VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Scientific guideline

This document aims to ensure international harmonization of genotoxicity testing. It recommends a standard battery of tests that can be used for the evaluation of the genotoxicity of veterinary drugs.

Keywords: VICH, consumer safety, genotoxicity testing, residues of veterinary drugs in human food

Current effective version

VICH GL23: Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision at step 9, for implementation at step 7

Adopted Reference Number: EMA/CVMP/VICH/526/2000 Summary:

In order to establish the safety of veterinary drug residues in human foods, a number of toxicological evaluations are recommended, including investigation of possible hazard from genotoxic activity. Many carcinogens and/or mutagens have a genotoxic mode of action and it is prudent to regard genotoxicants as potential carcinogens unless there is convincing evidence that this is not the case. Additionally, substances causing reproductive and/or developmental toxicity may have a mode of action that involves genotoxic mechanisms. The results of genotoxicity tests will not normally affect the numerical value of an acceptable daily intake (ADI), but they may influence the decision about whether an ADI can be established. The objective of this guideline is to ensure international harmonization of genotoxicity testing.

Revision 2

VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing (revision 2)

Draft: consultation closed Reference Number: EMA/CVMP/VICH/526/2000 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 
USA.
Comments should be provided using this template. The completed comments form should be sent to [e-mail].

Document history

Draft VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision 2

Draft: consultation closed Consultation dates: 21/06/2024 to 30/11/2024 Reference Number: EMA/CVMP/VICH/526/2000 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 
USA.
Comments should be provided using this template. The completed comments form should be sent to [e-mail].

VICH GL23: Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision at step 9, for implementation at step 7

Adopted Reference Number: EMA/CVMP/VICH/526/2000 Summary:

In order to establish the safety of veterinary drug residues in human foods, a number of toxicological evaluations are recommended, including investigation of possible hazard from genotoxic activity. Many carcinogens and/or mutagens have a genotoxic mode of action and it is prudent to regard genotoxicants as potential carcinogens unless there is convincing evidence that this is not the case. Additionally, substances causing reproductive and/or developmental toxicity may have a mode of action that involves genotoxic mechanisms. The results of genotoxicity tests will not normally affect the numerical value of an acceptable daily intake (ADI), but they may influence the decision about whether an ADI can be established. The objective of this guideline is to ensure international harmonization of genotoxicity testing.

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) topic GL23(R): Studies to evaluate the safety of residues of veterinary drugs in human food: G...

Draft: consultation closed Consultation dates: 18/01/2013 to 31/03/2013 Reference Number: EMA/CVMP/SWP/398880/2012 Summary:

The objective of this guideline is to ensure international harmonisation of genotoxicity testing.

VICH GL23: Safety studies for veterinary drug residues in human food: Genotoxicity studies - Step 7

Adopted Reference Number: CVMP/VICH/526/00-FINAL Legal effective date: 01/07/2002