[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1210]
[Page 237-241]
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. 177.1210 Closures with sealing gaskets for food containers.
Closures with sealing gaskets may be safely used on containers
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food in
accordance with the following prescribed conditions:
(a) Closures for food containers are manufactured from substances
generally recognized as safe for contact with food; substances that are
subject to the provisions of prior sanctions; substances authorized by
regulations in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter; and closure-sealing gaskets, as further prescribed in this
section.
(b) Closure-sealing gaskets and overall discs are formulated from
substances identified in Sec. 175.300(b) of this chapter, with the
exception of paragraph (b)(3) (v), (xxxi), and (xxxii) of that section,
and from other optional substances, including the following:
(1) Substances generally recognized as safe in food.
(2) Substances used in accordance with the provisions of a prior
sanction or approval within the meaning of section 201(s) of the act.
(3) Substances that are the subject of regulations in parts 174,
175, 176, 177, 178 and Sec. 179.45 of this chapter and used in
accordance with the conditions prescribed.
(4) Substances identified in paragraph (b)(5) of this section, used
in amounts not to exceed those required to accomplish the intended
physical or technical effect and in conformance with any limitation
provided; and further provided that any substance employed in the
production of closure-sealing gasket compositions that is the subject of
a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter conforms with the identity or specifications prescribed.
(5) Substances that may be employed in the manufacture of closure-
sealing gaskets include:
Table 1
------------------------------------------------------------------------
Limitations (expressed as
List of substances percent by weight of closure-
sealing gasket composition)
------------------------------------------------------------------------
Arachidy-l-behenyl amide (C20-C22fatty 5 percent.
acid amides).
Azodicarbonamide....................... 1. 2 percent.
[[Page 238]]
2. 5 percent; for use only in
the manufacture of
polyethylene complying with
item 2.1 in Sec. 177.1520(c)
of this chapter.
Balata rubber..........................
Benzyl alcohol......................... 1 percent.
Brominated isobutylene-isoprene
copolymers, produced when isobutylene-
isoprene copolymers complying with
Sec. 177.1420(a)(2) are modified by
bromination with not more than 2.3
weight-percent of bromine and having a
Mooney Viscosity (ML 1+8 (125 deg.C))
of 27 or higher. The viscosity is
determined by the American Society for
Testing and Materials (ASTM) method D
1646-81, ``Standard Test Method for
Rubber--Viscosity and Vulcanization
Characteristics (Mooney Viscometer),''
which is incorporated by reference in
accordance with 5 U.S.C. 522(a) and 1
CFR part 51. Copies are available from
the Association of Official Analytical
Chemists International, 481 North
Frederick Ave., Suite 500,
Gaithersburg, MD 20877-2504 and the
Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug
Administration, 200 C St. SW.,
Washington, DC 20204, or available for
inspection at the Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
1,3-Butanediol.........................
Calcium tin stearate................... 2 percent.
Calcium zinc stearate.................. Do.
Carbon, activated...................... 1 percent.
Castor oil, hydrogenated............... 2 percent.
Chlorinated isobutylene-isoprene
copolymers complying with Sec.
177.1420.
Coco amide (coconut oil fatty acids 2 percent.
amides).
Cork (cleaned, granulated).............
Diebenzamide phenyl disulfide.......... 1 percent; for use only in
vulcanized natural or
synthetic rubber gasket
compositions.
Di(C7, C9-alkyl) adipate............... Complying with Sec. 178.3740
of this chapter; except that,
there is no limitation on
polymer thickness.
Di-2-ethylhexyl adipate................
Di-2-ethylhexyl sebacate............... 2 percent.
Di-2-ethylhexyl terephthalate (CAS Reg. For use as a plasticizer at
No. 006422-86-2).. levels not exceeding 75 parts
per hundred by weight of
permitted vinyl chloride homo-
and/or copolymer resins used
in contact with food of Types
I, II, IV-B, VI-A, VI-B, VI-C
(up to 15 percent alcohol by
volume), VII-B, and VIII
described in Sec. 176.170(c)
of this chapter, table 1, and
under conditions of use A
through H described in Sec.
176. 170 (c) of this chapter,
table 2.
Dihexyl ester of sodium sulfosuccinate. 1 percent.
Diisodecyl phthalate................... No limitation on amount used
but for use only in closure-
sealing gasket compositions
used in contact with non-fatty
foods containing no more than
8 percent of alcohol.
Di--naphthyl-p- 1 percent.
phenylenediamine.
Dipentamethylenethiurametetrasulfide... 0.4 percent; for use only in
vulcanized natural or
synthetic rubber gasket
compositions.
Eicosane (technical grade) (water-white
mixture of predominantly straight-
chain paraffin hydrocarbons averaging
20 carbon atoms per molecule).
Epoxidized linseed oil.................
Epoxidized linseed oil modified with
trimellitic anhydride.
Epoxidized safflower oil...............
Epoxidized safflower oil modified with
trimellitic anhydride.
Epoxidized soybean oil modified with
trimellitic anhydride.
Erucylamide............................ 5 percent.
