The challenge.

Regulation (EU) 2025/40 — the Packaging and Packaging Waste Regulation, or PPWR — replaces a directive-based regime with a directly applicable, harmonised technical documentation requirement across the EU.

Every economic operator placing packaging on the EU market must hold an Annex VII Module A technical file for each packaging type, supported by an Annex VIII EU Declaration of Conformity.

The substantive obligations span Articles 5 through 14: substance restrictions, recyclability, recycled content, biobased feedstock, compostability, minimisation, reuse, harmonised labelling and environmental claims.

This is not a documentation refresh. It is a new evidentiary regime, layered on top of existing food-contact and chemicals legislation, with several articles still awaiting secondary legislation — delegated acts, implementing acts and harmonised standards yet to be adopted.

For brand owners and packaging users, the practical challenge is twofold: build dossiers that are defensible today against the obligations already in force, and structured to absorb the obligations that will be triggered as the Commission completes the implementing legislation between now and 2029.

Scope.

RegSurance prepared comprehensive PPWR-compliant technical documentation for two contrasting packaging formats:

• A food-contact aluminium beverage canister — a single-use primary packaging unit.
• A non-food-contact LDPE shrink wrap — a secondary packaging unit used for grouping primary containers in transit.

The two formats were chosen deliberately. They span the most material variables across PPWR: metal versus plastic, food-contact versus non-food-contact, primary versus secondary packaging, and the differential applicability of Articles 7 recycled content, 8 biobased feedstock, 9 compostability and 50 Deposit Return Systems between the two.

Building both in parallel forced the methodology to be material-agnostic and format-agnostic — a discipline that pays off as the same approach extends to glass, paper and board, composite and other formats.

Approach.

1. Regulatory mapping before documentation

The starting point was not a template — it was a clause-by-clause mapping of every Annex VII evidentiary obligation across Articles 5 to 14, with each obligation tagged as either currently in force, pending secondary legislation, or conditional on packaging characteristics.

This mapping disciplined every subsequent decision in the dossier structure. It is also what prevents two of the most common compliance errors visible in early industry drafts: asserting compliance against obligations that do not yet have an enforceable standard, and missing obligations that are already in force because they sit in articles that have not been widely socialised.

2. A modular template architecture

We built a family of reusable templates with a shared structural spine — general description, components, schemes, standards and technical specifications, substance compliance, qualitative assessments and evidence register — and a material-specific layer for the sections that genuinely differ between formats.

The result is that a new packaging format can be onboarded by inheriting the spine and customising perhaps fifteen percent of the content, rather than starting from a blank document each time.

A particular point of attention was the qualitative-assessments section. PPWR Annex VII §2(e) expressly names Articles 6, 10 and 11; but Articles 7, 8, 9, 12 and 14 each carry their own “shall be demonstrated in the technical documentation” hooks under their own paragraphs.

Consolidating all of these under a single qualitative-assessments umbrella, in article-number sequence, gives the dossier a coherent narrative arc that an inspector can follow in one pass.

3. Evidence-chain integrity from supplier to declaration

The Annex VII dossier sits at the centre of a longer evidence chain: supplier declarations and certificates of analysis at the upstream end, the dossier itself at the centre, and the Annex VIII EU Declaration of Conformity at the downstream end.

We designed the three sets of documents to be mutually referencing — every claim in the Annex VIII DoC traces back to a section of the Annex VII dossier, and every section of the dossier traces back to a piece of supplier-side or laboratory-side evidence.

The hinge point is Article 5(6). PPWR explicitly disqualifies a bare “not intentionally added” statement as sufficient evidence of substance compliance. Many existing supplier declarations were drafted before this requirement entered force and use exactly that language.

Our approach builds a dedicated supplier compliance declaration template that forces the supplier to identify both the substantive compliance position — yes, no, or not applicable per Article 5 sub-paragraph — and the evidence type, whether an accredited-laboratory certificate of analysis or a documented process and risk assessment.

The template includes an explicit auditor-facing reminder that “not intentionally added” is insufficient on its own. This single document closes the most common evidentiary gap we encounter in supplier files.

4. Honest treatment of pending secondary legislation

Where the substantive evidentiary detail of an article depends on a Commission implementing act or harmonised standard that has not yet been published — the Article 7(8) recycled content methodology due 31 December 2026, the Article 6(4) design-for-recycling delegated acts due 1 January 2028, the Article 12(6) and 12(7) labelling implementing acts due 12 August 2026, and the Article 10(3) minimisation harmonised standard — the corresponding sub-section of the dossier is built as a forward-looking introductory paragraph rather than as a placeholder for content that does not yet exist.

