Responsible Person for the European Union, United Kingdom and North America
Each region has its own regulations and requires the appointment of a legally responsible person located in the country to ensure compliance with these regulations. In the European Union (EU) and the United Kingdom (UK), this role is known as the Responsible Person. In the United States, we are talking about the US Agent, the main point of contact with the FDA for product and facility compliance. In the UAE, a local agent is also required to act as an Authorized Responsible Person . Below, we will explore in detail the responsibilities and requirements of these roles in each region:
Legal Representation for Cosmetics in the European Union
What is the Responsible Person in the European Union?
Since 11 July 2013, in order to sell cosmetics in Europe, a Responsible Person (RP) with offices in the EU is legally required (EC Regulation No 1223/2009). This person ensures compliance with cosmetics regulations and product safety.
Definition of Responsible Person in the European Union
As defined in Article 4 of Regulation EC No 1223/2009, a Responsible Person is a legal or natural person who ensures the compliance of each cosmetic product on the EU market with the relevant obligations set out in this Regulation. This may be the manufacturer (if based in the EU), the importer, the distributor or a third party located in the EU that has been designated by a written mandate.
Cosmetic Legal Representation for the United Kingdom
What is a Responsible Person in the UK?
As of 31 January 2020, the UK is no longer part of the European Union. Any company marketing or wishing to market cosmetic products in the UK must appoint a Responsible Person located in the UK.
Definition of Responsible Person in the United Kingdom
This person or entity is responsible for ensuring that cosmetic products comply with UK regulations, which are similar to but separate from EU legislation. The Responsible Person in the UK must manage product notification, maintain safety documentation, ensure appropriate labelling and report any adverse effects to the relevant UK authorities, thereby ensuring the compliance and safety of products in the UK market.
Cosmetic Legal Representation for the United States
What is the US Agent in the United States?
In the United States, the figure of the Responsible Person, known as US Agent, is crucial to ensure that cosmetic products and facilities comply with FDA regulations and to act as the main point of contact with the FDA.
Key Responsibilities of a US Agent
Registration and Listing: Ensures that all cosmetic products are properly registered and listed with the FDA.
Safety Documentation: Maintains safety documentation and testing to demonstrate that products are safe for use.
Labeling: Ensures that all products are labeled in accordance with FDA regulations.
Adverse Event Reporting: Report any adverse events related to the use of the products to the FDA.