The FSSAI has notified 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 in the Official Gazette on 23 December 2016. These regulations come into force with their publication in the Official Gazette and the Food Business Operator (FBO) shall comply with all the provisions of these regulations from 1st January, 2018.These regulations cover several categories of foods including foods containing Probiotics and Prebiotics.

The draft regulations notified in July 2015 had defined foods containing prebiotic ingredients as foods that contain only prebiotics specified in Schedule XI. The Schedule XI had a list of 12 prebiotics, some of them not approved as ingredients in other countries. You may please refer to earlier blog Prebiotics” – A case of disharmony in regulations and markets?. In the draft regulations, the exclusion of Galacto – Oligosaccharide (GOS) from the approved list of prebiotics in schedule XI, for which sufficient safety data existed and was approved in several countries, was rather surprising.

However, in the Gazette Notification for these regulations, Galacto – Oligosaccharide has been included in the list of approved prebiotic compounds as specified in Schedule VIII. This inclusion will enable the food industry in India to include this proven prebiotic ingredient in many food formulations. This will also provide opportunity for Indian ingredient players to manufacture this ingredient in India.

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