[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1620]
[Page 308]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177 INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1620 Polyethylene, oxidized.
Oxidized polyethylene identified in paragraph (a) of this section
may be safely used as a component of food-contact articles, in
accordance with the following prescribed conditions:
(a) Oxidized polyethylene is the basic resin produced by the mild
air oxidation of polyethylene conforming to the density, maximum n-
hexane extractable fraction, and maximum xylene soluble fraction
specifications prescribed under item 2.3 of the table in Sec.
177.1520(c). Such oxidized polyethylene has a minimum number average
molecular weight of 1,200, as determined by high temperature vapor
pressure osmometry, contains a maximum of 5 percent by weight of total
oxygen, and has an acid value of 9 to 19.
(b) The finished food-contact article, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use as determined from tables 1 and 2 of Sec. 176.170(c) of
this chapter, yields net acidified chloroform-soluble extractives not to
exceed 0.5 milligram per square inch of food-contact surface when tested
by the methods described in Sec. 177.1330(c), except that net acidified
chloroform-soluble extractives from paper and paperboard complying with
Sec. 176.170 of this chapter may be corrected for wax, petrolatum, and
mineral oil as provided in Sec. 176.170(d) (5)(iii)(b) of this chapter.
If the finished food-contact article is itself the subject of a
regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter, it shall also comply with any specifications and limitations
prescribed for it by such regulations. (Note: In testing the finished
food-contact article, use a separate test sample for each extracting
solvent.)
(c) The provisions of this section are not applicable to oxidized
polyethylene used as provided in Sec. Sec. 175.105 and 176.210 of this
chapter, and Sec. 177.2800. The provisions of paragraph (b) of this
section are not applicable to oxidized polyethylene used as provided in
Sec. Sec. 175.125 and 176.170(a)(5) of this chapter and Sec. 177.1200.
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