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177.1210 Closures with sealing gaskets for food containers.

Home > Regulations > Indirect food additives: Polymers > 177.1210 Closures with sealing gaskets for food containers.



[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: 21CFR177.1210]

[Page 250-254]
 
                        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

[[Page 251]]

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.
                                         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 AOAC 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, 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..
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-[beta]-naphthyl-p-phenylenediamine..  1 percent.
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.

[[Page 252]]


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).
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).
[alpha]-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).

[[Page 253]]


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.
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).



[[Page 254]]


  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   -----------------------------------------------------------
        Conditions of use            (see 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
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; 70 FR 67651, Nov. 8, 2005]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1210


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