GrokFood Home
Loading

101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.

Home > Regulations > Food labeling > 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.



[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.22]

[Page 72-76]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 101_FOOD LABELING--Table of Contents
 
              Subpart B_Specific Food Labeling Requirements
 
Sec.  101.22  Foods; labeling of spices, flavorings, colorings and 
chemical preservatives.


    (a)(1) The term artificial flavor or artificial flavoring means any 
substance, the function of which is to impart flavor, which is not 
derived from a spice, fruit or fruit juice, vegetable or vegetable 
juice, edible yeast, herb, bark, bud, root, leaf or similar plant 
material, meat, fish, poultry, eggs, dairy products, or fermentation 
products thereof. Artificial flavor includes the substances listed in 
Sec. Sec.  172.515(b) and 182.60 of this chapter except where these are 
derived from natural sources.
    (2) The term spice means any aromatic 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 significant function in food is seasoning rather than nutritional; 
that is true to name; and from which no portion of any volatile oil or 
other flavoring principle has been removed. Spices include the spices 
listed in Sec.  182.10 and part 184 of this chapter, such as the 
following:

Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, 
Chervil, Cinnamon, 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 aniseed, Tarragon, Thyme, 
Turmeric.


Paprika, turmeric, and saffron or other spices which are also colors, 
shall be declared as ``spice and coloring'' unless declared by their 
common or usual name.
    (3) The term natural flavor or natural flavoring means the essential 
oil, oleoresin, essence or extractive, protein hydrolysate, distillate, 
or any product of roasting, heating or enzymolysis, which contains the 
flavoring constituents derived from a spice, fruit or fruit juice, 
vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf 
or similar plant material, meat, seafood, poultry, eggs, dairy products, 
or fermentation products thereof, whose significant function in food is 
flavoring rather than nutritional. Natural flavors include the natural 
essence or extractives obtained from plants listed in Sec. Sec.  182.10, 
182.20, 182.40, and 182.50 and part 184 of this chapter, and the 
substances listed in Sec.  172.510 of this chapter.
    (4) The term artificial color or artificial coloring means any 
``color additive'' as defined in Sec.  70.3(f) of this chapter.
    (5) The term chemical preservative means any chemical that, when 
added to food, tends to prevent or retard deterioration thereof, but 
does not include common salt, sugars, vinegars, spices, or oils 
extracted from spices, substances added to food by direct exposure 
thereof to wood smoke, or chemicals applied for their insecticidal or 
herbicidal properties.
    (b) A food which is subject to the requirements of section 403(k) of 
the act shall bear labeling, even though such food is not in package 
form.
    (c) A statement of artificial flavoring, artificial coloring, or 
chemical preservative shall be placed on the food or on its container or 
wrapper, or on any two or all three of these, as may be necessary to 
render such statement likely to be read by the ordinary person under 
customary conditions of purchase and use of such food. The specific

[[Page 73]]

artificial color used in a food shall be identified on the labeling when 
so required by regulation in part 74 of this chapter to assure safe 
conditions of use for the color additive.
    (d) A food shall be exempt from compliance with the requirements of 
section 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 chemical 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 individual under customary conditions 
of purchase and use.
    (e) A food shall be exempt while held for sale from the requirements 
of section 403(k) of the act (requiring label statement of any 
artificial flavoring, artificial coloring, or chemical preservatives) if 
said food, having been received in bulk containers at a retail 
establishment, is displayed to the purchaser with either (1) the 
labeling of the bulk container plainly in view or (2) a counter card, 
sign, or other appropriate device bearing prominently and conspicuously 
the information required to be stated on the label pursuant to section 
403(k).
    (f) A fruit or vegetable shall be exempt from compliance with the 
requirements 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 flavor 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 ingredient, it shall be declared 
by its common 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 
nonflavor 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 flavor'', ``banana 
flavor'', or ``natural strawberry flavor''. In cases where the flavor 
contains both a natural flavor and an artificial flavor, the flavor 
shall be so labeled, e.g., ``natural and artificial strawberry flavor''. 
In cases where the flavor contains a solely artificial flavor(s), the 
flavor shall be so labeled, e.g., ``artificial strawberry flavor''.
    (h) The label of a food to which flavor is added shall declare the 
flavor in the statement of ingredients in the following way:
    (1) Spice, natural flavor, and artificial 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 ingredients if it meets the requirements of Sec.  
101.100(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 commonly understood by consumers to be food rather 
than flavor and shall be declared 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 
declared by its common or usual name ``monosodium glutamate.''
    (6) Any pyroligneous acid or other artificial smoke flavors used as 
an ingredient in a food may be declared as artificial flavor or 
artificial smoke flavor. No representation may be made, either directly 
or implied, that a food flavored with pyroligneous acid or other 
artificial smoke flavor has been smoked or has a true smoked flavor, or 
that a seasoning sauce or similar product containing pyroligneous acid 
or other artificial smoke flavor and used

