EMA: Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides

Where it is considered that residues of pharmacologically active substances in biocidal products used in animal husbandry might have the potential to lead to consumer health concerns a consumer safety evaluation must be undertaken with, where appropriate, the derivation of maximum residue limits (MRLs). This document briefly introduces the process by which a decision is taken on whether an MRL evaluation is needed and details the approach taken for the MRL evaluation.