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177.1620 Polyethylene, oxidized.

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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: 21CFR177.1620]

[Page 307]
                        TITLE 21--FOOD AND DRUGS
                          SERVICES (CONTINUED)
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 
    (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.

Additives that reference this regulation:

Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1620

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