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F(xiàn)DA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F(xiàn)DA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F(xiàn)DA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F(xiàn)DA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F(xiàn)DA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