Document X8rYN6mXVwmvBYNOkdo7bKV0d

June 27, 1990 /f/V 7 / // Os Bud Pazur ALTC RE: GEON 87349 WHITE 138 ISSUE 8 There are some ingredients in this compound which are either not acceptable, or for which I have no information as to their FDA status. The colorants B-287 Golden TY-70 and B-296 Brown 7739 (used in 87333-000-3052) are not acceptable for food contact. Enclosed is a list of colorants that could be used. There may be others, also. I have no information on the FDA status of Cenwax A (12Hydroxystearic acid), although hydrogenated fatty acids from vegetable and animal sources are permitted for some uses. Likewise, I'm not sure if AC-316A polyethylene meets the specifications for oxidized PE as listed in 177.1620. Loxiol G-70S (Pentaerythritol adipate-stearate) is limited to use conditions E, F & G in contact with foods except those containing more than 8% alcohol. Also, the total amount of ester (calculated as the free pentaerythritol) may not exceed 0.4% by weight of PVC. In addition, Mark 1984 is limited to use conditions D, E, F and G in contact with all foods except liquid milk. The temperature use conditions limitations and food use conditions described above would not exclude the compound from use as a refrigerator liner. Since Geon 87349, White 138 is not acceptable for food contact use under FDA regulations, it would not be acceptable to the USDA. If you have any questions, or I can be of further help, please call me at Ext. 3422. W. C. Bachtel 0627-1/jp cc: P. Tully - CL-OTM-3 20860001 BFG07536 w r-T copoi^ styrene to 3 I I (cyclopenta- iroduced by on of dienes licyclic, and es from dis ocks). iroduced by and subse ne. vinyltolistillates of ds. th rubber lentified in ^ and Drug Administration, HHS (vi) Coion (.total not to exceed 10 percent by weight of rubber product). CtiTonw oxide (Cr0>). C.I. pigment red 38, C.I. No. 21120. Iron oxide. -- phth&locysnine. v Phthalocyanine blue (C.I. pigment blue 15, C.I. No. 741 SO). Titanium dioxide. Ultramarine blue. Zinc chromate. (vii) Lubricants (total not to exceed 2 percent by weight of rubber product). polyethylene. Sodium stearate. (vlii) Emulsifiers. Fatty acid salts, sodium or potassium. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. Rosins and rosin-derivatives identified in } 175.105(c)(5) of this chapter. Sodium decylbenzenesullonate Sodium dodecylbenzenesulfonate Sodium lauryl sulfate. Tall oil mixed soap (calcium, potassium, and sodium). (lx) Miscellaneous (total not to exceed S percent by weight of rubber product). aer maker's dicyclo- iolite. or furnace 1 black not of rubber black con> weight of tse in con- Animal glue as described in ! 178.3120 of this chapter. Azodicarbonamide as chemical blowing agent. 2-Anthraquinone sulfonic acid sodium salt for use only as polymerization inhibitor in chloroprene polymers and not to exceed 0.03 percent by weight of the chloroprene polymers. n-Butyllithium for use only as polymeriza tion catalyst for polybutadiene. 4-tert-Butyl-o-thlocresol as peptizing agent. tert-Butyl peraeetate. p-tert-ButylpyrocatechoL Dialkyl (C*-Cu) dimethylammonium chlo ride for use only as a flocculating agent in the manufacture of silica. Di- and triethanolamine. Diethyl xanthogen disulfide. 4-(Dliodomethylsulfonyl) toluene. Chemical Abstracts Service Registry No. 20018-0901. for use as an antifungal preservative at levels not to exceed 0.3 percent by weight of the sealants and caulking materials. Dodecyl mercaptan isomers, single or mixed. 2-Ethoxyethanol. Iodoform. p-Menthane hydroperoxide. a-(p-NonylphenylXowpa-hydroxypoly (ox- yethylene) mixture of dihydrogen phos phate and monohydrogen phosphate esters, barium salt; the nonyl group is a propylene trimer isomer and the poly (ox- yethylene) content avenges 9 moles; for use only as residual polymerisation emul sifier at levels not to exceed 0.7 psneac by weight of ethyleno-propyleas 1.4-hexadiene copolymers Identified under para graph (cX4Xi) of this section. 