TITLE 8: AGRICULTURE AND ANIMALS
CHAPTER I: DEPARTMENT OF AGRICULTURE
SUBCHAPTER d: FEED
PART 200 COMMERCIAL FEED ACT


SUBPART A: COMMERCIAL FEED (EXCEPT PET FOOD)

Section 200.10 Brand and Product Names (Repealed)

Section 200.15 Definition of Terms

Section 200.20 Expression of Guarantees (Repealed)

Section 200.25 Label Format

Section 200.30 Definitions, Sampling and Analysis (Repealed)

Section 200.35 Brand and Product Names

Section 200.40 Ingredient Statement (Repealed)

Section 200.45 Expression of Guarantees

Section 200.50 Labeling (Repealed)

Section 200.55 Ingredients

Section 200.60 Minerals (Repealed)

Section 200.65 Directions for Use and Precautionary Statements

Section 200.70 Urea (Repealed)

Section 200.75 Non-Protein Nitrogen

Section 200.80 Artificial Color (Repealed)

Section 200.85 Drug and Feed Additives

Section 200.90 Registration of Commercial Feeds Containing Drugs, Artificial Color, Etc. (Repealed)

Section 200.95 Adulterants

Section 200.100 Weed Seeds in Concentrated Commercial Feeding Stuffs (Repealed)

Section 200.110 Administrative Rules (Repealed)


SUBPART B: PET FOOD

Section 200.120 Definitions

Section 200.130 Label Format and Labeling

Section 200.140 Brand and Product Names

Section 200.150 Expression of Guarantees

Section 200.160 Ingredients

Section 200.170 Drugs and Pet Food Additive


SUBPART C: GENERAL REQUIREMENTS

Section 200.200 Payment of Inspection Fee

Section 200.210 Firm License

Section 200.220 Administrative Rules


AUTHORITY: Implementing and authorized by the Illinois Commercial Feed Act of 1961 (Ill. Rev. Stat. 1991, ch. 56½, par. 66.1 et seq.).


SOURCE: Rules and Regulations Relating to the Illinois Commercial Feed Act, filed December 22, 1961, effective January 1, 1962; amended November 25, 1970, effective December 5, 1970; amended March 26, 1976, effective April 5, 1976; codified at 5 Ill. Reg. 10511; amended at 6 Ill. Reg. 14804, effective November 18, 1982; amended at 16 Ill. Reg. 15889, effective September 30, 1992.


SUBPART A: COMMERCIAL FEED (EXCEPT PET FOOD)

 

Section 200.10  Brand and Product Names (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.15  Definition of Terms

 

"AAFCO" means the Association of American Feed Control Officials which is adopted in Section 10 of the Act.

 

"Act" means the Illinois Commercial Feed Act of 1961 (Ill. Rev. Stat. 1991, ch. 56½, par. 66.1 et seq.).

 

"Commercial feed" means all materials, including customer formula feeds, which are distributed for use as feed, or labeled with a guaranteed analysis for use as feed, or for mixing in feed for birds or animals other than man (Section 3(d) of the Act).

 

The following commodities are hereby declared exempt from the definition of commercial feed under the provisions of Section 3(d) of the Act:   hay, straw, stover, silages, cobs, husks, and hulls when unground and when not mixed with other materials (Section 3(d) of the Act).

 

Individual chemical compounds and substances are hereby declared exempt from the definition of Commercial Feed under the provision of Section 3(d) of the Act when it has been determined that these products meet the following criteria:

 

There is an adopted AAFCO definition for the product.

 

The product is either GRAS or is not covered by a specific FDA Regulation.

 

The product is either a natural occurring product of uniform chemical composition or is manufactured to meet the AAFCO definition of the product.

 

Additives which are intended to impart special desirable characteristics (e.g., cheese flavoring) shall be permitted.

 

No apparent problems have been noted with the control of this product.

 

Loose salt is exempt from the definition of commercial feed.

 

"FDA" means United States Food and Drug Administration.

 

"GRAS" means generally recognized as safe by the United States Food and Drug Administration.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.20  Expression of Guarantees (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.25  Label Format

 

a)         Commercial feed, other than customer-formula feed, shall be labeled with the information prescribed in this Section on the principal display panel of the product and in the following general format:

 

1)         Net Weight (may be stated in metric units in addition to the required avoirdupois units).

 

2)         Product name and brand name, if any.

 

3)         If a drug is used:

 

A)        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.

 

B)        The purpose of the medication (claim statement).

 

C)        An active drug ingredient statement listing the active drug ingredients by their established name and the amounts in accordance with Section 200.45(d).

 

4)         Directions for use and precautionary statements or reference to their location if the detailed feeding directions and precautionary statements required by Sections 200.65 and 200.75 appear elsewhere on the label.

