Where Food Safety and Sustainability Meet: A Compliance Guide for Flexible Packaging

Food-safe flexible packaging and sustainable materials are no longer separate conversations. Regulators across the EU, UK, US, and Australia are bringing them together, and the frameworks governing what your packaging can be made from, how it performs, and what your suppliers must document are evolving fast. Staying across it all is complex, but manageable with the right information.

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The challenge is that there is no single global standard, and compliance in one market does not automatically carry to another.

This guide maps what your flexible packaging needs to meet across all four markets, so you know exactly where you stand.

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For an in-depth view of the sustainability benefits of incorporated post-consumer recycled content into your food packaging, read more here: PCR Material in Food Contact Packaging.

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The Shared Foundation: What is Food Contact Migration?

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Regardless of where you sell, the core principle of food contact regulation is the same: packaging must not transfer substances to food in quantities that could harm health, change food composition, or impair taste or odour of the product. This transfer process is called migration, and it is what all food contact migration (FCM) regulations are designed to control.

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Two categories of limit appear across most jurisdictions:

• Overall Migration Limits (OML) measure the total quantity of substances transferring from material to a food simulant. 
• Specific Migration Limits (SML) target individual hazardous substances, such as particular monomers or plasticisers, by name. 

Additionally, food contact migration testing conditions must reflect actual intended use: a film approved for dry ambient goods may fail the same tests when used for hot-fill or high-fat applications.
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Where Do You Sell? A Quick Overview

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The table below maps your primary market to the regulations that apply and what documentation you need. No single standard covers all regions, brands selling globally need to satisfy each jurisdiction independently.

Selling into multiple markets? EU compliance does not automatically satisfy FDA requirements, and vice versa. Each jurisdiction has its own authorisation basis, migration testing protocol, and documentation format. If your packaging is used in the EU and USA, you need separate compliance files for each.

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European Union

EU Food Contact Regulations for Flexible ackaging

The framework: Regulation (EC) 1935/2004 and Regulation (EU) 10/2011

The overarching EU framework is Regulation (EC) 1935/2004, which sets the general safety requirement for all food contact materials. For plastic packaging specifically, Regulation (EU) 10/2011 provides the rules: 

• a positive list of authorised substances, 
• numerical migration limits for both overall and specific migration, 
• and standardised food simulants for testing. 

Compliance is demonstrated through a Declaration of Compliance (DoC), a legal document that must reference the specific regulations met, list any restrictions on use, and remain available for inspection by authorities.

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Recycled Plastics: Regulation (EU) 2022/1616

Recycled plastics can be used in food contact packaging in the EU, but the recycling process must be formally authorised. EU Regulation 2022/1616 requires that any PCR plastic used in food contact applications comes from a technology listed on the EFSA register. Essentially verifying that the process removes contaminants below regulated migration limits.

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For flexible packaging, the most common compliance approach is a functional barrier: recycled content sits between layers of virgin plastic, preventing any contaminant migration from reaching the food contact surface.

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2030 recycled content targets: The PPWR also sets mandatory recycled content targets for plastic food-contact packaging, increasing incrementally toward 2030. Brands will need to balance these targets against migration and contaminant limits from the outset of product development, not as a retrofit.

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PFAS ban: Regulation (EU) 2025/40 (PPWR), Effective 12 August 2026

Under the Packaging and Packaging Waste Regulation (PPWR), intentionally added PFAS in food-contact packaging are banned from 12 August 2026. There is no grandfathering provision: packaging above the thresholds cannot be placed on the EU market after that date, even if manufactured before it. The PPWR sets three specific thresholds:

EU Documentation Requirements

For EU-destined products, make sure you have a Declaration of Compliance referencing (EC) 1935/2004 and (EU) 10/2011 as a minimum from your supplier. Where post-consumer recycled content is used, an additional declaration under Regulation 2022/1616 is required. With the introduction of PPWR, a PFAS compliance statement with supporting TOF test data is required from 12 August 2026. 

