Packaging and compliance
Food-contact material rules, by market
A carton, a tray, a liner, or a printed pouch touches the product for the whole time it sits in it, and every jurisdiction that regulates food safety extends that regulation to the packaging. The rules differ by market in their specifics, but the architecture is consistent enough that understanding it once means you can ask the right questions of any supplier, in any country, without needing to memorize a different rulebook for each destination. This guide covers that architecture: the core safety principle, how migration and positive lists work, who has to issue what document, the details that trip up recycled content and printed packaging, and what actually happens when the paperwork is missing.
Key facts
- Almost every food-contact regime rests on the same principle: a material must not transfer constituents into food in quantities that endanger health or change the food's taste, smell, or composition. Everything else, migration testing, positive lists, declarations, is machinery built to prove that principle is met.
- A declaration of compliance is issued by the material or article manufacturer, not the packer and not the exporter, and it must name the specific food type, temperature, and duration of contact it was tested against. A declaration with none of that detail is not evidence of anything.
- Recycled content, inks, adhesives, and coatings sit outside the base polymer's approval and each carries its own scrutiny, a recycled-PET tray can fail even when virgin PET of the same specification would pass.
- Absent documentation is a paperwork failure, not usually a safety failure, but it is treated as one at the border: shipments get held, sampled, or rejected on missing declarations regardless of whether the material itself would have passed testing.
The one principle every regime shares
Strip away the country-specific detail and food-contact regulation everywhere rests on a single test: a material or article must not transfer its constituents into the food it touches in quantities that could endanger human health, or in quantities that bring about an unacceptable change in the food's composition, taste, or smell. Regulators in the European Union, the United States, the United Kingdom, China, and most other major markets frame the obligation in almost identical terms, even where the enforcement mechanics differ.
That framing tells you what the downstream requirements are actually for. Migration limits give the health-endangerment half of the principle a measurable number. Positive lists pre-clear the substances allowed to be present, so a supplier is not left proving safety from scratch on every raw material. Declarations of compliance let everyone downstream, converter, packer, exporter, importer, rely on someone else's testing rather than repeating it. None of these are independent hoops. They are the same principle, worked three different ways.
The practical consequence for a packhouse or exporter: when a document or a test result looks unfamiliar, ask what part of the core principle it demonstrates. A migration result shows the quantity transferred. A positive-list citation shows the substance was pre-approved for that use. A declaration shows someone with direct knowledge of the material is willing to put their name behind both. A document that does none of those three things is not doing useful work.
Migration limits and how testing actually works
Migration is the transfer of a substance from packaging into food, and it is measured, not estimated. A lab exposes a sample of the packaging material to a food simulant, a liquid chosen to mimic the food's chemical behavior (fatty foods, aqueous foods, and acidic foods are typically simulated differently), for a set time at a set temperature that mimics the product's real shelf life and handling. The lab then measures how much of a given substance moved from the material into the simulant, expressed per unit of food-contact surface area or per kilogram of food.
Two kinds of limits usually apply. An overall migration limit caps the total mass of all substances that can transfer, a blunt check on whether the material behaves as a stable barrier at all. Specific migration limits cap individual substances, set well below the level associated with any health effect, with a safety margin built in. A material can pass the overall limit and still fail on one specific substance if that substance's own cap is tighter than its share of the overall budget.
This matters operationally because migration limits are tested against a specific food type and specific time-and-temperature conditions, not against packaging in the abstract. A tray cleared for chilled, low-fat produce over a two-week contact period is not automatically cleared for a hot-filled, high-fat sauce held for six months, even on the exact same polymer from the exact same supplier. If your product's fill temperature, fat content, or shelf time differ meaningfully from what the supplier tested against, ask directly whether the existing test covers your use case or a new one is needed. This is the single most common gap between a supplier's paperwork and a buyer's actual risk.
Positive lists: what they clear, and what they do not
A positive list is a regulator's inventory of substances authorized for use in food-contact materials, typically covering monomers, additives, and processing aids used to make plastics, along with any conditions attached to each entry, a maximum quantity, a restriction to certain food types, or a requirement that it only be used in specific layers of a multilayer material. If a substance is not on the applicable list, or is used outside the conditions attached to its listing, the material is non-compliant regardless of migration test results.
Positive lists exist primarily for plastics because plastics are chemically the most variable category, built from a wide menu of monomers and additives that a regulator can pre-screen. Other materials, paper and board, metal, glass, ceramics, are typically regulated more through general safety and good-manufacturing-practice requirements than through an exhaustive substance list, though coatings and printing applied to those materials often fall back under plastics-style substance controls because the coating or ink itself is a plastic or resin system.
A worked example makes this concrete. Suppose a converter proposes a new barrier layer for a produce liner using an additive that improves oxygen resistance. The additive might migrate at levels well inside any specific migration limit if tested, and still be non-compliant on day one if it simply is not on the relevant positive list yet, because the material was reformulated after the supplier's last authorization review. This is why a declaration of compliance that only cites a migration test, with no reference to positive-list status of the material's full substance set, is incomplete. Ask suppliers whether every intentionally added substance in the formulation, not just the base polymer, is cleared for the specific food category and contact conditions you need.
