Title 21—Food and Drugs--Volume 1
PART 137—CEREAL FLOURS AND RELATED PRODUCTS
§ 137.105   Flour.
(a) Flour, white flour, wheat flour, plain flour, is the food prepared by grinding and bolting cleaned wheat, other than durum wheat and red durum wheat. To compensate for any natural deficiency of enzymes, malted wheat, malted wheat flour, malted barley flour, or any combination of two or more of these, may be used; but the quantity of malted barley flour so used is not more than 0.75 percent. Harmless preparations of α-amylase obtained from Aspergillus oryzae, alone or in a safe and suitable carrier, may be used. When tested for granulation as prescribed in paragraph (c)(4) of this section, not less than 98 percent of the flour passes through a cloth having openings not larger than those of woven wire cloth designated “212 µm (No. 70)” complying with the specifications for such cloth set forth in “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), 13th Ed. (1980), Table 1, “Nominal Dimensions of Standard Test Sieves (U.S.A. Standard Series),” under the heading “Definitions of Terms and Explanatory Notes,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The flour 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 the sum of 1/20 of the percent of protein therein, calculated to a moisture-free basis, plus 0.35. Its moisture content is not more than 15 percent. It may contain ascorbic acid in a quantity not to exceed 200 parts per million as a dough conditioner. Unless such addition conceals damage or inferiority or makes the flour appear to be better or of greater value than it is, one or any combination of two or more of the following optional bleaching ingredients may be added in a quantity not more than sufficient for bleaching or, in case such ingredient has an artificial aging effect, in a quantity not more than sufficient for bleaching and such artificial aging effect:
(1) Oxides of nitrogen.
(2) Chlorine.
(3) Nitrosyl chloride.
(4) Chlorine dioxide.
(5) One part by weight of benzoyl peroxide mixed with not more than six parts by weight of one or any mixture of two or more of the following: potassium alum, calcium sulfate, magnesium carbonate, sodium aluminum sulfate, dicalcium phosphate, tricalcium phosphate, starch, calcium carbonate.
(6) Acetone peroxides complying with the provisions of § 172.802 of this chapter.
(7) Azodicarbonamide (complying with the requirements of § 172.806 of this chapter, including the quantitative limit of not more than 45 parts per million).
(b)(1) 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.
(2) When ascorbic acid is added, the label shall bear the statement “Ascorbic acid added as a dough conditioner”. When the optional ingredient α-amylase obtained from Aspergillus oryzae ” is used, it may alternatively be declared in the list of ingredients as “Fungal alpha -amylase,” “Fungal α-amylase”, “Enzyme”, or “Enzyme added for improved baking”. When any optional bleaching ingredient is used, the label shall bear the word “Bleached”. Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the word “Bleached” shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter; except that where such name is a part of a trademark or brand, other written, printed, or graphic matter, which is also a part of such trademark or brand, may so intervene if the word “Bleached” is in such juxtaposition with such trademark or brand as to be conspicuously related to such name.
(c) For the purposes of this section:
(1) Ash is determined by the method prescribed in the AOAC, 13th Ed. (1980), section 14.006, “Direct Method—Official Final Action,” under the heading “Ash (5),” which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a) of this section. Ash is calculated to a moisture-free basis by subtracting the percent of moisture in the flour from 100, dividing the remainder into the percent of ash, and multiplying the quotient by 100.
(2) Protein is 5.7 times the nitrogen as determined by the method prescribed in section 2.057, “Improved Kjeldahl Methods for Nitrate-Free Samples (20)—Official Final Action,” AOAC, 13th Ed. (1980), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a) of this section. Protein is calculated to a moisture-free basis by subtracting the percent of moisture in the flour from 100, dividing the remainder into the percent of protein, and multiplying the quotient by 100.
(3) Moisture is determined by the method prescribed in the AOAC, 13th Ed. (1980), sections 14.002 and 14.003, “Vacuum Oven Method (2)—Official Final Action,” under the heading “Total Solids Moisture, Indirect Method,” which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a) of this section.
