From Farm to Table: Food-Safe Masterbatch for Agricultural and Packaging Applications

Food safety is non-negotiable. Whether you’re manufacturing agricultural films, food packaging, processing equipment, or storage containers, the materials that contact food must meet rigorous safety standards. For manufacturers using masterbatch to colour or enhance plastic components in the food chain, understanding compliance requirements isn’t optional—it’s essential.

At Abbey Masterbatch, we understand that food contact applications represent some of the most demanding and regulated uses for our products. The consequences of non-compliance extend far beyond regulatory penalties to include product recalls, brand damage, and potential harm to consumers. This guide explores the critical considerations for selecting and using masterbatch in food contact applications.

Understanding Food Contact Regulations

Food contact regulations vary by geography, but share common principles: materials that contact food must not transfer harmful substances or alter the food’s characteristics.


UK and European Framework


Following Brexit, the UK maintains its own regulatory framework while largely aligning with EU standards:


UK Regulations: The Food Contact Materials (England) Regulations 2021 and equivalent regulations in Scotland, Wales, and Northern Ireland govern food contact materials. These implement many provisions previously covered by EU regulations.


EU Framework: Regulation (EC) No 1935/2004 provides the overarching framework, with specific measures for plastics in Regulation (EU) No 10/2011. While UK manufacturers serving the EU market must comply with EU regulations, those serving only UK markets follow UK-specific requirements.


Positive Lists: Both frameworks use positive lists—only substances specifically authorised may be used in food contact materials. If a pigment, additive, or polymer isn’t on the positive list, it cannot be used.


Migration Limits: Regulations specify maximum migration levels for authorised substances, ensuring that any transfer to food remains below safe thresholds.


United States FDA Requirements


The US Food and Drug Administration takes a different regulatory approach:


Food Contact Notifications (FCN): Manufacturers submit FCNs for specific formulations and applications, receiving clearance for defined uses.


Generally Recognised as Safe (GRAS): Some substances have GRAS status based on scientific consensus about their safety.


Prior Sanctioned Substances: Materials approved before modern regulations may maintain legal status under prior sanction.


Threshold of Regulation: Very low migration substances may qualify for exemption through threshold of regulation pathways.


Importantly, EU approval doesn’t automatically confer FDA compliance, and vice versa. Manufacturers serving both markets need dual compliance.


Other Global Standards


China GB Standards: China maintains separate standards under GB 4806 series regulations with specific requirements for plastics, additives, and colourants.


Japan: The Food Sanitation Law and positive lists govern food contact materials.


Other Markets: Many countries reference EU, FDA, or other established frameworks, but manufacturers must verify specific local requirements.

Migration Testing: Proving Safety

Regulatory approval of individual substances is only the first step. Manufacturers must demonstrate that their specific formulations, when used in actual applications, comply with migration limits.


What is Migration Testing?


Migration testing simulates food contact conditions to measure whether substances transfer from plastic into food:


Overall Migration: Measures the total amount of all substances migrating from the plastic. EU regulations typically limit overall migration to 10 mg per dm² of surface area or 60 mg per kg of food simulant.


Specific Migration: Measures the migration of individual substances of concern (e.g., specific plasticisers, stabilisers, or colourants). Each substance has its own particular migration limit (SML) or may be subject to non-detect requirements.


Food Simulants: Since testing with actual foods is impractical, standardised simulants represent different food types:


Contact Conditions: Testing must reflect actual use conditions—temperature, contact time, and whether contact is single-use or repeated.


Critical Testing Parameters

Accurate migration testing requires attention to detail:


Surface Area to Volume Ratio: The ratio of plastic surface contacting food to food volume dramatically affects results. Testing must use realistic ratios for the intended application.


Temperature and Time: Testing conditions must match or exceed actual use. A container for hot-filled foods requires testing at elevated temperatures, while refrigerated applications use lower temperatures.


Worst-Case Scenarios: Testing should represent worst-case conditions consumers might encounter, not just typical use.


Processing History: How the plastic was processed affects migration. The same formulation may show different migration when injection moulded versus blow moulded.


Shelf Life Simulation: Some applications require testing that simulates extended storage, accounting for migration over weeks or months.


Working with Testing Laboratories


Reliable migration testing requires specialised facilities:


Accredited Laboratories: Use laboratories with ISO 17025 accreditation for food contact testing. Accreditation ensures standardised methods and reliable results.


Method Selection: Work with the laboratory to select appropriate test methods (EN standards in Europe, FDA methods in US) that match your application and regulatory requirements.


Sample Preparation: Proper sample preparation is crucial. Samples should represent production material, not trial or development versions.


Documentation: Maintain complete testing records, including sample identification, test conditions, methods, and results as part of your compliance documentation.


Frequency: Retest when formulations change, when raw materials change suppliers, or when regulations update. Many companies maintain annual testing programs even for unchanged products.


Compliance Challenges for Masterbatch Users

Using masterbatch in food contact applications creates specific compliance considerations:


Declaration and Documentation


Supplier Declarations: Your masterbatch supplier must provide complete documentation, including:


Your Responsibility: Even with supplier declarations, you remain responsible for ensuring your finished products comply. Supplier documentation supports but doesn’t replace your own compliance verification.


Traceability: Maintain complete records linking masterbatch batches to finished product batches for traceability in case of issues.


Formulation Control


Approved Substances Only: Ensure every component in the masterbatch—pigments, dispersants, stabilisers, carrier resin, and processing aids—appears on relevant positive lists.


