[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: 21CFR101.4]
[Page 15-19]
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 A_General Provisions
Sec. 101.4 Food; designation of ingredients.
(a)(1) Ingredients required to be declared on the label or labeling
of a food, including foods that comply with standards of identity,
except those ingredients exempted by Sec. 101.100, shall be listed by
common or usual name in descending order of predominance by weight on
either the principal display panel or the information panel in
accordance with the provisions of Sec. 101.2, except that ingredients
in dietary supplements that are listed in the nutrition label in
accordance with Sec. 101.36 need not be repeated in the ingredient
list. Paragraph (g) of this section describes the ingredient list on
dietary supplement products.
(2) The descending order of predominance requirements of paragraph
(a)(1) of this section do not apply to ingredients present in amounts of
2 percent or less by weight when a listing of these ingredients is
placed at the end of the ingredient statement following an appropriate
quantifying statement, e.g., ``Contains -- percent or less of ------''
or ``Less than -- percent of ------.'' The blank percentage within the
quantifying statement shall be filled in with a threshold level of 2
percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as
appropriate. No ingredient to which the quantifying phrase applies may
be present in an amount greater than the stated threshold.
(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 declared according to the provisions of Sec. 101.22.
(2) An ingredient which itself contains two or more ingredients and
which has an established common or usual name, conforms to a standard
established pursuant to the Meat Inspection or Poultry Products
Inspection Acts by the U.S. Department of Agriculture, or conforms to a
definition and standard of identity established pursuant to section 401
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the
statement of ingredients on the label of such food by either of the
following alternatives:
(i) By declaring the established common or usual name of the
ingredient followed by a parenthetical listing of all ingredients
contained therein in descending order of predominance except that, if
the ingredient is a food subject to a definition and standard of
identity established in subchapter B of this chapter that has specific
labeling provisions for optional ingredients, optional ingredients may
be declared within the parenthetical listing in accordance with those
provisions.
(ii) By incorporating into the statement 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, reconstituted milk, and dry whole milk
may be declared as ``milk''.
(5) Bacterial cultures may be declared by the word ``cultured''
followed by the name of the substrate, e.g., ``made from cultured skim
milk or cultured buttermilk''.
(6) Sweetcream buttermilk, concentrated sweetcream buttermilk,
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may
be declared as ``buttermilk''.
(7) Whey, concentrated whey, reconstituted whey, and dried whey may
be declared as ``whey''.
(8) Cream, reconstituted cream, dried cream, and plastic cream
(sometimes known as concentrated milk fat) 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 declared as ``eggs''.
(11) Dried egg whites, frozen egg whites, and liquid egg whites may
be declared as ``egg whites''.
[[Page 16]]
(12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be
declared as ``egg yolks''.
(13) [Reserved]
(14) Each individual fat and/or oil ingredient of a food intended
for human consumption shall be declared by its specific common or usual
name (e.g., ``beef fat'', ``cottonseed oil'') in its order of
predominance in the food except that blends of fats and/or oils may be
designated in their order of predominance in the foods as ``------
shortening'' or ``blend of ------ oils'', the blank to be filled in with
the word ``vegetable'', ``animal'', ``marine'', with or without the
terms ``fat'' or ``oils'', or combination of these, whichever is
applicable if, immediately following the term, the common or usual name
of each individual vegetable, animal, or marine fat or oil is given in
parentheses, e.g., ``vegetable oil shortening (soybean and cottonseed
oil)''. For products that are blends of fats and/or oils and for foods
in which fats and/or oils constitute the predominant ingredient, i.e.,
in which the combined weight of all fat and/or oil ingredients equals or
exceeds the weight of the most predominant ingredient that is not a fat
or oil, the listing of the common or usual names of such fats and/or
oils in parentheses shall be in descending order of predominance. In all
other foods in which a blend of fats and/or oils is used as an
ingredient, the listing of the common or usual names in parentheses need
not be in descending order of predominance if the manufacturer, because
of the use of varying mixtures, is unable to adhere to a constant
pattern of fats and/or oils in the product. If the fat or oil is
completely hydrogenated, the name shall include the term hydrogenated,
or if partially hydrogenated, the name shall include the term partially
hydrogenated. If each fat and/or oil in a blend or the blend is
completely hydrogenated, the term ``hydrogenated'' may precede the
term(s) describing the blend, e.g., ``hydrogenated vegetable oil
(soybean, cottonseed, and palm oils)'', rather than preceding the name
of each individual fat and/or oil; if the blend of fats and/or oils is
partially hydrogenated, the term ``partially hydrogenated'' may be used
in the same manner. Fat and/or oil ingredients not present in the
product may be listed if they may sometimes be used in the product. Such
ingredients shall be identified by words indicating that they may not be
present, such as ``or'', ``and/or'', ``contains one or more of the
following:'', e.g., ``vegetable oil shortening (contains one or more of
the following: cottonseed oil, palm oil, soybean oil)''. No fat or oil
Fingredient shall be listed unless actually present if the fats and/or
oils constitute the predominant ingredient of the product, as defined in
this paragraph (b)(14).
