# 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 7.4: Section IV: studies concerning the efficacy of the additive

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

The requirements for the different categories/functional group of additives apply.
When the additive, for which animal studies are required, has been previously authorised for other physiological similar species, no further demonstration of efficacy is required provided the requested effect and mode of action are the same. If the additive has not been previously authorised, the requested effect, or the mode of action are different than former authorisation, efficacy shall be demonstrated following the general rules for Section IV in Annex II.
The duration of the long term efficacy trials shall be at least 28 days.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/7/division/7.4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-7/division-7.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.