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:

- 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;

- 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;

- the timescale from prevalidation to regulatory acceptance is usually six years, whereby prevalidation and validation of a method usually takes three years.