[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: 21CFR177.2480]
[Page 346-347]
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. 177.2480 Polyoxymethylene homopolymer.
Polyoxymethylene homopolymer identified in this section may be
safely used as articles or components of articles intended for food-
contact use in accordance with the following prescribed conditions:
(a) Identity. For the purpose of this section, polyoxymethylene homo
poly mer is polymerized formaldehyde [Chemical Abstracts Service
Registry No. 9002-81-7]. Certain optional adjuvant substances, described
in paragraph (b) of this section, may be added to impart desired
technological properties to the homopolymer.
(b) Optional adjuvant substances. The polyoxymethylene homopolymer
identified in paragraph (a) of this section may contain optional
adjuvant substances in its production. The quantity of any optional
adjuvant substance employed in the production of the homopolymer does
not exceed the amount reasonably required to accomplish the intended
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 this part, and the
following:
(1) Stabilizers. The homopolymer may contain one or more of the
following stabilizers. The total amount of stabilizers shall not exceed
1.9 percent of homopolymer by weight, and the quantity of individual
stabilizer used shall not exceed the limitations set forth below:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Hexamethylenebis(3,5-di-tert-butyl-4- At a maximum level of 1
hydroxy-hydrocinnamate) (CAS Reg. No. percent by weight of
35074-77-2). homopolymer. The finished
articles shall not be used
for foods containing more
than 8 percent alcohol.
2,2'-Methylenebis(4-methyl-6-tert- At a maximum level of 0.5
butylphenol). percent by weight of
homopolymer.
Nylon 66/610/6 terpolymer, respective At a maximum level of 1.5
proportions of nylon polymers by weight percent by weight of
are: 3/2/4. homopolymer.
Nylon 612/6 copolymer (CAS Reg. No. 51733- Do.
10-9), weight ratio 6/1.
Tetrakis[methylene(3,5-di-tert-butyl-4- At a maximum level of 0.5
hydroxy-hydrocinnamate)] methane. percent by weight of
homopolymer.
------------------------------------------------------------------------
(2) Lubricant. N,N'-Distearoylethyl-enediamine.
(3) Molding assistant. Polyethylene glycol 6,000.
(c) Specifications. (1) Polyoxymethylene homopolymer can be
identified by its characteristic infrared spectrum.
(2) Minimum number average molecular weight of the homopolymer is
25,000.
(3) Density of the homopolymer is between 1.39 and 1.44 as
determined by ASTM method D1505-68 (Reapproved 1979), ``Standard Test
Method for Density of Plastics by the Density-Gradient Technique,''
which is incorporated by reference. Copies may be obtained from the
American Society for Testing Materials, 100 Barr Harbor Dr., West
Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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) Melting point is between 172 [deg]C and 184 [deg]C as determined
by ASTM method D2133-66, ``Specifications for Acetal Resin Injection
Molding and Extrusion Materials'' (Revised 1966), which is incorporated
by reference. Copies are available from American Society for Testing and
Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia,
PA 19428-2959, 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) Polyoxymethylene homopolymer, in
[[Page 347]]
the finished form which is to contact food, when extracted with the
solvent or solvents characterizing the type of food and under conditions
of time and temperature characterizing the conditions of intended use
under paragraphs (c)(3) and (d) of Sec. 175.300 of this chapter and as
limited by paragraph (e) of this section, shall yield net chloroform-
soluble extractives not to exceed 0.5 milligram per square inch of food-
contact surface.
(2) Polyoxymethylene homopolymer, with or without the optional
adjuvant 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 extractives as follows:
(i) Formaldehyde not to exceed 0.0050 percent by weight of
homopolymer as determined by a method titled ``Formaldehyde Release and
Formaldehyde Analysis,'' which is incorporated by reference. Copies are
available from 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.
(ii) Total extractives not to exceed 0.20 percent by weight of
homopolymer when extracted for 6 hours with distilled water at reflux
temperature and 0.15 percent by weight of homopolymer when extracted for
6 hours with n-heptane at reflux temperature.
(e) Conditions of use. (1) Poly oxy methy lene homopolymer 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 homopolymer shall be thoroughly
cleansed prior to first use in contact with food.
[42 FR 14572, Mar. 15, 1977, as amended at 43 FR 44835, Sept. 29, 1978;
47 FR 11846, Mar. 19, 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111,
Mar. 19, 1984; 54 FR 24898, June 12, 1989]
Back to Top
© 2007 Betterchem Corp.
|
