When an Importer or Distributor Becomes the Manufacturer
The conversion rule: place packaging under your own name or trademark, or modify it in a way that may affect conformity, and the full manufacturer duty set lands on you. How businesses drift into it, and how to choose it deliberately.
The short answer
An importer or distributor is treated as the manufacturer - with the complete Article 15 duty set, file, declaration and all - in two situations: when it places packaging on the market under its own name or trademark, and when it modifies packaging already placed in a way that may affect its conformity with the regulation. The rule is automatic: it does not ask what the parties intended or what their contract calls them.
Its purpose is accountability without gaps. The name on the pack is the name the consumer, the retailer and the authority can find; the regulation makes that name carry the duties, so that responsibility can never be structured into invisibility between an anonymous maker and a branded seller.
How businesses drift into conversion
Three common drifts. The artwork drift: a distributor commissions its own label design for a maker's product, the brand hierarchy on the pack quietly inverts, and the 'distributor' is now the name the pack speaks in. The repacking drift: a wholesaler breaks bulk and repacks into own-branded units for smaller customers, creating new packaging units under its own name. The modification drift: a seller adds a component - a sleeve, a seal, a bundled insert - that changes the packaging unit's composition and therefore its grading and substance position.
None of these is prohibited; all of them are conversions. The failure is never the act, it is the missing file: converted businesses carrying manufacturer duties with distributor-grade paperwork. A role review inside any artwork, repacking or bundling project - five minutes with the conversion rule open - catches all three drifts at the cheap moment.
Choosing conversion deliberately
Many businesses should convert deliberately: own-brand is a legitimate model with margin logic, and the manufacturer duty set is survivable when it is planned - evidence rights in the supply contract, file assembly at specification stage, declaration signed by someone who has read it. The deliberate converter buys three things in its supply terms: the full composition and substance evidence, change notification with lead time, and cooperation duties for authority requests across the retention period. Priced into the contract, conversion is a manageable operating cost. Discovered at audit, it is a remediation programme.
Group and marketplace cases
Intra-group arrangements do not soften the rule: the group company whose brand the pack carries is the manufacturer, whichever group company physically makes or fills. Marketplace own-label programmes convert the platform's brand owner in the same way, and fulfilment arrangements where the platform's name becomes the pack's public identity deserve the same five-minute review. The question is always the same and always factual: whose name or trademark does this packaging go to market under, and who last modified it in a conformity-relevant way? Answer it per line, write the answer in the role register, and the conversion rule stops being a trap and becomes what it was designed to be - a labelling of responsibility that matches the label on the pack.
Contract language for the conversion boundary
Supply agreements touching own-brand or repacking should answer the conversion questions expressly. Whose trademark does the packaging bear, as placed? Who holds the technical file, and what evidence flows to the brand owner and on what trigger? Who signs the declaration - remembering the signature must be the manufacturer's, which after conversion is the brand owner, so the evidence clauses must be strong enough to sign against. What happens on specification change by the physical maker: notification period, re-approval right, and the treatment of stock in the pipeline.
Agreements that answer these four in writing convert cleanly and cheaply. Agreements that call one party 'distributor' while the artwork makes it the manufacturer are storing a dispute whose other party, when it matters, is not the counterparty but an authority - and authorities are not bound by the label the contract chose.
Primary sources on the record
- Regulation (EU) 2025/40 of 19 December 2024 on packaging and packaging waste, Official Journal text on EUR-Lex.
- European Commission, packaging waste topic page - guidance and act progress.
- Decision No 768/2008/EC of 9 July 2008 on a common framework for the marketing of products, text on EUR-Lex - the reference provisions for operator duties and the EU declaration of conformity.
- Regulation (EU) 2019/1020 of 20 June 2019 on market surveillance and compliance of products, text on EUR-Lex - the surveillance framework, including fulfilment service providers.
Legal status: Conversion rule in the operator chapter of Regulation (EU) 2025/40. Application position for this topic: From 12 August 2026.