12 KAR 3:007. Definitions and terms.

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: To define terms which serve as reference points in the application of labeling requirements to pet foods.

Section 1. "Principal display panel" means the part of a label that is most likely to be displayed, presented, shown or examined under normal and customary conditions of display for retail sale.

Section 2. "Ingredient statements" means a collective and contiguous listing on the label of the ingredients of which the pet food is composed.

Section 3. "Immediate container" means the unit, can, box, tin, bag, or other receptacle or covering in which a pet food is displayed for sale to retail purchasers but does not include containers used as shipping containers. (AES-2 (1973)-PF 1; 1 Ky.R. 1001; eff. 6-11-75.)

RELATES TO: KRS 250.501, 250.521, 15 USC 1451 to 1461
STATUTORY AUTHORITY: KRS 250.521(2)(e), (f), 250.571

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.491 to 250.631. KRS 250.521 requires that pet foods be labeled and establishes the information that shall be stated on the label. This administrative regulation establishes a uniform format for labeling information for pet foods and delineates criteria for product claims.

Section 1. The quantity statement and product name shall appear on the principal display panel of a pet food label. All other required information shall be:

1. Placed on the label; and

2. Easily read by a purchaser.

Section 2. The quantity statement shall conform with the United States Fair Packaging and Labeling Act of 15 USC 1451 through 1461.

Section 3.

1. The information required in the guaranteed analysis shall be listed in the following order:

A. Crude protein (minimum percentage);

B. Crude fat (minimum percentage);

C. Crude fiber (maximum percentage); and

D. Moisture (maximum percentage).

2. Additional guarantees shall follow moisture.

Section 4. The label of a pet food shall specify the name and address of the manufacturer, packer, or distributor. The statement shall include the street address unless the street address is shown in a current city directory or telephone directory of the city named on the label as the manufacturer's or distributor's address.

Section 5. If a person manufactures, packages, or distributes a pet food in a place other than his principal place of business, the label may state either address if it is not misleading.

Section 6. A vignette, graphic, or pictorial representation of a product on a pet food label shall not misrepresent the contents of the package.

Section 7. The word "proven" shall not be used in connection with a label claim for a pet food unless scientific or other empirical evidence substantiating the claim is available.

Section 8. A statement shall not appear upon the label of a pet food that makes a false or misleading comparison between that pet food and another pet food.

Section 9. A personal or commercial endorsement may be included on a pet food label if the endorsement is:

1. Factual; and

2. Not misleading.

Section 10. If a pet food intended for retail sale is enclosed in an outer container or wrapper, all required label information shall appear on the outside wrapper or container.

Section 11. The words "dog food," "cat food" or a similar designation shall appear conspicuously upon the principal display panel of the pet food label.

Section 12. The label of a pet food shall not contain an unqualified claim that the pet food, or recommended feeding of the pet food, is a complete, perfect, scientific or balanced ration for dogs or cats unless the product or feeding:

1.

A. Meets the nutrient requirements for all life stages established by the Association of American Feed Control Officials (AAFCO) Dog or Cat Food Nutrient Profiles, as contained in the Official Publication; or

B. Has had adequate testing to demonstrate the stated capabilities if:

1. A product ingredient provides a nutrient in an amount that substantially deviates from the established nutrient requirements; or

2. The stated capability has not been established by AAFCO; and

2. Contains a combination of ingredients which when fed to a normal animal as the only source of nourishment in accordance with the testing procedures established by AAFCO, meets the criteria of the testing procedures for the appropriate life stage.

Section 13. A label for a product formulated for or suitable for a limited purpose, such as feeding of puppies, shall state that the product, or its recommended feeding, meets the requirements of a complete, perfect, scientific or balanced ration for dogs or cats if:

1. Accompanied by a statement of the limited purpose for which the product is intended or suitable positioned on the same panel and in the same size, style and color print; and

2. An affidavit is provided upon request of the director substantiating that the pet food:

A. Meets the nutrient requirements established by the AAFCO Dog or Cat Food Nutrient Profiles; or

B. Has had its capabilities for the limited or qualified purpose demonstrated by adequate testing.

Section 14. Except as specified by 12 KAR 3:017, Section 1, the name of an ingredient on the label, other than in the product name shall:

1. Not be given undue emphasis so as to create the impression that it is present in a larger amount than is the fact;

2. Constitute at least three (3) percent of the total ingredients, excluding water sufficient for processing, if preceded by the designation "with" or a similar term;

3. Be in the same size, style and color print; and

4. Appear in the order of the ingredient's predominance by weight in the product if the names of more than one (1) ingredient are shown.