(4) Granulation is determined as follows: Use No. 70 sieve complying with the specifications for “Nominal Dimensions of Standard Test Sieves (U.S.A. Standard Series)” prescribed in paragraph (a) of this section. Attach bottom pan to sieve in Ro-Tap sifter (or an equivalent sifter). Place half of a rubber ball or other sieving aid in the sieve. Pour 100 grams of the sample in the sieve and turn on the sifter with knocker. Sift exactly 5 minutes. Weigh the residue on the No. 70 sieve and convert to percentage.
§ 137.155   Bromated flour.
Bromated flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for flour by § 137.105, except that potassium bromate is added in a quantity not exceeding 50 parts to each million parts of the finished bromated flour, and is added only to flours whose baking qualities are improved by such addition.
§ 137.160   Enriched bromated flour.
Enriched bromated flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for enriched flour by § 137.165, except that potassium bromate is added in a quantity not exceeding 50 parts to each million parts of the finished enriched bromated flour, and is added only to enriched flours whose baking qualities are improved by such addition.
§ 137.165   Enriched flour.
Enriched flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for flour by § 137.105, except that:
(a) It contains in each pound 2.9 milligrams of thiamin, 1.8 milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of folic acid, and 20 milligrams of iron.
(b) It may contain added calcium in such quantity that the total calcium content is 960 milligrams per pound. Enriched flour may be acidified with monocalcium phosphate within the limits prescribed by § 137.175 for phosphated flour, but, if insufficient additional calcium is present to meet the 960 milligram level, no claim may be made on the label for calcium as a nutrient;
(c) The requirement of paragraphs (a) and (b) of this section will be deemed to have been met if reasonable overages of the vitamins and minerals, within the limits of good manufacturing practice, are present to insure that the required levels of the vitamins and minerals are maintained throughout the expected shelf life of the food under customary conditions of distribution and storage. The quantitative content of the following vitamins shall be calculated in terms of the following chemically identifiable reference forms:
(d) It may contain not more than 5 percent by weight of wheat germ or partly defatted wheat germ;
(e) In determining whether the ash content complies with the requirements of this section, ash resulting from any added iron or salts of iron or calcium or wheat germ is excluded in calculating ash content.
(f) All ingredients from which the food is fabricated shall be safe and suitable. The vitamins and minerals added to the food for enrichment purposes may be supplied by any safe and suitable substance. Niacin equivalents as derived from tryptophan content shall not be used in determining total niacin content.
§ 137.170   Instantized flours.
(a) Instantized flours, instant blending flours, and quick-mixing flours, are the foods each of which conforms to the definition and standard of identity and is subject to the requirement for label statement of ingredients prescribed for the corresponding kind of flour by §§ 137.105, 137.155, 137.160, 137.165, 137.175, 137.180, and 137.185, except that each such flour has been made by one of the optional procedures set forth in paragraph (b) of this section, and is thereby made readily pourable. Such flours will all pass through a No. 20 mesh U.S. standard sieve (840-micron opening), and not more than 20 percent will pass through a 200 mesh U.S standard sieve (74-micron opening).
(b) The optional procedures referred to in paragraph (a) of this section are:
(1) A selective grinding and bolting procedure or other milling procedure, whereby controlled techniques are used to obtain a food too fine to meet the granulation specification prescribed in § 137.300(a) for farina.
(2) An agglomerating procedure, whereby flour that originally meets the granulation specification prescribed in § 137.105(a) has been modified by further processing, so that a number of the individual flour particles have been combined into agglomerates conforming to the granulation specifications set out in paragraph (a) of this section.
(c) The name of each product covered by this section is the name prescribed by the definition and standard of identity for the corresponding kind of flour as referred to in paragraph (a) of this section, preceded immediately and conspicuously by the words “Instantized”, “Instant blending”, or “Quick-mixing”.
§ 137.175   Phosphated flour.
Phosphated flour, phosphated white flour, and phosphated wheat flour, conform to the definition and standard of identity, and are subject to the requirements for label declaration of ingredients, prescribed for flour by § 137.105, except that:
(a) Monocalcium phosphate is added in a quantity not less than 0.25 percent and not more than 0.75 percent of the weight of the finished phosphated flour; and
(b) In determining whether the ash content complies with the requirements of this section allowance is made for the added monocalcium phosphate.
§ 137.180   Self-rising flour.
