In the context of cosmetics legislation, the term Responsible Person (RP) refers to a legal or natural person who is responsible for ensuring the compliance of cosmetic products with applicable regulations in a particular market. At Galex-lab , with our expertise, modern technology and many years of experience, we provide comprehensive Responsible Person support and services for various markets, in accordance with the latest regulatory requirements.

European Union (EU)

In the European Union, every cosmetic product made available on the market must have a designated Responsible Person established in the European Economic Area (EEA). This can be the manufacturer, importer, distributor or an authorised third party.

Key responsibilities Responsible persons in the EU:

✔ Ensuring compliance with the Cosmetics Regulation (EC) No. 1223/2009

✔ Preparation and maintenance of Product Information File (PIF)

✔ Product registration in the Cosmetic Products Notification Portal (CPNP) system

✔ Checking correct product marking and labeling

✔ Managing potential security issues and cooperating with regulatory authorities

At Galex-lab, with a professional approach and in-depth knowledge of EU legislation, we ensure that your products flawlessly meet all legislative requirements and are safely ready for the market.

United Kingdom (UK)

Following the UK's exit from the EU (Brexit), separate regulatory requirements apply to the UK market. Every cosmetic product marketed in the UK must have a Responsible Person based in the UK.

Key Responsibilities Responsible Persons in the UK:

✔ Ensuring compliance with UK cosmetics legislation

✔ Maintenance of Product Information File (PIF)

✔ Product registration in the UK Cosmetics Notification Portal (UK CPNP) system before sales start

✔ Communication with British supervisory authorities

✔ Managing safety issues and side effects

It is important to note that the Responsible Person in the UK must not have an address in the EU , and vice versa.

At Galex-lab, we offer reliable and professional support in the role of Responsible Person for the British market, including the entire product registration and compliance process.

United States of America (USA)

In the US market, the role of Responsible Person is usually performed by the manufacturer, packager or distributor of the cosmetic product.

Key Responsibilities Responsible Persons in the US:

✔ Ensuring the safety of the cosmetic product in accordance with FDA (US Food and Drug Administration) regulations

✔ Correct labeling and declaration of the product

✔ Product safety record keeping

✔ Reporting adverse reactions or safety incidents to the FDA

Galex-lab reliably guides you through the entire process of preparing documentation, checking compliance, and registering products for the American market, ensuring a high level of quality and compliance.