(a) Farina is the food prepared by grinding and bolting cleaned wheat, other than durum wheat and red durum wheat, to such fineness that, when tested by the method prescribed in paragraph (b)(2) of this section, it passes through a No. 20 sieve, but not more than 3 percent passes through a No. 100 sieve. It is 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 0.6 percent. Its moisture content is not more than 15 percent.

(b) For the purposes of this section: (1) Ash and moisture are determined by the methods therefor referred to in § 137.105(c).

(2) The method referred to in paragraph (a) of this section is as follows:

Use No. 20 and No. 100 sieves, having standard 8-inch full-height frames, complying with the specifications for wire cloth and sieve frames in "Standard Specifications for Sieves," published March 1, 1940, in L.C. 584 of the U.S. Department of Commerce, National Bureau of Standards, 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 Office of the Federal Register, 1100 L St. NW., Washington, DC 20408. Fit a No. 20 sieve into a No. 100 sieve. Attach bottom pan to the No. 100 sieve. Pour 100 grams of the sample into the No. 20 sieve. Attach cover and

hold the assembly in a slightly inclined position with one hand. Shake the sieves by striking the sides against the other hand with an upward stroke, at the rate of about 150 times per minute. Turn the sieves about onesixth of a revolution, each time in the same direction, after each 25 strokes. Continue shaking for 2 minutes. Weigh the material which fails to pass through the No. 20 sieve and the material which passes through the No. 100 sieve.

[42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982]

(a) Enriched farina conforms to the definition and standard of identity prescribed for farina by § 137.300, except that:

(1) It contains in each pound not less than 2.0 milligrams and not more than 2.5 milligrams of thiamine, not less than 1.2 milligrams and not more than 1.5 milligrams of riboflavin, not less than 16.0 milligrams and not more than 20.0 milligrams of niacin or niacinamide, and not less than 13.0 milligrams of iron (Fe).

(2) Vitamin D may be added in such quantity that each pound of the finished enriched farina contains not less than 250 U.S.P. units of the optional ingredient vitamin D.

(3) Calcium may be added in such quantity that each pound of the finished enriched farina contains not less than 500 milligrams of the optional ingredient calcium (Ca).

(4) It may contain not more than 8 percent by weight of the optional ingredient wheat germ or partly defatted wheat germ.

(5)(i) It may contain not less than 0.5 percent and not more than 1 percent by weight of the optional ingredient disodium phosphate; or

(ii) It may be treated with one of the proteinase enzymes papain or pepsin to reduce substantially the time required for cooking. In such treatment papain or pepsin, in an amount not to exceed 0.1 percent by weight, is added to the farina, which is moistened, warmed, and subsequently heated sufficiently to inactivate the enzyme and to dry the product to comply with the

limit for § 137.300(a).

moisture prescribed by

(6) In determining whether the ash content complies with the requirements of this section allowance is made for ash resulting from any added iron or salts of iron or calcium, or from any added disodium phosphate, or from any added wheat germ or partly defatted wheat germ.

Iron and calcium may be added only in forms which are harmless and assimilable. Dried irradiated yeast may be used as a source of vitamin D. 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 farina; such carrier is used only in the quantity necessary to effect an intimate and uniform admixture of such substances with the farina.

(b)(1) All optional ingredients used in the food shall be declared on the label as required by the applicable sections of Part 101 of this chapter.

(2)(i) When the optional ingredient disodium phosphate is used, the label shall bear the statement "Disodium phosphate added for quick cooking”.

(ii) When the proteinase enzyme treatment is used, the label shall bear the statement "Enzyme treated for quicker cooking”.

(3) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statements prescribed by paragraph (b)(2) of this section shall immediately and conspicuously precede or follow such name without intervening written, printed, or graphic matter; except that where the name of the food is a part of a trademark or brand, then other written, printed, or graphic matter that is also a part of the trademark or brand may so intervene, if such statement is in such juxtaposition with the trademark or brand as to be conspicuously related to the name of the food.

passes through a No. 100 sieve. It is 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 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 method entitled "Rapid Fluorometric MethodOfficial," beginning with section 38.32 of the book "Official Methods of Analysis of the Association of Official Agricultural Chemists," 8th Ed. (1955) [Ed. note, 10th Ed. (1965), p. 761, section 39.0281, 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. With a suitable aliquot determine riboflavin by the method enti

tled "Fluorometric Method-Official" in the same book, beginning with the third sentence of the second paragraph in section 38.35(a), “Adjust, with vigorous agitation ***.” [Ed. note, 10th edition, 1965, p. 762, sec. 39.035.] Determine niacin in a 200-milliliter aliquot of the filtrate by the method entitled "Chemical MethodOfficial" in the same book, beginning in the second sentence of the first paragraph in section 38.47(a), “adjust to pH 4.5 with ***" [Ed. note, 10th edition, 1965, p. 763, sec. 39.038.] Evaporate to dryness a 100-milliliter aliquot of the nonfiltered material withdrawn while agitating, and determine iron using the method on page 208 of the same book entitled "Iron-Official," [Ed. note, 10th edition, 1965, p. 192, secs. 13.011-13.013] and, if required, determine calcium as directed, on page 209 of the same book, entitled "Calcium-Official." [Ed. note, 10th edition, 1965, p. 193, sec. 13.014.]

(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.

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]

§ 139.110 Macaroni products.

(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 and Tentative Methods of Analysis of the Association of Official Agricultural Chemists," 5th Ed. (1940), page 235 [Ed. note, 10th Ed. (1965), p. 209, section 13.115], under "Vacuum Oven Method-Official," 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.

(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.

[42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19, 1982]

§ 139.115 Enriched macaroni products.

(a) 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 optional ingredients, prescribed for macaroni products by § 139.110 (a) and (f), 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);