The search for alternatives to animal testing stems from the fact that the primary concern of the cosmetics industry is to ensure the health, safety and well-being of all of its consumers and employees through the marketing of products that are safe and effective. According to COLIPA, dependence on animal testing is being reduced dramatically, and the industry is advancing towards the future elimination of animal testing by exploiting methods such as historical databases, information from ingredients suppliers, intelligent computer expert systems and developments in in vitro technology.

The need for postponement

Current European law aims to prohibit animal testing for cosmetic products and ingredients, but acknowledges that prohibition is contingent on there being satisfactory alternatives. The law, as set out in Article 4(1)(I) of Directive 76/768/EEC on cosmetic products, as amended by Council Directive 93/35/EC of 14 June 1993 (the 6th Amendment), states that Member States “shall prohibit the marketing of cosmetics products containing ingredients or combinations of ingredients tested on animals after 1 January 1998”. The article also specified that if there had been insufficient progress in developing satisfactory methods to replace animal testing, or where alternative test methods had not been scientifically validated, the Commission would submit draft measures by 1 January 1997 to postpone the date of implementation of this provision for a sufficient period, and for no less than two years.

The deadline was indeed postponed following a review of the status of development and validation of alternative methods at the end of 1997. While some progress had been made in the development of alternative methods, none had been scientifically validated and the OECD (Organisation of Economic Co-operation and Development) had not adopted guidelines for any toxicity tests using non-animal methods, meaning discrepancies in the legal situation between the EU and non-EU countries which could compromise European companies’ ability to trade globally. Without OECD acceptance of similar guidelines, any company which had avoided animal testing to market a product in the EU could find itself simply having to carry out such tests in order to export it to non-EU markets. Directive 97/18/EC was adopted by the Commission in April 1997; it postponed the ban until 30 June 2000, a date by which reasonable progress could be expected. Directive 97/18/EC also provides for a reassessment of the situation by 1 January 2000.

In 1998 the Commission put forward a draft proposal for a 7th Amendment to the Cosmetics Directive which had three key objectives:

• To revise the current legislative proposals with respect to the prohibition of animal testing in the cosmetics sector so as to make them WTO (World Trade Organisation) compliant and legally enforceable, thus offering a genuine benefit in animal welfare.

• To introduce a prohibition on the testing of finished cosmetic products on animals in the territory of the EU Member States.

• To amend the current prohibition on ingredient testing on animals and facilitate the introduction of alternative validated methods for the testing of chemicals used in cosmetic products as soon as such methods become available. Subsequently the deadline of June 2000 for a total ban on animal testing is abandoned as such an arbitrary deadline is not feasible.

Unfortunately in early 1999 political developments which led to the resignation of all European Commissioners left the issue in suspension and it was uncertain whether the proposals would move forward. This could have serious consequences for the European cosmetic industry, especially on questions related to consumer safety, on innovation requirements, on investments relative to alternative methods and on competitive advantage with other trading blocs/countries. The result may be that the provisions of Article 4.1 of the 6th Amendment will be finally implemented on 1 July 2000 but COLIPA has warned that if the Directives are implemented in their current form, in certain cases public health would be put in danger and it would be more difficult to ensure manufacturer responsibility regarding the safety of products. Legally, COLIPA states that the Commission has to postpone the ban for a second time because there is a real incompatibility of Article 4.1 of the 6th Amendment with the WTO rules and so if it was implemented it would probably cause a trade war.

Progress to date

Much has been achieved already in the quest to eliminate the need for animal tests. COLIPA has advised the European Commission that there will be a cessation in the undertaking of final product safety testing using animals in the EU from January 2000. Additionally alternative methods for four areas of ingredient testing are in the advanced stages of validation (skin irritation, skin corrosion, percutaneous absorption and photo irritation) and some have now been accepted at EU level.

In his keynote address, Jacques Leclaire, director of Life Sciences research for L’Oréal, France summarised these developments. In the fields of phototoxicity, skin corrosion and percutaneous absorption alternative methods have been considered as valid replacements for the evaluation of cosmetic ingredients.

In phototoxicity the 3T3 NRU PT (Neutral Red Uptake Photo Toxicity) test has been successfully validated and endorsed by the Commission’s expert services and its Scientific Committee on Cosmetic and Non-Food Products (SCCNFP). Guidelines and SOPS (Standard Operating Procedures) have been sent to the OECD. In the field of skin tolerance two alternative methods (Episkin and the TER methods) have been validated by ECVAM (European Centre for the Validation of Alternative Methods) and endorsed by the Commission’s expert services and the SCCNFP. Guidelines and SOPS have been sent to the OECD. COLIPA has published guidelines on the conduct of clinical tests to assess the skin compatibility of cosmetic finished products and cosmetic ingredients. ECVAM has also initiated a pre-validation study on reconstructed and excised skin models for the irritant potential of chemicals. In percutaneous absorption COLIPA has presented protocols and data generated by the cosmetics industry for the evaluation of cosmetic ingredients. These data have been reviewed by the SCCNFP and considered to support the rationale of in vitro studies for cosmetic ingredient evaluation. However, the SCCNFP is currently establishing “a minimal requirement list” to interpret the data submitted to this committee in a better way. Efforts at harmonisation have also been undertaken following exchanges between the SCCNFP and COLIPA. These data have also been shared with the OECD. ECVAM is currently conducting a pre-validation study in the field of skin irritation. ECVAM and COLIPA are involved in a pre-validation study on the cytokine IL 1 as a potential biomarker for sensitisation potential. COLIPA has launched a research programme on skin metabolism and sensitisation and a great deal of work has been achieved following international eye irritation studies covering short-term approaches to improving current methods and a research programme on the mechanisms of eye irritation.

