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FDA食品接触材料常见标准

常见FDA食品接触材料检测标准

有机涂层,金属和电镀制品要求

U.S. FDA CFR 21 175.300

water extractives 去离子水浸取法

8% alcohol extractives 8%酒精浸取法

heptane extractives  正庚烷浸取法

 

纸制品要求

U.S. FDA CFR 21 176.170

氯仿可溶萃取物去离子水浸取法

Net chloroform soluble extractives for water fraction  

法氯仿可溶萃取物8%酒精浸取

Net chloroform soluble extractives for 8 % alcohol fraction

氯仿可溶萃取物50%酒精浸取法

Net chloroform soluble extractives for 50 % alcohol fraction

氯仿可溶萃取物正庚烷浸取法

Net chloroform soluble extractives for n-heptane fraction  

 

木材要求

U.S. FDA CFR 21 178.3800

Pentachlorophenol and its salt   五氯苯酚PCP

 

ABS要求

U.S. FDA CFR 21 181.32 or 180.22

in water

去离子水浸取法

in 3% acetic acid    

3%醋酸浸取法

in 8% ethanol 

 8%酒精浸取法

in n-heptane  

正庚烷浸取法

 

丙烯酸树脂Acrylic要求

U.S. FDA CFR 21 177.1010

总提取物in water,8,50alcohol fraction,heptane去离子水、8%酒精

KMnO4 oxidizable extractive(in water,8,50alcohol fraction)Ultraviolet-absorbing(in water,8,50alcohol fraction)Ultraviolet-absorbing(in heptane fraction)

 

食品容器的密封圈密封衬垫要求如硅橡胶圈

U.S. FDA CFR 21 177.1210

Net chloroform soluble extractives for water fraction   

氯仿可溶萃取物去离子水浸取法

Net chloroform soluble extractives for 8 % alcohol fraction

氯仿可溶萃取物8%酒精浸取法

Net chloroform soluble extractives for n-heptane fraction 

氯仿可溶萃取物正庚烷浸取法

 

EVA要求

 U.S. FDA CFR 21 177.1350

 Net CHCI3 soluble fraction in different extractive (in different food simulants)

氯仿萃取

 Vinylidene fluoride & hexafluropropene Xanthan gum (coating)

 

三聚氰氨树脂(密胺)要求  

U.S. FDA CFR 21 177.1460

Net chloroform soluble water extractives  

氯仿可溶萃取物去离子水浸取法

Net chloroform soluble 8% alcohol extractives 

氯仿可溶萃取物8%酒精浸取法

Net chloroform soluble n-heptane extractives  

氯仿可溶萃取物正庚烷浸取法

 

尼龙塑料要求

U.S. FDA CFR 21 177.1500

Specific gravity

 密度

Melting point      

熔点

Solubility / boiling 4.2 N HCI 

中的溶解度

Water extractives  

去离子水浸取法

95% ethanol extractives

95%酒精浸取法

Ethyl acetate extractives

乙酸乙脂浸取法

Benzene extractives     

苯浸取法

 

PP要求

U.S. FDA CFR 21 177.1520

 Specific gravity 

密度

Melting point      

熔点

n-hexane extractives

正己烷浸取法

Xylene extractives

二浸取法

 

PE,OP要求  

U.S. FDA CFR 21 177.1520

Specific gravity 

密度

n-hexane extractives

正己烷浸取法

Xylene extractives

二浸取法

 

PC要求.

U.S. FDA CFR 21 177.1580

Water extractives at refluxing temperature

水回流萃取

50% ethanol extractives at refluxing temperature 

50酒精回流萃取

n-heptane extractives at refluxing temperature  

正庚烷回流萃取

 

PET要求

U.S. FDA CFR 21 177.1630 .

Net chloroform soluble fraction of distilled water 

氯仿可溶萃取物去离子水浸取法

Net chloroform soluble fraction of 8% ethanol    

氯仿可溶萃取物8%酒精浸取法

Net chloroform soluble fraction of 95% ethanol  

氯仿可溶萃取物95%酒精浸取法

Net chloroform soluble fraction of n-heptane      

氯仿可溶萃取物正庚烷浸取法

 

PS要求

U.S. FDA CFR 21 177.1640

Residual styrene monomer           

苯乙烯单体残留

 

聚枫树脂Polysulfone resin要求

U.S. FDA CFR 21 177.1655

Water extractives

去离子水浸取法

3 % acetic acid extractives

3%醋酸浸取法

50 % alcohol extractives    

50%酒精浸取法

n-heptane extractive 

正庚烷浸取法

 