 

5)         The guaranteed analysis of the commercial feed which shall include the following items, unless exempted in subsection J of this Section, and they shall appear in the order as listed:

 

A)        Minimum percentage of crude protein.

 

B)        Maximum or minimum percentage of equivalent protein from non-protein nitrogen as required in Section 200.45(e).

 

C)        Minimum percentage of crude fat.

 

D)        Maximum percentage of crude fiber.

 

E)        Minerals in commercial feeds shall be listed in the following order:

 

i)          minimum and maximum percentages of calcium,

 

ii)         minimum percentage of phosphorus,

 

iii)        minimum and maximum percentages of salt, and

 

iv)        maximum or minimum percentages of other minerals.

 

F)         Minerals in feed ingredients shall be those as specified by the official definitions of the Association of American Feed Control Officials which is adopted in Section 10 of the Act.

 

G)        Vitamins in such terms as specified in Section 200.45(c).

 

H)        Total percentages of sugars as invert on dried molasses products or products being sold primarily for their sugar content.

 

I)         Viable lactic acid producing microorganisms for use in silages in terms specified in Section 200.45(g).

 

J)         Exemptions:

 

i)          A mineral guarantee is not required when the feed or feed ingredient is not represented as or does not serve as a principal source of that mineral to the animal or where the commercial feed contains less than a total of 6.5% calcium, phosphorous or salt.

 

ii)         Guarantees for vitamins are not required when the commercial feed is neither formulated for nor represented in any manner as a vitamin supplement.

 

iii)        Guarantees for crude protein, crude fat, and crude fiber are not required when the commercial feed is intended for purposes other than to furnish these substances relating to the primary purpose of the product, e.g. such as drug premixes, mineral or vitamin supplements, and molasses.

 

iv)        Guarantees for microorganisms are not required when the commercial feed is intended for a purpose other than to furnish these substances relating to the primary purpose of the product, and no specific label claims are made.

 

6)         Feed ingredients or collective terms for the grouping of feed ingredients as required by Section 5(a)(4) of the Act.

 

A)        The common or usual name of each ingredient as defined in the Official Publication of the Association of American Feed Control Officials, which is adopted in Section 10 of the Act.

 

B)        Collective terms for the grouping of feed ingredients as defined in the Official Definitions of Feed Ingredients published in the Official Publication of the Association of American Feed Control Officials may be used in lieu of the individual ingredients provided that:

 

i)          when a collective term for a group of ingredients is used on the label, individual ingredients within that group shall not be listed on the label; and

 

ii)         the manufacturer shall provide the Director, upon request, with a list of individual ingredients, within a defined group, that are or have been used in the commercial feed.

 

7)         Name and principal mailing address of the manufacturer or person responsible for distributing the commercial feed. The principal mailing address shall include the city, state, and zip code.

 

8)         The information required by Section 5(a)(1) through (5) of the Act shall appear in its entirety on one side of the label.  The information required by Section 5(a)(6) and (7) of the Act shall be displayed in a prominent place on the label but not necessarily on the same side as the information required by Section 5(a)(1) through (5) of the Act. When the information required by Section 5(a)(6) and (7) of the Act is placed on a different side of the label, it must be referenced on the front side with a statement such as "See back of label for directions for use." None of the information required by Section 5 of the Act shall be subordinated or obscured by other statements or designs.

 

b)         Customer-formula feed shall be accompanied by a label, invoice, delivery ticket, or other shipping document bearing the following information:

 

1)         The name and address of the manufacturer.

 

2)         The name and address of the purchaser.

 

3)         The date of sale or delivery.

 

4)         The customer-formula product name and brand name, if any.

 

5)         The product name and net weight of each registered commercial feed and each other feed ingredient used in the mixture.

 

6)         The directions for use and precautionary statements as required by Sections 200.65 and 200.75.

 

7)         If a product containing a drug is used:

 

A)        The purpose of the medication (claim statement).

 

B)        The established name of each active drug ingredient and the level of each drug used in the final mixture expressed in accordance with Section 200.45(d).

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.30  Definitions, Sampling and Analysis (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.35  Brand and Product Names

 

a)         The brand or product name shall be appropriate for the intended use of the feed and shall not be misleading.  If the name indicates the commercial feed is made for a specific use, the character of the feed shall conform therewith.  A mixture labeled "Dairy Feed," for example, must be suitable for that purpose.

 

b)         Commercial, registered brand or trade names are not permitted in guarantees or ingredient listings.  Brand or trade names shall only appear in the product name of the feed produced by or for the firm holding the rights to such a name.

