Confusion about impact of REACH

The European Commission and the cosmetic industry have joined forces to significantly reduce animal testing. At the end of July, the Commission and the European association Colipa kicked off an ambitious joint EUR50m research programme into alternative safety testing methods aimed at full replacement of “repeated dose systemic toxicity” animal safety tests – in vitro tests that predict the toxicity of repeated use of cosmetic compounds over long periods of time. Four weeks after the announcement, experts for the replacement, refinement and reduction (“3 Rs”) of animal tests presented a study suggesting the Commission’s plan to systematically check the safety of all chemicals within the next ten years will cost the lives of around 54 million animals – 20 times more than the Commission estimated when it adopted REACH legislation. The researchers under Thomas Hartung have called for a moratorium on reproductive toxicity testing, which could represent 90% of projected animal use. Additionally, they underline the need for a large research programme to develop high-throughput and in silico 3R tests.

According to the study performed by Thomas Hartung from Johns Hopkins University, who headed the European Centre for the Validation of Alternative Methods (ECVAM) in Italy until last year, companies have pre-registered around 140,000 chemical substances for safety testing within REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) up to now. The European Commission had expected only about 29,000 registrations. In a best case scenario, says the study, testing all of these chemicals would require around 54 million test animals in the next decade, pushing the cost of REACH to EUR9.5bn – six times the original estimate. According to the 3R expert, the majority of the animal tests would also have only limited value. Hartung estimates that 40-60% of the “two-generation study for reproductive toxicity” – around 90% of the safety tests required in REACH – might lead to false-positive results. He has therefore called for a moratorium on these types of tests, as well as for a research partnership between the Commission and the industry, “similar to the a50m partership for research into alternatives for systemic toxicity” launched in July.

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