4,4-Oxybto (benzenesulfonhydrazide) ss chemical blowing agent. Phenothiazine. Potassium persulfate. Sodium formaldehyde sulfoxylate. Sodium polysulfide. Sodium nitrite. Sodium salt of ethyienediamine tetraacetic acid and glycine. Sodium sulfide. Styrene monomer. Tall oil. Thioxylenois as peptizing agents. Tridecyl mercaptan. Zinc 4-tert-butylthlophenate as peptizing agent. (d) Rubber articles intended for use with dry food are so formulated and cured under conditions of good manu facturing practice as to be suitable for repeated use. (e) Rubber articles intended for re peated use in contact with aqueous food shall meet the following specifi cations: The food-contact surface of the rubber article in the. finished form in which it is to contact food, when ex tracted with distilled water at reflux temperature, shall yield total extrac tives not to exceed 20 milligrams per square inch during the first 7 hours at extraction, nor to exceed 1 milligram per square inch during the succeeding 2 hours of extraction. (f) Rubber articles intended for re peated use in contact with fatty foods shall meet the following specifications: The food-contact surface of the rubber article in the finished form in which it is to contact food, when extracted with n-hexane at reflux temperature, shall yield total extractives not to exceed 175 milligrams per square inch during the first 7 hours of extraction, nor to exceed 4 milligrams per square inch during the succeeding 2 hours of extraction. (g) In accordance with good manu facturing practice finished rubber arti cles intended for repeated use in con tact with food shall be thoroughly cleansed prior to their first use in con tact with food. 301 20860002 BFG07537 -ylate ,, isahc*. <#,*. /I acrylate^ JjoffSwtb nom (M ) ie) of 1-41SOjr for nylon 1500 of thU epoxy resins and (viii) ot i level not to ing. iethacrylateuse only as -,ted in para>n. owing esters and methyl :>ne or more vcrylic acidcopolymers ight percent from meth- } more than >lymer units lethacrylate; ontact with Table i of 2-(Dimethytry No. 108oDtional ad- lore than ler solids lymerizayrene or ylic acid, acrylate, yi acrylate, styrene, inom 0 to 80 \ The other >e from 0 to iymer. The molecular i.OOO (as delroznatogratie polymer nomer con;rcent. The ontact with i table 1 of under use elofpsnType-^m :tion./f~ ti (gxl) customer* the bode poly mer: ' ;l gutadiene-acrylonitrile copolymer. Butadiene-acrylonitrile-styrene copolymer. Butadiene-styrene copolymer. Butyl rubber. Chlorinated rubber. 2-Chloro-l,3-butadiene (neoprene). Natural rubber (natural latex or natural latex solid* smoked or unsmoked), polyisobutylene. Rubber hydrochloride. Styrene-isobutylene copolymer. (xxii) Driers made by reaction of a metal from paragraph (b)(3)(xxii)(a) of this section with acid, to form the salt listed in paragraph (bX3)<xxiiXd of this section: (a) Metals: Aluminum. Calcium. Cerium. Cobalt. Iron. lithium. Magnesium. Manganese. Zinc. Zirconium. (ft) Saits: Caprate. Caprylate. Isodecanoate. Linoleate. Naphthenate. Neodecanoate. Octoate (2-ethylhexoate). Oleate. Palmitate. Resinate. Ricinoleate. Soyate. Stearate. Tallate. ' ' (xxiii) Waxes: Paraffin Type L Paraffin. Type IX. Polysthylene. Sperm oiL t Spermaceti. (xxiv) Plasticisers: Acetyl tributyl citrate. Acetyl triethyl citrate. Butyl phthalyl butyl #yee*ata, Butyl stearate. p-tert-Butyl phenyl aaheylste. Dibutylsebacate. " Diethyl phthalate. Diisobutyl adipate.' Diisooctyl phthalate. hama 14; Imam), as the Ethyl phthalyl ethyl 2-Ethylhexyl diphenyl dl-2-Ethylhexyl phttiaVatmftfe Glycerol. Olyceryl monooleate. Glyceryl triacetate. MonolsopropyT citrate. Propylene glycoL Sorbitol. Mono-, dl-, and tristearyl citrate. Triethyl citrate. Triethylene glycol. 