蒸汽用水添加物质的要求

TITLE21--FOODANDDRUGS21题--食品和药品CHAPTERI--FOODANDDRUGADMINISTRATIONDEPARTMENTOFHEALTHANDHUMANSERVICES第一章：食品和药品管理局健康和人类服务部SUBCHAPTERB--FOODFORHUMANCONSUMPTION(CONTINUED)B节人类消费食品（持续性）PART173--SECONDARYDIRECTFOODADDITIVESPERMITTEDINFOODFORHUMANCONSUMPTION173部分--人类消费食品中允许间接使用的食品添加剂SubpartD--SpecificUsageAdditives添加剂使用特性Sec.173.310Boilerwateradditives.锅炉用水添加剂Boilerwateradditivesmaybesafelyusedinthepreparationofsteamthatwillcontactfood,underthefollowingconditions:锅炉用水的添加剂在制备接触食品的蒸汽时应该是安全的，并符合下列要求：(a) Theamountofadditiveisnotinexcessofthatrequiredforitsfunctionalpurpose,andtheamountofsteamincontactwithfooddoesnotexceedthatrequiredtoproducetheintendedeffectinoronthefood.添加剂的用量不超出功能目的要求，与食品接触的蒸汽的量不超过对食品影响的预期效果。(b) Thecompoundsarepreparedfromsubstancesidentifiedinparagraphs(c)and(d)ofthissection,andaresubjecttothelimitations,ifany,prescribed:组分应为表C表D中所列物质并符合其限量要求。(c)Listofsubstances:允许使用物质目录Substances物质Limitations限值Acrylamide-sodiumacrylateresin丙烯酰胺-丙烯酸钠树脂Containsnotmorethan0.05percentbyweightofacrylamidemonomer.质量分数不超过0.05（以丙烯酰胺计）Acrylicacid/2-acrylamido-2-methylpropanesulfonicacidcopolymerhavingaminimumweightaveragemolecularweightof9,900andaminimumnumberaveragemolecularweightof5,700asdeterminedbyamethodentitled"DeterminationofWeightAverageandNumberAverageMolecularWeightof60/40AA/AMPS"丙烯酸/2-丙烯酰胺基-2-甲基丙磺酸共聚物（有最小重量，平均9900分子量，和数量平均5700分子量。因平均重量和分子量平均数60/40而不同）。Totalnottoexceed20partspermillion(active)inboilerfeedwater.在锅炉补给水中总量不超过20ppm。Ammoniumalginate澡酸铵Cobaltsulfate(ascatalyst)硫酸钴（以钴计）1-hydroxyethylidene-1,1-diphosphonicacid(CASReg.No.2809-21-4)anditssodiumandpotassiumsalts羟基乙叉二膦酸（CASReg.No.2809-21-4)）及其钠盐和钾盐Lignosulfonicacid木质磺酸Monobutylethersofpolyethylene-polypropyleneglycolproducedbyrandomcondensationofa1:1mixturebyweightofethyleneoxideandpropyleneoxidewithbutanol聚乙烯聚丙烯乙二醇单丁醚，由环氧乙烷和环氧乙烷质量比1：1蒸馏制的Minimummol.wt.1,500.最小摩尔质量1500.Poly(acrylicacid-co-hypophosphite),sodiumsalt(CASReg.No.71050-62-9),producedfroma4:1toa16:1mixturebyweightofacrylicacidandsodiumhypophosphite聚乙烯（丙烯酸树脂、次磷酸盐），钠盐（CASReg.No.71050-62-9),由质量分数为4:1丙烯酸、次磷酸钠盐稀释至16:1Totalnottoexceed1.5partspermillioninboilerfeedwater.Copolymercontainsnotmorethan0.5percentbyweightofacrylicacidmonomer(dryweightbasis).锅炉补给水中总量不超过1.5ppm。共聚物总量不超过0.5%（以丙烯酸单体计，干基）Polyethyleneglycol聚乙二醇Asdefinedin172.820ofthischapter.如本章172.820所示。Polymaleicacid[CASReg.No.26099-09-2],and/oritssodiumsalt.[CASReg.No.30915-61-8orCASReg.No.70247-90-4]聚马来酸或/和其钠盐。Totalnottoexceed1partpermillioninboilerfeedwater(calculatedastheacid).锅炉补给水中总量不超过1ppm（以酸计）Polyoxypropyleneglycol聚氧化丙烯二醇Minimummol.wt.1,000.