Select Committee on European Scrutiny Seventh 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: EM of 14 November 2001
Previous Committee Report: None; but see (21170) 7716/00; HC 23-xxi (1999-2000), paragraph 1 (14 June 2000) and HC 23-xxvii (1999-2000), paragraph 12 (25 October 2000)
To be discussed in Council: 26 November 2001
Committee's assessment: Legally and politically important
Committee's decision: For debate in European Standing Committee C


2.1  Council Directive 76/768/EC[9] 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.

2.2  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 that the change envisaged should be deferred for another two years, and that Council Directive 76/768/EEC should be further amended. The Commission's particular concern was that the WTO forbids any discriminatory measures between similar products, and more especially states that imported products shall be treated no less favourably than like products of national origin. It suggested that, as the test method does not have any physical effect on cosmetic products, a prohibition based on whether or not ingredients have been tested on animals, and which applies irrespective of whether such products have been manufactured in the Community or imported from third countries, could be considered as contrary to WTO rules.

2.3  The Commission therefore proposed that the intended prohibition on the marketing of products whose ingredients have been tested on animals should be rescinded, but that instead:

    —the performance of tests on animals on the territory of the Member States should be prohibited so far as finished cosmetic products are concerned; and

    —in the case of ingredients (where suitable alternative tests are not yet available), tests on animals should be prohibited once an alternative method has been scientifically validated, but that, even if such a method has not been agreed, the proposed prohibition should come into force after three years (or five years, if there has still been insufficient progress in developing satisfactory methods to replace animal testing).

2.4  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. In addition, it was proposing to improve consumer information by setting out guidelines to prevent misleading claims by manufacturers about the testing methods used.

2.5  In an Explanatory Memorandum of 11 May 2000, the then Minister for Competition and Consumer Affairs at the Department of Trade and Industry (Dr Howells) said that the key issues contained in the proposal were already in line with UK practice, and in particular that this country already had a voluntary ban in place, which prevented the testing on animals of any cosmetic product or ingredients or combinations of ingredients. He thus regarded the policy implications of the proposal as limited, but said that, unlike the marketing ban due to come into force, it was WTO compatible, and hence avoided the prospect of retaliatory action. He also pointed out that three alternative tests were available to ensure the safety of cosmetic products, and that, for those areas where such alternatives were not yet available, data from animal tests in previous years was relied upon.

2.6  In their Report of 14 June 2000, our predecessors noted that the Government considered the proposal would have limited policy implications within the UK, and they welcomed its aim of reducing, and eventually eliminating, tests in this area involving animals. However, they said that, before clearing it, they would like further clarification on certain aspects of the proposal. In particular, the existing prohibition on marketing would have affected both products produced within the Community and those imported from third countries, and thus did not appear to treat the latter less favourably than the former. They therefore asked the Minister to provide a "more convincing" explanation as to precisely why the intended measure should be regarded as susceptible to challenge within the WTO.

2.7  Such an explanation was set out at length in the Minister's letter of 27 July 2000, and quoted in paragraph 12.10 of our predecessors' Report of 25 October 2000. This, together with the answers provided to their other concerns, enabled them to clear the proposal.

Explanatory Memorandum of 14 November 2001

2.8  In her 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) says that the European Parliament's first reading of the proposal on 3 April 2001 sought to reinstate the marketing ban which had raised the question of WTO compatibility. This was unacceptable to the Council, and several compromise texts had been tabled without any agreement being reached among the Member States. However, the Belgian Presidency had now produced an unofficial text, which it was hoping might be agreed at the Internal Market, Consumers and Tourism Council on 26 November.

2.9  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 have been subject to animal testing, if an alternative testing method has been accepted and published by the Organisation for Economic Cooperation and Development (OECD);

    —a marketing ban within the Community for cosmetic products containing ingredients which have been subject to animal testing where there is an alternative method which has been accepted and published by OECD;

    —a ban on the carrying out of animal tests on finished cosmetic products within the Community; and

    —a ban on the carrying out of animal tests on cosmetic ingredients within the Community where such tests can be replaced by one or more of the alternative tests listed in an Annex to the Dangerous Substances Directive (67/548/EEC),[10] or in a new Annex to the Cosmetics Directive, which will contain a list of validated and published alternatives to animal tests.

2.10  The Presidency text would also require any additional data needed to carry out a risk assessment on potential carcinogens, mutagens or substances toxic to reproduction in cosmetic products to be generated only if no animal tests are used, or if the substances cannot be replaced by other substances; it would allow guidelines to be prepared so that manufacturers can make claims indicating that no animal tests have been carried out in the development or manufacture of a cosmetic product; and it would require manufacturers to prepare specific safety assessments for cosmetic products intended for use exclusively on children under the age of three, or for those intended exclusively for use in intimate hygiene.

2.11  The Minister says that the policy implications of the amended proposal are limited, as the restrictions in it are in line with the voluntary ban already in place in the UK, as are the guidelines it would provide for. She therefore believes that the Presidency text should not affect the costs and benefits set out in the Regulatory Impact Assessment provided in May 2000, but that, compared with the Directive as it stands, it should lessen the risk of a challenge in the WTO (or at least enable the Community to present a credible defence if there were such a challenge).


2.12  It is clear from the Minister's comments that the direct consequences of the changes proposed by the Presidency for cosmetics produced within the UK would be limited, and that its main impact would be on those imported from third countries. We also understand that the aim is to bring such products back within the ambit of the ban, albeit under certain conditions.

2.13  However, we share the concern of our predecessors that World Trade Organisation rules should apparently require imported cosmetics to be subject to less stringent conditions that those produced within the Community. We therefore consider that, before the Government commits itself to such a course, the House should have a chance to consider both the legal arguments involved and the practical impact of the arrangements envisaged in the Presidency text. We are accordingly recommending this document for debate in European Standing Committee C, and we would expect the Government to maintain a scrutiny reserve until that debate has taken place.

9  OJ No. L 262, 27.9.76, p.169. Back

10   OJ No. L 186, 16.8.67, p.1. Back

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