[Title 21 CFR 131.146]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 131 - MILK AND CREAM]
[Subpart B - Requirements for Specific Standardized Milk and Cream]
[Sec. 131.146 - Cultured skim milk.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  2
  1996-04-01
  1996-04-01
  false
  Cultured skim milk.
  131.146
  Sec. 131.146
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
    FOOD FOR HUMAN CONSUMPTION
    MILK AND CREAM
    Requirements for Specific Standardized Milk and Cream
  


Sec. 131.146  Cultured skim milk.

    (a) Description. Cultured skim 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 skim milk 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 0.5 percent, expressed as lactic 
acid. The food may be homogenized and shall be pasterurized or ultra-
pasterurized 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) 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 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.

[[Page 285]]

    (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 are available from the Association of Official 
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, 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 ``cultured skim milk'' or 
alternatively, ``cultured nonfat 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, e.g., ``kefir 
cultured nonfat milk'', ``acidophilus cultured nonfat milk'', or when 
characterizing ingredients such as those in paragraph (d) (6), (7), (8), 
and (9) of this section, and lactic acid-producing organisms are used 
the food may be named ``cultured skim milk buttermilk'' or alternatively 
``cultured nonfat 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.
    (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 9937, Jan. 30, 1981, as amended at 47 FR 11824, 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]