PPWR 10 – Who Is Responsible for Packaging Compliance?

Your Supplier Sent You the TDS, the Food-Contact Declaration and a "PPWR Certificate." Are You Compliant?

A converter sends a customer the packaging's technical data sheet, the TDS, the food-contact declaration and, sometimes, a private certificate from a lab or a certification scheme stating "PPWR compliant."

The customer replies: "Great, we're compliant."

Not necessarily. Because the questions that actually matter legally are different ones: who is, under PPWR, the manufacturer of this packaging? Who carries out the conformity assessment? Who holds the technical file? Who signs the EU Declaration of Conformity? A solid set of technical documents doesn't answer any of these on its own — and if nobody in the chain knows who the legal manufacturer is, the compliance file risks belonging, in practice, to no one.

That is what PPWR 10 is about: not what the packaging must contain, but who is answerable for it.

Who Is, Legally, the "Manufacturer" of the Packaging?

This is where most of the confusion in the industry originates. The "manufacturer" under PPWR is not automatically whoever ran the moulding machine, and the PPWR wording doesn't reduce to "whoever owns the brand" either. The legal test, as set out in the Commission's Guidance, looks at who manufactures or has the packaging designed or manufactured, under whose name or trademark it is manufactured, and the packaging type and the actual commercial flow.

In practice, the distinction depends on the packaging type. For sales packaging and grouped packaging, the manufacturer will normally be the economic operator that carries out the final processing step and fills the packaging with its own product before placing it on the Union market — in practice, the brand owner or the filler, not the converter who supplied the empty bottle. For transport packaging, service packaging in its final form and primary-production packaging, the manufacturer will normally be the company that manufactures the packaging itself — unless the packaging clearly carries the user's own name or trademark.

The baseline rule holds: for a given packaging unit placed on the market, there is only one manufacturer under PPWR. It is not the commercial contract that decides who this is — it is the test above.

Manufacturer vs. Producer — Two Roles, Two Different Tests

This is a distinction worth fixing once and for all. "Manufacturer" is a technical role — who is answerable for the packaging's conformity with Articles 5–12. "Producer" is a waste-financing role — who pays into and reports under the extended producer responsibility (EPR) scheme, in the Member State where the packaging becomes waste. The same company can hold both roles, but the legal tests differ, and for a packaging item placed on the market in several Member States there can be several "producers" (one per market), while there is only ever one "manufacturer."

Article 15 — Obligations of Manufacturers

The manufacturer may place on the market only packaging that complies with Articles 5–12. Before doing so, it must carry out (or have carried out) the conformity assessment required by Article 38, prepare the technical documentation required by Annex VII, and draw up the EU Declaration of Conformity required by Article 39.

Documentation must be kept for 5 years from placing on the market for single-use packaging, and 10 years for reusable packaging. The manufacturer must maintain procedures so that serial production stays compliant, respond to a reasoned authority request within 10 days, and — critically for converters and brand owners alike — reassess conformity whenever a design, material or specification change may affect it.

What Happens If the Packaging's Material or Design Changes?

This reassessment duty is not a best-practice recommendation — Article 15 requires it explicitly. The manufacturer must take into account changes in packaging design, in packaging characteristics, in harmonised standards, and in applicable technical specifications.

In practice: a change in polymer grade, a new masterbatch, a different closure, an added barrier layer, a new sleeve, or a different recycled-content source may require reassessment, where conformity can be affected. Not every minor change automatically invalidates a prior conclusion — but any change with a genuine potential effect on conformity needs to be assessed, not just logged administratively. Whoever is the manufacturer at the time of the change is the one who must reassess — which is why visibility into material or design changes, across the chain, matters even for operators who are not themselves the manufacturer.

Suppliers — Article 16

Suppliers must give the manufacturer all the information and documentation needed to demonstrate compliance, including the relevant Annex VII technical documentation required under Articles 5–11. This can be provided on paper or electronically, and food-contact documentation must be included where relevant.

The critical distinction: the supplier provides the evidence. The manufacturer draws the final conformity conclusion. A supplier declaration does not replace the manufacturer's own conformity assessment — it is one input into that assessment, not a substitute for it.

Authorised Representative — Article 17

A manufacturer may appoint an authorised representative under a written mandate, who may carry out the tasks specified in that mandate. What may not form part of the mandate: the manufacturer's core Article 15(1) duty to ensure conformity, and the duty to draw up the Annex VII technical documentation required under Articles 5–11.

