§ 72.10. Drugs and additives.
(a) An artificial color may be used in a pet food only if it has been shown to be harmless to pets. The permanent or provisional listing of an artificial color by the United States Food and Drug Administration at 21 CFR Parts 8 and 9 as safe for use, together with the conditions, limitations and tolerances, if any, incorporated therein, shall be deemed to be satisfactory evidence that the color is, when used, under the regulations, harmless to pets.
(b) Prior to approval of a facility registration for pet foods which contain additives, including drugs, other special purpose additives or nonnutritive additives, the distributor may be required to submit evidence to prove the safety and efficacy of the pet food, when used according to directions furnished on the label. Evidence of the safety and efficacy of a pet food is not required under the following conditions:
(1) The pet food contains additives which conforms to the requirements of Federal standards set forth at 21 CFR 121.101(a)—(h), or which are prior sanctioned or generally recognized as safe for that use.
(2) The pet food itself is a drug as defined in section 3 of the act (3 P. S. § 58.3) and is generally recognized as safe and effective for use or is marketed subject to an application approved by the United States Food and Drug Administration under the provisions of sections 505 and 507 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C.A. § § 355 and 357).
(c) The medicated labeling format recommended by Association of American Feed Control Officials shall be used.
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