(a) Self-rising flour, self-rising white flour, self-rising wheat flour, is an intimate mixture of flour, sodium bicarbonate, and one or more of the acid-reacting substances monocalcium phosphate, sodium acid pyrophosphate, and sodium aluminum phosphate. It is seasoned with salt. When it is tested by the method prescribed in paragraph (c) of this section not less than 0.5 percent of carbon dioxide is evolved. The acid-reacting substance is added in sufficient quantity to neutralize the sodium bicarbonate. The combined weight of such acid-reacting substance and sodium bicarbonate is not more than 4.5 parts to each 100 parts of flour used. Subject to the conditions and restrictions prescribed by § 137.105(a), the bleaching ingredients specified in such section may be added as optional ingredients. If the flour used in making the self-rising flour is bleached, the optional bleaching ingredient used therein (see § 137.105(a)) is also an optional ingredient of the self-rising flour.
(b) 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.
(c) The method referred to in paragraph (a) of this section is the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), 13th Ed. (1980), section 8.002, “Reagent (Displacement soln.),” and section 8.003, “Chittick apparatus,” under the heading “Total Carbon Dioxide (1)—Official Final Action,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The following procedure is substituted for the procedure specified in the AOAC, under section 8.004, “Determination”:
(1) Weigh 17 grams of the official sample into flask A, add 15-20 glass beads (4-6 mm. diameter), and connect this flask with the apparatus (fig. 22). Open stopcock C and by means of the leveling bulb E bring the displacement solution to the 25 cc. graduation above the zero mark. (This 25 cc. is a partial allowance for the volume of acid to be used in the decomposition.) Allow the apparatus to stand 1-2 minutes to insure that the temperature and pressure within the apparatus are the same as those of the room. Close the stopcock, lower the leveling bulb somewhat to reduce the pressure within the apparatus, and slowly run into the decomposition flask from burette F 45 cc. of sulfuric acid (1 + 5). To prevent the liberated carbon dioxide from escaping through the acid burette into the air, keep the displacement solution in the leveling bulb at all times during the decomposition at a lower level than that in the gas-measuring tube. Rotate and then vigorously agitate the decomposition flask for three minutes to mix the contents intimately. Allow to stand for 10 minutes to bring to equilibrium. Equalize the pressure in the measuring tube by means of the leveling bulb and read the volume of gas from the zero point on the tube. Deduct 20 cc. from this reading (this 20 cc. together with previous allowance of 25 cc. compensates for the 45 cc. acid used in the decomposition). Observe the temperature of the air surrounding the apparatus and also the barometric pressure and multiply the number of mL of gas evolved by the factor given in section 52.007, “Correction factors for gasometric determination of carbon dioxide,” AOAC, 13th Ed. (1980), which is incorporated by reference (the availability of this incorporation by reference is given in paragraph (c) of this section), for the temperature and pressure observed. Divide the corrected reading by 100 to obtain the apparent percent by weight of carbon dioxide in the official sample.
(2) Correct the apparent percent of carbon dioxide to compensate for varying atmospheric conditions by immediately assaying a synthetic sample by the same method in the same apparatus.
(3) Prepare the synthetic sample with 16.2 grams of flour, 0.30 gram of monocalcium phosphate, 0.30 gram of salt, and a sufficient quantity of sodium bicarbonate U.S.P. (dried over sulfuric acid) to yield the amount of carbon dioxide recovered in assay of official sample. Determine this quantity by multiplying weight of carbon dioxide recovered in assay of official sample by 1.91.
(4) Divide the weight of carbon dioxide recovered from synthetic sample by weight of carbon dioxide contained in sodium bicarbonate used.
(5) Divide the quotient into the apparent percent of carbon dioxide in official sample to obtain percent of carbon dioxide evolved from the official sample.
§ 137.185   Enriched self-rising flour.
Enriched self-rising flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for self-rising flour by § 137.180, except that:
(a) It contains in each pound 2.9 milligrams of thiamin, 1.8 milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of folic acid, and 20 milligrams of iron.
(b) It contains added calcium in such quantity that the total calcium content is 960 milligrams per pound. If a calcium compound is added for technical purposes to give self-rising characteristics to the flour, the amount of calcium per pound of flour may exceed 960 milligrams provided that the excess is no greater than necessary to accomplish the intended effect. However, if such calcium is insufficient to meet the 960-milligram level, no claim may be made on the label for calcium as a nutrient.
