The US FDA (Food and Drug Administration) regulates Food Contact Materials (FCMs) with a core focus on ensuring that, under intended conditions of use, substances migrating from the material into food do not pose a risk to human health, nor alter the food's composition, safety, or organoleptic properties (such as off-odor or discoloration). Its testing requirements are primarily based on relevant sections of Title 21 of the Code of Federal Regulations (21 CFR), with different provisions for different material types.

I. Core Regulatory Basis and Principles

FDA's regulation of food contact materials follows the principles of "safety" and "suitability," with core regulations concentrated in the following parts of 21 CFR:

  • Plastics: 21 CFR 177 (centered on 177.1520 for general-purpose plastics; others such as 177.1310 and 177.1350 address specific plastics);

  • Paper/Paperboard: 21 CFR 176 (e.g., 176.170 and 176.180, focusing on additives and extractables);

  • Coatings/Polymer Coatings: 21 CFR 175 (e.g., 175.300, for metal cans, baking molds, etc.);

  • Rubber: 21 CFR 177.2600 (natural and synthetic rubber);

  • Metals/Alloys: No dedicated section, but must comply with 21 CFR 178.3910 (heavy metal leaching limits) and others;

  • Other Materials: such as adhesives (175.105), printing inks (176.120), etc.

II. Testing Focus by Material Type

1. Plastics (Most Common, 21 CFR 177)

Plastics are the most comprehensively regulated category under FDA. Testing must account for both the positive list of permitted substances (e.g., base resins, additives) and migration limits:

  • Total Overall Migration (TOM): Simulating contact between the material and food, the limit for "total organic matter" migrating into food (e.g., 10 mg/dm², under different simulant conditions);

  • Specific Substance Migration: For substances restricted by regulation — such as Bisphenol A (BPA), phthalates (DEHP, etc.), heavy metals, and antioxidants — testing whether their migration levels fall below the specified limits;

  • Food Simulant Selection: Selecting the appropriate simulant based on food type (aqueous, acidic, alcoholic, fatty) — such as water, 3% acetic acid, 10%/50% ethanol, and n-hexane;

  • Test Conditions: Determining temperature (e.g., 40°C, 60°C, 121°C) and duration (e.g., 10 days, 24 hours) based on the intended use scenario (room temperature, high temperature, refrigeration, microwave, etc.).

2. Paper/Paperboard (21 CFR 176)

The focus is on contaminants in the material (such as heavy metals and fluorescent whitening agents) and the safety of extractable substances:

  • Extractables Testing: After extraction with simulants such as water or 80% ethanol, testing for "evaporation residue" (total residual organic matter) and heavy metals (lead, cadmium, etc.);

  • Fluorescent Whitening Agents: Prohibiting the use of fluorescent substances that may migrate (e.g., detection under UV light);

  • Microbial Indicators: In certain scenarios, testing for total bacterial count (e.g., for paper in direct contact with ready-to-eat foods).

3. Coatings / Rubber / Metals

  • Coatings: Testing stability under high temperature and acidic conditions (e.g., corrosion resistance of can coatings), as well as migration of free formaldehyde, phenols, and other substances from coatings;

  • Rubber: Focus on migration of vulcanizing agents and antioxidants (e.g., BHT), especially for fatty foods (using n-hexane as simulant);

  • Metals: Testing leaching of heavy metals such as lead, chromium, nickel, and arsenic (e.g., after immersion in 4% acetic acid, lead ≤ 0.5 mg/L).

III. General Testing Process

  1. Material Identification: Confirm material composition (e.g., plastic resin type, additive types) and match to the applicable regulatory section;

  2. Simulation Condition Determination: Select food simulant and test conditions based on intended use (food contact type, temperature, duration);

  3. Migration/Extraction Testing: Detect total or specific substances migrating into simulants through immersion, heating, and other methods;

  4. Sensory Testing: Assess whether the material causes off-odor or discoloration after food contact (e.g., taste and odor testing);

  5. Compliance Assessment: Compare test results with FDA limits to confirm whether requirements are met.

IV. Important Notes

  • FDA Does Not Mandate "Certification": Enterprises must self-verify compliance through testing; FDA supervises through market surveillance (e.g., customs detention and recalls);

  • Multi-Layer Packaging: Each layer of material must be tested separately, while also evaluating the mutual influence of substance migration between layers;

  • Regulatory Updates: FDA periodically updates its list of restricted substances (e.g., tightened restrictions on BPA and PFAS in recent years) — staying current with the latest regulations is essential.

In summary, the key to FDA food contact material testing is "specificity" — selecting the appropriate regulatory standard, simulant conditions, and test items based on material type and use scenario to ultimately ensure the safety of migrating substances. For professional FDA food contact material compliance testing and consulting, GreenArk (Shenzhen) Certification Co., Ltd. offers comprehensive services to support your product's successful entry into the US market.