# Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance), Division 6.3.2.1: Metabolic studies

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/6/division/6.3/division/6.3.2/division/6.3.2.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-6/division-6.3/division-6.3.2/division-6.3.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.