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BFGoodrich The BFGoodrich Company Geon Vinyl Division 6100 Oak Tree Boulevard Cleveland, Ohio 44131 216-447-6000 December 22, 1992 M 25/b Joel M. Mirsberger, Oscar Mayer Foods Corp. P.O. Box 7188 910 Mayer Ave. Madison, WI 53707 C.P.M. Dear Mr. Mirsberger: This letter is in response to your request for information on the FDA status of the recipe for Geon experimental compound X1501 790 0809. Based on our evaluation of the recipe, the FDA clearance for this compound is limited to sections 21 CFR 175.300 (Resinous and polymeric coatings), 21 CFR 176.170 (Components of paper and paperboard in contact with aqueous and fatty foods), 21 CFR 177.1200 (Cellophane), and 21 CFR 177.1210 (Closures and sealing gaskets for food containers). Furthermore, this experimental compound must meet the extraction requirements as described under 21 CFR 178.2650 (b)(1). Please call me at (216) 447-7831 if you have any questions. Sincerely, THE BFGOODRICH COMPANY Connie N. Dillon Regulatory and Data System Specialist CND/rm 1222-1 21678001 BFG15983 Cl . 0.'<2 C103F326 geon prod BFGOODRICH GEON VINYL. DIVISION RECIPE INQUIRY USERID: NSOWHDiA PTERHIi): py 120090 PRODUCT KIBE: X1.501 790 0809 XI.5017900809P -OCs 15 DEPT: 5169 ISSUE: 001 SBC: 1311 EFFECTIVE DATE: 920916 INTERMEDIATE RM NBR: TOTAL LBS RM: 160.800000 LBS PRODUCT: 160.800000 RECIPE TYPE; 2 SEQ RAW MATE DESCRIPTION QUANTITY LC 001 961-000498 110 X 450 FG 100.000000 002 931-710887 JAYFLEX 260 60.000000 003 912-711557 THERMOLITE 890 0.400000 004 919-710858 VANILLIN NF REG 0.050000 005 ?43-7UB5mQXI0L G-2l! ^ 0.200000 006 945<tT0353\0XI0L _HQS~7Tn>> 3 0.150000 frfykftSl PAGE PERCENT COMMENTS 62.1891 37.3134 0.2488 0.0311 0.1244 0.0933 1 OF -'nudyyj xmX i. / G NEXT RESPONSE;: DC900016 RECIPE INQUIRY OK SBYLT-1 Aa */f -1 1 to ??'?: 7//5S' 1>0 S 5 . YiH'-* 7 fO 35J NEXT KEY: PF5-PROP PF6-RMKS PF9-SAFE PF10-IWST '(lCr\ ^v-^tCrT- PV-l kj4t, -----------------...................................WZmrte irrf- D-'X>4 < -------- y / 75/2 6 S'0 l'rUyh&~y-M$l.7 os'o ~7> -U.iyU'- : T - At ,? > (3-~e-W a7'. .z ...... ... ..... ^Z7.(iaA "7// *> 7 - /r; r <*<* fltXA-y /?5", /as 17^-2-'O' r- - 2008Z-9TZ BFG15984 C103C-:>26 C103F:>2* (3EON PR 0D BFGUQDRICH C3EON VINYL BIVIS ION RECl !PE INQUIRY USERID: N50WBB1A PTERMID; PV120090 PRODUCTT NBR: X1501 790 0810 XI51'1790081 OP LOC: 15 DEPT 5169 ISSUE: 001 SBC: :1.311 EFFE CTIVE DATE: 920916 INTERMEDIATE RM NBR: TOTAL LBS Rti: 160,830000 LBS PR!0DUCT: 160.8310000 RECIPE TYPE: 2 PAGE SEQ RAW MATE DESCRIPTION QUANTITY LC PERCENT eoi'iriENTs 001 961--000498 110 X 450 FG 100.000000 62.1775 002 931--7i0887 JAY Ft.EX 260 60.000000 37.3065 13 ?*?> 003 912--711557 THERIfOLITE 890 0.400000 0.2487 004 919'-710858 VANILLIN I-1F REG 0.050000 0.0311 005 943--711857 LOXIQL 6-21 0.200000 0.1244 006 943--710353 LOXIOL HOB 7111 0.150000 0.0933 00? 943- -711619 LDXAMID "EBS-Fl 0.030000 0.0187 1 OF -* NEXT RESPONSE: DC90001A RECIPE INQUIRY OK SBfLT-1 Aa /Vd next key: PF5-PROP PF6-RMKS PF9-SAFE PFIO-INST i b. 23/018 -ytogt')', ba fi 178- 3 7<So) ' 7i~ ' f7i' /77,/5/dj ?77.X&C& 11/55 1 -........... r , ^ T-rT^-o; ~T/t> r- ;7* /V"T".%. c6.-- 7// f 5 ' ' r 7 /Q~33i : fdUrij. -r ^.J -r //<?/?: // /J' . '\ / ; ,f // 1 (U-J.7U Xl _,,2IZI m.trp7s^ff?7t.-6^ J- -7,J./3<&a*j 2iu 17/<^*,f'V<QV y/7f 7"s- / ^^ ~ atIJS fOS'Jpc 3 sce"5 ///?-s/>-r illl^lod) /?- /2/^Y ,/7-?. /3>5C7j 177.7470 BFG15985 N HO ooo o u> CFR Ch. I (4-1-90 Edition) percent by weight ot ethylene-pfOpyfone-5Krfymen conyrfykig with $ 177.1520 of this idiness of such polymers in the form in *n not exceed 0.005 ineh. 0.1 percent by weight of ofelin poiymera of this chapter, under conditions of use A table 2 of f 176.170(c) of this chapter. 0.1 percent by weight ot potystyrene end $ that comply with f 177.16A0 of this chapwd polystyrene and rubber-modified potystyper the conditions described in $ 176.170(c) .. under conditions of use E through G. }.S percent by weight of elastomers used m with 177.2600 of this chapter, percent by weight of nylon resins complying napter. Provided. That the finished polymer conditions of use E, F, and G desertoed in this chapter. ).3 percent by weight of polycarbonate resins j of this chapter. is 0.2 percent by weight of polystyrene and ne polymers complying with 177.1640 of this -*e finished polymer contacts food only under D. E. F, G, and H described in Table 2 oi ier. <3 0.25 percent by weight of olefin polymers 20(c) of this chapter, item i.l, 1.2. or 1.3. <d 0.2. percent by weight of olefin pofymens >0(c) of this chapter, item 2.1. 