An authorised representative may, however, hold the EU Declaration of Conformity and the technical documentation for authorities, and carry out administrative and cooperation tasks set out in the mandate, with the same retention periods — 5 years for single-use packaging, 10 years for reusable. An authorised representative does not "take over" PPWR compliance — it administers the file, it does not create it.

Importers — Article 18

The importer may place on the market only packaging that complies with Articles 5–12. Before doing so, it must ensure that the manufacturer has carried out the conformity assessment, that technical documentation exists, that the packaging is correctly labelled, that the required documents exist, and that manufacturer-identification requirements are met. The importer must also add its own identification and contact details to the packaging, or use the permitted digital or documentary alternatives where applicable.

The key practical message: "my Chinese or Turkish supplier says it's PPWR compliant" is not, by itself, sufficient. The importer has its own verification duty — it cannot simply pass through a non-EU supplier's unverified claim.

Distributors — Article 19

The distributor does not repeat the manufacturer's conformity assessment. Before making packaging available, it must verify that the producer responsible for EPR is registered where required, that the packaging is labelled in accordance with Article 12, and that the manufacturer and importer have met their own identification requirements. The distributor must act with due care, and if it has reason to believe the packaging is non-compliant, it cannot simply keep selling it. It would be inaccurate to say distributors have no PPWR obligations — the duty is lighter than the manufacturer's or importer's, but it is real.

Fulfilment Service Providers — Article 20

A new role, most relevant for e-commerce: fulfilment service providers must ensure that warehousing, handling, packing, addressing and dispatch do not compromise the packaging's compliance with Articles 5–12. This is an operational duty, distinct from the manufacturer's or importer's, but worth knowing for any company relying on third-party fulfilment warehouses to ship to EU consumers.

Article 21 — When an Importer or Distributor Becomes the Manufacturer

An importer or distributor becomes, under PPWR, the manufacturer of the packaging when it places the packaging on the market under its own name or trademark, or when it modifies packaging already placed on the market in a way that could affect compliance. From that point, it takes on the full set of manufacturer obligations under Article 15.

Not every minor change triggers this reclassification — updating printed artwork alone, for instance, is not automatically a compliance-affecting modification. But the line between a "cosmetic" change and one that is "compliance-affecting" is a case-by-case judgment, not a fixed rule, and where there is genuine doubt, the cautious approach is to treat it as triggering reassessment.

The Micro-Enterprise Exception — A Role Allocation, Not an Exemption

Where the person who has packaging designed or manufactured under its own name or trademark is a micro-enterprise, and the supplier of that packaging is established in the Union under the conditions PPWR sets out, the supplier may be considered the manufacturer for Article 15 purposes instead. It matters not to oversimplify this into "micro-enterprises are exempt from PPWR" — they are not. This is a reallocation of the manufacturer role to the supplier, under specific conditions, not a general exemption from the regulation.

Conformity Assessment — Article 38 and Annex VII

The standard procedure is Module A — internal production control. In practice, this means manufacturer self-assessment. The manufacturer may have testing or assessment work carried out by a laboratory, a certification scheme, or another technical expert — but the legal responsibility stays entirely with the manufacturer.

PPWR does not, as a general rule, require notified-body certification, third-party certification, or CE marking for packaging. This is one of the most common misunderstandings in the market, and it's worth stating plainly: no, your packaging does not need a "notified body" for the standard procedure.

Is There a "PPWR Certificate"? No.

Regulation (EU) 2025/40 does not create, and does not recognise, any official document called a "PPWR certificate." It's worth clearly separating five different things: the EU Declaration of Conformity, the technical documentation, the test report, the supplier declaration, and a private, third-party-issued certificate.

A private certificate can be useful supporting evidence. It is not the legal conformity instrument PPWR requires. The core idea: PPWR compliance is not a certificate you buy. It is a chain of evidence culminating in the manufacturer's own conformity assessment and its EU Declaration of Conformity.

Technical Documentation — Annex VII

Annex VII requires technical documentation that enables assessment of the packaging's conformity. It must include a general description of the packaging and its intended use, relevant design and manufacturing information, the relevant materials and components, the requirements applied, an analysis of non-conformity risks, and the evidence needed to demonstrate the applicable Articles 5–12 requirements.

In practice, this documentation often includes supplier declarations, test reports, a recyclability assessment, recycled-content evidence, a minimisation assessment, reuse evidence and labelling data — but each of these is evidence tied to the specific applicable requirement, not a fixed, universal checklist for every packaging.