(c) The requirements of paragraphs (a) and (b) of this section will be deemed to have been met if reasonable overages of the vitamins and minerals, within the limits of good manufacturing practice, are present to insure that the required levels of the vitamins and minerals are maintained throughout the expected shelf life of the food under customary conditions of distribution and storage. The quantitative content of the following vitamins shall be calculated in terms of the following chemically identifiable reference forms:
(d) It may contain not more than 5 percent by weight of wheat germ or partly defatted wheat germ;
(e) When calcium is added as dicalcium phosphate, such dicalcium phosphate is also considered to be an acid-reacting substance;
(f) When calcium is added as carbonate, the method set forth in § 137.180(c) does not apply as a test for carbon dioxide evolved; but in such case the quantity of carbon dioxide evolved under ordinary conditions of use of the enriched self-rising flour is not less than 0.5 percent of the weight thereof;
(g) All ingredients from which the food is fabricated shall be safe and suitable. The vitamins and minerals added to the food for enrichment purposes may be supplied by any safe and suitable substances. Niacin equivalents as derived from tryptophan content shall not be used in determining total niacin content.
§ 137.190   Cracked wheat.
Cracked wheat is the food prepared by so cracking or cutting into angular fragments cleaned wheat other than durum wheat and red durum wheat that, when tested by the method prescribed in § 137.200(c)(2), not less than 90 percent passes through a No. 8 sieve and not more than 20 percent passes through a No. 20 sieve. The proportions of the natural constituents of such wheat, other than moisture, remain unaltered. Cracked wheat contains not more than 15 percent of the moisture as determined by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), section 7.002 under “Preparation of Sample—Official Final Action,” and section 7.003 under “Moisture—Official Final Action. I. Drying in Vacuo at 95-100° (2),” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
§ 137.195   Crushed wheat.
Crushed wheat, coarse ground wheat, is the food prepared by so crushing cleaned wheat other than durum wheat and red durum wheat that, when tested by the method prescribed in § 137.200(c)(2), 40 percent or more passes through a No. 8 sieve and less than 50 percent passes through a No. 20 sieve. The proportions of the natural constituents of such wheat, other than moisture, remain unaltered. Crushed wheat contains not more than 15 percent of moisture as determined by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), section 7.002 under “Preparation of Sample—Official Final Action,” and section 7.003 under “Moisture—Official Final Action. I. Drying in Vacuo at 95-100° (2),” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
§ 137.200   Whole wheat flour.
(a) Whole wheat flour, graham flour, entire wheat flour is the food prepared by so grinding cleaned wheat, other than durum wheat and red durum wheat, that when tested by the method prescribed in paragraph (c)(2) of this section, not less than 90 percent passes through a 2.36 mm (No. 8) sieve and not less than 50 percent passes through a 850 µm (No. 20) sieve. The proportions of the natural constituents of such wheat, other than moisture, remain unaltered. To compensate for any natural deficiency of enzymes, malted wheat, malted wheat flour, malted barley flour, or any combination of two or more of these, may be used; but the quantity of malted barley flour so used is not more than 0.75 percent. It may contain harmless preparations of α-amylase obtained from Aspergillus oryzae, alone or in a safe and suitable carrier. The moisture content of whole wheat flour is not more than 15 percent. It may contain ascorbic acid in a quantity not to exceed 200 parts per million as a dough conditioner. Unless such addition conceals damage or inferiority or makes the whole wheat flour appear to be better or of greater value than it is, the optional bleaching ingredient azodicarbonamide (complying with the requirements of § 172.806 of this chapter, including the quantitative limit of not more than 45 parts per million) or chlorine dioxide, or chlorine, or a mixture of nitrosyl chloride and chlorine, may be added in a quantity not more than sufficient for bleaching and artificial aging effects.
(b)(1) 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.