2J2. 2.3, 3.1, or hs complying with Item 2.1, 2.2, or 2.3 having 4 gram per cubic centimeter and a thickness tinv- - (0.002 inch), shall contact food only v \ and G described in Table 2 ot 3k 0.2 percent by weight of ethylene-vinyl-acetate with 177.1360 of this chapter, and that are irr with food only under conditions of use E, F, ''able 2 of (176.170(c) of this chapter. The JCh polymers in the tom in which tfwy contact sed 0.1 mifihrwter (0.004 inch). ed 0.2 percent by weight of olefin polymers 1520(C) ot this chapter. Hem 4. The Wished mess greater than Q.0S1 miffimeter (0.002 inch), 1 under conditions of use 6, F. and G described Kc) of this chapter. k> 0.5 percent by weight oi acrylic and modified gki and rigid, complying with 177.1010 of this ixceed 0.1 percent by weight of isobutytene rth 177.1420 ot this chapter, mg with 175.105 of this chapter. ed 0.5 percent by weight of pressure sensitive with (175.125 of this chapter, ceed 0.5 percent by weight of can end cement ig with 175.300(b)(3) (od) ot this chapter. ed 0.5 percent by weight of side seam cement ng with 175.300(b)(3) (joocS) of this Chapter, wed 0.5 percent by weight of petroleum aficydte complying with {175.32p{bH3> of this chapter, ceed 0.5 percent by weight of petroleum alicycfic or their hydrogenated products complying with >s chapter. wed 0.5 percent by weight of resins and polymers .160(b) of this chapter. txceed 0.5 percent by weight of rosins and rosin 3 with 1176.210(d)(3) ol this chapter, exceed 0.5 percent by weight oi closures with plying with 177.1210 of this chapter. > exceed 0.5 percent by weight of petroleum and rosins and iron derivatives complying with Food and Drug Administration, HHS Substances Limitations 178.2650 21. At levels not to exceed 0.5 percent by weight ot reinforced wax complying with 178.3650. 22. At levels not to exoeed 0.5 percent by weight of olefin copolymers Tris(2-methyM-hydroxy-5-4w7-butytphenynbutane (CAS Reg. No. 1843-03-4). complying with ] 177.1520(c) of this chapter, item 3.3. The finished polymers may be used in contact with food under conditions of use A through H described in Table 2 of } 176.170(c) Of this chapter. For use only; 1. At levels not to exceed 0.25 percent by weight of polymers used as provided in 176.180 of this chapter. 2. At levels hot to exceed 0.25 percent by weight of the following polymers when used in articles that contact food of Types.!, II, IV-B, W-B, VU-B, and VII* desertoed In Table 1 of # 176.170(c) of this chapter Ofofin polymers complying with 177.1620(c) of this chapter. Hems 1.1, 1.2. 1.3, 2.1, 2.2, 2.3, 3.1. 3.2. 3.3, or 4 or complying with other sections fn Parts 174, 175. (76, 177, 178 sod 179.45 of tills chapter; vinyl chloride polymers; and/or vinyl chloride copolymers comp^ing with f 177.1960 of this chapter. 3. At levels not to exceed 0.1 percent by weight of the following polymers when used in articles that contact food of Types III, IV-A, V, VWA. Vl-C. Vll-A. and IX described in Table t of 176.170(c) of this chapter Olefin polymers complying with 177.1520(c) of this chapter, Ham* 1.1, li, 1.3, 2.1, 2.2. 2.3, 3.1, 3.2, 3.3, or 4 or complying wWh other sections in Parts 174, 175, 176, 177. 178 and 179.45 ol this chapter, vinyl chloride polymers; and/or vinyl chloride copolymers complying with 177.1960 of this chapter. 4. As provided In 175.105 of this chapter. 5. At levels not to exceed 0.2 percent by weight ol polystyrene and/or moffified polystyrene polymers identified in 177.1640 ot this chapter. . At levels not to exceed 0.25 percent by weight of acrylonitrilebutadiene-styrene copolymers used in contact with nonalcoholic foods. 