[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR136]
 
[Page 367]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 136--BAKERY PRODUCTS--Table of Contents
 
 
                      Subpart A--General Provisions
 
Sec.
136.3  Definitions.
 
    Subpart B--Requirements for Specific Standardized Bakery Products
 
136.110  Bread, rolls, and buns.
136.115  Enriched bread, rolls, and buns.
136.130  Milk bread, rolls, and buns.
136.160  Raisin bread, rolls, and buns.
136.180  Whole wheat bread, rolls, and buns.
 
    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR136.3]
 
[Page 367]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 136--BAKERY PRODUCTS--Table of Contents
 
                      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.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR136.110]
 
[Page 367-369]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 136--BAKERY PRODUCTS--Table of Contents
 
    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 Sec. 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.
 
[[Page 368]]
 
    (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 Association of Official Analytical Chemists International, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (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 
Sec. 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
 
[[Page 369]]
 
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]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR136.115]
 
[Page 369-370]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 136--BAKERY PRODUCTS--Table of Contents
 
    Subpart B--Requirements for Specific Standardized Bakery Products
 
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 Sec. 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:
 
------------------------------------------------------------------------
                                            Reference form
                             -------------------------------------------
           Vitamin                                Empirical    Molecular
                                    Name           formula       weight
------------------------------------------------------------------------
Thiamine....................  Thiamine         C12H17ClN4        337.28
                               chloride         OS[middot]HCl
                               hydrochloride.
Riboflavin..................  Riboflavin.....  C17H20N4O6        376.37
Niacin......................  Niacin.........  C6H5NO2           123.11
------------------------------------------------------------------------
 
    (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 Sec. 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 
Sec. 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 
Sec. 136.130 for milk bread, the name of the food may be "enriched milk 
bread", "enriched milk
 
[[Page 370]]
 
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 
Sec. 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]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR136.130]
 
[Page 370]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 136--BAKERY PRODUCTS--Table of Contents
 
    Subpart B--Requirements for Specific Standardized Bakery Products
 
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 Sec. 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.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR136.160]
 
[Page 370]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 136--BAKERY PRODUCTS--Table of Contents
 
    Subpart B--Requirements for Specific Standardized Bakery Products
 
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 Sec. 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 Sec. 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 
Sec. 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 Association of Official Analytical Chemists 
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877-2504, or may be examined at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (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 
Sec. 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]
 
[[Page 371]]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR136.180]
 
[Page 371]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 136--BAKERY PRODUCTS--Table of Contents
 
    Subpart B--Requirements for Specific Standardized Bakery Products
 
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 Sec. 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 Sec. 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.