Document 3JMbk0wkvNjQpKpK6GD7bodNx

. BUSINESS CONFIDENTIAL PROJECT REPORT STATUS OF UCC COATINGS RESINS UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AUTHORS: Z. E. Ster SUPERVISOR; w. B. Ackart DATE: April 17, 1980 PROJECT NO.: 321N01 FILE NO.. 6614 SUMMARY The food additive status of various UCC coatings resins is discussed in this report and lists of specific products suitable for food contact uses are given. The dynamic nature of our products prevents such lists from being all-inclusive for more than a few days so that for completely up-to-date information, this office should be consulted directly. Also, since products acceptable for food packaging are not automatically suitable for packaging drugs and cosmetics, the requirements for drug and cosmetic packaging are reviewed briefly. Those products additionally cleared with the USDA for use in meat and poultry processing are also discussed. R search and Development Department Chemicals and Plastics Union Carbida Corp ration Bound Brook N ew lorrf'v UCC 102509 DISCUSSION I. Food Packaging Applications The Federal Food, Drug, and Cosmetic Act administered by the FDA in the Department of Health, Education, and Welfare provides for the safe use of chemicals in foods. So-called inci dental food additives are those which may result from inadvertent migration during the processing or packaging operations. Since these are specifically included in the 1958 Food Additives Amend ment, plastic materials used in food contact applications must comply with the provisions of the law. There are four general categories of materials suitable for food contact uses. These include substances which (1) do not migrate to the food, (2) are generally recognized as safe, (3) were sanctioned by FDA for food contact use prior to the enactment of the amendment, or (4) are permitted by regulation under the amend ment. The regulation most important for coatings materials is 21 CFR 175.300 for resinous and polymeric coatings, which lists hundreds of substances which may be used as components of coatings. The regulation also provides for extraction limitations on the finished food contact coating under intended end use conditions. An excerpt of 175.300 xs given in the Appendix. This regulation was one of the earliest regulations issued by the FDA and resulted from a petition filed by the Can Manufacturers Association. It has been amended three times as a result of petitions filed by UCC covering our VERR and QEX-2033 (an experimental latex) resins. All listings are by chemical identity rather than trade names. Regulations 176.170 for components of paper in contact with aqueous and fatty foods and Regulation 177.1210 for closures refer to 175.300 for lists of acceptable materials so that resins cleared for coatings are also suitable for paper and closures. Both regulations include extraction limits on the finished article under intended use conditions. Regulation 176.180 for components of paper in contact with dry foods includes substances listed in 176.170 plus many additional materials, but does not include extraction specifica tions since migration to dry foods is conceded to be nil. Regulation 21 CFR 175.105 for adhesives lists in excess of 1000 substances suitable for use in food packaging adhesives and contains no extraction limitations but prohibits direct contact with food except for trace amounts at seams and edge exposures. Our customers for these coating resins who fabricate items intended for use in contact with foods are entitled to a written statement from us certifying that our products are suitable for use in contact with foods. All such letters originate from this office and will be sent in response to a written or telephone request. A sample copy is also given in the Appendix. 1025JO -3- II. The following sections contain excerpt s from 175.300 which describe various classes of resins and the chemical identity of its approved members. Lists of UCC resins which are covered are also given. (VI) Phenolic Resins (vl) Phenolic resins as the tonic poly mer formed by reaction of phenols with formaldehyde: <c) Phenolic resins formed by reac tion of formaldehyde with: Alkylated (methyl, ethyl, propyl. Isopropyl. butyl) phenols. p-(*r(-Amylph*nol. 4,4'-*ec-Butylidenedtphenol. p-torr-Buiylphenol. o-, m-. and p-Cresol. p-Cyciohtxylphenol. 4.4 -lsopropylldenedlphenol. p-Nonyiphenoi. p-Octylphenol. J-Ptntadeeyl phenol mixture obtained from csjhew nut shell liquid. Phenol. Phenyl o-cre*ot. p-Phenylphenol. Xylenol. (6) Adjunct for phenolic resins: Alu minum butyUte- Phenolic Resins BK-5918 BKR-2620 BKS-2555 BKS-2600 BKS-2602 BKS-2750 BKUA-2370 BLS-2700 CK-0036 CK-1282 CK-1634 CK-1636 CK*2103 CK-2400 CK-2432 CKU-2266 UCC 102511 -4(VIII) Epoxy Resins (vllO Epoxy retina, catajysta. and ad juncts: <a) Epoxy resins, as the basic poly mer: (AJkoxy C,,-C,,>2,3-eposypropane. in which the alkyl croups are even numbered and consist of a maximum of 1 percent C carbon atoms and a minimum of 48 percent C,, carbon atoms and a minimum of II per cent C,, carbon atoms, for use only in coatIncs that are Intended for contact with dry bulk foods at room temperature. 4.4-*ee-BuiytldenedJphenol-eplchlorohydrin 4.4 -sec-Buiylldenedlphenol-eptchlorohydrln reacted with one or more of the drying oils or fatty acids listed In paracraph <bX3Kl> of this section. 4.4-iec-Betylldenedlphenol-eplchlorohydrln chemically treated with one or more of the following substances: Ally! ether of mono-, dt-, or ulmethylol phenol. 4.4-sec-ButylldenedlphenoI-formaldehyde. 4.4'-IsopropyUdenedlphenol-lonaaldehyde- Melamine-formaldehyde. Phenol-formaldehyde. Urea-formaldehyde. Epoxldlsed polybuudiene. Olyrldyl ether* formed by resctlns phenolnovolak resins with eplchlorohydrln. 4.4-Isopropylldenedlphenol-eplchlorohydrin. 4.4-Uopropylldenediphenol-eplchlorohydrln reacted with one or more of the drying oils or fatty acids listed In parasraph <bX3xu of this section. 4.4-lsopropylidentdiphenol-epichlorohydrln chemically treated with one or more of the following substances: Allyl ether of mono-, dk or trlmethylol phenol. 4.4 -sec-Butylldenedlphenol-formaldehyde. 4.4-Isopropylldenedlphenolformaidehyde. Melamine-formaldehyde. Phenol-formaldehyde. Urea-formaldehyde. <fc> CstslysU and cross-linking agents for epoxy resins: Cyanocuanldine. Dlbutyl phthslate. for use only In coatings for container* having a capacity of 1.000 gallons or more when suen containers are Intended for repeated use In contact with alcoholic beverages containing up to I per cent of slcohol by volume. Dietnylenetriamlne. Dlphenylsmlne Ethylenediamlne. Isophthsiyi dihydrsiide for use only in costings subject to the provisions of para graph (c><3) or <41 of this section. 4.4 -MethylencdlaniUnc. for use only In coat ings for container* having a capacity of 1.000 gallons or more when such contain era are intended for repealed use In con tact with alcoholic beverages containing up to I percent of alcohol by volume. Af-Oleyl-l.l-propanedlamine with not more than 10 percent by weight of dtethylaminoethenol Polyamlne produced when 1 mole of the ehlorohydrin diether of polyethylene glycol 400 is made to react under dehydrohalogenattng conditions with 3 mn)es of M-octadecyltrimethylencdlamlne for use only In coatings that are subject to the provisions of parasraph (c) (3) or (4) of this section and that contact food at temperatures not to exceed room tempera ture. Salicylic acid, for use only In costings for containers having s capacity of 1,000 gal lons or more when such container* are in tended for repeated use In contact with al coholic beverages containing up to 8 per cent of alcohol by volume. Stannous 3-cthylhcxanostc for use only as s catalyst ai a level not to exceed l percent by weight of the resin used In costings that are Intended for contact with food under conditions of use D. E. P, and C de scribed In table 3 of paragraph (d) of this section. Styrene oxide, for use only In coatings for container* having s capacity of 1.000 gal lons or more when such container* are In tended for repeated use In contact with al coholic beverages containing up to 8 per cent of alcohol by volume. Tetraethylenepcntamlne- Tetraethylenepenumlne reacted with equi molar quantities of fatty acids. / TrKdtmeihylaminomeihyl) phenol and Its salts prepared from the fatty acid mole ties of the sails listed in paragraph (bXSxxxllxb) of this section, for use only In coatings subject to the provisions of paragraph <c > < 3) or < 4 > of this section. Trtelhyleneietramine. Trimelllilc anhydride for use only as a cross-linking agent at a level not to exceed 15 percent by weight of the resin Intended for use only in contact with food under conditions of use D, E, P. and Q described In table 3 of paragraph <d> of this section. (e) Adjuncts for epoxy resins: Aluminum butylate. ensoic acid, for use as a component In epoxy mins tor coatinss not exceeding a costing weight of 4 milligrams per square inch and that are intended tor contact under conditions of use D, E, P or O de scribed In table 2 of paragraph <d> or this section with alcoholic beverages contain ing leas than I percent alcohol. Polyamides from dimerized vegetable oils and the amine catalysts listed In para graph (bKSKvUixb) of this section, as the basic polymer. Succinic anhydride, for use as a component in epoxy resins for costings nol exceeding a coating weight of 4 milligrams per square inch, and