7. At levels not to exceed 1 percent by weight of closure-sealing gasket ?i drfxjtyidithiocartamale (CAS Reg. No. 136- compositions complying with 177.1210(b) ot this chapter. For use only: 1. At levels not to exceed 02 percent by weight of isobutyleneiaoprene Zinc palmrtate_.. copolymers complying with 177.1420 of this chapter Provided, That the finished copolymers contact food only of the types identified in ITe.lTCKc) Crf this chapter. Table 1, under Types V, VII. Vftl. and IX. 2. At levels not to exceed 0.02 percent by weight ol polypropylene polymers complying with 177.1520(c). item 1.1 of this chapter. Zinc salicylate_ For use onfy in rigid polyvinyl chloride and/or in rigid vinyl chloride Zinc stearate._ copolymers complying with 177.1980 of this chapter Provided, That total safieytates (calculated as the add) do not exceed 0.3 percent by weight of auch polymers. _________________ , , ____ i---------------------------------- ------------------ ------ ---------------. ----------------------------- 1 Copies are available from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pa. 19103. U2 FR 14609, Max. 15,1977) Editorial Note; For Federal Register citations affecting 178.2010, see the List of CFR Sections Affected in the Finding Aids section of this volume. 178,2550 4-Hydroxymethyl-2,6-<li-ter/butylphenoL 4-Hydroxymethyl-2,0-di-terf-butylphenol may be safely used as an anti oxidant (n articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) The additive has a solidification point of MQ'-141'C. <b) The concentration of the addi tive and any other permitted antioxi dants in the finished food-contact arti cle does not exceed a total of 0.5 milli gram per square inch of food-contact surface. 9178.2550 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 co polymers complying with the provi sions of 1177.1950 or 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 TibnSl- 327 21678004 BFG15986 178.2650 21 CFR Ch. I (4-1-90 Edition) coholic beverages), VII, VIII, and IX described in table 1 of 176.170(c) of this chapter, except for the organotin chemical identified in paragraph (a)(3) of this section, which may be used in contact with food of types I through IX at temperatures not exceeding 75 C (167 *F), and further that the or ganotin chemicals identified in para graphs (a) (5) and <6) of this section may be used in contact with food of types I through IX at temperatures not exceeding 66 C (150 *F), condi tions of use D through G described in table 2 of 5 176.170(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 bever ages and carbonated nonalcoholic bev erages), VII, VIII, and IX described in table 1 of 176.170(c) of this chapter at temperatures not exceeding 71 4C (160 *F), in accordance with the fol lowing 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(lso-octylmer-captoacetate) 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 al cohol. Di(n-octyl)tin dichloride has an organotin composition that is not less than 95 percent by weight of di(noctylltin dichloride and not more than 5 percent by weight of tri(n-octyl)tin chloride. Di(n-octyl)tm oxide has an organotin composition that is not less than 95 percent by weight of di(noctyDtin oxide and not more than 5 percent by weight of bisftrKnoctyl)tin] oxide, and/or mono n-octyl- tin oxide. (2) Di(n-octyl) tin maleate polymer is an octyltin chemical having the for mula [(C.H^ljSnC.I^OJ,, (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(noctyl)tin dichloride or di(n-octyl)tin oxide meeting the specifications pre scribed for di(n- octyl) tin dichloride or di(n-octyl) tin oxide in paragraph (a)(1) of this section. (3) Clo*i-Alkyl mercaptoacetates re action products with dichlorodioctyl- stannane and trichlorooctylstannane (CAS Reg. No. 83447-69-2) is an organ otin 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 dichlorlde and (n-octyl)tin trichloride which has an organotin composition that is not less than 95 percent by weight di(n- octylltin dichloride/(-octyl)tin tri chloride, and not more than 1.5 per cent by weight of tri(n-octyl)tin chlo ride. The alkyl radical in the mercap- toacetate is derived from a mixture of saturated n-alcohols which has a com position that is not less than 50 per cent 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 al cohol. (4) (n-Octyl)tin S,S'S" trisCisooctyl- mercaptoacetate) is an octyltin chemi cal having the formula n- C*HnSn(SCHaCOaCHi?)