FDA: 9 New Substances Added to FCNs

In February 2025, the U.S. Food and Drug Administration (FDA) added nine Food‑Contact Substance Notifications (FCNs) to its Inventory of Effective Notifications.

These additions include antimicrobial solutions, microbiological control agents in beverages, functional pigments, and microfibrillated cellulose pulp used as a component of paper packaging.

Each FCN is legally effective only for the manufacturer or supplier identified in the notification, pursuant to Section 409(h) of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Table of contents

• 1. Regulatory framework of the FCN

• 2. Main technical innovations

• 3. Implications for the industry

• 4. Belab Services operational recommendations

• Conclusion

• Official references

FDA: 9 New Substances Added to FCN

1. Regulatory framework of the FCN

The FCN program allows the marketing of substances intended for food contact materials when the FDA concludes, following a 120-day premarket review, that the proposed application is safe. The effectiveness of the notification—and therefore the marketing authorization—is restricted to the notifying company and its customers, requiring other manufacturers of the same substance to submit their own dossier if they wish to use it under identical conditions.

2. Main technical innovations

The technological relevance of the nine new FCNs is summarized below without reproducing the structure of the primary source:

• Antimicrobial and microbiological control agents

  • Chlorine dioxide (FCN 2395, Energis Solutions, 25-Feb-2025): authorized for processing water for meat, fish, fruits, vegetables, cereals and nuts with a maximum residue of 3 ppm.

  • Dimethyl dicarbonate (FCN 2414, LANXESS Corp., 19-Feb-2025): Approved as an antimicrobial agent in ready-to-drink alcoholic beverages (≤15% v/v), up to 250 ppm, cross-referenced to 21 CFR 172.133.

• Functional pigments

  • Fluorphlogopite pearlescent pigments (FCN 2407, Nihon Koken Kogyo, 04-Feb-2025): colorants for polymers in contact with food, up to 5% w/w, excluding uses with breast milk or infant formula.

  • Tricyclodecanedimethanol (FCN 2408, Metlac SpA, 04-Feb-2025): cyclic triol used as an intermediate for coating varnishes, expanding the range of monomers approved for metal cans.

• Microfibrillated cellulose (MFC) Five separate notifications (FCN 2409‑2413) cover microfibrillated cellulose pulp (CAS 65996‑61‑4) from different manufacturers – Stora Enso Oyj, Sappi Biochemtech BV, Evergreen Packaging LLC, Borregaard AS and Fiberlean Technologies – with effective dates between 08 and 12‑Feb‑2025. The approvals allow its use as an additive, raw material or coating in food papers and boards, up to 100% of the formulation, excluding contact with breast milk or infant formula.

  
  

3. Implications for the industry

1. Manufacturer exclusivity : Each FCN protects only the notifier's supply chain. Operators wishing to source from alternative suppliers must verify that the substance originates from the listed entity or, failing that, process a new FCN.

2. Material Trends : The surge in MFC requests confirms the growing interest in fiber-based packaging solutions with barrier performance and a lower carbon footprint.

3. Regulatory convergence : US authorisation of fluorphlogopite pigments or triols for varnishes may facilitate, but not guarantee, conformity assessments in other jurisdictions such as the EU (Regulation (EU) 10/2011) if an equivalent toxicological support dossier is submitted.

   
   

4. Belab Services operational recommendations

• Dependency Mapping : Identify which critical substances in your packaging depend on unique FCNs and secure contracts that guarantee traceability to the authorized manufacturer.

• EU-US Crosswalk Assessment : For projects seeking to market in both markets, work with our Brussels and Washington teams to assess the equivalence of specific migration limits and dietary exposure.

• Regulatory Oversight : Incorporate a continuous monitoring system for FDA inventory; changes such as limit restatements or FCN withdrawals can directly impact supply continuity.

  
  

Conclusion

The nine new notifications reinforce the FDA's trend toward accommodating highly effective microbiological control technologies and next-generation cellulosic materials.

This expansion of the Inventory confirms the agility of the FCN mechanism for introducing innovations in food packaging , always under the premise of a rigorous toxicological evaluation and with the individual responsibility of the manufacturer as its central axis.

Official references

1. FDA. Inventory of Effective Food-Contact Substance Notifications , FCN 2414.

2. FDA. Inventory of Effective Food-Contact Substance Notifications , FCN 2395.

3. FDA. Inventory of Effective Food-Contact Substance Notifications , FCN 2407.

4. FDA. Inventory of Effective Food-Contact Substance Notifications , general list (accessed 22-Apr-2025) .

5. FDA. Inventory of Effective Food-Contact Substance Notifications , FCN 2409

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