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REGULATIONS

TARGET 2000

Commission Decision 96/335/EC of May 8th, 1996 has adopted the European Inventory and a common nomenclature of ingredients employed in cosmetic products marketed in the European Union, as the fulfillment of Council Directive 76/768/EEC of July 27th 1976 on the approximation of laws of the Member States relating to cosmetic products, as amended by Council Directive 93/35/EEC and, in particular, Art. 5a and Art. 7(2) thereof.

The Inventory includes some 8,000 ca. chemical substances commonly used since many years as ingredients, in cosmetic products: these are identified by a series of code numbers of different value (INCI, IINN, Ph.Eur., CAS, EINECS, ELINCS, IUPAC names) and they belong to 36 different usual cosmetic functions. The presence of chemicals potentially harmful to consumers' health among cosmetic ingredients is limited to a small number of substances, because the majority of raw materials employed in cosmetic products are recognized as harmless, on the basis of their widespread human use by consumers over many decades. It should be considered that the cosmetic industry has been a highly self-regulating body, providing quality products with remarkable absence of human toxicity.

Out of the total number of cosmetic ingredients reported in the European Inventory, only 400 ca. (equivalent to 5%) are also seperately listed in Annexes III, IV, VI, and VII of Council Directive 76/768/EEC as they were recognized since 1976 to represent some risk to consumers' health, and they were submitted to specific restrictions of use, after the evaluation of their potential toxic hazard towards consumers' health.

For only these 400 cosmetic ingredients, representing hair dyes, preservatives, coloring agents, UV-filters, and very few other types of cosmetic ingredients, COLIPA, as requested by Directive 76/768/EEC has presented to the European Commission (DGXXIV) a dossier of toxicological information obtained from studies specifically developed, following recommendations issued by the Scientific Committee on Cosmetology (1982, 1990, 1997). As in the case of other fields of safety evaluation of chemical substances to which human exposure is documented, such as food additives, drugs, industrial chemicals, and pesticides, the basis for the safety evaluation of this group of cosmetic ingredients (ca. 400) by the Scientific Committee on Cosmetology has been the evaluation of toxicological studies developed by cosmetic industries according to well established toxicological guidelines adopted by the European Commission (Directives 87/302/EEC and 92/69/EEC) or by OECD (1993).

In the 1994 DGXXIV Report to the European Parliament on "Development, Validation, and Legal Acceptance of Alternative Methods to Animal Experiments" (Com (94), 606 final) some interesting information on the use of animal tests for cosmetics have been made available, on the basis of also the partial information by the Member States under Directive 86/609/EEC.

"During 1991, the number of rodents and rabbits used to test cosmtics and body hygiene products compared to the total number of animals of the same species used in toxicity tests in the field of human, animal, and environmental protection, are:

  • 248 out of 25,994 in the Netherlands
  • 2,2028 out of 19,468 in Spain
  • 22,880 out of 89,620 in France
  • 3,082 out of 171,530 in the United Kingdom

The Report specifies, however, that these data may not be as revealing as one might think, since:

  • toxicity tests for American and Japanese companies are mainly conducted in France, United Kingdom, and Germany
  • most of the tests were performed on finished products or for internal monitoring purposes;
  • the statistical data furnished by the Member States are incomplete."

In the 1995 DGXXIV Report to the European Parliament (Com (96) 365 final), the following information were made available:

  • eight Member States have declared that animal tests for finished cosmetic products have not been carried out on their territory (Italy, Greece, Belgium, Ireland, Sweden, Finland, Luxembourg, Germany)
  • six Member States have declared that animal tests for cosmetic ingredients have not been carried out on their territory (Greece, The Netherlands, Ireland, Sweeden, Finland, Luxembourg)
  • only three Member States (Austria, France, United Kingdom) have communicated figures relating to the number of animals used, while pointing our however, that these figures could not be interpreted and that uncertainties remain as to their correspondence to reality
  • as regards the declaration that tests have not been carried out, it should also be noted that certain Member States do not produce ingredients and that certain ingredients used for cosmetic products may have been tested for other purposes.

Information provided by DGXXIV have been confirmed also during 1996 and they will be included in the last Report.

It must be recognized that there are no numerical statistics on the use of animals in the European Union for the safety testing of cosmetic ingredients. The Commission strongly regrets that it does not have more precise data at this moment.

The only rough estimate on the number of animals used for cosmetic ingredients in the European Union is that elaborated by N. Loprieno in 1994 for 43 cosmetic ingredients notified to the Commission by COLIPA, for their inclusion in the Technical Annexes of Council Directive 76/768/EEC, and evaluated by the Scientific Committee on Cosmetology during 1993.

The 43 cosmetic ingredients included 5 preservatives (Annex VI), 8 UV-filters (Annex VII), and 30 hair dyes (Annex III).

The total number of animals used to evaluate the safety of the 43 cosmetic ingredients, calculated on the basis of the dossiers examined by the SCC, has been of 38,900 individually, relating to 5 species: rats: 21,000; mice: 14,500; guinea pigs: 2,600; rabbits: 700; hamsters: 100.

This number corresponds to approximately 900 animals per cosmetic ingredient or less than 100 animals per ingredient per year (based on 10 years time, during which the dossiers of the 43 cosmetic ingredients were prepared).

The figure of 38,900 animals related to the numbers of rodents and rabbits used to test cosmetic ingredients is extremely low (0.33%) in comparison with the total number of animals used in all sectors (11, 790,485: Council Directive 86/609/EEC; COM(94), 606 final; N. Loprieno Alternative Methodologies for the Safety Evaluation of Chemicals in the Cosmetic Industries, CRC Press, USA, 1995).

The possibility to reduce further the number of animals needed for the safety evaluation of cosmetic ingredients depends very much on the availability during the next two years of reliable alternative methodologies which do not make use of animals. As recently stated by J.F.H. Purchase (1997), and well-known to many scientists, Validation is a time-consuming exercise which historically has taken 10 years from the recent publication of the method to international acceptance of a validated test. The most recent validation studies on a specific toxic endpoint, such as eye irritancy testing, has moreover demonstrated that one group of different methods (battery of tests) rather than one specific method is scientifically adequate to predict the potential for toxic effects of different chemicals.

Cosmetic Industries, in order to develop cosmetics safe for customers without making use of animal models, have gone beyond the problem of validating a single new methodology. They have succeeded in defining the "in-house" best strategy of non-animal testing for the safety evaluation of cosmetics in different fields of toxicology. These new and complex strategies have a scientific basis, so that in the future they will be able to meet the requirements of the SCC by providing for their new cosmetic ingredients a scientifically acceptable toxicological dossier.

If this is the correct interpretation of the scientific results obtained in the field of safety evaluation of cosmetics, due to the great effort made by the Cosmetic Industries, there are some consequences to be considered in the sector of the application of Directive 93/35/EEC (ban of animal testing when in vitro methodologies will be available).

The present animal testing models for the safety evaluation of cosmetics (and chemicals) as presented by Directives 87/302/EEC ad 92/69/EEC, could not be replaced in the near future (5-10 years) by a single in vitro methodology. However, it is possible that, in a very short time for some of the tests (ocular and skin irritation, skin sensitization, phototoxicity, etc.), more than one methodology, including biological system(s) and intelligent systems(s), combined in a sequential or tier strategy could be defined and made available for distinct groups of chemicals (cosmetics).

Each cosmetic company of international relevance (L'oreal, Unilever, Proctor & Gamble, etc.) has its own sector of cosmetics, chemically different one from the other. These companies have successfully developed integrated batteries of methodologies which allow an adequate safety evaluation of cosmetics of their interest. The basis of these batteries of methods (the results of all the experiments performed on several groups of chemicals of own interest) represents the complex and extended studies performed "in house" which will not be available for general use (for other cosmetic companies) although they will be used to support toxicological dossiers to be presented to the EC-SCC or to the public authority (dossier of information).

This indicates that in the next future there could be no validated individual methodologies, approved by international agencies such as OECD, which could be used by all cosmetic industries for the safety evaluation of ingredients, or finished products of their interest. However, it is possible that the validation positively concluded for a single methodology is relevant only for a few chemicals.

In preparing its opinion to DGXXIV before January 1997 for the implementation of the ban requested by Council Directive 93/35/EEC, the Scientific Committee on Cosmetology has confirmed its opinion already adopted in 1990 (SPC/803-50/90) that the safety evaluation of finished cosmetic products in general can be obtained by knowledge of the toxicity if the cosmetic ingredients. Therefore, these finished products should not be tested on animals starting from 1998. ECVAM has expressed a similar opinion (Interim Report from ECVAM to DGXXIV, April 1996: XXIV/1318/96). According to COLIPA, for finished product testing, many companies are already applying in vitro assays in its product safety evaluation procedures (Report from COLIPA to DGXXIV, April 1996; XXIV/1317/96).