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- octyDtin trichloride. The isooctyl radi cal in the mercaptoacetate is derived from oxo process isooctyl alcohol. The (n-octyl)tin trichloride has an organo tin composition that Is not less than 95 percent by weight of (n-octyl)tin tri chloride and not more than 5 percent by weight of tri(noctyl)tin chloride. (5) Bis(beto-carbobutoxyethyl)tin bls(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' carbobutoxyethyDtin. dichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohols. The bis(5efa- carbobutoxyethyl)tin dichloride has an organotin composition that is not less than 95 percent by weight of bis(5cta-carbobutoxyethyl)tin dichlo- 328 21678005 pre ride aph rre- :tyilane gan- 8 to `and it ol in a wide i-has i not dlCnStriperchlorcapje of com("oer- d ->y pd/or yl al- ui octylhemt- H n' JReg. 1*14.8 Stand reight im (nl'radlerived It The rganoaan95 In triercent Ide. ifyljtln D(CAS stertin iercent. t't7,5> irgapto s(befair The icetate rimary is(6edole has .is not eht of hlo- Food and Drug Administration, HHS 178.2650 ride and not more than 5 percent by be included and simulated by 3-per weight of bi.s(bcda-carbobutoxyethyl- cent acetic acid at temperatures speci tin trichloride. The triestertin chloride fied for water in Table 2 of . intent of bis(6ela-carbobutoxyethyl- 8 176.170(c) of this chapter. The ex Inn) dichloride shall not exceed 0.02 / traction tests shall cover at least three equilibrium periodic determinations, ) Beda-carbobutoiyethyltin as follows: .ylmercaptoacetate) (CAS (I) The exposure time for the first Reg.\ No. 63438-80-2) is/an estertin determination shall be at least 72 chemical having 13.0 ty 14.0 percent hours for aqueous solvents, and at jbjjr weight of tin (Sn) and having 10.5 least 6 hours for heptane. ` 11.5(percent by weight of mercapto (ii) Subsequent determinations shall sulfur. It is made from bela-carbobu- be at a minimum of 24-hour intervals yethyitin trichlonde. The isooctyl for aqueous solvents, and 2-hour inter ical in the mercaptoacetate is de vals for heptane. These tests shall lved from oxo process primary octyl yield total octylln stabilizers not to Icohol. Tne beta-carbobutoxyethyltln exceed 0.5 parts per million as deter chloride has aiyorganotln composi- mined by analytical method entitled 'tion that is not less than 95 percent by "Atomic Absorption Spectrometric De i freight of Wdo-carbobutoxyethyltin termination of Sub-part-per-Million ,,jjHchloride and/not more than 5 per- Quantities of Tin in Extracts and Bio i/&nt total of yriestertin chloride and logical Materials with Graphite Fur 'Jdiestertin chloride. nace," Analytical Chemistry, Vol. 49, The donecylttn stabilizer is p. 1090-1093 (1977), which is incorpo .-.mixture of 5u to\60 percent by weight rated by reference.Coples are available <>P n-dodecyltin S,S'JS"- from the Division of Food and Color trisdsooctylmercaptoacetate) (CAS Additives, Center for Food Safety and i Rfeg. No. 67649-65-4) and 40 to 50 per Applied Nutrition (HFF-330), Food il cent by weight of diWdodecyUtiri S,S'- and Drug Administration, 200 C St., . dieisooctylmercaptoacetate) (CAS Reg. SW,, Washington, DC 20204, or avail Noi-84030161-5) having 13 to 14 per- able for Inspection at the Office of the deht by weight of tin (Sn) and having Federal Register, 1100 L St. NW, 8`to 9 percent by weight of mercapto Washington, DC 20408. sulfur. Tit is made from\a mixture of (lit) Subsequent determinations for dodecyltin trichloride and the dodecyltin mixture described in dKdodecyDtin dichloride 'which has paragraph (a)(7) of this section shall ndt'more than 0.2 percent y weight be at a minimum of 24-hour intervals off dodecyltin trichloride, not more for aqueous solvents and 2-hour Inter " 1 2 percent by weight of'dodecyl- vals for heptane. These tests shall Huiyltin dichloride and not mole than yield di(n-octyl)tin S.S'- 3jpercent by weight of tri(dodecyl)tin bis(isooctylmercaptoacetate), or di(n- loride. The isooctyl radical irnthe octyl)tin maleate polymer, or (Cio-Cw)- .ercaptoacetate is derived from oxo alkylmercaptoacetate reaction prod Pno&sg nrimarv octyl alcohols. ucts with dichlorodioctylstannane and if(b>The vinyl cEIbride plastic con trichlorooctylstannane, or n-octyltin tainers, film or panels in the finished S,S',S''-tris(lsoocty]mercaptoacetate), form in which they are to contact trls(isooctylmercaptoacetate) and di(n- food, shall meet the following limita dodecylltin tions: bis(isooctylmercaptoacetate) or any <1 > The finished plastics intended combination thereof, not to exceed 0.5 for contact with foods of the types parts per million as determined by an listed in this section shall be extracted analytical method entitled "Atomic with the solvent or solvents character Absorption Spectrophotometric Deter izing those types of foods as deter mination of Sub-part-per-Million mined from Table 2 of 8 176.170(c) of Quantities of Tin in Extracts and Bio this chapter at the temperaWire re logical Materials with Graphite Fur flecting the conditions of intended use nace," Analytical Chemistry, Vol. 49, as-:determined therein. Additionally, pp. 1090-1093 (1977), which is incorpo extraction tests for acidic foods shall rated by reference in accordance with 329 BFG15988 Part 1 (f) fled 1 the p ter. [42 P 53 FF PAR Tl1 Al Sub] Sec 118 178 178. 