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177.1040 Acrylonitrile/styrene copoly-mer.

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[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: 21CFR177.1040]

[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.  177.1040  Acrylonitrile/styrene copoly-mer.

    Acrylonitrile/styrene copolymers identified in this section may be 
safely used as a component of packaging materials subject to the 
provisions of this section.
    (a) Identity. For the purposes of this section acrylonitrile/styrene 
copoly-mers are basic copolymers meeting the specifications prescribed 
in paragraph (c) of this section.
    (b) Adjuvants. (1) The copolymers identified in paragraph (c) of 
this section may contain adjuvant substances required in their 
production, with the exception that they shall not contain mercaptans or 
other substances which form reversible complexes with acryl-onitrile 
monomer. Permissible 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 those authorized in paragraph (b)(2) of this section.
    (2) The optional adjuvants for the acrylonitrile/styrene copolymer 
identified in paragraphs (c) (1) and (3) of this section are as follows:

------------------------------------------------------------------------
                Substances                           Limitation
------------------------------------------------------------------------
Condensation polymer of toluene             0.15 pct maximum.
 sulfonamide and formaldehyde.
------------------------------------------------------------------------

    (c) Specifications.

----------------------------------------------------------------------------------------------------------------
                                                                           Maximum
                                  Maximum residual                       extractable
                                    acrylonitrile       Nitrogen        fractions at         Conformance with
Acrylonitrile/styrene copolymers   monomer content     content of         specified       certain specifications
                                     of finished       copolymer      temperatures and
                                       article                              times
----------------------------------------------------------------------------------------------------------------
1. Acrylonitrile/styrene          80 ppm\1\.......  17.4 to 19 pct.  Total nonvolatile   Minimum number average
 copolymer consisting of the                                          extractives not     molecular weight is
 copolymer produced by                                                to exceed 0.01 mg/  30,000.\1\
 polymerization of 66-72 parts                                        in \2\ surface
 by weight of acrylonitrile and                                       area of the food
 28-34 parts by weight of                                             contact article
 styrene; for use with food of                                        when exposed to
 Type VI-B identified in table 1                                      distilled water
 of Sec.   176.170(c) of this                                         and 3 pct acetic
 chapter under conditions of use                                      acid for 10 d at
 C, D, E, F, G described in                                           66 [deg]C (150
 table 2 of Sec.   176.170(c) of                                      [deg]F).
 this chapter.                                                       The extracted
                                                                      copolymer shall
                                                                      not exceed 0.001
                                                                      mg/in \2\ surface
                                                                      area of the food
                                                                      contact article
                                                                      when exposed to
                                                                      distilled water
                                                                      and 3 pct acetic
                                                                      acid for 10 d at
                                                                      66 [deg]C (150
                                                                      [deg]F) \1\.
2. Acrylonitrile/styrene          50 ppm\1\.......  12.2 to 17.2     Extracted           Minimum 10 pct solution
 copolymer consisting of the                         pct.             copolymer not to    viscosity at 25 [deg]C
 copolymer produced by                                                exceed 2.0 ppm in   (77 [deg]F) is
 polymerization of 45-65 parts                                        aqueous extract     10cP.\1\
 by weight of acrylonitrile and                                       or n-heptane
 35-55 parts by weigth of                                             extract obtained
 styrene; for use with food of                                        when 100 g sample
 Types, I, II, III, IV, V, VI                                         of the basic
 (except bottles), VII, VIII,                                         copolymer in the
 and IX identified in table 1 of                                      form of particles
 Sec.   176.170(c) of this                                            of a size that
 chapter under conditions B (not                                      will pass through
 to exceed 93 [deg]C (200                                             a U.S. Standard
 [deg]F)), C, D, E, F, G                                              Sieve No. 6 and
 described in table 2 of Sec.                                         that will be held
 176.170(c) of this chapter.                                          on a U.S.
                                                                      Standard Sieve
                                                                      No. 10 is
                                                                      extracted with
                                                                      250 mil of
                                                                      deionized water
                                                                      or reagent grade
                                                                      n-heptane at
                                                                      reflux
                                                                      temperature for 2
                                                                      h.\1\

[[Page 244]]


3. Acrylonitrile/styrene          0.10 ppm          17.4 to 19 pct.  Total nonvolatile   Maximum carbon dioxide
 copolymer consisting of the       (calculated on                     extractives not     permeability at 23
 copolymer produced by             the basis of                       to exceed 0.01 mg/  [deg]C (73 [deg]F) for
 polymerization of 66-72 parts     the weight of                      in \2\ surface      the finished article
 by weight of acrylonitrile and    the                                area of the food    is 0.04 barrer.\3\
 28-34 parts by weight of          acrylonitrile                      contact article
 styrene; for use with food of     copolymer resin                    when exposed to
 Types VI-A and VI-B identified    in the finished                    distilled water
 in table 1 of Sec.   176.170(c)   articles).\2\                      and 3 pct acetic
 of this chapter under                                                acid for 10 d at
 conditions of use C, D, E, F, G                                      66 [deg]C (150
 described in table 2 of Sec.                                         [deg]F).
 176.170(c) of this chapter.                                         The extracted
                                                                      copolymer shall
                                                                      not exceed 0.001
                                                                      mg/in \2\ surface
                                                                      area of the food
                                                                      contact article
                                                                      when exposed to
                                                                      distilled water
                                                                      and 3 pct acetic
                                                                      acid for 10 d at
                                                                      66 [deg]C (150
                                                                      [deg]F).\1\.
----------------------------------------------------------------------------------------------------------------
\1\ Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction,
  number average molecular weight, and solution viscosity, titled: ``Determination of Residual Acrylonitrile and
  Styrene Monomers-Gas Chromatographic Internal Standard Method''; ``Infrared Spectrophotometric Determination
  of Polymer Extracted from Barex 210 Resin Pellets''; ``Procedure for the Determination of Molecular Weights of
  Acrylonitrile/Styrene Copolymers,'' and ``Analytical Method for 10% Solution Viscosity of Tyril,'' which are
  incorproated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-
  200), 5100 Paint Branch Pkwy., College Park, MD 20740, 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\ As determined by the method titled ``Headspace Sampling and Gas-Solid Chromatographic Determination of
  Residual Acrylonitrile in Acrylonitrile Copolyemr Solutions,'' which is incorporated by reference. Copies are
  available from the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College
  Park, MD 20740, 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.
\3\ As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a
  multilayer construction by ASTM method D-1434-82, ``Standard Method for Determining Gas Permeability
  Characteristics of Plastic Film and Sheeting,'' which is incorporated by reference. Copies are available from
  the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740,
  and 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.

    (d) Interim listing. Acrylonitrile copolymers identified in this 
section shall comply with the provisions of Sec.  180.22 of this 
chapter.
    (e) Acrylonitrile copolymer identified in this section may be used 
to fabricate beverage containers only if they comply with the 
specifications of item 3 in paragraph (c) of this section.

[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 
47 FR 11841, Mar. 19, 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, 
Sept. 8, 1987]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1040


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