WRITTEN QUESTION E-3409/02 by Chris Davies (ELDR) to the Commission. Seventh amendment to the Cosmetics Directive.
Date: 2002-11-29
Institutions: European Parliament, Provisional data
Subjects: animal experimentation, cosmetic product, cosmetics industry, market approval, testing

14.8.2003

EN

Official Journal of the European Union

C 192 E/113

It is particularly interesting that the Daphne programme could be used to combat this phenomenon,
because this means that grassroots level organisations can collaborate with each other, but also with the
academic world and the authorities, to tackle this problem on the field and, most of the time, with the
direct involvement of the victims.

Female circumcision will only disappear if people, including women, become convinced that they can give
up the practice without giving up the related aspects of their culture. Multifaceted strategies are needed,
including actions directed at the education of health and social workers. The dissemination of appropriate
information emphasising the dangerous health consequences is another important tool.

(2003/C 192 E/109)

WRITTEN QUESTION E-3409/02

by Chris Davies (ELDR) to the Commission

(29 November 2002)

Subject: Seventh amendment to the Cosmetics Directive

The cosmetics industry has warned that the timescales for the introduction of alternative non-animal
testing methods, necessary if the sales ban proposals agreed by the Parliament and the Council are to be
avoided, cannot be achieved unless there is a significant reduction in the time taken by current validation
procedures.

What steps does the Commission intend to take to try and ensure an end to avoidable delays and thereby
secure a major reduction in the time taken to gain approval for alternative, non-animal testing methods?

Answer given by Mr Busquin on behalf of the Commission

(21 January 2003)

Validation is a crucial stage in the evolution of any alternative test from its development to its routine
application, since validation consists of the independent assessment of the relevance and reliability of the
test, and therefore forms the scientific basis on which regulators can decide to incorporate the alternative
test into regulations or test guidelines. A number of successfully validated alternative tests have already
been accepted by regulatory authorities at national and international levels, and incorporated into various
regulations and test guidelines.

The Commission has taken the following steps to speed up the overall validation and approval process:

(cid:1) introduction of a prevalidation study, which is a small-scale inter-laboratory study, carried out to
ensure that the protocol of a test method is sufficiently optimised and standardised for inclusion in a
formal validation study, has speeded up the validation process by identifying the problems at an
earlier stage, and therefore enabling to solve them more easily;

(cid:1) establishment of catch-up validation studies in which the structural and performance criteria of a
method are compared with those of a similar method, which has already undergone formal validation
and has been accepted as scientifically valid. This procedure has also permitted to validate methods in
a much faster way;

(cid:1) the timescale from prevalidation to regulatory acceptance is usually six years, whereby prevalidation

and validation of a method usually takes three years.