Chapter 3

European legislation and key players in the testing of cosmetics and toiletries
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Within the European Union, some kinds of cosmetics ingredients are specifically regulated by the Cosmetics Directive (4). These include specific hazardous ingredients which are permitted only with restrictions, as well as preservatives, colouring agents and ultraviolet filters.
However, many cosmetics ingredients, being chemicals which are also used in other areas (such as household or industrial products), are normally required to go through a more extensive series of tests laid down by the Dangerous Substances Directives (5). Many of the tests conducted on chemicals are carried out on animals (see Chapter 4). The tests aim to identify the health hazards of a chemical so that it can be classified, labelled, handled and used according to those hazards.
The cosmetic industry uses animal testing for three interrelated purposes. Firstly, tests are undertaken by individual companies or suppliers in order to find the safest of a range of potentially new ingredients. Most companies are already using several non-animal tests, as well as animal tests, for this purpose. Secondly, there are regulatory requirements – where novel substances are classified into broad toxic categories, and it is here that animal testing has been used most widely. Thirdly, some companies still test finished products on animals.
Cosmetic products are defined as any substance or preparation which is intended to be placed in contact with various parts of the human body, such as the skin, hair, nails, lips and the external sexual organs, the teeth and the lining of the mouth. Cosmetics and toiletries are intended to clean, perfume, alter the appearance or reduce the odour of the human body. They should not have marked therapeutic effects.
Any cosmetic product put on the market within the European Community must not cause damage to human health when used under normal or “reasonably foreseeable conditions” of use.
Cosmetic materials have been used by humans over thousands of years and they have made use of ingredients from plants, animals and mineral sources. However, over the past fifty years increasingly sophisticated technology has arisen, and this has meant that many synthetic chemicals are now a fundamental part of cosmetics and toiletries.
In addition such chemicals are also added to other products which we use every day. The chemical combinations bring potentially unpredicted toxicological exposure to those who use them. In addition many cosmetics are used over many years, sometimes for the lifespan of the user and this might have relevance to the formation of cancers or disturbances of reproduction or fertility in those who use the products.

Key aspects of European legislation

The Cosmetics Directive 76/768/EEC

The Cosmetics Directive (6) and its subsequent amendments impose a number of rules relating to the safety of cosmetic and toiletry products. The sixth amendment (7) was principally about EU legislation and the single market. There had been long-standing concern about the disparity of product information required by member states and the impact this might have on trade. Two main features of the sixth amendment particularly concern animal testing issues:
Firstly, it required that a dossier of information on each product should be made available to the competent authorities. Secondly, there would be a prohibition of all products containing ingredients or combination of ingredients tested on animals after 1 January 1998, subject to the development of alternative non-animal methods.
The seventh amendment to the EU Cosmetics Directive 76/768/EEC was adopted by the European Parliament on 15 January 2003 (8). It introduced sequential deadlines for implementing marketing bans for cosmetics containing animal-tested ingredients, as well as a deadline for an animal testing ban within EU member states.
The seventh amendment states that, by 2009, no further animal testing of cosmetics ingredients shall be conducted in the EU for the purposes of the Cosmetics Directive. This is regardless of the status of alternative, non-animal testing methods.
As of September 2004, there will be an EU marketing ban on cosmetics containing animal-tested ingredients, if EU-validated non-animal testing methods exist. This partial ban would apply to products from anywhere in the world..
In 2009, a further partial marketing ban will prohibit the sales of cosmetics in the EU containing any ingredients tested on animals, whether or not non-animal methods are available. The ban applies to tests conducted anywhere in the world as long as they are done for the purposes of the Cosmetics Directive (testing under the Dangerous Substances Directive or because of the safety testing requirements of non-EU countries is unaffected by the seventh amendment). Exceptions are for three types of toxicity only: reproductive toxicity, toxicokinetics and repeat-dose toxicity. Cosmetics containing ingredients tested on animals for these three toxic endpoints can be marketed until 2013. If non-animal methods have not been finalised by that time, the deadline can be postponed yet again, by means of the EU co-decision process.

The Dangerous Substances Directives

At the moment the EU chemicals policy associated with the Dangerous Substances Directives (9) is undergoing a major revision which will result in a new Europe-wide strategy, and this is relevant to the chemical ingredients used in cosmetics. The new policy will apply both to new chemicals and to existing chemicals whose hazards have not been fully tested in the past. Under the current scheme, there has been little emphasis on the replacement or reduction of animal tests, which are conducted mainly in an attempt to identify human health effects.
The current system has not encouraged the submission and rational use of in vitro and computer modelling data in place of animal tests. As a result of intensive political and scientific lobbying by the European animal protection movement, the new EU policy is expected to incorporate stepwise testing strategies that maximise the role of non-animal methods.