 

c)         The name of a commercial feed shall not be derived from one or more ingredients of a mixture to the exclusion of other ingredients and the name shall not be one representing any components of a mixture, unless all components are included in the name:  provided, that if any ingredient or combination of ingredients is intended to impart a distinctive characteristic to the product, the name of that ingredient or combination of ingredients may be used as a part of the brand name or product name if the ingredients or combination of ingredients is quantitatively guaranteed in the guaranteed analysis, and the brand or product name is not otherwise false or misleading.

 

d)         The word "protein" shall not be permitted in the product name of a commercial feed that contains added non-protein nitrogen.

 

e)         When the name carries a percentage value, it shall be understood to signify protein, or equivalent protein content only, or both, even though it may not explicitly modify the percentage with the word "protein":  provided, that other  percentage values may be permitted if they are followed by the identifying description.  Digital numbers shall not be used in such a manner as to be misleading or confusing to the customer.

 

f)         A single ingredient feed shall have a product name in accordance with the designated definition of the feed ingredient as recognized by the Association of American Feed Control Officials as adopted in Section 10 of the Act.

 

g)         The word "vitamin," or a contraction thereof, or any word suggesting vitamin can be used only in the name of a commercial feed which is represented to be a vitamin supplement, and which is labeled with the minimum content of each vitamin declared, as specified in Section 200.45(c).

 

h)         The term "mineralized" shall not be used in the name of a commercial feed except for "trace mineralized salt". Trace mineralized salt shall contain amounts of trace minerals which are essential for animal nutrition.

 

i)          The term "meat" and "meat by-products" shall be qualified to designate the animal from which the meat and meat by-products are derived, unless the meat and meat by-products are from cattle, swine, sheep or goats.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.40  Ingredient Statement (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.45  Expression of Guarantees

 

a)         The guarantees for crude protein, equivalent protein from non-protein nitrogen, crude fat, crude fiber and mineral guarantees, when required by Section 200.25(a)(5) and subsection (f) of this Section, shall be in terms of percentage.

 

b)         Commercial feeds containing 6.5% or more calcium, phosphorus, sodium and chloride shall include in the guaranteed analysis the minimum and maximum percentages of calcium (Ca), the minimum percentage of phosphorus (P), and if salt is added, the minimum and maximum percentages of salt (NaCl).  Minerals, except salt (NaCl), shall be guaranteed in terms of percentage of the elements.

 

1)         When a calcium or salt guarantee is given in the guaranteed analysis, guarantee shall be stated and conform to the following:

 

A)        When the minimum guarantee is 5.0% or less, the maximum shall not exceed the minimum by more than one percentage point.

 

B)        When the minimum guarantee is above 5.0%, the maximum shall not exceed the minimum by more than 20% of the minimum and in no case shall the maximum exceed the minimum by more than five percentage points.

 

2)         When required by Section 200.25(a)(j), guarantees for minimum potassium, magnesium, sulfur and maximum fluorine shall be stated in terms of percentage. Other minimum mineral guarantees shall be stated in parts per million (ppm) when the concentration is less than 10,000 ppm and in percentage when the concentration is 10,000 ppm (1%) or greater.

 

c)         Guarantees for minimum vitamin content of commercial feeds shall be listed in the order specified and are stated in milligrams per pound (mg/lb) unless otherwise specified:

 

1)         Vitamin A, other than precursors of vitamin A, in International Units per pound.

 

2)         Vitamin D-3 in products offered for poultry feeding, in International Chick Units per pound.

 

3)         Vitamin D for other uses, in International Units per pound.

 

4)         Vitamin E, in International Units per pound.

 

5)         Concentrated oils and feed additive premixes containing vitamins A, D or E may, at the option of the distributor, be stated in units per gram instead of units per pound.

 

6)         Vitamin B-12, in milligrams or micrograms per pound.

 

7)         All other vitamin guarantees shall express the vitamin activity in milligrams per pound in terms of the following:  menadione; riboflavin; d-pantothenic acid; thiamine; niacin; vitamin B-6; folic acid, choline, biotin, inositol; p-amino benzoic acid; ascorbic acid; and carotene.

 

d)         Guarantees for drugs shall be stated in terms of percent by weight, except:

 

1)         Antibiotics, present at less than 2,000 grams per ton (total) of commercial feed, shall be stated in grams per ton.

 

2)         Antibiotics, present at 2,000 or more grams per ton (total) of commercial feed, shall be stated in grams per pound.

 

3)         Commercial feeds containing growth promotion or feed efficiency levels of antibiotics, which are to be fed continuously as the sole ration, are not required to have quantitative guarantees on the label, except as specifically required in the Federal Food Additive Regulations as adopted in Section 10 of the Act.

 

4)         The term "milligrams per pound" may be used for drugs or antibiotics in cases in which a dosage is given in "milligrams" in the feeding directions.