Leclaire concluded that the development of alternative strategies to assess the safety of finished cosmetic ingredients is the sole responsibility of the cosmetics industry. The larger companies have already devoted many years of R&D to come up with appropriate strategies and this knowledge is being shared with smaller enterprises. Leclaire proclaimed, “It is therefore a huge success to be able to say that we are ready to accept a ban on animal testing for the safety assessment of cosmetic finished product”. However, in the larger field of the toxicology of cosmetic ingredients, Leclaire states that the search for alternative methods is the shared responsibility of scientists from all industries and academia.

EU acceptance

In a round table session on the acceptance of alternative methods in the EU, moderator Professor Michael Balls, head of ECVAM, suggested that a more apt term would be advanced methods as it is the objective that replacement non-animal methods should be better than the original testing procedures. Therefore animal testing does not represent a good benchmark for the new alternative methods. Michael Balls then outlined the validation procedure; having carried out a validation study, ECVAM puts forward a report to the European Commission where DGXXIV consults with the SCCNFP to decide whether the method should be accepted.

Guy Corcelle, head of the the Commission’s DGXI (Environment, Nuclear Safety and Civil Protection), broached the subject of international acceptance of validated methods. He stated that although this is desirable the fact that the European Commission and OECD operate in very different ways makes it difficult. He concluded that validation and acceptance represent a “learning by doing” exercise. Despite the complexity, all parties involved are committed to making progress.

The Commission’s DGXXIV (Consumer Policy & Health Protection) was represented in the round table by its head of unit, Dr Mercedes de Solà Domingo. She highlighted five areas of conflict in the alternatives to animal testing issue: the conflict between protecting human health and ensuring animal welfare; animal testing versus human testing; alternative methods in cosmetics against alternative methods in other sectors (for example, pharmaceuticals); the difference between SMEs and larger companies and the problem of banning the marketing of products and ingredients tested on animals in the EU while ensuring that world trade remains fair.

Jack Dupuis, COLIPA’s senior scientific officer stated that acceptance just within the EU is not enough. He stated his belief that human testing is not an alternative method and should only be used in the final stage of evaluation. Dupuis also suggested some lessons that have been learned during the quest to find validated alternative methods, including the fact that acceptance is not a straightforward process, but validation is easier; the need to aim for “the best science” in finding alternative methods; and the fact that people are often conservative and reluctant to accept change, but they must. Dupuis also suggested that different regions across the world are divided in their opinion on animal testing; indeed there are even differences between the North and South of Europe. He proposed how the roles of different parties involved in the issue might be changed, for example, he proposed that animal welfare groups, who do have resources, should make more of a contribution to the search and SMEs, who are major generators of new jobs, should receive more help.

In response to the round table session, Patrick Deboyser, head of DGIII offered a comment from the floor regarding the global acceptance of alternative methods. He suggested that there is a real need for Mutual Recognition Agreements. Hermann Koëter, principal administrator of the OECD, also commented on global acceptance. He pointed out that the OECD has more countries’ views to take into account than the EU – the OECD has 29 members. Gerald McEwen, vice president, Science, CTFA, also stated that there could be problems with the US specifically because of differing definitions of cosmetic products.

The way ahead

Frank Baker, director of human and environmental safety for Procter & Gamble in the US provided a view of the cosmetic industry’s research commitment and future plans. He explained that looking for alternative methods is a rather imprecise science because scientific progress occurs in unexpected ways on a timescale which can be driven neither by legislation nor regulation. Nor is progress guaranteed as a result of ethical demands or large investments of money. Scientific progress comes from breakthroughs and breakthroughs by their very nature are unpredictable and surprising in their impact.

Looking to the future, Baker suggests that the challenge over the next five years is to internalise what has been learned. “We have found that the validation process is easy (despite the initial concerns). The tough work is developing test methods which can be validated. Progress will only come based on high quality science and deep understanding of the biological phenomena which we are studying.” He added that the cosmetic industry cannot solve the challenge of finding replacements alone. “The chemical industry which supplies ingredients needs to become involved. Government funding will enable broader participation of academic experts in the research effort.”

To conclude, Frank Baker warned that to ban the testing of ingredients on animals prematurely is irresponsible and places consumers at risk unnecessarily, but not to stop animal testing as soon as science allows is equally irresponsible. “Reducing animal testing to a minimum in a responsible manner is a goal that we all can share and support. By working productively together, we can and will achieve it.”

Julie Forster

Julie Forster is editor of the monthly trade magazine European Cosmetic Markets, published by UK-based Wilmington Business Publishing Ltd. European Cosmetic Markets focuses on retail trends in the major European markets, providing in-depth information on the main cosmetics and toiletries categories, alongside company profiles, regional reports and all the latest news and new products. Contact: European Cosmetic Markets, Wilmington Publishing, 6-14 Underwood Street, London N1 7JQ, UK. Tel. +44-20-7549-8626, Fax +44-20-7549-8622, e-mail: jforster@wilmington.co.uk