[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: 21CFR177.2470]
[Page 345-346]
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 346]]
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]
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