Purpose
- This Industry Advice Notice (IAN) is to advise industry stakeholders and manufacturers on the process to meet India’s requirements for nutraceutical manufacturers exporting to India to be registered with Food Safety and Standards Authority of India (FSSAI) (refer MAA2023-03).
Key points
- As per (MAA2023-03), the FSSAI requires all foreign food manufacturing facilities of nutraceutical products being exported to India to be registered with FSSAI. These requirements take effect from 1 February 2023.
- The competent authorities of exporting countries must provide FSSAI a list of existing and new manufacturers intending to export nutraceuticals to India.
- Manufacturing facilities must be registered with FSSAI at least 24 hours before exported products arrive in India.
- Depending on the nature for the nutraceutical intended for export to India, manufacturing facilities will either apply to Australia’s competent authorities, the Department of Agriculture, Fisheries and Forestry (the Department) and/or the Therapeutic Goods Administration (TGA). The Department and the TGA will coordinate the provision of the lists to FSSAI.
- The Department will provide its initial list to FSSAI on Monday 30 January 2023. To be included in the initial list, please respond by 24 January 2023. New facilities will then be added on an as-needed basis.
Definition of Nutraceutical products
The Indian government defines a nutraceutical product as follows:
Nutraceutical - 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 refers exporters to the further guidance provided by FSSAI in its nutraceuticals regulation of 29 March 2022 (FSSAI (Nutra) Regulations, 2022).
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 webpage 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.
Applying for listing within the department
India’s requirements apply to manufacturing facilities whose product is intended for export to India. Other businesses in the export supply chain (e.g. exporters, freight forwarders, storage facilities) do not need to apply. Exporters should work with their suppliers to apply to the Department.
An authorised person in management of the manufacturing facility must complete both forms below. Once completed return them to the Department via email to the Non-prescribed Goods Exports Program at NPGExports@aff.gov.au. To aid the timely processing of applications, please note ‘FSSAI Registration’ in the subject line of your email.
- Application for export listing of establishments manufacturing/exporting non-prescribed goods
- Export Listing Form
The Department will submit an initial list to FSSAI on Monday 30 January 2023. To be include on the list applications must be received by the Department by COB 24 January 2023. The Department will add new manufacturing facilities on an as needs basis moving forward
- The Department encourages all exporters to work closely with their importers to ensure that product meets India’s current importing country requirements.
- Once the initial listing with the FSSAI is complete, the Department will provide advice on any changes needed to simplify the process for industry.
Contact Information
If you have any questions regarding this IAN please email the Non-prescribed Goods Export Program at NPGExports@aff.gov.au.
Jemma Martin
A/g Assistant Secretary
Exports and Veterinary Services Division