8 CCR 1202-7, pt. 7 - Additives and Drugs
7.1. An
artificial color may be used in a pet food or a specialty pet food only if it
has been shown to be harmless to pets or specialty pets. The permanent or
provisional listing of an artificial color in the United States Food and Drug
Administration regulations 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 pursuant to such
regulations, harmless to pets or specialty pets.
7.2. Evidence may be required to prove the
safety and efficacy or utility of a pet food or specialty pet food which
contains additives or drugs, when used according to directions furnished on the
label. Satisfactory evidence of the safety and efficacy of a pet food or
specialty pet food may be established;
7.2.1.
When the pet food or specialty pet food 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 "Generally
Recognized as Safe" for such use; or
7.2.2. When the pet food or specialty pet
food itself is a drug or contains a drug as defined in Section
35-60-102(8),
C.R.S., 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)
7.3. When a drug is
included in a pet food or specialty pet food, the following format is required:
7.3.1. The word "medicated" shall appear
directly following and below the product name in type size no smaller than
one-half the type size of the product name.
7.3.2. A purpose statement shall be listed
that includes the following information:
7.3.2.1. The specific species and animal
class for which the feed is intended.
7.3.2.2. The purpose statement may be
excluded from the label if the product name includes a description of the
species and animal class(es) for which the product is intended.
7.3.2.3. The purpose statement of a premix
for the manufacture of feed may exclude the animal class and species and state
"For Further Manufacture of Feed" if the nutrients contained in the premix are
guaranteed and sufficient for formulation into various animal species feeds and
premix specifications are provided by the end user of the premix.
7.3.2.4. The purpose statement of a single
purpose ingredient blend may exclude the animal class and species and state
"For Further Manufacture of Feed" if the label guarantees of the nutrients
contained in the single purpose nutrient blend are sufficient to provide for
formulation into various animal species feeds.
7.3.2.5. The purpose statement of a product
shall include a statement of enzyme functionality if enzymatic activity is
represented in any manner.
7.3.3. The purpose of medication (claim
statement).
7.3.4. An active
ingredient statement listing the active drug ingredients by their established
name and guarantees for drugs stated in terms of percent by weight, except:
7.3.4.1. Antibiotics present at less than
2,000 grams per ton (total) in a pet or specialty pet food shall be stated in
grams per ton of feed.
7.3.4.2.
Antibiotics present at 2,000 or more grams per ton (total) in a pet or
specialty pet food shall be stated in grams per pound of feed.
7.3.4.3. Labels for commercial feeds
containing growth promotion and/or feed efficiency levels of antibiotics, which
are to be fed continuously as the sole ration, are not required to make
quantitative guarantees except as specifically noted in the Federal Food
Additive Regulations for certain antibiotics, wherein, quantitative guarantees
are required regardless of the level or purpose of the antibiotic.
7.3.4.4. The term "milligrams per pound" may
be used for drugs or antibiotics in those cases where a dosage is given in
"milligrams" in the feeding directions.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.