There is no such thing as a food-grade material in Union law. There is a material that has been manufactured, tested and documented so that it can be shown not to transfer its constituents into food in quantities that endanger human health, change the composition of the food unacceptably, or spoil its taste and smell. The phrase “food grade” is a shorthand for that documentary position, and a supplier who offers it as a property of the plastic rather than as a file you can inspect has told you nothing you can rely on at an audit.
This guide sets out what the file has to contain, who is supposed to produce each part of it, and where the responsibility sits when the packaging is bought in one country, filled in a second and sold in a third. It closes with the packaging and packaging waste regulation, which became applicable in August 2026 and moved a set of questions that used to be environmental into the same conformity assessment discipline as safety.
The four instruments that matter
Union food contact law is built in layers, and confusion usually comes from reading one layer as if it were the whole thing.
Regulation (EC) No 1935/2004 is the framework. It applies to every material and article intended to come into contact with food, whatever it is made of: plastic, paper, board, metal, glass, adhesive, printing ink, coating. It sets the general safety requirement described above, requires traceability at all stages, and requires that materials not yet in contact with food carry either the words “for food contact”, the glass-and-fork symbol, or wording specific to their use.
Commission Regulation (EU) No 10/2011 is the specific measure for plastics. It establishes a Union list of authorised substances, sets an overall migration limit and substance-level specific migration limits, prescribes testing with food simulants under defined time and temperature conditions, and requires a written declaration of compliance at every stage of production, processing and distribution up to but not including the retail stage. Its Article 15 and Annex IV are the operative text for that declaration.
Commission Regulation (EC) No 2023/2006 sets good manufacturing practice for food contact materials. It is short and it is the part most often missing from a supplier file. It requires a quality assurance system, quality control, and documentation appropriate to the process, and it carries specific rules for printing inks on the non-food-contact side of a material.
Regulation (EU) 2025/40, the packaging and packaging waste regulation, replaced Directive 94/62/EC and has applied generally since 12 August 2026. It is not a food safety instrument, but it now imposes a conformity assessment, an EU declaration of conformity and a technical documentation retention obligation on packaging in its own right, alongside the food contact file.
For paper and board there is no equivalent Union specific measure. Compliance is demonstrated against the framework regulation plus national measures in the Member State concerned, which is why a board supplier will typically hand you a declaration referencing a national recommendation rather than a Union list. That is not a deficiency in the supplier; it is the state of the law, and the contract has to name which reference you are accepting.
What a declaration of compliance has to say
The declaration of compliance is the document that carries the whole chain. For plastics, Annex IV to Regulation (EU) No 10/2011 sets out what it contains. A declaration that omits any of the following is not a declaration, whatever it is titled.
- The identity and address of the business operator issuing it, and of the operator that manufactured or imported the material.
- The identity of the material, article, or product from an intermediate stage, in terms specific enough to link it to a delivered lot.
- The date of the declaration.
- Confirmation that the material meets the relevant requirements of Regulation (EU) No 10/2011 and of Regulation (EC) No 1935/2004.
- Adequate information on the substances used for which restrictions apply, so that the downstream operator can comply with those restrictions in turn.
- Specifications on the use of the material: the food types it is intended for, the time and temperature of treatment and storage in contact with the food, and the ratio of food contact surface area to volume used to establish compliance.
- Where a functional barrier is used, confirmation that the material complies with the corresponding requirements.
The sixth and seventh items are the ones buyers skip and auditors find. A liner declared for contact with aqueous food at ambient temperature has not been declared for contact with a fatty product held at minus twenty-five degrees Celsius and then thawed in the bag. A declaration is conditional on a use, and if your use is outside the declared conditions the declaration does not cover you.
Primary packaging is where this bites hardest, because that is the layer in contact with the food. Secondary packaging and the transport layer still need to be traceable under the framework regulation, and any migration route through the primary layer has to be considered, but the specific plastics measure applies to what touches the product.
Migration, simulants and why the test conditions matter more than the result
Migration testing substitutes a food simulant for the real food, because real food is variable and cannot be analysed for unknown migrants at low levels. Regulation (EU) No 10/2011 assigns simulants to food categories and sets test times and temperatures intended to represent the worst foreseeable conditions of use.
Two consequences follow for a buyer.