 

e)         Commercial feeds containing any added non-protein nitrogen shall be labeled as follows:

 

1)         For ruminants:

 

A)        Complete feeds, supplements, and concentrates containing added non-protein nitrogen and containing more than 5% protein from natural sources shall be guaranteed as follows:

 

Crude Protein, minimum, (insert number) % (This includes not more than (insert number) & equivalent protein from non-protein nitrogen).

 

B)        Mixed feed concentrates and supplements containing less than 5% protein from natural sources may be guaranteed as follows:

 

Equivalent Crude Protein from Non-Protein Nitrogen, minimum, (insert number) %

 

C)        Ingredient sources of non-protein nitrogen such as Urea, DiAmmonium Phosphate, Ammonium Polyphosphate Solution, Ammoniated Rice Hulls, or other basic non-protein nitrogen ingredients defined by the Association of American Feed Control Officials shall be guaranteed as follows:

 

Nitrogen, minimum, (insert number) %

 

Equivalent Crude Protein from Non-Protein Nitrogen, minimum, (insert number) %

 

2)         For non-ruminants:

 

A)        Complete feeds, supplements and concentrates containing crude protein from all forms of non-protein nitrogen, added as such, shall be labeled as follows:

 

Crude protein, minimum, (insert number) % (This includes not more than (insert number) % equivalent crude protein which is not nutritionally available to (species of animal for which feed is intended)).

 

B)        Premixes, concentrates or supplements intended for non-ruminants containing more than 1.25% equivalent crude protein from all forms of non-protein nitrogen, added as such, shall contain directions for use and a prominent statement:  "WARNING:  This feed must be used only in accordance with directions furnished on the label".

 

f)         Mineral phosphatic materials for feeding purposes shall be labeled with the guarantee for minimum and maximum percentage of calcium (when present), the minimum percentage of phosphorus, and the maximum percentage of fluorine.

 

g)         Guarantees for microorganisms shall be stated in colony forming units per gram (CFU/g) when directions are for using the product in grams, or in colony forming units per pound (CFU/lb) when directions are for using the product in pounds.  A parenthetical statement following the guarantee shall list each species in order of predominance.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.50  Labeling (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.55  Ingredients

 

a)         The name of each ingredient or collective term for the grouping of ingredients, when required by Section 200.25 to be listed, shall be the same as defined in the Official Definitions of Feed Ingredients as published in the Official Publication of the Association of American Feed Control Officials, which is adopted in Section 10 of the Act.

 

b)         The name of each ingredient shall be shown in letters or type of the same size.

 

c)         No reference to quality or grade of an ingredient shall appear in the ingredient statement of a feed.

 

d)         The term "dehydrated" may precede the name of any product that has been artificially dried.

 

e)         A single ingredient product defined by the Association of American Feed Control Officials, which is adopted in Section 10 of the Act, is not required to have an ingredient statement.

 

f)         Tentative definitions for ingredients shall not be used until adopted as official by the Association of American Feed Control Officials, unless no official definition exists or the ingredient has a common accepted name that requires no definition (e.g. sugar).

 

g)         When the word "iodized" is used in connection with a feed ingredient, the feed ingredient shall contain not less than 0.007% iodine, uniformly distributed.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.60  Minerals (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.65  Directions for Use and Precautionary Statements

 

a)         Directions for use and precautionary statements on the labeling of all commercial feeds and customer-formula feed containing additives (including drugs, special purpose additives, or non-nutritive additives) shall:

 

1)         be adequate to enable safe and effective use for the intended purposes by users with no special knowledge of the purpose and use of such articles; and

 

2)         include, but not be limited to, all information described by all applicable regulations under the Federal Food, Drug and Cosmetic Act as adopted in Section 10 of the Act.

 

b)         Directions for use and precautionary statements are required for feeds containing non-protein nitrogen as specified in Section 200.75.

 

c)         Directions for use and precautionary statements necessary for safe and effective use are required on commercial feeds distributed to supply particular dietary needs or for supplementing or fortifying the usual diet or ration with any vitamin, mineral, or other dietary nutrient or compound.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.70  Urea (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.75  Non-Protein Nitrogen

 

a)         Urea and other non-protein nitrogen products as defined in the Official Publication of the Association of American Feed Control Officials, which is adopted in Section 10 of the Act, are acceptable ingredients only in commercial feeds for ruminant animals as a source of equivalent crude protein.  If the commercial feed contains more than 8.75% of equivalent crude protein from all forms of non-protein nitrogen, added as such, or the equivalent crude protein from all forms of non-protein nitrogen, added as such, exceeds one-third of the total crude protein, the label shall bear directions for the safe use of feeds and a precautionary statement:  "Caution:  use as directed." The directions for use and the caution statement shall be in type of such size so placed on the label that they will be read and understood by ordinary persons under customary conditions of purchase and use.

