Legal Representation for your cosmetic products

As your designated EU or UK Responsible Person, Biorius will:

• Represent and defend your cosmetic brand to EU or UK authorities.
• Assist with legal questions related to EU or UK cosmetic regulations.
• Manage customer complaints.
• Perform regulatory monitoring to ensure ongoing compliance.
• Handle any undesirable effects from your products.
• Maintain and update your Product Information File (PIF).

Additionally, your brand must display Biorius’s name and EU or UK address on product labels, making us the point of contact for regulatory inspections or consumer complaints.

Yes, non-EU companies can designate an EU-based third party to act as their Responsible Person. This third party will assume all responsibilities outlined in Regulation EC No 1223/2009, ensuring the company’s products comply with EU regulations.

Failing to appoint an EU Responsible Person means non-compliance with Regulation EC No 1223/2009, which can result in:

• Prohibition from marketing the cosmetic products within the EU.
• Potential legal actions and fines.
• Damage to the brand’s reputation.

Ensuring compliance by appointing a Responsible Person is crucial for lawful market access and consumer safety.

The Responsible Person can be the manufacturer, packager, or distributor of the cosmetic product. Their name must be labeled on the product packaging. While the Responsible Person does not need to be located in the U.S., foreign Responsible Persons must designate a U.S. Agent to represent them.

The U.S. Agent acts as a liaison between foreign Responsible Persons and the FDA.

Responsibilities include:

• Communicating efficiently with the FDA and other stakeholders.
• Assisting in fulfilling legal obligations that must be executed from the U.S. territory.
• Being available 24/7 for adverse event reporting, questions, health emergencies, controls, and inspections.

Yes, as of April 12, 2024, non-Canadian companies can appoint a Canadian-based individual or entity as their Responsible Person. This update allows brands outside of Canada to have a local representative to ensure compliance with Canadian cosmetic regulations.

Yes, you can change your Responsible Person even after your products are on the market. However, it’s essential to ensure that the new RP conducts a thorough audit of your Product Information Files (PIFs) to confirm compliance with current regulations.

The duration varies depending on the number of products and the completeness of existing documentation. Biorius employs a pragmatic strategy to minimize costs and streamline the process, avoiding the systematic audit of the entire product portfolio during the transfer.