Declarations of compliance: who issues them and what they must say
A declaration of compliance is issued by the manufacturer of the food-contact material or article, the party with direct knowledge of the formulation, not by a distributor, not by the converter who merely printed or laminated it, and not by the packer using it. In a multi-stage supply chain, each stage that changes the material meaningfully, adding a coating, laminating layers, printing, should issue its own declaration covering what it added, referencing the declarations it received from its own upstream suppliers. A single declaration passed down unchanged through three converters, none of whom did anything to it, is a red flag that no one along the chain actually verified the material still complies after each transformation.
A usable declaration states, at minimum: the specific material or article it covers, by product code or specification, not a generic description; the food types and food categories it has been assessed as suitable for, fatty, aqueous, alcoholic, dry; the time and temperature conditions of use it was assessed against; any restrictions or specific migration limits that apply and confirmation the material meets them; and the identity of the party issuing it, with a signature or authorized approval, dated within a reasonable period and tied to a specific formulation version. A declaration missing the food-type and conditions-of-use fields is functionally a marketing letter, not a compliance document, because it gives the reader nothing to check the material's suitability against their actual use case.
Ask for the declaration before finalizing a packaging order, not after goods have shipped. Suppliers routinely have the document on file, and a request at the quoting stage costs nothing; a request after the container has left port, when a customs officer or a buyer's quality team asks for it, costs days and sometimes the shipment.
Recycled content: why it draws extra scrutiny
Recycled material carries a contamination history a virgin material does not: the prior life of the plastic, what it held, how it was collected, and what cleaning and decontamination process converted it back into food-grade resin, all affect whether unknown or unintended substances could be present at levels a standard migration test on virgin material would never encounter. Regulators generally respond by requiring the decontamination process itself to be separately assessed and, in most regimes, formally authorized, on top of ordinary migration testing on the finished material.
The practical result: a recycled-content tray or liner is not simply a variant of the equivalent virgin-material product with a lower price and a sustainability claim attached. It typically needs its own supporting file: evidence of the recycling process used, evidence of the feedstock's origin, and a declaration that addresses the recycled content specifically rather than treating the finished article as generically equivalent to virgin resin. A supplier who cannot produce that file, only a general declaration for the polymer type, has not actually demonstrated the recycled-content product is compliant, whatever the marketing material claims.
For a packhouse weighing a move to recycled packaging on sustainability grounds, build in lead time for this. The extra documentation and, in some cases, extra approval steps for the recycling process are not a formality, they are frequently the longest step in qualifying a new recycled-content supplier, longer than sourcing or price negotiation.
Inks, adhesives, and why the outside of the carton matters
Printing and adhesives sit on the non-food-contact side of most packaging, the outer surface of a carton, the label on a jar, the print on the outside of a flexible pouch, and it is easy to assume that side is unregulated because it never touches the product. It is not unregulated. Ink components and adhesive components can migrate through the substrate itself, from the outer print layer through cardboard or a thin film to the inner food-contact surface, a pathway usually called set-off or through-migration, and regulators treat that pathway as a real migration route requiring its own controls, particularly for inks containing photoinitiators or solvents.
This is a common gap in practice: a converter sources food-grade board or film and gets full documentation for it, then applies printing or lamination using a standard commercial ink or adhesive that was never assessed for food-contact suitability at all, on the assumption that surface printing is cosmetic and out of scope. The finished carton can fail even though the base substrate was fully compliant, because the print layer is now part of the finished article and its migration behavior has never been characterized.
When qualifying a new carton, pouch, or labeled container supplier, ask specifically whether the inks and adhesives used are food-contact-suitable and whether the finished, printed article, not just the raw substrate, has been assessed or tested. A declaration covering only the unprinted board is not a declaration covering the product you are actually going to fill.
What happens at the border without documentation
Missing food-contact documentation is overwhelmingly a paperwork failure rather than evidence the material is actually unsafe, but customs and import food-safety authorities generally cannot distinguish the two at the point of inspection, and their default response treats an undocumented material as unverified rather than presumed safe. The practical consequences scale with how the shipment is flagged: a hold pending document submission, a request for sampling and laboratory testing at the importer's cost and on the importer's timeline, or, in the more disruptive case, outright rejection or destruction of the shipment if documentation cannot be produced within the window the authority allows.
Consider a realistic scenario. A packhouse ships chilled produce in trays sourced from a new supplier, and the export paperwork includes commercial invoices and phytosanitary certificates but no declaration of compliance for the tray material, because nobody on the export side thought to request one before the order shipped. At the destination port, an inspector doing a routine documentary check on the packaging flags the absence. The product itself is almost certainly fine, the tray was made from an ordinary, widely used food-grade polymer, but the shipment sits in a hold queue while the importer scrambles to get an emergency declaration issued by the tray manufacturer, and for chilled produce with days of shelf life, that delay can cost more than the shipment is worth even if it eventually clears.
The fix is procedural, not technical: treat the food-contact declaration as a standing part of the packaging supplier qualification file, requested and reviewed before the first order, refreshed whenever the material formulation changes, and attached to the shipping documentation as a matter of course rather than produced reactively when a border asks for it.
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