Animal food labelling (21 CFR 501.1-501.18)

15 Food and Drug Administration, HHS § 501.1 12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 276–9120; or go to http://www.fda.gov/ AboutFDA/CentersOffices/OfficeofFoods/ CVM/CVMFOIAElectronicReadingRoom/ default.htm. You may inspect a copy at the Division of Dockets Management (HFA–305), Food and Drug Administra tion, 5630 Fishers Lane, Rm. 1061, Rock ville, MD 20852, (301) 827–6860, between 9 a.m. and 4 p.m., Monday through Fri day or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741–6030, or go to: http://www.archives.gov/federal register/cfr/ibr-locations.html. (b) Related conditions of use. See §§ 522.814 and 522.955 of this chapter. [76 FR 72618, Nov. 25, 2011, as amended at 77 FR 9528, Feb. 17, 2012] PART 501—ANIMAL FOOD LABELING Subpart A—General Provisions Sec. 501.1 Principal display panel of package form animal food. 501.2 Information panel of package for ani mal food. 501.3 Identity labeling of animal food in package form. 501.4 Animal food; designation of ingredi ents. 501.5 Animal food; name and place of busi ness of manufacturer, packer, or dis tributor. 501.8 Labeling of animal food with number of servings. 501.15 Animal food; prominence of required statements. 501.17 Animal food labeling warning state ments. 501.18 Misbranding of animal food. Subpart B—Specific Animal Food Labeling Requirements 501.22 Animal foods; labeling of spices, flavorings, colorings, and chemical pre servatives. Subparts C–E [Reserved] Subpart F—Exemptions From Animal Food Labeling Requirements 501.100 Animal food; exemptions from label ing. 501.103 Petitions requesting exemptions from or special requirements for label declaration of ingredients. 501.105 Declaration of net quantity of con tents when exempt. 501.110 Animal feed labeling; collective names for feed ingredients. AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371. SOURCE: 41 FR 38619, Sept. 10, 1976, unless otherwise noted. Subpart A—General Provisions § 501.1 Principal display panel of pack age form animal food. The term principal display panel as it applies to food in package form and as used in this part, means the part of a label that is most likely to be dis played, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accom modate all the mandatory label infor mation required to be placed thereon by this part with clarity and conspicu ousness and without obscuring design, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be du plicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term area of the principal display panel means the area of the side or surface that bears the principal display panel, which area shall be: (a) In the case of a rectangular pack age where one entire side properly can be considered to be the principal dis play panel side, the product of the height times the width of that side; (b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the con tainer times the circumference; (c) In the case of any otherwise shaped container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious principal display panel such as the top of a triangular or circular package, the area shall consist VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00025 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 16 21 CFR Ch. I (4–1–16 Edition) § 501.2 of the entire top surface. In deter mining the area of the principal dis play panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or near ly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circum ference which is most likely to be dis played, presented, shown, or examined under customary conditions of display for retail sale. § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food means that part of the label immediately contig uous and to the right of the principal display panel as observed by an indi vidual facing the principal display panel with the following exceptions: (1) If the part of the label imme diately contiguous and to the right of the principal display panel is too small to accommodate the necessary infor mation or is otherwise unusable label space, e.g., folded flaps or can ends, the panel immediately contiguous and to the right of this part of the label may be used. (2) If the package has one or more al ternate principal display panels, the in formation panel is immediately contig uous and to the right of any principal display panel. (3) If the top of the container is the principal display panel and the pack age has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel. (b) All information required to ap pear on the label of any package of food pursuant to §§ 501.4, 501.5, 501.8 and 501.17 shall appear either on the prin cipal display panel or on the informa tion panel, unless otherwise specified by regulations in this chapter. (c) All information appearing on the principal display panel or the informa tion panel pursuant to this section shall appear prominently and conspicu ously, but in no case may the letters and/or numbers be less than 1⁄16 inch in height unless an exemption pursuant to paragraph (f) of this section is estab lished. The requirements for conspicu ousness and legibility shall include the specifications of §§ 501.15 and 501.105(h) (1) and (2). (1) Packaged foods are exempt from the type size requirements of this para graph: Provided, That: (i) The package is designed such that it has a surface area that can bear an information panel and/or an alternate principal display panel. (ii) The area of surface available for labeling on the principal display panel of the package as this term is defined in § 501.1 is less than 10 square inches. (iii) The label information includes a full list of ingredients in accordance with regulations in this part. (iv) The information required by paragraph (b) of this section appears on the principal display panel or informa tion panel label in accordance with the provisions of this paragraph (c) except that the type size is not less than 3⁄64 inch in height. (2) Packaged foods are exempt from the type size requirements of this para graph: Provided, That: (i) The package is designed such that it has a single obvious principal display panel as this term is defined in § 501.1 and has no other available surface area for an information panel or alternate principal display panel. (ii) The area of surface available for labeling on the principal display panel of the package as this term is defined in § 501.1 is less than 12 square inches and bears all labeling appearing on the package. (iii) The label information includes a full list of ingredients in accordance with regulations in this part. (iv) The information required by paragraph (b) of this section appears on the single, obvious principal display panel in accordance with the provisions of this paragraph (c) except that the type size is not less than 1⁄32 inch in height. (3) Packaged foods are exempt from the type size requirements of this para graph: Provided, That: (i) The package is designed such that it has a total surface area available to bear labeling of less than 12 square inches. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00026 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 17 Food and Drug Administration, HHS § 501.3 (ii) The label information includes a full list of ingredients in accordance with regulations in this part. (iii) The information required by paragraph (b) of this section appears on the principal display panel or informa tion panel label in accordance with the provisions of this paragraph (c) except that the type size is not less than 1⁄32 inch in height. (d) All information required to ap pear on the principal display panel or on the information panel pursuant to this section shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, any vignettes, design, and other nonmandatory label informa tion shall not be considered. If there is insufficient space for all of this infor mation to appear on a single panel, it may be divided between these two pan els except that the information re quired pursuant to any given section or part shall all appear on the same panel. A food whose label is required to bear the ingredient statement on the prin cipal display panel may bear all other information specified in paragraph (b) of this section on the information panel. (e) All information appearing on the information panel pursuant to this sec tion shall appear in one place without other intervening material. (f) If the label of any package of food is too small to accommodate all of the information required by §§ 501.4, 501.5, 501.8, and 501.17, the Commissioner may establish by regulation an acceptable alternative method of disseminating such information to the public, e.g., a type size smaller than one-sixteenth inch in height, or labeling attached to or inserted in the package or available at the point of purchase. A petition re questing such a regulation, as an amendment to this paragraph shall be submitted pursuant to part 10 of this