Injection-site residues: considerations for risk assessment and residue surveillance - Scientific guideline

This document describes the approach to be used to develop appropriate maximum residue limits for injectable sites for food producing animals.

Keywords: Injection site residues, consumer safety, withdrawal periods, injection site residue reference value

Current effective version

Draft reflection paper on injection-site residues: considerations for risk assessment and residue surveillance (revision 1)

Consultation dates: 18/10/2013 to 30/04/2014Draft: consultation closedReference Number: EMA/CVMP/520190/2007-Rev.1Summary:

Residues in injection-site muscle for some products tend to be dramatically higher than residues in non-injection-site muscle (as well as in fat, liver and kidney). The result is that a single carcass may contain muscles with very different residue levels of injectable substances, and these differing levels of residues in a single tissue type make setting an appropriate maximum residue limit (MRL) very challenging. The Committee for Medicinal Products for Veterinary Use (CVMP) has developed an approach that could be used consistently to develop appropriate MRLs for injectable substances. This reflection paper describes that approach.

Document history

Reflection paper on injection site residues: considerations for risk assessment and residue surveillance

Reference Number: EMEA/CVMP/520190/2007