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21CFR177-食品接觸材料FDA標準檢測認證
2017-06-29

常見FDA食品接觸材料FDA檢測標準-21CFR 177.XXXX

1. 材料

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

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


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

丙烯酸-丁二烯-苯乙烯樹脂共聚物FDA檢測

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

 

c. 177.1460 Melamine-formaldehyde resins in molded articles (MF)  密胺/甲醛樹脂FDA檢測

i)  Net chloroform-soluble extractives in distilled water

ii)  Net chloroform-soluble extractives in n-heptane

iii)  Net chloroform-soluble extractives in 8% alcohol

 

d. 177.1500 Nylon resins  尼龍樹脂

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

 

e. Polyethylene resins (PE) , 21 CFR 177.1520  聚乙烯樹脂

i) Density

ii) Extractable fraction in n-hexane

iii) Soluble fraction in xylene

 

f. Polypropylene resins (PP) , 21 CFR 177.1520 聚丙烯樹脂

'i) Density

ii) Melting point 

iii) Extractable fraction in n-hexane

iv) Soluble fraction in xylene

 

g.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

 

h. Polycarbonate resins (PC), 21 CFR 177.1580聚碳酸酯FDA檢測

i) Total extractives in distilled water

ii) Total extractives in 50% ethyl alcohol

iii) Total extractives in n-heptane

 

i. 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

 

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

i)  Total extractives in n-heptane 

 

k. Polyoxymethylene copolymer (POM), 21 CFR 177.2470 聚甲醛樹脂

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

 

l. Polyphenylene sulphide (PPS), 21 CFR 177.2490  聚苯硫醚樹脂

 i) Total extractives in distilled water 

 ii) Total extractives in 3% acetic acid 

 iii) Total extractives in 50% ethanol

iv)  Total extractives in heptane

 

m. Poly (2,6-dimethyl-1,4-phenylene) oxide (PPO), 21 CFR 177.2460 聚氧化樹脂FDA檢測

 i) Total extractives in n-heptane 

 

 

n. Rubber, 21 CFR 177.2600 橡膠,硅膠FDA檢測

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 

 

o.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

 

P. Polystyrene resins(PS), 21 CFR 177.1640  聚苯乙烯FDA檢測

i)   Total residual styrene monomer content

 

q. Resinous and polymeric coating, 21 CFR 175.300  樹脂和聚合物的涂料FDA檢測

i) Total extractives in distilled water

ii) Total extractives in 8% alcohol

iii) Total extractives in n-heptane

 

r.  Phenolic resins in molded articles, 21 CFR 177.2410  酚醛樹脂FDA檢測

i) Total extractives in distilled water

ii) Extracted phenol in distilled water

iii) Extracted aniline in distilled water

 

s. Ion-exchange resins, 21 CFR 173.25 離子交換樹脂FDA檢測

i) Organic extractives in distilled water

ii) Organic extractives in 15% alcohol

iii) Organic extractives in 5% acetic acid

 

t. Reinforced wax, 21 CFR 178.3850密封蠟

i) Chloroform-soluble portion in distilled water

 

u. Per fluorocarbon Resins, 21 CFR 177.1550 特氟龍FDA檢測

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

 

v. Closures with sealing gaskets for food containers, 21 CFR 177.1210 密封墊片FDA檢測

i)   Chloroform fraction of water extractives

ii)  Chloroform fraction of heptane extractives

iii)  Chloroform fraction of 8% alcohol extractives

 

2.  FDA Regulation for Paper and paperboard 紙張材料FDA檢測

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

 

3.  FDA Regulation for Wood  木制品

a. Preservatives for wood 21 CFR 178.3800

   i)   Pentachlorophenol (PCP)

 

4.   FDA Regulation for glass and Ceram 玻璃

a. FDA 7117.06 & 7117.07

i) Metal release-lead and cadmium


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