The Animal Protection Directive 86/609/EEC

The third type of EU legislation relevant to cosmetics testing is Directive 86/609/EEC (10) on the protection of animals used in laboratories. It affirms a number of general principles governing the use of animals, including the principles that pain and distress must always be minimised and that animals should not be used when non-animal methods are available.

Key players in the regulation of cosmetics and toiletries

The European Commission

Several Directorate Generals (DGs) of the Commission play a role in the production, safety assessment and marketing of cosmetics in the EU. These include:
DG Enterprise, whose interests are in entrepreneurship and fostering EU competitiveness.
DG Research, which develops the EU’s research and technology policies, has an interest in developing new testing methods for evaluating risk and safety issues of novel chemicals and cosmetics. Through the Sixth Framework Programme, some funding will be targeted to further developing and validating non-animal tests.
DG Joint Research Centre which, among other activities, includes the work of ECVAM: the European Centre for the Validation of Alternative Methods (see below).
DG Health and Consumer Protection safeguards the interests and safety of EU consumers. It is interested in consumer product safety, which includes cosmetics and chemicals.
DG Environment is concerned that ingredients in cosmetics do not cause damage to wildlife or other aspects of the environment.

The SCCNFP

The Scientific Committee on Cosmetic and Non-Food Products (SCCNFP) assists the European Commission in examining the scientific and technical problems associated with the safety evaluation of cosmetics and toiletries. The SCCNFP comprises scientific experts from several member states. It provides formal opinions on the safety of new and existing cosmetics ingredients as well as related advice, such as adapting to technical progress the testing methods used.
The SCCNFP plays a key role in the safety evaluation of cosmetic ingredients (not finished products) thought to pose a significant risk to human health. These include ingredients contained in Annexes III, IV, VI and VII of the Cosmetics Directive 76/768/EEC. Annex III lists ingredients which are subjected to restrictions on their use, and these may include many types of ingredient, including hair dyes. Annexes IV, VI and VII respectively contain colouring agents, preservatives and ultraviolet filters. Only a few hundred ingredients are listed in these four Annexes.
The remaining majority of ingredients of other types, such as bleaching agents, fragrances, detergents and other chemicals are not generally the responsibility of the SCCNFP (but are covered under the Dangerous Substances Directives).
The SCCNFP weighs up the safety of cosmetic ingredients by:
1. Analysing the various studies which are presented by the cosmetic industry on possibly hazardous cosmetic ingredients;
2. Evaluating the scientific literature on toxicological methods of importance to safety evaluation of cosmetic ingredients;
3. Calling for additional toxicity tests (see Chapter 4), to be undertaken where any new potential hazard connected with a specific ingredient is suspected – this leads to a reassessment of safety.
Toxicity studies are the first step in the evaluation of the hazard potential of a cosmetic ingredient, with regard to tissue damage, loss of organ function or death. It is generally assumed that animals provide a necessary and sufficient model of human responses to test substances, although OneVoice, among many other organisations and some members of the scientific community, disputes this assumption.
France is represented on the SCCNFP and should use its influence to actively promote the validation and acceptance of non-animal test methods.

ECVAM

The European Centre for the Validation of Alternative Methods (ECVAM) is part of the Commission’s Joint Research Centre at Ispra, Italy. The role of ECVAM is to oversee and/or conduct validation studies of methods which replace or reduce animal testing of consumer or medical products.
ECVAM has its own research team and also awards external contracts to laboratories throughout Europe. It is not involved in the early stages of laboratory development of non-animal methods, but is active in the validation process. Thus ECVAM is dependent on scientists around Europe, in academia or in industry, to put forward for validation new tests which they have developed. Scientists in every member state have a responsibility to contribute in this way.
When a successful validation study has been completed, ECVAM’s Scientific Advisory Committee expresses its opinion on the validity of the new method to the Commission services. If the Commission agrees, the new method will be incorporated into EU testing guidelines.

The OECD

The Organisation for Economic Co-operation and Development (OECD) is the international body which provides officially agreed testing guidelines for chemicals. It also helps develop guidance on issues such as how to conduct validation studies of new test methods.
Decisions about which tests should be performed for which purposes are not the main responsibility of the OECD. Its test guidelines provide agreed ‘recipes’ which, if followed, should ensure that the results are acceptable in all the member countries of the OECD. This helps prevent duplication of testing.
Often the OECD’s test guidelines are the same as those listed in EU testing annexes. However, sometimes the EU accepts a new test method faster than does the OECD, which works extremely slowly because of the large number of its member states. As the OECD operates by consensus, sometimes agreement on a new technique is stalled because just one member state refuses to agree.
As a member state of the OECD, France should take a more active role in promoting the rapid acceptance of valid non-animal tests into the OECD test guidelines.