First, a migration report is only meaningful next to the conditions it was run under. A test at forty degrees Celsius for ten days is the conventional representation of long-term ambient storage. It says nothing about a hot-fill process, and it over-represents a product held frozen for its entire life. The report has to be read as an answer to a specific question, and you have to check that the question matches what you do.
Second, the overall migration limit and the specific migration limits are set in the regulation, and this guide does not restate them as numbers. The consolidated text is the reference, it is amended regularly as substances are added to or restricted on the Union list, and a figure copied into a specification in 2023 is a liability by 2026. Cite the instrument, not the number.
Where the responsibility actually sits
The chain runs from resin producer to converter to packaging supplier to filler to brand owner, and each link passes a declaration downstream. Two positions cause most of the disputes.
The filler is responsible for using the material within its declared conditions and for holding the declarations for the materials it uses. A processor who buys a lined carton, fills it with a fatty product and freezes it has to be able to show a declaration that covers fatty food at that temperature.
The importer or brand owner placing the finished food on the Union market is responsible for the food, and in practice for being able to produce the food contact file on request. When you buy private label from a third-country plant, the declarations sit with that plant, and a framework contract that does not require them to be transferred with each pack format leaves you unable to answer a competent authority. Ask for them at qualification, not at the first inspection. The supplier approval file described in the agreed product specification is the natural place to keep them.
What Regulation (EU) 2025/40 changed
The packaging and packaging waste regulation is a market access instrument for the packaging itself, and it has applied generally since 12 August 2026. It matters to a food buyer in five concrete ways.
- Conformity assessment and documentation. Packaging placed on the Union market requires a conformity assessment, an EU declaration of conformity and technical documentation retained for a defined period. This sits alongside, not instead of, the food contact declaration.
- Substances of concern. The regulation restricts per- and polyfluorinated alkyl substances in food contact packaging above defined thresholds. Grease-resistant paper and board are the formats where this changes sourcing rather than paperwork.
- Empty space. Grouped, transport and e-commerce packaging is subject to an empty space limit. A carton specified two sizes above the product because it was what the line already ran is now a compliance question and not only a freight cost question.
- Recyclability. All packaging must be recyclable by 1 January 2030, assessed against recyclability performance grades, with packaging below the defined grade threshold not counted as recyclable. Multi-material laminates are the exposure here, which is the practical reason the film comparison in PE against PP against PA now has a regulatory dimension it did not have five years ago.
- Extended producer responsibility. Producer fees are modulated by recyclability performance, so the packaging decision has a recurring cost consequence rather than a one-off unit cost.
None of this replaces the food contact file. It adds a second file with a different owner, and on a private label programme the two are frequently held by different companies.
A practical qualification checklist
Ask for these at supplier qualification, per pack format rather than per supplier, and file them against the product specification rather than in a general folder.
- Declaration of compliance under Regulation (EU) No 10/2011 for every plastic component, with the declared conditions of use written out.
- Declaration against Regulation (EC) No 1935/2004 for non-plastic components, naming the national reference relied on for paper and board.
- A statement of good manufacturing practice under Regulation (EC) No 2023/2006, covering printing inks where the format is printed.
- Supporting migration test reports, with the simulant, time and temperature stated, and a check that these cover your actual process.
- The EU declaration of conformity under Regulation (EU) 2025/40, and confirmation of who the producer is for extended producer responsibility purposes in each market you sell into.
- A traceability statement that lets a delivered pallet be linked back to a converter lot, consistent with the traceability requirements that apply to the food itself.
Common failure modes
- Accepting a declaration addressed to the converter rather than to you, with no lot linkage.
- A declaration issued once at qualification and never refreshed, while the Union list and the specification both moved.
- Declared conditions narrower than actual use: ambient rather than frozen, aqueous rather than fatty, short contact rather than twenty-four month shelf life.
- Printing ink treated as outside scope because it is on the reverse. It is inside scope, and the set-off route onto the food contact face is the reason.
- Transport packaging treated as out of scope entirely. It is in scope of the framework regulation for traceability and now in scope of the packaging regulation for empty space and recyclability.
- No named owner for the packaging regulation obligations on a private label line, where the filler, the brand owner and the importer can each reasonably think it is one of the others.
Vorezan does not manufacture packaging, does not issue declarations of compliance and does not act as an authorised representative for conformity assessment purposes. Where a packaging decision has legal consequences, the declarations should be obtained from the converter and reviewed against the consolidated text of the instruments in force at the time of placing on the market.
