[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135.110]
[Page 366-369]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 135 FROZEN DESSERTS--Table of Contents
Subpart B Requirements for Specific Standardized Frozen Desserts
Sec. 135.110 Ice cream and frozen custard.
(a) Description. (1) Ice cream is a food produced by freezing, while
stirring, a pasteurized mix consisting of one or more of the optional
dairy ingredients specified in paragraph (b) of this section, and may
contain one or more of the optional caseinates specified in paragraph
(c) of this section subject to the conditions hereinafter set forth, one
or more of the optional hydrolyzed milk proteins as provided for in
paragraph (d) of this section subject to the conditions hereinafter set
forth, and other safe and suitable nonmilk-derived ingredients; and
excluding other food fats, except such as are natural components of
flavoring ingredients used or are added in incidental amounts to
accomplish specific functions. Ice cream is sweetened with safe and
suitable sweeteners and may be characterized by the addition of
flavoring ingredients.
(2) Ice cream contains not less than 1.6 pounds of total solids to
the gallon, and weighs not less than 4.5 pounds to the gallon. Ice cream
contains not less than 10 percent milkfat, nor less than 10 percent
nonfat milk solids, except that when it contains milkfat at 1 percent
increments above the 10 percent minimum, it may contain the following
milkfat-to-nonfat milk solids levels:
------------------------------------------------------------------------
Minimum
percent
Percent milkfat nonfat
milk
solids
------------------------------------------------------------------------
10.......................................................... 10
11.......................................................... 9
12.......................................................... 8
13.......................................................... 7
14.......................................................... 6
------------------------------------------------------------------------
Except that when one or more bulky flavors are used, the weights of
milkfat and total milk solids are not less than 10 percent and 20
percent, respectively, of the remainder obtained by subtracting the
weight of the bulky flavors from the weight of the finished food; but in
no case is the weight of milkfat or total milk solids less than 8
percent and 16 percent, respectively, of the weight of the finished
food. Except in the case of frozen custard, ice cream contains less than
1.4 percent egg yolk solids by weight of the food, exclusive of the
weight of any bulky flavoring ingredients used. Frozen custard shall
contain 1.4 percent egg yolk solids by weight of the finished food:
Provided, however, That when bulky flavors are added the egg yolk solids
content of frozen custard may be reduced in proportion to the amount by
weight of the bulky flavors added, but in no case is the content of egg
yolk solids in the finished food less than 1.12 percent. A product
containing egg yolk solids in excess of 1.4 percent, the maximum set
forth in this paragraph for ice cream, may be marketed if labeled as
specified by paragraph (e)(1) of this section.
(3) When calculating the minimum amount of milkfat and nonfat milk
solids required in the finished food, the solids of chocolate or cocoa
used shall be considered a bulky flavoring ingredient. In order to make
allowance for additional sweetening ingredients needed when certain
bulky ingredients are used, the weight of chocolate or cocoa solids used
may be multiplied by 2.5; the weight of fruit or nuts used may be
multiplied by 1.4; and the weight of partially or wholly dried fruits or
fruit juices may be multiplied by appropriate factors to obtain the
original weights before drying and this weight may be multiplied by 1.4.
(b) Optional dairy ingredients. The optional dairy ingredients
referred to in paragraph (a) of this section are: Cream; dried cream;
plastic cream (sometimes known as concentrated milkfat); butter; butter
oil; milk; concentrated milk; evaporated milk; sweetened condensed milk;
superheated condensed milk; dried milk; skim milk; concentrated skim
milk; evaporated skim milk; condensed skim milk; superheated condensed
skim milk; sweetened condensed skim milk; sweetened condensed part-skim
milk; nonfat
[[Page 367]]
dry milk; sweet cream buttermilk; condensed sweet cream buttermilk;
dried sweet cream buttermilk; skim milk, that may be concentrated, and
from which part or all of the lactose has been removed by a safe and
suitable procedure; skim milk in concentrated or dried form that has
been modified by treating the concentrated skim milk with calcium
hydroxide and disodium phosphate; and whey and those modified whey
products (e.g., reduced lactose whey, reduced minerals whey, and whey
protein concentrate) that have been determined by FDA to be generally
recognized as safe (GRAS) for use in this type of food. Water may be
added, or water may be evaporated from the mix. The sweet cream
buttermilk and the concentrated sweet cream buttermilk or dried sweet
cream buttermilk, when adjusted with water to a total solids content of
8.5 percent, has a titratable acidity of not more than 0.17 percent,
calculated as lactic acid. The term ``milk'' as used in this section
means cow's milk. Any whey and modified whey products used contribute,
singly or in combination, not more than 25 percent by weight of the
total nonfat milk solids content of the finished food. The modified skim
milk, when adjusted with water to a total solids content of 9 percent,
is substantially free of lactic acid as determined by titration with
0.1N NaOH, and it has a Ph value in the range of 8.0 to 8.3.