Section 15. The label of a dog or cat food, other than one (1) prominently identified as a snack or treat, shall bear on the principal display panel or the information panel as defined in 21 CFR 501.1 and 501.2 in type of a size reasonably related to the largest type on the panel, a statement of the nutritional adequacy or purpose of the product. The statement shall:

1. Consist of one (1) of the following:

A. A claim that the pet food meets the nutritional requirements of one (1) or more of the recognized life-stage categories, which shall include gestation, lactation, growth, maintenance, or complete for all life stages. The claim shall be stated as one (1) of the following:

1. (Insert name of product) is formulated to meet the nutritional levels established by the AAFCO (dog or cat) Food Nutrient Profiles for (insert life-stage category; or

2. Animal feeding tests using AAFCO procedures substantiate that (insert name of product) provides complete and balanced nutrition for (insert life-stage category);

B. A nutrition or dietary claim for purposes other than those listed in Sections 12 and 13 of this administrative regulation, if the claim is scientifically substantiated; or

C. The statement, "this product is intended for intermittent or supplemental feeding only", if the product does not meet either the requirements of Section 12 or 13 of this administrative regulation or other special nutritional or dietary need; and

2. If the product is intended for use by or under the supervision of direction of a veterinarian, the statement "use only as directed by your veterinarian".

Section 16. A claim on a pet food label that states:

1. "Improved" or "new" shall be:

A. Substantiated by the manufacturer; and

B. Limited to six (6) months of production; or

2. A preference or comparative attribute shall be:

A. Substantiated by the manufacturer; and

B. Limited to one (1) year of production, after which the claim shall be removed or resubstantiated.

Section 17. Dog and cat food labeled as complete and balanced for a life stage, except a pet food labeled in accordance with Section 15(2) of this administrative regulation, shall list feeding directions on the label. These directions shall be expressed in common terms and appear prominently on the label. Feeding directions shall, at a minimum, state, "feed (weight or unit of product) per (weight unit) of dog (or cat)".

Section 18. Incorporation by Reference.

1. "Official Publication", (1998 Edition), Association of American Feed Control Officials, is incorporated by reference.

2. This material may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (AES-2 (1973)-PF 2; 1 Ky.R. 1001; eff. 6-11-75; Am. 23 Ky.R. 1613; eff. 1-10-97; 25 Ky.R. 1088; 2359; eff. 4-14-99.)

RELATES TO: KRS 250.501, 250.521, 250.531
STATUTORY AUTHORITY: KRS 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for efficient enforcement of KRS 250.491 to 250.631. This administrative regulation establishes the conditions for use of a brand or product name.

Section 1.

1. A flavor designation shall:

A. Not be used on a pet food label unless the flavor is:

1. Detectable by a recognized test method; or

2. Distinguishable by the pet; and

B. Conform to the name of its source as shown in the ingredient statement. The word "flavor" shall be printed in the same size type and equally conspicuous as the ingredient term from which the flavor is derived.

2. A distributor shall supply verification of the designated or claimed flavor upon request of the director.

Section 2. The designation "100 percent" or "all" or words of similar connotation shall not be used in the brand or product name of a pet food if it contains more than one (1) ingredient. Water sufficient for processing, a required decharacterizing agent or trace amount of a preservative or a condiment shall not be considered an ingredient.

Section 3. The terms "meat" or "meat by-products" shall be qualified to designate the animal or animals from which the meat or meat by-products are derived, unless the meat is from cattle, swine, sheep, or goats.

