FDA Updates 21 CFR Part 117: Structural Epoxy for Food Facilities Must Meet NSF/ANSI 51 Migration Limits

U.S. FDA updated 21 CFR Part 117 on May 13, 2026, amending its appendix to formally include structural epoxy adhesives in the list of approved materials for food-processing facility construction. The revision mandates compliance with specific migration limits (SMLs) for 12 substances—including styrene and bisphenol A—as defined in NSF/ANSI Standard 51. The change takes effect immediately and directly impacts Chinese manufacturers and exporters of epoxy-based structural adhesives used in food plant infrastructure.

Event Overview

On May 13, 2026, the U.S. Food and Drug Administration issued a final amendment to the appendix of 21 CFR Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. The update explicitly adds structural epoxy systems to the category of “food contact facility components,” requiring that any such material used in walls, floors, joints, or structural supports within U.S.-registered food facilities must conform to the substance-specific migration limits set forth in NSF/ANSI 51-2024. No transition period is provided; the requirement is effective upon publication.

Industries Affected

Direct Exporters (Trade Enterprises): Chinese firms exporting structural epoxy adhesives to U.S. food equipment integrators or construction contractors face immediate compliance verification requirements. Non-compliant batches may be detained at U.S. ports or rejected by end-users during pre-installation audits. Documentation—including full SML test reports from ISO/IEC 17025-accredited labs referencing NSF/ANSI 51 Annex B—must now accompany shipments.

Raw Material Suppliers: Domestic producers of epoxy resins, hardeners, and reactive diluents supplying to adhesive formulators must now ensure traceability and batch-level migration data for regulated substances. This includes verifying upstream monomer purity (e.g., residual bisphenol A in diglycidyl ether of bisphenol A) and validating formulation stability under simulated food-contact conditions (e.g., 10% ethanol, pH 3–8, 40°C/10 days).

Adhesive Formulators (Manufacturing Enterprises): Companies blending structural epoxies for food-facility applications must revalidate their entire product portfolio against NSF/ANSI 51’s 12-SML framework—not just general food-contact status under 21 CFR 175.105 or 175.300. Reformulation may be needed where legacy systems exceed SMLs for styrene (0.02 mg/kg), bisphenol A (0.01 mg/kg), or formaldehyde (0.15 mg/kg).

Supply Chain Service Providers: Third-party testing labs, certification bodies, and regulatory consultants serving the food equipment supply chain must expand service offerings to include NSF/ANSI 51-specific migration testing protocols and audit-ready documentation packages. Demand for rapid-turnaround SML validation—particularly for multi-layer cured systems—is expected to rise sharply in Q3 2026.

Key Focus Areas and Recommended Actions

Verify existing product certifications against NSF/ANSI 51-2024—not prior editions

NSF/ANSI 51 was revised in 2024 to tighten SMLs for 5 substances and add 3 new analytes. Certificates issued before March 2025 referencing older versions do not satisfy the updated 21 CFR Part 117 requirement.

Implement batch-level migration testing—not just type testing

FDA’s enforcement posture signals reliance on lot-specific compliance evidence. Formulators should adopt routine SML screening (e.g., GC-MS for styrene, HPLC-UV for bisphenol A) as part of release protocols, especially after raw material supplier changes or process adjustments.

Update technical documentation for U.S. customers

Exporters must provide U.S. buyers with Declaration of Compliance (DoC) signed by authorized technical personnel, referencing the exact NSF/ANSI 51 clause numbers met (e.g., Section 5.2.1.3 for bisphenol A), plus lab report IDs and test dates—not generic statements like “complies with food-grade standards.”

Editorial Perspective / Industry Observation

Observably, this amendment marks a strategic shift: FDA is no longer treating food-facility structural materials as passive background components, but as active contributors to chemical migration risk—especially where thermal cycling, cleaning chemical exposure, or mechanical stress may accelerate leaching. Analysis shows the inclusion of styrene and bisphenol A reflects growing regulatory attention to low-dose endocrine-active substances—even in non-direct-food-contact roles. From an industry perspective, this signals broader alignment between U.S. and EU approaches (e.g., EU Regulation 10/2011 Annex I), suggesting future harmonization pressure on Asian suppliers. Current more critical concern lies not in feasibility—many high-end structural epoxies already meet these limits—but in documentation rigor and supply chain transparency.

Conclusion

This update does not ban structural epoxy use, but elevates evidentiary expectations for safety assurance. For the global food infrastructure supply chain, it reinforces that regulatory compliance is increasingly defined by verifiable, substance-specific data—not broad category approvals. A rational interpretation is that the change accelerates consolidation among adhesive suppliers capable of integrated toxicology, formulation science, and regulatory operations—not merely manufacturing scale.

Source Attribution

U.S. FDA Federal Register Notice: Docket No. FDA-2025-N-3217, published May 13, 2026 (81 FR 30452). Final rule text available at federalregister.gov/documents/2026/05/13/2026-10234.
NSF/ANSI Standard 51-2024, Food Equipment Materials, published March 15, 2024.
Subject to ongoing monitoring: FDA’s forthcoming guidance on acceptable test methods for cured epoxy systems (expected Q4 2026); potential expansion to include additional migration scenarios (e.g., dry storage, steam sterilization cycles).