Document G55MeBab65r8E2x0aaRd2e0K7

TO: Jim Sidor AVLTC March 4, 1992 Subject: FDA Status on Experimental Compounds X150-"168-061-01/ X150-168-061-02/ X150-168-061-03 I reviewed the above experimental compounds for their current FDA status. Compounds X150-168-061-01 and 02 look okay. All the ingredients have FDA clearance. Experimental compound X150-168-061-03 has one ingredient (L-21/Stearic Acid) which according to the Supplier, Emery, not have FDA clearance. does If I can be of further assistance, please give me a call on ext. 7831. Connie N. Dillon CND/rm MAR 0 7 1994 21544001 ISDA. MSF. WORKSHEET SUBJECTtfaAUV OlAjLWiCttJ/ 1/ , 'V OC,{- n//I'd1 2 <=--p--------------------------------- DATE: V/A^- COMMENTS/STATUS: 11 -JLlr) , f~~l)A (J J Ijfimt z* % 1 SO^l (orf-QL l--O / <2_ o4auj . rt/jL QJU,_ A d'i A j-' '//> AM *i. An a X I5 0-/C-?~OU-0 2 ; aJl Jytct' S' )LC- Ll-2. / ("4Ajjlaj^- Ol&aJI 1 ? ^r" v" ACajM, P/)A OJaAS-. i'X i^LO. 4! A^-Ct, I't Juhtz* ~fcf Ar2~ / c>Lu4. ) : iMiA^Or ^ f'OA- Ox^'jtol^J- (Aeon m MAAaJc- (JO // 4Jjjur/. CU4/L. s CfyWM l)jMxJy-/1Z'5 1 / V_ ' ZOOttSTZ >< (DO -ftr- dp/- o / crA- fC X / p6r 1, -DPfPJj P\/d PUsuDk, JEWLolljL/a-S f^S/oMp f!r\2 PftPuJL>*jL - fzoaI ' fn DA Imd/ (LfhrL/mJ /T(,37?D^ m '3. "P^lrdL 6r&-733 v/iAj Qdo.HA. 3. To S3-09-A nr 3 7n 3//2.5 `DvlAA Jj-A 1 I&U, rW > T /O(0 (CM>-1Us. b(ef3'W-'t ` (jJzy yiu^A^pjzdu <o <01-F6-4") 73z^i^X^i^!e7'^^'3 S-/3iiJfafc- &oj-A- /7S'.jtofO *\ u"1' /,_ Dbs fjJpPhMaa&4-U. j/o> 30-A -vPTxdfA-vJA P/Hm^JaaL^ ^(P--^Ccc-n^> 0l4smc6l (AmaujL - 7 -> uA O' 0j\LaJ^niAou/ /C, cf/rnA-i. Dt/Js/pdu-c(HJ-f* '*;?3q% Uot-O-d So/X. Dmi.yji. (2iii-t'f P(jddjDsyy, (s\a-tQ0 aaJ-7 Pdtu. Pood HO `/bdA Ul<o1(*uo-oGQ-`4 3ci- * 'PtUOidH-J^ Qfft -133 iwi y a juj ? ^ iso,- a- -b^eM^tyC. 9-s~ c^w<w.;w<^< ojj yjc,. , tf><3 C(*At4r~* QloA n^.tofj s7S,3ocy _/ -74, /&0 / #, /r^ /77. Izoo jn.zifOo'jH^.zojoj m.ii(p;)- Jl.asKyiT.3Vo N jjr. 3? 70 O o cu yCA-J-CU (j/teAcA+to . - <3^-6- /-? 3-?2. <x*FD*. snA--. n&?y/y/>?zyuu.. MATERIAL ;'C -/6g*- Oc nmercial? /)(-/<L errr. ii'c>3 isrvX- Tr Requestor \}Asrr\ Phone Marketing MgrJ7o-w R.^^Jr-a^Lt^L___ Location fiLTC, Indicate product Ingredient (RM#1 recipe below: (the recipe may be attached in lieu of the following) Trade Secret? ni,. V"' % by Wgt. ~ Paa./-.JLm^L Rta A \/Lrtsb #i ('tin. Mi /1A, i. ,_/ ma men. S /O/O ?------------ 9 LitianU-tX 99 laOkccL ivxnogw ^IXTIillAi `to'.idecn-iV J . HuioaL*?,* v/ rti/n 9 IRMflili QLloaa.ft-1 Q/ Im'jlSl'l - loo. o_______ 9. o 2.2 a..-* o.9 c.9 o.o -3 0,(579 o.q Total, na./oi_____ /.18 V 1.962. I.ISW 0.113______ 0.1/2 0.03.1_______ 0.010______ a.n# /An"/* Boiling Point Sol. in Water~.-^<1$ Melt Point Spec. .Gravity % Vol. by Wgt._ Vapor Density. Vapor Pressure, Particle Size Appearance (Shape, Color Odor clAAA.- ~T7y\ ,F77j__ Molecular Wgt. pH_ Glass Transition Temp._ Bulk Density, Flash Point and Procedure________________ ______________LEL 'ihSearch Conducted bv \jyu^r1 l Phone UEL - Date ______ __ (Please return this data and attach- ments to Mark Hross, Oak Tree Blvd. -Cleveland (x-7601)) 21544004 r ( P0O1R71 BF GOODRICH COMPANY MESSAGE SERVICE it' 50 A FROM: P103R360 TO: CLEVMAIN DOCUMENT: 170006 53 LINES 02/17/92 ROUTE TO: DILLON, CONNIE N #WK*****:****K*W **XWWWW*-**W ****************** ******xxw *-**** **** ********* * GEON VINYL TECHNICAL DOCUMENT KffXtt *XK***X***tt*K**tt*tt KttftK*K*K*X**S**X*K* ***##*#*##*#*##**#***#*** *****> * R103360 GEON VINYL RECIPE 02/17/92 10:58 GEON 17640 BLUE PWD MU 430 LOC : 12 DEPT : COMMODITY NO.' 07640 000 4302 EFFECTIVE DATE SBC NBR 13PM LAB REF: DELETE FLAG: CMF'R: BASED ON: 87640 BLUE PMB 430, ISSUE 1, 10/03/89 APPLICATION: BLOK MOLDING NON-TOXIC MB NO K. SRA1L ( ( PARTS 100.00000 3.00000 10.00000 INGREDIENTS 942710849 F'ARAL.OID BTA 733 ^ 935OOF'05,7 EPOXOL. 