This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[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: 21CFR137]
[Page 371]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart A [Reserved]
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related 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.
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]
[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: 21CFR137.105]
[Page 371-373]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 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 [alpha]-amylase obtained from Aspergillus oryzae, alone
or in a safe and suitable carrier, may be used. When tested for
granulation as prescribed in paragraph (c)(4) of this section, not less
than 98 percent of the flour passes through a cloth having openings not
larger than those of woven wire cloth designated "212 [mu]m (No. 70)"
complying with the specifications for such cloth set forth in "Official
Methods of Analysis of the Association of Official Analytical Chemists"
(AOAC), 13th Ed. (1980), Table 1, "Nominal Dimensions of Standard Test
Sieves (U.S.A. Standard Series)," under the heading "Definitions of
Terms and Explanatory Notes," which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists International,
[[Page 372]]
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. The flour is freed from bran
coat, or bran coat and germ, to such extent that the percent of ash
therein, calculated to a moisture-free basis, is not more than the sum
of 1/20 of the percent of protein therein, calculated to a moisture-free
basis, plus 0.35. Its moisture content is not more than 15 percent. It
may contain ascorbic acid in a quantity not to exceed 200 parts per
million as a dough conditioner. Unless such addition conceals damage or
inferiority or makes the flour appear to be better or of greater value
than it is, one or any combination of two or more of the following
optional bleaching ingredients may be added in a quantity not more than
sufficient for bleaching or, in case such ingredient has an artificial
aging effect, in a quantity not more than sufficient for bleaching and
such artificial aging effect:
(1) Oxides of nitrogen.
(2) Chlorine.
(3) Nitrosyl chloride.
(4) Chlorine dioxide.
(5) One part by weight of benzoyl peroxide mixed with not more than
six parts by weight of one or any mixture of two or more of the
following: potassium alum, calcium sulfate, magnesium carbonate, sodium
aluminum sulfate, dicalcium phosphate, tricalcium phosphate, starch,
calcium carbonate.
(6) Acetone peroxides complying with the provisions of Sec. 172.802
of this chapter.
(7) Azodicarbonamide (complying with the requirements of
Sec. 172.806 of this chapter, including the quantitative limit of not
more than 45 parts per million).
(b)(1) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
(2) When ascorbic acid is added, the label shall bear the statement
"Ascorbic acid added as a dough conditioner". When the optional
ingredient [alpha]-amylase obtained from Aspergillus oryzae" is used,
it may alternatively be declared in the list of ingredients as "Fungal
alpha-amylase," "Fungal [alpha]-amylase", "Enzyme", or "Enzyme
added for improved baking". When any optional bleaching ingredient is
used, the label shall bear the word "Bleached". Wherever the name of
the food appears on the label so conspicuously as to be easily seen
under customary conditions of purchase, the word "Bleached" shall
immediately and conspicuously precede or follow such name, without
intervening written, printed, or graphic matter; except that where such
name is a part of a trademark or brand, other written, printed, or
graphic matter, which is also a part of such trademark or brand, may so
intervene if the word "Bleached" is in such juxtaposition with such
trademark or brand as to be conspicuoulsy related to such name.
(c) For the purposes of this section:
(1) Ash is determined by the method prescribed in the AOAC, 13th Ed.
(1980), section 14.006, "Direct Method--Official Final Action," under
the heading "Ash (5)," which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(a) of this section. Ash is calculated to a moisture-free basis by
subtracting the percent of moisture in the flour from 100, dividing the
remainder into the percent of ash, and multiplying the quotient by 100.
(2) Protein is 5.7 times the nitrogen as determined by the method
prescribed in section 2.057, "Improved Kjeldahl Methods for Nitrate-
Free Samples (20)--Official Final Action," AOAC, 13th Ed. (1980), which
is incorporated by reference. The availability of this incorporation by
reference is given in paragraph (a) of this section. Protein is
calculated to a moisture-free basis by subtracting the percent of
moisture in the flour from 100, dividing the remainder into the percent
of protein, and multiplying the quotient by 100.
(3) Moisture is determined by the method prescribed in the AOAC,
13th Ed. (1980), sections 14.002 and 14.003, "Vacuum Oven Method (2)--
Official Final Action," under the heading
[[Page 373]]
"Total Solids Moisture, Indirect Method," which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (a) of this section.
(4) Granulation is determined as follows: Use No. 70 sieve complying
with the specifications for "Nominal Dimensions of Standard Test Sieves
(U.S.A. Standard Series)" prescribed in paragraph (a) of this section.
Attach bottom pan to sieve in Ro-Tap sifter (or an equivalent sifter).
Place half of a rubber ball or other sieving aid in the sieve. Pour 100
grams of the sample in the sieve and turn on the sifter with knocker.
Sift exactly 5 minutes. Weigh the residue on the No. 70 sieve and
convert to percentage.
[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]
[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: 21CFR137.155]
[Page 373]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.155 Bromated flour.
Bromated flour conforms to the definition and standard of identity,
and is subject to the requirements for label statement of ingredients,
prescribed for flour by Sec. 137.105, except that potassium bromate is
added in a quantity not exceeding 50 parts to each million parts of the
finished bromated flour, and is added only to flours whose baking
qualities are improved by such addition.
[57 FR 2877, Jan. 6, 1993]
[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: 21CFR137.160]
[Page 373]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.160 Enriched bromated flour.
Enriched bromated flour conforms to the definition and standard of
identity, and is subject to the requirements for label statement of
ingredients, prescribed for enriched flour by Sec. 137.165, except that
potassium bromate is added in a quantity not exceeding 50 parts to each
million parts of the finished enriched bromated flour, and is added only
to enriched flours whose baking qualities are improved by such addition.
[58 FR 2877, Jan. 6, 1993]
[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: 21CFR137.165]
[Page 373-374]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.165 Enriched flour.
Enriched flour conforms to the definition and standard of identity,
and is subject to the requirements for label statement of ingredients,
prescribed for flour by Sec. 137.105, except that:
(a) It contains in each pound 2.9 milligrams of thiamin, 1.8
milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of
folic acid, and 20 milligrams of iron.