[[Page 74]]

to season or flavor other foods will result in a smoked product or one 
having a true smoked flavor.
    (7) Because protein hydrolysates function in foods as both 
flavorings and flavor enhancers, no protein hydrolysate used in food for 
its effects on flavor may be declared simply as ``flavor,'' ``natural 
flavor,'' or ``flavoring.'' The ingredient shall be declared by its 
specific common or usual name as provided in Sec.  102.22 of this 
chapter.
    (i) If the label, labeling, or advertising of a food makes any 
direct or indirect 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 reason 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 flavor shall be 
considered the characterizing flavor and shall be declared in the 
following way:
    (1) If the food contains no 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 of the characterizing flavor, 
e.g., ``vanilla'', 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 commonly expected to contain a 
characterizing food ingredient, e.g., strawberries in ``strawberry 
shortcake'', and the food contains natural flavor derived from such 
ingredient and an amount of characterizing ingredient insufficient to 
independently 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 followed by 
the word ``flavored'' in letters not less than one-half the height of 
the letters in the name of the characterizing flavor, e.g., ``natural 
strawberry flavored shortcake,'' or ``strawberry flavored shortcake''.
    (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 labeled either with the flavor of the product from which 
the flavor is derived or as ``artificially flavored.''
    (iii) If the food contains both a characterizing flavor from the 
product whose flavor is simulated and other natural flavor which 
simulates, resembles or reinforces the characterizing flavor, the food 
shall be labeled in accordance with the introductory text and paragraph 
(i)(1)(i) of this section and the name of the food shall be immediately 
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 
accompanied by the word(s) ``artificial'' or ``artificially flavored'', 
in letters not less than one-half the height of the letters in the name 
of the characterizing flavor, e.g., ``artificial vanilla'', 
``artificially flavored strawberry'', or ``grape artificially 
flavored''.
    (3) Wherever the name of the characterizing flavor appears on the 
label (other than in the statement of ingredients) so conspicuously as 
to be easily seen under customary conditions of purchase, the words 
prescribed by this paragraph shall immediately and conspicuously precede 
or follow such name, without any intervening written, printed, or 
graphic matter, except:
    (i) Where the characterizing flavor and a trademark or brand are 
presented 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 related to the characterizing flavor; and
    (ii) If the finished product contains more than one flavor subject 
to the requirements of this paragraph, the statements required by this 
paragraph need appear only once in each statement of characterizing 
flavors present

[[Page 75]]

in such food, e.g., ``artificially flavored vanilla and strawberry''.
    (iii) If the finished product contains three or more distinguishable 
characterizing flavors, or a blend of flavors with no primary 
recognizable flavor, the flavor may be declared by an appropriately 
descriptive generic term in lieu of naming each flavor, e.g., 
``artificially flavored fruit punch''.
    (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 
requirement for such certification may be satisfied by a guarantee under 
section 303(c)(2) of the act which contains such a specific statement. A 
flavor user shall be required to make such a written certification only 
where he adds to or combines another flavor with a flavor which has been 
certified by a flavor supplier as containing no artificial flavor, but 
otherwise such user may rely upon the supplier's certification and need 
make no separate certification. All such certifications shall be 
retained by the certifying party throughout the period in which the 
flavor is supplied and for a minimum of three years thereafter, and 
shall be subject to the following conditions:
    (i) The certifying party shall make such certifications available 
upon request at all reasonable hours to any duly authorized office 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 regarded by the Food and Drug Administration as 
reports to the government and as guarantees or other undertakings within 
the meaning of section 301(h) of the act and subject the certifying 
party to the penalties for making any false report to the government 
under 18 U.S.C. 1001 and any false guarantee 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 provided 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 Administration has reason to believe that the supplier 
or user may utilize this period to alter inventories or records, such 
additional time shall not be permitted. Where such additional time is 
provided, the Food and Drug Administration 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 provide, to an officer or 
representative duly designated by the Secretary, such qualitative 
statement of the composition of the flavor or product covered by the 
certification as may be reasonably expected to enable the Secretary's 
representatives to determine which relevant raw and finished materials 
and flavor ingredient records are reasonably necessary to verify the 
certifications. The examination conducted by the Secretary's 
representative shall be limited to inspection and review of inventories 
and ingredient records for those certifications which are to be 
verified.
    (v) Review of flavor ingredient records shall be limited to the 
qualitative formula and shall not include the quantitative formula. The 
person verifying the certifications may make only such notes as are 
necessary to enable him to verify such certification. Only such notes or 
such flavor ingredient records as are necessary to verify such 
certification or to show a potential or actual violation may be removed 
or transmitted from the certifying party's place of business: Provided, 
That, where such removal or transmittal is necessary for such purposes 
the relevant records and notes shall be retained as separate documents 
in Food and Drug Administration files, shall not be copied in other

[[Page 76]]

reports, and shall not be disclosed publicly other than in a judicial 
proceeding brought pursuant to the act or 18 U.S.C. 1001.
    (j) A food to which a chemical preservative(s) is added shall, 
except when exempt pursuant to Sec.  101.100 bear a label declaration 
stating both the common or usual name of the ingredient(s) and a 
separate description of its function, e.g., ``preservative'', ``to 
retard spoilage'', ``a mold inhibitor'', ``to help protect flavor'' or 
``to promote color retention''.
    (k) The label of a food to which any coloring has been added shall 
declare the coloring in the statement of ingredients in the manner 
specified in paragraphs (k)(1) and (k)(2) of this section, except that 
colorings added to butter, cheese, and ice cream, if declared, may be 
declared in the manner specified in paragraph (k)(3) of this section, 
and colorings added to foods subject to Sec. Sec.  105.62 and 105.65 of 
this chapter shall be declared in accordance with the requirements of 
those sections.
    (1) A color additive or the lake of a color additive subject to 
certification under 721(c) of the act shall be declared by the name of 
the color additive listed in the applicable regulation in part 74 or 
part 82 of this chapter, except 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 declaration of the lake of the 
certified color additive (e.g., Blue 1 Lake). Manufacturers may 
parenthetically declare an appropriate alternative name of the certified 
color additive following its common or usual name as specified in part 
74 or part 82 of this chapter.
    (2) Color additives not subject to certification may be declared as 
``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added'' (or 
by an equally informative term that makes clear that a color additive 
has been used in the food). Alternatively, such color additives may be 
declared as ``Colored with ------'' or ``------ color'', the blank to be 
filled with the name of the color additive listed in the applicable 
regulation in part 73 of this chapter.
    (3) When a coloring has been added to butter, cheese, or ice cream, 
it need not be declared in the ingredient list unless such declaration 
is required by a regulation in part 73 or part 74 of this chapter to 
ensure safe conditions of use for the color additive. Voluntary 
declaration of all colorings added to butter, cheese, and ice cream, 
however, is recommended.

[42 FR 14308, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 44 
FR 37220, June 26, 1979; 54 FR 24891, June 12, 1989; 58 FR 2875, Jan. 6, 
1993; 63 FR 14818, Mar. 27, 1998]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 101, Section 22


Home | About | Search