The Boyd group is a forum for the open exchange of views on issues of concern related to the use of animals in science. As such it will from time to time formulate position statements on a particular matter. Statements are based on a full evaluation of the issue in question, often initially collated by a sub-group, with subsequent debate between group members, and where necessary including discussion with 'major players' outside of the group. This paper summarises the group's deliberations on the use of animals for testing cosmetics.
The use of animals for testing cosmetics is regulated in the UK by the Animals (Scientific Procedures) Act 1986 (ASPA). The Act is based on the utilitarian principle that some use of animals, even where this causes suffering, is justified provided there is sufficient benefit. This principle is embodied in Section 5(4) of the Act, 'the cost-benefit assessment', which requires the likely adverse effects of scientific procedures on animals (the costs) to be weighed against the benefits likely to accrue from the work. The cost-benefit assessment is often said to ensure that animals are only used if fully justified and absolutely necessary. Since the testing of cosmetic substances is permitted under the Act, it must meet this definition. Nevertheless, testing cosmetic substances on animals is widely condemned, and the issue has become an icon for the overall animal experimentation debate - for the public, the media, animal protection groups, politicians and to a certain extent the scientific community. Although each of these groups may approach it from a different angle, the majority are either morally opposed to the use of animals for testing cosmetics, or express serious concern at such use. The moral concerns within society as a whole are reflected in legislation. Changing moral concerns can be accommodated within ASPA, since the cost-benefit principle involves subjective judgements on the nature and importance of benefits without rigidly defining them. Such judgements are influenced by the way those making them perceive current issues.
The cosmetics issue provides a useful test case for evaluating the interpretation of the cost-benefit assessment and hence justification for animal use under the Act. This aspect provided the focus of discussion for the Boyd Group. The current status of humane alternatives, problems in their development and validation, or in achieving their regulatory approval were not examined in detail since members were familiar with the situation and much has been written about this elsewhere (see, for example: Balls et al., 1990; Balls, 1991; Eurogroup for Animal Welfare, 1991; Home Office, 1994; Clark, 1994; Langley & Fisher, 1995; European Commission, 1997). However, representatives from the cosmetics industry and from British Union for the Abolition of Vivisection (BUAV) were invited to present their respective views on all aspects of cosmetics testing including these latter points.
People's individual perceptions of, and responses to, the use of animals for testing cosmetics depends very much on their interests, awareness, understanding and commitment. This is, in turn, influenced by presentation of the issue by the various interested parties (e.g. animal protection groups, media, politicians, industry, life scientists, government bodies). The nature of the products and the amount of animal suffering, real or perceived, are critical factors.
2.1 The nature of the product in relation to public concern
One of the reasons that there is so much concern about the use of animals for testing cosmetics is because these products are seen as trivial, used solely to satisfy the vanity of the wearer. Causing animals to suffer for this purpose is widely considered to be unjustified. However, there are two points at issue here.
Firstly, the definition of a 'cosmetic product' encompasses a much broader range of products than the decorative cosmetics which are usually ascribed to vanity. Thus, the definition in Article 1 of the European Cosmetics Directive (European Commission, 1976) includes creams, face masks, deodorants, depilatories, hair dyes and perms, shaving products, anti-wrinkle creams, skin-whiteners, toothpastes, and sunscreens (see Appendix 1). In November 1997, the UK Government stated its intention to "see an end to the testing of ingredients in certain forms of cosmetics which can be called vanity products", although vanity products were not defined. There may be difficulties in this respect. For example, toothpastes and sunscreens are not usually considered as vanity products because of their 'semi-medical' function. On the other hand, some types of cosmetic which no doubt would be classed as 'beautifying' can have a therapeutic function where they are used to cover disfigurements. The range of different types of product defined as cosmetics may surprise the public, but is unlikely to shift their opinion on the justification for using animals to test them.
The second point is that it could be argued that other classes of products are equally trivial and that it is illogical to focus solely on cosmetics. Why, for example, should the availability of different types of paint, polish or detergent be any more important to the consumer than choice of hair colourant or deodorant? The public, the media, politicians and most animal protection groups do not express the same level of concern (or in all but the latter two groups, any concern) about the majority of other types of product, even though the issues are similar and more animals are involved. In fact, since the substances concerned may be more toxic, the tests may cause greater suffering.
