§ 101.18 21 CFR Ch. I (4–1–12 Edition) (8) Persons engaged in handling or misdescriptive. A trademark or trade storing packed shell eggs for retail dis- name composed in whole or in part of tribution shall permit authorized rep- geographical words shall not be consid- resentatives of FDA to make at any ered deceptively misdescriptive if it: reasonable time such inspection of the (i) Has been so long and exclusively establishment in which shell eggs are used by a manufacturer or distributor being held, including inspection and that it is generally understood by the sampling of the labeling of such eggs as consumer to mean the product of a par- may be necessary in the judgment of ticular manufacturer or distributor; or such representatives to determine com- (ii) Is so arbitrary or fanciful that it pliance with the provisions of this sec- is not generally understood by the con- tion. Inspections may be made with or sumer to suggest geographic origin. without notice and will ordinarily be (3) A part of the name required by ap- made during regular business hours. plicable Federal law or regulation. (9) No State or local governing entity (4) A name whose market signifi- shall establish or continue in effect cance is generally understood by the any law, rule, regulation, or other re- consumer to connote a particular class, quirement requiring safe handling in- kind, type, or style of food rather than structions on unpasteurized shell eggs to indicate geographical origin. that are less stringent than those re- quired in paragraphs (h)(1) through Subpart B—Specific Food Labeling (h)(5) of this section. Requirements [42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977; 49 FR 13690, Apr. 6, § 101.22 Foods; labeling of spices, 1984; 49 FR 28548, July 13, 1984; 61 FR 20100, flavorings, colorings and chemical May 3, 1996; 62 FR 2249, Jan. 15, 1997; 63 FR preservatives. 8118, Feb. 18, 1998; 63 FR 37055, July 8, 1998; 63 (a)(1) The term artificial flavor or arti- FR 63982, Nov. 18, 1998; 66 FR 17358, Mar. 30, ficial flavoring means any substance, 2001; 65 FR 76111, Dec. 5, 2000; 72 FR 46378, the function of which is to impart fla- Aug. 20, 2007] vor, which is not derived from a spice, § 101.18 Misbranding of food. fruit or fruit juice, vegetable or vege- table juice, edible yeast, herb, bark, (a) Among representations in the la- bud, root, leaf or similar plant mate- beling of a food which render such food rial, meat, fish, poultry, eggs, dairy misbranded is a false or misleading products, or fermentation products representation with respect to another thereof. Artificial flavor includes the food or a drug, device, or cosmetic. substances listed in §§ 172.515(b) and (b) The labeling of a food which con- 182.60 of this chapter except where tains two or more ingredients may be these are derived from natural sources. misleading by reason (among other rea- (2) The term spice means any aro- sons) of the designation of such food in matic vegetable substance in the such labeling by a name which includes whole, broken, or ground form, except or suggests the name of one or more for those substances which have been but not all such ingredients, even traditionally regarded as foods, such as though the names of all such ingredi- onions, garlic and celery; whose signifi- ents are stated elsewhere in the label- cant function in food is seasoning rath- ing. er than nutritional; that is true to (c) Among representations in the la- name; and from which no portion of beling of a food which render such food any volatile oil or other flavoring prin- misbranded is any representation that ciple has been removed. Spices include expresses or implies a geographical ori- the spices listed in § 182.10 and part 184 gin of the food or any ingredient of the of this chapter, such as the following: food except when such representation is either: Allspice, Anise, Basil, Bay leaves, Caraway (1) A truthful representation of geo- seed, Cardamon, Celery seed, Chervil, Cin- namon, Cloves, Coriander, Cumin seed, Dill graphical origin. seed, Fennel seed, Fenugreek, Ginger, (2) A trademark or trade name pro- Horseradish, Mace, Marjoram, Mustard vided that as applied to the article in flour, Nutmeg, Oregano, Paprika, Parsley, question its use is not deceptively Pepper, black; Pepper, white; Pepper, red; 72 VerDate Mar<15>2010 20:16 May 07, 2012 Jkt 226068 PO 00000 Frm 00082 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT ofr150 PsN: PC150 Food and Drug Administration, HHS § 101.22 Rosemary, Saffron, Sage, Savory, Star ani- (d) A food shall be exempt from com- seed, Tarragon, Thyme, Turmeric. pliance with the requirements of sec- tion 403(k) of the act if it is not in