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U.S. FDA inspection of food contact materials

The US Food and Drug Administration, a subordinate of the US Department of Health, Education and Welfare, is in charge of the management of the drugs, food, biological, cosmetic, veterinary drug, medical equipment and diagnostic product all over the country. In the States, FDA controls most contacting with food products through Food Additives Petition (FAP). If a certain type of food additive or food contacting material is approved by the FAP, then it will be recorded into a relevant regulation in the US FDA CFR 21 PARTS 170-189. Manufacturers shall comply with food laws strictly in order to produce qualified food contacting products and materials. Once pass the test, the enterprise can acquire competitive advantages, loyalty customers, thus acquire considerable economic benefits.**The common test items of FDA certification are as follows**

Material quality |
Test item |
Test standard |

（PP） |
Total extractable fraction in n-hexane |
21 CFR 177.1520 |

Soluble fraction in xylene | ||

Melting point | ||

Density | ||

（PE） |
Total extractable fraction in n-hexane |
21 CFR 177.1520 |

Soluble fraction in xylene | ||

Density | ||

TPR |
Total extractable fraction in D.I. water for 7 hours |
21 CFR 177.2600 |

- Total extractable fraction in D.I. water for 7 hours then maintaining for 2 hours. | ||

Total extractable fraction in n-hexane for 7 hours | ||

Total extractable fraction in n-hexane for 7 hours then maintaining for 2 hours | ||

（PC） |
Total extractable fraction in D.I. water |
21 CFR 177.1580 |

Total extractable fraction in 50% ethanol | ||

Total extractable fraction in n-heptane | ||

（AS） |
Residual acrylonitrile monomer |
21 CFR 177.1040 |

The maximum extractable fraction | ||

（PS） |
Styrene monomer content |
21 CFR 177.1640 |

SBCs |
Solubility |
21 CFR 177.1810 |

Total extractable fraction in D.I. water | ||

Total extractable fraction in 50% ethanol | ||

Acrylic resin |
Total extractable fraction of non-volatile in D.I. water |
21 CFR 177.1010 |

Total extractable fraction of non-volatile in 8% ethanol | ||

Total extractable fraction of non-volatile in n-heptane | ||

Total extractable fraction of absorbance of potassium permanganate oxidizable in D.I. water | ||

Total extractable fraction of absorbance of potassium permanganate oxidizable in 8% ethanol | ||

Total extractable fraction of absorbance of potassium permanganate oxidizable in 50% ethanol | ||

Total extractable fraction of UV absorbance in D.I. water | ||

Total extractable fraction of UV absorbance in 8% ethanol | ||

Total extractable fraction of UV absorbance in 50% ethanol | ||

Total extractable fraction of in n-heptane | ||

（SMMA） |
Total extractable fraction of non-volatile in D.I. water |
21 CFR 177.1830 |

Total extractable fraction of non-volatile in 8% ethanol | ||

Total extractable fraction of non-volatile in n-heptane | ||

Total extractable fraction of absorbance of potassium permanganate oxidizable in D.I. water | ||

Total extractable fraction of absorbance of potassium permanganate oxidizable in 8% ethanol | ||

Total extractable fraction of absorbance of potassium permanganate oxidizable in 50% ethanol | ||

Total extractable fraction of UV absorbance in D.I. water | ||

Total extractable fraction of UV absorbance in 8% ethanol | ||

Total extractable fraction of UV absorbance in 50% ethanol | ||

Total extractable fraction of in n-heptane | ||

（ABS） |
Total extractable fraction of residual acrylonitrile monomer in D.I. water |
21 CFR 181.32&21 CFR 180.22 |

Total extractable fraction of residual acrylonitrile monomer in 3% acetic acid | ||

Total extractable fraction of residual acrylonitrile monomer in 8% ethanol | ||

Total extractable fraction of residual acrylonitrile monomer in n-heptane | ||

Food container cover with seal gasket |
Total extractable fraction of chloroform in D.I. water |
21 CFR 177.1210 |

