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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 April 1 2019.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2019]
[CITE: 21CFR133]


Subpart A - General Provisions

Sec. 133.3 Definitions.

(a) Milk means the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows, which may be clarified and may be adjusted by separating part of the fat therefrom; concentrated milk, reconstituted milk, and dry whole milk. Water, in a sufficient quantity to reconstitute concentrated and dry forms, may be added.

(b) Nonfat milk means skim milk, concentrated skim milk, reconstituted skim milk, and nonfat dry milk. Water, in a sufficient quantity to reconstitute concentrated and dry forms, may be added.

(c) Cream means cream, reconstituted cream, dry cream, and plastic cream. Water, in a sufficient quantity to reconstitute concentrated and dry forms, may be added.

(d) Pasteurized when used to describe a dairy ingredient means that every particle of such ingredient shall have been heated in properly operated equipment to one of the temperatures specified in the table of this paragraph and held continuously at or above that temperature for the specified time (or other time/temperature relationship which has been demonstrated to be equivalent thereto in microbial destruction):

Temperature Time
145 deg.F 130 min.
161 deg.F 115 s.
191 deg.F1 s.
204 deg.F0.05 s.
212 deg.F0.01 s.

1 If the dairy ingredient has a fat content of 10 percent or more, the specified temperature shall be increased by 5 deg.F.

(e) Ultrapasteurized when used to describe a dairy ingredient means that such ingredient shall have been thermally processed at or above 280 deg.F for at least 2 seconds.

[48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983]

Sec. 133.5 Methods of analysis.

Moisture, milkfat, and phosphatase levels in cheeses will be determined by the following methods of analysis from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th ed., 1980, which is incorporated by reference (copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection 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 ):

(a) Moisture content - section 16.233 "Method I (52) - Official Final Action", under the heading "Moisture".

(b) Milkfat content - section 16.255 "Fat (60) - Official Final Action".

(c) Phenol equivalent value - section 16.275 "Reagents", section 16.276 "Sampling", and section 16.277 "Determination", under the heading "Residual Phosphatase (27) Official Final Action".

(d) Milkfat in solids (fat on a dry basis) - Subtract the percent of moisture found from 100; divide the remainder into the percent milkfat found. The quotient, multiplied by 100, shall be considered to be the percent of milkfat contained in the solids.

[48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 54 FR 24893, June 12, 1989; 63 FR 14035, Mar. 24, 1998]

Sec. 133.10 Notice to manufacturers, packers, and distributors of pasteurized blended cheese, pasteurized process cheese, cheese food, cheese spread, and related foods.

(a) Definitions and standards of identity have recently been promulgated under the authority of the Federal Food, Drug, and Cosmetic Act for a number of foods made in part from cheese, including pasteurized process cheese; pasteurized process cheese with fruits, vegetables, or meats; pasteurized blended cheese; pasteurized process cheese food; pasteurized process cheese spread, and related foods. These standards prescribe the name for each such food. The act requires that this name appear on the label. Many of these names consist of several words. In the past it has been the practice of some manufacturers to subordinate the words "pasteurized," "blended," "process," "food," and "spread" to give undue prominence to the word "cheese" and to words naming the variety of cheese involved.

(b) When placing the names of these foods on labels so as to comply with the requirements of section 403 (a), (f), and (g) of the act, all the words forming the name specified by a definition and standard of identity should be given equal prominence. This can readily be accomplished by printing the specified name of the food in letters of the same size, color, and style of type, and with the same background.

(c) Where the names of optional ingredients are required to appear on the label, the designations of all such ingredients should be given equal prominence. The names of the optional ingredients should appear prominently and conspicuously but should not be displayed with greater prominence than the name of the food. The word "contains" may precede the names of the optional ingredients, and when so used will not be considered as intervening printed matter between name of food and name of optional ingredients required to be placed on the label.

(d) Where a manufacturer elects to include a label statement of fat and moisture content, the declaration should be on the basis of the food as marketed. A fat declaration on a moisture-free basis is likely to be misleading, and should not be used in labeling.

Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.