Document 10B240V343np645a2Ga6bLkvq

FEB-19-92 WED 14:03 eiF atochem Elf Atochem North America Inc. Throe Parkway, Philadelphia, PA 19102 Tel: (215) 507-7000 P. 02 19 February 1992 Ms. Connie Dillon THE B.F. GOODRICH COMPANY Dept: 5458 6100 oak Tree Blvd. Independence, Ohio 44131 FAX: 216-447-6459 Dear Ms. Dillon, Per our conversation today, the Elf Atochem North America, Inc. product Thermolite* 890S is an octyltin stabilizer certified for use in food applications as specified in 21 CFR section 178,2650 Organotin Stabilizers in 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. Product Safety Specialist cc: Steve Hulme Tom Bole M 0 t*G T Z FEB 19 '92 14:04 15 BFG14968 PPRP WO FEB-19-92 WED 14:03 eiF atochem Elf Atochem North America Inc. Three Parkway, Phfocfelphia. PA 10102 Tel: (215) 687-7000 P.01 ELF ATOCHEM NORTH AMERICA, INC. THREE PARKWAY PHILADELPHIA, PENNSYLVANIA 19102 FAX NUMBER: (215) 587-6605 THIS DOCUMENT IS TO BE DELIVERED TO: NAME: C#yurL4lt, " fcfCt 21 b -4^7- DATE: J-Omju olu^ /_ FROM: yceu _____________________ NUMBER OF PAGES (Including cover): & COMMENTS: ^PjA) UJS' If there is a problem with the fax transmission, call (215) 5877917. FEB IS '92 14:04 BFG14969 PAGE.001 00 o> 0Z.6WDtia n (7/0/ '/// '--- - --, ~ -- r~*72*/(-7ps'~yys>~n? Ty^/^tzyyy 'vyr ~~r~&Y} x^QJ" #f/'/// ( o 'SZ/Ji ~2 %/ Is//y^p /<y 'yyc&-v3sjy*^' i-pqyp* ^Ky fO O^r /LLf' Off *)U SO 0*7/ 'si /  178.3800 21 CFR Ch. I (4-1-90 Edition) ; Food and Drug Acrylonitrile. and/or copolymers of ethyl acrylate; Butadiene. a-Methylstyrene. Styrene. Vinylidene chloride. (iii) Polymers identified in paragraphs (a)(1) (1) and (ii) of this section containing no more than 5 weight-percent of total polymer units derived by copolymerization with one or more of the following monomers: and methyl methacrylate, and not more than 30 weight-percent of poly-1 mer units derived from copolymers of methyl methacrylate, o-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 petroleum hydrocarbon copolymerization or abcyclic. and monobe of cracked petrotem Pentacriloroprienof and Rosins and rosin derwv Zinc salt of sutfonaiee f 178.3850 Reinf Li Acrylic acid. 1,3-Butylene glycol dimethacrylate. the vinyl chloride polymers and the ' modifying polymers present in the Reinforced Divinylbenzene. Methacrylic acid. (iv) Mixtures of polymers identified polymer mixture used in the manufac-; ture of the finished plastic food-con- f| tact article. as an article o: intended for u facturing, pad in paragraph (a)(1) (1), (ii), and (iii) of ( (d) The finished plastic food-contact ' this section: provided that no chemical article, when extracted with the sol-`; porting, or hol< provisions of tl reactions, other than addition reac vent or solvents characterizing the (a) Reinforce tions, occur when they are mixed. type of food and under the conditions, leum wax to v (2) Polymers identified in paragraph of time and temperature characteriz-)' certain optiona (a)(1) of this section combined during ing the conditions of its intended use its production, their polymerization with butadiene- as determined from Tables 1 and 2 of: sired physical c styrene copolymers: provided that no 5 176.170(c) of thic-ohqpter. yields ex-', (b) The Quan chemical reactions, other than addi tractives not to exceed the limits pre-t juvant substan tion reactions, occur when they are scribed in 177.1010 (b) (1), (2), (3)?; duction of or s combined. Such combined polymers and (A) of this chapter when tested by does not excei may contain 50 weight-percent or the methods prescribed in 177.1010 more of total polymer units derived ) (c) of this ohwpter.^./ ably required tended physics from the butadiene-styrene copoly mers. (b) The polymer content of the fin ished plastic food-contact article con sists of: (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 (e) Acrylonitrile copolymers identi fied in this section shall comply with' the provisions of 180.22 of this chap-' ter. : 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-? any limitation (c) Any subs production of ing any option: subject of a r 175, 176, 177, : chapter, confo: tion in such ref (d) The subs juvant substaj identified in paragraph (a)(1) of this ucts subject to the provisions of this^ production of section and may optionally contain up section: $j wax include: to 15 weight-percent of polymer units (a) The preservatives are prepared, (1) Substanc derived from butadiene-styrene co from substances identified in para as safe in food. polymers: or graph (b) of this section and applied in^ (2) Substanc* (2) Not less than 50 weight-percent amounts not to exceed those necessary; tion for use i of polymer units derived from the to