Ethylene-propylene copolymer...........
Ethylene-propylene modified copolymer
elastomers produced when ethylene and
propylene are copolymerized with 5-
methylene-2-norbornene and/or 5-
ethylidine-2-norbornene. The finished
copolymer elastomers so produced shall
contain not more than 5 weight-percent
of total polymer units derived from 5-
methylene-2-norbornene and/or 5-
ethylidine-2-norbornene, and shall
have a minimum viscosity average
molecular weight of 120,000 as
determined by the method described in
Sec. 177.1520(d)(5), and a minimum
Mooney viscosity of 35 as determined
by the method described in Sec.
177.1520(d)(6).
[[Page 239]]
Ethylene-vinyl acetate copolymer.......
Glyceryl mono-12-hydroxystearate 2 percent.
(hydrogenated glyceryl ricinoleate).
Gutta-percha...........................
Hexamethylenetetramine................. 1 percent.
Hexylene glycol........................ 0.5 percent.
Isobutylene-isoprene copolymers
complying with Sec. 177.1420.
Maleic anhydride-polyethylene copolymer 5 percent.
Maleic anhydride-styrene copolymer..... Do.
2,2'-Methylenebis[6-(1- 1 percent.
methylcylcohexyl)-p-cresol].
Mixed octylated diphenylamine (CAS Reg. 0.1 percent in isobutylene-
No. 68411-46-1). isoprene and chlorinated
isobutylene-isoprene
copolymers complying with Sec.
177.1420, and brominated
isobutylene-isoprene
copolymers complying with this
section.
Napthalene sulfonic acid-formaldehyde 0.2 percent.
condensate, sodium salt.
Natural rubber (crepe, latex,
mechanical dispersions).
-cis-9-Octadecenyl-omega- 0.5 percent.
hydroxypoly (oxyethylene); the
octadecenyl group is derived from
oleyl alcohol and the poly
(oxyethylene) content averages 20
moles.
Oleyl alcohol.......................... 1 percent.
4,4'-Oxybis (benzene sulfonyl 0.5 percent.
hydrazide).
Paraformaldehyde....................... 1 percent.
Polybutadiene..........................
Poly-p-dinitroso benzene (activator for 1 percent; for use only in
butyl rubber). vulcanized natural or
synthetic rubber gasket
compositions.
Polyethylene glycol 400 esters of fatty 1 percent.
acids derived from animal and
vegetable fats and oils.
Polyisobutylene complying with Sec.
177.1420.
Polyoxypropylene-polyoxyethylene 0.05 percent.
condensate, average mol. wt. 2750-3000.
Polyurethane resins manufactured from For use only:
diphenylmethane diisocyanate, 1,4- No limitation on amount used,
butanediol, and adipic acid (CAS Reg. but for use only in closure
No. 26375-23-5).. gasket compositions used in
contact with food types VI-A
and VI-C (up to 15 percent
alcohol) under conditions of
use D, E, F, and G, as
described in Sec. 176.170(c)
of this chapter, tables 1 and
2, respectively.
Potassium benzoate..................... 1 percent.
Potassium perchlorate.................. Do.
Potassium propionate................... 2 percent.
Potassium and sodium persulfate........ 1 percent.
Resorcinol............................. 0.24 percent; for use only as a
reactive adjuvant substance
employed in the production of
gelatin-bonded cord
compositions for use in lining
crown closures. The gelatin so
used shall be technical grade
or better.
Rosins and rosin derivatives as defined
in Sec. 175.300(b)(3)(v) of this
chapter for use only in resinous and
polymeric coatings on metal
substrates; for all other uses as
defined in Sec. 178.3870 of this
chapter.
Sodium cetyl sulfate................... 1 percent.
Sodium decylbenzenesulfonate........... Do.
Sodium decyl sulfate................... Do.
Sodium formaldehyde sulfoxylate........ 0.05 percent.
Sodium lauryl sulfate.................. 1 percent.
Sodium lignin sulfonate................ 0.2 percent.
Sodium myristyl sulfate (sodium 0.6 percent.
tetradecyl sulfate).
Sodium nitrite......................... 0.2 percent; for use only in
annular ring gaskets applied
in aqueous dispersions to
closures for containers having
a capacity of not less than 5
gallons.
Sodium o-phenylphenate................. 0.05 percent.
Sodium polyacrylate.................... 5 percent.
Sodium and potassium pentachlorophenate 0.05 percent.
Sodium salt of trisopropyl 0.2 percent.
napthalenesulfonic acid.
Sodium tridecylsulfate................. 0.6 percent.
Stearic acid amide..................... 5 percent.
Sulfur................................. For use only as a vulcanizing
agent in vulcanized natural or
synthetic rubber gasket
compositions at a level not to
exceed 4 percent by weight of
the elastomer content of the
rubber gasket composition.
Tallow, sulfated....................... 1 percent.
Tin-zinc stearate...................... 2 percent.
[[Page 240]]
Tri(mixed mono- and dinonylphenyl) 1 percent.
phosphite.
