Article 5 Extrapolation from major to related minor species

When considering the extrapolation of MRLs from major reference species to minor concerned species within the related species category, the F1appropriate authority shall apply the following criteria:

1. (a)

   extrapolation of the reference species MRLs to the concerned species on a one to one basis is possible where the parent substance is the marker residue in the reference species;

2. (b)

   where the parent substance is not the marker residue in the reference species, then confirmation that the marker residue is present in the concerned tissues/food commodities may be required from the applicant;

3. (c)

   the established MRLs shall be extrapolated in accordance with the pattern set out in the Annex;

4. (d)

   the tissue/food commodity of the major and minor species shall be the same;

5. (e)

   a ‘No MRL required’ status may be directly extrapolated to the concerned species.