EU Cosmetics Responsible Person vs CPSR

European Union · Cosmetics Regulation (EC) No 1223/2009 · Reviewed August 25, 2026.

Responsible Person, CPSR, PIF and CPNP compared

Who becomes the EU Responsible Person?

Article 4 of Regulation (EC) No 1223/2009 assigns the role according to who manufactures, imports, brands or materially changes the product. The arrangement must be established product by product; a postal address bought in isolation does not complete the compliance work. Read Article 4 in the consolidated Regulation.

1. EU manufacturer. For a product manufactured in the EU and not later exported and re-imported, the EU-established manufacturer is the Responsible Person by default. The manufacturer can appoint another EU-established person by written mandate, and that person must accept in writing. Article 4(3).
2. Manufacturer outside the EU for an EU-made product. If the manufacturer is outside the EU but the product is manufactured in the EU and not re-imported, the manufacturer must designate an EU-established person in writing. Article 4(4).
3. Imported product. Each importer is the Responsible Person for the cosmetic product it places on the market unless it appoints another EU-established person by written mandate and that person accepts in writing.
4. Distributor using its own name or changing the product. A distributor becomes the Responsible Person when placing the product under its own name or trademark, or when modifying a product in a way that may affect compliance. Translating label information alone is not treated as such a modification by Article 4(6).

Private label does not remove the role question. The contract, label, import route and actual market-placement chain determine who occupies the legal role. Confirm the named legal entity and the products covered before relying on a service agreement.

Responsibilities of the Responsible Person

Article 5 makes the Responsible Person the compliance point for the obligations listed across the Regulation. The role is broader than storing a PIF or submitting a portal form. It includes ensuring product safety, good manufacturing practice, safety assessment, the PIF, sampling and analysis where applicable, restrictions on substances, notification, labelling, claims, serious-undesirable-effect reporting and information for authorities.

If the Responsible Person has reason to believe that a product is not compliant, Article 5 requires appropriate corrective measures to bring it into conformity, withdraw it or recall it. Where a product presents a risk to human health, the relevant national authorities must be informed. A contract can allocate operational tasks, but it does not turn an incomplete product file into a compliant one. Read Article 5.

Who prepares and signs the CPSR?

Article 10 requires the Responsible Person to ensure that a cosmetic product undergoes a safety assessment and that a CPSR is set up before market placement. Annex I divides the report into Part A, the cosmetic product safety information, and Part B, the cosmetic product safety assessment.

The assessment in Part B must be performed by a person with the formal qualifications specified in Article 10(2): a diploma or other evidence of formal qualification awarded after university-level theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State. See Article 10 and Annex I.

How the CPSR fits inside the PIF

The CPSR is one component of the PIF, not a substitute for the complete file. Article 11 requires the PIF to contain:

• a description that clearly attributes the file to the cosmetic product;
• the CPSR required by Article 10;
• a description of the manufacturing method and a statement on compliance with good manufacturing practice;
• proof of the effect claimed for the product where justified by the nature or effect of that product; and
• data on animal testing performed by the manufacturer, its agents or suppliers in relation to development or safety assessment, including testing used to meet third-country requirements.

The Responsible Person must keep the PIF readily accessible in electronic or other format at the address shown on the label. The retention period is ten years after the last batch of the product was placed on the market. See Article 11.

CPNP happens after the evidence chain is ready

Article 13 requires the Responsible Person to submit specified product information electronically to the European Commission before placing a cosmetic product on the market. The Commission describes CPNP as a free-of-charge online notification system and makes submitted information available to competent authorities and poison centres for market surveillance, analysis, evaluation and medical treatment.

A consultant can charge for collecting, checking and submitting the data, but there is no Commission portal fee. A CPNP reference does not prove that the formula is safe, the CPSR is complete, the label is compliant or the product has been approved. The Responsible Person must still maintain the underlying file and update the notification where the Regulation requires changes. Read the Commission’s CPNP guidance.

Minimum sequence before an EU launch

1. Confirm the product and market. Verify that the product is a cosmetic under the EU definition and that the launch territory is the EU rather than Great Britain.
2. Map the responsible-person route. Identify the EU manufacturer, importer or appointed EU entity and record the written mandate where required.
3. Assemble product evidence. Collect the exact formula, raw-material data, manufacturing and GMP information, packaging details, microbiological and stability evidence, claims support and final label artwork.
4. Complete the safety assessment. Give the product-specific evidence to a qualified assessor and resolve gaps before Part B is signed.
5. Complete and control the PIF. Include the CPSR and the other Article 11 elements, establish the accessible address and define update responsibility.
6. Check the label and claims. Confirm the Responsible Person name and address, required particulars, language requirements and support for claimed effects.
7. Submit the CPNP notification. Notify before market placement and retain the submission record with the controlled product file.
8. Run post-market controls. Monitor new safety information, complaints and serious undesirable effects; update, correct, withdraw or recall when required.

Common buying mistakes

When outside support is useful

External help can be useful when no EU entity in the supply chain can take the Responsible Person role, when the product evidence needs a qualified safety assessor, when the PIF has material gaps, or when testing, artwork and notification work needs coordination. Before buying a complete package, inventory the evidence already held and ask for a written gap review.

XrdaGrid provides general informational content about cosmetics regulation and service scopes. This page is not legal advice, does not assess a formula or product, and does not certify regulatory or marketplace compliance.