Regulatory Compliance for Custom Food Packaging (FDA, EU)

Ensuring Compliance in Food Packaging Design

Custom food packaging plays a central role in product safety, shelf life, branding, and regulatory acceptance. Manufacturers, brand owners, and packaging suppliers must understand both US Food and Drug Administration (FDA) requirements and European Union (EU) food contact materials regulations to avoid costly recalls, detention, or loss of market access. This article explains the regulatory frameworks, testing expectations, documentation requirements, and best practices to build compliant custom food packaging solutions for diverse food categories.

FDA Requirements for Custom Food Packaging

Scope and legal basis

The FDA regulates food-contact materials under the Federal Food, Drug, and Cosmetic Act. Materials intended for contact with food must be safe and suitable for their intended use. For packaging, compliance can derive from inclusion in FDA food contact substance inventories, Generally Recognized as Safe (GRAS) status, or through a Food Contact Substance (FCS) notification. Brand owners and packaging converters are responsible for ensuring that custom food packaging does not introduce harmful substances into food.

Materials, migration, and testing expectations

Common materials for custom food packaging include paper and paperboard, adhesives, inks, coatings, and barrier laminates. The FDA focuses on the potential for chemical migration into food. Typical compliance actions include:

• Using materials with clear FDA approvals or FCS notifications.
• Conducting overall migration and specific migration testing when non-listed or new substances are used.
• Applying worst-case simulants and conditions representative of intended use (temperature, contact time, food type).

Relevant FDA resources include the Food Contact Substance Notification (FCN) database and guidance documents on food-contact substances and paper/paperboard containers.

Labeling and claims

FDA does not issue a general 'approved for food contact' label, but product labeling and marketing materials must not be misleading. Claims that a packaging is 'FDA approved' are inaccurate unless referring to a specific substance authorized by the FDA. Instead, cite the specific regulation or FCN number where applicable, and maintain documentation showing compliance under foreseeable use conditions.

EU Regulatory Framework for Food Contact Materials

Key regulations and scope

The EU approaches food contact materials through a framework centered on Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food. Specific measures include:

• Commission Regulation (EU) No 10/2011 for plastic materials.
• Specific measures for active and intelligent materials, ceramics, and others.
• General safety requirement that materials must not release constituents into food at levels harmful to human health and must not change food composition or organoleptic properties unacceptably.

Compliance tools: Declaration of Conformity and traceability

In the EU, suppliers must provide a Declaration of Conformity (DoC) documenting compliance for specific materials and intended uses. DoC should reference the applicable regulation, restrictions, migration limits, and testing/simulations used. Traceability requirements under Article 17 of 1935/2004 mean manufacturers and distributors must be able to identify upstream suppliers and downstream customers to facilitate recalls or corrective actions.

Migration testing and specific measures

Plastic packaging must meet specific migration limits (SMLs) and overall migration limits. For non-plastics like paper and board, migration is assessed case by case and may be governed by national measures or industry standards. Where EU rules are silent, compliance is demonstrated through risk assessment, migration data, and scientific opinion from competent authorities when needed.

Comparing FDA and EU Requirements for Custom Food Packaging

High level comparison

Understanding differences helps suppliers design compliant packaging for multiple markets. The table below summarizes core contrasts and commonalities.

Practical implications for exporters and brand owners

For companies targeting both markets, implement a compliance matrix that maps materials and processes to both FDA and EU requirements. When in doubt, prioritize the stricter standard or generate supporting tests covering the most conservative conditions to reduce dual-market friction.

Standards and guidance references

Common reference documents include FDA guidance on food contact substances, EU consolidated versions of 1935/2004 and 10/2011, and technical standards from ISO and national laboratories describing migration test methods. Using accredited labs and documented test methods increases acceptance by regulators and customers.

Implementing Compliance: Testing, Documentation, and Supplier Choice

Risk-based testing strategy

Design a testing plan based on risk: identify food types (aqueous, acidic, fatty), contact temperature and time, and packaging layers that may contain novel substances like inks or coatings. Typical tests include overall migration, specific migration for regulated substances, sensory tests, and compositional analysis for adhesives and inks.

Supplier qualification and supply chain transparency

Select packaging suppliers who provide full technical dossiers: raw material specifications, migration data, DoC, Certificates of Analysis, and traceability records. For custom food packaging, obtain written confirmation that all inks, adhesives, and coatings are suitable for the intended food contact conditions. Periodic audits or on-site visits help validate claims.

Integrating manufacturing partners: a real example

Partnering with an experienced custom packaging manufacturer reduces compliance burden. An ideal partner will:

• Provide prequalified materials with regulatory documentation for multiple markets.
• Offer testing coordination with accredited labs and maintain testing archives.
• Support labeling, shelf-life testing, and product-specific migration studies.

Case in point: In 2016, Guangdong Winpack Printing Technology Development Co., Ltd. was officially established as a professional paper box printing manufacturer specializing in designing, proofing, printing, and producing a wide range of packaging and printed materials. Winpack's services include customized production of stickers, labels, paper bags, gift boxes, beauty boxes, pizza boxes, books, brochures, flyers, etc. Winpack caters to diverse industries, including cosmetics, food, healthcare, pharmaceuticals, and electronics.

