this paragraph, any combination of finely ground soybeans and water, in which the weight of the finely ground soybeans is not less than 10 percent of the weight of the water. The finely ground soybeans are subjected to a heat treatment before or after mixing with the water. The soybeans may or may not be dehulled.

(ix) Water in lieu of any of the foregoing articles of this subparagraph. Congealing is effected, either with or without contact with water, and the congealed mixture may be worked.

(3) In the preparation of oleomargarine one or more of the following optional ingredients may also be used: (i) Artificial coloring. For the purposes of this subdivision provitamin A shall be deemed to be artificial coloring.

(ii) Sodium benzoate or benzoic acid or a combination of these, in a quantity not to exceed 0.1 percent of the weight of the finished product.

(iii) Vitamin A (with or without any accompanying vitamin D and with or without vitamin D concentrate), in such quantity that the finished oleomargarine contains not less than 15,000 United States Pharmacopeia units of vitamin A per pound, as determined by the method prescribed in the Pharmacopeia of the United States for total biological vitamin A activity. The vitamin A potency prescribed may be furnished by fish liver oil; by concentrates of vitamin A or its fatty acid esters from animal sources; by synthetic vitamin A or its fatty acid esters; by mixtures of synthetic vitamin A or its fatty acid esters with harmless substances formed during the synthesis of the vitamin A, if the vitamin A or its fatty acid ester constitutes not less than 50 percent of the mixture; by provitamin A; or by any combination of two or more of these. For the purposes of this subdivision the term "fatty acid" may include acetic acid.

(iv) Any safe and suitable artificial flavoring substance that imparts to the food a flavor in semblance of butter. Such artificial flavoring substances are deemed to be safe if they are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or, if they are food additives as so defined, they are used in conformity with regulations established pursuant to section 409 of the act.

(v) (a) Lecithin, in an amount not exceeding 0.5 percent of the weight of the finished oleomargarine; or

(b) Monoglycerides or diglycerides of fat-forming fatty acids, or a combination of these, in an amount not exceeding 0.5 percent of the weight of the finished oleomargarine; or

(c) Such monoglycerides and diglycerides in combination with the sodium sulfo-acetate derivatives thereof, in a total amount not exceeding 0.5 percent of the weight of the finished oleomargarine; or

(d) A combination of (a) and (b) of this subdivision, in which the amount of neither exceeds that above stated; or

(e) A combination of (a) and (c) of this subdivision, in a total amount not exceeding 0.5 percent of the weight of the finished oleomargarine.

The weight of the diglycerides in each of ingredients (b), (c), (d), and (e) of this subdivision is calculated at one-half actual weight.

(vi) Butter. (vii) Salt.

(viii) Citric acid incorporated in the fat or oil ingredient used.

(ix) Isopropyl citrates incorporated in the fat or oil ingredient used, in an amount not to exceed 0.02 percent by weight of the finished oleomargarine.

(x) Stearyl citrate incorporated in the fat or oil ingredient used, in an amount not to exceed 0.15 percent by weight of the finished oleomargarine.

(xi) Potassium sorbate, in an amount not to exceed 0.1 percent by weight of the finished oleomargarine.

(xii) Calcium disodium EDTA (calcium disodium ethylenediaminetetraacetate), in an amount not to exceed 75 parts per million by weight of the finished oleomargarine.

The finished oleomargarine contains not less than 80 percent fat, as determined by the method prescribed in “Official Methods of Analysis of the Association of Official Agricultural Chemists," 7th Edition, page 259 under "Indirect Method," section 15.111. [Ed. note, 10th edition, 1965, p. 242, sec. 15.132.1

(b) The name of the food for which a definition and standard of identity is prescribed by this section is "oleomargarine" or "margarine." The presence of optional ingredients, provided for in paragraph (a) of this section, in the

finished margarine shall be declared as set forth in this paragraph.

(1) Fat ingredients shall be declared first in the ingredient statement by the name of the specific fat or oil or stearin used. Where combinations of fat ingredients are used, the names shall be arranged in order of decreasing predominance. If any fat ingredient is hydrogenated, the ingredient statement shall include the word "hydrogenated" or "hardened" at such place or places in the list of fats as to indicate which fats are hydrogenated; for example, “corn oil, hardened soybean oil."

(2) Immediately following the listing of fat ingredients, other optional ingredients used shall be named in the order of decreasing predominance.

