[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR168.122]

[Page 541]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 168--SWEETENERS AND TABLE SIRUPS--Table of Contents
 
 Subpart B--Requirements for Specific Standardized Sweeteners and Table 
                                 Sirups
 
Sec. 168.122  Lactose.

    (a) Lactose is the carbohydrate normally obtained from whey. It may 
be anhydrous or contain one molecule of water of crystallization or be a 
mixture of both forms.
    (b) The food shall meet the following specifications:
    (1) The lactose content is not less than 98.0 percent, mass over 
mass (m/m), calculated on a dry basis.
    (2) The sulfated ash content is not more than 0.3 percent, m/m, 
calculated on a dry basis.
    (3) The pH of a 10.0-percent m/m solution is not less than 4.5 nor 
more than 7.5.
    (4) The loss on drying for 16 hours at 120  deg.C is not more than 
6.0 percent, m/m.
    (c) The name of the food is ``Lactose'' or, alternatively, ``Milk 
sugar''.
    (d) The methods of analysis in paragraphs (d)(1), (d)(2), (d)(3), 
(d)(4), and (d)(5) of this section are to be used to determine whether 
the food meets the requirements of paragraphs (b)(1), (b)(2), (b)(3), 
and (b)(4) of this section. The methods are contained in ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists'', 14th Ed. (1984), including the 4th Supp. (1988), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a). Copies of 
the material incorporated by reference 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) Lactose content, sections 31.064 to 31.071, ``Purity of Lactose, 
Liquid Chromatographic Method,'' First Action, 14th Ed. (1984), pp. 583 
and 584.
    (2) Lactose content, sections 31.064 to 31.071, ``Purity of Lactose, 
Liquid Chromatographic Method,'' ``Changes in Official Methods of 
Analysis,'' 14th Ed., 4th Supp. (1988), p. 212. This reference 
recognizes the change in status of the method from first action to final 
action.
    (3) Sulfated ash content, section 31.014, ``Ash of Sugars and 
Sirups,'' Final Action, Sulfated Ash, 14th Ed. (1984), p. 575.
    (4) pH, section 14.022, ``pH of Flour, Potentiometric Method,'' 
Final Action, except that a 10-percent m/m solution of lactose in water 
is used for the determination, 14th Ed. (1984), p. 252.
    (5) Loss on drying at 120  deg.C, section 31.070, 14th Ed. (1984), 
p. 584.

[42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 
49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 55 FR 8459, Mar. 
8, 1990; 63 FR 14035, Mar. 24, 1998]