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131.112 Cultured milk.

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[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR131.112]

[Page 292-294]
                        TITLE 21--FOOD AND DRUGS
                          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,

[[Page 293]]

buttermilk, whey, lactose, lact al bum ins, 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 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 
    (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 AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available 
for inspection at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to:
    (1) Milkfat content--section 16.059, ``Roese-Gottlieb Method 
(Reference Method) (11)--Official Final Action,'' under the heading 
    (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

[[Page 294]]

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]

Additives that reference this regulation:

Source: U.S. Code of Federal Regulations - CFR Title 21, Part 131, Section 112

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