EU regulatory guide

Private label: whose compliance is it?

White label and private label brands often assume the factory's paperwork travels with the product. It does not. The moment your name goes on the jar, most of the compliance burden becomes yours, and the difference between reselling and rebranding decides everything.

Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 27 July 2026

Do I need my own compliance if I private-label in the EU?

Yes. Under Article 4, a distributor who places a product on the market under its own name or trademark steps into the responsible chain for that product. Your branded product needs its own Responsible Person arrangement, its own Product Information File and its own CPNP notification.

Selling a manufacturer's product unchanged under their brand makes you a distributor with lighter duties. Putting your brand on it makes it your product in the regulation's eyes; the roles are drawn in Regulation (EC) No 1223/2009.

Article 4 of Regulation 1223/2009 on EUR-Lex with the responsible person requirement highlighted — Article 4 of Regulation (EC) No 1223/2009, where branding decides responsibility, as published on EUR-Lex, consolidation of 1 May 2026 (02009R1223, EN, 040.001). Captured 26 July 2026. View the official text.

Can I use the manufacturer's CPSR and PIF?

Not as they stand. The PIF is product-specific and includes your label, your claims and your notification, none of which exist in the factory's file. The manufacturer's formula and test data feed your CPSR, so with a cooperative supplier the assessment is fast, but the file must be yours.

The practical path: ask the manufacturer for the exact formula with percentages, raw material safety data sheets, GMP evidence and existing test reports, the same list as the CPSR inputs. A supplier who will not share them with your assessor under confidentiality is telling you something.

Who is the Responsible Person for a white-label product?

Whoever you appoint, and it should not default to the factory. The manufacturer can be the RP only if EU-established and willing; tying the role to your supplier ties your market access to that commercial relationship, the same trap as distributor-held appointments.

One default to know: for a product manufactured inside the EU, the regulation makes the EU manufacturer the Responsible Person unless a written mandate appoints someone else, so without paperwork your factory holds the role whether either of you noticed or not. An independent appointment keeps your notifications and file portable when you change suppliers, which private label brands do more often than most. The mechanics are in the EU RP guide and the switching guide.

Does the same logic apply on marketplaces and in other markets?

Yes. Amazon asks the brand owner for Responsible Person details, not the factory. Great Britain mirrors the EU rules; under MoCRA the responsible person on the US label carries the listing duty even when a contract manufacturer registers the facility. Branding decides responsibility everywhere.

The reseller side of the question, what you can demand from a wholesaler when you are not rebranding, is covered in the marketplace guide. For your own range, request a quote with your supplier situation in the notes.

Sources

Primary sources cited in this guide. Regulatory status last verified 27 July 2026.