that are intended for contact under conditions of use D. E. P or O described in table 2 of paragraph (d> of this section with alcoholic beverages con taining Isas than percent alcohol. Phenoxy Resins PKHA PKHC PKHH PKHJ UCC 102512 -5- (XV) Vinyl Resinous Substances ^ -- > , -y <xv> Vinyl resinous substance, u the basic polymer*: Pclyvlny) utUU Polyvinyl alcohol Polyvinyl butyml Polyvinyl chloride. Polyvinyl formal. Polyvinyllden* chloride. Polyvinyl pyrrolldone. Polyvinyl aiearate. Vinyl chlorlde-amaU-34-epoxypropyl methacrylate copolymer* containing not more than 10 weight percenl of total poly mer untu derived from 2.4-epoxypropyl methacrylate and not more than 4.1 weight percenl of unreacted 2,2-epoxypro- pyl methacrylate monomer for uae In coating* for container*. vinyl chlorideacetate, hydroxyl-modified copolymer- VInyl chloride-acetate, hydroxyl-modified copolymer, reacted with tfimelliUc anhy dride. Vinyl chloride copolymerlaed with acryla mide and ethylene in auch a manner that the futUhed copolymer* have a minimum wet*hi average molecular welehl of JO.000 and contain not more than 1.4 weight per cent of total polymer units derived from acrylamide: the acrylamide portion may or may not be subsequently partially hy drolyied Vinyl chloride copolymcrteed with one or more of the following aubatancei Acrylonitrile. Pumaric acid and/or lu methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl. or octyl eaten Maleic acid and/or tie methyl, ethyl. propyl, butyl, amyl, hexyl, heptyl. or octyl eaten. >-Norbomene-2.1-dtcarboxylic acid, mono-abutyl eater: for uac auch thu the finkhed vinyl chloride copolymen contain not more than 4 welcht percent of total polymer unite derived from thie comon omer. Vinyl acetate. Vlnylldene chloride. Vinyl chlortde-vinylldene chlortde-2.3-epoxypropyt methacrylate copolymer* containbig not more than 10 weight percent of total polymer unite derived from J.l-epoxypropyl methacrylate and not more than 0.04 weight percent of unreacted 2.4-epoxypropyl methacrylate monomer baaed on polymer aolid* for uae only In eoaling* for eoniainera Intended for contact with food* under conditions E. C. D. X. P. Q. or H deecrlbed in Table 3 of paragraph id) of Uile section. <--- '<-- e.__ i I Vinyl Acetate Resins AYAA AYAB* AYAC* AYAF AYAT Vinyl Butyral Resins XYHL XYSG Vinyl Chloride Acetate Resins VAGD VAGH VERR-40 VMCA VMCC VMCH VYDS VYDS-66 VYHD VYHH VYLF VYNS UCC vinyl acetate resins AYAB and AYAC are also cited by chemical identity in Title 21 CFR 172.615 for chewing gum base. AYAB and AYAC meet the specifications for polyvinyl acetate given in the Food Chemicals Codex and may therefore be used as components of chewing gum. UCC 102513 -6- Although vinyl resins have recently been suspect because of the chronic toxicity associated with vinyl chloride monomer, their use as coatings materials has never been questioned by the Food and Drug Administration. In their proposal of 1973 which has never been either implemented or withdrawn, the FDA confirmed the safe use of vinyl resins as coatings, gaskets and cap liners, flexible tubing, and plasticized films and indicated the continued validity of regulations permitting these uses (see Section I). Union Carbide has continually been in touch with the FDA regarding continued use of our vinyl resins in coating applications and is presently preparing a report for submission to the FDA describing an extensive study which documents the low level of residual monomer in these resins, demonstrates that monomer levels are drastically reduced in the solution coating process, and concludes that use of these resins in food contact coatings would not reasonably be expected to result in monomer becoming a component of foods. Ill. Drug Packaging Products that comply with appropriate food additive regulations are not automatically qualified for packaging drugs and pharmaceuticals. There are no blanket clearances for drug packaging materials comparable to the food additive regulations. Bach drug package must be proven to be both safe and effective for the particular drug involved, usually through long-term storage and stability tests. These data are included as part of the New Drug Application which the drug manufacturer must file with the Food and Drug Administration before he can market his product. XV. Cosmetic Packaging Again, there are no blanket clearances for cosmetic packaging materials as there are for food packaging materials. Sec. 601 of the General Regulations states that a cosmetic shall be deemed to be adulterated if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. Under this regulation any packaging material that complies with the food additive reg ulations is also suitable for packaging cosmetics. In addition, many products which are not suitable for food contact uses may be perfectly safe for cosmetics. In this case it is necessary to consider the toxicity of the questionable component, together with its tendency to extract into the cosmetic and, in consultation with the UCC Law and Medical Departments, determine whether the product is suitable for use in the particular application. Ques tions regarding specific products should be directed to us. UCC 102514 -7- V. Meat and Poultry Packaging The Wholesome Meat Act and the Wholesome Poultry Act provide for Federal Inspection of meat and poultry packaging plants by the Food Safety and Quality Service (FSQS) of the U.S. Depart ment of Agriculture (formerly known as the MID, MIB, and aphis). All raw materials used in such establishments must be "approved" individually by the FSQS. For packaging materials that comply with the FDA food additive requirements, USDA clearance is almost auto matic and we receive a letter from them indicating that the specific product is chemically acceptable provided that it is functionally effective. We provide a copy of this letter to our customer which ultimately is filed at the packing plant for scrutiny of the USDA Inspector. These clearances are obtained at the customer's request and normally, require four to six weeks. We have obtained letters of acceptability for the following active products: Phenolic Resins Vinyl Acetate Resins CK-0036 CK-1634 CK-2103 CK-2400 CK-2432 Phenoxy Resins PKHC PKHJ AYAA Vinyl Chloride Acetate Resins VAGD VAGH VMCC VMCH VYHD VYHH VYNS It is intended that this report will be updated at periodic intervals or as required. If we can be of further help, please contact us. ZES:bs 9-A-16 UCC 102515 APPENDIX 1. Regulation 175.300 2. Sample customer letter UCC 102516 } 175.270 IK. -(M mmi On*, panediol In each extracting solvent 1175X04 RmIbmm mm4 polymeric coat not to exceed 0.3 micrograma per ings. square Inch of food-contact surface. In testing the finished food-contact arti cles. a separate test sample la to be used for each required extracting sol vent. Resinous and polymeric coatings may be safely used as the food-contact surface of articles intended for use In producing, manufacturing, packing, processing, preparing, treating, pack | ITUn Polyfvlnyl fluoride) mins. aging. transporting, or holding food, in accordance with the following pre Poly(vinyl fluoride) resins identified in this section may be safely used as components of food-contact coatings for containers having a capacity of not leas than 5 gallons, subject to the pro visions of this section. fa) For the purpose of this section, poly(vinyl fluoride) resins consist of basic resins produced by the polymer isation of vinyl fluoride. <b) The polyfvtnyl fluoride) basic resins have an Intrinsic viscosity of not less than 0.7S deciliter per gram as de termined by ASTM Method D 1243-60, modified as follows: scribed conditions: (a) The coating Is applied as a con tinuous film at enamel over a metal substrate, or the coating Is Intended for repeated food-contact use and Is applied to any suitable substrate as s continuous fUm or enamel that serves ss a functional barrier between the food and the substrate. The coating is characterized by one or more of the following descriptions: (1) Coatings cured by oxidation. (2) Coatings cured by polymeriza tion. condensation, and/or cross-link ing without oxidation. (1) Solvent: MJV-Dlmethylacetamlde, (3) Coatings prepared from prepoly technical grade. merized substances. (2) Solution: Powdered resin and sol vent are heated at 120' C until the resin Is dissolved. (3) Temperature: Plow times of the solvent and solution are determined at 110' C. (b) The coatings are formulated from optional substances that may In clude: (1) Substances generally recognized as safe In food. (2) Substances the use of which is (4) Viscometer Cannon-Ubbelohde size 50 semlmlcro dilution viscometer (or equivalent). (5) Calculation: The calculation method used Is that described In ap pendix Al.2.2 (ASTM Method D 124366) with the reduced viscosity deter mined for three concentration levels, not greater than 0.5 gram per deciliter, and extrapolated to zero concentration for intrinsic viscosity. The following formula is used for determining re duced viscosity: permitted by regulations In this part or which are permitted by prior sanc tion or approval and employed under the specific conditions. If any, of the prior sanction or approval. (3) Any substance employed In the production of resinous and polymeric coatings that Is the subject of a regu lation In Subchapter B of this chapter and confonhs with any specification In such regulation. Substances