Annex VII checklist: the technical documentation

Why the documentation counts, not just the declaration

The declaration of conformity is a commitment. The technical documentation is the evidence for it. The two belong together: a signed declaration without documentation behind it 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 documentation 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 manufacturer carries out the assessment itself, without a notified body and without third-party certification. So there is nobody who checks and releases the documentation in advance.

That eases the procedure and increases the responsibility. Because no external body countersigns, the documentation is the only evidence that the assessment took place at all.

What Annex VII point 2 requires

The technical documentation lists the applicable requirements, includes an adequate analysis and assessment of the risks of non-conformity, and covers the design, manufacture and operation of the packaging as far as relevant for the assessment. On top of that come elements (a) to (f):

• (a) a general description of the packaging and its intended use
• (b) designs, manufacturing drawings and the materials of components — in practice a bill of materials per component
• (c) descriptions and explanations needed to understand the drawings, the plans and how the packaging works
• (d) a list of the standards and specifications applied: harmonised standards, common specifications, other specifications used for measurement or calculation, parts applied partially, solutions chosen where no standard was applied
• (e) a qualitative description of how the assessments under Art. 6 (recyclability), Art. 10 (minimisation) and Art. 11 (reusability) were carried out
• (f) test reports

Which requirements apply today

The documentation has to contain evidence for every requirement that applies — and, for each one that does not apply yet, the date from which it will. Since 12 August 2026 these are:

• Art. 5: minimise substances of concern, heavy metals at most 100 mg/kg, PFAS limits for food-contact packaging — evidenced by supplier declarations or test reports per component
• Art. 6(1): recyclability at the level of the previous packaging directive; an assessment under Annex VII is only foreseen once the delegated act is adopted
• Minimisation under EN 13428:2004 until the end of 2029 (Art. 70(1)(b))
• Art. 11 for reusable packaging and Art. 12(8): no misleading labels
• Later: EPR symbols only via QR code (2027), compostability (2028), material label (from 2028), recyclability grades, recycled-content targets and minimisation under Annex IV (from 2030)

Standards: none harmonised, but other specifications

No harmonised standards have been published under Art. 36 so far. The EN 13427 series from the old packaging directive no longer gives a presumption of conformity; if you use those standards, list them as other technical specifications with their edition. For heavy metals the Commission recommends CR 13695-1:2000.

Production, retention and disclosure

Under Annex VII point 3 the manufacturing process and its monitoring must ensure that the packaging matches the documentation and the requirements: goods-in checks, supplier qualification, change management and defined triggers for a reassessment.

The declaration and the documentation must be kept for five years from placing on the market, ten years for reusable packaging, and produced within ten days on a reasoned request. Ten days are not enough to start requesting supplier evidence. An authorised representative can take over retention and disclosure; drawing up the documentation stays with the manufacturer.

Where the information comes from inside the company

• Material composition and layer structure — from the packaging supplier, not from your own ERP
• Heavy-metal and PFAS information — from the supplier, referring to the specific batch or specification
• Weight and dimensions — from master data, but checked against the real packaging
• Recycled content — from the material supplier, with evidence, not as a promise by email

The most common gaps

• The risk analysis is missing: the documentation collects evidence but does not assess where non-conformity could arise
• Recycled content or recyclability grades appear in the declaration instead of the documentation
• 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 documentation — it is created once and then goes out of date