(b) It may contain added calcium in such quantity that the total
calcium content is 960 milligrams per pound. Enriched flour may be
acidified with monocalcium phosphate within the limits prescribed by
Sec. 137.175 for phosphated flour, but, if insufficient additional
calcium is present to meet the 960 milligram level, no claim may be made
on the label for calcium as a nutrient;
(c) The requirement of paragraphs (a) and (b) of this section will
be deemed to have been met if reasonable overages of the vitamins and
minerals, within the limits of good manufacturing practice, are present
to insure that the required levels of the vitamins and minerals are
maintained throughout the expected shelf life of the food under
customary conditions of distribution and storage. The quantitative
content of the following vitamins shall be calculated in terms of the
following chemically identifiable reference forms:
------------------------------------------------------------------------
Reference form
-------------------------------------------
Vitamin Empirical Molecular
Name formula weight
------------------------------------------------------------------------
Thiamine.................... Thiamine C12H17ClN4OS[m 337.28
chloride iddot]HCl
hydrochloride.
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
requirements of this section, ash resulting from any added iron or salts
of iron or calcium or wheat germ is excluded in calculating ash content.
(f) All ingredients from which the food is fabricated shall be safe
and suitable. The vitamins and minerals added to the food for enrichment
purposes may be supplied by any safe and suitable substance. Niacin
equivalents as derived from tryptophan content shall
[[Page 374]]
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]
[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: 21CFR137.170]
[Page 374]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.170 Instantized flours.
(a) Instantized flours, instant blending flours, and quick-mixing
flours, are the foods each of which conforms to the definition and
standard of identity and is subject to the requirement for label
statement of ingredients prescribed for the corresponding kind of flour
by Secs. 137.105, 137.155, 137.160, 137.165, 137.175, 137.180, and
137.185, except that each such flour has been made by one of the
optional procedures set forth in paragraph (b) of this section, and is
thereby made readily pourable. Such flours will all pass through a No.
20 mesh U.S. standard sieve (840-micron opening), and not more than 20
percent will pass through a 200 mesh U.S standard sieve (74-micron
opening).
(b) The optional procedures referred to in paragraph (a) of this
section are:
(1) A selective grinding and bolting procedure or other milling
procedure, whereby controlled techniques are used to obtain a food too
fine to meet the granulation specification prescribed in Sec. 137.300(a)
for farina.
(2) An agglomerating procedure, whereby flour that originally meets
the granulation specification prescribed in Sec. 137.105(a) has been
modified by further processing, so that a number of the individual flour
particles have been combined into agglomerates conforming to the
granulation specifications set out in paragraph (a) of this section.
(c) The name of each product covered by this section is the name
prescribed by the definition and standard of identity for the
corresponding kind of flour as referred to in paragraph (a) of this
section, preceded immediately and conspicuously by the words
"Instantized", "Instant blending", or "Quick-mixing".
[42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2877, Jan. 6, 1993]
[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: 21CFR137.175]
[Page 374]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.175 Phosphated flour.
Phosphated flour, phosphated white flour, and phosphated wheat
flour, conform to the definition and standard of identity, and are
subject to the requirements for label declaration of ingredients,
prescribed for flour by Sec. 137.105, except that:
(a) Monocalcium phosphate is added in a quantity not less than 0.25
percent and not more than 0.75 percent of the weight of the finished
phosphated flour; and
(b) In determining whether the ash content complies with the
requirements of this section allowance is made for the added monocalcium
phosphate.
[42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2877, Jan. 6, 1993]
[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: 21CFR137.180]
[Page 374-375]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.180 Self-rising flour.
(a) Self-rising flour, self-rising white flour, self-rising wheat
flour, is an intimate mixture of flour, sodium bicarbonate, and one or
more of the acid-reacting substances monocalcium phosphate, sodium acid
pyrophosphate, and sodium aluminum phosphate. It is seasoned with salt.
When it is tested by the method prescribed in paragraph (c) of this
section not less than 0.5 percent of carbon dioxide is evolved. The
acid-reacting substance is added in sufficient quantity to neutralize
the sodium bicarbonate. The combined weight of such acid-reacting
substance and sodium bicarbonate is not more than 4.5 parts to each 100
parts of flour used. Subject to the conditions and restrictions
prescribed by Sec. 137.105(a), the bleaching ingredients specified in
such section may be added as optional ingredients. If the flour used in
making the self-rising flour is bleached, the optional bleaching
ingredient used therein (see Sec. 137.105(a)) is also an optional
ingredient of the self-rising flour.
(b) Label declaration. Each of the ingredients used in the food,
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
(c) The method referred to in paragraph (a) of this section is the
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists" (AOAC), 13th Ed. (1980), section
8.002, "Reagent (Displacement soln.)," and section 8.003, "Chittick
apparatus," under the heading "Total Carbon Dioxide (1)--Official
[[Page 375]]
Final Action," which is incorporated by reference. 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. The following
procedure is substituted for the procedure specified in the AOAC, under
section 8.004, "Determination":
(1) Weigh 17 grams of the official sample into flask A, add 15-20
glass beads (4-6 mm. diameter), and connect this flask with the
apparatus (fig. 22). Open stopcock C and by means of the leveling bulb E
bring the displacement solution to the 25 cc. graduation above the zero
mark. (This 25 cc. is a partial allowance for the volume of acid to be
used in the decomposition.) Allow the apparatus to stand 1-2 minutes to
insure that the temperature and pressure within the apparatus are the
same as those of the room. Close the stopcock, lower the leveling bulb
somewhat to reduce the pressure within the apparatus, and slowly run
into the decomposition flask from burette F 45 cc. of sulfuric acid
(1+5). To prevent the liberated carbon dioxide from escaping through the
acid burette into the air, keep the displacement solution in the
leveling bulb at all times during the decomposition at a lower level
than that in the gas-measuring tube. Rotate and then vigorously agitate
the decomposition flask for three minutes to mix the contents
intimately. Allow to stand for 10 minutes to bring to equilibrium.
