Division 6.3.2.1 Metabolic studies

The requirements for the different categories and functional groups of additives apply.

In addition, metabolic studies are not required if the additive is already authorised for use in a species which is physiologically comparable to the minor species for which the authorisation is sought. In the absence of physiological similarity, a comparison of metabolic profile based on in vitro studies (e.g. performed in hepatocytes using labelled compound) is considered sufficient to assess metabolic proximity.

If the minor species is not physiologically similar to a major species, then an indication of the metabolic fate of the additive shall be obtained in the minor species.