Definition of nutraceutical products
Under India's Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022. [FSSAI (Nutra) Regulations, 2022] nutraceuticals are defined as: “a category of foods which consists of extracts, isolates and purified chemical compounds having a physiological benefit and help to maintain health. [They are] not intended to treat or cure any medical condition, disease, or disorder."
The Department of Agriculture, Fisheries and Forestry (the Department) refers industry and exporters to the further guidance provided by FSSAI in its Regulation of 29 March 2022 FSSAI (Nutra), 2022 (PDF | 1.9MB).
Registration requirement
From 1 February 2023, the Food Safety and Standards Authority of India (FSSAI) required all foreign food manufacturing facilities of nutraceutical products, being exported to India, to be registered with FSSAI. Other businesses in the export supply chain (e.g., exporters, freight forwarders, storage facilities) do not need to be registered.
The Department, provided FSSAI with an initial list on 30 January 2023. The list included information such as:
- Details of the Food Manufacturer: name: address: contact details.
- Approval/Licence no. issued by the competent authority.
- Name of product/s to be exported to India.
The Department will update lists (add new or change manufacturing facility details) for FSSAI, upon request.
To be listed, please read the following.
When a manufacturing facility of nutraceutical products needs to apply to the TGA
If the product/s:
- are currently registered with the TGA
- do appear on the Australian Register of Therapeutic Goods (ARTG)
- do make claims of providing a physiological benefit or help in the maintaining good health
- do contain any of the following ingredients as listed in the FSSAI (Nutra) Regulations, 2022:
- Schedule I vitamins and minerals
- Schedule II amino acids and other nutrients
- Schedule IV plant or botanical ingredients
- Schedule VI list of ingredients as nutraceuticals (caffeine, glucosamine, herbal extracts)
- Schedule VII probiotics
- Schedule VIII prebiotics
- And have been assigned an AUST L identification number
Please refer to your sponsor, the Therapeutic Goods Administration or via email to Complementary Medicines Complementary.Medicines@health.gov.au for advice on manufacturing facilities applying to be registered with the FSSAI for export to India.
When a manufacturing facility of nutraceutical products needs to apply to the Department
All manufacturers of nutraceutical products (consistent with the FSSAI definition) that wish to export to India that do not meet the above TGA requirements, will need to apply to the Department.
To apply to the Department for registration, an authorised person in management at the manufacturing facility, must complete both forms below and return to the Department via email to the Non-prescribed Goods Exports Program at NPGExports@agriculture.gov.au.
Please state 'FSSAI Registration' in the subject line of your email.
Once updated lists are received by FSSAI, registration of facilities will be completed by FSSAI staff within the FSSAI portal. For more information on this process, please refer to FSSAI Order dated 10 December 2022 (PDF | 200KB).
The Department encourages all exporters to work closely with their importers to ensure that product meets India's current importing country requirements.