Equalize the pressure in the measuring tube by means of the leveling
bulb and read the volume of gas from the zero point on the tube. Deduct
20 cc. from this reading (this 20 cc. together with previous allowance
of 25 cc. compensates for the 45 cc. acid used in the decomposition).
Observe the temperature of the air surrounding the apparatus and also
the barometric pressure and multiply the number of mL of gas evolved by
the factor given in section 52.007, "Correction factors for gasometric
determination of carbon dioxide," AOAC, 13th Ed. (1980), which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (c) of this section), for the
temperature and pressure observed. Divide the corrected reading by 100
to obtain the apparent percent by weight of carbon dioxide in the
official sample.
(2) Correct the apparent percent of carbon dioxide to compensate for
varying atmospheric conditions by immediately assaying a synthetic
sample by the same method in the same apparatus.
(3) Prepare the synthetic sample with 16.2 grams of flour, 0.30 gram
of monocalcium phosphate, 0.30 gram of salt, and a sufficient quantity
of sodium bicarbonate U.S.P. (dried over sulfuric acid) to yield the
amount of carbon dioxide recovered in assay of official sample.
Determine this quantity by multiplying weight of carbon dioxide
recovered in assay of official sample by 1.91.
(4) Divide the weight of carbon dioxide recovered from synthetic
sample by weight of carbon dioxide contained in sodium bicarbonate used.
(5) Divide the quotient into the apparent percent of carbon dioxide
in official sample to obtain percent of carbon dioxide evolved from the
official sample.
[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]
[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: 21CFR137.185]
[Page 375-376]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.185 Enriched self-rising flour.
Enriched self-rising flour conforms to the definition and standard
of identity, and is subject to the requirements for label statement of
ingredients, prescribed for self-rising flour by Sec. 137.180, except
that:
(a) It contains in each pound 2.9 milligrams of thiamin, 1.8
milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of
folic acid, and 20 milligrams of iron.
(b) It contains added calcium in such quantity that the total
calcium content is 960 milligrams per pound. If a calcium compound is
added for technical purposes to give self-rising characteristics to the
flour, the amount of calcium per pound of flour may exceed 960
milligrams provided that the excess is no greater than necessary to
accomplish the intended effect. However, if such calcium is insufficient
to meet the 960-milligram level, no claim may
[[Page 376]]
be made on the label for calcium as a nutrient.
(c) The requirements of paragraphs (a) and (b) of this section will
be deemed to have been met if reasonable overages of the vitamins and
minerals, within the limits of good manufacturing practice, are present
to insure that the required levels of the vitamins and minerals are
maintained throughout the expected shelf life of the food under
customary conditions of distribution and storage. The quantitative
content of the following vitamins shall be calculated in terms of the
following chemically identifiable reference forms:
------------------------------------------------------------------------
Referemce form
-------------------------------------------
Vitamin Empirical Molecular
Name formula weight
------------------------------------------------------------------------
Thiamine.................... Thiamine C12H17ClN4OS[m 337.28
chloride iddot]HCl
hydrochloride.
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 carbonate, the method set forth in
Sec. 137.180(c) does not apply as a test for carbon dioxide evolved; but
in such case the quantity of carbon dioxide evolved under ordinary
conditions of use of the enriched self-rising flour is not less than 0.5
percent of the weight thereof;
(g) All ingredients from which the food is fabricated shall be safe
and suitable. The vitamins and minerals added to the food for enrichment
purposes may be supplied by any safe and suitable substances. Niacin
equivalents as derived from tryptophan content shall not be used in
determining total niacin content.
[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]
[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: 21CFR137.190]
[Page 376]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.190 Cracked wheat.
Cracked wheat is the food prepared by so cracking or cutting into
angular fragments cleaned wheat other than durum wheat and red durum
wheat that, when tested by the method prescribed in Sec. 137.200(c)(2),
not less than 90 percent passes through a No. 8 sieve and not more than
20 percent passes through a No. 20 sieve. The proportions of the natural
constituents of such wheat, other than moisture, remain unaltered.
Cracked wheat contains not more than 15 percent of the moisture as
determined by the method prescribed in "Official Methods of Analysis of
the Association of Official Analytical Chemists," 13th Ed. (1980),
section 7.002 under "Preparation of Sample--Official Final Action,"
and section 7.003 under "Moisture--Official Final Action. I. Drying in
Vacuo at 95-100 deg. (2)," which is incorporated by reference. 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.
[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]
[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: 21CFR137.195]
[Page 376-377]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 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 Sec. 137.200(c)(2), 40 percent
or more passes through a No. 8 sieve and less than 50 percent passes
through a No. 20 sieve. The proportions of the natural constituents of
such wheat, other than moisture, remain unaltered. Crushed wheat
contains not more than 15 percent of moisture as determined by the
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists," 13th Ed. (1980), section 7.002 under
"Preparation of Sample--Official Final Action," and section 7.003
under "Moisture--Official Final Action. I. Drying in Vacuo at 95-
100 deg. (2)," which is incorporated by reference. Copies may be
obtained from
[[Page 377]]
the Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersbuerg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
[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]
[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: 21CFR137.200]
[Page 377-378]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 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 [mu]m
(No. 20) sieve. The proportions of the natural constituents of such
wheat, other than moisture, remain unaltered. To compensate for any
natural deficiency of enzymes, malted wheat, malted wheat flour, malted
barley flour, or any combination of two or more of these, may be used;
but the quantity of malted barley flour so used is not more than 0.75
percent. It may contain harmless preparations of [alpha]-amylase
obtained from Aspergillus oryzae, alone or in a safe and suitable
carrier. The moisture content of whole wheat flour is not more than 15
percent. It may contain ascorbic acid in a quantity not to exceed 200
parts per million as a dough conditioner. Unless such addition conceals
damage or inferiority or makes the whole wheat flour appear to be better
or of greater value than it is, the optional bleaching ingredient
azodicarbonamide (complying with the requirements of Sec. 172.806 of
this chapter, including the quantitative limit of not more than 45 parts
per million) or chlorine dioxide, or chlorine, or a mixture of nitrosyl
chloride and chlorine, may be added in a quantity not more than
sufficient for bleaching and artificial aging effects.