(2) When ascorbic acid is added, the label shall bear the statement “Ascorbic acid added as a dough conditioner”. When the optional ingredient “α”-amylase obtained from Aspergillus oryzae ” is used, it may alternatively be declared in the list of ingredients as “Fungal alpha -amylase,” “Fungal α-amylase”, “Enzyme”, or “Enzyme added for improved baking”. When any optional bleaching ingredient is used, the label shall bear the word “Bleached”. Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the word “Bleached” shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter; except that where such name is a part of a trademark or brand, other written, printed or graphic matter, which is also a part of such trademark or brand, may so intervene if the word “Bleached” is in such juxtaposition with such trademark or brand as to be conspicuously related to such name.
(c) For the purposes of this section:
(1) Moisture is determined by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), 13th Ed. (1980), section 14.002. “Vacuum Oven Method—Official Final Action,” and section 14.003, “Determination,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) The method referred to in paragraph (a) of this section is as follows: Use No. 8 and No. 20 sieves, having standard 8-inch full-height frames, complying with the specifications set forth in the AOAC, Table 1, “Nominal Dimensions of Standard Test Sieves (U.S.A. Standard Series),” under the heading “Definitions of Terms and Explanatory Notes,” which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this section. Fit a No. 8 sieve into a No. 20 sieve. Attach bottom pan to the No. 20 sieve. Pour 100 gm. of the sample into the No. 8 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 one-sixth 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. 8 sieve and the material which passes through the No. 20 sieve.
§ 137.205   Bromated whole wheat flour.
Bromated whole wheat flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for whole wheat flour by § 137.200, except that potassium bromate is added in a quantity not exceeding 75 parts to each million parts of finished bromated whole wheat flour.
§ 137.211   White corn flour.
(a) White corn flour is the food prepared by so grinding and bolting cleaned white corn that when tested by the method prescribed in paragraph (b)(2) of this section, not less than 98 percent passes through a No. 50 sieve and not less than 50 percent passes through No. 70 woven-wire cloth. Its moisture content is not more than 15 percent. In its preparation, part of the ground corn may be removed, but in any such case, the content (on a moisture-free basis) of neither the crude fiber nor fat in the finished white corn flour exceeds the content (on a moisture-free basis) of such substance in the cleaned corn from which it was ground.
(b)(1) For the purpose of this section, moisture, fat, and crude fiber are determined by methods therefore referred to in § 137.250(b)(1).
(2) The method referred to in paragraph (a) of this section is as follows: Weigh 5 grams of sample into a tared truncated metal cone (top diameter 5 centimeters, bottom diameter 2 centimeters, height 4 centimeters), fitted at bottom with 70-mesh wire cloth complying with the specifications for No. 70 wire cloth in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), Table 1, “Nominal Dimensions of Standard Test Sieves (U.S.A. Standard Series),” under the heading “Definitions of Terms and Explanatory Notes,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Attach cone to a suction flask. Wash with 150 ml. of petroleum ether applied in a small stream without suction, while gently stirring the sample with a small glass rod. Apply suction for 2 minutes after washing is completed, then shake the cone for 2 minutes with a vigorous horizontal motion, striking the side against the hand, and then weigh. The decrease in weight of sample, calculated as percent by weight of sample shall be considered the percent passing through No. 70 wire cloth. Transfer the residue from cone to a No. 50 sieve having a standard 20.3 centimeter (8-inch) diameter full-height frame, complying with the specifications for wire cloth and sieve frame in “Nominal Dimensions of Standard Test Sieves (U.S.A. Standard Series).” Shake for 2 minutes with a vigorous horizontal motion, striking the side against the hand; remove and weigh the residue; calculate the weight of residue as percent by weight of sample, and subtract from 100 percent to obtain the percent of sample passing through the No. 50 sieve.
§ 137.215   Yellow corn flour.
Yellow corn flour conforms to the definition and standard of identity prescribed by § 137.211 for white corn flour except that cleaned yellow corn is used instead of clean white corn.
§ 137.220   Durum flour.
(a) Durum flour is the food prepared by grinding and bolting cleaned durum wheat. When tested for granulation as prescribed in § 137.105(c)(4), not less than 98 percent of such flour passes through the No. 70 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 1.5 percent. Its moisture content is not more than 15 percent.
(b) For the purpose of this section, ash, moisture, and granulation are determined by the methods prescribed in § 137.105(c).
§ 137.225   Whole durum flour.
