PPWR technical documentation must describe the packaging, identify its applicable requirements, assess risks of non-conformity, and explain the design, materials, methods and evidence supporting compliance. Annex VII sets out the minimum contents, wherever applicable. For a brand sourcing custom boxes for EU sale, the practical aim is a file that connects the approved packaging version to the evidence used to assess it.
The PPWR—Regulation (EU) 2025/40—has generally applied since 12 August 2026. Article 15 requires manufacturers to complete the conformity assessment and draw up technical documentation before placing packaging on the EU market. The assessment covers the applicable requirements under Articles 5–12. Several substantive requirements have later application dates, so the file must make clear which requirements and assessment methods apply to the packaging concerned.
What Annex VII requires
Annex VII, point 2, requires the documentation to cover the packaging’s design, manufacture and operation as far as relevant to assessing conformity. The table below separates the prescribed elements from examples of how they can be expressed in a custom packaging project.
| Required element | What it should establish |
|---|---|
| Applicable requirements and an adequate analysis and assessment of non-conformity risks | Which requirements apply to this packaging, where conformity could fail, and how the assessment addresses those risks. A requirements register and a short risk assessment are practical ways to present this. |
| General description and intended use — point 2(a) | What the packaging is and what it does: for example, a folding carton for a sealed skincare bottle, its intended packing and distribution conditions, and whether it is intended for single use or reuse. |
| Conceptual design, manufacturing drawings and component materials — point 2(b) | The physical construction being assessed. Relevant records can include structural drawings, dimensions, material specifications and a component list covering board, wrapping paper, inks, coatings, adhesives and inserts. |
| Explanations of drawings, schemes and operation — point 2(c) | How the design works where drawings alone are insufficient: assembly, attachment of components, opening, separation, emptying or reconditioning, as relevant. |
| Standards, common specifications and other technical specifications — point 2(d) | Which harmonised standards and common specifications were applied fully or partly, the particular parts used, and other specifications used for measurement or calculation. Where harmonised standards or common specifications are not applied, describe the solutions adopted to meet the requirements. |
| Qualitative descriptions of assessments — point 2(e) | How the assessments under Article 6 on recyclability, Article 10 on minimisation and Article 11 on reusable packaging were carried out, where applicable. Explain the approach and reasoning behind the conclusions. |
| Test reports — point 2(f) | The relevant test evidence supporting the assessment, with sufficient identification to connect the tested samples and results to the packaging or materials concerned. |
Annex VII specifies content rather than a universal folder layout. An index, document owner, revision history and evidence register make that content easier to maintain. These are useful organisational choices. Manufacturing controls and the EU declaration of conformity are additional obligations within the Annex VII procedure; they should remain connected to the technical documentation.
Identify the packaging and explain the assessment
Begin with a packaging version that everyone can identify. Give the specification a packaging code and revision, and connect it to the relevant drawings and material records. Define the assessment’s boundary: an outer gift box, its insert and its attached components should be recognisable within the file. Identify other packaging assessed separately, such as the product bottle or shipping carton, so that evidence for one part of the packaging system is used within its proper scope.
A wrapped rigid box illustrates why the material description needs detail. Greyboard supplies the structure; printed wrapping paper supplies the visible surface; adhesive joins them. A varnish, film laminate, ribbon or plastic insert introduces further materials and relationships. Recording how those parts are attached helps explain both manufacture and end-of-life behaviour. Under Article 6’s component-assessment rules, whether components are integrated, separate or capable of separating during transport or sorting affects how recyclability is assessed.
At CMIC, we can use structural development and sampling to turn these details into a shared specification. For example, two wrapping options may look similar while using different coatings or adhesives. Connecting each option to its material information allows the customer’s team to consider appearance, performance and available conformity evidence together. The useful result is a defined construction with identifiable components and a clear account of any information still needed.
The risk assessment explains where that construction or its manufacture could fail an applicable requirement. An ink substitution could leave chemical evidence covering the wrong formulation. A permanently bonded film could change the basis of a recyclability assessment. For each significant risk, record the affected requirement, the evidence used to assess it and the relevant control—for example, an approved material specification, supplier information or targeted testing. This gives the choice of evidence a reason and connects the assessment to production.
