As BfR notes, one bone of contention with the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation, approved by the European Parliament last December after more than three years of impassioned debate, is that it will push up substantially the volume of animal experiments required to assess the safety of chemicals.
The regulation calls for some 30,000 industrial chemicals to have their toxicity evaluated and defined by 2018, with the first tests scheduled to begin next year. The chemicals will be reviewed by a new European Chemicals Agency, which will have the power to ban chemicals seen to pose a significant health threat.
With the regulation due to take effect on 1 July, the animal testing issue is taking on increasing urgency. BfR, the agency that prepares expert reports and opinions on the safety of foods and other substances for the competent federal ministries and other risk-management bodies in Germany, already claims some success on this front.
In 2004, when the REACH bill was still at the draft stage, BfR lobbied for the use of new toxicological approaches that, according to its calculations, would reduce from 45 million to 7.5 million the number of experimental animals needed over the next 15 years to satisfy the preconditions envisaged by REACH.
As the agency points out, the final REACH regulation explicitly states that animal experiments should be replaced wherever possible by modern test methods that do not involve animals. Where this is not possible, the number of experimental animals used should be cut to a minimum.
Now BfR is turning its attention specifically to reproductive toxicity testing. According to the European Commission, it says, around 70 per cent of all experimental animals are used to test chemicals for their reprotoxic effects. This is also where around 70 per cent of animal testing costs are incurred, particularly when evaluating substances for impairment of fertility and reproductive ability, BfR adds.
The reason for this heavy burden, the agency says, is that REACH prescribes a two-generation reproductive toxicity treatment in rats - in accordance with Test Guideline 416 of the Organisation for Economic Co-operation and Development's (OECD) guidelines for the testing of chemicals - as the standard procedure for chemicals with production volumes of more than 1,000 tonnes. At present, this means around 3,000 animals are needed to test a single substance.
What BfR advocates instead is a "graduated procedure" in which the basic reprotoxicity test would be limited to one generation of animal. "There is growing evidence that the examination of only one generation hardly leads to any loss of information of relevance for assessment," it maintains.
Before a one-generation test (OECD Guideline 415) could be applied within the framework of REACH, however, the corresponding OECD Test Guidelines would have to be updated, BfR points out.
The agency has therefore submitted a proposal to the OECD for "an improved one-generation test" that it says would spare around 1,400 laboratory animals for each substance tested. With an estimated 2,000 chemicals slated for reproductive toxicity testing over the next three years under REACH, this would add up to a 2.8 million reduction in the number of animals used.
If the initiative - which is supported by the US Environmental Protection Agency (EPA) - is successful, the updated basic test could be in use within the REACH framework by 2009, BfR predicts. Preliminary work for a single-generation test in a graduated programme of pesticide testing has already been undertaken by the non-profit International Life Sciences Institute's (ILSI) Health and Environmental Sciences Institute in the US, it notes.
Modifying the OECD guidelines to allow for single-generation reprotoxicity testing of chemicals "could simplify the implementation of REACH without in any way reducing consumer safety and make a major contribution to protecting laboratory animals too", commented BfR president Professor Dr Andreas Hensel.
