This electronic document was downloaded from the GPO web site, November 2003, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated April 1 of each year. The most current version of the regulations may be found at the GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135]
 
[Page 359]
 
                        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 A--General Provisions
 
Sec.
135.3  Definitions.
 
    Subpart B--Requirements for Specific Standardized Frozen Desserts
 
135.110  Ice cream and frozen custard.
135.115  Goat's milk ice cream.
135.130  Mellorine.
135.140  Sherbet.
135.160  Water ices.
 
    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135.3]
 
[Page 359-360]
 
                        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 A--General Provisions
 
Sec. 135.3  Definitions.
 
 
    For the purposes of this part, a pasteurized mix is one in which 
every particle of the mix has been heated in properly operated equipment 
to one of the temperatures specified in the table in this section and 
held continuously at or above that temperature for the specified time 
(or other time/temperature relationship which has been demonstrated to 
be equivalent thereto in microbial destruction):
 
[[Page 360]]
 
 
 
------------------------------------------------------------------------
                 Temperature                             Time
------------------------------------------------------------------------
155  deg.F..................................  30 min.
175  deg.F..................................  25 sec.
------------------------------------------------------------------------
 
 
[42 FR 19132, Apr. 12, 1977]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135.110]
 
[Page 360-363]
 
                        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 361]]
 
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 
Association of Official Analytical Chemists International, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (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 362]]
 
    (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 363]]
 
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]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135.115]
 
[Page 363]
 
                        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. 135.115  Goat's milk ice cream.
 
    (a) Description. Goat's milk ice cream is the food prepared in the 
same manner prescribed in Sec. 135.110 for ice cream, and complies with 
all the provisions of Sec. 135.110, except that the only optional dairy 
ingredients that may be used are those in paragraph (b) of this section; 
caseinates and hydrolyzed milk proteins may not be used; and paragraphs 
(f)(1) and (g) of Sec. 135.110 shall not apply.
    (b) Optional dairy ingredients. The optional dairy ingredients 
referred to in paragraph (a) of this section are goat's skim milk, 
goat's milk, and goat's cream. These optional dairy ingredients may be 
used in liquid, concentrated, and/or dry form.
    (c) Nomenclature. (1) The name of the food is "goat's milk ice 
cream" or, alternatively, "ice cream made with goat's milk", except 
that when the egg yolk solids content of the food is in excess of that 
specified for ice cream in paragraph (a) of Sec. 135.110, the name of 
the food is "goat's milk frozen custard" or, alternatively, "frozen 
custard made with goat's milk", or "goat's milk french ice cream", 
or, alternatively, "french ice cream made with goat's milk", or 
"goat's milk french custard ice cream", or, alternatively, "french 
custard ice cream made with goat's milk".
    (2) 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 "goat's milk 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.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
 
[47 FR 41526, Sept. 21, 1982, as amended at 58 FR 2896, Jan. 6, 1993; 59 
FR 47080, Sept. 14, 1994]
 
[[Page 364]]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135.130]
 
[Page 364]
 
                        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. 135.130  Mellorine.
 
