Many importers into the EU feel reasonably confident about compliance.
- They have a technical file, including a risk assessment.
- They have test reports that cover mandatory testing requirements.
- They have a signed Declaration of Conformity for their product.
Those documents may be enough to demonstrate the product’s compliance, but they do not necessarily demonstrate that its packaging complies with the EU Packaging and Packaging Waste Regulation, or PPWR.
Regulation (EU) 2025/40 generally applies from 12 August 2026. From that date, packaging placed on the EU market must be supported by a conformity assessment, technical documentation and an EU Declaration of Conformity covering the PPWR requirements applicable to it at that time.
Several of the PPWR’s substantive requirements will apply later. Your packaging documentation will therefore need to be reviewed and updated as further recyclability, recycled-content, minimisation and labelling requirements take effect.
PPWR technical documentation is the evidence used to show that packaging placed on the EU market complies with the requirements that apply to it. This may be maintained as a standalone packaging file or as a clearly identifiable part of a wider product compliance file.
PPWR technical documentation is the evidence file used to show that packaging placed on the EU market complies with the Packaging and Packaging Waste Regulation. For importers, this means packaging may need its own structured file, separate from the product’s existing technical file.
What changed: the EU PPWR
The Packaging and Packaging Waste Regulation (EU) 2025/40 introduces a new way of looking at packaging.
Packaging was already regulated under the previous Packaging and Packaging Waste Directive and the national laws implementing it. However, the PPWR introduces a more explicit and harmonised EU-wide conformity assessment and documentation framework for packaging.
Packaging must therefore be treated as a regulated object with its own compliance obligations, even when it is supplied around a separate product.
As the regulation states, it:
“lays down requirements over the entire life cycle of packaging as regards environmental sustainability and labelling…”
(Regulation (EU) 2025/40 official text)
That includes how packaging is designed, documented, and proven compliant.
This is not a one-time update.
The different PPWR requirements are being introduced in stages. Your documentation will need to evolve as further requirements become applicable to your packaging.
Packaging now needs its own technical file
Under PPWR, the manufacturer must carry out the required conformity assessment, prepare technical documentation in accordance with Annex VII and draw up an EU Declaration of Conformity in accordance with Article 39 and Annex VIII.
That technical documentation must cover the packaging itself. It can be kept as a standalone packaging compliance file or incorporated into a wider technical file, provided the packaging evidence is clearly identifiable and can be supplied to the authorities.
The regulation is clear:
“Compliance… shall be demonstrated in the technical documentation… in Annex VII”
“Manufacturers shall… draw up the technical documentation referred to in Annex VII”
(Regulation (EU) 2025/40 official text)
This means:
- Packaging must be covered by its own identifiable technical documentation.
- The documentation must meet the applicable Annex VII requirements.
- The conformity assessment and documentation must be completed before the packaging is placed on the EU market.
- The evidence must cover the requirements in Articles 5 to 12 that apply to the packaging at that time.
If your existing file only covers the product, the file itself may still be complete for product compliance. However, your PPWR packaging evidence is likely to be incomplete.
We have seen the same pattern with companies that aren’t ready:
- Strong product compliance
- No structured packaging compliance documentation
- No Annex VII conformity-assessment records
- No clear traceability
Packaging compliance also mattered under the previous rules. What changes under PPWR is the introduction of a clearer, directly applicable EU framework for technical documentation, conformity assessment and the EU Declaration of Conformity.
From 12 August 2026, companies should be ready to demonstrate that the conformity-assessment steps required at that time have been completed.
Authorities can request proof of packaging compliance. If you cannot provide it, you are exposed.
What does Annex VII mean in practice?
Annex VII establishes the Module A internal production control conformity assessment procedure.
It requires the manufacturer to prepare technical documentation that allows the packaging’s conformity with the applicable PPWR requirements to be assessed. It also requires the manufacturer to operate its production process and monitoring controls so that manufactured packaging remains consistent with the documented and assessed design.
