The PPWR Declaration of Conformity and Technical File: What Goes In and Who Signs

The Declaration of Conformity is the document everyone talks about. The technical file is the document that matters.

The declaration fits on one page and takes five minutes to sign. The technical file behind it, which has to support every statement in the declaration, is where the months of work go. Companies that discover this in August 2026 also discover that it cannot be accelerated.

This article sets out exactly what goes into each of the two documents. For the wider context of the obligations, see the main article on the PPWR in FMCG.

The correct order of operations

Regulation (EU) 2025/40 sets a sequence that cannot be reversed.

Before placing packaging on the market, the manufacturer carries out the conformity assessment procedure referred to in Article 38 and draws up the technical documentation set out in Annex VII. Only then, under Article 39, do they draw up and sign the EU Declaration of Conformity following the model in Annex VIII.

In other words, the declaration is the conclusion, not the starting point. A declaration signed without a file behind it is not an incomplete document. It is a false one.

A useful detail: packaging does not carry CE marking. Conformity is demonstrated exclusively through the declaration and the technical file supporting it.

Conformity assessment: Module A, no notified body

The procedure in Annex VII is Module A, internal production control. The manufacturer assesses conformity on their sole responsibility, with no notified body involved.

This is good news for the budget and bad news for any sense of reassurance. There is no third party validating your file before a market surveillance authority asks for it. Your internal check is the only check you will get.

Module A also requires an analysis of the risks of non-conformity, not just a collection of documents.

What goes into the technical file, Annex VII

The file must contain, wherever applicable, at least the following elements.

A general description of the packaging and its intended use. This establishes what the file covers, at packaging type level rather than commercial SKU level.

The conceptual design, manufacturing drawings and materials of the components. For multilayer packaging that means the composition of each layer and the weight of each part, not a description along the lines of "plastic film".

The descriptions and explanations needed to understand the documents above.

The list of harmonised standards applied and, where a standard does not cover a requirement, the alternative solutions adopted.

The results of design verification, calculations, simulations and tests carried out.

On top of this structure sit the article-by-article proof points. For Article 5, laboratory reports or substantiated supplier declarations on heavy metals and, for food contact packaging, PFAS. As the later articles come into force, the file expands with recyclability, recycled content, compostability and minimisation assessments.

What goes into the declaration, Annex VIII

The declaration follows a numbered model. The usual elements are a unique identification number, identification of the packaging type covered, the manufacturer's name and address, an explicit reference to Regulation (EU) 2025/40, the standards applied, and the date, place and signature of the authorised person.

The rule most teams miss: a point in the model that does not apply to you is not deleted. The numbering is kept and the point is marked as not applicable. The notified body point, for instance, is normally marked not applicable, because under Module A there is no notified body. Authorities read the model by its numbering, and a missing field can be treated as though the declaration never existed.

How much the first declaration covers

This is where most wasted effort is avoided.

The first version of the declaration covers only the requirements already applicable on 12 August 2026, essentially those on substances. You do not declare conformity with recyclability criteria, recycled content thresholds or minimisation requirements, because they do not apply yet.

The declaration expands later as the subsequent articles become applicable. Treating it as a living, versioned document is the only approach that survives to 2030.

When a new version is required

Any change that could affect conformity triggers a new version of the packaging type and, with it, a new declaration.

In FMCG practice that means: a change of resin grade, a supplier change where composition or the scope of the evidence changes, adding or removing a layer or a component, a change in grammage, or a switch to a material with recycled content.

An artwork change, by contrast, does not normally trigger a new version, as long as it does not change composition or inks in a relevant way.

How long you keep the documents

The declaration and the technical file are kept for at least five years for single-use packaging and ten years for reusable packaging. These periods are longer than under the previous directive, and the documents must be available on request from the authority.

The operational consequence is that you need an archiving structure that survives staff and supplier turnover. A shared folder with files named after whoever uploaded them is not an archiving structure.

The real problem is scale

An FMCG portfolio with 200 packaging types means 200 declarations, each with its own technical file. Each file depends on information received from suppliers, and those suppliers have supply chains of their own.

This is why the PPWR is in practice a data quality project. The file fails when supplier data is scattered, unverified or stale, not when the packaging itself is non-compliant. Most companies already meet the physical requirements. What they lack is the proof.

Who signs depends on your role on each packaging unit. If you have not established that yet, start with the role determination guide.

Frequently asked questions

Do I need a notified body?

No. Assessment is by self-assessment under Module A, internal production control. Legal responsibility stays entirely with the manufacturer, including where parts of the assessment are carried out by third parties.

Do I issue one declaration per SKU or per packaging type?

Per packaging type. Several commercial SKUs using exactly the same packaging, with the same composition and the same suppliers, can be covered by one declaration. An artwork difference does not create a new type.

What if a supplier refuses to give me composition data?

That is a contractual problem, not a technical one. Without supplier information you cannot compile the file, and without the file you cannot place the packaging on the market. A compliance data clause needs to sit in the contract, with a deadline and a consequence attached.

Does the importer have to issue a declaration?

No. The importer requests the declaration from the manufacturer and verifies, before placing packaging on the market, that the conformity assessment was carried out and the technical documentation drawn up. This changes if the importer places the product on the market under their own brand, in which case they become the manufacturer.

Does CE marking apply to packaging?

No. The regulation does not provide for CE marking on packaging, specifically to avoid confusion with product CE marking. Conformity is demonstrated through the declaration and the file.

Where we come in

We build the technical file and the declaration alongside quality and procurement teams, starting from the real packaging inventory and from what can actually be obtained from suppliers. We deliver the file structure, the list of documents to request per supplier, and the matrix showing, type by type, which evidence exists and which is missing.

See our PPWR compliance services.