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: 21CFR131]
[Page 290]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart A--General Provisions
Sec.
131.3 Definitions.
131.25 Whipped cream products containing flavoring or sweetening.
Subpart B--Requirements for Specific Standardized Milk and Cream
131.110 Milk.
131.111 Acidified milk.
131.112 Cultured milk.
131.115 Concentrated milk.
131.120 Sweetened condensed milk.
131.125 Nonfat dry milk.
131.127 Nonfat dry milk fortified with vitamins A and D.
131.130 Evaporated milk.
131.147 Dry whole milk.
131.149 Dry cream.
131.150 Heavy cream.
131.155 Light cream.
131.157 Light whipping cream.
131.160 Sour cream.
131.162 Acidified sour cream.
131.170 Eggnog.
131.180 Half-and-half.
131.200 Yogurt.
131.203 Lowfat yogurt.
131.206 Nonfat yogurt.
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Source: 42 FR 14360, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 131 appear at 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: 21CFR131.3]
[Page 290-291]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart A--General Provisions
Sec. 131.3 Definitions.
(a) Cream means the liquid milk product high in fat separated from
milk, which may have been adjusted by adding thereto: Milk, concentrated
milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry
milk. Cream contains not less than 18 percent milkfat.
(b) Pasteurized when used to describe a dairy product means that
every particle of such product shall have been heated in properly
operated equipment to one of the temperatures specified in the table of
this paragraph 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):
------------------------------------------------------------------------
Temperature Time
------------------------------------------------------------------------
145 deg.F \1\........................... 30 minutes
161 deg.F \1\........................... 15 seconds
191 deg.F............................... 1 second
204 deg.F............................... 0.05 second
[[Page 291]]
212 deg.F............................... 0.01 second
------------------------------------------------------------------------
\1\ If the dairy ingredient has a fat content of 10 percent or more, or
if it contains added sweeteners, the specified temperature shall be
increased by 5 deg.F.
(c) Ultra-pasteurized when used to describe a dairy product means
that such product shall have been thermally processed at or above 280
deg.F for at least 2 seconds, either before or after packaging, so as to
produce a product which has an extended shelf life under refrigerated
conditions.
[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: 21CFR131.25]
[Page 291]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart A--General Provisions
Sec. 131.25 Whipped cream products containing flavoring or sweetening.
The unqualified name "whipped cream" should not be applied to any
product other than one made by whipping the cream that complies with the
standards of identity for whipping cream (Secs. 131.150 and 131.157 of
this chapter). If flavoring and/or sweetening is added, the resulting
product is a flavored and/or sweetened whipped cream, and should be so
identified.
[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: 21CFR131.110]
[Page 291-292]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.110 Milk.
(a) Description. Milk is the lacteal secretion, practically free
from colostrum, obtained by the complete milking of one or more healthy
cows. Milk that is in final package form for beverage use shall have
been pasteurized or ultrapasteurized, and shall contain not less than
8\1/4\ percent milk solids not fat and not less than 3\1/4\ percent
milkfat. Milk may have been adjusted by separating part of the milkfat
therefrom, or by adding thereto cream, concentrated milk, dry whole
milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may be
homogenized.
(b) Vitamin addition (Optional). (1) If added, vitamin A shall be
present in such quantity that each quart of the food contains not less
than 2000 International Units thereof within limits of good
manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
quart of the food contains 400 International Units thereof within limits
of good manufacturing practice.
(c) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Characterizing flavoring ingredients (with or without coloring,
nutritive sweetener, emulsifiers, and stabilizers) as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavorings.
(d) Methods of analysis. Referenced methods are from "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) Milkfat content--"Fat, Roese-Gottlieb Method--Official Final
Action," section 16.059.
(2) Milk solids not fat content--Calculated by subtracting the milk
fat content from the total solids content as determined by the method
"Total Solids, Method I--Official Final Action," section 16.032.
(3) Vitamin D content--"Vitamin D--Official Final Action,"
sections 43.195-43.208.
(e) Nomenclature. The name of the food is "milk". The name of the
food shall be accompanied on the label by a declaration indicating the
presence of any characterizing flavoring, as specified in Sec. 101.22 of
this chapter.
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half the height of the letters used
in such name:
(i) If vitamins are added, the phrase "vitamin A" or "vitamin A
added", or "vitamin D" or "vitamin D added", or "vitamin A and D"
or "vitamins A and D added", as is appropriate. The word "vitamin"
may be abbreviated "vit.".
(ii) The word "ultra-pasteurized" if the food has been ultra-
pasteurized.
[[Page 292]]
(2) The following terms may appear on the label:
(i) The word "pasteurized" if the food has been pasteurized.
(ii) The word "homogenized" if the food has been homogenized.
(f) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982;
49 FR 10090, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, 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: 21CFR131.111]
[Page 292-293]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.111 Acidified milk.