 

b)         Non-protein nitrogen as defined in the Official Publication of the Association of American Feed Control Officials, which is adopted in Section 10 of the Act, when so indicated, are acceptable ingredients in commercial feeds distributed to non-ruminant animals as a source of nutrients other than equivalent crude protein.  The maximum equivalent crude protein from non-protein nitrogen sources when used in non-ruminant rations shall not exceed 1.25% of the total daily ration.

 

c)         On labels such as those for medicated feeds which bear feeding directions or warning statements, the presence of added non-protein nitrogen shall not require a duplication of the feeding directions or the precautionary statements as long as those statements include information to ensure the safe and effective use of this product due to the presence of non-protein nitrogen.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.80  Artificial Color (Repealed)

 

(Source:  Repealed at 6 Ill. Reg. 14804, effective November 18, 1982)

 

Section 200.85  Drug and Feed Additives

 

a)         Prior to approval of registration application or approval of a label for commercial feed which contain an additive (including drugs, other special purpose additives, or non-nutritive additives), the distributor shall 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.

 

b)         Satisfactory evidence of safety and efficacy of a commercial feed shall be:

 

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", "informal review sanctioned" or "generally recognized as safe" for such use by the FDA, or

 

2)         when the commercial feed is itself a drug as defined in Section 3(g) of the Act 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

 

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

 

4)         when the commercial feed is a direct fed microbial product and:

 

A)        The product meets the particular fermentation product definition;

 

B)        The microbial content statement, as expressed on the label, is limited to the following:  "Contains a source of live (viable) naturally occurring microorganisms.";

 

C)        The source is stated with a corresponding guarantee expressed in accordance with Section 200.45(g).

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.90  Registration of Commercial Feeds Containing Drugs, Artificial Color, Etc. (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.95  Adulterants

 

a)         For the purpose of Section 7(a)(1) of the Act, the terms "poisonous or deleterious substances" include, but are not limited to, the following:

 

1)         Fluorine and any mineral or mineral mixture which is to be used directly for the feeding of domestic animals and in which the fluorine exceeds 0.20% for breeding and dairy cattle; 0.30% for slaughter cattle; 0.30% for sheep; 0.35% for lambs; 0.45% for swine; and 0.60% for poultry.

 

2)         Fluorine bearing ingredients when used in such amounts that they raise the fluorine content of the total ration (exclusive of roughage) above the following amounts:  0.004% for breeding and dairy cattle; 0.009% for slaughter cattle; 0.006% for sheep; 0.01% for lambs; 0.015% for swine; and 0.03% for poultry.

 

3)         Fluorine bearing ingredients incorporated in any feed that is fed directly to cattle, sheep or goats consuming roughage (with or without) limited amount of grain, that results in a daily fluorine intake in excess of 50 milligrams of fluorine per 100 pounds of body weight.

 

4)         Soybean meal, flakes or pellets or other vegetable meals, flakes or pellets which have been extracted with trichlorethylene or other chlorinate solvents.

 

5)         Sulfur dioxide, sulfurous acid, and salts of sulfurous acid when used in or on feeds or feed ingredients which are reported to be a source of vitamin B1 (thiamine).

 

b)         All screenings or by-products of grains and seeds containing weed seeds, when used in commercial feed or sold as such to the ultimate consumer, shall be ground fine enough or otherwise treated to destroy the viability of such weed seeds so that the finished product contains no viable prohibited weed seeds, not more than 4 viable restricted weed seeds per pound, and not more than 50 per pound of other weed seed.  Prohibited and restricted weed seeds shall be those listed in 8 Ill. Adm. Code 230.20 and 230.30 of the rules adopted for the Illinois Seed Act.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.100  Weed Seeds in Concentrated Commercial Feeding Stuffs (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.110  Administrative Rules (Repealed)

 

(Source:  Repealed at 16 Ill. Reg. 15889, effective September 30, 1992)


SUBPART B: PET FOOD

 

Section 200.120  Definitions

 

The definitions that appear in Section 200.15 shall apply to the provisions of this Subpart.  In addition, the following terms are defined for the purposes of this Subpart:

 

            "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.

 

            "Information Panel" means the part of the label immediately contiguous and to the right of the principal display panel as prescribed in 21 CFR 501.2 (1992).

 

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

 

            "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 as prescribed in 21 CFR 501.1 (1992).

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.130  Label Format and Labeling

 

a)         The statement of net content and product name shall be shown on the principal display panel.  All other required information may be placed elsewhere on the label but shall be conspicuous as to render it easily read under ordinary conditions of purchase and sale.

