Consumer Testing Technology

USA Regulations

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

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).

No	Materials			Test Items	Limits		Regulation
1	Resinous and polymeric coatings	Disposable		Distilled water extractives	≤0.5mg/inch² /1.8mg/inch²		U.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-use		Distilled water extractives	≤18mg/inch²
				8% Ethanol extractives	≤18mg/inch²
				N-Heptane extractives	≤18mg/inch²
		-		BPA content	N.D.
2	Paper and paperboard			Distilled water extractives	≤0.5mg/inch²		U.S. FDA CFR 21 176.170
				8% Ethanol extractives	≤0.5mg/inch²
				50% Ethanol extractives	≤0.5mg/inch²
				N-Heptane extractives	≤0.5mg/inch²
3	Wood			PCP	50ppm		U.S. FDA CFR 21 178.3800
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
				Oxidizable extractives（Distilled water, 8% & 50％ Ethanol）	For each simulants	≤0.15
				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
				8% Ethanol extractives	50ppm
				N-Heptane extractives	50ppm, 250ppm, 500ppm
6	Ethylene-vinyl acetate copolymers			Distilled water extractives	≤0.5mg/inch²		US FDA CFR 21 177.1350
				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
				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
				Melting point
				Solubility in 4.2N HCL
				Distilled water extractives
				95% ethanol extractives
				Ethyl acetate extractives
				Benzene extractives
9	PP		Homo-PP	Density	0.880-0.913 g/cm³		U.S. FDA CFR 21 177.1520
				Melting point	160-180℃
				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
				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
				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
				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
				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
				Hexane extractives	≤175mg/inch²
15	Ceramic, glass, enamel			Extractable Pb& Cd	Requirements are different of each shape, please call us for counseling		CPG 7117 06&07
				Lip&Rim testing	Pb：4.0 mg/L Cd：0.4 mg/L		SGCD&CSC
16	Stainless steel			Total Chromium	Cooking: 16% Non-cooking: 10.5%		CMA/GRAS

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