Achieving FDA-Compliant Color in Food Packaging Coatings

A multinational food packaging corporation — one of the top five producers of aluminum cans and flexible packaging materials in the Middle East and Africa region — reached out to TRESAI Chemical with a regulatory compliance challenge. They were reformulating their interior coating systems to meet both FDA 21 CFR 175.300 and EU Regulation 10/2011 requirements, and needed pigments that could pass strict migration testing while maintaining vibrant, brand-specific colors across hundreds of product lines.

The Challenge: Navigating Dual Regulatory Frameworks

Food packaging coatings intended for direct or indirect contact with food must satisfy an intricate web of regulatory requirements. For this client, the reformulation effort was complicated by the need to comply simultaneously with two major regulatory frameworks, each with its own testing protocols and migration limits.

• FDA 21 CFR 175.300 governs resinous and polymeric coatings in direct or indirect food contact. The regulation mandates that all components of the coating — including pigments, resins, and additives — must be listed in the applicable food contact substance (FCS) inventory or be covered by an effective food contact notification (FCN). Pigments used in coatings must comply with FDA 21 CFR 178.3297 (Colorants for Polymers) or be the subject of an effective FCN.
• EU Regulation 10/2011 applies to plastic materials and articles intended to contact food. It establishes Specific Migration Limits (SML) for individual substances and an Overall Migration Limit (OML) of 60 mg/kg for total non-volatile extractables.
• Specific Migration Limits (SML) are set for each pigment component, requiring that individual substances migrating into food simulants do not exceed their designated thresholds — typically expressed in mg/kg of food simulant.
• Overall Migration Limit (OML) of 60 mg/kg caps the total amount of all non-volatile substances that may transfer from the coating into food under standardized testing conditions.
• Heavy metal testing is mandatory across both frameworks: lead (Pb), cadmium (Cd), mercury (Hg), and hexavalent chromium (Cr(VI)) must all be below 1 ppm in the final pigment grade.
• Third-party verification from an accredited laboratory such as SGS or Intertek is required to validate compliance claims before the coatings can be deployed in commercial production.

Pigment Selection: Why PV19 and PY151

After evaluating the client’s color requirements, substrate conditions, and regulatory constraints, TRESAI’s technical team recommended a dual-pigment system built around PV19 and PY151 — two organic pigments with well-established compliance histories and complementary color properties.

• PV19 (Quinacridone Violet/Red): This polycyclic pigment exists in beta (violet) and gamma (red) crystal forms. The gamma form offers a bright yellow-shade red with excellent overall properties. PV19 provides excellent lightfastness (rated 7–8 on the Blue Wool Scale), outstanding heat stability above 200°C, and chemical inertness in both acidic and alkaline environments. Its fully aromatic quinacridone ring system provides long-term color stability in food packaging applications that may involve pasteurization or hot-fill processes. PV19 is FDA approved for food-contact applications.
• PY151 (Benzimidazolone Yellow): A high-purity organic azo pigment with very low heavy metal content, PY151 provides bright, clean yellow tones with good tinting strength and excellent dispersibility. Its molecular structure has been extensively studied and is listed in multiple global positive inventories for food-contact applications. Unlike Hansa Yellows, PY151 belongs to the benzimidazolone family, offering superior alkali and heat stability.
• Both pigments have well-documented compliance histories, with decades of use in food-contact coatings across North America, Europe, and Asia. This established track record significantly reduces the regulatory risk for formulators.
• TRESAI’s manufacturing process ensures consistent purity below detection limits for regulated heavy metals and organic impurities. Each production batch undergoes full spectroscopic and chromatographic analysis before release, with certificates of analysis available upon request.

Testing & Compliance Results

The reformulated coating systems were subjected to a comprehensive testing program conducted by SGS, one of the world’s leading inspection, verification, testing, and certification companies. The testing protocol followed both FDA and EU methodologies, using the specified food simulants and conditions for each regulatory framework.

• Overall migration: 2.3 mg/kg — well below the 60 mg/kg OML mandated by EU 10/2011, representing approximately 4% of the permissible limit.
• Specific migration: All individual components measured below 0.01 mg/kg, comfortably under their respective SML values for every regulated substance identified in the formulation.
• Heavy metals: All tested metals — Pb, Cd, Hg, and Cr(VI) — registered below the 0.5 ppm detection limit, far under the 1 ppm maximum allowed by both regulatory frameworks.
• Third-party verification by SGS confirmed full compliance, with results documented and available for regulatory submission.
• Passed 90-day food simulant storage test at 40°C with no measurable change in migration values, confirming long-term stability of the coating system under accelerated shelf-life conditions.
• An overall migration of 2.3 mg/kg represents only a small fraction of the EU 60 mg/kg limit — demonstrating that TRESAI’s pigment grades provide a wide compliance margin for food packaging formulators.

Implementation Across Product Lines

Following the successful completion of regulatory testing, TRESAI worked closely with the client to deploy the reformulated coating systems across their full product portfolio. The implementation was carried out in phases to minimize production disruption while ensuring consistent color quality across all product lines.

• Interior can coatings for beverages — both carbonated and still — were reformulated using the PV19/PY151 pigment system. The coatings passed all relevant food simulant tests for acidic, alcoholic, and aqueous food types, covering the full range of beverage applications.
• Exterior decorative coatings were also upgraded with the new pigment system to ensure UV resistance and long-term exterior color retention, critical for products displayed on retail shelves in high-light environments.
• Flexible packaging printing inks for snack food products were transitioned to the compliant pigment grades, with TRESAI’s application engineers optimizing dispersion parameters to maintain gloss levels and print adhesion on BOPP and PET substrates.
• Over 200 SKU color matches were completed within a 3-month implementation window, covering the client’s entire product catalog across the Middle East and Africa region.

Key Takeaways

Regulatory compliance in food packaging is not a one-time milestone — it is an ongoing commitment. Choosing the right pigment partner from the outset can save formulators months of reformulation and testing downstream.

• Always request third-party compliance documentation. Self-reported test data is insufficient for regulatory submissions. Independent verification from accredited laboratories like SGS or Intertek provides the evidentiary basis that regulators and brand owners require.
• Start regulatory testing early in the formulation process. Migration testing timelines can span 90 days or more, and unexpected failures may require reformulation. Building compliance testing into the development schedule from day one prevents costly production delays.
• Choose pigments with established compliance track records. Pigments like PV19 and PY151, with decades of documented use in food-contact applications, carry significantly lower regulatory risk than newer, less-characterized colorants.
• Work with suppliers who understand both color and regulatory requirements. The best pigment partners combine deep technical expertise in color science with thorough knowledge of global food-contact regulations, enabling faster time-to-market with fewer reformulation cycles.