chapter. [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 4716, Jan. 25, 1977; 42 FR 15675, Mar. 22, 1977] § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of: (1) The name now or hereafter speci fied in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) The common or usual name of the food; or, in the absence thereof, (3) An appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. (c) Where a food is marketed in var ious optional forms (whole, slices, diced, etc.), the particular form shall be considered to be a necessary part of the statement of identity and shall be declared in letters of a type size bear ing a reasonable relation to the size of the letters forming the other compo nents of the statement of identity; ex cept that if the optional form is visible through the container or is depicted by an appropriate vignette, the particular form need not be included in the state ment. This specification does not affect the required declarations of identity under definitions and standards for foods promulgated pursuant to section 401 of the act. (d) This statement of identity shall be presented in bold type on the prin cipal display panel, shall be in a size reasonably related to the most promi nent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed. (e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is an imitation of another food unless its label bears, in type of uniform size and prominence, the word imitation and, immediately thereafter, the name of the food imi tated. (1) A food shall be deemed to be an imitation and thus subject to the re quirements of section 403(c) of the act if it is a substitute for and resembles another food but is nutritionally infe rior to that food. (2) A food that is a substitute for and resembles another food shall not be deemed to be an imitation provided it VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00027 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 18 21 CFR Ch. I (4–1–16 Edition) § 501.4 meets each of the following require ments: (i) It is not nutritionally inferior to the food for which it substitutes and which it resembles. (ii) Its label bears a common or usual name that complies with the provisions of § 502.5 of this chapter and that is not false or misleading, or in the absence of an existing common or usual name, an appropriately descriptive term that is not false or misleading. The label may, in addition, bear a fanciful name which is not false or misleading. (3) A food for which a common or usual name is established by regulation (e.g., in a standard of identity pursuant to section 401 of the act, in a common or usual name regulation and may, in addition, bear a fanciful name which is not false or misleading, and established pursuant to part 502 of this chapter), and which complies with all of the ap plicable requirements of such regula tion(s), shall not be deemed to be an imitation. (4) Nutritional inferiority includes: (i) Any reduction in the content of an essential nutrient that is present in a measurable amount. (ii) If the Commissioner concludes that a food is a substitute for and re sembles another food but is inferior to the food imitated for reasons other than those set forth in this paragraph, he may propose appropriate revisions to this regulation or he may propose a separate regulation governing the par ticular food. (f) A label may be required to bear the percentage(s) of a characterizing ingredient(s) or information con cerning the presence or absence of an ingredient(s) or the need to add an in gredient(s) as part of the common or usual name of the food pursuant to part 502 of this chapter. [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 54 FR 18279, Apr. 28, 1989] § 501.4 Animal food; designation of in gredients. (a) Ingredients required to be de clared on the label of a food, including foods that comply with standards of identity that require labeling in com pliance with this part 501, except those exempted by § 501.100, shall be listed by common or usual name in descending order of predominance by weight on ei ther the principal display panel or the information panel in accordance with the provisions of § 501.2. (b) The name of an ingredient shall be a specific name and not a collective (generic) name, except that: (1) Spices, flavorings, colorings and chemical preservatives shall be de clared according to the provisions of § 501.22. (2) An ingredient which itself con tains two or more ingredients and which has an established common or usual name, conforms to a standard es tablished pursuant to the Meat Inspec tion or Poultry Products Inspection Acts by the U.S. Department of Agri culture, or conforms to a definition and standard of identity established pursu ant to section 401 of the Federal Food, Drug, and Cosmetic Act, shall be des ignated in the statement of ingredients on the label of such food by either of the following alternatives: (i) By declaring the established com mon or usual name of the ingredient followed by a parenthetical listing of all ingredients contained therein in de scending order of predominance except that, if the ingredient is a food subject to a definition and standard of identity established in this subchapter E, only the ingredients required to be declared by the definition and standard of iden tity need be listed; or (ii) By incorporating into the state ment of ingredients in descending order of predominance in the finished food, the common or usual name of every component of the ingredient without listing the ingredient itself. (3) Skim milk, concentrated skim milk, reconstituted skim milk, and nonfat dry milk may be declared as skim milk or nonfat milk. (4) Milk, concentrated milk, reconsti tuted milk, and dry whole milk may be declared as milk. (5) Bacterial cultures may be de clared by the word cultured followed by the name of the substrate, e.g., made from cultured skim milk or cultured but termilk. (6) Sweetcream buttermilk, con centrated sweetcream buttermilk, re constituted sweetcream buttermilk, VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00028 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 19 Food and Drug Administration, HHS § 501.5 and dried sweetcream buttermilk may be declared as buttermilk. (7) Whey, concentrated whey, recon stituted whey, and dried whey may be declared as whey. (8) Cream, reconstituted cream, dried cream, and plastic cream (sometimes known as concentrated milkfat) may be declared as cream. (9) Butteroil and anhydrous butterfat may be declared as butterfat. (10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may be de clared as eggs. (11) Dried egg whites, frozen egg whites, and liquid egg whites may be declared as egg whites. (12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be declared as egg yolks. (13) A livestock or poultry feed may be declared by a collective name listed in § 501.110 if it is an animal feed within the meaning of section 201(w) of the act and meets the requirements for the use of a collective name as prescribed in § 501.110 for certain feed ingredients. (14) [Reserved] (15) When all the ingredients of a wheat flour are declared in an ingre dient statement, the principal ingre dient of the flour shall be declared by the name(s) specified in §§ 137.105, 137.200, 137.220, 137.225 of this chapter, i.e., the first ingredient designated in the ingredient list of flour, or bromated flour, or enriched flour, or self-rising flour is flour, white flour, wheat flour, or plain flour; the first in gredient designated in the ingredient list of durum flour is durum flour; the first ingredient designated in the ingre dient list of whole wheat flour, or bromated whole wheat flour is whole wheat flour, graham flour, or entire wheat flour; and the first ingredient designated in the ingredient list of whole durum wheat flour is whole durum wheat flour. (c) When water is added to reconsti tute, completely or partially, an ingre dient permitted by paragraph (b) of this section to be declared by a class name, the position of the ingredient class name in the ingredient statement shall be determined by the weight of the unreconstituted ingredient plus the weight of the quantity of water added to reconstitute that ingredient, up to the amount of water needed to recon stitute the ingredient to single strength. Any water added in excess of the amount of water needed to recon stitute the ingredient to single strength shall be declared as water in the ingredient statement. [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 60 FR 38480, July 27, 1995] § 501.5 Animal food; name and place of business of manufacturer, packer, or distributor. (a) The label of a food in packaged form shall specify conspicuously the name and place of business of the man ufacturer, packer, or distributor. (b) The requirement for declaration of the name of the manufacturer, pack er, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an indi vidual, partnership, or association, the name under which the business is con ducted shall be used. (c) Where