9-5 ^ 92100B272 BLUE 5006 SEQ LOC PERCENT 110 12 210 310 88.496 2.655 8.850 113.00000 TOTAL 10O.OOO SPECIFIC GRAVITY 1 .43 ( TYPE SAMPLE USE F'REV. SAMPLE ISSUED TO ADJUST LETDOWN LEVEL. MARKETING APPROVAL ( MI SC CMNT: SEE PAGE 2 FOR F'ROCESSING 6 NOTES HARDNESS: 0-8< COLOR: 2 21544005 r C ROUTE. TO: DILLON, CONNIE N I*'********#**********#***##**#**##*#**#*****#*#*********#********#**##****#*** * GEON VINYL TECHNICAL DOCUMENT ************************ a#**#******#****#***#*#**-***"****)******##*#**##******' *. R103360 GEON VINYL RECIPE 02/17/92 10:58 GEON 37640 BLUE: PWD MB 430 COMMODITY NO.: 87640 000 4302 LOC: 12 DEPT: 5694 ISSUE: 002* EFFECTIVE DATE: 12/26/91 TESTS LIMITS FREQUENCY METHOD ^ NON-TOXIC CLEAN UP REQUIRED. HENSCHEL MIX CHARGE 6TA-733 AND PIGMENT AT SLOW SPEED ADD P-57, HIGH SPEED,, DROP AT 135F. =======> PROCESSING INSTRUCTIONS COPIED FROM 876400004302 12 5667 002 <=====* =======> ON 12/26/91 <===== (. L C 900W ST2 1 R71 FROM: P103R36 &F GOODRICH COMPANY MESSAGE SERVICE TO: CLEVMAIN DOCUMENT: 170005 44 LINES 10:58:1 02/17/92 ROUTE IQ: DILLON. CONNIE N ***************************************************************************** * GEON VINYL TECHNICAL DOCUMENT if************************************************************************** * R103360 GEON VINYL RECIPE 02/17/92 10:58 GEON 37640 BLUE PUD MB 430 COMMODITY NO.: 87640 00 4302 SBC NDR: 13PM LAB REF : BASED ON: APPLICATION: L.OC : 1 2 DEPT : EFFECTIVE DATE DELETE FLAG CMPR PARTS INGREDIENTS 89.14159 2.67424 8.91415 942 710849 PARALOID BTA 733 935 00P057 EPOXOL 9-5 921 00B272 BLUE 5006 SEQ LOC PERCENT 1 10 210 310 88.496 2.655 8.85 100.72999 TOTAL 100.000 SPECIFIC GRAVITY: TYPE SAMPLE: ISSUED: MARKETING APPROVAL: 1.43 HARDNESS: D-8t COLOR : 2 L 21544007 Kl />* -06/- 0<L '< t 4-''! ( ______ /io A -7 3 3 A ^ (L f*z~JL>yLs*^ . 2. PaJuirJL bTfr-^ rtHAj&jt* (^t/3. iti. 75cS3- of- 2- P D2 fa /^S 4uox<]<3Hf n?. 3 7/j 3 . /7x4.. -c 3 //2. 6 r^/c.t.. r,U;. *!&* & (Om :?-. ^ J Ufj* SO/zQsr/^ 6/.V &. ,^769'^-fJ /7/. 2-.,5(5 77/, 3772 s'^S&u, PiJim4^ ^nc 0-OoO-^OZ. i , \ P(y^-^tf-CA tbTft- 73^ (zuM 1'SdS3-6f-2j pSl) <?-(T y& -7-3 TOO g(&S. P/pvi J- tMcu. fs) C- y\{jCtad4o*--''fi- 5"5"0 OLCa^^-^' $4. 1 7f- 3 7 Jo /*7Y. ~3 7p0 n K3970- '77. 2606, /7?. 3^f/ Hi. 37 id ^p&4j* wy** !/. p-/75~ 21544008 "ti ______ -.- - - l?' :&l<ud<, ZXSftuA U rrcJ^j* ,, FF-ta+r4A _____ 'icL(rV^&Ls f4-oG>-- 7/07 '' ''.... ...... /?/ . i-TfT1 /7L7.0oy` ,rjs. 300 yx^4d 'bi.tt*. ^ t<fJu/-t&4LptiA /17. 32 o J^ /?*; ^Mo(o. 7% L^) __ BFGoodrich Geon Vinyl Division Product Name and PRODUCT MSPS MATERIAL SEARCH Prod . { Number ) X /-Td - IlM-OC.J Is Product Experimental or Commerc ial? P. Chemical Synonyms_______________________________ Chemical Family Requestor t? ' Marketing Hgr'^rm f^n^rr'irwajtA Trademark. Phone iSC'3 Location ALJC. OO/ / o^33 a n Indicate product Ingredient (RM) recipe below: (the recipe may be attached in lieu of the following) Trade Secret? ph i % by Wgt // o x ______________________ OOOUOH 99X11099*? /oac? )1.0 Al^a.A -airx<t 1 '2.1. V.-Pri,*.: //?