EFSA Releases Expert Opinion on Marine Biotoxin Testing

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A revised version of Directive 86/609 was formally proposed
by the European Commission on 5th November 2008. Since
the directive was issued in 1986 Member States have passed
national laws on animal experiments with varying standards.
The review was started six years ago with the intention of
unifying standards and including modern technology. The
Commission have responded to demands to promote
validation of alternatives by stating an intention to
set up new research facilities for this purpose. This promise
must be delivered or there will be consequences for our
Environment because in Europe today most regulated
alternatives are concerned with toxicity testing of chemicals.

The new European chemical testing policy called REACH was
introduced because prior to 1981 chemicals did not have to be
safety tested as a legal requirement before being put on the
market. Chemical producers must register safety data for over
30,000 chemicals in general use to the European Chemicals
Agency. The European Commission have estimated that
Reach will cost industry up to 5.2bn euros over the next 11
years. They defend the huge cost of REACH by saying it will
eliminate the most toxic chemicals from the environment and
so protect human health. This belief is justified if the testing
methods used are validated alternatives that have been proven
to reliably test the toxicity of chemicals.

About a million animals are used every year in Europe alone
to test chemicals. But testing methods do not reflect today’s
scientific progress. New technologies such as in vitro (cell
culture), bioinformatics, genomics and in silico (computer-
based) systems offer alternatives which are quicker, cheaper
and more reliable than animal tests but are being overlooked.
The criterion necessary to legally endorse alternatives are
strict and comprehensive. However, the Commission’s list of
approved methods does not include non-animal techniques
that were approved for scientific validity in 2007 by the
European Centre for the Validation of Alternative Methods.
This delay was criticised by MEPs because it encourages
companies to avoid using validated alternatives based on
human biology and continue using animal tests that have
remain unchanged for decades. To satisfy the REACH
regulations new procedures based on modern technology
must be developed if only animal testing is available. This
requires investment and a commitment to make medical
progress a priority.

A report entitled Toxicity Testing in the Twenty-first Century:
A Vision and a Strategy was published by the US National
Research Council in June 2008 and provides further insight
into how chemicals can be tested. It makes it clear that the
testing of chemicals is better done with recent research
concentrating on how damage occurs at the genetic and
cellular level. Testing thousands of chemicals, the report
states, is impractical due to the large number of combinations
of chemicals required to produce realistic exposure scenarios.
However, modern procedures such as in vitro tests should
make this possible. The report concludes that over time the
need for traditional animal testing can be eliminated with
emphasis on more efficient alternative techniques.

It is known that marine biotoxins found in shellfish and other
marine life are toxic to humans when consumed as food.
However, in Europe legislated methods to detect these toxins
are not sensitive enough and put our health at risk. This was
made clear in October by a report from the European Food
Safety Authority which supports In vitro (test tube) research,
such as “chemico-physical analyses”, as being superior to
regulated animal methods for the detection of these biotoxins.
Germany already uses sensitive analytical methods for marine
biotoxin detection and has answered criticism with evidence
that supported this approach over the use of established
animal testing. The Federal Institute for Risk Assessment is
calling for European law to endorse these methods for the
detection of marine biotoxins. Also, in Spain scientists have
developed their own in vitro test for detecting marine biotoxins
with statements to reflect their confidence that they provide
improved results. The scientists concluded that to protect our
health from these marine biotoxins animal testing was not the
solution.

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