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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 is the original version (as it was originally adopted).
The whole of Section I of Annex II applies.
The whole of Section II of Annex II applies.
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
The whole of Section IV of Annex II applies.
Additives favourably affecting animal production, performance or welfare and for the functional group ‘other zootechnical additives’.
The effects can only be demonstrated in relation to each target animal species or category. Depending on the properties of the additive, outcome measures may be based either on performance characteristics (e.g. feed efficiency, average daily gain, increasing of animal products), carcass composition, herd performance, reproduction parameters or animal welfare. Evidence of the mode of action can be provided by short term efficacy studies or laboratory studies measuring relevant end-point.
Additives favourably affecting the environmental consequences of animal production
For these additives which favourably affect the environment (e.g. reduced nitrogen or phosphorus excretion or reduced methane production, off-flavours), evidence of efficacy for the target species can be given by three short term efficacy studies with animals showing significant beneficial effects. The studies shall take into consideration the possibility of an adaptive response to the additive.
This section shall apply under provision of Article 7(3)(g) of Regulation (EC) No 1831/2003.
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