(c) Optional caseinates. The optional caseinates referred to in
paragraph (a) of this section that may be added to ice cream mix
containing not less than 20 percent total milk solids are: Casein
prepared by precipitation with gums, ammonium caseinate, calcium
caseinate, potassium caseinate, and sodium caseinate. Caseinate may be
added in liquid or dry form, but must be free of excess alkali.
(d) Optional hydrolyzed milk proteins. One or more of the optional
hydrolyzed milk proteins referred to in paragraph (a) of this section
may be added as stabilizers at a level not to exceed 3 percent by weight
of ice cream mix containing not less that 20 percent total milk solids,
provided that any whey and modified whey products used contribute,
singly or in combination, not more than 25 percent by weight of the
total nonfat milk solids content of the finished food. Further, when
hydrolyzed milk proteins are used in the food, the declaration of these
ingredients on the food label shall comply with the requirements of
Sec. 102.22 of this chapter.
(e) Methods of analysis. The fat content shall be determined by the
method prescribed in ``Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), sections 16.287 and
16.059, under ``Fat, Roese-Gottlieb Method--Official Final Action,''
which is incorporated by reference. Copies may be obtained from the AOAC
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or may be examined 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.
(f) Nomenclature. (1) The name of the food is ``ice cream''; except
that when the egg yolk solids content of the food is in excess of that
specified for ice cream by paragraph (a) of this section, the name of
the food is ``frozen custard'' or ``french ice cream'' or ``french
custard ice cream''.
(2)(i) If the food contains no artificial flavor, the name 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 words ``ice cream''.
(ii) If the food contains both a natural characterizing flavor and
an artificial flavor simulating it, and if the natural flavor
predominates, the name on the principal display panel or panels of the
label shall be accompanied by the common name of the characterizing
flavor, in letters not less than one-half the height of the letters used
in the words ``ice cream'', 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., ``Vanilla flavored'', or ``Peach
flavored'', or ``Vanilla flavored and Strawberry flavored''.
[[Page 368]]
(iii) If the food contains both a natural characterizing flavor and
an artificial flavor simulating it, and if the artificial flavor
predominates, or if artificial flavor is used alone the name on the
principal display panel or panels of the label shall be accompanied by
the common name of the characterizing flavor in letters not less than
one-half the height of the letters used in the words ``ice cream'',
preceded by ``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'', or ``artifically
flavored Strawberry'' or ``artificially flavored Vanilla and
artificially flavored Strawberry''.
(3)(i) If the food is subject to the requirements of paragraph
(f)(2)(ii) of this section or if it contains any artificial flavor not
simulating the characterizing flavor, the label shall also bear the
words ``artificial flavor added'' or ``artificial ------ flavor added'',
the blank being filled with the common name of the flavor simulated by
the artificial flavor in letters of the same size and prominence as the
words that precede and follow it.
(ii) Wherever the name of the characterizing flavor appears on the
label 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, in a size reasonably
related to the prominence of the name of the characterizing flavor and
in any event the size of the type is not less than 6-point on packages
containing less than 1 pint, not less than 8-point on packages
containing at least 1 pint but less than one-half gallon, not less than
10-point on packages containing at least one-half gallon but less than 1
gallon, and not less than 12-point on packages containing 1 gallon or
over: Provided, however, That 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 provided further, That if the finished product contains more
than one flavor of ice cream subject to the requirements of this
paragraph, the statements required by this paragraph need appear only
once in each statement of characterizing flavors present in such ice
cream, e.g., ``Vanilla flavored, Chocolate, and Strawberry flavored,
artificial flavors added''.
