8 CCR 1202-6, pt. 10 - Drug and Feed Additives
10.1.
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, or
10.2.2. 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, or
10.2.3. 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, or
10.2.4. When the
commercial feed is a direct fed microbial product and:
10.2.4.1. The product meets the particular
fermentation product definition; and
10.2.4.2. 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; and
10.2.4.3. 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, and
10.2.5.2. The enzyme is stated with a
correspo nding guarantee expressed in accordance with Part 5.8.
Notes
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