One reason may be that there is a general lack of awareness that other types of product involve animal testing. Furthermore, although some members of the public have deep concerns about the risks from 'dangerous chemicals' used in the workplace, at home, on farms, or in foods, cosmetics are seldom linked to such worries. The perception that there are already alternatives to animal tests for cosmetics, and that there are plenty of 'cruelty-free' cosmetic products available, are also contributory factors in separating cosmetics from other products. The way the different types of product are marketed by manufacturers and retailers also has a significant effect on how 'trivial' they are perceived to be.
Surveys of public opinion show what the public thinks, but not necessarily how they act in respect of their purchasing habits. Products marketed as 'cruelty-free' are undoubtedly popular, but the majority of cosmetics and toiletries available bear no reference to animal testing and the public as a whole spends a vast amount of money on them - 'cosmetics and toiletries' is a multi-billion pound industry.
2.2 Perceptions of the reasons for and nature of animal use
Unless they are closely involved with the issue, the majority of people have little knowledge of the basic facts regarding cosmetics testing, e.g. the nature of regulatory requirements, the international dimension, the nature of animal tests and the status and availability of alternative methods. One particular factor contributing to the level of public concern is the perception that a huge number of animals, of a confusing variety of species, are used for testing cosmetics, and that a great deal of suffering is caused to them. In reality, the numbers are relatively small compared with total animal usage in research and testing (i.e. 2,634 animals, representing 0.1% of the total 2,646,026 in the UK in 1996), as is the number of species involved. The degree of suffering is more difficult to determine (see section 3.1 below).
Even people associated with animal use in biomedical research (particularly outside the cosmetics, chemical or pharmaceutical industries) though usually aware that cosmetics testing occurs, are often uninformed as to the scale of this in relation to other uses of animals under the ASPA. Many share the general public's view that testing cosmetics on animals is wrong. A common argument put forward is that 'medical research' using animals is vital, but cosmetics testing is unacceptable. Some scientists use this argument to counter anticipated criticisms of their own work by making an ethical distinction between the two types of animal use.
Whether or not people are fully aware of the facts, the situation is such that cosmetics testing will remain a matter of serious public concern. This situation will continue regardless of how many or how few animals are used, or of how much or how little suffering occurs.
3. The nature of the problem in relation to the cost-benefit assessment under the Animals (Scientific Procedures) Act 1986
For a critical evaluation of the interpretation of para 5(4) of ASPA, it is essential to know how the costs and benefits of cosmetics testing are assessed, what criteria are used by the Home Office (HO) (and in this case the Animal Procedures Committee (APC)) in weighing one against the other, and hence how the use of animals is justified. The bases for these judgements, particularly regarding benefit and justification, are not defined other than in the brief description set out by the (then) Chief Inspector in the APC report for 1993. (The APC and the HO are currently considering this further). The Boyd Group therefore had to speculate on the basis of the limited information that is available.
3.1 The costs to animals
The costs to animals include both the numbers used, i.e. individual lives taken, and the amount of suffering.
In 1996, 2,634 animals were used for testing cosmetics of which 220 were for testing cosmetic products and 2,414 for ingredients, the latter being substances intended for use mainly or exclusively in cosmetics. The numbers of animals used in cosmetics testing in the UK has decreased considerably in recent years (in 1989 there were 12,090 procedures), although the 1996 figure shows a small rise from 1995. The species used in 1996 were guinea-pigs (1,603), rats (835) and rabbits (196).
The only figures available for other European countries are from 1991. Not all countries list cosmetics tests separately, but those that do reported using approximately 30,000 animals: Spain reported using 2,036 rodents and rabbits, France reported using 27,337 rodents and rabbits and some 'other' animals and the Netherlands reported using 248 rodents and rabbits; Greece and Portugal said no cosmetics tests were carried out.
It is difficult to find out how much suffering is involved in cosmetics tests. According to the 1996 Home Office Statistics, the majority of procedures (2,803) are for skin irritation and sensitisation, with 494 acute limit setting procedures. Eye irritation tests were performed on three rabbits. This is ironic given that for most members of the public the Draize eye test is representative of cosmetics testing as a whole.