(b)(1) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
(2) When ascorbic acid is added, the label shall bear the statement
"Ascorbic acid added as a dough conditioner". When the optional
ingredient "[alpha]"-amylase obtained from Aspergillus oryzae" is
used, it may alternatively be declared in the list of ingredients as
"Fungal alpha-amylase," "Fungal [alpha]-amylase", "Enzyme", or
"Enzyme added for improved baking". When any optional bleaching
ingredient is used, the label shall bear the word "Bleached". Wherever
the name of the food appears on the label so conspicuously as to be
easily seen under customary conditions of purchase, the word
"Bleached" shall immediately and conspicuously precede or follow such
name, without intervening written, printed, or graphic matter; except
that where such name is a part of a trademark or brand, other written,
printed or graphic matter, which is also a part of such trademark or
brand, may so intervene if the word "Bleached" is in such
juxtaposition with such trademark or brand as to be conspicuously
related to such name.
(c) For the purposes of this section:
(1) Moisture is determined by the method prescribed in "Official
Methods of Analysis of the Association of Official Analytical Chemists"
(AOAC), 13th Ed. (1980), section 14.002. "Vacuum Oven Method--Official
Final Action," and section 14.003, "Determination," which is
incorporated by reference. Copies may be obtained from the 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.
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 8 and No. 20 sieves, having standard 8-inch full-height
frames, complying with the specifications set forth in the AOAC, Table
1, "Nominal Dimensions of Standard Test Sieves (U.S.A. Standard
Series)," under the heading "Definitions of Terms and Explanatory
Notes," which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (c)(1) of this section.
Fit a No. 8 sieve into a No. 20 sieve. Attach bottom pan to the No. 20
sieve. Pour 100 gm. of the sample into the No. 8 sieve. Attach cover and
hold
[[Page 378]]
the assembly in a slightly inclined position with one hand. Shake the
sieves by striking the sides against the other hand with an upward
stroke, at the rate of about 150 times per minute. Turn the sieves about
one-sixth of a revolution each time in the same direction, after each 25
strokes. Continue shaking for 2 minutes. Weigh the material which fails
to pass through the No. 8 sieve and the material which passes through
the No. 20 sieve.
[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]
[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: 21CFR137.205]
[Page 378]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.205 Bromated whole wheat flour.
Bromated whole wheat flour conforms to the definition and standard
of identity, and is subject to the requirements for label statement of
ingredients, prescribed for whole wheat flour by Sec. 137.200, except
that potassium bromate is added in a quantity not exceeding 75 parts to
each million parts of finished bromated whole wheat flour.
[58 FR 2877, Jan. 6, 1993]
[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: 21CFR137.211]
[Page 378]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.211 White corn flour.
(a) White corn flour is the food prepared by so grinding and bolting
cleaned white corn that when tested by the method prescribed in
paragraph (b)(2) of this section, not less than 98 percent passes
through a No. 50 sieve and not less than 50 percent passes through No.
70 woven-wire cloth. Its moisture content is not more than 15 percent.
In its preparation, part of the ground corn may be removed, but in any
such case, the content (on a moisture-free basis) of neither the crude
fiber nor fat in the finished white corn flour exceeds the content (on a
moisture-free basis) of such substance in the cleaned corn from which it
was ground.
(b)(1) For the purpose of this section, moisture, fat, and crude
fiber are determined by methods therefore referred to in
Sec. 137.250(b)(1).
(2) The method referred to in paragraph (a) of this section is as
follows: Weigh 5 grams of sample into a tared truncated metal cone (top
diameter 5 centimeters, bottom diameter 2 centimeters, height 4
centimeters), fitted at bottom with 70-mesh wire cloth complying with
the specifications for No. 70 wire cloth in "Official Methods of
Analysis of the Association of Official Analytical Chemists," 13th Ed.
(1980), Table 1, "Nominal Dimensions of Standard Test Sieves (U.S.A.
Standard Series)," under the heading "Definitions of Terms and
Explanatory Notes," which is incorporated by reference. Copies may be
obtained from the 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. Attach cone to
a suction flask. Wash with 150 ml. of petroleum ether applied in a small
stream without suction, while gently stirring the sample with a small
glass rod. Apply suction for 2 minutes after washing is completed, then
shake the cone for 2 minutes with a vigorous horizontal motion, striking
the side against the hand, and then weigh. The decrease in weight of
sample, calculated as percent by weight of sample shall be considered
the percent passing through No. 70 wire cloth. Transfer the residue from
cone to a No. 50 sieve having a standard 20.3 centimeter (8-inch)
diameter full-height frame, complying with the specifications for wire
cloth and sieve frame in "Nominal Dimensions of Standard Test Sieves
(U.S.A. Standard Series)." Shake for 2 minutes with a vigorous
horizontal motion, striking the side against the hand; remove and weigh
the residue; calculate the weight of residue as percent by weight of
sample, and subtract from 100 percent to obtain the percent of sample
passing through the No. 50 sieve.
[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]
[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: 21CFR137.215]
[Page 378]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.215 Yellow corn flour.
Yellow corn flour conforms to the definition and standard of
identity prescribed by Sec. 137.211 for white corn flour except that
cleaned yellow corn is used instead of clean white corn.
[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: 21CFR137.220]
[Page 378-379]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.220 Durum flour.
(a) Durum flour is the food prepared by grinding and bolting cleaned
durum
[[Page 379]]
wheat. When tested for granulation as prescribed in Sec. 137.105(c)(4),
not less than 98 percent of such flour passes through the No. 70 sieve.
