Division 8.3.2.3 Food additives for which no ADI is allocated

The reasons why an ADI was not allocated shall be clearly specified. If concerns arise from this, and the use of the additive in feed would contribute to a significant increase in consumer exposure, a full toxicological evaluation is required.

Additional exposure from feed use can be extrapolated from residue data from the literature.

Where residue studies are necessary, the requirement is limited to a comparison of the levels in tissues or products in an untreated group with the group supplemented with the highest dose that is claimed.