named in this paragraph (b)(3) and further identified as required: Reduced viscosity In terms of deciliters per gram (o/(o* c (i> Drying oils, including the trigly cerides or fatty acids derived there from: Where: (^Solution efflux time. (o = Solvent efflux time. c- Concentration of solution In terms of rams per deciliter. Beechnut. Candlenut. Castor (Including dehydrated). Chinawood Uung). Coconut. UCC 102517 530 Chapter I food and Drug Administration $175X00 Com. Cottonseed. Fish (re(lned). Hempseed. Linseed. Oltlclca. Perllla. poppyseed. Pumpklnseed. Safflower. Sesame. Soybean. Sunflower. Tall oil. Walm' The oils may be raw, heat-bodied, or blown. They may be refined by filtra tion, degumming, acid or alkali wash ing. bleaching, distillation, partial de hydration. partial polymerization, or solvent extraction, or modified by combination with maleic anhydride. (II) Reconstituted oils from triglycer ides or fatty acids derived from the oils listed In paragraph (bX3Xi) of this section to form esters with: Butylene glycol. Ethylene glycol. Fentaerythntol. Polyethylene glycol. Polypropylene glycol. Propylene glycol. Sorbitol. Trlmethylol ethane. TrlmethyloJ propane. (iii) Synthetic drying oils, as the basic polymer: Butadiene and methylstyrene copolymer. Butadiene and styrene copolymer, blown or unblown. Maleic anhydride adduct of butadiene sty rene. Poly butadiene (iv) Natural fossil resins, as the basic resin: Copal Damar. Elrmj Gilsonite. Gljcerol ester of dmar. copal, eleml. and s&ndarac. Sandarac Shellac. Utah coal resin (v) Rosins and rosin derivatives, with or without modification by polymer ization. Isomerization, incidental de carboxylation. and/or hydrogenation, as follows: (a) Rosins, refined to color grade of K or paler: Oum rosin. Tall oil roaln. Wood rosin. (b) Rosin esters formed by reacting rosin (paragraph (b)(3) (v)(a) of this section) with: 4.4` -sec-Bu tylIdenedlphenol-epl c hioroh ydrln (epoxy). Diethylene glycoi. Ethylene glycol. Glycerol. 4.4'-IsopropyIidenedipheno1-eplchloroh ydrIn (epoxy). Methyl alcohol. Pentaerythrilol. (c) Rosin esters (paragraph (b)(3) (v)(b) of this section) modified by reac tion with: Maleic anhydride c. m . and p substituted phenol formalde hydes listed in paragraph (bX3i(vi) of this section. Phenol-formaldeh yde. id) Rosin salts: Calcium resinate (limed rosin). Zinc resinate (vl) Phenolic resins as the basic poly mer formed by reaction of phenols with formaldehyde (a) Phenolic resins formed by reac tion of formaldehyde with: Alkylated (methyl, ethyl, propyl, isopropyl, butyl) phenols p (ert-Amylphenol. 4.4 sec Butylidenediphenol p-ferf-Butylphrnol. o . m-. and p Cresol p-Cyclohexylphenol 4.4 Isopropylidenediphenol. p Nonylpheno! p Octylphenol 3-Penladecyl phenol mixture obtained from cashew nut shell liquid Phenol fhieny 1 o-cresoi P PI >en> iphruol Xylenol. 531 9 175.300 HH# 31 Food and Drugs ) lb) Adjunct tor phenolic resins: Alu minum butylate. <vi() Polyester resins (including slkyd-type). as the basic polymers, formed as esters of acids listed in para graph (bX3Mvll) (a) and (6> of this sec tion by reaction with alcohols In para graph (b)(3) (vli) (c) and (d) ot this section. (a) Polybasic acids: fd> Monohydric alcohols: Cetyl alcohol. Decjrl alcohol, louryl alcohol. Myrlatyl alcohol. Octet alcohol. Bleary] alcohol. <vlii> Epoxy resins, catalysts, and ad iuncts: (a) Epoxy resins, ss the basic poly mer. Adipic. Dimerized fatty acids derived (rom oil* listed in paragraph (bxJKI) of this sec tion. DlphenoUc add. Fumarlc. Isophthallc. Maleic. Orthophthallc. Sebaclc. Terephthallc. Terpene-malelc acid adduct. TrlmelUtlc. lAikoxy C,,-C..>-;,3-cpoxypropane. In which the alkyl groups are even numbered and consist of a maximum of 1 percent C,, carbon atoms and a minimum of 48 per cent C,, carbon atoms and a minimum al 18 percent C,, cs'bon atoms, for use only In coatlnga that tie Intended tor contact with dry bulk foods at room temperature. 4.4'sec-ButyUdenedlphenol-eplchlorohydrin. 4,4'-sec-ButyUden*dipheoo)-eplcblorohy<irlr reacted with one or more of the drying oils or fatty acids listed In paragraph <bX3XI) of this section. 4.4' -sec-Betylldenediphenol -eplchlorohy drln (b) Monobasic acids: chemically treated with one or more ol the following substances: Benzoic acid. Allyl ether of mono-, di-. trimethylol phenol. (er(-Butyl benzoic acid. Fatty adds derived from oils listed in para graph ibXSXI) of this section. Rosins listed In paragraph <bx3KvKal of this section, tor use only as reactants in oil-based or fatty add-baaed alkyd retina 4.4-rec-ButylldenediphenolfornJaldehyde 4.4'-lsopropylldenedlphenolform aldehyde. Melamine-formaldehyde. Phenol-formaldehyde. U res-formaldehyde. (c) Polyhydric alcohols: Epoxidlzed polybutadiene. Glycfdyl ethers formed by reacting phenol- Butylene glycol. Diethylene slycol. 2.3-Dlmelhyl-l. J-propanediol for use only in forming polyester resins for coatings In tended for use In contact with non-alcohollc foods. Ethylene glycol. Glycerol. Mannitol. a-Methyl glucoside. Pentaerythrltol. Propylene glycol. novolak resins with eplchlorotiydrin. 4.4-Isopropylldenediphenol-eplchlorohydrln. 4.4-IsopropylidenedIphenol-epichlorohydrln reacted with one or more of the drying oils or Istty acids listed In paragraph (b3Xi) of this section. 4.4Isopropylidenedi p h eno] -epic hi oroh ydrln chemically treated with one or more of the following substances: Allyl ether of mono-, dl-, or trimethylol phenol. 4.4'-*ec-Butyltdenedtphenolformaldehyde. Sorbitol. 4.4-Isopropylldenedlphenol- Trlethyien.* glycol, for use as a component In polyester resins (or coatings not exceed ing a coating weight of 4 milligrams per (ormaldehyde. M elamine- tormaldehyde. Phenol- tarmaldeh yde square inch and 'hat are intended (or con U rea-1ormaldeh yde. tact under conditions of use D. E. F or G described in table 3 ol paragraph cd) of this section with alcoholic beverages con (b) Catalysts and agents for epoxy resins: cross-linking taining less than 8 percent alcohol. Tilmethylol ethane. Trimethylol propane. Cyanoguan idine. Dibutyl phthalate. for use only in coatings for containers having a capacity of 1.000 Chapt r I--food and Drug Administration 175.300 gallons or more when such containers are Intended for repeated use In contact with alcoholic beverages containing up to B per cent of alcohol by volume. Die thylenetrlamlne. Dlphenylamine. Eihylenedtamine. bophthalyl dlhydrazlde for use only in costings subject to the provisions of para graph <c> (3) or (4) of this section. 4.4 -Methylenedianlltne. for use only in coat ings for containers having a capacity of 1,000 gallons or more when such contain ers arc intended for repeated use In con tact with alcoholic beverages containing up to 8 percent of alcohol by volume. N-Oleyl-l,3-propanediamlne with not more than 10 percent by weight of dlethylamtn- oethanol. Polyamine produced when 1 mole of the chlorohydrln dlether ol polyethylene glycol 400 is made to react under dehydrohalogenatlng conditions with 3 motes of N-octadecyilrimethytencdismtne lor use only In coatings that are subject to the provisions of paragraph tc) (3) or (4) of this section and that contact food at temperatures not to exceed room tempera ture. Sailcylic acid, tor use only in coatings for containers having a capacity of 1.000 gal lons or more when such containers are in tended fnr repeated use In contact with al coholic beverages containing up to 8 per cent of alcohol by volume. Stannous t-elhylhexanoate for use only as a catalyst at a level not to exceed t percent by weight of the resin used in coatings that are Intended for contact with food under conditions of use D, E. F. and G de scribed in table 3 of paragraph (dl of this section. Styrene oxide, for use only In coatings for containers having s capacity of 1.000 gal lons or more when such containers are intended for repeated use tn contact with al coholic beverages containing up to 8 per cent of alcohol by volume. Te(raet bylenepentaroine. Tetraethylenepentamine reacted with equi molar quantities of fatty acids Trudimethylaminomethyl) phenol and its salts prepared from the tatty acid moie ties of the salts listed in paragraph <bitsMxxiiKbi of this section, for use only tn coalings subject to the provisions of paragraph (cl (31 or 14) of this section 1 riethyienetetramlrie Tr:ine!lttic anhydr.de for us? only as a coss linking agent al a level not to exceed 15 percent by weight of 'he resin intended lor use only in conlact with food under conditions of use D. E. F. and G described In table 3 of paragraph (dr of this section, (c) Adjuncts for epoxy resins: Aluminum butylste Benzoic acid, for use as a component in epoxy resins for costings not exceeding a coating weight of 4 milligrams per square Inch and that are Intended for contact under conditions of use D. E. F or G de scribed In table 3 of paragraph (d) of this section with alcoholic beverages contain ing less than 9 percent alcohol. Polyamides trom dimerized vegetable oils and the amine catalysts listed tn para graph (bxSMvtllH b) of this section, as the basic polymer. Succinic anhydride, for use as a component in epoxy resins (or coatings not exceeding a coating weigh: of 4 milligrams per square Inch, and that are Intended for contact under conditions of use D, E. F or G described In table 3 of paragraph (d) of this section with alcoholic beverages con taining less than 8 percent alcohol. (ix) Coumarone-indene resin, as the basic polymer. (x) Petroleum hydrocarbon resin (cyclopentadiene type), as the basic polymer. (xl) Terpene resins, as the basic polymer, from one or more of the fol lowing: Dipentene. o-Plnene. 