Representation | Cosmetics

Your Responsible Person for Cosmetic Products

We offer a Responsible Person service for cosmetic products, ensuring regulatory compliance and efficient access to the European market.

Marketing of Cosmetic Products in the EU

According to Regulation (EC) 1223/2009, it is mandatory for manufacturers without an establishment in the EU to designate a Responsible Person (RP) to market cosmetic products in the EU. The Responsible Person is fully accountable for the product’s safety and legal compliance.

Regulation (EC) 1223/2009 sets out the rules that all cosmetic products marketed in the European Union (EU) must comply with to ensure the functioning of the internal market and achieve a high level of human health protection.

All cosmetic products marketed in the European Union must undergo a Safety Assessment conducted by a qualified person.

A Cosmetic Product Safety Report (CPSR) must be completed and included in the Product Information File (PIF).

As the Responsible Person, CMC can assist the manufacturer in carrying out specific tasks related to their obligations. This includes writing, compiling, and maintaining the Product Information File (PIF), conducting the Cosmetic Product Safety Report (CPSR), registering the Cosmetic Product in the Cosmetic Products Notification Portal (CPNP), as well as helping the manufacturer prepare Good Manufacturing Practices to document and regulate the production, control, storage, and dispatch of cosmetic products.

Expert regulatory representation services for cosmetics

Complete the contact form and one of our consultants will get in touch as soon as possible.

Find Us Around the World

Frequently asked questions about EU Cosmetic Regulation

In the European Union, the legal framework for cosmetic products is governed by the Cosmetic Regulation EC 1223/2009. This regulation also applies to countries in the European Economic Area (EEA) such as Iceland, Liechtenstein, and Norway. Since Brexit in 2021, the UK Cosmetic Products Regulation governs the Great Britain market, while the EU Regulation continues to apply in Northern Ireland.

The Responsible Person (RP) is a designated individual or entity responsible for ensuring that all cosmetic products comply with the requirements set out in the EU Cosmetic Regulation. The RP ensures the safety of the products before they are placed on the EU market and acts as the contact point for Cosmeto-Vigilance.

Yes, non-EU manufacturers cannot act as their own Responsible Person and must designate one based in the EU or EEA. Their importers can serve as the RP, or they can appoint a third-party RP established in the EU or EEA. This is mandatory for selling cosmetic products in the EU market.

The Cosmetic Products Notification Portal (CPNP) is a central online system where all cosmetic products must be notified before they can be placed on the EU market. The Responsible Person must complete the CPNP notification, which involves providing evidence of conformity within the Product Information File (PIF). A successful notification indicates that the product meets all regulatory requirements and is ready to be marketed in the EU.

The Product Information File (PIF) is a comprehensive document that contains all the necessary information to prove a cosmetic product’s compliance with EU regulations. It includes data on the product’s ingredients, safety assessments, labelling, and Good Manufacturing Practices. The PIF must be kept readily accessible by the Responsible Person and made available to regulatory authorities upon request.

The Safety Assessment Report is a critical component of the PIF and consists of two parts:
● Part A: Safety Information: This includes data gathered from suppliers of raw materials, producers of the finished product, and results from laboratory tests.
● Part B: Safety Assessment: This is completed by a “Safety Assessor,” a qualified professional with a relevant European degree in pharmacy, medicine, toxicology, or a related field. The Safety Assessor must ensure that the cosmetic product is safe for use, particularly for special products like those intended for children under three years or for external intimate hygiene.

No, a cosmetic product notified once to the CPNP can be marketed in any EU country, provided that the labelling complies with the specific language requirements of each country. No additional national notifications are necessary after the CPNP notification

We offer a Responsible Person service for cosmetic products

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

Other CMC Services

ppe services
legal representative service
representation services
free sale certificate service
cro services