§ 501.22 21 CFR Ch. I (4–1–11 Edition)

Subpart B—Specific Animal Food rather than nutritional. Natural fla- Labeling Requirements vors, include the natural essence or ex- tractives obtained from plants listed in § 501.22 Animal foods; labeling of subpart A of part 582 of this chapter, , flavorings, colorings, and and the substances listed in § 172.510 of chemical preservatives. this chapter. (a)(1) The term artificial flavor or arti- (4) The term artificial color or artificial ficial flavoring means any substance, coloring means any color additive as de- the function of which is to impart fla- fined in § 70.3(f) of this chapter. vor, which is not derived from a , (5) The term chemical preservative fruit or fruit juice, vegetable or vege- means any chemical that, when added table juice, edible yeast, , bark, to food, tends to prevent or retard de- bud, root, leaf or similar plant mate- terioration thereof, but does not in- rial, meat, fish, poultry, eggs, dairy clude common , sugars, vinegars, products, or fermentation products spices, or oils extracted from spices, thereof. Artificial flavor includes the substances added to food by direct ex- substances listed in §§ 172.515(b) and posure thereof to wood smoke, or 582.60 of this chapter except where chemicals applied for their insecticidal these are derived from natural sources. or herbicidal properties. (2) The term spice means any aro- (b) A food which is subject to the re- matic vegetable substance in the quirements of section 403(k) of the act whole, broken, or ground form, except shall bear labeling, even though such for those substances which have been food is not in package form. traditionally regarded as foods, such as (c) A statement of artificial fla- onions, and ; whose signifi- voring, artificial coloring, or chemical cant function in food is rath- preservative shall be placed on the er than nutritional; that is true to food, or on its container or wrapper, or name; and from which no portion of on any two or all of these, as may be any volatile oil or other flavoring prin- necessary to render such statement ciple has been removed. Spices include likely to be read by the ordinary indi- the spices listed in subpart A of part vidual under customary conditions of 582 of this chapter, such as the fol- purchase and use of such food. lowing: (d) A food shall be exempt from com- , , , Bay leaves, pliance with the requirements of sec- seed, Cardamon, Celery seed, , Cin- tion 403(k) of the act if it is not in namon, , , seed, package form and the units thereof are seed, seed, , , so small that a statement of artificial , Mace, , flavoring, artificial coloring, or chem- flour, , , , , ical preservative, as the case may be, Pepper, black; Pepper, white; Pepper, red; cannot be placed on such units with , , Sage, Savory, Star ani- seed, , , . such conspicuousness as to render it likely to be read by the ordinary indi- Paprika, turmeric, and saffron or other vidual under customary conditions of spices which are also colors, shall be purchase and use. declared as spice and coloring unless de- (e) A food shall be exempt while held clared by their common or usual name. for sale from the requirements of sec- (3) The term natural flavor or natural tion 403(k) of the act (requiring label flavoring means the essential oil, oleo- statement of any artificial flavoring, resin, essence or extractive, protein hy- artificial coloring, or chemical preserv- drolysate, distillate, or any product of atives) if said food, having been re- roasting, heating or enzymolysis, ceived in bulk containers at a retail es- which contains the flavoring constitu- tablishment, is displayed to the pur- ents derived from a spice, fruit or fruit chaser with either (1) the labeling of juice, vegetable or vegetable juice, edi- the bulk container plainly in view or ble yeast, herb, bark, bud, root, leaf or (2) a counter card, sign, or other appro- similar plant material, meat, seafood, priate device bearing prominently and poultry, eggs, dairy products, or fer- conspicuously the information required mentation products thereof, whose sig- to be stated on the label pursuant to nificant function in food is flavoring section 403(k) of the act.

