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Re-evaluation of animal numbers and costs for in vivo tests to accomplish REACH legislation requirements for chemicals - a report by the Transatlantic Think Tank for Toxicology (t4)

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Costanza Rovida1 and Thomas Hartung2
1 Private Consultant, Varese, Italy
2 John Hopkins University, Baltimore, USA and University of Konstanz, Germany


The EU REACH legislation for chemicals of 2006 represents the largest investment into consumer product safety ever. A reanalysis of cost and animal use estimates was carried out based on the final legislation, test guidance for industry published by the European Chemical Agency, and the preregistration completed in December 2008. The new estimates for the number of substances falling under REACH range from 68 to 101,000 chemicals, substantially exceeding the earlier estimates of 29,000 substances. The latter estimates were, however, based on data before 1994 and both expansion of the EU and growth of the chemical industry since have contributed to higher numbers today.

The lower estimate of 68,000 chemicals was carried through current testing requirements with due regard to emerging alternative approaches, using in all cases the most optimistic assumptions (minimal animal numbers per test and neglecting most triggering of additional tests and confirmatory (re-)tests as well as tests requested but not yet defined for endocrine disruption, respiratory irritation, respiratory sensitization and developmental neurotoxicity). The most demanding studies are in the area of reproductive toxicity testing with about 90% of all animal use and 70% of the required costs for registration. The overall result suggests a demand of 54 million vertebrate animals and testing costs of 9.5 billion euro. This clearly challenges the feasibility of the program without a major investment into high-throughput methodologies.

ALTEX 26(3), 187-208
doi: 10.14573/altex.2009.3.187

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