178 178 Su 171 17: 17 17 17 17 17 V, V V 1 1 1 1 ] ] 178*3010 5 U.S.C. 552(a). The availability of this incorporation by reference is given In paragraph (b)(l)(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 sol vents, 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: 21 CFR Ch. I (4-1-90 Edition) --Continued List of substances Limitations 1,1,2,2-Tetrachioroethytene. Toluene...,......... .......... For use onty as a blowing agent adjuvant in polystyrene at a level not to exceed 0.3 percent by. weight of finished foamed polysty rene intended for use in contact .: with food only of the types identi- < Red In $ 176.170(c) ol this chapter. Table 1, under Categories 1. II. VI, and VIII. For use only as a blowing agent adjuvant In polystyrene at a level not to exceed 0.35 percent by weight of finished foamed polysty rene. Food-simulating solvent -Time (hours) Temperature- (degrees Fahren heit) Type II.--..... Acetic add, 3 pet_____ Type V--------- Heptane---------.--------- Type VL-A.... Ethyl alcohol. 6 pet------ Type Vf-C...... Ethyl aleohoi, 50 percent . 40 2 24 24 135 100 120 120 [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, 1965; 50 FR 37998, Sept. 19, 1985: 50 FR 47212, Nov. 15, 1985; 54 FR 24898, June 12. 1989] Subpart D--Certain Adjuvants and Production Aids 178.3010 Adjuvant substances used in the manufacture of foamed plastics. The following substances may be safely used as adjuvants in the manu facture of foamed plastics intended for use in contact with food, subject to any prescribed limitations: List of substances Limitations Azodcarbonamide... Isopentane......... ........ o-Pentane..... ........ . For use aa. a .Mowing agent in pol yethylene complying with item 2.1 in {177.1520(c) of this chapter at a level not to exceed 5 percent by weight of finished focuned polyeth ylene. For use as a blowing agenl in poly styrene: Do. [47 FR 22090, May 21,19821 178.3120 Animal glue. Animal glue may be safely used as a component of articles Intended for use. In producing, manufacturing, packing, processing, preparing, treating, pack aging, transporting, or holding food, subject to the provisions of this sec tion. (a) Animal glue consists of the pro-, teinaceous extractives obtained from hides, bones, and other collagen-rich substances of animal origin (excluding diseased or rotted animals), to which may be added other optional adjuvant substances required in its production or added to impart desired properties. (b) The quantity of any substance employed in the production of animal glue does not exceed the amount rea sonably required to accomplish the in tended physical or technical effect nor any limitation further provided. (c) Any substance employed in the production of animal glue and which is the subject of a regulation In Parts 114, 175, 176, 177, 178 and S J79.45 of this chapter conforms with any speci fication in such regulation. (d) , Optional adjuvant substances employed in the production of animal glue include: (1) Substances generally recognizee as safe in food.. (2) Substances subject to prior sane tion or approval for use in animal glu< and used in accordance with suet sanction or approval. (3) Substances identified in thi paragraph (d)(3) and subject to sue) limitations as are provided: 330 21678007 21 CFR Ch. I (4-1-90 Edition)] ier.~d petroleum wax is permitted irj Subchapter B of this chapter as a1 component of articles intended to con? act food, provided that the synthetics aetroleum wax meets the definition; md specifications prescribed in 1 172.888 of this chapter. 1 378.3730 Piperonyl butoxide and pyreth- rins as components of bags. I Piperonyl butoxide in combination! with pyrethrins may be safely used for) nsect control on bags that are intend- ;d for use in contact with dried feed ii? compliance with 561.310 and 561.340 of this chapter, or that are in* tended for use in contact with dried :ood in compliance with 193.60 and L93.390 of this chapter. 