    (a) Description. (1) Mellorine is a food produced by freezing, while 
stirring, a pasteurized mix consisting of safe and suitable ingredients 
including, but not limited to, milk-derived nonfat solids and animal or 
vegetable fat, or both, only part of which may be milkfat. Mellorine is 
sweetened with nutritive carbohydrate sweetener and is characterized by 
the addition of flavoring ingredients.
    (2) Mellorine contains not less than 1.6 pounds of total solids to 
the gallon, and weighs not less than 4.5 pounds to the gallon. Mellorine 
contains not less than 6 percent fat and 2.7 percent protein having a 
protein efficiency ratio (PER) not less than that of whole milk protein 
(108 percent of casein) by weight of the food, exclusive of the weight 
of any bulky flavoring ingredients used. In no case shall the fat 
content of the finished food be less than 4.8 percent or the protein 
content be less than 2.2 percent. The protein to meet the minimum 
protein requirements shall be provided by milk solids, not fat and/or 
other milk-derived ingredients.
    (3) When calculating the minimum amount of milkfat and protein 
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) Fortification. Vitamin A is present in a quantity which will 
ensure that 40 international units (IU) are available for each gram of 
fat in mellorine, within limits of good manufacturing practice.
    (c) Methods of analysis. Fat and protein content, and the PER shall 
be determined by following the methods contained in "Official Methods 
of Analysis of the Association of Official Analytical Chemists," 13th 
Ed. (1980), which is incorporated by reference. Copies may be obtained 
from the Association of Official Analytical Chemists International, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (1) Fat content shall be determined by the method: "Fat, Roese-
Gottlieb Method--Official Final Action," section 16.287.
    (2) Protein content shall be determined by one of the following 
methods: "Nitrogen--Official Final Action," Kjeldahl Method, section 
16.285, or Dye Binding Method, section 16.286.
    (3) PER shall be determined by the method: "Biological Evaluation 
of Protein Quality--Official Final Action," sections 43.212-43.216.
    (d) Nomenclature. The name of the food is "mellorine". The name of 
the food on the label shall be accompanied by a declaration indicating 
the presence of characterizing flavoring in the same manner as is 
specified in Sec. 135.110(c).
    (e) 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 sources of milkfat or milk 
solids not fat may be declared in descending order of predominance 
either by the use of 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.
 
[42 FR 19137, Apr. 12, 1977, as amended at 47 FR 11826, Mar. 19, 1982; 
49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, Jan. 
6, 1993; 63 FR 14035, Mar. 24, 1998]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135.140]
 
[Page 364-366]
 
                        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. 135.140  Sherbet.
 
    (a) Description. (1) Sherbet 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, and 
other safe and suitable nonmilk-
 
[[Page 365]]
 
derived ingredients; and excluding other food fats, except such as are 
added in small amounts to accomplish specific functions or are natural 
components of flavoring ingredients used. Sherbet is sweetened with 
nutritive carbohydrate sweeteners and is characterized by the addition 
of one or more of the characterizing fruit ingredients specified in 
paragraph (d) of this section or one or more of the nonfruit-
characterizing ingredients specified in paragraph (e) of this section.
    (2) Sherbet weighs not less than 6 pounds to the gallon. The milkfat 
content is not less than 1 percent nor more than 2 percent, the nonfat 
milk-derived solids content not less than 1 percent, and the total milk 
or milk-derived solids content is not less than 2 percent nor more than 
5 percent by weight of the finished food. Sherbet that is characterized 
by a fruit ingredient shall have a titratable acidity, calculated as 
lactic acid, of not less than 0.35 percent.
    (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, superheated condensed 
milk, sweetened condensed milk, dried milk, skim milk, concentrated skim 
milk, evaporated skim milk, condensed skim milk, sweetened condensed 
skim milk, sweetened condensed part-skim milk, nonfat dry milk, sweet 
cream buttermilk, condensed sweet cream buttermilk, dried sweet cream 
buttermilk, skim milk that has been concentrated and from which part of 
the lactose has been removed by crystallization, 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.
    (c) Optional caseinates. The optional caseinates referred to in 
paragraph (a) of this section which may be added to sherbet mix are: 
Casein prepared by precipitation with gums, ammonium caseinate, calcium 
caseinate, potassium caseinate, and sodium caseinate. Caseinates may be 
added in liquid or dry form, but must be free of excess alkali, such 
caseinates are not considered to be milk solids.
    (d) Optional fruit-characterizing ingredients. The optional fruit-
characterizing ingredients referred to in paragraph (a) of this section 
are any mature fruit or the juice of any mature fruit. The fruit or 
fruit juice used may be fresh, frozen, canned, concentrated, or 
partially or wholly dried. The fruit may be thickened with pectin or 
other optional ingredients. The fruit is prepared by the removal of 
pits, seeds, skins, and cores, where such removal is usual in preparing 
that kind of fruit for consumption as fresh fruit. The fruit may be 
screened, crushed, or otherwise comminuted. It may be acidulated. In the 
case of concentrated fruit or fruit juices, from which part of the water 
is removed, substances contributing flavor volatilized during water 
removal may be condensed and reincorporated in the concentrated fruit or 
fruit juice. In the case of citrus fruits, the whole fruit, including 
the peel but excluding the seeds, may be used, and in the case of citrus 
juice or concentrated citrus juices, cold-pressed citrus oil may be 
added thereto in an amount not exceeding that which would have been 
obtained if the whole fruit had been used. The quantity of fruit 
ingredients used is such that, in relation to the weight of the finished 
sherbet, the weight of 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 not less 
than 2 percent in the case of citrus sherbets, 6 percent in the case of 
berry sherbets, and 10 percent in the case of sherbets prepared with 
other fruits. For the purpose of this section, tomatoes and rhubarb are 
considered as kinds of fruit.
 