Vinyl chloride-vinyl stearate copolymer
Zinc dibutyldithiocarbamate............ 0.8 percent; for use only in
vulcanized natural or
synthetic rubber gasket
compositions.
------------------------------------------------------------------------
Table 2--Maximum Extractives Tolerances
[In parts per million]
------------------------------------------------------------------------
Chloroform Chloroform Chloroform
Type of closure-sealing gasket fraction of fraction of fraction of
composition water heptane alcohol
extractives extractives extractives
------------------------------------------------------------------------
1. Plasticized polymers, 50 500 50
including unvulcanized or
vulcanized or otherwise cured
natural and synthetic rubber
formed in place as overall discs
or annular rings from a hot
melt, solution, plastisol,
organisol, mechanical
dispersion, or latex............
2. Preformed overall discs or 50 250 50
annular rings of plasticized
polymers, including unvulcanized
natural or synthetic rubber.....
3. Preformed overall discs or 50 50 50
annular rings of vulcanized
plasticized polymers, including
natural or synthetic rubber.....
4. Preformed overall discs or 50 250 50
annular rings of polymeric or
resinous-coated paper,
paperboard, plastic, or metal
foil substrates.................
5. Closures with sealing gaskets (\1\) (\1\) (\1\)
or sealing compositions as
described in 1, 2, 3, and 4, and
including paper, paperboard, and
glassine used for dry foods only
------------------------------------------------------------------------
\1\ Extractability tests not applicable.
(c) The closure assembly to include the sealing gasket or sealing
compound, together with any polymeric or resinous coating, film, foil,
natural cork, or glass that forms a part of the food-contact surface of
the assembly, when extracted on a suitable glass container with a
solvent or solvents characterizing the type of foods, and under
conditions of time and temperature characterizing the conditions of its
use as determined from tables 3 and 4 shall yield net chloroform-soluble
extractives (corrected for zinc as zinc oleate) not to exceed the
tolerances specified in table 2, calculated on the basis of the water
capacity of the container on which the closure is to be used. Employ the
analytical method described in Sec. 175.300 of this chapter, adapting
the procedural details to make the method applicable to closures; such
as, for example, placing the closed glass container on its side to
assure contact of the closure's food-contacting surface with the
solvent.
Table 3--Types of Food
I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar
or both, and including oil-in-water emulsions of low- or high-fat
content.
II. Acidic (pH 5.0 or below), aqueous products; may contain salt or
sugar or both, and including oil-in-water emulsions of low- or high-fat
content.
III. Aqueous, acid or nonacid products containing free oil or fat; may
contain salt, and including water-in-oil emulsions of low- or high-fat
content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oils.
VI. Beverages:
A. Containing alcohol.
B. Nonalcoholic.
VII. Bakery products.
VIII. Dry solids (no end-test required).
Table 4--Test Procedures With Time-Temperature Conditions for Determining Amount of Extractives From Closure-
Sealing Gaskets, Using Solvents Simulating Types of Foods and Beverages
----------------------------------------------------------------------------------------------------------------
Extractant
Types of food (see -----------------------------------------------------------
Conditions of use table 3) 8 percent alcohol
Water \2\ Heptane \1\\2\ \2\
----------------------------------------------------------------------------------------------------------------
A. High temperature heat- I, IV-B........... 250 deg.F, 2 hr.. ..................
sterilized (e.g., over 212 III, IV-A, VII.... ......do.......... 150 deg.F, 2 hr..
deg.F).
B. Boiling water-sterilized..... II................ 212 deg.F, 30 min ..................
III, VII.......... ......do.......... 120 deg.F, 30 min
[[Page 241]]
C. Hot filled or pasteurized II, IV-B.......... Fill boiling, cool ..................
above 150 deg.F. III, IV-A......... to 100 deg.F. 120 deg.F, 15 min
V................. ......do.......... ......do..........
D. Hot filled or pasteurized II, IV-B, VI-B.... 150 deg.F, 2 hr.. .................. ..................
below 150 deg.F. III, IV-A......... ......do.......... 100 deg.F, 30 min 150 deg.F, 2 hr
V................. .......do.........
VI-A..............
E. Temperature filled and stored II, IV-B, VI-B.... 120 deg.F, 24 hr. .................. ..................
(no thermal treatment in the III, IV-A......... ......do.......... 70 deg.F, 30 min. 120 deg.F, 24 hr.
container). V................. ......do..........
VI-A..............
F. Refrigerated storage (no I, II, III, IV-A, 70 deg.F, 48 hr.. 70 deg.F, 30 min. ..................
thermal treatment). IV-B, VI-B, VII. 70 deg.F, 48 hr.
VI-A..............
G. Frozen storage (no thermal I, II, III, IV-B, 70 deg.F, 24 hr.. ..................
treatment in the container). VII.
----------------------------------------------------------------------------------------------------------------
\1\ Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.
\2\ Time and temperature.
[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at
47 FR 22090, May 21, 1982; 49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug.
23, 1990; 61 FR 14480, Apr. 2, 1996; 65 FR 26745, May 9, 2000; 65 FR
52908, Aug. 31, 2000]