Through a notification dated 10 May 2019, the FSSAI has clarified some issues related to the implementation of the Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use. Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 which is known as the Nutraceutical Regulations 2016. Through this notification, the FSSAI wishes to inform all Food Business Operators about its decision on certain issues so they may take necessary action.
In the Nutraceutical Regulations 2016 under the ‘General Requirements’ the FSSAI has stated that (21) The mere combination of vitamins and minerals formulated in tablets, capsules, syrup formats shall not be covered in any of the categories of these regulations except when vitamins and minerals are added to an article of food or in a food format.
- However, on this issue the FSSAI has decided that Food Business Operators will be allowed to continue the business of existing formulations that contain “mere combinations of vitamins, minerals only upto one RDA in dosage formats such as tablets, capsules and syrups, for a period of three months upto 30 June, 2019 or until further FSSAI orders.
- Further the FSSAI has clarified that any ingredient which is not been included in the Nutraceutical Regulations through the FSSAI directions dated 29 December 2017, 29 June2018, 24 August 2018 and 31 December 2018 are not permitted to be used in any food product, unless the use of the ingredient is specifically permitted by any of the other regulations under the Food Safety and Standards Regulations.
The above-mentioned directions may be read here so FBOs know which of the ingredients are permitted or not permitted by the FSSAI as ingredients in these amendment directions have been added later to the implementation of Nutraceutical Regulations 2016.