21 CFR - § 137.105-137.350 - Cereal flours and related products

553 Food and Drug Administration, HHS Pt. 137 (5) The total solids are determined by the method prescribed in § 136.110(d), except that section 14.091(b) of ‘‘Offi cial Methods of Analysis of the Asso ciation of Official Analytical Chem ists,’’ 13th Ed. (1980), which is incor porated by reference, will apply. 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 avail ability 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. (b) The name of the food is ‘‘raisin bread’’, ‘‘raisin rolls’’, ‘‘raisin buns’’, as applicable. When the food contains not less than 2.56 percent by weight of whole egg solids, the name of the food may be ‘‘raisin and egg bread’’, ‘‘raisin and egg rolls’’, or ‘‘raisin and egg buns’’, as applicable, accompanied by the statement ‘‘Contains medium sized egg(s) per pound’’ in the manner prescribed by § 102.5(c)(3) of this chap ter, the blank to be filled in with the number which represents the whole egg content of the food expressed to the nearest one-fifth egg but not greater than the amount actually present. For purposes of this regulation, whole egg solids are the edible contents of eggs calculated on a moisture-free basis and exclusive of any nonegg solids which may be present in standardized and other commercial egg products. One medium-sized egg is equivalent to 0.41 ounce of whole egg solids. [42 FR 14400, Mar. 15, 1977, as amended at 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 63 FR 14035, Mar. 24, 1998] § 136.180 Whole wheat bread, rolls, and buns. (a) Each of the foods whole wheat bread, graham bread, entire wheat bread, whole wheat rolls, graham rolls, entire wheat rolls, whole wheat buns, graham buns, and entire wheat buns conforms to the definition and stand ard of identity and is subject to the label statement of ingredients pre scribed for bread, rolls and buns by § 136.110, except that: (1) The dough is made from the op tional ingredient whole wheat flour, bromated whole wheat flour, or a com bination of these. No flour, bromated flour, or phosphated flour is used. The potassium bromate in any bromated whole wheat flour used is deemed to be an additional optional ingredient in the whole wheat bread, whole wheat rolls, or whole wheat buns. (2) The limitation prescribed by § 136.110(c)(6) on the quantity and com position of milk and/or other dairy products does not apply. (b) The name of the food is ‘‘whole wheat bread’’, ‘‘graham bread’’, ‘‘entire wheat bread’’, ‘‘whole wheat rolls’’, ‘‘graham rolls’’, ‘‘entire wheat rolls’’, ‘‘whole wheat buns’’, ‘‘graham buns’’, ‘‘entire wheat buns’’, as applicable. PART 137—CEREAL FLOURS AND RELATED PRODUCTS Subpart A [Reserved] Subpart B—Requirements for Specific Standardized Cereal Flours and Re lated Products Sec. 137.105 Flour. 137.155 Bromated flour. 137.160 Enriched bromated flour. 137.165 Enriched flour. 137.170 Instantized flours. 137.175 Phosphated flour. 137.180 Self-rising flour. 137.185 Enriched self-rising flour. 137.190 Cracked wheat. 137.195 Crushed wheat. 137.200 Whole wheat flour. 137.205 Bromated whole wheat flour. 137.211 White corn flour. 137.215 Yellow corn flour. 137.220 Durum flour. 137.225 Whole durum flour. 137.250 White corn meal. 137.255 Bolted white corn meal. 137.260 Enriched corn meals. 137.265 Degerminated white corn meal. 137.270 Self-rising white corn meal. 137.275 Yellow corn meal. 137.280 Bolted yellow corn meal. 137.285 Degerminated yellow corn meal. 137.290 Self-rising yellow corn meal. 137.300 Farina. 137.305 Enriched farina. 137.320 Semolina. 137.350 Enriched rice. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. 554 21 CFR Ch. I (4–1–24 Edition) § 137.105 SOURCE: 42 FR 14402, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 137 appear at 63 FR 14035, Mar. 24, 1998. Subpart A [Reserved] Subpart B—Requirements for Spe cific Standardized 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 a-amylase obtained from Aspergillus oryzae, alone or in a safe and suitable carrier, may be used. When tested for granulation as pre scribed in paragraph (c)(4) of this sec tion, 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 specifica tions for such cloth set forth in ‘‘Offi cial Methods of Analysis of the Asso ciation of Official Analytical Chem ists’’ (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 incor porated by reference. Copies may be obtained from the AOAC INTER NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar chives and Records Administration (NARA). For information on the avail ability 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, cal culated to a moisture-free basis, plus 0.35. Its moisture content is not more than 15 percent. It may contain ascor bic acid in a quantity not to exceed 200 parts per million as a dough condi tioner. 