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172.860 Fatty acids.

Home > Regulations > Food additives permitted for direct addition to food for human consumption > 172.860 Fatty acids.



[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 860


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