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1、文档来源为：从网络收集整理.word版本可编辑.欢迎下载支持.MaterialsCode of Federal RegulationTest ItemsRequirementTest Method1Resinous andPolymeric Coating 树脂和聚合物涂料21CFR 175.300OverallMigration 总迁移Coating employed as a component of a container not to exceed 1 gallon and intend for one-time use.容器体积不超过1加仑且一次性使用。磅.5mg/in2Table
2、2: Test procedure of using simulant solvents. 使用模拟溶液测试方法详 见表2。Coating employed as a component of a container having a capacity in excess of 1 gallon and intend for one-time use.容器体积超过1加仑且一次性使用。司.8mg/in2Coating employed as a component of a container for repeat use.可以反复使用的容器。司8mg/in2Coating intend for
3、 repeated use, and employed other than as a component of a container.涂层/、是容器的组成成分，且可以反复 使用。司8mg/in22Paper or paperboard 纸及纸制品21CFR 176.170Overall Migration 总迁移-, 2磅.5mg/inDitto3Acrylonitrile/Butadiene /Styrene Co-polymer 丙烯月青/丁二烯/苯乙烯 共聚物ABS21CFR 177.1020Acrylonitrile Monomer 丙烯月青单体磅.0015mg/in2Expose
4、 to distilled water and 3% acetic acid at 150F for 15 days.蒸储水或3%乙酸在150F 浸提15天。MaterialsCode of Federal RegulationTest ItemsRequirementTest Method4Closures with sealing gasket 密封垫圈21CFR 177.1210Overall Migration 总迁移Plasticized polymer, including rubber from hot melt, solution, plastisol, or latex 液体
5、增塑密封橡胶垫圈30Ppm (Water), 300Ppm (Heptane), 30Ppm (Alcohol)Unvulcanized natural or synthetic rubber 非硫化型橡胶垫圈30Ppm (Water),磴50Ppm (Heptane), 30Ppm (Alcohol)Vulcanized natural or synthetic rubber 硫化型橡胶垫圈30Ppm (Water), 普0Ppm (Heptane), 30Ppm (Alcohol)Polymeric or resinous- coated paper, plastic or metal f
6、oil substance 有涂层的纸塑料金属膜30Ppm (Water),磴50Ppm (Heptane), 30Ppm (Alcohol)5Olefin Polymers 烯姓聚合物(PP/PE/OP)21CFR 177.15201.Density, 密度，2.Melting Point 熔点3. N-hexane extractive, 正己烷提取4. Xylene extractive 二甲苯提取Details see (c) specification of 177.1520. Test result expressed as %w/w.Details see (d) of 177.
7、1520MaterialsCode of Federal RegulationTest ItemsRequirementTest Method6Polycarbonate Resins 聚碳酸酯PC21CFR 177.1580Water extractives 水提取物磅.15%w/wExtracted with distilled water at reflux temperature for 6h.Ethyl alcohol extractives 乙醇提取物磅.15%w/wExtracted with 50% ethyl alcohol in distilled water at ref
8、lux temperature for 6h.N-heptane extractives 正己烷提取物磅.15%w/wExtracted with n-heptane at reflux temperature for 6h.7Polyethylene phthalate polymers 聚对苯二甲酸乙二酯(PET )21CFR 177.1630Chloroform Extractives 氯仿提取物Used for packaging, transporting or holding food excluding alcoholic beverages. 食品接触但不包括酒精饮料0.5mg
9、/in2 (distilled water )或Omg/in2 (n- heptane)Used for packaging, transporting or holding alcoholic beverages (do not exceed 50 percent by volume) 接触酒精饮料(不超过50%)0.5mg/in2 (distilled water )磅。mg/in2 (n- heptane)或Omg/in2 (ethyl ethanol )Used for contain food during oven baking or cooking at temperature
10、above 250F. 烘烤烹煮食品(不超过 250F)磅.02mg/in2 (distilled water)磅.02mg/in2 (n- heptanRUsed for contact dry food, bulk food include alcohol beverage not exceed 50 percent by volume.接触干食品，散装食品以及 不超过50%的酒精饮料。0.2mg/in2 (distilled water )磅.2mg/in2 (n- heptane)磅.2mg/in2 (ethyl ethanol )Used for packaging, transpo
11、rting or holding alcoholic foods that do not exceed 95 percent by volume. 接触含量不超过95%的酒精 饮料。或Omg/in2 (distilled water )或Omg/in2 (n- heptane)磅.005mg/in2 (ethanol )Container capacity:Greater than 50ml2 磅.05mg/in(ethanol )Container capacity: Less than or equal to 50ml8Polystyrene and rubber- modified po
12、lystyrene 聚苯乙烯和橡胶改性 聚苯乙烯PS21CFR 177.1640Residual styrene monomer 苯乙烯单体 残留PS except contact with fatty foods不接触油性食品的聚苯乙烯%w/wDetails see (d) of 177.1640PS contact with fatty foods 接触油性食品的聚苯乙烯5%w/wRubber-modified polystyrene 橡胶改性聚苯乙烯5%w/w9Rubber articles intended for repeated use (excluding nursingbott
13、le nipples) 重复使用的橡胶制品 (不包括婴儿橡胶奶嘴)21CFR 177.2600OverallMigration 总迁移Used in contact with aqueous foods 接触水性食品磴0mg/in2 (first 7h of extraction)司mg/in2 (succeeding2h of extraction)Extracted with distilled water at reflux temperature 蒸储水回流Used in contact with fatty foods 接触油性食品司 75mg/in2 (first 7h of extraction)Nmg/in2 (succeeding2h of extraction)Extracted with n-hexane at reflux temperature 正己烷回流 5文档来源为：从网络收集整理.word版本可编辑.
FDA食品级材料测试要求限量标准列表