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 combina tion of two or more of the following op tional bleaching ingredients may be added in a quantity not more than suf ficient for bleaching or, in case such in gredient 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 per oxide mixed with not more than six parts by weight of one or any mixture of two or more of the following: potas sium alum, calcium sulfate, magne sium carbonate, sodium aluminum sul fate, dicalcium phosphate, tricalcium phosphate, starch, calcium carbonate. (6) Acetone peroxides complying with the provisions of § 172.802 of this chap ter. (7) Azodicarbonamide (complying with the requirements of § 172.806 of this chapter, including the quan titative limit of not more than 45 parts per million). (b)(1) Label declaration. Each of the ingredients used in the food shall be de clared 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 ‘‘Ascor bic acid added as a dough conditioner’’. When the optional ingredient a-amy lase obtained from Aspergillus oryzae’’ is used, it may alternatively be de clared in the list of ingredients as ‘‘Fungal alpha-amylase,’’ ‘‘Fungal a 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 conspicu ously as to be easily seen under cus tomary conditions of purchase, the word ‘‘Bleached’’ shall immediately 555 Food and Drug Administration, HHS § 137.165 and conspicuously precede or follow such name, without intervening writ ten, 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 ref erence. The availability of this incor poration by reference is given in para graph (a) of this section. Ash is cal culated to a moisture-free basis by sub tracting the percent of moisture in the flour from 100, dividing the remainder into the percent of ash, and multi plying the quotient by 100. (2) Protein is 5.7 times the nitrogen as determined by the method pre scribed in section 2.057, ‘‘Improved Kjeldahl Methods for Nitrate-Free Samples (20)—Official Final Action,’’ AOAC, 13th Ed. (1980), which is incor porated 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 pro tein, 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 Meth od,’’ which is incorporated by ref erence. The availability of this incor poration by reference is given in para graph (a) of this section. (4) Granulation is determined as fol lows: Use No. 70 sieve complying with the specifications for ‘‘Nominal Dimen sions of Standard Test Sieves (U.S.A. Standard Series)’’ prescribed in para graph (a) of this section. Attach bot tom pan to sieve in Ro-Tap sifter (or an equivalent sifter). Place half of a rub ber 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 con vert to percentage. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 47 FR 24693, June 8, 1982; 47 FR 43363, Oct. 1, 1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, Jan. 6, 1993] § 137.155 Bromated flour. Bromated flour conforms to the defi nition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for flour by § 137.105, except that potas sium 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 bak ing qualities are improved by such ad dition. [57 FR 2877, Jan. 6, 1993] § 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, pre scribed 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 fin ished enriched bromated flour, and is added only to enriched flours whose baking qualities are improved by such addition. [58 FR 2877, Jan. 6, 1993] § 137.165 Enriched flour. Enriched flour conforms to the defi nition 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 mil ligrams of thiamin, 1.8 milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of folic acid, and 20 milli grams 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 556 21 CFR Ch. I (4–1–24 Edition) § 137.170 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 over ages of the vitamins and minerals, within the limits of good manufac turing practice, are present to insure that the required levels of the vitamins and minerals are maintained through out the expected shelf life of the food under customary conditions of dis tribution and storage. The quantitative content of the following vitamins shall be calculated in terms of the following chemically identifiable reference forms: Vitamin Reference form Name Empirical formula Molec ular weight Thiamine ... Thiamine chlo ride hydro chloride. C12H17ClN4OS·HCl 337 .28 Riboflavin .. Riboflavin ........ C17H20N4O6 376 .37 Niacin ........ Niacin .............. C6H5NO2 123 .11 (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 require ments 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 suit able. The vitamins and minerals added to the food for enrichment purposes may be supplied by any safe and suit able substance. Niacin equivalents as derived from tryptophan content shall not be used in determining total niacin content. [42 FR 14402, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29, 1978; 46 FR 43414, Aug. 28, 1981; 58 FR 2877, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] § 137.170 Instantized flours. (a) Instantized flours, instant blend ing 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 pre scribed for the corresponding kind of flour by §§ 137.105, 137.155, 137.160, 137.165, 137.175, 137.180, and 137.185, ex cept that each such flour has been made by one of the optional procedures set forth in paragraph (b) of this sec tion, and is thereby made readily pour able. 