Procedures would be expected to be mild because of the nature of the products concerned (i.e. they are not toxic chemicals and unlike pharmaceuticals they should not have a physiological effect), but this may not necessarily be the case. As well as the potential toxic effect of the chemical, animals can suffer distress from associated procedures such as restraint or use of occlusive dressings. It is likely that the level of suffering varies with the substance tested, the nature of the regulatory requirements and the end-points deemed necessary. The interpretation of the requirements by the establishment where tests are done and of the individual doing the test will also have an effect. A clearer idea of the degree of suffering could be obtained from the test protocols, and by discussing test methods with those involved in doing them in contract-testing houses in the UK.
3.2 Benefits and justification
Animals are used in testing cosmetic ingredients and/or products because such tests are required to satisfy regulatory requirements, or product safety legislation, put in place by national and international agencies to safeguard human health and safety and protect the environment. Animal tests are either explicit or implicit in this legislation. Testing is, in general, only necessary where new ingredients/products are developed, unless the safety of an established substance is questioned and needs to be reassessed. Companies engaged in the development and use of new substances cannot, at present, avoid animal tests.
In the UK, tests are carried out by contract testing houses rather than by cosmetic companies themselves. The contract testing houses may do studies for companies from other countries such as Japan or the USA and/or to satisfy the national requirements of such countries which can be more stringent than those of the UK or Europe.
3.2.1 Defining benefit
The immediate benefits from the animal tests are likely to be described as stemming from: (a) the desire to protect human health and safety and safeguard the environment; and (b) the underlying assumption that there is a benefit in the development of a new ingredient or product. In practice, the justification is likely to be the need to satisfy a regulatory requirement.
a) Protecting human health and safety: Clearly, protecting human health and safety, or safeguarding the environment, is not a trivial aim - it is indeed a benefit - and the need to assess safety is not in doubt. The relevant question is whether animal tests are an essential part of the safety assessment.
The necessity for, and validity of, each type of animal test, the validity of alternative methods, the way the regulatory process determines what is currently done and how this process responds to change are all relevant factors in the debate. There is a considerable degree of consensus on some of these matters across all the interested parties (including toxicologists, specialists in alternatives, industry, regulators, government bodies, animal protection organisations). Thus for some animal tests (e.g. photo-irritancy, percutaneous absorption) there is broad agreement that there are validated alternatives that could immediately be used as replacements. However, there is an international scientific and political perspective to the debate, and a consensus is required across a very broad arena before any action to replace animals can be taken. As a result, even where there is a consensus, the wheels of the regulatory decision making process revolve very slowly, and substituting a validated alternative for an animal test takes years.
b) The benefit of the product: There must be an assumption that new substances (leading to the development and marketing of new products) are a commodity of sufficient benefit to warrant the expenditure of animal life and suffering, otherwise the testing procedures would not be licensed. Such benefits may be seen as applying to:
Most of these 'benefits' have an economic and hence political emphasis, i.e. in terms of the ASPA (clause 20.2) they satisfy the "legitimate requirements of .... industry" rather than improving human health or increasing scientific knowledge.
The two classes of benefit (a) and (b) are inextricably linked. If companies were not developing new substances there would not be any need to check safety; if humane alternatives were accepted for all tests then new products could be developed without causing animal suffering. Either stopping product development or ensuring acceptable alternatives are available would solve the animal testing problem. Both approaches are advocated by various groups but neither are likely to achieve results in the short or even medium term.
3.3 Weighing costs and benefits
The costs and benefits have been defined above, but in the overall context of the legislation there are additional factors to be taken into account when weighing these. The substantial level of public concern on the morality of, and hence justification for, animal use must influence decisions. Another important factor is the status of alternative tests. For example, a substantial body of authoritative opinion may consider that there are acceptable alternatives available for a particular animal test. However, there may not be a consensus in the international political and regulatory arena and, even where there is agreement, the bureaucratic process leading to replacement of the animal test may take years. In the meantime, the animal test is still requested by regulatory bodies to assess safety - and hence is still licensed under ASPA. Since an alternative method is technically available, this could be seen as being in conflict with clause 5(5) of the Act which states that "an animal cannot be used if the purpose of the programme of work can be achieved by alternative means". Presumably, in applying clause 5.5 to toxicity testing, the HO responds to regulatory requirements - which may have more to do with international politics than human or environmental safety.