the food is not manufac tured by the person whose name ap pears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as ‘‘Manufactured for llllll,’’ ‘‘Distributed by llllll,’’ or any other wording that expresses the facts. (d) The statement of the place of business shall include the street ad dress, city, state, and ZIP Code; how ever, the street address may be omitted if it is shown in a current city direc tory or telephone directory. The re quirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear either on the label or the labeling (including in voice). (e) If a person manufactures, packs, or distributes a food at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such food was manufactured or VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00029 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 20 21 CFR Ch. I (4–1–16 Edition) § 501.8 packed or is to be distributed, unless such statement would be misleading. § 501.8 Labeling of animal food with number of servings. (a) The label of any package of a food which bears a representation as to the number of servings contained in such package shall bear in immediate con junction with such statement, and in the same size type as is used for such statement, a statement of the net quantity (in terms of weight, measure, or numerical count) of each such serv ing; however, such statement may be expressed in terms that differ from the terms used in the required statement of net quantity of contents (for exam ple, cupfuls, tablespoonfuls, etc.) when such differing term is common to cook ery and describes a constant quantity. Such statement may not be misleading in any particular. A statement of the number of units in a package is not in itself a statement of the number of servings. (b) If there exists a voluntary prod uct standard promulgated pursuant to the procedures found in 15 CFR part 10 by the Department of Commerce, quan titatively defining the meaning of the term serving with respect to a par ticular food, then any label representa tion as to the number of servings in such packaged food shall correspond with such quantitative definition. (Copies of published standards are available upon request from the Na tional Bureau of Standards, Depart ment of Commerce, Washington, DC 20234.) § 501.15 Animal food; prominence of required statements. (a) A word, statement, or other infor mation required by or under authority of the act to appear on the label may lack that prominence and conspicuous ness required by section 403(f) of the act by reason (among other reasons) of: (1) The failure of such word, state ment, or information to appear on the part or panel of the label which is pre sented or displayed under customary conditions of purchase; (2) The failure of such word, state ment, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so de signed as to render it likely to be, under customary conditions of pur chase, the part or panel displayed; (3) The failure of the label to extend over the area of the container or pack age available for such extension, so as to provide sufficient label space for the prominent placing of such word, state ment, or information; (4) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space for any word, statement, design, or device which is not required by or under au thority of the act to appear on the label; (5) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space to give ma terially greater conspicuousness to any other word, statement, or information, or to any design or device; or (6) Smallness or style of type in which such word, statement, or infor mation appears, insufficient back ground contrast, obscuring designs or vignettes, or crowding with other writ ten, printed, or graphic matter. (b) No exemption depending on insuf ficiency of label space, as prescribed in regulations promulgated under section 403(e) or (i) of the act, shall apply if such insufficiency is caused by: (1) The use of label space for any word, statement, design, or device which is not required by or under au thority of the act to appear on the label; (2) The use of label space to give greater conspicuousness to any word, statement, or other information that is required by section 403(f) of the act; or (3) The use of label space for any rep resentation in a foreign language. (c)(1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language: Provided, how ever, That in the case of articles dis tributed solely in the Commonwealth of Puerto Rico or in a territory where the predominant language is one other than English, the predominant lan guage may be substituted for English. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00030 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 21 Food and Drug Administration, HHS § 501.18 (2) If the label contains any represen tation in a foreign language, all words, statements, and other information re quired by or under authority of the act to appear on the label shall appear thereon in the foreign language. (3) If any article of labeling (other than a label) contains any representa tion in a foreign language, all words, statements, and other information re quired by or under authority of the act to appear on the label or labeling shall appear on such article of labeling. § 501.17 Animal food labeling warning statements. (a) Self-pressurized containers. (1) The label of a food packaged in a self-pres surized container and intended to be expelled from the package under pres sure shall bear the following warning: Warning Avoid spraying in eyes. Con tents under pressure. Do not puncture or incinerate. Do not store at tempera ture above 120 °F. Keep out of reach of children. (2) In the case of products intended for use by children, the phrase ‘‘except under adult supervision’’ may be added at the end of the last sentence in the warning required by paragraph (a)(1) of this section. (3) In the case of products packaged in glass containers, the word ‘‘break’’ may be substituted for the word ‘‘puncture’’ in the warning required by paragraph (a)(1) of this section. (4) The words ‘‘Avoid spraying in eyes’’ may be deleted from the warning required by paragraph (a)(1) of this sec tion in the case of a product not ex pelled as a spray. (b) Self-pressurized containers with halocarbon or hydrocarbon propellants. (1) In addition to the warning required by paragraph (a) of this section, the label of a food packaged in a self-pres surized container in which the propel lant consists in whole or in part of a halocarbon or a hydrocarbon shall bear the following warning: Warning Use only as directed. Inten tional misuse by deliberately concen trating and inhaling the contents can be harmful or fatal. (2) The warning required by para graph (b)(1) of this section is not re quired for the following products: (i) Products expelled in the form of a foam or cream, which contain less than 10 percent propellant in the container. (ii) Products in a container with a physical barrier that prevents escape of the propellant at the time of use. (iii) Products of a net quantity of contents of less than 2 ozs that are de signed to release a measured amount of product with each valve actuation. (iv) Products of a net quantity of contents of less than 1⁄2 oz. (c) Animal food containing or manufac tured with a chlorofluorocarbon or other ozone-depleting substance. Labeling re quirements for animal foods that con tain or are manufactured with a chlorofluorocarbon or other ozone-de pleting substance designated by the Environmental Protection Agency (EPA) are set forth in 40 CFR part 82. [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 22033, Apr. 29, 1977; 61 FR 20101, May 3, 1996] § 501.18 Misbranding of animal food. (a) Among representations in the la beling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic. (b) The labeling of a food which con tains two or more ingredients may be misleading by reason (among other rea sons) of the designation of such food in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredi ents are stated elsewhere in the label ing. (c) Among representations in the la beling of a food which render such food misbranded is any representation that expresses or implies a geographical ori gin of the food or any ingredient of the food except when such representation is either: (1) A truthful representation of geo graphical origin. (2) A trademark or trade name pro vided that as applied to the article in question its use is not deceptively misdescriptive. A trademark or trade name comprised in whole or in part of geographical words shall not be consid ered deceptively misdescriptive if it: (i) Has been so long and exclusively used by a manufacturer or distributor VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00031 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 22 21 CFR Ch. I (4–1–16 Edition) § 501.22 that it is generally understood by the consumer to mean the product of a par ticular manufacturer or distributor; or (ii) Is so arbitrary or fanciful that it is not generally