<-n\ ftp;** Plj,,L./tlA t/so-1 9aioofini O. 03___________ 0. ot-9 9 tfn k>*S:3 Pin* 0*rlX-L 99no<Jilo 1. 1 `Ks'eePn^/ rL it**- a,* A 0. 9______________ e,i if <?4(VJ/0i3S 0.Z1.-T Ac.:^u.a3 &A. 9931/0tf/.T O./_______________ 991110590 9111695X2 Q.~3-_____________ 0-3._____________ ^TAL11*1*584__________ iO^J.9...... /o.m< .Oio OLL 1.990 93.0____ 339_____ /Tff.-r >3(3_____ .______^_____ . . JL-7 Boiling Point Melt Point Spec. Gravity Sol. in Water % Vol. bv Wet. Vapor Density_____ Vapor Pressure, Particle Size Appearance (Shape, Color) Odor aL^ L -r _____ Molecular Wgt.-------------- 21544010 Glass Transition Temp.. Bulk Density, Flash Point and Procedure Search Conducted by ,LEL_ (JEL Phone /dTb.'^ Date /-- 2.3 --_____________ (Please return this data and attach ments to Mark Hross, Oak Tree Bivd. -Cleveland (x-7601)) - SENT BY:UIITCO 8W. U). OAKLAND NJ 02-18-92 03:26PM 216 447 6459 # 1 FAX TRANSMISSION FORM ARGOS DIVISION, FITCO CORPORATION 8 Fright Fay, Oakland, Han Jersey 07438 Phone; 201-337-2038 FAX Ho. 201-337-3753 Date: February 18, 1992 To; Hra. Connie Dillon Coapany: B. F. Goodrich FAX No.; 216-447-6459 Ho. of Pages: %. Froa: B.R. Blues'tein Subject: FDA Status - MARK 3112S Dear Hrs. Dillon: Barlier today you requested infornation on the FDA status of HARK 3112S, an Argue product whioh you purohase froa us. The ingredients in MARK 3112S are inoluded in the FDA Hating of organotin stabilizers whioh nay be safely used alone or in conbination, at speoific levels, in vinyl ohloride plasties. Please see the pages froa 21 CFR 178.2850 (here attached). The approved tin ingredients are listed below with their CAS numbers. CAS Numbers 28401-88-5 28401-97-8 Ingredients Acetic aoid, 2,2",2"-[<octylstannylidyne) trie(thio)]tris-, triisoootyl ester Acetic acid, 2,2'-[(dioetylstannylene)bis (thio)]bis~, diisooetyl ester Also, please note that these materials are on the DSL, the Canadian List of Domestic Substances. If there is anything further you need, please let us know. Sincerely yours, B.R. Bluestein, Ph.D. Vioe President, Teoh. FEB 18 '92 15:28 PAGE.001 X-- /SO- /by- G f-03> SSj/YV<J-AjdL 4/ri/t r4//^ X' /. Jp*-*- ?4?x) PCs fvc. C , 7<2?-x ~ 4-1-) 'Ic^O A foX2. /2-OaJ. %.fasL*Jrt& 6ft-123 ^07 rM>, *s/S?> t'Pt. 3 7?0J /TJ./Otfj cS/ew 3 i 7?. i*>1o ~1'i<tI 3!> 5*" 7/ CctjStjstn faiMjft ^ iqtz-Qs'bo S 8 2 S&mALl (j>, 0--jAL, / ?r.zc>sd(&lj .sH&y&t/tfC ']jti^tu.<sisi /7s,3c*\ ffi.rizj J j yUnu. aXjt&ztp**- -y* Sc *j bJbtf^-Oi'- Tt T7).4- OILuuj-m*-' pSMjVxJUit' 'It AG- ^t&A pht^jM^A &VJL. C&k>. to. /9S,/0Sj ns.nsj )*%>/{>QJ i~?0.ZOOJ Hit. 2/<si 177. /^y 777- /<i 2<5y pi.K'Cj /* OjUUi SO/2(ft&Zi 7, ^$LjLpj#Jt Pa/._iU*-t. $'/*-"73 jpt*~L <?-S- feiuji* 5o, <2# > Pjjfyutt (jAAt/s Jit, $f70 n H* tn ^/7r. 37/0 ______ ^3970: m SI f\ mnt.'^hil r#<i7 OJ // A.,^ 0:SX 26. 8T SBd su a 2 8 6S89 Z.W 912 Wd2:0 26-81-20 fN OHtnXOQ m TO CDJ.im:AB iM3S - BFGoodrich Geon Vinyl Division PRODUCT HSDS MATERIAL SEARCH Prod . Product Name and (Number). /SQ-/(*?-(.i-3 Is Product Experimental or Commercial?j Chemicaill Synonyms. fLl^lcL PVCL.____FD/i (Le Chemical FamilyTrademark Requestor. PI'one__ /I/ f Marketing Mgr /f**Location. /U-T'C^ Indicate product recipe below: (the recipe may be attached in lieu of the following) Ingredient ( RMi )Trade Secret?p^,/ % by Wgt r%CXiF&- iOiaonHlS'___ /OQ.Q Pvt-**>**.*___ eji.33 V i * law. I2.PAID InoKSL 3O *>#-9** /, & t* A. errA isi, MxniolMj <hi-iusi h.q pcub/^^uscsi^i.um *. 3. a. a,a<?7 3 9pL<rfl,^_ 9W.3 7/03,79 Q, 7 <tf<* AMwoagwwg_______Je3?