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For all companies wishing to place cosmetic products on the European Union market, the appointment of a Responsible Person (RP) is a mandatory legal requirement. This obligation is clearly defined under the EU Cosmetics Regulation (EC) No 1223/2009.
The Responsible Person is the authorized natural or legal entity responsible for ensuring that a cosmetic product is placed on the market safely, in compliance with legislation, and in a manner that protects consumer health.
The Responsible Person may be:
A manufacturer established within the EU
An importer established within the EU
An authorized representative appointed in writing by the manufacturer or importer
For non-EU manufacturers, typically an independent regulatory or compliance consultancy
Companies established outside the EU must work with a Responsible Person located within the EU in order to place their products on the EU market.
The Responsible Person guarantees that every cosmetic product placed on the market is safe for human health. This includes:
Compliance of the product formulation with legislation
Verification of prohibited and restricted substances
Performance of a cosmetic safety assessment
The RP is responsible for verifying that products are manufactured in accordance with ISO 22716 Cosmetic GMP standards.
This verification is based on:
Manufacturing site audits
GMP certificates
Technical documentation
The Responsible Person:
Prepares a complete PIF
Retains the PIF for at least 10 years after the product has been withdrawn from the market
Ensures immediate accessibility to competent authorities upon request
The PIF must include:
Cosmetic Product Safety Report (CPSR)
Formulation details
Test reports
Label samples
Evidence supporting product claims
Before placing a product on the EU market, it must be notified via the Cosmetic Products Notification Portal (CPNP).
The notification includes critical information such as:
Product formulation
Labeling details
Responsible Person information
and must be completed prior to market placement.
The Responsible Person ensures that product labeling fully complies with EU legislation.
Key elements reviewed include:
INCI ingredient list
Nominal content
PAO / Expiry date
Warnings and directions for use
Responsible Person name and address
Cosmetic product claims must:
Not be misleading
Be scientifically substantiated
Comply with the Common Criteria for Cosmetic Claims (EU)
The Responsible Person reviews and verifies the compliance of all marketing and advertising claims.
The Responsible Person:
Monitors product safety while on the market
Notifies competent authorities in cases of Serious Undesirable Effects (SUEs)
Manages product recall processes when necessary
The RP ensures traceability of:
Production batches
Manufacturing locations
Markets where the product is placed
and acts as the direct point of contact with official supervisory authorities.
Without a Responsible Person:
❌ Products cannot be placed on the EU market
❌ Serious regulatory sanctions may be imposed during inspections
❌ Products may be withdrawn or recalled from the market
The Responsible Person is the fundamental guarantee that cosmetic products are placed on the EU market in a legal, safe, and transparent manner.
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