Today, sustainable packaging is more than a marketing term; it covers material safety, regulatory compliance, and brand reputation. FDA regulatory standards ensure that the materials coming into contact with the contents of the packaging of food, dietary supplements, and cosmetics sold within the U.S. are not threatening to health. That immediately raises the bar regarding the required material selection that will influence shelf life, product integrity, and perceived consumer value. Some of the risks associated with choosing eco-friendly custom packaging materials without considering their regulatory suitability are unwanted substance migration, poor barrier performance, recalls, or even brand damage.
The intersection of sustainability, material safety, and regulatory risk is where packaging design must aim, not only for recycled content, compostability, or a low-carbon footprint-but also to comply with the legal framework in control of materials in contact with food or consumables. A compostable film may sound great from the point of view of sustainability, but it could very well be exposed to possible liability in case migration testing is lacking or not properly authorized as a food-contact material. Early integration of sustainability goals into regulatory review empowers safe, compliant, customized packaging that supports long-term brand trust.
Will Sustainable Materials Meet FDA Requirements?
Understanding what constitutes a Food Contact Substance
Under U.S. Federal Law, the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a Food Contact Substance is defined in Section 409(h) as:
“The term includes any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, if such use is not intended to have any technical effect in such food.”
In other words, all materials that come into contact with food, whether considered eco-friendly, biodegradable, or recyclable, need to be safe and comply with FDA requirements as an FCS. Such materials include:
Polymers and plastics, virgin and recycled
Plant-based or bio-resins
Adhesives, coatings, inks, and sealants
Paper, cardboard, and bioplastic films
Reusable and compostable containers
Whatever the conditions, whether it is labeled “green” or “sustainable”, under normal conditions of use – food temperature, humidity, storage time, among others – the material cannot leach or migrate toxic substances to food. Whatever environmental profile can be attributed to a given material – for example, compostable – does not exempt that material from compliance with the FDA.
FDA’s Regulatory Pathways for Sustainable and Recycled Materials
To legally market a new food-contact material in the United States, manufacturing companies must utilize one of the three major regulatory pathways under FDA oversight.
1. Food Contact Substance Notification (FCN) Program
This is the most common and modern pathway.
A company submits scientific and chemical data to the FDA that show the substance is safe for its intended use.
Where the FDA does not object after 120 days, then for that manufacturer, the use is authorized.
Each FCN is specific to the manufacturer, the substance, and intended conditions of use; thus, other firms cannot automatically rely on it.
2. Food Additive Petition (FAP)
Applied to substances not eligible under the FCN program or those that are expected to have widespread applications by multiple manufacturers
The process is longer and results in a published regulation in 21 CFR Parts 174–186
3. Threshold of Regulation Exemption
Only very small, so-called trace levels of substances used within the company can be exempted from formal approval due to negligible exposure.
FDA Guidance on Recycled Plastics and Resin Safety
The most valuable FDA resource on issues of sustainability for packaging is provided by the following guidance document titled:
“Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations).”
Chemical testing of the recycled plastic, coupled with validation of cleaning.
The importance of the evaluation of post-consumer contamination that can comprise residuals, inks, or chemicals.
Migration studies are designed to ensure that contaminants will not migrate from the recycled layer into food.
The requirements for Letter of No Objection submissions, which document that the FDA has reviewed the recycling process and finds no safety concerns.
The FDA does not, therefore, give automatic approval to packaging materials that are recycled, but allows their use once the method of recycling is able to adequately prove the safety of the end material.
“Reasonable Certainty of No Harm”: The FDA’s Core Safety Standard
The same standard of safety, “reasonable certainty of no harm,” has been applied to both sustainable and conventional materials.
In other words, the FDA must be reasonably certain, based upon scientific evidence, that a substance migrating from a food packaging material will not harm consumers.
Legal basis for this is in the FDA’s Indirect Food Additives Regulations (21 CFR Parts 174–186), which define:
Materials allowed and conditions of use
Limits of Migration and Test Methods.
Acceptable additives and stabilizers in plastics and coatings.
For example,
Polymers and plastic resins are classified under 21 CFR Part 177.