In practical terms, the documentation may include:
- A general description of the packaging and its intended use
- The packaging specifications, drawings, dimensions and component information
- Information about the materials from which the packaging is made
- Relevant manufacturing information and process controls
- An assessment of which PPWR requirements currently apply
- A list of the harmonised standards, common specifications, test methods or other technical specifications used
- Design calculations, examinations and technical assessments
- Test reports and supporting supplier evidence
- Evidence showing how the packaging is identified and linked to its specifications and compliance records
- Change-control records showing how material, supplier, design and manufacturing changes are assessed
- Evidence supporting the EU Declaration of Conformity
BOM references, packaging specifications, supplier declarations, purchase records and product SKUs can provide useful supporting traceability. These are practical ways of organising the evidence, rather than specific file structures mandated by Annex VII.
The documentation can be proportionate to the complexity of the packaging. However, it must be complete enough to demonstrate compliance with every PPWR requirement applicable when the packaging is placed on the market.
How to mark your packaging correctly
Packaging must also be identifiable.
The regulation requires:
“a type, batch or serial number or other element allowing its identification”
(Regulation (EU) 2025/40 official text)
Plus:
- The manufacturer’s name, registered trade name or registered trademark
- Postal address
- Where available, an electronic means of communication through which the manufacturer can be contacted
Where packaging is imported into the EU, the importer must also provide its name, registered trade name or registered trademark, postal address and, where available, an electronic means of communication.
Who qualifies as the PPWR manufacturer depends on the legal definition and the particular supply arrangement. Under Article 21, an importer or distributor takes on the manufacturer’s obligations if it places packaging on the market under its own name or trademark, or modifies packaging already on the market in a way that could affect compliance.
This should not be determined solely by whose name appears on the product inside the packaging.
This ensures traceability back to your documentation.
As a practical approach, you can use a dedicated packaging reference or a product reference that is clearly linked to the packaging specification and supporting records.
The regulation allows certain manufacturer and importer contact information to be provided using a QR code or another data carrier. However, a QR code should not be treated as a blanket replacement for every required identifier or label. The permitted location and format depend on the particular information concerned.
The key question:
Can a regulator trace your packaging back to a compliant file?
What we recommend you do next to be compliant with PPWR
Start simple:
- List all packaging formats that you place on the EU market, using the PPWR categories where applicable:
- Sales packaging: packaging that forms the sales unit supplied to the end user, such as many product containers or retail boxes
- Grouped packaging: packaging that groups together a number of sales units
- Transport packaging: packaging used to facilitate handling and transport, such as shipping cartons, pallets and pallet wrap
- E-commerce packaging: transport packaging used to deliver products sold online or through another form of distance sale
- Service packaging and other specialist packaging categories where relevant
- Determine who is legally acting as the manufacturer, importer and producer for each packaging format
- Collect material data and test reports
- Collect design specifications, manufacturing information, supplier declarations and traceability records
- Identify which requirements in Articles 5 to 12 currently apply to each packaging format
- Carry out the Annex VII conformity-assessment procedure and assemble the supporting technical documentation
- Prepare an EU Declaration of Conformity following Article 39 and Annex VIII
- Decide whether the packaging Declaration of Conformity will be standalone or combined with declarations covering other applicable EU legislation
- Establish a process for assessing changes to materials, suppliers, designs and manufacturing processes
- Retain the Declaration of Conformity and ensure the technical documentation remains available for five years for single-use packaging and ten years for reusable packaging
- Review the documentation as further PPWR requirements become applicable
Your documentation can be proportionate to the complexity of the packaging, but it must be structured, defensible and complete enough to demonstrate compliance with all applicable requirements before the packaging is placed on the EU market.
Get help from Sofeast
Sofeast can help you review and strengthen your packaging approach before products are placed on the EU market. From design to sourcing to compliance, we have you covered. Speak with us about your project.
FAQs: PPWR technical documentation for packaging
Does packaging need its own technical file under PPWR
Packaging needs technical documentation that covers the packaging itself and demonstrates compliance with the PPWR requirements applicable to it.
This documentation may be maintained as a standalone packaging compliance file or as a clearly identifiable section within a wider product technical file. What matters is that the packaging, the applicable requirements and the supporting evidence can be clearly identified.