It is freed from bran coat, or bran coat and germ, to such extent that
the percent of ash therein, calculated to a moisture-free basis, is not
more than 1.5 percent. Its moisture content is not more than 15 percent.
(b) For the purpose of this section, ash, moisture, and granulation
are determined by the methods prescribed in Sec. 137.105(c).
[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: 21CFR137.225]
[Page 379]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.225 Whole durum flour.
Whole durum wheat flour conforms to the definition and standard of
identity, and is subject to the requirements for label statement of
ingredients, prescribed for whole wheat flour by Sec. 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]
[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: 21CFR137.250]
[Page 379-380]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.250 White corn meal.
(a) White corn meal is the food prepared by so grinding cleaned
white corn that when tested by the method prescribed in paragraph (b)(2)
of this section not less than 95 percent passes through a No. 12 sieve,
not less than 45 percent through a No. 25 sieve, but not more than 35
percent through a No. 72 grits gauze. Its moisture content is not more
than 15 percent. In its preparation coarse particles of the ground corn
may be separated and discarded, or reground and recombined with all or
part of the material from which they were separated, but in any such
case the crude fiber content of the finished corn meal is not less than
1.2 percent and not more than that of the cleaned corn from which it was
ground, and its fat content does not differ more than 0.3 percent from
that of such corn. The contents of crude fiber and fat in all the
foregoing provisions relating thereto are on a moisture-free basis.
(b)(1) For the purposes of this section, moisture, fat, and crude
fiber content will be determined by the following methods of analysis
from "Official Methods of Analysis of the Association of Official
Analytical Chemists," 13th Ed. (1980), which is incorporated by
reference (copies may be obtained from the 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):
(i) Moisture content--sections 14.062 and 14.063 (Official Final
Action).
(ii) Fat content--sections 14.062 and 14.067 (Official Final
Action).
(iii) Crude fiber content--sections 14.062 and 14.065 (Official
Final Action).
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 12 and No. 25 sieves, having standard 20.3 centimeter
(8-inch) diameter full-height frames, complying with the specifications
for wire cloth and sieve frames in "Nominal Dimensions of Standard Test
Sieves (U.S.A. Standard Series)" prescribed in Sec. 137.105(a), which
is incorporated by reference. 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. A sieve with frame of the same
dimensions as the Nos. 12 and 25 and fitted with 72 XXX grits gauze is
used as the third sieve. It is referred to hereafter as the No. 72
sieve. The 72 XXX grits gauze has openings equivalent in size with those
of No. 70 woven-wire cloth, complying with specifications for such cloth
contained in such "Standard Specifications for Sieves." Attach bottom
pan to No. 72 sieve. Fit the No. 25 sieve into the No. 72 sieve and the
No. 12 sieve into the No. 25 sieve. Pour 100 grams of sample into the
No. 12 sieve, attach cover and hold the assembly in a slightly inclined
position and shake the assembly of sieves by striking the sides against
one hand with an upward stroke, at the rate of about 150 times per
minute. Turn the assembly of sieves about one-sixth of a revolution,
each time in the same direction, after each 25 strokes. Continue shaking
for 2 minutes. Weigh separately the material remaining on each sieve and
in the pan, and calculate each weight as percent of sample. Sometimes
when meals are tested, fine
[[Page 380]]
particles clog the sieve openings. If any sieve is clogged by fine
material smaller than its openings, empty the contents onto a piece of
paper. Remove the entrapped material on the bottom of the sieve by a
hair brush and add to the sieve below. In like manner, clean the
adhering material from inside the sieve and add to the material on the
paper. Return mixture on the paper to the sieve, reassemble the sieves,
and shake in the same manner as before for 1 minute. Repeat cleaning
procedure if necessary until a 5-gram or less loss in weight occurs in
any sieve during a 1-minute shaking. The percent of sample passing
through No. 12 sieve shall be determined by subtracting from 100
percent, the percent of material remaining on the No. 12 sieve. The
percent passing through a No. 25 sieve shall be determined by adding the
percents remaining on the No. 72 sieve and the percent in pan. The
percent in the pan shall be considered as the percent passing through a
No. 72 XXX grits gauze.
[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]
[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: 21CFR137.255]
[Page 380]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.255 Bolted white corn meal.
(a) Bolted white corn meal is the food prepared by so grinding and
sifting cleaned white corn that:
(1) Its crude fiber content is less than 1.2 percent but its fat
content is not less than 2.25 percent; and
(2) When tested by the method prescribed in Sec. 137.250(b)(2),
except that a No. 20 standard sieve is used instead of the No. 12 sieve,
not less than 95 percent passes through a No. 20 sieve, not less than 45
percent through a No. 25 sieve, but not more than 25 percent through No.
72 XXX grits gauze. Its moisture content is not more than 15 percent. In
its preparation particles of ground corn which contain germ may be
separated, reground, and recombined with all or part of the material
from which it was separated, but in any such case the fat content of the
finished bolted white corn meal does not exceed by more than 0.3 percent
the fat content of the cleaned corn from which it was ground. The
contents of crude fiber and fat in all the foregoing provisions relating
thereto are on a moisture-free basis.
(b) For the purposes of this section, moisture, fat and crude fiber
are determined by the methods therefor referred to in
Sec. 137.250(b)(1).
[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: 21CFR137.260]
[Page 380-381]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.260 Enriched corn meals.
(a) Enriched corn meals are the foods, each of which conforms to the
definition and standard of identity prescribed for a kind of corn meal
by Secs. 137.250, 137.255, 137.265, 137.270, 137.275, 137.280, 137.285,
and 137.290, except that:
(1) It contains in each pound not less than 2.0 milligrams (mg) and
not more than 3.0 mg of thiamin, not less than 1.2 mg and not more than
1.8 mg of riboflavin, not less than 16 mg and not more than 24 mg of
niacin or niacinamide, not less than 0.7 mg and not more than 1.0 mg of
folic acid, and not less than 13 mg and not more than 26 mg of iron
(Fe);
(2) It may contain in each pound not less than 250 U.S.P. units and
not more than 1,000 U.S.P. units of vitamin D; and
(3) It may contain in each pound not less than 500 milligrams and
not more than 750 milligrams of calcium (Ca); Provided, however, That
enriched self-rising corn meals shall contain in each pound not more
than 1,750 milligrams of calcium (Ca). Iron and calcium may be added
only in forms which are harmless and assimilable. The substances
referred to in this paragraph (a)(3) and in paragraphs (a) (1) and (2)
of this section may be added in a harmless carrier which does not impair
the enriched corn meal; such carrier is used only in the quantity
necessary to effect an intimate and uniform admixture of such substances
with the kind of corn meal used. Dried yeast in quantities not exceeding
1.5 percent by weight of the finished food may be used.
