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Food Contact Packaging Regulations: An Overview for Flexible Packaging

Food contact packaging regulations in the US and EU explained for flexible films and laminates: frameworks, migration testing, declarations and supplier questions.

A declaration for the wrong food or temperature can leave a film unsuitable for its intended use. Match the destination market, exact structure and food-contact conditions first, then check the substance authorization and supporting test documents for those conditions.

Documents by market

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Check US evidence EU evidence
Structure and intended food/time/temperature Applicable CFR listing, FCN or other legal basis for the actual use Applicable framework and material-specific measure, with use conditions
Substance supplier FCN inventory entry identifies the authorized manufacturer/supplier Supplier declaration and supporting composition information
Recycled plastic Suitability evidence; FDA process opinion if voluntarily sought Regulation 2022/1616 route and applicable documentation
Supporting documents Supplier statement tied to the use; relevant chemistry evidence Declaration of compliance and supporting testing/assessment

Read the intended-use conditions before accepting a generic “food safe” statement.

Takeaway: Match the declaration to the actual market and intended use.

US food contact framework

Under the Federal Food, Drug, and Cosmetic Act, a substance that reasonably can be expected to migrate to food from packaging is a food additive unless it is generally recognized as safe or otherwise exempt. FDA’s guidance describes three practical routes for a food contact substance:

  • Listing in the regulations. Many substances are listed as indirect food additives in 21 CFR. Part 174 holds general provisions (including good manufacturing practice expectations), Part 175 covers adhesives and components of coatings, Part 176 covers paper and paperboard components, Part 177 covers polymers, and Part 178 covers adjuvants, production aids and sanitizers. A listing sets conditions: permitted food types, temperature ranges and sometimes limits on extractives or composition.
  • Food contact notification (FCN). A manufacturer or supplier notifies FDA of a new use, and if FDA does not object within the statutory period the notification becomes effective. An effective FCN applies to the named notifier’s substance, but customers buying that substance from the named supplier can rely on it for the notified use.
  • Threshold of regulation exemption. Under 21 CFR 170.39, FDA can exempt a substance whose migration is so low that regulation as a food additive is not needed, subject to strict conditions.

For a flexible package, typical citations include polymer sections in Part 177 for the polyolefin, polyester or nylon layers, adhesive provisions in Part 175, and colorant or adjuvant provisions in Part 178. FDA also publishes inventories of effective FCNs and listed substances that suppliers use to show their raw materials are covered.

The US has no single mandatory declaration form. Instead, suppliers usually provide a written statement or guarantee saying that the material complies with the relevant FDA regulations for the stated use. Federal rules also sit alongside state requirements, for example on certain chemical classes, so check state law for your distribution area. For recycled plastics, FDA offers case-by-case informal advice on process suitability. Its July 2021 chemistry guidance says submissions are voluntary, not a universal approval requirement; underlying food-contact law still applies. See PCR packaging for the material checks.

Hands reviewing compliance documents next to a laminate film sample
Supplier declarations and test reports should match the exact structure and use conditions of the pack.

Takeaway: Match any FCN reliance to the named substance supplier and notified use.

EU food contact framework

The EU framework has three tiers.

  1. Framework Regulation (EC) No 1935/2004 applies to all food contact materials. Its core principle is that materials must be manufactured so they do not transfer constituents to food in quantities that endanger health, bring about unacceptable change in the food’s composition, or deteriorate taste and odor. It also covers labeling, traceability and a written declaration of compliance for materials with specific measures.
  2. Good Manufacturing Practice Regulation (EC) No 2023/2006 sets GMP requirements for the groups of food contact materials. It requires a quality assurance system, quality control and documentation. It also contains provisions on printing inks applied to the non-food-contact side of materials.
  3. Specific measures. For plastics, Regulation (EU) No 10/2011 sets a Union list of authorized monomers and additives, an overall migration limit, specific migration limits for listed substances, testing rules using food simulants, and a declaration of compliance requirement. Regulation (EU) 2022/1616 governs recycled plastic materials, replacing the earlier regime, and rests on authorized recycling technologies and a Union register.

Regulation (EU) 2025/351 amended the plastics, recycled-plastics and GMP rules. Bisphenol restrictions under Regulation (EU) 2024/3190 cover listed material groups, including adhesives, plastics, printing inks, varnishes and coatings; they are a separate check from general plastics compliance. The transition table below distinguishes entry into force from first-placement deadlines.

Other substances and material types, such as many adhesives, coatings and inks, have no EU-wide specific measure. They still must meet the framework regulation’s general safety requirement and GMP, and Member States may have national rules. That gap is the main reason supplier documentation matters so much.

Takeaway: Identify the applicable material measure before choosing the test evidence.

