USA Regulations

DownloadHome - CTT Services

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

ExtractivesDistilled water, 8% & 50 Ethanol, N-Heptane

For each simulants

≤0.3mg/inch2

U.S. FDA  CFR 21 177.1010

Oxidizable  extractivesDistilled water, 8% & 50 Ethanol

For each simulants

≤0.15

Ultraviolet-absorbing

For each simulantsDistilled 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

0.8501.000 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

Pb4.0 mg/L

Cd0.4 mg/L

SGCD&CSC

16

Stainless steel

Total  Chromium

Cooking: 16%

Non-cooking: 10.5%

CMA/GRAS









CTT ServicesConsumer Product TestingFood & Healthcare Product TestingEnvironment TestingTraining and Consultation
About CTTCTT ProfileCTT DevelopmentCTT Lab Qualification
Resource CenterReport SearchingProduct RecallsAccess to China MarketDocument Download
News CenterIndustry NewsCorporate NewsLatest Event
Contact CTT