VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI - Scientific guideline

This document provides guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.

Keywords: VICH, consumer safety, residues of veterinary drugs in human food, acceptable daily intake (ADI), microbiological ADI, colonisation barrier

Current effective version

VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - Revision 2

Reference Number: EMA/CVMP/VICH/467/2003 Legal effective date: 01/08/2019

Document history

VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - Revision 2

Reference Number: EMA/CVMP/VICH/467/2003 Legal effective date: 01/08/2019

Draft VICH GL36: Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological acceptable daily intake - Revision 1

Draft: consultation closed Consultation dates: 10/03/2011 to 14/09/2011 Reference Number: EMA/CVMP/VICH/467/2003-Rev.1

VICH GL36(R): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - First version

Adopted Reference Number: EMA/CVMP/VICH/467/2003 Summary:

This guideline has been developed by the appropriate VICH Expert Working Group and is subject to consultation by the parties, in accordance with the VICH Process. At Step 7 of the Process the final draft will be recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.