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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 2016.

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, 2016]
[CITE: 21CFR136.110]



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

PART 136 -- BAKERY PRODUCTS

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/federal_register/code_of_federal_regulations/ibr_locations.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.

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