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MaterialsCodeofFederalRegulationTestItemsRequirementTestMethod1ResinousandPolymericCoating树脂和聚合物涂料21CFR175.300OverallMigration总迁移Coatingemployedasacomponentofacontainernottoexceed1gallonandintendforone-timeuse.容器体积不超过1加仑且一次性使用。≤0.5mg/in2Table2:Testprocedureofusingsimulantsolvents.使用模拟溶液测试方法详见表2。Coatingemployedasacomponentofacontainerhavingacapacityinexcessof1gallonandintendforone-timeuse.容器体积超过1加仑且一次性使用。≤1.8mg/in2Coatingemployedasacomponentofacontainerforrepeatuse.可以反复使用的容器。≤18mg/in2Coatingintendforrepeateduse,andemployedotherthanasacomponentofacontainer.涂层不是容器的组成成分,且可以反复使用。≤18mg/in22Paperorpaperboard纸及纸制品21CFR176.170OverallMigration总迁移≤0.5mg/in2Ditto3Acrylonitrile/Butadiene/StyreneCo-polymer丙烯腈/丁二烯/苯乙烯共聚物ABS21CFR177.1020AcrylonitrileMonomer丙烯腈单体≤0.0015mg/in2Exposetodistilledwaterand3%aceticacidat150Ffor15days.蒸馏水或3%乙酸在150F浸提15天。MaterialsCodeofFederalRegulationTestItemsRequirementTestMethod4Closureswithsealinggasket密封垫圈21CFR177.1210OverallMigration总迁移Plasticizedpolymer,includingrubberfromhotmelt,solution,plastisol,orlatex液体增塑密封橡胶垫圈≤50ppm(Water),≤500ppm(Heptane),≤50ppm(Alcohol)Unvulcanizednaturalorsyntheticrubber非硫化型橡胶垫圈≤50ppm(Water),≤250ppm(Heptane),≤50ppm(Alcohol)Vulcanizednaturalorsyntheticrubber硫化型橡胶垫圈≤50ppm(Water),≤50ppm(Heptane),≤50ppm(Alcohol)Polymericorresinous-coatedpaper,plasticormetalfoilsubstance有涂层的纸塑料金属膜≤50ppm(Water),≤250ppm(Heptane),≤50ppm(Alcohol)5OlefinPolymers烯烃聚合物(PP/PE/OP)21CFR177.15201.Density,密度,2.MeltingPoint熔点3.N-hexaneextractive,正己烷提取4.Xyleneextractive二甲苯提取Detailssee(c)specificationof177.1520.Testresultexpressedas%w/w.Detailssee(d)of177.1520MaterialsCodeofFederalRegulationTestItemsRequirementTestMethod6PolycarbonateResins聚碳酸酯PC21CFR177.1580Waterextractives水提取物≤0.15%w/wExtractedwithdistilledwateratrefluxtemperaturefor6h.Ethylalcoholextractives乙醇提取物≤0.15%w/wExtractedwith50%ethylalcoholindistilledwateratrefluxtemperaturefor6h.N-heptaneextractives正己烷提取物≤0.15%w/wExtractedwithn-heptaneatrefluxtemperaturefor6h.7Polyethylenephthalatepolymers聚对苯二甲酸乙二酯(PET)21CFR177.1630ChloroformExtractives氯仿提取物Usedforpackaging,transportingorholdingfoodexcludingalcoholicbeverages.食品接触但不包括酒精饮料≤0.5mg/in2(distilledwater)≤0.5mg/in2(n-heptane)Usedforpackaging,transportingorholdingalcoholicbeverages(donotexceed50percentbyvolume)接触酒精饮料(不超过50%)≤0.5mg/in2(distilledwater)≤0.5mg/in2(n-heptane)≤0.5mg/in2(ethylethanol)Usedforcontainfoodduringovenbakingorcookingattemperatureabove250F.烘烤烹煮食品(不超过250F)≤0.02mg/in2(distilledwater)≤0.02mg/in2(n-heptane)Usedforcontactdryfood,bulkfoodincludealcoholbeveragenotexceed50percentbyvolume.接触干食品,散装食品以及不超过50%的酒精饮料。≤0.2mg/in2(distilledwater)≤0.2mg/in2(n-heptane)≤0.2mg/in2(ethylethanol)Usedforpackaging,transportingorholdingalcoholicfoodsthatdonotexceed95percentbyvolume.接触含量不超过95%的酒精饮料。≤0.5mg/in2(distilledwater)≤0.5mg/in2(n-heptane)≤0.005mg/in2(ethanol)Containercapacity:Greaterthan50ml≤0.05mg/in2(ethanol)Containercapacity:Lessthanorequalto50ml8Polystyreneandrubber-modifiedpolystyrene聚苯乙烯和橡胶改性聚苯乙烯PS21CFR177.1640Residualstyrenemonomer苯乙烯单体残留PSexceptcontactwithfattyfoods不接触油性食品的聚苯乙烯≤1%w/wDetailssee(d)of177.1640PScontactwithfattyfoods接触油性食品的聚苯乙烯≤0.5%w/wRubber-modifiedpolystyrene橡胶改性聚苯乙烯≤0.5%w/w9Rubberarticlesintendedforrepeateduse(excludingnursing-bottlenipples)重复使用的橡胶制品(不包括婴儿橡胶奶嘴)21CFR177.2600OverallMigration总迁移Usedincontactwithaqueousfoods接触水性食品≤20mg/in2(first7hofextraction)≤1mg/in2(succeeding2hofextraction)Extractedwithdistilledwateratrefluxtemperature蒸馏水回流Usedincontactwithfattyfoods接触油性食品≤175mg/in2(first7hofextraction)≤4mg/in2(succeeding2hofextraction)Extractedwithn-hexaneatrefluxtemperature正己烷回流
本文标题:FDA食品级材料测试要求限量标准-列表
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