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 pre scribed in § 137.105(a) has been modified by further processing, so that a number of the individual flour particles have been combined into agglomerates con forming to the granulation specifica tions 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 iden tity for the corresponding kind of flour as referred to in paragraph (a) of this section, preceded immediately and con spicuously by the words ‘‘Instantized’’, ‘‘Instant blending’’, or ‘‘Quick-mix ing’’. [42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2877, Jan. 6, 1993] § 137.175 Phosphated flour. Phosphated flour, phosphated white flour, and phosphated wheat flour, con form to the definition and standard of identity, and are subject to the re quirements for label declaration of in gredients, 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 require ments of this section allowance is 557 Food and Drug Administration, HHS § 137.180 made for the added monocalcium phos phate. [42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2877, Jan. 6, 1993] § 137.180 Self-rising flour. (a) Self-rising flour, self-rising white flour, self-rising wheat flour, is an inti mate mixture of flour, sodium bicar bonate, and one or more of the acid-re acting substances monocalcium phos phate, sodium acid pyrophosphate, and sodium aluminum phosphate. It is sea soned 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 suffi cient quantity to neutralize the sodium bicarbonate. The combined weight of such acid-reacting substance and so dium bicarbonate is not more than 4.5 parts to each 100 parts of flour used. Subject to the conditions and restric tions prescribed by § 137.105(a), the bleaching ingredients specified in such section may be added as optional ingre dients. If the flour used in making the self-rising flour is bleached, the op tional bleaching ingredient used there in (see § 137.105(a)) is also an optional ingredient of the self-rising flour. (b) Label declaration. Each of the in gredients used in the food, shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. (c) The method referred to in para graph (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 (Dis placement soln.),’’ and section 8.003, ‘‘Chittick apparatus,’’ under the head ing ‘‘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, Gai thersburg, MD 20877, or may be exam ined 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/fed eral register/code of federal regulations/ ibr locations.html.The following proce dure 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 in sure 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 re duce 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 decomposi tion 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 con tents intimately. Allow to stand for 10 minutes to bring to equilibrium. Equal ize 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 pre vious allowance of 25 cc. compensates for the 45 cc. acid used in the decompo sition). 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, ‘‘Correc tion factors for gasometric determina tion of carbon dioxide,’’ AOAC, 13th Ed. (1980), which is incorporated by ref erence (the availability of this incorpo ration by reference is given in para graph (c) of this section), for the tem perature and pressure observed. Divide the corrected reading by 100 to obtain the apparent percent by weight of car bon dioxide in the official sample. (2) Correct the apparent percent of carbon dioxide to compensate for vary ing atmospheric conditions by imme diately assaying a synthetic sample by the same method in the same appa ratus. 558 21 CFR Ch. I (4–1–24 Edition) § 137.185 (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 so dium bicarbonate U.S.P. (dried over sulfuric acid) to yield the amount of carbon dioxide recovered in assay of of ficial sample. Determine this quantity by multiplying weight of carbon diox ide recovered in assay of official sam ple by 1.91. (4) Divide the weight of carbon diox ide recovered from synthetic sample by weight of carbon dioxide contained in sodium bicarbonate used. (5) Divide the quotient into the ap parent percent of carbon dioxide in of ficial sample to obtain percent of car bon dioxide evolved from the official sample. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, Jan. 6, 1993] § 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, pre scribed for self-rising flour by § 137.180, except that: (a) It contains in each pound 2.9 mil ligrams of thiamin, 1.8 milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of folic acid, and 20 milli grams of iron. (b) It contains added calcium in such quantity that the total calcium con tent is 960 milligrams per pound. If a calcium compound is added for tech nical purposes to give self-rising char acteristics 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 accom plish 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 manufac turing practice, are present to insure that the required levels of the vitamins and minerals are maintained through out the expected shelf life of the food under customary conditions of dis tribution and storage. The quantitative content of the following vitamins shall be calculated in terms of the following chemically identifiable reference forms: Vitamin Reference form Name Empirical formula Molec ular weight Thiamine ... Thiamine chlo ride hydro chloride. C12H17ClN4OS·HCl 337 .28 Riboflavin .. Riboflavin ........ C17H20N4O6 376 .37 Niacin ........ Niacin .............. C6H5NO2 123 .11 (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 car bonate, 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 suit able. The vitamins and minerals added to the food for enrichment purposes may be supplied by any safe and suit able substances. Niacin equivalents as derived from tryptophan content shall not be used in determining total niacin content. [42 FR 14402, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29, 1978; 46 FR 43414, Aug. 28, 1981; 58 FR 2877, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] § 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 pre scribed 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 559 Food and Drug Administration, HHS § 137.200 unaltered. Cracked wheat contains not more than 15 percent of the moisture as determined by the method pre scribed in ‘‘Official Methods of Anal ysis of the Association of Official Ana lytical Chemists,’’ 13th Ed. (1980), sec tion 7.002 under ‘‘Preparation of Sam ple—Official Final Action,’’ and section 7.003 under ‘‘Moisture—Official Final Action. I. Drying in Vacuo at 95–100° (2),’’ which is incorporated by ref erence. 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 Admin istration (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. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989] § 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 con stituents of such wheat, other than moisture, remain unaltered. Crushed wheat contains not more than 15 per cent of moisture as determined by the method prescribed in ‘‘Official Methods of Analysis of the Association of Offi cial 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 ref erence. 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 Admin istration (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. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989] § 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 nat ural deficiency of enzymes, malted wheat, malted wheat flour, malted bar ley 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 a-am ylase 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 quan tity not to exceed 200 parts per million as a dough conditioner. Unless such ad dition 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 chap ter, including the quantitative limit of not more than 45 parts per million) or chlorine dioxide, or chlorine, or a mix ture of nitrosyl chloride and chlorine, may be added in a quantity not more than sufficient for bleaching and artifi cial aging effects. (b)(1) Label declaration. Each of the ingredients used in the food shall be de clared 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 ‘‘Ascor bic acid added as a dough conditioner’’. When the optional ingredient ‘‘a’’-amy lase obtained from Aspergillus oryzae’’ is used, it may alternatively be de clared in the list of ingredients as 560 21 CFR Ch. I (4–1–24 Edition) § 137.205 ‘‘Fungal alpha-amylase,’’ ‘‘Fungal a 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 conspicu ously as to be easily seen under cus tomary conditions of purchase, the word ‘‘Bleached’’ shall immediately and conspicuously precede or follow such name, without intervening writ ten, 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 Offi cial 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 avail ability 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 para graph (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 Ex planatory Notes,’’ which is incor porated by reference. The availability of this incorporation by reference is given in paragraph (c)(1) of this sec tion. 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 po sition 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 direc tion, after each 25 strokes. Continue shaking for 2 minutes. Weigh the mate rial which fails to pass through the No. 8 sieve and the material which passes through the No. 20 sieve. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 47 FR 24693, June 8, 1982; 47 FR 43364, Oct. 1, 1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, Jan. 6, 1993] § 137.205 Bromated whole wheat flour. Bromated whole wheat flour con forms to the definition and standard of identity, and is subject to the require ments for label statement of ingredi ents, prescribed for whole wheat flour by § 137.200, except that potassium bro mate is added in a quantity not exceed ing 75 parts to each million parts of finished bromated whole wheat flour. [58 FR 2877, Jan. 6, 1993] § 137.211 White corn flour. (a) White corn flour is the food pre pared 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 mois ture-free basis) of neither the crude fiber nor fat in the finished white corn flour exceeds the content (on a mois ture-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 deter mined by methods therefore referred to in § 137.250(b)(1). (2) The method referred to in para graph (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 centi meters, height 4 centimeters), fitted at 561 Food and Drug Administration, HHS § 137.250 bottom with 70-mesh wire cloth com plying 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 ‘‘Defini tions of Terms and Explanatory Notes,’’ which is incorporated by ref erence. 