# 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 4.5: Efficacy requirements for additive categories and functional groups

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

For all additives intended to have an effect on animals, in vivo studies are requested.
For the categories of zootechnical additives and coccidiostats and histomonostats, efficacy shall be demonstrated by at least three long term efficacy studies. However, for some zootechnical additives and the other additive categories having an effect on animals, short term efficacy studies may be accepted if efficacy can be unequivocally demonstrated.
For other additive categories without a direct effect on animals at least one in vitro efficacy study shall be provided.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/II/division/4/division/4.5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-4/division-4.5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.