Division 3.4 Studies concerning the safety of use of the additive for the environment

Consideration of the environmental impact of additives is important since administration of additives typically occurs over long periods, often involves large groups of animals and the active substance(s) may be excreted to a considerable extent either as the parent compound or its metabolites.

To determine the environmental impact of additives, a stepwise approach shall be followed. All additives have to be assessed through Phase I to identify those additives which do not need further testing. For the other additives a second phase (Phase II) assessment is needed to provide additional information, based upon which further studies may be considered necessary. These studies shall be conducted according to F1Regulation (EC) No 1272/2008.