Select Committee on European Scrutiny Nineteenth Report


The European Scrutiny Committee has agreed to the following Report:—



Amended draft Council Directive amending for the seventh time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products.

Legal base:Articles 95, 152(1) and 153(2) EC; co-decision; qualified majority voting
Department:Trade and Industry
Basis of consideration:Minister's letter of 4 February 2002
Previous Committee Report:HC 152-vii (2001-02), paragraph 2 (21 November 2001) and HC 152-xvi (2001-02)(30 January 2002)
Discussed in Council:26 November 2001
Committee's assessment:Legally and politically important
Committee's decision:For debate in European Standing Committee C (decision reported on 21 November 2001)


  1.1  Council Directive 76/768/EC[1] seeks to protect public health by laying down rules governing the contents, labelling, and conditions for use of cosmetic products within the Community. In response to growing animal welfare concerns, an amendment would have introduced with effect from 1 January 1998 a ban on the marketing of such products if they contained ingredients (or combinations of ingredients) which had been tested on animals; but, since there had in the meantime been insufficient progress in developing satisfactory methods to replace animal testing, this deadline was subsequently extended to 30 June 2000.

  1.2  However, as a result of doubts which had arisen in the meantime over the drafting of the proposed ban, and its compatibility with the rules of the World Trade Organisation (WTO), the Commission proposed in April 2000[2] that the change envisaged should be deferred for another two years, and that Council Directive 76/768/EEC should be further amended, so as to rescind the intended marketing prohibition, and prohibit instead animal testing of cosmetics within the Community. In putting forward this proposal, the Commission recognised that these prohibitions would not apply to imported products, but it said that, once methods not involving animals had been validated within the Community, it would make efforts within the OECD and in bilateral negotiation to secure their international acceptance as well as mutual recognition of test data.

  1.3  This proposal was considered by our predecessors in June 2000 and November 2000, following which they cleared it. However, in an Explanatory Memorandum of 14 November 2001, the Parliamentary Under-Secretary of State for Competition, Consumers and Markets at the Department of Trade and Industry (Miss Melanie Johnson) told us that the European Parliament had sought to reinstate the marketing ban which had raised the question of WTO compatibility, and that, as this was unacceptable to the Council, the Belgian Presidency had produced an unofficial text, which it was hoping might be agreed at the Internal Market, Consumers and Tourism Council on 26 November. This would make a number of changes, of which the most significant would be the introduction of a marketing ban for finished cosmetic products which had been subject to animal testing, if an alternative testing method has been accepted and published by the Organisation for Economic Cooperation and Development (OECD), and a marketing ban within the Community for cosmetic products containing ingredients which had been subject to animal testing where there is an alternative method which has been accepted and published by OECD.

  1.4  In our Report of 21 November 2001, we noted the Government's broad support for the Presidency compromise, but said that we were concerned that WTO rules should apparently require imported cosmetics to be subject to less stringent conditions than those produced within the Community. We therefore recommended the proposal for debate in European Standing Committee C, adding that we expected the Government to maintain a scrutiny reserve until that debate had taken place. However, since it subsequently became apparent that the UK had agreed the Presidency text at the Council on 26 November, we took oral evidence from the Parliamentary Under-Secretary of State on 9 January 2002, and, in our Report of 30 January 2000, we confirmed the earlier debate recommendation[3].

Minister's letter of 4 February 2002

  1.5  In taking evidence from the Parliamentary Under-Secretary of State, we asked (QQ 18-22) about the extent to which alternative tests to those involving animals had been accepted by OECD, and she undertook to provide further information on this. She has now written as follows:

"Work to develop non­animal tests that can deliver the mandatory standards of safety for human users goes very much wider than the cosmetics sector alone. RSPCA figures (Safe & Sound, 2001) show that tests for cosmetic ingredients account for only around 0.3% of all animal tests undertaken in Europe.

"The EU's mandatory standards for chemicals (which include new cosmetic ingredients) are listed in Directive 65/548/EEC on the Classification, Packaging and Labelling of Dangerous Substances. New EU proposals in this area last Spring led to Michael Meacher, Minister of State for the Environment, who leads for the government on this very important issue, to commission work from the Institute of Environmental Health. Their report "The Assessment of the Feasibility of Replacing Current Regulatory In Vivo Toxicity Tests with In Vitro Tests within the Framework Specified in the EU White Paper" was published in December 2001 and I attach a copy for your information. The report provides a useful assessment of the status of research and development in alternatives to animal tests across the whole of the chemicals field which I hope will be of assistance to the Committee.

"Section 2 of the report shows the volume of current work to develop more non­animal tests. The timescale for success remains uncertain. However, the report notes the importance of continuing efforts to agree international standards for validation of alternatives — via the OECD — as a major means of reducing the volume of testing on animals worldwide. The 7th Amendment's link to a bigger push towards OECD validated standards should help drive forward the EU's wider agenda to influence other countries to move closer to adopting our views on animal welfare issues more generally.

"As the report makes clear, there are fourteen tests commonly used for assuring the safety of cosmetic ingredients. Alternatives to two of these — the Skin Corrosion and Photo Toxicity tests — have been validated in Europe by the European Centre for the Validation of Alternative Methods (ECVAM). There is a validated OECD alternative to a third test, that for mutagenicity, and there are draft guidelines awaiting OECD acceptance on alternatives for five existing tests. Work has started on achieving validation for four others. The European Commission is working on a timetable for a work programme on addressing alternatives to the remaining current tests.

"As I explained, the government has an important role to play in trying to drive forward the development of alternatives to animal tests. We believe the Presidency proposal for the 7th Amendment to the Cosmetics Directives can contribute to this. We will continue to press for a realistic timetable to develop alternatives to animal tests in the ongoing discussions on the proposed Amendment."


  1.6  We are grateful to the Minister for this further information, which is relevant to the debate we have recommended and which (with the exception of the report by the Institute of Environmental Health) we are therefore making available in this Report. We are, however, arranging for a copy of the Institute's report to be placed in the Library of the House.

1   OJ No. L 262, 27.9.76, p.169. Back

2   (21170) 7716/00; see HC 23-xxi (1999-2000), paragraph 1 (14 June 2000) and HC 23-xxvii (1999-2000), paragraph 12 (25 October 2000) Back

3   See HC 152-xvi (2001-02). Back

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