THE REACH PERSPECTIVE: TOWARD A NEW CONCEPT OF TOXICITY TESTING

A sustainable society and a healthy society are major goals for European policymakers. Although most Europeans live a longer healthy life than ever, there is growing concern and anxiety about unknown health risks and threats of chemicals and a strong demand for more knowledge and more control. European legislation is responding to these demands. An example is the program on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), which came into force in 2007. It is a gigantic task for industry and for administrators to evaluate safety files of thousands of chemicals in a period of 12 years and to collect new data for chemicals not yet evaluated. Costs, number of toxicity tests, and number of animals that are needed are already well documented. REACH uses strict guidelines and focuses on apical endpoints that have been covered in the past by animal tests. Animal tests are slow, use unrealistic high doses, and have been shown to not always predict human toxicity correctly. The REACH program has made a clear opening for reduction of in vivo animal tests. Sharing toxicity data is a major improvement. For low tonnage levels, no further in vivo testing is allowed. The combination of scientifically valid information from alternative tests with available animal and human data into a weight-of-evidence approach is part of the integrated test strategy under REACH. Interpretation of this integrated information requires a high degree of expertise, flexibility, and openness toward scientific advances. This will be crucial for the success of the REACH program. It means a shift of attitude and will put a heavy responsibility on scientific experts and regulators, but it is also an opportunity for meeting the safety expectations of our modern society.