[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: 21CFR178.2650]
[Page 394-397]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
Subpart C Antioxidants and Stabilizers
Sec. 178.2650 Organotin stabilizers in vinyl chloride plastics.
The organotin chemicals identified in paragraph (a) of this section
may be safety used alone or in combination, at levels not to exceed a
total of 3 parts per hundred of resin, as stabilizers in vinyl chloride
homopolymers and copolymers complying with the provisions of Sec.
177.1950 or Sec. 177.1980 of this chapter and that are identified for
use in contact with food of types I, II, III, IV (except liquid milk),
V, VI (except malt beverages and carbonated nonalcoholic beverages),
VII, VIII, and IX described in table 1 of Sec. 176.170(c) of this
chapter, except for the organotin chemical identified in paragraph
(a)(3)
[[Page 395]]
of this section, which may be used in contact with food of types I
through IX at temperatures not exceeding 75 [deg]C (167 [deg]F), and
further that the organotin chemicals identified in paragraphs (a) (5)
and (6) of this section may be used in contact with food of types I
through IX at temperatures not exceeding 66 [deg]C (150 [deg]F),
conditions of use D through G described in table 2 of Sec. 176.170(c)
of this chapter, and further that dodecyltin chemicals identified in
paragraph (a)(7) of this section which may be used in contact with food
of types I, II, III, IV (except liquid milk), V, VI (except malt
beverages and carbonated nonalcoholic beverages), VII, VIII, and IX
described in table 1 of Sec. 176.170(c) of this chapter at temperatures
not exceeding 71 [deg]C (160 [deg]F), in accordance with the following
prescribed conditions:
(a) For the purpose of this section, the organotin chemicals are
those listed in paragraphs (a) (1), (2), (3), (4), (5), (6), and (7) of
this section.
(1) Di(n-octyl)tin S,S'-bis(isooctylmercaptoacetate) is an octyltin
chemical having 15.1 to 16.4 percent by weight of tin (Sn) and having
8.1 to 8.9 percent by weight of mercapto sulfur. It is made from di(n-
octyl)tin dichloride or di(n-octyl)tin oxide. The isooctyl radical in
the mercaptoacetate is derived from oxo process isooctyl alcohol. Di(n-
octyl)tin dichloride has an organotin composition that is not less than
95 percent by weight of di(n-octyl)tin dichloride and not more than 5
percent by weight of tri(n-octyl)tin chloride. Di(n-octyl)tin oxide has
an organotin composition that is not less than 95 percent by weight of
di(n-octyl)tin oxide and not more than 5 percent by weight of bis[tri(n-
octyl)tin] oxide, and/or mono n-octyltin oxide.
(2) Di(n-octyl) tin maleate polymer is an octyltin chemical having
the formula
[(C8H17)2SnC4H2O4
]n (where n is between 2 and 4 inclusive), having 25.2 to
26.6 percent by weight of tin (Sn) and having a saponification number of
225 to 255. It is made from di(n-octyl)tin dichloride or di(n-octyl)tin
oxide meeting the specifications prescribed for di(n-octyl) tin
dichloride or di(n-octyl) tin oxide in paragraph (a)(1) of this section.
(3) C10.16-Alkyl mercaptoacetates reaction products with
dichlorodioctylstannane and trichlorooctylstannane (CAS Reg. No. 83447-
69-2) is an organotin chemical mixture having 10.8 to 11.8 percent by
weight of tin (Sn) and having 8.0 to 8.6 percent by weight of mercapto
sulfur. It is made from a mixture of di(n-octyl)tin dichloride and (n-
octyl)tin trichloride which has an organotin composition that is not
less than 95 percent by weight di(n-octyl)tin dichloride/(n-octyl)tin
trichloride, and not more than 1.5 percent by weight of tri(n-octyl)tin
chloride. The alkyl radical in the mercaptoacetate is derived from a
mixture of saturated n-alcohols which has a composition that is not less
than 50 percent by weight tetradecyl alcohol, and that is not more than
50 percent by weight total of decyl alcohol and/or dodecyl alcohol, and/
or hexadecyl alcohol.
(4) (n-Octyl)tin S,S'S'' tris(isooctyl-mercaptoacetate) is an
octyltin chemical having the formula n-
C8H17Sn(SCH2CO2C8H
17)3 (CAS Reg. No. 26401-86-5) having 13.4 to 14.8
percent by weight of tin (Sn) and having 10.9 to 11.9 percent by weight
of mercapto sulfur. It is made from (n-octyl)tin trichloride. The
isooctyl radical in the mercaptoacetate is derived from oxo process
isooctyl alcohol. The (n-octyl)tin trichloride has an organotin
composition that is not less than 95 percent by weight of (n-octyl)tin
trichloride and not more than 5 percent by weight of tri(n-octyl)tin
chloride.
(5) Bis(beta-carbobutoxyethyl)tin bis(isooctylmercaptoacetate) (CAS
Reg. No. 63397-60-4) is an estertin chemical having 14.0 to 15.0 percent
by weight of tin (Sn) and having 7.5 to 8.5 percent by weight of
mercapto sulfur. It is made from bis(beta-carbobutoxyethyl)tin
dichloride. The isooctyl radical in the mercaptoacetate is derived from
oxo process primary octyl alcohols. The bis(beta-carbobutoxyethyl)tin
dichloride has an organotin composition that is not less than 95 percent
by weight of bis(beta-carbobutoxyethyl)tin dichloride and not more than
5 percent by weight of bis(beta-carbobutoxyethyltin trichloride. The
triestertin chloride content of bis(beta-carbobutoxyethyltin)
[[Page 396]]
dichloride shall not exceed 0.02 percent. p
(6) Beta-carbobutoxyethyltin tris(isooctylmercaptoacetate) (CAS Reg.
