Food Contact Material & Recycled Plastic

US FDA FCN Update: 15 New Effective Food Contact Notifications Recorded from March to May 2026

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REACH24H FCM Compliance Team

The food contact materials (FCM) team of REACH24H specializes in global regulatory compliance for food contact and recycled materials. Covering markets including China, the US, the EU, Canada and MERCOSUR, we bring over 10 years of proven experience in new substance applications with in-depth knowledge of category-specific requirements. Our services span the entire product lifecycle, from raw materials, new ingredient applications and intermediates to end-product compliance.

Written by REACH24H FCM Compliance Team

U.S. FDA FOOD CONTACT NOTIFICATION UPDATE

From March 1 to May 31, 2026, the U.S. FDA recorded 15 effective Food Contact Notifications covering food-contact resins, additives, coatings and related applications. Five records list China-based companies. The update also reinforces a core compliance point: an effective FCN is manufacturer- or supplier-specific. Companies evaluating U.S. market access can review REACH24H's U.S. FDA Food Contact Notification support for the applicable pathway.

15 Effective FCNs      March-May 2026      5 China-Based Companies      Supplier-Specific Authorization

At a Glance: What Companies Should Watch

Key PointMarch-May 2026 SnapshotBusiness Relevance
Effective FCNs15 records with effective dates from March 1 to May 31, 2026Recent activity spans both functional additives and base material systems.
China-based companies5 companies listed in the periodThe FCN pathway is increasingly relevant to Chinese resin and additive suppliers entering the U.S. market.
Main use areasAntioxidants, antimicrobials, nucleating agents, lubricants, resins, coatings, adhesives and paper systemsCompanies should assess both substance identity and the exact intended conditions of use.
Core compliance ruleAn FCN is effective only for the identified manufacturer or supplier and notified conditions of use.Downstream users should confirm source traceability and use-condition alignment before relying on an existing FCN.

What Is a U.S. FDA Food Contact Notification?

A Food Contact Notification (FCN) is a U.S. FDA premarket notification mechanism for food contact substances (FCSs). The FDA's Inventory of Effective Food Contact Substance Notifications lists information such as the FCS, notifier, manufacturer or supplier, intended use, use limitations, specifications, effective date and environmental decision.

An FCN is not a universal authorization for all companies or all uses of the same substance. It is effective only for the manufacturer or supplier identified in the notification, and downstream users may rely on it only when the FCS is obtained from that source and used within the stated conditions. A broader U.S. FDA food contact materials and substances compliance review can help determine whether 21 CFR, GRAS, prior sanction, Threshold of Regulation or an FCN is the appropriate route.

Overview of FDA FCNs Effective from March to May 2026

The following table summarizes the 15 FCN records identified for the period from March 1 to May 31, 2026. It is intended as a practical overview only.

Unless otherwise specified, none of the entries in the original list may be used in applications involving contact with infant formula or breast milk.

FCN No.Notifier / Manufacturer or SupplierEffective DateFood Contact Substance and Use Summary
FCN 2490SI GroupMay 26, 2026Cyclic neopentanetetrayl bis(octadecyl phosphite), used as an antioxidant and/or stabilizer in PET polymers, with a maximum use level of 0.2 wt% in the finished PET polymer.
FCN 2498Laboratorios Argenol SLMay 22, 2026Silver-zinc-calcium-sodium-borate-phosphate glass, used as an antimicrobial agent in food-contact polymers, with use and silver-content limits.
FCN 2507Evonik Active Oxygens, LLCMay 16, 2026An aqueous mixture of PAA, HP, AA, HEDP, DPA, and optionally SA, used as an antimicrobial agent in the conditioning and pre-milling treatment of wheat, corn, and rice, subject to component limits.
FCN 2473Clariant CorporationMay 7, 2026Oxidized rice bran wax and its calcium salt, used as a processing aid, lubricant, release agent and/or slip agent in single- and repeated-use rigid PVC, subject to use-level and temperature limitations.
FCN 2504CelluForceApr. 22, 2026Nanocrystalline cellulose, used as a coating component in multilayer materials, including as a non-food-contact layer under specified conditions.
FCN 2474Kao Specialties Americas LLCApr. 9, 20261,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters, used as a lubricant or lubricant component for incidental food contact applications in food-processing machinery.
FCN 2478Rianlon CorporationApr. 8, 2026Pentaerythritol tetra(3-dodecylthiopropionate), used as an antioxidant/stabilizer in polypropylene and copolymers, styrenic block copolymers, adhesives, and pressure-sensitive adhesives, subject to material-specific use limits.
FCN 2495Jiangsu Jiyi New Material Co., Ltd.Mar. 31, 20261,2-Cyclohexanedicarboxylic acid, calcium salt (1:1), (1R, 2S)-rel-, used as a nucleating or clarifying agent in polyolefins, with a maximum use level of 0.25 wt%.
FCN 2494Zhejiang Honor Biomaterials Co., Ltd.Mar. 31, 2026Polylactide (PLA), used as a component of food-contact articles under specified conditions of use.
FCN 2491KLK Kolb Specialties B.V.; KLK Tensachem S.A.Mar. 25, 2026Poly(oxy-1,2-ethanediyl), alpha-sulfo-omega-hydroxy-, C12-14-alkyl ethers, sodium salts, used as an emulsifier/surfactant in styrene-butadiene-acrylonitrile copolymer coatings for paper and paperboard.
FCN 2486Sinopec Chongqing SVW Chemical Co., Ltd.Mar. 17, 2026Ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers, used as base resin components in films, bottles, molded articles, and paper/paperboard coatings, subject to use-specific limitations.
FCN 2485Unitika Ltd.; Asahi Kasei CorporationMar. 13, 2026A methacrylate/vinylidene chloride/acrylonitrile/acrylic acid polymer, used as a gas barrier coating for nylon 6 film, subject to coating thickness and use limitations.
FCN 2484WACKER Chemie AGMar. 13, 2026Dodecanoic acid, ethenyl ester polymer with chloroethene and ethenyl acetate, used as a coating for single-use food contact articles, subject to maximum dry coating weight and use conditions.
FCN 2466Les Derives Resiniques et TerpeniquesMar. 13, 2026Terpene resin polymers and condensates with phenol, used as components of adhesives and pressure-sensitive adhesives under applicable FDA food contact provisions.
FCN 2483Zhejiang Sinoview Materials & Technology Co., Ltd.Mar. 8, 20261,2-Cyclohexanedicarboxylic acid, calcium salt (1:1), (1R, 2S)-rel-, used as a nucleating or clarifying agent in polyolefins, with a maximum use level of 0.25 wt%.