understood by the con sumer to suggest geographic origin. (3) A part of the name required by ap plicable Federal law or regulation. (4) A name whose market signifi cance is generally understood by the consumer to connote a particular class, kind, type, or style of food rather than to indicate geographical origin. Subpart B—Specific Animal Food Labeling Requirements § 501.22 Animal foods; labeling of spices, flavorings, colorings, and chemical preservatives. (a)(1) The term artificial flavor or arti ficial flavoring means any substance, the function of which is to impart fla vor, which is not derived from a spice, fruit or fruit juice, vegetable or vege table juice, edible yeast, herb, bark, bud, root, leaf or similar plant mate rial, meat, fish, poultry, eggs, dairy products, or fermentation products thereof. Artificial flavor includes the substances listed in §§ 172.515(b) and 582.60 of this chapter except where these are derived from natural sources. (2) The term spice means any aro matic vegetable substance in the whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, such as onions, garlic and celery; whose signifi cant function in food is seasoning rath er than nutritional; that is true to name; and from which no portion of any volatile oil or other flavoring prin ciple has been removed. Spices include the spices listed in subpart A of part 582 of this chapter, such as the fol lowing: Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, Chervil, Cin namon, Cloves, Coriander, Cumin seed, Dill seed, Fennel seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour, Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper, red; Rosemary, Saffron, Sage, Savory, Star ani seed, Tarragon, Thyme, Turmeric. Paprika, turmeric, and saffron or other spices which are also colors, shall be declared as spice and coloring unless de clared by their common or usual name. (3) The term natural flavor or natural flavoring means the essential oil, oleo resin, essence or extractive, protein hy drolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constitu ents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edi ble yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fer mentation products thereof, whose sig nificant function in food is flavoring rather than nutritional. Natural fla vors, include the natural essence or ex tractives obtained from plants listed in subpart A of part 582 of this chapter, and the substances listed in § 172.510 of this chapter. (4) The term artificial color or artificial coloring means any color additive as de fined in § 70.3(f) of this chapter. (5) The term chemical preservative means any chemical that, when added to food, tends to prevent or retard de terioration thereof, but does not in clude common salt, sugars, vinegars, spices, or oils extracted from spices, substances added to food by direct ex posure thereof to wood smoke, or chemicals applied for their insecticidal or herbicidal properties. (b) A food which is subject to the re quirements of section 403(k) of the act shall bear labeling, even though such food is not in package form. (c) A statement of artificial fla voring, artificial coloring, or chemical preservative shall be placed on the food, or on its container or wrapper, or on any two or all of these, as may be necessary to render such statement likely to be read by the ordinary indi vidual under customary conditions of purchase and use of such food. (d) A food shall be exempt from com pliance with the requirements of sec tion 403(k) of the act if it is not in package form and the units thereof are so small that a statement of artificial flavoring, artificial coloring, or chem ical preservative, as the case may be, cannot be placed on such units with such conspicuousness as to render it likely to be read by the ordinary indi vidual under customary conditions of purchase and use. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00032 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 23 Food and Drug Administration, HHS § 501.22 (e) A food shall be exempt while held for sale from the requirements of sec tion 403(k) of the act (requiring label statement of any artificial flavoring, artificial coloring, or chemical preserv atives) if said food, having been re ceived in bulk containers at a retail es tablishment, is displayed to the pur chaser with either (1) the labeling of the bulk container plainly in view or (2) a counter card, sign, or other appro priate device bearing prominently and conspicuously the information required to be stated on the label pursuant to section 403(k) of the act. (f) A fruit or vegetable shall be ex empt from compliance with the re quirements of section 403(k) of the act with respect to a chemical preservative applied to the fruit or vegetable as a pesticide chemical prior to harvest. (g) A flavor shall be labeled in the following way when shipped to a food manufacturer or processor (but not a consumer) for use in the manufacture of a fabricated food, unless it is a fla vor for which a standard of identity has been promulgated, in which case it shall be labeled as provided in the standard: (1) If the flavor consists of one ingre dient, it shall be declared by its com mon or usual name. (2) If the flavor consists of two or more ingredients, the label either may declare each ingredient by its common or usual name or may state ‘‘All flavor ingredients contained in this product are approved for use in a regulation of the Food and Drug Administration.’’ Any flavor ingredient not contained in one of these regulations, and any non flavor ingredient, shall be separately listed on the label. (3) In cases where the flavor contains a solely natural flavor(s), the flavor shall be so labeled, e.g., strawberry fla vor, banana flavor, or natural strawberry flavor. In cases where the flavor con tains both a natural flavor and an arti ficial flavor, the flavor shall be so la beled, e.g., natural and artificial straw berry flavor. In cases where the flavor contains a solely artificial flavor(s), the flavor shall be so labeled, e.g., arti ficial strawberry flavor. (h) The label of a food to which flavor is added shall declare the flavor in the statement of ingredients in the fol lowing way: (1) Spice, natural flavor, and artifi cial flavor may be declared as spice, natural flavor, or artificial flavor, or any combination thereof, as the case may be. (2) An incidental additive in a food, originating in a spice or flavor used in the manufacture of the food, need not be declared in the statement of ingredi ents if it meets the requirements of § 501.100(a)(3). (3) Substances obtained by cutting, grinding, drying, pulping, or similar processing of tissues derived from fruit, vegetable, meat, fish, or poultry, e.g., powdered or granulated onions, garlic powder, and celery powder, are com monly understood by consumers to be food rather than flavor and shall be de clared by their common or usual name. (4) Any salt (sodium chloride) used as an ingredient in food shall be declared by its common or usual name salt. (5) Any monosodium glutamate used as an ingredient in food shall be de clared by its common or usual name monosodium glutamate. (6) Any pyroligneous acid or other ar tificial smoke flavors used as an ingre dient in a food may be declared as arti ficial flavor or artificial smoke flavor. No representation may be made, either di rectly or implied, that a food flavored with pyroligneous acid or other artifi cial smoke flavor has been smoked or has a true smoked flavor, or that a sea soning sauce or similar product con taining pyroligneous acid or other arti ficial smoke flavor and used to season or flavor other foods will result in a smoked product or one having a true smoked flavor. (i) If the label, labeling, or adver tising of a food makes any direct or in direct representations with respect to the primary recognizable flavor(s), by word, vignette, e.g., depiction of a fruit, or other means, or if for any other rea son the manufacturer or distributor of a food wishes to designate the type of flavor in the food other than through the statement of ingredients, such fla vor shall be considered the character izing flavor and shall be declared in the following way: (1) If the food contains no artificial flavor which simulates, resembles or VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00033 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 24 21 CFR Ch. I (4–1–16 Edition) § 501.22 reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label shall be accompanied by the common or usual name of the characterizing fla vor in letters not less than one-half the height of the letters used in the name of the food, except that: (i) If the food is one that is com monly expected to contain a character izing food ingredient, and the food con tains natural flavor derived from such ingredient and an amount of character izing ingredient insufficient to inde pendently characterize the food, or the food contains no such ingredient, the name