WRITTEN QUESTION P-2248/03

by Caroline Lucas (Verts/ALE) to the Commission

(1 July 2003)

Subject: Nanotechnology

Is the Commission aware of the use of nanoparticles in cosmetic products? If so, what kind of nanoparticles are currently being used in what kind of cosmetics and which companies are marketing them in the EU?

Nanoparticles have different properties as compared to larger particles of the same compounds. Have adequate safety assessments been made with regard to the use of nanoparticles in cosmetics? In what way has such safety assessment differentiated between different sizes and shapes of particles of the same compound? Where it is currently impossible to accurately predict the toxic effects of nanoparticles, does the Commission agree that such use should be prohibited?

What other uses of nanoparticles in consumer products is the Commission aware of, and what safety assessments have been made for them?

Answer given by Mr Liikanen on behalf of the Commission

(24 July 2003)

Nanotechnology encompasses many different (scientific) areas and can be seen as an enabling technology, which can have an impact in many different technology areas.

Council Directive 76/768/EEC(1) states as a general principle that only cosmetic products that do not cause damage to human health can be put on the market (Article 2 of the Directive). Therefore, cosmetic products can only contain safe ingredients.

Regarding an adequate safety assessment of cosmetic products, there is an obligation for the manufacturer to keep information on its cosmetic products readily accessible for the control authorities of the Member States (Article 7a of the Directive). This information must contain the physico-chemical and microbiological specifications of the raw materials and the finished product as well as the assessment of the safety for human health of the finished product, taking into consideration the general toxicological profile of its ingredients and its chemical structure.

In its Notes of guidance for testing of cosmetic ingredients for their safety evaluation(2) the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) has stated that the precise chemical nature of the ingredient and its structural formula, if it is known, should be identified in the safety assessment file. The evaluation of a cosmetic ingredient should be carried out with respect to its physical, chemical and physico-chemical properties. This means that regardless of the process used to manufacture it and the particle size of a given ingredient used in cosmetic products, the above safety requirements need to be fulfilled before this ingredient can be used in cosmetics. Therefore, there are no specific requirements for ingredients produced with nanotechnology.

In relation to other consumer products containing chemical substances, or medicinal products for human use, or veterinary medicinal products, the existing evaluation procedures take place according to the normal requirements provided for in the legislation related to each sector.

(1) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, OJ L 262, 27.9.1976.

(2) http://europa.eu.int/comm/food/fs/sc/sccp/out130_en.pdf.