FDA食品添加劑使用衛(wèi)生標(biāo)準(zhǔn).rar

FDA食品添加劑使用衛(wèi)生標(biāo)準(zhǔn).rar,FDA,食品添加劑,使用,衛(wèi)生標(biāo)準(zhǔn) [Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2006] [CITE: 21CFR175] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED) ? PART 175 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS ? Subpart A [Reserved] Subpart B--Substances for Use Only as Components of Adhesives Sec. 175.105 Adhesives. ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ Abietic acid........................... Acetone................................ Acetone-formaldehyde condensate (CAS Reg. No. 25619-09-4). Acetone-urea-formaldehyde resin........ N-Acetyl ethanolamine.................. Acetyl tributyl citrate................ Acetyl triethyl citrate................ 2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, sodium salt (CAS Reg. No. 35641-59-9). Albumin, blood......................... (2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983-55-0). 4-[2-[2-2-(Alkoxy (C12-C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate. 1-Alkyl (C6-C18) amino-3-amino-propane monoacetate. Alkylated (C4 and/or C8) phenols....... Alkyl (C7-C12) benzene................. Alkyl (C10-C20) dimethylbenzyl ammonium chloride. n-Alkyl(C12, C14, C16, or C18) dimethyl For use as preservative only. (ethylbenzyl) ammonium cyclohexylsulfamate. Alkyl ketene dimers as described in 176.120 of this chapter. Alkyl (C7-C12) naphthalene............. alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, potassium, and sodium salts. 2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111-41-1). 3-Aminopropanediol..................... For use only in the preparation of polyurethane resins. Aluminum............................... Aluminum acetate....................... Aluminum di(2-ethylhexoate)............ Aluminum potassium silicate............ N-[beta]-Aminoethyl-gamma-aminopropyl trimethoxysilane. 3-(Aminomethyl)-3,5,5- trimethylcyclohexylamine. Aminomethylpropanol.................... Ammonium benzoate...................... For use as preservative only. Ammonium bifluoride.................... For use only as bonding agent for aluminum foil, stabilizer or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Ammonium borate........................ Ammonium citrate....................... Ammonium persulfate.................... Ammonium polyacrylate.................. Ammonium potassium hydrogen phosphate.. Ammonium silico-fluoride............... For use only as bonding agent for aluminum foil, stabilizer, or preservative. Total fluoride from all sources not to exceed 1 percent by weight of the finished adhesive. Ammonium sulfamate..................... Ammonium thiocyanate................... Ammonium thiosulfate................... Amyl acetate........................... Anhydroenneaheptitol................... Animal glue as described in 178.3120 of this chapter. 2-Anthraquinone sulfonic acid, sodium For use only as polymerization- salt. control agent. Antimony oxide......................... Asbestos............................... Asphalt, paraffinic and naphthenic..... Azelaic acid........................... Azo-bis-isobutyronitrile............... Balata rubber.......................... Barium acetate......................... Barium peroxide........................ Barium sulfate......................... Bentonite.............................. Benzene (benzol)....................... 1,4-Benzenedicarboxylic acid, bis[2- For use as a stabilizer. (1,1-dimethylethyl)-6-[[3-(1,1- dimethylethyl)-2-hydroxy-5- methylphenyl]methyl]-4-methyl- phenyl]ester (CAS Reg. No. 57569-40-1). 1,2-Benzisothiazolin-3-one (CAS For use as preservative only. Registry No. 2634-33-5). Benzothiazyldisulfide.................. p-Benzoxyphenol........................ For use as preservative only. Benzoyl peroxide....................... Benzyl alcohol......................... Benzyl benzoate........................ Benzyl bromoacetate.................... For use as preservative only. p-Benzyloxyphenol...................... Do. BHA (butylated hydroxyanisole)......... BHT (butylated hydroxytoluene)......... Bicyclo[2.2.1]hept-2-ene-6-methyl acrylate. 2-Biphenyl diphenyl phosphate.......... Bis(benzoate-O)(2-propanolato)aluminum For use only as a reactant in (CAS Reg. No. 105442-85-1). the preparation of polyester resins. 1,2-Bis(3,5-di-tert-butyl-4- For use at a level not to hydroxyhydrocinnamoyl)hy-drazine (CAS exceed 2 percent by weight of Reg. No. 32687-78-8). the adhesive. 