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Probiotics/Prebiotics Registration and Notification India

Probiotics are live microorganisms which when administered in adequate amount can confer health benefits on the host. Probiotics promote a healthy balance of gut bacteria and have been linked to a wide range of health benefits. Another category of food additive which is beneficial to the human body is – Prebiotics. These are non-digestible ingredients which help in boosting the immune system of human body. Both prebiotics and probiotics help in boosting the immune system of human body and inhibit the growth of harmful gut bacteria, while promoting the production of natural antibodies in the body. In the current scenario of COVID-19, Probiotics/Prebiotics are considered critical to boost the immunity. But with the decline in the global supply chains of Probiotics/Prebiotics, meeting the demand right on time would be challenging.

To ensure the world sustain the international health crisis, as a prominent Probiotics/Prebiotics manufacturer you might be willing to market your products across the globe or to be specific in the India. In India, just like health supplements, Probiotics/Prebiotics are regulated through the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 and are regulated by the Food Safety and Standards Authority of India (FSSAI). According to the regulations of the FSSAI, only 13 prebiotic compounds are permitted to be used in any health supplements. Additionally, a prebiotic product doesn’t require the approval of the FSSAI before being placed into the market, if the product complies with all the requirements of the FSSAI. However, if the health supplement contains any new prebiotic compound which is not listed in regulation, novel ingredient, novel additive, any new processing aid, or any non-specified food product, it must obtain approval from the FSSAI.

Probiotics/Prebiotics – Freyr’s Regional Focus

With a vast knowledge on the Food Safety and Standards Authority of India (FSSAI) and Probiotics/Prebiotics Regulatory requirements, Freyr team of subject matter experts (SMEs) can assist you with compliance check of the product’s registration, label and claims to identify if the product is able to comply to the requirements listed by the FSSAI or will need a product approval. If the Probiotic/Prebiotic product needs approval from FSSAI, Freyr team can assist you in preparing, compiling and submitting the complete dossier to the FSSAI as per the regulations on approval for non - specified products/ingredients. Freyr is specialized in:

  • Probiotics/Prebiotics registration in the India
  • Probiotics/Prebiotics market entry
  • Evaluation of your label or labeling information for compliance
  • Review of immunity boosting claims
  • Design or develop artwork for Immunity boosters
  • Review or assess the product formula to identify the product category and to check the acceptability of all the ingredients in the product in line with the FSSAI
  • Suggesting mandatory, missing information and nutritional/supplemental facts or the corrections to be made on the label of the product as per the country specific regulations
  • Monitor compliance with FSSAI including advising on general labelling and advertising issues, nutrition labelling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
  • Prepare and submit dossier for Probiotics/Prebiotics registration
  • Assist with devising a robust Regulatory pathway for your product

As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registrations of Probiotics/Prebiotics in the India. 

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