(i) The optional ingredients butter, salt, water, cream, milk, skim milk, sweet cream buttermilk, dried sweet cream buttermilk and water, condensed sweet cream buttermilk and water, nonfat dry milk and water, ground soybeans and water, lecithin, mono- or diglycerides, sodium sulfo-acetate derivatives mono- or diglycerides shall each be declared by those terms.

of

(ii) Artificial colors shall be declared by the statement "Artificially colored" or "Artificial coloring added" or "With added artificial coloring."

(iii) Artificial flavors shall be declared by the statement "Artificially flavored" or "Artificial flavoring added" or "With added artificial flavoring."

(iv) Margarine that contains the optional ingredients citric acid, isopropyl citrate, stearyl citrate, or calcium disodium EDTA shall be labeled by the statement“. added as a preservative" or added to protect flavor." Margarine that contains the optional ingredients sodium benzoate or benzoic acid shall be labeled by the statement "

66

66

added as a preservative" as a preservative" or "With as a preservative." Margarine that contains the optional ingredient potassium sorbate shall be labeled by the statement added as a preservative" or added to retard mold growth." The blank in each of the statements in this subdivision is filled in with the common name of the preservative ingredient used.

66

(v) Vitamin A shall be declared by the statement "Vitamin A added" or "With added vitamin A." Vitamin D shall be

declared by the statement "Vitamin D Added" or "With added vitamin D.” Margarine containing added vitamin A, vitamin D, or both, is subject to the regulations for foods for special dietary use promulgated under the provisions of section 403 (j) of the act.

(vi) Where two or more optional ingredients named in paragraph (a)(3) of this section are used the words "Added" or "With added" need appear only once, either at the beginning or end of the list of such ingredients declared.

(3) Wherever the name "oleomargarine" or "margarine” appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the words and statements prescribed in this section, showing the ingredients used shall immediately and conspicuously precede or follow, or in part precede and in part follow, such name, without intervening written, printed, or other graphic matter.

(Secs. 401, 701, 52 Stat. 1046, as amended, 1055, as amended; 21 U.S.C. 341, 371) [20 F.R. 9615, Dec. 20, 1955, as amended at 28 F.R. 7473, July 23, 1963; 29 F.R. 2383, Feb. 12, 1964; 31 F.R. 5433, Apr. 6, 1966; 33 F.R. 17752, Nov. 28, 1968]

§ 45.2 Liquid

oleomargarine,

liquid margarine; identity; label statement of optional ingredients.

(a) Liquid oleomargarine, liquid margarine conforms to the definition and standard of identity and to the requirements for label declaration of optional ingredients prescribed for oleomargarine by § 45.1, except that it is in liquid rather than plastic form.

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

(Secs. 401, 701, 52 Stat. 1046, 1055 as amended, 70 Stat. 919, 72 Stat. 948; 21 U.S.C. 341, 371) [31 FR. 5434, Apr. 6, 1966]

§ 46.1

Peanut butter; identity; label statement of optional ingredients. (a) Peanut butter is the food prepared by grinding one of the shelled and roasted peanut ingredients provided for by paragraph (b) of this section, to which may be added safe and suitable seasoning and stabilizing ingredients provided for by paragraph (c) of this section, but such seasoning and stabilizing ingredierts do not in the aggregate exceed 10 percent of the weight of the finished food. To the ground peanuts, cut or chopped, shelled, and roasted peanuts may be added. During processing, the oil content of the peanut ingredient may be adjusted by the addition or subtraction of peanut oil. The fat content of the finished food shall not exceed 55 percent when determined as prescribed in section 25.004 Crude Fat-Official, First Action, paragraph (a) Direct method, in "Official Methods of Analysis of the Association of Official Agricultural Chemists," 10th Edition, page 412.

(b) The peanut ingredients referred to in paragraph (a) of this section are: (1) Blanched peanuts, in which the germ may or may not be included.

(2) Unblanched peanuts, including the skins and germ.

(c) The seasoning and stabilizing ingredients referred to in paragraph (a) of this section are suitable substances which are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act, or if they are food additives as so defined, they are used in conformity with regulations established pursuant to section 409 of the act. Seasoning and stabilizing ingredients that perform a useful function are regarded as suitable, except that artificial flavorings, artificial sweeteners, chemical preservatives, added vitamins, and color additives are not suitable ingredients of peanut butter. Oil products used as optional stabilizing ingredients shall be hydrogenated vegetable oils. For the purposes of this section, hydrogenated vegetable oil shall be considered to include partially hydrogenated vegetable oil.

(d) If peanut butter is prepared from unblanched peanuts as specified in paragraph (b)(2) of this section, the name shall show that fact by some such statement as "prepared from unblanched peanuts (skins left on)." Such statement shall appear prominently and conspicu

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ously and shall be in type of the same style and not less than half of the point size of that used for the words "peanut butter." This statement shall immediately precede or follow the words "peanut butter," without intervening written, printed. or graphic matter.

