New European Parliament chemical policy will increase animal testing

From ANIMAL PEOPLE, January/February 2007:
BRUSSELS–The Environment 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.
But it will result in increased animal testing, at least in
the near future.

“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 Nicola Smith.
“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 performed.
“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 future.”

Conflicting reports

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
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
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 Vicky
“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 are permitted.”
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.”

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