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 Admin istration (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 suc tion flask. Wash with 150 ml. of petro leum ether applied in a small stream without suction, while gently stirring the sample with a small glass rod. Apply suction for 2 minutes after wash ing is completed, then shake the cone for 2 minutes with a vigorous hori zontal motion, striking the side against the hand, and then weigh. The decrease in weight of sample, cal culated 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 hav ing a standard 20.3 centimeter (8-inch) diameter full-height frame, complying with the specifications for wire cloth and sieve frame in ‘‘Nominal Dimen sions of Standard Test Sieves (U.S.A. Standard Series).’’ Shake for 2 minutes with a vigorous horizontal motion, striking the side against the hand; re move 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. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989] § 137.215 Yellow corn flour. Yellow corn flour conforms to the definition and standard of identity pre scribed 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 de termined by the methods prescribed in § 137.105(c). § 137.225 Whole durum flour. Whole durum wheat flour conforms to the definition and standard of iden tity, and is subject to the requirements for label statement of ingredients, pre scribed 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. [58 FR 2877, Jan. 6, 1993] § 137.250 White corn meal. (a) White corn meal is the food pre pared 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 prepara tion coarse particles of the ground corn may be separated and discarded, or re ground 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 there to are on a moisture-free basis. 562 21 CFR Ch. I (4–1–24 Edition) § 137.255 (b)(1) For the purposes of this sec tion, moisture, fat, and crude fiber con tent will be determined by the fol lowing methods of analysis from ‘‘Offi cial Methods of Analysis of the Asso ciation of Official Analytical Chem ists,’’ 13th Ed. (1980), which is incor porated by reference (copies may be ob tained from the AOAC INTER NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar chives and Records Administration (NARA). For information on the avail ability 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 para graph (a) of this section is as follows: Use No. 12 and No. 25 sieves, having standard 20.3 centimeter (8-inch) di ameter full-height frames, complying with the specifications for wire cloth and sieve frames in ‘‘Nominal Dimen sions 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 Admin istration (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 equiva lent in size with those of No. 70 woven wire cloth, complying with specifica tions 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 po sition 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 di rection, after each 25 strokes. Continue shaking for 2 minutes. Weigh sepa rately 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 small er than its openings, empty the con tents 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 re maining on the No. 12 sieve. The per cent passing through a No. 25 sieve shall be determined by adding the per cents 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. [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] § 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 pre scribed in § 137.250(b)(2), except that a No. 20 standard sieve is used instead of the No. 12 sieve, not less than 95 per cent passes through a No. 20 sieve, not less than 45 percent through a No. 25 sieve, but not more than 25 percent 563 Food and Drug Administration, HHS § 137.270 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 con tent 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 deter mined 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 pre scribed 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 ri boflavin, not less than 16 mg and not more than 24 mg of niacin or niacina mide, 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 harm less and assimilable. The substances re ferred 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 in timate and uniform admixture of such substances with the kind of corn meal used. Dried yeast in quantities not ex ceeding 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’’ fol lowed 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 in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] § 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 per cent; and (2) When tested by the method pre scribed 