Determination of withdrawal periods for edible tissue - Scientific guideline

This guideline provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software. Read together with the Note for guidance on approach towards harmonisation of withdrawal periods - Updated application software

Keywords: Withdrawal periods, tissues, statistical approach, alternative approach

Current effective version

Adopted guideline on determination of withdrawal periods for edible tissues - Revision 2

Adopted Reference Number: EMA/CVMP/SWP/735325/2012 Rev.2 Legal effective date: 01/08/2022

Document history

Adopted guideline on determination of withdrawal periods for edible tissues - Revision 2

Adopted Reference Number: EMA/CVMP/SWP/735325/2012 Rev.2 Legal effective date: 01/08/2022

Overview of comments received on the Guideline on determination of withdrawal periods for edible tissues (EMA/CVMP/SWP/735325/2012) - Revision 2

Reference Number: EMA/CVMP/SWP/10857/2022

Draft guideline on determination of withdrawal periods for edible tissues - Revision 2

Draft: consultation closed Consultation dates: 15/10/2021 to 17/12/2021 Reference Number: EMA/CVMP/SWP/735325/2012 Rev.2

Guideline on determination of withdrawal periods for edible tissues - Revision 1

Adopted Reference Number: EMA/CVMP/SWP/735325/2012 Legal effective date: 01/04/2019 Summary:

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated application software.

Overview of comments received on 'Guideline on approach towards harmonisation of withdrawal periods (EMA/CVMP/SWP/735325/2012)' - Revision 1

Reference Number: EMA/CVMP/SWP/81095/2017

Draft guideline on approach towards harmonisation of withdrawal periods

Draft: consultation closed Consultation dates: 25/07/2016 to 31/01/2017 Reference Number: EMA/CVMP/SWP/735325/2012 Summary:

In January 2014 the CVMP published a concept paper (EMA/CVMP/SWP/285070/2013) proposing a revision of the Note for guidance: approach towards harmonisation of withdrawal periods, in order to look again at the approach used for considering residues present at levels below the limit of quantification (LOQ). The concept paper noted that the original Note for guidance recommends that a value of half of the limit of quantification should be applied to data points below the limit of quantification, but that since publication of the Note for guidance, more sophisticated methods for dealing with levels below the limit of quantification have become available, such as the maximum likelihood approach (i.e. determining the depletion curve that would maximise the likelihood of the observed data).

Concept paper on the revision of the note for guidance on the approach towards harmonisation of withdrawal periods

Draft: consultation closed Consultation dates: 18/10/2013 to 31/01/2014 Reference Number: EMA/CVMP/SWP/285070/2013 Summary:

The Committee for Medicinal Products for Veterinary Use (CVMP) note for guidance: approach towards harmonisation of withdrawal periods was published in 1996. While the approach recommended for dealing with residues below the limit of quantification is simple and easy to apply, more sophisticated methods for dealing with data below the limit of

quantification are now available. It is therefore considered that the Safety Working Party should review these alternative methods and, if appropriate, incorporate these into the note for guidance.

Note for guidance: Approach towards harmonisation of withdrawal periods

Adopted Reference Number: EMEA/CVMP/036/95 - FINAL Legal effective date: 01/01/1997