4 $ 178.3740 Plasticizers in polymeric sub^ stances. . Subject to the provisions of this regUation, the substances listed in para?1 jraph (b) of this section may be safely ` lsed as plasticizers in polymeric sub;tances used in the manufacture of ar ticles or components of articles intend ed for use in producing, manufacture ng, packing, processing, preparing, treating, packaging, transporting, o loiding food. (a) The Quantity used shall not* the amount reasonably rei i to accomplish the intended^ tec-.iical effect. <b) List of substances: kJ in 175.105 and 176.180 of this chapter, nc substances usad in food-contact ertictes complying i 175,320, or 176.170 of this chapter Provided. That tfWJ /I phthalate contains not more than 1 percent by weight t1 iihaiata ric substances used in other permitted food-contact i That the butyl benzyl phthalate contains not more than '' weight of dtoenzyl phthalate; and Provided further, That thel wd-contact article, when extracted with the solvent naracterizing the type of food and under the conditions f amperature characterizing the conditions of its intended uaej ned from Tables t and 2 of $ 175.300(d) of this chapter! net chloroform-soluble extractives not to exceed 0.5 mg. perl x as determined by the methods prescribed in $ I75.300(e)j oter. levels not exceeding 33 percent by weight of xnopolymers used in contact with food (except foods i ire than 8 percent of alcohol) at temperatures not to exceed wrature. The average thickness of such homopolymers ini n which they contact food shall not exceed 0.CO4 inch.1 food and Drug Administration, HHS 178.3740 .^C. c.-aikyl) adipate, in which the C,. C.-alky1 groups are derived from linear alpha olefins by :ne o*o process. > n-aikyi adipate made from C C,-Ci (predominatety C. and C,,) or C,-C>. synthetic latty alco hols complying with 172.864 of this chapter. Ocycichexyt phthalate. E>(2-ethylhexyl) adipate... Dwsononyl adipate........... For use only under the conditions listed below, and excluding use as a component of resinous and polymeric coatings described in { 175.300 of this chapter. 1. At levels not to exceed 24 percenl by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nontatty foods. The average thickness of such polymers in the form in which they contact food shad not exceed 0.005 inch. 2. At levels not to exceed 24 pci by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in Table 2 of 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pet by weight The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pet by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymer in the form in which they contact food'shafl not exceed 0.002 inch. 4. At levels not exceeding 35 pet by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in Table 2 of 5 176.170(c) of this chapter with fatty foods having a fat and oil content not exceeding a total of 40 pet by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. For use only: 1. At levels not exceeding 24 pet by weight ot permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness ot such potymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pet by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in Table 2 of 176.170(c) of this chapter, with tatty foods having a fat and oil content not exceeding a total of 40 pet by weight The average thickness ol such polymers in the form in which they contact food shail not exceed 0.005 inch. 3. At levels not exceeding 35 pet by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. .4 At levels not exceeding 35 pet by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions ot use F and G described in Table 2 ol $ 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pet by weight The average thickness of such polymers in which they contact food shall not exceed 0.002 inch. For use only: 1. As provided in 9175.105, 176.170, 176.180, and 177.1200 Ot this chapter. 