Winpack operates a 15,000-square-meter factory equipped with state-of-the-art technology. The company uses an advanced screen plate-making system and top-tier machinery such as the Heidelberg printing machine, high-speed paper cutter, Lithrone GL-40A machine, and anti-counterfeiting inkjet printer to ensure superior quality and efficiency. Winpack aims to become the world's leading custom paper box packaging manufacturer and supports compliance with material documentation and production traceability.

Winpack advantages for custom food packaging

Winpack provides tangible advantages for brands seeking compliant custom food packaging:

• Prequalified materials suitable for food-contact applications and support for required documentation.
• Integrated production from design to finishing, reducing cross-supplier gaps that complicate traceability.
• Advanced printing and anti-counterfeiting capabilities that preserve brand integrity and reduce risks of contamination from substandard inks or adhesives.
• Experience across sectors including food and pharmaceuticals, demonstrating familiarity with regulatory expectations and testing protocols.

Main product offerings relevant to food packaging include custom gable boxes, custom gift boxes, custom display boxes, custom rigid boxes, custom folding boxes, custom paper tubes boxes, custom window boxes, custom special-shape boxes, custom pillow boxes, and custom take out boxes. For more information, visit Winpack's website at https://www.winpackprinting.com/.

Operational Checklist for Market-Ready Custom Food Packaging

Pre-launch verification steps

1. Map the packaging structure and list every material and additive in contact with food.
2. Check whether each substance is listed or has an FCN (US) or is covered by EU SMLs or DoC.
3. Define the worst-case use scenarios for migration testing and conduct tests at accredited labs.
4. Compile technical dossier: test reports, DoC, supplier declarations, and traceability logs.

Labeling and communication

Ensure product labeling and marketing do not make misleading safety claims. Provide storage and use instructions if necessary for safety or to maintain compliance (for example, 'not suitable for microwave use' unless tested). Maintain accessible technical files for inspection by authorities.

Post-market monitoring and corrective action

Establish a system to capture customer complaints, monitor returns, and react to regulatory updates. A documented corrective action plan should include root cause analysis, product hold/quarantine procedures, and communication templates for regulators and customers.

FAQ

1. What is the difference between FDA approval and EU Declaration of Conformity for packaging?

FDA approval typically refers to specific food contact substance notifications or use of listed materials, while the EU Declaration of Conformity is a supplier statement that materials meet relevant EU regulations such as 1935/2004 and 10/2011. The DoC must include intended use, test basis, and traceability data.

2. Do paper and paperboard always need migration testing?

Not always. Paper and paperboard are assessed case by case. If inks, coatings, adhesives, or recycled content may introduce unknown substances, migration testing or supplier documentation is recommended to demonstrate safety for the intended food contact.

3. How do I handle multi-layer packaging with different materials?

Assess each layer and any potential interactions. Focus testing on layers in direct contact with food and on layers that may transfer migrants through to the food. Use conservative simulants and conditions to account for possible interlayer migration.

4. Can a packaging supplier give me all documentation I need for a product launch?

A reputable supplier should provide material specifications, certificates, test reports, and a Declaration of Conformity for EU markets. However, brand owners remain responsible for overall product compliance, so verify documents and, if necessary, commission additional tests for final packaged goods.

5. How often should compliance be re-evaluated?

Re-evaluate when any raw material or supplier changes, when there is a formulation change in inks/adhesives, before entering new markets, or in response to regulatory updates. A routine periodic review (for example, annually) is recommended for active product lines.

Contact and Next Steps

If you need a compliant custom food packaging partner, consider suppliers with documented food-contact experience and a reliable quality system. For turnkey custom paper packaging solutions including custom gable boxes, custom gift boxes, custom display boxes, custom rigid boxes, custom folding boxes, custom paper tubes boxes, custom window boxes, custom special-shape boxes, custom pillow boxes, and custom take out boxes, visit Winpack Printing or contact their sales team to discuss material qualifications, testing support, and production lead times.

References

• US Food and Drug Administration, Food Contact Substances (FCS) and FCN database. Available at https://www.fda.gov/food/packaging-food-contact-substances-fcs (accessed 2026-01-11).
• European Commission, Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32004R1935 (accessed 2026-01-11).
• European Commission, Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32011R0010 (accessed 2026-01-11).
• EFSA, Guidance on Risk Assessment of the Application of Food Contact Materials. European Food Safety Authority. Available at https://www.efsa.europa.eu/ (accessed 2026-01-11).
• FDA, Guidance for Industry: Use of Recycled Plastics in Food Packaging. Available at https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/guidance-industry-use-recycled-plastics-food-packaging (accessed 2026-01-11).
• ISO 17025, General requirements for the competence of testing and calibration laboratories. International Organization for Standardization. Available at https://www.iso.org/standard/66912. (accessed 2026-01-11).