SCCP Releases Opinion on Safety of Nanomaterials in Cosmetic Products

The European Commission’s (EC) Scientific Committee on Consumer Products (SCCP) released on March 3, 2008, a document entitled Opinion on Safety of Nanomaterials in Cosmetic Products (Opinion). In its Opinion, the SCCP divides nanoparticles into two groups: 1) soluble and/or biodegradable nanoparticles; and 2) insoluble particles. The SCCP states that, for the soluble and/or biodegradable group, “conventional risk assessment methodologies based on mass metrics may be adequate, whereas for the insoluble particles other metrics, such as the number of particles, and their surface area as well as their distribution are also required.” According to the SCCP, when assessing possible risks associated with nanoparticles, it is crucial to consider their uptake, and that it is primarily for the insoluble particles that health concerns related to possible uptake may arise. The SCCP concludes that, at present, there is inadequate information on: hazard identification; exposure assessment; uptake; the role of physico-chemical parameters of nanoparticles determining absorption and transport across membranes in the gut and lungs; the role of physico-chemical parameters of nanoparticles in systemic circulation determining biokinetics and accumulation in secondary target organs; possible health effects; and translocation of nanoparticles via the placenta to the fetus. The Opinion states that review of the safety of the insoluble nanomaterials presently used in sunscreens is required.

Danish Report Finds Nanotechnology Covered by Existing Legislation

According to a report recently released by the Danish Ministry of Health and Prevention, nanotechnology research, development, and applications are covered by existing legislation. The report, which includes an English summary, reviews existing national and international legislation in the areas of foods, medicines, the environment, chemicals, and the working environment in relation to current knowledge of nanotechnological products and processes.  The report also includes a chapter on national and international research policy activities, and describes the initiatives, working groups, and network groups the relevant government departments are taking part in, both nationally and internationally. The working group that prepared the report included representatives from the Ministry of the Interior and Health, the Danish Board of Health, the Danish Environmental Protection Agency, the Danish Medicines Agency, the Danish Veterinary and Food Administration, the National Food Institute at the Technical University of Denmark, the Danish Agency for Science, Technology, and Innovation, the Danish Working Environment Authority, and Danish Standards.

The General Summary states:

It is the opinion of the working group that research, development and application of nanotechnology are covered by existing legislation.  In view of this, the working party does not consider there to be a need for special nano-legislation.

However, the working group also considers that there will continue to be a need, determined by future development, to assess and if necessary adapt rules and executive orders etc. within the framework of existing legislation. Work is in progress in a number of national and international forums to create the necessary conditions for such adaptation, in part by establishing standards and limit values.

The [European Union (EU)] and the [Organization for Economic Cooperation and Development (OECD)] are playing a key role in connection with risk assessment of nanotechnology, in part through the EU’s [Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and Scientific Committee on Consumer Products (SCCP)].  It is therefore important to keep an eye out for recommendations and assessments issued by the EU and the OECD, as it will be possible to use these actively in connection with the adjustment of Danish rules and executive orders.

EC Committee Accepting Comments on Nanomaterials in Cosmetic Products

Until September 6, 2007, the European Commission (EC) Scientific Committee on Consumer Products (SCCP) is accepting comments on its Preliminary Opinion on the Safety of Nanomaterials in Cosmetic Products. According to the SCCP, traditional risk assessment methods -- hazard identification, hazard characterization, and exposure assessment -- may not be suitable for nanomaterials in cosmetics.  The SCCP suggests that either a new method should be developed, or the existing methodologies for hazard characterization and exposure assessment should be validated.  The SCCP recommends that the risk assessment of nanoparticles in cosmetics should be carried out on a case-by-case basis, taking into account the specific physical, chemical, and surface area characteristics of nanomaterials.  Previous safety evaluations on nanomaterials used in cosmetics would also need to be revised.