WRITTEN QUESTION E-0046/01

by Ursula Schleicher (PPE-DE) to the Commission

(22 January 2001)

Subject: L-cysteine from human hair

The Commission's answer of 28 November 2000 to my Question P-3343/00(1) states that it is currently looking into whether a Commission Directive to amend No 416 of Annex II (a proposal for which is given) by adapting Directive 76/768/EEC(2) to technical progress is feasible. I am grateful to the Commission for the detailed answer. Unfortunately, no answer was given to my first question, which was as follows: Did the Commission take ethical aspects as well as scientific ones into account in its consideration of this derogation?

In the light of the Commission's answer, I would reformulate this question as follows:

- does the Commission take ethical aspects into account in its consideration of whether the existing directive can be modified?

- one reason for the existing ban on producing L-cysteine from human hair was the risk of transmitting Creutzfeldt-Jacob disease and certain virus diseases.

- in the light of the most recent findings on BSE and the uncertainty as to how Creutzfeldt-Jacob disease is transmitted, does the Commission really think it is responsible to water down the ban?

(1) OJ C 136 E, 8.5.2001, p. 224.

(2) OJ L 262, 27.9.1976, p. 169.

Answer given by Mr Liikanen on behalf of the Commission

(19 March 2001)

As stated in Council Directive 76/768/EEC, of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, the Cosmetics Directive, the pursuit of the safeguarding of public health must inspire the Community legislation in the cosmetic sector. This objective must be attained by means which also take into account economic and technological requirements. Technical progress necessitates rapid adaptation of the technical provisions of the Directive ensuring that only safe cosmetic products are put on the market. To this end, the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) is mandated to give opinions on consumer health and safety issues in the field of cosmetics, based on scientific data, while taking into account ethical considerations such as the use of human volunteers for testing purposes.

Therefore, when proposing its technical adaptation of the Directive, the Commission takes into account the scientific as well as the ethical aspects considered by the SCCNFP in its opinions.

The risk assessment of amino acids such as L-cysteine obtained by hydrolysis of human hair carried out by the SCCNFP and the Scientific Steering Committee (SSC) has shown that such amino acids are safe.

This is based on the following facts:

- at present prions associated with transmissible spongiform encephalopathies (TSE) have not been detected in hair;

- cosmetic uses of these hydrolysates are for topical application only and there is no evidence indicating that TSE may be transmitted by topical application;

- the very rigorous procedure leading to an absence of peptides may guarantee the exclusion of the responsible prion;

- by their nature amino acids cannot transmit TSE.

In conclusion the current scientific knowledge fully supports the modification of entry 416 of Annex II of the Cosmetics Directive.