0Pinene. (xii) Urea-formaldehyde, resins and their curing catalyst: (a) Urea-formaldehyde resins, as the basic polymer: Urea formaldehyde. Urea-formaldehyde chemically modified with methyl, ethyl, propyl. Isopropyl. butyl, or isobutyl alcohol. Urea-formaldehyde chemically modified with one or more of the amine catalysts listed in paragraph (b)OxvlllHb) or tilts section. <b> Curing (cross-linking) catalyst lor urea-formaldehyde resins: Dodecyl benzenrsulfonlc acid 1C A. Registry No 21116 81-0). (xiii) Triazine-formaldehyde resins and their curing catalyst: (a) Triazine-formaldehyde resins, as the basic polymer: UCC 102518 532 533 5 175.300 TM 21--food and Drugs Benzoguanamine-formaldehyde. Puxnarlc acid and/or its methyl, ethyl, Ketamine-formaldehyde. propyl, butyl, amyl, hexyl, heptyl. or octyl Ketamine-formaldehyde chemically modi esters. fied with one or more of the followlna amine catalysts: Maleic acid and/or Ils methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or Amine catalysts listed In paragraph octyl esters. (bxaxvUIKb) of this section. 5-Norbomene-2.3-dicarboxylic acid, morto-n- Dimethylamlne-3-methyl-l-prapanol. butyl ester for use such that the fin Methylpropanolamlne. Triethanolamine. Melamine-formaldehyde chemically modi fied with methyl, ethyl, propyl. Isopropyl, butyl, or Isobutyl alcohol. (6) Curing (cross-linking) catalyst for triazlne-formaldehyde resins: ished vinyl chloride copolymers contain not more than 4 weight percent of total polymer units derived from this comon omer. Vinyl acetate. Vlnyltdene chloride. Vinyl chlorlde-vlrtylldene chloride-2.3-epoxypropyl methacrylate copolymers contain Dodecyl bensenesulfonlc acid (C.A. Registry No. rrns-rr-o). ing not more than 10 weight percent of total polymer units derived from 2,3-epox ypropyl methacrylate and not more than (xlv) Modifiers (for oils and alkyds. Including polyesters), as the basic polymer Butyl methacrylate. Cyclopentadiene. Methyl, ethyl, butyl, or octyl esters of acryl 0.05 wright percent of unreacted 2.3-epox ypropyl methacrylate monomer based on polymer solids for use only In coatings for containers Intended for contact with foods under conditions B. C, D. E. F. O, or H de scribed In Table 3 of paragraph (d) of this section. ic acid. Methyl methacrylate. Styrene. (xvl) Celluloslcs. as the basic poly mer: Vinyl toluene. Carboxyme th yIcell ulose. (xv) Vinyl resinous substance, as the Cellulose acetate. basic polymers: Polyvinyl acetate. Polyvinyl alcohol. Polyvinyl butyrai. Polyvinyl chloride. Polyvinyl formal. Polyvlnylldene chloride. Polyvinyl pyrrolldone. Cellulose acetate-butyrate. Cellulose acetate-propionate Ethylcellulose. Ethyl hydroxyethylcellulose. Hydroxyethylcetl ulose. Hydroxypropyl methylcellulose. Meth yIcell ulose. Nitrocellulose. Polyvinyl stearate. (xvil) Styrene polymers, as the basic Vinyl chlorldeacetate-2.3-epoxypropyl polymer: methacrylate copolymers containing not more than 10 weight percent ol total poly mer units derived from 2.3-epoxypropyl methacrylate and not more than 0 1 weight percent of unreacted 2.3-epoxypro pyl methacrylate monomer for use in Polystyrene. a Methyl styrene polymer. Styrene copolymerized with one or more of the following: Acrylonitrile. coatings for containers. a-Methylstyrene. Vinyl chloride-acetate, hydroxyl-modified copolymer. Vinyl chloride-acetate, hydroxyl-modified (xviil) Polyethylene and its copo lymers as the basic polymer: copolymer, reacted with trimellftlc anhy dride. Vinyl chloride copolymerized with acryla mide and ethylene in such a manner that the (irtlshed copolymers have a minimum weight average molecular weight of 30.000 and contain not more than 3.5 weight per cent of total polymer units derived from Ethylene-ethyl acrylate copolymer. Ethylene-isobutyl acrylate copoljmers con taming no more than 35 weight percent of total polymer units derived from isobulyl acrylate Ethylene-vinyl acetate copolymer Polyethylene. acrylamide: the acrylamide portion may (xix> Polypropylene as the basic or may not be subsequently partially hy drolyzed polymer: Vinyl chloride copolymerized with one or Polypropylene. more of the following substances: Maleic anhydride adduct of polypropylene Arrylomlrile The polypropylene used in the manufac UCC 102519 534 Chapter I--food and Drug Administration 9 175.300 lure of the adduct compiles with 1177.1520(c). Item 1.1; and the adduct has s maximum combined maleic anhydride content of 0.8 percent and a minimum In trinsic viscosity of 0.0. determined at 135` C on a 0.1 percent solution of the modified polypropylene In decahydronaphthalene as determined by a method available on request from the Commissioner of Food and Drugs. (xx) Acrylics and their copolymers, as the basic polymer Acrylamide with ethylacrylate and/or sty rene and/or methacryllc acid, subsequent ly reacted with formaldehyde and buta nol. Acrylic acid and the following esters there of: Ethyl. Methyl. Butyl aerylate-styrene-methacry11c acld-hy- droxyethyl methacrylate copolymers con taining no more than 20 weight percent of total polymer units derived from metha cryllc acid and containing no more than 7 weight percent of total polymer units de rived from hydroxyethyl methacrylate: for use only In coatings that are applied by e lectrodeposition to metal substrates. Butyl acrylate-styrene-methacryllc acld-hydroxypropyl methacrylate copolymers containing no more than 20 weight per cent of total polymer units derived from methacryllc acid and containing no more than 7 weight percent of total polymer units derived from hydroxypropyl metha crylate: for use only In coatings that are applied by electrodeposition to metal sub strates and that are Intended for contact, under condition of use D, E. F, or G de scribed In table 2 of paragraph (d) of this section, with food containing no more than b percent of alcohol. Ethyl . :rylate-styrene-methacry lie acid co polymers for use only as modifiers for epoxy resins listed In paragraph <b)(3)(vlil)(q) of this section. Ethyl acrylate-methyl methacrylate-styrene-methacryllc acid copolymers for use only as modifiers for epoxy resins listed In paragraph (bX3XvillXa) of this section ! Elhylhexyl acrylate-ethyl acrylate copo lymers prepared by copolymerization of iethylhexyl acrylate and ethyl acrylate in a 7/3 weight ratio and having a number average molecular weight range of 5.800 to 6,500 and a refractive Index. n,," HQ percent In 2.2.4-trlmethyl pentane) of 14130-1.4190, for use as a modifier for nylon resins complying with 1 177.1500 of this chapter and for phenolic and epoxy resins listed In paragraph ibii3) (vl) and 1 vlIt i of thla section, respeclti ely. at a level not to exceed 1.5 percent of the coaling 2-Ethylhexy! acrylate-methyl methacrylate- . acrylic acid copolymers for use only as modifiers for epoxy resins listed In para graph (bK3Kvill> of this section. Methacryllc add and the following eaten thereof: Butyl. Ethyl. Methyl. Methacryllc acid or Its ethyl and methyl esters copolymertzed with one or more of the following: Acrylic acid. Ethyl acrylate. Methyl acrylate. n-Bulyl acrylate-styrene-methacryllc acldhydroxyethyl methacrylate copolymers containing no more than 2 weight percent of total polymer units derived from meth acryllc acid and containing no more than 9.5 weight percent of total polymer units derived from hydroxethyl methacrylate: for use only In coatings In contact with dry food (food type VIII In table 1 of para graph tdt of this section). 2-lDlmethylamtno) ethanol (C.A.S. Registry No. 10801-0) may be employed as an optional ad luvant substance limited to no more than 2 weight percent based on polymer solids In the coating emulsion. (xxl) Elastomers, as the basic poly mer Butad)ene-acrylomtrlle copolymer. Butadiene-acrylonitrlfe-styrene copolymer. Butadiene-styrene copolymer. Butyl rubber. Chlorinated rubber. 2-Chloro-1,3-butadiene (neoprene). Natural rubber (natural latex or natural latex solids, smoked or unsmoked). Polyisobutylene Rubber hydrochloride. Styrene-isobutylene copolymer. (xxii) Driers made by reaction of a metal from paragraph (bx3)(xx!i)(a> of this section with acid, to form the salt listed in paragraph <bX3)(xxll>(b) of this section: (a) Metals: Aluminum Calcium. Cerium Cobalt. Iron Lithium Magnesium ManganeseZinc Zirconium (b) Salts: Caprate. 535 UCC 102520 ^^5.300 Till* 21--Food and Drugt Caprylate. Ixodecanoale. Unoleale Ntphthenate. Neodecanoate. Octoate i2-ethylhexoate). Olrate. Palmi tate. Resinate. Riclnoleate. Soyate. Stearate. siloxanes having up to and including i sitoxy units. Silicones tnot leas than 100 centlstokes us cosityl: Dimethylpolyslloxanes and/or methyIphenylpolysiloxanes limited to use only on metal substrates. The methylphenylpolysiloxanes contain not more than 3.0 percent by weight of cyclo siloxanes having up to and including 4 alloxy units. (xxvi) Pigments and colorants: TaUal*. Aluminum. (xxiii) Waxes: Aluminum hydrate. Paraffin. Type I. Paraffin. Type II. Polyethylene. Sperm oil. Spermaceti. Aluminum and potassium silicate (mica). Aluminum mono-, dt-. trlslearate. Aluminum silicate (China clay). Barium sulfate. Bentonite. Bentonite, modified with dimethyl dioctadr (xxiv) Plasticizers: cyl ammonium ton. Burnt umber. Acetyl trfbutyl citrate. Calcium carbonate. Acetyl trlelhyl citrate. Calcium silicate. Butyl phthalyl butyl slycolate. Calcium sulfate. Butyl stearate. Carbon black (channel process). p-terf-Sutyl phenyl salicylate. Cobalt oxide-aluminum oxide. Dibutyl sebacate. Dtatomaceous earth. Diethyl phthalale. Iron oxides. Diisobutyl adipate. Magnesium oxide. Dtlsooctyl phthalale Magnesium silicate (talc). Epoxidized soybean oil f iodine number Phthalocyanine blue tC.I. pigment blue 15. maximum 14: oxirane oxygen content 6% C.I. Ho. 74160). minimum), as the basic polymer. Raw sienna. Ethyl phthalyl ethyl glycolate. Silica. 