Source: U.S. FDA Inventory of Effective Food Contact Substance Notifications.

Key Observations from the March-May 2026 FCN Records

Functional additives remain a major focus of FCN activity

The latest records include antioxidants and stabilizers, antimicrobial agents, nucleating and clarifying agents, emulsifiers/surfactants, processing aids, lubricants, release agents and slip agents. These substances are widely used across food contact polymers, coatings, adhesives, paper and paperboard systems, and food-processing equipment applications.

Base resins and material innovation continue to appear in the FCN inventory

The March-May records include materials such as PLA, EVOH copolymers, nanocrystalline cellulose and gas barrier coating polymers. These entries show that FCNs continue to be relevant not only for small functional additives, but also for base resin systems, multilayer structures, coatings and packaging materials with specific barrier or sustainability-related functions.

China-based manufacturers and suppliers are increasingly visible in the FCN pathway

Five records in this period list China-based companies, including Rianlon Corporation, Jiangsu Jiyi New Material Co., Ltd., Zhejiang Honor Biomaterials Co., Ltd., Sinopec Chongqing SVW Chemical Co., Ltd., and Zhejiang Sinoview Materials & Technology Co., Ltd. Their records cover PLA, EVOH copolymers, polyolefin nucleating/clarifying agents and antioxidant/stabilizer applications. This suggests that more food contact material companies are using the FCN route as part of their U.S. market access and supply chain compliance strategy.

Which Companies Should Assess Whether an FDA FCN Is Needed?

New substances

Enterprises intending to export new food contact substances to the U.S. that are not listed as authorized under existing regulations, such as additives, resins or coatings, should assess whether an FCN or another premarket pathway is required.

Uses beyond existing provisions

Enterprises whose intended uses or application scenarios are not fully covered by existing regulatory provisions, or that seek to expand the permitted conditions of use for existing substances, such as food type, temperature, use level or coating thickness, should conduct a route assessment before market entry.

Practical Recommendations for Preparing an FDA FCN

1. Conduct a compliance review to confirm whether an FCN is required

Before formally initiating a Food Contact Notification, companies should first verify whether the food contact substance and its intended use are already covered under relevant provisions of 21 CFR, GRAS (Generally Recognized as Safe) status or prior-sanctioned uses in the U.S.

If the substance is not covered by an existing authorization, or if the existing authorization does not match the company's specific specifications or intended conditions of use, a formal FCN submission will be required.

2. Define the intended use and scope of the submission

The scope of an FCN should be aligned with the company's actual commercial plans. Companies should define key parameters in advance, including the maximum use level of the substance, the food types expected to come into contact with the material, the temperature and duration of use, and whether the material is intended for microwave heating or repeated use.

Clearly defining these core boundaries is essential for designing a scientifically sound and accurate testing and submission strategy, while avoiding both excessive testing and insufficient data generation.

3. Perform a gap analysis and complete a pre-submission assessment

An FCN submission typically requires data and documentation covering the substance identity, specifications, migration levels, consumer exposure, safety assessment and environmental impact.

Before formally launching the FCN process, REACH24H recommends that companies conduct a systematic gap analysis to identify potential risks at an early stage. This helps avoid situations where the available data may not support the intended use, or where the submitted materials may be insufficient to address FDA review concerns.

How REACH24H Can Support FDA FCN Compliance

REACH24H closely monitors U.S. FDA food contact material regulations and the FCN inventory. We support food contact substance manufacturers, packaging companies, additive suppliers and downstream supply chain stakeholders with FDA food contact compliance services, including:

  • U.S. FDA food contact regulatory status assessments;

  • pre-FCN technical feasibility reviews and data gap analysis;

  • FCN dossier preparation and full-process submission support;

  • communication with FDA, question response and supplemental data preparation.

For companies planning to supply food contact substances or food contact materials to the U.S. market, early FCN strategy planning can help clarify the applicable compliance route, reduce review risks and support smoother market access.

Need support with U.S. FDA FCN compliance?

REACH24H can help assess whether an FCN is required, define the intended-use scope, identify data gaps, prepare the dossier and support communication with FDA.

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