Division Safety assessment

This is based on studies intended to demonstrate the safety of the use of the additive in relation to:

1. (a)

   the target species at the highest proposed levels of incorporation in the feed or water and at a multiple of that level to establish a margin of safety;

2. (b)

   consumers who ingest food products obtained from animals that have received the additive, its residues or its metabolites. In this case, safety will be ensured by the setting of maximum residue limits (MRLs) and withdrawal periods based on an Acceptable Daily Intake (ADI) or an Tolerable Upper Intake Level (UL);

3. (c)

   persons likely to be exposed to the additive by respiratory, mucosal, eye or cutaneous contact while handling the additive or incorporating it into premixtures or complete feed or water or using feed or water containing the additive concerned;

4. (d)

   animals and humans with respect to the selection and spread of antimicrobial resistance genes; and

5. (e)

   the environment, as a result of the additive itself or products derived from the additive, either directly and/or as excreted by animals.

Where an additive has multiple components, each one may be separately assessed for consumer safety and then consideration given to the cumulative effect (where it can be shown that there are no interactions between the components). Alternatively, the complete mixture shall be assessed.