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166.110 Margarine.

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[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: 21CFR166.110]

[Page 543-544]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 166_MARGARINE--Table of Contents
 
       Subpart B_Requirements for Specific Standardized Margarine
 
Sec.  166.110  Margarine.


    (a) Description. Margarine (or oleomargarine) is the food in plastic 
form or liquid emulsion, containing not less than 80 percent fat 
determined by the method prescribed in ``Official Methods of Analysis of 
the Association of Official Analytical Chemists,'' 13th Ed. (1980), 
section 16.206, ``Indirect Method,'' under the heading ``Fat (47)--
Official Final Action,'' which is incorporated by reference. Copies 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. Margarine contains only safe and suitable ingredients, 
as defined in Sec.  130.3(d) of this chapter. It is produced from one or 
more of the optional ingredients in paragraph (a)(1) of this section, 
and one or more of the optional ingredients in paragraph (a)(2) of this 
section, to which may be added one or more of the optional ingredients 
in paragraph (b) of this section. Margarine contains vitamin A as 
provided for in paragraph (a)(3) of this section.
    (1) Edible fats and/or oils, or mixtures of these, whose origin is 
vegetable or rendered animal carcass fats, or any form of oil from a 
marine species that has been affirmed as GRAS or listed as a food 
additive for this use, any or all of which may have been subjected to an 
accepted process of physico-chemical modification. They may contain 
small amounts of other lipids, such as phosphatides or unsaponifiable 
constituents, and of free fatty acids naturally present in the fat or 
oil.
    (2) One or more of the following aqueous phase ingredients:
    (i) Water and/or milk and/or milk products.
    (ii) Suitable edible protein including, but not limited to, the 
liquid, condensed, or dry form of whey, whey modified by the reduction 
of lactose and/or minerals, nonlactose containing whey components, 
albumin, casein, caseinate, vegetable proteins, or soy protein isolate, 
in amounts not greater than reasonably required to accomplish the 
desired effect.
    (iii) Any mixture of two or more of the articles named under 
paragraphs (a)(2) (i) and (ii) of this section.
    (iv) The ingredients in paragraphs (a)(2) (i), (ii), and (iii) of 
this section shall be pasteurized and then may be subjected to the 
action of harmless bacterial starters. One or more of the articles 
designated in paragraphs (a)(2) (i), (ii), and (iii) of this section is 
intimately mixed with the edible fat and/or ingredients to form a 
solidified or liquid emulsion.
    (3) Vitamin A in such quantity that the finished margarine contains 
not less than 15,000 international units per pound.
    (b) Optional ingredients. (1) Vitamin D in such quantity that the 
finished oleomargarine contains not less than 1,500 international units 
of vitamin D per pound.
    (2) Salt (sodium chloride); potassium chloride for dietary margarine 
or oleomargarine.
    (3) Nutritive carbohydrate sweeteners.
    (4) Emulsifiers.
    (5) Preservatives including but not limited to the following within 
these maximum amounts in percent by weight of the finished food: Sorbic 
acid, benzoic acid and their sodium, potassium, and calcium salts, 
individually, 0.1 percent, or in combination, 0.2 percent, expressed as 
the acids; calcium disodium EDTA, 0.0075 percent; propyl, octyl, and 
dodecyl gallates, BHT, BHA, ascorbyl palmitate, ascorbyl stearate, all 
individually or in combination, 0.02 percent; stearyl citrate, 0.15 
percent; isopropyl citrate mixture, 0.02 percent.
    (6) Color additives. For the purpose of this subparagraph, 
provitamin A (beta-

[[Page 544]]

carotene) shall be deemed to be a color additive.
    (7) Flavoring substances. If the flavoring ingredients impart to the 
food a flavor other than in semblance of butter, the characterizing 
flavor shall be declared as part of the name of the food in accordance 
with Sec.  101.22 of this chapter.
    (8) Acidulants.
    (9) Alkalizers.
    (c) Nomenclature. The name of the food for which a definition and 
standard of identity are prescribed in this section is ``margarine'' or 
``oleomargarine''.
    (d) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter. For the purposes of this section the 
use of the term ``milk'' unqualified means milk from cows. If any milk 
other than cow's milk is used in whole or in part, the animal source 
shall be identified in conjunction with the word milk in the ingredient 
statement. Colored margarine shall be subject to the provisions of 
section 407 of the Federal Food, Drug, and Cosmetic Act as amended.

[42 FR 14478, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 
48 FR 13024, Mar. 29, 1983; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, 
June 12, 1989; 58 FR 2886, Jan. 6, 1993; 58 FR 21649, Apr. 23, 1993; 59 
FR 26939, May 25, 1994; 63 FR 14035, Mar. 24, 1998]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 166, Section 110


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