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Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council amending for the seventh time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products"

(2000/C 367/01)

On 26 May 2000 the Council decided to consult the Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 1 September 2000. The rapporteur was Mr Braghin.

At its 375th plenary session 2000 (meeting of 20 September), the Economic and Social Committee adopted the following opinion by 87 votes to one with one abstention.

Foreword

The main aim of the basic directive (Directive 76/768/EEC) is to protect consumer health. An assessment of the current market situation shows beyond any doubt that the directive has improved the quality of cosmetic products. The subsequent Council Directive 93/35/EC of 14 June 1993 (known as the "sixth amendment" of Directive 76/768/EEC) set the additional priority aim of reducing the suffering of animals used in tests necessary for consumer safety. This was to be achieved by the use of alternative validated methods. So far, however, only three alternative methods have been validated, despite all endeavours.

It should be pointed out that animals used in cosmetics testing form a very small percentage of the total number of animals used to guarantee product safety. Independent authoritative estimates based on the second Commission report to the Council and the European Parliament on the number of animals used for experiments in the EU suggest that only 0,3 % of experiments concern tests for cosmetic products. It must also be borne in mind that the tests do not involve killing the animal, and that particular suffering is not inflicted on it. The main species used are guinea pigs, rats, rabbits and fish; in no cases are primates used.

1. Introduction

1.1. The proposed seventh amendment to Council Directive 76/768/EEC has four key objectives:

- to introduce a permanent and definitive prohibition on the performance of experiments on animals for finished cosmetic products in the territory of the European Union;

- to amend the prohibition on the marketing of cosmetic products containing ingredients or combinations of ingredients tested on animals as soon as validated alternative methods become available (postponing the current deadline to three years after implementation of the directive by the Member States);

- to revise current legislative provisions so as to make them WTO (World Trade Organisation) compliant and legally and practically enforceable;

- to regulate the use of information indicating that neither a product nor its ingredients have been tested on animals, in order to improve consumer information and ensure that consumers are not misled.

1.2. The definition of "cosmetic products" in Directive 93/35/EEC covers a range of products not restricted to those generally known as beauty products. Article 1 of the directive states that "a 'cosmetic product' shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (...) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition".

1.2.1. Annex 1 of Directive 76/768/EEC defines the types of products covered. Examples range from toilet soap, bubble bath, shampoo and toothpaste to sun-tan lotion, moisturisers, skin food, perfumes and make-up products.

1.2.2. Since these cosmetic products are for everyday use throughout life, they must not be harmful, either immediately (e.g. allergic reactions) or in the long term (e.g. leading to cancer or birth defects). To protect human heath, the safety of the finished product and its ingredients must be assessed, taking into consideration the general toxicological profile of each ingredient, its chemical structure and the level of exposure.

1.3. For reasons of consumer protection, it is not possible to abandon safety testing. The directive contains lists of prohibited substances, substances subject to restrictions and requirements, and authorised substances. These lists are regularly adapted to take account of technical progress, after the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) has delivered its opinion.

1.4. Ethical concerns regarding respect for life have been raised by public opinion and are shared by the scientific community and by many public authorities and institutions, as well as by the parties concerned. These demand a reduction in the number of tests and animals used, and in the duration of tests and the suffering caused and, wherever possible and as soon as possible, the elimination of all animal testing, provided that consumer safety is guaranteed.

1.5. For the measures adopted to be effective and enforceable, account must be taken of the constraints arising from international trade rules, in particular those of the World Trade Organisation (WTO), ensuring that the prohibition of the marketing of cosmetic products containing ingredients tested on animals after 30 June 2000 does not become a form of discrimination contrary to WTO rules and in particular the provisions of Article III (4) of the GATT.

1.6. For finished cosmetic products, the Commission therefore proposes to ban animal experiments in the Member States from the date of implementation of the directive by the Member States. For ingredients, the ban on animal experiments should be introduced within three years, subject to publication in the Official Journal of alternative methods that have been scientifically validated and officially endorsed by the European Centre for the Validation of Alternative Methods (ECVAM) and deemed applicable to cosmetic products by the SCCNFP, provided those alternative methods offer "an equivalent level of protection for the consumer" [Article 4a 1(b)]. This ban on experiments does not mean a ban on marketing cosmetic products tested on animals, in order to prevent discrimination between products of different geographical origin, which would infringe current marketing rules and international law.

1.7. To improve the information supplied to the consumer, the proposal also offers the manufacturer or person responsible for placing the cosmetic product on the market the possibility to claim that no animal tests have been carried out (either directly or indirectly) on the product, its prototype or its ingredients. Guidelines will be provided containing specific provisions designed to ensure that common criteria are used, that only one interpretation is possible, and above all, that consumers cannot be misled.

1.8. Finally, the draft directive includes formal measures, adjusting the names of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) and the Standing Committee on Cosmetic Products, and establishing decision-making procedures following the adoption of Council Decision 1999/468/EC of 28 June 1999, laying down procedures for the exercise of implementing powers conferred upon the Commission.

2. General comments

2.1. The Committee endorses the aims and objectives of the draft directive which, as part of its primary purpose of protecting public health by means of toxicological tests to evaluate the safety of cosmetic products for human health, also aims to progressively abolish animal experiments, insofar as this is possible, and clarifies the practical procedures and timetables for making the prohibition of such experiments effective on the territory of the Member States.

2.2. The draft directive gives a clear outline of the scope of the ban on ingredients and their combinations, an area that had previously been subject to divergent interpretations and applications. It also lays down deadlines for implementing the ban: three years from the date on which the Member States put the directive into effect, possibly extended by two years where alternative methods scientifically validated as offering an equivalent level of consumer protection have not been developed.

