[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: 21CFR177.1030]
[Page 243-244]
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. 177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate
copolymer.
Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer
identified in this section may be safely used as an article or component
of articles intended for use with food identified in table 1 of Sec.
176.170(c) of this chapter as Type I, II, III, IVA, IVB, V, VIB, (except
bottles intended to hold carbonated beverages), VIIA, VIIB, VIII and IX,
under conditions of use C, D, E, F, and G described in table 2 of Sec.
176.170(c) of this chapter with a high temperature limitation of 190
[deg]F.
(a) Identity. For the purpose of this section, acrylonitrile/
butadiene/styrene/methyl methacrylate copolymer consists of: (1) 73 to
79 parts by weight of a matrix polymer containing 64 to 69 parts by
weight of acrylonitrile, 25 to 30 parts by weight of styrene and 4 to 6
parts by weight of methyl methacrylate; and (2) 21 to 27 parts by weight
of a grafted rubber consisting of (i) 16 to 20 parts of butadiene/
styrene/elastomer containing 72 to 77 parts by weight of butadiene and
23 to 28 parts by weight of styrene and (ii) 5 to 10 parts by weight of
a graft polymer having the same composition range as the matrix polymer.
(b) Adjuvants. The copolymer 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:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
2-Mercaptoethanol......................... The finished copolymer shall
contain not more than 800
ppm 2-mercaptoethanol
acrylonitrile adduct as
determined by a method
titled ``Analysis of
Cycopac Resin for Residual
[beta]-(2-Hydroxyethylmerca
pto) propionitrile,'' which
is incorporated by
reference. Copies are avail
able from the Bureau of
Foods (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 copolymer is in the
range of 13.0 to 16.0 percent as determined by Micro-Kjeldahl analysis.
(2) Residual acrylonitrile monomer content of the finished copolymer
articles is not more than 11 parts per million 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) Extractive limitations. (1) Total nonvolatile extractives not to
exceed 0.0005 milligram per square inch surface area of the food-contact
article when exposed to distilled water, 3 percent acetic acid, 50
percent ethanol, and n-heptane for 10 days at 120 [deg]F.
(2) The finished food-contact article shall yield not more than
0.0025 milligram per square inch of acrylonitrile monomer when exposed
to distilled water, 3 percent acetic acid and n-heptane at 190 [deg]F
for 2 hours, cooled to
[[Page 244]]
120 [deg]F (80 to 90 minutes) and maintained at 120 [deg]F for 10 days
when analyzed by a polarographic method titled ``Extracted Acrylonitrile
by Differential Pulse Polarography,'' 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.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
(f) 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 48543, Sept. 23, 1977;
47 FR 11841, Mar. 19, 1982; 54 FR 24898, June 12, 1989]
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