THE EUROPEAN-COMMUNITY DIRECTIVE ON THE CLASSIFICATION AND LABELING OF CHEMICALS FOR REPRODUCTIVE TOXICITY

The classification and labeling of dangerous substances was first intr oduced in 1967 in the European Community with Council Directive 67/548 /EEC, known as the Dangerous Substances Directive. The Sixth Amendment to this directive in 1979 introduced a notification procedure for new chemicals and a requirement for labeling chemicals for toxicity. Thre e special categories for labeling were for carcinogenicity, mutagenici ty, and teratogenicity. The teratogenicity classification was restrict ed to chemicals inducing teratogenic effects in the classical sense of the word, ie, producing only gross structural malformations. Discussi ons by expert advisors to the European Commission over several years l ed to a widening of concern in this area of toxicology and under the r ecent Seventh Amendment,(1) the classification of ''teratology'' has b een changed to ''toxic to reproduction.'' This includes adverse effect s on fertility, pre- and postnatal development, and lactation, and enc ompasses not only structural but also functional deficits. This will b ring about a major change in the testing requirements to allow adequat e classification of chemicals for these other aspects of reproductive toxicity.