[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: 21CFR168.122]
[Page 546]
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 AOAC
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or may be examined 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/code--of--federal--regulations/ibr--locations.html.
(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]
Additives that reference this regulation: |
