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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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The whole of Section I of Annex II applies.
The Section II of Annex II applies as following:
for additives not subject to a specific holder of the authorisation the paragraphs 2.1.2, 2.1.3, 2.1.4, 2.1.4.2, 2.2, 2.3.1, 2.3.2, 2.4.1, 2.4.2, 2.4.4, 2.5, 2.6 apply;
for other additives subject to a specific holder of the authorisation, the whole of Section II applies.
No studies are required for urea, and amino acids, their salts and analogues authorised by Directive 82/471/EEC and compounds of trace elements and vitamins, pro-vitamins and chemically well-defined substances having similar effect which do not have a potential to accumulate already authorised as feed additives under Directive 70/524/EEC.
For those additives that fall within the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ and having a potential to accumulate, tolerance will only be required to be demonstrated for compounds for which potency is expected or has been demonstrated to be different from that of the well established vitamin(s). In certain cases elements of the tolerance test (design or criteria) could be combined with one of the efficacy trials.
Tolerance will be demonstrated for urea derivatives amino acid analogues and compounds of trace elements not previously authorised. The fermentation products will be requested by tolerance demonstration, unless the active substance is separated from the crude fermentation product and highly purified, or the production organism has a history of apparent safe use and well known about its biology to exclude a potential for the production of toxic metabolites.
Where the application is for all animal species/categories, one tolerance study on the most sensitive species (or even an appropriate laboratory animal) under the most recent knowledge is sufficient.
The whole of subsection 3.1.2 of Annex II applies.
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).
These are required for fermentation products and additives not already authorised. For fermentation products, genotoxicity and subchronic toxicity studies must be provided unless:
the active substance is separated from the crude fermentation product and is highly purified; or
the production organism has a history of apparent safe use and there is sufficient knowledge of its biology to exclude a potential for the production of toxic metabolites.
Where the production organism belongs to a group in which some strains are known to produce toxins, their presence shall be specifically excluded.
The whole of subsection 3.2.3 of Annex II applies.
The whole of subsection 3.3 of Annex II applies
The whole of subsection 3.4 of Annex II applies for new active substances belong to the compound of trace elements.
Efficacy studies are not required for urea, amino acids, amino acid salts and analogues already authorised as feed additives, compounds of trace elements already authorised as feed additives and vitamins, pro-vitamins and chemically well-defined substances having similar effect already authorised as feed additives.
A short term study is required to support efficacy for urea derivatives, amino acid salts and analogues not already authorised as feed additives, compounds of trace elements not already authorised as feed additives and for vitamins, pro-vitamins and chemically well-defined substances having similar effect not already authorised as feed additives.
For other substances for which a nutritional effect is requested at least one long term efficacy study under provisions of Section 4 of Annex II is requested.
Where required, studies shall demonstrate that the additive can provide the animals' nutritional requirements. Tests shall include a test group with a diet that contains the nutrient at concentrations below the animals' requirements. However, trials using a severely deficient control group shall be avoided. Generally, it will be sufficient to demonstrate efficacy in a single animal species or category including laboratory animals.
This section shall apply under provision of Article 7(3)(g) of Regulation (EC) No 1831/2003.
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