1. Introduction
Food contact articles (FCAs) can be produced from a wide range of materials, including plastics, paperboard, glass, metals, and ceramics. The choice depends on the intended function necessitating certain physical properties, such as elasticity, with options spanning from rigid (for example bottles, cans, jars, and trays) to semi-rigid items (like closures and boxes) and fully flexible formats (such as wraps, bags, and squeezable tubes). Some materials, like ceramics, have been around for thousands of years, while others, like plastics, have been around for less than 100 years.
With ever-increasing technical needs to balance consumer lifestyles, trends, regulations, sustainability and safety concerns, as well as to enable marketing, there has been an explosion of interest and investment in new food contact materials (FCMs) in recent years. What evidence-based considerations should be taken into account when developing and using these “novel” materials?
2. What is novel?
In practice, “novel” means any FCM that uses new chemistries, structures, or manufacturing technologies not already covered by specific authorizations, positive lists, or long-standing practices.
The term novel is not a standalone legal category in the EU, US, or elsewhere. Instead, it is a useful label for FCMs for which existing rules/assessments do not clearly apply.
Novel FCMs could involve one (or more) of the following:
- New chemistries or structures (e.g., bio-based polymers made from seaweed or other non-standard sources, nanostructured coatings).
- New functions such as active (e.g., oxygen/moisture scavengers, antimicrobial layers) or intelligent (e.g., time-temperature indicators, freshness sensors) packaging.
- New sources or processes, notably post-consumer recyclate (PCR) and novel recycling technologies.
3. What regulations cover novel materials?
Across jurisdictions, the core requirement is that FCMs must not transfer constituents (i.e., chemicals and in some places particles) to food in quantities that could endanger health or change composition or organoleptic properties (i.e., taste, texture, etc.).
In the EU, this sits in the Framework Regulation (EC) 1935/2004 and the GMP Regulation (EC) 2023/2006; plastics, including potentially novel polymers that are bio-based, biodegradable, and/or compostable, have extra rules laid out in (EU) 10/2011. Recycled plastics are covered under (EU) 2022/1616, and the European Food Safety Authority’s (EFSA’s) 2024 guidance explains how mechanical PET recycling processes are assessed. Active/intelligent materials fall under Regulation (EC) 450/2009. The European Commission’s FCM legislation hub is the best single place to review these texts.
In the US, most novel substances go through the Food and Drug Administration’s (FDA’s) Food Contact Notification (FCN) program.[1] The FDA also maintains a public inventory of effective FCNs, which is useful for benchmarking whether a substance/use is already cleared.[2]
Other countries also have baseline FCM regulations applying to all materials that contact food during manufacture, transport, and sale. These include China (GB 4806.10-2016), Japan (Food Sanitation Act), Indonesia (FCM Regulation), India (Food Safety & Standards (Packaging) Regulations 2018), MERCOSUR (GMC Resolution No. 03/92), and others. The difficulty is that regulations between jurisdictions often do not completely align, which can make developing and marketing a novel material difficult.
What about edible packaging?
If a piece of packaging is edible (e.g., an edible sausage casing or a seaweed-based edible sachet), it is no longer an FCM according to EU regulations, but rather it is a food and must adhere to separate food safety regulations. The EU FCM Regulation explicitly excludes “covering or coating materials … which form part of the food and may be consumed together with this food” (Art. 2(3)(b) and recital 9).[3] The US is a little different since food additives and food contact substances are regulated together. The FDA treats food contact chemicals (FCCs, which it calls food contact substances) as a subset of “food additives” under the same standard.[4]
4. Chemical safety
The existing regulations outlined in the previous sections do consider the chemical constituents of FCMs, but they do not provide comprehensive guidance. Considering the available scientific evidence, there are some general guidelines that can be useful to consider for all FCMs.
