Commission Regulation (EC) No 429/2008Show full title

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:

(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;

(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.

3.4.1.1. Additives for terrestrial animals

When excreta from livestock are applied on land, the use of feed additives can lead to contamination of soil, ground water, and surface water (via drainage and run-off).

The worst case PEC for soil (PEC_soil) would arise considering all excreted compounds being spread on land. If the PEC_soil (default: 5 cm depth) is less than 10 μg/kg, no further assessment is required.

If the PEC for contamination of groundwater (PEC_gw) is less than 0,1 μg/l, no Phase II assessment of the environmental impact of the additive on groundwater is necessary.

3.4.1.2. Additives for aquatic animals

Feed additives used in aquaculture can result in contamination of sediment and water. The compartment of concern for the environmental risk assessment for fish farmed in cages is assumed to be the sediment. For fish farmed in land-based systems the effluent flowing to surface water is considered to pose the major environmental risk.

The worst case PEC for sediment (PEC_sediment) would arise considering all excreted compounds being deposited in the sediment. If the PEC_sediment (default: 20 cm depth) is less than 10 μg/kg wet weight, then no further assessment is required.

If the PEC in the surface water (PEC_sw) is less than 0,1 μg/l, no further assessment is required.

Phase I — Decision tree