A cosmetic product may be placed on the EU market only when a Responsible Person established within the European Union has been designated for it.
Who can be the Responsible Person
Depending on the supply chain, the role may fall to an EU manufacturer, importer, distributor in specific circumstances or another EU person designated by written mandate.
The role and address should be defined before finalising labelling, the PIF and CPNP notification. The agreement should distinguish Responsible Person duties from those of the manufacturer, brand owner and other partners.
Core regulatory obligations
The Responsible Person ensures compliance with safety, GMP, CPSR, PIF, CPNP, substance restrictions, labelling, claims and public-information requirements.
Merely possessing documents is not sufficient. Their completeness, consistency and connection with the actual marketed product must be reviewed.
Practical checkpoint
Every conclusion should be linked to the exact formula, document and market-material version. This makes it possible to demonstrate which evidence supported the regulatory decision.
Documentation access and authority communication
The PIF must be readily accessible in electronic or another format at the address indicated on the label. The competent authority must receive timely access to requested information.
The Responsible Person needs a process for regulatory correspondence, non-compliance assessment and documented decisions. Response time and expert availability are important contractual criteria.
Post-market responsibilities
The role continues after launch. Procedures are required for complaints, undesirable effects, serious undesirable effects, corrective measures, withdrawals and recalls.
Regulatory changes and new safety information must be assessed at product and portfolio level. The agreement should cover maintenance rather than only initial notification.
Selecting a service provider
Assess expertise, contractual scope, PIF access, business continuity, regulatory monitoring, complaint handling and emergency arrangements.
A change of Responsible Person requires a transfer plan covering documentation, labelling, CPNP records and responsibility during the transition.
Frequently asked questions
Must the Responsible Person be identified on the label?
Yes. The name or registered name and address form part of the mandatory particulars.
Can the Responsible Person be established outside the EU?
No. The Responsible Person must be established within the European Union.
Does responsibility end after CPNP notification?
No. Obligations continue for as long as the product is made available on the market.
Official sources and further reading
This article is for general information and does not replace an assessment of the specific product, formula and supply chain. Legislation and guidance may change after publication.