(e) (1) The label of peanut butter shall name, by their common names, the optional ingredients used, as provided in paragraph (c) of this section. If hydrogenated vegetable oil is used, the label statement of optional ingredients shall include the words "hydrogenated

oil" or "hardened

oil," the blank being filled in either with the names of the vegetable sources of the oil or, alternatively, with the word "vegetable"; for example, "hydrogenated peanut oil" or "hardened peanut and cottonseed oils" or "hydrogenated vegetable oil."

[33 F.R. 10510, July 24, 1968]

NOTE: The provisions of § 46.1 were stayed in their entirety at 33 F.R. 16333, Nov. 7, 1968.

§ 46.51

Mixed nuts; identity; label statement of optional ingredients.

(a) Mixed nuts is the food consisting of a mixture of four or more of the optional shelled tree nut ingredients, with or without one or more of the optional shelled peanut ingredients, of the kinds prescribed by paragraph (b) of this section; except that when 2 ounces or less of the food is packed in transparent containers, three or more of the optional tree nut ingredients shall be present. Each such kind of nut ingredient when used shall be present in a quantity not less than 2 percent and not more than 80 percent by weight of the finished food. For purposes of this section, each kind of tree nut and peanut is an optional ingredient that may be prepared by any suitable method in accordance with good manufacturing practice. The finished food may contain one or more of the optional nonnut ingredients provided for in paragraph (c) of this section.

(b) The optional shelled nut ingredients referred to in paragraph (a) of this section are:

(1) Almonds, black walnuts, Brazil nuts, cashews, English walnuts (alternatively "walnuts"), filberts, pecans, and other suitable kinds of tree nuts.

(2) Peanuts of the Spanish, Valencia, Virginia, or similar varieties, or any

combination of two or more such varieties.

(c) The optional nonnut ingredients referred to in paragraph (a) of this section consist of suitable substances that are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or if they are food additives as so defined, they are used in conformity with regulations established pursuant to section 409 of the act. Nonnut ingredients that perform a useful function are regarded as suitable, except that color additives are not suitable ingredients of the food.

(d) The name of the food is "mixed nuts." If the percentage of a single tree nut ingredient or the total peanut content by weight of the finished food exceeds 50 percent but not 60 percent, the statement "contains up to 60% or "contains 60%

or "60% shall immediately follow the name "mixed nuts" and shall appear on the same background, be of the same color or, in the case of multicolors, in the color showing distinct contrast with the background, and be in letters not less than one-half the height of the largest letter in the words "mixed nuts." The blank is to be filled in with the appropriate name of the predominant nut ingredient; for example, “contains up to 60% pecans" or "contains up to 60% Spanish peanuts." The numbers "70" or "80" shall be substituted for the number "60" when the percentage of the predominant nut ingredient exceeds 60 but not 70, or exceeds 70 but not 80, respectively. Compliance with the requirements for percentage of nut ingredients of this section and the fill of container requirements of § 46.52 will be determined by the following procedure:

(1) Take at random from a lot, in the case of containers bearing a weight declaration of 16 ounces or less, at least 24 containers, and for containers bearing a weight declaration of more than 16 ounces, enough containers to provide a total quantity of at least 24 pounds of nuts.

(2) If compliance with § 46.52 is to be determined, first follow the procedure set forth therein.

(3) Determine the percent by weight of each nut ingredient present in each container separately. Calculate the average percentage of each nut ingredient present. If the average percent found for each nut ingredient present is 2 per

cent or more and none of the individual nut ingredients exceeds 80 percent by weight of the finished food, the lot will be deemed to be in compliance with the percentage requirements of paragraph (a) of this section. If the average percent found for a single nut ingredient exceeds 50 percent by weight of the finished food and the average percent found is within the range indicated by the number declared on the label in accordance with this paragraph, the lot will be deemed to be in compliance with the labeling requirements of this paragraph.

(e) Optional nut ingredients and optional nonnut ingredients used in the food, as provided for in paragraphs (b) and (c) of this section, shall be declared on the label by their common names in the order of decreasing predominance by weight except that:

(1) If the Spanish variety of peanuts: is used, it shall be declared as "Spanish peanuts." Other varieties of peanuts. shall be declared as "peanuts," or alternatively peanuts," the blank being filled in with the varietal name of the peanuts used.

66

(2) If the peanut ingredient or ingredients as provided for in paragraph (b)(1) of this section are unblanched, the label shall show that fact by such statement as "peanuts unblanched," "peanuts skins on," or words of similar import, unless the vignette clearly depicts peanuts with skins on.

