常见FDA食品接触材料检测标准

 

宁波欧标检测 美国FDA 服务中心,具备专业丰富的 FDA 服务经验。协助众多经营食品及接触材料、药品、海鲜、化妆护肤品、医疗器械等相关出口美国的企业成功将商品投入美国市场，帮助企业及时解决各类产品被扣留、被拒绝的疑难问题。协助企业遵守美国食品与药品管理局（FDA）相关标准，为企业提供已履行FDA注册要求的手续。

美国FDA机构不发放或确认注册证书，宁波欧标检测机构并非美国FDA的附属机构。

 

(友情提示：为了更透明了解FDA建议收藏此页面)

美国食品药品管理局FDA官网：http://www.fda.gov/

 

  a. 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

    b. 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

    c. 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

    d. 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

    e. 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

    f. 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

    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

    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

    l. 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

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

    i) Total extractives in n-heptane 

    n. 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

    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 forappropriate time of use

    ii) Acrylonitrile monomer extraction for finished product in 8% or 50% ethanol (selectone) at 120°F for appropriate time of use

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

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

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

    i) Total residual styrene monomer content

    q. 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

    r. 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

    s. 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

    t. Reinforced wax, 21 CFR 178.3850密封蜡

    i) Chloroform-soluble portion in distilled water

    u. 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

    v. 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

 

    2. FDA Regulation for Paper and paperboard

    a. Paper and coated paper, 21CFR 176.170 +