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172.105 Anoxomer.

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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: 21CFR172.105]

[Page 32]
 
                        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 B_Food Preservatives
 
Sec.  172.105  Anoxomer.


    Anoxomer as identified in this section may be safely used in 
accordance with the following conditions:
    (a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with 
diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4'-
(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-
57-2) prepared by condensation polymerization of divinylbenzene (m- and 
p-) with tert-butylhydroquinone, tert-butylphenol, hydroxyanisole, p-
cresol and 4,4'-isopropylidenediphenol.
    (b) The polymeric antioxidant meets the following specifications:
    (1) Polymer, not less than 98.0 percent as determined by an 
ultraviolet method entitled ``Ultraviolet Assay, ``1982, 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 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) Molecular weight: Total monomers, dimers and trimers below 500 
not more than 1 percent as determined by a method entitled ``Low 
Molecular Weight Anoxomer Analysis,'' 1982, 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 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) Phenol content: Not less than 3.2 milliequivalent/gram and not 
more than 3.8 milliequivalent/gram as determined by a method entitled 
``Total Phenols,'' 1982, 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 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) Heavy metals as lead (as Pb), not more than 10 parts per 
million. Arsenic (as As), not more than 3 parts per million. Mercury (as 
Hg), not more than 1 part per million.
    (c) Anoxomer may be safely used as an antioxidant in food at a level 
of not more than 5,000 parts per million based on fat and oil content of 
the food.

[48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 105


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