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(f) A fruit or vegetable shall be ex- vegetable, meat, fish, or poultry, e.g., empt from compliance with the re- powdered or granulated onions, garlic quirements of section 403(k) of the act powder, and celery powder, are com- with respect to a chemical preservative monly understood by consumers to be applied to the fruit or vegetable as a food rather than flavor and shall be de- pesticide chemical prior to harvest. clared by their common or usual name. (g) A flavor shall be labeled in the (4) Any salt (sodium chloride) used as following way when shipped to a food an ingredient in food shall be declared manufacturer or processor (but not a by its common or usual name salt. consumer) for use in the manufacture (5) Any monosodium glutamate used of a fabricated food, unless it is a fla- as an ingredient in food shall be de- vor for which a standard of identity clared by its common or usual name has been promulgated, in which case it monosodium glutamate. shall be labeled as provided in the (6) Any pyroligneous acid or other ar- standard: tificial smoke flavors used as an ingre- (1) If the flavor consists of one ingre- dient in a food may be declared as arti- dient, it shall be declared by its com- ficial flavor or artificial smoke flavor. No mon or usual name. representation may be made, either di- (2) If the flavor consists of two or rectly or implied, that a food flavored more ingredients, the label either may with pyroligneous acid or other artifi- declare each ingredient by its common cial smoke flavor has been smoked or or usual name or may state ‘‘All flavor has a true smoked flavor, or that a sea- ingredients contained in this product soning sauce or similar product con- are approved for use in a regulation of taining pyroligneous acid or other arti- the Food and Drug Administration.’’ ficial smoke flavor and used to season Any flavor ingredient not contained in or flavor other foods will result in a one of these regulations, and any non- smoked product or one having a true flavor ingredient, shall be separately smoked flavor. listed on the label. (i) If the label, labeling, or adver- (3) In cases where the flavor contains tising of a food makes any direct or in- a solely natural flavor(s), the flavor direct representations with respect to shall be so labeled, e.g., strawberry fla- the primary recognizable flavor(s), by vor, banana flavor, or natural strawberry word, vignette, e.g., depiction of a fruit, flavor. In cases where the flavor con- or other means, or if for any other rea- tains both a natural flavor and an arti- son the manufacturer or distributor of ficial flavor, the flavor shall be so la- a food wishes to designate the type of beled, e.g., natural and artificial straw- flavor in the food other than through berry flavor. In cases where the flavor the statement of ingredients, such fla- contains a solely artificial flavor(s), vor shall be considered the character- the flavor shall be so labeled, e.g., arti- izing flavor and shall be declared in the ficial strawberry flavor. following way: (h) The label of a food to which flavor (1) If the food contains no artificial is added shall declare the flavor in the flavor which simulates, resembles or statement of ingredients in the fol- reinforces the characterizing flavor, lowing way: the name of the food on the principal (1) Spice, natural flavor, and artifi- display panel or panels of the label cial flavor may be declared as spice, shall be accompanied by the common natural flavor, or artificial flavor, or any or usual name of the characterizing fla- combination thereof, as the case may vor in letters not less than one-half the be. height of the letters used in the name (2) An incidental additive in a food, of the food, except that: originating in a spice or flavor used in (i) If the food is one that is com- the manufacture of the food, need not monly expected to contain a character- be declared in the statement of ingredi- izing food ingredient, and the food con- ents if it meets the requirements of tains natural flavor derived from such § 501.100(a)(3). ingredient and an amount of character- (3) Substances obtained by cutting, izing ingredient insufficient to inde- grinding, drying, pulping, or similar pendently characterize the food, or the processing of tissues derived from fruit, food contains no such ingredient, the

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name of the characterizing flavor may words are in such relationship with the be immediately preceded by the word trademark or brand as to be clearly re- natural and shall be immediately fol- lated to the characterizing flavor; and lowed by the word flavored in letters (ii) If the finished product contains not less than one-half the height of the more than one flavor subject to the re- letters in the name of the character- quirements of this paragraph, the izing flavor. statements required by this paragraph (ii) If none of the natural flavor used need appear only once in each state- in the food is derived from the product ment of characterizing flavors present whose flavor is simulated, the food in in such food. which the flavor is used shall be la- (iii) If the finished product contains beled either with the flavor of the prod- three or more distinguishable charac- uct from which the flavor is derived or terizing flavors, or a blend of flavors as artificially flavored. with no primary recognizable flavor, (iii) If the food contains both a char- the flavor may be declared by an appro- acterizing flavor from the product priately descriptive generic term in whose flavor is simulated and other lieu of naming each flavor. natural flavor which simulates, resem- (4) A flavor supplier shall certify, in bles or reinforces the characterizing writing, that any flavor he supplies flavor, the food shall be labeled in ac- which is designated as containing no cordance with the introductory text artificial flavor does not, to the best of and paragraph (i)(1)(i) of this section his knowledge and belief, contain any and the name of the food shall be im- artificial flavor, and that he has added mediately followed by the words with no artificial flavor to it. The require- other natural flavor in letters not less ment for such certification may be sat- than one-half the height of the letters isfied by a guarantee under section used in the name of the characterizing 303(c)(2) of the act which contains such flavor. a specific statement. A flavor used (2) If the food contains any artificial shall be required to make such a writ- flavor which simulates, resembles or ten certification only where he adds to reinforces the characterizing flavor, or combines another flavor with a fla- the name of the food on the principal vor which has been certified by a flavor display panel or panels of the label supplier as containing no artificial fla- shall be accompanied by the common vor, but otherwise such user may rely or usual name(s) of the characterizing upon the supplier’s certification and flavor, in letters not less than one-half need make no separate certification. the height of the letters used in the All such certifications shall be re- name of the food and the name of the tained by the certifying party through- characterizing flavor shall be accom- out the period in which the flavor is panied by the word(s) artificial or artifi- supplied and for a minimum of 3 years cially flavored, in letters not less than thereafter, and shall be subject to the one-half the height of the letters in the following conditions: name of the characterizing flavor. (i) The certifying party shall make (3) Wherever the name of the charac- such certifications available upon re- terizing flavor appears on the label quest at all reasonable hours to any (other than in the statement of ingre- duly authorized officer, or employee of dients) so conspicuously as to be easily the Food and Drug Administration or seen under customary conditions of any other employee acting on behalf of purchase, the words prescribed by this the Secretary of Health and Human paragraph shall immediately and con- Services. Such certifications are re- spicuously precede or follow such garded by the Food and Drug Adminis- name, without any intervening writ- tration as reports to the government ten, printed, or graphic matter, except: and as guarantees or other under- (i) Where the characterizing flavor takings within the meaning of section and a trademark or brand are pre- 301(h) of the act and subject the certi- sented together, other written, printed, fying party to the penalties for making or graphic matter that is a part of or is any false report to the government associated with the trademark or under 18 U.S.C. 1001 and any false guar- brand may intervene if the required antee or undertaking under section