聚亚氨树脂PU要求

U.S. FDA CFR 21 177.1680

Adhesive resistance test  

耐磨测试

water extractives 

去离子水浸取法

8% ethanol extractives  

8%酒精浸取法

 

苯乙烯要求Styrene block polymer

U.S. FDA CFR 21177.1810

Water extractives

去离子水浸取法

50% ethanol extractives   

50酒精回流萃取

Solubility

溶解度

molecular weight

分子量

glass transition point

玻璃化转变温度

 

MMAMBS要求

U.S.FDA CFR 21 177.1830

 Non-volatile residue

 KmnO4 oxidized water extractives

KmnO4 oxidized 8% ethanol extractives

UV absorbing water extractives

UV absorbing 8% ethanol extractives

UV absorbing n-heptane extractives

 

脲醛树脂UF要求

U.S. FDA CFR 21 177.1900

 water extractives

去离子水浸取法

 8% alcohol extractives

8%酒精浸取法

 n-heptane extractives 

正庚烷浸取法

 

PVC要求  

U.S. FDA CFR 21 175.300

water extractives

去离子水浸取法

n-heptane extractives     

正庚烷浸取法

8% alcohol extractives  

8%酒精浸取法

 附加

U.S. FDA CFR 21 177.1975   Residual vinyl chloride monomer VCM单体残留

 

聚脂树脂Polyester resin要求

 U.S. FDA CFR 21 177.2420

chloroform soluble fraction in water     

氯仿可溶萃取物去离子水浸取法

Net chloroform soluble fraction in 8 % ethanol 

氯仿可溶萃取物8%酒精浸取法

Net chloroform soluble fraction in 50 % ethanol 

氯仿可溶萃取物50%酒精浸取法

n-heptane extractives      

正庚烷浸取法

 

橡胶要求SBS,TPR,TPE硅胶等弹性体

 U.S. FDA CFR 21 177.2600

water extractives

离子水浸取法

 n-hexane extractives

正己烷浸取法(只针对脂肪类食物接触)镀银制品要求

U.S. FDA CPG 7117.05

 extractable lead铅萃取

 

陶瓷、玻璃、搪瓷器皿要求

 U.S. FDA CPG 7117.06,07

 extractable lead and cadmium 

溶出铅、镉测试

 

金属要求

U.S. FDA CFR 175.300 & CPG 7117.05

water extractives

去离子水浸取法

8% alcohol extractives

8%酒精浸取法

n-heptane extractives 

正庚烷浸取法

extractable lead

铅萃取

 

常见FDA食品接触材料检测标准

FDA 21CFR,食品接触材料检测标准,HK

21CFR 177.1040 Acrylonitrile/styrene copoly-mer(AS)丙烯晴-苯乙烯共聚物

i) maximum residual acrylonitrile monomer content

ii) Nitrogen content of the copolymer

iii) Total non-volatile extractives in distilled water

iv) Total non-volatile extractives in 3% acetic acid

v) The extracted copolymer in distilled water

vi) The extracted copolymer in 3% acetic acid

 

21CFR 177.1020 Acrylonitrile/butadiene/styrene co-polymer( ABS) 

丙烯酸-丁二烯-苯乙烯树脂共聚物

i) Nitrogen content of the copolymer

ii) Residual acrylonitrile monomer content

iii) total non-volatile extractives in distilled water

iv) total non-volatile extractives in 3%acetic acid

v) total non-nvolatile extractives in n-heptane

vi) acrylonitrile monomer migration in distilled water

vii) acrylonitrile monomer migration in 3%acetic acid

 

21CFR 177.1460 Melamine-formaldehyde resins in molded articles (MF)  密胺/甲醛树脂

i)  Net chloroform-soluble extractives in distilled water

ii)  Net chloroform-soluble extractives in n-heptane

iii)  Net chloroform-soluble extractives in 8% alcohol

 

21CFR 177.1500 Nylon resins  尼龙树脂

i) Specific gravity

ii) melting point

iii) solubility in boiling 4.2NHCl

iv) maxium extractable fraction in water

v) maxium extractable fraction in 95% alcohol

vi) maxium extractable fraction in ethyl acetate

viii) maxium extractable fraction in benzene

 

Polyethylene resins (PE) , 21 CFR 177.1520  聚乙烯树脂

i) Density

ii) Extractable fraction in n-hexane

iii) Soluble fraction in xylene

 

Polypropylene resins (PP) , 21 CFR 177.1520 聚丙烯树脂

'i) Density

ii) Melting point 

iii) Extractable fraction in n-hexane

iv) Soluble fraction in xylene

 

Ethylene-vinyl acetate copolymer (EVA), 21 CFR 177.1350乙烯/乙酸乙酯共聚物

i) Total extractives in distilled water

ii) Total extractives in n-heptane

iii) Total extractives in 8% alcohol

iv) Total extractives in 50% alcohol

 