2-Ethylhexyl diphenyl phosphate. Tarlrazine lake (certified FD&C Yellow So dl-2Ethylhexyl phthalale. 5 only). Glycerol. Titanium dioxide. Glyceryl monooleate. Titanium dioxide-barium sulfate. Glyceryl triacetate. Titanium dioxide-magnesium silicate. Monoisopropyl citrate. Zinc carbonate. Propylene glycol. Zinc oxide. Sorbitol. Mono-, dr. and trlstearyl citrate (xxvfi) Surface lubricants: Triethyl citrate. Triethylene glycol. 3(2-Xenox y I)-1,2-epox y propane. Cottonseed oil and other edible oils. Dibutyl sebacate. Dioctyl sebacate. txxv) Release agents, as the basic polymer, when applicable: Glyceryl monostearate. Lanolin Mineral oil, white. W.Af-Distearoyl rthylenedlamine. Palm oil. Linoleic acid amide. Paraffin. Type I. Oleic actd amide. Paraffin. Type II. Palmitic actd amide. Petrolatum. Petrolatum Stearic acid. Polyethylene wax. Polyoxyethylene glycol monooleate tmol. wt. of the polyoxyethylene glycol moiety greater than 300). (xxviii) Silicones and their curing catalysts: (o) Silicones as the basic polymer: Polytctrafluoroethylene. Silicones (not less than 300 centlstokes vis cosity) Dimethylpolyslloxanes and/or methylphenylpoiyslloxanes. The Siloxane resins originating from methyl hydrogen polysiioxane, dimethyl potysilox ane. and melhylphenyl polysiioxane. melh>lphenylpolysiloxanes contain not (i>) Curing (cross-linking) catalysts more than 2.0 percent by weight of cyclo- for silicones (the maximum amount of 536 Chapter I--Fo d and Drug Adminiltrati n & 175.300 tin catalyst used shall be that required to effect optimum cure but shall not exceed 1 part of tin per 100 parts of sllox&ne resins solids): DibulyJtin dilaurate. Stannous oleate. Tetrabutyl tltanate. (xxix) Surface active agents: Poly (2-(dlethylamJno) ethyl metharylatel phosphate (minimum intrinsic viscosity In water at IS* C U not less than g.O decili ters per gram aa determined by ASTM Method D 1243-60). for use only as a sus pending agent in the manufacture of vinyl chloride copolymers and limited to use at levels not to exceed 0.1 percent by weight of the copolymers. Sodium dioctyl sulfosucclnale. Sodium dodecyl benzenesul/onate. Sodium laury) sulfate. (xxx) Antioxidants: Butylsted hydroxyanisole. Butylated hydroxytoluene. Gum gualac. Diiauryl thiodipropionate. NordlhydroguaJaretlc acid. Propyl gallate. Dlstearyi thiodipropionate. Thiodipropionlc acid. 2.4.5-Trihydroxybutyrophenone. (xxxl) 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 177.1210(b)(5) of this chapter, the following may be used: Butadiene-styrene- fumaric acid copolymer. 4.4'-Butylidenebis (8-tert-butyl-m-cresol). Dibenzamido phenyl disulfide. Df-B-naphthyl phenylenediamine. Dlpentamethylene thfuram tetrasulfide. Isobutylene-ksoprene-divinylbenzene copo lymers for use only at levels not to exceed IS percent by weight ot the dry cement composition. Naphthalene sulfonic acid-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. Sodnim 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 ol not less than 5 gallons. Sodium 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. * Sodium phenylphenale. Tetrakls I methylenet 3.3 di (erf - butyl - 4 - hy- droxyhydroclnnamate)! methane for use aa an antioxidant at levels not to exceed 0.05 percent by weight of isobutylene-Isoprenedlvlnylbenzene copolymers In the cement. Tetrasodium EDTA ttetrasodlum ethylenediaminetetraac elate l. Tri (mixed mono- and dlnonylphenyl) phos phite. Zinc dibutyldtthtocarbamate. (xxxil) Side seam cements: In addi tion to the substances listed In para graph (b)(3) (I) to (xxx). Inclusive, of this section, the following may be used. pfert-Bulyl perbenzoate as a catalyst for epoxy resin. epsilonCaprolactam-l ethylene-ethyl acry late) graft polymer. Dicumyt peroxide for use only as polymer ization catalyst. Dllaodecyl phthalale for use only as plasti cizer in side seam cementa for containers Intended for use in contact with food only of the types Identified in paragraph id) of this section, table 1. under categories I. II, and VI. Ethyi toluene sulfonamide. Polyamides derived from the following acids and amines: Acids: Adipic. Azelaic. Sebacic. Vegetable oil acids (with or without di merization 1. Amines: Dlethylenetriamine. Diphenylamine. Elhylenediamine. Hexamethylenediamme Tetraethylenepentamine. Tnethylenetetrarmne. Sodium 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. Toluene sulfonamide formaldehyde resin (basic polymer). Trielhylene glycol methacrylate for use only as polymerization cross-linking agent in side seam cements for containers in tended for use In contact with food only of the types identified in paragraph id) of this section, table 1. under categories I. II. and VI. Urea (xxxiii) Miscellaneous materials: Ammonium citrate 537 $ 175.300 TWo 21 --Food and Drugs Ammonium potassium phosphate. Calcium acetate. Calcium ethyl acetoacetate. Calcium glycerophosphate of monomer acids) and ethytenedia mine, as the basic resin, for use only in coatings that contact food at tempera Calcium, sodium, and potassium oleates. tures not to exceed room temperature. Calcium, sodium, and potassium riclnoleatea. Calcium, sodium, and potassium stearates. Castor oil. hydrogenated. Cetyl alcohol. Cyclohexanone-formaldehyde resin pro duced when 1 mole of cyclohexanone la made to react with 1.05 moles of formalde hyde such that the finished resin has an (xxxv) Polyamide resins having g maximum acid value of 5 and a maxi mum amine value o! 8.5 derived from dimerized vegetable oil acids (contain lng not more than 10 percent of mon omer acids), ethylenedtamine, and 4.4- bis (4-hydroxyphenyl) pentanoic acid (in an amount not to exceed 10 per average molecular weight of 000-010 as de cent by weight of said polyamide termined by ASTM Method D3503. For use only in contact with nonalcoholic and nonfatty foods under conditions of use C. F. and O. described In table 3 of para graph (d) of this section. Decyl alcohol. Disodlum hydrogen phosphate. resins): as the basic resin, for use only In coatings that contact food at tem peratures not to exceed room tempera ture provided that the concentration of the polyamide resins in the finished food-contact coating does not exceed 5 Ethyl acetoacetate. milligrams per square Inch of food- Lauryl alcohol. contact surface. Lecithin. Magnesium, sodium, and potassium citrate. Magnesium glycerophosphate Magnesium stearate. Mono-, dl-. and trtcalcium phosphate. Monodibutyiamfne pyrophosphate as se- queatrant for Iron. (xxxvi) Methacrylonltrile grafted polybutadiene copolymers containing no more than 41 weight percent of total polymer units derived from methacrylonitrile; for use only in coat ings that are Intended for contact, Mono-, dt-. and trlmagneslum phosphate. under conditions of use D. E, F. or G Myristyl alcohol. Octyl alcohol. Phosphoric acid. Polybutene, hydrogenated: complying with the Identity and limitations prescribed by 1 170.3740 of this chapter. Polyl ethylene oxide). described in Table 2 of paragraph (dt of this section, with food containing no more than 8 percent of alcohol. (c) The coating in the finished form in which it is to contact food, when ex tracted with the solvent or solvents Sodium pyrophosphate. characterizing the type of food, and Stannous chloride. Stannous stearate. Stannous sulfate. Slearyt alcohol. Tetrasodium pyrophosphate. Tridecyl alcohol produced from teirepropylene by the oxo process, for use only as a processing aid in polyvinyl chloride resins. Vinyl acetate-dibutyl maleale copolymers under conditions of time and tempera ture characterizing the conditions of its intended use as determined from Tables 1 and 2 of paragraph (d> of this section, shall yield chloroform-soluble extractives, corrected for zinc extrac lives as zinc oleate. not to exceed the following: produced when vinyl acetate and dlbutyl maleate are copolymerized with or with out one of the monomers: Acrylic acid or glyddyl methacrylate. For use only in coatings for metal foil used in contact with foods that are dry solids with the surface containing no free fat or oil. The (1) From a coating intended for or employed as a component of a contain er not to exceed l gallon and Intended for one-time use, not to exceed 0.5 mil ligram per square inch nor to exceed that amount as milligrams per square finished copolymers shall contain at least inch that would equal 0.005 percent of 50 weight-percent of polymer units de rived from vinyl acetate and shall contain no more than 5 weight-percent of total polymer units derived from acrylic add or glyddyl methacrylate. ixxxiv) Polyamide resins derived from dimerized vegetable oil acids (containing not more than 20 percent the water capacity of the container, in milligrams, divided by the area of the food-contact surface of the container in square inches. From a fabricated container