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A recent study suggests that the chemical industry will have to spend €9.5 billion (US$13.6 billion) on safety testing over the next decade. This is to comply with European Union (EU) legislation (REACH) on chemical safety. It is six times more than expected, and worse than that, the tests may require an estimated 54 million animals.
Europe lacks the laboratories to carry out all the tests that the legislation demands. This will render the legislation unfeasible, the paper's author Thomas Hartung concluded at the World Congress on Alternatives and Animal Use in the Life Sciences in Rome earlier this month. But the analysis was described as a 'worst-case scenario' by the European Chemical Industry Council (Cefic), a Brussels-based organisation representing the European chemical industry.
Two pieces of European legislation present particular conflicts. One is the 2006 Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) Directive, requiring retrospective testing of chemicals that are being marketed, which may overburden existing testing capacities as described above. The other is the 2003 amendment to the 1976 Cosmetics Directive, which phases out all testing of cosmetic ingredients on animals by 2013. This also applies to imported products marketed in Europe.
Now, according to a news article in the scientific journal Nature, the European Commission has revealed details of a major programme to develop new high-throughput approaches to repeat-dose toxicity testing which will reduce the use of animals. The €50-million pot represents the largest-ever injection of money into the development of alternative toxicity testing.
But replacing animals to test for adverse consequences — like cancer or neurological disease — of prolonged exposure to chemicals is no easy task. It is much more difficult than replacing animals in single-exposure toxicity work, which is already making progress.
A US initiative — the Tox21 programme co-ordinated by the Environmental Protection Agency and the National Institutes of Health — is taking a similar high-throughput, systems approach to toxicology. With US$22 million committed for this year alone, it aims to increase the predictive value of toxicity tests while reducing animal use, and is prioritising chemicals most in need of testing.
International co-operation is needed to ensure that there is no need to duplicate test data generated in Europe, the USA or elsewhere.
Last edited: 11 January 2022 08:53