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184.1979c Whey protein concentrate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1979c Whey protein concentrate.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1979c]

[Page 582-583]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1979c  Whey protein concentrate.

    (a) Whey protein concentrate is the substance obtained by the 
removal of sufficient nonprotein constituents from whey so that the 
finished dry product contains not less than 25 percent protein. Whey 
protein concentrate is produced by physical separation techniques such 
as precipitation, filtration, or dialysis. As with whey, whey protein 
concentrate can be used as a fluid, concentrate, or dry product form. 
The acidity of whey protein concentrate may be adjusted by the addition 
of safe and suitable pH-adjusting ingredients.
    (b) The whey protein concentrate meets the following specifications:
    (1) The analysis of whey protein concentrate, 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 Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 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, minimum 25 percent--as determined by the 
methods

[[Page 583]]

prescribed in section 16.036 (liquid sample), entitled ``Total 
Nitrogen--Officials 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 10 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, 2 to 15 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 60 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 Solids.''
    (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 Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 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 whey protein concentrate shall be derived from milk that has 
been pasteurized, or the whey protein concentrate shall be subjected to 
pasteurization techniques or its equivalent before use in food.
    (c) The whey protein concentrate may be used in food in accordance 
with good manufacturing practice as indicated in Sec.  184.1(b)(1).
    (d) The percent of protein present on a dry product basis, i.e., 
``whey protein concentrate (----% protein),'' shall be declared on the 
label of the package sold to food manufacturers. The percent of protein 
may be declared in 5-percent increments, expressed as a multiple of 5, 
not greater than the actual percentage of protein 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 whey protein concentrate in a finished food 
product shall be listed as ``whey protein concentrate''.

[46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989; 
64 FR 1761, Jan. 12, 1999]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1979c


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