Is my existing product technical file enough?
Not necessarily.
If your existing file already includes the technical documentation required under PPWR Annex VII, it may be possible to incorporate the packaging evidence into that file.
However, if it only covers product safety, product testing and the product’s existing Declaration of Conformity, it is unlikely to contain all the packaging-specific evidence required under PPWR.
What is PPWR Annex VII?
Annex VII sets out the Module A internal production control conformity-assessment procedure for packaging.
It requires the manufacturer to prepare technical documentation that allows the packaging’s conformity with the applicable PPWR requirements to be assessed. The manufacturer must also ensure that its production process and monitoring controls keep manufactured packaging consistent with that documentation.
A practical Annex VII documentation package may include:
- Packaging description
A description of the packaging, its intended use and the relevant packaging types, such as sales, grouped, transport or e-commerce packaging. - Design and manufacturing information
Packaging specifications, drawings, dimensions, materials, components and relevant manufacturing information. - Material and composition information
Material specifications, composition data, supplier declarations and recycled-content information where applicable. - Applicable PPWR requirements
Evidence showing how the packaging has been assessed against the PPWR requirements that currently apply to it, including requirements relating to substances, recyclability, minimisation, labelling and recycled content where relevant. - Standards and assessment methods
The harmonised standards, common specifications, test methods, calculations or technical justifications used to assess compliance. - Test reports and supporting evidence
Relevant test results, calculations, examinations, supplier documents and other evidence supporting the compliance assessment. - Production and change controls
Evidence showing how the manufacturer ensures that ongoing production remains consistent with the documented and assessed packaging design. - Identification and traceability
A packaging reference, type, batch or serial number, or another identification method that links the packaging to the relevant documentation.
The supporting documentation should also provide the evidence needed for the EU Declaration of Conformity required under Article 39 and Annex VIII.
Does PPWR apply to imported products from China?
Yes. PPWR applies to packaging placed on the EU market, regardless of where the packaged product or packaging was manufactured.
Before placing the packaging on the EU market, the importer must check that the manufacturer has carried out the required conformity assessment, prepared the technical documentation and EU Declaration of Conformity, and provided the required identification and contact information.
The importer must also provide its own required identification and contact details and ensure that the relevant documentation can be made available to market-surveillance authorities.
Does packaging need a Declaration of Conformity?
Yes.
Once the packaging’s conformity with the applicable PPWR requirements has been demonstrated, the manufacturer must draw up an EU Declaration of Conformity in accordance with Article 39 and Annex VIII.
The company may prepare a standalone PPWR Declaration of Conformity or use a single combined EU Declaration of Conformity covering PPWR and other applicable EU legislation. If a combined declaration is used, it should clearly identify each applicable piece of legislation and the requirements covered.
The information required will depend on the packaging and the PPWR requirements applicable to it, but importers and manufacturers should generally request:
- Packaging and material specifications.
- Material composition and restricted-substance information.
- Design and manufacturing information.
- Supplier declarations and supporting compliance evidence.
- Recycled-content information where applicable.
- Recyclability assessments and evidence where applicable.
- Test reports, calculations and technical justifications.
- Labelling and material-identification information.
- Packaging type, batch or other traceability references.
- Notification of changes to materials, suppliers, manufacturing processes or packaging designs.
Supplier documents provide important supporting evidence, but they do not automatically transfer the manufacturer’s legal responsibility for PPWR compliance to the supplier.
What should importers ask packaging suppliers for?
In most cases, importers should request material specifications, test reports, recyclability evidence, substance compliance evidence, labelling information, and ideally traceability references.
Recommended PPWR sources
- European Commission PPWR overview
- Regulation (EU) 2025/40 official text
- UK Department for Business and Trade PPWR overview
Further reading
- 9 Types of Packaging (Benefits, Costs, Sustainability, and more) – Guide for Importers
- EU Ecodesign regulation – part of the wider EU sustainability rules
- Product compliance mistakes (Podcast episode)
- Packaging quality inspections
- Improving Worsening Product & Packaging Quality – Disputes With Chinese Suppliers: Q&A (Volume 5)