2. Alone or in combination with other phthalates. in plastic Rim or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chlo ride copolymers complying with $177.1980 of this chapter. Such plastic Km or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pet by weight of total phthalates. calculated as phthalic acid. For use only: 1. At levels not exceeding 24 pet by weight of peonitlQd_vip^Lch)ocide homo- and/or copolymers used in contact with nonfatty. nonalcoholic foods. The average thickness of such ooMwors in the form in which they contact food^hatt not exceed 0.005 inchjt*^* 2. At levels not exceeding 24 pet-by we*gm w permitted vinyl chloride homo- and/or copolymers used In contact under conditions of use F and G described in Table 2 ot 176.170(g) of this chapter with tatty, nonalcoholic foods having a (at and oil content not exoeedmg a total of 30 pet by weight The average thickness of such potymers in the form in which they contact food shall not exceed 0.005 inch. 3. At tevels not exceeding 35 pel by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty. nonalcoholic foods. The average thickness ol Mich potymers in the form in which they contact food shad not exceed 0.002 inch. 357 21678008 BFG15990 Part 17 (11 A fied in the pri ter. [42 FR 53 FR! PART TIV Alt Sub pai Sec. 178.10 178.10 178.3740 21 CFR Ch. I (4-1-90 Edition Limitations Oiisononyl phthalate.. Di-o-hexylazelate... Dihexyi phthalale... Diphenyl phthalate... . Epoxidized butyl eslers ol linseed oil fatty acids...... ^ Epoxidized linseed oil........................ .......................... ^Mineral oil, white........................................................... Polybutene. hydrogenated (minimum viscosity at 99' F, 39 Sayboit Universal seconds, as deter mined by ASTM methods D445-82 ("Standard Test Method tor Kinematic Viscosity of Transpar ent and Opaque Liquids (and the Calculation of Dynamic Viscosity)") and 02161-62 ("Standard Method for Conversion ol Kinematic Viscosity to Sayboit Universal Viscosity or to Sayboit Furol Viscosity''), and bromine number ol 3 or less, as determined by ASTM method Di492-78 ("Stand ard Test Method lor Bromine Index of Aromatic Hydrocarbons by Coulometnc Titration"), which are incorporated by reference. Copies may be obtained from the American Society lor Testing Materials. 1916 Race Si. Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 1100 L St. NW,, Washington, D C. 20408. Polyisobutylene (mol weight 300-6.0001.................... 4. At levels not exceeding 35 pet by weight of permitted vinyl < homo- and/or copolymers used in contact under conditions < and G described in Table 2 of $ 176.170(c) of this chapter with t nonalcoholic foods having a (at and oil content not exceeding a v of 40 pet by weight The average thickness ol such polymers in f form in which they contact food shall not exceed 0.002 inch. For use onty at levels not exceeding 43 pet by weight of permitted v chloride homo- and/or copolymers used in contact with food onlylfi the types identified in (176.170(c) of this chapter. Table 1, i Categories I, It IV-B, and VIII, at temperatures not exceeding r temperature. The average thickness of such polymers in the form! which they contact food shall not exceed 0.005 inch. For use only; 1. At levels not exceeding 24 pet by weight of permitted vinyl < homo- and/or copolymers used in contact with nonratty, . food. The average thickness of such polymers in the form in they conlad food shall not exceed 0.003 inch. 2. At levels not exceeding 24 pet by weight ol permitted vinyl t homo- and/or copolymers used in contact under conditions of use and G described in Table 2 of $ 176.170(c) of this chapter, with fat nonalcoholic food having a fat and oil content not exceeding a total '8 30 percent by weight. The average thickness ol such polymers it form in which they contact food shall not exceed 0.003 inch. For use only; 1. In polymeric substances used in contact with nonfatty food. 2. In polymeric substances used in contact with fatty food and limited 1i use at levels not exceeding 15 pet by weight of such polyn substance except as provided under limitation 3. 3. At levels greater then IS but not exceeding 24 pet by weight < permitted vinyl chloride homo- and/or copolymers used in conta' under conditions of use F or G described in Table 2 of (176.170(c) this chapter, with tatty food having a fat and oil content not exc a total of 30 pci by weight The average thickness of such polymers Ir the form in which they contact food shall not exceed 0.003 i For use only: 1. As provided in ( 175.105 of this chapter. 2. In articles that contact foodffiSof the types identified in 8 176 itoiAI of this chapter. Table 1, under(Categories I, II, IV-B, Vi-B, and Villi' For use only: 1. As provided in ( 175.105 of this chapter. 