(a) Description. Acidified milk is the food produced by souring one
or more of the optional dairy ingredients specified in pargaph (c) of
this section with one or more of the acidifying ingredients specified in
paragraph (d) of this section, with or without the addition of
characterizing microbial organisms. One or more of the other optional
ingredients specified in paragraphs (b) and (e) of this section may also
be added. When one or more of the ingredients specified in paragraph
(e)(1) of this section are used, they shall be included in the souring
process. All ingredients used are safe and suitable. Acidified milk
contains not less than 3.25 percent milkfat and not less than 8.25
percent milk solids not fat and has a titratable acidity of not less
than 0.5 percent, expressed as lactic acid. The food may be homogenized
and shall be pasteurized or ultra-pasteurized prior to the addition of
the microbial culture and, when applicable, the addition of flakes or
granules of butterfat or milkfat.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Optional acidifying ingredients. Acetic acid, adipic acid,
citric acid, fumaric acid, glucono-delta- lactone, hydrochloric acid,
lactic acid, malic acid, phosphoric acid, succinic acid, and tartaric
acid.
(e) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present, shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup;
malt extract, dried malt extract; malt sirup, dried malt sirup; honey;
maple sugar; or any of the sweeteners listed in part 168 of this
chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulalting that of
milkfat or butterfat.
(5) Stabilizers.
(6) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(7) Aroma- and flavor-producing microbial culture.
(8) Salt.
(9) Citric acid, in a maximum amount of 0.15 percent by weight of
the milk used, or an equivalent amount of sodium citrate, as a flavor
precursor.
(f) Methods of analysis. The following referenced methods of
analysis are from "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street NW., suite 700,
Washington, DC.
[[Page 293]]
(1) Milkfat content--As determined by the method prescribed in
section 16.059, "Roese-Gottlieb Method (Reference Method) (11)--
Official Final Action," under the heading "Fat."
(2) Milk solids not fat content--Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, "Method I--Official Final
Action," under the heading "Total Solids."
(3) Titratable acidity--As determined by the method prescribed in
section 16.023, "Acidity (2)--Official Final Action," or by an
equivalent potentiometric method.
(g) Nomenclature. The name of the food is "acidified milk". The
full name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in Sec. 101.22 of this chapter,
and may be accompanied by a declaration such as a traditional name of
the food or the generic name of the organisms used, thereby indicating
the presence of the characterizing microbial organisms or ingredients
when used, e.g., "acidified kefir milk", "acidified acidophilus
milk", or when characterizing ingredients such as those in paragraphs
(e) (6), (7), (8), and (9) of this section are used, the food may be
named "acidified buttermilk".
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half of the height of the letters
used in such name:
(i) The phrase "vitamin A" or "vitamin A added", or "vitamin
D" or "vitamin D added", or "vitamins A and D added", as
appropriate. The word "vitamin" may be abbreviated "vit.".
(ii) The word "sweetened" if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(2) The term "homogenized" may appear on the label if the dairy
ingredients used are homogenized.
(h) 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.
[46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982; 47
FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, June
12, 1989; 58 FR 2890, 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: 21CFR131.112]
[Page 293-294]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.112 Cultured milk.
(a) Description. Cultured milk is the food produced by culturing one
or more of the optional dairy ingredients specified in paragraph (c) of
this section with characterizing microbial organisms. One or more of the
other optional ingredients specified in paragraphs (b) and (d) of this
section may also be added. When one or more of the ingredients specified
in paragraph (d)(1) of this section are used, they shall be included in
the culturing process. All ingredients used are safe and suitable.
Cultured milk contains not less than 3.25 percent milkfat and not less
than 8.25 percent milk solids not fat and has a titratable acidity of
not less than 0.5 percent, expressed as lactic acid. The food may be
homogenized and shall be pasteurized or ultra-pasteurized prior to the
addition to the microbial culture, and when applicable, the addition of
flakes or granules of butterfat or milkfat.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present, shall not be decreased as a
result of adding such ingredients.
[[Page 294]]
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup;
malt extract, dried malt extract; malt sirup, dried malt sirup; honey;
maple sugar; or any of the sweeteners listed in part 168 of this
chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulating that of
milkfat or butterfat.
(5) Stabilizers.
(6) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(7) Aroma- and flavor-producing microbial culture.
(8) Salt.
(9) Citric acid, in a maximum amount of 0.15 percent by weight of
the milk used, or an equivalent amount of sodium citrate, as a flavor
precursor.
(e) Methods of analysis. The following referenced methods of
analysis are from "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 available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
(1) Milkfat content--section 16.059, "Roese-Gottlieb Method
(Reference Method) (11)--Official Final Action," under the heading
"Fat."
(2) Milk solids not fat content--Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, "Method I--Official Final
Action," under the heading "Total Solids."
(3) Titratable acidity--As determined by the methods prescribed in
section 16.023 "Acidity (2)--Official Final Action," or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is "cultured milk". The
full name of the food shall appear on the principal display panel in
type of uniform size, style, and color. The name of the food shall be
accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in Sec. 101.22 of this chapter,
and may be accompanied by a declaration such as a traditional name of
the food or the generic name of the organisms used, thereby indicating
the presence of the characterizing microbial organisms or ingredients,
e.g., "kefir cultured milk", "acidophilus cultured milk", or when
characterizing ingredients such as those in paragraphs (d) (6), (7),
(8), and (9) of this section, and lactic acid-producing organisms are
used the food may be named "cultured buttermilk".
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half of the height of the letters
used in such name:
(i) The phrase "vitamin A" or "vitamin A added", or "vitamin
D" or "vitamin D added", or "vitamin A and D added", as
appropriate. The word "vitamin" may be abbreviated "vit.".
