[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: 21CFR184.1979]
[Page 578-580]
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. 184.1979 Whey.
(a)(1) Whey. Whey is the liquid substance obtained by separating the
coagulum from milk, cream, or skim milk in cheesemaking. Whey obtained
from a procedure, in which a significant amount of lactose is converted
to lactic acid, or from the curd formation by direct acidification of
milk, is known as acid whey. Whey obtained from a procedure in which
there is insignificant conversion of lactose to lactic acid is known as
sweet whey. Sweet whey has a maximum titratable acidity of not more than
0.16 percent, calculated as lactic acid, and an alkalinity of ash of not
more than 225 milliliters of 0.1N hydrochloric acid per 100 grams. The
acidity of whey, sweet or acid, may be adjusted by the addition of safe
and suitable pH-adjusting ingredients.
(2) Concentrated whey. Concentrated whey is the liquid substance
obtained by the partial removal of water from whey, while leaving all
other constituents in the same relative proportions as in whey.
(3) Dry or dried whey. Dry or dried whey is the dry substance
obtained by the removal of water from whey, while leaving all other
constituents in the same relative proportions as in whey.
(b) The ingredients meet the following specifications:
(1) The analysis of whey, concentrated whey, and dry (dried) whey,
on a dry product basis, based on analytical methods in the referenced
sections of ``Official Methods of Analysis
[[Page 579]]
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, 10 to 15 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, 0.2 to 2.0 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, 7 to 14 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, 61 to 75 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 8 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 must be derived from milk that has been pasteurized, or
the whey and modified whey product must be subjected to pasteurization
techniques or its equivalent before use in food.
(c) Whey, concentrated whey, and dry (dried) whey may be used in
food in accordance with good manufacturing practice as indicated in
Sec. 184.1(b)(1).
(d) The label on the whey form sold to food manufacturers shall read
as follows:
(1) For whey: ``(Sweet or acid) whey'' or ``whey (----% titratable
acidity).
(2) For concentrated whey: ``Concentrated (sweet or acid) whey, ----
% solids'' or ``Concentrated whey (----% titratable acidity), ----%
solids''.
[[Page 580]]
(3) For dry (dried) whey: ``Dry (dried) (sweet or acid) whey'' or
``dry (dried) whey, (----% titratable acidity)''.
(e) Whey, concentrated whey, or dry (dried) whey in a finished food
product shall be listed as ``whey.''
[46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, 1982, as amended at 54
FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, 1999]
Additives that reference this regulation: |
