Annex VII checklist: the technical file

Why the file counts, not just the declaration

The declaration of conformity is an assertion. The technical file is the evidence for it. The two belong together: a signed declaration without an underlying file is, in case of doubt, an unsubstantiated assurance.

Market surveillance authorities request the documents when there is cause. The timing cannot be planned — which is why the only workable strategy is to maintain the file continuously rather than assemble it when needed.

Module A: you assess yourself — and you are liable for it

Annex VII governs the conformity assessment procedure for packaging. It is Module A, internal production control: the producer carries out the assessment themselves, without a notified body and without third-party certification. So there is nobody who checks and releases the file in advance.

That eases the procedure and increases the responsibility. Because no external body countersigns, the file is the only evidence that the assessment took place at all. If it is missing, what is missing is not just a document but the proof of the conformity assessment itself.

The components

Annex VII requires a general description of the packaging and everything needed to assess its conformity. In practice that means:

• A general description of the packaging, its intended use and its field of application
• Design and manufacturing drawings, schematics of the components
• Descriptions and explanations needed to understand those drawings
• Material composition and bill of materials per component, with material data sheets
• A list of the harmonised standards or other technical specifications applied
• The results of the calculations and tests carried out
• Test reports — your own or your supplier’s

Which requirements have to be evidenced

The file is not an end in itself: it has to contain evidence for every substantive requirement of the regulation. That mapping is what is missing most often in practice — the documents are there, but nobody can say which requirement they substantiate.

• Substance restrictions — material declarations, supplier declarations, laboratory analyses and test reports
• Recyclability — the assessment against the criteria of the regulation, not the supplier’s marketing claim
• Recycled content — evidence from the material supplier, relating to the specific specification
• Packaging minimisation — a justification that weight and volume do not go beyond what function and safety require
• Labelling — evidence that the prescribed information appears on the packaging

Retention and the deadline for producing it

The file must be kept after placing on the market: five years for single-use packaging, ten years for reusable packaging. On a reasoned request from an authority the documents must be produced within ten days.

Those ten days are the real test. They are not enough to start requesting supplier evidence — anyone intending to meet them has to keep the file in order already. An authorised representative may keep the documents but not create them; the duty to create stays with the producer.

Where the information comes from inside the company

• Material composition and layer structure — from the packaging supplier, not from your own ERP
• Recycled content — from the material supplier, with evidence, not as an assurance by email
• Weight and dimensions — from the master data, but checked against the real packaging
• Information on substances of concern and PFAS — from the supplier, referring to the specific batch or specification
• Recyclability — from the assessment against the applicable criteria, not from the supplier’s marketing claim

The most common gaps

• The recycled content is in the declaration but the supplier evidence for it is missing
• Drawings exist but are not assigned to the version actually on the market
• Test reports are older than the last material change
• For packaging made of several components the breakdown per component is missing
• Nobody is named to maintain the file — it is created once and then goes out of date