(ii) The word "sweetened" if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(2) The term "homogenized" may appear on the label if the dairy
ingredients used are homogenized.
(g) 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.
[46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982; 47
FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, June
12, 1989; 58 FR 2890, 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: 21CFR131.115]
[Page 294-295]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.115 Concentrated milk.
(a) Description. Concentrated milk is the liquid food obtained by
partial removal of water from milk. The milkfat and total milk solids
contents of the food are not less than 7.5 and 25.5 percent,
respectively. It is pasteurized, but is not processed by heat so as to
prevent spoilage. It may be homogenized.
(b) Vitamin addition (Optional). If added, vitamin D shall be
present in such quantity that each fluid ounce of
[[Page 295]]
the food contains 25 International Units thereof, within limits of good
manufacturing practice.
(c) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Carrier for vitamin D.
(2) Characterizing flavoring ingredients, with or without coloring,
as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. Referenced methods are from "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) Milkfat content--"Fat--Official Final Action," section 16.172.
(2) Total milk solids--"Total Solids--Official Final Action,"
section 16.169.
(3) Vitamin D content--"Vitamin D in Milk--Official Final Action,"
sections 43.195-43.208.
(e) Nomenclature. The name of the food is "Concentrated milk" or
alternatively "Condensed milk". If the food contains added vitamin D,
the phrase "vitamin D" or "vitamin D added" shall accompany the name
of the food wherever it appears on the principal display panel or panels
of the label in letters not less than one-half the height of the letters
used in such name. The word "homogenized" may appear on the label if
the food has been homogenized. The name of the food shall include a
declaration of the presence of any characterizing flavoring, as
specified in Sec. 101.22 of this chapter.
(f) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982;
48 FR 13024, Mar. 29, 1983; 49 FR 10090, Mar. 19, 1984; 54 FR 24892,
June 12, 1989; 58 FR 2890, 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: 21CFR131.120]
[Page 295]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.120 Sweetened condensed milk.
(a) Description. Sweetened condensed milk is the food obtained by
partial removal of water only from a mixture of milk and safe and
suitable nutritive carbohydrate sweeteners. The finished food contains
not less than 8 percent by weight of milkfat, and not less than 28
percent by weight of total milk solids. The quantity of nutritive
carbohydrate sweetener used is sufficient to prevent spoilage. The food
is pasteurized and may be homogenized.
(b) Optional ingredients. The following safe and suitable
characterizing flavoring ingredients, with or without coloring and
nutritive carbohydrate sweeteners, may be used:
(1) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(2) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists," 13th Ed. (1980), section 16.185,
under "Fat--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.
(d) Nomenclature. The name of the food is "Sweetened condensed
milk." The word "homogenized" may appear on the label if the food has
been homogenized. The name of the food shall include a declaration of
the presence of any characterizing flavoring, as specified in
Sec. 101.22 of this chapter.
(e) 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 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982; 49
FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, 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: 21CFR131.125]
[Page 295-296]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.125 Nonfat dry milk.
(a) Description. Nonfat dry milk is the product obtained by removal
of water only from pasteurized skim milk. It
[[Page 296]]
contains not more than 5 percent by weight of moisture, and not more
than 1\1/2\ percent by weight of milkfat unless otherwise indicated.
(b) Optional ingredients. Safe and suitable characterizing flavoring
ingredients (with or without coloring and nutritive carbohydrate
sweetener) as follows:
(1) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(2) Natural and artificial food flavorings.
(c) Methods of analysis. The following referenced methods of
analysis are from "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) Milkfat content--"Fat in Dried Milk--Official Final Action,"
sections 16.199-16.200.
(2) Moisture content--"Moisture--Official Final Action," section
16.192.
(d) Nomenclature. The name of the food is "Nonfat dry milk". If
the fat content is over 1\1/2\ percent by weight, the name of the food
on the principal display panel or panels shall be accompanied by the
statement "Contains --% milkfat", the blank to be filled in with the
percentage to the nearest one-tenth of 1 percent of fat contained,
within limits of good manufacturing practice. The name of the food shall
include a declaration of the presence of any characterizing flavoring,
as specified in Sec. 101.22 of this chapter.
(e) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 43 FR 19836, May 9, 1978; 47
FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June
12, 1989; 58 FR 2890, 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: 21CFR131.127]
[Page 296-297]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.127 Nonfat dry milk fortified with vitamins A and D.
(a) Description. Nonfat dry milk fortified with vitamins A and D
conforms to the standard of identity for nonfat dry milk, except that
vitamins A and D are added as prescribed by paragraph (b) of this
section.
(b) Vitamin addition. (1) Vitamin A is added in such quantity that,
when prepared according to label directions, each quart of the
reconstituted product contains 2000 International Units thereof.
(2) Vitamin D is added in such quantity that, when prepared
according to label directions, each quart of the reconstituted product
contains 400 International Units thereof.
(3) The requirements of this paragraph will be deemed to have been
met if reasonable overages, within limits of good manufacturing
practice, are present to ensure that the required levels of vitamins are
maintained throughout the expected shelf life of the food under
customary conditions of distribution.
