Nanotechnology – Could the internet allow poorly regulated nanocosmetics into the EU?

The risk of unsafe nanoparticles making their way over the Atlantic to the EU in cosmetic products is unlikely through standard channels, but there is a risk regarding internet sales, warned Gerald Renner, director of science and research at European Cosmetics Association Colipa.

Speaking during a trans-Atlantic conference on nanotechnology in Brussels Renner said: “Importers have to follow the same rules as EU manufacturers and a US company has to have somebody in Europe who is responsible for ensuring this happens.” He said the problem would have most potential to arise from “direct internet sales when a consumer could purchase a product that would not necessarily be in line with the EU cosmetics regulation”.

However, Renner said that the recently agreed recast of the EU cosmetics regulation also defines the need for companies to provide a “responsible person” to deal with products supplied via the internet, though he admitted he was “not sure how this will work in practice”.

In general, Renner said: “The main nanoproducts used in the EU, namely titanium dioxide, zinc oxide and silica, are the same as those used in all regions of the world.” It is “only at the fringes” that potentially more dangerous products such as “buckyballs” are used, he claimed. “These are niche markets found mainly in countries such as Japan.”

He suggested that the EU’s stricter regulatory framework could help shed light on the safety of products such a buckyballs. “These products can be sold in the EU if they have a full safety dossier – some of the niche products might have to do a lot of work to show whether they are safe and this is not a bad thing.”

The one area most likely to cause controversy between the EU and the US in the future, according to Renner, is labelling as the updated EU cosmetics regulation will require companies to label nanomaterials in the ingredients list on the packaging, a procedure not required in the US. “It is not clear whether an EU company could label an ingredient as ‘nano’ in the US or whether this would be seen as mislabelling,” said Renner.

This problem and other trans-Atlantic differences will be discussed by the International Cooperation on Cosmetic Regulation (ICCR) group at its next meeting in Tokyo in September. “We will look at how we can make sure that we [the EU and the US] are not going in different directions,” he said. “There are more administrative steps for companies using nanomaterials in the EU and the ICCR will play a role to make sure that in the end the practice is the same in both regions even if the regulatory approach is not. For example, under the recast, manufacturers in the EU will have to notify [the Commission before adding nanomaterials to a beauty product] – US manufacturers may not have to do this, but they could be asked to provide the same data.”

Robert Madelin, director general of the European Commission’s health and consumer directorate general (DGSanco), told conference delegates that the EU’s actions were indeed “driving increasing attention globally to concerns [about nanomaterials].” Linda Tollefson, director of the Europe regional office for the US Food and Drink Administration (FDA), agreed that “we have a lot to learn from working together, but we will not let the EU run the show.”

While the EU has opted to update its cosmetics regulation to take account of new technologies such as nanomaterials, Tollefson was clear that in the US “we agree that no new regulations are needed at this time” and that “we will continue to study products on a case by case basis”. She added that research by the FDA had concluded that “the challenges posed by nanotechnology are not unique, but similar to those posed by other new technologies. Just because nanoparticles are small does not mean their safety considerations are unique.”

James Bridges, professor of toxicology and environmental health at Britain’s University of Surrey and chair of the EU scientific committee on emerging and newly identified health risks, agreed. While “there is no conclusive evidence that [nanoparticles] have unique properties,” recent research has suggested that they could have unwanted effects. “Nanoparticles may affect protein folding” and could therefore be responsible for certain health problems, and they may also provoke “electron release on the activation of a product” – for example, when cream is put on the skin, he said.

Renner continued: “As regards cosmetics we believe we have moved out of uncertainty and to a situation where we know a lot. Thanks to a survey we carried out in 2008 we know what ingredients are used in our sector, the characteristics of these nanomaterials and their safety profiles.”

However, Bridges said the hazards and risks of “very few nanoparticles have been studied” and called, along with the majority of the speakers, for more and better data to analyse these products and create a “risk benefit framework” for them.

The call was echoed by the Trans-Atlantic Consumer Dialogue group, which co-organised the conference. In a statement it urged “the EU and the US to convene intensive consultations among the relevant regulatory bodies on both sides of the Atlantic to exchange data and establish sound approaches to assessing and preventing risks”.