(b) The name of each kind of enriched corn meal is the word
"Enriched" followed by the name of the kind of corn meal used which is
prescribed in the definition and standard of identity therefor.
(c) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the
[[Page 381]]
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]
[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: 21CFR137.265]
[Page 381]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.265 Degerminated white corn meal.
(a) Degerminated white corn meal, degermed white corn meal, is the
food prepared by grinding cleaned white corn and removing bran and germ
so that:
(1) On a moisture-free basis, its crude fiber content is less than
1.2 percent and its fat content is less than 2.25 percent; and
(2) When tested by the method prescribed in Sec. 137.250(b)(2),
except that a No. 20 standard sieve is used instead of a No. 12 sieve,
not less than 95 percent passes through a No. 20 sieve, not less than 45
percent through a No. 25 sieve, but not more than 25 percent through No.
72 XXX grits gauze. Its moisture content is not more than 15 percent.
(b) For the purposes of this section, moisture, fat and crude fiber
are determined by methods therefor referred to in Sec. 137.250(b)(1).
[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: 21CFR137.270]
[Page 381-382]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.270 Self-rising white corn meal.
(a) Self-rising white corn meal is an intimate mixture of white corn
meal, sodium bicarbonate, and one or both of the acid-reacting
substances monocalcium phosphate and sodium aluminum phosphate. It is
seasoned with salt. When it is tested by the method prescribed in
paragraph (b) of this section, not less than 0.5 percent of carbon
dioxide is evolved. The acid-reacting substance is added in sufficient
quantity to neutralize the sodium bicarbonate. The combined weight of
such acid-reacting substance and sodium bicarbonate is not more than 4.5
parts to each 100 parts of white corn meal used.
(b) The method referred to in paragraph (a) of this section is the
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists" (AOAC), 13th Ed. (1980), section
8.002, "Reagent (Displacement soln.)," and section 8.003, "Chittick
apparatus," under the heading "Total Carbon Dioxide (1)--Official
Final Action," which is incorporated by reference. Copies may be
obtained from the 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. The following
procedure is substituted for the procedure specified in the AOAC, under
section 8.004, "Determination":
(1) Weigh 17 grams of the official sample into flask A, add 15-20
glass beads (4-6 mm. diameter), and connect this flask with the
apparatus (fig. 25). Open stopcock C and by means of the leveling bulk E
bring the displacement solution to the 25 cc. graduation above the zero
mark. (This 25 cc. is a partial allowance for the volume of acid to be
used in the decomposition.) Allow the apparatus to stand 1-2 minutes to
insure that the temperature and pressure within the apparatus are the
same as those of the room. Close the stopcock, lower the leveling bulb
somewhat to reduce the pressure within the apparatus, and slowly run
into the decomposition flask from burette F 45 cc. of sulfuric acid
(1+5). To prevent the liberated carbon dioxide from escaping through the
acid burette into the air keep the displacement solution in the leveling
bulb at all times during the decomposition at a lower level than that in
the gas-measuring tube. Rotate and then vigorously agitate the
decomposition flask for 3 minutes to mix the contents intimately. Allow
to stand for 10 minutes to bring to equilibrium. Equalize the pressure
in the measuring tube by means of the leveling bulb and read the volume
of gas from the zero point on the tube. Deduct 20 cc. from this reading
(this 20 cc. together with previous allowance of 25 cc. compensates for
the 45 cc. acid used in the decomposition). Observe the temperature of
the air surrounding the apparatus and also the barometric pressure and
multiply the number of mL of gas evolved by the factor given in the
AOAC, 13th Ed. (1980), section 52.007 under Reference Tables for the
temperature and pressure observed, which is incorporated by reference.
The availability of this incorporation by reference is given in
paragraph (b) of this section. Divide the corrected reading by 100 to
obtain
[[Page 382]]
the apparent percent by weight of carbon dioxide in the official sample.
(2) Correct the apparent percent of carbon dioxide to compensate for
varying atmospheric conditions by immediately assaying a synthetic
sample by the same method in the same apparatus.
(3) Prepare the synthetic sample with 16.2 grams of corn meal, 0.30
gram of monocalcium phosphate, 0.30 gram of salt, and a sufficient
quantity of sodium bicarbonate U.S.P. (dried over sulfuric acid) to
yield the amount of carbon dioxide recovered in assay of official
sample. Determine this quantity by multiplying weight of carbon dioxide
recovered in assay of official sample by 1.91.
(4) Divide the weight of carbon dioxide recovered from synthetic
sample by weight of carbon dioxide contained in sodium bicarbonate used.
(5) Divide the quotient into the apparent percent of carbon dioxide
in official sample to obtain percent of carbon dioxide evolved from the
official sample.
(c) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[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]
[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: 21CFR137.275]
[Page 382]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.275 Yellow corn meal.
Yellow corn meal conforms to the definition and standard of identity
prescribed by Sec. 137.250 for white corn meal except that cleaned
yellow corn is used instead of cleaned white corn.
[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: 21CFR137.280]
[Page 382]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.280 Bolted yellow corn meal.
Bolted yellow corn meal conforms to the definition and standard of
identity prescribed by Sec. 137.255 for bolted white corn meal except
that cleaned yellow corn is used instead of cleaned white corn.
[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: 21CFR137.285]
[Page 382]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.285 Degerminated yellow corn meal.