of the characterizing flavor may be immediately preceded by the word natural and shall be immediately fol lowed by the word flavored in letters not less than one-half the height of the letters in the name of the character izing flavor. (ii) If none of the natural flavor used in the food is derived from the product whose flavor is simulated, the food in which the flavor is used shall be la beled either with the flavor of the prod uct from which the flavor is derived or as artificially flavored. (iii) If the food contains both a char acterizing flavor from the product whose flavor is simulated and other natural flavor which simulates, resem bles or reinforces the characterizing flavor, the food shall be labeled in ac cordance with the introductory text and paragraph (i)(1)(i) of this section and the name of the food shall be im mediately followed by the words with other natural flavor in letters not less than one-half the height of the letters used in the name of the characterizing flavor. (2) If the food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label shall be accompanied by the common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the characterizing flavor shall be accom panied by the word(s) artificial or artifi cially flavored, in letters not less than one-half the height of the letters in the name of the characterizing flavor. (3) Wherever the name of the charac terizing flavor appears on the label (other than in the statement of ingre dients) so conspicuously as to be easily seen under customary conditions of purchase, the words prescribed by this paragraph shall immediately and con spicuously precede or follow such name, without any intervening writ ten, printed, or graphic matter, except: (i) Where the characterizing flavor and a trademark or brand are pre sented together, other written, printed, or graphic matter that is a part of or is associated with the trademark or brand may intervene if the required words are in such relationship with the trademark or brand as to be clearly re lated to the characterizing flavor; and (ii) If the finished product contains more than one flavor subject to the re quirements of this paragraph, the statements required by this paragraph need appear only once in each state ment of characterizing flavors present in such food. (iii) If the finished product contains three or more distinguishable charac terizing flavors, or a blend of flavors with no primary recognizable flavor, the flavor may be declared by an appro priately descriptive generic term in lieu of naming each flavor. (4) A flavor supplier shall certify, in writing, that any flavor he supplies which is designated as containing no artificial flavor does not, to the best of his knowledge and belief, contain any artificial flavor, and that he has added no artificial flavor to it. The require ment for such certification may be sat isfied by a guarantee under section 303(c)(2) of the act which contains such a specific statement. A flavor used shall be required to make such a writ ten certification only where he adds to or combines another flavor with a fla vor which has been certified by a flavor supplier as containing no artificial fla vor, but otherwise such user may rely upon the supplier’s certification and need make no separate certification. All such certifications shall be re tained by the certifying party through out the period in which the flavor is supplied and for a minimum of 3 years thereafter, and shall be subject to the following conditions: VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00034 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 25 Food and Drug Administration, HHS § 501.22 (i) The certifying party shall make such certifications available upon re quest at all reasonable hours to any duly authorized officer, or employee of the Food and Drug Administration or any other employee acting on behalf of the Secretary of Health and Human Services. Such certifications are re garded by the Food and Drug Adminis tration as reports to the government and as guarantees or other under takings within the meaning of section 301(h) of the act and subject the certi fying party to the penalties for making any false report to the government under 18 U.S.C. 1001 and any false guar antee or undertaking under section 303(a) of the act. The defenses provided under section 303(c)(2) of the act shall be applicable to the certifications pro vided for in this section. (ii) Wherever possible, the Food and Drug Administration shall verify the accuracy of a reasonable number of certifications made pursuant to this section, constituting a representative sample of such certifications, and shall not request all such certifications. (iii) Where no person authorized to provide such information is reasonably available at the time of inspection, the certifying party shall arrange to have such person and the relevant materials and records ready for verification as soon as practicable; provided that, whenever the Food and Drug Adminis tration has reason to believe that the supplier or user may utilize this period to alter inventories or records, such ad ditional time shall not be permitted. Where such additional time is pro vided, the Food and Drug Administra tion may require the certifying party to certify that relevant inventories have not been materially disturbed and relevant records have not been altered or concealed during such period. (iv) The certifying party shall pro vide, to an officer or representative duly designated by the Secretary, such qualitative statement of the composi tion of the flavor or product covered by the certification as may be reasonably expected to enable the Secretary’s rep resentatives to determine which rel evant raw and finished materials and flavor ingredient records are reason ably necessary to verify the certifi cations. The examination conducted by the Secretary’s representative shall be limited to inspection and review of in ventories and ingredient records for those certifications which are to be verified. (v) Review of flavor ingredient records shall be limited to the quali tative formula and shall not include the quantitative formula. The person verifying the certifications may make only such notes as are necessary to en able him to verify such certification. Only such notes or such flavor ingre dient records as are necessary to verify such certification or to show a poten tial or actual violation may be re moved or transmitted from the certi fying party’s place of business: Pro vided, That, where such removal or transmittal is necessary for such pur poses the relevant records and notes shall be retained as separate docu ments in Food and Drug Administra tion files, shall not be copied in other reports, and shall not be disclosed pub licly other than in a judicial pro ceeding brought pursuant to the act or 18 U.S.C. 1001. (j) A food to which a chemical pre servative(s) is added shall, except when exempt pursuant to § 501.100, bear a label declaration stating both the com mon or usual name of the ingredient(s) and a separate description of its func tion, e.g., preservative, to retard spoilage, a mold inhibitor, to help protect flavor or to promote color retention. (k) The label of an animal food to which any coloring has been added shall declare the coloring in the state ment of ingredients in the manner specified in paragraphs (k)(1) and (k)(2) of this section. (1) A color additive or the lake of a color additive subject to certification under section 721(c) of the act shall be declared by the name of the color addi tive listed in the applicable regulation in part 74 or part 82 of this chapter, ex cept that it is not necessary to include the ‘‘FD&C’’ prefix or the term ‘‘No.’’ in the declaration, but the term ‘‘Lake’’ shall be included in the dec laration of the lake of the certified color additive (e.g., Blue 1 Lake). Man ufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00035 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 26 21 CFR Ch. I (4–1–16 Edition) § 501.100 common or usual name as specified in part 74 or part 82 of this chapter. (2) Color additives not subject to cer tification may be declared as ‘‘Artifi cial Color,’’ ‘‘Artificial Color Added,’’ or ‘‘Color Added’’ (or by an equally in formative term that makes clear that a color additive has been used in the food). Alternatively, such color addi tives may be declared as ‘‘Colored with llll’’ or ‘‘llll color,’’ the blank to be filled with the name of the color additive listed in the applicable regula tion in part 73 of this chapter. [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 42 FR 15675, Mar. 22, 1977; 76 FR 71254, Nov. 17, 2011] Subparts C–E [Reserved] Subpart F—Exemptions From Ani mal Food Labeling Require ments § 501.100 Animal food; exemptions from labeling. (a) The following foods are exempt from compliance with the require ments of section 403(i)(2) of the act (re quiring a declaration on the label of the common or usual name of each in gredient when