Whole durum wheat flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for whole wheat flour by § 137.200, except that cleaned durum wheat, instead of cleaned wheat other than durum wheat and red durum wheat, is used in its preparation.
§ 137.250   White corn meal.
(a) White corn meal is the food prepared by so grinding cleaned white corn that when tested by the method prescribed in paragraph (b)(2) of this section not less than 95 percent passes through a No. 12 sieve, not less than 45 percent through a No. 25 sieve, but not more than 35 percent through a No. 72 grits gauze. Its moisture content is not more than 15 percent. In its preparation coarse particles of the ground corn may be separated and discarded, or reground and recombined with all or part of the material from which they were separated, but in any such case the crude fiber content of the finished corn meal is not less than 1.2 percent and not more than that of the cleaned corn from which it was ground, and its fat content does not differ more than 0.3 percent from that of such corn. The contents of crude fiber and fat in all the foregoing provisions relating thereto are on a moisture-free basis.
(b)(1) For the purposes of this section, moisture, fat, and crude fiber content will be determined by the following methods of analysis from “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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html ):
(i) Moisture content—sections 14.062 and 14.063 (Official Final Action).
(ii) Fat content—sections 14.062 and 14.067 (Official Final Action).
(iii) Crude fiber content—sections 14.062 and 14.065 (Official Final Action).
(2) The method referred to in paragraph (a) of this section is as follows: Use No. 12 and No. 25 sieves, having standard 20.3 centimeter (8-inch) diameter full-height frames, complying with the specifications for wire cloth and sieve frames in “Nominal Dimensions of Standard Test Sieves (U.S.A. Standard Series)” prescribed in § 137.105(a), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. A sieve with frame of the same dimensions as the Nos. 12 and 25 and fitted with 72 XXX grits gauze is used as the third sieve. It is referred to hereafter as the No. 72 sieve. The 72 XXX grits gauze has openings equivalent in size with those of No. 70 woven-wire cloth, complying with specifications for such cloth contained in such “Standard Specifications for Sieves.” Attach bottom pan to No. 72 sieve. Fit the No. 25 sieve into the No. 72 sieve and the No. 12 sieve into the No. 25 sieve. Pour 100 grams of sample into the No. 12 sieve, attach cover and hold the assembly in a slightly inclined position and shake the assembly of sieves by striking the sides against one hand with an upward stroke, at the rate of about 150 times per minute. Turn the assembly of sieves about one-sixth of a revolution, each time in the same direction, after each 25 strokes. Continue shaking for 2 minutes. Weigh separately the material remaining on each sieve and in the pan, and calculate each weight as percent of sample. Sometimes when meals are tested, fine particles clog the sieve openings. If any sieve is clogged by fine material smaller than its openings, empty the contents onto a piece of paper. Remove the entrapped material on the bottom of the sieve by a hair brush and add to the sieve below. In like manner, clean the adhering material from inside the sieve and add to the material on the paper. Return mixture on the paper to the sieve, reassemble the sieves, and shake in the same manner as before for 1 minute. Repeat cleaning procedure if necessary until a 5-gram or less loss in weight occurs in any sieve during a 1-minute shaking. The percent of sample passing through No. 12 sieve shall be determined by subtracting from 100 percent, the percent of material remaining on the No. 12 sieve. The percent passing through a No. 25 sieve shall be determined by adding the percents remaining on the No. 72 sieve and the percent in pan. The percent in the pan shall be considered as the percent passing through a No. 72 XXX grits gauze.
§ 137.255   Bolted white corn meal.
(a) Bolted white corn meal is the food prepared by so grinding and sifting cleaned white corn that:
(1) Its crude fiber content is less than 1.2 percent but its fat content is not less than 2.25 percent; and
(2) When tested by the method prescribed in § 137.250(b)(2), except that a No. 20 standard sieve is used instead of the No. 12 sieve, not less than 95 percent passes through a No. 20 sieve, not less than 45 percent through a No. 25 sieve, but not more than 25 percent through No. 72 XXX grits gauze. Its moisture content is not more than 15 percent. In its preparation particles of ground corn which contain germ may be separated, reground, and recombined with all or part of the material from which it was separated, but in any such case the fat content of the finished bolted white corn meal does not exceed by more than 0.3 percent the fat content of the cleaned corn from which it was ground. The contents of crude fiber and fat in all the foregoing provisions relating thereto are on a moisture-free basis.
