[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2011]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
PART 166 -- MARGARINE
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_regi...locations.html
. Margarine contains only safe and suitable ingredients, as defined in 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.
(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 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 "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]