1,3-Bis(2-benzothiazolylmercaptomethyl) urea. 4,4[prime]-Bis([alpha],[alpha]- dimethylbenzyl)diphenylamine. 2,6-Bis(1,1-dimethylethyl)-4-(1- For use as an antioxidant and/ methylpropyl)phenol (CAS Reg. No. or stabilizer only. 17540-75-9). 2,6-Bis (1-methylheptadecyl)-p-cresol.. 4-[[4, 6-Bis(octylthio)6- Bis(octylthio)6-Bis(octylthio)-s- triazin-2-yl]amino]-2,6-di-tert- butylphenol (CAS Reg. No. 991-84-4). Bis(tri-n-butyltin) oxide.............. For use as preservative only. Bis(trichloromethyl)sulfone C.A. Do. Registry No. 3064-70-8. Borax.................................. Boric acid............................. 2-Bromo-2-nitro-1, 3-propanediol (CAS For use only as an Reg. No. 52-51-7). antibacterial preservative. Butanedioic acid, sulfo-1,4-di-(C9-C11 For use as a surface active alkyl) ester, ammonium salt (also agent in adhesives. known as butanedioic acid, sulfo-1,4- diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]).. 1,3-Butanediol......................... 1,4-Butanediol......................... 1,4-Butanediol modified with adipic acid. Butoxy polyethylene polyproplyene glycol (molecular weight 900-4,200). Butyl acetate.......................... Butyl acetyl ricinoleate............... Butyl alcohol.......................... Butylated reaction product of p-cresol As identified in and dicyclopentadiene. 178.2010(b) of this chapter. Butylated, styrenated cresols identified in 178.2010(b) of this chapter. Butyl benzoate......................... Butyl benzyl phthalate................. Butyldecyl phthalate................... ............................... 1,3-Butylene glycoldiglycolic acid copolymer. tert-Butyl hydroperoxide............... 4,4[prime]-Butylidenebis(6-tert-butyl-m- cresol). Butyl lactate.......................... Butyloctyl phthalate................... p-tert-Butylphenyl salicylate.......... Butyl phthalate butyl glycolate........ p-tert-Butylpyrocatechol............... For use only as polymerization- control agent. Butyl ricinoleate...................... Butyl rubber polymer................... Butyl stearate......................... Butyl titanate, polymerized............ Butyraldehyde.......................... Calcium ethyl acetoacetate............. Calcium nitrate........................ Calcium metasilicate................... Camphor................................ Camphor fatty acid esters.............. Candelilla wax......................... epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer. Carbon black, channel process.......... Carbon disulfide-1,1[prime]- methylenedipiperidine reaction product. Carbon tetrachloride................... Carboxymethylcellulose................. Castor oil, polyoxyethylated (4-84 moles ethylene oxide). Cellulose acetate butyrate............. Cellulose acetate propionate........... Ceresin wax (ozocerite)................ Cetyl alcohol.......................... Chloracetamide......................... Chloral hydrate........................ Chlorinated liquid n-paraffins with chain lengths of C10-C17, containing 40-70 percent chlorine by weight. Chlorinated pyridine mixture with For use as preservative only. active ingredients consisting of 2,3,5,6-tetrachloro-4-(methylsulfonyl) pyridine, 2,3,5,6-tetrachloro-4- (methylsulfinyl) pyridine and pentachloropyridine. Chlorinated rubber polymer (natural rubber polymer containing approximately 67 percent chlorine). 1-(3-Chloroallyl)-3,5,7-triaza-1- For use as preservative only. azoniaadamantane chloride. Chlorobenzene.......................... 4-Chloro-3,5-dimethylphenol (p-chloro-m- For use as preservative only. xylenol). 4-Chloro-3-methylphenol................ Do. 5-Chloro-2-methyl-4-isothiazolin-3-one For use only as an (CAS Reg. No. 26172-55-4) and 2-methyl- antimicrobial agent in polymer 4-isothiazolin-3-one (CAS Reg. No. latex emulsions. 2682-20-4) mixture at a ratio of 3 parts to 1 part, manufactured from methyl-3-mercaptopropionate (CAS Reg. No. 2935-90-2). The mixture may contain magnesium nitrate (CAS Reg. No. 10377-60-3) at a concentration equivalent to the isothiazolone active ingredients (weight/weight). Chloroform............................. Chloroprene............................ Chromium caseinate..................... Chromium nitrate....................... Chromium potassium sulfate............. Cobaltous acetate...................... Coconut fatty acid amine salt of For use as preservative only. tetrachlorophenol. Copal.................................. Copper 8-quinolinolate................. For use as preservative only. Coumarone-indene resin................. Cresyl diphenyl phosphate.............. Cumene hydroperoxide................... Cyanoguanidine......................... Cyclized rubber as identified in 176.170(b)(2) of this chapter. Cyclohexane............................ 1,4-Cyclohexanedimethanoldibenzoate (CAS Reg. No. 35541-81-2). Cyclohexanol........................... Cyclohexanone resin.................... Cyclohexanone-formaldehyde condensate.. N-Cyclohexyl p-toluene sulfonamide..... ([eta]\5\-Cyclopentadienyl)-([eta]\6\- For use only as a isopropylbenzene)iron(II) photoinitiator. hexafluorophosphate (CAS Reg. No. 32760-80-8). Damar.................................. Defoaming agents as described in 176.210 of this chapter. Dehydroacetic acid..................... ............................... Diacetone alcohol...................... Diacetyl peroxide...................... N,N[prime]-Dialkoyl-4,4[prime]- diaminodiphenylmethane mixtures where; the alkoyl groups are derived from marine fatty acids (C12-C24). 2,5-Di-tert-amylhydroquinone........... Diamines derived from dimerized vegetable oil acids. Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or xylyl. 1,2-Dibromo-2,4-dicyanobutane (CAS For use as a preservative only. Registry No. 3569-65-7). 2,2-Dibromo-3-nitrilopropionamide (CAS For use as a preservative only. Reg. No. 10222-01-2).. Di(butoxyethyl) phthalate.............. 2,5-Di-tert-butylhydroquinone.......... Dibutyl maleate........................ 2,6-Di-tert-butyl-4-methylphenol....... For use as preservative only. Di(C7, C9-alkyl)adipate................ Dibutyl phthalate...................... Dibutyl sebacate....................... Dibutyltin dilaurate for use only as a catalyst for polyurethane resins. 1,2-Dichloroethylene (mixed isomers)... Dicumyl peroxide....................... Dicyclohexyl phthalate................. Diethanolamine......................... Diethanolamine condensed with animal or vegetable fatty acids. Diethylamine........................... Diethylene glycol...................... Diethylene glycol adipic acid copolymer Diethylene glycol dibenzoate........... Diethylene glycol hydrogenated tallowate monoester. Diethylene glycol laurate.............. Diethylene glycol monobutyl ether...... Diethylene glycol monobutyl ether acetate. Diethylene glycol monoethyl ether...... Diethylene glycol monoethyl ether acetate. Diethylene glycol monomethyl ether..... Diethylene glycol monooleate........... Diethylene glycol monophenyl ether..... Diethylene glycol copolymer of adipic acid and phthalic anhydride. Di(2-ethylhexyl) adipate............... Di(2-ethylhexyl)hexahydrophthalate..... Di(2-ethylhexyl)phthalate.............. Diethyl oxalate........................ Diethyl phthalate...................... Dihexyl phthalate...................... Dihydroabietylphthalate................ Di(2-hydroxy-5-tert-butylphenyl) sulfide. 2,2[prime]-Dihydroxy-5,5[prime]- dichlorodiphenylmethane (dichlorophene). 4,5-Dihydroxy-2-imidazolidinone........ 4-(Diiodomethylsulfonyl) toluene CA For use as an antifungal Registry No.: 20018-09-01. preservative only. Diisobutyl adipate..................... Diisobutyl ketone...................... Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride. Diisobutyl phthalate................... Diisodecyl adipate..................... Diisodecyl phthalate................... Diisooctyl phthalate................... Diisopropylbenzene hydroperoxide....... N,N-Dimethylcyclohexylamine dibutyldithiocarbamate. Dimethyl formamide..................... Dimethyl hexynol....................... 2,2-Dimethyl-1,3-propanediol dibenzoate Dimethyl octynediol.................... N-(1,1-dimethyl-3-oxobutyl) acrylamide. Dimethyl phthalate..................... 3,5-Dimethyl-1,3,5,2H- For use as preservative only. tetrahydrothiadiazine-2-thione. Di-[beta]-naphthyl-p-phenylenediamine.. 4,6-Dinonyl-o-cresol................... Dinonylphenol.......................... Di-n-octyldecyl adipate................ Dioctyldiphenylamine................... Dioctylphthalate....................... Dioctylsebacate........................ Dioxane................................ Dipentaerythritol pentastearate........ Dipentamethylene-thiuram-tetrasulfide.. Dipentene.............................. ............................... Dipentene resins....................... Dipentene-beta-pinene-styrene resins... Dipentene-styrene resin (CAS Registry No. 64536-06-7). Diphenyl-2-ethylhexyl phosphate........ Diphenyl, hydrogen ated................ N,N[prime]-Diphenyl-p-phenylenediamine. Diphenyl phthalate..................... 1,3-Diphenyl-2-thiourea................ Dipropylene glycol..................... Dipropylene glycol dibenzoate.......... Dipropylene glycol monomethyl ether.... Dipropylene glycol copolymer of adipic acid and phthalic anhydride. Disodium cyanodithioimidocarbonate..... Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294-49-8). N,N[prime]-Distearoylethylenediamine... Distearyl thiodipropionate............. 3,5-Di-tert-butyl-4- For use as antioxidant only. hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hydroxyethyl)-s- triazine-2,4,6(1H, 3H, 5H)-trione. 4,4[prime]-Dithiodimorpholine.......... n-Dodecylmercaptan..................... tert-Dodecylmercaptan.................. Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium, and sodium salts. Elemi gum.............................. Epichlorohydrin-4,4[prime]- isopropylidenediphenol resin. Epichlorohydrin-4,4[prime]-sec- butylidenediphenol resin. Epichlorohydrin-4,4[prime]- isopropylidene-di-o-cresol resin. Epichlorohydrin-phenolformaldehyde resin. Erucamide (erucylamide)................ Ethanolamine........................... Ethoxylated primary linear alcohols of greater than 10 percent ethylene oxide by weight having molecular weights of 390 to 7,000 (CAS Reg. No. 97953-22-5). Ethoxypropanol butyl ether............. Ethyl alcohol (ethanol)................ 5-Ethyl-1,3-diglycidyl-5- methylhydantoin (CAS Reg. No. 15336-82- 0). Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No. 97756-27-9). Ethylene-acrylic acid copolymer, partial sodium salt containing no more than 20 percent acrylic acid by weight, and no more than 16 percent of the acrylic acid as the sodium salt (CAS Reg. No. 25750-82-7). Ethylenediamine........................ Ethylenediaminetetra-acetic acid, calcium, ferric, potassium, or sodium salts, single or mixed. Ethylene dichloride.................... Ethylene glycol........................ Ethylene glycol monobutyl ether........ Ethylene glycol monobutyl ether acetate Ethylene glycol monoethyl ether........ Ethylene glycol monoethyl ether acetate Ethylene glycol monoethyl ether ricinoleate. Ethylene glycol monomethyl ether....... Ethylene glycol monophenyl ether....... Ethylene-carbon monoxide copolymer (CAS Reg. No. 25052-62-4) containing not more than 30 weight percent of the units derived from carbon monoxide. Ethylene-maleic anhydride copolymer, ammonium or potassium salt. Ethylene-methacrylic acid copolymer partial salts: Ammonium, calcium, magnesium, sodium, and/or zinc. Ethylene-methacrylic acid-vinyl acetate copolymer partial salts: Ammonium, calcium, magnesium, sodium, and/or zinc. Ethylene-octene-1 copolymers containing not less than 70 weight percent ethylene (CAS Reg. No. 26221-73-8). Ethylene-propylene-dicyclopentadiene copolymer rubber. Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer. Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No. 26337-35- 9) containing not more than 15 weight percent of units derived from carbon monoxide. 2,2[prime]-Ethylidenebis (4,6-di-tert- butylphenol) (CAS Reg. No. 35958-30-6). Ethyl-p-hydroxybenzoate................ For use as preservative only. Ethyl hydroxyethylcellulose............ Ethyl lactate.......................... 2,2[prime]-Ethylidenebis(4,6-di-tert- For use as an antioxidant and/ butylphenyl)fluorophosphonite (CAS or stabilizer only. Reg. No. 118337-09-0). Ethyl phthalyl ethyl glycolate......... Ethyl-p-toluene sulfonamide............ ............................... Fats and oils derived from animal or vegetable sources, and the hydrogenated, sulfated, or sulfonated forms of such fats and oils. Fatty acids derived from animal or vegetable fats and oils; and salts of such acids, single or mixed, as follows: Aluminum............................. Ammonium............................. Calcium.............................. Magnesium............................ Potassium............................ Sodium............................... Zinc................................. Ferric chloride........................ Fluosilicic acid (hydrofluosilicic For use only as bonding agent acid). for aluminum foil, stabilizer, or preservative. Total fluoride from all sources not t