资源描述
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.
容器体积不超过1加仑且一次性使用。
≤0.5mg/in2
Table 2: Test procedure of using simulant solvents.
使用模拟溶液测试措施详见表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/in2
Coating employed as a component of a container for repeat use.
可以反复使用旳容器。
≤18mg/in2
Coating intend for repeated use, and employed other than as a component of a container.
涂层不是容器旳构成成分，且可以反复使用。
≤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
有涂层旳纸塑料金属膜
≤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%w/w
Extracted with distilled water at reflux temperature for 6h.
Ethyl alcohol extractives
乙醇提取物
≤0.15%w/w
Extracted with 50% ethyl alcohol in distilled water at reflux temperature for 6h.
N-heptane extractives
正己烷提取物
≤0.15%w/w
Extracted with n-heptane at reflux temperature for 6h.
7
Polyethylene phthalate polymers
聚对苯二甲酸乙二酯（PET ）
21CFR 177.1630
Chloroform Extractives
氯仿提取物
Used for packaging, transporting or holding food excluding alcoholic beverages.
食品接触但不涉及酒精饮料
≤0.5mg/in2 （distilled water ）
≤0.5mg/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 ）
≤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 （distilled 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%旳酒精饮料。
≤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 not exceed 95 percent by volume.
接触含量不超过95%旳酒精饮料。
≤0.5mg/in2 （distilled water ）
≤0.5mg/in2 （n-heptane ）
≤0.005mg/in2 （ethanol ）
Container capacity: Greater than 50ml
≤0.05mg/in2 （ethanol ）
Container capacity: Less than or equal to 50ml
8
Polystyrene and rubber-modified polystyrene
聚苯乙烯和橡胶改性聚苯乙烯PS
21CFR 177.1640
Residual styrene monomer
苯乙烯单体残留
PS except contact with fatty foods
不接触油性食品旳聚苯乙烯
≤1%w/w
Details see (d) of 177.1640
PS contact with fatty foods
接触油性食品旳聚苯乙烯
≤0.5%w/w
Rubber-modified polystyrene
橡胶改性聚苯乙烯
≤0.5%w/w
9
Rubber articles intended for repeated use (excluding nursing-bottle nipples)
反复使用旳橡胶制品(不涉及婴儿橡胶奶嘴)
21CFR 177.2600
Overall 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
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