The European Union's REACH (Registration, Evaluation, Authorization and Restriction of Chemical) legislation is intended as a comprehensive safety evaluation for commercial chemicals used in consumer products that are traded in Europe at amounts more than one ton per year. Currently, the EU uses approximately 900,000 animals at a cost of €600 mln (US$847 mln) per year to evaluate new chemicals, drugs, pesticides and food additives. However, implementation of the regulation may require 54 million research animals and €9.5 bln (US$13.4 bln) over the next 10 years. This translates to 20 times the number of animals and six times the cost anticipated in previous estimates, according to an analysis led by researchers at the Johns Hopkins Bloomberg School of Public Health. Estimates for the number of chemicals to be covered by REACH range from 68,000 to 101,000, which is higher than the earlier estimate of 29,000 chemicals. The analysis was based on the conservative estimate of 68,000 registered chemicals. Results showed that 90% of the projected animal use and 70% of the projected cost would come from research into reproductive toxicity testing. This often requires that data be collected from two species of test animals and their offspring. 54 million vertebrate animals will be required over the next 10 years. The biggest problem comes with the two-generation test used to evaluate reproductive toxicology, in which toxic effects are studied in the offspring of exposed rats and then in a second generation. These typically take two years; require 3200 animals per chemical tested and cost €600,000 per substance. An alternative, extended one-generation test is under development. This would reduce animal use by about half. However, two member states are against using this alternate method. The chemical industry is committed to reducing animal testing through the implementation of alternative methods. The US Environmental Protection Agency regulations do not include two-species provisions. Industry has to identify which chemicals should be tested by December 2010, and the researchers hope this analysis will encourage adjustments to be made to the legislation. It is important to priorities the most suspicious chemicals; otherwise the testing facilities will be blocked by substances that are not worth the test. The European Chemicals Agency (ECHA), responsible for managing REACH, has been actively promoting data sharing and the use of some in vitro tests has also been approved in a bid to reduce the number of animals needed for testing. |