(15) When all the ingredients of a wheat flour are declared in an
ingredient statement, the principal ingredient of the flour shall be
declared by the name(s) specified in Sec. Sec. 137.105, 137.200,
137.220 and 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 ingredient designated in
the ingredient list of durum flour is ``durum flour''; the first
ingredient designated in the ingredient 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''.
(16) Ingredients that act as leavening agents in food may be
declared in the ingredient statement by stating the specific common or
usual name of each individual leavening agent in parentheses following
the collective name ``leavening'', e.g., ``leavening (baking soda,
monocalcium phosphate, and calcium carbonate)''. The listing of the
common or usual name of each individual leavening agent in parentheses
shall be in descending order of predominance: Except, That if the
manufacturer is unable to adhere to a constant pattern of leavening
agents in the product, the listing of individual leavening agents need
not be in descending order of predominance. Leavening agents not present
in the product may be listed if they are sometimes used in the product.
Such ingredients shall be identified by words indicating that they may
not be present, such as
[[Page 17]]
``or'', ``and/or'', ``contains one or more of the following:''.
(17) Ingredients that act as yeast nutrients in foods may be
declared in the ingredient statement by stating the specific common or
usual name of each individual yeast nutrient in parentheses following
the collective name ``yeast nutrients'', e.g., ``yeast nutrients
(calcium sulfate and ammonium phosphate)''. The listing of the common or
usual name of each individual yeast nutrient in parentheses shall be in
descending order of predominance: Except, That if the manufacturer is
unable to adhere to a constant pattern of yeast nutrients in the
product, the listing of the common or usual names of individual yeast
nutrients need not be in descending order of predominance. Yeast
nutrients not present in the product may be listed if they are sometimes
used in the product. Such ingredients shall be identified by words
indicating that they may not be present, such as ``or'', ``and/or'', or
``contains one or more of the following:''.
(18) Ingredients that act as dough conditioners may be declared in
the ingredient statement by stating the specific common or usual name of
each individual dough conditioner in parentheses following the
collective name ``dough conditioner'', e.g., ``dough conditioners (L-
cysteine, ammonium sulfate)''. The listing of the common or usual name
of each dough conditioner in parentheses shall be in descending order of
predominance: Except, That if the manufacturer is unable to adhere to a
constant pattern of dough conditioners in the product, the listing of
the common or usual names of individual dough conditioners need not be
in descending order of predominance. Dough conditioners not present in
the product may be listed if they are sometimes used in the product.
Such ingredients shall be identified by words indicating that they may
not be present, such as ``or'', ``and/or'', or ``contains one or more of
the following:''.
(19) Ingredients that act as firming agents in food (e.g., salts of
calcium and other safe and suitable salts in canned vegetables) may be
declared in the ingredient statement, in order of predominance
appropriate for the total of all firming agents in the food, by stating
the specific common or usual name of each individual firming agent in
descending order of predominance in parentheses following the collective
name ``firming agents''. If the manufacturer is unable to adhere to a
constant pattern of firming agents in the food, the listing of the
individual firming agents need not be in descending order of
predominance. Firming agents not present in the product may be listed if
they are sometimes used in the product. Such ingredients shall be
identified by words indicating that they may not be present, such as
``or'', ``and/or'', ``contains one or more of the following:''.
(20) For purposes of ingredient labeling, the term sugar shall refer
to sucrose, which is obtained from sugar cane or sugar beets in
accordance with the provisions of Sec. 184.1854 of this chapter.
(21) [Reserved]
(22) Wax and resin ingredients on fresh produce when such produce is
held for retail sale, or when held for other than retail sale by packers
or repackers shall be declared collectively by the phrase ``coated with
food-grade animal-based wax, to maintain freshness'' or the phrase
``coated with food-grade vegetable-, petroleum-, beeswax-, and/or
shellac-based wax or resin, to maintain freshness'' as appropriate. The
terms ``food-grade'' and ``to maintain freshness'' are optional. The
term lac-resin may be substituted for the term shellac.