conforming with the de scription in this paragraph (c)(1). the extractives shall not exceed 0.5 milli gram per square inch of food-contact UCC 102521 538 Chapter I--Food and Drug Administration 5 175.300 surface nor exceed 50 parts per million of the water capacity of the container w determined by the methods pro dded in paragraph (e> of this section. (3) From a coating Intended for or employed as a component or a contain er haring a capacity In excess of 1 gallon and Intended for one-time use. not to exceed 1.8 milligrams per square Inch nor to exceed that amount as milligrams per square inch that would equal 0.005 percent of the water capacity of the container In milli grams. divided by the area of the foodcontact surface of the container In square Inches. (3) From a coating intended for or employed as & component of a contain er for repeated use. not to exceed 18 milligrams per square inch nor to exceed that amount as milligrams per square Inch that would equal 0.005 percent of the water capacity of the container in milligrams, divided by the area of the fodd-contact surface of the container In square Inches. (4) From coating Intended for re peated use, and employed other than as a component of a container, not to exceed 18 milligrams per square inch of coated surface. (d) Tables: Turns l--Types oUood I Nonnid {pH ft 0). nutoui product*. mty ccwv feet m/I of tugA or both, and ftclixing o*-n- waiar aneiawnI of low- or high-fal contani II ACMfcc |pH SO or ba*ow}. aquaous product*, may ContftA tan ok ugar or botfi. ana ocfudng cMtn- vator amdatom of to*- or rogh-fti content HI Aqueous, kkI or nomad produces containing od Or tat. may contan tart. and rncfudng water^-of amt*non* of low- or high fai comant IV Oaay products and dotftftcaoorta A wataMn-orf amdaon. tagh or low fai B. Of^-atla amulaon, Fogh or lew fat V Low moisture tala and o*a VI BavaragaaA Contaaang alcohol B Nonatcohofec VW Qatar/ product* VUI. Ory aohda {no and test raquredt !UJ2_T*u ptocadum H* dtrriwwi9 ro wrourf trom rmous tmxnng ryp** ot loodt and bmng oauigi. ump w***"1* Eitractam Goncftriort of uaa Typed ot food (am labia 1J Water <una and lamperalura) Heptane11 ibma and l#mparatura| A Hgh temperature heat stantoed l. IV-B it g, ovar 2\T Fj Hi tV-A. VII 0 Boang water tienfcrad tl ill VII C Hot litad or pasteurized above 150" H, IV-B F Mf IV-A V 0 not f or pasteuftiad beta* i%0' ti iv-B vi-B lit IV- A V Vi-A E doom temperature Mlad and siored * n tv-B. Vl-B (no tharmaltreatment m tha con- Hi iv-a tamer} V VII VIA F Ralnqaratad Homage no Ibarmai i Ji, w. IV-A. iv-0 treatment tn Ihe container) VI-0 VII Vl-A 0 otari storage (no thermal treai J >i m iv-B vn menr tn Ihe container | h Frozen storage Beady prepared >ood? intended lo fee reoeaied *n coniauter at lime oi use 1 Aqueous or o<i m waiar emulsion i n iv-8 of n*gt ot low tat 2 Aqueous, high or tow tree c*' or 'll. iv-A yni do 212* F, XI mm do FM balmg. cool lo 100* F do 150* F 2 hr do 120' F 24 hi do 70' f 4ft tv 70' F 24 hr 212' f 30 rrun oo ISO' F. 2 hr 12C* F. 30 Ten 1 rr F 15 m- dn 100' F 30 min do 70* F 30 rmn do 1 ?Q' F }0 m*n ft pet kronen (lure and lamper atura| ISO' F 2 r.r 120' F. 24 hr 70 F 46 hr Heptane enraciant nol io t>e us*"5 on wax uc.ttd containers rtecun* mulU n-i.il M tli.oeo t a 1*0v cl I.,* r. i-'w.cxj a' r< rtiJ'l .ir, lv 1 loo<3 OOO'jO 539 5 '".300 THto 21--Food and Omg* (e) Analytical methods--( 1) Selection of extractability conditions. First as certain the type of food product (Table 1, paragraph (d) of this section} that Is being packed commercially In the test container and the normal con ditions of thermal treatment used In packaging the type of food Involved. Using Table 2 (paragraph <d) of this water rinsing equipment, consisting in Its simplest form of a Vi-Inch- v. lnch Internal diameter metal tube attached to a hot water line and bent so as to direct a stream of water upward, may be used. Be sure hot water hu reached a temperature of 190` F-200` F before starting to rinse the contain er. Invert the container over the top of section), select the food-simulating sol the fountain and direct a strong vent or solvents (demineralized dis stream of hot water against the tilled water, heptane, and/or 8 percent bottom and all sides for 1 minute, ethyl alcohol) and the time-tempera drain, and allow to dry. ture exaggerations of the container- use conditions. Aqueous products (types I, H. 1V-B, and Vl-B) require only a water-extractabllity test at the temperature and time conditions shown for the most severe "conditions of use." Aqueous products with free oil or fat. and water-oil emulsions (types III, IV-A, and VII) will require deter minations of both water extractability and heptane extractability. Low-mois ture fats and oils (type V with no free water) require only the heptane extractabiifty. Alcoholic beverages (type VI-A) require only the 8 percent alco hol extractant. Having selected the ap (4) Exposure conditions--(t) Water tZSO' F for 2 hours), simulating hightemperature heat sterilization. Fill the container within v;-tnch of the top with a measured volume of deminera lized distilled water. Cover the con tainer with clean aluminum foil and place the container cn a rack In a pres sure cooker. Add a small amount of de mineralized distilled water to the pres sure cooker, but do not allow the water to touch the bottom of the con tainer. Close the cooker securely and start to heat over a suitable burner. When a steady ^ stream of steam emerges from the vent, close the vent propriate extractant or extractants and allow the pressure to rise to 13 simulating various types of foods and pounds per square inch (250` F) and beverages and the time-temperature continue to maintain this pressure for exaggerations over normal use, follow 2 hours. Slowly release the pressure, the applicable extraction procedure. open the pressure cooker when the Adapt the procedure, when necessary, pressure reads zero, and composite the for containers having a capacity of water of each replicate immediately in over l gallon. a clean Pyrex flask or beaker. Proceed (2) Selection oj coated-container with the determination of the amount samples. For consumer-sized contain of extractives by the method described ers up to 1 gallon, quadruplicate sam in paragraph (eH5) of this section. ples of representative containers (using for each replicate sample the number ot containers nearest to an area of 180 square inches) should be selected from the lot to be examined. (3) Cleaning procedure preliminary to determining the amount of extraclables from coated containers. Quadru plicate samples of representative con tainers should be selected from the lot to be examined and must be carefully rinsed to remove extraneous material prior to the actual extraction proce dure. Soda fountain pressure-type hot (ii) Water (21? F for 30 minutes), simulating boiling water sterilisation. Fill the container within Winch of the top with a measured volume of boiling, demineralized distilled water. Cover the container with clean aluminum foil and place the container on a rack in a pressure cooker in which a small amount of demineralized distilled water is boiling. Do not close the pres sure vent, but operate at atmospheric pressure so that there is a continuous escape of a small amount of steam. Continue to heat for 30 minutes, then UCC 102522 540 q,n)r^# |--food and Drug Administration 175.300 remove the test container and compos ite the contents of each replicate im mediately in a clean Pyrex flask or beaker. Proceed with the determina tion of the amount of extractives by the method described in paragraph texSiof this section. <llf) Water (from boiling to 100* F), nmulating hot fill or pasteurisation above ISO" F. Fill the container within i,.-inch of the top with a measured tolume ot boiling, demineralized dis tilled water. Insert a thermometer in the water and allow the uncovered container to stand In a room at 70* F- 85' F. When the temperature reads 100' F. composite the water from each repiicate Immediately In a clean Pyrex flask or beaker. Proceed with the de termination of the amount of extrac tives by the method described in para graph (e)(5) of this section. (lv) Water (ISO" F for Z hours), simu lating hot fill or pasteurisation below ISO" F. Preheat demineralized distilled alter to 150* F in a clean Pyrex flask. Fill the container within y-inch of the top with a measured volume of the ISO' F water and cover with clean alu minum foil. Place the test container in (vl> Water (70' F for 48 hoursI, simu lating refrigerated storage. Bring de mineralized distilled water to 70* F In a clean Pyrex flask. Fill the container within y-lnch of the top with a meas ured volume of the 70' F water, and cover with clean aluminum foil. Place the test container in a suitable room maintained at 70' F. After 48 hours. Immediately composite the water of each replicate in a clean Pyrex flask or beaker. Proceed with the determina tion of the amount of extractives by the method described in paragraph (e)(5) of this section. (vii) Wafer (70* F for 24 hours), stmu- lating frozen storage. Bring deminera lized distilled water to 70* F in a clean Pyrex flask. Fill the container within V*-inch of the top with a measured volume of the 70* F water and cover with clean aluminum foil. Place the container In a suitable room main tained at 70* F. After 24 hours, imme diately composite the water of each