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freed from bran coat, or bran coat and germ, to such extent that the percent of ash therein, calculated to a moisture-free basis, is not more than 0.92 percent. Its moisture content is not more than 15 percent.

(b) For the purpose of this section, ash and moisture are determined by the methods therefor referred to in § 137.105(c).

§ 137.350 Enriched rice.

(a) The foods for which definitions and standards of identity are prescribed by this section are forms of milled rice (except rice coated with talc and glucose and known as coated rice), to which nutrients have been added so that each pound of the rice contains:

(1) Not less than 2.0 milligrams and not more than 4.0 milligrams of thiamine; not less than 1.2 milligrams and not more than 2.4 milligrams of riboflavin; not less than 16 milligrams and not more than 32 milligrams of niacin or niacinamide; and not less than 13 milligrams and not more than 26 milligrams of iron (Fe).

(2) Each pound may contain not less than 250 U.S.P. units and not more than 1,000 U.S.P. units of vitamin D.

(3) Each pound may contain not less than 500 milligrams and not more than 1,000 milligrams of calcium (Ca). Calcium carbonate derived from the use of this substance in milling rice, when present in quantities that furnish less than 500 milligrams of calcium (Ca) per pound, is considered a normal ingredient of the milled rice used and not an optional ingredient of the enriched rice unless such enriched rice is labeled to show it contains the optional ingredient calcium. Iron and calcium may be added only in forms that are harmless and assimilable. The vitamins referred to in paragraphs (a) (1) and (2) of this section may be combined with harmless substances to render them insoluble in water, if the water-insoluble products are assimila

ble.

(4) In the case of enriched parboiled rice, butylated hydroxytoluene may be added as an optional ingredient in an amount not to exceed 0.0033 percent by weight of the finished food.

(b) The substances referred to in paragraphs (a) (1), (2), and (3) of this section may be added in a harmless carrier. Such carrier is used only in the quantity necessary to effect an intimate and uniform mixture of such substances with the rice.

(c) Unless the label of the food bears the statement "To retain vitamins do not rinse before or drain after cooking" immediately preceding or following the name of the food and in letters not less than one-fourth the point size of type used for printing the name of the food (but in no case less than 8point type) and the label bears no cooking directions calling for washing or draining or unless the food is precooked and it is packaged in consumer packages which are conspicuously and prominently labeled with directions for preparation which, if followed, will avoid washing away or draining off enriching ingredients, the substances named in paragraphs (a) (1), (2), and (3) of this section shall be present in such quantity or in such form that when the enriched rice is washed as prescribed in paragraph (e) of this section, the washed rice contains not less than 85 percent of the minimum quantities of the substances named in paragraph (a)(1) of this section, as required for enriched rice; and in case any optional ingredients named in paragraphs (a) (2) and (3) of this section are used, the washed rice also contains not less than 85 percent of the minimum quantity specified for the substance or substances used.

(d) The name specified for each food for which a definition and standard of identity is prescribed by this section is the common name of the kind of milled rice to which the enriching substances are added, preceded by the word "enriched" as, for example, "Enriched rice" or "Enriched parboiled rice".

(e) The method referred to in paragraph (c) of this section is as follows: Mix the contents of one or more containers and transfer 1⁄2 pound thereof to a 4-liter flask containing 2 liters of distilled water at room temperature (but not below 20° C). Stopper the flask and swirl it moderately for 2 minute so that the rice is in motion and in uniform suspension. Allow the

rice to settle for 1⁄2 minute, then pour off 1,600 milliliters of the water, together with any floating and suspended matter, and discard. To the contents of the flask, add 1,600 milliliters of distilled water and 20 milliliters of 10 N hydrochloric acid. Agitate vigorously and wash down the sides of the flask with 150 milliliters of 0.1 N hydrochloric acid. In order to avoid excess foaming during the extraction, heat the mixture slowly to about 100° C, agitate if necessary, and maintain at this temperature until air is expelled. Again wash down the sides of the flask with 150 milliliters of 0.1 N hydrochloric acid. Heat the mixture in an autoclave at 120° C to 123° C for 30 minutes, remove and cool to room temperature. Dilute the mixture with distilled water so that the total volume is 2,500 milliliters. Swirl the flask, and while the solids are in uniform suspension pour off about 250 milliliters of the mixture for later determination of iron (and calcium, if this is to be determined). With filter paper that has been shown not to adsorb thiamine, riboflavin, or niacin, filter enough of the remaining mixture for determination of thiamine, riboflavin, and niacin. (In the case of a mixture difficult to filter, centrifuging or filtering through fritted glass, or both, using a suitable analytical filter-aid, may be substituted for, or may precede, filtering through paper.) Dilute an aliquot of filtrate with 0.1 N hydrochloric acid, so that each milliliter contains about 0.2 microgram of thiamine, and determine thiamine by the "Rapid Fluorometric Method-Official Final Action," in section 43.034 of "Official Methods of Analysis of the Association of Official Analytical Chemists" (AOAC), 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20001. With a suitable aliquot determine riboflavin by the method prescribed in section 43.041(a) by the "Fluorometric Method-Official Final Action," AOAC, 13th Ed. (1980), beginning with the third sen