accomplish the technical effect of; used in accord: vinyl chloride polymers identified in protecting the wood from decay,-j or approvaL the introduction to this section, not mildew, and water absorption. (3) Substand more than 50 weight-percent of poly (b) The substances permitted are as paragraph and mer units derived from homopolymers follows: tions provided List of substances Copper-8-quinolinolate_, Mineral spirits_________ Paraffin wax___________ Used singly or in combination so as to constitute not toy than 50% of the solids. Erucamide (erucytamidE yV-Oiolooytothytenedk 366 N BFG14911 IFR Ch. I (4-1-90 Edition) xw* toy weight of ethyteoe-propyteoe-5ater* complying with $ 177.1520 of this <** of >ch polymers in the form in 01 exceed 0.005 inch. percent by weight of olefin pofymere tms chapter, under conditions of use A 2 of $ 176.170(c) of this chapter. percent by weight of polystyrene and st comply with $ 177.1640 of this chap, polystyrene and rubber-modified polystyme conditions described in 176.170(c) conditions of use E through G. eroent by weight of elastomers used to 5177.2600 of this chapter. nt by weight of nyton resins complying otnr: Provided. That the finished polymer aborts use E. F. and G described to chapter. srcent by weight of polycarbonate resins rxs Chapter. : percent by weight of polystyrene and ymers complying with $ 177.1640 of this isned polymer contacts food only under l F. G. and H described in Table 2 of b percent by weight of olefin polymers of this chapter, item 1.1. 1.2. or 1.3. percent by weight of olefin polymers af this chapter. Hem 2.1, 2.2, 2.3. 3.1, or mpfying with Hem 2.1, 2.2, or 2.3 having n per cubic centimeter and a thickness inch), shall contact food only G described in Table 2 of vcent by weight of ethylene-vinyl-acetate 177.1350 of this chapter, and that are food only under conditions of use E. F, ot $ 176.170(c) of this chapter. The ymers in the form to which they contact millimeter (0.004 inch). : percent by weight of olefin polymers of this chapter, item 4. The finished reater than 0.051 millimeter (0.002 inch), conditions of use E, F, and G described ms chapter. ercent by weight of acrylic and modified rigid, complying with $ 177.1010 of this 0.1 percenl by weight of isobutylene .1420 of this chapter. } 175.105 of this chapter, percent by weight of pressure sensitive j. 125 oi this chapter, percent by weight of can end cement 175.300(b)(3) (xxxi) of this chapter, percent by weight of side seam cement 17S.300(b)(3) (xxxii) of this chapter, percent by weight of petroleum aficycfic i with j 175.320(b)(3) of this chapter. percent by weight of petroleum alicycfic hydrogenated products complying with ercent by weight of resins and polymers this chapter. percent by weight of rosins and rosin 6210(d)(3) of this chapter. 5 percent by weight of closures with 9 177.1210 of this chapter. 0.5 percenl by weight of petroleum ; and rosin derivatives con*>fying with ] . , ` food and Drug Administration, HHS 178.2650 limitations 21. At levels not to exceed 0.5 percenl by weight ol reinforced wax complying with $ 178.3650. 22. At levels not to exceed 0.5 percent by weight ol olefin copolymers complying with 177.1520(c) of Ihis chapter. Hem 3.3. The finished polymers may be used in contact with food under conditions of use A through H described in Table 2 of 176170(c) of this chapter. TrisiS-methyM-hydroxy-S-ferf-butylphenyObutane (CAS Beg No. 1643-03-4). For use only: 1. At levels not to exceed 0.25 percent by weight of polymers used as provided in 176.160 of this chapter. 2. At levels not to exceed 025 percent by weight of the following polymers when used to articles that contact food of Types I. II. IV-Q, Vi-B. vil-B, and VIII described in Table 1 of 176.170(c) ol this chapter Olefin polymers complying with 177.1520(c) of this chapter, Hems 1.1, 1.2, 1.3, 2.1, 22. 2.3. 3.1. 3-2. 3.3. or 4 or complying with other sections in Parts 174. 175, 176, 177. t78 and 179.45 of this chapter, vinyl chloride polymers; and/or vinyl chloride copolymers complying with 177.1900 of this chapter. 3. At levels not to exceed 0.1 percent by weight of the following polymers when used to articles that contact lood of Types III, IV-A, V, Vl-A, Vl-C, Vll-A, and IX described in Table i of 176.170(c) of this chapter Olefin polymers complying with 177.1520(c) of this chapter, items 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 to Parts 174, 175. 176. 177, 178 and 179.45 of this chapter vinyl chloride polymers; and/or vinyl chloride copolymers complying with 177.1960 of this chapter. 4. As provided in 175.105 cf this chapter. 