21 CFR 172.105 - Anoxomer.

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER B: FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172: FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart B: Food Preservatives

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]

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