the likelihood of exposure occurring to prioritise nanoparticles for detailed risk assessment. Priority needs to be given to nanoparticles where significant exposure to man and environment are anticipated."

He said insufficient attention had been given to the environmental impact of nanomaterials. "There is a lot of talk about nanomaterials in sunscreen, but what happens when it washes off?," Bridges asked. 

Caroline Cairns, programme leader for product safety at the Consumers Union in the US said there are lessons to be drawn for nanotechnology regulation from the financial services meltdown of 2008. 

Referring to the complex financial products being sold by banks and insurers, Cairns said "if you don't understand a product, don't invest in it". She also said it is clear that those who sell products cannot be expected to regulate them. 

Research by the Consumers Union found nanomaterials such as titanium oxide and zinc oxide in four supposedly 'nano-free' products. "Consumers expect products to be safe and to know how they will perform, but governments cannot act as the public expects without information," she said.