(4) If the food contains both a natural characterizing flavor and an
artificial flavor simulating the characterizing flavor, any reference to
the natural characterizing flavor shall, except as otherwise authorized
by this paragraph, be accompanied by a reference to the artificial
flavor, displayed with substantially equal prominence, e.g.,
``strawberry and artificial strawberry flavor''.
(5) An artificial flavor simulating the characterizing flavor shall
be deemed to predominate:
(i) In the case of vanilla beans or vanilla extract used in
combination with vanillin if the amount of vanillin used is greater than
1 ounce per unit of vanilla constituent, as that term is defined in
Sec. 169.3(c) of this chapter.
(ii) In the case of fruit or fruit juice used in combination with
artificial fruit flavor, if the quantity of the fruit or fruit juice
used is such that, in relation to the weight of the finished ice cream,
the weight of the fruit or fruit juice, as the case may be (including
water necessary to reconstitute partially or wholly dried fruits or
fruit juices to their original moisture content) is less than 2 percent
in the case of citrus ice cream, 6 percent in the case of berry or
cherry ice cream, and 10 percent in the case of ice cream prepared with
other fruits.
(iii) In the case of nut meats used in combination with artificial
nut flavor, if the quantity of nut meats used is such that, in relation
to the finished ice cream the weight of the nut meats is less than 2
percent.
(iv) In the case of two or more fruits or fruit juices, or nut
meats, or both, used in combination with artificial flavors simulating
the natural flavors and dispersed throughout the food, if the quantity
of any fruit or fruit juice or nut meat is less than one-half the
applicable percentage specified in paragraph (e)(5) (ii) or (iii) of
this section.
[[Page 369]]
For example, if a combination ice cream contains less than 5 percent of
bananas and less than 1 percent of almonds it would be ``artificially
flavored banana-almond ice cream''. However, if it contains more than 5
percent of bananas and more than 1 percent of almonds it would be
``banana-almond flavored ice cream''.
(6) If two or more flavors of ice cream are distinctively combined
in one package, e.g., ``Neapolitan'' ice cream, the applicable
provisions of this paragraph shall govern each flavor of ice cream
comprising the combination.
(7) Until September 14, 1998, when safe and suitable sweeteners
other than nutritive carbohydrate sweeteners are used in the food, their
presence shall be declared by their common or usual name on the
principal display panel of the label as part of the statement of
identity in letters that shall be no less than one-half the size of the
type used in the term ``ice cream'' but in any case no smaller than one-
sixteenth of an inch. If the food purports to be or is represented for
special dietary use, it shall bear labeling in accordance with the
requirements of part 105 of this chapter.
(g) Label declaration. Each of the ingredients used shall be
declared on the label as required by the applicable sections of parts
101 and 130 of this chapter, except that the sources of milkfat or milk
solids not fat may be declared in descending order of predominance
either by the use of all the terms ``milkfat and nonfat milk'' when one
or any combination of two or more of the ingredients listed in Sec.
101.4(b)(3), (b)(4), (b)(8), and (b)(9) of this chapter are used or,
alternatively, as permitted in Sec. 101.4 of this chapter. Under
section 403(k) of the Federal Food, Drug, and Cosmetic Act, artificial
color need not be declared in ice cream, except as required by Sec.
101.22(c) or (k) of this chapter. Voluntary declaration of all colors
used in ice cream and frozen custard is recommended.
[43 FR 4598, Feb. 3, 1978, as amended at 45 FR 63838, Sept. 26, 1980; 46
FR 44433, Sept. 4, 1981; 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar.
19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, Jan. 6, 1993; 59 FR
47079, Sept. 14, 1994; 63 FR 14035, Mar. 24, 1998; 63 FR 14818, Mar. 27,
1998]
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