Best Labs for USA Food Contact Material Safety Testing

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Update time : 2026-05-01

Products intended for export to the U.S. that come into contact with food must comply with Title 21 of the U.S. Code of Federal Regulations (CFR). The U.S. Food and Drug Administration (FDA) is an internationally recognized authoritative scientific and regulatory agency responsible for the safety supervision of food, cosmetics, drugs, biological products, medical devices, radioactive products and more in the United States.

The U.S. is one of China’s major export destinations for tableware, kitchen utensils, small kitchen appliances and similar goods. FDA compliance testing for food contact materials is an essential prerequisite for products to enter the U.S. market.

What is FDA Food Contact Material Testing

FDA food contact material testing refers to safety testing and compliance assessment for materials and articles that directly or potentially come into contact with food. Its core purpose is to ensure that under normal use conditions, these materials will not migrate harmful substances into food, thereby protecting consumer health.

FDA regulates food contact materials mainly under 21 CFR Parts 170–189, adopting the substance exemption principle: materials are compliant as long as their ingredients fall within regulatory allowances and migration levels meet limit requirements. This is fundamentally different from the European Union’s Positive List system.

Applicable Product Scope

Product Category	Specific Examples
Tableware	Knives, forks, bowls, chopsticks, spoons, cups, plates, etc.
Kitchen Utensils	Pans, spatulas, cutting boards, stainless steel kitchenware, etc.
Food Packaging Containers	Various food packaging bags, beverage and food storage containers, etc.
Home Kitchen Appliances	Coffee machines, juicers, blenders, electric kettles, rice cookers, ovens, microwave ovens, etc.

Why Conduct FDA Food Contact Material Testing

1. Mandatory Regulatory Requirement

The U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) clearly stipulates that all food contact materials must be safe and comply with relevant 21 CFR provisions. Non-compliant products may face FDA detention, entry refusal or mandatory recall.

2. E-commerce Platform Access

Major cross-border e-commerce platforms including Amazon, TEMU and SHEIN require food contact products to provide FDA compliance test reports; otherwise, products cannot be listed for sale.

3. Consumer Trust & Brand Protection

An FDA test report serves as credible endorsement of product quality, helping boost consumer purchasing confidence and reduce brand reputation losses caused by product safety issues.

4. Avoid Import Alert Listing

FDA issues Import Alerts for enterprises and products with repeated violations, adding them to the automatic detention list and seriously affecting subsequent customs clearance efficiency.

Testing & Evaluation Standards

Material	Corresponding Regulatory Standard
Coatings	FDA 21 CFR 175.300
Paper Products	FDA 21 CFR 176.170
Polycarbonate (PC)	FDA 21 CFR 177.1580
Polypropylene (PP)	FDA 21 CFR 177.1520
Polyethylene (PE)	FDA 21 CFR 177.1520
PET	FDA 21 CFR 177.1630
Polystyrene (PS)	FDA 21 CFR 177.1640
ABS, AS	FDA 21 CFR 180.22 & 181.32
Rubber & Silicone	FDA 21 CFR 177.2600
Glass	Refer to CPG 7117.06/.07
General Metals	Refer to FDA 21 CFR 175.300; Refer to CPG 7117.05/06/07
Stainless Steel & Aluminum Products	NSF/ANSI 51
Melamine	FDA 21 CFR 177.1460
Nylon (PA)	FDA 21 CFR 177.1500
Bamboo & Wooden Products	Refer to FDA 21 CFR 178.3800 (preservative requirements)
California Proposition 65	California Proposition 65 (additional hazardous substance restrictions)

Note: For new substances not listed in 21 CFR, separate approval is required via the FDA Food Contact Notification (FCN) procedure.

Test Items

Test Item	Application Scenario / Purpose
Water Extractives	Simulate contact with aqueous food
8% Ethanol Extractives	Simulate contact with alcoholic food
50% Ethanol Extractives	Simulate contact with high-fat food
Heptane Extractives	Simulate contact with oily food
Hexane Extractives	For specific plastics and coating materials
Density	Basic physical property verification of materials
Melting Point	Compliance confirmation for thermoplastic materials
Heavy Metal Migration	For ceramics, glass and metal products
Overall Migration	Comprehensive safety assessment

Test conditions (temperature × time) are determined based on actual product usage scenarios, common combinations include:

• Long-term room temperature contact

• Boiling disinfection conditions

• High-temperature microwave / oven use conditions

Conventional Sample Quantity Requirements

Sample requirements vary by product; the following are standard references:

Material	Sample Quantity
Plastic Products	600 cm²
Stainless Steel	50 grams
Ceramic Products	6 finished pieces
Glass & Enamel Products	6 finished pieces (same as ceramics)
Paper Products	1000 cm²
Coating Samples	400 cm²
Silicone & Rubber Products	100 cm²

For exact sample requirements, consult a professional testing institution according to your actual product.