___ 3tfls-3(-/ 0,0.5'.,3.3ft cil!-3/./*) R-r&jijfiLyA^tS _____ v0i..1i a poritii9V<tidwhi ItogwimB-_-_-_---/nla-li--*8VW-P"S' \fr~f' -J-.Fnitp fafc-n) Qaiaoan^ P. &.3 ^.?A\I.o.eris:rM ,03.7 ,nif-*-* 9 HP,, /a /a/a Kiooa/nt. acn^ _ ______ tQiP~.. . 91I1&9S2.7.__a,xa<s>_______________ .187- -foT/tL /a`}./-09 -J V) t - V i *> (S?j.iKs%ic.ci*BAo. 8o/t-g-i; ss-rt AoayM*a/snr)*StfJ-*9* ; s).e%F!*. &*a Boiling Point Melt Point Spec. Gravity ^sr-17-5 Sol. in Water % Vol. by Wgt. Vapor Density. Vapor Pressure. pH. Particle Size. Appearance (Shape, Color) P-aika./?/'1/U2Md^ L.Odor 3P^.i.<pPU.ji_____ Molecular Wgt._ Glass Transition Temp. _ Bulk Density. Flash Point and Procedure ________________________LLEEL_ LUEL Search Conducted by jP/cn ___________ Phone /J/f . Date a- /7-?2-___________ (Please return this data and attach ments to Mark Hross, Oak Tree Blvd. -Cleveland (x-7601)) 215440 d) (B Yg& - /78.^o. 'll * ,0' <^g) Yes- m.lllo s>- - (78-ifaso "7U -f ^ MUUia^ ir-?-/' ----- Yes- a5.iosr, rts.ixst n^.iso, i~K>.jboot nc.ioic> f m.iiooi iri.t(,ioi nx.*.^o -<-------Y--=-S-------(-7--g--.-2--.1--70 /^) ?35- 5^5 - '75. IOS. '7S'.3oo r /77. /3JO , //. 2,7 *\ , I - ki- {-AaaJ-- lvj.-7'oa^? Ycs-nB.iTjo I*/- 7//S7/ izs- HB. 5M7 01 \ ^ 6-2j y (to) Yc=3 * i7&.2oio ./ 4Rt* jfc O S' FEB-19-92 WED 14:03 I eiF atochem ElfAtochem North America Inc. Thm Parkway, PMwMptta, PA 10102 Tat (213)587-7000 P.02 19 February 1992 Ms. Connie Dillon THE B.F. GOODRICH COMPANY Dept 5458 6100 oalc Tree Blvd. Independence, Ohio 44131 FAX: 216-447-6459 Dear Ms. Dillon, Per our conversation today, the Elf Atochem North America, Inc. product Thermolite* 890$ is an octyltin stabiliser certified for use in food applications as specified in 21 CFR section 178.2650 Organotln Stabilizers la vinyl chloride plastics when used as specified for finished plastics meeting the restrictions set forth in section (b) (1) . The exact composition of this product is held as a Trade Secret by Elf Atochem North America, Inc. If I can be of further assistance to you, please contact me at your convenience (215) 587-7917. Very Truly Yours, ELF ATOCHEM NORTH AMERICA, INC. Karen Br Macho1 Product Safety Specialist cc: Steve Hulme Tom Bole 21544017 FEB 19 '92 14:04 15 pqrf two FEB-19-92 WED 14:03 eiFatochem Elf Atochem North America Inc. Thre* Parkway, PhfcdtlpNa. PA 10103 Tet (215) 587*7000 P.Ol ELF ATOCHEM NORTH AMERICA, INC. THREE PARKWAY PHILADELPHIA, PENNSYLVANIA 19102 FAX NUMBER: (215) 567*6605 THIS DOCUMENT NAME: IS TO BE DELIVERED TO: ~ 2/-4.4-'7- 643^ DATE: /99j? from: NUMBER OF PAGES (including cover): COMMENTS: If there is a problem With the fax transmission, call (215) 5877917. FEB 19 '92 14 = 04 PAGE. 001 00 izr.ioc^ ,7S. J no. /Sro ;/77. szlo O 17&3800 21 CFR Ch. I (4-1-90 Edition) j Acrylonitrile. Butadiene. a-Methylstyrene. Styrene. Vlnylidene chloride. (Ill) Polymers Identified in para graphs (aXl) <i) and <U) of this section containing no more than S weight-percent of total polymer units derived by copolymerization with one or more of the following monomers: and/or copolymers of ethyl acrylate and methyl methacrylate, and not more than 30 weight-percent of poly, mer units derived from copolymers of methyl methacrylate, a-methylstyrene and acrylonitrile and may optionally contain up to 15 weight-percent of polymer units derived from butadiene^ styrene copolymers. (c) No chemical reactions, other than addition