USA Regulations for Food Contact Materials

1. Summary

The United States food and drug administration (FDA) is responsible for the management of national drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies. The Food Contact Substances(FCSs) are defined by FDA as follows: A food contact substance is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.

The specific general requirements of food contact containers and materials are as follows:

– Factory can operation in accordance with the GMP(Good Manufacturing Practice) system

– Use the materials conformed in the regulations (U.S. FDA CFR 21 Part 170-189)

– Approved raw materials should be in line with the norms of technical indicators (U.S. FDACFR Part 170-189)

– Any new materials enter the market must be approved by U.S. FDA review and approval

USA Regulations for Food Contact Materials

2. Authentication range

Usually involved products include:

1) Toaster, sandwichoven, electric kettle, etc and food contact electrical products

2) Food storage products, tempered glass cutting board, stainless steel kitchen utensils

3) Bowl, knife, fork, spoon, cup dish and table-wares-Vessels shipping to California must comply with the California Proposition 65 regulations requirements (including the part that vessels contacted with food , external decoration, the edge of glass parts). The products include but not limited:

1) glass and ceramic products used for storage, carrying food or drinks

2) glass and ceramic products not contact with food or drinks(daily necessities).

USA Regulations for Food Contact Materials

NoMaterialsTest ItemsLimitsRegulation
1Resinous and  polymeric coatingsDisposableDistilled  water extractives≤0.5mg/inch2/1.8mg/inch2U.S. FDA  CFR 21 175.300
8%  Ethanol extractives≤0.5mg/inch2/1.8mg/inch2
N-Heptane  extractives≤0.5mg/inch2/1.8mg/inch2
Re-useDistilled  water extractives≤18mg/inch2
8%  Ethanol extractives≤18mg/inch2
N-Heptane  extractives≤18mg/inch2
BPA  contentN.D.
2Paper and paperboardDistilled  water extractives≤0.5mg/inch2U.S. FDA CFR 21 176.170
8%  Ethanol extractives≤0.5mg/inch2
50% Ethanol extractives≤0.5mg/inch2
N-Heptane  extractives≤0.5mg/inch2
3WoodPCP50ppmU.S. FDA CFR  21 178.3800
4Acrylic and modified  acrylic plastics, semirigid and rigidExtractives (Distilled water, 8% & 50% Ethanol, N-Heptane)For each simulants≤0.3mg/inch2U.S. FDA  CFR 21 177.1010
Oxidizable  extractives(Distilled water, 8% & 50% Ethanol)For each simulants≤0.15
Ultraviolet-absorbingFor each simulants(Distilled water, 8% & 50% Ethanol)≤0.30
5Closures with sealing gaskets for food containersDistilled water extractives50ppmU.S. FDA  CFR 21 177.1210
8%  Ethanol extractives50ppm
N-Heptane  extractives50ppm, 250ppm, 500ppm
6Ethylene-vinyl  acetate copolymersDistilled  water extractives≤0.5mg/inch2US FDA CFR  21 177.1350
8%  Ethanol extractives≤0.5mg/inch2
50%  Ethanol extractives≤0.5mg/inch2
N-Heptane  extractives≤0.5mg/inch2
7Melamine-formaldehyde resins in molded articlesDistilled  water extractives≤0.5mg/inch2U.S. FDA  CFR 21 177.1460
8%  Ethanol extractives≤0.5mg/inch2
N-Heptane  extractives≤0.5mg/inch2
8Nylon resinsDensityRequirements are  different of each type, please call us for counselingU.S. FDA CFR  21 177.1500
Melting  point
Solubility  in 4.2N HCL
Distilled  water extractives
95% ethanol extractives
Ethyl  acetate extractives
Benzene  extractives
9PPHomo-PPDensity0.880-0.913 g/cm3U.S. FDA CFR 21  177.1520
Melting  point160-180℃
Hexane  extractives≤6.4%
Xylene  extractives≤9.8%
Co-PPDensity0.850-1.000 g/cm3
Hexane  extractives2.6%
Xylene  extractives30%
10PEDensity0.880-0.913 g/cm3U.S. FDA CFR 21  177.1520
Hexane  extractives2.6%/5.5% (Cooking/non-cooking)
Xylene  extractives11.3%
11PCDistilled  water extractives≤0.15%U.S. FDA CFR  21 177.1580
50%Ethanol  extractives≤0.15%
N-Heptane  extractives≤0.15%
12PETDistilled  water extractives≤0.5mg/inch2U.S. FDA CFR  21 177.1630
50%  Ethanol extractives≤0.5mg/inch2
95%  ethanol extractives≤0.5mg/inch2
N-Heptane  extractives≤0.5mg/inch2
13Polyvinylidene  fluoride resinsDistilled  water extractives≤0.01mg/inch2US FDA CFR  21.177.2510
50%Ethanol  extractives≤0.01mg/inch2
N-Heptane  extractives≤0.01mg/inch2
14Rubber articles intended for repeated useDistilled  water extractives≤20mg/inch2U.S. FDA CFR  21 177.2600
Hexane extractives≤175mg/inch2
15Ceramic, glass, enamelExtractable Pb& CdRequirements are different of each shape, please call us for counselingCPG 7117 06&07
Lip&Rim testingPb:4.0 mg/L
Cd:0.4 mg/L
16Stainless steelTotal  ChromiumCooking: 16%
Non-cooking: 10.5%


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