replicate in a clean Pyrex flask or beaker. Proceed with the determina tion of the amount of extractives by the method described in paragraph (e)(5) of this section. (viii) Wafer (2/2" F for 30 minut *i, an oven maintained at 150* F. After 2 simulating frozen foods reheated in hours, remove the test container from the container. Fill the container to the oven and immediately composite within y-inch of the top with a meas the water of each replicate In a clean ured volume of boiling, demineralized Pyrex flask or beaker. Proceed with distilled water. Cover the container the determination of the amount of with clean aluminum foil and place extractives by the method described in the container on a rack in a pressure paragraph (e)(5) of this section. cooker in which a small amount of de (v)Water tlZO" Ffor 24 hours), simu- mineralized distilled water is boiling. lating room temperature filling and Do not close the pressure vent, but op storage. Preheat demineralized dis erate at atmospheric pressure so that tilled water to 120' F in a clean Pyrex there is a continuous escape of a small flask. Pill the container within Vi-inch amount oi steam. Continue to heat for of the top with a measured volume of 30 minutes, then remove the test con the 120* F water and cover with clean tainer and composite the contents of aluminum foil. Place the test contain each replicate immediately in a clean er in an incubator or oven maintained Pyrex flask or beaker. Proceed with at 120' F. After 24 hours, remove the the determination of the amount of test container from the incubator and extractives by the method described in immediately composite the water of paragraph (e)(5) of this section. each replicate in a clean Pyrex flask or (ix) Heptane tlSO' F for 2 hours) Jim- beaker. Proceed with the determina tion of the amount of extractives by the method described in paragraph <ex5l of this section uiating high-temperature heat steril isation for fatty foods only. Preheat redistilled reagent-grade heptane (boiiing point 208* F) carefully in a 541 5175.300 THI* 21--Fwod and Dr** (hSsadcPaccopbttnwhtmiteatsebPopahhe2onmsreiuorprhp(oeoPtuembhfseuhcooeanp0tsnlect.imhxeisviIsresboteaaefxzcptilmhpmeeptonllrac(ovcny5ctsroeolseoihnaiyiitfuenaereitArxdoetroopte)meelpI*rrusgcruaneovradsmelaeeanc,tnIlritueeue)snnnpaoeuaehtbhpnenrroetagneFtHtceotsafgnbatcdtIvhsslxm..trdcsrhteodtInSetraHwuhratossdanrn)erueeelnyitneu,ete.epmitaydntetFtihapnuhOepttoetpiiooiwetwalbhhc-erpohttefavsansi.agfoArpPgedtoeexkeelanItaioc'paeoattffecoreaetcattdenilhiiiaenerrhiaeartlyfntnlgnoPtooatokitrFlosna1meksarcemhthtaenwnolsihrhraslmsecrIdaeceoenotttdlI<5ffyddlekoanmexaaneeurstnhhfnobboefiegoo0fpkirdcaersoeb.cno-otngtunmecxerpaedocagtyeetnhe'cacroemltruaKslovewU2kaileoemalT3arhersuamo-horoetelrkrsiebr0PdeU5efrItyfhevrta0lhFe2teatccebSianfvheheeinIlbhi5apiesa)t1riattenayneqt2ito9hdanldoeatofsOhvglmp*hrolentiibh5rsimolystiryrsssnnpvaug0t"gtinvemIaeerototrf0toi*ueeepoaeh1e.t,tnoifbkaenaIrattm*ieiesid*nltFyrsFon5rvaaxmipFnteraeurpeeewrltctwlPsnlspenneey>oad0ahauFh,kinreFtuxlopmarhI,vofrunfetwahett*clrninnIfaeIoetflmem.epy-eiottoint,lnebnlenrneecoglfsstcntpehigp-ephdaotsrtoteelicdAheoyirhpohhoc.pntoetdFttiiado(rsoranstrsndaannashashc(eIeaeoouoeeteeesftrrttc,aurtrIdcnksbcinsesaeIcPiautteohSehd)msdecinknbhnfanohnehrolttrcwt(psch3oraeontmmersoeeesoeehodeefoa5PeetIvogainetuniot9mtaaenueoinnuanpaaotohiroaemuetrele)rtar1nIepoyt.rcbcirhptoh-lcurnncnkctm1anmsdfeu2efperlatlkrremornceheooatwpysbyootwmoeeruine2oFuc0eiiogtrddzaitieos..lvnoratoaoi.rneah0onepta*ruribaiefbnn1xoieaiienilizdoenirmcA*tetufaaltfg.sktbcaiheef2bltmaaFulPrehlhelnaetaeupaekhtptylekrftotns0e.ceierafaePtatt-htPtleoiwpsnqa1eirtsotomrhttoeos*earhlvilhotidxnfanoehii2eeeltinunlgl)eTunleionatdaaerieotsrrehasysekpiinoQiFt.dnhpei.iasIra,erotiInmiseimhnrsd)ckennvelnhnV*ttenso,Idfo2ediar*tdngsae-irswatoicwtcas3cpetnsivcohptlipnnhlcnl(ofe0sbhseoemrioieaiscw(oitocarbsreotpIntlcedrtocseosIvhmeopxeiesvedeaSttlhcnthllppfohesnlnecmn(enoroueseeeuihloanklaterexainsaoeoectrxspoletsroebhmoct.siamvdmisedehmlenltshstreriatnultaeonrsntutawlaekhxiuenr)ieeantpoeatrhsyputFtbenhPsmeabimn.tmlhe)irhotrttwrodastntragsrsananreraPrHmoiuipeaeghelecpiatyreoyFnIfetPpfyabutcHtireleiauitwiSrtorrhtogtndanayglnesetareoiopkogklaardecioP1mryfctihniOeyevoafreIcreitutpcntpelapeiarcdaltt0tfntrsemnarot,oelynxodegpahkoo"ihmok1ictgteorhs0sfehonvetacontcaporetpxgaosctrttendf2iemitau*oeeen,oroFteexdioanllohahoiinkhfsrofgh(nel0fhetrmrnnoctrtkexlsetpbenfwoogefeeeen,ehoF*haaeottmafetooalldiaie(kf1edhsryi)1meeoamdnirrrtrtttlfokeimbseniez(0ote(roameftnhashhF0ttsieas2s57Iel1rtk(ny)hte0et1IsIariraur0mtnspfetie1omeytv1h0nf(nimzik0eae2)eorn*i2shdafisis*n5rsp0sknito8tn0rnaetei0a"tcam0ooaluoeepehl1feFetnteed0mhiku)Ia*lal0ooc'IaFh*idnolcsvaugr2rtptwmfr*Fnoaed.tcooimeoml"e`tutnoohFeneAedn0nheumectliFoFtccyatnohtioAvraifeobpwdfbt*aFphih.hmotInedt-meidFhunonoenenc)aanenhrestisnteatittteAtfeotrointibifnaeIbchtapheohosItee-arihtauPeidntrohttnknnacnagfecohspuncwnhtaioetroaolorhoiettkhopatmncay3eesshevIeehraeirauaiunbtaghettetrkfntdenenfneaduanlc0hnearoewphurhp,hkorirlsbeam-l3seerscyevcputbdoygIeceatcecrtreeu.telsedfpeaean9mrtpdhaoreahiwu,woeetrbtmeaooe-ofoofcraprotcaitcrteccuoperutpe.bPuopmsfmeaetdroienaFinmraotiwoteetunwnosonmolorothaeil.frhraanhtertt.bmrlopfreohlpaltrtcepmPielblihoaieoueinreyynmiiee1na.sye-nleenzterlasrtnsleA.tfqohlicmvPrao.oebetlrclt0piihl.pahneuaaixsleoubieetnUy.ane.uenes-TserluftttaantArhsoipuaoQattPevitrtoritoeiaPenislishahnenbxmseaneinuieethittscnnrlugefTponeuFdnihuedtrouler'sstaepetdiuemoetrsdidirhunneuntere*taernoheciidnvedr'rettmrudewrdsr.at*t UCC 102523 542 |__good and Drop Administration 175.300 htpune and cover with clean alumi num foil. Place the test container In a Mutable room maintained at 30* F. After 30 minutes, composite the hep tane of each replicate tn a clean Pyrex flask or beaker. Proceed with the de termination of the amount of extrac ure* by the method described in para graph <eX5) of this section. i*lv) Heptane U2<F F for 30 min utest, simulating frozen fatty foods re heated in the container. Preheat redis tilled reagent-grade heptane (boiling point 208* F> carefully in a clean pyrex flask on a water bath or hot plate In a well-ventilated hood to 120* F At the same time, preheat a pres sure cooker to 120* F tn an Incubator. This pressure cooker Is to serve only u s container for the heptane-conuming test package Inside the Incuba tor tn order to minimize the danger of riplosion. Fill the test container iithln Winch of the top with a meas ured volume of the 120* F heptane and rover with clean aluminum foil. Place the test container in the preheated pressure cooker and then put the as sembly Into a 120* F incubator. After 10 minutes, remove the pressure rooker from the Incubator, open the assembly and immediately composite the heptane from each replicate Into a stored. Preheat 8 percent (by volume) ethyl alcohol in demineralized distilled water to 120* F in a clean Pyrex flask. Fill the test container within h-fnch of the top with a measured volume of the 8 percent alcohol, cover the con tainer with clean aluminum foil and place in an oven or incubator main tained at 120* F. After 31 hours, remove the container from the oven or incubator and immediately composite the alcohol from each replicate into a clean Pyrex flaak. Proceed with the determination of the amount of ex tractives by the method described in paragraph (eXS) of this section. (xvii) Alcohol--3 percent (70" F for 43 hours), simulating alcoholic beverages in refrigerated storage. Bring B percent (by volume) ethyl alcohol in deminera lized distilled water to 70* P in a clean Pyrex flask. Fill the test container within y.-lnch of the top with a meas ured volume of the 8 percent alcohol. Cover the container with clean alumi num foil. Place the test container in a suitable room maintained at 70* F. After 48 hours, immediately composite the alcohol from each replicate into a clean Pyrex flask. Proceed with the determination of the amount of ex tractives by the method described in paragraph (eX5) of this section. clean Pyrex flask. Proceed with the Note: The tests specified In paragraph determination of the amount of ex (e)(4) (i) through (xvlit of this section are tractives by the method described in applicable to flexible packages consisting of paragraph (e)(5) of this section. <xv) Alcohol--3 percent t!50" F for 2 (lourji, simulating alcoholic beverages (io( filled or pasteurized below ISO' F. coaled meta) contacting food, in which case the closure end is double-folded and clamped with metal spring clips by which the package can be suspended Preheat B percent (by volume) ethyl (5) XJefenmnafion of amount of ex slrohol in demineralized distilled tractives--(i) Total residues. Evaporate *ater to 150* P in a clean Pyrex flask. the food-simulating solvents from F*iil the lest cu: mer with within '/- paragraph (e)(4) (1) to (xvii). inclusive, inch of the io,j with a measured of this section to about 100 milliliters volume of the 8 percent alcohol. Cover in the Pyrex flask and transfer to a Uie container with clean aluminum clean, tared platinum dish, washing leu) and place in an oven maintained at the flask three times with the solvent 150' F. After 2 hours, remove the con used tn the extraction procedure, and tainer from the oven and immediately evaporate to a few milliliters on a non composite the alcohol from each repli- sparking low-temperature