[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: 21CFR177.1430]
[Page 275]
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. 177.1430 Isobutylene-butene copolymers.
Isobutylene-butene copolymers identified in paragraph (a) of this
section may be safely used as components of articles intended for use in
contact with food, subject to the provisions of this section.
(a) For the purpose of this section, isobutylene-butene copolymers
consist of basic copolymers produced by the copolymerization of
isobutylene with mixtures of n-butenes such that the finished basic
copolymers contain not less than 45 weight percent of polymer units
derived from isobutylene and meet the specifications prescribed in
paragraph (b) of this section when tested by the methods described in
paragraph (c) of this section.
(b) Specifications:
----------------------------------------------------------------------------------------------------------------
Maximum
Isobutylene-butene copolymers Molecular weight (range) Viscosity (range) bromine
value
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1. Used as release agents in petroleum 300 to 5,000............ 40 to 20,000 seconds Saybolt at 200 40
wax complying with Sec. 178.3710 of [deg]F.
this chapter.
2. Used as plasticizers in 300 to 5,000............ 40 to 20,000 seconds Saybolt at 200 40
polyethylene or polypropylene [deg]F.
complying with Sec. 177.1520, and
in polystyrene complying with Sec.
177.1640.
3. Used as components of nonfood 300 to 5,000............ 40 to 20,000 seconds Saybolt at 200 40
articles complying with Sec. Sec. [deg]F.
175.300, 176.170, 176.210,
177.2260(d)(2), 177.2800, and
178.3570 (provided that addition to
food does not exceed 10 parts per
million), or Sec. 176.180 of this
chapter.
4. Used as production aids in the 150 to 5,000............ Less than 20,000 seconds Saybolt at 90.
manufacture of expanded (foamed) 200 [deg]F.
polystyrene articles complying with
Sec. 177.1640 of this chapter.
5. Used in release coatings on 150 to 5,000............ Less than 20,000 seconds Saybolt at 90
backings or linings for pressure- 200 [deg]F.
sensitive adhesive labels complying
with Sec. 175.125 of this chapter.
----------------------------------------------------------------------------------------------------------------
(c) The analytical methods for determining whether isobutylene-
butene copolymers conform to the specifications in paragraph (b) are as
follows:
(1) Molecular weight. Molecular weight shall be determined by
American Society for Testing and Materials (ASTM) method D2503-82,
``Standard Test Method for Molecular Weight (Relative Molecular Mass) of
Hydrocarbons by Thermoelectric Measurement of Vapor Pressure,'' 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.
(2) Viscosity. Viscosity shall be determined by ASTM method D445-74,
``Test for Kinematic Viscosity of Transparent and Opaque Liquids,''
which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (c)(1) of this section.
(3) Maximum bromine value. Maximum bromine value shall be determined
by ASTM method D1492-78, ``Standard Test Method for Bromine Index of
Aromatic Hydrocarbons by Coulometric Titration,'' which is incorporated
by reference. The availability of this incorporation by reference is
given in paragraph (c)(1) of this section.
(d) The provisions of this section are not applicable to
isobutylene-butene copolymers used as provided under Sec. 175.105 of
this chapter.
[52 FR 11641, Apr. 10, 1987, as amended at 63 FR 36175, July 2, 1998]
[[Page 276]]
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