Division 3.4.1 Phase I assessment

The purpose of Phase I assessment is to determine if a significant environmental effect of the additive or its metabolites is likely and whether a Phase II assessment is necessary (see decision tree).

Exemption from Phase II assessment may be made on one of two criteria, unless there is scientifically-based evidence for concern:

1. (a)

   the chemical nature and the biological effect of the additive and its conditions of use indicate that impact will be negligible, i.e. where the additive is:

   • a physiological or natural substance that will not result in a substantial increase of the concentration in the environment; or

   • intended for non-food producing animals;

2. (b)

   the worst case Predicted Environmental Concentration (PEC) is too low to be of concern. The PEC shall be evaluated for each compartment of concern (see below), assuming that 100 % of the dose ingested is excreted as the parent compound.

If the applicant cannot demonstrate that the additive falls into one of these exemption categories, a Phase II assessment will be required.