Division 1.3.2.2 Toxicological studies

Toxicological studies are not required if:

1. (1)

   the substance or its metabolites are not present in the feedingstuff at time of feeding; or

2. (2)

   the substance is absorbed in the form of physiological compound(s); or

3. (3)

   the product consists of micro-organisms commonly encountered in ensiled materials or those already used in food; or

4. (4)

   the product consists of enzymes with a high degree of purity arising from micro-organisms with a history of documented safe use.

For micro-organisms and enzymes not excluded above, genotoxicity studies (including mutagenicity) and a subchronic oral toxicity study are required. Genotoxicity studies shall not be made in the presence of living cells.

For xenobiotic substances, not exempted above, the whole of subsection 3.2.2 Annex II applies.

For other substances a case by case approach shall be taken, taking into account the level and means of exposure.