What is a Responsible Person?
A Responsible Person is a mandatory designation for every cosmetic product to be placed on the European Union market. This Responsible Person is legally responsible for ensuring that the product complies with EU legislation, particularly the safety requirements.
The EU Cosmetic Regulation (EC) No 1223/2009 mandates that every cosmetic product placed on the EU market must have a designated Responsible Person (RP) to ensure compliance with safety and regulatory requirements. Our Responsible Person Service provides expert regulatory support, acting as the official RP for your cosmetic products in the EU.
What are the Responsibilities of the Responsible Person?
The main duties and responsibilities of the Responsible Person in the EU are as follows:
- Ensures product safety through the Cosmetic Product Safety Report (CPSR), which must be conducted by a safety assessor with appropriate qualifications and experience.
- Prepares and maintains a detailed Product Information File (PIF) for each cosmetic product. The RP ensures the PIF is up to date, kept in a location easily accessible to competent authorities, and retained for 10 years after the last batch is placed on the market.
- Submits electronic notification of the product to the Cosmetic Product Notification Portal (CPNP) before the product is placed on the EU market.
- Ensures the product label complies with all labelling requirements under the EU Cosmetic Regulation.
- Ensures that any serious undesirable effects resulting from the product are promptly reported to the competent authorities. Maintains product traceability data for a period of three years.
- Upon request from competent authorities, provides all information and documentation necessary to demonstrate regulatory compliance.
Why Do You Need a Responsible Person?
- Regulatory Expertise: Extensive experience in EU cosmetic compliance
- Risk-Free Market Entry: Ensure smooth product placement in the EU
- Comprehensive Service: Full support from formulation to post-market compliance
Your Solution is Ready with Chemleg
Chemleg offers outsourced Responsible Person services to assist companies in fulfilling their legal obligations without the need to hire an in-house expert.
Product Safety Assessment: Ensuring cosmetic products are safe for use through risk evaluations and compliance checks
Regulatory Compliance: Verifying adherence to the EU Cosmetic Regulation
Product Information File (PIF) Preparation & Maintenance
- Compile, maintain, and update the Product Information File (PIF)
- Conduct Cosmetic Product Safety Reports (CPSR) – Part A & Part B
Cosmetic Product Notification Portal (CPNP) Registration
- Notify your products to the EU Cosmetic Product Notification Portal (CPNP)
Labeling & Claims Review
- Ensure product labeling meets EU legal requirements
- Review marketing claims for compliance with EU regulations
Good Manufacturing Practices (GMP) Compliance
- Provide guidance on GMP compliance for cosmetic production facilities
Ongoing Compliance & Post-Market Surveillance
- Monitor regulatory updates and notify you of any changes
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Frequently Asked Questions
Who qualifies as a Responsible Person?
The following parties may act as the Responsible Person:
- A manufacturer established within the EU
- An importer who imports the product from outside the EU
- A distributor who places a product on the market under their own name or brand, or modifies a product already on the market
- Another individual or entity appointed by the manufacturer or importer through a written mandate
Who is the Responsible Person when a product is imported into the EU?
For a product imported from outside the EU (e.g., from Turkey), the importer established in the EU typically becomes the Responsible Person. However, the manufacturer may appoint another person or entity within the EU to act as the Responsible Person.
Is a Responsible Person the same as an Only Representative?
No. A Responsible Person is generally applicable to cosmetic , while the term “Only Representative” is used in chemical registration systems such as REACH and KKDIK. Their roles and scopes are different.
Is it mandatory for companies outside the EU to appoint a Responsible Person?
Yes. If a company located outside the EU intends to place cosmetic products on the EU market, it must appoint a Responsible Person established in the EU.
In which country must the Responsible Person be located?
The RP must be legally established in one of the EU Member States. Countries within the European Economic Area (EEA) may also be included.
Can more than one Responsible Person be appointed for a product?
No. Only one Responsible Person can be appointed per product. This is required for traceability and accountability.
Can the Responsible Person be changed?
Yes, a change of Responsible Person is possible upon company request. However, the change must be updated both on the product label and in the CPNP notification.
Does the Responsible Person bear legal risk?
Yes. In the EU, the RP is directly responsible for any health, safety, or regulatory violations related to the product. Therefore, it is critical to work with an experienced Responsible Person.