Inertness and chemical complexity
Polymer- and paper-based FCAs are by default chemically complex, potentially containing many different substances that can transfer from the packaging or container into the food they carry, contact, or cook. However, the extent of the chemical migration into food is dependent on the structural composition of the material, contact time, temperature, food type, and the amount of contact between the article and the food. Containers made of stainless steel, glass, and glazed ceramic release far fewer chemicals into food when they are used under the same conditions. These are examples of highly “inert” materials, meaning that they hardly interact chemically with the foods they are brought into contact with. Inert materials are often also the most suitable for recycling and reuse.
The EU currently sets an overall migration limit of 60 ppm for plastic FCMs in Regulation EU 10/2011, however this limit cannot be considered as a suitable threshold for defining material inertness, as it does not sufficiently take health aspects into consideration. Some substances, such as certain endocrine disrupting chemicals, are known to cause health effects in much smaller doses than 60 ppm.
Known chemicals of concern and NIAS
At present, FCM regulatory assessments focus on one chemical at a time, particularly cancer-causing chemicals that are genotoxic (i.e., damage DNA). In addition to making this a slow process, the focus of the assessments are primarily on the substances intentionally used in manufacturing, which overlook non-intentionally added substances (NIAS) that emerge during production (such as contaminants, reaction byproducts, and degradation products). As a result, many chemicals in food packaging and cookware remain untested, especially NIAS, even though these chemicals are relevant for human exposure.
Additionally, cumulative exposure matters. The European Food Safety Authority’s (EFSA) 2023 re-evaluation of bisphenol A (BPA, CAS 80-05-7) dramatically lowered the tolerable daily intake, illustrating how new hazard and exposure evidence can reset safety margins and trigger product reformulations.
To better address this in regulations, there are proposals to assess the whole cocktail of chemicals that migrate from finished FCAs and test their effects with respect to multiple growing health concerns including cardiovascular disease and metabolic disorders (FPF reported).
The recently developed Food Contact Chemical Priority (FCCprio) List systematically identifies and prioritizes known food contact substances based on an internationally recognized framework of hazard properties (GHS) and using publicly available governmental harmonized hazard evaluations (FPF reported). It subsequently ranks them based on their exposure potential. In total, the list contains 1,222 FCCs identified as hazardous, which are further ranked based on their relevance for human exposure from FCMs. To be on the list, a chemical must have been found to have at least one human health hazard of concern: persistence, bioaccumulation, mobility, carcinogenicity, mutagenicity, reproductive toxicity, specific-target-organ toxicity after repeated exposure, or endocrine disruption.
In practice
Producers and consumers can reduce chemical migration from FCMs into food by understanding the key principles behind it. Using highly inert materials (such as stainless steel, glass, and glazed ceramics) significantly reduces the migration of chemicals into food. Whenever materials are non-inert (such as plastics, paper, and coatings), consider these common drivers of chemical migration:
1) Chemical migration increases at higher temperatures. Heat (and microwave) foods in suitable, inert containers.
2) In general, migration levels increase over time. Migration can be limited by shortening the storage time of food.
3) Avoid small portion sizes. Small packaging formats have a high surface-to-volume ratio, enabling higher migration levels.
4) Many chemicals migrate at higher levels in fatty and/or acidic foods than in aqueous foods. Prefer inert containers especially for fatty and hot foods.
5. A practical pathway for innovators and investors
For innovators and investors working in the novel FCM space, below are a few key questions you can ask yourselves and your teams when developing new products:
- Where is your market? Have you reviewed the regulations?
- EU: Is your material covered by a specific measure? In the absence of material-specific regulations, Article 3 of the FCM Framework Regulation applies ((EC) 1935/2004): “materials and articles, […], shall be manufactured […] so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health.”
- US: Check whether your use is already cleared in FDA’s FCN inventory; otherwise plan an FCN.
- Are there new regulations underway in your market?
PFAS, BPA-analogs, and ortho-phthalates are under scrutiny in many jurisdictions and can become rapidly moving targets. Choose chemistries with low regrettable substitution risk and good disclosure upstream.[5] - Are you avoiding regrettable substitution?
When developing a novel FCA that is specifically designed to be free of a certain chemical (e.g., BPA, PFAS), make sure that the alternative has been sufficiently tested to be safe. - What are all the ways your product may be used?
