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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.
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.
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“PRIMS is very well designed by TRC and extremely user friendly with easy and fast access to all specifications, and exact product compliance status under EU and UK Cosmetics Regulations. It is an extremely helpful tool to track detailed information of raw materials and to manage registration compliance through the REACH compliance dashboard. We found PRIMS very useful in the tremendous effort of ingredient evaluation as a result of the Chemical Strategy for sustainability (CSS) in light of the EU Green Deal."
“We have found an all-round long-term partner in The Regulatory Company. Together we work on ensuring safety and regulatory compliance of our products and our proprietary ingredients. We jointly monitor and manage the impact of regulatory amendments. This way we stay focused on that what truly matters for the TCI clients’ brands.”
“Product compliance and product safety are key. With TRC as our compliance partner, and PRIMS cloud solution as a very easy to use, high quality and value adding tool, we feel very confident that the highest level of compliance and safety of our products will be maintained. Now, and in the future, as regulations continue to evolve.”
“We are thrilled to announce a new service agreement between the CIRS Group and The Regulatory Company | TRC. TRC, a renowned regulatory toxicology and product compliance consultancy firm based in The Hague, Netherlands, has become our trusted partner. As part of this collaboration, we're excited to leverage TRC's cutting-edge PRIMS software for our EU and UK cosmetics services, paving the way for future expansion into other regions.”
“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.”
