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used shall comply with the specification of the United States Pharmacopeia, except that it may exceed the concentration specified therein and it does not contain a preservative.

(2) Yeast procedure. The pH of the liquid egg yolks is adjusted to the range of 6.0 to 7.0, if necessary, by the addition of dilute, chemically pure hydrochloric acid, and controlled fermentation is maintained by adding food-grade baker's yeast (Saccharomyces cerevisiae). quantity of yeast used and the time of reaction are sufficient to substantially reduce the glucose content of the liquid egg yolks.

The

(c) The name of the food for which a definition and standard of identity is prescribed by this section is "Dried egg yolks," or "Dried yolks," and if the glucose content was reduced, as provided in paragraph (b) of this section, the name shall be followed immediately by the statement "Glucose removed for stability" or "Stabilized, glucose removed."

(d) (1) When either of the optional anticaking ingredients specified in paragraph (a) of this section is used, the label shall bear the statement "Not more than 1 percent silicon dioxide added as an anticaking agent" or "Less than 2 percent sodium silicoaluminate added as an anticaking agent," whichever is applicable.

(2) The name of any optional ingredient used, as provided in subparagraph (1) of this paragraph, shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render such statement likely to be read and understood by the ordinary individual under customary conditions of purchase. [29 F.R. 16984, Dec. 11, 1964, as amended at 32 F.R. 12604, Aug. 31, 1967]

§ 42.70 Egg whites, liquid egg whites, liquid egg albumen; identity; label statement of optional ingredients.

(a) Egg whites, liquid egg whites, liquid egg albumen is the food obtained from eggs of the domestic hen, broken from the shells and separated from yolks. The food may be mixed, or mixed and strained, and is pasteurized or otherwise treated to destroy all viable Salmonella micro-organisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment

used. Safe and suitable substances that aid in protecting or restoring the whipping properties of liquid egg whites may be added. For the purposes of this paragraph, safe and suitable substances are those that perform a useful function as whipping aids or in the pasteurization or other treatment to render liquid egg whites free of viable Salmonella microorganisms and 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, they are used in conformity with regulations established pursuant to section 409 of the act.

(b) Any optional ingredients used as whipping aids, as provided for in paragraph (a) of this section, shall be named on the principal display panel or panels of labels with such prominence and conspicuousness as to render such names likely to be read and understood by ordinary individuals under customary conditions of purchase.

[31 F.R. 4678, Mar. 19, 1966]

§ 42.71 Frozen egg whites, frozen egg albumen; identity; label statement of optional ingredients.

(a) Frozen egg whites, frozen egg albumen is the food prepared by freezing liquid egg whites that conform to § 42.70, with such precautions that the finished food is free of viable Salmonella microorganisms.

(b) When frozen egg whites are prepared from liquid egg whites containing any optional ingredients added as whipping aids, as provided for in § 42.70 (a), the common names of such optional ingredients shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render such names likely to be read and understood by ordinary individuals under customary conditions of purchase. [31 F.R. 4678, Mar. 19, 1966]

§ 42.72 Dried egg whites, egg white solids, dried egg albumen, egg albumen solids; identity; label statement of optional ingredients.

(a) The food dried egg whites, egg white solids, dried egg albumen, egg aibumen solids is prepared by drying liquid egg whites conforming to the requirements of § 42.70 (or deviating from that section only by not being Salmonella free). As a preliminary step to drying, the glucose content of the liquid egg whites is reduced by adjusting the pH, where necessary, with food-grade

acid and by following one of the optional procedures set forth in paragraph (b) of this section. If the food is prepared from liquid egg whites conforming in all respects to the requirements of § 42.70, drying shall be done with such precautions that the finished food is free of viable Salmonella micro-organisms. If the food is prepared from liquid egg whites that are not Salmonella free, the dried product shall be so treated by heat or otherwise as to render the finished food free of viable Salmonella microorganisms. Dried egg whites may be powdered.

(b) The optional glucose-removing procedures are:

(1) Enzyme procedure. A glucoseoxidase-catalase preparation and hydrogen peroxide solution are added to liquid egg whites. The quantity used and the time of reaction are sufficient to substantially reduce the glucose content. The glucose-oxidase-catalase preparation used is one that is generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. The hydrogen peroxide solution used shall comply with the specifications of the United States Pharmacopeia, except that it may exceed the concentration specified therein and it does not contain a preservative.

(2) Controlled fermentation procedures (i) Yeast procedure. Food-grade baker's yeast (Saccharomyces cerevisiae) is added to the liquid egg whites and controlled fermentation is maintained. The quantity of yeast used and the time of reaction are sufficient to substantially reduce the glucose content.

