Independent of the stage your products are in we ensure full compliance through a clear 5 step approach. We start with a free Prescan of your portfolio to be clear on the possibilities, lead-times and the needed resources to market in the individual EU member states. Appointing TRC as your principal consultant for the EU market will ensure continued services and the safety and compliance of your products.
Contact us and have your product portfolio pre-assessed for free! We will look into your needs and discuss your products, marketing material and roll out plan. It is key to have products that are in line with EU and member state specific regulations in order for you to succeed on the EU market.
We will jointly create a comprehensive Product Information File (PIF) to satisfy all EU and individual member state requirements. TRC will provide clear instructions templates, and checklists for your R&D, manufacturing, QC and procurement departments to ensure that all required data, documents and test reports are timely and correctly included in the PIF.
Our in-house expert team of toxicologists, chemists and experienced assessors will perform the safety assessment and the regulatory assessment on a country-by-country basis. Once completed, the safety and compliance report and the regulatory content brief for your labels and claims will be issued.
We will deliver the regulatory content briefs for your labels including the product claims, ingredients listing, allergen list, QUID declaration and other mandatory label information. We will review the content of your artwork and marketing materials to avoid cumbersome post launch relabelling and/or costly reworks.
Most EU member states require product notification through a local procedure with local requirements and in most cases registration fees. We will assist you to have your products notified.
The food business operator responsible for the food information (RFBO) shall be the operator under whose name the food is marketed or, if that operator is not established in the EU, the importer into the EU. The RFBO shall ensure the presence and the accuracy of the food information in accordance with the applicable food information law and requirements of relevant national provisions.
“We are very satisfied with the diligent services by The Regulatory Company. We moved ahead with our EU entrance very efficiently. And we are very happy to provide great reference to anyone who needs to work with TRC.”
“It was a very informative conference*. The content was relevant and the format was visually appealing, easy to follow and understand. The conference offered a one to one forum with the presenters. This was a great opportunity for me to have in depth discussions with them. Thanks to the conference I have a better understanding of regulations and its application in my daily work.”
* 1st International Congress on Food Supplements Safety and Compliance - Vienna 2018 - Congress Chair, Zoran Gavric of TRC
“TRC contributed to our success story, and is one of the reasons why the global fragrance and beauty company has taken our brand on board and is investing with us in large-scale expansion.”
“We are very impressed by the quality and consistency of the PIF's, the Safety Assessments and services in general by TRC.”
“The TRC expert that we work with is a highly experienced expert, very responsive and a great partner to our team to ensure market presence in many EU member states.”