[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: 21CFR172.372]
[Page 50-51]
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. 172.372 N-Acetyl-L-methionine.
The food additive N-acetyl-L-methionine may be safely added to food
(except infant foods and foods containing added nitrites/nitrates) as a
source of L-methionine for use as a nutrient in accordance with the
following conditions:
(a) N-Acetyl-L-methionine (Chemical Abstracts Service Registry No.
65-82-7) is the derivative of the amino acid methionine formed by
addition of an acetyl group to the alpha-amino group of methionine. It
may be in the free, hydrated or anhydrous form, or as the sodium or
potassium salts.
(b) The additive meets the following specifications:
(1) Purity assay, on a dry basis: Minimum 99 percent.
(2) Residue on ignition: Maximum 0.1 percent.
(3) Specific optical rotation [alpha]\20\D: Between -
19[deg] and -23[deg].
(4) The additive may contain residues of not more than 500 ppm ethyl
acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm
acetone, when used as processing solvents.
(c) The additive is used or intended for use as a source of L-
methionine to improve significantly the biological quality of the total
protein in a food containing naturally occurring primarily intact
vegetable 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 vegetable
protein.
(2) The additive results in a protein efficiency ratio (PER) of
protein in the
[[Page 51]]
finished ready-to-eat food equivalent to casein as determined by the
method specified in paragraph (d) of this section.
(3) The use of the additive 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 additive to achieve the
desired effect must be used, and the increase in PER over the primarily
intact naturally occurring vegetable 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 purpose shall not
exceed the level that will provide a total of 3.1 percent L- and DL-
methionine (expressed as the free amino acid) by weight of the total
protein of the finished food, including the amount naturally present in
free and combined (as protein) form.
(5) The additive shall not be added to infant foods or to foods
containing added nitrites/nitrates.
(d) Compliance with the limitations concerning PER under paragraph
(c) of the 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 under the provisions
of this section shall keep and maintain throughout the period of use of
the additive 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. Those records shall
be made available upon request at all reasonable hours by any officer or
employee acting on behalf of the Secretary of Health and Human Services.
Those officers or employees shall be permitted to conduct inventories of
raw and finished materials on hand as are deemed necessary to verify the
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:
(1) The name of the additive contained therein.
(2) The amounts of additive and 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) When the food additive is added as a nutrient to special dietary
foods that are intended for use solely under medical supervision to meet
nutritional requirements in specific medical conditions and these foods
comply with the requirements of part 105 of this chapter, the food
additive is exempt from the limitations in paragraphs (c)(1) through (4)
and (d) of this section and may be used in those foods at levels not to
exceed good manufacturing practices.
[43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981; 49
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
Additives that reference this regulation: |