Section 4. The name of the pet food shall not be derived from one (1) or more ingredients of a mixture to the exclusion of the other ingredients, except as specified by Sections 1, 5, and 6 of this administrative regulation. If an ingredient or combination of ingredients is intended to impart a distinctive characteristic that is important to the purchaser, the name of that ingredient or combination of ingredients may be used as a part of the name of the pet food if:

1. The ingredient or combination of ingredients is present in sufficient quantity to impart a distinctive characteristic to the product or is present in an amount which has a significant bearing upon the price of the product or upon acceptance of the product by the purchaser;

2. The name does not imply that the ingredient or combination of ingredients is present to the exclusion of other ingredients; and

3. The name is not false or misleading.

Section 5. If an ingredient or a combination of ingredients derived from animals, poultry, or fish constitutes ninety-five (95) percent or more of the total weight of a pet food, the name or names of the ingredient or ingredients may be a part of the product name. If more than one (1) ingredient is part of the product name, all of the ingredient names shall be in the same size, style and color print. Water sufficient for processing shall be excluded when calculating the percentage of the ingredients. The named ingredients shall constitute at least seventy (70) percent of the total product.

Section 6.

1. If an ingredient or a combination of ingredients constitutes at least twenty-five (25) percent but less than ninety-five (95) percent of the total weight of a pet food, the name or names of the ingredient or ingredients may form a part of the name of the pet food if:

A. Each of the ingredients constitutes at least three (3) percent of the product weight excluding sufficient water for processing; and

B. The product name:

1. Includes a primary descriptive term such as "dinner", "platter", or similar designation; and

2. Describes the contents of the product without being misleading.

2. If the names of more than one (1) ingredient are shown, they shall appear in the order of their predominance by weight.

3. An ingredient name and the primary descriptive term shall be in the same size, style and color print.

4. Water sufficient for processing shall be excluded when calculating the percentage of the ingredients. The named ingredients shall constitute at least ten (10) percent of the total product.

Section 7. A contraction or coined name referring to an ingredient shall not be used in the brand name of a pet food unless it s in compliance with Sections 1, 4, 5, or 6 of this administrative regulation. (AES-2 (1973)-PF 3; 1 Ky.R. 1002; eff. 6-11-75; Am. 23 Ky.R. 1615; eff. 1-10-97; 25 Ky.R. 1090; 2361; eff. 4-14-99.)

RELATES TO: KRS 250.501, 250.521
STATUTORY AUTHORITY: KRS 250.521(1)(b), 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for efficient enforcement of KRS 259.491 to 250.631. KRS 250.521(1)(b) requires that a commercial feed label contain a guaranteed analysis that advises the purchaser of the composition of the feed or to support claims made in the labeling. This administrative regulation establishes a uniform format for expressing guarantees for pet foods.

Section 1. A guaranteed analysis shall not be expressed as a range, such as "protein 15-18 percent".

Section 2.

1. The label of a pet food that is a mineral supplement shall include in the guaranteed analysis the minimum:

A. And maximum percentages of calcium;

B. Percentage of phosphorous;

C. And maximum percentages of added salt; and

D. Content of all other essential nutrient elements recognized by the Association of American Feed Control Officials (AAFCO) Dog or Cat Food Nutrient Profile.

2. Each element shall be stated using the unit of measurement identified in the Nutrient Profile, except that:

A. A product labeled with a quantity statement in units of tablets, capsules, granules, or liquid measures may express the mineral guarantees in milligrams (mg) per unit. The unit shall be consistent with the unit used in the quantity statement or directions for use; and

B. A liquid expressed as a volume shall list a weight equivalent, with one (1) fluid ounce equal to twenty-eight (28) grams.

Section 3. The guaranteed analysis on a pet food label shall state the vitamin content as follows:

1. For Vitamin A, D, or E, in international units per kilogram (IU/kg);

2. For Vitamin B₁₂, in milligrams per kilogram (mg/kg) or in micrograms per kilogram (ug/kg); or

3. For all other vitamins, in milligrams per kilogram (mg/kg).

Section 4. A vitamin supplement shall guarantee the minimum content of each vitamin declared in the ingredient statement. A vitamin guarantee shall be stated using the unit of measurement required by Section 3 of this administrative regulation; or per quantity unit (tablet, capsule, granule, or liquid measure) consistent with the quantity statement or directions for use. A liquid expressed as a volume shall list a weight equivalent, with one (1) fluid ounce equal to twenty-eight (28) grams.

Section 5.

1. A comparison may be stated using the units of measurement used by AAFCO if the label:

A. Does not claim that the pet food is a vitamin or mineral supplement; and

B. Includes a table comparing a typical analysis of the vitamin, mineral, or nutrient content with the levels recommended in the AAFCO Dog or Cat Food Nutrient Profile.

2. The statement in a table of comparison of the vitamin, mineral, or nutrient content shall:

A. Constitute a guarantee; and

B. Appear on the label separate from the guaranteed analysis.

Section 6.

1. Except as provided in subsection (2) of this section, a percentage or other reference to a nutrient level established by the AAFCO Dog or Cat Food Nutrient Profile shall not be used on a pet food label.

2. A direct comparison between the individual nutrient contents and the recommended nutrient profile may be made if the comparison is:

A. Expressed in the same quantitative units; and

B. Preceded by a statement that the product meets the nutrient profile recommended by AAFCO.

Section 7. A guarantee for crude protein, crude fat, or crude fiber shall not be required if:

1. The pet food is intended for a purpose other than to furnish that substance; and

2. The substance is of minor significance to the primary purpose of the product, such as a mineral or vitamin supplement.

Section 8. Incorporation by Reference.

1. "Official Publication," (1998 Edition), Association of American Feed Control Officials, is incorporated by reference.

2. This material may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (AES-2 (1973)-PF 4; 1 Ky.R. 1002; eff. 6-11-75; Am. 23 Ky.R. 1616; eff. 1-10-97; 25 Ky.R. 898; 2362; eff. 4-14-99.)

RELATES TO: KRS 250.501, 250.521
STATUTORY AUTHORITY: KRS 250.521(1)(c), 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for efficient enforcement of KRS 250.491 to 250.631. KRS 250.521(1)(c) requires that a commercial feed label list the common or usual name of each ingredient used in the manufacture of a commercial feed, unless the director promulgates an administrative regulation permitting the use of a collective term for a group of ingredients. This administrative regulation establishes the maximum moisture content allowed and the required format for listing ingredients on the label of pet foods.

Section 1.

1. Except as provided in subsection (2) of this section, the maximum moisture in pet food shall be guaranteed and shall not exceed seventy-eight (78) percent by weight or the natural moisture content of the constituent ingredients of the product, whichever is greater.

2. Pet food that consists principally of stew, gravy, sauce, broth, juice or a milk replacer, which is so labeled, may contain moisture in excess of seventy-eight (78) percent.

Section 2. Each ingredient of the pet food shall be:

1. Listed in the ingredient statement;

2. Shown in letters or type of the same size;

3. Listed in descending order by the ingredient’s predominance by weight; and

4. Identified by the:

A. Name of the ingredient as established by the Association of American Feed Control Officials, if a name and definition has been established; or

B. Common or usual name of the ingredient, if a name and definition has not been established. A brand or trade name shall not be used in the ingredient statement.

Section 3. The term "dehydrated" may precede the name of an ingredient if it has been artificially dried.

Section 4. A reference to the quality or grade of an ingredient shall not appear in the ingredient statement unless the:

1. Designation of quality, nature, form, or other attribute of an ingredient is accurate; and

2. Ingredient imparts a distinctive characteristic to the pet food.

Section 5. Incorporation by Reference.

1. "Official Publication", (1998 Edition), Association of American Feed Control Officials, is incorporated by reference.

2. This material may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (AES-2 (1973)-PF 5; 1 Ky.R. 1003; eff. 6-11-75; Am. 23 Ky.R. 1617; eff. 1-10-97; 25 Ky.R. 899; 2363; eff. 4-14-99.)

RELATES TO: KRS 250.491 to 250.631
STATUTORY AUTHORITY: KRS 250.571

NECESSITY, FUNCTION, AND CONFORMITY: To ensure that special purpose pet food products have adequate labeling to provide for safe use.

Section 1. The label of a pet food product which is suitable only for intermittent or supplemental feeding or for some other limited purpose should:

1. Bear a clear and conspicuous disclosure to that effect; or

2. Contain specific feeding directions which clearly state that the product should be used only in conjunction with other foods. (AES-2 (1973)-PF 6; 1 Ky.R. 1003; eff. 6-11-75.)

