ple, "Hydrogenated peanut oil" or "Hardened peanut and cottonseed oils" or "Hydrogenated vegetable oil". [42 FR 14475, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982]

PART 165-NONALCOHOLIC BEVERAGES

Subpart A-[Reserved]

Subpart B-Requirements for Specific Standardized Nonalcoholic Beverages § 165.175 Soda water.

(a) Description. Soda water is the class of beverages made by absorbing carbon dioxide in potable water. The amount of carbon dioxide used is not less than that which will be absorbed by the beverage at a pressure of one atmosphere and at a temperature of 60° F. It either contains no alcohol or only such alcohol, not in excess of 0.5 percent by weight of the finished beverage, as is contributed by the flavoring ingredient used. Soda water designated by any name which includes the word "cola" or "pepper" shall contain caffeine from kola nut extract and/or other natural caffeine-containing extracts. Caffeine may also be added to any soda water. The total caffeine content in the finished food shall not exceed 0.02 percent by weight. Soda water may contain any safe and suitable optional ingredient, except that vitamins, minerals, and proteins added for nutritional purposes and artificial sweeteners are not suitable for food encompassed by this standard.

(b) Nomenclature. (1) The name of the beverage for which a definition and standard of identity is established by this section, which is neither flavored nor sweetened, is soda water, club soda, or plain soda.

name; for example, ginger ale, root beer, or sparkling water, that name may be used in lieu of the name prescribed in paragraph (b) (1) and (2) of this section. For the purposes of this section, a proprietary name that is commonly used by the public as the designation of a particular kind of soda water may be used in lieu of the name prescribed in paragraph (b) (1) and (2) of this section.

(c) Label declaration. Each of the optional ingredients used shall be declared on the label as required by the applicable sections of Part 101 of this chapter.

(Secs. 401, 701, 52 Stat. 1046 as amended, 1055-1056 as amended by 70 Stat. 919 and 72 Stat. 948 (21 U.S.C. 341, 371))

[42 FR 14477, Mar. 15, 1977]

§ 166.40 Labeling of margarine.

The Federal Food, Drug, and Cosmetic Act was amended by Pub. L. 459, 81st Congress (64 Stat. 20) on colored oleomargarine or margarine by adding thereto a new section numbered 407. Among other things, this section requires that there appear on the label of the package the word "oleomargarine" or "margarine" in type or lettering at least as large as any other type or lettering on the label, and a full and accurate statement of all the ingredients contained in such oleomargarine or margarine. It provides that these requirements "shall be in addition to and not in lieu of any of the other requirements of this Act”.

(a) Under section 403(g) of the Federal Food, Drug, and Cosmetic Act, any article that is represented as or purports to be oleomargarine or margarine must conform to the definition

and standard of identity for oleomargarine or margarine promulgated under section 401 of the act (Subpart B of this part), and its label must bear the name "oleomargarine" or "margarine".

(b) The identity standard for oleomargarine or margarine applies to both the uncolored and the colored article.

(c) In considering the requirement that the word "oleomargarine" or "margarine" be in type or lettering at least as large as any other type or lettering on the label, it must be borne in mind that at least three factors are involved-the height of each letter, the area occupied by each letter as measured by a closely fitting rectangle drawn around it, and the boldness of letters or breadth of the lines forming the letters. The type or lettering used should meet the following tests:

(1) The height of each letter in the word "oleomargarine” or “margarine" should equal or exceed the height of any other letter elsewhere on the label.

(2) The area of the closely fitting rectangle with respect to any of the letters in the word "oleomargarine" or “margarine” should equal or exceed the area of such rectangle applied to the same or a corresponding letter elsewhere on the label.

(3) The letters in the word "oleomargarine" or "margarine" should be equal to or exceed in prominence and boldness, such as breadth of lines forming the letters, the same or corresponding letters elsewhere on the label.

(d) [Reserved]

(e) The word "oleomargarine" or “margarine” (and thus the other information called for by the statute) should appear on each panel of the package label that might reasonably be selected by the grocer for display purposes at the point of sale.