Concentration Control: Even approved substances may have maximum use levels. Your masterbatch loading and formulation must keep all substances below regulatory limits.


Dual Compliance: If serving multiple markets, all components must comply with all relevant regulations. A substance approved in Europe but not FDA-cleared cannot be used for products entering the US market.


Processing Considerations


Temperature Management: Excessive processing temperatures can degrade polymers or additives, potentially creating non-compliant substances not present in the original formulation.


Cross-Contamination: Production equipment used for both food and non-food applications requires rigorous cleaning procedures to prevent cross-contamination.


Rework and Recycled Content: Using rework or recycled content in food contact applications requires careful consideration of compliance and safety.


Application-Specific Requirements

Different food contact applications present unique challenges:


Food Packaging


Direct Contact: Materials directly contacting food face the strictest requirements. Every component must be food-approved for direct contact.


Indirect Contact: Outer layers or components not directly touching food may have less stringent requirements, but must still prevent migration through inner layers.


Barrier Layers: Multi-layer structures may use functional barriers to prevent migration from outer layers, but barrier effectiveness must be demonstrated.


Packaging Types: Different packaging forms have different requirements:


Agricultural Films


Crop Protection Films: Greenhouse films, mulch films, and crop covers contact produce and soil:


Silage and Storage Films: Films used for animal feed storage must meet feed contact safety standards, which, while different from human food standards, still require careful material selection.


Food Processing Equipment


Processing Surfaces: Equipment surfaces contacting food during processing face demanding requirements:


Sanitary Design: Beyond material compliance, components must support sanitary design principles—smooth surfaces, no harbouring points for microorganisms, and easy to clean.


Storage and Transport


Bulk Containers: Tanks, pallets, and bulk storage equipment require materials that:


Temperature Exposure: Refrigerated, frozen, and heated storage each present different migration scenarios requiring appropriate testing.


Selecting Food-Safe Masterbatch

Making appropriate masterbatch choices for food applications requires diligence:


Pigment Selection


Approved Pigments: Only use pigments specifically approved for food contact. Many general industrial pigments are not food-approved.


Organic vs. Inorganic: Both organic and inorganic pigments can be food-safe, but selection depends on:


Additive Packages


Minimalist Approach: Use only necessary additives. Each additional component increases compliance complexity.


Approved Additives: UV stabilisers, antioxidants, processing aids, and dispersants must all be food-approved for your specific application.


Migration Characteristics: Select additives known for low migration and excellent polymer bonding.


Functionality vs. Compliance: Sometimes the best-performing additive isn’t food-approved. Working with an experienced supplier helps identify compliant alternatives that provide acceptable performance.


Carrier Resin


Resin Matching: The masterbatch carrier resin should match your base polymer. Mismatched carriers may affect compliance or migration.


Food-Grade Carriers: Ensure the carrier resin itself is food-approved. Not all polymer grades meet food contact standards.


Virgin vs. Recycled: Most food contact regulations require virgin polymers, though some jurisdictions now permit certain recycled content with appropriate safeguards.


Quality Assurance and Best Practices

Maintaining compliance requires robust systems:


Documentation Systems


Compliance Files: Maintain comprehensive files, including:


Change Control: Document and review any changes to formulations, suppliers, or processes for compliance impact.


Audit Trail: Maintain records linking masterbatch lots to finished product batches for traceability.


Supplier Qualification


Audit Suppliers: Evaluate masterbatch suppliers on food safety capabilities:


Regular Review: Periodically review supplier compliance documentation and test reports, especially when regulations change.


Training and Awareness


Staff Training: Ensure personnel understand:


Supplier Communication: Maintain clear communication with suppliers about your food contact requirements and any changes in regulations or applications.


Looking Ahead: Evolving Requirements

Food contact regulations continue to evolve:


Increased Scrutiny: Regulatory authorities worldwide are strengthening food contact material oversight in response to concerns about endocrine disruptors, nanomaterials, and other emerging issues.


Harmonisation Efforts: Efforts continue toward international harmonisation of food contact standards, though significant differences remain.


Sustainable Materials: Growing interest in recycled content and bio-based polymers for food packaging creates new regulatory challenges requiring updated frameworks.


Digital Compliance: Some jurisdictions are developing digital systems for compliance declarations and traceability.


Staying current with regulatory developments and maintaining flexible systems helps ensure ongoing compliance.


Abbey Masterbatch: Your Food Safety Partner

At Abbey Masterbatch, food safety isn’t just about compliance—it’s about partnership. We offer:


Food-Grade Formulations: Comprehensive range of masterbatch products specifically developed and qualified for food contact applications across EU, UK, FDA, and other global standards.


Compliance Documentation: Complete declarations, migration data, and certificates of analysis supporting your compliance requirements.


Technical Expertise: Over 40 years of experience helping manufacturers navigate food contact regulations and select appropriate materials.


Quality Assurance: Dedicated food-grade production facilities with segregation, testing, and traceability systems ensuring consistent compliance.


Regulatory Monitoring: We track regulatory developments globally and proactively address changes affecting our products and your applications.


Custom Development: Working with you to develop tailored solutions meeting specific application requirements while maintaining food safety compliance.


Food safety is too important to compromise. Whether you’re producing agricultural films, food packaging, or processing equipment, Abbey Masterbatch can help ensure your colouring and additive solutions meet the highest safety standards while delivering the performance and aesthetics your products demand.


Contact Abbey Masterbatch today to discuss your food contact application requirements and how we can support your compliance and quality objectives.