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United Kingdom

UK Food Contact Regulations

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UK food contact materials are governed by the UK Food Safety Act 1990 and retained EU legislation that was incorporated into UK law at Brexit. In practice, the requirements closely mirror the EU framework: the UK equivalent of Regulation (EC) 1935/2004 applies, along with the positive list approach of (EU) 10/2011, and required documentation is the same: a Declaration of Compliance referencing the applicable retained UK legislation.

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The gap to watch is divergence. The UK has not enacted a direct equivalent to the EU's PPWR, which means PFAS thresholds and mandatory recycled content targets that apply from August 2026 in the EU do not yet have a confirmed UK parallel. If you're operating in both markets, your EU and UK compliance documentation are currently similar, but that may not hold.

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United States

US Food Contact Regulations: FDA 21 CFR

How the FDA system works

The US regulatory framework for food packaging is administered by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA). The detailed rules sit in Title 21 of the Code of Federal Regulations (21 CFR). The FDA treats substances in food packaging as indirect food additives: materials not intentionally added to food but which may migrate into it in trace amounts during storage or processing.

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Unlike the EU, the FDA does not operate a single centralised positive list requiring pre-approval for all materials. Instead, a packaging substance is considered legally compliant in the US if it satisfies one of four conditions:

• Listed in 21 CFR (Parts 174-189): The substance is already authorised in the relevant CFR section for its specific intended use, food type, and temperature conditions. 
• Generally Recognised as Safe (GRAS): The substance has a long history of safe use or has been reviewed under the FDA's GRAS notification programme. 
• Food Contact Substance Notification (FCN): A manufacturer submits a safety dossier to FDA's Office of Food Additive Safety. If FDA does not object within 120 days, the FCN becomes effective.
• Threshold of Regulation (TOR): For substances with very low dietary exposure and no carcinogenic potential, FDA may grant a TOR exemption where migration falls below a defined safety threshold, providing a streamlined route for minor packaging components.

One practical distinction from EU practice is how migration is measured. Where the EU sets per-substance migration limits, FDA testing typically measures the total concentration of extractives from the packaging under conditions simulating actual use. For example, a film intended for boiling water fill is tested under very different parameters than one intended for dry ambient storage. 

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Inks, adhesives, and coatings in flexible packaging each have their own CFR pathway. Adhesives in direct food contact are governed by 21 CFR 175.105, which requires either separation from food by a functional barrier, or compliance with specific migration limits under defined temperature conditions. Compliance applies to the entire converted structure, not the base film alone.

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Recycled Plastics in the US: the FDA LNO Programme

The FDA doesn't require pre-market clearance for post-consumer recycled plastics based on the recycling process itself. Compliance is assessed on material composition and purity under 21 CFR 174.5.

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In practice, the FDA's Letter of No Objection (LNO) programme is the primary mechanism suppliers use to demonstrate that a recycling process consistently produces food-safe output. A recycler submits process and safety data; if the FDA raises no objection, an LNO is issued for that specific material and process.

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PFAS in US Food Packaging: Federal Action and the State Patchwork

At the federal level, the FDA announced in February 2024 that PFAS-based grease-proofing agents for paper and paperboard food packaging are no longer sold in the United States, completing a voluntary market phase-out for that specific application. However, this was a voluntary phase-out for a narrow use case, not a binding statutory ban across all packaging formats. For flexible plastic films and other substrate types, there is currently no equivalent federal PFAS restriction.

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The result is that PFAS regulation for food packaging in the US is driven by state law, producing a complex and expanding patchwork. As of early 2026, more than 15 states have enacted restrictions, each with different scope, thresholds, and timelines:

Brands selling nationally in the US cannot treat FDA compliance as equivalent to PFAS compliance. A specification that meets FDA's current framework may still be unlawful in several major markets. Nearly 350 PFAS-related bills were introduced across state legislatures in 2025 alone, and the pace of new restrictions is accelerating toward 2027 and beyond.

