Food supplement registration - Overview

Before any food supplement or product can be legally marketed, it must undergo a thorough registration process. Food supplement registration is a process that involves submitting detailed documentation and evidence to the Regulatory authorities, demonstrating that the product meets all the necessary standards and requirements for food product compliance.

Food product classification is challenging as it is dependent on various factors like intended use, presentation form, ingredients used, usage levels, borderline products (drug-food interface), ingredients falling both in the drug and food categories (vitamins and minerals) and other factors. Food and Food Supplements are termed and referred to differently by global Health Authorities (HAs). Some of the terminologies used are ‘health supplements,’ ‘dietary supplements’ (USA), ‘food supplements’ (EU/UK), ‘nutraceuticals,’ ‘Health Functional Foods (HFF), ‘health functional beverages,’ ‘foods for special dietary use,’ ‘functional foods,’ and so on. Food product classification can vary from country to country. For food product approval in any country, one must determine the class or category based on the regulations and requirements of the respective HA.

Freyr offers an extensive array of Regulatory assistance to companies to determine first the classification of their product and food product registration. We provide specialized Regulatory services like region-specific food product classification, formulating reviews for acceptability of food ingredients/dietary ingredients, vitamins, minerals, and food additives, identification of prohibited ingredients, pre-formulation assessment, Novel ingredient identification, and recommendations on the reformulation. Freyr also devises Regulatory strategies and pathways for successful product launches.