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EU Regulation 1223/2009
EU Responsible Person (RP)
Every cosmetic product placed on the European Union market must have a designated EU Responsible Person (RP). The Responsible Person serves as the primary contact for the competent authorities and is responsible for ensuring that the product complies with the applicable requirements of the EU Cosmetics Regulation.
This page explains the role and responsibilities of the EU Responsible Person. Information on equivalent requirements in other markets can be found on the respective country and regional pages.
Definition
What is a Responsible Person?
The Responsible Person is a legal or natural person responsible for ensuring that cosmetic products are:
- Safe for human health
- Fully compliant with EU cosmetics legislation
Only cosmetic products for which a legal or natural person is designated within the Community as 'responsible person' shall be placed on the market. (EU Regulation 1223/2009, Article 4.1)
Eligibility
Who can be an EU Responsible Person?
Any EU-based legal or natural person, including:
- Manufacturer (if EU-based)
- Importer
- Distributor
- A third party/company accepting the role in writing
There must be one RP per product for the entire EU market.
In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community. (EU Regulation 1223/2009, Article 11)
For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located. (EU Regulation 1223/2009, Article 17)
Key requirements
- RP must be established in the EU
- Must be formally designated in writing and accept the role
- RP can be the manufacturer (if established in the EU), a distributor, an importer, or a professional (designated) Responsible person
- Each product must be clearly linked to one RP
Who needs an EU Responsible Person (RP)?
An EU Responsible Person is generally required if you are:
- a manufacturer located outside the EU;
- a brand owner marketing cosmetics in the EU;
- an importer looking to appoint an independent RP;
- an online retailer placing products on the EU market.
Compliance duties
Core obligations
For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation. (EU Regulation 1223/2009, Article 4.2)
Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1), (2) and (5), as well as Articles 20, 21, 23 and 24. (EU Regulation 1223/2009, Article 5.1.)
They must ensure:
- A Product Information File (PIF) is available at a single EU address
- PIF is accessible to authorities for 10 years after the last batch
- Compliance with Safety (Article 3), Good Manufacturing Practice (Article 8), Safety assessment (Article 10), Notification via CPNP (Article 13), Labelling, claims, nanomaterials, CMR substances, etc.
Our EU Responsible Person service includes
- Appointment as your EU Responsible Person
- Maintenance of the Product Information File
- Communication with competent authorities
- Review of regulatory documentation
- Regulatory advice
- CPNP notifications
- Support during inspections
- Post-market surveillance support
- Management of serious undesirable effects
- Regulatory updates
Practical duties
Responsibilities in practice
01
Safety & regulatory compliance
Ensure product safety and regulatory compliance before and during market placement.
04
Substantiate product claims
Ensure the product claims are properly substantiated and in line with the cosmetic product definition.
07
Report serious undesirable effects
Report serious undesirable effects to the relevant competent authorities.
08
Take corrective actions
Take corrective actions (e.g., recall or withdrawal) if non-compliance occurs.
09
Cooperate with authorities
Cooperate with competent authorities upon request.
Why independent RP
Why appoint an independent Responsible Person?
Why independent RP
Why appoint an independent Responsible Person?
Many companies choose an independent RP because it:
- provides a single point of contact with authorities;
- simplifies market access across the EU;
- avoids transferring regulatory responsibility to importers or distributors;
- allows greater control over regulatory documentation;
- provides ongoing regulatory expertise.
Our process
How our Responsible Person service works
01
Sign Agreement
Sign the Responsible Person agreement.
02
Review Documentation
Review your product documentation.
03
Identify Requirements
Identify any missing compliance requirements.
04
Complete PIF
Complete the preparation of the Product Information File (PIF).
05
Notify Through CPNP
Notify the product through CPNP.
06
Provide Ongoing Support
Continue supporting you after market launch.
Related services
Related services
CE.way can offer various services related to EU Responsible Person. We can offer:
Client reviews
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"We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced."
"We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services."
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