Docstoc

Food and Drug Administration HHS

Document Sample
Food and Drug Administration HHS Powered By Docstoc
					                                                                    Food and Drug Administration, HHS                                                                     § 175.365

                                                                      (d) Optional substances as provided                           acrylate, methacrylic acid, methyl ac-
                                                                    in paragraph (a) of this section include:                       rylate, methyl methacrylate (CAS Reg.
                                                                      (1) Substances generally recognized                           No. 80–62–6; maximum use level 6
                                                                    as safe in food.                                                weight percent) and 2-sulfoethyl meth-
                                                                      (2) Substances subject to prior sanc-                         acrylate (CAS Reg. No. 10595–80–9; max-
                                                                    tion or approval for uses with a copoly-                        imum use level 1 weight percent). The
                                                                    mer of vinyl acetate and crotonic acid                          finished copolymers contain at least 50
                                                                    and used in accordance with such sanc-                          weight percent of polymer units de-
                                                                    tion or approval.                                               rived from vinylidene chloride. The fin-
                                                                      (3) Substances identified in this sub-                        ished coating produced from vinylidene
                                                                    paragraph and subject to such limita-                           chloride copolymers produced by co-
                                                                    tions as are provided:                                          polymerizing vinylidene chloride with
                                                                            List of substances                 Limitations
                                                                                                                                    methyl       methacrylate     and/or    2-
                                                                                                                                    sulfoethyl methacrylate, or with meth-
                                                                     Silica.                                                        yl methacrylate and/or 2-sulfoethyl
                                                                     Japan wax.
                                                                                                                                    methacrylate together with one or
                                                                                                                                    more of the other monomers from this
                                                                       (e) Copolymer of vinyl acetate and
                                                                                                                                    section, is restricted to use at or below
                                                                    crotonic acid used as a coating or as a
                                                                                                                                    room temperature.
                                                                    component of a coating conforming
                                                                                                                                       (c) Optional adjuvant substances em-
                                                                    with the specifications of paragraph
                                                                                                                                    ployed in the production of the coat-
                                                                    (e)(1) of this section are used as pro-
                                                                                                                                    ings or added thereto to impart desired
                                                                    vided in paragraph (e)(2) of this sec-
                                                                                                                                    properties      may     include    sodium
                                                                    tion.
                                                                       (1) Specifications. (i) The chloroform-                      dodecylbenzenesulfonate.
                                                                                                                                       (d) The coating in the finished form
                                                                    soluble portion of the water extractives
                                                                    of the coated film obtained with dis-                           in which it is to contact food, when ex-
                                                                    tilled water at 120 °F for 24 hours does                        tracted with the solvent or solvents
                                                                    not exceed 0.5 milligram per square                             characterizing the type of food, and
                                                                    inch of coated surface.                                         under conditions of time and tempera-
                                                                       (ii) The chloroform-soluble portion of                       ture characterizing the conditions of
                                                                    the n-heptane extractives of the coated                         its intended use as determined from ta-
                                                                    film obtained with n-heptane at 70 °F                           bles 1 and 2 of § 176.170(c) of this chap-
                                                                    for 30 minutes does not exceed 0.5 milli-                       ter, shall yield net chloroform-soluble
                                                                    gram per square inch of coated surface.                         extractives not to exceed 0.5 milligram
                                                                       (2) Conditions of use. The copolymer                         per square inch of coated surface when
                                                                    of vinyl acetate and crotonic acid is                           tested by the methods described in
                                                                    used as a coating or as a component of                          § 176.170(d) of this chapter.
                                                                    a coating for polyolefin films for pack-                           (e) Acrylonitrile copolymers identi-
                                                                    aging bakery products and confec-                               fied in this section shall comply with
                                                                    tionery.                                                        the provisions of § 180.22 of this chap-
                                                                                                                                    ter.
                                                                    § 175.360 Vinylidene chloride copoly-                           [42 FR 14534, Mar. 15, 1977, as amended at 43
                                                                         mer coatings for nylon film.                               FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21,
                                                                       Vinylidene chloride copolymer coat-                          1980; 47 FR 54430, Dec. 3, 1982]
                                                                    ings identified in this section and ap-
                                                                    plied on nylon film may be safely used                          § 175.365 Vinylidene chloride copoly-
                                                                    as food-contact surfaces, in accordance                              mer coatings for polycarbonate
                                                                    with the following prescribed condi-                                 film.
                                                                    tions:                                                             Vinylidene chloride copolymer coat-
                                                                       (a) The coating is applied as a contin-                      ings identified in this section and ap-
                                                                    uous film over one or both sides of a                           plied on polycarbonate film may be
                                                                    base film produced from nylon resins                            safely used as food-contact surfaces, in
                                                                    complying with § 177.1500 of this chap-                         accordance with the following pre-
                                                                    ter.                                                            scribed conditions:
                                                                       (b) The coatings are prepared from                              (a) The coating is applied as a contin-
                                                                    vinylidene chloride copolymers pro-                             uous film over one or both sides of a
                                                                    duced by copolymerizing vinylidene                              base film produced from polycarbonate
cprice-sewell on PRODPC61 with CFR




                                                                    chloride with one or more of the mono-                          resins complying with § 177.1580 of this
                                                                    mers acrylic acid, acrylonitrile, ethyl                         chapter.