Method references need similar precision. Record the standard’s edition and the clauses applied, especially where it was used only partly. Under Articles 36 and 37, the presumption of conformity associated with an Official Journal-referenced harmonised standard or an applicable common specification extends to the requirements it covers. Other technical methods can contribute useful evidence, but the file must explain their relevance and the solutions adopted. A familiar standard number alone leaves the assessor unable to see what was actually evaluated.
Match requirements to the packaging’s use and timing
The evidence needed depends on the packaging’s use and the applicable date. Record the basis for an exemption or a later application date alongside the relevant requirement. The following distinctions are particularly useful for paper packaging projects, drawing on the Regulation and the Commission’s 2026 interpretative guidance.
- Substances, Article 5: connect applicable chemical requirements to the actual materials, including inks, coatings and adhesives. Intended use matters: food-contact packaging also falls within the PPWR’s PFAS restrictions applying from 12 August 2026, requiring an appropriate evidence basis.
- Recyclability, Article 6: the Commission’s guidance distinguishes the general recyclability obligation applying from 12 August 2026 from the later detailed design-for-recycling requirements. It says the Article 38 and Annex VII conformity assessment for recyclability is not required until the relevant Article 6(4) delegated acts enter into force. For the interim period, it points to the existing Packaging and Packaging Waste Directive approach and EN 13430:2004. The detailed Article 6(2)(a) conditions apply from 1 January 2030 or 24 months after the relevant delegated acts enter into force, whichever is later. Identify the basis and stage of any assessment retained in the file.
- Minimisation, Article 10: the Commission explains that the existing minimisation requirements and associated standard remain in effect through the end of 2029; Article 10(1) and (2) apply from 1 January 2030. Retain the assessment supporting current packaging and distinguish preparation for the later Annex IV approach.
- Plastic components, Article 7: check the scope, exceptions and phased recycled-content requirements for the plastic parts of paper-based packaging. Where relying on Article 7(5)(b)’s exemption for a plastic part representing less than 5% of the whole packaging unit’s weight, retain the weights and calculation supporting it. The applicable calculation and verification rules also matter; Article 7 provides for further implementing measures and a technical-documentation format.
- Compostability and reuse, Articles 9 and 11: include the relevant evidence where these requirements apply. A reusable-packaging assessment should explain how the packaging is designed for repeated use and can be emptied, refilled or reloaded and reconditioned while maintaining its function and applicable safety and hygiene requirements.
Labelling under Article 12 also forms part of the conformity-assessment scope. Link the relevant approved artwork and information to the requirements applicable at the time of placing the packaging on the market. Keeping the artwork revision identifiable helps prevent a correctly assessed structure from being supplied with an outdated information version.
What minimisation evidence needs to explain
The future Article 10 assessment shows why an explanation can be as important as a report. Article 10(4) and Annex IV require the technical basis used, the design requirements preventing further reduction, and supporting tests, studies or other evidence. Annex IV also calls for the calculated minimum necessary weight and volume and documented production-batch variation. Working through its performance criteria makes the reasoning specific: protection, manufacturing, logistics, information, safety, packaging functionality and circularity requirements can each impose different constraints.
Consider a gift box holding two glass fragrance bottles. Reducing insert thickness may allow the bottles to move towards each other during handling. A comparison of designs and suitable transport testing could establish the protection needed and support the chosen insert. The outer dimensions still deserve their own assessment: retaining insert strength may leave room to reduce an unnecessary gap. Annex IV recognises gift-purpose functionality, while requiring a reasoned account of the design constraints. Simply changing the packaging material does not complete the reduction assessment.
Connect the evidence to the approved version
Each document should answer a particular conformity question. A specification establishes what is intended to be supplied. A supplier declaration records information about the identified material or component. A calculation explains a quantity or relationship, using stated inputs and assumptions. A test report records what happened to identified samples under a stated method. The assessment connects these records and explains what their combined evidence establishes for the packaging.
