Division 3.3.2.2 Toxicological studies

These are required for fermentation products and additives not already authorised. For fermentation products, genotoxicity and subchronic toxicity studies must be provided unless:

1. 1..

   the active substance is separated from the crude fermentation product and is highly purified; or

2. 2..

   the production organism has a history of apparent safe use and there is sufficient knowledge of its biology to exclude a potential for the production of toxic metabolites.

Where the production organism belongs to a group in which some strains are known to produce toxins, their presence shall be specifically excluded.