If you manufacture, import, or place packaging on the EU market, the clock is running. From 12 August 2026, Regulation (EU) 2025/40 — the Packaging and Packaging Waste Regulation (PPWR) — requires every packaging type to be backed by a signed Declaration of Conformity (DoC). This is not a soft launch or a voluntary scheme: it is an enforceable market-access requirement with no grace period.
This guide walks you through every mandatory element of the DoC under Annex VIII, what must sit in your supporting technical file under Annex VII, who is legally responsible for signing, and the most common mistakes that will invalidate your declaration before an authority even opens it.
Quick Answer
A PPWR Declaration of Conformity is a legally binding, self-issued document in which the manufacturer confirms that a specific packaging type meets the sustainability requirements of Articles 5–12 of Regulation (EU) 2025/40. It must follow the model structure in Annex VIII, be backed by a technical file (Annex VII), and be issued per distinct packaging type — not as a blanket declaration for your entire product range. The mandatory deadline is 12 August 2026.
Who Is Legally Responsible for Issuing the DoC
Under Article 3 of PPWR, the ‘manufacturer’ is the legal person who makes the packaging — or has it made — and markets it under their own name or trademark. This means brand owners in private-label arrangements, importers who place packaging under their own brand, and distributors who substantially modify packaging all qualify as manufacturers and must issue the declaration themselves.
Appointing an Authorised Representative under Article 17 of Regulation (EU) 2025/40 is optional, not mandatory: a non-EU manufacturer may — by written mandate — designate one, and where they do, that representative may sign the DoC on the manufacturer’s behalf. A manufacturer with no EU presence may instead draw up the DoC and hold the technical file itself, provided it can produce both to market surveillance authorities on request. Either way, legal responsibility for the accuracy of the declaration and the completeness of the technical documentation always remains with the manufacturer. This is a separate matter from Article 45, which does mandate that non-EU producers selling packaging directly to end users in the EU appoint an EPR Authorised Representative in each relevant member state for extended producer responsibility purposes — a distinct, genuinely compulsory role covering different obligations.
Importers who do not modify or rebrand packaging do not create the DoC — but they must collect and retain a copy from each supplier, verify it covers the correct packaging type, and be able to present it to market surveillance authorities within ten days of a request. Accepting a generic ISO 9001 or food-contact certificate in place of a PPWR-specific DoC is one of the most common and costly errors importers make.
The Ten Mandatory Elements of Annex VIII
Each Declaration of Conformity must contain all ten elements specified in Annex VIII. Missing even one invalidates the document. Work through them in order when drafting.
1. Unique DoC identification number — an internal reference that lets you trace the declaration to a specific packaging type and version in your document management system. 2. Manufacturer’s name and address (or authorised representative if one has been appointed). 3. A statement confirming sole manufacturer responsibility — Annex VIII prescribes specific verbatim wording; do not paraphrase it. 4. Specific packaging identification — type, intended use, material composition, and batch or article number. 5. Declaration object — a description of the packaging and its materials, which may reference a technical drawing or photograph held in your technical file. 6. Conformity statement explicitly referencing Regulation (EU) 2025/40 and Articles 5–12. 7. References to harmonised standards or technical specifications used to demonstrate conformity — where harmonised EN standards have not yet been published, cite common specifications or your own validated internal methods. 8. Notified body details, where applicable — most packaging falls under Module A (internal production control), which does not require a notified body; only note this field if implementing acts require third-party involvement for your packaging type. 9. Supplementary information relevant to any conformity claim. 10. Manufacturer’s signature, place, and date — the signatory assumes personal legal liability for accuracy, so assign this to a named individual with the appropriate authority.
Each revision to your packaging — a change in recyclability grade, a new PFAS supplier, a modified layer composition — requires a reissued declaration with a new date. Version control is not optional; it is the mechanism that proves your declaration was current at the time of market placement.
Building the Technical File Behind the DoC
The Declaration of Conformity is the downstream output of a process, not the starting point. Behind every valid DoC sits a technical file structured under Annex VII (Module A — internal production control). Market surveillance authorities will request this file alongside the DoC, and one without the other constitutes a compliance gap.
