How to Complete FDA Food-Contact Material Registration? A Complete Step-by-Step Guide

For food packaging companies exporting to the US,FDA food-contact material registration FDA food contact material registration is the “passport” to the US market. The US Food and Drug Administration (FDA) has strict requirements for food contact materials — any packaging material, container or processing equipment that directly contacts food must comply with FDA 21 CFR (Title 21 of the Code of Federal Regulations). Starting from real-world practice, this article explains the full registration process in detail.

1. What are the FDA food contact material regulations?

The FDA regulates food contact materials under the “indirect food additive” logic: any substance that may migrate into food is considered an indirect food additive. These substances are controlled throughFDA 21 CFR, which covers them in multiple parts:

• 21 CFR 170-199: general food additive regulations, covering substances in packaging materials.
• 21 CFR 175: adhesives and coating components.
• 21 CFR 176: paper and paperboard components.
• 21 CFR 177: polymer (plastic) components — the section packaging companies deal with most often.
• 21 CFR 178: adjuvants and production aids.

Simply put, if all ingredients used in the packaging material are on the permitted lists of the above regulations and the use conditions and limits comply, the product is deemed “FDA compliant”. For moreexport food packaging certification in a side-by-side comparison, seeOMOPACK OMOPACK’s related in-depth analyses.

2. Three paths to FDA food contact material registration

Path 1: Use ingredients directly from the regulatory lists

If the polymer resins, additives and processing aids you use are clearly recorded in 21 CFR and the use conditions fully comply, no additional filing is needed. Most standardized packaging materials (PE, PP, PET) fall into this category. Companies must ensure the raw materials from resin suppliers meet the corresponding 21 CFR section requirements.

Path 2: Food Contact Substance Notification (FCN)

If the food contact substance (FNS) used is not on the existing regulatory lists, or the use conditions exceed the specified scope, the supplier must submit anFCN（Food Contact Notification） application. FCN is currently the most common compliance path, but it applies only to the applicant’s products — other companies cannot directly use someone else’s FCN. To understand the differences between certification paths, see ourPackaging Knowledge column for detailed explanations.

Path 3: Food additive petition

For novel materials or substances of high concern, without prior FDA approval, a full Food Additive Petition must be submitted. This is the most time-consuming and costly path, typically taking 6 months to 2 years.

3. Concrete steps for FDA food contact material registration

Step 1: Confirm the compliance path

First, list all the raw materials you use — resins, additives, pigments, processing aids, etc. Check each ingredient against 21 CFR to see if it is listed. Common compliance lookup tools include the “Inventory of Effective Food Contact Substance Notifications” database on the FDA website.

Step 2: Collect raw material compliance documents

Request compliance statements (Letter of Guarantee or Compliance Letter) from raw material suppliers. The document should clearly state the specific 21 CFR sections the material complies with and provide migration test data (if applicable).

Step 3: Conduct migration testing

Migration testing is the core of FDA compliance. Testing must simulate actual use conditions, including:

• Temperature: ambient, refrigerated, frozen, high temperature (e.g. retort pouches require 121°C testing)
• Time: from short-term contact (minutes) to long-term storage (months)
• Food simulants: water (aqueous foods), 3% acetic acid (acidic foods), 10% ethanol (alcoholic foods), vegetable oil (fatty foods)
• Test indicators: overall migration and specific migration

We recommend commissioning qualified third-party testing labs (e.g. SGS, Intertek, Eurofins) to run the tests and issue bilingual Chinese-English reports.

Step 4: Compile the technical documentation package

Organize all materials into a compliance dossier, including:

1. Raw material list and compliance basis
2. Layer structure descriptions
3. Migration test reports
4. Use condition statements
5. Production flow chart

Step 5: Submit or file (if required)

For standard materials, companies only need to keep the compliance documents — the FDA does not proactively audit. But with the FCN path, the application is submitted to the FDA by the raw material supplier, and the FDA reviews it within 120 days.

4. Common questions and cautions

4.1 The difference between FDA registration and FDA certification

The FDA does not issue “certification certificates”. The so-called FDA registration is essentially a process of companies making their own compliance declarations. Some agencies in the market claim they can “arrange FDA certification certificates” — be sure to tell fact from fiction. True FDA compliance means the company builds a sound quality management system and compliance documentation system.

4.2 Compliance strategy for multi-layer laminated packaging

Each layer of a multi-layer laminate is assessed separately. Lamination adhesives must also comply with 21 CFR 175.105 or 175.1395. Barrier layer materials (such as EVOH and aluminum foil) must meet the corresponding section requirements.

4.3 Substances of high concern to the FDA

• Phthalate plasticizers — restricted in some food contact materials
• PFAS (per- and polyfluoroalkyl substances) — being phased out by the FDA for food packaging
• Bisphenol A (BPA) — banned in baby product packaging
• Heavy metals — lead, cadmium, mercury, hexavalent chromium and others have strict limit standards

5. Differences between FDA and EU regulations

Many companies export to both the US and EU markets; understanding the core differences between the two systems helps build more efficient compliance strategies. The FDA system is based on a “positive list” model — substances on the list can be used, substances off the list need additional filing. The EU, through Regulation EU 10/2011, uses a comprehensive approach combining “overall migration + specific migration + functional barrier”. For companies exporting to both markets, prepare to the stricter standard.

Summary:FDA food-contact material registration FDA food contact material registration is not a one-off “certificate-getting” exercise but a continuous compliance process spanning product design, raw material procurement, production management and quality testing. Building a sound compliance system is not only a requirement for entering the US market but also an important way to improve product quality and customer trust.

Need FDA food contact material compliance consulting? Welcome to contactOMOPACK. Our compliance team provides you with one-stop solutions.