The European Community Directive on the classification and labeling of chemicals for reproductive toxicity

The classification and labeling of dangerous substances was first introduced 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. Three special categories for labeling were for carcinogenicity, mutagenicity, and teratogenicity. The teratogenicity classification was restricted to chemicals inducing teratogenic effects in the classical sense of the word, ie, producing only gross structural malformations. Discussions by expert advisors to the European Commission over several years led to a widening of concern in this area of toxicology and, under the recent Seventh Amendment,1 the classification of “teratology” has been changed to “toxic to reproduction.” This includes adverse effects on fertility, pre- and postnatal development, and lactation, and encompasses not only structural but also functional deficits. This will bring about a major change in the testing requirements to allow adequate classification of chemicals for these other aspects of reproductive toxicity.