ANNEX IIISPECIFIC REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3 WITH RESPECT TO CERTAIN CATEGORIES OF ADDITIVES OR CERTAIN PART ICULAR SITUATIONS, AS PROVIDED FOR IN ARTICLE 7(5) OF REGULATION (EC) No 1831/2003

11.RE-EVALUATION OF CERTAIN ADDITIVES ALREADY AUTHORISED UNDER DIRECTIVE 70/524/EEC

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.