Custom Food Packaging Compliance: FDA, EU and Labeling

Custom food packaging must meet safety, legal and market expectations across jurisdictions. This article summarizes the key FDA and EU requirements for materials and labels, explains testing and documentation needed to demonstrate compliance, and offers actionable best practices for brands and packaging suppliers. It also compares US and EU approaches and highlights how manufacturers can reduce regulatory risk through material selection, migration testing, and clear labeling strategies.

Why regulatory compliance matters for food packaging

Public health and consumer protection

Food-contact materials (FCMs) can transfer substances into food. Even small chemical migration can cause safety concerns, allergic reactions, or affect shelf life and flavor. Regulatory systems—like the US Food and Drug Administration (FDA) and EU food contact framework—exist to protect consumers by defining permitted materials, migration limits, and required documentation. See FDA guidance on food contact substances: fda.gov.

Market access and liability

Non-compliant packaging can lead to market removal, recalls, fines, or civil liability. Brands selling internationally must design custom food packaging that meets the strictest applicable standard or maintain multiple SKUs for different markets. Documentation such as declarations of compliance (DoC), migration testing reports, and Good Manufacturing Practice (GMP) records are often required during audits or in case of incidents. For EU roles and obligations, see Regulation (EC) No 1935/2004: ec.europa.eu and GMP Regulation (EC) No 2023/2006: eur-lex.europa.eu.

Understanding US (FDA) requirements for custom food packaging

Material authorization and Food Contact Notifications

In the US, many common packaging materials (paper, paperboard, inks, adhesives) are considered safe when they comply with existing regulations or are covered by an FDA listing. Some novel materials or additives require a Food Contact Notification (FCN) or premarket clearance. Manufacturers should verify whether a material is listed in the Code of Federal Regulations (CFR), particularly 21 CFR parts relevant to adhesives, coatings, and polymers. Search FDA listings and FCNs: FDA Food Contact Substances.

Labeling claims and ingredient transparency

Labels must not be misleading. While packaging material itself does not require ingredient disclosure like food does, claims such as compostable or biodegradable have legal implications and may fall under FTC or state-level regulations. If packaging includes contact with allergens (e.g., wax coatings with nut oils), these should be disclosed through supplier documentation to the brand owner to manage consumer safety and supply-chain transparency.

Testing and migration considerations in the US context

FDA does not mandate a single migration test for all materials; instead, safety is demonstrated via authorized materials, toxicological data, and exposure estimates. Many companies use standardized migration tests (e.g., overall migration, specific migration) and follow USDA/FDA accepted methods. Third-party labs with GLP accreditation are commonly used to produce defensible data for due diligence or FCNs.

Understanding EU requirements and labeling obligations

Fundamental EU framework and specific rules

The EU approach is statutory and prescriptive: Regulation (EC) No 1935/2004 provides the general framework ensuring that materials do not transfer constituents into food at levels harmful to human health or that change the composition or organoleptic properties of the food. For plastics, Commission Regulation (EU) No 10/2011 applies and lists authorized substances; other materials (paper, inks, coatings) may refer to national standards or specific provisions. See the EU food contact legislation overview: European Commission - Food contact materials.

Declarations of Compliance and documentation

EU law expects supply chain documentation including a Declaration of Compliance (DoC) from the FCM manufacturer to the food business operator. DoC should reference applicable regulations, migration limits, and testing or supporting evidence. Good Manufacturing Practice as per Regulation (EC) No 2023/2006 must be documented and audited. Templates and guidance are available from national food safety authorities (e.g., the UK Food Standards Agency) and EFSA: efsa.europa.eu.

Labeling rules and consumer information

EU labeling requirements for the packaged food itself are harmonized; packaging material claims (e.g., food-grade, recyclable) must be accurate and substantiated. In the EU, materials in contact with food should be identified with symbols where relevant (e.g., glass/fork symbol) and must avoid misleading consumers regarding safety. National guidance may apply for specific claims like compostability (EN 13432 certification for industrial composting).

Testing, documentation and best practices for compliance

Common tests and technical controls

Standard tests include overall and specific migration, sensory testing (organoleptic), and specific substance analysis (e.g., primary aromatic amines from azo dyes). Accredited labs follow ISO/IEC 17025. For plastics, EU methods and simulants (e.g., ethanol solutions, acetic acid) are used; US labs often replicate international methods to satisfy cross-border requirements. See ISO/IEC accreditation principles: iso.org.