(f) The amendment covering colored oleomargarine or colored margarine states that, "for the purposes of * section 407 of the Federal Food, Drug, and Cosmetic Act, as amended, the term ‘oleomargarine' or ‘margarine' includes: (1) All substances, mixtures, and compounds known as oleomargarine or margarine; (2) all substances,

mixtures, and compounds which have a consistency similar to that of butter and which contain any edible oils or fats other than milk fat if made in imitation or semblance of butter". Notwithstanding the difference between this definition and the definition and standard of identity for oleomargarine or margarine promulgated under section 401 of the act, it was the clear intent of Congress that any article which is represented as or purports to be oleomargarine or margarine is misbranded if it fails to comply with the definition and standard of identity for oleomargarine or margarine even though it may meet the statutory definition.

(g) Section 407(a) states that "Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the same manner and to the same extent to the provisions of this act as if it had been introduced in interstate commerce".

(h) Section 407(b)(4) requires that each part of the contents of the package be "contained in a wrapper which bears the word 'oleomargarine' or 'margarine' in type or lettering not smaller than 20-point type". The Food and Drug Administration interprets this to mean that the height of the actual letters is no less than 20 points, or 20/72 of 1 inch.

(i) The wrappers on the subdivisions of oleomargarine or margarine contained within the package sold at retail are labels within the meaning of section 201(k) and shall contain all of the label information required by sections 403 and 407 of the Federal Food, Drug, and Cosmetic Act, just as in the case of 1-pound cartons, except that wrappers on the subdivisions contained within the retail package shall be exempt from the requirements for label declaration of ingredients of section 403(g)(2), (i)(2), and (k) of the act when the subdivisions are securely enclosed within and are not intended to be separated from the retail package under conditions of retail sale, the wrappers on the subdivisions are labeled with the statement "This Unit Not Labeled For Retail Sale" in type size not less than one-sixteenth inch in height, and each multiunit package

principal display panel is labeled with the statement "Inner Units Not Labeled for Retail Sale" in type size not smaller than the minimum size required for the declaration of net quantity of contents by § 101.105 of this chapter.

(Sec. 407, 64 Stat. 20 (21 U.S.C. 347); secs. 401, 701(e), 52 Stat. 1046, 70 Stat. 919 as amended (21 U.S.C. 341, 371(e)))

[42 FR 14477, Mar. 15, 1977, as amended at 46 FR 31005, June 12, 1981]

EFFECTIVE DATE NOTE: Paragraph (b) of § 166.40 was revised at 46 FR 31005, June 12, 1981, effective date for compliance July 1, 1983. The effective date for compliance was extended to July 1, 1985, and confirmed at 47 FR 3108, Jan. 22, 1982. Paragraph (b) published at 42 FR 14477, Mar. 15, 1977, and set forth below is currently effective.

§ 166.40 Labeling of margarine.

(b) The identity standard for oleomargarine or margarine applies to both the uncolored and the colored article. Although this standard does not require that all permitted optional ingredients be declared on the label, the amendment to the Federal Food, Drug, and Cosmetic Act made by Pub. L. 459, 81st Congress, requires the labels on packages of colored oleomargarine or margarine to bear "a full and accurate statement of all the ingredients contained in such oleomargarine or margarine". The optional ingredients permitted by the identity standard for oleomargarine or margarine and the names by which we believe such ingredients, when present, should be declared in order to constitute "a full and accurate statement" are set forth below:

(1) The rendered fat or oil, or stearin derived therefrom (any or all of which may be hydrogenated), of cattle, sheep, swine, or goats, or any combination of two or more such articles-to be declared by the name of the specific animal fat, oil, or stearin, for example, "beef fat". If the animal fat or oil is hydrogenated the name should include the word "hydrogenated" or "hardened". Where combinations are used, the names are to be arranged in order of predominance, with the

animal fat, oil, or stearin present in greatest proportion named first.

(2) Any vegetable food fat or oil, or oil or stearin derived therefrom (any or all of which may be hydrogenated), or any combination of two or more such articles-to be declared by the name of the specific vegetable food fat, oil, or stearin, for example "cottonseed oil" or "soybean oil". If the vegetable fats or oils present are hydrogenated, the declaration should include the word "hydrogenated" or "hardened", for example, "hydrogenated cottonseed oil" or "hardened cottonseed oil". If two or more vegetable food fats or oils are used they are to be named in order of predominance with the one present in greatest proportion named first in the series, as, for example, "cottonseed oil, soybean oil, and corn oil".