The Scientific Committee on Cosmetology has also recognized that especially for cosmetic ingredients, studies for assessing percutaneous absorption are particularly important and that alternative methods for the study of percutaneous absorption will be available in the near future (Notes of Guidance for Testing of Cosmetic Ingredients for Their Safety Evaluation: XXIV/1878/97).

It must be stressed that for these two sectors of toxicity testing, phototoxicity, and percutaneous absorption, there are no scientifically accepted and internationally validated methodologies.

In conclusion, the target of 50% reduction of the use of animal in the safety testing of cosmetic ingredients by the year 2000 does not seem impossible in the cosmetic sector because of a set of considerations:

  1. The most interested industrial sector in the development of alternative methods to the use of animals is the cosmetic sector; the major scientific contribution to development and validation of alternative methods is well documented in the scientific literature of the last 5 years.
  2. Real possibilities of reducing the use of animals in the safety evaluation of cosmetic ingredients exist in the next 2-3 years in some fields of toxicology and toxicity testing studies, namely phototoxicity and percutaneous absorption.
  3. The present estimated fraction of animals used by the cosmetic industrial sector is so low (0.33% of the total) that it seems reasonable to assume that the impact on the reduction of animals by the introduction of alternative methods in the safety evaluation of cosmetic ingredients will be negligeable for the year 2000.
  4. There are other industrial sectors (chemical substances, pesticides) in which the number of animals in testing procedures is extremely high and it has been potentially increased in the last years after the introduction of some EC regulations, such as for example, the revision of 100 pesticides per year starting from 1994 (Council Directive 91/414/EEC), a decision that has stimulated an enormous development of new toxicological animal studies, finalized to the production of results already known to public Authorities.

The 76/768/EEC Council Directive and its Sixth Amendment (Council Directive 93/35/EEC) require that a cosmetic product put on the market within the Community must not cause damage to human health and that the methods to replace animal testing must be scientifically validated as offering an equivalent level of protection for the consumers: this objective is very important for DGXXIV and for its consulting Scientific Committee on Cosmetology and should not be ignored by any of the animal issues currently under discussion.

Several actions could be considered, however, by this Conference, which could contribute to reduce the use of animals in the cosmetic sector.

  1. DGXXIV should be directly involved in the development and validation of alternative methods to be applied to the cosmetic ingredients' safety evaluation. This would better guide and stimulate all fields of research and reduce the time needed for transferring new information.
  2. The Sixth Amendment requires the preparation of a dossier of information for each finished cosmetic product, containing the safety evaluation of individual ingredients present in the cosmetic product at issue.

Preparation of the dossier requires that the producer gathers extensive toxicological information for a multitude of cosmetic ingredients that are normally employed in the formulation of a cosmetic product. Most of this information does exist. Therefore, there is a need, independently from the development and validation of alternative methods, to organize by DGXXIV a databank containing all the existing toxicological information relating to cosmetic ingredients, also including the 400 chemicals evaluated by the Scientific Committee on Cosmetology during the last twenty years. This seems the only significant action which could have been done since the approval of the Sixth Amendment to cosmetic regulation by the European Commission's specific institutions.

This databank would make possible to remove the need for animal experimentation, by showing that information already exists and providing it to producers, in compliance with Art. 7 of Council Directive 86/609/EEC (An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practically available).

This databank might provide adequate background so that the extent of animal experimentation can be reduced.

This databank might provide evidence on whether experimental procedures are useful, so that unproductive animal experiments can be eliminated.

This databank, at last, might strongly support the development of alternative methods to the use of animals by providing modeling, prediction, simulation, and risk assessment systems that may, in turn, replace or reduce animal experimentation (D. Bawden: Information systems and databases as alternatives. ATLA 18, 83-90, 1990; N. Loprieno and G. Loprieno: The Sixth Amendment to Council Directive 76/768/EEC and the Need for Developing and Validating in vitro Alternative Methods for the Safety Evaluation of Cosmetic Ingredients. In Vitro Toxicology, 8, 291.332, 1995; ECVAM Workshop Report 7, ATLA, 23, 398-409, 1995).

 

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