5. At levels not to exceed 0.2 percent by weight of polystyrene and/or modified polystyrene polymers identified to 177.1640 of this chapter. Zinc dibutykjithiocaibamate (CAS Reg. No. 13623-2). 6. At levels not to exceed 0.2S percent by weight of acrylonitritobutadiene-styrene copolymers used in contact with nonaicohofic foods. 7. At levels not to exceed 1 percenl by weight of closure-seatingjjaskBt__ compositions complying with 177.1210(b) of this chapter. For use only: 1. At levels not to exceed 0.2 percent by weight of isotoutyleneisoprene copolymers complying with 177.1420 of this chapter Provided, Thai the finshed copolymers contact food only of the types identified to 176.170(c) of this chapter. Table 1. under Types V, VII. VIII, and IX. 2. At levels not to exceed 0.02 percent by weight of polypropylene polymers complying with 177.1520(c), item 1.1 of this chapter. Zinc palmitate.. Zinc salicylate.......... ................. .........-................... -....... For use only in rigid potyvinyt chloride and/or in rigid vinyl chloride copolymers complying with 177.1980 of this chapter: Provided. That total salicylates (calculated as the acid) do not exceed 0.3 percent by weight of such polymers. Zinc stearate... Copies are avalable from the American Society for Testing and Materials, 1916 Race Street, Philadelphia. Pa. 19103. [42 PR 14609. Mar. 15,19771 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-di-er- butylphenol. 4-Hydroxymethy]-2,6-di-er-butylphenol may be safely used as an antioxidant 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 artiy cle does not exceed a total of 0.5 milli-i gram per square inch of food-contactx surface. 178.2650 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 S 177.1950 or $ 177.1980 of this chapter and that are idenillied^loruse" in contact with food of types I, II, III, IV (except liquid milk), V, VI (except malt beverages and carbonated nonal- 327 BFG14972  178.2650 21 CFR Ch. I (4-1-90 Edition) coholic beverages), VII, VIII, and IX / oxide meeting the specifications pre- described in table 1 of 176.170(c) of scribed for di(n- octyl) tin dichloride this chapter/'except for t'Ke~orgaftOtln~ or di(n-octyl) tin oxide in paragraph chemical identified in paragraph (a)(3) (a)(1) of this section. of this section, which may be used in (3) Ci,,-,,-Alkyl mercaptoacetates re contact with food of types I through action products with dichlorodioctyl- 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 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 octyl)tin 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 tetradecyl 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 i!u FgTThe purpose of this section, dodecyl alcohol, and/or hexadecyl al the organo/in chemicals are those cohol. 11MWU HI Paragraphs (a) (1), (2). (3), (4) (n-Octyl)tin S.S'S' tris(isooctyl- (4), (5), (6), and (7) of this section. mercaptoacetate) is an octyltin chemi (1) Di(n-octyl)tin S,S'-bis(iso-oc- cal having the formula n- tylmer-captoacetate) is an octyltin C.H,7Sn(SCHaCOIC.H,,)3 (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 isooctyl 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 di(n- percent by weight of (n-octyl)tln tri octylltin dichloride and not more than chloride and not more than 5 percent 5 percent by weight of tri(n-octyl)tin by weight of tri(n-octyl)tin chloride. chloride. Di(n-octyl)tin oxide has an (5) Bis(6efa-carbobutoxyethyl)tin organotin composition that is not less bis(isooctylmercaptoacetate) (CAS than. 95 percent by weight of di(n- Reg. No. 63397-60-4) is an estertin octyi)tin oxide and not more tlian~5 chemical having 14.0 to 15.0 percent percent by weight of" bis[tri(n- by weight of tin (Sn) and having 7.5 to octylltinl oxide, and/or mono h-octyl- 8.5 percent by weight of mercapto I tin oxide. ' sulfur. It is made.. from bis( beta- (2) Di(n-octyl) tin maleate polymer carbobutoxyethyDtin dichloride. The is an octyltin chemical having the for isooctyl radical in the mercaptoacetate mula [(CJItOiSnC.HjO.]. (where n is is derived from oxo process primary between 2 and 4 inclusive), having 25.2 octyl alcohols. The bis(beta- to 26.6 percent by weight of tin (Sn) carbobutoxyethyl)tin 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 octylltin dichloride or di(n-octyl)tin bis(beta-carbobutoxyethyl)tin dichlo- 328 21S44G2Z BFG14973 W.6frIOd8 21544023 '^^jn3Trrfo lT*r^ft US/^crry -y^-TTV ^o -*-o -'-* -**- yq Q _j^>tvv7T^ ~f^X? ^ g, j(, / z-7 "m-v^ * Z^- (?n<^ -, ~y?^y~v7' yriiy /'fz-vjj JD Y04 ~>^>^~' Q o--j ^ o - -8*91 -oj*/x ^`>7Ti/A' VQ^ -^r^r? T<? VVxl lo~/*)0 -i^l-0^1 X ~^~np '^ojf' 'T ^-^^'r^i'iTi/ Q> rfjO'lftnHkfifJO- /*)Q-g*)/- QjrJ X W~ MO'S*)/-QCJ'X O - I 9 0-J2P~ 'fTM *7:?n/y(ij: / 'P jy /? // ^ltpy x 01