With regard to product (or ingredient) development, it is difficult to see how the potential benefits to groups (i) to (v) above can be weighed. The HO is unlikely to be able to define the degree of benefit of every new substance tested in these terms. Where then should the responsibility for this assessment lie? The producer is bound to consider that a new product/substance is of benefit to them otherwise they would not wish to develop it - but who should dictate what industry produces - the public, the Government, or industry itself? The public can really only express its view through purchasing habits and through political pressure. Sometimes these produce conflicting responses - people write to their MPs about cosmetics testing but continue to spend millions on cosmetics which have involved animal testing. Should these decisions be made by the HO under the ASPA or are they political decisions for the government as a whole, taking into account the interests of industry and animal welfare and public concern?
The key questions with respect to ASPA are:
3.3.1 Cosmetic products - a test case
The testing of finished products (now ended in the UK) can be used as a test case to consider the application of the cost/benefit assessment. There is very broad agreement amongst those interested parties such as the UK cosmetics industry, the Department of Trade and Industry (DTI), the European Centre for the Validation of Alternative Methods (ECVAM) and animal protection groups, that there should be no need to carry out finished product testing on animals to ensure human safety and allow marketing of the product. There is neither a scientific nor a regulatory requirement for such tests in Europe. Safety data on the ingredients is considered sufficient in conjunction with alternative tests prior to human volunteer testing. However, there is disagreement between member states at EU level on this issue, although the cosmetics industry in Europe is working towards a voluntary cessation of finished product testing. A European wide ban on the sale of finished cosmetic products that had been tested using animals was not introduced under the Cosmetics Directive during consideration of the '1998 deadline' because there was some disagreement by companies in France and Spain, and because of problems with the World Trade Organisation and the General Agreement on Tariffs and Trade.
As stated earlier, the ASPA is based on the utilitarian philosophy that some use of animals is justified, provided this results in sufficient benefit for the greater good. In the case of testing cosmetic products, 'the greater good' appears to have more to do with trade and bureaucracy than the protection in practice of human health and safety, scientific advancement, or animal welfare.
In 1997, the Boyd Group concluded that the use of animals for testing finished cosmetics products was no longer justified under the terms of the ASPA. In the same year, the Government adopted this position and asked for the voluntary handing in of cosmetic product testing licences. No new licences will be issued for this purpose.
3.3.2 Cosmetic ingredients
There was a spectrum of opinion within the Boyd Group as to the justification for testing cosmetic ingredients on animals. Some members consider that testing cosmetics ingredients (however they are defined) calls into question application of the basic principles of ASPA, and should not be allowed. Some felt that any such ban should only apply to ingredients intended for 'vanity products'. Others felt that separating out vanity products was simply not possible and this was in any case an artificial classification.
Three distinctions can be made between the justification for ingredient and product testing. Firstly, one of the reasons that cosmetic product testing can cease is because of the knowledge about the product gained from the testing of the constituent ingredients! Secondly, there are regulatory requirements that demand animal tests for cosmetics ingredients. Thirdly, there is no authoritative scientific consensus that alternatives for all the required toxicological endpoints for ingredient testing are available, although a significant number of protagonists believe that satisfactory validated alternatives exist for some (in particular phototoxicity and percutaneous absorption), with the barriers to their acceptance lying within the regulatory process. A decision not to allow any tests for cosmetic ingredients would therefore reflect the question of justification for developing new substances, rather than the scientific need for the tests.
The Boyd Group as a whole recognised that in order to reduce the conflicting demands of animal welfare, industry and the consumer, there is a need to expedite validation, adoption and immediate use of alternatives. This also applies to fields other than cosmetics where substances are tested under legislation such as the EU Directive on dangerous chemicals (European Commission, 1967). The role the cosmetics industry has played with respect to alternatives was recognised, as was the fact that alternatives are already widely used within the industry.
The Group believed that the concept of a phased introduction of alternatives under the Cosmetics Directive should likewise be promoted - i.e. immediately an alternative method is accepted, the corresponding animal test should be replaced, and then disallowed. All the Government departments concerned (DTI, Department of Health, HO) should be actively pursuing these objectives in Europe and in the international arena. Funding for alternatives development is also important as is support for ECVAM. However, perhaps the most important matter to pursue is the need to speed up the process whereby alternatives are accepted and implemented in the regulatory arena. The Group advocates the development and publication of a clearly defined strategy, both within the relevant Government departments and within industry to address these issues.
