FDA食品级材料测试要求限量统一标准列表.docVIP

Materials Code of Federal Regulation Test Items Requirement Test Method 1 Resinous and Polymeric Coating 树脂和聚合物涂料 21CFR 175.300 Overall Migration 总迁移 Coating employed as a component of a container not to exceed 1 gallon and intend for one-time use. 容器体积不超出1加仑且一次性使用。 ≤0.5mg/in2 Table 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. 容器体积超出1加仑且一次性使用。 ≤1.8mg/in2 Coating employed as a component of a container for repeat use. 能够反复使用容器。 ≤18mg/in2 Coating intend for repeated use, and employed other than as a component of a container. 涂层不是容器组成成份，且能够反复使用。 ≤18mg/in2 2 Paper or paperboard 纸及纸制品 21CFR 176.170 Overall Migration 总迁移 ≤0.5mg/in2 Ditto 3 Acrylonitrile/Butadiene/Styrene Co-polymer 丙烯腈/丁二烯/苯乙烯 共聚物ABS 21CFR 177.1020 Acrylonitrile Monomer 丙烯腈单体 ≤0.0015mg/in2 Expose to distilled water and 3% acetic acid at 150F for 15 days. 蒸馏水或3%乙酸在150F浸提15天。 Materials Code of Federal Regulation Test Items Requirement Test Method 4 Closures with sealing gasket 密封垫圈 21CFR 177.1210 Overall 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), ≤500ppm (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 有涂层纸塑料金属膜 ≤50ppm (Water), ≤250ppm (Heptane), ≤50ppm (Alcohol) 5 Olefin Polymers 烯烃聚合物（PP/PE/OP） 21CFR 177.1520 1.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 177.1520 Materials Code of Federal Regulation Test Items Requirement Test Method 6 Polycarbonate Resins 聚碳酸酯PC 21CFR 177.1580 Water extractives 水提取物 ≤0.15%