[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
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://
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
(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
(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
(3) Nutritive carbohydrate sweeteners.
(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-
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.
(c) Nomenclature. The name of the food for which a definition and
standard of identity are prescribed in this section is ``margarine'' or
(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: