In cosmetic products, reference to “nanotechnology” usually means the use of insoluble nanoparticles as ingredients. EU legislation provides a high level of protection of human health where nanomaterials are used in cosmetic products.
According to the Regulation (EC) No 1223/2009 Art.16 (3), the manufacturer or importer of a cosmetic product has to assess and document the safety of the product prior to placing it on the market. This has to be done while taking into consideration 'the general toxicological profile of the ingredients, their chemical structure, and their level of exposure'.
This safety evaluation is then assessed by the authorities of EU countries during in-market controls. If the authorities find that the safety evaluation is insufficient to support the safety of the product, they have to take measures to enforce EU rules.
Apart from these general rules, certain groups of substances, including UV-filters, have to be permitted by the European Commission prior to their use in cosmetic products placed on the EU market. This permission is preceded by an opinion from the Scientific Committee on Consumer Safety (SCCS) which reviews submitted toxicological data. The data submitted usually has to follow the SCCS-guidelines.
In view of the safety-evaluation of insoluble nanoparticles as cosmetic ingredients, the Commission has mandated its independent risk-assessment bodies to assess whether and how existing methodologies are suitable. The opinions are available on the website of SCCS.
Insoluble nanoparticles in cosmetic products are essentially used as UV-filters or preservatives. Some minerals, if used on a nanoscale, become invisible but still absorb UV radiation. These UV-filtering substances are increasingly used for broad-band sun protection including UVA radiation. The advantage of mineral UV-filters is that they usually do not cause cutaneous adverse effects such as contact allergies.
Up until now, the Commission has permitted one mineral UV-filter usually used in its nanoscale in sunscreen products (titanium dioxide). Another substance at nanoscale, zinc oxide, has been assessed by the SCCS in 2003 as a UV-filter. The SCCS, in its opinion SCCNFP/0649/03, concluded that the safety of zinc oxide as a UV-filter had not been sufficiently demonstrated. As a result, zinc oxide has not been permitted as a UV-filter by the Commission.
In the above-mentioned opinion of December 2007, the SCCS suggested a re-evaluation of titanium dioxide to address abnormal skin conditions, as well as the possible impact of mechanical effects (e.g. flexing) on skin penetration. This opinion is being followed up by the Commission as risk manager.
Concerning other purposes than UV-filters, it is unclear to what extent insoluble nanoparticles are used in cosmetic products. A recent survey by the Danish Ministry of the Environment indicates that the use of micronised particles for purposes other than as a UV-filter are rare.
In any case, according to the legal framework in the EU, any use has to be supported by a product information file with safety data which is controlled by the competent authority in the market.
The Commission sees a need to better understand whether and how insoluble nanoparticles are used in applications other than UV-filters. Together with regulatory authorities from the US, Canada and Japan, the Commission agreed with respective industry associations to set up an inventory of current applications of nanotechnology in cosmetic products. The results of this work will be assessed by the four authorities.
According to Art.16(10a) the Commission has to consult all EU country authorities and publish a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as UV-filters, colourants and preservatives in a different section, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions.
These measures will help to strengthen in-market control of products which contain certain nanoparticles.
To improve its scientific knowledge, the Commission is actively supporting research activity in Europe. For example, within the Sixth Framework Programme (FP6), there were several projects devoted to studying the potential toxicity of nanoparticles for living organisms and cells. To help contribute to the implementation of the Environment and Health Action Plan, there has been a further increase of resources within the Seventh Framework Programme (FP7).