Report - A4-0277/1997Report

REPORT on the Commission report on the development, validation and legal acceptance of alternative methods to animal experiments in the field of cosmetics - 1996 (COM(97)0182 - C4-0369/97)

24 September 1997

Committee on the Environment, Public Health and Consumer Protection
Rapporteur: Dagmar Roth-Behrendt

By letter of 6 May 1997 the Commission forwarded to Parliament its 1996 annual report on the development, validation and legal acceptance of alternative methods to animal experiments in the field of cosmetics.

At the sitting of 18 July 1997 the President of Parliament announced that he had referred this to the Committee on the Environment, Public Health and Consumer Protection as the committee responsible.

At its meeting of 2 July 1997 the Committee had appointed Mrs Roth-Behrendt rapporteur.

At its meetings of 3 September and 24 September 1997, it considered the Commission's annual report together with the draft report.

At the last meeting it adopted the motion for a resolution unanimously.

The following took part in the vote: Ken Collins, chairman; Poggiolini, Dybkjær and Lannoye, vicechairmen; Blokland, Bowe, Breyer, Cabrol, Flemming, Florenz, Grossetête, Hautala (for McKenna), Jackson, Kirsten Jensen, Kuhn, Lange (for Lienemann), Needle, Pollack, Roth-Behrendt, Schleicher, Schnellhardt, Tamino and Virgin.

The report was tabled on 24 September 1997.

The deadline for tabling amendments will be indicated in the draft agenda for the relevant partsession.


Resolution on the Commission report on the development, validation and legal acceptance of alternative methods to animal experiments in the field of cosmetics - 1996 (COM(97)0182 - C40369/97)

The European Parliament,

- having regard to the 1996 Commission report on the development, validation and legal acceptance of alternative methods to animal experiments in the field of cosmetics (COM(97)0182

- C4-0369/97)[1],

- having regard to the 1995 Commission report on the development, validation and legal acceptance of alternative methods to animal experiments in the field of cosmetic products (COM(96)0365 - C4-0662/96)[2],

- having regard to its resolution of 14 July 1995 on the 1994 annual report of the Commission on the development, validation and legal acceptance of alternative methods to animal experiments[3],

- having regard to its decision at second reading[4] on the common position adopted by the Council with a view to adopting a directive amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (C3-0010/93 - 00/0307(SYN)),

- having regard to its resolution of 8 April 1997 on the 1995 annual report from the Commission on the development, validation and legal acceptance of alternative methods to animal experiments[5] ,

- having regard to Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products[6],

- having regard to the animal welfare protocol to the TEC agreed at the European Council on 18 June 1997 (Amsterdam),

- having regard to its resolution of 14 November 1996 on trade and environment[7],

- having regard to the report of the Committee on the Environment, Public Health and Consumer protection (A4-0277/97),

1. Deeply regrets the acceptance by the Council of Ministers of the Commission proposal to postpone the date of implementation of the ban until 1 June 2000 and the delayed presentation of the long-awaited Council/Parliament directive on finished products;

2. Regrets that more than four years after the adoption of Directive 93/35/EEC, the Commission is still not able to meet the requirements of Article 4(1)(i) of Directive 76/768/EEC (as amended by Directive 93/35/EEC) to provide detailed statistics on cosmetics testing in the European Union;

3. Regrets that so little progress has been made in replacing experiments on animals for cosmetic testing with alternative methods, which calls into question whether all reasonable endeavours have been made to develop and validate such alternatives, as is required by Article 4(1)(i) of Directive 76/768/EEC (as amended by Directive 93/35/EEC);

4. Calls on the Commission to:

a) bring forward, without delay, the long-awaited Council/Parliament proposal to ban animal testing of finished cosmetic products with effect from 1 January 1998, and to include cosmetic ingredients in this measure. Parliament believes that this approach would provide the incentive needed for the industry, Member States and the Commission to complete the necessary development, validation and legal acceptance of non-animal alternative tests - with the estimated 8,000 ingredients being available to the cosmetics industry for the development of new cosmetic products in the interim;

b) at the very least, to include in the awaited Council/Parliament proposal a full ban on animal testing of finished products and a fixed date for final implementation of the ban in respect of animal testing of cosmetic ingredients, which should in no case be later than the year 2000;

c) take positive and urgent measures to give new momentum to efforts to develop and validate alternatives. In particular, the draft 5th Research and Development Framework Programme should be amended to include specific provisions for out-of-house research into alternative methods and the allocation of an adequate individual 'ring-fenced' budget for the European Centre for the Validation of Alternative Methods (ECVAM), this being essential to allow ECVAM to achieve its potential. The 5th Framework Programme should include R&D activities aimed at discovering alternative testing methods relating to acute and chronic toxicity, carcinogenicity, teratogenicity and toxicity in reproduction;