Degerminated yellow corn meal, degermed yellow corn meal, conforms
to the definition and standard of identity prescribed by Sec. 137.265
for degerminated white corn meal except that cleaned yellow corn is used
instead of cleaned white corn.
[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: 21CFR137.290]
[Page 382]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.290 Self-rising yellow corn meal.
Self-rising yellow corn meal conforms to the definition and standard
of identity prescribed by Sec. 137.270 for self-rising white corn meal
except that yellow corn meal is used instead of white corn meal.
[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: 21CFR137.300]
[Page 382-383]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.300 Farina.
(a) Farina is the food prepared by grinding and bolting cleaned
wheat, other than durum wheat and red durum wheat, to such fineness
that, when tested by the method prescribed in paragraph (b)(2) of this
section, it passes through a No. 20 sieve, but not more than 3 percent
passes through a No. 100 sieve. It is freed from bran coat, or bran coat
and germ, to such extent that the percent of ash therein, calculated to
a moisture-free basis, is not more than 0.6 percent. Its moisture
content is not more than 15 percent.
(b) For the purposes of this section:
(1) Ash and moisture are determined by the methods therefor referred
to in Sec. 137.105(c).
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 20 and No. 100 sieves, having standard 20.3 centimeter
(8-inch) full-height frames, complying with the specifications for such
cloth set forth in "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), Table 1, "Nominal
Dimensions of Standard Test Sieves (U.S.A. Standard Series)," under the
heading "Definitions of Terms and Explanatory Notes," which is
incorporated by reference. Copies may be obtained from the 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. Fit a No. 20 sieve into a No. 100 sieve. Attach bottom
pan to the No. 100 sieve. Pour 100 grams of the sample into the No. 20
sieve. Attach cover and hold the assembly in a slightly inclined
position with one hand. Shake the sieves by striking the sides against
the other hand with
[[Page 383]]
an upward stroke, at the rate of about 150 times per minute. Turn the
sieves about one-sixth of a revolution, each time in the same direction,
after each 25 strokes. Continue shaking for 2 minutes. Weigh the
material which fails to pass through the No. 20 sieve and the material
which passes through the No. 100 sieve.
[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]
[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: 21CFR137.305]
[Page 383]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.305 Enriched farina.
(a) Enriched farina conforms to the definition and standard of
identity prescribed for farina by Sec. 137.300, except that:
(1) It contains in each pound not less than 2.0 milligrams (mg) and
not more than 2.5 mg of thiamin, not less than 1.2 mg and not more than
1.5 mg of riboflavin, not less than 16.0 mg and not more than 20.0 mg of
niacin or niacinamide, not less than 0.7 mg and not more than 0.87 mg of
folic acid, and not less than 13.0 mg of iron (Fe).
(2) Vitamin D may be added in such quantity that each pound of the
finished enriched farina contains not less than 250 U.S.P. units of the
optional ingredient vitamin D.
(3) Calcium may be added in such quantity that each pound of the
finished enriched farina contains not less than 500 milligrams of the
optional ingredient calcium (Ca).
(4) It may contain not more than 8 percent by weight of the optional
ingredient wheat germ or partly defatted wheat germ.
(5)(i) It may contain not less than 0.5 percent and not more than 1
percent by weight of the optional ingredient disodium phosphate; or
(ii) It may be treated with one of the proteinase enzymes papain or
pepsin to reduce substantially the time required for cooking. In such
treatment papain or pepsin, in an amount not to exceed 0.1 percent by
weight, is added to the farina, which is moistened, warmed, and
subsequently heated sufficiently to inactivate the enzyme and to dry the
product to comply with the limit for moisture prescribed by
Sec. 137.300(a).
(6) In determining whether the ash content complies with the
requirements of this section allowance is made for ash resulting from
any added iron or salts of iron or calcium, or from any added disodium
phosphate, or from any added wheat germ or partly defatted wheat germ.
Iron and calcium may be added only in forms which are harmless and
assimilable. Dried irradiated yeast may be used as a source of vitamin
D. The substances referred to in paragraphs (a) (1) and (2) of this
section may be added in a harmless carrier which does not impair the
enriched farina; such carrier is used only in the quantity necessary to
effect an intimate and uniform admixture of such substances with the
farina.
(b)(1) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
(2)(i) When the optional ingredient disodium phosphate is used, the
label shall bear the statement "Disodium phosphate added for quick
cooking".
(ii) When the proteinase enzyme treatment is used, the label shall
bear the statement "Enzyme treated for quicker cooking".
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements prescribed by paragraph (b)(2) of this section
shall immediately and conspicuously precede or follow such name without
intervening written, printed, or graphic matter; except that where the
name of the food is a part of a trademark or brand, then other written,
printed, or graphic matter that is also a part of the trademark or brand
may so intervene, if such statement is in such juxtaposition with the
trademark or brand as to be conspicuously related to the name of the
food.
[42 FR 14402, Mar. 15, 1977, as amended at 58 FR 2878, Jan. 6, 1993; 61
FR 8796, Mar. 5, 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: 21CFR137.320]
[Page 383-384]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.320 Semolina.
(a) Semolina is the food prepared by grinding and bolting cleaned
durum wheat to such fineness that, when tested by the method prescribed
in Sec. 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
[[Page 384]]
germ, to such extent that the percent of ash therein, calculated to a
moisture-free basis, is not more than 0.92 percent. Its moisture content
is not more than 15 percent.
(b) For the purpose of this section, ash and moisture are determined
by the methods therefor referred to in Sec. 137.105(c).
[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: 21CFR137.350]
[Page 384-385]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 137--CEREAL FLOURS AND RELATED PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Cereal Flours and
Related Products
Sec. 137.350 Enriched rice.