(3) The optional ingredients cream, milk, skim milk, nonfat dry milk and water, ground soybeans and water, butter, and salt should be declared by those terms.

(4) Artificial color and artificial flavor should be declared as such by the terms prescribed in the identity standard for oleomargarine or margarine (Subpart B of this part). They need not be declared additionally by the names of the specific colors or fla

vors.

(5) The presence of sodium benzoate or benzoic acid should be declared as prescribed by the identity standard for oleomargarine or margarine.

(6) The optional ingredient vitamin A added in an essential carrier should be declared as "vitamin A added" or "with added vitamin A".

(7) The optional ingredient vitamin D should be declared as "vitamin D added" or "with added vitamin D".

(8) The optional emulsifying ingredients lecithin, mono- or diglycerides and sodium sulfo-acetate derivatives of mono- or diglycerides should be declared by those terms.

(9) The presence of citric acid, isopropyl citrate, and stearyl citrate should be declared as prescribed by the identity standard for oleomargarine or margarine.

(10) The statement of all the ingredients contained in colored olemargarine or colored margarine is subject to

the requirements pertaining_to_conspicuousness in section 403 (f) of the

act.

Subpart B-Requirements for Specific Standardized Margarine

§ 166.110 Margarine.

(a) Magarine (or oleomargarine) is the food in plastic form or liquid emulsion, containing not less than 80 percent fat determined by the method prescribed under section 16.163, "Indirect Method," of the "Official Methods of Analysis of the Association of Official Analytical Chemists," 11th Ed. (1970), which is incorporated by reference. Copies are available from the Division of Food Technology, Bureau of Foods (HFF-210), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 1100 L St. NW., Washington, DC 20408. Margarine contains only safe and suitable ingredients. 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, 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 contain

ing 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 sweeten

ers.

(4) Emulsifiers including but not limited to the following within these maximum amounts in percent by weight of the finished food: Monoand diglycerides of fatty acids esterified with the following acids; acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts, 0.5 percent; such mono- and diglycerides in combination with the sodium sulfoacetate derivatives thereof, 0.5 percent; polyglycerol esters of fatty acids, 0.5 percent; 1,2-propylene glycol esters of fatty acids, 2 percent; lecithin, 0.5 percent.

(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 com

bination, 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.

(8) Acidulants.

(9) Alkalizers.

(c) The name of the food for which a definition and standard of identity are prescribed in this section is "margarine” or “oleomargarine”.

(d) Each of the optional ingredients used shall be declared on the label as required by the applicable sections of Part 101 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.

(Secs. 401, 701, 52 Stat. 1046 as amended, 1055-1056 as amended by 70 Stat. 919 and 72 Stat. 948 (21 U.S.C. 341, 371))

[42 FR 14478, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982]

PART 168-SWEETENERS AND TABLE SIRUPS

Subpart A-[Reserved]

Subpart B-Requirements for Specific Standardized Sweeteners and Table Sirups

Sec.

168.110 Dextrose anhydrous. 168.111 Dextrose monohydrate. 168.120 Glucose sirup.

168.121 Dried glucose sirup. 168.122 Lactose.

168.130 Cane sirup.

168.140 Maple sirup.

168.160 Sorghum sirup. 168.180 Table sirup.

§ 168.111 Dextrose monohydrate.

(a) Dextrose monohydrate is purified and crystallized D-glucose containing one molecule of water of crystallization with each molecule of Dglucose.

(b) The food shall meet the following specifications:

(1) The total solids content is not less than 90.0 percent mass/mass (m/ m), and the reducing sugar content (dextrose equivalent), expressed as Dglucose, is not less than 99.5 percent m/m calculated on a dry basis.

(2) The sulfated ash content is not more than 0.25 percent m/m (calculated on a dry basis), and the sulfur dioxide content is not more than 20 mg/kg.

(c) The name of the food is "Dextrose monohydrate" or "Dextrose".

(d) For purposes of this section, the methods of analysis to be used to determine if the food meets the specifications of paragraphs (b) (1) and (2) of this section are the following sections in "Official Methods of Analysis of the Association of Official Analytical Chemists," 11th Ed. (1970), which is incorporated by reference. Copies are available from the Division of Food Technology, Bureau of Foods (HFF210), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the