(23) When processed seafood products contain fish protein
ingredients consisting primarily of the myofibrillar protein fraction
from one or more fish species and the manufacturer is unable to adhere
to a constant pattern of fish species in the fish protein ingredient,
because of seasonal or other limitations of species availability, the
common or usual name of each individual fish species need not be listed
in descending order of predominance. Fish species not present in the
fish protein ingredient may be listed if they are sometimes used in the
product. Such ingredients must be identified by words indicating that
they may not be present, such as ``or'', ``and/or'', or ``contains one
or more of the following:'' Fish protein ingredients may
[[Page 18]]
be declared in the ingredient statement by stating the specific common
or usual name of each fish species that may be present in parentheses
following the collective name ``fish protein'', e.g., ``fish protein
(contains one or more of the following: Pollock, cod, and/or pacific
whiting)''.
(c) When water is added to reconstitute, completely or partially, an
ingredient 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 reconstitute the ingredient to single strength. Any water added in
excess of the amount of water needed to reconstitute the ingredient to
single strength shall be declared as ``water'' in the ingredient
statement.
(d) When foods characterized on the label as ``nondairy'' contain a
caseinate ingredient, the caseinate ingredient shall be followed by a
parenthetical statement identifying its source. For example, if the
manufacturer uses the term ``nondairy'' on a creamer that contains
sodium caseinate, it shall include a parenthetical term such as ``a milk
derivative'' after the listing of sodium caseinate in the ingredient
list.
(e) If the percentage of an ingredient is included in the statement
of ingredients, it shall be shown in parentheses following the name of
the ingredient and expressed in terms of percent by weight. Percentage
declarations shall be expressed to the nearest 1 percent, except that
where ingredients are present at levels of 2 percent or less, they may
be grouped together and expressed in accordance with the quantifying
guidance set forth in paragraph (a)(2) of this section.
(f) Except as provided in Sec. 101.100, ingredients that must be
declared on labeling because there is no label for the food, including
foods that comply with standards of identity, shall be listed
prominently and conspicuously by common or usual name in the manner
prescribed by paragraph (b) of this section.
(g) When present, the ingredient list on dietary supplement products
shall be located immediately below the nutrition label, or, if there is
insufficient space below the nutrition label, immediately contiguous and
to the right of the nutrition label and shall be preceded by the word
``Ingredients,'' unless some ingredients (i.e., sources) are identified
within the nutrition label in accordance with Sec. 101.36(d), in which
case the ingredients listed outside the nutrition label shall be in a
list preceded by the words ``Other ingredients.'' Ingredients in dietary
supplements that are not dietary ingredients or that do not contain
dietary ingredients, such as excipients, fillers, artificial colors,
artificial sweeteners, flavors, or binders, shall be included in the
ingredient list.
(h) The common or usual name of ingredients of dietary supplements
that are botanicals (including fungi and algae) shall be consistent with
the names standardized in Herbs of Commerce, 1992 edition, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the American Herbal Products
Association, 8484 Georgia Ave., suite 370, Silver Spring, MD 20910, 301-
588-1171, FAX 301-588-1174, e-mail: ahpa@ahpa.org, or may be examined at
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal
Register, 800 N. Capitol St. NW., suite 700, Washington, DC. The listing
of these names on the label shall be followed by statements of:
(1) The part of the plant (e.g., root, leaves) from which the
dietary ingredient is derived (e.g., ``Garlic bulb'' or ``Garlic
(bulb)''), except that this designation is not required for algae. The
name of the part of the plant shall be expressed in English (e.g.,
``flower'' rather than ``flos'');
(2) The Latin binomial name of the plant, in parentheses, except
that this name is not required when it is available in the reference
entitled: Herbs of Commerce for the common or usual name listed on the
label, and, when required, the Latin binomial name may be listed before
the part of the plant.
[[Page 19]]
Any name in Latin form shall be in accordance with internationally
accepted rules on nomenclature, such as those found in the International
Code of Botanical Nomenclature and shall include the designation of the
author or authors who published the Latin name, when a positive
identification cannot be made in its absence. The International Code of
Botanical Nomenclature (Tokyo Code), 1994 edition, a publication of the
International Association for Plant Taxonomy, is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
of the International Code of Botanical Nomenclature may be obtained from
Koeltz Scientific Books, D-61453 Konigstein, Germany, and University
Bookstore, Southern Illinois University, Carbondale, IL 62901-4422, 618-
536-3321, FAX 618-453-5207, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, 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/
code--of--federal--regulations/ibr--locations.html.
(3) On labels of single-ingredient dietary supplements that do not
include an ingredient list, the identification of the Latin binomial
name, when needed, and the part of the plant may be prominently placed
on the principal display panel or information panel, or included in the
nutrition label.
[42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978;
43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr.
25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR 49847, Sept. 23, 1997; 62 FR
64634, Dec. 8, 1997; 64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. 30,
2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003]
Additives that reference this regulation: |
