Cost Of REACH Underestimated

Complying with European Union legislation that requires retroactive toxicological testing of tens of thousands of chemicals will cost six times more money and 20 times more experimental animals than expected, according to a new study. In particular, the study estimates that 54 million animals will need to be sacrificed and €9.5 billion ($13.5 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, a professor at John Hopkins University, former EU regulator, and leader of the study, which was published today (ALTEX 2009, 26, 75; Nature 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 reporting, Hartung estimates in the study that some 68,000 chemicals will have to undergo toxicological testing to comply with REACH regulations—more than twice the expected number.

According to the study, one key factor driving up the testing numbers is REACH's requirement for more animal studies per compound than is common. Because new toxicological testing strategies that could reduce the animal burden are under development, Hartung calls for a moratorium on reproductive toxicology tests—which consume a lot of animals—"until alternatives are approved."

The European Chemicals Agency, which oversees REACH compliance, responded to the study 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. We do not expect that the originally estimated number of tests, including the costs and use of laboratory animals, will differ significantly from the original estimates."

Christopher Bryce, who monitors the European chemical industry for Marsh, a risk and insurance services firm, says the new report reinforces that for REACH regulations, "the devil has always been in the details." He says that the new study's conclusions will surely "fan the flames" of animal-rights activity in Europe.