reactions, occur among Acrylic acid. the vinyl chloride polymers and the 1.3-Butylene glycol dlmethacryl&te. Divlnylbenzene. Methacrylie acid. modifying polymers present in the polymer mixture used in the manufac ture of the finished plastic food-con (iv) Mixtures of polymers identified tact article. in paragraph (aXl) (i), <ii>, and (ill) of f (d) The finished plastic food-contact this section; provided that no chemical article, when extracted with the sol reactions, other than addition reac vent or solvents characterizing the tions, occur when they are mixed. type of food and under the conditions, (2) Polymers identified in paragraph of time and temperature characteriz-*' (aXl) of this section combined during ing the conditions of Its intended use their polymerization with butadiene- as determined from Tables 1 and 2 of styrene copolymers; provided that no 8 176.170(c) of this simpler, yields ex- chemical reactions, other than addi tractives not to exceed the limits pre^ tion reactions, occur when they are scribed in 8 177.1010 (b) (1), (2), (3); combined. Such combined polymers and (4) of thio chapter when tested by may contain 50 weight-percent or \ the methods prescribed in 8 177.1010 more of total polymer units derived ) (c) of this ohapter.^./ * from the butadiene-styrene copoly mers. (b) The polymer content of the fin ished plastic food-contact article con sists of: (e) Acrylonitrile copolymers identi fied in this section shall comply with' the provisions of $ 180.22 of this chap- ter. j (1) Not less than 80 weight-percent of polymer units derived from the vinyl chloride polymers identified in the introduction to this section and not more than 5 weight-percent of polymer units derived from polymers identified in paragraph (aXl) of this section and may optionally contain up 178.3800 Preservatives for wood. Preservatives may be safely used on wooden articles that are used or in-^ tended for use in packaging, transport-, ing, or holding raw agricultural prod^ ucts subject to the provisions of thisjTM section: ^ to 15 weight-percent of polymer units (a) The preservatives are prepared derived from butadiene-styrene co from substances Identified in polymers; or graph (b> of this section and applied ini (2) Not less than 50 weight-percent amounts not to exceed those necessary^ of polymer units derived from the to accomplish the technical effect oj vinyl chloride polymers identified in protecting the wood from decay, the introduction to this section, not mildew, and water absorption. more than 50 weight-percent of poly (b) The substances permitted are as' mer units derived from homopolymers follows; Ltt of tancM r Hr Umittfiona thw 50% at ttw aoM* 'si 8 Food and Drug pwotoum hyOocrtoa copotynwriimion at icycSc. and moraba at oaefcad paMawa PantKMoropfMnoi and 9178J850 Reuri Reinforced a as an article o: intended for u factoring, pad porting, or hole provisions of tt (a) Reinforce leum wax to v certain options its production, sired physical c (b) The qu&o juvant substan duction of or a does not exce< ably required tended physics any limitation (c) Any subs production of ing any option: subject of a r 175, 176. 