the food is fabricated from two or more ingredients). (1) An assortment of different items of food, when variations in the items that make up different packages packed from such assortment normally occur in good packing practice and when such variations result in vari ations in the ingredients in different packages, with respect to any ingre dient that is not common to all pack ages. Such exemption, however, shall be on the condition that the label shall bear, in conjunction with the names of such ingredients as are common to all packages, a statement (in terms that are as informative as practicable and that are not misleading) indicating by name other ingredients which may be present. (2) A food having been received in bulk containers at a retail establish ment, if displayed to the purchaser with either (i) the labeling of the bulk container plainly in view or (ii) a counter card, sign, or other appropriate device bearing prominently and con spicuously the information required to be stated on the label pursuant to sec tion 403(i)(2) of the act. (3) Incidental additives that are present in a food at insignificant levels and do not have any technical or func tional effect in that food. For the pur poses of this paragraph (a)(3), inci dental additives are: (i) Substances that have no technical or functional effect but are present in a food by reason of having been incor porated into the food as an ingredient of another food, in which the substance did have a functional or technical ef fect. (ii) Processing aids, which are as fol lows: (a) Substances that are added to a food during the processing of such food but are removed in some manner from the food before it is packaged in its fin ished form. (b) Substances that are added to a food during processing, are converted into constituents normally present in the food, and do not significantly in crease the amount of the constituents naturally found in the food. (c) Substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food. (iii) Substances migrating to food from equipment or packaging or other wise affecting food that are not food additives as defined in section 201(s) of the act; or if they are food additives as so defined, they are used in conformity with regulations established pursuant to section 409 of the act. (b) A food repackaged in a retail es tablishment is exempt from the fol lowing provisions of the act if the con ditions specified are met. (1) Section 403(e)(1) of the act (requir ing a statement on the label of the name and place of business of the man ufacturer, packer, or distributor). (2) Section 403(g)(2) of the act (requir ing the label of a food which purports to be or is represented as one for which a definition and standard of identity has been prescribed to bear the name of the food specified in the definition and standard and, insofar as may be re quired by the regulation establishing VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00036 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 27 Food and Drug Administration, HHS § 501.100 the standard the common names of the optional ingredients present in the food), if the food is displayed to the purchaser with its interstate labeling clearly in view, or with a counter card, sign, or other appropriate device bear ing prominently and conspicuously the information required by these provi sions. (3) Section 403(i)(1) of the act (requir ing the label to bear the common or usual name of the food), if the food is displayed to the purchaser with its interstate labeling clearly in view, or with a counter card, sign, or other ap propriate device bearing prominently and conspicuously the common or usual name of the food, or if the com mon or usual name of the food is clear ly revealed by its appearance. (c) [Reserved] (d) Except as provided by paragraphs (e) and (f) of this section, a shipment or other delivery of a food which is, in ac cordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establish ment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such estab lishment, from compliance with the la beling requirements of section 403 (c), (e), (g), (h), (i), (j) and (k) of the act if: (1) The person who introduced such shipment or delivery into interstate commerce is the operator of the estab lishment where such food is to be proc essed, labeled, or repacked; or (2) In case such person is not such op erator, such shipment or delivery is made to such establishment under a written agreement, signed by and con taining the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such food in such establishment as will ensure, if such specifications are followed, that such food will not be adulterated or mis branded within the meaning of the act upon completion of such processing, la beling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such food from such establishment, and shall make such copies available for inspec tion at any reasonable hour to any offi cer or employee of the Department who requests them. (e) Conditions affecting expiration of exemptions. (1) An exemption of a shipment or other delivery of a food under para graph (d)(1) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment be come void ab initio if the food com prising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so re moved. (2) An exemption of a shipment or other delivery of a food under para graph (d)(2) of this section shall be come void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by paragraph (d)(2) of this section. (3) An exemption of a shipment or other delivery of a food under para graph (d)(2) of this section shall expire: (i) At the beginning of the act of re moving such shipment or delivery, or any part thereof, from such establish ment if the food comprising such ship ment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed; or (ii) Upon refusal by the operator of the establishment where such food is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement as required by such paragraph. (f) [Reserved] (g) The label declaration of a harm less marker used to identify a par ticular manufacturer’s product may re sult in unfair competition through re vealing a trade secret. Exemption from the label declaration of such a marker is granted, therefore, provided that the following conditions are met: (1) The person desiring to use the marker without label declaration of its presence has submitted to the Commis sioner of Food and Drugs full informa tion concerning the proposed usage and VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00037 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 28 21 CFR Ch. I (4–1–16 Edition) § 501.103 the reasons why he believes label dec laration of the marker should be sub ject to this exemption; and (2) The person requesting the exemp tion has received from the Commis sioner of Food and Drugs a finding that the marker is harmless and that the exemption has been granted. § 501.103 Petitions requesting exemp tions from or special requirements for label declaration of ingredients. The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition pursuant to part 10 of this chapter may issue a pro posal to amend § 501.4 to specify the manner in which an ingredient(s) shall be declared, i.e., by specific or class name, or § 501.100 to exempt an ingre dient(s) from the requirements for label declaration. [41 FR 38619, Sept. 10, 1976, as amended at 42 FR 15675, Mar. 22, 1977] § 501.105 Declaration of net quantity of contents when exempt. (a) The principal display panel of a food in package form shall bear a dec laration of the net quantity of con tents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The statement shall be in terms of fluid measure if the food is liquid, or in terms of weight if the food is solid, semisolid, or viscous, or a mixture of solid and liquid; except that such state ment may be in terms of dry measure if the food is a fresh fruit, fresh vege table, or other dry commodity that is customarily sold by dry measure. If there is a firmly established general consumer usage and trade custom of declaring the contents of a liquid by weight, or a solid, semisolid, or viscous product by fluid measure, it may be used. Whenever the Commissioner de termines that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination in the case of a specific packaged food does not facilitate value comparisons by consumers and offers opportunity for consumer confusion, he will by regulation designate the appro priate term or terms to be used for such commodity. (b)(1) Statements of weight shall be in terms of avoirdupois pound and ounce. (2) Statements of fluid measure shall be in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid ounce subdivisions thereof, and shall: (i) In the case of frozen food that is sold and consumed in a frozen state, express the volume at the frozen tem perature. (ii) In the case of refrigerated food that is sold in the refrigerated state, express the volume at 40 °F (4 °C). (iii) In the case of other