tence of the second paragraph, “Adjust, with vigorous agitation ." Determine niacin in a 200milliliter aliquot of the filtrate by the "Colorimetric Method-Official Final Action," in section 43.045, AOAC, 13th Ed. (1980), beginning with the sixth sentence of the first paragraph, "Adjust to pH 4.5 with ***." Evaporate to dryness a 100-milliliter aliquot of the nonfiltered material withdrawn while agitating, and determine iron using the method "Iron-Official Final Action," in sections 14.011, 14.012, and 14.013, AOAC, 13th Ed. (1980), and, if required, determine calcium as directed in section 14.014 under the heading "Calcium-Official Final Action," AOAC, 13th Ed. (1980). (f) When the optional ingredient specified in paragraph (a)(4) of this section is added, the statement "Butylated hydroxytoluene added as a preservative" shall be placed on the label prominently and with such conspicuousness (as compared with other words, statements, designs, or devices in the label) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase.

(g) 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.

NOTE: The Order of the Commissioner of Food and Drugs appearing at 23 FR 1170, Feb. 25, 1958, amending paragraphs (a)(1) and (c) provides in part as follows: The regulations in § 137.350 (formerly § 15.525) are stayed insofar as they require each pound of the food to contain not less than 1.2 milligrams and not more than 2.4 milligrams of riboflavin. This stay shall continue until final action is taken disposing of the objections, after public hearing thereon.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 6, 1993]

EFFECTIVE DATE NOTE: At 58 FR 2878, Jan. 6, 1993 in § 137.350 paragraph (g) was added, effective May 8, 1993.

PART 139-MACARONI AND

NOODLE PRODUCTS

Subpart A-[Reserved]

Subpart B-Requirements for Specific Standardized Macaroni and Noodle Products

Sec.

139.110 Macaroni products.

139.115 Enriched macaroni products. 139.117 Enriched macaroni products with fortified protein.

139.120 Milk macaroni products. 139.121 Nonfat milk macaroni products. 139.122 Enriched nonfat milk macaroni products.

139.125 Vegetable macaroni products. 139.135 Enriched vegetable macaroni products.

139.138 Whole wheat macaroni products. 139.140 Wheat and soy macaroni products. 139.150 Noodle products.

139.155 Enriched noodle products. 139.160 Vegetable noodle products. 139.165 Enriched vegetable noodle products.

139.180 Wheat and soy noodle products.

AUTHORITY: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376). SOURCE: 42 FR 14409, Mar. 15, 1977, unless otherwise noted.

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(a) Macaroni products are the class of food each of which is prepared by drying formed units of dough made from semolina, durum flour, farina, flour, or any combination of two or more of these, with water and with or without one or more of the optional ingredients specified in paragraphs (a) (1) to (6), inclusive, of this section.

(1) Egg white, frozen egg white, dried egg white, or any two or all of these, in such quantity that the solids thereof are not less than 0.5 percent and not more than 2.0 percent of the weight of the finished food.

(2) Disodium phosphate, in a quantity not less than 0.5 percent and not more than 1.0 percent of the weight of the finished food.

(3) Onions, celery, garlic, bay leaf, or any two or more of these, in a quantity which seasons the food.

(4) Salt, in a quantity which seasons the food.

(5) Gum gluten, in such quantity that the protein content of the finished food is not more than 13 percent by weight. The finished macaroni product contains not less than 87 percent of total solids as determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), in section 14.133, under the heading "Vacuum Oven Method-Official Final Action," which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20001.

(6) Concentrated glyceryl monostearate (containing not less than 90 percent monoester), in a quantity not exceeding 2 percent by weight of the finished food.

(b) Macaroni is the macaroni product the units of which are tube-shaped and more than 0.11 inch but not more than 0.27 inch in diameter.

(c) Spaghetti is the macaroni product the units of which are tube-shaped or cord-shaped (not tubular) and more than 0.06 inch but not more than 0.11 inch in diameter.

(d) Vermicelli is the macaroni product the units of which are cord-shaped (not tubular) and not more than 0.06 inch in diameter.

(e) The name of each food for which a definition and standard of identity is prescribed by this section is "Macaroni product"; or alternatively, the name is "Macaroni", "Spaghetti", or "Vermicelli", as the case may be, when the units of the food are of the shapes and sizes specified in paragraph (b), (c), or (d), respectively, of this section.

(f) (1) When disodium phosphate is used the label shall bear the statement "Disodium phosphate added for quick cooking”.

(2) When any ingredient specified in paragraph (a)(3) of this section is used the label shall bear the statement

"Seasoned with -", the blank being filled in with the common name of the ingredient; or in the case of bay leaves the statement “Spiced”, “Spice added", or "Spiced with bay leaves".

(3) When the ingredient specified in paragraph (a)(6) of this section is used, the label shall bear the statement "Glyceryl monostearate added" or the statement "With added glyceryl monostearate".

(4) Wherever the name of the food 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 optional ingredients used, shall immediately and conspicuously precede or follow, or in part precede and in part follow, such name, without intervening written, printed, or graphic matter.

