1. FDA introduce:
In 1997, the Food and Drug Administration Modernization Act (FDAMA), amended the Food Drug and Cosmetic Act (FD&C Act) to streamline the way in which the FDA conducted business. One of the new procedures established to accomplish this goal was a notification process for food-contact substances. The amended FD&C Act (United States, 1998a) defined a food-contact substance as "any substance 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 a technical effect in such food."
This notification process is intended to replace the petition process as the primary means for authorizing new uses of food additives that are food-contact substances. However, discretion is given to the FDA for deciding when the petition process is more appropriate for evaluating data to provide an adequate assurance of safety.
2. FDA test item :
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).
No |
Materials |
Test Items |
Limits |
Regulation |
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1 |
Resinous and polymeric coatings |
Disposable |
Distilled water extractives |
≤0.5mg/inch2 |
U.S. FDA CFR 21 175.300 |
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8% Ethanol extractives |
≤0.5mg/inch2 |
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N-Heptane extractives |
≤0.5mg/inch2 |
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Re-use |
Distilled water extractives |
≤18mg/inch2 |
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8% Ethanol extractives |
≤18mg/inch2 |
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N-Heptane extractives |
≤18mg/inch2 |
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- |
BPA content |
N.D. |
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2 |
Paper and paperboard |
Distilled water extractives |
≤0.5mg/inch2 |
U.S. FDA CFR 21 176.170 |
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8% Ethanol extractives |
≤0.5mg/inch2 |
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50% Ethanol extractives |
≤0.5mg/inch2 |
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N-Heptane extractives |
≤0.5mg/inch2 |
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3 |
Wood |
PCP |
50ppm |
U.S. FDA CFR 21 178.3800 |
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4 |
Acrylic and modified acrylic plastics, semirigid and rigid |
Extractives(Distilled water, 8% & 50% Ethanol, N-Heptane) |
For each simulants |
≤0.3mg/inch2 |
U.S. FDA CFR 21 177.1010 |
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Oxidizable extractives(Distilled water, 8% & 50%Ethanol) |
For each simulants |
≤0.15 |
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Ultraviolet-absorbing |
For each simulants(Distilled water, 8% & 50%Ethanol) |
≤0.30 |
|||||
N-Heptane |
≤0.10 |
||||||
5 |
Closures with sealing gaskets for food containers |
Distilled water extractives |
50ppm |
U.S. FDA CFR 21 177.1210 |
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8% Ethanol extractives |
50ppm |
||||||
N-Heptane extractives |
50ppm, 250ppm, 500ppm |
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6 |
Ethylene-vinyl acetate copolymers |
Distilled water extractives |
≤0.5mg/inch2 |
US FDA CFR 21 177.1350 |
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8% Ethanol extractives |
≤0.5mg/inch2 |
||||||
50% Ethanol extractives |
≤0.5mg/inch2 |
||||||
N-Heptane extractives |
≤0.5mg/inch2 |
||||||
7 |
Melamine-formaldehyde resins in molded articles |
Distilled water extractives |
≤0.5mg/inch2 |
U.S. FDA CFR 21 177.1460 |
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8% Ethanol extractives |
≤0.5mg/inch2 |
||||||
N-Heptane extractives |
≤0.5mg/inch2 |
||||||
8 |
Nylon resins |
Density |
Requirements are different of each type, please call us for counseling |
U.S. FDA CFR 21 177.1500 |
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Melting point |
|||||||
Solubility in 4.2N HCL |
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Distilled water extractives |
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95% ethanol extractives |
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Ethyl acetate extractives |
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Benzene extractives |
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9 |
PP |
Homo-PP |
Density |
0.880-0.913 g/cm3 |
U.S. FDA CFR 21 177.1520 |
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Melting point |
160-180℃ |
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Hexane extractives |
≤6.4% |
||||||
Xylene extractives |
≤9.8% |
||||||
Co-PP |
Density |
0.850-1.000 g/cm3 |
|||||
Hexane extractives |
2.6% |
||||||
Xylene extractives |
30% |
||||||
10 |
PE |
Density |
0.880-0.913 g/cm3 |
U.S. FDA CFR 21 177.1520 |
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Hexane extractives |
2.6%/5.5% (Cooking/non-cooking) |
||||||
Xylene extractives |
11.3% |
||||||
11 |
PC |
Distilled water extractives |
≤0.15% |
U.S. FDA CFR 21 177.1580 |
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50%Ethanol extractives |
≤0.15% |
||||||
N-Heptane extractives |
≤0.15% |
||||||
12 |
PET |
Distilled water extractives |
≤0.5mg/inch2 |
U.S. FDA CFR 21 177.1630 |
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50% Ethanol extractives |
≤0.5mg/inch2 |
||||||
95% ethanol extractives |
≤0.5mg/inch2 |
||||||
N-Heptane extractives |
≤0.5mg/inch2 |
||||||
13 |
Polyvinylidene fluoride resins |
Distilled water extractives |
≤0.01mg/inch2 |
US FDA CFR 21.177.2510 |
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50%Ethanol extractives |
≤0.01mg/inch2 |
||||||
N-Heptane extractives |
≤0.01mg/inch2 |
||||||
14 |
Rubber articles intended for repeated use |
Distilled water extractives |
≤20mg/inch2 |
U.S. FDA CFR 21 177.2600 |
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Hexane extractives |
≤175mg/inch2 |
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15 |
Ceramic, glass, enamel |
Extractable Pb& Cd |
Requirements are different of each shape, please call us for counseling |
CPG 7117 06&07 |
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Lip&Rim testing |
Pb:4.0 mg/L |
SGCD&CSC |
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16 |
Stainless steel |
Total Chromium |
Cooking: 16% |
CMA/GRAS |
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