Food Product Dossier Compilation

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Food Product Dossier Compilation


Food Product Dossier Compilation – Overview

Ensuring food product compliance is crucial in the food industry. One of the key steps in achieving compliance is the meticulous compilation of a Food Product Dossier. The process of dossier compilation involves gathering and organizing all the necessary documentation and data related to food and food supplement registration in any country. The food product dossier compilation thus needs focus as it includes food registration requirements, ingredient information, labeling requirements, and safety assessments.

Food and food supplement classification, product compliance, and registration requirements may vary from country to country. Few countries mandate food supplement registration or notification requirements, while others are merely compliance-based, without the need for registration. For food product registration-based countries, food products may be categorized as low-risk, medium-risk, and high-risk foods or borderline products (of the drug-food category). For those without any categorization also, registration is a must. Food registration terminology may vary for each country; a few countries call it a simple notification or approval as well.

A food product dossier contains all the technical data (administrative, manufacturing, quality, control, nonclinical, and clinical) of a product to be approved/registered/ marketed in a country. Any food supplement registration process requires a dossier, a technical file, or a set of technical documents, which for example, include a few or a combination of the following:

  • Food Product formula, composition, ingredients, and source data.
  • Product Label and artwork.
  • Claims and supporting data.
  • Batch formula.
  • Manufacturing process.
  • Food Product Specifications.
  • Standard testing methods/method of analysis.
  • Control procedure for active and inactive raw materials, including the certificate of analysis of active ingredient(s) with its specifications.
  • Control procedure for finished products.
  • Stability data and storage conditions.
  • Safety data.
  • Nutritional analysis.
  • Food supplement and nutritional fact panel.
  • Packaging material (food grade certificate).
  • Allergen, GMO type declarations.
  • Plant certifications- HACCP, HALAL, Kosher, GMP, ISO.

At Freyr, we understand your technical documents/dossier compilation requirements. These include food supplement classification, gap analysis, review, and compilation of the documents required for product registration/notification as per the respective Health Authority (HA) requirements. Freyr assists in preparing the food product dossier, suggesting additional safety report information and documentation required by the respective HA.

Freyr Expertise and Advantages


Food Product Dossier Compilation - Freyr Expertise

  • Food product registration/notification/approval documents’ gap analysis and compilation.
  • Food supplement classification/ food product classification.
  • Document review as per Health Authority (HA) requirements.
  • Support for food and food supplements/nutraceutical product dossier compilation and safety report preparation.
  • Advice on additional mandatory documents.
  • Food and food supplements/nutraceutical product compliance check.
  • Recommending testing requirements.


Food Product Dossier Compilation - Freyr Advantages

  • Cost-effective.
  • End-to-end food product registration/notification and approval support.
  • Qualified team of Regulatory experts with hands-on experience across all classification of food products like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
  • Support for region-specific Regulatory complexities.
  • Extensive partner network across the globe.
  • A strong relationship with different health authorities.