foods, ex press the volume at 68 °F (20 °C). (3) Statements of dry measure shall be in terms of the U.S. bushel of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions there of. (c) When the declaration of quantity of contents by numerical count does not give adequate information as to the quantity of food in the package, it shall be combined with such statement of weight, measure, or size of the indi vidual units of the foods as will provide such information. (d) The declaration may contain common or decimal fractions. A com mon fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds; except that if there ex ists a firmly established general con sumer usage and trade custom of em ploying different common fractions in the net quantity declaration of a par ticular commodity, they may be em ployed. A common fraction shall be re duced to its lowest terms; a decimal fraction shall not be carried out to more than two places. A statement that includes small fractions of an ounce shall be deemed to permit small er variations than one which does not include such fractions. (e) The declaration shall be located on the principal display panel of the label, and with respect to packages bearing alternate principal panels it shall be duplicated on each principal display panel. (f) The declaration shall appear as a distinct item on the principal display panel, shall be separated (by at least a VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00038 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 29 Food and Drug Administration, HHS § 501.105 space equal to the height of the let tering used in the declaration) from other printed label information appear ing above or below the declaration and (by at least a space equal to twice the width of the letter ‘‘N’’ of the style of type used in the quantity of contents statement) from other printed label in formation appearing to the left or right of the declaration. It shall not include any term qualifying a unit of weight, measure, or count (such as jumbo quart and full gallon) that tends to exag gerate the amount of the food in the container. It shall be placed on the principal display panel within the bot tom 30 percent of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed: Provided, That on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the declaration of net quantity of contents meets the other requirements of this part. (g) The declaration shall accurately reveal the quantity of food in the pack age exclusive of wrappers and other material packed therewith; provided that in the case of foods packed in con tainers designed to deliver the food under pressure, the declaration shall state the net quantity of the contents that will be expelled when the instruc tions for use as shown on the container are followed. The propellant is included in the net quantity declaration. (h) The declaration shall appear in conspicuous and easily legible boldface print or type in distinct contrast (by typography, layout, color, embossing, or molding) to other matter on the package; except that a declaration of net quantity blown, embossed, or mold ed on a glass or plastic surface is per missible when all label information is so formed on the surface. Requirements of conspicuousness and legibility shall include the specifications that: (1) The ratio of height to width (of the letter) shall not exceed a differen tial of 3 units to 1 unit (no more than 3 times as high as it is wide). (2) Letter heights pertain to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter ‘‘o’’ or its equivalent that shall meet the min imum standards. (3) When fractions are used, each component numeral shall meet one half the minimum height standards. (i) The declaration shall be in letters and numerals in a type size established in relationship to the area of the prin cipal display panel of the package and shall be uniform for all packages of substantially the same size by com plying with the following type speci fications: (1) Not less than 1⁄16 inch in height on packages the principal display panel of which has an area of 5 square inches or less. (2) Not less than 1⁄8 inch in height on packages the principal display panel of which has an area of more than 5 but not more than 25 square inches. (3) Not less than 3⁄16 inch in height on packages the principal display panel of which has an area of more than 25 but not more than 100 square inches. (4) Not less than 1⁄4 inch in height on packages the principal display panel of which has an area of more than 100 square inches, except not less than 1⁄2 inch in height if the area is more than 400 square inches. Where the declaration is blown, em bossed, or molded on a glass or plastic surface rather than by printing, typ ing, or coloring, the lettering sizes specified in paragraphs (i) (1) through (4) of this section shall be increased by 1⁄16 of an inch. (j) On packages containing less than 4 pounds or 1 gallon and labeled in terms of weight or fluid measure: (1) The declaration shall be expressed both in ounces, with identification by weight or by liquid measure and, if ap plicable (1 pound or 1 pint or more) fol lowed in parentheses by a declaration in pounds for weight units, with any re mainder in terms of ounces or common or decimal fractions of the pound (see examples set forth in paragraphs (m) (1) and (2) of this section), or in the case of liquid measure, in the largest whole units (quarts, quarts and pints, or pints, as appropriate) with any re mainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see examples in para graphs (m) (3) and (4) of this section). VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00039 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 30 21 CFR Ch. I (4–1–16 Edition) § 501.105 (2) If the net quantity of contents declaration appears on a random pack age, that is a package which is one of a lot, shipment, or delivery of packages of the same consumer commodity with varying weights and with no fixed weight pattern, it may, when the net weight exceeds 1 pound, be expressed in terms of pounds and decimal fractions of the pound carried out to not more than two decimal places. When the net weight does not exceed 1 pound, the declaration on the random package may be in decimal fractions of the pound in lieu of ounces (see example in paragraph (m)(5) of this section). (3) The declaration may appear in more than one line. The term net weight shall be used when stating the net quantity of contents in terms of weight. Use of the terms net or net con tents in terms of fluid measure or nu merical count is optional. It is suffi cient to distinguish avoirdupois ounce from fluid ounce through association of terms; for example, Net wt. 6 oz. or 6 oz. net wt. and 6 fl. oz. or net contents 6 fl. oz. (k) On packages containing 4 pounds or 1 gallon or more and labeled in terms of weight or fluid measure, the declaration shall be expressed in pounds for weight units with any re mainder in terms of ounces or common or decimal fraction of the pound, or in the case of fluid measure, it shall be expressed in the largest whole unit (gallons followed by common or dec imal fraction of a gallon or by the next smaller whole unit or units (quarts, or quarts and pints)) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see paragraph (m)(6) of this section). (l) [Reserved] (m) Examples: (1) A declaration of 11⁄2 pounds weight shall be expressed as Net Wt. 24 oz. (1 lb. 8 oz.), Net Wt. 24 oz. (11⁄2 lb.), or Net Wt. 24 oz. (1.5 lb.). (2) A declaration of 3⁄4 pound avoirdu pois weight shall be expressed as Net Wt. 12 oz. (3) A declaration of 1 quart liquid measure shall be expressed as Net 32 fl. oz. (1 qt.). (4) A declaration of 13⁄4 quarts liquid measure shall be expressed as Net con tents 56 fluid ounces (1 quart 11⁄2 pints) or as Net 56 fluid oz. (1 qt. 1 pt. 8 oz.), but not in terms of quart and ounce such as Net 56 fluid oz. (1 quart 24 ounces). (5) On a random package, declaration of 3⁄4 pound avoirdupois may be ex pressed as Net Wt. .75 lb. (6) A declaration of 21⁄2 gallons liquid measure shall be expressed as Net con tents 21⁄2 gallons, Net contents 2.5 gallons, or Net contents 2 gallons 2 quarts and not as 2 gallons 4 pints. (n) For quantities, the following ab breviations and none other may be em ployed (periods and plural forms are optional): weight wt. ounce oz. pound lb. gallon gal. pint pt. quart qt. fluid fl. (o) Nothing in this section shall pro hibit supplemental statements at loca tions other than the principal display panel(s) describing in nondeceptive terms the net quantity of contents; provided, that such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the food contained in the package; for ex ample, jumbo quart and full gallon. Dual or combination declarations of net quantity of contents as provided for in paragraphs (a), (c), and (j) of this sec tion (for example, a combination of net weight plus numerical count, net con tents plus dilution directions of a con centrate, etc.) are not regarded as