Part III—Safety information
1. Details of any information relevant to the safety of the product, including a summary and evaluation of any studies carried out with the product or its ingredients which are necessary to establish the safety of the product for the purposes of the test.
2. In the case of a product intended for administration in the test to food-producing animals—
(a) details of any entry in Annexes I to IV of Council Regulation (EEC) No. 2377/90(1), in relation to the product or any of its ingredients, and
(b) a proposal and justification for a withdrawal period.
(1)
O.J. No. L224, 18.8.90, p.1.