 

b)         The declaration of the net content shall be made in conformity with the Illinois Weights and Measures Act (Ill. Rev. Stat. 1991, ch. 147, par. 101 et seq.).

 

c)         The information which is required to appear in the "Guaranteed Analysis" shall be listed in the following order:

 

1)         Crude protein (Minimum Percent)

 

2)         Crude fat (Minimum Percent)

 

3)         Crude fiber (Maximum Percent)

 

4)         Moisture (Maximum Percent)

 

5)         Additional guarantees, if any, shall follow moisture.

 

d)         The label of a pet food shall specify the name and address of the manufacturer, packer or distributor of the pet food.

 

e)         If a person manufactures, packages, or distributes a pet food in a place other than the principal place of business, the label may state the principal place of business in lieu of the actual place where each package of such pet food was manufactured or packaged or is to be distributed, if such statement is not misleading in any particular.

 

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

 

g)         The use of the word "proven" in connection with label claims for a pet food is not permitted unless scientific or other empirical evidence establishing the claim represented as "proven" is available.

 

h)         No statement shall appear upon the label of a pet food which makes false or misleading comparisons between that pet food and any other pet food.

 

i)          Personal or commercial endorsements are permitted on pet food labels where said endorsements are factual and not otherwise misleading.

 

j)          When a pet food is enclosed in any outer container or wrapper which is intended for retail sale, all required label information shall appear on such outside container or wrapper.

 

k)         The words "Dog Food", "Cat Food", or similar designations shall appear conspicuously upon the principal display panel of the pet food label.

 

l)          The label of a pet food shall not contain an unqualified representation or claim that the pet food is or meets the requisites of a complete, perfect, scientific or balanced ration for dogs or cats unless such product:

 

1)         contains ingredients in quantities sufficient to provide the estimated nutrient requirements for all stages of the life of a dog or cat which have been determined by the AAFCO Pet Food Nutrient Profile, as adopted in Section 10 of the Act; or

 

2)         contains a combination of ingredients which when fed to a normal animal as the only source of nourishment shall provide for fertility, gestation and lactation of females, normal growth from weaning to maturity without supplemental feeding, and will maintain the normal weight of an adult animal whether working or at rest and has had its capabilities demonstrated by testing.

 

m)        Labels for products which are compounded for or which are suitable for only a limited purpose (i.e., a product designed for the feeding of puppies) may contain representations (e.g., "complete food for puppies") stating that the product meets the requisites of a complete, perfect, scientific or balanced ration for dogs or cats only if:

 

1)         Such representations and the required qualification shall appear on the same panel and in the same size, style and color print; and

 

2)         The pet food contains:

 

A)        ingredients in quantities sufficient to satisfy the estimated nutrient requirements as determined by AAFCO and adopted in Section 10 of the Act; or

 

B)        a combination of ingredients which when fed for such limited purpose shall satisfy the nutrient requirements for such limited purpose and has had its capabilities demonstrated by testing.

 

n)         Except as specified by Section 200.140(a), the name of any ingredient which appears on the label, other than in the product name, shall not be given emphasis so as to create the impression that such an ingredient is present in the product in a larger amount than is the fact, shall constitute at least 3% of the total ingredients (exclusive of water sufficient for processing) when preceded by the designation "with" or like term, and shall be in the same size, style and color print.  If the names of more than one such ingredient are shown, they shall appear in the order of their respective predominance by weight in the product.

 

o)         The label of a dog or cat food, other than one prominently identified as a snack or treat as part of the designation required upon the principal display panel under subsection (k) of this Section shall bear, on either the principal display panel or the information panel in type of the same size as the largest type on the panel, a statement of the nutritional adequacy or purpose of the product. Such statement shall consist of one of the following:

 

1)         A claim that the pet food meets or exceeds the requirements of one or more of the recognized categories of nutritional adequacy (i.e., gestation, lactation, growth, maintenance, and complete for all life stages) in accordance with subsection (l) and (m) of this Section.

 

2)         A nutrition or dietary claim for purposes other than those listed in subsections (l) and (m) of this Section if the claim is scientifically substantiated.

 

3)         The statement:  "This product is intended for intermittent or supplemental feeding only," if a product does not meet either the requirements of subsections (l) and (m) of this Section or any other special nutritional or dietary need and so is suitable only for limited or intermittent or supplementary feeding.

 

4)         The statement:  "Use only as directed by your veterinarian", if it is pet food product intended for use by, or under the supervision or direction of, a veterinarian and shall make a statement in accordance with subsections (o)(1) or (o)(3) above.

 

p)         The use of claims on pet food labels stating improvement or newness shall be substantiated by the manufacturer and limited to six months production.  The use of claims stating preference or comparative attribute claims shall be substantiated by the manufacturer and limited to one (1) year production after which the claim must be removed or resubstantiated.