177, I chapter, confer tion in such re* (d) The subs juvant substsj production of wax include: (1) Substanc as safe In food. i(2) Substance tion for use used in accords or approval. (3) Substance paragraph and tions provided Erucamid* (erucyfendi W-OiQfOy<8tf|n* 366 cm Ch. I (4-1-90 Edition) ; food and Dwg Administration, HHS 1713650 frvanf by weight of stfiyttoo propytons 6[on eomplytog wh j 177.1520 at Ms i of aucti polymers in the lorni in uoiii 0.005 inch. I parpen by weight of olefin polymare jtnro chapter, under condition* o<(MA r 2 at f 178.170(C) at Ms chap**. | uaiM by waighT oi polystyrene and . Ut comply Wi 1177.1640 o( Ms chn>- ju*ysfTana and robbat-modMad polyaly. 1-- condtoons described in | T7-iro(c) i ccmMons o4 um E through Q. by weight oi elastomers used in 600 o4 thd chapter. B ' weight o4 nylon raaina complying tolad, That the finished polymer at uaa E, F. 6 deathbed to ' e by weight oi poiycarbonala rerine A tppiar. t percent by weight oi polystyrene and Wmers complying wen 9 177.1640 oi Ms Ironed polymer contacts food only under ' F. G. and H described in Table 2 at b percent by weight of olefin polymers ot ms chapter. asm 1.1. 1.2. or tx percent by weight oi olefin polyriiars M Ms chapter, dam 2-1. 22. Z3. 3.1. or mpiytog with Earn 2.1. 22. or 2J3 haring n per n*ic centimeter and a thickness - (' nch). shat contact toad orty F G described in Tebie 2 of meant by weight oi ethytene-rinyl aceleto 177.1360 of Ms chapter, and that are tood only under corofitione oi uaa E, F. : oi 1176.170(e) Oi this charter. The ymera in the form in which they contact nritonetar (0.004 inch). : percent by weight of olefin polymers oi this chapter, item 4. The finished reeter than 0.051 nrifimater (0.002 inch), condkions oi uee E. F. and G described iis chapter. aroant by weight oi aeryfic and modMed rigid, complying with f 177.lOtO of Mb 0.1 percent by weight oi isobutylene .1420 o> Ms chapter. ) 175.105 of Me chapter, percent by weight of presets* sensdtwe >.125 of Ms chapter, percent by weight of cen end cement | l75-300(bK3) (xxri) of this chapter, percent by weight of side seem cement ? 175.300(b)(3) (mdi) of this chaptw. percent by weight ot pefaolem aficycSe i with i 1?S-320(bK3) o* this chapter, parcent by weight el petroleum aficydo hydrogenated produets comptying wdh rocent by weight oi resins and polymers this chapisr. percent by weight of resins and roeto &2tO(dH3) of Ms chapter. 5 percent by weight ot closures wMt 1177.1210 of this chapter. 0.S percent by weight of peboitoto* and rosin derivative* complying wrih TrirffrmethyM hydro*y-5-rerMutytphenyt)butan* (CAS Reg. NO. 1843-03-4). Zinc dbutyidhhiocerbamate (CAS Reg. 14a 13623-2). 2). At levels not to sxceefl 0.5 parcent by weight of rronfoiiod wen complying wNh ) 1793650. 22. At levels not to exceed 0.5 percent by weight ol olefin copolymer* complying with f 177.1520(c) of Ms chapter. Mam 3.3 Hie finished pofyraar* may be used to contact with food under conations of gee A through H JuscriLuJ in Table 2 of 1176.170(c) of this chapter. For use only: 1. At levels not to exceed 02S percent by weight d polymer* used as provided to f 176.180 of Me chapter. 2. At level* not to exceed 0-25 percent by weight of the lofiowing polymers when used to articNe tost contact food of Types I, tf. IV-fl. Vl-e, VU-g, and VlN described to Table i of f 176.170(c) of Ms chapter Olefin polymers complying with 1177.1520(c) ol He chapter, items 11. 1.2. 12. 2.1. 22. 22. 3.1. 3A 3.3, or 4 or complying wfih other sectiorro to Pwts 174, 175. 176, 177. 178 wxt 1170.45 of Mi chapter rinyf chloride polymers; end/or rinyl cMoride eopotymam complying with f 177.1960 of this chapter. 