Food-Contact Packaging Compliance in the EU, UK and US

How do food contact packaging regulations differ between the EU, UK and US?

The EU and Great Britain use a framework-plus-specific-measures model with a written Declaration of Compliance for plastics; the US uses a substance-by-substance authorisation model in which every component must be cleared for its intended use. In the EU and GB, paper and board have no harmonised specific measure, so industry benchmarks such as BfR Recommendation XXXVI fill the gap.

The EU framework in practice

Regulation (EC) 1935/2004 is the foundation for all food-contact materials in the EU. Three articles matter most to packaging buyers. Article 3 requires that materials do not transfer constituents to food in quantities that could endanger health, bring about an unacceptable change in composition, or deteriorate taste and odour. Article 15 covers labelling, including the "for food contact" wording or the glass-and-fork symbol where the article's purpose is not obvious. Article 17 requires traceability at all stages, which in practice means batch or lot coding that links a carton of finished packaging back to its board, ink and coating lots.

Regulation (EC) 2023/2006 sets good manufacturing practice: a documented quality-assurance and quality-control system at each production stage. It contains one rule that directly shapes printed packaging: inks applied to the non-food-contact side must not transfer to the food-contact side through the substrate or by set-off in the stack or reel. That is why ink selection, drying and stacking procedures are a compliance topic and not only a print-quality topic.

Regulation (EU) 10/2011 applies to plastic materials and to plastic layers within a multi-material structure. For paper packaging buyers, this is the regulation that covers PE extrusion coatings on cups and containers, plastic windows on bakery bags, and plastic bags and pouches. It sets an overall migration limit of 10 mg/dm² and specific migration limits for listed substances, and it requires a written Declaration of Compliance at each marketing stage other than retail.

Paper and board: why BfR XXXVI is the de facto benchmark

There is no harmonised EU measure for paper and board. Buyers and authorities therefore rely on national references, of which the German Federal Institute for Risk Assessment's Recommendation XXXVI is the most widely used. A typical paper-based DoC references Regulation 1935/2004 and states conformity with BfR XXXVI for the intended food types and conditions. A recommendation is not a law, but in practice a paper DoC without a recognised benchmark will rarely pass a chain's supplier approval.

Inks, mineral oil and BPA

Three substance-level topics now come up in most chain audits:

• Printing inks. Germany's Printing Ink Ordinance (Druckfarbenverordnung, introduced as the 21st amendment of the Bedarfsgegenständeverordnung) creates a positive list for substances in inks used on food-contact materials. After an extension, the transition ends on 31 December 2026 and the rules apply from 1 January 2027. It is German law, but because Germany is a large market it is becoming the reference for inks on packaging sold across the EU. The Swiss Ordinance SR 817.023.21 (Annex 10) and EuPIA guidance are established market references for low-migration inks.
• Mineral oil hydrocarbons (MOSH/MOAH). There is no binding EU limit for packaging as of October 2026. The main risk factors are recycled fibre and mineral-oil-based inks; the usual mitigations are virgin fibre, functional barriers or mineral-oil-free inks. An EU measure has been discussed for years, so treat this as an area to watch. The detail on barrier cartons sits in our guide to mineral oil barriers and food-safe cartons.
• Bisphenol A. Regulation (EU) 2024/3190 entered into force on 20 January 2025 and its main transition period ended on 20 July 2026. It covers coatings, varnishes, printing inks and adhesives used in food-contact materials, not the paper itself. Ask for confirmation that inks, varnishes and adhesives in your specification are not made with BPA.

PFAS

From 12 August 2026 the Packaging and Packaging Waste Regulation (EU) 2025/40 restricts PFAS in food-contact packaging placed on the EU market. The limits, test methods and alternatives are covered in our dedicated guide to PFAS-free food packaging.

How does food-contact law work in the UK after Brexit?

Great Britain kept the EU rules as assimilated law: Regulations 1935/2004, 2023/2006 and 10/2011 continue to apply in England, Scotland and Wales in their retained form. Northern Ireland follows EU food-contact rules under the Windsor Framework. For most printed paper and plastic packaging the technical content of a GB DoC and an EU DoC is the same, but the legal references and the business named on the document should match the market.