holplate. c(e in a clean Pyrex flask. Proceed The last few milliliters should be evap *nh the determination of the amount orated in an oven maintained at a tem of extractives by the method described perature of 212' F. Cool the platinum in paragraph (e)(5) of this section. (xvi) Alcohol--S percent <120' F for It /lours), simulating alcoholic bever ages room-temperature filled and dish in a desiccator for 30 minutes and weigh the residue to the nearest 0 1 milligram ie>. Calculate the extrac lives in milligrams per square inch and 543  175.300 TJtta 31--Food and Druq, In parts per million for the particular second portion of chloroform. Add tins { size of container being tested and for filtrate to the original filtrate and the specific food-simulating solvent evaporate the total down to a few mil used. liliters on a low-temperature hotplate (o> Water and 8-percent alcohoL The last few milliliters should be evap Milligrams extractives per square Inch - e/s Extractives residue - i(eHoK1000)/(cK) (M Heptane: orated In an oven maintained at 211 F. Cool the platinum dish in a desiccx tor for 30 minutes and weigh to the nearest 0.1 milligram to get the chlo Milligrams extractives per square Inch >e/ roform-soluble extractives residue le t i$HF) Extractives residue-Er-(eMaHtOOO)/ IcXsHFl This is substituted for e In the equs lions in paragraph (eX5Mf) (a) and <fc> of this section. If the concentration of Where: extractives (x> still exceeds 50 parts Ex-Extractives residue In ppm for any container size. e-Milligrams extractives per sample tested. s -Total coated area. Including closure In square Inches. c-Water capacity of container. In grama per million or the extractives in milli grams per square inch exceed the llmi tations prescribed in paragraph (c) of this section for the particular contain er size, proceed as follows to correct for zinc extractives ("C" enamels i *- Surface of coated area tested. In square only): Ash the residue in the platinum inches. dish by heating gently over a Meeker- F- Five, the ratio of the amount of extrac tives removed from a coated container by heptane under exaggerated timetemperature test conditions compared to the amount extracted by a fat or oil from a container tested under exagger ated conditions of thermal steriliza type burner to destroy organic matter and hold at red heat for about l minute. Cool in the air for 3 minutes, and place the platinum dish in the desiccator for 30 minutes and weigh to the nearest 0.1 milligram. Analyze this tion and use. ash for zinc by standard Association of t - Chloroform-soluble extractives residue, Official Agricultural Chemists mc`h- re' = Zinc corrected chloroform-soluble ex tractive residue. c' or ee is substituted for e In the above equations when necessary. If when calculated by the equations in paragraph (e)(5)(f) (a) and (6) of this section, the concentration of extrac tives residue (j) exceeds 50 parts per million or the extractives in milli ods or equivalent. Calculate the zinc >n the ash as zinc oieate, and subtract from the weight of chloroform-soluble extractives residue lei to obtain the zinc-corrected chloroform-soluble ex tractives residue (ee'). This ee is sub stituted for e in the formulas in para graph (eX5)(i) (a) and ibi of this sec tion. To comply with the limitations tn grams per square inch exceed the limi paragraph (c) of this section, the chlo tations prescribed in paragraph (c) of roform-soluble extractives residue (but this section for the particular contain after correction for the zinc extrac er size, proceed to paragraph (e)(5)(il) lives in case of "C" enamels) must not of this section (method for determin exceed 50 parts per million and must ing the amount of chloroform-soluble not exceed in milligrams per square extractives residue). inch the limitations for the particular (if) Chloroform-soluble extractives article as prescribed in paragraph (c) residue. Add 50 milliliters of chloro form (freshly distilled reagent grade or a grade having an established con sistently low blank) to the dried and of this section. (f) Equipment and reagent require merits--(1) Equipment. weighed residue, (e), in the platinum dish, obtained In paragraph <e)(5)(i) of this section. Warm carefully, and filter through Whatman No. 41 filter paper in a Pyrex funnel, collecting the fil trate in a clean, tared platinum dish. Repeat the chloroform extraction, Rinsing equipment, soda fountain pres sure-type hot water, consisting in simplest form of a Va-fnch-Vt-inch inside diamrler metal tube attached to a hot water line deli vering 190' F-200' F water and bent so os lo direct a stream of water upward. Pressure cooker. 21-quart capacity wish pressure gage, safety release, and removable washing the filter paper with this rack. 12.S inches Inside diameter > I i UCC 102524 544 Chapter I--Food and Drug Admlnisirati n V/5.330 inches Inside height, 20 pounds per square Inch safe operating pressure. Oven, mechanical convection, range to in fied in this section shall comply with the provisions of f 130.22 of this chap ter. clude 120* F-212* F explosion-proof, inside dimensions (minimum). 10' x 19" x IS", constant temperature to rt2` F (water bath (42 FR 14534. Mar. 15. 1911. as amended at 42 FR 18610, Apr. 8. 1011: 42 FR 21111. Apr. 29. 1011; 43 FR 2813, Jan. 20. 1918; 43 FR may be substituted). Incubator, inside dimensions (minimum) 8218. Feb. 14. 1918; 43 FR 11891. Mar. 21. 19' x 19" x 19" for use at 100* Fs:2* F ex 1918) plosion proof (water bath may be substitut $ 175.320 Resinous and polymeric coatings edC).onstant-temperature room or chamber 10* F2* F minimum Inside dimensions 19" for polyolefin films. , Resinous and polymeric coatings 19" x 19". may be safely used as the food-contact Hot plate, nonsparking (explosion proof), surface of articles intended for use in top 12" x 20". 2,500 watts, with temperature producing, manufacturing, packing, control. Platinum dish, 100-mi11(liter minimum. Alt glass. Pyrex or equivalent. (2) Reagents. capacity processing, preparing, treating, pack aging, transporting, or holding food, in accordance with the following pre scribed conditions: (a) The coating is applied as a con Water, all water used in extraction proce tinuous film over one or both sides of dure should be freshly demineralized a base film produced from one or more (deionized) distilled water. Heptane, reagent grade, freshly redistilled before use, using only materia) boiling at of the basic olefin polymers complying with 1171.1520 of this chapter. The base polyolefin film may contain op 208* F. Alcohol, 8 percent (by volume), prepared from undenatured 05 percent ethyl alcohol diluted with demineralized or distilled wster. Chloroform, reagent grade, freshly redis tilled before use. or a grade having an estab tional adjuvant substances permitted for use in polyolefin film by applicable regulations in Parts 170 through 189 of this chapter. (b) The coatings are formulated from optional substances which are: lished. consistently low blank. (1) Substances generally recognized Filter paper. Whatman No. 41 or equlva- as safe for use in or on food. .ent. (2) Substances the use of which is (g) In accordance with good manu facturing practice, finished coatings intended for repeated food-contact use Khali be thoroughly cleansed prior to their first use in contact with food. (h> Acrylonitrile copolymers identl- permitted under applicable regulations in Parts 170 through 189 of this chap ter. by prior sanctions, or approvals. (3) Substances identified In this paragraph (b)(3) and subject to such limitations as are provided; Lot o! tutaunM Imuliont hi Resins and polymers. Acjyhc sod polymer and 4s ethyl or methyl . Aciytsmaje copcFymerged with ethyl ecrylaie end/or tty- ren# end/or methacy*c aerft. end the copolymer sub sequently reecled with formaldehyde end butanol 6uted*ene sciytonarle copolymer........... But*ene aclytonarte-sfyre"* tarpotymer BiVuVty-l&rupbhb#enryt p.-p.he.ny.tenet^arnna For use onty if a potymemabon rfVutator tn 2 sutioethyl methscryl*!*. eodum self 2 Efhyfhexyt acrytefe eopotymenjed with one or more ol the foio*nr>9 Acrytorainle ffacomc ec Mathacryiooi'*# Methyl ecryiaie Methyl meirkacryiate 4 4 isopropyedened<9he'iolepc/uoronytJnn sverape mo- tecuisr we^ghi POO Ueiamwve-tormafOetYyfSe as (he bew: potymer or chene- csPy modified wxh methyl e*cohol 545 UNION CARBIDE CORPORATION CHEMICALS AND PLASTICS mven noAO. bound brook, n, .. oaaos <tii T. W. Carmody-NY-22 M. E, E isenhour-TC W. F. Gorham-BB-200 R. A. Gregory-BB-203 J. T. Lucking-NY-46 G. M. Palm-BB-98 G. S. Peacock-BB-98 N. H. Reinking-BB-98 D. F. Smith-BB-200 W. I. Wertz-BB-98 Mr. Dear Mr. We have been asked to write you regarding the food additive status of BAKELITE brand resin, resin Is listed by chemical Identity in Food Additive Regulation 175.300* for Resinous and Polymeric Coatings as food contact surfaces applied to metal substrates. Food Additive Regulation 176.170 for components of paper and paperboard and 177.1210 for closures refer to 175.300 for a list of acceptable materials. resin may be used under use conditions B, C, 0, Et F, 6, or H. An excerpt of 176.170 is attached which explains these use conditions. The finished coating or closure must meet the extraction specifications given In the appropriate regulation. *^ Very truly yours. W. B. Ackart, Ph.O. Manager, FDA Liaison WBAisdb 29-A-20 Attachment * formerly 121.2514 ucc 102525