Testing Application Process

1. Consultation & Evaluation
Submit information including material composition, intended use and sales platform

2. Confirm Testing Solution
The institution matches applicable regulatory standards per product characteristics

3. Sample Delivery
Send samples to the laboratory as required

4. Laboratory Testing
Conventional testing completed in 5–7 working days

5. Issue Test Report
Obtain official FDA compliance test report

6. Platform Upload / Customs Clearance
Use the report for e-commerce platform entry or U.S. customs clearance

Testing Cycle & Cost

Item	Reference Information
Standard Cycle	5–7 working days (excluding sample shipping time)
Expedited Service	3–5 working days (available at extra cost by selected institutions)
Cost Range	Starting from approximately USD 500 per single material, depending on material complexity and test item quantity
Multi-material Products	Each food-contact component requires separate testing; fees are calculated cumulatively

Exact quotation is determined by actual material and testing scheme; advance consultation is recommended for detailed solutions.

Labeling Requirements

Food contact products exported to the U.S. must meet the following labeling rules:

1. Material Marking

• Clearly indicate material composition, e.g. Stainless Steel 304, Borosilicate Glass, Food-Grade Silicone

• Stainless steel products must specify grade (304, 316, etc.)

2. Food Contact / Food Safe Statement
Indicate the product is suitable for food contact use

3. Manufacturer Information

• Manufacturer name or trademark

• Place of origin (country)

4. Instructions & Warnings

• Applicable temperature range

• Inapplicable usage scenarios (e.g. Not for Microwave Use)

5. Tracking Code
For product traceability and recall management

Platforms such as Amazon have additional labeling requirements; please review platform compliance guidelines before listing.

Comparison Dimension	US FDA	EU (EU 10/2011, EC 1935/2004, etc.)
Regulatory Principle	Substance Exemption	Positive List System
Core Regulations	21 CFR 170–189	EU 10/2011, EC 1935/2004, etc.
Compliance Mode	Enterprise self-declaration + third-party testing	Must comply with Specific Migration Limit (SML) & Overall Migration Limit (OML)
New Substance Regulation	FCN notification procedure	Requires EFSA assessment and inclusion in authorized list
Test Report Format	No unified format; issued by accredited labs	Must follow EU standard test methods
Market Access	Relatively flexible with enterprise accountability	Strict supervision; official registration required for some products

FDA vs EU Food Contact Material Testing Comparison

Products exported to both the U.S. and EU must comply with both regulatory systems; reports are not mutually recognized.

New Substance Application (FCN Procedure)

If a product uses food contact substances not listed in 21 CFR, the FDA Food Contact Notification (FCN) procedure is required:

Key FCN Application Points

• Submitted by the substance manufacturer or supplier

• Full toxicological data, migration assessment and dietary exposure calculation are required

• FDA completes review within 120 days; approval takes effect automatically if no objection is raised

• Approved FCN is only valid for the applicant and their designated customers

Recommendation

Using conventional listed substances can greatly reduce costs and compliance risks. If new materials are necessary, initiate FCN application 6–12 months in advance.

FAQ

Is FDA testing mandatory for all food contact materials?

Yes. All food contact materials and articles must comply with 21 CFR and obtain third-party complianCE certification before exporting to the U.S.

Are test reports universally applicable?

No. Different materials and separate product types require independent testing. Different colors or batches of the same product may also need separate tests.

Does FDA conduct random inspections on marketed products?

FDA mainly supervises via import inspection and market sampling. Non-compliant products may be detained or recalled, and relevant enterprises may face fines or Import Alert listing.

Do bamboo and wooden products need FDA testing?

Yes. Besides general FDA food contact requirements, bamboo and wooden products must ensure preservatives and fungicides comply with provisions including 21 CFR 178.3800.

What is the relationship between California Proposition 65 and FDA testing?

California Proposition 65 is a state-level regulation restricting known carcinogenic and reproductive toxic substances or requiring clear warning labels. FDA testing does not cover Proposition 65 requirements; extra compliance checks are needed for products sold in California.