Two practical points arise. First, if you supply both GB and Northern Ireland from one stock, use a specification that meets current EU rules, since GB and EU texts can drift apart over time. Second, UK buyers often still ask for BfR XXXVI on paper DoCs, because GB has no paper-specific measure either. Wider UK packaging duties (EPR, Plastic Packaging Tax, single-use plastic bans) are covered in our UK packaging regulations guide.

How does the US FDA regulate food packaging?

In the US, every substance in a food-contact material must have a legal basis for its intended use: a listing in 21 CFR Parts 174-178, GRAS (generally recognised as safe) status, a prior sanction, or an effective Food Contact Notification (FCN). Compliance is demonstrated by showing that each component and the finished article meet those conditions, usually in a supplier's letter of guaranty.

For paper packaging, two sections do most of the work:

• 21 CFR 176.170 covers components of paper and paperboard in contact with aqueous and fatty foods, with extraction limits and conditions of use by food type and temperature. Burger wraps, pizza boxes, cups and soup containers are typically assessed here.
• 21 CFR 176.180 covers paper and paperboard in contact with dry food, such as bakery bags for dry goods or sugar sachets.

Plastic components fall under Part 177 (for example the olefin polymer listings for polyethylene coatings), and adhesives and coating components under Parts 175 and 176. An FCN is company-specific: it covers the notifier's substance and customers using it, not every similar substance on the market. That matters when a supplier cites an FCN; ask whose notification it is and whether your material is the notified substance.

Why "FDA approved packaging" is usually a misleading claim

The FDA does not approve, certify or register finished packaging products, and it does not issue certificates to packaging factories. When a supplier says "FDA approved", the accurate version is normally "made with substances that comply with the applicable FDA regulations for the stated food types and conditions of use". Treat "FDA approved" on a quotation as a prompt to ask for the actual compliance statement: which CFR sections, which food types, which temperature conditions, and who signs it. A useful statement names the finished product, its components and the regulations they meet.

PFAS and state laws

The FDA announced on 28 February 2024 that PFAS grease-proofing agents are no longer sold for US food contact, and in January 2025 it determined that 35 PFAS FCNs were no longer effective. Many states have their own bans on PFAS in food packaging. These, together with state EPR and bag laws, are covered in our US foodservice packaging regulations guide.

Who is responsible for food-contact compliance?

Responsibility is shared along the chain, and each party must be able to show that its part is compliant. The packaging manufacturer is responsible for the material it produces and for the DoC; the brand owner or chain is responsible for using it as specified and for the safety of the packed food; importers and distributors must hold and pass on the documentation.

Brand owner or restaurant chain

The chain or brand decides how the packaging will be used: which foods, at what temperature, for how long. That information defines whether a DoC is valid for the application. A wrap declared for "dry and moist food at room temperature" is not covered for hot fried chicken held under a heat lamp. Your duties typically include giving the supplier accurate conditions of use, checking that the DoC covers them, keeping documentation for audits and training sites not to repurpose packaging for foods outside the declared conditions. If you are also the food business operator, you carry the food-safety responsibility for the packed product.

Importer into the EU, GB or US

An importer is the first party placing the packaging on that market and is expected to hold the supplier's DoC or compliance statement, check that it references the correct legislation, and be able to present it to authorities. In the US, the importer typically needs a letter of guaranty from the manufacturer. If you import unfilled printed packaging from outside the market, you are the party the authority will usually approach first.

Distributor or wholesaler

Distributors that resell packaging must pass the DoC down the chain, keep traceability records (which lot went to which customer), and not alter conditions of use in their own sales literature. A distributor that reprints or converts the material takes on manufacturer duties for that step.

Foreign manufacturer

A manufacturer outside the market (for example a converter in Türkiye supplying the EU, UK or US) must produce to the destination market's rules, issue the DoC or compliance statement, operate GMP and maintain traceability back to raw-material lots. Its DoC relies on declarations from board mills, ink makers, coating and adhesive suppliers, so the quality of the upstream documents determines the quality of the finished-product DoC.

What should a Declaration of Compliance contain?

A usable DoC identifies the business issuing it, the exact material or article, the legislation it complies with, the substances subject to restrictions, and the conditions of use for which compliance was verified. For plastics, Regulation (EU) 10/2011 Annex IV sets the content; paper DoCs usually follow the same structure. German-speaking quality teams ask for the same document as a Konformitätserklärung (for food packaging, Konformitätserklärung Lebensmittelverpackung).