Specify realistic use conditions (i.e., food types, temperatures, durations) and choose migration test food simulants accordingly. Validate barrier performance and decontamination (for post-consumer recycled materials) with conservative assumptions.[6] - Do you have a NIAS strategy?
Plan non-targeted screening, structure elucidation/prioritization, and exposure/risk assessment tiers. Include adhesives/inks/primers. Leverage recognized guidance to streamline acceptance. The European Printing Inks Association, for example, has a guidance on NIAS.[7] - Is it safe and sustainable?
PPWR-driven design choices (i.e., reuse, mono-materials, labeling) must still pass FCM safety rules. [8] Don’t assume “bio-based” or “compostable” equals safe or low chemical migration. - Are you using the correct terms?
When labeling a material, it is key to use the right term to avoid confusion amongst consumers and the foodservice industry. See definitions below. - How complex is your material?
Many novel materials are marketed as “plastic free” or “100% natural.” However, this does not necessarily mean that no potentially harmful constituents migrate into the food, such as additives, NIAS, or in the case of bio-based materials, even pesticides [9] - Are you focusing on the right chemicals?
The Food Packaging Forum’s Food Contact Chemicals Priority (FCCprio) List highlights food contact chemicals to phase out and avoid based on their hazard properties and exposure potential, divided into four tiers. Focus on tier 1 chemicals first when screening your supply chain and carrying out testing. - Sustainability is more than CO2
While greenhouse gas emissions are a key point to consider when establishing a product’s sustainability across its entire lifecycle, it is not the only metric. Water use, sourcing, plastic pollution, recoverability, and chemicals of concern are all important as well.[10][11] Product and market specifications can be entered into the Understanding Packaging (UP) Scorecard to compare materials across these metrics. This online tool is entirely free, and the methodology is transparent.
6. Useful Definitions
The terms below reflect where the market is moving. These labels can signal different technical and regulatory expectations, and misuse creates confusion throughout the value chain. Clear, shared definitions can help innovators make accurate claims, select the right tests and certifications, and ensure new materials deliver both safety and sustainability.
Active and Intelligent
EU — active materials are “intended to extend shelf-life or to maintain or improve the condition of packaged food,” designed to release or absorb substances into/from the food or its headspace (Regulation (EC) 450/2009, Art. 3(a)). While Intelligent materials monitor the condition of the packaged food or its environment (e.g., time–temperature indicators) (Regulation (EC) 450/2009, Art. 3(b)).[12]
US — The FDA does not formally define active or intelligent packaging. Instead, it regulates food contact substances as those not intended to have a technical effect in food; if a packaging component does have a technical effect on food (e.g., releases an antimicrobial), FDA treats it as a food additive in the food, and it requires the appropriate authorization (often via a Food Contact Notification or the food additive regulation).[13]
Biodegradable
“Biodegradable” is a term to describe materials breaking down into their component parts. Biodegradation is typically defined as ≥90% conversion to CO₂ within a set period under controlled conditions (e.g., harmonized standard EN 13432 requires ≥90% within 6 months).[14]
EU — No FCM-specific definition of biodegradable or biodegradation. The European Commission’s 2022 policy framework explains that materials labeled “biodegradable plastics” only biodegrade under specified conditions (environment, time, temperature) and warns against vague claims.[15]
US — According to the Federal Trade Commission (FTC) Green Guides, a “biodegradable/degradable” claim requires competent evidence the entire article completely breaks down and returns to nature within a reasonably short time after customary disposal; for items entering the solid-waste stream, within one year.[16]
Compostable
A subset of biodegradable materials are compostables. The compostable label adds requirements for speed of degradation, conditions, disintegration, and non-toxicity in composting systems. “Whereas biodegradable plastic may be engineered to biodegrade in soil or water, compostable plastic refers to biodegradation into soil conditioning material (i.e., compost) under a certain set of conditions.”[17]
Compostable: Industrially compostable
EU — Defined by harmonized standards, especially EN 13432 (packaging) and EN 14995 (plastics).[18] Key elements include:
- Biodegradation ≥90% CO₂ in ≤6 months;
- Disintegration (≤10% residue >2 mm after 12 weeks);
- No ecotoxicity / heavy metals limits.