(c) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Characterizing flavoring ingredients, with or without coloring
and nutritive carbohydrate sweetener, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavorings.
(d) Methods of analysis. The following referenced methods of
analysis are from "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) Milkfat content--"Fat in Dried Milk--Official Final Action,"
sections 16.199-16.200.
(2) Moisture content--"Moisture--Official Final Action," section
16.192.
(3) Vitamin D content--"Vitamin D--Official Final Action,"
sections 43.195-43.208.
(e) Nomenclature. The name of the food is "Nonfat dry milk
fortified with
[[Page 297]]
vitamins A and D". If the fat content is over 1\1/2\ percent by weight,
the name of the food on the principal display panel or panels shall be
accompanied by the statement "Contains --% milkfat", the blank to be
filled in to the nearest one-tenth of 1 percent with the percentage of
fat contained within limits of good manufacturing practice. The name of
the food shall include a declaration of the presence of any
characterizing flavoring, as specified in Sec. 101.22 of this chapter.
(f) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 43 FR 19836, May 9, 1978; 43
FR 29769, July 11, 1978; 43 FR 36622, Aug. 18, 1978; 47 FR 11823, Mar.
19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR
2890, 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: 21CFR131.130]
[Page 297]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.130 Evaporated milk.
(a) Description. Evaporated milk is the liquid food obtained by
partial removal of water only from milk. It contains not less than 6.5
percent by weight of milkfat, not less than 16.5 percent by weight of
milk solids not fat, and not less than 23 percent by weight of total
milk solids. Evaporated milk contains added vitamin D as prescribed by
paragraph (b) of this section. It is homogenized. It is sealed in a
container and so processed by heat, either before or after sealing, as
to prevent spoilage.
(b) Vitamin addition. (1) Vitamin D shall be present in such
quantity that each fluid ounce of the food contains 25 International
Units thereof within limits of good manufacturing practice.
(2) Addition of vitamin A is optional, If added, vitamin A shall be
present in such quantity that each fluid ounce of the food contains not
less than 125 International Units thereof within limits of good
maufacturing practice.
(c) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Emulsifiers.
(3) Stabilizers, with or without dioctyl sodium sulfosuccinate (when
permitted by and complying with the provisions of Sec. 172.810 of this
chapter) as a solubilizing agent.
(4) Characterizing flavoring ingredients, with or without coloring
and nutritive carbohydrate sweeteners, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. The following referenced methods of
analysis are from "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) Milkfat content--"Fat--Official Final Action," section 16.172.
(2) Total milk solids--"Total Solids--Official Final Action,"
section 16.169.
(3) Vitamin D content--"Vitamin D in Milk--Official Final Action,"
sections 43.195-43.208.
(e) Nomenclature. The name of the food is "Evaporated milk." The
phrase "vitamin D" or "vitamin D added", or "vitamins A and D" or
"vitamins A and D added", as is appropriate, shall immediately precede
or follow the name of the food wherever it appears on the principal
display panel or panels of the label in letters not less than one-half
the height of the letters used in such name. The name of the food shall
include a declaration of a the presence of any characterizing flavoring,
as specified in Sec. 101.22 of this chapter.
(f) 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 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982; 49
FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6,
1993; 59 FR 17691, Apr. 14, 1994]
[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: 21CFR131.147]
[Page 297-298]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.147 Dry whole milk.
(a) Description. Dry whole milk is the product obtained by removal
of water only from pasteurized milk, as defined
[[Page 298]]
in Sec. 131.110(a), which may have been homogenized. Alternatively, dry
whole milk may be obtained by blending fluid, condensed, or dried nonfat
milk with liquid or dried cream or with fluid, condensed, or dried milk,
as appropriate, provided the resulting dry whole milk is equivalent in
composition to that obtained by the method described in the first
sentence of this paragraph. It contains the lactose, milk proteins,
milkfat, and milk minerals in the same relative proportions as the milk
from which it was made. It contains not less than 26 percent but less
than 40 percent by weight of milkfat on an as is basis. It contains not
more than 5 percent by weight of moisture on a milk solids not fat
basis.
(b) Vitamin addition. (1) Addition of vitamin A is optional. If
added, vitamin A shall be present in such quantity that, when prepared
according to label directions, each quart of the reconstituted product
shall contain not less than 2,000 International Units thereof.
(2) Addition of vitamin D is optional. If added, vitamin D shall be
present in such quantity that, when prepared according to label
directions, each quart of the reconstituted product shall contain 400
International Units thereof.
(3) The requirements of this paragraph will be met if reasonable
overages, within limits of good manufacturing practice, are present to
ensure that the required levels of vitamins are maintained throughout
the expected shelf life of the food under customary conditions of
distribution.
(c) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Emulsifiers.
(3) Stabilizers.
(4) Anticaking agents.
(5) Antioxidants.
(6) Characterizing flavoring ingredients (with or without coloring
and nutritive carbohydrate sweetener) as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. The following referenced methods of
analysis are from "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) Milkfat content--"Fat in Dried Milk--Official Final Action,"
sections 16.199-16.200.
(2) Moisture content--"Moisture--Official Final Action," section
16.192.
(3) Vitamin D content--"Vitamin D--Official Final Action,"
sections 43.195-43.208.