d) avoid further delays to both the implementation of the ban and the acceptance of valid non-animal alternatives resulting from efforts to gain the widest international acceptance. Such acceptance is not required by Directive 93/35/EEC, and any failure to utilise available non-animal methods may be contrary to Directive 86/609/EEC. Full weight should be given to the fact that not all animal tests have been validated when considering the level of validation of alternatives. With regard to GATT/WTO, the EU should formulate a definitive position without further delay and test GATT guidelines to the limit. In parallel, it should press for a positive change to GATT guidelines in order to reconcile trade and valid environmental and animal welfare concerns;

e) take immediate measures to enforce the obligation on Member States to collect the statistical information required by Directive 93/35/EEC, and produce without further delay detailed data on the number and type of experiments carried out on animals for cosmetic testing in each Member State;

f) take firm leadership in drawing up a comprehensive strategy in agreement with all interested parties to boost the development, validation and legal acceptance of alternative methods to experimenting on animals in the area of cosmetics, which should include the allocation/co-ordination of responsibilities between the Commission, industry, governments and the OECD. Measures should also be included to oblige greater industry commitment (such as the previous suggestion from the Parliament whereby all companies and institutions undertaking animal tests in the EU would be required to participate in development and validation studies - or to pay a levy/duty to fund such work on alternatives);

5. Instructs its President to forward this resolution to the Council and the Commission.

  • [1]  OJ ...
  • [2]  OJ ...
  • [3]  OJ C 249, 25.9.1995, p. 198.
  • [4]  OJ C 150, 31.5.1993, p. 65.
  • [5]  See minutes of 8.4.1997.
  • [6]  OJ L 151, 23.6.1993, p. 32.
  • [7]  OJ C 362, 2.12.1996, p. 225.



In June 1993, the Council adopted Directive 93/35/EEC amending for the sixth time Directive 76/768/EEC concerning cosmetic products. Throughout the co-operation process, the issue of animal testing dominated consideration of this Directive. The European Parliament supported the

view that production of new cosmetics should not cause animal suffering and that, if necessary, the cosmetics industry could rely on the estimated 8,000 ingredients currently in use.

At first reading, Parliament overwhelmingly supported amendments to the Directive, which would have effectively prohibited the marketing of cosmetics containing ingredients or combinations of ingredients tested on animals after 31 January 1995. After much discussion, a compromise position was reached with the Commission which delayed implementation until 1 January 1998. Furthermore, a provision was included which would enable the Commission to submit draft measures to postpone this date if 'despite all reasonable endeavours' there had been insufficient progress in developing and validating alternative measures offering equivalent protection to consumers. Parliament reluctantly agreed to such a provision - on the basis that any postponement proposal would necessarily be subject to codecision with Parliament.

The compromise text agreed in negotiation between the Parliament and the Commission was not accepted in full by the Council. In particular, the proposal that postponement should be subject to codecision was rejected in favour of decision by a technical committee of the Member States.

Several amendments were re-tabled by Parliament and adopted by an absolute majority - this included the demand for any postponement to be made subject to the codecision procedure. All the amendments adopted by Parliament at second reading were rejected by the Council without

further debate. Had this approach been taken post-Maastricht, it is likely that this draft Directive would have been rejected by Parliament.

Parliament's worst fears were realised when, on 20 March 1997, the technical committee (the Committee on the Adaptation to Technical Progress - CATP) agreed to postponement of the ban until 1 June 2000 (with scope for yet further postponement).

However, the representatives of the Member States expressed serious concern about the speed of development of alternative methods and demanded that the Commission makes every effort possible to develop such alternatives, ensures that available alternatives are used instead of animal tests and takes all necessary steps to bring about the international acceptance of this position. They also demanded the submission of the proposed Council/Parliament directive on finished products.

Despite the Commission's stated intention of bringing forward a Council/Parliament directive to confirm a ban on animal testing for finished products, and the official demand by Member States representatives, this measure has still not been presented. It is clearly overdue given the 1 January

1998 deadline for a ban set out in Directive 76/768/EEC.

Parliament continues to press for a complete end to animal testing for cosmetics by 1998.



The 1996 report consists of two parts. The first, more general part:

- describes the objectives and constraints which have to be addressed,

- summarises the existing and expected results,

- specifies the conclusions drawn by the Commission from these objectives, constraints and results in preparing its draft proposal for a Directive postponing the deadline of 1 January 1998.

The second part of the report is more scientific. It explains:

- the initiatives taken in 1996 by the various parties,

- the difficulties involved in obtaining statistics,

- the state of progress in each domain.