(a) The foods for which definitions and standards of identity are
prescribed by this section are forms of milled rice (except rice coated
with talc and glucose and known as coated rice), to which nutrients have
been added so that each pound of the rice contains:
(1) Not less than 2.0 milligrams (mg) and not more than 4.0 mg of
thiamin, not less than 1.2 mg and not more than 2.4 mg of riboflavin,
not less than 16 mg and not more than 32 mg of niacin or niacinamide,
not less than 0.7 mg and not more than 1.4 mg of folic acid, and not
less than 13 mg and not more than 26 mg of iron (Fe).
(2) Each pound may contain not less than 250 U.S.P. units and not
more than 1,000 U.S.P. units of vitamin D.
(3) Each pound may contain not less than 500 milligrams and not more
than 1,000 milligrams of calcium (Ca). Calcium carbonate derived from
the use of this substance in milling rice, when present in quantities
that furnish less than 500 milligrams of calcium (Ca) per pound, is
considered a normal ingredient of the milled rice used and not an
optional ingredient of the enriched rice unless such enriched rice is
labeled to show it contains the optional ingredient calcium. Iron and
calcium may be added only in forms that are harmless and assimilable.
The vitamins referred to in paragraphs (a) (1) and (2) of this section
may be combined with harmless substances to render them insoluble in
water, if the water-insoluble products are assimilable.
(4) In the case of enriched parboiled rice, butylated hydroxytoluene
may be added as an optional ingredient in an amount not to exceed 0.0033
percent by weight of the finished food.
(b) The substances referred to in paragraphs (a) (1), (2), and (3)
of this section may be added in a harmless carrier. Such carrier is used
only in the quantity necessary to effect an intimate and uniform mixture
of such substances with the rice.
(c) Unless the label of the food bears the statement "To retain
vitamins do not rinse before or drain after cooking" immediately
preceding or following the name of the food and in letters not less than
one-fourth the point size of type used for printing the name of the food
(but in no case less than 8-point type) and the label bears no cooking
directions calling for washing or draining or unless the food is
precooked and it is packaged in consumer packages which are
conspicuously and prominently labeled with directions for preparation
which, if followed, will avoid washing away or draining off enriching
ingredients, the substances named in paragraphs (a) (1), (2), and (3) of
this section shall be present in such quantity or in such form that when
the enriched rice is washed as prescribed in paragraph (e) of this
section, the washed rice contains not less than 85 percent of the
minimum quantities of the substances named in paragraph (a)(1) of this
section, as required for enriched rice; and in case any optional
ingredients named in paragraphs (a) (2) and (3) of this section are
used, the washed rice also contains not less than 85 percent of the
minimum quantity specified for the substance or substances used.
(d) The name specified for each food for which a definition and
standard of identity is prescribed by this section is the common name of
the kind of milled rice to which the enriching substances are added,
preceded by the word "enriched" as, for example, "Enriched rice" or
"Enriched parboiled rice".
(e) The method referred to in paragraph (c) of this section is as
follows: Mix the contents of one or more containers and transfer \1/2\
pound thereof to a 4-liter flask containing 2 liters of distilled water
at room temperature (but not below 20 deg.C). Stopper the flask and
swirl it moderately for \1/2\ minute so that the rice is in motion and
in uniform suspension. Allow the rice to settle for \1/2\ minute, then
pour off 1,600 milliliters of the water, together with any floating and
suspended matter, and discard. To the contents of the flask, add 1,600
milliliters of distilled water
[[Page 385]]
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 deg.C, agitate if
necessary, and maintain at this temperature until air is expelled. Again
wash down the sides of the flask with 150 milliliters of 0.1 N
hydrochloric acid. Heat the mixture in an autoclave at 120 deg.C to 123
deg.C for 30 minutes, remove and cool to room temperature. Dilute the
mixture with distilled water so that the total volume is 2,500
milliliters. Swirl the flask, and while the solids are in uniform
suspension pour off about 250 milliliters of the mixture for later
determination of iron (and calcium, if this is to be determined). With
filter paper that has been shown not to adsorb thiamine, riboflavin, or
niacin, filter enough of the remaining mixture for determination of
thiamine, riboflavin, and niacin. (In the case of a mixture difficult to
filter, centrifuging or filtering through fritted glass, or both, using
a suitable analytical filter-aid, may be substituted for, or may
precede, filtering through paper.) Dilute an aliquot of filtrate with
0.1 N hydrochloric acid, so that each milliliter contains about 0.2
microgram of thiamine, and determine thiamine by the "Rapid
Fluorometric Method--Official Final Action," in section 43.034 of
"Official Methods of Analysis of the Association of Official Analytical
Chemists" (AOAC), 13th Ed. (1980), which is incorporated by reference.
Copies may be obtained from the 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. With a suitable aliquot determine riboflavin by the method
prescribed in section 43.041(a) by the "Fluorometric Method--Official
Final Action," AOAC, 13th Ed. (1980), beginning with the third sentence
of the second paragraph, "Adjust, with vigorous agitation * * *."
Determine niacin in a 200-milliliter aliquot of the filtrate by the
"Colorimetric Method--Official Final Action," in section 43.045, AOAC,
13th Ed. (1980), beginning with the sixth sentence of the first
paragraph, "Adjust to pH 4.5 with * * *." Evaporate to dryness a 100-
milliliter aliquot of the nonfiltered material withdrawn while
agitating, and determine iron using the method "Iron--Official Final
Action," in sections 14.011, 14.012, and 14.013, AOAC, 13th Ed. (1980),
and, if required, determine calcium as directed in section 14.014 under
the heading "Calcium--Official Final Action," AOAC, 13th Ed. (1980).
(f) When the optional ingredient specified in paragraph (a)(4) of
this section is added, the statement "Butylated hydroxytoluene added as
a preservative" shall be placed on the label prominently and with such
conspicuousness (as compared with other words, statements, designs, or
devices in the label) as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase.
(g) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
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 Sec. 137.350 (formerly
Sec. 15.525) are stayed insofar as they require each pound of the food
to contain not less than 1.2 milligrams and not more than 2.4 milligrams
of riboflavin. This stay shall continue until final action is taken
disposing of the objections, after public hearing thereon.
[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]