EU Declaration of Conformity — Article 39 and Annex VIII

The declaration follows the Annex VIII model, confirms that the Articles 5–12 requirements are met, is kept continuously updated, must be available in the languages required by the Member State concerned, and is drawn up under the manufacturer's own responsibility. Annex VIII covers the packaging's unique identification, the manufacturer's name and address, a statement of sole responsibility, a description of the packaging, the applicable Union legislation, the relevant harmonised standards or specifications, and the signature, place and date.

The manufacturer draws up one written declaration per packaging type — not a separate declaration for every individual unit. The declaration does not need to be printed on the packaging itself; a copy must, however, be made available to authorities on request.

Components vs. the Final Packaging

It isn't accurate to say, categorically, that a component never needs its own declaration of conformity — it depends on the situation. What is clear is that the final conformity conclusion attaches to the packaging actually placed on the market by its manufacturer. For a PET bottle with a cap, a label and adhesive, the component suppliers provide data under Article 16, and that evidence feeds into the finished packaging's manufacturer's technical file — without each component, taken on its own, automatically generating its own EU Declaration of Conformity.

Converter vs. Brand Owner — the Right Question

Neither "the converter is always responsible" nor "the brand owner is always responsible" is a correct answer. The right question is: who is the PPWR manufacturer for this specific packaging flow?

For sales and grouped packaging, the answer is normally the brand owner or the company that fills the product — whoever performs the final processing step before market. For transport packaging or service packaging in its final form, the answer is normally the converter that physically manufactures the packaging, unless it carries the customer's name or trademark.

Even when it is not the manufacturer, the converter still carries substantial obligations under Article 16 — it must provide the manufacturer with all the data needed for the compliance file. Not being the "manufacturer" under PPWR does not mean having no responsibility in the chain at all.

Private Label

A typical example: a retailer sells a product under its own brand. The packaging is made by Company A, the product is filled by Company B. Who is the manufacturer under PPWR? Applying the test above — including control over the name or trademark — the answer will normally be the retailer, regardless of which company physically manufactured or filled the packaging, unless the micro-enterprise exception described above applies. This isn't a conclusion that collapses to one sentence without checking the legal test — but in the overwhelming majority of private-label cases, that is where it lands.

Contract Manufacturing

Commercial contracts can allocate data obligations, costs, warranties, indemnities, change-notification duties and commercial liability between the parties. What they cannot do is rewrite who the Regulation treats as the manufacturer, the importer, or the distributor. A clause stating "the supplier is responsible for PPWR compliance" binds the parties to each other commercially, but it does not change who a market surveillance authority can act against directly.

Imported Empty Packaging

Example: a Romanian company imports empty bottles from Turkey, fills them in Romania, and places the packaged product on the EU market. There is no single answer that holds universally — it depends on whose name or trademark the finished product carries, whether the imported empty bottle had itself already been placed on the EU market as such, and who actually has the packaged product manufactured. In practice, the same Romanian company can hold several roles at once — importer for the empty bottle, and manufacturer for the finished, branded product it places on the market.

Imported, Already-Packaged Goods

A different scenario: a Romanian company imports shampoo that is already packaged in China. At minimum, the Romanian company is the importer and must carry out the verification required under Article 18. If it rebrands or modifies the packaging in a way that affects compliance, Article 21 can also make it the manufacturer — stacking both roles on the same company.

The Link to the PPWR 04–09 Series

PPWR 04 answered who proves recyclability. PPWR 05, who proves recycled content. PPWR 06, who proves minimisation. PPWR 07, who checks restricted formats. PPWR 08, who proves reusability and who operates the reuse system. PPWR 09, who ensures correct labelling. PPWR 10 answers the question that ties them all together: who owns the final conformity conclusion. The answer stays constant across every one of them — the legally identified manufacturer owns the final conclusion on Articles 5–12, but the evidence behind it comes from multiple suppliers and operators across the chain.

The Supply Chain, in Data

The raw-material supplier generates composition data. The recycler or compounder adds recycled-content and traceability data. The converter adds design, weight and process data. Whoever fills the product, or the brand owner, integrates all of it into a conformity conclusion. The importer verifies and adds its own identification. The distributor verifies, in turn, a narrower set of elements. Every link generates and passes data forward — but not every link signs the final declaration.

Non-Conformity

If a manufacturer finds that its packaging is non-compliant, it must take corrective action and cooperate with the authorities. Importers and distributors, in turn, must not continue to place on the market, or make available, packaging they have reasonable grounds to believe is non-compliant. It is not the purpose of this article to detail penalties — the principle simply stands: a confirmed non-conformity calls for action, not silence.