(e) Nomenclature. The name of the food is "Dry whole milk." The
name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in Sec. 101.22 of this chapter.
The following phrases in type size not less than one-half the height of
the type size used in such name shall accompany the name of the food
wherever it appears on the principal display panel or panels.
(1) The phrase "Contains --% milkfat", the blank to be filled in
with the whole number closest to the actual fat content of the food.
(2) If vitamins are "added", the phrase "vitamin A", or
"vitamin A added", or "vitamin D", or "vitamin D added", or
"vitamins A and D", or "vitamins A and D added", as appropriate. The
word "vitamin" may be abbreviated "vit."
(f) 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 19836, May 9, 1978, as amended at 47 FR 11824, Mar. 19, 1982; 49
FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, 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: 21CFR131.149]
[Page 298-299]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.149 Dry cream.
(a) Description. Dry cream is the product obtained by removal of
water only from pasteurized milk or cream or a mixture thereof, which
may have been
[[Page 299]]
homogenized. Alternatively, dry cream may be obtained by blending dry
milks as defined in Secs. 131.125(a) and 131.147(a) with dry cream as
appropriate: Provided, That the resulting product is equivalent in
composition to that obtained by the method described in the first
sentence of this paragraph. It contains not less than 40 percent but
less than 75 percent by weight of milkfat on an as is basis. It contains
not more than 5 percent by weight of moisture on a milk solids not fat
basis.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Anticaking agents.
(4) Antioxidants.
(5) Nutritive carbohydrate sweeteners.
(6) Characterizing flavoring ingredients, with or without coloring,
as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The following referenced methods of
analysis are from "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) Milkfat content--"Fat in Dried Milk--Official Final Action,"
sections 16.199-16.200.
(2) Moisture content--"Moisture--Official Final Action," section
16.192.
(d) Nomenclature. The name of the food is "Dry cream." The name of
the food shall appear on the principal display panel of the label in
type of uniform size, style, and color. The name of the food shall be
accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in Sec. 101.22 of this chapter.
The following terms shall accompany the name of the food wherever it
appears on the principal display panel or panels of the label, in
letters not less than one-half of the height of the letters used in such
name:
(1) The phrase "Contains --% milkfat", the blank to be filled in
with the whole number closest to the actual fat content of the food.
(2) The word "sweetened" if no characterizing flavoring
ingredients are used but nutritive carbohydrate sweetener is added.
(e) 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 19836, May 9, 1978, as amended at 44 FR 3965, Jan. 19, 1979; 47
FR 11824, Mar. 19, 1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10092, Mar.
19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993; 61 FR
59002, Nov. 20, 1996]
[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: 21CFR131.150]
[Page 299-300]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.150 Heavy cream.
(a) Description. Heavy cream is cream which contains not less than
36 percent milkfat. It is pasteurized or ultra-pasteurized, and may be
homogenized.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring)
as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists," 13th Ed. (1980), sections 16.156 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.
(d) Nomenclature. (1) The name of the food is "Heavy cream" or
alternatively "Heavy whipping cream". The name of
[[Page 300]]
the food shall be accompanied on the label by a declaration indicating
the presence of any characterizing flavoring, as specified in
Sec. 101.22 of this chapter. The following terms shall accompany the
name of the food wherever it appears on the principal display panel or
panels of the label in letters not less than one-half the height of the
letters used in such name:
(i) The word "ultra-pasteurized" if the food has been ultra-
pasteurized.
(ii) The word "sweetened" if no characterizing flavoring
ingredients are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word "pasteurized" if the food has been pasteurized.
(ii) The word "homogenized" if the food has been homogenized.
(e) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982;
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, 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: 21CFR131.155]
[Page 300]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.155 Light cream.
(a) Description. Light cream is cream which contains not less than
18 percent but less than 30 percent milkfat. It is pasteurized or ultra-
pasteurized, and may be homogenized.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Stabilizers.
(2) Emulsifiers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring)
as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists," 13th Ed. (1980), sections 16.156 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.
(d) Nomenclature. The name of the food is "Light cream", or
alternatively "Coffee cream" or "Table cream". The name of the food
shall be accompanied on the label by a declaration indicating the
presence of any characterizing flavoring, as specified in Sec. 101.22 of
this chapter.
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half the height of the letters used
in such name:
(i) The word "ultra-pasteurized" if the food has been ultra-
pasteurized.
(ii) The word "sweetened" if no characterizing flavoring
ingredients are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word "pasteurized" if the food has been pasteurized.
(ii) The word "homogenized" if the food has been homogenized.
(e) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982;
49 FR 10092, Mar. 1, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, 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: 21CFR131.157]
[Page 300-301]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.157 Light whipping cream.
(a) Description. Light whipping cream is cream which contains not
less than 30 percent but less than 36 percent milkfat. It is pasteurized
or ultra-pasteurized, and may be homogenized.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring)
as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
[[Page 301]]
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists," 13th Ed. (1980), sections 16.156 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.
(d) Nomenclature. The name of the food is "Light whipping cream"
or alternatively "Whipping cream". The name of the food shall be
accompanied on the label by a declaration indicating the presence of any
characterizing flavoring, as specified in Sec. 101.22 of this chapter.
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half the height of the letters used
in such name:
(i) The word "ultra-pasteurized" if the food has been ultra-
pasteurized.