最小分子量1000Potassiumcarbonate碳酸钾Potassiumtripolyphosphate三聚磷酸盐Sodiumacetate乙酸钠Sodiumalginate海藻酸钠Sodiumaluminate铝酸钠Sodiumcarbonate碳酸钠Sodiumcarboxymethylcellulose羟甲基化纤维素钠Containsnotlessthan95percentsodiumcarboxymethylcelluloseonadry-weightbasis,withmaximumsubstitutionof0.9carboxymethylcellulosegroupsperanhydroglucoseunit,andwithaminimumviscosityof15centipoisesfor2percentbyweightaqueoussolutionat25deg.C;bythe"ViscosityofCelluloseGum"methodprescribedintheFoodChemicalsCodex,pp.1128-1129.Sodiumglucoheptonate葡庚糖酸钠Lessthan1partpermillioncyanideinthesodiumglucoheptonate.Sodiumhexametaphosphate六聚偏磷酸钠Sodiumhumate腐殖酸钠Sodiumhydroxide氢氧化钠Sodiumlignosulfonate木素磺化盐Sodiummetabisulfite焦亚硫酸钠Sodiummetasilicate偏硅酸钠Sodiumnitrate硝酸钠Sodiumphosphate(mono-,di-,tri-)磷酸钠（单、双、三Sodiumpolyacrylate聚丙烯酸酯钠Sodiumpolymethacrylate聚甲基丙烯酸酯Sodiumsilicate硅酸钠Sodiumsulfate硫酸钠Sodiumsulfite(neutraloralkaline)亚硫酸钠（中性或碱性）Sodiumtripolyphosphate三磷酸钠Sorbitolanhydrideesters:Amixtureconsistingofsorbitanmonostearateasdefinedin172.842ofthischapter;polysorbate60((polyoxyethylene(20)sorbitanmonostearate))asdefinedin172.836ofthischapter;andpolysorbate20((polyoxyethylene(20)sorbitanmonolaurate)),meetingthespecificationsoftheFoodChemicalsCodex,pp.825-827.三梨醇、酐、脂（三梨聚糖、聚山梨醇酯60，聚山梨醇酯20的混合物）符合食品用化学品的要求。Themixtureisusedasananticorrosiveagentinsteamboilerdistributionsystems,witheachcomponentnottoexceed15milligramsperkilograminthesteam.Tannin(includingquebrachoextract)鞣酸TetrasodiumEDTAEDTATetrasodiumpyrophosphate焦磷酸四钠(d)Substancesusedaloneorincombinationwithsubstancesinparagraph(c)ofthissection:可单独使用或者和表C中组合使用的物质。Substances组成Limitations限值Cyclohexylamine环己胺Nottoexceed10partspermillioninsteam,andexcludinguseofsuchsteamincontactwithmilkandmilkproducts.蒸汽中量不超过10ppm，接触牛奶及牛奶制品的蒸汽除外Diethylaminoethanol环己胺Nottoexceed15partspermillioninsteam,andexcludinguseofsuchsteamincontactwithmilkandmilkproducts.蒸汽中量不超过15ppm，接触牛奶及牛奶制品的蒸汽除外。Hydrazine肼Zeroinsteam.蒸汽中不得检出。Morpholine吗啉Nottoexceed10partspermillioninsteam,andexcludinguseofsuchsteamincontactwithmilkandmilkproducts.蒸汽中量不超过10ppm，接触牛奶及牛奶制品的蒸汽除外Octadecylamine十八胺Nottoexceed3partspermillioninsteam,andexcludinguseofsuchsteamincontactwithmilkandmilkproducts.蒸汽中量不超过310ppm，接触牛奶及牛奶制品的蒸汽除外Trisodiumnitrilotriacetate次氮基三乙酸酯三钠Nottoexceed5partspermillioninboilerfeedwater;nottobeusedwheresteamwillbeincontactwithmilkandmilkproducts.锅炉补给水中量不超过5ppm，接触牛奶及牛奶制品的蒸汽除外(e)Toassuresafeuseoftheadditive,inadditiontotheotherinformationrequiredbytheAct,thelabelorlabelingshallbear:为保证添加剂的安全使用，除了实际的要求，还标签和标识内容还应符合：(1)Thecommonorchemicalnameornamesoftheadditiveoradditives.添加剂或添加物质的俗称，化学名称(2)Adequatedirectionsforusetoassurecompliancewithalltheprovisionsofthissection.使用说明，以符合本部分条款的所有要求。(f)ThestandardsrequiredinthissectionareincorporatedbyreferenceintothissectionwiththeapprovaloftheDirectoroftheFederalRegisterunder5U.S.C.552(a)and1CFRpart51.CopiesmaybeexaminedattheFoodandDrugAdministration'sMainLibrary,10903NewHam