FDA食品级材料测试要求限量标准-列表(共5页).doc

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1、精选优质文档-倾情为你奉上MaterialsCode of Federal RegulationTest ItemsRequirementTest Method1Resinous and Polymeric Coating 树脂和聚合物涂料21CFR 175.300Overall Migration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。0.5mg/in2Table 2: Test procedur

2、e 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。1.8mg/in2Coating employed as a component of a container for repeat use. 可以反复使用的容器。18mg/in2Coating intend for repeated use,

3、and employed other than as a component of a container. 涂层不是容器的组成成分，且可以反复使用。 18mg/in22Paper or paperboard 纸及纸制品21CFR 176.170Overall Migration总迁移0.5mg/in2Ditto3Acrylonitrile/Butadiene/Styrene Co-polymer丙烯腈/丁二烯/苯乙烯 共聚物ABS21CFR 177.1020Acrylonitrile Monomer 丙烯腈单体0.0015mg/in2Expose to distilled water and

4、 3% acetic acid at 150F for 15 days. 蒸馏水或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液体增塑密封橡胶垫圈50ppm (Water),500p

5、pm (Heptane),50ppm (Alcohol)Unvulcanized natural or synthetic rubber非硫化型橡胶垫圈50ppm (Water),250ppm (Heptane),50ppm (Alcohol)Vulcanized natural or synthetic rubber硫化型橡胶垫圈50ppm (Water),50ppm (Heptane),50ppm (Alcohol)Polymeric or resinous-coated paper, plastic or metal foil substance 有涂层的纸塑料金属膜50ppm (Wat

6、er),250ppm (Heptane),50ppm (Alcohol)5Olefin Polymers烯烃聚合物（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 177.1520MaterialsCode of Federal RegulationTe

7、st ItemsRequirementTest Method6Polycarbonate Resins聚碳酸酯PC21CFR 177.1580Water extractives 水提取物0.15%w/wExtracted with distilled water at reflux temperature for 6h. Ethyl alcohol extractives 乙醇提取物0.15%w/wExtracted with 50% ethyl alcohol in distilled water at reflux temperature for 6h.N-heptane extracti

8、ves 正己烷提取物0.15%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/in2 （distilled water ）0.5mg/in2 （n-heptan

9、e ）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 ）0.5mg/in2 （n-heptane ）0.5mg/in2 （ethyl ethanol ）Used for contain food during oven baking or cooking at temperature above 250F.烘烤烹煮食品（不超过250F）0.02mg/in2 （di

10、stilled water）0.02mg/in2 （n-heptane）Used 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 ）0.2mg/in2 （n-heptane ）0.2mg/in2 （ethyl ethanol ）Used for packaging, transporting or holding alcoholic foods that do n

11、ot exceed 95 percent by volume.接触含量不超过95%的酒精饮料。0.5mg/in2 （distilled water ）0.5mg/in2 （n-heptane ）0.005mg/in2 （ethanol ）Container capacity: Greater than 50ml0.05mg/in2 （ethanol ）Container capacity: Less than or equal to 50ml 8Polystyrene and rubber-modified polystyrene 聚苯乙烯和橡胶改性聚苯乙烯PS21CFR 177.1640Re

12、sidual 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1%w/wDetails see (d) of 177.1640PS contact with fatty foods接触油性食品的聚苯乙烯0.5%w/wRubber-modified polystyrene 橡胶改性聚苯乙烯0.5%w/w9Rubber articles intended for repeated use (excluding nursing-bottle nipples)重复使用的橡胶制品(不包括婴儿橡胶奶嘴)21CFR 1

13、77.2600Overall Migration总迁移Used in contact with aqueous foods接触水性食品20mg/in2 (first 7h of extraction)1mg/in2 (succeeding 2h of extraction)Extracted with distilled water at reflux temperature 蒸馏水回流Used in contact with fatty foods 接触油性食品175mg/in2 (first 7h of extraction)4mg/in2 (succeeding 2h of extraction)Extracted with n-hexane at reflux temperature 正己烷回流专心-专注-专业