Article 4 Minimum criteria for extrapolation

The F1appropriate authority may undertake extrapolation only when all of the following conditions are fulfilled:

1. (a)

   a full set of residue data for the reference species is available to the appropriate authority;

2. (b)

   the degree to which the pharmacologically active substance is metabolised in the reference species is established;

3. (c)

   a suitably validated analytical method is available for the reference species;

4. (d)

   when considering extrapolation between unrelated species, the similarity of the metabolic profiles in the reference and concerned species is established;

5. (e)

   the extrapolated MRLs result in the Theoretical Maximum Daily Intake (TMDI) not exceeding the Acceptable Daily Intake (ADI);

6. (f)

   for substances where the marker residue does not include parent compound, it is confirmed that the marker residue is present in the concerned species/food commodity;

7. (g)

   in case of extrapolations between different food commodities, an unused portion of the ADI is available to accommodate the additional food item.