 

q)         Dog and cat foods labeled as complete and balanced for any or all life's stages as provided in subsection (o)(1) above, except those pet foods labeled in accordance with subsection (o)(4) above, shall list feeding directions on the product label.  These directions shall be expressed in common terms and shall appear prominently on the label.  Feeding directions shall, at a minimum, state "Feed (weight/unit of product) per (weight unit) of dog (or cat)".

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.140  Brand and Product Names

 

a)         No flavor designation shall be used on a pet food label unless the designated flavor is detectable by test methods, as adopted in Section 9 of the Act.  Any flavor designation on a pet food label shall either conform to the name of its source as shown in the ingredient statement or the ingredient statement shall show the source of the flavor.  The word flavor shall be printed in the same size type and with an equal degree of conspicuousness as the ingredient term(s) from which the flavor designation is derived. Distributors of pet food employing such flavor designation or claims on the labels of the product distributed by them, shall upon written request, supply verification of the designated or claimed flavor to the Director.

 

b)         The designation "100%" 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 ingredient.  However, for the purpose of this provision, water sufficient for processing, decharacterizing agents and trace amounts of preservatives and condiments shall not be considered ingredients.

 

c)         The term "meat" and "meat by-products" shall be qualified to designate the animal from which the meat and meat by-products are derived unless the meat and meat by-products are from cattle, swine, sheep or goats.  For example, "horsemeat" and "horsemeat by-products."

 

d)         The name of the pet food shall not be derived from one or more ingredients of a mixture of a pet food product unless all components or ingredients are included in the name except as specified by subsection (a), (e) or (f) of this Section; provided that the name of an ingredient or combination of ingredients may be used as a part of the product name if:

 

1)         the ingredient or combination of ingredients is present in a quantity to impart a distinctive characteristic to the product;

 

2)         it does not constitute a representation that the ingredient or combination of ingredients is present to the exclusion of other ingredients; or

 

3)         it is not otherwise false or misleading.

 

e)         When an ingredient or a combination of ingredients derived from animals, poultry, or fish constitutes 95% or more of the total weight of all ingredients of a pet food mixture, the name or names of such ingredient(s) may form a part of the product name of the pet food; provided that where more than one ingredient is part of such product name, then all such 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 named ingredient(s). However, such named ingredient(s) shall constitute at least 70% of the total product.

 

f)         When an ingredient or a combination of ingredients constitutes at least 25% but less than 95% of the total weight of all ingredients of a dog or cat food mixture, the name or names of such ingredient or ingredients may form a part of the product name of the pet food if each of the ingredients constitutes at least 3% of the product weight excluding water used for processing and only if the product name also includes a primary descriptive term such as "dinner", "platter", or similar designation so that the product name describes the contents of the product so that the product name is not misleading.  If the names of more than one such ingredient are shown, they shall appear in the order of their respective predominance by weight in the product.  All such ingredient names and the primary descriptive term shall be in the same size, style and color print.  For the purpose of this provision, water sufficient for processing shall be excluded when calculating the percentage of the named ingredient(s).  However, such named ingredient(s) shall constitute at least 10% of the total product.

 

g)         Contractions or coined names referring to ingredients shall not be used in the brand name of a pet food unless it is in compliance with subsection (a), (d), (e), or (f) above.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.150  Expression of Guarantees

 

a)         The sliding scale method of expressing a guaranteed analysis (for example, "protein 15-18%") is prohibited.

 

b)         Pursuant to Section 5(a)(3) of the Act, the label of a pet food which is formulated as and represented to be a mineral supplement, shall include in the guaranteed analysis the minimum and maximum percentages of calcium, the minimum percentage of phosphorus and the minimum and maximum percentages of salt.  The minimum content of all other essential nutrient elements recognized by the AAFCO Dog or Cat Food Nutrient Profile, as adopted in Section 10 of the Act, from sources declared in the ingredient statement shall be expressed as the element in units specified in the recognized nutrient profile.

 

c)         The label of pet food which is formulated as and represented to be a vitamin supplement shall include a guarantee of the minimum content of each vitamin declared in the ingredient statement.

 

d)         Vitamins guaranteed on pet foods shall be stated in International Units per kilogram (IU/kg) for vitamins A, D, and E.  All other vitamins shall be stated in milligrams per kilogram (mg/kg) except vitamin B12 which may be guaranteed in micrograms per kilogram (mcg/kg).

 

e)         The vitamin potency of pet food products distributed in containers smaller than 1 lb. may be guaranteed in International Units (IU) per kilogram of weight for vitamins A, D, and E.  All other vitamins may be guaranteed in milligrams per kilogram of weight (mg/kg) except vitamin B12 which may be guaranteed in micrograms per kilogram (mcg/kg).