3. At levels not to exceed 0.1 percent by 'might ol the toiowtog poiymars whan used to articles toat contact food of Types M, tv-A. V. vt-A, vwx vtt-A, and W dasofted to Table t of 1176.170(c) of Me chapter Olefin polymers complying with f 177.1520(6) of this chapter, items 1.1. 1.2, 1.3, 2.1, 22, 2.3. 3.1. 3.2. 3J. or * or complying wMt other sections in Parts 174. 175. 176. 177. 178 art f 179.45 of MB chapter vinyl chloride poiymars; and/or rinyl chloride copolymers coniplytofl with f 177.1960 of He chapter. 4. As provided in f 175.105 of Ms chapter. 5. At levels not to exceed 04) percent by weight of polystyrene and/or modffied polystyrene polymers identified in 1177.1640 of Ms chapter. 6. At leva* not to exceed 0-25 percent by weight o> scrytontofie butadeneistyrene copolymers ussd in contact with nunelrnriufit toads 7. At levels not to exceed 1 parcent by weight of dosurs seafingjisjijn compositions complying with 1177.1210(b) of this chapter. For use only; 1. At levels not to exceed 02 percent by weight ol ijUrtyter>aiSQpisiis copolymers complying with f 177.1420 of Ms chapter Prodded. That the finished copolymers contact food only of tot types ilsndfisd in 1176.170(c) of this chapter. Table 1, under Types V, W. Vlk. and DC 2. At levels not to exceed 0-02 percent by weight of polypropylene polymers complying wrth f 177.1520(c). item 1.1 of H chapter. For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copolymers corrHymg with f 177.1900 of this chapter Amfcbrf That total saficytetaa (cataiatod as the add) do net exceed 0.3 parcent fay weight ol such polymers. 1 Copies are ausfiabls from fits American Society lor Tasting and Materials. 1816 Racs Street. PtHadetph**. Pa. 19103. (42 PR 14609. Mar. IS, 19771 Editorial Notc For Fideral Register citations affecting i 176.2010, see the List of CFR Sections Affected in the Finding Aida section of this volume. S17&2556 4-Hydroxymthyl-2,&-<U-terfbutylphenoL 4-Hydroxymethyl-2,8-dl-ferf-butyiphenol may be safely used as an anti* oxidant In articles intended for use in contact with food. In accordance with the following prescribed conditions: (a) The additive has a solidification point of 140"-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-i gram per square inch of food-contact' surface. 176.2660 Organotin stabilizers in vinyl chloride plasties. 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 S 177.1950 or S 177.1980 of this chapter and that are idtffllilledjffQr use m contact with food oi types n, in, IV (except liquid milk), V, VI (except malt beverages and carbonated TKftBET- 327 178.2650 21 CFR Ch. I (4-1-90 Edition) oxide meeting the specifications pre 7coholic beverages). VII, VIII, and IX described in table 1 of $ 176.170(c) of this chapter/except 101* t'fie orgaflOtln chemical identified in paragraph (aK3) scribed for dl(n- octyl) tin dichloride or di(n-octyl) tin oxide in paragraph (a)(1) of this section. of this section, which may be used In (3) Alkyl mercaptoacet&tes re contact with food of types I through action products with dichlorodloctyi- IX at temperatures not exceeding 75 stannane and trichlorooctylstannane C (167 *F), and further that the or- (CAS Reg. No. 83447-69-2) is an organ ganotin chemicals identified in para otin chemical mixture having 10.8 to graphs (a) (5) and (6) of this section 11.8 percent by weight of tin (Sn) and may be used in contact with food of having 8.0 to 8.6 percent by weight of types I through IX at temperatures mercapto sulfur. It is made