                                                                                                                              197



                                     VerDate Nov<24>2008   14:38 May 05, 2009     Jkt 217067     PO 00000   Frm 00207    Fmt 8010   Sfmt 8010   Y:\SGML\217067.XXX   217067
                                                                    § 175.380                                                               21 CFR Ch. I (4–1–09 Edition)

                                                                      (b) The coatings are prepared from                       substances identified in § 175.300(b)(3),
                                                                    vinylidene chloride copolymers pro-                        with the exception of paragraph (b)(3)
                                                                    duced by copolymerizing vinylidene                         (xxxi) and (xxxii) of that section.
                                                                    chloride with acrylonitrile, methyl ac-                       (b) The resins identified in paragraph
                                                                    rylate, and acrylic acid. The finished                     (a) of this section may be used as a
                                                                    copolymers contain at least 50 weight-                     food-contact coating for articles in-
                                                                    percent of polymer units derived from                      tended for contact at temperatures not
                                                                    vinyldene chloride.                                        to exceed 160 °F with food of Types I,
                                                                      (c) Optional adjuvant substances em-                     II, VI-A and B, and VIII described in
                                                                    ployed in the production of the coat-                      table 1 of § 176.170(c) of this chapter
                                                                    ings or added thereto to impart desired                    provided that the coating in the fin-
                                                                    properties    may       include      sodium                ished form in which it is to contact
                                                                    dodecylbenzenesulfonate in addition to                     food meets the following extractives
                                                                    substances described in § 174.5(d) of this                 limitations when tested by the meth-
                                                                    chapter.                                                   ods provided in § 175.300(e):
                                                                      (d) The coating in the finished form                        (1) The coating when extracted with
                                                                    in which it is to contact food, when ex-                   distilled water at 180 °F for 24 hours
                                                                    tracted with the solvent or solvents                       yields total extractives not to exceed
                                                                    characterizing the type of food, and                       0.05 milligram per square inch of food-
                                                                    under the conditions of time and tem-                      contact surface.
                                                                    perature characterizing the conditions                        (2) The coating when extracted with 8
                                                                    of its intended use as determined from                     percent (by volume) ethyl alcohol in
                                                                    tables 1 and 2 of § 176.170(c) of this chap-               distilled water at 160 °F for 4 hours
                                                                    ter, shall yield net chloroform-soluble                    yields total extractives not to exceed
                                                                    extractives in each extracting solvent                     0.05 milligram per square inch of food-
                                                                    not to exceed 0.5 milligram per square                     contact surface.
                                                                    inch of coated surface as determined by
                                                                                                                                  (c) The resins identified in paragraph
                                                                    the methods described in § 176.170(d) of
                                                                                                                               (a) of this section may be used as a
                                                                    this chapter. In testing the finished
                                                                                                                               food-contact coating for articles in-
                                                                    food-contact articles, a separate test
                                                                                                                               tended for contact at temperatures not
                                                                    sample is to be used for each required
                                                                                                                               to exceed room temperature with food
                                                                    extracting solvent.
                                                                                                                               of Type VI-C described in table 1 of
                                                                      (e) Acrylonitrile copolymers identi-
                                                                                                                               § 176.170(c) of this chapter provided the
                                                                    fied in this section shall comply with
                                                                                                                               coating in the finished form in which it
                                                                    the provisons of § 180.22 of this chapter.
                                                                                                                               is to contact food meets the following
                                                                    § 175.380 Xylene-formaldehyde resins                       extractives limitations when tested by
                                                                        condensed         with        4,4′-                    the methods provided in § 175.300(e):
                                                                        isopropylidenediphenol-                                   (1) The coating when extracted with
                                                                        epichlorohydrin epoxy resins.                          distilled water at 180 °F for 24 hours
                                                                      The resins identified in paragraph (a)                   yields total extractives not to exceed
                                                                    of this section may be safely used as a                    0.05 milligram per square inch of food-
                                                                    food-contact coating for articles in-                      contact surface.
                                                                    tended for use in contact with food, in                       (2) The coating when extracted with
                                                                    accordance with the following pre-                         50 percent (by volume) ethyl alcohol in
                                                                    scribed conditions.                                        distilled water at 180 °F for 24 hours
                                                                      (a) The resins are produced by the                       yields total extractives not to exceed
                                                                    condensation of xylene-formaldehyde                        0.05 milligram per square inch.
                                                                    resin and 4,4′-isopropylidenediphenol-
                                                                    epichlorohydrin epoxy resins, to which                     § 175.390 Zinc-silicon       dioxide      matrix
                                                                    may have been added certain optional                           coatings.
                                                                    adjuvant substances required in the                          Zinc-silicon dioxide matrix coatings
                                                                    production of the resins or added to im-                   may be safely used as the food-contact
                                                                    part desired physical and technical                        surface of articles intended for use in
                                                                    properties. The optional adjuvant sub-                     producing, manufacturing, packing,
                                                                    stances may include resins produced by                     processing, preparing, treating, pack-
                                                                    the condensation of allyl ether of                         aging, transporting, or holding food,
cprice-sewell on PRODPC61 with CFR




                                                                    mono-, di-, or trimethylol phenol and                      subject to the provisions of this sec-
                                                                    capryl alcohol and also may include                        tion;

                                                                                                                         198



                                     VerDate Nov<24>2008   14:38 May 05, 2009   Jkt 217067   PO 00000   Frm 00208   Fmt 8010   Sfmt 8010   Y:\SGML\217067.XXX   217067

				
DOCUMENT INFO