Division I.7

For chemical-unlike biological substances, a report describing the scientific basis for the request on whether a full MRL evaluation is required or not shall be required together with the following information:

1. (a)

   the nature of the biological substance (e.g. cell, tissue, live or killed organism) and a comparison with similar biological substances to which consumers are known to be routinely exposed;

2. (b)

   a description of the mechanism of action underlying the substances therapeutic effect and, if available, information on its potency;

3. (c)

   the fate of the substance in the treated animal (i.e. is it bioavailable, are residues expected in food commodities);

4. (d)

   any activity that the substance may have in the human gut (are the residues inactive or do they produce local effects);

5. (e)

   the systemic availability of residues following ingestion of residues by consumers, along with a worst case consumer exposure estimate.

The information provided above shall be evaluated in accordance with the guidance published by the F1appropriate authority in order to determine whether there is the need for a MRL evaluation. Biological substances for which it is concluded that a MRL evaluation is not required shall be published by F2the appropriate authority in a list of such substances.