Division II.6.3.6.7

A substance that directly induces clearly positive findings in genotoxicity tests may only be accepted for use in food-producing animals if the genotoxicity findings are demonstrated not to be of relevance for the consumer. Results from carcinogenicity studies demonstrating the absence of neoplasia may form part of such a demonstration. Mechanistic data shall also be needed in order to demonstrate that the mechanism underlying the observed genotoxicity is not relevant for the consumer.