[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]