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172.320 Amino acids.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.320]

[Page 46-48]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN 
CONSUMPTION--Table of Contents
 
           Subpart D_Special Dietary and Nutritional Additives
 
Sec.  172.320  Amino acids.

    The food additive amino acids may be safely used as nutrients added 
to foods in accordance with the following conditions:
    (a) The food additive consists of one or more of the following 
individual amino acids in the free, hydrated or anhydrous form or as the 
hydrochloride, sodium or potassium salts:

L-Alanine
L-Arginine
L-Asparagine
L-Aspartic acid
L-Cysteine
L-Cystine
L-Glutamic acid
L-Glutamine
Aminoacetic acid (glycine)
L-Histidine
L-Isoleucine
L-Leucine
L-Lysine
DL-Methionine (not for infant foods)
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine

    (b) The food additive meets the following specifications:
    (1) As found in ``Food Chemicals Codex,'' National Academy of 
Sciences/National Research Council (NAS/NRC), 3d Ed. (1981), which is 
incorporated by reference (Copies may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.) for the following:

L-Alanine
L-Arginine
L-Arginine Monohydrochloride
L-Cysteine Monohydrochloride
L-Cystine
Aminoacetic acid (glycine)
L-Leucine
DL-Methionine
L-Methionine
L-Tryptophan
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
Glutamic Acid Hydrochloride
L-Isoleucine
L-Lysine Monohydrochloride
Monopotassium L-glutamate
L-Tyrosine
L-Valine

    (2) As found in ``Specifications and Criteria for Biochemical 
Compounds,'' NAS/NRC Publication, 3rd Ed. (1972), which is incorporated 
by reference (Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.) for the following:

L-Asparagine
L-Aspartic acid
L-Glutamine
L-Histidine

    (c) The additive(s) is used or intended for use to significantly 
improve the biological quality of the total protein in a food containing 
naturally occurring primarily-intact protein that is considered a 
significant dietary protein source, provided that:
    (1) A reasonable daily adult intake of the finished food furnishes 
at least 6.5 grams of naturally occurring primarily intact protein 
(based upon 10 percent of the daily allowance for the ``reference''

[[Page 47]]

adult male recommended by the National Academy of Sciences in 
``Recommended Dietary Allowances,'' NAS Publication No. 1694, 7th Ed. 
(1968), which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (2) The additive(s) results in a protein efficiency ratio (PER) of 
protein in the finished ready-to-eat food equivalent to casein as 
determined by the method specified in paragraph (d) of this section.
    (3) Each amino acid (or combination of the minimum number necessary 
to achieve a statistically significant increase) added results in a 
statistically significant increase in the PER as determined by the 
method described in paragraph (d) of this section. The minimum amount of 
the amino acid(s) to achieve the desired effect must be used and the 
increase in PER over the primarily-intact naturally occurring protein in 
the food must be substantiated as a statistically significant difference 
with at least a probability (P) value of less than 0.05.
    (4) The amount of the additive added for nutritive purposes plus the 
amount naturally present in free and combined (as protein) form does not 
exceed the following levels of amino acids expressed as percent by 
weight of the total protein of the finished food:

------------------------------------------------------------------------
                                                              Percent by
                                                               weight of
                                                                 total
                                                                protein
                                                              (expressed
                                                                as free
                                                                 amino
                                                                 acid)
------------------------------------------------------------------------
L-Alanine...................................................         6.1
L-Arginine..................................................         6.6
L-Aspartic acid (including L-asparagine)....................         7.0
L-Cystine (including L-cysteine)............................         2.3
L-Glutamic acid (including L-glutamine).....................        12.4
Aminoacetic acid (glycine)..................................         3.5
L-Histidine.................................................         2.4
L-Isoleucine................................................         6.6
L-Leucine...................................................         8.8
L-Lysine....................................................         6.4
L- and DL-Methionine........................................         3.1
L-Phenylalanine.............................................         5.8
L-Proline...................................................         4.2
L-Serine....................................................         8.4
L-Threonine.................................................         5.0
L-Tryptophan................................................         1.6
L-Tyrosine..................................................         4.3
L-Valine....................................................         7.4
------------------------------------------------------------------------

    (d) Compliance with the limitations concerning PER under paragraph 
(c) of this section shall be determined by the method described in 
sections 43.212-43.216, ``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/
federal--register/code--of--federal--regulations/ibr--locations.html. 
Each manufacturer or person employing the additive(s) under the 
provisions of this section shall keep and maintain throughout the period 
of his use of the additive(s) and for a minimum of 3 years thereafter, 
records of the tests required by this paragraph and other records 
required to assure effectiveness and compliance with this regulation and 
shall make such records available upon request at all reasonable hours 
by any officer or employee of the Food and Drug Administration, or any 
other officer or employee acting on behalf of the Secretary of Health 
and Human Services and shall permit such officer or employee to conduct 
such inventories of raw and finished materials on hand as he deems 
necessary and otherwise to check the correctness of such records.
    (e) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:

[[Page 48]]

    (1) The name of the amino acid(s) contained therein including the 
specific optical and chemical form.
    (2) The amounts of each amino acid contained in any mixture.
    (3) Adequate directions for use to provide a finished food meeting 
the limitations prescribed by paragraph (c) of this section.
    (f) The food additive amino acids added as nutrients to special 
dietary foods that are intended for use solely under medical supervision 
to meet nutritional requirements in specific medical conditions and 
comply with the requirements of part 105 of this chapter are exempt from 
the limitations in paragraphs (c) and (d) of this section and may be 
used in such foods at levels not to exceed good manufacturing practices.

[42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 
47 FR 11836, Mar. 19, 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, 
June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR 14480, Apr. 2, 1996]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 320


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