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.