[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: 21CFR177.1050]
[Page 244-246]
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. 177.1050 Acrylonitrile/styrene copoly-mer modified with
butadiene/styrene elastomer.
Acrylonitrile/styrene copolymer modified with butadiene/styrene
elastomer identified in this section may be safely used as a component
of bottles intended for use with foods identified in table I of Sec.
176.170(c) of this chapter as Type VI-B under conditions for use E, F,
or G described in table 2 of Sec. 176.170(c) of this chapter.
(a) Identity. For the purpose of this section, acrylonitrile/styrene
copoly- mer modified with butadiene/styrene elastomer consists of a
blend of:
(1) 82-88 parts by weight of a matrix copolymer produced by
polymerization of 77-82 parts by weight of acrylonitrile and 18-23 parts
of styrene; and
(2) 12-18 parts by weight of a grafted rubber consisting of (i) 8-12
parts of butadiene/styrene elastomer containing 77-82 parts by weight of
butadiene and 18-23 parts by weight of styrene and (ii) 4-6 parts by
weight of a graft copolymer consisting of 70-77 parts by weight of
acrylonitrile and 23-30 parts by weight of styrene.
(b) Adjuvants. The modified copoly-mer identified in paragraph (a)
of this section may contain adjuvant substances required in its
production. 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:
[[Page 245]]
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Substances Limitations
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n-Dodecylmercaptan........................ The finished copolymer shall
contain not more than 500
parts per million (ppm)
dodecylmercaptan as
dodecylmercapto-
propionitrile as determined
by the method titled,
``Determination of [beta]-
Dodecyl-
mercaptopropionitrile in NR-
16 Polymer,'' 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.
------------------------------------------------------------------------
(c) Specifications. (1) Nitrogen content of the modified copolymer
is in the range of 17.7-19.8 percent.
(2) Intrinsic viscosity of the matrix copolymer in butyrolactone is
not less than 0.5 deciliter/gram at 35 [deg]C, as determined by the
method titled ``Molecular Weight of Matrix Copolymer by Solution
Viscosity,'' 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.
(3) Residual acrylonitrile monomer content of the modified copolymer
articles is not more than 11 ppm as determined by a gas chromatographic
method titled ``Determination of Residual Acrylonitrile and Styrene
Monomers-Gas Chromatographic Internal Standard Method,'' 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) Extractives limitations. The following extractives limitations
are determined by an infrared spectro photo metric method titled
``Infrared Spectro photo metric Determination of Polymer Extracted from
Borex [reg] 210 Resin Pellets,'' 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. Copies are applicable to the modified
copolymers in the form of particles of a size that will pass through a
U.S. Standard Sieve No. 6 and that will be held on a U.S. Standard Sieve
No. 10:
(1) The extracted copolymer shall not exceed 2.0 ppm in aqueous
extract obtained when a 100-gram sample of copolymer is extracted with
250 milliliters of freshly distilled water at reflux temperature for 2
hours.
(2) The extracted copolymer shall not exceed 0.5 ppm in n-heptane
when a 100-gram sample of the basic copol-ymer is extracted with 250
milliliters spectral grade n-heptane at reflux temperature for 2 hours.
(e) Accelerated extraction end test. The modified copolymer shall
yield acrylonitrile monomer not in excess of 0.4 ppm when tested as
follows:
(1) The modified copolymer shall be in the form of eight strips \1/
2\ inch by 4 inches by .03 inch.
(2) The modified copolymer strips shall be immersed in 225
milliliters of 3 percent acetic acid in a Pyrex glass pressure bottle.
(3) The pyrex glass pressure bottle is then sealed and heated to 150
[deg]F in either a circulating air oven or a thermostat controlled bath
for a period of 8 days.
(4) The Pyrex glass pressure bottle is then removed from the oven or
bath
[[Page 246]]
and cooled to room temperature. A sample of the extracting solvent is
then withdrawn and analyzed for acrylonitrile monomer by a gas
chromatographic method titled ``Gas-Solid Chromatographic Procedure for
Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers
and Food Simulating Solvents,'' 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.
(f) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
(g) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23, 1977;
47 FR 11841, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898,
June 12, 1989]
Additives that reference this regulation: |