(g) 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.

[42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan. 6, 1993]

EFFECTIVE DATE NOTE: At 58 FR 2878, Jan. 6, 1993 in § 139.110 paragraph (g) was added, effective May 8, 1993.

§ 139.115 Enriched macaroni products.

(a) Description. Enriched macaroni products are the class of food each of which conforms to the definition and standard of identity and is subject to the requirements for label statement of ingredients, prescribed for macaroni products by § 139.110(a), (f), and (g), except that:

(1) Each such food contains in each pound not less than 4 mg. and not more than 5 mg. of thiamine, not less than 1.7 mg. and not more than 2.2 mg. of riboflavin, not less than 27 mg. and not more than 34 mg. of niacin or niacinamide, and not less than 13 mg. and not more than 16.5 mg. of iron (Fe);

(2) Each such food may also contain as an optional ingredient added vitamin D in such quantity that each pound of the finished food contains not less than 250 U.S.P. units and not

more than 1000 U.S.P. units of vitamin D.

(3) Each such food may also contain as an optional ingredient added calcium in such quantity that each pound of the finished food contains not less than 500 mg. and not more than 625 mg. of calcium (Ca);

(4) Each such food may also contain as an optional ingredient partly defatted wheat germ but the amount thereof does not exceed 5 percent of the weight of the finished food;

(5) Each such food may be supplied, wholly or in part, with the prescribed quantity of any substance referred to in paragraphs (a) (1), (2), and (3) of this section through the use of dried yeast, dried torula yeast, partly defatted wheat germ, enriched farina, or enriched flour, or through the direct additions of any of the substances prescribed in paragraphs (a) (1), (2), and (3) of this section.

Iron and calcium may be added only in forms which are harmless and assimilable. The substances referred to in paragraphs (a) (1) and (2) of this section may be added in a harmless carrier which does not impair the enriched macaroni product, such carrier being used only in the quantity reasonably necessary to effect an intimate and uniform distribution of such substances in the finished enriched macaroni product.

(b) Enriched macaroni is the enriched macaroni product the units of which conform to the specifications of shape and size prescribed for macaroni by § 139.110(b).

(c) Enriched spaghetti is the enriched macaroni product the units of which conform to the specifications of shape and size prescribed for spaghetti by § 139.110(c).

(d) Enriched vermicelli is the enriched macaroni product the units of which conform to the specifications of shape and size prescribed for vermicelli by § 139.110(d).

(e) The name of each food for which a definition and standard of identity is prescribed by this section is "Enriched Macaroni product"; or alternatively, the name is "Enriched macaroni", "Enriched spaghetti", or "Enriched vermicelli", as the case may be, when

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(a) (1) Each of the foods for which a standard of identity is prescribed by this section is produced by drying formed units of dough made witn one or more of the milled wheat ingredients designated in §§ 139.110(a) and 139.138(a), and other ingredients to enable the finished food to meet the protein requirements set out in paragraph (a)(2)(i) of this section. Edible protein sources, including food grade flours or meals made from nonwheat cereals or from oilseeds, may be used. Vitamin and mineral enrichment nutrients are added to bring the food into conformity with the requirements of paragraph (b) of this section. Safe and suitable ingredients, as provided for in paragraph (c) of this section, may be added. The proportion of the milled wheat ingredient is larger than the proportion of any other ingredient used.

(2) Each such finished food, when tested by the methods described in the cited sections of "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference (copies may be obtained from the Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC

20001), meets the following specifications:

(i) The protein content (N x 6.25) is not less than 20 percent by weight (on a 13 percent moisture basis) as determined by the method in section 14.142. The protein quality is not less than 95 percent that of casein as determined on the cooked food by the method in sections 43.212 through 43.216 of the official methods.

(ii) The total solids content is not less than 87 percent by weight as determined by the method in section 14.133 of the official methods.

(b) (1) Each food covered by this section contains in each pound 5 milligrams of thiamin, 2.2 milligrams of riboflavin, 34 milligrams of niacin or niacinamide, and 16.5 milligrams of iron.

(2) Each pound of such food may also contain 625 milligrams of calcium.

(3) Iron and calcium may be added only in forms which are harmless and assimilable. The enrichment nutrients may be added in a harmless carrier used only in a quantity necessary to effect a uniform distribution of the nutrients in the finished food. The requirements of paragraphs (b) (1) and (2) of this section shall be deemed to have been met if reasonable overages, within the limits of good manufacturing practice, are present to assure that the prescribed levels of the vitamins and mineral(s) are maintained throughout the expected shelf life of the food under customary conditions of distribution.

(c) The safe and suitable ingredients referred to in paragraph (a) of this section are ingredients that serve a useful purpose, e.g., to fortify the protein or facilitate production of the food, but they do not include color additives, artificial flavorings, artificial sweeteners, chemical preservatives, or starches. Ingredients deemed suitable for use by this paragraph are added in amounts that are not in excess of those reasonably required to achieve their intended purposes. Ingredients are deemed to be safe if they are not food additives within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act, or in case they are food additives, if they are used in conformity with regulations

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