FDA食品级材料测试要求限量标准 列表
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≤0.5mg/in2 （nheptane ） ≤0.5mg/in2 （ethyl ethanol ）
≤0.02mg/in2 （distilled water）
≤0.02mg/in2 （nheptane）
Used for contact dry food, bulk food include alcohol beverage not exceed 50 percent by volume.
≤0.2mg/in2 （nheptane ）
≤0.2mg/in2 （ethyl ethanol ）
≤0.5mg/in2 （distilled water ）
≤0.5mg/in2 （nheptane ）
Polystyrene and
rubber-modified polystyrene
8
聚苯乙烯和橡胶
21CFR 177.1580
21CFR 177.1630
1.Density, 密度， 2.Melting Point 熔点 3. Nhexane extractive, 正己烷 提取 4. Xylene extractive 二甲苯 提取
Test Items
Water extractives
水提取 物
苯乙烯 单体残留
Overall Migration
总迁移
接触含量不超过 95%的 酒精饮料。
PS except contact with fatty foods
不接触油性食品的聚苯 乙烯
PS contact with fatty foods 接触油性食品的聚苯乙 烯 Rubber-modified polystyrene 橡胶改性聚苯乙烯 Used in contact with aqueous foods 接触水性食品
接触干食品，散装食品 以及不超过 50%的酒精饮 料。
Used for packaging, transporting or holding alcoholic foods that do not exceed 95 percent by volume.
≤0.2mg/in2 （distilled water ）
Materials
Resinous and Polymeric Coating
1 树脂和聚合物涂 料
Code of Federal Regulation
Test Items
21CFR 175.300
Overall Migration
总迁移
Requirement
Test Method
Coating employed as a component of a
21CFR 176.170
Migration 总迁移
≤0.5mg/in2
Acrylonitrile/Butadiene /Styrene Co-polymer
3 丙烯腈/丁二烯/苯 乙烯 共聚物 ABS
21CFR 177.1020
Acrylonitril
e Monomer 丙烯腈
单体
≤0.0015mg/in2
液体增塑密封橡胶 垫圈
Unvulcanized natural or synthetic rubber
非硫化型橡胶垫圈
Vulcanized natural or synthetic rubber
硫化型橡胶垫圈
≤50ppm (Water), ≤500ppm (Heptane), ≤50ppm (Alcohol)
≤50ppm (Water), ≤250ppm (Heptane), ≤50ppm (Alcohol) ≤50ppm (Water), ≤50ppm (Heptane), ≤50ppm (Alcohol)
Polymeric or resinouscoated paper, plastic or metal foil substance
Test Method
Olefin Polymers 5 烯烃聚合物 （PP/PE/OP）
Materials
Polycarbonate Resins 6 聚碳酸酯 PC
po7lymePrsolyethylene phthalate
21CFR 177.1520
Code of Federal Regulation
Ethyl alcohol extractives
乙醇提 取物
N-heptane extractives
正己烷提 取物
Chloroform Extractives
Details see (c) specification of 177.1520. Test result expressed as %w/w.
Test Method Extracted with distilled water at reflux temperature for 6h. Extracted with 50% ethyl alcohol in distilled water at reflux temperature for 6h. Extracted with n-heptane at reflux temperature for 6h.
改性聚苯乙烯 PS
21CFR 177.1640
Rubber articles
intended for repeated use
(excluding nursing-bottle
nip9ples) 重复使用的橡胶
制品(不包括婴儿橡胶 奶嘴)
21CFR 177.2600
Residual styrene monomer
有涂层的纸塑料金 属膜
≤50ppm (Water), ≤250ppm (Heptane), ≤50ppm (Alcohol)
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。
≤0.15%w/w
Requirement
≤0.15%w/w
≤0.15%w/w
Used for packaging,
≤0.5mg/in2
transporting or holding food excluding （distilled water ）
Details see (d) of 177.1520
聚对苯二甲酸乙 二酯（PET ）
氯仿提 取物
alcoholic beverages. 食品接触但不包括酒精
饮料
Used for packaging, transporting or holding alcoholic beverages (do not exceed 50 percent by volume)
≤4mg/in2 (succeeding 2h of extraction)
Extracted with distilled water at reflux temperature
蒸馏水回流
Extracted with n-hexane at reflux temperature
正己烷回流
≤1%w/w
Details see (d) of 177.1640
≤0.5%w/w
≤0.5%w/w
≤20mg/in2 (first 7h of extraction)
≤1mg/in2 (succeeding 2h of extraction)
≤175mg/in2 (first 7h of extraction)
Materials Cl4osur密es 封with垫se圈aling gasket
Code of Federal Regulation
21CFR 177.1210
Test Items
Overall Migration
总Βιβλιοθήκη Baidu移
Requirement
Plasticized polymer, including rubber from hot melt, solution, plastisol, or latex
接触酒精饮料(不超过 50%)
Used for contain food during oven baking or cooking at temperature above 250F.
烘烤烹煮食品（不超过 250F）
≤0.5mg/in2 （nheptane ）
≤0.5mg/in2 （distilled water ）
Used in contact with fatty foods 接触油性食品
≤0.005mg/in2 （ethanol ）
Container capacity: Greater than 50ml
≤0.05mg/in2 （ethanol ）
Container capacity: Less than or equal to 50ml
≤0.5mg/
Table 2: Test procedure of
container not to exceed 1 gallon and intend for one- in2
using simulant solvents.
time use.
使用模拟溶液测试方
容器体积不超过 1 加仑且一次性使
法详见表 2。
可以反复使用的容器。
≤18mg/i n2
Coating intend for repeated use, and employed
other than as a component of a container.
n2
涂层不是容器的组成成分，且可以
反复使用。
≤18mg/i
Overall
Ditto
Paper or paperboard 2 纸及纸制品
用。
Coating employed as a component of a
≤1.8mg/
container having a capacity in excess of 1 gallon and in2
intend for one-time use. 容器体积超过 1 加仑且一次性使
用。
Coating employed as a component of a container for repeat use.
≤0.02mg/in2 （distilled water）
≤0.02mg/in2 （nheptane）
Used for contact dry food, bulk food include alcohol beverage not exceed 50 percent by volume.
≤0.2mg/in2 （nheptane ）
≤0.2mg/in2 （ethyl ethanol ）
≤0.5mg/in2 （distilled water ）
≤0.5mg/in2 （nheptane ）
Polystyrene and
rubber-modified polystyrene
8
聚苯乙烯和橡胶
21CFR 177.1580
21CFR 177.1630
1.Density, 密度， 2.Melting Point 熔点 3. Nhexane extractive, 正己烷 提取 4. Xylene extractive 二甲苯 提取
Test Items
Water extractives
水提取 物
苯乙烯 单体残留
Overall Migration
总迁移
接触含量不超过 95%的 酒精饮料。
PS except contact with fatty foods
不接触油性食品的聚苯 乙烯
PS contact with fatty foods 接触油性食品的聚苯乙 烯 Rubber-modified polystyrene 橡胶改性聚苯乙烯 Used in contact with aqueous foods 接触水性食品
接触干食品，散装食品 以及不超过 50%的酒精饮 料。
Used for packaging, transporting or holding alcoholic foods that do not exceed 95 percent by volume.
≤0.2mg/in2 （distilled water ）
Materials
Resinous and Polymeric Coating
1 树脂和聚合物涂 料
Code of Federal Regulation
Test Items
21CFR 175.300
Overall Migration
总迁移
Requirement
Test Method
Coating employed as a component of a
21CFR 176.170
Migration 总迁移
≤0.5mg/in2
Acrylonitrile/Butadiene /Styrene Co-polymer
3 丙烯腈/丁二烯/苯 乙烯 共聚物 ABS
21CFR 177.1020
Acrylonitril
e Monomer 丙烯腈
单体
≤0.0015mg/in2
液体增塑密封橡胶 垫圈
Unvulcanized natural or synthetic rubber
非硫化型橡胶垫圈
Vulcanized natural or synthetic rubber
硫化型橡胶垫圈
≤50ppm (Water), ≤500ppm (Heptane), ≤50ppm (Alcohol)
≤50ppm (Water), ≤250ppm (Heptane), ≤50ppm (Alcohol) ≤50ppm (Water), ≤50ppm (Heptane), ≤50ppm (Alcohol)
Polymeric or resinouscoated paper, plastic or metal foil substance
Test Method
Olefin Polymers 5 烯烃聚合物 （PP/PE/OP）
Materials
Polycarbonate Resins 6 聚碳酸酯 PC
po7lymePrsolyethylene phthalate
21CFR 177.1520
Code of Federal Regulation
Ethyl alcohol extractives
乙醇提 取物
N-heptane extractives
正己烷提 取物
Chloroform Extractives
Details see (c) specification of 177.1520. Test result expressed as %w/w.
Test Method Extracted with distilled water at reflux temperature for 6h. Extracted with 50% ethyl alcohol in distilled water at reflux temperature for 6h. Extracted with n-heptane at reflux temperature for 6h.
改性聚苯乙烯 PS
21CFR 177.1640
Rubber articles
intended for repeated use
(excluding nursing-bottle
nip9ples) 重复使用的橡胶
制品(不包括婴儿橡胶 奶嘴)
21CFR 177.2600
Residual styrene monomer
有涂层的纸塑料金 属膜
≤50ppm (Water), ≤250ppm (Heptane), ≤50ppm (Alcohol)
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。
≤0.15%w/w
Requirement
≤0.15%w/w
≤0.15%w/w
Used for packaging,
≤0.5mg/in2
transporting or holding food excluding （distilled water ）
Details see (d) of 177.1520
聚对苯二甲酸乙 二酯（PET ）
氯仿提 取物
alcoholic beverages. 食品接触但不包括酒精
饮料
Used for packaging, transporting or holding alcoholic beverages (do not exceed 50 percent by volume)
≤4mg/in2 (succeeding 2h of extraction)
Extracted with distilled water at reflux temperature
蒸馏水回流
Extracted with n-hexane at reflux temperature
正己烷回流
≤1%w/w
Details see (d) of 177.1640
≤0.5%w/w
≤0.5%w/w
≤20mg/in2 (first 7h of extraction)
≤1mg/in2 (succeeding 2h of extraction)
≤175mg/in2 (first 7h of extraction)
Materials Cl4osur密es 封with垫se圈aling gasket
Code of Federal Regulation
21CFR 177.1210
Test Items
Overall Migration
总Βιβλιοθήκη Baidu移
Requirement
Plasticized polymer, including rubber from hot melt, solution, plastisol, or latex
接触酒精饮料(不超过 50%)
Used for contain food during oven baking or cooking at temperature above 250F.
烘烤烹煮食品（不超过 250F）
≤0.5mg/in2 （nheptane ）
≤0.5mg/in2 （distilled water ）
Used in contact with fatty foods 接触油性食品
≤0.005mg/in2 （ethanol ）
Container capacity: Greater than 50ml
≤0.05mg/in2 （ethanol ）
Container capacity: Less than or equal to 50ml
≤0.5mg/
Table 2: Test procedure of
container not to exceed 1 gallon and intend for one- in2
using simulant solvents.
time use.
使用模拟溶液测试方
容器体积不超过 1 加仑且一次性使
法详见表 2。
可以反复使用的容器。
≤18mg/i n2
Coating intend for repeated use, and employed
other than as a component of a container.
n2
涂层不是容器的组成成分，且可以
反复使用。
≤18mg/i
Overall
Ditto
Paper or paperboard 2 纸及纸制品
用。
Coating employed as a component of a
≤1.8mg/
container having a capacity in excess of 1 gallon and in2
intend for one-time use. 容器体积超过 1 加仑且一次性使
用。
Coating employed as a component of a container for repeat use.