Tens of millions of animals could be saved from use in chemical-safety tests over the next eight years after Europe’s chemical regulator gave the go-ahead to a new streamlined study to assess the safety of substances.
European Union (EU) legislation requires companies to test the safety of the chemicals they produce in two generations of animals to assess the effects on their reproductive systems. Toxicologists were concerned that the testing requirement would mean up to 54 million animals would be used in chemical-safety studies to meet the requirements of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) legislation introduced in 2007 (see Chemical-safety costs uncertain).
A proposed new test would allow just one generation of animals to be used, with additional tests on a second generation required only if the first round raised concerns. The regulator, the European Chemical Agency (ECHA), based in Helsinki, had threatened to reject the test, saying that there is not yet enough evidence to rely on one-generation testing (see Streamlined chemical tests rebuffed).
But on 15 February, ECHA announced that it has now changed its mind in favour of the Extended One-Generation Reproductive Toxicity Study (EOGRTS). The agency says that the streamlined test will, “under certain conditions”, provide sufficient safety information to replace the two-generation reproductive toxicity study. It says it has already received around 230 proposals from companies to carry out the new test. Clarifying its role, ECHA says, “Our role is neither to reject or generally approve test guidelines but to assess whether, and under which conditions, relevant new test guidelines could be applied to fill standard information requirements.”
The move comes after Nature revealed that chemical companies were not providing the safety data on reproductive and developmental toxicity REACH requires of them. Nature also found that very few companies were proposing to carry out alternative non-animal tests, causing further concern that REACH would boost the number of animals used in toxicity testing.
Toxicologists say that allowing the streamlined test, which is quicker and cheaper to conduct, will encourage more companies to test their products.
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It is important to be clear that the ECHA statement does not mean that the two generation test will be replaced by one generation tests, because it is based on the assumption that registrants using the extended one generation test will breed to a second generation. This could mean that almost the same amount of animals will be used. The statement does acknowledge the possibility of using only one generation but while ECHA has unlocked the door to fewer animals being used in reproductive toxicity testing, it has not yet opened it. It is important that ECHA now recognises that Annex XI of REACH empowers registrants to avoid using two generations of animals for reproductive toxicity testing under weight-of-evidence provisions, but there are still bureaucratic – not scientific – obstacles in the way of companies seeking to use this method. REACH was designed to be flexible and this is a test case for that flexibility. The evidence is already clear that the extended one generation test is sufficient, as evidenced by OECD’s acceptance of TG 443. With this ECHA decision one more barrier has been overcome. We urge registrants to exploit this opportunity and urge the Commission and all member states to clear the remaining barriers as soon as possible, in the interests of both good ethics and good science. For more information about REACH and its effects on animal testing, please see http://www.peta.org.uk/features/REACH/ (Dr Gilly Stoddart, Science Advisor, People for the Ethical Treatment of Animals)