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177.2470 Polyoxymethylene copolymer.

Home > Regulations > Indirect food additives: Polymers > 177.2470 Polyoxymethylene copolymer.



[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: 21CFR177.2470]

[Page 344-345]
 
                        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 C_Substances for Use Only as Components of Articles Intended for 
                              Repeated Use
 
Sec.  177.2470  Polyoxymethylene copolymer.

    Polyoxymethylene copolymer identified in this section may be safely 
used as an article or component of articles intended for food-contact 
use in accordance with the following prescribed conditions:
    (a) Identity. For the purpose of this section, polyoxymethylene 
copolymers are identified as the following: The reaction product of 
trioxane (cyclic trimer of formaldehyde) and ethylene oxide (CAS Reg. 
No. 24969-25-3) or the reaction product of trioxane (cyclic trimer of 
formaldehyde) and a maximum of 5 percent by weight of butanediol formal 
(CAS Reg. No. 25214 85-1). Both copolymers may have certain optional 
substances added to impart desired technological properties to the 
copolymer.
    (b) Optional adjuvant substances. The polyoxymethylene copolymer 
identified in paragraph (a) of this section may contain optional 
adjuvant substances required in its production. The quantity of any 
optional adjuvant substance employed in the production of the copolymer 
does not exceed the amount reasonably required to accomplish the 
intended technical or physical effect. Such adjuvants may include 
substances generally recognized as safe in food, substances used in 
accordance with prior sanction, substances permitted under applicable 
regulations in parts 170 through 189 of this chapter, and the following:
    (1) Stabilizers (total amount of stabilizers not to exceed 2.0 
percent and amount of any one stabilizer not to exceed 1.0 percent of 
polymer by weight)

Calcium ricinoleate.
Cyanoguanidine.
Hexamethylene bis(3,5-di-tert-butyl-4-hydroxy hydro cinnamate) (CAS Reg. 
No. 35074-77-2).
Melamine-formaldehyde resin.
2,2'-Methylenebis(4-methyl-6-tert-butylphenol).
Nylon 6/66, weight ratio 2/3.
Tetrakis [methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] 
methane.

    (2) Lubricant: N,N'Distearoylethyl-enediamine.
    (c) Specifications. (1) Poly oxy meth ylene copolymer can be 
identified by its characteristic infrared spectrum.
    (2) Minimum number average molecular weight of the copolymer is 
15,000 as determined by a method titled ``Number Average Molecular 
Weight,'' 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 
available for inspection 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.
    (d) Extractive limitations. (1) Poly oxy methylene copolymer in the 
finished form in which it is to contact food, when extracted with the 
solvent or solvents characterizing the type of food and under conditions 
of time and temperature as determined from tables 1 and 2 of Sec.  
175.300(d) of this chapter, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of food-contact 
surface.
    (2) Polyoxymethylene copolymer with or without the optional 
substances described in paragraph (b) of this section, when ground or 
cut into particles that pass through a U.S.A. Standard Sieve No. 6 and 
that are retained on a U.S.A. Standard Sieve No. 10, shall yield total 
extractives as follows:
    (i) Not to exceed 0.20 percent by weight of the copolymer when 
extracted for 6 hours with distilled water at reflux temperature.
    (ii) Not to exceed 0.15 percent by weight of the copolymer when 
extracted for 6 hours with n-heptane at reflux temperature.
    (e) Conditions of use. (1) The polyoxymethylene copolymer is for use 
as articles or components of articles intended for repeated use.
    (2) Use temperature shall not exceed 250 [deg]F.
    (3) In accordance with good manufacturing practice, finished 
articles containing polyoxymethylene copolymer

[[Page 345]]

shall be thoroughly cleansed before their first use in contact with 
food.

[42 FR 14572, Mar. 15, 1977, as amended at 48 FR 56204, Dec. 20, 1983; 
49 FR 5748, Feb. 15, 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, May 
17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR 24898, June 12, 1989]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 2470


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