What are the rules in Europe for the use of insoluble nanoparticles in cosmetics?
According to the Cosmetics Directive 76/768/EEC, the manufacturer or importer of a cosmetic product has to assess the safety of the product prior to placing it on the market and document this. This has to be done taking "into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure" (Art. 7a (1) (d) Cosmetics Directive 76/768/EEC).
This safety evaluation is being assessed by the competent authorities of the Member States in in-market controls. If these authorities find that the safety evaluation is insufficient to support the safety of the product, they have to take the necessary measures to enforce the Community 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. Such permission is preceded by an opinion of Scientific Committee for Consumer Products (SCCP). The SCCP reviews submitted toxicological data. The data submitted usually has to follow the SCCP-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 here:
- Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks on "The appropriateness of the risk assessment methodology in accordance with the Technical Guidance Documents for new and existing substances for assessing the risks of nanomaterials" (June 2007)
- Opinion of the Scientific Committee for Consumer Products (SCCP) on the "safety of nanomaterials in cosmetic products" (December 2007). In this opinion, the SCCP stressed the difficulties to carry out a robust safety evaluation in view of existing knowledge gaps.
What specific measures has the Commission taken to address the safety of insoluble nanoparticles?
Insoluble nanoparticles in cosmetic products are essentially used as UV-filters. Some minerals, if used in a nanoscale, become invisible but still absorb UV radiation. These UV-filtering substances are increasingly used in order to have a broad-band sun protection including UVA radiation ( more information on the need to ensure efficient sunscreen products). Moreover, 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 which is usually used in its nanoscale in sunscreen products (titanium dioxide).
Another substance at nanoscale, zinc oxide, has been assessed by the SCCP in 2003 in view of permission as UV-filter. The SCCP, in its opinion SCCNFP/0649/03 , concluded that the safety of zinc oxide as UV-filter had not been sufficiently demonstrated. Consequently, zinc oxide has not been permitted by the European Commission as UV-filter.
In the above-mentioned opinion of December 2007, the SCCP suggested a re-evaluation of titan dioxide in order to address in particular abnormal skin conditions as well as the possible impact of mechanical effects (eg flexing) on skin penetration. This opinion is being followed-up actively 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 those micronised particles in other uses than as UV-filter is very exceptional.
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 in particular a need to better understand whether and how insoluble nanoparticles are used in applications other than UV-filters. To this end, the Commission, together with the regulatory authorities from the U.S., Canada and Japan, agreed with the respective industry associations to set up an inventory of current applications of nanotechnology in cosmetic products. Results of this work will be assessed by the four authorities.
Such measures shall help to strengthen in-market control of products which contain certain nanoparticles.
What is the Commission doing in terms of research?
In order to obtain more 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. With a view to contributing to the implementation of the Environment and Health Action Plan, there has been a further increase of resources within the Seventh Framework Programme (FP7).