Food Contact Materials: EU Regulation Deep Dive

What Are Food Contact Materials?

Food Contact Materials (FCM) are any materials intended to come into contact with food. This includes obvious items like plates, cups, and food packaging, but also extends to processing equipment, conveyor belts, and even materials that contact food indirectly—like the ink on food packaging exteriors.

EU regulations governing FCM are among the most stringent in the world. Unlike general consumer products where safety assessment may be manufacturer-declared, FCM compliance requires specific testing, controlled manufacturing processes, and detailed documentation that travels with products through the supply chain.

For sellers of kitchenware, food packaging, or food-adjacent products, understanding these requirements is essential for EU market access.

Key Takeaways

• FCM regulations apply to any material intended to contact food
• Regulation (EC) 1935/2004 establishes the framework for all FCM
• Specific rules apply to different materials (plastics, ceramics, recycled materials)
• Migration testing demonstrates that harmful substances do not transfer to food
• Declaration of Compliance (DoC) is required at each stage of the supply chain
• Traceability must enable tracking one step forward and one step back

The FCM Regulatory Framework

EU FCM regulation operates at multiple levels:

Framework Regulation (EC) 1935/2004

This regulation establishes the basic principle that FCM must not:

• Transfer components to food in quantities that could endanger human health
• Bring about unacceptable changes in food composition
• Bring about deterioration in the sensory characteristics of food

The framework regulation applies to all FCM regardless of material type.

Material-Specific Regulations

Detailed requirements exist for specific materials:

Plastics: Regulation (EU) 10/2011

The most comprehensive material-specific regulation covers plastic FCM. It includes:

• Positive list of authorized monomers and additives
• Specific migration limits for regulated substances
• Overall migration limit of 10 mg/dm² (or 60 mg/kg food)
• Detailed testing protocols

Ceramics: Directive 84/500/EEC

Sets limits for lead and cadmium release from ceramic articles.

Regenerated Cellulose: Directive 2007/42/EC

Covers cellophane and similar materials.

Recycled Plastics: Regulation (EU) 2022/1616

New regulation governing recycled plastic in FCM applications, establishing authorization requirements for recycling processes.

Active and Intelligent Materials: Regulation (EC) 450/2009

Covers materials designed to extend shelf life or provide information about food condition.

National Measures

Where no EU-specific rules exist (e.g., paper, rubber, silicone), national regulations of individual member states apply. Germany's BfR recommendations are often referenced as best practice.

Migration Testing: The Core Requirement

Migration testing determines whether substances transfer from FCM to food under intended use conditions. Two types of migration are measured:

Overall Migration

Overall migration measures total mass of all substances transferring to food. The EU limit is 10 mg/dm² of food contact surface (or 60 mg/kg food for containers up to 500ml or articles where surface area cannot be determined).

Specific Migration

Specific migration measures individual substances of concern. Regulation 10/2011 sets specific migration limits (SML) for hundreds of substances based on toxicological evaluation. Common examples:

Testing Conditions

Migration testing must simulate real-world use conditions:

Food Simulants

Testing uses standardized food simulants rather than actual food:

• Simulant A: 10% ethanol (aqueous foods)
• Simulant B: 3% acetic acid (acidic foods)
• Simulant C: 20% ethanol (alcoholic foods)
• Simulant D1: 50% ethanol (dairy and oil-in-water emulsions)
• Simulant D2: Vegetable oil (fatty foods)

Time and Temperature

Test conditions reflect intended use:

• Room temperature storage: 10 days at 40°C
• Hot fill: 2 hours at 70°C
• Heating/cooking applications: specified high-temperature conditions
• Long-term storage: conditions reflecting 6 months or more

Declaration of Compliance

Every business operator in the FCM supply chain must issue a Declaration of Compliance (DoC) to their customers. This is distinct from the Declaration of Conformity used for CE-marked products.

Required Information

The DoC must include:

1. Identity and address of the business operator issuing the declaration
2. Identity and address of the manufacturer
3. Identity of the materials, intermediates, or products
4. Date of declaration
5. Confirmation that FCM meets applicable requirements
6. Adequate information on substances subject to restrictions to enable downstream compliance verification
7. Adequate information on substances subject to food-type restrictions
8. Specifications on use (food types, time/temperature conditions)
9. For products behind a functional barrier: confirmation of barrier function and relevant migration data

Supply Chain Flow

DoCs flow through the supply chain:

• Raw material supplier → converter
• Converter → finished article manufacturer
• Manufacturer → distributor
• Distributor → retailer

Each operator relies on upstream declarations while issuing their own to downstream customers.

