Annex VII · art. 38 · module A
Packaging technical documentation
The document you send to nobody and whose absence you notice only during an inspection. It holds the evidence your declaration of conformity rests on.
In short
Technical documentation is a body of evidence: description of the packaging, materials, calculation and assessment results, and the supplier documents they are based on. It stays with the manufacturer and is made available to market surveillance authorities on request.
- You do not send it to customers or to any register — you have to hold it and be able to produce it.
- Conformity assessment runs under module A, internal production control, with no notified body.
- Retention: 5 years for single-use packaging, 10 years for reusable packaging.
- The documentation underpins the declaration. A declaration without documentation is a statement with nothing behind it.
What goes into the file
Annex VII describes the content in general terms, because the documentation has to fit very different kinds of packaging. A practical list for a board packaging manufacturer looks like the one below — and most of it is material the plant already has, just scattered.
The key difference from a datasheet: the documentation answers „how do you know”, not „what is it”.
- A general description of the packaging and its intended use, with its format and function under PPWR.
- Construction drawings, blank layout and dimensions — internal and external.
- A list of materials with their origin and material code, together with supplier declarations.
- A description of the manufacturing process to the extent it affects the properties of the packaging.
- A list of harmonised standards or other technical specifications applied.
- Results of calculations, measurements and assessments made for the requirements of articles 5–12, including volume and weight minimisation.
- Supplier statements on substances — the sum of heavy metals and, for food-contact packaging, PFAS.
Module A, internal production control
Conformity assessment for packaging runs under module A. That means the manufacturer assesses conformity themselves, on their own responsibility, with no notified body involved. There is no certificate to win and no audit to pass.
It sounds convenient and is often treated that way — until somebody asks for evidence. The whole weight of this module lies in documenting the assessment at the moment you make it, rather than reconstructing it from memory six months later.
The practical consequence: the documentation is not one PDF. It is a set of linked artefacts, each with its own version and date.
Retention and what survives it
Documentation and declarations are kept for five years for single-use packaging and ten years for reusable packaging, counted from placing the packaging on the market.
That is not a feature, it is an obligation. And it is what usually breaks a solution based on a folder on a network drive: the files are there, but a year later nobody can reconstruct which version went to whom, because in the meantime the supplier changed the grammage and a regenerated document looks different.
So what you archive is the generated file, not just the data. An issued document should be frozen — its bytes and checksum written once, with no silent edits. A correction goes out as a new version with its own number.
- You can produce a document from six months ago in the version that went to the customer — not regenerate it.
- You know who issued each document and when, and what the next version changed.
- You know what happens to the archive if you change systems or software vendors.
- You have settled whether the signature is wet ink on a printout or electronic — and who provides it.
What happens during an inspection
The documentation is not filed proactively. A market surveillance authority requests it and sets a deadline. Which makes the test simple: can you assemble a complete file, within a reasonable time, for a specific packaging placed on the market in a specific month.
An honest caveat: enforcement practice is still taking shape and interpretations can differ. The client we rolled this out for put it most briefly — the standards speak, among other things, about the permitted share of empty space in transport packaging, and an inspector may challenge the choice of board itself. The defence is standardisation: fewer grades, fewer combinations, fewer documents to defend.
Frequently asked questions
How does technical documentation differ from a declaration of conformity?+
Technical documentation stays with the manufacturer and holds the evidence. The EU declaration of conformity is a one-page statement issued to customers, and it follows from that documentation.
Do we need documentation for every SKU?+
The documentation describes the packaging placed on the market. In practice it is maintained per packaging type — like the declaration — with dimensional differences handled inside one description, as long as they do not change the assessment.
Is a notified body required?+
Not under module A. The manufacturer assesses conformity and carries the responsibility. The notified-body clause in the declaration is then left empty or marked as not applicable.
Can the documentation live in the cloud?+
Yes. What matters is not the location but versioning and availability throughout the retention period, including after a change of software vendor.
What if a supplier has not sent their declaration yet?+
Then the fields that depend on it stay empty or read „to be confirmed”. Writing a value with no source document is worse than leaving a blank, because you are the one signing it.
Related topics
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Reference material written during a real rollout, based on Regulation (EU) 2025/40. It is not legal advice or a conformity assessment. Confirm labelling deadlines with your legal adviser.