21 CFR Part 175 relates to adhesives and coatings.
21 CFR Part 178 addresses the additives and colorants used to manufacture packaging materials.
Therefore, sustainability does not replace safety. Plant-based or recycled material, instead of virgin, should demonstrate that it:
1. Indicates that the required barrier properties are maintained.
2. It does not emit harmful chemicals into food.
3. Meets FDA-enforced limits on migration of components
4. Manufactured under Good Manufacturing Practices (GMPs).
Compliance Achievement through Eco-Friendly Custom Packaging Material
Below is the introduction of the eco-friendly packaging product to the U.S. market, with future compliance with FDA standards.
1. Perform Migration Testing:
The applicant shall demonstrate that unsafe levels of chemical components do not migrate from the material into food.
2. Filing an FCN or Obtaining an LNO:
Depending on whether the material is new or recycled.
3. Raw Material Composition Testing:
Ensure that all of the ingredients are either listed in 21 CFR or are approved under an FCN or FAP.
4. Forms Processing Controls:
Incorporate under conditions of temperature, exposure, and intended use.
5. Ensure Traceability:
Origin and process tracing of materials should be done through either digital labelling or batch trace systems.
6. Partner with Certified Suppliers:
Use only those suppliers of resin and paper whose products are FDA-compliant.
Biodegradable and Compostable Packaging Regulations
What does the FDA say about compostable, or bio-based materials, in contact with food or food-adjacent products?
Biodegradable, compostable, and biobased are just some of the ways in which packaging can be said to deliver sustainability benefits-but none of these claims exempt the material from the FDA’s food-contact regulatory regime. As the FDA makes clear, everything coming in contact with food shall be assessed under the FCS framework-migration tests, exposure assessments, and documentation of intended use. As NASA Food Contact Regulatory Overview describes it, “Any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food.” needs to be treated under the food contact regulatory pathway.
The material either needs to be included under 21 CFR or approved via FCN/food additive petition routes if the compostable film is to be used as an immediate package and hence in direct contact with food. These are to be done by providing information on how the film will serve under conditions of use, contact time, temperature, and product type/matrix: oil, water, acid.
Distinctions between legally authorised food-contact materials vs. newer green formats
Authorized materials include those listed in the substance inventory in 21 CFR or covered under effective FCNs. Specific uses, limitations, and conditions of use are described in the FDA’s “Inventory of Effective Food Contact Substance (FCS) Notifications.”
By contrast, most of the newer eco-materials — plant-based resins, compostable films, mono-material pouches — may not yet have full food contact authorization. Industry guidance notes that “the FDA has not yet promulgated any specific regulatory requirements pertaining to the use of recycled plastics in food packaging materials” and emphasizes manufacturer responsibility.
Therefore, even though marketing may refer to a film as “compostable,” from a regulatory point of view, it would nonetheless have to meet the FCS safety evaluation if in contact with food or supplements. The regulatory burden may be less when the eco-material is used only in outer or secondary packaging, which is not in direct contact with the consumable; due diligence nonetheless is prudent.
Examples of materials being reviewed or accepted via FCN routes
rPET is probably the best-documented example, with information that is required for the review of recycling processes and the acceptability of rPET for food contact having been described in the FDA’s guidance on recycled plastics. While not all FCNs are published in detail publicly, a brand or converter can rely upon the public inventory of effective notifications. For newer bio-based or compostable films, manufacturers are increasingly providing data or working with converters to validate performance, although full regulatory precedent is more limited.
The challenge, therefore, for packaging materials is twofold: to be at once environmentally responsible and compliant with FDA regulations in the U.S. market. Any material coming into contact with food shall meet thresholds for safety, from the very concept of FCS itself through the use of approval pathways like FCN, ToR, and food additive petitions. Recyclable plastics and their eco-alternatives represent a step forward, but their use has to be anchored in validated chemistry, migration testing, and traceability.
Where biodegradable or compostable materials are used, one will need to make sure due attention is given to their regulatory status by using only those demonstrated to be suitable for food contact in primary packaging without increased risk. Sustainability and compliance go hand in hand, protecting consumers and brand credibility in the U.S. market.
