# 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 2.1.3: Section III: studies concerning the safety of the use of the additive

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

Subsection 3.3 of Annex II applies fully for every additive.
(1)For substances which, when fed to animals, add colours to food of animal origin Section III subsections 3.1, 3.2 and 3.4 of Annex II apply in full.
(2)For substances that add or restore colour in feedingstuffs, studies concerning Section III subsection 3.1 shall be performed on animals receiving the additive at the recommended dose. Evidence can also be provided by reference to existing scientific literature. Section III subsections 3.2 and 3.4 of Annex II apply.
(3)For substances which favourably affect the colour of ornamental fish or birds, studies concerning Section III subsection 3.1 of Annex II are required and shall be performed on animals receiving the additive at the recommended dose. Evidence can also be provided by reference to existing scientific literature. However, subsections 3.2 and 3.4 are not required.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/2/division/2.1/division/2.1.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-2/division-2.1/division-2.1.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.