EU Food Contact Materials (FCM) Compliance: Regulations, Testing & Documentation Guide 2026

Food Contact Materials (FCMs) are a critical part of the food supply chain, covering packaging, containers, processing equipment, utensils, transport materials, storage articles, and distribution components that come into direct or indirect contact with food.

To protect consumer health and ensure chemical safety, material inertness, and migration control, the European Union has established a comprehensive regulatory system governing EU food packaging compliance, migration testing, NIAS risk assessment, and Declarations of Conformity (DoC).

This guide from Maven Regulatory Solutions explains the legal framework, compliance pathway, technical documentation, testing requirements, and 2026 regulatory trends for EU FCM compliance.

1. What Are Food Contact Materials (FCMs)?

FCMs include any material or article intended to meet food or that may reasonably transfer substances to food.

Examples:

2. Core EU Regulatory Framework

The foundation of EU FCM law is:

Regulation (EC) No. 1935/2004

Establishes the general safety principle that materials must not:

• Endangering human health
• Change food composition
• Deteriorate organoleptic characteristics

Additional Specific Measures

3. EFSA’s Role in FCM Compliance

The European Food Safety Authority (EFSA) evaluates:

• Substances used in FCMs
• Toxicological data
• Migration safety limits
• New substance authorization

4. Key Technical Compliance Requirements

5. Declarations of Conformity (DoC)

A DoC must include:

• Manufacturer details
• Substance identity
• Migration limits
• Testing conditions
• Compliance references

6. Emerging 2026 Regulatory Trends

• Increased scrutiny of recycled materials
• Stricter NIAS toxicological evaluations
• Sustainability & PFAS restrictions
• Digital compliance documentation
• Supply chain traceability

7. Compliance Strategy for Manufacturers

1. Collect Bill of Materials (BOM)
2. Identify regulated substances
3. Conduct migration testing
4. Perform NIAS toxicology review
5. Prepare DoC
6. Maintain GMP documentation

How Maven Regulatory Solutions Supports FCM Compliance

• EU FCM regulatory strategy
• Migration testing program design
• NIAS toxicological risk assessments
• Worst-case modeling
• DoC preparation & audit
• EFSA dossier support
• GMP compliance consulting

FAQ

What is the main EU FCM regulation?
Regulation (EC) 1935/2004.

What is NIAS?
Unintended substances require risk assessment.

Is testing mandatory?
Yes, to demonstrate migration compliance.