Need for maximum residue limit (MRL) evaluation for biological substances - Scientific guideline

This guideline addresses the need for an MRL evaluation for biological substances, when it is intended that those substances are included in products for use in food-producing species.

Keywords: biological substances, MRL assessment, consumer safety

Current effective version - effective from 29/05/2026

Guideline on determination of the need for an MRL evaluation for chemical-unlike biological substances - Revision 1

Adopted Reference Number: EMA/CVMP/SWP/591282/2021 Rev.1 Legal effective date: 29/05/2026

Document history

Guideline on determination of the need for an MRL evaluation for chemical-unlike biological substances

Adopted Reference Number: EMA/CVMP/SWP/591282/2021 Legal effective date: 01/08/2024

Draft guideline on determination of the need for an MRL evaluation for biological substances

Draft: consultation closed Consultation dates: 28/01/2022 to 29/04/2022 Reference Number: EMA/CVMP/SWP/591282/2021 Summary:

This draft guideline aims to provide a structured and transparent procedure on how to determine the need for an MRL evaluation according to Regulation (EC) No 470/2009 for ‘chemical unlike’ biologicals.

Overview of comments received on Concept paper on the development of a guideline on determination of the need for an MRL evaluation for biological substances

Concept paper on the development of a guideline on determination of the need for an MRL evaluation for biological substances

Draft: consultation closed Consultation dates: 23/07/2021 to 30/09/2021 Reference Number: EMA/CVMP/SWP/207500/2021