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The Directive on Dangerous Substances

The potency of carcinogens

Annex I to Directive 67/548/EEC contains a list of some 8000 dangerous substances for which classification and labelling have been agreed at Community level. To agree on the classification and labelling of substances the Commission regularly convenes a number of Working Groups composed of experts from the Member States. Carcinogenic substances are dealt with by the Working Group “Health Effects”, known as “CMR Working Group”, since they harmonise classification and labelling of carcinogenic, mutagenic and reproduction toxic substances. In this Working Group also experts from industry, from the trade unions and from Norway (as a member of the European Area Agreement) are participating.

An important element of classification and labelling are the specific concentration limits displayed for a range of substances in Annex I. They relate to dangerous preparations, which are mixtures of substances of which one is dangerous and which are governed by Directive 1999/45/EC. If a preparation contains a dangerous substance in a concentration that exceeds the specific limit in Annex I to Directive 67/548/EEC, the preparation is classified as dangerous. If no specific limit is given the “general” limits laid down in Directive 88/379/EEC are applicable.

The CMR Working Group has considered that for carcinogens the establishment of these specific concentration limits should also take account of the potency (or power) of a carcinogen to trigger cancer. This element is not yet included in Directive 67/548/EEC. The higher potent a carcinogen is, the lower should be the specific concentration limit. Therefore the document “Setting of Specific Concentration Limits for Carcinogens in Annex I of Directive 67/548/EEC. Guidelines for Inclusion of Potency Considerations” (pdf 138K) gives guidance as to how potency considerations may be included in the setting of specific concentration limits for carcinogens.