[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 139_MACARONI AND NOODLE PRODUCTS--Table of Contents
Subpart B_Requirements for Specific Standardized Macaroni and Noodle
Sec. 139.117 Enriched macaroni products with fortified protein.
(a)(1) Each of the foods for which a standard of identity is
prescribed by this section is produced by drying formed units of dough
made with one or more of the milled wheat ingredients designated in
Sec. Sec. 139.110(a) and 139.138(a), and other ingredients to enable
the finished food to meet the protein requirements set out in paragraph
(a)(2)(i) of this section. Edible protein sources, including food grade
flours or meals made from nonwheat cereals or from oilseeds, may be
used. Vitamin and mineral enrichment nutrients are added to bring the
food into conformity with the requirements of paragraph (b) of this
section. Safe and suitable ingredients, as provided for in paragraph (c)
of this section, may be added. The proportion of the milled wheat
ingredient is larger than the proportion of any other ingredient used.
(2) Each such finished food, when tested by the methods described in
the cited sections of ``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 AOAC
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or may be examined at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
meets the following specifications:
(i) The protein content (N x 6.25) is not less than 20 percent by
weight (on a 13 percent moisture basis) as determined by the method in
section 14.142. The protein quality is not less than 95 percent that of
casein as determined on the cooked food by the method in sections 43.212
through 43.216 of the official methods.
(ii) The total solids content is not less than 87 percent by weight
as determined by the method in section 14.133 of the official methods.
(b)(1) Each food covered by this section contains in each pound 5
milligrams of thiamin, 2.2 milligrams of riboflavin, 34 milligrams of
niacin or niacinamide, and 16.5 milligrams of iron.
(2) Each pound of such food may also contain 625 milligrams of
(3) Iron and calcium may be added only in forms which are harmless
and assimilable. The enrichment nutrients may be added in a harmless
carrier used only in a quantity necessary to effect a uniform
distribution of the nutrients in the finished food. The requirements of
paragraphs (b) (1) and (2) of this section shall be deemed to have been
met if reasonable overages, within the limits of good manufacturing
practice, are present to assure that the prescribed levels of the
vitamins and mineral(s) are maintained throughout the expected shelf
life of the food under customary conditions of distribution.
(c) The safe and suitable ingredients referred to in paragraph (a)
of this section are ingredients that serve a useful purpose, e.g., to
fortify the protein or facilitate production of the food, but they do
not include color additives, artificial flavorings, artificial
sweeteners, chemical preservatives, or starches. Ingredients deemed
for use by this paragraph are added in amounts that are not in excess of
those reasonably required to achieve their intended purposes.
Ingredients are deemed to be safe if they are not food additives within
the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic
Act, or in case they are food additives, if they are used in conformity
with regulations established pursuant to section 409 of the act.
(d)(1) The name of any food covered by this section is ``Enriched
Wheat ------ Macaroni Product--with Fortified Protein'', the blank being
filled in with appropriate word(s) such as ``Soy'' to show the source of
any flours or meals used that were made from nonwheat cereals or from
oilseeds. In lieu of the words ``Macaroni Product'' the word
``Macaroni'', ``Spaghetti'', or ``Vermicelli'', as appropriate, may be
used if the units conform in shape and size to the requirements of Sec.
139.110 (b), (c), or (d).
(2) When any ingredient, not designated in the part of the name
prescribed in paragraph (d)(1) of this section, is added in such
proportion as to contribute 10 percent or more of the quantity of
protein contained in the finished food, the name shall include the
statement ``Made with ------'', the blank being filled in with the name
of each such ingredient, e.g., ``Made with nonfat milk''.
(3) When, in conformity with paragraph (d) (1) or (2) of this
section, two or more ingredients are listed in the name, their
designations shall be arranged in descending order of predominance by
(4) In the case of a food made to comply with another section of
this part, but which also meets the compositional requirements of this
section, it may alternatively bear the name set out in that other
(e) 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 14409, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982;
49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2878, Jan.
6, 1993; 63 FR 14035, Mar. 24, 1998]
Effective Date Note: Section 139.117 was stayed in its entirety at
43 FR 11695, Mar. 21, 1978.
Additives that reference this regulation: