申请流程
Inspection process
FDA is the Food and Drug Administration (Food and Drug Administration) for short. FDA may also represent the United States FDA, that the US Food and Drug Administration, the FDA is an international medical audit authority from the US Congress authorized the Federal Government, specializing in the highest law enforcement authority of the Food and Drug Administration; is a by doctors, lawyers, microorganisms scientists, pharmacologists, chemists and statisticians and other professionals dedicated to protecting, promoting and enhancing national health monitoring government health regulatory agency. Many other countries to promote and monitor the safety of their own products through the FDA seek and receive help.
FDA certified food material
Refers to all food contact materials used in the manufacture, production, packaging, storage and transportation of food process, can come into contact with food materials. Common materials include various plastics, metals, ceramics, glass, wood products and so on. Environmental safety of these foods can come into contact with the material directly related to food safety and health of users. Therefore, these products are exported to the United States need to follow FDA standards related to testing and certification.
Common food contact materials FDA certification testing items are as follows:
■ organic coatings, electroplating and metal products require U.S. FDA CFR 21 175.300.
In deionized water, 8% alcohol extraction method, n-heptane extraction method
■ paper products require U.S. FDA CFR 21 176.170
Chloroform soluble extract (in deionized water, 8% alcohol extraction method, 50% ethanol extraction method, n-heptane extraction method)
■ timber requirements U.S. FDA CFR 21 178.3800
Pentachlorophenol PCP
■ ABS requirements U.S. FDA CFR 21 181.32 or 180.22.
In deionized water, 3% acetic acid extraction method, extraction method 8% alcohol, n-heptane extraction method
■ acrylic resin (Acrylic) requires U.S. FDA CFR 21 177.1010
Total extracts (in water, 8%, 50% alcohol fraction, heptane) of deionized water, 8% alcohol
KMnO4 oxidizable extractive (in water, 8%, 50% alcohol fraction)
Ultraviolet-absorbing (in water, 8%, 50% alcohol fraction)
Ultraviolet-absorbing (in heptane fraction)
■ seals, gasket food packagings, such as silicone rubber rings U.S. FDA CFR 21 177.1210
Chloroform soluble extract (in deionized water, 8% alcohol extraction method, n-heptane extraction method)
■ EVA requires U.S. FDA CFR 21 177.1350
Chloroform extraction
■ melamine resin (melamine) requires U.S. FDA CFR 21 177.1460
Chloroform soluble extract (in deionized water, 8% alcohol extraction method, n-heptane extraction method)
■ nylon plastic requires U.S. FDA CFR 21 177.1500
Density, melting point, hydrochloric acid solubility in deionized water, 95% ethanol extraction method, ethyl acetate extraction method, benzene extraction method
■ PP requires U.S. FDA CFR 21 177.1520
Density, melting point, n-hexane extraction method, xylene extraction method ..
■ PE, OP requires U.S. FDA CFR 21 177.1520
Density, n-hexane extraction method, xylene extraction method
■ PC requirements .U.S. FDA CFR 21 177.1580
Water extraction under reflux, refluxed for 50% ethanol extraction, reflux extraction of n-heptane
■ PET requires U.S. FDA CFR 21 177.1630.
Chloroform soluble extract (in deionized water, 8% alcohol extraction method, 95% ethanol extraction method, n-heptane extraction method)
■ PS requires U.S. FDA CFR 21 177.1640
Residual styrene monomer
■ Maple poly resin (Polysulfone resin) requires U.S. FDA CFR 21 177.1655
In deionized water, 3% acetic acid extraction method, 50% ethanol extraction method, n-heptane extraction method
■ poly amino resin (PU) requires U.S. FDA CFR 21 177.1680
Wear testing, in deionized water, 8% alcohol extraction method
■ styrene Requirements (Styrene block polymer) U.S. FDA CFR 21177.1810
In deionized water, 50% ethanol reflux extraction, solubility, molecular weight, glass transition temperature
■ MMA, MBS requires .. 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
■ urea formaldehyde resin (UF) requires U.S. FDA CFR 21 177.1900
In deionized water, 8% alcohol extraction method, n-heptane extraction method
■ PVC requires U.S. FDA CFR 21 175.300
In deionized water, heptane extraction method, 8% alcohol extraction method, VCM monomer residue
■ polyester resin (Polyester resin) requires U.S. FDA CFR 21 177.2420
Chloroform soluble extract (in deionized water, 8% alcohol extraction method, 50% ethanol extraction method, n-heptane extraction method)
■ requirements elastomeric rubber (SBS, TPR, TPE) such as silica gel U.S. FDA CFR 21 177.2600
In deionized water, hexane extraction method (only for fatty food contact)
■ silver products require U.S. FDA CPG 7117.05
Lead Extraction
■ ceramics, glass, enamel ware requirements U.S. FDA CPG 7117.06,07
Dissolution of lead, cadmium test
■ metal requires U.S. FDA CFR 175.300 & CPG 7117.05
In deionized water, 8% alcohol extraction method, n-heptane extraction method, lead extraction
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