US — Market claims usually rely on the American Society for Testing and Materials (ASTM) standard D6400 (plastics) and ASTM D6868 (coated/fiber items) for labeling “compostable in municipal/industrial facilities.”
Australia — AS 4736 is similar to Europe’s EN 13432, with the addition of a worm test that verifies there is “no toxic effect of the resulting compost on plants and earthworms.”[19]
International — ISO 17088:2021 sets requirements for plastics suitable for organic recycling (industrial composting).
Compostable: Home compostable
EU — There is a dedicated standard, EN 17427:2022, but only for carrier bags. It sets requirements for biodegradation/disintegration under well-managed home composting, plus compost quality and hazardous substances controls. (Other product types still rely on national schemes like NF T 51-800 in France or privately developed standards.)
US — There is no national standard for home composting.[20] Claims must follow FTC guidance (i.e., be truthful and substantiated for home compost conditions). In 2025, the Biodegradable Products Institute (BPI) introduced a voluntary “home compostable” certification that is used in the US but has no regulatory standing.
Australia — AS 5810 covers home compostability for plastics.[21]
International — Many products worldwide use TÜV Austria’s “OK compost HOME,” which was the basis for development of the EU and Australian standards.[22]
Inert
There is no formal definition of inert in the EU or US. While most food contact materials on the market have overall migration levels well below the current EU 60 ppm threshold, there is a lack of robust analytical approaches with low enough detection limits that are suitable for routine measurements and enforcement. Considering the known health impacts that occur from some chemicals at even lower levels, the current overall migration limit of 60 ppm specified for plastic FCMs in EU 10/2011 cannot be considered as a suitable threshold for inertness. Therefore, new approaches are needed for both defining and measuring inertness that are sufficiently protective of human health.
Nanomaterials/ nanocomposites
EU — a material is considered a nanomaterial when ≥50% of the constituent particles (by number-based size distribution) have one or more external dimensions in the range 1–100 nm (with detailed qualifiers on particles/aggregates/agglomerates). Notably, this definition excludes large solid products with only internal or surface nanoscale structure, listing nanocomposite materials as an example of what the definition itself does not cover—though such products may still use nanomaterials.[23]
Risk assessments for FCMs that use nanoscale substances can follow EFSA’s 2021 guidance (characterization, migration, and nanospecific testing where relevant).[24]
US — FDA has guidance but no regulatory definition. FDA asks whether a product “involves the application of nanotechnology.” Two screening points apply to determine this: (1) any dimension ~1–100 nm, or (2) properties/phenomena attributable to dimension(s) (sometimes up to 1,000 nm) that could affect safety, effectiveness, or regulatory status.[25]
7. Conclusion
Many novel food-contact materials promise real gains in performance and sustainability, but they do not get an automatic pass on their chemical safety: wherever you market them, they should avoid harmful chemical migration, work under real-world use conditions, and be supported by transparent chemistry and testing. Because “novel” is not a legal category, innovators can anchor plans in the existing frameworks (EU 1935/2004 + GMP and specific measures; US FDA’s FCN pathway), then layer on NIAS strategies, end-of-life clarity (recyclable vs. industrially/home-compostable), and evidence-based claims that will not mislead users. To avoid regrettable substitutions, prioritize inherently safer chemistries, assess realistic use scenarios (time, temperature, food type), and benchmark against evolving lists of substances of concern such as the FCCprio List. Finally, design for both safety and sustainability—beyond CO₂ emissions alone—so that the material or product can scale across jurisdictions without surprises later for regulators, customers, or investors.
8. Useful resources
Food Packaging Forum. (n.d.). “A crash course in food contact materials and health.”
