PPWR Technical Documentation (Annex VII): What Has to Be in the File Before You Sign

The One-Page Document and the Folder Behind It

The EU declaration of conformity for packaging is one page. Annex VIII of Regulation (EU) 2025/40 prescribes ten elements: identification of the packaging, manufacturer details, the requirements you are declaring against, a signature. Drafting it takes an afternoon, and the declaration of conformity guide walks through every field.

The technical documentation behind that page is the actual work. Annex VII requires it. Article 15 makes you keep it for years. And when a market surveillance authority sends a reasoned request, the declaration is not what they read. They read the file. From 12 August 2026, every packaging unit placed on the EU market needs both, and signing the one-pager without holding the file behind it is a false statement with your name on it.

This guide covers what goes in the folder, who keeps it, for how long, and how importers and distributors check that it exists before money changes hands.

Module A: You Are the Auditor

PPWR conformity assessment follows the procedure in Annex VII: internal production control, known across EU product law as Module A. No notified body. No third-party certificate. No fee to an inspection agency. The manufacturer assesses its own packaging, compiles the evidence, and declares conformity on its sole responsibility.

You grade your own homework. That sounds generous until you notice how the system is built: the regulator spends nothing up front and keeps the right to demand the full file at any point during the retention period. The cost of assessing moved from the state to you. The cost of being wrong stayed with you too.

Module A has one operating rule worth memorising: if it is not documented, it did not happen. A verbal assurance from your carton supplier is nothing. A dated PDF signed by that supplier is evidence.

What Annex VII Requires

The technical documentation must make it possible to assess the packaging against every requirement that applies to it, including an assessment of the risks of non-conformity. In practice the file contains:

• A description of the packaging and its intended use
• Design and manufacture information: drawings, specifications, component diagrams
• Materials: what every component is made of, with weights
• A list of harmonised standards or other technical specifications applied, in full or in part, plus a description of the solutions adopted where none were applied
• Results of design calculations and examinations carried out
• Test reports

That is the skeleton. Articles 5 to 12 supply the organs: each substantive requirement generates its own piece of evidence, and the folder is where that evidence lives.

What Goes in the Folder, Article by Article

Folder section	Legal basis	What counts as evidence
Packaging description	Annex VII	Photos, drawings, dimensions, weight, full component list
Materials and composition	Annex VII	Material per component, supplier specification sheets
Heavy metals	Article 5(1)	Supplier declaration or test report: lead + cadmium + mercury + hexavalent chromium, combined, at or below 100 mg/kg
PFAS (food-contact packaging only)	Article 5	Supplier declaration of no intentionally added PFAS; test report for high-risk materials. Limits: 25 ppb for any single measured PFAS, 250 ppb for the sum, 50 ppm total fluorine
Recyclability	Article 6	Design-for-recycling assessment; updated once the delegated acts land
Minimisation	Article 10, Annex IV	Written justification that weight and volume are the minimum necessary, argued against the Annex IV performance criteria
Labelling	Article 12	Final artwork showing the required markings
Standards applied	Annex VII	List with edition years
Declaration of conformity	Annex VIII	The signed one-pager, filed with everything that supports it

The 100 mg/kg heavy metals limit is not new. It carried over from Directive 94/62/EC, which has required it since the 1990s. What is new is the uniform enforcement machinery around it. The regulation does not care how nice your box looks. It cares whether you can prove the ink is not two percent cadmium.

Supplier Declarations vs Your Own Lab Tests

Not every row in that table needs a lab invoice. The question is who already holds the data.

A supplier declaration usually suffices when:

• The material is standard and the supplier tests it as part of its own compliance programme
• The packaging is not food-contact
• You buy finished packaging and change nothing about it

Commission your own test when:

• The packaging is food-contact and the material carries known PFAS risk: grease-resistant paper, moulded fibre, coated board
• The supplier declaration is vague, undated, or fails to cite the 100 mg/kg and PFAS limits by number
• You print, coat, or laminate the packaging after purchase, because your modification sits outside the supplier's declaration
• The supplier will not put numbers in writing

A supplier who declines to state "below 100 mg/kg" in a signed document is telling you something. Worth listening.

Whichever route you take, keep the chain of custody boring: sample reference, date, laboratory, method, result, filed next to the declaration it confirms or replaces.

Who Keeps the File, and for How Long

Article 15: the manufacturer keeps the technical documentation and the declaration of conformity for 5 years after the single-use packaging is placed on the market, and 10 years for reusable packaging. The clock runs from placing on the market, so a packaging type you ship continuously restarts it with every batch. Practical translation: keep the file as long as you sell the packaging, plus five years.

If you appointed an authorised representative, the mandate must cover keeping the declaration and the technical documentation at the disposal of the authorities.

Importers keep a copy of the declaration of conformity and must be able to make the technical documentation available on request. Which brings us to the part where other people's paperwork becomes your problem.

Articles 18 and 19: The File Gets Checked Before Customs Does

Article 18 puts importers on the hook before the goods move. Before placing packaged products on the EU market, the importer verifies that:

• The manufacturer carried out the Annex VII conformity assessment
• The technical documentation has been drawn up
• The declaration of conformity exists
• The packaging bears the required labelling

An importer with reason to believe the packaging does not conform must hold it back until it does. "I assumed the factory handled it" is not a recognised conformity assessment procedure.

Article 19 gives distributors a lighter version: verify the labelling, verify that manufacturer and importer met their obligations, including that the declaration was drawn up. Lighter, not optional.

The commercial consequence: the technical file is now a procurement document. EU buyers have started requesting evidence of it before signing purchase orders, for the sensible reason that their own Article 18 and 19 duties depend on it. Sell packaging or packaged goods into the EU and "send us the Annex VII documentation" will appear in due diligence, right next to the insurance certificate.

Before You Sign Anything: The Five Asks

Whether you are the importer signing a purchase order or the brand signing off on new packaging, request five things first:

1. The signed Annex VIII declaration of conformity for the exact packaging type
2. The heavy metals evidence: declaration or test report citing the 100 mg/kg limit
3. For food-contact packaging: the PFAS statement addressing 25 ppb, 250 ppb, and 50 ppm by number
4. The minimisation justification against Annex IV
5. Confirmation of who holds the full technical file and for how long

Silence on any of the five is your answer.

Find Your Gaps in Ten Minutes

The Complydex wizard includes a free documentation gap check: answer a short set of questions about your packaging and it flags which evidence your Annex VII file is missing, requirement by requirement. Run the free documentation gap check.

For the one-pager that sits on top of the file, see the declaration of conformity guide. For the full August 2026 to-do list, the PPWR compliance checklist covers the other seven steps.