Complying with European Union legislation that requires retroactive toxicological testing of tens of thousands of chemicals may cost six times more than expected and 20 times more in experimental animals, according to a new report published online on Aug. 26 in ALTEX, the official journal of the Center for Alternatives to Animal Testing (CAAT) at Johns Hopkins University and three other related groups. The report estimates that 54 million animals will need to be sacrificed and $13.5 billion (€9.5 billion) spent over a decade to abide by the EU legislation.
Introduced in 2006, the Registration, Evaluation, Authorization & Restriction of Chemical substances (REACH) program aims to assess the potential health hazards of chemicals introduced to the market before existing safety evaluations for new chemicals were set in place in 1981.
REACH is the “biggest investment into consumer safety ever,” says Thomas Hartung, director of CAAT, former EU regulator, and coauthor of the report and of a related Nature commentary (2009, 460, 1080). “As a toxicologist, I’m in favor of REACH’s aims,” he tells C&EN. “But I think we ought to do this right.”
Earlier this year, the number of chemicals preregistered in REACH passed the 140,000 mark, several times higher than the 29,000 substances EU regulators had expected on the basis of 1994 industry data (C&EN, April 27, page 18). Although there was likely a lot of redundant preregistration, Hartung estimates in the report that some 68,000 chemicals will have to undergo toxicological testing to comply with REACH regulations.
The European Chemicals Agency, which oversees REACH compliance, responded to the report in a statement, saying, “Despite the unexpectedly large number of pre-registrations, the original estimates of the number of substances to be registered remain valid.”
Richard A. Denison of the Environmental Defense Fund criticizes the report in a blog posting, writing that the authors “vastly overstate” the number of chemicals to be registered and tested under REACH.
Christopher Bryce, who monitors the European chemical industry for Marsh, a risk and insurance services firm, says the new report will surely “fan the flames” of animal-rights activity in Europe.