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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)
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This legislation may since have been updated - see the latest available (revised) version
The whole of subsection 3.1 of Annex II applies.
Metabolic and residue studies
These studies are not required if:
the substance or its metabolites can be demonstrated to be excreted unchanged and essentially to be not absorbed; or
the substance is absorbed in physiological form and physiological level of compound(s).
No metabolic studies are needed if the substance is naturally present in significant amounts in food or feedingstuffs or if 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 a comparison of the levels in the tissues or products in an untreated group to the levels found in the group supplemented with the highest recommended dose.
In all other cases the whole of subsection 3.2.1 of Annex II applies.
Toxicological studies
Toxicological studies are not required if the substance is absorbed in the form of physiological compound(s).
For xenobiotic substances the whole of subsection 3.2.2 of Annex II applies.
For other substances, a case by case approach shall be used, taking into account the level and means of exposure, and any omission of data prescribed in this section must be fully justified.
Assessment of consumer safety
The whole of subsection 3.2.3 of Annex II applies for food producing animals.
The whole of subsection 3.3 of Annex II applies.
The whole of subsection 3.4 of Annex II applies
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