Guidance

#08 ADME EVALUATION IN THE CONTEXT OF RISK ASSESSMENT OF FEED INGREDIENTS

This guidance document provides recommendations regarding the approach for the evaluation of Absorption, Distribution, Metabolism, and Excretion (ADME) of feed ingredients, especially in the context of hazard assessment for the consumer of animal products. The guidance document considers feed ingredients are mixture of chemical substances (constituent entities), as described in the guidance document on identification and characterization (Guidance Document#07) and thus excludes feed ingredients containing microorganisms. For each constituent entity of the feed ingredient, the ADME evaluation starts with a weight of evidence approach (i.e., read across, in silico models and in vitro studies). If the weight of evidence approach is not sufficient to conclude the evaluation, in vivo studies may be required.

Suggested citation:

ICCF EWG ‘ADME Evaluation in the context of risk assessment of feed ingredients’. Betancourt A.1, Chen C.Q.2, Manini P.3, Ladics G.4, Smith M.5, Hahn U.6, Fraatz K.7, 2024. Guidance on the ADME evaluation in the context of risk assessment of feed ingredients. ICCF, 2024; 28 pages.

1 FDA / 2 CFIA / 3 EFSA / 4 AFIA / 5 ANAC / 6 FEFANA / 7 IFIF

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