(b) For the purposes of this section, moisture, fat and crude fiber are determined by the methods therefor referred to in § 137.250(b)(1).
§ 137.260   Enriched corn meals.
(a) Enriched corn meals are the foods, each of which conforms to the definition and standard of identity prescribed for a kind of corn meal by §§ 137.250, 137.255, 137.265, 137.270, 137.275, 137.280, 137.285, and 137.290, except that:
(1) It contains in each pound not less than 2.0 milligrams (mg) and not more than 3.0 mg of thiamin, not less than 1.2 mg and not more than 1.8 mg of riboflavin, not less than 16 mg and not more than 24 mg of niacin or niacinamide, not less than 0.7 mg and not more than 1.0 mg of folic acid, and not less than 13 mg and not more than 26 mg of iron (Fe);
(2) It may contain in each pound not less than 250 U.S.P. units and not more than 1,000 U.S.P. units of vitamin D; and
(3) It may contain in each pound not less than 500 milligrams and not more than 750 milligrams of calcium (Ca); Provided, however, That enriched self-rising corn meals shall contain in each pound not more than 1,750 milligrams of calcium (Ca). Iron and calcium may be added only in forms which are harmless and assimilable. The substances referred to in this paragraph (a)(3) and in paragraphs (a) (1) and (2) of this section may be added in a harmless carrier which does not impair the enriched corn meal; such carrier is used only in the quantity necessary to effect an intimate and uniform admixture of such substances with the kind of corn meal used. Dried yeast in quantities not exceeding 1.5 percent by weight of the finished food may be used.
(b) The name of each kind of enriched corn meal is the word “Enriched” followed by the name of the kind of corn meal used which is prescribed in the definition and standard of identity therefor.
(c) 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.
§ 137.265   Degerminated white corn meal.
(a) Degerminated white corn meal, degermed white corn meal, is the food prepared by grinding cleaned white corn and removing bran and germ so that:
(1) On a moisture-free basis, its crude fiber content is less than 1.2 percent and its fat content is less than 2.25 percent; and
(2) When tested by the method prescribed in § 137.250(b)(2), except that a No. 20 standard sieve is used instead of a No. 12 sieve, not less than 95 percent passes through a No. 20 sieve, not less than 45 percent through a No. 25 sieve, but not more than 25 percent through No. 72 XXX grits gauze. Its moisture content is not more than 15 percent.
(b) For the purposes of this section, moisture, fat and crude fiber are determined by methods therefor referred to in § 137.250(b)(1).
§ 137.270   Self-rising white corn meal.
(a) Self-rising white corn meal is an intimate mixture of white corn meal, sodium bicarbonate, and one or both of the acid-reacting substances monocalcium phosphate and sodium aluminum phosphate. It is seasoned with salt. When it is tested by the method prescribed in paragraph (b) of this section, not less than 0.5 percent of carbon dioxide is evolved. The acid-reacting substance is added in sufficient quantity to neutralize the sodium bicarbonate. The combined weight of such acid-reacting substance and sodium bicarbonate is not more than 4.5 parts to each 100 parts of white corn meal used.