Understanding Packaging Scorecard. (June 2025). “Webinar: Safe & Sustainable? Understanding the Biobased and Compostable Alternatives to Plastics in Food Packaging.”
Food Packaging Forum (2025). “Food Contact Chemicals Priority (FCCprio) List.”
Food Packaging Forum. (March 2022). “Bioplastics Fact Sheet.” (pdf).
Food Packaging Forum. (n.d.). “Food packaging materials and recycling fact sheets.”
Lacourt, C., et al. (2024). “Recent and emerging food packaging alternatives: Chemical safety risks, current regulations, and analytical challenges.” Comprehensive Reviews in Food Science and Food Safety. DOI: 10.1111/1541-4337.70059
9. References
[1] Keller & Heckman. (n.d.). “A Brief Tutorial on the U.S. Food Contact Notification System.”
[2] US Food and Drug Administration. (n.d.). “Inventory of Effective Food Contact Substance (FCS) Notifications.” [Accessed October 14, 2025].
[3] European Parliament and European Council. (2004). “Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food…” EUR-Lex. [Accessed October 19, 2025].
[4] US Food and Drug Administration. (May 8, 2025). “Understanding How the FDA Regulates Substances that Come into Contact with Food.”
[5] https://echa.europa.eu/es/-/echa-publishes-updated-pfas-restriction-proposal
[6] https://www.efsa.europa.eu/en/efsajournal/pub/8879
[7] European Printing Inks Association. (May 11, 2025). “EuPIA Guidance for Risk Assessment of Non-Intentionally Added Substances (NIAS) and Non-Evaluated or Non-Listed Substances (NLS) in printing inks for food contact Materials.” (pdf). [Accessed October 4, 2025].
[8] https://www.consilium.europa.eu/en/press/press-releases/2024/12/16/sustainable-packaging-council-signs-off-on-new-rules-for-less-waste-and-more-re-use-in-the-eu/
[9] European Consumer Organization (BEUC). (May 27, 2021). “Towards Safe and Sustainable Food Packaging: European consumer organisations call for action on single-use tableware made of alternatives to plastic.” (pdf). [Accessed October 19, 2025].
[10] World Business Council for Sustainable Development. (2022). “SPHERE: the packaging sustainability framework.” [Accessed October 19, 2025].
[11] Understanding Packaging (UP) Scorecard. (n.d.) “Methodology.” [Accessed October 19, 2025].
[12] European Commission. (May 2009). “Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food.” EUR-Lex.
[13] US Food and Drug Administration. (September 25, 2025). “Title 21.” Code of Federal Regulations, National Archive. [Accessed October 19, 2025].
[14] European Bioplastics. (April 2015). “EN 13432 Certified bioplastics: Performance in industrial composting.” (pdf).
[15] European Commission. (November 2022). “Biobased, biodegradable and compostable plastics.” [Accessed October 4, 2025].
[16] US Federal Trade Commission. (2012). “Part 260- Guides for the use of environmental marketing claims.” (pdf). [Accessed October 5, 2025].
[17] US Environmental Protection Agency. (November 21, 2024). “Frequently asked questions about plastic recycling and composting.” [Accessed October 5, 2025].
[18] European Bioplastics. (n.d.). “Harmonised standards for bioplastics.” [Accessed October 5, 2025].
[19] Because We Care. (n.d.). “Australian Standard AS4736-2006.” [Accessed October 5, 2025].
[20] US Environmental Protection Agency. (November 21, 2024). “Frequently asked questions about plastic recycling and composting.” [Accessed October 5, 2025].
[21] AdventPac. (n.d.). “Australian Compostability Standards: AS4736 & AS5810.” [Accessed October 5, 2025].
[22] TUV Austria. (n.d.). “TÜV AUSTRIA Certification Scheme: OK compost HOME.” [Accessed October 5, 2025].
[23] European Commission. (2022). “Commission recommendation of 10 June 2022 on the definition of nanomaterial.” Eur-Lex.
[24] European Food Safety Authority. (June 30, 2021). “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.”
[25] US Food and Drug Administration. (June 2014). “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.”
