Overview

Demand for food supplements/health functional foods (HFFs) in Germany is growing constantly. Despite a booming market, the actual definition of HFFs and their claims in their region still results to be a concerning factor for new market entrants. To procure marketing approvals, manufacturers must comply with the requirements of the European Food Safety Authority (EFSA) and individual Health Authorities (HAs). Without complete knowledge on the Regulatory requirements, the approval process for HFFs in Germany can become challenging which leads to exhaustion of time and resources, and can even affect the ROI.

Freyr has deep understanding of global markets with specialized focus towards liaising with regional HAs for successful submissions. Our Regulatory team in Europe, assists manufacturers in compiling the documentation as per The Food Supplements Directive (FSD), Directive 2002/46/EC. With a dedicated delivery center in Germany, Freyr caters end-to-end Regulatory support for HFFs for varied compliance needs such as review of labels, claims substantiation, etc. 

Freyr Expertise

  • Product Classification
  • Ingredient Analysis
  • Claims Assessment
  • Labeling Compliance
  • Label Designing
  • Product Compliance Check
  • Creation of Product Information File (PIF) to Support regional documentation (including Administrative Data relating to Food Business Operator and Manufacturer; e.g., Technical Documentation – Presentation, Composition, Specifications, Stability, Product Label, and Other Scientific Support)

Freyr Advantages

  • Cost-effective Regulatory solutions
  • End-to-end Regulatory consultation
  • Qualified team of experts with hands-on experience across all categories of health foods like health supplements, dietary supplements, food supplements/nutraceuticals, health functional foods (HFF), health functional beverages, foods for special dietary use, etc.
  • Support for region-specific Regulatory complexities
  • Extensive partner network across the globe
  • Strong relationship with different Health Authorities (HAs)
  • Structured approach to ensure quick market access