3-(2-Xenolyl)-l,2-epoxypn>pane. -" (xxv) Release agent* as the bssier polymer, when applicable: N, N'-Dioleoylethylenediamine (CAS Ret. No. 110-31-8) for use only In kmomerlc resins complying with 1117.1330 of this chapter and in ethylene vinyl acetate co-' polymers complying with f 177.1380' of: this chapter at a level not to exceed 0.0088 milligram per square centimeter tOltt: milligram per square inch) in tha hniaUtpE food-contact article. , //.AT-Distearoyl ethylenediamine. . Llnoleic add amide. .^' Oleic add amide. Palmitic add amide. ^ Petrolatum. Polyethylene wax. ^ Polyoxyethylene glycol monooleaMroacL wt. of the polyoxyethylene greater than 300). Polytetnfluoroethyiene. '-ikn. i.- . SiUconea (pot less than 300 oentlsticfli vl4P coaity): Dlmethylpolyafloxaner' aadi/28* methjdphenylpeftafloyanea. Tbet-mdhBk phenylrdyslloxanse contain *n0t.-j*g aA * ` "-- aops tyying up fftjndC units. Siheoaer (not Uwa than cosily): methylphenylpolysilo: only on metal DhenyloolyaOoxanes than 2.0 percent by weight of anea havins up unit* ' ~r>r - >uto *n,ixtL& (xxvt) Figments ntfeoteahto wsmi Aluminum. - -jrJ'tt'flkn Pqrtiaw hfstfcoqeitr r.oUufoS sttOi *068 -:;3raoa r.sotwmA sd3: rcr^osiih*! Mk mi 30-068 0--89-----# BFG07 538 -*1 CPt Ot I (4.149MHM) U.St'-'O- m>rninrnii aarttau Iron mUrtm , Magnaafiim aOfcate (talc). *>. T~htlii\mysntnr blue. (CL pigment blue IS, CL So. 74180). soiea. 5-u" Tartrasine lake (certified FDdsC Tallow No. Sanlftt. r Tltanittucfloxlde. ^ Titanium dioxide-fry*1"" stilfate. Zinc carbonate Zincex^ (xxvtttBurfaoe lubricants: ddttoi&difotl and other edible oils. DOMdVMBaccte. Oioctn sebaeate. (^yosgytmcmostearate. lanolin mneMl oil. white. PahnolL Paraffin, Type I. Paraffin, Type n. Petrolatum. Stearic add. (xxvtti) Silicones and their curing catalysts* <aXSilicones as. the basic polymer 80oxane resins originating from methyl hydrogen polyslloxane. dimethyl polysiloxaoe, and mgthylphenyl polyslloxane. <b) Curing (cross-linking) catalysts for sQlcozies (the maximum amount of tin catalyst used shall be that required to effect optimum cure but shall not exceed 1 part of tin per 100 parts of siloxane mins solids): Dtbutyltin dQaurate. Stannous oleate. Tetributyl titanate. (srix) Surface active agents: Ethylene oxide adduct of 2,4,7,8-tetramethyhMaogrn-4.7-diol (CAS Reg. No. 0O14-8S-1). Poly(2-<dtethylamlno) ethyl methacrylate! phosphate <rnin<rmim intrinsic viscosity in wmter at M'C is not less than 9.0 decili ters per gfam as determined by A8TM method D1MS-79, "Standard Teat Method -for Dilute Solution Viscosity of Vinyl Chloride Polymers." which isincorporated the American Society tor TbsmflUSartaMItlfVUce St.. FhUadelphia,*Ll9lS8, or may be. examined at the Office of the Federal Register. 1100 L St. NW.. Wash ington. DC 20408), for use only as a sus pending agent in the manufacture of vinyl chloride copolymers and limited to uee at levels not to exceed 0.1 percent by weight of the copolymers. Sodium dioctyl sulfosuccinate. Sodium dodecylbensenesulfonate Sodium lauryl sulfate. 2,4.7,9-Tetramethyl-5-deeyn-4,7-dlol (CJLS. Reg. No. 128-86-3), for use only in can coatings which are subsequently dried and cured at temperatures of at least 193* C (380: F) for 4 minutes. (xxx) Antioxidants: Butylated hydroxyanisole. Butylated hydroxytoluene. Qum guaiac. Dilauryl thlodlpropionate. Nordihydroguaiaretic acid. Propyl gallate. Distearyl thlodlpropionate. Thiodiproplonic arid. 2,4,5-Trihydroxybutyrophenone. (xxxi) Can end cements (sealing compounds used for sealing can ends only): In addition to the substances listed in paragraph (b) of this section and those listed in $ 177.121(XbX5) of this chapter, the following may be used: Butadiene-styrene-divinylbenzene copoly mer (CAS Reg. No. 26471-45-4) for use only at levels not to exceed 23.8 percent by weight of the cement solids in can end cements. Butadiene-styrene-fumarlc acid copolymer. 