Dossier Preparation for Food 

Ensuring Compliance within the Food and Beverages Industry

Comprehensive Functional Food and beverages Product Dossier Compilation Services – Overview  

Ensuring Compliance within the Food and Beverages Industry

Ensuring compliance in the food & Beverage industry is paramount, and a crucial step toward achieving this is the meticulous compilation of a Food Product Dossier. This process entails the thorough gathering and organization of all essential documentation and data associated with food and food supplement registration in various countries. Food product dossier compilation requires a focused approach, encompassing food registration requisites, ingredient details, labelling specifications, and safety assessments.

Across different countries, the classification, compliance, and registration requirements for food and food supplements can vary. Some nations mandate registration or notification for food supplements, while others follow a compliance-based approach that doesn’t necessitate registration. In countries where food product registration is required, products can be categorized as low-risk, medium-risk, high-risk foods, or even borderline products falling within the drug-food category. In cases without categorization, registration remains mandatory. Terminology for food registration may differ from country to country; certain regions might refer to it as a simple notification or approval.

A food product dossier encompasses all the technical data (administrative, manufacturing, quality, control, nonclinical, and clinical) pertaining to a product intended for approval, registration, or marketing in a specific country. Any process involving food supplement registration demands a dossier, a technical file, or a set of technical documents. These documents may include, but are not limited to, the following:

  • Food product formulation, composition, ingredient details, and source data.
  • Product labelling and artwork.
  • Claims and supporting evidence.
  • Batch formula.
  • Manufacturing process.
  • Food product specifications.
  • Standard testing methods/analytical procedures.
  • Control measures for active and inactive raw materials, including certificates of analysis for active ingredients along with their specifications.
  • Control measures for finished products.
  • Stability data and recommended storage conditions.
  • Safety data.
  • Nutritional analysis.
  • Nutritional fact panel for food supplements.
  • Certification of packaging materials (food grade).
  • Declarations regarding allergens, GMOs.
  • Plant certifications like HACCP, HALAL, Kosher, GMP,

At FRL, we grasp the significance of your technical documentation and dossier compilation requirements. Our services encompass food supplement classification, gap analysis, review, and the compilation of necessary documents for product registration/notification, tailored to meet the requirements of relevant Health Authorities. FRL provides assistance in preparing food product dossiers, offering suggestions for additional safety report information and the requisite documentation, aligned with specific Health Authority guidelines.

  • Thorough gap analysis and compilation of registration/notification documents for food products.
  • Classification support for food supplements and food products.
  • Document review aligned with Health Authority (HA) stipulations.
  • Assistance for compiling dossiers and safety reports related to food, food supplements, and nutraceutical products.
  • Guidance on essential additional documents.
  • Recommendations for necessary testing requirements.
  • Cost-effective solutions.
  • End-to-end support for food product registration/notification and approval processes.
  • A qualified team of Regulatory experts with extensive experience across diverse classifications of food products, including health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, and foods for special dietary use.
  • Profound understanding of region-specific Regulatory intricacies.
  • Well-established network of partners across the global landscape.
  • Strong rapport with various health authorities."
  • Key contact

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