8 Colo. Code Regs. § 1202-6, pt. 10
Current through Register Vol. 48, No. 1, January 10, 2025
Part 10 - Drug and Feed Additives10.1. Prior to approval of a registration application and/or approval of a label for commercial feed which contains additives (including drugs, other special purpose additives, or non-nutritive additives) the distributor may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label.10.2. Satisfactory evidence of safety and efficacy of a commercial feed may be:10.2.1. When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in the Code of Federal Regulations, Title 21, or which are "prior sanctioned" or "informal review sanctioned" or "generally recognized as safe" for such use, or10.2.2. When the commercial feed is itself a drug as defined in Section 35-60-102(8) of the Colorado Feed Law and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the Food and Drug Administration under Title 21 U.S.C. 360 b, or10.2.3. When one of the purposes for feeding a commercial feed is to impart immunity (that is to act through some immunological process) the constituents imparting immunity have been approved for the purpose through the Federal Virus, Serum and Toxins Act of 1913, as amended, or10.2.4. When the commercial feed is a direct fed microbial product and: 10.2.4.1. The product meets the particular fermentation product definition; and10.2.4.2. The microbial content statement, as expressed in the labeling, is limited to the following: "Contains a source of live (viable) naturally occurring microorganisms." This statement shall appear on the label; and10.2.4.3. The source is stated with a corresponding guarantee expressed in accordance with Part 5.7.10.2.5. When the commercial feed is an enzyme product and: 10.2.5.1. The product meets the particular enzyme definition as defined in the Official Definitions of Feed Ingredients published in the 2022 Official Publication of AAFCO, and10.2.5.2. The enzyme is stated with a correspo nding guarantee expressed in accordance with Part 5.8.38 CR 05, March 10, 2015, effective 3/30/201539 CR 05, March 10, 2016, effective 3/30/201639 CR 23, December 10, 2016, effective 12/30/201640 CR 20, October 25, 2017, effective 11/30/201743 CR 22, November 25, 2020, effective 12/15/202045 CR 22, November 25, 2022, effective 12/15/2022