Paprika, turmeric, and saffron or other package form and the units thereof are spices which are also colors, shall be so small that a statement of artificial declared as ‘‘spice and coloring’’ unless flavoring, artificial coloring, or chem- declared by their common or usual ical preservative, as the case may be, name. cannot be placed on such units with (3) The term natural flavor or natural such conspicuousness as to render it flavoring means the essential oil, oleo- likely to be read by the ordinary indi- resin, essence or extractive, protein hy- vidual under customary conditions of drolysate, distillate, or any product of purchase and use. roasting, heating or enzymolysis, (e) A food shall be exempt while held which contains the flavoring constitu- for sale from the requirements of sec- ents derived from a spice, fruit or fruit tion 403(k) of the act (requiring label juice, vegetable or vegetable juice, edi- statement of any artificial flavoring, ble yeast, herb, bark, bud, root, leaf or artificial coloring, or chemical preserv- similar plant material, meat, seafood, atives) if said food, having been re- poultry, eggs, dairy products, or fer- ceived in bulk containers at a retail es- mentation products thereof, whose sig- tablishment, is displayed to the pur- nificant function in food is flavoring chaser with either (1) the labeling of rather than nutritional. Natural fla- the bulk container plainly in view or vors include the natural essence or ex- (2) a counter card, sign, or other appro- tractives obtained from plants listed in priate device bearing prominently and §§ 182.10, 182.20, 182.40, and 182.50 and conspicuously the information required part 184 of this chapter, and the sub- to be stated on the label pursuant to stances listed in § 172.510 of this chap- section 403(k). ter. (f) A fruit or vegetable shall be ex- (4) The term artificial color or artificial empt from compliance with the re- coloring means any ‘‘color additive’’ as quirements of section 403(k) of the act defined in § 70.3(f) of this chapter. with respect to a chemical preservative (5) The term chemical preservative applied to the fruit or vegetable as a means any chemical that, when added pesticide chemical prior to harvest. to food, tends to prevent or retard de- (g) A flavor shall be labeled in the terioration thereof, but does not in- following way when shipped to a food clude common salt, sugars, vinegars, manufacturer or processor (but not a spices, or oils extracted from spices, consumer) for use in the manufacture substances added to food by direct ex- of a fabricated food, unless it is a fla- posure thereof to wood smoke, or vor for which a standard of identity chemicals applied for their insecticidal has been promulgated, in which case it or herbicidal properties. shall be labeled as provided in the (b) A food which is subject to the re- standard: quirements of section 403(k) of the act (1) If the flavor consists of one ingre- shall bear labeling, even though such dient, it shall be declared by its com- food is not in package form. mon or usual name. (c) A statement of artificial fla- (2) If the flavor consists of two or voring, artificial coloring, or chemical more ingredients, the label either may preservative shall be placed on the food declare each ingredient by its common or on its container or wrapper, or on or usual name or may state ‘‘All flavor any two or all three of these, as may be ingredients contained in this product necessary to render such statement are approved for use in a regulation of likely to be read by the ordinary per- the Food and Drug Administration.’’ son under customary conditions of pur- Any flavor ingredient not contained in chase and use of such food. The specific one of these regulations, and any non- artificial color used in a food shall be flavor ingredient, shall be separately identified on the labeling when so re- listed on the label. quired by regulation in part 74 of this (3) In cases where the flavor contains chapter to assure safe conditions of use a solely natural flavor(s), the flavor for the color additive. shall be so labeled, e.g., ‘‘strawberry 73 VerDate Mar<15>2010 20:16 May 07, 2012 Jkt 226068 PO 00000 Frm 00083 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT ofr150 PsN: PC150 § 101.22 21 CFR Ch. I (4–1–12 Edition) flavor’’, ‘‘banana flavor’’, or ‘‘natural vor may be declared simply as ‘‘fla- strawberry flavor’’. In cases where the vor,’’ ‘‘natural flavor,’’ or ‘‘flavoring.’’ flavor contains both a natural flavor The ingredient shall be declared by its and an artificial flavor, the flavor shall specific common or usual name as pro- be so labeled, e.g., ‘‘natural and artifi- vided in § 102.22 of this chapter.