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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2019]
[CITE: 21CFR136]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
 
PART 136BAKERY PRODUCTS
 

Subpart A--General Provisions

Sec. 136.3 Definitions.

For purposes of this part, the following definitions apply:

(a) The word bread when used in the name of the food means the unit weighs one-half pound or more after cooling.

(b) The words rolls and buns when used in the name of the food mean the unit weighs less than one-half pound after cooling.

Subpart B--Requirements for Specific Standardized Bakery Products

Sec. 136.110 Bread, rolls, and buns.

(a) Bread, white bread, and rolls, white rolls, or buns, and white buns are the foods produced by baking mixed yeast-leavened dough prepared from one or more of the farinaceous ingredients listed in paragraph (c)(1) of this section and one or more of the moistening ingredients listed in paragraphs (c) (2), (6), (7), and (8) of this section and one or more of the leavening agents provided for by paragraph (c)(3) of this section. The food may contain additional ingredients as provided for by paragraph (c) of this section. Each of the finished foods contains not less than 62 percent total solids as determined by the method prescribed in paragraph (d) of this section.

(b) All ingredients from which the food is fabricated shall be safe and suitable.

(c) The following optional ingredients are provided for:

(1) Flour, bromated flour, phosphated flour, or a combination of two or more of these. The potassium bromate in any bromated flour used and the monocalcium phosphate in any phosphated flour used are deemed to be additional optional ingredients in the bread, rolls, or buns. All ingredients in any flour, bromated flour, or phosphated flour used are deemed to be optional ingredients of the bread, rolls, or buns prepared therefrom.

(2) Water.

(3) Yeast--any type which produces the necessary leavening effect.

(4) Salt.

(5) Shortening, in which or in conjunction with which may be used one or any combination of two or more of the following:

(i) Lecithin, hydroxylated lecithin complying with the provisions of part 172 of this chapter, either of which may include related phosphatides derived from the corn oil or soybean oil from which such ingredients were obtained.

(ii) Mono- and diglycerides of fat-forming fatty acids, diacetyl tartaric acid esters of mono- and diglycerides of fat-forming fatty acids, propylene glycol mono- and diesters of fat-forming fatty acids, and other ingredients that perform a similar function.

(6) Milk and/or other dairy products in such quantity and composition as not to meet the requirements for milk and/or other dairy products prescribed for milk bread by 136.130. Whenever nonfat milk solids in any form are used, carrageenan or salts of carrageenan complying with the provisions of part 172 of this chapter may be used in a quantity not in excess of 0.8 percent by weight of such nonfat milk solids.

(7) Egg products.

(8) Nutritive carbohydrate sweeteners.

(9) Enzyme active preparations.

(10) Lactic-acid-producing bacteria.

(11) Nonwheat flours, nonwheat meals, nonwheat grits, wheat and nonwheat starches, any of which may be wholly or in part dextrinized, dextrinized wheat flour, or any combination of 2 or more of these, if the total quantity is not more than 3 parts for each 100 parts by weight of flour used.

(12) Ground dehulled soybeans which may be heat-treated, and from which oil may be removed, but which retain enzymatic activity, if the quantity is not more than 0.5 part for each 100 parts by weight of flour used.

(13) Yeast nutrients and calcium salts, if the total quantity of such ingredients, with the exception of monocalcium phosphate and calcium propionate, is not more than 0.25 part for each 100 parts by weight of flour used. The quantity of monocalcium phosphate, including any quantity in the flour used, is not more than 0.75 part for each 100 parts by weight of flour used. Any calcium propionate used as a preservative in bread, rolls, or buns is not subject to the limitation prescribed in this paragraph.

(14)(i) Potassium bromate, calcium bromate, potassium iodate, calcium iodate, calcium peroxide, or any combination of 2 or more of these if the total quantity, including the potassium bromate in any bromated flour used, is not more than 0.0075 part for each 100 parts by weight of flour used.

(ii) Azodicarbonamide, if the total quantity, including any quantity in the flour used, is not more than 0.0045 part for each 100 parts by weight of flour used.

(15) Dough strengtheners and other dough conditioners not listed or referred to in this paragraph, if the total quantities of such ingredients or combination is not more than 0.5 part for each 100 parts by weight of flour used.

(16) Spices, spice oil, and spice extract.

(17) Coloring may not be added as such or as part of another ingredient except as permitted by paragraph (c)(16) of this section and except that coloring which may be present in butter or margarine if the intensity of the butter or margarine color does not exceed "medium high" (MH) when viewed under diffused light (7400 Kelvin) against the Munsell Butter Color Comparator. The MH designation corresponds to the Munsell renotation of 3.8Y7.9/7.6.

(18) Other ingredients that do not change the basic identity or adversely affect the physical and nutritional characteristics of the food.

(d) Total solids are determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), section 14.091(a), which is incorporated by reference, except that if the baked unit weighs 454 grams (1 pound) or more, one entire unit is used for the determination; if the baked unit weighs less than 454 grams, enough units to weigh 454 grams or more are used. Copies of the material incorporated by reference 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/federalregister/codeoffederalregulations/ibrlocations.html.