Romania

We have not yet identified an official, unified clarification clear enough to present as a definitive structure. We will therefore not name a Romanian authority as the market surveillance authority for PPWR until an official designation is clearly confirmed.

Common Misunderstandings

• "The converter is always responsible." False — it depends on the packaging type and whose name or trademark it carries to market; often it's the brand owner.
• "The brand owner is always responsible." Needs qualification — true in many sales-packaging cases, but not universally.
• "My supplier gave me a PPWR certificate, so I'm covered." False — no such official document exists; a private certificate is, at most, supporting evidence.
• "PPWR requires third-party certification." False — the standard procedure is manufacturer self-assessment, Module A.
• "A lab report is the Declaration of Conformity." False — the report is possible supporting evidence; the declaration is a distinct document, signed by the manufacturer.
• "Every packaging component needs its own PPWR declaration." False, generally — the declaration attaches to the finished packaging; components supply data, not separate declarations.
• "If I import from China, the supplier's declaration is enough." False — the importer has its own, independent verification duty.
• "A contract can transfer all PPWR legal responsibility." False — a contract allocates commercial liability; it does not rewrite the roles the Regulation establishes.
• "Distributors have no PPWR obligations." False — they have a due-care duty and a defined set of checks.
• "Food-contact compliance means PPWR compliance." False — these are separate legal regimes with different requirements.

What a Converter Should Provide Its Customer

• Material and component specification.
• Packaging composition and weight.
• Recycled-content evidence, where relevant.
• Relevant test data.
• Design-for-recycling (DfR) relevant information.
• Food-contact documentation, where applicable.
• Technical drawing and batch identification.
• Notification of relevant material or design changes.

The exact package depends on the converter's legal role and on the specific requirement each document supports — not every item is mandatory in every situation.

What a Converter Should Ask Its Customer

• The intended use and the product being packaged.
• The target Member States / markets.
• Performance requirements and shelf life.
• Barrier requirements and transport conditions.
• Deposit-return system (DRS) status.
• Reuse-system status, if any.
• Who is responsible for the final artwork.
• Who will act as the manufacturer under PPWR.

Many PPWR conclusions cannot be reached from material data alone — they also depend on application context that only the customer holds.

What a Supply Contract Should Cover — a Recommendation, Not a PPWR Requirement

• Data-sharing obligations relevant to compliance.
• Notification of material or design changes.
• Access to test data and recycled-content evidence.
• Document-retention periods aligned with the 5/10-year window.
• Clear allocation of responsibility for artwork.
• A mechanism for future regulatory changes.
• Cooperation on corrective action.
• Contractual liability allocation between the parties.

None of these clauses is mandated by PPWR itself. A contract allocates commercial risk between the parties — it cannot rewrite the roles the Regulation itself establishes.

What Companies Can Do Now

Do now: establish, in writing, for each product line, who is the PPWR manufacturer — the packaging-type and name/trademark test above decides this.

Prepare now: the Article 16 data hand-off structure, to and from your direct suppliers and customers.

Ask your suppliers for: composition, recycled-content evidence, and data relevant to recyclability and minimisation.

Ask your customers for: intended use, markets, performance requirements, and DRS/reuse-system status.

Put into contracts: change notification, data access, retention periods, and clear allocation of artwork responsibility.

Monitor: any official designation of the competent authority in Romania.

Don't do yet: don't assume a private certificate, or a bare supplier statement, discharges your own compliance obligation.

The practical takeaway stays simple: build the compliance file before someone asks for it.

Conclusion

PPWR compliance is not a certificate you buy. It is a chain of evidence culminating in the conformity assessment and the signature on the EU Declaration of Conformity of the legally identified manufacturer. That manufacturer cannot be compliant without accurate data from suppliers, converters, fillers, importers and other operators across the chain — but it is the one that, in the end, answers for it.

OFFICIAL SOURCES

• Regulation (EU) 2025/40 on packaging and packaging waste.
• Commission Notice C(2026) 3702 — guidance document for Regulation (EU) 2025/40.
• Articles 3, 15–21, 38 and 39 of Regulation (EU) 2025/40.
• Annex VII — conformity assessment procedure.
• Annex VIII — EU Declaration of Conformity model.

CONTEXT SOURCES

• Industry analyses and guides on economic operator roles under PPWR, used for cross-checking the interpretation of the articles.
• Romanian-language publications on the state of national PPWR implementation, at the time of research.