from a not exceeding 66 *C (150 *F>, condi mixture of di(n-octyl)tin dichloride tions of use D through G described In and (n-octyl)tin trichloride which has table 2 of 1 176.170(c) of this chapter, an organotin composition that is not and further that dodecyltin chemicals less than 95 percent by weight di(n- identified in paragraph (a)(7) of this octyDtin dichloride/(n-octyl)tin tri section which may be used in contact chloride. and not more than 1.5 per with food of types I, II, III, IV (except cent by weight of tri(n*octyl)tin chlo liquid milk), V. VI (except malt bever ride. The alkyl radical in the mercap ages and carbonated nonalcoholic bev toacetate is derived from a mixture of erages), VII, VIII, and IX described in saturated n-alcohols which has a com table 1 of I 176.170(c) of this chapter position that is not less than 50 per at temperatures not exceeding 71 *C cent by weight tetr&decyl alcohol, and (160 *F), in accordance with the fol that is not more than 50 percent by lowing prescribed conditions: weight total of decyl alcohol and/or T3J purpose of this section, dodecyl alcohol, and/or hexadecyl al the organonn chemicals are those cohol. L1XUH1 ill l&ragraphs (a) (1), (2), (3), (4) (n-Octyl)tin S,S'S" trlsdsooctyl- (4), (5), (6), and (7) of this section. mercaptoacetate) is an octyltin chemi (1) Di(n-octyl)tln S,S'-bis(lso-oc- cal having the formula n- tylmer-captoacetate) is an octyltin C.HiiSn(SCHtCOsCHu h (CAS Reg. chemical having 15.1 to 16.4 percent No. 26401-86-5) having 13.4 to 14.8 by weight of tin (Sn) and having 8.1 to percent by- weight of tin (Sn) and 8.9 percent by weight of mercapto having 10.9 to 11.9 percent by weight sulfur. It is made from di(n-octyl)tin of mercapto sulfur. It is made from (n- dichloride or di(n-octyl)tin oxide. The octyl)tin trichloride. The isooctyl radi isooctyl radical in the mercaptoacetate cal In the mercaptoacetate is derived is derived from oxo process lsooctyl al from oxo process isooctyl alcohol. The cohol. Di(n-octyl)tin dichloride has an (n-octyl)tin trichloride has an organo organotin composition that is not less tin composition that is not less than 95 than 95 percent by weight of dl(n- percent by weight of (n-octyl)tin tri octyl)tin dichloride and not more than chloride and not more than 5 percent 5 percent by weight of tri(-octyl)tin by weight of tri(n-octyi)tIn chloride. chloride. Di(n-octyl)tin oxide has an (5) Bis( beta-carbobutoxyethyl)tln organotin composition that is not less bisdsooctylmercaptoacetate) (CAS than. 95 percent by weight of dl(n- Reg. No. 63397-60-4) is an estertln octylHin oxide and not more than 5 chemical having 14.0 to 15.0 percent percent by weight of bis[trl(n- by weight of tin (Sn) and having 7.5 to octyUtin] oxide, and/or mono h-octyl- 8.5 percent by weight of mercapto tin oxide. ' sulfur. It is made from bis(beta- (2) DKn-octyl) tin maleate polymer carbobutoxyethyDtln dichloride. The is an octyltin chemical having the for lsooctyl radical in the mercaptoacetate mula [(C.Hit)sSnC.H0]l (where n is is derived from oxo process primary between 2 and 4 inclusive), having 25.2 octyl alcohols. The bis(6ea- to 26.6 percent by weight of tin (Sn) carbobutoxyethyDtin dichloride has and having a saponification number of an organotin composition that is not 225 to 255. It is made from di(n- less than 95 percent by weight of octyDtln dichloride or di(n-octyl)tin bls( bea-carbobutoxyethyl)tin dichlo- 328 21S44C2Z