(e)(1) The name of the food is "bread", "white bread", "rolls", "white rolls", "buns", "white 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 "egg bread", "egg rolls", or "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 chapter, 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 the purpose 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.

(2) When the label bears any representation, other than in the ingredient listing, of the presence of egg in the food, e.g., the word egg or any phonetic equivalent spelling of the word egg, or a picture of an egg, the food shall contain not less than 2.56 percent of whole egg solids.

(f) Label declaration. Each of the ingredients used shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14400, Mar. 15, 1977, as amended at 43 FR 47177, Oct. 13, 1978; 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, 1984; 49 FR 13692, Apr. 6, 1984; 54 FR 24894, June 12, 1989; 58 FR 2877, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998]

Sec. 136.115 Enriched bread, rolls, and buns.

(a) Each of the foods enriched bread, enriched rolls, and enriched buns conforms to the definition and standard of identity and is subject to the requirements for label statement of ingredients prescribed for bread, rolls or buns by 136.110, except that:

(1) Each such food contains in each pound 1.8 milligrams of thiamin, 1.1 milligrams of riboflavin, 15 milligrams of niacin, 0.43 milligrams of folic acid, and 12.5 milligrams of iron.

(2) Each such food may contain added calcium in such quantity that the total calcium content is 600 milligrams per pound. If insufficient calcium is added to meet the 600-milligram level per pound of the finished food, no claim may be made on the label for calcium as a nutrient except as a part of nutrition labeling.

(3) The requirements of paragraphs (a) (1) and (2) 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 ensure 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:

Vitamin Reference form
Name Empirical formula Molecular weight
ThiamineThiamine chloride hydrochlorideC12H17ClN4 OS.HCl337.28
RiboflavinRiboflavinC17H20N4O6376.37
NiacinNiacinC6H5NO2123.11

(4) Each such food may also contain wheat germ or partly defatted wheat germ, but the total quantity thereof, including any wheat germ or partly defatted wheat germ in any enriched flour used, shall not be more than 5 percent of the flour ingredient.

(5) Enriched flour may be used, in whole or in part, instead of flour. As used in this section, the term "enriched flour" includes enriched bromated flour.

(6) The limitation prescribed by 136.110(c)(6) on the quantity and composition of milk and/or other dairy products does not apply.

(7) 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.

(b) The name of the food is "enriched bread", "enriched rolls", or "enriched 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 "enriched egg bread", "enriched egg rolls", or "enriched 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 chapter, 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 the purpose of this regulation, whole egg solids are the edible contents of eggs calculated on a moisture-free basis and exclusive of any non-egg 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. When the food complies with the requirements for milk and/or other dairy products content in 136.130 for milk bread, the name of the food may be "enriched milk bread", "enriched milk rolls", or "enriched milk buns", as applicable. When the food complies with the requirements for both enriched egg bread and enriched milk bread in this section, the name of the food may be "enriched milk and egg bread", "enriched milk and egg rolls", or "enriched milk 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 chapter, 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 no 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 non-egg solids which may be present in standardized or 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 43 FR 38578, Aug. 29, 1978; 46 FR 43413, Aug. 28, 1981; 61 FR 8796, Mar. 5, 1996; 61 FR 14245, Apr. 1, 1996]

Sec. 136.130 Milk bread, rolls, and buns.

(a) Each of the foods milk bread, milk rolls, and milk buns conforms to the definition and standard of identity and is subject to the requirements for label statement of ingredients prescribed for bread, rolls or buns by 136.110 except that:

(1) The only moistening ingredient permitted in the preparation of the dough is milk or, as an alternative, a combination of dairy products in such a proportion that the weight of the nonfat milk solids is not more than 2.3 times and not less than 1.2 times the weight of the milkfat therein, with or without water, in a quantity that provides not less than 8.2 parts milk solids for each 100 parts by weight of flour.

(2) No buttermilk, buttermilk product, cheese whey, cheese whey product, or milk protein is used.

(b) The name of the food is "milk bread", "milk rolls", "milk buns", as applicable.

Sec. 136.160 Raisin bread, rolls, and buns.

(a) Each of the foods raisin bread, raisin rolls, and raisin buns conforms to the definition and standard of identity and is subject to the requirements for label statement of ingredients prescribed for bread, rolls or buns by 136.110, except that:

(1) Not less than 50 parts by weight of seeded or seedless raisins are used for each 100 parts by weight of flour used.

(2) Water extract of raisins may be used, but not to replace raisins.

(3) The baked units may bear icing or frosting.

(4) The limitation prescribed by 136.110(c)(6) on the quantity and composition of milk and/or other dairy products does not apply.

(5) The total solids are determined by the method prescribed in 136.110(d), except that section 14.091(b) of "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.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 chapter, 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]

Sec. 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 standard of identity and is subject to the label statement of ingredients prescribed for bread, rolls and buns by 136.110, except that:

(1) The dough is made from the optional ingredient whole wheat flour, bromated whole wheat flour, or a combination 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 composition 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.

Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

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