Fewer experimental animals but same degree of safety for consumers!

On 1 July 2007 the new European chemicals legislation, REACH, enters into force. It aims to close the major knowledge gaps in the health assessment of approximately 30,000 so-called existing substances. The bone of contention: the implementation of REACH will actually lead to an increase in animal experiments. BfR already drew attention to this with some success in 2004. At the same time, it submitted proposals on how to replace animal experiments with alternative test methods (BfR Press Release 09/2004). The new REACH Regulation does now explicitly state that animal experiments are to be replaced whenever possible with modern test methods involving no laboratory animals. When this is not possible, the number of experimental animals must be reduced to a minimum. BfR hopes for similar success in the field of reproduction toxicology. Under the current REACH scheme around 3,000 animals are needed for each test to determine the toxic effect of substances on reproduction. This could soon change and the lives of millions of animals could be saved. Together with other institutions on the international level, BfR has launched an initiative to change an OECD Guideline that would reduce the number of animals and improve the scientific findings. BfR President Professor Dr. Dr. Andreas Hensel comments, "This could simplify the implementation of REACH without in any way reducing consumer safety and make a major contribution to protecting laboratory animals, too."

According to estimates of the European Commission, around 70 percent of all experimental animals are used to test chemicals for their reprotoxic effects. This is also where about 70 percent of costs are generated - particularly for testing substances for impairment of fertility and reproductive ability. The reason: REACH prescribes a two-generation test in rats (OECD Test Guideline 416) as the standard procedure for chemicals with production volumes of more than 1,000 tonnes. At the present time, around 3,000 animals are needed to test one substance.

BfR advocates a graduated procedure with a lower number of animals. According to BfR and other leading international institutions, the basic test could be limited to one generation. There is growing evidence that the examination of only one generation hardly leads to any loss of information of relevance for assessment. However, before a one-generation test (OECD Guideline 415) could be used within the framework of REACH, the corresponding OECD Test Guidelines would have to be updated. Preliminary work for the use of a test of this kind in a graduated programme of pesticide testing was done by the International Life Science Institute/Health and Environmental Sciences, USA.

BfR has submitted a proposal for an improved one-generation test to OECD. This proposal also enjoys the support of the US-EPA (Environmental Protection Agency). If this work is successful, the updated basic test could already be used in 2009 within the framework of REACH. This would mean a saving of around 1,400 experimental animals for each substance tested. With an estimated 2,000 substances that have to be tested over the next three years in conjunction with chemicals assessment, this would mean a 2.8 million reduction in the number of laboratory animals used.

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