# 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 1.3.2.1: Metabolic and residue studies

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

Metabolic and residue studies are not required if:
(1)the substance or its metabolites are not present in the feedingstuff at time of feeding; or
(2)the substance excreted unchanged, or its metabolites can be demonstrated to be essentially not absorbed; or
(3)the substance is absorbed in the form of physiological compounds; or
(4)the active component(s) of the additive consists only of micro-organisms or enzymes).
Metabolic studies also are not required if the substance is naturally present in significant amounts in food or feedingstuffs or the substance is a normal constituent of body fluids or tissues. However, in these cases, there is a requirement for residue studies which can be limited to the comparison of the tissues/products levels in an untreated group and in the group supplemented with the highest recommended dose.

---
Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/1/division/1.3/division/1.3.2/division/1.3.2.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-1/division-1.3/division-1.3.2/division-1.3.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.