WRITTEN QUESTION E-3258/01

by Paul Lannoye (Verts/ALE) to the Commission

(23 November 2001)

Subject: Animal testing

1. Given that chimpanzees do not respond to HIV (the virus responsible for AIDS in humans), are only mildly affected by hepatitis B virus (responsible for chronic hepatitis and liver cancer in humans), and die when infected by Ebola virus (just as humans do), would the Commission consider the chimpanzee, our closest relative in evolution, to be a reliable model for the biological responses in humans? More generally, given that any species is defined by its reproductive isolation, linked to its unique genetic outfit which determines all aspects of its biological activities, and in particular its responses to toxic aggressions, would the Commission consider valid for humans the toxicity assessment made in some animal model? Would the Commission consider that long-term toxic effects (carcinogenic effects, neurotoxicity leading to neurodegenerative conditions, toxicities responsible for liver or kidney failure etc), which are usually diagnosed years, sometimes decades, after the start of exposure to the noxious agents, can be faithfully assessed by animal models with life expectancy limited to 20 or 30 months only?

2. Toxicology is the study of the biological behaviour of a living being in the environment of the toxic agent. It can therefore make use of the wealth of concepts and methods developed in modern biology over the past decades, which allowed unprecedented progress to be made in this field. Given that an appropriate selection of these methods, applied to the investigation of toxicity in human cells, organs, tissues and at the systemic level in man, reveal the target(s), the effect(s) the mechanism(s) of action and the long-term activity of the toxic product with scientific rigour, would the Commission consider this science-based toxicology more reliable than the empirical tests on animal models, which are poorly reproducible, irrelevant to human toxicity and allow highly noxious products to be released to the consumer? Doesn't the Commission think that we should ban animal testing as soon as possible?

Answer given by Mrs Wallström on behalf of the Commission

(28 January 2002)

The Commission is aware that the utility of animal experiments to detect the severity of noxious agents to humans may be limited in some cases. The necessity of animal experiments has to be carefully evaluated on a case-by-case basis, and the use of non-human primates is considered a particularly sensitive issue. In this context, the Scientific Steering Committee has expressed the opinion that in the current stage of the knowledge, apart from future vaccine strategy evaluation, chimpanzees need not be used in research about transmissible spongiform encephalopathies (TSEs) such as the long-term noxe bovine spongiform encephalopathy (BSE). However, the Committee considered that lemurs, macaques and squirrel monkeys constitute a valuable scientific and relevant model of human TSEs.

The Commission recognises the desirability to reduce, replace and refine animal testing and developing suitable alternatives. To this end, a number of studies, including the development of novel in vitro methods, are supported under the current Quality of Life programme of the fifth Framework Programme for Research and Technological Development. In its modified proposal for the sixth multiannual Framework Programme(1), the Commission foresees to continue its support in favour of alternative methods.

One of the major tasks of the European Centre for the Validation of Alternative Methods (ECVAM) of the Joint Research Centre of the Commission is to validate alternative methods that reduce, refine or replace animal experiments (Three Rs approach). Once an alternative method has been established the Commission proposes its inclusion in the relevant Community legislation and the corresponding animal tests

should no longer be used. Thus, the Commission has recently placed three in vitro methods in Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2), these methods are now available for regulatory purposes. To date, however, alternative methods are not available to cover all toxicological concerns and so some animal testing continues to be necessary.

In its recent White Paper on a Strategy for a Future Chemicals Policy(3), the Commission identified the promotion of non-animal testing as a political objective and proposed to maximise the use of non-animal test methods, encourage development of new non-animal test methods and to minimise test programmes.

(1) COM(2001) 709 final.

(2) OJ P 196, 16.8.1967.

(3) COM(2001) 88 final.