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 deter mined 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 suffi cient quantity to neutralize the sodium bicarbonate. The combined weight of such acid-reacting substance and so dium bicarbonate is not more than 4.5 parts to each 100 parts of white corn meal used. 564 21 CFR Ch. I (4–1–24 Edition) § 137.275 (b) The method referred to in para graph (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 (Dis placement soln.),’’ and section 8.003, ‘‘Chittick apparatus,’’ under the head ing ‘‘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, Gai thersburg, MD 20877, or may be exam ined 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/fed eral register/code of federal regulations/ ibr locations.html. The following proce dure 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 in sure 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 re duce 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 decomposi tion 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 min utes 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 read ing (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 sur rounding 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 pres sure observed, which is incorporated by reference. The availability of this in corporation by reference is given in paragraph (b) of this section. Divide the corrected reading by 100 to obtain the apparent percent by weight of car bon dioxide in the official sample. (2) Correct the apparent percent of carbon dioxide to compensate for vary ing atmospheric conditions by imme diately assaying a synthetic sample by the same method in the same appa ratus. (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 so dium bicarbonate U.S.P. (dried over sulfuric acid) to yield the amount of carbon dioxide recovered in assay of of ficial sample. Determine this quantity by multiplying weight of carbon diox ide recovered in assay of official sam ple by 1.91. (4) Divide the weight of carbon diox ide recovered from synthetic sample by weight of carbon dioxide contained in sodium bicarbonate used. (5) Divide the quotient into the ap parent percent of carbon dioxide in of ficial sample to obtain percent of car bon dioxide evolved from the official sample. (c) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [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] § 137.275 Yellow corn meal. Yellow corn meal conforms to the definition and standard of identity pre scribed by § 137.250 for white corn meal except that cleaned yellow corn is used instead of cleaned white corn. 565 Food and Drug Administration, HHS § 137.305 § 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 iden tity prescribed by § 137.265 for degerminated white corn meal except that cleaned yellow corn is used in stead of cleaned white corn. § 137.290 Self-rising yellow corn meal. Self-rising yellow corn meal con forms to the definition and standard of identity prescribed by § 137.270 for self rising white corn meal except that yel low 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, cal culated 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 para graph (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 incor porated by reference. Copies may be obtained from the AOAC INTER NATIONAL, 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/fed eral 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. At tach 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 min utes. 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; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989] § 137.305 Enriched farina. (a) Enriched farina conforms to the definition and standard of identity pre scribed 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 ri boflavin, not less than 16.0 mg and not more than 20.0 mg of niacin or niacina mide, 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 fin ished enriched farina contains not less than 250 U.S.P. units of the optional in gredient vitamin D. (3) Calcium may be added in such quantity that each pound of the fin ished enriched farina contains not less than 500 milligrams of the optional in gredient calcium (Ca). (4) It may contain not more than 8 percent by weight of the optional in gredient wheat germ or partly defatted wheat germ. 566 21 CFR Ch. I (4–1–24 Edition) § 137.320 (5)(i) It may contain not less than 0.5 percent and not more than 1 percent by weight of the optional ingredient diso dium 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 require ments 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 assimi lable. Dried irradiated yeast may be used as a source of vitamin D. The sub stances referred to in paragraphs (a) (1) and (2) of this section may be added in a harmless carrier which does not im pair the enriched farina; such carrier is used only in the quantity necessary to effect an intimate and uniform admix ture of such substances with the farina. (b)(1) Label declaration. Each of the ingredients used in the food shall be de clared 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 ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the