Declaration of compliance for food contact materials

Who owes the declaration, and to whom

The framework rule is short. Article 16(1) of Regulation (EC) No 1935/2004 requires materials and articles covered by a specific measure to be accompanied by a written declaration stating that they comply with the rules applicable to them, with appropriate documentation available to demonstrate that compliance and produced to the competent authorities on demand. The duty therefore exists only where a specific measure exists — and as the European Parliament research service restated in a March 2026 briefing, only four material types are fully harmonised at EU level: plastics, ceramics, regenerated cellulose film, and active and intelligent materials. Everything else runs on national law.

For plastics the specific measure is Regulation (EU) No 10/2011. Article 15(1) requires that, at the marketing stages other than at the retail stage, a written declaration under Article 16 of Regulation (EC) No 1935/2004 is available for plastic materials and articles, for products from intermediate stages of their manufacturing, and for the substances intended for manufacturing them. That defines the direction of travel: the declaration moves from supplier to business customer at every link — resin producer to compounder, compounder to converter, converter to packer, packer to brand owner, brand owner to distributor — and it stops at retail. A shop does not hand a declaration to a consumer, and a consumer cannot demand one.

That stop-at-retail rule is where online sellers misread their position. If you import trays, bottles, kitchenware or lidding film and sell them on, you are not the retail stage relative to your own supplier: you are the recipient of a declaration you must hold, and the issuer of one to any business you sell to. Importing also makes you the operator that placed the goods on the EU market, so the supporting documentation behind that declaration is what an inspector asks you for. Holding a PDF signed in Shenzhen is not the same as holding the evidence it rests on.

Article 15(3) adds the maintenance duty everyone forgets: the declaration shall be renewed when substantial changes in the composition or production occur that bring about changes in the migration, or when new scientific data becomes available. A declaration is a living document tied to a formulation and a process, not a one-off document tied to a company.

Annex IV, field by field

Annex IV of Regulation (EU) No 10/2011 fixes what the written declaration for plastics must contain. It is nine blocks, and a declaration that skips any of them is incomplete on its face. The table below is the working checklist; the paragraphs after it explain the three blocks that carry the real content.

Point 6 separates a real declaration from a template. It requires adequate information on the substances used, and their degradation products, for which restrictions or specifications are set out in Annexes I and II, so that downstream operators can stay inside those restrictions. In practice that means naming the restricted substances actually present and giving numbers: the specific migration limit that applies, and the migration you measured or modelled. Annex I fixes SMLs substance by substance; where none is set, Article 11(2) applies a generic specific migration limit of 60 mg/kg. Annex II carries the across-the-board restrictions, including the primary aromatic amines rule as amended by Regulation (EU) 2020/1245: PAAs listed in entry 43 of Appendix 8 to Annex XVII of REACH must not be detectable at a limit of detection of 0.002 mg/kg food or simulant each, and the sum of the remaining PAAs must not exceed 0.01 mg/kg (checked 2026-08).

Point 7 covers dual-use additives — substances authorised both as plastic additives and as food additives or flavourings. Article 11(3) requires that they not migrate in quantities having a technical effect in the final food, and not exceed the restrictions in Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008 or Annex I. Your declaration therefore has to give the downstream user a migration figure, because only the food business operator can total it against the food-additive limit for that food. Dual-use additives listed without numbers make a declaration unusable, and it is a routine audit finding.

Point 8 is the use envelope, and it is the field most often silently wrong. It requires specifications on the use of the material or article: the type or types of food it is intended to contact, 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. That is what gives a declaration edges. A tub declared for aqueous foods at 40C for 10 days does not cover a fatty sauce hot-filled at 85C, and used that way the declaration no longer covers your product. Point 9 handles multi-layer materials with a functional barrier, requiring confirmation of compliance with Article 13(2), (3) and (4) or Article 14(2) and (3) — the regime that lets non-authorised substances sit behind a barrier only if their migration is not detectable at 0.01 mg/kg and they are not mutagenic, carcinogenic, toxic to reproduction, or in nanoform.

The supporting documentation nobody sends you

Article 16 of Regulation (EU) No 10/2011 requires the business operator to make appropriate documentation available to the competent authorities on request, and that documentation shall contain the conditions and results of testing, calculations including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance. Since 1 January 2016 it has had to rest on the regulation's own migration testing rules, not on legacy methods. The dossier is deliberately not sent down the chain: it stays with the operator that issued the declaration. That is legitimate, and it is also the gap non-EU supply chains exploit, because a declaration with no retrievable dossier behind it looks identical to one with a full dossier behind it.

