In the fast-growing flexible packaging industry, ensuring that materials meet EU food contact regulations is critical. Flexible packaging—ranging from pouches to roll stock films—comes into direct contact with food products. Compliance not only guarantees consumer safety but also helps manufacturers avoid legal issues and maintain brand trust across European markets.

1. Overview of EU Food Contact Regulations
1.1 EU Framework Regulation (EC) No 1935/2004
Le Framework Regulation (EC) No 1935/2004 is the cornerstone of food contact legislation in the EU. It mandates that all materials intended to come into contact with food:
- Must not transfer harmful substances to food in quantities that could endanger human health.
- Must not alter the food’s composition, taste, or odor.
- Must be traceable, enabling authorities to identify the source in case of safety concerns.
1.2 Specific Measures for Plastic and Flexible Packaging
Flexible packaging primarily uses plastic films, which fall under Regulation (EU) No 10/2011. Key requirements include:
- Positive List Compliance: Only substances approved by EFSA (European Food Safety Authority) are allowed in packaging materials.
- Migration Limits: The packaging must meet overall migration limits (OML) et specific migration limits (SML), ensuring chemicals do not leach into food.
- Documentation: Manufacturers must provide a Declaration of Compliance (DoC) certifying the material meets EU standards.
1.3 Good Manufacturing Practices (GMP)
Under Regulation (EC) No 2023/2006, manufacturers must adopt GMP for food contact materials. This includes:
- Quality control systems to monitor production processes.
- Traceability and batch record-keeping.
- Ensuring that additives, inks, and adhesives are safe for food contact.

2. Common Testing and Certification for Flexible Packaging
2.1 Migration Testing
Migration testing verifies that chemicals do not exceed safe limits. Tests include:
- Overall Migration Test (OMT): Measures total substances migrating into food simulants.
- Specific Migration Test (SMT): Targets particular chemicals of concern, such as plasticizers or heavy metals.
2.2 Sensory and Functional Tests
Flexible packaging must also pass sensory tests to ensure it does not impart off-flavors or odors, along with mechanical tests to confirm durability during transport and storage.
2.3 Documentation and Labeling
Manufacturers are required to provide a Declaration of Compliance, detailing:
- Material composition.
- Approved substances used.
- Migration test results.
This ensures traceability and reassures buyers of regulatory compliance.
3. Best Practices for Manufacturers
- Stay Updated: EU regulations are periodically revised; compliance requires continuous monitoring.
- Partner with Accredited Labs: Third-party testing ensures credible verification of safety.
- Implement Robust Quality Management Systems: Regular audits and traceability protocols are essential.
4. Why Compliance Matters
Compliance with EU food contact regulations is more than a legal requirement—it reflects brand responsibility, consumer safetyet market access readiness. Non-compliance can result in product recalls, legal penalties, and reputational damage.
Stanley Package: Your Reliable OEM/ODM Flexible Packaging Manufacturer
Fondée en 1998, Paquet Stanley is a global leader in custom flexible packaging manufacturing. We specialize in pouches and roll stock packaging films, offering high-quality, environmentally friendly solutions. Our 15,000 m² facility features:
- Ten-color gravure electronic high-speed printing press.
- High-speed dry coating laminators and solvent-free coating lines.
- Extrusion coating machines producing low-odor, eco-friendly films.
- Efficient Système RTO to treat VOC emissions, ensuring green production.
We pride ourselves on advanced equipment, stringent quality managementet fast, reliable delivery for global clients.
Work with Paquet Stanley for compliant, high-performance flexible packaging solutions.





