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Chemical regulators have overreached

from Nature 460, 27 August 2009

Thomas Hartung & Costanza Rovida

The costs—both in animal lives and euros—of the European REACH legislation on chemical testing are escalating. Thomas Hartung and Costanza Rovida argue for a suspension of certain toxicity tests.

More than 100,000 synthetic chemicals are used in consumer products. In 1981, both the United States and the European Union (EU) introduced comprehensive safety evaluations for novel chemicals coming on to the market. However, existing chemicals represent about 97% of those in use today and 99% of the production volume. Safety testing data are needed for most of these 'old' chemicals. Over the next decade, the EU's 2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation aims to assess the toxicity of all chemicals sold in Europe in quantities of more than one tonne per year.

As toxicologists, we support the aims of REACH — it is the biggest investment into consumer safety ever. However, we feel that legislators have underestimated the scale of the challenge. Our report, released today by the Trans-Atlantic Think Tank for Toxicology at John Hopkins University in Baltimore, Maryland, is the first analysis of REACH costs to be published in 5 years. It is based, among other things, on the pre-registration of chemicals, which ended in 2008. It was expected that 27,000 companies would submit 180,000 pre-registrations on 29,000 substances. Instead, some 65,000 companies made more than 2.7 million pre-registrations for in excess of 140,000 substances. REACH aims to complete data collection on these substances by 2018. In recent decades Europe has tested some 200–300 new chemicals each year, making REACH an unprecedented challenge. Toxicologists do not have the appropriate tools—whether high-throughput methods or acceptable alternatives to animal testing—to meet these expectations.

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