The European Parliament

The Parliament has consistently been more radical than the Commission or the Council of Ministers, in arguing for an end to the testing of cosmetics ingredients and products on animals. In this respect MEPs have represented the European public well, by expressing moral opposition to the practice of making laboratory animals suffer for the production of essentially trivial products.
For example, during the lengthy debate over the sixth amendment to the Cosmetics Directive (11), the Parliament sought to establish an absolute date by which new cosmetics marketed in the EU could no longer have been tested on animals, either as ingredients or as finished products. Such a deadline would have hastened the development and validation of alternative testing methods, because the Parliament wanted the ban to be implemented whether or not alternative tests were available. As the Parliament held firm to this principle, the Council was required to reach a unanimous decision. The Council finally adopted a ‘qualified’ moral position, making a proposed ban conditional on the availability of non-animal test methods (see above for details of the recent seventh amendment to the Cosmetics Directive).
French MEPs should take every opportunity to support the proposed ban on animal testing of cosmetics ingredients, as well as pressing for greater EU funding for developing non-animal tests.

The European Coalition to End Animal Experiments

The Coalition is Europe’s leading alliance of animal protection organisations who campaign together for laboratory animals. The Coalition has member organisations from France (OneVoice), Austria, Belgium, Denmark, Finland, Germany, Italy, Spain, Sweden, Switzerland and the UK, as well as several international observer groups.
First formed in 1990 to oppose cosmetics testing on animals, the Coalition continues this campaign as well as many others. It was recently instrumental in achieving progress towards a European marketing and testing ban in the seventh amendment to the Cosmetics Directive. In 1998, the Coalition launched the Humane Cosmetics Standard – the only international standard for cosmetics and toiletries that are not tested on animals. The Humane Cosmetics Standard’s cruelty-free criteria help EU consumers to choose non-animal-tested products produced by ethical companies.

COLIPA

COLIPA is the European Cosmetic Toiletry and Perfumery Association, representing the industry.
In response to heavy consumer pressure from the European public in the 1980s and ’90s, and facing the threat of a ban on animal-tested ingredients, COLIPA launched an initiative to develop non-animal alternatives to standard animal tests. Its member companies’ laboratories, including L’Oréal, Laboratoires Pierre Fabre Dermo-Cosmétique, Beiersdorf, Unilever and others, have conducted non-animal method development and validation studies.
While speaking in favour of non-animal test methods, COLIPA does not agree with a testing ban until a full range of non-animal techniques are available. It claims that such a ban would jeopardise consumer safety and reduce the innovation of new products. However, there are already some 8 400 existing ingredients in the EU inventory, considered to be safe, from which novel products can be created – without any additional risk to consumers.

CEFIC

CEFIC is the European Chemical Industry Council, which represents about 40 000 chemical companies of all sizes throughout Europe. In comparison to COLIPA (see above) CEFIC has done little to fund and promote the development and validation of non-animal methods of testing. This is only beginning to change now that the EU is proposing a new chemicals policy, which may require the industry to finance a huge programme of animal testing of existing chemicals. This would be very costly, and so CEFIC is belatedly beginning to show more interest in non-animal methods.

4 - Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal L 262, 27.7.1976, p. 169-200.
5 - In particular Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances. Official Journal 196, 16.8.1967, p. 1-98, and its amendments and adaptations to technical progress.
6- Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal L 262, 27.7.1976, p. 169-200.
7 - Council Directive 93/35/EEC of 14 June 1993 (amending for the sixth time Directive 76/768/EEC), Official Journal L 151, 23.6.1993, p. 32-37.
8 - Council Directive 2003/15/EEC of 27 February 2003 (amending for the seventh time Directive 76/768/EEC), Official Journal L 66, 11.3.2003, p. 26-35.
9 - In particular Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances. Official Journal 196, 16.8.1967, p. 1-98, and its amendments and adaptations to technical progress.
10 - Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the member states regarding the protection of animals used for experimental and other scientific purposes. Official Journal L 358, 24.11.1986.
11 - Council Directive 93/35/EEC of 14 June 1993 (amending for the sixth time Directive 76/768/EEC), Official Journal L 151, 23.6.1993, p. 32-37.