11.3.Section III: studies concerning the safety of the additives
Where an additive has been assessed for safety for target species, consumers, users/workers and the environment, a summary of the safety studies submitted for the previous authorisation, plus any new information arising since the previous authorisation shall be provided. Where a formal safety assessment has not been undertaken for the use of the substance as a feed additive, studies and data from the scientific literature can be used provided it is equivalent to that which would be required in a new application. Otherwise, a complete set of safety studies shall be provided.