Migration testing and declarations of compliance

Compliance rests on several pieces of evidence, not on one test.

  • Migration testing. Laboratories measure overall migration (total transfer of non-volatile substances) and specific migration of named substances into food simulants under time and temperature conditions that mirror use. In the EU, simulants include ethanol and acetic acid solutions, vegetable oil or its substitutes, and a solid simulant for dry foods. The test conditions must match worst-case intended use, such as hot fill, retort or long ambient storage. Retort packs need special attention; see retort pouch.
  • Composition review. A supplier checks that each material in the structure appears on the relevant list or is covered by an FCN, and that restrictions on food type and temperature are met.
  • Declaration of compliance. In the EU, written declarations are required for plastics and other materials with specific measures, and each business in the chain generally supplies one to its customer. A declaration identifies the material, the regulations met, the conditions of use and the supporting evidence. It should state what it covers; for example, it may apply to a stated structure and a stated food type.

Keep this assessment separate from seal-strength testing and shelf-life validation.

Be careful with extrapolation. A test on one structure does not automatically cover a different thickness, adhesive or print coverage.

Multilayer structures, functional barriers and inks

A functional barrier is a demonstrated migration-control function for the intended use, not a description inferred from foil or film thickness. See laminated packaging and barrier film for structure terminology.

For plastic multilayers, 10/2011 Article 13(2)-(4) and Article 11(4) allow certain non-listed substances in a non-food-contact plastic layer behind a functional barrier. They must not migrate detectably: the default detection limit is 0.01 mg/kg, unless a specific limit applies. Article 13(3) includes set-off and applies the detection limit to related substance groups or unrelated individual substances. Article 13(4) excludes substances meeting the cited mutagenic, carcinogenic or reproductive-toxicity classification criteria, and substances in nanoform. Vinyl chloride retains its restriction under Article 13(2)(a).

For multi-material multilayers, read Article 14(2)-(6) separately. It retains functional-barrier and excluded-substance provisions, but the amended text does not cross-reference Article 13(3)’s numerical detection rule. Do not extend the 0.01 mg/kg rule to all materials. Article 14(4) applies Articles 11-12 when the food-contact surface layer falls within the plastics regulation; Article 14(6) allows national limits where it does not. The general safety framework also matters.

Printing inks and adhesives need composition and migration review, including possible set-off from the reel. A layer behind a barrier is not a blanket exemption from safety assessment.

Takeaway: Specify the multilayer type before applying a functional-barrier exception.

What to ask suppliers for

Keep one intended-use record for each structure and market; copy the fields below.

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Field Entry
Market / SKU / supplier / structure version ____
Food type / simulant basis ____
Fill or processing temperature / storage temperature ____ / ____
Contact duration / single or repeat use / area-to-food ratio ____
CFR or FCN reference / named substance supplier ____
EU declaration / applicable material measures / issue date ____
Migration reports / conditions / composition and NIAS assessment ____
Recycled-plastic route / bisphenol statement / change control ____

Use the supplier questionnaire to resolve missing entries. The regulations hub separates food-contact evidence from waste obligations.

Takeaway: Complete the use conditions and document references for each structure.

Transition dates and exceptions

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Measure Entry into force Transition relevant to final articles
2025/351, Articles 4-5 16 March 2025 Plastic materials/articles meeting the previous rules and other relevant EU law, first placed before 16 September 2026, can continue until stocks are exhausted. Noncompliant intermediate products first placed after 16 December 2025 need the specified declaration warning.
2024/3190 as amended, Article 11 Original regulation: 20 January 2025 General BPA single-use final-article first-placement deadline: 20 July 2026. Specified preservation of fruit/vegetables (excluding Directive 2001/112/EC juice products) and fishery-product uses, and BPA coating only on an exterior metal surface: 20 January 2028. Filling/sealing is allowed for 12 months after the applicable period; resulting packaged food may be sold until stocks are exhausted.
2024/3190 as amended, Article 12 Same original entry date Repeat-use final articles: first placement until 20 July 2026; professional food-production equipment until 20 January 2028. Articles first placed under those routes may remain on the market until 20 July 2027 and 20 January 2029, respectively (Article 12(3)).

These stock transitions depend on the exact article, previous compliance and first-placement history. They are not blanket extensions for new products. This overview is not legal advice; use the current text and qualified review for an exception or a changed formulation.

Questions and answers

What is a food contact notification?

An FCN is one FDA authorization route for an intended food-contact-substance use. It is tied to the identified manufacturer or supplier, substance and use conditions; an effective notification for a similar substance from another source is not a blanket authorization. Match the inventory entry to the actual supply chain and intended use.

Sources

Last checked: 8 October 2026. Regulations change; confirm the current text before relying on it.

Pouch filled with food simulant undergoing migration testing in a laboratory
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