Despite the Commission's specific obligation to 'ensure the development, validation and legal acceptance of experimental methods which do not use live animals', and the Parliament's comments set out in its reports on the 1994 & 1995 Commission' reports to the effect that there was a lack

of urgency in its proposals for future action (with no future timetable/targeted programme or specific allocation of tasks and responsibilities), the 1996 report still lacks such urgency and focus on future work schedules.

The report states that "the reduction and elimination of animal suffering is an ethical imperative". This is a view which the Parliament entirely supports. However, it questions the vigour with which this 'ethical imperative' is pursued by the Commission, Member States and the industry as regards cosmetic testing - particularly in relation to other less altruistic interests.

A similar 'laissez-faire' attitude is taken by the Commission in respect of the breach by certain Member States of their obligation to provide the statistical information required by Directive 93/35/EEC. It is totally unacceptable that more than four years after the adoption of the Directive, the Commission is still unable to provide a detailed analysis of animal testing for cosmetics and

their ingredients performed in the EU. Furthermore, it is disgraceful that certain Member States continue to flout this obligation.

The Commission's Obligations

The provision in Article 4(1)(i) of Directive 93/35/EEC obliging the Commission to submit draft measures to postpone the 1 January 1998 ban should only have been triggered if there had "been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines". It is the opinion of the Parliament that all reasonable endeavours have not been made to ensure that validated alternatives were available in 1998. In particular, the 1995 and 1996 Commission reports included no urgent measures to speed up the process of developing missing alternative tests, no comprehensive and co-ordinated strategy, no task allocation, no future timetable, and no meaningful statistics were provided.

Furthermore, the Commission would appear to be acting against the spirit of both Directive 93/35/EEC and Directive 86/609/EEC if it is responsible for delaying the ban on animal testing of finished products beyond the original deadline of 1 January 1998 when it acknowledges that animal testing is no longer necessary (due to a combination of existing knowledge on the safety of ingredients and the availability of alternative methods).

In practice, in vitro tests are already used for screening and some are in the OECD Guidelines. The Parliament is of the view that the use of non-animal alternatives should be made compulsory as soon as these are available. This is required under Directive 86/609/EEC and should be categorically stated in the forthcoming amendment to the Cosmetics Directive.

Directive 93/35/EEC also obliged the Commission to provide an annual report to the Parliament and the Council on progress in the development, validation and legal acceptance of alternative methods. The 1996 Commission report responds to this obligation. However, the report is - yet again - deficient in that it does not contain "precise data on the number and type of experiments related to cosmetic products carried out on animals".

Objectives and Constraints

The Commission cites two main objectives - ensuring the safety of cosmetic products for human health and eliminating/reducing animal suffering. In balancing these objectives, it is unfortunate that the Commission sets so much store by the advice of the conservative SCC (Scientific Committee for Cosmitology) and the industry lobby. The Parliament remains of the view that banning new ingredients pending the development of non-animal alternatives would not compromise human safety, and refutes the need for any retesting (using animals) of products already on the market. Products on the market are undergoing the ultimate experiment - that of sustained human use, and if there is any cause for concern as regards human health, the precautionary approach should be adopted and the product withdrawn or reformulated. In any event, 'scientific progress' should be in the field of new 'alternative' methodologies, with the aim of replacement of animal tests by more reliable alternatives to improve consumer safety.

The two 'constraints' cited by the Commission are GATT/WTO and the interests of SMEs. The Commission claims that outlawing innovation would 'bankrupt numerous SMEs'. This assertion is unlikely to be accurate. How many of the annual 30,000 (industry figure as quoted by the Commission) animal tests on cosmetics are carried out by SMEs ? It would normally be the larger companies which could afford to developed new ingredients. Innovation could continue with the

reformulation of existing cosmetic ingredients, and SMEs would probably be in an improved competitive position vis-à-vis larger companies. Certainly they would gain substantial benefit from the faster introduction of (cheaper and simpler) alternative testing methods.

In the case of GATT/WTO, it is not clear why the Commission feels that this aspect needs more investigation before the overdue Council/Parliament directive can be prepared ? The Commission has long been aware of the possible GATT/WTO implications. Now is the time for positive action

- not further unproductive reflection. In this case, the choice is either to press for a definitive EU

position banning both animal testing for cosmetics and the import of animal tested cosmetics (and test GATT/WTO to the limit) or to amend the measure to relate to the testing of cosmetic products and ingredients in the EU. The former is preferable. The latter would not stop third country animal tested products entering the EU and - unless there was compulsory labelling on animal tested cosmetics imported from third countries - would mislead consumers and disadvantage EU producers. In relation to the broader GATT/WTO picture, the EU should lead action to ensure that legitimate animal welfare and environmental concerns are taken into account.