Non-toxic Inks and Coatings for Green Packaging
When green packaging is selected, inks, coatings, and adhesives become critical components of such a package-not just for aesthetic purposes but also from the viewpoint of safety and regulatory compliance. Materials have to be compliant according to U.S. regulations, mainly under 21 CFR Part 175 and 21 CFR Part 178, amongst others.
For example, § 175.105 provides: adhesives for contact with fatty or aqueous foods must result in only “trace amounts” migrating into the food unless separated by a functional barrier.
Coatings’ coefficients are also controlled: § 175.300 addresses resinous and polymeric coatings that are applied as continuous films over food-contact surfaces.
Checks that come into play in the practical designing of green packaging:
Material compatibility: A compostable film may need a coating to improve barrier and print adhesion; the coating formula shall comply with 21 CFR if there is food contact.
Migration risk: Although the ink applied is in the outer layer, the exposure by “set-off” or migration via the substrate should be checked. From the results of the regulatory evaluations, ink components may migrate into food unless there is a so-called “functional barrier.”
Records shall be provided by suppliers regarding declarations of compliance, traceable lot records, and test results to confirm migration limits and efficacy of functional barriers. Inks and coatings marketed as ‘eco-friendly’ must also maintain full traceability and regulatory justification.
For this reason, brands considering green packaging should revisit whether the adhesives/coatings used are covered under Parts 175/178 or are the subject of a documented food-contact submission. Without that, even sustainable materials have the potential to trigger regulatory risk.
Balancing Sustainability with Regulatory Compliance
Apart from the regulatory aspects, sustainability goals of high recycled content, compostability, minimal packaging, or mono-material formats also drive branding and environmental stewardship. These do need to be aligned with regulatory compliance for safe food/supplement/cosmetic contact, however. The most important elements in the FDA regulatory framework are the nature of the migrating components, potential consumer exposure, and safe level of exposure.
Practical decision-making framework:
1. Material and contact scenario: Food/ consumables come into contact under conditions of temperature, time, and product type.
2. Regulatory check: Does the material-or coating, ink, or adhesive-appear in the listing of 21 CFR parts 175–178 and 177; or is it covered under a Food Contact Notification or exemption under Threshold of Regulation?
3. Performance & barrier properties evaluation: Sustaina¬bility materials shall be able to provide equivalent barrier-moisture, oxygen, and light to standard materials. Materials/substrates shall also allow for durable print and legibility of required label elements.
4. Suppliers must provide documentation of recycled content where applicable, origin of material, process validation, compliance with ink/coating/adhesive requirements, and migration/extractables test records.
5. Trade-offs between performance and risk: A high-PCR-content film may well be sustainable, but if the barrier properties of the film drop and shelf life suffers, brand or regulatory risk then appears. Likewise, a compostable film must continue to meet migration safety and print durability.
6. Lifecycle and end-of-use considerations: Preference for sustainability programs such as recyclability or compostability. However, packaging shall protect the integrity of the product and meet the required label readability, and be auditable for regulatory compliance.
The integration of sustainability, regulatory justification, and functionality will make packaging both brand-forward and compliant at the same time.
Some Examples of Eco-Friendly Brands
Other strong case studies are brands that have done environmentally friendly packaging while still being compliant. Specific name-brand regulatory disclosure in the public domain is sparse; however, noted practices include:
One dietary supplement company that recently converted to PCR HDPE jars reported that the resin supplier provided a documented recycling process reviewed under the FDA’s recycled plastics guidance that allowed continued use in food-contact applications without compromising compliance.
The cosmetic brand transitioned to mono-material compostable tubes with compliant, food-contact-approved inner liners and adhesives/coatings according to 21 CFR 175/178. This hybrid design enables compostability on the outside while maintaining internal product protection along with regulatory clearances.
Lessons learned and best practices:
Early integration of the regulatory review avoids redesigns in later stages of package design.
Records of food contact compliance by material suppliers, ink/coating suppliers, and adhesive suppliers shall be audited and maintained, especially in cases of components involving recycled or bio-based materials.
Even green packaging should support label legibility, durability, and compliance. Brands that sacrifice any one of these invite misbranding or recall.
