[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
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
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.
(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.
(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: http://www.archives.gov/federal--register/
(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
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: