fda食品级材料测试要求限量标准列表

Test Method Table 2: Test procedure
a container not to exceed 1 gallon
of using simulant
and intend for one-time use.
solvents.
容器体积不超过 1 加仑且一次性使用。
使用模拟溶液测试方法详
to 50ml
PS except contact with ≤1%w/w
Details see (d) of
fatty foods
不接触油性食品的聚苯乙烯
PS contact with fatty
≤%w/w
foods
接触油性食品的聚苯乙烯
Rubber-modified
≤%w/w
polystyrene
a container for repeat use.
可以反复使用的容器。
1
Paper or paperboard
2
21CFR
纸及纸制品
Acrylonitrile/Butad
iene/Styrene Co-
3 polymer
21CFR
丙烯腈/丁二烯/苯乙
烯 共聚物 ABS
v1.0 可编辑可修改
Coating intend for repeated use, ≤18mg/in2
Polyethylene
phthalate polymers 7
聚对苯二甲酸乙二酯
（PET ）
21CFR
Used for packaging,
≤in2 （distilled
transporting or holding water ）
food excluding alcoholic ≤in2 （n-
橡胶改性聚苯乙烯
8
Rubber articles
intended for
repeated use
(excluding nursing-
9
21CFR
bottle nipples)
重复使用的橡胶制品
(不包括婴儿橡胶奶
嘴)
Used in contact with aqueous foods 接触水性食品
v1.0 可编辑可修改
Materials
Resinous and 1 Polymeric Coating
树脂和聚合物涂料
Code of Federal Regulation
Test Items
21CFR
Overall Migration 总迁移
Requirement Coating employed as a component of ≤in2
alcoholic foods that do ≤in2 （n-
not exceed 95 percent by heptane ）
v1.0 可编辑可修改
7
Polystyrene and
rubber-modified
polystyrene 8
聚苯乙烯和橡胶改性
聚苯乙烯 PS
21CFR
v1.0 可编辑可修改
or latex
液体增塑密封橡胶垫圈
Unvulcanized natural ≤50ppm (Water),
or synthetic rubber ≤250ppm (Heptane),
非硫化型橡胶垫圈
≤50ppm (Alcohol)
Vulcanized natural ≤50ppm (Water),
6
cooking at temperature
≤in2 （n-heptane）
above 250F.
烘烤烹煮食品（不超过
250F）
Used for contact dry
≤in2 （distilled
food, bulk food include water ）
alcohol beverage not
not exceed 50 percent by heptane ）
volume)
≤in2 （ethyl
接触酒精饮料(不超过 50%) ethanol ）
Used for contain food
≤in2 （distilled
during oven baking or
water）
v1.0 可编辑可修改
Coating employed as a component of ≤in2
见表 2。
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。
Coating employed as a component of ≤18mg/in2
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。
Overall
Ditto
Migration ≤in2
总迁移
Expose to distilled
Acrylonitri le Monomer ≤in2 丙烯腈单体
正己烷提取
4. Xylene
extractive
二甲苯提取
v1.0 可编辑可修改
Details see (d) of
4
Materials
Code of Federal Regulation
Test Items
Water extractives ≤%w/w 水提取物
Polycarbonate 6 Resins
or synthetic rubber ≤50ppm (Heptane),
硫化型橡胶垫圈
≤50ppm (Alcohol)
v1.0 可编辑可修改
Test Method
3
Olefin Polymers 5 烯烃聚合物
（PP/PE/OP）
21CFR
来自百度文库
Polymeric or resinous-coated paper, plastic or metal foil substance
beverages.
heptane ）
食品接触但不包括酒精饮料
Chloroform Used for packaging,
≤in2 （distilled
Extractives transporting or holding water ）
氯仿提取物 alcoholic beverages (do ≤in2 （n-
water and 3% acetic acid at 150F for 15 days. 蒸馏水或 3%乙酸在 150F 浸
提 15 天。
2
Materials
Closures with 4 sealing gasket
密封垫圈
Code of Federal Regulation
21CFR
Test Items
Residual styrene monomer 苯乙烯单体 残留
volume.
≤in2 （ethanol ）
接触含量不超过 95%的酒精 Container capacity:
饮料。
Greater than 50ml
≤in2 （ethanol ）
Container capacity:
Less than or equal
聚碳酸酯 PC
21CFR
Ethyl alcohol
≤%w/w extractives 乙醇提取物
N-heptane extractives ≤%w/w 正己烷提取物
Requirement
5
v1.0 可编辑可修改
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 nheptane at reflux temperature for 6h.
Extracted with distilled water at reflux temperature 蒸馏水回流
Extracted with n-hexane at reflux temperature 正己烷回流
9
≤in2 （n-
exceed 50 percent by
heptane ）
volume.
≤in2 （ethyl
接触干食品，散装食品以及 ethanol ）
不超过 50%的酒精饮料。
Used for packaging,
≤in2 （distilled
transporting or holding water ）
Overall Migration 总迁移
Used in contact with fatty foods 接触油性食品
v1.0 可编辑可修改
≤20mg/in2 (first 7h of extraction) ≤1mg/in2 (succeeding 2h of extraction) ≤175mg/in2 (first 7h of extraction) ≤4mg/in2 (succeeding 2h of extraction)
≤50ppm (Water), ≤250ppm (Heptane), ≤50ppm (Alcohol)
有涂层的纸塑料金属膜
,
Details see (c) specification of .
密度，
Test result expressed as %w/w.
Point
熔点
3. N-hexane
extractive,
Requirement
Overall Migration 总迁移
Plasticized polymer,
including rubber
≤50ppm (Water),
from hot melt,
≤500ppm (Heptane),
solution, plastisol, ≤50ppm (Alcohol)