4. Exporting the problem - the morality of sending animal tests abroad
The existing licences for testing cosmetic products in the UK have voluntarily been relinquished and the Government has stated that no more licences will be issued. This satisfies the concerns regarding the justification of cosmetics product testing under the ASPA, but may not solve the problem for animals because the tests can still be done elsewhere.
As long as there remain some countries that allow the use of animals for testing cosmetics to continue, a unilateral ban will not be effective in stopping this area of animal use. Is it therefore morally acceptable to act in a unilateral manner? One view is that this can have an indirect positive effect by signalling a firm intention to the rest of the world that testing cosmetics on animals is considered unacceptable. The general feeling of the Boyd Group was that on this particular issue, i.e. testing cosmetic products on animals, taking into account the level of public concern and the agreed positions on the necessity of the tests, the UK is fully justified in urging other countries to follow its lead. Implementing such bans, however, is insufficient action on its own since the problem will not go away. It is essential for all interested parties to continue to lobby in the appropriate international forum for a world wide solution.
5. Summary and conclusions
The Boyd Group debated the use of animals in testing cosmetics in relation to its justification under ASPA taking into account the complexity of the issue and the symbolic importance of cosmetics testing as an 'icon' in the public debate about the use of laboratory animals in general.
Public perceptions of the reasons for, and nature of, cosmetics testing and how this accorded with reality were explored. The definition of cosmetics and the belief that they are trivial in nature, and therefore different from other non-medical products, was discussed.
The Group went on to consider the application of the cost-benefit assessment under ASPA. The costs to animals concern potential suffering and loss of life. The benefits of the procedures were more difficult to define, but were presumed to be twofold. The first is the desire to protect human health and safety and safeguard the environment. The second class of benefit relies on the underlying assumption that there is a benefit in the development of a new substance. This benefit is presumably to industry, the economy, the Government, society, the consumer and the environment. The question of how such benefits are assessed and where the responsibility for making decisions should lie was also discussed. Key questions regarding the application of the ASPA were listed.
Cosmetic products and ingredients were considered separately. In the former case, there is broad agreement amongst all interested parties (at least in the UK) that there is no need to test finished products on animals. Safety data on the ingredients is considered sufficient in conjunction with alternative tests prior to human volunteer testing.
Ingredients differ from products in that there are regulatory requirements to test them, and there is no authoritative scientific consensus that there are alternatives available for all the tests required. In practice, the justification for procedures is likely to be the need to satisfy a regulatory requirement. Because of the absence of validated alternative for all tests, a decision not to allow ingredient testing under ASPA would be based on moral grounds.
The main conclusions from this part of the discussion were:
The Group also agreed the following points (note, these have relevance to safety testing of chemical substances in general and not just to cosmetics):
Finally, the Boyd Group debated whether it is morally acceptable to take unilateral action that leads to animal work being exported from one country to another. The Group concluded that on the specific issue of cosmetic product testing unilateral action was justified. However, such action was dependent on all interested parties continuing to work in the appropriate international forums to achieve a world wide solution to the problem.
Balls, M. (1991). On Establishing the Safety of Cosmetic Ingredients and Products Produced and/or Marketed within the European Economic Community. Alternatives to Laboratory Animals 19, 237-244.
Balls, M. et al., (1990). Report and Recommendations of an International Workshop on Promotion of the Regulatory Acceptance of Validated Non-animal Toxicity Test Procedures. Alternatives to Laboratory Animals 18, 339-344.
Clark, D.G. (1994). Barriers to the acceptance of in vitro alternatives. Toxicology in Vitro, 8(4), 907-909.
Eurogroup for Animal Welfare (1991). Cosmetics, labelling and animal testing: A Report arising from Contract No. 6800.90.011010 of the Commission of the European Community entitled 'A study to be used as the basis for the use of a possible Community label "cosmetics not tested on animals" or similar'. Eurogroup for Animal Welfare, Brussels.
European Commission (1967). Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European Communities, L196.
European Commission (1976). Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetics products. Official Journal of the European Communities, L262.
European Commission (1997). 1996 Commission Report on the Development, Validation and Legal Acceptance of Alternative Methods to Animal Experiments in the Field of Cosmetics. European Commission, Brussels. COM(97) 182 final.
Home Office (1994). Animal Procedures Committee. Report to the Home Secretary on Regulatory Toxicity. Home Office, London.
Langley, G. & Fisher, C. (1995). New perspectives in cosmetics toxicology. Non-animal tier-testing strategies. Ideal Publications, London.