For example, a report limited to lead, cadmium, mercury and hexavalent chromium can support the corresponding heavy-metals assessment for the materials tested. Its usefulness depends on linking the sample descriptions to the approved paper, ink, adhesive or insert. Retain the report number, sample identification, test date, methods, results, units and relevant detection limits. Recyclability, recycled content and other chemical requirements need their own evidence. A passing result for the submitted material set establishes that stated result within the report’s scope.
Relevant evidence can be referenced across packaging variants where its coverage is justified. The file should explain that connection. A seasonal folding carton may retain the same dieline and board while changing its ink system or coating; the structural evidence and chemical evidence may therefore need different reviews. Record which findings carry forward and which require additional information or testing. A shared report is useful when the material, process and conditions relevant to its conclusion remain covered.
Keep production consistent with the file
Annex VII uses Module A: internal production control. This places responsibility for the assessment and conformity declaration with the manufacturer and does not impose universal third-party certification for every box. Independent testing or review can provide necessary expertise and evidence, with the particular work determined by the applicable requirements and assessment. Article 35 requires reliable, accurate and reproducible test, measurement and calculation methods that reflect the generally recognised state of the art and produce results of low uncertainty.
The manufacturing process and its monitoring must keep production consistent with the technical documentation and applicable requirements. For custom boxes, useful controls can include identifying approved material grades, controlling substitutions and linking production orders to the released specification. Article 15 requires reassessment where changes in design, characteristics, standards or specifications could affect conformity. A material change should therefore prompt a review of its consequences, followed by the evidence and document updates that review identifies.
Identify who is responsible for the documentation
Responsibility for the file follows the PPWR manufacturer role. A brand that has packaging or a packaged product designed or manufactured under its own name or trademark will generally be the manufacturer under Article 3(1)(13), even when a factory in China physically produces the boxes. Specialist work can be carried out on the manufacturer’s behalf, while the manufacturer retains responsibility. Identify the legal roles first, then agree who supplies, assembles, reviews and maintains the evidence.
The micro-enterprise exceptions have specific location conditions. Article 3(1)(13)(b) refers to a packaging supplier in the same Member State when determining manufacturer status; Article 15(12) assigns Article 15 duties to the supplier where the qualifying micro-enterprise’s supplier is located in the EU. These provisions do not give a small brand a blanket exemption when it buys directly from a China-based supplier.
Article 16 requires suppliers to provide the information and documentation necessary for the manufacturer to demonstrate conformity. For our packaging projects, we can help organise component specifications, coordinate supplier evidence and arrange project-specific testing where needed. An EU importer has its own checks under Article 18, including ensuring that the manufacturer has completed the conformity assessment and drawn up the technical documentation before placing the packaging on the market.
Complete the declaration and retain the records
Once the assessment demonstrates conformity with the applicable requirements, the manufacturer draws up the EU declaration of conformity. Annex VIII supplies its model structure, including manufacturer details, traceable packaging identification, the conformity statement, relevant legislation and technical references, and signature details. Annex VII requires a written declaration for each packaging type. The declaration records the manufacturer’s responsibility and the assessment’s outcome; the technical documentation contains the supporting reasoning and evidence. Article 39 requires the declaration to be continuously updated and drawn up in, or translated into, the language or languages required by the Member State concerned.
Manufacturers must retain the technical documentation and declaration for five years for single-use packaging and ten years for reusable packaging, measured from placing the packaging on the market. Importers must retain a declaration copy and ensure access to the technical documentation for the corresponding periods. Under Articles 15 and 18, relevant documents must be made available within ten days of a reasoned national-authority request, in a language the authority can easily understand, electronically and also on paper if requested. An organised file should therefore remain accessible after the original project team or supplier contact changes.
EPR records serve a separate purpose: registration, reporting and responsibility for packaging waste in the relevant Member State. Material weights may feed both EPR reporting and technical assessments, but an EPR registration does not establish the packaging’s conformity. Our guide to PPWR labels, technical documentation and EPR explains how these responsibilities fit together.
For a custom packaging project destined for the EU, you can talk with us using the drawing, sample or reference you already have. We can help define the construction, connect its components to available evidence and identify where further information or testing is needed. That gives your responsible team a concrete packaging version to assess—and helps carry the decisions behind it into repeat production.