[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: 21CFR172.860]
[Page 99-100]
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 I_Multipurpose Additives
Sec. 172.860 Fatty acids.
The food additive fatty acids may be safely used in food and in the
manufacture of food components in accordance with the following
prescribed conditions:
(a) The food additive consists of one or any mixture of the
following straight-chain monobasic carboxylic acids and their associated
fatty acids manufactured from fats and oils derived from edible sources:
Capric acid, caprylic acid, lauric acid, myristic acid, oleic acid,
palmitic acid, and stearic acid.
(b) The food additive meets the following specifications:
(1) Unsaponifiable matter does not exceed 2 percent.
(2) It is free of chick-edema factor:
(i) As evidenced during the bioassay method for determining the
chick-edema factor as prescribed in paragraph (c)(2) of this section; or
[[Page 100]]
(ii) As evidenced by the absence of chromatographic peaks with a
retention time relative to aldrin (RA) between 10 and 25, using the gas
chromatographic-electron capture method prescribed in paragraph (c)(3)
of this section. If chromatographic peaks are found with RA values
between 10 and 25, the food additive shall meet the requirements of the
bioassay method prescribed in paragraph (c)(2) of this section for
determining chick-edema factor.
(c) For the purposes of this section:
(1) Unsaponifiable matter shall be determined by the method
described in the 13th Ed. (1980) of the ``Official Methods of Analysis
of the Association of Official Analytical Chemists,'' which is
incorporated by reference. Copies are available from the AOAC
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, 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) Chick-edema factor shall be determined by the bioassay method
described in ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), sections 28.127-28.130,
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.
(3) The gas chromatographic-electron capture method for testing
fatty acids for chick-edema shall be the method described in the
``Journal of the Association of Official Analytical Chemists,'' Volume
50 (No. 1), pages 216-218 (1967), or the modified method using a
sulfuric acid clean-up procedure, as described in the ``Journal of the
Association of the Offical Analytical Chemists,'' Volume 51 (No. 2),
pages 489-490 (1968), which are incorporated by reference. See paragraph
(c)(2) of this section for availability of these references.
(d) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and as a defoaming agent in
accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(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 common or usual name of the acid or acids contained therein.
(2) The words ``food grade,'' in juxtaposition with and equally as
prominent as the name of the acid.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982;
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
Additives that reference this regulation: |