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US documentation requirements

For the US market, brands should verify their supplier's 21 CFR authorisation basis for each material in the structure, confirm LNO status and applicable conditions of use for any PCR resin, and obtain PFAS-free declarations or certificates for any state where restrictions are in effect. Unlike the EU, there is no standardised "Declaration of Compliance" format under US federal law, but several states with PFAS restrictions require a Certificate of Compliance for products sold in those markets.

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Australia & New Zealand

Australia and New Zealand: FSANZ Standard 1.1.1

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Food contact materials in Australia and New Zealand are governed by FSANZ Standard 1.1.1, which sets a general obligation: packaging must not contaminate food or render it unsuitable for consumption. Unlike the EU, FSANZ does not maintain a positive list of approved substances. For post-consumer recycled content, Australia has no formal authorisation programme equivalent to EFSA or the FDA's LNO scheme. Compliance is based on general food safety principles, and many Australian retailers and brands additionally require EU or FDA documentation as a practical proxy, particularly where FSANZ provides no specific guidance.

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On PFAS, there is no specific ban in Australia equivalent to the EU or major US state laws, though existing AICIS obligations and general food safety duties still apply. Brands operating globally will typically default to their most restrictive market standard. The required documentation for both Australia and New Zealand is a Certificate of Conformance (CoC).

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What Documentation Should Your Packaging Supplier Provide?

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Generic "food safe" claims are no longer a viable compliance strategy in any major market. The table below summarises what to ask for by region:

Grounded’s Perspective

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Navigating the complex landscape of global food contact regulations can understandably feel overwhelming. While there is undeniably a lot to consider across different jurisdictions, you don't have to manage it alone. 

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We take the guesswork out of compliance by proactively ensuring that your flexible packaging meets all relevant market obligations, no matter where you sell. Whether you are navigating the EU's new PFAS thresholds, FDA requirements in the US, or FSANZ standards in Australia, we have you covered. Please reach out to our team with any questions or to discuss your specific packaging compliance needs.

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Frequently asked questions

Which US states currently ban PFAS in food packaging?

As of 2026, more than 15 US states have enacted restrictions. Live bans include New York (December 2022), California (January 2023 for plant-fibre packaging), Vermont and Connecticut (2023), Colorado, Maryland, and Minnesota (2024), and Oregon, Rhode Island, and Hawaii (2025). Illinois and Maine added restrictions in 2026. Each state has different scope, thresholds, and documentation requirements. Brands selling nationally should verify compliance against the most restrictive applicable state law.

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When does the EU PFAS ban on food packaging take effect?

The PFAS restrictions under the PPWR apply from 12 August 2026 to all food-contact packaging placed on the EU market. There is no sell-through exemption for packaging manufactured before that date if it exceeds the thresholds set out in Regulation 2025/40.

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Is recycled plastic packaging safe for food contact?

Recycled plastic can be used safely in food contact applications when produced through an EFSA-authorised process (EU) or covered by an FDA LNO (USA), and when the packaging either passes migration testing or incorporates a functional barrier. The recycling technology, waste stream source, food type, and conditions of use all affect compliance. Not all recycled plastics are suitable for all applications.

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Does EU compliance cover me for the Australian market?

Not automatically, though EU compliance is widely used as a supporting reference. FSANZ Standard 1.1.1 requires packaging not to contaminate food, but does not adopt the EU positive list. Many Australian retailers and brand owners additionally request EU or FDA documentation as a risk management measure. A Certificate of Conformance is the formal requirement for the Australian and New Zealand markets.

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Sources and further reading

• EU food contact materials legislation overview: food.ec.europa.eu
• EU Regulation 2022/1616 on recycled plastic FCMs (EUR-Lex): eur-lex.europa.eu
• PPWR PFAS provisions and August 2026 deadline (Keller and Heckman): khlaw.com
• PPWR draft guidance on stepwise PFAS testing (Packaging Law): packaginglaw.com
• FDA food contact material testing under 21 CFR (Measurlabs): measurlabs.com
• FDA LNO programme and 2025 programme uncertainty (Resource Recycling): resource-recycling.com
• FDA guidance on recycled plastics in food packaging: fda.gov‍
• FDA regulation of adhesives in food packaging (Keller and Heckman): khlaw.com