[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: 21CFR177.1570]
[Page 302-303]
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. 177.1570 Poly.1-butene resins and butene/ethylene copolymers.
The poly.1-butene resins and butene/ethylene copolymers identified
in this section may be safely used as articles or components of articles
intended for use in contact with food subject to the provisions of this
section.
(a) Identity. Poly.1-butene resins are produced by the catalytic
polymerization of 1-butene liquid monomer. Butene/ethylene copolymers
are produced by the catalytic polymerization of 1-butene liquid monomer
in the presence of small amounts of ethylene monomer so as to yield no
higher than a 6-weight percent concentration of polymer units derived
from ethylene in the copolymer.
(b) Specifications and limitations. Poly.1-butene resins and butene/
ethylene copolymers shall conform to the specifications prescribed in
paragraph (b)(1) of this section, and shall meet the extractability
limits prescribed in paragraph (b)(2) of this section.
(1) Specifications--(i) Infrared identification. Poly.1-butene
resins and butene/ethylene copolymers can be identified by their
characteristic infrared spectra.
(ii) Viscosity. Poly.1-butene resins and the butene/ethylene
copolymers have
[[Page 303]]
an intrinsic viscosity 1.0 to 3.2 as determined by ASTM method D1601-78,
``Standard Test Method for Dilute Solution Viscosity of Ethylene
Polymers,'' 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.
(iii) Density. Poly.1-butene resins have a density of 0.904 to 0.920
gms/cm\3\, and butene/ethylene copolymers have a density of 0.890 to
0.916 gms/cm\3\ 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. The availability of
this incorporation by reference is given in paragraph (b)(1)(ii) of this
section.
(iv) Melt index. Poly.1-butene resins have a melt index of 0.1 to 24
and the butene/ethylene copolymers have a melt index of 0.1 to 20 as
determined by ASTM method D1238-82, condition E, ``Standard Test Method
for Flow Rates of Thermoplastics by Extrusion Plastometer,'' which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (b)(1)(ii) of this section.
(2) Limitations. Poly.1-butene resins and butene/ethylene copolymers
for use in articles that contact food, and for articles used for packing
or holding food during cooking shall yield no more than the following
extractables:
(i) Poly.1-butene resins may be used as articles or components of
articles intended for use in contact with food, provided that the
maximum extractables do not exceed 2.5 percent by weight of the polymer
when film or molded samples are tested for 2 hours at 50 [deg]C (122
[deg]F) in n-heptane.
(ii) Butene/ethylene copolymers containing no more than 6 percent by
weight of polymer units derived from ethylene may be used as articles or
components of articles intended for contact with food under conditions
of use B, C, D, E, F, G, or H described in table 2 of Sec. 176.170(c)
of this chapter, subject to the provisions of this section and provided
that the maximum extractables from test films 0.1 to 0.2 millimeter
(0.004 to 0.008 inch) in thickness do not exceed 0.80 percent by weight
of the polymer when extracted in a soxhlet extractor for 6 hours with
refluxing 95 percent ethanol.
(iii) Poly.1-butene resins may be used as articles or components of
articles intended for packaging or holding food during cooking, provided
that the thickness of such polymers in the form in which they contact
food shall not exceed 0.1 millimeter (0.004 inch) and yield maximum
extractables of not more than 2.5 percent by weight of the polymer when
films are extracted for 2 hours at 50 [deg]C (122 [deg]F) in n-heptane.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984;
50 FR 31349, Aug. 2, 1985]
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