[[Page 366]]
 
    (e) Optional nonfruit characterizing ingredients. The optimal 
nonfruit characterizing ingredients referred to in paragraph (a) of this 
section include but are not limited to the following:
    (1) Ground spice or infusion of coffee or tea.
    (2) Chocolate or cocoa, including sirup.
    (3) Confectionery.
    (4) Distilled alcoholic beverage, including liqueurs or wine, in an 
amount not to exceed that required for flavoring the sherbet.
    (5) Any natural or artificial food flavoring (except any having a 
characteristic fruit or fruit-like flavor).
    (f) Nomenclature. (1) The name of each sherbet is as follows:
    (i) The name of each fruit sherbet is "------ sherbet", the blank 
being filled in with the common name of the fruit or fruits from which 
the fruit ingredients used are obtained. When the names of two or more 
fruits are included, such names shall be arranged in order of 
predominance, if any, by weight of the respective fruit ingredients 
used.
    (ii) The name of each nonfruit sherbet is "------ sherbet", the 
blank being filled in with the common or usual name or names of the 
characterizing flavor or flavors; for example, "peppermint", except 
that if the characterizing flavor used is vanilla, the name of the food 
is "------ sherbet", the blank being filled in as specified by 
Sec. 135.110(e) (2) and (5)(i).
    (2) When the optional ingredients, artificial flavoring, or 
artificial coloring are used in sherbet, they shall be named on the 
label as follows:
    (i) If the flavoring ingredient or ingredients consists exclusively 
of artificial flavoring, the label designation shall be "artificially 
flavored".
    (ii) If the flavoring ingredients are a combination of natural and 
artificial flavors, the label designation shall be "artificial and 
natural flavoring added".
    (iii) The label shall designate artificial coloring by the statement 
"artificially colored", "artificial coloring added", "with added 
artificial coloring", or "------, an artificial color added", the 
blank being filled in with the name of the artificial coloring used.
    (g) Characterizing flavor(s). Wherever there appears on the label 
any representation as to the characterizing flavor or flavors of the 
food and such flavor or flavors consist in whole or in part of 
artificial flavoring, the statment required by paragraph (f)(2) (i) and 
(ii) of this section, as appropriate, shall immediately and 
conspicuously precede or follow such representation, without intervening 
written, printed, or graphic matter (except that the word "sherbet" 
may intervene) 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.
    (h) Display of statements required by paragraph (f)(2). Except as 
specified in paragraph (g) of this section, the statements required by 
paragraph (f)(2) of this section shall be set forth on the principal 
display panel or panels of the label with such prominence and 
conspicuousness as to render them likely to be read and understood by 
the ordinary individual under customary conditions of purchase and use.
    (i) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
 
[43 FR 4599, Feb. 3, 1978, as amended at 46 FR 44434, Sept. 4, 1981; 58 
FR 2896, Jan. 6, 1993]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135.160]
 
[Page 366-367]
 
                        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. 135.160  Water ices.
 
    (a) Description. Water ices are the foods each of which is prepared 
from the same ingredients and in the same manner prescribed in 
Sec. 135.140 for sherbets, except that the mix need not be pasteurized, 
and complies with all the provisions of Sec. 135.140 (including the 
requirements for label statement of ingredients), except that no milk or 
milk-derived ingredient and no egg ingredient, other than egg white, is 
used.
 
[[Page 367]]
 
    (b) Nomenclature. The name of the food is "------ ice", the blank 
being filled in, in the same manner as specified in Sec. 135.140(f)(1) 
(i) and (ii), as appropriate.
 
[42 FR 19132, Apr. 12, 1977, as amended 58 FR 2876, Jan. 6, 1993]
 
 
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