sup plemental net quantity statements and may be located on the principal display panel. (p) A separate statement of the net quantity of contents in terms of the metric system is not regarded as a sup plemental statement and an accurate statement of the net quantity of con tents in terms of the metric system of weight or measure may also appear on the principal display panel or on other panels. (q) The declaration of net quantity of contents shall express an accurate statement of the quantity of contents of the package. Reasonable variations caused by loss or gain of moisture dur ing the course of good distribution practice or by unavoidable deviations in good manufacturing practice will be recognized. Variations from stated VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00040 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 31 Food and Drug Administration, HHS § 501.110 quantity of contents shall not be un reasonably large. (r) [Reserved] (s) On a multiunit retail package, a statement of the quantity of contents shall appear on the outside of the pack age and shall include the number of in dividual units, the quantity of each in dividual unit, and, in parentheses, the total quantity of contents of the multi unit package in terms of avoirdupois or fluid ounces, except that such declara tion of total quantity need not be fol lowed by an additional parenthetical declaration in terms of the largest whole units and subdivisions thereof, as required by paragraph (j)(1) of this section. A multiunit retail package may thus be properly labeled: 6–16 oz. bottles—(96 fl. oz.) or 3–16 oz. cans—(net wt. 48 oz). For the purposes of this sec tion, multiunit retail package means a package containing two or more indi vidually packaged units of the iden tical commodity and in the same quan tity, intended to be sold as part of the multiunit retail package but capable of being individually sold in full compli ance with all requirements of the regu lations in this part. Open multiunit re tail packages that do not obscure the number of units nor prevent examina tion of the labeling on each of the indi vidual units are not subject to this paragraph if the labeling of each indi vidual unit complies with the require ments of paragraphs (f) and (i) of this section. (t) Where the declaration of net quantity of contents is in terms of net weight and/or drained weight or vol ume and does not accurately reflect the actual quantity of the contents or the product falls below the applicable standard of fill of container because of equipment malfunction or otherwise unintentional product variation, and the label conforms in all other respects to the requirements of this chapter (ex cept the requirement that food falling below the applicable standard of fill of container shall bear the general state ment of substandard fill specified in § 564.14(b) of this chapter), the mis labeled food product, including any food product that fails to bear the gen eral statement of substandard fill spec ified in § 564.14(b) of this chapter, may be sold by the manufacturer or proc essor directly to institutions operated by Federal, State or local govern ments: Provided, That: (1) The purchaser shall sign a state ment at the time of sale stating that he is aware that the product is mis labeled to include acknowledgement of the nature and extent of the mislabeling, e.g., ‘‘Actual net weight may be as low as ll% below labeled quantity’’ and that any subsequent dis tribution by him of said product except for his own institutional use is unlaw ful. This statement shall be kept on file at the principal place of business of the manufacturer or processor for 2 years subsequent to the date of ship ment of the product and shall be avail able to the Food and Drug Administra tion upon request. (2) The product shall be labeled on the outside of its shipping container with the statement(s): (i) When the variation concerns net weight and/or drained weight of vol ume—‘‘Product Mislabeled. Actual net weight (drained weight or volume where appropriate) may be as low as ll% below labeled quantity. This Product Not for Retail Distribution,’’ the blank to be filled in with the max imum percentage variance between the labeled and actual weight or volume of contents of the individual packages in the shipping container, and (ii) When the variation is in regard to a fill of container standard—‘‘Product Mislabeled. Actual fill may be as low as ll% below standard of fill. This Product Not for Retail Distribution.’’ (3) The statements required by para graphs (t)(2) (i) and (ii) of this section, which may be consolidated where ap propriate, shall appear prominently and conspicuously as compared to other printed matter on the shipping container and in boldface print or type on a clear, contrasting background in order to render them likely to be read and understood by the purchaser under ordinary conditions of purchase. [41 FR 38619, Sept. 10, 1976, as amended at 54 FR 18279, Apr. 28, 1989] § 501.110 Animal feed labeling; collec tive names for feed ingredients. (a) An animal feed shall be exempt from the requirements of section 403(i)(2) of the act with respect to its VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00041 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 32 21 CFR Ch. I (4–1–16 Edition) Pt. 502 label bearing the common or usual names of the animal feed ingredients listed in paragraph (b) of this section under the following prescribed condi tions: (1) The animal feed is intended solely for livestock and poultry. (2) The label of the animal feed bears the collective name(s) prescribed in paragraph (b) of this section in lieu of the corresponding common or usual names of the individual feed ingredi ents contained therein. (3) The label of the animal feed oth erwise conforms to the requirements of section 403(i)(2) of the act. (4) The ingredients of any feed listed in paragraph (b) of this section neither contain nor are food additives as de fined in section 201(s) of the act unless provided for by and in conformity with applicable regulations established pur suant to section 409 of the act. (b) Each collective name referred to in this paragraph may be used for the purpose of labeling where one or more of the ingredients listed for that collec tive name are present. The animal feed ingredients listed under each of the collective names are the products de fined by the Association of American Feed Control Officials. The collective names are as follows: (1) Animal protein products include one or more of the following: Animal prod ucts, marine products, and milk prod ucts. (2) Forage products include one or more of the following: Alfalfa meals, entire plant meals, hays, and stem meals. (3) Grain products include one or more of the following: Barley, grain sor ghums, maize (corn), oats, rice, rye, and wheat. (4) Plant protein products include one or more of the following: Algae meals, coconut meals (copra), cottonseed meals, guar meal, linseed meals, pea nut meals, safflower meals, soybean meals, sunflower meals, and yeasts. (5) Processed grain byproducts include one or more of the following: Brans, brewers dried grains, distillers grains, distillers solubles, flours, germ meals, gluten feeds, gluten meals, grits, groats, hominy feeds, malt sprouts, middlings, pearled, polishings, shorts, and wheat mill run. (6) Roughage products include one or more of the following: Cobs, hulls, husks, pulps, and straws. PART 502—COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS Sec. 502.5 General principles. 502.19 Petitions. AUTHORITY: 21 U.S.C. 321, 343, 371. § 502.5 General principles. (a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its charac terizing properties or ingredients. The name shall be uniform among all iden tical or similar products and may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name. Each class or subclass of food shall be given its own common or usual name that states, in clear terms, what it is in a way that distinguishes it from dif ferent foods. (b) The common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or component(s) when the proportion of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erro neous impression that such ingre dient(s) or component(s) is present in an amount greater than is actually the case. The following requirements shall apply unless modified by a specific reg ulation in this part. (1) The percentage of a characterizing ingredient or component shall be de clared on the basis of its quantity in the finished product (i.e., weight/ weight in the case of solids, or volume/ volume in the case of liquids). (2) The percentage of a characterizing ingredient or component shall be de clared by the words ‘‘containing (or contains) ll percent (or %) ll’’ or ‘‘ll percent (or %) ll’’ with the first blank filled in with the percentage ex pressed as a whole number not greater VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00042 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B