Division II.5.3

When considering the need to maintain an unused portion of the ADI, a number of substance specific factors shall be considered, including:

1. (a)

   information relating to the likely usefulness of the substance in other species (e.g. indication in the original species, mechanism of action, known toxicity of the substance in different species);

2. (b)

   physico-chemical and pharmacokinetic data that may indicate the likely distribution of the substance to milk, eggs or honey;

3. (c)

   whether the intended use of the substance requires MRLs that use up almost the entire ADI and are there particular considerations (such as availability concerns) that would justify recommending MRLs that would limit the possibility for future development of the substance;

4. (d)

   consideration of existing uses of the substance in fields other than veterinary medicine, and the consumer exposure that may result from these uses (indicated under Section II.6).