2.2.1. The Committee is aware that the development, validation, standardisation and regulatory acceptance of alternative methods is a complex, difficult process, as acknowledged in the Commission's proposal, which notes that only three alternative methods have been validated to date in spite of the efforts made since the adoption of Directive 93/35/EEC (the "sixth amendment" of Directive 76/768/EEC). The Commission also suggests that the prospects are less promising for research into long-term effects and certain acute effects to the skin and eyes (difficulty in standardising certain types of in vitro tests, e.g. for skin sensitivity and eye irritation).

2.2.2. The Committee agrees that clear objectives should be set for the progressive reduction and eventual prohibition of animal testing, and hopes that every effort will be made to comply with the dates indicated, provided that consumer safety is not compromised. The Committee however proposes that the deadline be extended if it proves impossible to secure the expected results.

2.3. The moral objective of applying the "three 'R's rule" (replacing the use of animals, reducing their number, and refining techniques) will require an additional research effort on the part of the Joint Research Centres, private and university research establishments and national research bodies. The Committee calls on the Commission to do all it can to locate appropriate resources, especially under the fifth framework programme and for the ECVAM.

2.4. The Committee fully endorses the Commission's commitment to publish details of alternative methods that have been validated at Community level immediately (approved by the ECVAM and given a positive assessment by the SCCNFP as to their applicability in the cosmetics industry) with a view to guaranteeing the safety of the ingredients and combinations of ingredients used, providing those methods offer an equivalent level of consumer protection to animal experiments. Such methods should be disseminated using all available means, and the industry should apply them as speedily as possible.

2.5. The Committee approves of the innovative approach of using regulatory acceptance at European level as a means of opening the door to the legal acceptance of alternative experimentation methods. The Union is thus leading the way in the legal acceptance of harmonised alternative methods, removing the need for acceptance by all OECD members, which can take several years.

2.6. The Committee also welcomes the Commission's undertaking to step up negotiations within the OECD to ensure genuine acceptance of alternatives to animal testing on a global scale, and to secure mutual recognition of data demonstrating the safety of products and ingredients by means of alternative validated and standardised methods (thus preventing the repetition of studies using animal models).

2.7. The Committee is concerned about the additional cost to industry - SMEs in particular - that the ban on animal tests will entail, especially in terms of global competitiveness if third countries do not promptly apply the methods that are validated and accepted in the EU.

2.7.1. The Committee urges the Commission to ensure that the new European legislation does not create distortions in the single market and in trade flows with other regions to the detriment of European products.

2.8. Commission intervention, in conjunction with the Member States, is needed to draw up guidelines for better and more comprehensive consumer information, with a view to preventing confusion, abuse, and the risk of consumers being misled. Experience shows that finished cosmetic products often claim not to have been tested on animals but give no information on ingredients, and that there is a tendency to present "natural" ingredients as if they were exempt from testing requirements. The Committee recognises the validity of the relevant work being carried out by the Commission, and suggests that precise rules and guidelines for labelling in this area be applied as soon as they become available, irrespective of the stage reached by the present draft directive in the legislative process, which could be very lengthy.

2.9. Article 4a(3) states that until the entry into force of the prohibition referred to under paragraph 1(b) of Article 4(a), the Commission is to present an annual report to the European Parliament and the Council on progress in the development, validation and legal acceptance of alternative methods to those involving animal experiments. This report should contain not only accurate data on the number and type of animal experiments relating to cosmetic products, but also information on the adverse reactions encountered (as laid down by Directive 93/35/EEC, which has not been fully implemented by the Member States) and the risks to human health demonstrated.

2.10. The information which the Member States must forward to the Commission regarding the sector covered by Directive 76/768/EEC and subsequent amendments, particularly the sixth amendment under Directive 93/35/EEC, is sometimes late or inaccurate. The Committee calls upon the Commission to be more vigilant in this respect and to prepare a general framework on the national legal provisions adopted in the meantime by the Member States, and on how they are applied.

3. Specific comments

3.1. Consumer safety must be the primary focus, especially for certain sections of the population, such as children under the age of three. An assessment should therefore be made as to whether broader restrictions (e.g. regarding fragrances) should apply to the lists of ingredients allowed in products destined for infants.

3.2. The continued growth of allergic diseases and the massive rise in allergies, linked to air pollution and foodstuffs, would suggest that the range of methods used should be widened beyond toxicological tests to include the study of possible side-effects, and that these should be mentioned on the label.

3.3. Aromatic and perfumed substances of a highly complex nature - sometimes unknown or concealed by industrial secrets - are widely used through the entire range of cosmetic products: this structural complexity makes it impossible to specify each individual ingredient on product labels. However, such substances should be indicated by an appropriate term on the label, at least when they have a proven capacity to produce allergic reactions.

3.4. The use of substances which are carcinogenic, mutagenic or toxic to reproductive organs, under the list of dangerous substances referred to in Directive 67/548/EEC, should be prohibited, as should more generally, the use of substances which have been shown to produce significant allergic reactions, given the length of time that consumers use cosmetic products.

3.5. The producers and suppliers of ingredients and intermediates for cosmetic products should provide the Member States and the Commission with information on toxicity studies already included in the Safety Dossier and Material Safety Data Sheet, so that they can, if necessary, act more effectively and swiftly to protect public health.

3.6. Clear and comprehensive labelling should include the use-by date, subject to the verification of data on the stability of the finished product, which the producer should provide in the dossier.

3.7. The alternative methods mentioned in point 2.2 of the explanatory memorandum do not specifically include tests based on human or animal cell culture. These should be considered for possible use in toxicological tests as regards both short- and long-term effects.

Brussels, 20 September 2000.

The President

of the Economic and Social Committee

Beatrice Rangoni Machiavelli