APPENDIX 4
Memorandum from the Biosciences Federation
INTRODUCTION
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: www.bsf.ac.uk) 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 EU CHEMICAL
LEGISLATION
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 (www.europa.eu.int/comm/environment/chemicals/whitepaper.htm).
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.
INCREASE IN
ANIMAL USE
IN THE
UK
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.
EXTRA FINANCIAL
BURDEN ON
UK INDUSTRY
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
| 
