Select Committee on Science and Technology Written Evidence


Memorandum from the Biosciences Federation


  The Biosciences Federation (BSF) was founded in December 2002 in order to create a single authority within the life sciences that decision-makers can consult for opinion and information. It brings together the strengths of the Institute of Biology and societies that were formerly members of the UK Life Sciences Committee. The societies that have already joined the BSF (see: represent some 60,000 members and cover the whole of life sciences, from physiology, neuroscience, biochemistry, and microbiology, to ecology.

  The Animal Science Group of the Biosciences Federation represents all major learned societies associated with biological and biomedical research. It is concerned with all aspects of the use of animals in fundamental research in the UK and aims to:

    —  support and promote UK science and facilitate animal welfare and implementation of the 3R's;

    —  maintain close dialogue between scientists and groups interested in the use of animals in research including Government, policy makers, the media and the commercial sector; and

    —  improve public understanding and awareness and education about the use of animals in research.


  The Biosciences Federation supports the general thrust of the new EU legislation on chemicals. It can see the benefits of ensuring that the consumer and the environment are both protected from the harm that could be produced by the uncontrolled release of potential harmful substances. We also welcome the provision of extensive documentation on the legislation (

  However, the Biosciences Federation has two main concerns about the new legislation:

    —  there is likely to be a substantial increase in the number of animals used for safety testing; and

    —  the introduction of the present proposals in their entirety will increase the financial burden on the EU and UK chemical industries, which may affect their competitiveness. It will also have indirect effects on the consumers of their products, including biomedical researchers, via an increase in the cost of chemicals, and the like.

  Both these concerns will now be discussed in more detail.


  The latest figures available for the use of animals in research in the EU (1999) indicate that almost 10 million animals (9,814,171) were used for this purpose. The figures for the UK are more up-to-date and give a total of 2.73 million living animals used for scientific procedures (2002). This is more than a quarter of the EU total. Approximately 6% (162,000) of these were used by industry in the UK for some form of safety testing. It is worth noting that total of animal use has approximately halved in the last two decades as alternate methods have made it possible in some areas of research to replace animals with a variety of other techniques.

  Figures taken from various documents on EU chemical legislation indicate that somewhere in the region of 100,000 chemicals will have to be evaluated, of which some 30,000 will need to have full verification as to their safety. It is expected that a substantial portion of these 30,000 may need new or additional animal testing to produce the data required to accurately estimate their likely hazard. Full implementation of the legislation will be phased in over a period of 11 years, and the safety testing is likely to be spread across the EU states. However, it is expected that most of the safety testing work will be concentrated in the early years of implementation.

  The explanatory document that provides some information on the expected increase in the use of animals in safety testing ("Implications of the proposal for new chemical legislation—REACH system—for animal testing) is very limited in scope. It provided no estimates of the numbers of extra animals that would be needed, whether in the EU as a whole, or in member states. We support the proposal contained in the document that research on new alternative testing methods using fewer and no animals will be fostered by way of the Community Framework Programme for Research and Technological Development. However, in our opinion it is unlikely that this will have much impact in the timescale of the implementation of the new chemicals legislation.

  The recently released Commission Staff Working Paper, entitled "Extended Impact Assessment" (dated 29 October 2003), contains two short paragraphs on animal testing (pages 23-24). It is claimed that, "The need for animal testing has been minimised by a number of measures. For example, information requirements have been trimmed to enable smart and targeted testing without compromising the safety for human health and the environment. Also, registrants will not necessarily need to do new testing to register. They can make use of other information available such as studies from other countries, previous animal testing, available in vitro data, epidemiological studies, etc." Whilst such suggestions are welcome, they provide no basis for estimating the number of additional animal studies that may be required.

  We would suggest therefore that there is likely to be at least a 50% increase each year over the present levels (ie 80,000 additional scientific procedures) in the use of animals for safety testing in the UK. If testing is, as expected, concentrated in the first few years of the implementation period, then this could be even greater.

  This expected increase in the use of animals in safety testing has impelled us to urge the UK government to:

    —  ask the European Commission to provide its own detailed analysis of the likely increase in animal use for testing that is expected to happen as a result of the EU chemicals legislation well before it is implemented; and

    —  consult with industry in an attempt to develop procedures that will reduce to a minimum the need for additional animal safety testing.


  The governments of the UK, Germany and France were sufficiently concerned about the potential negative financial and competitive effects of the EU chemical legislation to write to the President of the European Commission on 23 September 2003. The letter was a joint one from Tony Blair, Prime Minister of the UK, Gerhard Schroder, Federal Chancellor of the Federal Republic of Germany, and Jacques Chirac, President of the French Republic. They recorded concern that the registration regime for chemicals was too bureaucratic and unnecessarily complicated. They also emphasised that the proposals must not disadvantage legitimate EU business interests in the global market, by imposing requirement, which are not pertinent to protecting health and the environment. As a result of such concerns the three leaders asked the European Commission to carry out a full evaluation of the concrete effects of the planned regulations on the European chemical industry, as well as the economy, taking account of the effects throughout the supply chain. This report was requested for the December 2003 meeting of the European Council.

  The response to such a request was that the European Commission, after analysis of the responses and presentation of a revised text, formally adopted the REACH proposals on the 29 October 2003. After this adoption, a stakeholder workshop was held on 21 November 2003, and a large number of new documents were released to coincide with it, including the Extended Impact Assessment. None of these provided all of the detailed information that has been requested. However, a business impact study carried out by independent consultants did provide a cost estimate, based on historical prices for testing chemicals, and the most likely testing assumptions, of 12.6 billion Euros (approximately £9 billion) over the 11 year period of the implementation of the EU chemical legislation!

  A recent statement from the Chemical Industries Association (24 November 2003) says that the "industry is looking for regulation, which has a proportionate, risk-based approach that will speed up the provision of information on chemicals and enable sound decisions to take place on appropriate risk management." The Biosciences Federation fully supports these views, and those outlined in the earlier letter co-signed by the British Prime Minister, and asks the UK government to continue to support this approach.

  The Biosciences Federation remains concerned that the new legislation:

    —  will be unworkable in its present form;

    —  will lead to an excessive increase in animal use for safety testing; and

    —  will damage the competitiveness of the chemical industry.

  To emphasize the importance of the chemical industry to the UK economy it should be pointed out that it is the UK's top manufacturing exporter with an annual trade surplus of nearly £5 billion on sales of £33 billion.

December 2003

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