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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR184.1979b]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

Subpart B - Listing of Specific Substances Affirmed as GRAS

Sec. 184.1979b Reduced minerals whey.

(a) Reduced minerals whey is the substance obtained by the removal of a portion of the minerals from whey. The dry product shall not contain more than 7 percent ash. Reduced minerals whey is produced by physical separation techniques such as precipitation, filtration, or dialysis. As with whey, reduced minerals whey can be used as a fluid, concentrate, or a dry product form. The acidity of reduced minerals whey may be adjusted by the additional of safe and suitable pH-adjusting ingredients.

(b) The reduced minerals whey meets the following specifications:

(1) The analysis of reduced minerals whey, on a dry product basis, based on analytical methods in the referenced sections of "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th ed. (1980), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or 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.

(i) Protein content, 10 to 24 percent - as determined by the methods prescribed in section 16.036 (liquid sample), entitled "Total Nitrogen - Official Final Action" under the heading "Total Solids," or in section 16.193 (dry sample), entitled "Kjeldahl Method" under the heading "Protein - Official Final Action."

(ii) Fat content, 1 to 4 percent - as determined by the methods prescribed in section 16.059 (liquid sample), "Reese-Gottlieb Method [Reference Method] (11) - Official Final Action" under the heading "Fat," or in section 16.199 (dry sample), entitled "Fat in Dried Milk (45) - Official Final Action."

(iii) Ash content, maximum 7 percent - as determined by the methods prescribed in section 16.035 (liquid sample), entitled "Ash (5) - Official Final Action" under the heading "Total Solids," or in section 16.196 (dry sample), entitled "Ash - Official Final Action" under the heading "Dried Milk, Nonfat Dry Milk, and Malted Milk."

(iv) Lactose content, maximum 85 percent - as determined by the methods prescribed in section 16.057 (liquid sample), entitled "Gravimetric Method - Official Final Action" under the heading "Lactose," or in section 31.061 (dry sample), entitled "Lane-Eynon General Volumetric Method" under the heading "Lactose - Chemical Methods - Official Final Action."

(v) Moisture content, 1 to 6 percent - as determined by the methods prescribed in section 16.192, entitled "Moisture (41) - Official Final Action" under the heading "Dried Milk, Nonfat Dry Milk, and Malted Milk."

(vi) Solids content, variable - as determined by the methods prescribed in section 16.032, entitled "Method I - Official Final Action" under the heading "Total Solid."

(vii) Titratable Acidity, variable - as determined by the methods prescribed in section 16.023, entitled "Acidity (2) - Official Final Action" under the heading "Milk," or by an equivalent potentiometric method.

(2) Limits of impurities are: Heavy metals (as lead). Not more than 10 parts per million (0.001 percent), as determined by the method described in the "Food Chemicals Codex," 4th ed. (1996), pp. 760-761, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu ), or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or 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.

(3) The reduced minerals whey shall be derived from milk that has been pasteurized, or the reduced minerals whey shall be subjected to pasteurization techniques or its equivalent before use in food.

(c) The reduced minerals whey may be used in food in accordance with good manufacturing practice as indicated in § 184.1(b)(1).

(d) The percent of minerals present on a dry product basis, i.e., "reduced minerals whey (____% minerals)," shall be declared on the label of the package sold to food manufacturers. The percent of minerals may be declared in 2-percent increments expressed as a multiple of 2, not greater than the actual percentage of minerals in the product, or as an actual percentage provided that an analysis of the product on which the actual percentage is based is supplied to the food manufacturer.

(e) The presence of reduced minerals whey in a finished food product shall be listed as "reduced minerals whey".

[46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, 1999; 81 FR 5596, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023]

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