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

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

These additives protect the animals from the results of an invasion of Eimeria spp. or Histomonas meleagridis. Importance shall be attached to evidence of the specific effects of the additive (e.g. species controlled) and its prophylactic properties (e.g. reduction in morbidity, mortality, oocyst count and lesion score). Information on the effect on growth and feed conversion (fattening birds, replacement layers and rabbits), effects on hatchability (breeding birds) shall be provided, as appropriate.
The required efficacy data shall derive from three types of target animal experiments:
artificial single and mixed infections
natural/artificial infection to simulate use conditions
actual use conditions in field trials
Experiments with artificial single and mixed infections (e.g. battery cages for poultry) are intended to demonstrate the relative effectiveness against the parasites and do not require replication. Three significant results are required for studies simulating use conditions (e.g. floor pen studies with poultry, battery cage studies with rabbits). Three field studies in which a degree of natural infection is present are also required.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/5/division/5.4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-5/division-5.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.