# 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 3.2.1.1: Metabolic studies

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

The purpose of metabolic studies is to evaluate the absorption, distribution, biotransformation and excretion of the additive in the target species.
The studies required are:
(1)metabolic balance following a single dose administration of the active substance at the doses proposed for use (total amount corresponding to the daily intake) and possibly a multiple dose (if justified) to assess an approximate rate and extent of the absorption, distribution (plasma/blood) and excretion (urine, bile, faeces, milk or eggs, expired air, excretion via gills) in male and female animals, where appropriate; and
(2)metabolic profiling, identification of the metabolite(s) in excreta and tissues and distribution in tissues and products shall be established following repeated dose administration of the labelled compound to animals to the steady state (metabolic equilibrium) identified by plasma levels. The dose applied shall correspond to the highest dose proposed for use, and shall be incorporated into the feed.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/II/division/3/division/3.2/division/3.2.1/division/3.2.1.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.2/division-3.2.1/division-3.2.1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.