MONTH: January/February 2007
New European Parliament chemical policy will increase animal testing
Council of the European Parliament on December 19, 2006 unanimously ratified
REACH, a consolidated chemical safety regulation approved by the Plenary
of the European Parliament on December 13.
The REACH acronym is short for "registration,
evaluation, authorisation and restriction of chemicals." Three years
in negotiation between the Environment Council and the main body of the
European Parliament, REACH replaces more than 40 older regulations. Applying
to "all substances manufactured or imported in quantities over 1
metric ton per year," according to a summary description released
to news media, REACH "is expected to be applied to approximately
30,000" chemical products.
"Current estimates of the number
of animals to be affected range from the 16 million predicted by the chemical
industry to 45 million over 15 years, calculated by Germany's Federal
Institute for Risk Assessment," wrote London Times correspondent
"The aim of REACH is to ensure that
health and the environment, including animals, are protected from adverse
effects due to dangerous chemical substances," the media briefing
stated, acknowledging that "Acquiring the necessary knowledge on
the properties of substances will entail some animal testing. However,"
the briefing paper asserted, "REACH has been designed to reduce animal
testing to the absolute minimum," incorporating an "obligation
to share all data generated through testing on vertebrate animals, and
by the provision that for large volume substances, testing proposals must
be approved by the [REACH] agency before new tests on animals will be
"An increase of 3% of animal testing
is expected for the first eleven years after adoption of REACH,"
the briefing admitted. "After 11 years, the burden of lack of knowledge
about substances in use today should be adequately addressed, and the
numbers should then go down steeply because only a few new substances
per year will have to be tested."
European Union Science and Research Commissioner
Janez Potocnik on December 18 told the European Partnership for Alternative
Approaches to Animal Testing conference in Brussels that REACH may require
more animal testing than was initially estimated, but said "This
just makes me even more determined to speed up our work in this area [developing
non-animal tests], so that we can reduce these numbers by as much as half."
Potocnik noted that the EU agreed in 2003
to ban testing cosmetics on animals after 2009, and that the European
Commission in June 2006 began a review of laboratory animal welfare, with
findings due in early 2007.
Potocnik pledged continuing support for
the European Centre for the Validation of Alternative Methods. "I
can assure you," Potocnik concluded, "of my firm commitment,
and that of the European Commission, to research that will develop reliable
alternatives so we can refine, replace, and reduce animal testing in the
Midway between the European Parliament
approval of REACH and the Environment Council ratification, the British
Medical Journal published a review of recent studies in six areas of medicine
by a team from the London School of Hygiene & Tropical Medicine, who
found that animal testing matched human results in only three of the six.
Lead author Ian Roberts told BBC News
that his investigations found some animal studies were poorly carried
out, involving too few animals, and that they could be influenced by "design
or publication bias." Roberts suggested that animal experiments could
be designed to better reflect human experience, and that there may be
some areas of drug research where animal testing is relevant, but others
where it is not.
But one day before the European Parliament
approved REACH, a review of the scientific validity of non-human primate
research commissioned by the Royal Society, the Medical Research Council,
the Wellcome Trust, and the Academy of Medical Sciences concluded in the
words of lead author Sir David Weatherall, a retired Oxford University
geneticist, that "There is a scientific case for careful, meticulously
regulated non-human primate research, at least in the foreseeable future,
provided it is the only way of solving important scientific or medical
questions and high standards of welfare are maintained."
The Weatherall report recommended that
Britain should consolidate the 13 university primate labs and six primate
labs operated by private enterprise into four new facilities.
"As we had feared," said British
Union for the Abolition of Vivisection chief executive Michelle Thew,
"this report turned out to be yet another whitewash of the important
scientific and ethical issues involved in experimenting on non-human primates."
"Despite a ringing endorsement for
the work being done to reduce primate use, the Weatherall report did not
go far enough in trying to map out the priorities for development and
adoption of new alternatives," commented National Centre for the
Replacement, Refinement and Reduction of Animals in Research chief executive
"Regardless of the scientific validity
of primate experiments," added Royal SPCA Research Animals Department
chief Maggy Jennings, "that these animals are confined and used in
research is incredibly sad."
"Last year 4,652 medical procedures
were carried out on monkeys," wrote Guardian science correspondent
Ian Sample, "representing 0.16% of all animal tests. The research
involved 3,115 monkeys, 12% up from 2004. Three-quarters of the monkeys
were used for toxicology tests on new drugs. The remainder were used in
studies of basic neuroscience and debilitating conditions. Experiments
on great apes, such as chimpanzees and gorillas, are expressly forbidden
in Britain," Sample noted, "but experiments with smaller primates
The percentage of British studies done
on non-human primates declined in 2005, even though more primate research
was done, because the total number of animal experiments rose to 2.9 million,
the most in 13 years, the Home Office reported in July 2006.
"Genetically modified animals accounted for nearly one million procedures, but two-thirds are those involved in breeding genetically modified offspring who are used in experiments," wrote Guardian science correspondent James Randerson. "Without these breeding animals, there would have been a slight decrease in the overall figure. The number of unmodified animals used was down 1%, to 1.65 million."