Division 3.2.3.3 Consumer exposure

The total intake of the additive and/or its metabolites from all sources by the consumer shall be below the ADI or UL.

Calculation of the theoretical intake from food of animal origin shall be performed considering the concentration (total residues as the arithmetic mean and the highest single value) measured in tissues and products at the termination of use of the additive. In addition, if necessary, at the different withdrawal times, the human daily food consumption values shall be determined following a worst case scenario.

For additives intended for multi-species, the exposure from tissues shall be independently calculated for mammals, birds and fish and the highest value taken. Where appropriate, exposure from milk and eggs shall be added to this figure. For example, where an additive is applied for lactating mammals and laying birds, the respective highest edible tissue values are added to those for milk and egg consumption. Where the additive is applied for fish and laying birds and lactating mammals, the respective highest edible tissue values are added to those for egg and milk consumption. Other combinations shall be envisaged in the same way.

In certain situations (e.g. some nutritional and sensory additives or additives intended for minor species) it may be appropriate to subsequently refine the human exposure assessment using more realistic consumption figures, but still keeping the most conservative approach. Where this is possible this shall be based on F1data in Great Britain.