Pitfalls include assuming “eco” equals “safe” without validating barrier, migration, or print durability; or using compostable materials not yet cleared for primary food contact uses.
These examples have shown that sustainability and compliance are not in opposition to each other but complement one another: green packaging, if done right, strengthens brand positioning while ensuring regulatory readiness.
This would mean paying attention to inks, coatings, and adhesives under 21 CFR Parts 175-178, performing a balancing act among sustainability goals, FDA compliance, and performance criteria, and learning from brands that have already successfully deployed compliant and sustainable packaging systems. Strong documentation, supplier traceability, migration testing, and label integrity remain the key considerations for packaging safety in the US market.
Emerging Trends & Future Outlook
The US market is moving fast, with several regulatory and technological signals pointing to a future that will be more transparent, traceable, and chemically prudent. FDA activity related to the use of recycled resin, PFAS, microplastics, and digital traceability is evolving, and brands with custom packaging plans should track these developing trends.
Smart/Traceable Packaging, Recycled Resin Approvals, PFAS-Free Coatings, Microplastics & Regulatory Awareness
Digital traceability has increased via QR codes, batch tracking, and supply-chain transparency. Though the FDA does not require digital labels on foods and beverages at this time, that agency does say, “through a voluntary program, the FDA reviews recycling processes to ensure that the recycled material is suitable for use in food-contact applications.”
Recycled resins are reviewed on a case-by-case basis. This July 2021 guidance, “Use of Recycled Plastics in Food Packaging (Chemistry Considerations)” describes the expectation that recycled plastic will not allow contamination to migrate into food above safe levels.
PFASs have come under greater scrutiny. The FDA announced the market phase-out of certain grease-proofing substances containing PFAS in food contact paper and paperboard packaging. For example, it said that sales in the U.S. of these materials were no longer being made by February 2024. U.S. Food and Drug Administration Microplastics and the migration of lesser-known chemical constituents from packaging are emerging as concern areas, while the FDA has not yet issued blanket regulations; the continuing updates on PFAS testing by the agency signal a future of more detailed material scrutiny.
It also means innovation in customized packaging should be rooted in data-driven material health, migration testing, and documentation. Smart features on packaging, like QR codes, will be able to reinforce traceability. Material selection needs to look ahead at potentially strict future regulatory controls-such as PFAS and microplastics-rather than simply current ones.
What’s Coming from the FDA in the Sustainability Context
A spate of recent indicators suggests regulatory momentum:
FDA has issued multiple Constituent Updates related to PFAS in food and packaging. This portends active surveillance and, perhaps, rulemaking for the future.
The Recycled Plastics document and LNO process represent the approach of the agency to enable the use of circular economy materials, when safety can be demonstrated.
Industry commentary suggests that the FDA may consider additional actions in the future that would include PFAS, microplastics, added resin purity documentation, and possibly threshold migration limits.
In other words, packaging strategies for customization need to allow for flexibility in the materials and label formats, permit supplier traceability, and develop methods for periodic review of material science updates. Packaging that can be re-validated, updated, or replaced as regulatory standards evolve carries with it greater longevity and risk mitigation.
Conclusion
Material safety, sustainability, and regulatory alignment are three strong pillars on which, from a U.S. perspective, effective custom packaging can be based.
Material Safety: Materials in the package shall offer foods, dietary supplements, or cosmetics with safe contact, minimum migration, functional barrier integrity, and documented conformity from suppliers.
Sustainability: Priorities would be for recycled content, smart traceability, or eco-friendly formats. The effectiveness can only be at the right threshold limits w.r.t regulation while still preserving the protection of product integrity.
Comply with new FDA food-contact regulations, guidance on recycled plastics, PFAS, etc. Good artwork/label design ensures access to markets and your reputation.
This interplay is important for any brand wanting to create trust in the longer term. Packaging design is more than just good looks, and sustainability is more than a popular marketing catchphrase. Packages designed to perform both creatively and in compliance, helping to secure consumer confidence and regulatory readiness.
In this regard, customized packaging refers to a strategic investment that protects the integrity of one’s brand in the changing regulatory landscape and delivers on sustainability promises.
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