 

f)         If the label of a pet food does not represent the pet food to be either a vitamin or a mineral supplement, but does include a table of comparison of a typical analysis of the vitamin, mineral, or nutrient content of the pet food with levels determined by the AAFCO, as adopted in Section 10 of the Act, the statement in a table of comparison of the vitamin, mineral, or nutrient content shall constitute a guarantee, but need not be repeated in the guaranteed analysis.  Such table of comparison may appear on the label separate and apart from the guaranteed analysis.

 

g)         The use of percentages or words of similar import when referring to nutrient levels established by the AAFCO Pet Food Nutrient Profile, as adopted in Section 10 of the Act, shall not be permitted on pet food labels, except that such direct comparisons in whole or part of the individual nutrient contents of a pet food with those recommended by the recognized nutrient profile may be made where the comparisons are expressed in the same quantitative units as those used by the cited nutrient profile and,

 

1)         the product in question meets the nutrient profile determined by AAFCO, and

 

2)         the comparison is preceded by a statement to that effect.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.160  Ingredients

 

a)         The maximum moisture in all pet foods shall be guaranteed and shall not exceed 78.00% or the natural moisture content of the constituent ingredients of the product, whichever is greater.  Pet foods such as those consisting principally of stew, gravy, sauce, broth, juice or a milk replacer which are so labeled may contain moisture in excess of 78.00%.

 

b)         Each ingredient of the pet food shall be listed in the ingredient statement, and names of all ingredients in the statement shall be shown in letters or type of the same size.  The failure to list the ingredients of a pet food in descending order by their predominance by weight in non-quantitative terms shall be misleading.  Any ingredient for which the AAFCO has established a name and definition shall be identified by the name so established.  Any ingredient for which no name and definition has been so established shall be identified by the common or usual name of the ingredient.  Brand or trade names shall not be used in the ingredient statement.

 

c)         The term "dehydrated" may precede the name of any ingredient in the ingredient list that has been artificially dried.

 

d)         No reference to quality or grade of an ingredient shall appear in the ingredient statement of a pet food.

 

e)         No reference to the quality, nature, form, or other attribute of an ingredient shall be made unless such designation is accurate.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.170  Drugs and Pet Food Additive

 

a)         An artificial color may be used in a pet food only if it has been shown to be harmless to pets.  The permanent or provisional listing of an artificial color in the United States Food and Drug Regulations, as adopted in Section 10 of the Act, 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.

 

b)         Prior to approval of a registration application or approval of a label for pet food which contains additives (including drugs, other special purpose additives, or non-nutritive additives), the distributor shall submit evidence to prove the safety and efficacy of the pet food, when used according to directions furnished on the label.  Satisfactory evidence of the safety and efficacy of a pet food may be:

 

1)         when the pet food contains such additives, the use of which conforms to the requirements of the applicable regulations in the 21 CFR, or which are "prior sanctioned" or "generally recognized as safe" for such use, or

 

2)         when the pet food itself is a drug as defined in Section 3(g) of the Act and is generally recognized as safe and effective or is marketed subject to an application approved by the Food and Drug Administration under 21 U.S.C. 360(b).

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)


SUBPART C: GENERAL REQUIREMENTS

 

Section 200.200  Payment of Inspection Fee

 

The inspection fee as set forth in Section 6 of the Act is to be paid on all registered commercial feed shipped into Illinois or distributed in Illinois by the person who first distributes the commercial feed, except the inspection fee is not required on the first distribution if made to exempt buyers who shall become responsible for the fee.  Any person may request "exempt buyer" status from the Director by providing business information which indicates the person does 50% or more business as an interstate distributor or central buyer.  The Director shall grant exempt buyer status to persons doing 50% or more business as interstate distributors or central buyers.  A list of "exempted buyers" may be obtained from the Director.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.210  Firm License

 

Any person who manufactures feed in this State or whose name appears on the label shall register on forms furnished by the Department.  The following information is required:  the complete firm name, complete address of home office, phone number, and list of any and all additional facilities giving complete address of same which are operated under the same firm name and are registered under one firm license in the State of Illinois.  A facility operating under a name different from the home office is required to obtain a separate firm license.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)

 

Section 200.220  Administrative Rules

 

All decisions and actions of the Department are subject to the Illinois Administrative Procedure Act (Ill. Rev. Stat. 1991, ch. 127, par. 1-1001 et seq.) and the Department's Administrative Rules (8 Ill. Adm. Code 1) which pertain to administrative proceedings, administrative hearings, contested cases, petitions, and public disclosure of files.

 

(Source:  Added at 16 Ill. Reg. 15889, effective September 30, 1992)