EU 2025/351 FCM Regulation Starts Sept 2026
foodmachtech | 2026-05-25 | 371
The European Union's Commission Regulation (EU) 2025/351 will enter a key implementation phase on September 16, 2026.
As European food manufacturers and packaging companies continue to strengthen food safety audits, Food Contact Materials (FCM)-related requirements are increasingly affecting food processing equipment, conveying systems, and food-contact components.
For food machinery manufacturers exporting to the EU market, the importance of food-grade materials, migration testing, and supply chain traceability is increasing significantly.
Quick Impact Summary
For food processing and food packaging equipment manufacturers, food-contact plastic parts, seals, conveying systems, lubricants, and packaging-contact components are becoming key audit targets.
Companies involved in dairy equipment, meat processing equipment, beverage filling systems, food packaging machinery, and food-grade piping systems should pay closer attention to food-grade material documentation, migration testing, and material traceability management.
As food safety audits continue to tighten across Europe, material sourcing, cleaning validation, and supply chain traceability are becoming increasingly important requirements in European procurement projects.
Policy Background
The introduction of Commission Regulation (EU) 2025/351 is closely linked to the EU’s ongoing efforts to strengthen food safety, recycled plastics management, and sustainable packaging regulations.
In 2011, the EU adopted Regulation (EU) No 10/2011, establishing the core regulatory framework for plastic Food Contact Materials (FCM). As circular economy and recycled plastics policies continue to advance, the EU has further strengthened management requirements related to chemical migration risks, material traceability, and GMP production systems.
Against this background, the EU officially introduced Commission Regulation (EU) 2025/351 in 2025, further strengthening requirements related to chemical migration risks, recycled plastic safety, material traceability, and GMP production management.
Under the current regulatory timeline, the regulation will enter a key implementation phase on September 16, 2026.
Direct Impact
For equipment manufacturers using food-contact plastic components, rubber seals, food-grade hoses, stainless steel tanks, and conveying systems, material compliance and migration testing are becoming increasingly important.
Based on current EU market audit trends, the focus is no longer limited to food materials themselves, but is gradually expanding to include:
- Potential contamination risks within equipment systems
- Traceability of food-contact components
- Compliance of cleaning systems with food safety requirements
- Effectiveness of contamination control during production
This means that some traditional general-purpose food equipment solutions may need to be reassessed for EU market suitability.
European customers are also expected to place greater emphasis on material declarations, migration testing documentation, Declarations of Compliance (DoC), and supply chain traceability records.
Under current European food safety audit trends, cross-contamination risks caused by shared production lines are also receiving increased attention.
Key Compliance Changes
| Area | Key Change | Impact on Equipment / Production Lines |
|---|---|---|
| Food Contact Materials Regulation | Stronger migration testing and material audits | Increased scrutiny of food-contact plastic components |
| Recycled Plastics Management | Higher safety requirements for recycled materials | Stricter requirements for packaging and food-contact systems |
| GMP Systems | Enhanced production and documentation management | Increased supplier and equipment chain audits |
| Food Safety Audits | Greater focus on clean ability and contamination control | Increased demand for CIP systems and cleaning validation |
| Traceability Systems | Stronger material and batch record requirements | Increased demand for DoC and material documentation |
Action Checklist
Companies should prioritize reviewing food-contact plastic components, rubber seals, conveying systems, food-grade hoses, and packaging-contact parts to ensure compliance with EU FCM requirements.
Manufacturers of dairy equipment, meat processing systems, beverage filling equipment, and packaging machinery should closely assess food-contact materials, migration testing documentation, food-grade lubrication systems, and CIP cleaning systems for potential compliance or contamination risks.
From a compliance management perspective, companies are advised to prepare:
- Declaration of Compliance (DoC)
- Material declaration documents
- Migration testing reports
- GMP documentation
- Material traceability records
These documents may become increasingly important as European customers and audit bodies strengthen supply chain review requirements.
For food packaging equipment manufacturers, it is also advisable to monitor EU regulatory trends related to recycled plastics and sustainable packaging, and evaluate packaging material compatibility and recyclable packaging adaptability in advance.
This article is based on publicly available regulations and market information and does not constitute legal or compliance advice. Specific requirements should be confirmed according to official regulations and final implementation requirements.
