Extrapolation between unrelated species and from a minor reference species to a major concerned species
Article 6
When considering the extrapolation of MRLs between unrelated species and from a minor reference species to a major concerned species, the EMA shall apply the following criteria: (a) extrapolation on a one to one basis from minor to major species may be justified only in cases where it is clear that metabolism in the reference and concerned species are similar; (b) where extrapolation is considered between unrelated species (including minor species), supportive substance-specific information regarding the similarity of metabolism between the reference and concerned species may be required from the applicant; (c) where MRLs have been established for more than one unrelated species, the set of MRLs leading to the lowest consumer intake shall be extrapolated to the concerned species on a one to one basis; (d) the use of other specific safety factors on a case-by-case basis may be considered by the EMA to account for specific uncertainties in the data; (e) ‘no MRL required’ status may be extrapolated to the concerned species if the metabolism is similar; (f) extrapolation of MRLs from terrestrial species to fish with muscle and skin in natural proportions is directly possible where the parent compound is the marker residue and MRL has been established in muscle of the reference species; (g) extrapolation from fish to mammals/avian species shall not be carried out.