(ii) The word "sweetened" if no characterizing flavoring
ingredients are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word "pasteurized" if the food has been pasteurized.
(ii) The word "homogenized" if the food has been homogenized.
(e) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982;
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, 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: 21CFR131.160]
[Page 301-302]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.160 Sour cream.
(a) Description. Sour cream results from the souring, by lactic acid
producing bacteria, of pasteurized cream. Sour cream contains not less
than 18 percent milkfat; except that when the food is characterized by
the addition of nutritive sweeteners or bulky flavoring ingredients, the
weight of the milkfat is not less than 18 percent of the remainder
obtained by subtracting the weight of such optional ingredients from the
weight of the food; but in no case does the food contain less than 14.4
percent milkfat. Sour cream has a titratable acidity of not less than
0.5 percent, calculated as lactic acid.
(b) Optional ingredients. (1) Safe and suitable ingredients that
improve texture, prevent syneresis, or extend the shelf life of the
product.
(2) Sodium citrate in an amount not more than 0.1 percent may be
added prior to culturing as a flavor precursor.
(3) Rennet.
(4) Safe and suitable nutritive sweeteners.
(5) Salt.
(6) Flavoring ingredients, with or without safe and suitable
coloring, as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Safe and suitable natural and artificial food flavoring.
(c) Methods of analysis. Referenced methods in paragraph (c) (1) and
(2) of this section are from "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) Milkfat content--"Fat--Official Final Action," section 16.172.
(2) Titratable acidity--"Acidity--Official Final Action," section
16.023.
(d) Nomenclature. The name of the food is "Sour cream" or
alternatively "Cultured sour cream". The full name of the food shall
appear on the principal display panel of the label in type of uniform
size, style, and color. The name of the food shall be accompanied by a
declaration indicating the presence of any flavoring that characterizes
the product, as specified in Sec. 101.22 of this chapter. If nutritive
sweetener in an amount sufficient to characterize
[[Page 302]]
the food is added without addition of characterizing flavoring, the name
of the food shall be preceded by the word "sweetened".
(e) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982;
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, 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: 21CFR131.162]
[Page 302]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.162 Acidified sour cream.
(a) Description. Acidified sour cream results from the souring of
pasteurized cream with safe and suitable acidifiers, with or without
addition of lactic acid producing bacteria. Acidified sour cream
contains not less than 18 percent milkfat; except that when the food is
characterized by the addition of nutritive sweeteners or bulky flavoring
ingredients, the weight of milkfat is not less than 18 percent of the
remainder obtained by subtracting the weight of such optional
ingredients from the weight of the food; but in no case does the food
contain less than 14.4 percent milkfat. Acidified sour cream has a
titratable acidity of not less than 0.5 percent, calculated as lactic
acid.
(b) Optional ingredients. (1) Safe and suitable ingredients that
improve texture, prevent syneresis, or extend the shelf life of the
product.
(2) Rennet.
(3) Safe and suitable nutritive sweeteners.
(4) Salt.
(5) Flavoring ingredients, with or without safe and suitable
coloring, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Safe and suitable natural and artificial food flavoring.
(c) Methods of analysis. Referenced methods in paragraphs (c) (1)
and (2) of this section are from "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) Milkfat content--"Fat--Official Final Action," section 16.172.
(2) Titratable acidity--"Acidity--Official Final Action," section
16.023.
(d) Nomenclature. The name of the food is "Acidified sour cream".
The full name of the food shall appear on the principal display panel of
the label in type of uniform size, style, and color. The name of the
food shall be accompanied by a declaration indicating the presence of
any flavoring that characterizes the product, as specified in
Sec. 101.22 of this chapter. If nutritive sweetener in an amount
sufficient to characterize the food is added without addition of
characterizing flavoring, the name of the food shall be preceded by the
word "sweetened".
(e) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19, 1982;
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, 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: 21CFR131.170]
[Page 302-303]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.170 Eggnog.
(a) Description. Eggnog is the food containing one or more of the
optional dairy ingredients specified in paragraph (b), one or more of
the optional egg yolk-containing ingredients specified in paragraph (c)
of this section, and one or more of the optional nutritive carbohydrate
sweeteners specified in paragraph (d) of this section. One or more of
the optional ingredients specified in paragraph (e) of this section may
also be added. All ingredients used are safe and suitable. Eggnog
contains not less than 6 percent milkfat and not less than 8.25 percent
milk solids not fat. The egg yolk solids content is not less than 1
percent by weight of the finished food. The food shall be pasteurized or
ultra-pasteurized and may be homogenized. Flavoring ingredients and
color additives may be added after the food is pasteurized or ultra-
pasteurized.
(b) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
[[Page 303]]
(c) Egg yolk-containing ingredients. Liquid egg yolk, frozen egg
yolk, dried egg yolk, liquid whole eggs, frozen whole eggs, dried whole
eggs, or any one or more of the foregoing ingredients with liquid egg
white or frozen egg white.
(d) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup;
malt extract, dried malt extract; malt sirup, dried malt sirup; honey;
maple sugar; or any of the sweeteners listed in part 168 of this
chapter, except table sirup.
(e) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Salt.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulating that of
egg yolk, milkfat, or butterfat.
