FDA
  • FDA introduction

    FDA is short for food and drug administration. FDA sometimes also represents the US FDA, i.e. the US Food and drug administration. The US FDA is the international medical audit authority authorized by the US Congress, i.e. the federal government, and the highest law enforcement agency specialized in food and drug management. It is a professional composed of doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians who are committed to protection, promotion and improvement National Health government health control monitoring agency. Many other countries seek and receive FDA assistance to promote and monitor the safety of their own products.

    FDA certification of food materials

    Food contact materials refer to all materials that can be contacted with food in the process of processing, production, packaging, storage and transportation of food. Common materials include various plastics, metals, ceramics, glass, bamboo and wood products, etc. The environmental protection and safety of these materials that can be contacted with food is directly related to the food safety and health of users. Therefore, the export of such products to the United States needs to be tested and certified in accordance with FDA standards.

    The common inspection items of FDA certification for materials in contact with food are as follows:

    ■ U.S. FDA CFR 21 175.300 for organic coatings, metals and electroplated products

    Deionized water extraction, 8% alcohol extraction, n-heptane extraction

    ■ paper requirements U.S. FDA CFR 21 176.170

    Chloroform soluble extract (deionized water extraction, 8% alcohol extraction, 50% alcohol extraction, n-heptane extraction)

    ■ wood requirements U.S. FDA CFR 21 178.3800

    PCP pentachlorophenol

    ■ ABS requires U.S. FDA CFR 21 181.32 or 180.22

    Deionized water extraction, 3% acetic acid extraction, 8% alcohol extraction, n-heptane extraction

    ■ acrylic requirements U.S. FDA CFR 21 177.1010

    In water, 8%, 50% alcohol fraction (heptane) 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)

    ■ sealing ring and gasket requirements for food containers, such as silicone rubber ring U.S. FDA CFR 21 177.1210

    Chloroform soluble extract (deionized water extraction, 8% alcohol extraction, n-heptane extraction)

    ■ EVA requirements U.S. FDA CFR 21 177.1350

    chloroform extraction

    ■ melamine resin requirements U.S. FDA CFR 21 177.1460

    Chloroform soluble extract (deionized water extraction, 8% alcohol extraction, n-heptane extraction)

    ■ nylon plastic requirements U.S. FDA CFR 21 177.1500

    Density, melting point, solubility in hydrochloric acid, deionized water extraction, 95% alcohol extraction, acetate extraction, benzene extraction

    ■ PP requirements U.S. FDA CFR 21 177.1520

    Density, melting point, n-hexane leaching, xylene leaching

    ■ PE, Op requirements U.S. FDA CFR 21 177.1520

    Density, n-hexane extraction, xylene extraction

    ■ PC requirements. U.S. FDA CFR 21 177.1580

    Water reflux extraction, 50% alcohol reflux extraction, n-heptane reflux extraction

    ■ pet requirements U.S. FDA CFR 21 177.1630

    Chloroform soluble extract (deionized water extraction, 8% alcohol extraction, 95% alcohol extraction, n-heptane extraction)

    ■ PS requirements U.S. FDA CFR 21 177.1640

    Styrene monomer residue

    ■ polysulfone resin requirements U.S. FDA CFR 21 177.1655

    Deionized water extraction, 3% acetic acid extraction, 50% alcohol extraction, n-heptane extraction

    ■ polyurethane resin (PU) requirements U.S. FDA CFR 21 177.1680

    Wear resistance test, deionized water extraction, 8% alcohol extraction

    ■ styrene block polymer U.S. FDA CFR 21177.1810

    Deionized water extraction, 50% alcohol reflux extraction, solubility, molecular weight, glass transition temperature

    ■ MMA, MBS requirements.. 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

    ■ UF requirements U.S. FDA CFR 21 177.1900

    Deionized water extraction, 8% alcohol extraction, n-heptane extraction

    ■ PVC requirements U.S. FDA CFR 21 175.300

    Deionized water extraction, n-heptane extraction, 8% alcohol extraction, VCM monomer residue

    ■ polyester resin requirements U.S. FDA CFR 21 177.2420

    Chloroform soluble extract (deionized water extraction, 8% alcohol extraction, 50% alcohol extraction, n-heptane extraction)

    ■ rubber requirements (SBS, TPR, TPE) elastomers such as silica gel U.S. FDA CFR 21 177.2600

    Deionized water extraction, n-hexane extraction (only for fatty food contact)

    ■ silver plating product requirements U.S. FDA CpG 7117.05

    Lead extraction

    ■ requirements for ceramic, glass and enamel vessels U.S. FDA CpG 7117.06,07

    Dissolved lead and cadmium test

    ■ metal requirements U.S. FDA CFR 175.300 & CpG 7117.05

    Deionized water extraction, 8% alcohol extraction, n-heptane extraction, lead extraction