Typical contents to check:

• Name and address of the business issuing the declaration (manufacturer or importer).
• Identity of the material or article (product name, specification, construction, layers).
• Date of the declaration (and revision number).
• Confirmation that the material complies with Regulation (EC) 1935/2004, Regulation (EC) 2023/2006 and, where relevant, Regulation (EU) 10/2011 and BfR Recommendation XXXVI (or the GB assimilated equivalents).
• Substances with specific migration limits or other restrictions, and dual-use additives, where applicable.
• Conditions of use: food types (dry, moist, fatty, acidic, alcoholic), contact time and temperature, surface-to-volume ratio used in testing.
• Information on functional barriers, if compliance relies on one.
• Signature of a responsible person.

The DoC is supported by test reports (overall and specific migration, organoleptic tests where relevant) that the buyer can request but which are often shared under confidentiality.

Timelines buyers should have on file

Documents to request from your packaging manufacturer

Ask for these before approving a new item, and again whenever the material, coating, ink system or factory changes:

• Declaration of Compliance for the finished article, referencing the target market's legislation and your conditions of use.
• For paper and board: statement of conformity with BfR Recommendation XXXVI (and the relevant sub-part if specialised papers are used).
• For plastic layers (PE coating, window film, bags): DoC under Regulation (EU) 10/2011 and migration test summary.
• Ink and varnish declaration from the ink supplier: low-migration suitability for the application, BPA status under Regulation (EU) 2024/3190, and from 2027 conformity with the German Printing Ink Ordinance where the packaging is sold in Germany.
• Mineral oil statement: fibre source (virgin or recycled), ink system, barrier if any.
• PFAS statement (no intentionally added PFAS, test data where available); see PFAS-free food packaging.
• For the US: letter of guaranty or compliance statement naming the CFR sections (for example 21 CFR 176.170) and any FCNs relied on.
• GMP evidence: description of the quality system and traceability (how lot numbers are applied to cartons).

At 9 Packaging, the documentation set for each item is agreed during quotation and technical review, because it depends on the board, coating, ink system and destination market of that specific job.

What this means for foodservice and e-commerce packaging

The same principle applies everywhere: match the declared conditions of use to the real application.

• Burger wraps and greaseproof sheets: fatty, hot contact, often held for several minutes. Check the DoC covers fatty food at elevated temperature, and that the grease barrier is PFAS-free. See custom printed greaseproof paper.
• Burger, pizza and takeaway boxes: board may be recycled or virgin; for direct contact with hot food, ask about mineral oil and the food-contact side. See custom printed burger boxes, custom printed pizza boxes and custom printed takeaway food boxes.
• Cups and food containers: a PE lining is a plastic layer under 10/2011; for dispersion coatings, ask which legislation or recommendation the coating is assessed against. Hot liquids define the test conditions. See custom printed paper cups and custom printed paper food containers.
• Food bags with windows: the paper and the film need separate declarations. See custom printed paper food bags.
• Wet wipes handed out with food: the wipe is not a food-contact material, so cosmetics, labelling and plastics rules apply instead; see wet wipes and the single-use plastics rules.
• E-commerce mailers and outer cartons: usually no direct food contact, so food-contact rules do not apply unless the box is the primary food packaging (for example unwrapped baked goods). Specify this clearly so the supplier does not over- or under-declare.

The barrier layer is often the hardest part of the declaration; our guide to barrier coatings for paper packaging compares PE, dispersion, PLA and wax.

Next step: specify food contact in your RFQ

A supplier can only issue a meaningful declaration if the request is specific. When you ask for a quotation, include: the foods (with fat, moisture and acidity), the contact temperature and time, target markets (EU, GB, NI, US), whether the printed side touches food, required documents from the list above, and any chain-specific requirements such as ink standards. Our packaging RFQ guide shows how to structure the rest of the request, and you can send the specification directly via our contact page for technical review.

Related reading

• Packaging glossary: paper, board, print and compliance terms
• PPWR Declaration of Conformity: What It Must Contain and Who Signs It
• Packaging Regulation, Sustainability and Trade Glossary