The whole of Section IV of Annex II applies.

1. (1)

   Additives favourably affecting animal production, performance or welfare and for the functional group ‘other zootechnical additives’.

   The effects can only be demonstrated in relation to each target animal species or category. Depending on the properties of the additive, outcome measures may be based either on performance characteristics (e.g. feed efficiency, average daily gain, increasing of animal products), carcass composition, herd performance, reproduction parameters or animal welfare. Evidence of the mode of action can be provided by short term efficacy studies or laboratory studies measuring relevant end-point.

2. (2)

   Additives favourably affecting the environmental consequences of animal production.

   For these additives which favourably affect the environment (e.g. reduced nitrogen or phosphorus excretion or reduced methane production, off-flavours), evidence of efficacy for the target species can be given by three short term efficacy studies with animals showing significant beneficial effects. The studies shall take into consideration the possibility of an adaptive response to the additive.