That evidence set has four parts. Overall migration: Article 12 caps the transfer of total constituents at 10 mg per dm2 of food contact surface, with a derogation to 60 mg per kg for materials intended for food for infants and young children. Specific migration: substance by substance against Annex I, or the generic 60 mg/kg where Annex I is silent, tested or modelled under the simulants, times and temperatures of Annexes III and V matching the declared use. Non-intentionally added substances — impurities, reaction and degradation products — which Article 19 requires to be assessed under internationally recognised scientific principles even though they are on no list. And good manufacturing practice under Regulation (EC) No 2023/2006, which is what makes the numbers reproducible.

You cannot audit that dossier from your desk, but three questions expose an empty one fast. Which laboratory produced the migration data, and what is the report reference? Which simulant, time and temperature were used, and do they match the conditions you actually apply? When was the declaration last reissued, and against which formulation change? A supplier holding real evidence answers all three in a day; a supplier holding a template answers none.

The special case: polyamide and melamine kitchenware from China and Hong Kong

If your product is polyamide or melamine plastic kitchenware — nylon spatulas, tongs and ladles, melamine plates, bowls, mugs, children's tableware — originating in or consigned from the People's Republic of China or the Hong Kong Special Administrative Region, an Annex IV declaration is not enough. Commission Regulation (EU) No 284/2011 stacks import conditions on top of it, and they bite per consignment, not per product.

For every consignment the importer submits the declaration set out in the Annex to that regulation, accompanied by a laboratory report showing that the polyamide kitchenware releases no primary aromatic amines in a detectable quantity and that the melamine kitchenware releases no more than 15 mg/kg of formaldehyde into food or simulant. The importer or its representative must give the competent authority at the designated first point of introduction at least two working days advance notice of the estimated arrival. That authority runs documentary checks on every consignment plus identity and physical checks, including laboratory analysis, on 10% of them, distributed unpredictably. Release for free circulation is conditional on presenting the completed declaration.

Two practical consequences. First, this is a recurring cost and lead time, not a one-time approval: budget the lab report and the two-day notice into every purchase order, and confirm your port is a designated point of introduction before you book. Second, the limits the report must clear are the current ones in Regulation (EU) No 10/2011 as amended, not the 2011-era figures — melamine at a specific migration limit of 2.5 mg/kg, formaldehyde at 15 mg/kg expressed as total formaldehyde including hexamethylenetetramine, and primary aromatic amines under the 0.002 mg/kg non-detectable and 0.01 mg/kg sum rules above. Melamine tableware is a standing enforcement target: food contact materials were 2.8% of notifications in the Commission's Alert and Cooperation Network in 2025 (250 notifications), 68.8% of them flagged as a possible health risk, and more than half of the issues were migration hazards.

Paper, board, inks and coatings: no EU measure, still a legal duty

Because Article 16 only bites where a specific measure exists, there is no EU-level declaration duty for paper and board, printing inks, varnishes, coatings, adhesives, rubber, metal or glass. That is not a free pass. Article 3 of Regulation (EC) No 1935/2004 still forbids transferring constituents to food in quantities that endanger human health, change the food's composition unacceptably or deteriorate its organoleptic characteristics — and the same regulation expressly leaves member states free to retain or adopt national provisions on declarations of compliance where no specific measure exists. Several have.

Germany is the market that most often ends up setting the de facto EU specification. The Federal Institute for Risk Assessment publishes the BfR Recommendations on food contact materials — Recommendation XXXVI for paper and board is the one buyers cite most — which are not legally binding but function as the recognised state of the art and are the benchmark German enforcement applies. Since 8 December 2021 Germany has also had a binding Printing Ink Ordinance, the 21st amendment to the Consumer Goods Ordinance, whose Annex 14 sets a positive list of substances permitted in inks and varnishes for food contact materials. Its transition was extended by one year in December 2025 and now runs to 31 December 2026 (checked 2026-08), so printed packaging sold in Germany has to be brought onto that list within the deadline; Switzerland operates a comparable list. A converter that can show compliance with the German list and the relevant BfR recommendation holds a document that travels across the single market. One that cannot holds a document that stops at the German border.

For these materials, ask for a statement of compliance rather than an Article 16 declaration, and make it name what it is measured against: Article 3 of Regulation (EC) No 1935/2004, the national provision, the BfR recommendation number and version, the Council of Europe resolution where relevant, and the migration or extraction testing behind it. A statement that says only 'suitable for food contact' is worth nothing at an inspection.

