[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: |
