Division II.6.6.2.2.1

When consumer exposure to residues of the active substance in food of animal origin is negligible or very low compared to the level of exposure that already occurs as a result of the presence of the material in the environment or already present in commodities (most notably foods), then it may be possible to argue that the impact (in terms of consumer exposure to residues) of the proposed use in veterinary medicinal products is negligible and that the establishment of an ADI shall not be necessary. A worst case estimate of residue levels that may occur as a result of the proposed use of the substance shall be provided, along with an estimate of the resulting consumer exposure. This shall be compared with the level of exposure known to occur via other sources. This approach may be particularly relevant for herbal medicines and vegetable extracts, as well as for natural organic acids (e.g. oxalic acid).