“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,” say Thomas Hartung [1] and Constanza Rovida [2] the authors of a study funded by the Trans-Atlantic Think Tank for Toxicology at John Hopkins University in Baltimore, Maryland, and commented in the August 26 edition of Nature. The full analysis appears as an electronic prepublication of the September 2009 edition of the journal ALTEX, Alternatives to Animal Experimentation.

Unprecedented challenge

Hartung and Costanza have calculated that REACH may require 54 million research animals and EUR 9.5 billion (USD 13.4 billion) over the next 10 years, which represents 20 times the number of animals and 6 times the cost anticipated in previous estimates. Currently, the EU uses approximately 900,000 animals at a cost of EUR 600 million (USD 847 million) per year to evaluate new chemicals, drugs, pesticides and food additives.

When REACH was voted, 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. However, 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 to meet these expectations,” claim the authors of the study.

According to them, 90 percent of the projected animal use and 70 percent of the projected cost would come from research into reproductive toxicity testing. “A revision of test approaches especially for reproductive toxicity is essential. There is no alternative to REACH, but there will be no REACH without alternatives,” says Hartung.

Numbers inaccurate, says ECHA

“Clearly, the exact numbers will only be known once all the registrations are submitted and testing proposals are received, but, based on the information that we have and our discussions with industry, the numbers provided in this study are thankfully very wide of the mark,” commented Geert Dancet, Executive Director of ECHA, the European Chemicals Agency.

According to ECHA, Hartung and Costanza’s study overestimates three things: the likely number of substances that will be registered under REACH and requiring a full data set, the likely number of tests and laboratory animals required, and the likely costs for conducting the tests.

“The original estimates on the number of animals still hold,” concludes ECHA, that is to say that 9 million laboratory animals would be involved in the tests required and that the costs for conducting the tests would amount to 1.3 billion euros.