Why a generic supplier declaration fails, and what changed in 2026

The declaration that arrives with an Asian shipment fails for the same handful of reasons, none of them exotic. It confirms compliance with Regulation (EU) No 10/2011 but not with Regulation (EC) No 1935/2004, so point 5 is half-answered. It names the trading company rather than the manufacturer, so point 2 is wrong and the supporting documentation is untraceable. It carries no use envelope, or a blanket 'all food types, all conditions', which is a refusal to specify rather than a specification. It lists no restricted substances and no migration values, leaving points 6 and 7 empty. It is undated or years old, which under Article 15(3) makes it invalid the moment the formulation moved. And it covers 'the products' rather than an identified article with a part number, failing point 3 and making it impossible to match to the goods in the container.

Three 2026 changes have to show up in the declarations you accept from here on. Bisphenols: Commission Regulation (EU) 2024/3190 banned bisphenol A and other hazardous bisphenols in food contact materials from 20 January 2025, the main transition period ended on 20 July 2026, later dates run to 2029 for some reusable and professional categories, the Commission published industry guidance in January 2026, and bisphenols used in manufacture must be declared. Recycled plastic: Regulation (EU) 2022/1616 allows food contact recycled plastic only from EU-authorised recycling technologies and sets its own declaration models in Annex III — Part A for recyclers, Part B for converters — so post-consumer content needs those, not an Annex IV declaration alone. PFAS: the Packaging and Packaging Waste Regulation (EU) 2025/40 applies from 12 August 2026 and caps PFAS in food contact packaging at 25 ppb for any individual PFAS by targeted analysis, 250 ppb for the sum of targeted PFAS, and 50 ppm for total fluorine including polymeric PFAS. A 2023-vintage declaration covers none of this, and demanding a reissue dated after your relevant deadline is the cheapest control you have.

Do not wait for the fragmentation to be legislated away. The Commission evaluated Regulation (EC) No 1935/2004 and has been preparing a revision to harmonise more materials, but as of the March 2026 EPRS state-of-play briefing no proposal had been tabled. Build the file on the rules that exist now, and keep the national layer — German inks, BfR recommendations, national paper rules — inside your supplier questionnaire.

Sources (checked 2026-08)

Framework and plastics: Regulation (EC) No 1935/2004 Articles 3, 5, 6 and 16 and Annex I (list of materials for which specific measures may be adopted); Commission Regulation (EU) No 10/2011 Articles 11 (specific migration limits, generic 60 mg/kg, dual-use additives), 12 (overall migration, 10 mg/dm2 and the 60 mg/kg infant derogation), 13 and 14 (multi-layer materials and functional barriers), 15 (declaration of compliance, retail-stage carve-out, renewal), 16 (supporting documents), 18 and 19 (migration testing, non-listed substances) and Annex IV (declaration content, points 1-9), consulted via the legislation.gov.uk assimilated-law mirror of the EU texts; Commission Regulation (EU) 2020/1245 for the current primary aromatic amines rules in Annex II; Regulation (EC) No 2023/2006 on good manufacturing practice; the Commission's Union Guidance on Regulation (EU) No 10/2011 and the German BVL information note on the declaration of compliance.

Imports and enforcement: Commission Regulation (EU) No 284/2011 Articles 3 to 8 and its Annex (per-consignment declaration, laboratory report, two working days notice, documentary checks on all consignments and identity plus physical checks including laboratory analysis on 10%, release for free circulation only against the completed declaration) with the Commission guidelines on its application; European Commission Alert and Cooperation Network annual report 2025 (food contact materials 2.8% of notifications, 250 in total, 68.8% with a possible health risk, over half migration-related).

2025-2026 changes and national layer: Commission Regulation (EU) 2024/3190 on bisphenol A and other bisphenols (application from 20 January 2025, main transition period ended 20 July 2026, later dates to 2029, Commission guidance published January 2026); Regulation (EU) 2022/1616 on recycled plastic materials and articles (EU-authorised recycling technologies, declaration models in Annex III Parts A and B); Regulation (EU) 2025/40 (PPWR) applying from 12 August 2026 with PFAS limits of 25 ppb individual, 250 ppb sum of targeted PFAS and 50 ppm total fluorine in food contact packaging; the German 21st ordinance amending the Consumer Goods Ordinance (Printing Ink Ordinance, in force 8 December 2021, Annex 14 positive list, transition extended in December 2025 to 31 December 2026); BfR Recommendations on food contact materials, in particular XXXVI for paper and board; European Parliamentary Research Service briefing 'Food contact materials in the EU: state of play', March 2026 (four harmonised material types, revision not yet proposed).

Check your specific case

• Food contact material compliance checker
• PFAS food packaging checker (PPWR limits)
• REACH SVHC and restriction checker

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