2. Alone or in combination with other phthalates. in plastic film or a prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl c ride copolymers complying with (177.1980 of this chapter, f plastic film or sheet shall be used in contact with food at temperatir not to exceed room temperature and shall contain no more than lt pet by weight of total phthalates, calculated as phthalic acid. Iodine number, maximum 5; oxkane oxygen, minimum 7.8 pet. Iodine number, maximum 5; onrane oxygen, minimum 9-pct. For use only 1. In polymeric substances used in contact with non-fatty food. 2. In polyethylene complying with ( 177.1520 of this chapter and used ir contact with tatty food, provided that the hydrogenated polybutene ii added in an amount not to exceed 0.5 pet by weight of the potyetti ene. and further provided that such plasticized polyethylene shall r be used as a component of articles intended for packing or hoktingj food during cooking. 3. In polystyrene complying with (177.1640 of this chapter and used i contact with tatty food, provided that the hydrogenated polybutene fa _ added In an aroUn^not to exceed 5 pet by weight of the polystyrene* and further provided that such plasticized polystyrene shall not bea used as a component of articles intended for packing or holding foods during cooking. For use in polyethylene complying with ( 177.1520 of this chapter, 1 provided that the potyisobutylene is added in an amount not exceeding 1 j0.5 pet by weight of the potyethyiene, and further provided that such plasticized polyethylene shall not be used as a component of articles I intended for packing or holding food during cooking. 358 21678009 Food and D '*P*ctwtYtene a n^yprepyiene glye 4. (irwwnum me nropyW'W gtyed 3000) inrmytene glycol. ?.7.4-Tr*nethy1-1.3 (c) The u. polymeric s to any reg 176. 177, lr must comp and limitat ulation for substance c (42 FR 14605 42 FR 4422: Aug. 22, 198< KR 10113. M 30.1986] 176.3750 1 lecular \ Polyethy section ma: nent of ai contact wii the followl (a> The i mer of eth a mean rr 9.5C0. (b) It cot cent total diethylene lar weighl more than of ethyler its mean 350, whei methods ] this chapt (c) The of this sc polyethyli packaging 5 175.105 i BFG15991 P103R60 M10360 PRODUCT NO. DESCRIPTION PRODUCTION RECIPE INQUIRY PAGE 1 00110 450 FGOO LOC 80 DEPT E120 ISSUE S92 11OX450FG00 SBC 111B INT. RM. 961000816 7EM RM NUMBER DESCRIPTION 010 968 000094 06611 E00 020 953 710760 LUPERSOL 225M60 030 953 00GO98 METHOCEL F50 PRE 040 957 00W013 PVA, 88% 050 911 00A030 BHT DISPERSION 060 911.-OQA028. DTAHQ DISPERSION 080 .710680 ALCOTEX 55-002H QUANTITY 100.024561 .061093 .031744 .040030 .061093 .037634 .144246 USERID: N50CND1A TERMID: PV120069 CO. CODE E END OF INQUIRY TOTAL 100.400401 TO MAKE 100.000000 'A.'' 21678010 BFG15992 , PAGE: 04 OF 05 FDA AKRON DISPERSIONS - YES 175.105, 176.170, 177.2600 American dispersions - yes 175.105, 175.125, 175.300, 176.170, 176.180, 176.210, 177.1200, 177.1210, 177.1650, 177.2600, 178.3120 NEXT RESPONSE: REGCINQ NEXT KEY: PRESS PF8 TO PAGE FORWARD AND PF7 TO PAGE BACK 21678011 BFG15993 JH : P103R36A 9F GOODRICH COMPANY MESSAGE SERVICE TO: Cl.EVMAIN DOCUMENT 020002 47 LINES 12:12-11 09702/91 ROUTE TO: DILLON. CONNIE N *******#*****##**K***#***#*##*##******#*********###****#*##**W**************** if. * LA PORTE '! E C H N I C A L h 0 C U M E. N '! it *******#***K*#****#****#****#****#*#******#****#***#******##**#######**#**# R1336 L.APORTE RECIFE 09/62/92 12:12:09 GEDN RESIN 110X45OFG C 0 M M 0 D IT Y N 0 . ; 001 1 450 F&0O SBC NBR : 1 1 1 B LAB REE BASED ON: APPLICATION' LUC: SO DEPT: 12 1SS EFFECTIVE DATE 01 01 /92 DELETE FLAG NO CM PR 792 parts INGREDIENT L>' SEQ L..OC PERCENT 100.02456 .06109 .03174 . 04003 .06169 .03763 .14424 968 953 953 957 91 1 91 1 953 000094 710760 00G098 0QW013 00AO30 00A02.8 710689 06611 E0O LUPEPSOL 225M60 HETHOCEL F50 PREMIUM PVA, 88% BHT DISPERSION D FAHQ DISPERSION AlXOTEX 55-002H 40% 010 O20 030 040 050 060 080 99.626 .061 .032 .040 .061 . 037 . 1 44 100,40040 TOTAL 1 00.OOO TYPE SAMPLE: ISSUED: MARKETING APPROVAL' 21678012 BFG15994 C617D096 C617F096 CAS NO. 15571-58-1* 27107-89-7, INVENTORY NO / CAS INQUIRY GEON PROD INVENTORY NUMBER 912 /(11 / 1557/ CONCT PCT. DESCRIPTION 075.0000 040.0000 USERID: N50CND1A PTERMID: PV120103 NEXT RESPONSE: RMCASINQ NEXT KEY: NO MORE CAS NUMBERS TO BE DISPLAYED L 21678013 BFG15995