Division 1.3 Section III: studies concerning the safety of the additive

Subsections 3.1, 3.2 and 3.4 of Annex II do not apply to silage additives where it can be demonstrated that:

• no detectable amounts of the active substance(s) or relevant metabolites or the active agent(s) survive in the final feed; or

• the active substance(s) and agent(s) occur as normal constituents of silage and use of the additive does not substantially increase their concentration compared to silage prepared without use of the additive (i.e. where there is no substantial change in exposure).

In the other cases the whole of Section 3 of Annex II applies.