statements prescribed by paragraph (b)(2) of this section shall immediately and con spicuously 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 writ ten, 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 trade mark or brand as to be conspicuously related to the name of the food. [42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996] § 137.320 Semolina. (a) Semolina is the food prepared by grinding and bolting cleaned durum wheat to such fineness that, when test ed 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 mois ture-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 pre scribed 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). Cal cium 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 ingre dient of the milled rice used and not an optional ingredient of the enriched rice unless such enriched rice is labeled to 567 Food and Drug Administration, HHS § 137.350 show it contains the optional ingre dient calcium. Iron and calcium may be added only in forms that are harm less and assimilable. The vitamins re ferred to in paragraphs (a) (1) and (2) of this section may be combined with harmless substances to render them in soluble 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 inti mate and uniform mixture of such sub stances 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 direc tions calling for washing or draining or unless the food is precooked and it is packaged in consumer packages which are conspicuously and prominently la beled with directions for preparation which, if followed, will avoid washing away or draining off enriching ingredi ents, the substances named in para graphs (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 con tains not less than 85 percent of the minimum quantities of the substances named in paragraph (a)(1) of this sec tion, as required for enriched rice; and in case any optional ingredients named in paragraphs (a) (2) and (3) of this sec tion are used, the washed rice also con tains 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 ‘‘en riched’’ as, for example, ‘‘Enriched rice’’ or ‘‘Enriched parboiled rice’’. (e) The method referred to in para graph (c) of this section is as follows: Mix the contents of one or more con tainers and transfer 1⁄2 pound thereof to a 4-liter flask containing 2 liters of dis tilled 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 uni form suspension. Allow the rice to set tle 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 mix ture 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 uni form suspension pour off about 250 mil liliters of the mixture for later deter mination of iron (and calcium, if this is to be determined). With filter paper that has been shown not to adsorb thi amine, 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 fil tering through fritted glass, or both, using a suitable analytical filter-aid, may be substituted for, or may pre cede, filtering through paper.) Dilute an aliquot of filtrate with 0.1 N hydro chloric acid, so that each milliliter contains about 0.2 microgram of thi amine, and determine thiamine by the ‘‘Rapid Fluorometric Method—Official Final Action,’’ in section 43.034 of ‘‘Of ficial Methods of Analysis of the Asso ciation of Official Analytical Chem ists’’ (AOAC), 13th Ed. (1980), which is incorporated by reference. Copies may 568 21 CFR Ch. I (4–1–24 Edition) Pt. 139 be obtained from the AOAC INTER NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar chives and Records Administration (NARA). For information on the avail ability 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 ali quot determine riboflavin by the meth od prescribed in section 43.041(a) by the ‘‘Fluorometric Method—Official Final Action,’’ AOAC, 13th Ed. (1980), begin ning with the third sentence of the sec ond 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, ‘‘Ad just 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 sec tion 14.014 under the heading ‘‘Cal cium—Official Final Action,’’ AOAC, 13th Ed. (1980). (f) When the optional ingredient specified in paragraph (a)(4) of this sec tion is added, the statement ‘‘Butylated hydroxytoluene added as a preservative’’ shall be placed on the label prominently and with such con spicuousness (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 in gredients used in the food shall be de clared 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 inso far 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 pub lic 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; 61 FR 8796, Mar. 5, 1996] 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 prod ucts. 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: 21 U.S.C. 321, 341, 343, 348, 371, 379e. SOURCE: 42 FR 14409, Mar. 15, 1977, unless otherwise noted. Subpart A [Reserved] Subpart B—Requirements for Spe cific Standardized Macaroni and Noodle Products § 139.110 Macaroni products. (a) Macaroni products are the class of food each of which is prepared by dry ing 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), in clusive, 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