(ii) Bacterial procedure. The liquid egg whites are subjeted to the action of a culture of glucose-fermenting bacteria either generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act, or the subject of a regulation established pursuant to section 409 of the act, and the culture is used in conformity with such regulation. The quantity of the culture used is sufficient to predominate in the fermentation and the time and temperature of reaction are sufficient to substantially reduce the glucose content.

(c) When the dried egg whites are prepared from liquid egg whites containing any optional ingredients added as whipping aids, as provided for in § 42.70 (a), the common names of such optional ingredients shall be listed on the principal display panel or panels of

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§ 45.1 Oleomargarine, margarine; identity; label statement of optional ingredients.

(a) Oleomargarine, margarine is the plastic food prepared with one or more of the optional fat ingredients named in subparagraph (1) (i), (ii), (iii), and (iv) of this paragraph, as follows:

(1) (i) 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 of such articles.

(ii) 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 of such articles.

(iii) Any combination of ingredients named in subdivisions (i) and (ii) of this subparagraph, in such proportion that the weight of the ingredients named in subdivision (i) either equals the weight of the ingredients named in subdivision (ii), or exceeds such weight by a ratio of not greater than 9 to 1.

(iv) Any combination of ingredients named in subdivisions (i) and (ii) of this subparagraph, in such proportion that the weight of the ingredients named in subdivision (ii) exceeds the weight of the ingredients named in subdivision (i) by a ratio not greater than 9 to 1.

(2) One of the articles designated in subdivisions (i), (ii), (iii), (iv), (v), (vi), or (vii) of this subparagraph is intimately mixed with the fat ingredient or ingredients. The ingredients named in subdivisions (i), (ii), (iii), (iv), and (v) of this subparagraph are pasteurized and then may be subjected to the action of harmless bacterial starters. The term "milk" as used in this subparagraph means cow's milk.

(i) Cream. (ii) Milk.

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(iii) Skim milk.

(iv) Any combination of nonfat dry milk and water, in which the weight of the nonfat dry milk is not less than 10 percent of the weight of the water.

(v) Any mixture of two or more of the articles named in subdivisions (i), (ii), (iii), and (iv).

(vi) In case only of the fat ingredient designated in subparagraph (1) (ii) of 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.

(vii) Water in lieu of any of the foregoing articles of this subparagraph. Congealing is effected, either with or without contact with water, and the con. gealed 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, nonfat dry milk and water, ground soybeans and water, lecithin, mono- or diglycerides, sodium sulfo-acetate derivatives of mono- or diglycerides shall each be declared by those terms.

(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

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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.

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(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 21 F.R. 6566, Aug. 31, 1956; 28 F.R. 7473, July 23, 1963; 29 F.R. 2383, Feb. 12, 1964; 31 F.R. 5433, Apr. 6, 1966; 32 F.R. 2893, Feb. 15, 1967] § 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 F.R. 5434, Apr. 6, 1966]

PART 46-NUT PRODUCTS

§ 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 ingredients do not in the aggregate

exceed 10 percent of the weight of the finished food. To the ground peanuts, cut or chopped, sheiled, 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 sec. 25.004 Crude Fat-First Action(a) Direct method, in "Official Methods of Analysis of the Association of Official Agricultural Chemists," 9th Edition, page 356.

(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 prod

ucts used as optional stabilizing ingredients shall be hydrogenated peanut oil or other vegetable oils in hydrogenated form, but the proportion of such other hydrogenated vegetable oils shall not exceed 3 percent by weight of the finished peanut butter. For the purposes of this paragraph and of paragraph (e) of this section, the hydrogenated form of a 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 conspicuously 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.

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(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. The label declaration naming the hydrogenated vegetable oils used shall include the word "hydrogenated" or "hardened"; for example, "hydrogenated peanut oil" or "hardened cottonseed oil."

(2) The common names of the optional ingredients used, as provided in subparagraph (1) of this paragraph, shall be set out on the principal display panel or panels of the label with such prominence and conspicuousness as to render them likely to be read and understood by the ordinary individual under customary conditions of purchase and

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51.20 Canned corn, canned sweet corn, canned sugar corn; identity; label statement of optional ingredients. 51.21 Canned corn, canned sweet corn, canned sugar corn; quality; label statement of substandard quality. 51.22 Canned corn, canned sweet corn,

canned sugar corn where the corn ingredient is in one of the forms known as fritter corn, ground corn, or cream-style corn; fill of container; label statement of substandard fill.

51.30 Canned field corn; identity; label statement of optional ingredients. 51.32 Canned field corn where the corn ingredient is in one of the forms known as fritter field corn, ground

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