In 2009, the OECD Guidance document on the Definition of the Residue (No. 63, ENV/JM/MONO(2009)30) has been published. Clear purpose of the guidance document was to provide a harmonized approach for the residue definition that can be used by applicants during the process of generating residue data and by regulatory authorities during the review of such data. The guidance documents recommends to establish two residue definitions: The definition for risk assessment emphasizes analysis of the parent compound and its toxicologically significant metabolites, taking into consideration both exposure and relative toxicities. The definition for tolerance/MRL enforcement purposes focuses on those analytes which would indicate a possible misuse of the pesticide and which can be measured by a broad base of national laboratories. In the actual registration process, the recommendations are only followed by few authorities which is resulting in perceived trade barriers or as worst case the non-acceptance of entire residue data sets. In the poster, the current status, but also an outlook on future needs from industry perspective will be shown.

Challenges in setting appropriate residue definitions

248th National Meeting (2014)

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