(3) Vegetable oils used shall be declared by the words "vegetable oil" or "hydrogenated vegetable oil," or alternatively oil" or "hydrogenated oil," as the case

66

may be, the blank being filled in with the name or names of the vegetable source(s) of the oil. For the purposes of this section, hydrogenated vegetable oil shall be considered to include partially hydrogenated vegetable oil.

(4) When antioxidant preservatives are used in the finished food, the label shall bear the statement ". added as a preservative" or added to inhibit rancidity," the blank being filled in with the name or names of the preservative(s) used.

(f) The words and statements specified in paragraph (e) of this section showing the optional ingredients present shall be listed on the principal display panel or panels or any appropriate information panel without obscuring de

sign, vignettes, or crowding. The declaration shall appear in conspicuous and easily legible letters of boldface print or type the size of which shall be not less than one-half of that required by Part 1 of this chapter for the statement of net quantity of contents appearing on the label, but in no case less than onesixteenth of an inch in height. The entire ingredient statement shall appear on at least one panel of the label. If the label bears any pictorial representation of the mixture of nuts, it shall depict the relative proportions of the nut ingredients of the food. If the label bears a pictorial representation of only one of each nut ingredient present, the nuts shall be depicted in the order of decreasing predominance by weight. A factual statement that the food does not contain a particular nut ingredient or ingredients may be shown on the label if the statement is not misleading and does not result in an insufficiency of label space for the proper declaration of information required by or under authority of the act to appear on the label.

[35 F.R. 10450, June 26, 1970, as amended at 35 F.R. 15989, Oct. 10, 1970]

NOTE: The amendment at 35 F.R. 10450, June 26, 1970, as amended at 35 F.R. 15989, Oct. 10, 1970 is effective Feb. 15, 1971.

§ 46.52

Shelled nuts in rigid or semirigid containers; fill of containers; label statement of substandard fill.

(a) The standard of fill for shelled nuts in rigid or semirigid containers is a fill such that the average volume of nuts, from the number of containers specified in § 46.51(d) (1), is not less than 85 percent of the container volume as determined by the method in paragraph (b) of this section.

(b) The method for determining the percent of fill is as follows:

(1) For the shelled nuts in each container, determine the loose volume, the settled volume, and the average volume in cubic centimeters. For the purposes of this subparagraph, consider volume in milliliters to be numerically equal to volume in cubic centimeters. Open the container and pour the nuts loosely into a vertical graduated cylinder (do not tilt) of appropriate size fitted with a funnel which has been modified, if necessary, to provide a minimum opening of 11⁄2-inch diameter. (If the loose volume of the nuts is less than 500 milliliters, use a 500-milliliter cylinder with

an inside diameter of approximately 1% inches; but if the loose volume is 500 milliliters or more, use a 1,000-milliliter cylinder with an inside diameter of approximately 24 inches.) Without shaking the cylinder, estimate the location of a horizontal plane representing the average height of the product, read the volume of the nuts, and record as the loose volume. Raise the cylinder 2 inches and allow it a free vertical drop onto a level, firm, but resilient surface (do not tamp) for a total of 5 times and observe the volume as above. Repeat in successive five-drop increments until the nuts have so settled that the volume decreases less than 2 percent in the last five-drop increment. Read the last volume in the manner described above and record as the settled volume. The arithmetical average of the loose volume and the settled volume equals the average volume of nuts.

(2) Classify the container by shape and determine its volume in cubic centimeters according to one of the following methods as appropriate:

(i) For containers of irregular shape, including glass jars, follow the general method for water capacity of containers as prescribed in § 10.6(a) of this chapter and determine the container volume, considering the water capacity in grams to be numerically equivalent to volume in cubic centimeters, or the water capacity in ounces (avoirdupois) to be equivalent to 28.35 cubic centimeters per ounce.

(ii) For box-shaped containers (that is, with opposite sides parallel), measure the inside height, width, and depth and calculate the volume as the product of these three dimensions. For such containers used to enclose vacuum packs and containing 4 ounces or less of the product, consider the height to be the inside height minus three-eighths inch.

(iii) For cylindrical containers, calculate the container volume in cubic centimeters as 12.87 times the product of the height times the diameter squared, both measured in inches; or as 0.7854 times the product of the height times the diameter squared, when measured in centimeters. For containers that do not have indented ends, take the inside diameter and height as the dimensions. For containers with indented ends (that is, metal cans with ends attached by double seams), consider the height to be the outside height at the double seam minus three-eighths inch and the diameter to