(b) The method referred to in paragraph (a) of this section is the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), 13th Ed. (1980), section 8.002, “Reagent (Displacement soln.),” and section 8.003, “Chittick apparatus,” under the heading “Total Carbon Dioxide (1)—Official Final Action,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The following procedure is substituted for the procedure specified in the AOAC, under section 8.004, “Determination”:
(1) Weigh 17 grams of the official sample into flask A, add 15-20 glass beads (4-6 mm. diameter), and connect this flask with the apparatus (fig. 25). Open stopcock C and by means of the leveling bulk E bring the displacement solution to the 25 cc. graduation above the zero mark. (This 25 cc. is a partial allowance for the volume of acid to be used in the decomposition.) Allow the apparatus to stand 1-2 minutes to insure that the temperature and pressure within the apparatus are the same as those of the room. Close the stopcock, lower the leveling bulb somewhat to reduce the pressure within the apparatus, and slowly run into the decomposition flask from burette F 45 cc. of sulfuric acid (1 + 5). To prevent the liberated carbon dioxide from escaping through the acid burette into the air keep the displacement solution in the leveling bulb at all times during the decomposition at a lower level than that in the gas-measuring tube. Rotate and then vigorously agitate the decomposition flask for 3 minutes to mix the contents intimately. Allow to stand for 10 minutes to bring to equilibrium. Equalize the pressure in the measuring tube by means of the leveling bulb and read the volume of gas from the zero point on the tube. Deduct 20 cc. from this reading (this 20 cc. together with previous allowance of 25 cc. compensates for the 45 cc. acid used in the decomposition). Observe the temperature of the air surrounding the apparatus and also the barometric pressure and multiply the number of mL of gas evolved by the factor given in the AOAC, 13th Ed. (1980), section 52.007 under Reference Tables for the temperature and pressure observed, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b) of this section. Divide the corrected reading by 100 to obtain the apparent percent by weight of carbon dioxide in the official sample.
(2) Correct the apparent percent of carbon dioxide to compensate for varying atmospheric conditions by immediately assaying a synthetic sample by the same method in the same apparatus.
(3) Prepare the synthetic sample with 16.2 grams of corn meal, 0.30 gram of monocalcium phosphate, 0.30 gram of salt, and a sufficient quantity of sodium bicarbonate U.S.P. (dried over sulfuric acid) to yield the amount of carbon dioxide recovered in assay of official sample. Determine this quantity by multiplying weight of carbon dioxide recovered in assay of official sample by 1.91.
(4) Divide the weight of carbon dioxide recovered from synthetic sample by weight of carbon dioxide contained in sodium bicarbonate used.
(5) Divide the quotient into the apparent percent of carbon dioxide in official sample to obtain percent of carbon dioxide evolved from the official sample.
(c) 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.
§ 137.275   Yellow corn meal.
Yellow corn meal conforms to the definition and standard of identity prescribed by § 137.250 for white corn meal except that cleaned yellow corn is used instead of cleaned white corn.
§ 137.280   Bolted yellow corn meal.
Bolted yellow corn meal conforms to the definition and standard of identity prescribed by § 137.255 for bolted white corn meal except that cleaned yellow corn is used instead of cleaned white corn.
§ 137.285   Degerminated yellow corn meal.
Degerminated yellow corn meal, degermed yellow corn meal, conforms to the definition and standard of identity prescribed by § 137.265 for degerminated white corn meal except that cleaned yellow corn is used instead of cleaned white corn.
§ 137.290   Self-rising yellow corn meal.
Self-rising yellow corn meal conforms to the definition and standard of identity prescribed by § 137.270 for self-rising white corn meal except that yellow corn meal is used instead of white corn meal.
§ 137.300   Farina.
(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 20.3 centimeter (8-inch) full-height frames, complying with the specifications for such cloth set forth in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), Table 1, “Nominal Dimensions of Standard Test Sieves (U.S.A. Standard Series),” under the heading “Definitions of Terms and Explanatory Notes,” which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. 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 one-sixth 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.
§ 137.305   Enriched farina.
(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 (mg) and not more than 2.5 mg of thiamin, not less than 1.2 mg and not more than 1.5 mg of riboflavin, not less than 16.0 mg and not more than 20.0 mg of niacin or niacinamide, not less than 0.7 mg and not more than 0.87 mg of folic acid, and not less than 13.0 mg 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 moisture prescribed by § 137.300(a).
(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.
(b)(1) 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.
(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.
§ 137.320   Semolina.
(a) Semolina is the food prepared by grinding and bolting cleaned durum wheat to such fineness that, when tested by the method prescribed in § 137.300(b)(2), 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 0.92 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 (mg) and not more than 4.0 mg of thiamin, not less than 1.2 mg and not more than 2.4 mg of riboflavin, not less than 16 mg and not more than 32 mg of niacin or niacinamide, not less than 0.7 mg and not more than 1.4 mg of folic acid, and not less than 13 mg and not more than 26 mg 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 assimilable.
(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 8-point 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 1/2 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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. 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 sentence of the second paragraph, “Adjust, with vigorous agitation * * *.” Determine niacin in a 200-milliliter 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.
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.