Development and Validation: State of Play

There are thirteen main types of testing performed in the cosmetics industry, which potentially involve the use of animals. These comprise tests for eye and skin irritancy, skin absorption, skin sensitisation, photo-irritation, mutagenicity, photo-mutagenicity, acute and chronic toxicity, carcinogenicity, reproductive toxicity, teratogenicity and finished product safety evaluation.

Standard animal tests currently used were never validated. They have passed into common use through empirical experience and by allowing substantial margins for error. Yet in the case of non-animal alternatives, a very different approach is taken by the industry, the Commission and regulators, who generally demand that such methods should be 'suitably validated'. Thus, potentially effective non-animal alternatives may be denied official acceptance, despite the fact that the reliability and accuracy of the method to be replaced is not quantifiably known. In some cases, non-acceptance of new methods is directly due to the lack of available data about existing animal test methods. Additionally, double standards are shown by the fact that even recent proposals for new animal tests have not always been subjected to the vigorous validation demanded for in vitro methods.

When considering whether to ban animal testing of given cosmetic ingredients, the Commission should not expect to be able to do so on the basis of an established consensus, nor should it seek to rely upon agreement at OECD level (which itself moves - by consensus - at the pace of the slowest member).

Given the option, a minority of companies would choose to use animal tests in certain circumstances, especially as they feel this would maximise their options for product development. However, even within the narrow terms specified in the Directive, the Commission has a responsibility to do more than merely accommodate the most conservative companies in the industry; if it is seriously to pursue the objective of eliminating animal testing it must be willing to set the agenda and move at the fastest pace possible.

Some non-animal alternatives already have regulatory approval. For example, the HET-CAM test for eye irritancy is officially approved in Germany, and positive results from the BCOP test are officially accepted in Belgium. In vitro mutagenicity tests are accepted by all countries of the OECD. For photo irritancy and skin penetration, some leading scientific experts believe that in vitro methods are already better than existing animal tests. In other areas (and not forgetting the scientific criticisms of the animal tests), it is generally agreed that more work is needed to develop non-animal tests. In the case of acute and chronic toxicity, carcinogenicity, teratogenicity and reproductive toxicity, there is a strong case for targeting EU research funds towards developmental research for non-animal test methods in these fields given the wider importance of such tests.

Taking account of the practices of many cosmetics companies, the regulatory approval granted in some Member States, and the opinions of many respected experts, the Commission should have no difficulty in banning animal tests with respect to skin irritation, skin absorption, mutagenicity, photo-irritation, photo-mutagenicity, and finished product tests. These should, at the very least, be incorporated in the proposed Council/Parliament Directive for a 1998 ban.

In the case of eye irritation, despite problems experienced with the EC/HO eye irritancy study, there is still potential for achieving the 1998 deadline. The unreliability of the Draize eye irritancy test must not be discounted when considering the merits of the alternatives. The Commission should follow the example set by France, Germany and Belgium, and accept the use of selected in vitro tests for particular types of chemicals or classes of irritancy.

As regards skin sensitisation, it should be recognised that there are substantial limitations to the existing animal tests, a fact which highlights the need for caution. Some additional development work with non-animal methods is necessary, but the utilisation of chemical structural alerts and the rejection of chemicals when there is reason to suspect that they may have sensitising potential, could prove to be a more viable and sensible approach.


The Commission report for 1996 demonstrates an overall lack of urgency and commitment to bring forward any ban on animal testing of cosmetics in 1998. The Commission repeatedly prioritises cosmetic industry profits over animal suffering and lives, ignoring public opinion and the views

of the Parliament in this matter.

There has been little in the way of a structured and focused approach to achieving progress in alternative methods by 1998, and there are no indications that the Commission plans to introduce a comprehensive and targeted strategy for the future. Such a strategy is vital to the development of alternative methods, and must have the positive backing of the Member States, the industry and the scientific community, as well as adequate dedicated financial resources, if it is to succeed.

The failure to produce basic statistical information is indicative of the lack of commitment from many Member States, and also of the Commission's lack of determination successfully to implement the animal testing provisions of this Directive.

There has been an unacceptable delay in bringing forward the promised Council/Parliament directive on finished products - despite the fact that this proposed measure is likely to be conservative in the extreme. Based on current technical progress, the Commission should have pushed to maintain the 1998 ban with respect to not only finished products (without exceptions), but also at the very least to:- skin absorption, skin irritation, photo-irritation, photo-mutagenicity and mutagenicity. The Commission should also be able to support at least a partial ban with respect to eye irritancy and skin sensitisation.

It is imperative to the momentum of alternatives development that final dates (no later than the year 2000) are given for the ban on remaining cosmetic ingredients. If at the end of this period sufficient progress has still not been made with the development of non-animal alternatives, then for the interim period until this process is completed, the industry should be obliged to rely upon the wide range of ingredients currently available.