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172.736 Glycerides and polyglycides of hydrogenated vegetable oils.

Home > Regulations > Food additives permitted for direct addition to food for human consumption > 172.736 Glycerides and polyglycides of hydrogenated vegetable oils.



[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: 21CFR172.736]

[Page 75-76]
 
                        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 H_Other Specific Usage Additives
 
Sec.  172.736  Glycerides and polyglycides of hydrogenated vegetable oils.

    The food additive glycerides and polyglycides of hydrogenated 
vegetable oils may be safely used in food in accordance with the 
following prescribed conditions:
    (a) The additive is manufactured by heating a mixture of 
hydrogenated oils of vegetable origin and polyethylene glycol in the 
presence of an alkaline catalyst followed by neutralization with any 
acid that is approved or is generally recognized as safe for this use to 
yield the finished product.
    (b) The additive consists of a mixture of mono-, di- and tri-
glycerides and polyethylene glycol mono- and di-esters of fatty acids 
(polyglycides) of hydrogenated vegetable oils and meets the following 
specifications:
    (1) Total ester content, greater than 90 percent as determined by a 
method entitled ``Determination of Esterified Glycerides and 
Polyoxyethylene Glycols,'' approved November 16, 2001, printed by 
Gattefosse S.A.S., and incorporated by reference. The Director of the 
Office of the Federal Register approves this incorporation by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a 
copy from the Office of Food Additive Safety, 5100 Paint Branch Pkwy., 
College Park, MD 20740 or you may examine a copy at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or 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) Acid value, not greater than 2, and hydroxyl value, not greater 
than 56 as determined by the methods entitled ``Acid Value,'' p. 934 and 
``Hydroxyl Value,'' p. 936, respectively, in the Food Chemicals Codex, 
5th ed., effective January 1, 2004, and incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the National Academies Press, 500 Fifth St. NW., Washington, DC 
20055 (Internet address http://www.nap.edu), or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and

[[Page 76]]

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) Lead, not greater than 0.1 mg/kg as determined by the American 
Oil Chemists' Society (A.O.C.S.) method Ca 18c-91, ``Determination of 
Lead by Direct Graphite Furnace Atomic Absorption Spectrophotometry,'' 
updated 1995, and incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from American Oil 
Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be 
examined in the library at the Center for Food Safety and Applied 
Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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.
    (4) 1,4-Dioxane, not greater than 10 milligrams per kilogram (mg/
kg), and ethylene oxide, not greater than 1 mg/kg, as determined by a 
gas chromatographic method entitled ``Determination of Ethylene Oxide 
and 1,4-Dioxane by Headspace Gas Chromatography,'' approved November 5, 
1998, printed by Gattefosse S.A.S., and incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51; see paragraph (b)(1) 
of this section for availability of the incorporation by reference.
    (c) The additive is used or intended for use as an excipient in 
dietary supplement tablets, capsules, and liquid formulations that are 
intended for ingestion in daily quantities measured in drops or similar 
small units of measure.

[71 FR 12620, Mar. 13, 2006]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 736


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