(5) Stabilizers.
(f) Methods of analysis. The following referenced methods of
analysis are from "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists International, 481 North Frederick Ave, suite 500,
Gaithersburg, MD 20877-2504, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
(1) Milkfat content--As determined by the method prescribed in
section 16.059, "Roese-Gottlieb Method (Reference Method) (11)--
Official Final Action," under the heading "Fat."
(2) Milk solids not fat content--Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, "Method I--Official Final
Action," under the heading "Total Solids."
(g) Nomenclature. The name of the food is "eggnog". The name of
the food shall be accompanied by a declaration indicating the presence
of any characterizing flavoring as specified in Sec. 101.22 of this
chapter. If the food is ultra-pasteurized, the phrase "ultra-
pasteurized" shall accompany the name of the food wherever it appears
on the label in letters not less than one-half of the height of the
letters used in the name. The following terms may accompany the name of
the food on the label:
(1) The word "pasteurized" if the food has been pasteurized.
(2) The word "homogenized" if the food has been homogenized.
(h) 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.
[46 FR 9938, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47
FR 41524, Sept. 21, 1982; 47 FR 49638, Nov. 2, 1982; 48 FR 24869, June
3, 1983; 54 FR 24893, June 12, 1989; 58 FR 2891, 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: 21CFR131.180]
[Page 303-304]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.180 Half-and-half.
(a) Description. Half-and-half is the food consisting of a mixture
of milk and cream which contains not less than 10.5 percent but less
than 18 percent milkfat. It is pasteurized or ultra-pasteurized, and may
be homogenized.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring)
as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists," 13th Ed. (1980), in sections 16.156
and 16.059, under "Fat, Roese-Gottlieb Method--Official Final Action,"
which is incorporated
[[Page 304]]
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.
(d) Nomenclature. The name of the food is "Half-and-half". The
name of the food shall be accompanied on the label by a declaration
indicating the presence of any characterizing flavoring, as specified in
Sec. 101.22 of this chapter.
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half the height of the letters used
in such name:
(i) The word "ultra-pasteurized" if the food has been ultra-
pasteurized.
(ii) The word "sweetened" if no characterizing flavor ingredients
are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word "pasteurized" if the food has been pasteurized.
(ii) The word "homogenized" if the food has been homogenized.
(e) 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.
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19, 1982;
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, 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: 21CFR131.200]
[Page 304-305]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.200 Yogurt.
(a) Description. Yogurt is the food produced by culturing one or
more of the optional dairy ingredients specified in paragraph (c) of
this section with a characterizing bacterial culture that contains the
lactic acid-producing bacteria, Lactobacillus bulgaricus and
Streptococcus thermophilus. One or more of the other optional
ingredients specified in paragraphs (b) and (d) of this section may also
be added. When one or more of the ingredients specified in paragraph
(d)(1) of this section are used, they shall be included in the culturing
process. All ingredients used are safe and suitable. Yogurt, before the
addition of bulky flavors, contains not less than 3.25 percent milkfat
and not less than 8.25 percent milk solids not fat, and has a titratable
acidity of not less than 0.9 percent, expressed as lactic acid. The food
may be homogenized and shall be pasteurized or ultra-pasteurized prior
to the addition of the bacterial culture. Flavoring ingredients may be
added after pasteurization or ultra-pasteurization. To extend the shelf
life of the food, yogurt may be heat treated after culturing is
completed, to destroy viable microorganisms.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of current good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of current good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup;
malt extract, dried malt extract; malt sirup, dried malt sirup; honey;
maple sugar; or any of the sweeteners listed in part 168 of this
chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives.
(5) Stabilizers.
[[Page 305]]
(e) Methods of analysis. The following referenced methods of
analysis are from "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists International, 481 North Frederick Ave, suite 500,
Gaithersburg, MD 20877-2504, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
(1) Milkfat content--As determined by the method prescribed in
section 16.059 "Roese-Gottlieb Method (Reference Method) (11)--Official
Final Action," under the heading "Fat."
(2) Milk solids not fat content--Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, "Method I--Official Final
Action," under the heading "Total Solids."
(3) Titratable acidity--As determined by the method prescribed in
section 16.023, "Acidity (2)--Official Final Action," or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is "yogurt". The name of
the food shall be accompanied by a declaration indicating the presence
of any characterizing flavoring as specified in Sec. 101.22 of this
chapter.
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half of the height of the letters
used in such name:
(i) The word "sweetened" if nutritive carbohydrate sweetener is
added without the addition of characterizing flavor.
(ii) The parenthetical phrase "(heat-treated after culturing)"
shall follow the name of the food if the dairy ingredients have been
heat-treated after culturing.
(iii) The phrase "vitamin A" or "vitamin A added", or "vitamin
D" or "vitamin D added", or "vitamins A and D added", as
appropriate. The word "vitamin" may be abbreviated "vit".
(2) The term "homogenized" may appear on the label if the dairy
ingredients used are homogenized.
(g) 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.
[46 FR 9939, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47
FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June
12, 1989; 58 FR 2891, 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: 21CFR131.203]
[Page 305-306]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.203 Lowfat yogurt.
