The RFBO must be an EU legal entity (a person or a company established in the EU). The name and the address of the RFBO (the dossier holder) must be displayed on the product label. The RFBO is the primary contact point for the authorities and must be at the disposal of the authorities at all times. In case of authority inspection or monitoring, the RFBO must provide full access to the mandatory PIF for inspection and monitoring.
Unlike under EU cosmetic product legislation, the RFBO cannot delegate legal liability for food supplements it places on the EU market. The RFBO may however contract a professional 3rd party to support the RFBO and execute the RFBO related tasks on its behalf, and to represent the RFBO towards the local competent authorities and to advocate for and defend product safety and compliance.
As your principal RFBO service provider, TRC will support you in all correspondence and information exchange with the member state competent authorities. TRC will also support you in the case of product and/or site inspections. For several EU member states TRC will need to make use of partners in our network, 3rd parties or local representatives with exhaustive local expertise.
In the case of an urgent request from the local competent authorities regarding any information that the RFBO must have available, TRC will support you, your local representatives or local 3rd parties to ensure an appropriate and timely response. TRC will always advocate for and defend the safety and compliance of your product portfolio, while taking your IP rights and marketing/commercial objectives into account.
We strongly advise our clients to appoint TRC to both perform all the regulatory steps towards market readiness including notification, as well as to provide you with continuous regulatory support and product stewardship services. You will benefit from clear advantages in terms of efficiency, lead-times, and costs.
Performing the steps towards regulatory compliance and safety, and providing continuous support are highly interdependent tasks. Future changes will have to be carried through in the PIF, the safety and regulatory compliance assessment, the labels and claims, and member state notifications.
TRC keeps track of all changes in the applicable regulations, and changes initiated by you and your suppliers. We will inform you timely about the impact on your product portfolio, and will advise you on how to stay compliant in the everchanging field of regulations while serving your commercial interests.
We have successfully guided many member state authority inspections for our clients backed by our long-standing experience with many products for small sized to globally operating companies.