Title 012 | Chapter 003 | Regulation 037REG
PROPOSED
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PREVIOUS VERSION
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Agricultural Experiment Station
(Amended at ARRS Committee)
12 KAR 3:037.Drugs and pet food additives.
Section 1.
An artificial color may be used in a pet food or specialty pet food only if the artificial colorSection 2.
Before approval of a label and a registration application, the distributor of a pet food, containing an additive including a drug, another special purpose additive, or a nonnutritive additive shall, upon request of the director, submit evidence to prove the safety and efficacy of the pet food if used according to label directions. Evidence of the safety and efficacy of a pet food or specialty pet food shall be:(1)
If the pet food or specialty pet food contains an additive that conforms to 21 C.F.R. 570.3(1), 570.30, or Part 582; or(2)
If the pet food or specialty pet food is a drug as defined by KRS 250.501(7) and is generally recognized by the Food and Drug Administration as safe and effective for its labeled use or is marketed pursuantSection 3.
If a drug is included in a pet food or specialty pet food, the medicated labeling format recommended by the Association of American Feed Control Officials (AAFCO), incorporated by reference in 12 KAR 3:012,Section 4.
(1)
(2)
FILED WITH LRC: March 9, 2026
CONTACT PERSON: G. Alan Harrison, Feed & Milk Director, University of Kentucky Division of Regulatory Services, 103 Regulatory Services Building, Lexington, Kentucky 40546, phone (859) 257-2785, fax (859) 323-9931, email alan.harrison@uky.edu.
Agricultural Experiment Station
(Amended at ARRS Committee)
12 KAR 3:037.Drugs and pet food additives.
Section 1.
An artificial color may be used in a pet food or specialty pet food only if the artificial color has been shown to be harmless to pets or specialty pets. The permanent or provisional listing of an artificial color in 21 C.F.R. Part 70, 71, 73, 74, 80, 81, or 82, or 501.22 as safe for use, together with the conditions, limitations, and tolerances, if any, shall constitute evidence that the color is harmless to pets or specialty pets.Section 2.
Before approval of a label and a registration application, the distributor of a pet food, containing an additive including a drug, another special purpose additive, or a nonnutritive additive shall, upon request of the director, submit evidence to prove the safety and efficacy of the pet food if used according to label directions. Evidence of the safety and efficacy of a pet food or specialty pet food shall be:(1)
If the pet food or specialty pet food contains an additive that conforms to 21 C.F.R. 570.3(1), 570.30, or Part 582; or(2)
If the pet food or specialty pet food is a drug as defined by KRS 250.501(7) and is generally recognized by the Food and Drug Administration as safe and effective for its labeled use or is marketed pursuant to an application approved by the Food and Drug Administration under 21 U.S.C. 360(b).Section 3.
If a drug is included in a pet food or specialty pet food, the medicated labeling format recommended by the Association of American Feed Control Officials (AAFCO), incorporated by reference in 12 KAR 3:012, Official Publication shall be used to ensure that adequate labeling is provided.FILED WITH LRC: March 9, 2026
CONTACT PERSON: G. Alan Harrison, Feed & Milk Director, University of Kentucky Division of Regulatory Services, 103 Regulatory Services Building, Lexington, Kentucky 40546, phone (859) 257-2785, fax (859) 323-9931, email alan.harrison@uky.edu.