(a) Description. Lowfat yogurt is the food produced by culturing one
or more of the optional dairy ingredients specified in paragraph (c) of
this section with a characterizing bacterial culture that contains the
lactic acid-producing bacteria, Lactobacillus bulgaricus and
Streptococcus thermophilus. One or more of the other optional
ingredients specified in paragraphs (b) and (d) of this section may also
be added. When one or more of the ingredients specified in paragraph
(d)(1) of this section are used, they shall be included in the culturing
process. All ingredients used are safe and suitable. Lowfat yogurt,
before the addition of bulky flavors, contains not less than 0.5 percent
nor more than 2 percent milkfat and not less than 8.25 percent milk
solids not fat, and has a titratable acidity of not less than 0.9
percent, expressed as lactic acid. The food may be homogenized and shall
be pasteurized or ultra-pasteurized prior to the addition of the
bacterial culture. Flavoring ingredients may be added after
pasteurization or ultra-pasteurization. To extend the shelf life of the
food, lowfat yogurt may be heat treated after culturing is completed, to
destroy viable microorganisms.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of current good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of current good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
[[Page 306]]
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose, maltose sirup, dried maltose sirup;
malt extract, dried malt extract; malt sirup, dried malt sirup; honey;
maple sugar; or any of the sweeteners listed in part 168 of this
chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives.
(5) Stabilizers.
(e) Methods of analysis. The following referenced methods of
analysis are from "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504 or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
(1) Milkfat content--As determined by the method prescribed in
section 16.059 "Roese-Gottlieb Method (Reference Method) (11)--Official
Final Action," under the heading "Fat."
(2) Milk solids not fat content--Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, "Method I--Official Final
Action," under the heading "Total Solids."
(3) Titratable acidity--As determined by the method prescribed in
section 16.023, "Acidity (2)--Official Final Action," or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is "lowfat yogurt". The
full name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in Sec. 101.22 of this chapter.
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half of the height of the letters
used in such name.
(i) The phrase "--% milkfat", the blank to be filled in with the
fraction \1/2\ or multiple thereof closest to the actual fat content of
the food.
(ii) The word "sweetened" if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(iii) The parenthetical phrase "(heat-treated after culturing)"
shall follow the name of the food if the dairy ingredients have been
heat-treated after culturing.
(iv) The phrase "vitamin A" or "vitamin A added", or "vitamin
D" or "vitamin D added", or "vitamins A and D added", as
appropriate. The word "vitamin" may be abbreviated "vit".
(2) The term "homogenized" may appear on the label if the dairy
ingredients used are homogenized.
(g) 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.
[46 FR 9939, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47
FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June
12, 1989; 58 FR 2891, 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: 21CFR131.206]
[Page 306-308]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 131--MILK AND CREAM--Table of Contents
Subpart B--Requirements for Specific Standardized Milk and Cream
Sec. 131.206 Nonfat yogurt.
(a) Description. Nonfat yogurt is the food produced by culturing one
or more of the optional dairy ingredients specified in paragraph (c) of
this section with a characterizing bacterial culture that contains the
lactic acid-producing bacteria, Lactobacillus bulgaricus and
Streptococcus thermophilus. One or more of the other optional
ingredients specified in paragraphs (b) and (d) of this section may also
be added. When one or more of the ingredients specified in paragraph
(d)(1) of this section are
[[Page 307]]
used, they shall be included in the culturing process. All ingredients
used are safe and suitable. Nonfat yogurt, before the addition of bulky
flavors, contains less than 0.5 percent milkfat and not less than 8.25
percent milk solids not fat, and has a titratable acidity of not less
than 0.9 percent, expressed as lactic acid. The food may be homogenized
and shall be pasteurized or ultra-pasteurized prior to the addition of
the bacterial culture. Flavoring ingredients may be added after
pasteurization or ultra-pasteurization. To extend the shelf life of the
food, nonfat yogurt may be heat treated after culturing is completed, to
destroy viable microorganisms.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup;
malt extract, dired malt extract; malt sirup, dried malt sirup; honey;
maple sugar; or any of the sweeteners listed in part 168 of this
chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives.
(5) Stabilizers.
(e) Methods of analysis. The following referenced methods of
analysis are from "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
(1) Milkfat content--As determined by the method prescribed in
section 16.059, "Roese-Gottlieb Method (Reference Method) (11)--
Official Final Action," under the heading "Fat."
(2) Milk solids not fat content--Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, "Method I--Official Final
Action," under the heading "Total Solids."
(3) Titratable acidity--As determined by the method prescribed in
section 16.023, "Acidity (2)--Official Final Action," or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is "nonfat yogurt". The
full name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in Sec. 101.22 of this chapter.
(1) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half of the height of the letters
used in such name:
(i) The word "sweetened" if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(ii) The parenthetical phrase "(heat-treated after culturing)"
shall follow the name of the food if the dairy ingredients have been
heat-treated after culturing.
(iii) The phrase "vitamin A" or "vitamin A added", or "vitamin
D" or "vitamin D added", or "vitamins A and
[[Page 308]]
D added", as appropriate. The word "vitamin" may be abbreviated
"vit".
(2) The term "homogenized" may appear on the label if the dairy
ingredients used are homogenized.
(g) 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.
[46 FR 9940, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47
FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June
12, 1989; 58 FR 2891, Jan. 6, 1993]
