European Union (CPNP)

Responsible Person vs Distributor Duties Under 1223/2009

A plain breakdown of what an EU Responsible Person owes versus what a distributor owes, so brands don't accidentally take on liability they didn't budget for.

Diane R.4 min read

A brand owner emailed me last month convinced their EU importer was "handling everything." Turns out the importer thought the brand's US-based founder was the Responsible Person. Nobody had actually filed a PIF, nobody had a signed CPSR, and the product had been on shelves in Germany for four months. This is the exact confusion Regulation (EC) No 1223/2009 tries to prevent by naming specific roles with specific duties, and it's worth knowing which one you are before you ship a single unit.

The Responsible Person carries the weight

Under 1223/2009, every cosmetic product placed on the EU market must have a Responsible Person (RP), and that RP has to be established within the EU. This isn't a formality. The RP is the entity the authorities go to first if something goes wrong, and their job list is long:

  • Notify the product through the CPNP portal before it goes on sale
  • Keep a Product Information File (PIF) available, including the formula, manufacturing method, and labeling
  • Hold a Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor
  • Monitor the product once it's on the market and act on serious undesirable effects
  • Ensure the label meets every EU labeling requirement, including the mandatory allergen list

If you're a brand based outside the EU, you cannot be your own RP unless you have a genuine EU establishment. You need to appoint one, whether that's a subsidiary, a distributor willing to take the role, or a third-party RP service.

What a distributor actually owes

A distributor is a different, narrower role. In EU cosmetics law, distributing means making a product available on the market without being the manufacturer or importer. A pure distributor's obligations are lighter:

  • Check that a label is present and legible before making the product available
  • Check that the language requirements of the member state are met
  • Check that the mandatory information (RP name, ingredient list, date of minimum durability where relevant) actually appears on the pack
  • Not distribute a product past its expiry, and not tamper with it in a way that could compromise compliance

Crucially, a distributor is not on the hook for the CPSR, the PIF, or the CPNP notification. They're checking that someone else already did that work, not doing it themselves.

Where the line blurs

Here's the trap. If a distributor does something that changes how the product is marketed, like translating the label themselves, repackaging it under their own brand, or altering it in a way that could affect compliance with the regulation, EU law treats them as taking on RP obligations for that product. Private label and white label arrangements are a classic place this happens. A retailer buys bulk product, slaps its own name on the jar, and suddenly it may be the RP whether it planned to be or not.

The same applies to parallel importers who reformat packaging for a new market. The moment you're not just passing the product along untouched, ask whether you've stepped into RP territory.

A quick way to check where you stand

Question If yes, you're likely...
Do you sign the CPSR or commission the safety assessment? Responsible Person
Do you control the CPNP notification content? Responsible Person
Do you only check the label and pass the product on unchanged? Distributor
Do you relabel, repackage, or rebrand the product? Likely taking on RP duties
Are you established outside the EU with no EU legal entity? You need to appoint an RP, you cannot be one

Why this matters before launch, not after

Getting this wrong isn't just a paperwork problem. If a product is recalled or an authority asks for the PIF and nobody can produce it, the entity legally holding the RP role is the one facing enforcement action, not whoever happens to be easiest to find. Small brands sometimes assume their EU-based fulfillment partner is quietly acting as RP. Ask them directly and get it in writing. It should be named on the label anyway, since the RP's name and address are mandatory label elements.

If you're expanding into the EU and still sorting out who holds which role, it's worth mapping your whole distribution chain against this list before you file anything. Cosmetic Comply is built for the notification and ingredient-screening side of this process today for the Canadian market, with EU support in development, but the RP-versus-distributor question is one you'll want settled with your own legal counsel or a dedicated RP service regardless of which tool handles your filings.

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