Total extractable fraction of chloroform in n-heptane | ||

Total extractable fraction of chloroform in 8% ethanol | ||

Total extractable fraction in D.I. water |
21 CFR 175.300 | |

Total extractable fraction in n-heptane | ||

Total extractable fraction in 8% ethanol | ||

Paper and paper board |
Total extractable fraction in D.I. water |
21 CFR 176.170 |

Total extractable fraction in n-heptane | ||

Total extractable fraction in ethanol | ||

Melamine resin |
Total extractable fraction of chloroform in D.I. water |
21 CFR 177.1460 |

Total extractable fraction of chloroform in n-heptane | ||

Total extractable fraction of chloroform in 8% ethanol | ||

Nylon |
Melting point |
21 CFR 177.1500 |

Density | ||

4.2mol/L沸腾盐酸中的溶解度 | ||

Total extractable fraction in D.I. water | ||

Total extractable fraction in 95% ethanol | ||

Total extractable fraction in ethyl acetate | ||

Total extractable fraction in benzene | ||

（POM） |
Total extractable fraction of chloroform in D.I. water |
21 CFR 177.2470 |

Total extractable fraction of chloroform in 8% ethanol | ||

Total extractable fraction of chloroform in n-heptane | ||

Total extractable fraction in D.I. water | ||

Total extractable fraction in 8% ethanol | ||

Total extractable fraction in n-heptane | ||

（POM） |
Total extractable fraction of chloroform in D.I. water |
21 CFR 177.2480 |

Total extractable fraction of chloroform in 8% ethanol | ||

Total extractable fraction of chloroform in n-heptane | ||

Formaldehyde content | ||

Total extractable fraction in D.I. water | ||

Total extractable fraction in 8% ethanol | ||

Melting point | ||

Density | ||

Polysulfone resin |
Total extractable fraction in D.I. water |
21 CFR 177.1655 |

Total extractable fraction in 50% ethanol | ||

Total extractable fraction in 3% acetic acid | ||

Total extractable fraction in n-heptane | ||

Urea resin |
Total extractable fraction in D.I. water |
21 CFR 177.1900 |

Total extractable fraction in n-heptane | ||

Total extractable fraction in 8% ethanol | ||

Polyester resin |
Total extractable fraction of chloroform in D.I. water |
21 CFR 177.2420 |

Total extractable fraction of chloroform in 8% ethanol | ||

Total extractable fraction of chloroform in 50％ethanol | ||

Total extractable fraction of non-volatile in n-heptane | ||

Ceramic and glass product |
Extractable Lead |
FDA CPG 7117.06,07 / A.O.A.C. 15th.Ed.(973.32) |

Extractable Cadmium | ||

Enamel cookware |
Extractable Lead |
FDA CPG 7117.06,07 / A.O.A.C. 15th.Ed.(984.19) |

Extractable Cadmium | ||

Silver-plated tableware |
Extractable Lead |
FDA / CPG 7117.05 |

Cup edge test |
Lead, Cadmium |
U.S. SGCD & CSC ASTM C-927 (Rim-Area) |

Internal contact with food parts of ceramic and glass container |
Extractable Lead |
California 65 |

Extractable Cadmium | ||

Exterior decoration of ceramic and glass product |
Lead, Cadmium |
California 65 |

Stainless steel and metal |
Total extractable fraction in D.I. water |
21 CFR 175.300 |

Total extractable fraction in n-heptane | ||

| ||

Phenolic resin |
Total extractable fraction in D.I. water |
21 CFR 177.2410 |

Total extractable fraction of phenol in D.I. water | ||

Chloroethylene and vinyl copolymer |
Total extractable fraction in D.I. water |
21CFR 177.1950 |

Total extractable fraction in n-heptane | ||

Wood product |
PCP |
21 CFR 178.3800 |