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303(a) of the act. The defenses provided fying party’s place of business: Pro- under section 303(c)(2) of the act shall vided, That, where such removal or be applicable to the certifications pro- transmittal is necessary for such pur- vided for in this section. poses the relevant records and notes (ii) Wherever possible, the Food and shall be retained as separate docu- Drug Administration shall verify the ments in Food and Drug Administra- accuracy of a reasonable number of tion files, shall not be copied in other certifications made pursuant to this reports, and shall not be disclosed pub- section, constituting a representative licly other than in a judicial pro- sample of such certifications, and shall ceeding brought pursuant to the act or not request all such certifications. 18 U.S.C. 1001. (iii) Where no person authorized to (j) A food to which a chemical pre- provide such information is reasonably servative(s) is added shall, except when available at the time of inspection, the exempt pursuant to § 501.100, bear a certifying party shall arrange to have label declaration stating both the com- such person and the relevant materials mon or usual name of the ingredient(s) and records ready for verification as and a separate description of its func- soon as practicable; provided that, tion, e.g., preservative, to retard spoilage, whenever the Food and Drug Adminis- a mold inhibitor, to help protect flavor or tration has reason to believe that the to promote color retention. supplier or user may utilize this period to alter inventories or records, such ad- [41 FR 38619, Sept. 10, 1976, as amended at 42 ditional time shall not be permitted. FR 14091, Mar. 15, 1977; 42 FR 15675, Mar. 22, Where such additional time is pro- 1977] vided, the Food and Drug Administra- tion may require the certifying party Subparts C–E [Reserved] to certify that relevant inventories have not been materially disturbed and Subpart F—Exemptions From Ani- relevant records have not been altered mal Food Labeling Require- or concealed during such period. (iv) The certifying party shall pro- ments vide, to an officer or representative § 501.100 Animal food; exemptions duly designated by the Secretary, such from labeling. qualitative statement of the composi- tion of the flavor or product covered by (a) The following foods are exempt the certification as may be reasonably from compliance with the require- expected to enable the Secretary’s rep- ments of section 403(i)(2) of the act (re- resentatives to determine which rel- quiring a declaration on the label of evant raw and finished materials and the common or usual name of each in- flavor ingredient records are reason- gredient when the food is fabricated ably necessary to verify the certifi- from two or more ingredients). cations. The examination conducted by (1) An assortment of different items the Secretary’s representative shall be of food, when variations in the items limited to inspection and review of in- that make up different packages ventories and ingredient records for packed from such assortment normally those certifications which are to be occur in good packing practice and verified. when such variations result in vari- (v) Review of flavor ingredient ations in the ingredients in different records shall be limited to the quali- packages, with respect to any ingre- tative formula and shall not include dient that is not common to all pack- the quantitative formula. The person ages. Such exemption, however, shall verifying the certifications may make be on the condition that the label shall only such notes as are necessary to en- bear, in conjunction with the names of able him to verify such certification. such ingredients as are common to all Only such notes or such flavor ingre- packages, a statement (in terms that dient records as are necessary to verify are as informative as practicable and such certification or to show a poten- that are not misleading) indicating by tial or actual violation may be re- name other ingredients which may be moved or transmitted from the certi- present.

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