Documentation package: what buyers should request

Brands should request from suppliers: material specifications, DoC, migration test reports, GMP certificates, safety data sheets for inks/adhesives, and lot traceability logs. This information is often required in audits by retailers or regulatory bodies. Maintain these records for the product lifecycle and for at least the shelf-life plus a reasonable period per local regulation.

Risk-based material selection and design choices

To reduce compliance burden, prefer well-characterized substrates (untreated paperboard, approved coatings), avoid unknown recycled content for direct food contact if migration risk is unclear, and minimize use of complex multi-component laminates unless justified by functional need (e.g., barrier for high-fat foods). Using mono-materials where feasible helps recycling and simplifies regulatory assessment.

Regulatory comparison: US vs EU (summary)

Partner profile: Winpack — compliant custom paper packaging solutions

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. Our 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.

Our 15,000-square-meter factory is equipped with state-of-the-art technology. We utilize 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. Our vision is to become the world's leading custom paper box packaging manufacturer. Our website is https://www.winpackprinting.com/ and our email is [email protected].

Winpack focuses on producing compliant packaging for food brands with attention to material traceability, printed-ink approvals, and DoC generation. Core products 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, custom take out boxes. Winpack differentiates through:

• Manufacturing scale and modern equipment enabling tight process control and consistent print runs.
• Technical support for compliance documentation, migration testing coordination, and materials traceability.
• Cross-industry experience (food, cosmetics, pharma) allowing tailored barrier and ink solutions for sensitive products.

By working with a partner like Winpack, brands can reduce time-to-market and supply-chain complexity. Winpack can assist in producing Declarations of Compliance and coordinate tests with accredited labs when required, helping you meet both FDA and EU expectations.

Practical checklist for launching custom food packaging

Before design

- Define food type (aqueous, acidic, fatty) and intended use (hot-fill, microwave, single-use). Different foods influence simulant choice and barrier needs.
- Decide markets of sale (US, EU, others) to identify applicable regulations.

During material selection

- Prefer materials with existing positive listings or supplier-provided DoCs.
- Avoid unknown recycled streams for direct food contact without validated testing.
- Confirm inks and adhesives are food-contact appropriate and request SDS and compliance evidence.

Before production

- Secure migration testing if needed; obtain written DoC and traceability info from your supplier.
- Ensure labels and marketing claims are accurate and substantiated for each market.

FAQs

1. Do I always need migration testing for custom food packaging?

Not always. If you use materials and inks already covered by recognized lists (e.g., FDA listings or EU authorized substances) and the supplier provides a DoC, additional testing may not be necessary. However, for novel materials, recycled content, or high-risk foods (fatty, alcoholic), migration testing is strongly advised.

2. What is a Declaration of Compliance (DoC) and who issues it?

A DoC is a document provided by the manufacturer or supplier of a food-contact material declaring that the material complies with applicable regulations and often summarizing supporting migration test data, authorized substances, and GMP adherence. In the EU, DoC is commonly required by food business operators.

3. Can recycled paper be used for direct food contact?

Recycled paper can pose higher migration risks due to contamination with unknown substances. Many regulators and brands avoid recycled content for direct contact with high-fat foods unless there is validated testing and clear traceability showing safety.

4. How do labeling claims like food-grade or biodegradable affect compliance?

Claims must be truthful and substantiated. Food-grade is not a standardized legal term—it's better to reference specific compliance (e.g., Compliant with EU Regulation (EC) No 1935/2004). Environmental claims like biodegradable or compostable require certification (e.g., EN 13432) and may be regulated by consumer protection agencies.

5. Where can I find official lists of approved substances for plastics?

For the EU, Commission Regulation (EU) No 10/2011 lists authorized substances for plastics; consult the consolidated text and updates on the European Commission website: EU plastics FCM. For the US, FDA maintains databases of Food Contact Substances and FCNs: FDA FCS.

Contact and next steps

If you need help designing compliant custom food packaging, creating Declarations of Compliance, or coordinating migration testing, contact Winpack at [email protected] or visit https://www.winpackprinting.com/. Winpack can provide turnkey solutions for 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 with documentation support for FDA and EU markets.

Key resources and references:

• FDA Food Contact Substances: fda.gov
• EU Regulation (EC) No 1935/2004: ec.europa.eu
• EFSA: efsa.europa.eu
• ISO/IEC 17025 for testing laboratories: iso.org
• General overview of food packaging (Wikipedia): en.wikipedia.org

Adopting a compliance-first approach to custom food packaging reduces regulatory risk, supports market access, protects consumers, and preserves brand reputation. Work with experienced suppliers, maintain thorough documentation, and apply a risk-based testing strategy tailored to your food type and target markets.