Europe: guidance on the establishment of the residue definition for dietary assessment

The EFSA Panel on Plant Protection Products and their Residues (PPR Panel) has published a guidance on the establishment of the residue definition for dietary assessment. The residue definition for risk assessment is used by risk assessors to evaluate the potential risk of dietary intake of residues resulting from the application of a pesticide.

The guidance describes a stepwise approach starting with the compilation of an inventory of identified metabolites and the assessment of their genotoxicity endpoints (Module 1), followed by the assessment of other regulatory endpoints of toxicity (termed ‘general toxicity’; Module 2). The assessment is based on factual information (derived from toxicological data, metabolism data) and non-testing methods and tools ((quantitative) structure–activity relationship ((Q)SAR), read-across, threshold of toxicological concern (TTC)). For every single metabolite, this screening generates an inventory of toxicity complemented with dietary exposure information for consumers and livestock. All together the toxicity and exposure information forms the basis to estimate the contribution of each metabolite to the toxicological burden for consumers and to derive the final proposal of the residue definition for dietary risk assessment (Module 3). The scenario-specific information has to be completed by a list of identified uncertainties deemed relevant for decision making by risk managers.

The guidance document is complemented with three practical case studies that are intended to demonstrate the applicability of the proposed decision scheme.

Although the guidance document and the case studies describe EFSA’s current thinking on this topic, this has to be viewed as recommendation only. However, it is expected that scientifically justified evidence is given when deviating from the decision scheme described in this guidance document.

To download:

Guidance on the establishment of the residue definition for dietary risk assessment (EFSA Journal 2016;14(12):4549)

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