RELATES TO: KRS 250.501, 250.511, 250.541(1)(a), (b), (c), (d), (e), (f), (j), (2)(c), (d), (e), 21 CFR Parts 70, 71, 73, 74, 80, 81, 82, 501.22, 570.3(1), 570.30, 582, 21 USC 360(b)
STATUTORY AUTHORITY: KRS 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for efficient enforcement of KRS 250.491 to 250.631. KRS 250.541 defines adulterated commercial feeds and states how they may be adulterated by additives. KRS 250.551(1) and (2) prohibits the manufacturing and distribution of adulterated products as animal feeds. This administrative regulation establishes requirements to ensure that a drug or additive used in pet food is safe and effective for its intended purpose.

Section 1. An artificial color may be used in a pet food if it has been shown to be harmless to pets. The permanent or provisional listing of an artificial color in 21 CFR 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 be satisfactory evidence that the color is harmless to 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. Satisfactory evidence of the safety and efficacy of a pet food shall be:

1. If the pet food contains an additive that conforms to 21 CFR 570.3(1), 570.30, or Part 582; or

2. If the pet food is a drug as defined in 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 subject to an application approved by the Food and Drug Administration under 21 USC 360(b).

Section 3. The medicated labeling format recommended by the Association of American Feed Control Officials in its Official Publication shall be used to insure that adequate labeling is provided.

Section 4. Incorporation by Reference.

1. "Official Publication", (1998 Edition), Association of American Feed Control Officials, is incorporated by reference.

2. This material may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (AES-2 (1973)-PF 7; 1 Ky.R. 1003; eff. 6-11-75; Am. 23 Ky.R. 1618; eff. 1-10-97; 25 Ky.R. 900; 2364; eff. 4-14-99.)

RELATES TO: KRS 250.501, 250.521
STATUTORY AUTHORITY: KRS 250.571(1)

NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for efficient enforcement of KRS 250.491 to 250.631. This administrative regulation establishes a uniform procedure for determining the caloric content of dog and cat foods and expressing it on product labels.

Section 1. If the label of a dog or cat food bears a statement of calorie content, all of the following requirements shall be met:

1. The caloric statement shall be separate from the guaranteed analysis and shall appear under the heading "Calorie Content".

2. The statement shall be:

A. In terms of metabolizable energy (ME);

B. On an as-fed basis; and

C. Expressed as:

1. "Kilocalories per kilogram" (kcal/kg) of product; or

2. Kilocalories (kcal) per familiar household measure, which shall be a can, cup, pound, or similar designation.

3. An affidavit shall be provided upon request of the director, substantiating that the calorie content was determined by the method established in paragraph (a) or (b) of this subsection:

A. Calculation using the Modified Atwater formula:

ME (kcal/kg) = 10 ((3.5 x CP) + (8.5 x CF) + (3.5 x NFE))

where CP = % crude protein as fed, CF = % crude fat as fed, NFE = % nitrogen-free extract (carbohydrate) as fed, and the percentages of CP and CF are the arithmetic averages from proximate analyses of at least four (4) production batches of the product and the NFE is calculated as the difference between 100 and the sum of CP, CF, and the percentages of crude fiber, moisture, and ash (determined in the same manner as CP and CF). The results of all the analyses used in the calculation shall accompany the affidavit, and the claim on the label shall be followed parenthetically by the word 'calculated'; or

B. Testing using the procedure established by the Association of American Feed Control Officials in the Official Publication. The summary data used in the determination of calorie content shall accompany the affidavit. The value stated on the label shall not exceed or understate the value determined by the Modified Atwater formula by more than fifteen (15) percent.

4. A comparative claim shall:

A. Not be false, misleading or given undue emphasis; and

B. Be based on the same methodology for all products compared.

Section 2. Incorporation by Reference.

1. "Official Publication", (1998 Edition), Association of American Feed Control Officials, is incorporated by reference.

2. This material may be inspected, copied, or obtained at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m. (23 Ky.R. 1810; eff. 1-10-97; Am. 25 Ky.R. 1091; 2364; eff. 4-14-99.)