Polycarbonate resins (PC), 21 CFR 177.1580聚碳酸酯

i) Total extractives in distilled water

ii) Total extractives in 50% ethyl alcohol

iii) Total extractives in n-heptane

 

Polyethylene phthalate polymers (polyester, e.g. PET), 21 CFR 177.1630苯二甲酸乙二酯

i) Chloroform-soluble extractives in distilled water

ii) Chloroform-soluble extractives in n-heptane

iii) Chloroform-soluble extractives in 50% ethyl alcohol

 

Polyvinyl alcohol film, 21 CFR 177.1670 聚乙烯醇薄膜

i)  Total extractives in n-heptane 

 

Polyoxymethylene copolymer (POM), 21 CFR 177.2470 聚甲醛树脂

i)   Net-chloroform soluble extractives in distilled water

ii)  Net-chloroform soluble extractives in n-heptane

iii)  Net-chloroform soluble extractives in 8% alcohol

iv)  Total extractives in distilled water at reflux temperature for 6 hours

v)  Total extractives in n-heptane at reflux temperature for 6 hours

 

Polyphenylene sulphide (PPS), 21 CFR 177.2490  聚苯硫醚树脂

 i) Total extractives in distilled water 

 ii) Total extractives in 3% acetic acid 

 iii) Total extractives in 50% ethanol

iv)  Total extractives in heptane

 

Poly (2,6-dimethyl-1,4-phenylene) oxide (PPO), 21 CFR 177.2460 聚氧化树脂

 i) Total extractives in n-heptane 

  

Rubber, 21 CFR 177.2600 橡胶,硅胶

i) Total extractives in distilled water (intended to contact with aqueous food) for

 ii) Total extractives in n-hexane (intended to contact with fatty food) for 

 

Acrylonitrile copolymers, Single-use, 21 CFR 180.22丙烯晴共聚物

i)     Acrylonitrile monomer extraction for finished product in distilled water at 120°F for

appropriate time of use

ii)    Acrylonitrile monomer extraction for finished product in 8% or 50% ethanol (select

one) at 120°F for appropriate time of use

iii)   Acrylonitrile monomer extraction for finished product in 3% acetic acid at 120°F for

appropriate time of use

iv)    Acrylonitrile monomer extraction for finished product in n-heptane at 120°F for

appropriate time of use

 

Polystyrene resins(PS), 21 CFR 177.1640  聚苯乙烯

i)   Total residual styrene monomer content

 

Resinous and polymeric coating, 21 CFR 175.300  树脂和聚合物的涂料

i) Total extractives in distilled water

ii) Total extractives in 8% alcohol

iii) Total extractives in n-heptane

 

Phenolic resins in molded articles, 21 CFR 177.2410  酚醛树脂

i) Total extractives in distilled water

ii) Extracted phenol in distilled water

iii) Extracted aniline in distilled water

 

Ion-exchange resins, 21 CFR 173.25 离子交换树脂

i) Organic extractives in distilled water

ii) Organic extractives in 15% alcohol

iii) Organic extractives in 5% acetic acid

 

Reinforced wax, 21 CFR 178.3850密封蜡

i) Chloroform-soluble portion in distilled water

 

Per fluorocarbon Resins, 21 CFR 177.1550 特氟龙

i)   Total extractives in distilled water

ii)  Total extractives in n-heptane

iii)  Total extractives in 50% alcohol

iv)  Total extractives in ethyl acetate

v)   Fluoride extractives calculated as fluorine in distilled water

vi) Fluoride extractives calculated as fluorine in n-heptane

vii) Fluoride extractives calculated as fluorine in 50% alcohol

viii) Fluoride extractives calculated as fluorine in ethyl acetate

 

Closures with sealing gaskets for food containers, 21 CFR 177.1210 密封垫片

i)   Chloroform fraction of water extractives

ii)  Chloroform fraction of heptane extractives

iii)  Chloroform fraction of 8% alcohol extractives

 

FDA Regulation for Paper and paperboard

a. Paper and coated paper, 21CFR 176.170 +

i)  Net chloroform-soluble extractives in distilled water

ii)  Net chloroform-soluble extractives in 8% alcohol

iii)   Net chloroform-soluble extractives in 50% alcohol

iv) Net chloroform-soluble extractives in heptane

 

FDA Regulation for Wood

a. Preservatives for wood 21 CFR 178.3800

   i)   Pentachlorophenol (PCP)

 

FDA Regulation for glass and Ceram

a. FDA 7117.06 & 7117.07

i) Metal release-lead and cadmium


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