No. 63438-80-2) is an estertin chemical having 13.0 to 14.0 percent by
weight of tin (Sn) and having 10.5 to 11.5 percent by weight of mercapto
sulfur. It is made from beta-carbobutoxyethyltin trichloride. The
isooctyl radical in the mercaptoacetate is derived from oxo process
primary octyl alcohol. The beta-carbobutoxyethyltin trichloride has an
organotin composition that is not less than 95 percent by weight of
beta-carbobutoxyethyltin trichloride and not more than 5 percent total
of triestertin chloride and diestertin chloride.
(7) The dodecyltin stabilizer is a mixture of 50 to 60 percent by
weight of n-dodecyltin S,S',S''-tris(isooctylmercaptoacetate) (CAS Reg.
No. 67649-65-4) and 40 to 50 percent by weight of di(n-dodecyl)tin S,S'-
di(isooctylmercaptoacetate) (CAS Reg. No. 84030-61-5) having 13 to 14
percent by weight of tin (Sn) and having 8 to 9 percent by weight of
mercapto sulfur. It is made from a mixture of dodecyltin trichloride and
di(dodecyl)tin dichloride which has not more than 0.2 percent by weight
of dodecyltin trichloride, not more than 2 percent by weight of
dodecylbutyltin dichloride and not more than 3 percent by weight of
tri(dodecyl)tin chloride. The isooctyl radical in the mercaptoacetate is
derived from oxo process primary octyl alcohols.
(b) The vinyl chloride plastic containers, film or panels in the
finished form in which they are to contact food, shall meet the
following limitations:
(1) The finished plastics intended for contact with foods of the
types listed in this section shall be extracted with the solvent or
solvents characterizing those types of foods as determined from table 2
of Sec. 176.170(c) of this chapter at the temperature reflecting the
conditions of intended use as determined therein. Additionally,
extraction tests for acidic foods shall be included and simulated by 3-
percent acetic acid at temperatures specified for water in table 2 of
Sec. 176.170(c) of this chapter. The extraction tests shall cover at
least three equilibrium periodic determinations, as follows:
(i) The exposure time for the first determination shall be at least
72 hours for aqueous solvents, and at least 6 hours for heptane.
(ii) Subsequent determinations shall be at a minimum of 24-hour
intervals for aqueous solvents, and 2-hour intervals for heptane. These
tests shall yield total octylin stabilizers not to exceed 0.5 parts per
million as determined by analytical method entitled ``Atomic Absorption
Spectrometric Determination of Sub-part-per-Million Quantities of Tin in
Extracts and Biological Materials with Graphite Furnace,'' Analytical
Chemistry, Vol. 49, p. 1090.1093 (1977), 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.
(iii) Subsequent determinations for the dodecyltin mixture described
in paragraph (a)(7) of this section shall be at a minimum of 24-hour
intervals for aqueous solvents and 2-hour intervals for heptane. These
tests shall yield di(n-octyl)tin S,S'-bis(isooctylmercaptoacetate), or
di(n-octyl)tin maleate polymer, or (C10-C16)-
alkylmercaptoacetate reaction products with dichlorodioctylstannane and
trichlorooctylstannane, or n-octyltin S,S',S''-
tris(isooctylmercaptoacetate), tris(isooctylmercaptoacetate) and di(n-
dodecyl)tin bis(isooctylmercaptoacetate) or any combination thereof, not
to exceed 0.5 parts per million as determined by an analytical method
entitled ``Atomic Absorption Spectrophotometric Determination of Sub-
part-per-Million Quantities of Tin in Extracts and Biological Materials
with Graphite Furnace,'' Analytical Chemistry, Vol. 49, pp. 1090.1093
(1977), which is incorporated by reference in accordance with 5 U.S.C.
[[Page 397]]
552(a). The availability of this incorporation by reference is given in
paragraph (b)(1)(ii) of this section.
(2) In lieu of the tests prescribed in paragraph (b) (1) of this
section, the finished plastics intended for contact with foods only of
Types II, V, VI-A (except malt beverages), and VI-C may be end-tested
with food-simulating solvents, under conditions of time and temperature,
as specified below, whereby such tests shall yield the octyltin residues
cited in paragraph (b)(1) of this section not in excess of 0.5 ppm:
------------------------------------------------------------------------
Temperature
Food-simulating solvent Time (degrees
(hours) Fahrenheit)
------------------------------------------------------------------------
Type II............... Acetic acid, 3 pct....... 48 135
Type V................ Heptane.................. 2 100
Type VI-A............. Ethyl alcohol, 8 pct..... 24 120
Type VI-C............. Ethyl alcohol, 50 percent 24 120
------------------------------------------------------------------------
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982;
48 FR 7170, Feb. 18, 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612,
Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR 62, Jan. 2, 1985; 50 FR
3510, Jan. 25, 1985; 50 FR 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15,
1985; 54 FR 24898, June 12, 1989]
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