Food Supplements

The EU regulatory framework for food supplements, also commonly referred to as ingestibles, health supplements, dietary supplements or nutraceuticals is complex and only partially harmonized across Europe. It is important to make sure that your suppliers, ingredients, formula compositions, and product claims are in line with the EU and individual member state regulations where you market and sell your products.

Fully compliant in 5 steps

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.

Dossier building

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.

Safety and regulatory assessment

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.

Label and claim review

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.

EU member state product notification

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.

Your product is now EU member state market ready!

Resp. Food Business Operator (RFBO)

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.

Related questions

What is the typical lead-time for notification in the EU?
When to start?
How much do regulatory services cost?
What should be my first step now as an EU importer?

“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.”

Co-Founder & CMO
US-based luxury organic beauty brand

“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

Regulatory Affairs Specialist Food and non-Food Products
Global beauty and health company

“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.”

Regulatory affairs coordinator
India-based Ayurvedic beauty brand

“We are very impressed by the quality and consistency of the PIF's, the Safety Assessments and services in general by TRC.”

Research Centre Director
Global fragrance and beauty company

“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.”

COO / Co-Founder
EU-based leading food supplements for special purposes brand