Your technical file should contain: a general description of the packaging and its intended use; layer-by-layer material composition drawings or specifications; supplier declarations confirming the absence of restricted substances (heavy metals, PFAS); for food-contact packaging, analytical test reports from ISO/IEC 17025-accredited laboratories confirming PFAS limits; recyclability compliance assessments referencing the applicable grading criteria; recycled content documentation aligned with the 2030 and 2040 thresholds relevant to your plastic type; and any design verification calculations or third-party results that support a conformity claim.
One practical warning on PFAS testing: accredited laboratory lead times can run to several months. If you have food-contact packaging that has not yet been tested, commissioning samples late risks arriving after the 12 August deadline. Prioritise PFAS testing above any other documentation task.
Retention rules are straightforward: keep the DoC and technical file for five years from the last unit of single-use packaging placed on the market, or ten years for reusable packaging. The clock starts from market placement, not from the manufacture date.
Common Mistakes That Invalidate a PPWR Declaration of Conformity
One DoC for multiple variants is the most widespread error. Each distinct material specification — even a minor change in layer thickness or a different recycled-content percentage — requires its own declaration. Build a SKU-level mapping exercise before you draft a single document, so you know exactly how many declarations your portfolio requires.
Delaying the technical file is the second most damaging mistake. Many companies draft the DoC first and assume they can collect supporting evidence later. Regulators expect the technical documentation to pre-exist the declaration; a signed DoC without a corresponding technical file is legally hollow.
Accepting non-PPWR documents from suppliers — such as material safety data sheets, food-contact migration certificates, or ISO quality certificates — instead of a PPWR-specific DoC per Annex VIII will leave importers exposed. When writing to suppliers, specify the exact Annex VIII format and confirm that technical documentation under Annex VII also exists and is accessible.
PDF-only, unindexed storage creates an audit failure even when the documents themselves are correct. Market surveillance authorities expect on-demand retrieval; a structured digital system with version history, expiry tracking, and supplier linkage will serve you far better than email threads or shared drives.
Finally, language: the regulation requires the declaration to be maintained in a language easily understood by users in the relevant member state. If you are placing packaging across multiple EU markets, plan for translations of the core declaration text accordingly.
Explore more: EU packaging compliance guides.
PPWR Declaration of Conformity FAQs
Does every single product on a shelf need its own PPWR Declaration of Conformity?
No — the DoC is issued per packaging type, not per individual unit. One declaration covers all units of a specific packaging format with the same material composition and design. However, if you have two variants of the same product in different packaging materials or configurations, each variant needs its own declaration.
Must a non-EU manufacturer appoint an EU Authorised Representative to issue the Declaration of Conformity?
No — Article 17 of Regulation (EU) 2025/40 makes appointing an Authorised Representative optional, not mandatory. A non-EU manufacturer may, by written mandate, appoint an AR established in the EU, and that representative can then sign the DoC on the manufacturer’s behalf. Without one, the manufacturer can still draw up the DoC and hold the technical file itself, provided it can produce them to market surveillance authorities within ten days of a request — though in practice, having no EU-established point of contact makes that harder. This is different from Article 45, which does require non-EU producers selling packaging directly to EU end users to appoint an EPR Authorised Representative in each relevant member state — a genuinely compulsory, distinct obligation from the Article 17 compliance AR.
What is the difference between Module A and a notified body assessment under PPWR?
Module A — internal production control — is the standard conformity assessment route for most packaging under PPWR. The manufacturer conducts the assessment internally and holds the technical file without involving a third-party notified body. A notified body only becomes relevant if specific implementing acts issued by the European Commission require third-party verification for a particular packaging category; check whether any implementing acts apply to your packaging type before assuming Module A applies.
When do I need to reissue a Declaration of Conformity?
Any change that affects a compliance claim requires a new, dated declaration. This includes changes to material composition, recyclability grade, recycled-content percentage, a switch to a different PFAS-tested supplier, or any design modification that alters the packaging’s weight or volume. Version-controlled storage makes it straightforward to track which declaration was current at any given point in time.
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Photo by Arisa Chattasa on Unsplash.