Testing food contact materials (FCMs) is a critical step to ensure food safety and regulatory compliance worldwide. These materials, which come into direct or indirect contact with food, must be rigorously tested to prevent harmful substances from migrating into food products, thereby protecting consumer health. This comprehensive guide will cover the global regulatory frameworks, essential testing methodologies, chemical safety considerations, physical performance evaluations, and innovations in food packaging that define the current landscape of FCM testing.
Global Regulatory Framework for Food Contact Materials
European Union (EU)
The EU regulates FCMs primarily under Regulation (EC) No. 1935/2004, which sets general safety and documentation requirements for all materials intended to contact food. This framework ensures that materials do not transfer harmful substances to food under normal use conditions. For plastics specifically, EU Commission Regulation No. 10/2011 outlines detailed rules including overall migration (OM) and specific migration limit (SML) testing to assess safety. Additionally, Good Manufacturing Practices (GMP) are mandated under Regulation (EC) 2023/2006 to ensure consistent quality and safety in production.
United States (FDA)
In the U.S., the Food and Drug Administration (FDA) governs FCMs under 21 CFR Parts 174–178. Compliance involves adherence to positive substance lists and conditions defined in these regulations. The Food Contact Notification (FCN) program requires manufacturers to submit safety data for new food contact substances, undergoing a 120-day premarket review process. The FDA's approach differs from the EU in substance lists, purity criteria, and the absence of a distinction between food additives and food contact substances.
China (GB Standards)
China has developed its own standards for FCMs, notably the GB 4806.x series and the recent GB 31604.1-2023, which governs migration testing. These standards specify testing conditions and simulants that sometimes differ from EU protocols, such as the use of olive oil for high-fat food migration tests. China also recently introduced GB 4806.15-2024, the first standard for food contact adhesives, detailing chemical and sensory requirements and positive substance lists for adhesives in contact with food.
Upcoming Regulation
The EU is advancing its regulatory framework with the Packaging and Packaging Waste Regulation (PPWR) for 2025/2040, emphasizing the use of post-consumer recycled (PCR) content and recyclability in packaging materials, reflecting growing sustainability concerns in food packaging.
Migration Testing: Overall (OM) and Specific (SML)
Migration testing is central to FCM safety evaluation. Overall Migration (OM) measures the total amount of substances that can migrate from the material into food simulants, ensuring it stays below established thresholds. Specific Migration Limit (SML) testing targets particular substances of concern, assessing their individual migration levels.
Common food simulants used in testing include 3% acetic acid for acidic foods, 10% ethanol for alcoholic foods, and olive oil for fatty foods, reflecting realistic food contact scenarios. European standards such as EN 1186 and Chinese standards like GB 31604.8-2021 provide detailed methodologies for these tests. For example, the olive oil migration test in GB 31604.8-2021 addresses migration under high-fat food conditions, a critical factor for certain packaging materials.
Chemical Safety: Hazardous Substance Testing
Chemical safety testing targets a range of potentially hazardous substances that may be present in FCMs, including Non-Intentionally Added Substances (NIAS), aromatic amines, per- and polyfluoroalkyl substances (PFAS), bisphenol A (BPA), UV ink photoinitiators, mineral oil saturated hydrocarbons (MOSH), mineral oil aromatic hydrocarbons (MOAH), phthalates, and heavy metals.
Analytical techniques employed include Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography coupled with Quadrupole Time-of-Flight (LC-QTOF), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Fourier-Transform Infrared Spectroscopy (FTIR), and High-Performance Liquid Chromatography (HPLC). These methods ensure precise detection and quantification, with traceability and repeatability maintained under ISO and Good Laboratory Practice (GLP) standards.
Physical vs Performance Testing of Packaging Materials
Beyond chemical safety, physical and performance testing assesses the mechanical and sensory properties of packaging materials to ensure durability and consumer acceptance.
Key tests include:
- Mechanical properties: tensile strength, flexibility, and durability to withstand handling and transport stresses.
- Optical clarity: ensuring transparency or opacity as required.
- Barrier performance: resistance to moisture, oxygen, and other environmental factors.
- Organoleptic testing (DIN 10955): evaluating the impact of packaging on taste, odor, and appearance of food.
- Fluorescent agent testing (EN 648): detecting unauthorized fluorescent substances.
- Color fastness (EN 646): assessing color stability under various conditions.
Testing food contact materials is a multifaceted process governed by stringent international regulations and advanced scientific methodologies. Ensuring compliance not only protects consumer health but also supports innovation and sustainability in food packaging. By understanding and applying these comprehensive testing frameworks, manufacturers can confidently deliver safe, high-quality food contact materials to the global market.
Innovation Support for New Packaging Materials
Testing for innovative packaging materials involves specialized assessments to ensure safety and functionality. This includes active packaging that interacts with food to extend shelf life, intelligent packaging with sensors or indicators, and antimicrobial layers designed to inhibit microbial growth. Testing also covers complex multi-layer structures and advanced nano-coatings, with particular focus on oxygen and moisture barrier properties critical for food preservation. Regulatory implications for these new materials vary across regions, requiring compliance with EU, FDA, and Chinese GB standards to ensure market acceptance and safety.
End-to-End Testing & Total Quality Assurance
A comprehensive testing strategy spans the entire lifecycle of packaging materials—from research and development through production, market release, and recyclability assessment. Leading global laboratory networks such as Intertek, SGS, TÜV, NSF, and HQTS provide integrated testing solutions that align with emerging regulations like the EU’s Packaging and Packaging Waste Regulation (PPWR) and broader circular economy goals. This end-to-end approach ensures consistent quality, regulatory compliance, and sustainability throughout the packaging lifecycle.
How to Choose the Right Testing Laboratory
Selecting an appropriate testing laboratory is crucial for reliable results and regulatory compliance. Key criteria include ISO/IEC 17025 accreditation, adherence to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards, and demonstrated expertise in food contact materials. Laboratories should offer extensive food simulant libraries, state-of-the-art analytical instruments, and fast turnaround times. Comparing services among top providers such as Intertek, SGS, HQTS, and TÜV SÜD helps identify the best fit based on specific testing needs and geographic coverage.
Compliance Optimization vs Risk Management
Effective compliance management involves thorough documentation, including Declarations of Compliance (DoC), traceability records, and conformity reports. Risk mitigation strategies encompass audits, challenge testing, and screening for non-intentionally added substances (NIAS) to preempt safety issues. Preparing for upcoming regulations such as the EU PPWR 2025/2040 and China’s GB 31604.9 standard positions manufacturers to maintain market access and uphold consumer safety.
Final Takeaways vs Actionable Advice
Building a robust food contact material testing strategy requires integrating packaging safety, sustainability, and regulatory compliance from concept through market launch. Drawing on expert insights from industry leaders like Kimecopak, manufacturers can navigate complex regulatory landscapes while fostering innovation and environmental responsibility. Prioritizing comprehensive testing and quality assurance ensures safe, compliant, and sustainable packaging solutions that meet evolving global standards.