4,4'-Butylidenebis (6-fert-butyl-m-cresol). Dlbenzamldo phenyl disulfide. Di-0-naphthyl phenylenedlamine. Dipentamethylene thluram tetrasulfide. Isobutylene-isoprene-dlvinylbenzene copoly mers for use only at levels not to exceed 15 percent by weight of the dry cement composition. Naphthalene sulfonic arid-formaldehyde condensate, sodium salt, for use only at levels not to exceed 0.6 percent by weight of the cement solids in can end cements for containers having a capacity of not less than 5 gallons. Sodium decylbenzene sulfonate. Sodium nitrite for use only at levels not to exceed 0.3 percent by weight of the cement solids in can end cements for con tainers having a capacity of not leas than 5 gallons. 8odlum pentachlorophenate for use as a preservative at 0.1 percent by weight in can-sealing compounds on containers having a capacity of 5 gallons or more. 8odtum phenylphenate. 152 methyl and bu -use onfy at to Mnt at the < diaminetetraac Tri (mixed mon< phite. Zinc dibutyidith (xxxii) Side tion to the si graph (b)(3) < this section, used. p-terf-Butyl pe epoxy resin. epsiZon-Caprols late) graft po Dicumyl perox zation cataiy 4-<Diiodometh No. 20018-OS at a level n weight in car Diiaodecyl pht riser in side intended for of the types this section, n. and VI. 4,4'-Bis( alpha, dimethylber No. 10081-6': Ethyl toluene W.^-Hexamet hydroxyhyd 23128-74-7. Polyamides cc Copolymer ejpiion-cs 25181-04Homopoly acid, CA. Homopoly Reg. No. Polyamides and amine Acids: Adipic. Azelaic. Sebacic. Vegetab merizi Amines: Diethyl Dlphen Ethylei Hexam Tetraei Trieth: Pcflypropy 69-4. Sodium p preaervi BFG07539 ilFGoodrich ,.o -Uj., l/: A XzY F/T-gwv <__ F/i X)__FaOr-'VSA /--,_ u VX? CaOrrv., Yl.34 ^ Yfa_. \?S?S ^ -CySr-^--dL J2 _*L^ ^Jr \ a >-^iX~ JA_ cr yc~ w-o-^a 2J~xJX ~ c Lg Skru_ .jF~ DA _c jlLzX*. -KL: Vrr <7 ^ .o La. ^2. ,/V-^ O y FjU ZF^/^ua___ ^____________________________ Q---f^--g-? x -____ho.iL Fb A. H ,-bY *Y J --^S?~ r-4^1.X--e-. * s-^r riJLc^. , g i3 J ~^y>^-a--^-^) c? -Sa*__ LlSf^A /g^ CC : ...CF^ i/s g^). Y BFG-I I 29- B 1/77 rc ~cr $ -tfv o o JJL PRINTED IN U.3.- BFG07540 R*O**U*TE***TO**: **C*H*U*C*K**F'*lJ*R*K*S********************************** ** ************************G*E*O*N**V*I*N*Y*L**T*E*C**H*N*IC*A**L**DO*C*U*M**E*NT* * CUSTOMER NO / DESC: TRAYCO F;l' 'SO GEON VINYL RECIPE 03/ 16/90 1 Os 30: O'? OSHA WARNING LABEL: A GEON 87349 WHITE 138 LGC: 12 DEPT: 5667 ISSUE: 0OS- COMMODITY NO.: 87349 000 1380 SBC NBR; 13C6 EFFECTIVE DATE: 03/15/90 DELETE FLAG: NO LAB REF: 40-12-65 CMFR: A.S.PA2UR/DB BASED ON: 87349 WHITE 138, ISSUE 7, 3/13/90 APPLICA TION: THERMOFORMED SANITARYWARE PARTS 100.00000 12.00000 1.50000 1.00000 3.00000 2.00000 4.50000 12.00000 3.50000 .01400 .00500 .00500 1.00000 1.00000 .40000 >//***" .20000 INGREDIENTS SEC LUC 961 000475 36X1 FG 110 942 710849 PARALOID BTA 733 210 941 O0KOO6 PARALOID K-120N 220 941 709120 PARALOID K-175 230 912 000300 MARK -I. 931 00P075 DIOCTYL PHTHAuATE 320 935 00P031 EPOXY SOYA 410 925 7103S6 ULTRAPFLEX H 510 924 008123 TI-PURE R-100 77 *Z- 610 961 000405 87333-000-2102 620 921 OOB287 GOLDEN TY-70 630 961 000534 87333-000-3052 640 943 710889 LOXIOL 6-70S 710 943 710339 GLYCOLU8E 825 BEADS 720 943 00L029 CENWAX A 730 943 710867 AC-316A POLYETHYLENE 740 1 PERCENT 7d.361 8.4-i 2 2.111 1.407 142.12400 TOTAL SPECIFIC GRAVITY: TYPE SAMPLE: MATCHED TO: ISSUED: MARKETING APPROVAL: USE PREVIOUS ISSUE GEON 87341 WHITE 138 TO ADD 71QQ67 //o ^ 3 y? L ' _ zt*- 5*5 'pfzhz's*TM - fH33~ (DOO /(Ol 37? - jtMtJTfa*v*>7?$9 -glfli r> 90009802 BFG07541