This is a deliberate discipline. It avoids the trap of asserting compliance against a standard that has not been adopted; it makes clear which sections are deliberately lean pending secondary legislation; and it leaves a natural expansion point for when each implementing act is published.

Dossiers built this way are designed to age, rather than to need rewriting every six months as the regulation matures.

5. Distinguishing legal terms of art from technical terms

PPWR uses several terms that have specific legal meanings under EU standardisation and conformity-assessment law — “harmonised standard” under Article 36, “common specification” under Article 37, “notified body” and “presumption of conformity”.

Each of these has a precise meaning that differs from how the same words are used in industry conversation. A standard issued by a recognised European standardisation organisation is not automatically a “harmonised standard” under PPWR; only a standard whose reference has been published in the Official Journal of the EU under PPWR specifically qualifies.

We treat these distinctions with care throughout the documentation, because a dossier that conflates technical and legal terms is one that an auditor will reject on a first read.

Deliverables produced.

The engagement produced a coherent set of reusable assets, plus the two populated dossiers themselves.

Both dossiers carry the supplier evidence chain back to the upstream packaging manufacturers’ technical specifications, declarations of compliance and analytical evidence.

Approach to due diligence.

Several specific decisions during the engagement illustrate the depth of regulatory diligence applied.

• Recognising that a supplier declaration titled “Declaration of Conformity with the REACH Regulation” does not, by its title alone, satisfy PPWR Article 5(4) — REACH and PPWR have different substantive scopes. Acceptance of such a declaration required reading the actual clause and confirming that it explicitly addressed the four heavy metals at the 100 mg/kg sum threshold of Article 5(4).
• Verifying that the UNE-EN 15343:2008 recycled-content traceability standard referenced by a polymer supplier was a European standard but had not been harmonised under PPWR. Citing it in Section 4.3 “Other technical specifications” rather than Section 4.1 “Harmonised standards” avoids a category error that an auditor would catch immediately.
• Applying the Article 7(5)(b) plastic-part exemption correctly when assessing recycled-content obligations for the metal canister. Where a primarily-metal packaging unit incorporates a minor plastic part, the 5%-by-weight threshold determines whether Article 7 applies to that part — and the dossier records the determination explicitly rather than skipping the article.
• Treating environmental claims under Article 14 as a conditional obligation. Article 14 imposes documentation duties only where claims are made on the packaging. If no claim is made, the section is correctly marked Not applicable. The trigger condition for permitted claims is “exceeds the applicable PPWR minimum requirement” — a subtle but important distinction often missed in early dossiers.
• Maintaining a clean separation between the technical dossier and the operational compliance register. Country-by-country Deposit Return System tracking, EPR scheme registrations and member-state-specific labelling artwork are operational data, not Annex VII technical evidence. Holding them in the dossier makes it brittle; holding them in a separately maintained register makes them updatable as schemes go live, without disturbing the technical file.
• Distinguishing analytical methods from compliance standards. Where a supplier provided heavy-metal migration data generated using EN 71-3 — a standard harmonised under the Toy Safety Directive, not under PPWR — we recorded it as a reliable analytical method under Article 38 of PPWR, in Section 5 of the dossier alongside the substance evidence, rather than as a “standard applied” in Section 4.

Outcome.

The packaging user now holds a defensible documentation set for the two pilot formats, a reusable methodology for onboarding further formats, and a clear roadmap of which sections expand as the Commission completes the secondary legislation between 2026 and 2030.

The Annex VII dossiers and the Annex VIII declarations are aligned with each other, the supplier evidence chains are explicit, and the lean-versus-detailed treatment of each article is rationalised against the current state of the regulation.

The approach is deliberately conservative on assertions and deliberately specific on evidence. It is designed to age well — to remain accurate as harmonised standards are published, as recycled-content methodologies are adopted, and as Deposit Return Systems go live across the Member States — without requiring a fundamental rewrite at each milestone.

The investment made in the methodology pays back across every subsequent format the same operator brings into PPWR scope.

Key takeaway.

PPWR Annex VII documentation should not be treated as a static template exercise. A defensible dossier needs regulatory mapping, supplier-evidence discipline, careful legal terminology, and a structure that can mature as secondary legislation is adopted.