# 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 3.3.2.1: Metabolic and residue studies

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

Metabolic studies normally are not required. For urea derivatives, ruminal metabolism shall be studied in the efficacy trials.
Residue or deposition studies are only required for those additives that fall within the functional group ‘vitamins, pro-vitamins and chemically well-defined substances, having similar effect’ that have a potential for accumulation in the body and for the functional group of compounds of trace elements where bioavailability has been enhanced. In that case, the procedure described in subsection 3.2.1 of Annex II does not apply. The requirement is limited to the comparison of the levels in the tissues or products between the group supplemented with the highest dose of the substance claimed and a positive control (reference compound).

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/3/division/3.3/division/3.3.2/division/3.3.2.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-3/division-3.3/division-3.3.2/division-3.3.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.