Good Manufacturing Practice

Regulation (EC) 2023/2006 requires FCM to be manufactured according to Good Manufacturing Practice (GMP). This includes:

Quality Management Systems

Manufacturers must operate quality management systems covering:

• Materials selection and verification
• Manufacturing process control
• Finished product inspection
• Non-conformance handling
• Documentation and records

Quality Assurance

Quality assurance activities ensure:

• Appropriate raw materials are selected
• Operations are carried out according to established procedures
• Finished products meet specifications
• All operations are documented

Quality Control

Quality control verifies compliance through:

• Incoming material inspection
• In-process controls
• Finished product testing
• Retention of samples

Traceability Requirements

Traceability is mandatory for all FCM. Business operators must be able to identify:

• Suppliers (one step back)
• Customers (one step forward)

This enables rapid withdrawal of non-compliant products and supports enforcement actions.

Implementation

Practical traceability requires:

• Unique identification of products and batches
• Records linking incoming materials to outgoing products
• Retention of records for appropriate periods
• Systems enabling rapid retrieval

Special Categories

Kitchenware from Third Countries

Kitchenware imported from non-EU countries requires particular attention. Products from certain countries are subject to enhanced controls:

China: Melamine and polyamide kitchenware from China faces intensified official controls, including systematic testing upon import.

The importer must ensure:

• Products meet EU requirements before import
• Migration testing performed under relevant conditions
• Documentation available for authorities
• DoC issued to customers

Multi-Component Products

Products combining multiple materials (e.g., a plastic container with silicone lid and metal clasp) require assessment of each material. The overall product must meet requirements for all applicable materials.

Children's Products

Food contact articles intended for children (feeding bottles, training cups) receive particular scrutiny. Lower migration limits may apply, and testing conditions must reflect how children use products.

Compliance Roadmap

For sellers of FCM products, follow this compliance path:

Step 1: Material Identification

Identify all materials in your products that contact food. Consider direct and indirect contact.

Step 2: Regulatory Mapping

Determine which regulations apply:

• Framework Regulation 1935/2004 (all FCM)
• Material-specific EU regulations
• Applicable national regulations

Step 3: Supplier Documentation

Obtain from suppliers:

• Declaration of Compliance
• Migration test reports (relevant conditions)
• Composition information (for plastic FCM)
• GMP documentation

Step 4: Testing Requirements

Determine if additional testing is needed:

• Are existing test reports relevant to your application?
• Do they cover the correct food simulants?
• Do they address the correct time/temperature conditions?

Step 5: Documentation Package

Compile your compliance documentation:

• Supplier DoCs and test reports
• Your own testing (if performed)
• GMP evidence
• Traceability records

Step 6: Issue Declaration

Prepare your DoC for customers including:

• All required information per Regulation 10/2011 or applicable rules
• Use restrictions and conditions
• Substance information enabling downstream compliance

Common Compliance Failures

Inadequate Testing Conditions

Migration testing must reflect actual use. Testing at 40°C is insufficient for products used for cooking or hot beverages.

Missing DoC Information

DoCs lacking required information cannot be relied upon by downstream operators. Ensure all required elements are present.

Ignoring National Rules

For materials without EU-specific rules, national regulations apply. Products compliant in one member state may not comply elsewhere.

Outdated Documentation

Regulatory requirements and authorized substance lists change. Documentation must reflect current requirements.

How SellSafe Addresses FCM Compliance

FCM compliance is among the most complex product safety challenges. SellSafe's platform guides you through the regulatory maze, identifying which requirements apply to your specific products and materials.

Our document analysis system extracts key information from supplier documentation, flagging gaps in testing coverage and missing DoC elements. Our templates ensure your own declarations meet regulatory requirements.

Moving Forward with FCM Compliance

Food Contact Materials compliance requires attention to detail and robust supply chain management. The consequences of non-compliance—from border rejections to recalls to health enforcement actions—make proper compliance essential.

Start with your supply chain. Ensure suppliers provide complete documentation covering the right testing conditions. Build your own documentation system to compile this evidence and generate compliant declarations.

FCM regulations continue to evolve, with particular expansion around recycled materials and sustainability requirements. Building strong compliance foundations now prepares you for future requirements.

The EU FCM market remains attractive for compliant sellers. Demonstrating proper compliance is increasingly a competitive advantage as authorities intensify enforcement and retailers demand evidence of safety.