Date of issue: 12 January 2023
Date of effect: 1 February 2023
Reference Number: MAA2023-03
Attention
- Industries — Australian Food and Grocery Council, Complimentary Medicines Australia
- Export establishments
- Exporters
- Department of Agriculture, Fisheries and Forestry — Central and Regional offices
Purpose
This Market Access Advice (MAA) is to notify industry of a new registration requirement for nutraceutical products, by the Food Safety and Standards Authority of India (FSSAI), which comes into effect from 1 February 2023.
Summary of key points
On 14 November 2022, FSSAI notified to the World Trade Organization (WTO) mandatory registration requirements for all foreign food manufacturing facilities exporting the below products to India:
- Milk and milk products
- Meat and meat products including poultry, fish and their products
- Egg powder
- Infant food
- Nutraceuticals
The WTO notification includes a copy of an Order dated 10 October 2022. The Order states the registration of foreign food manufacturing facilities, exporting the above listed products, will be a requirement effective from 1 February 2023.
The Order is based on provisions of the Food Safety and Standards (Import) First Amendment Regulations, 2021. This Regulation requires competent authorities of exporting countries to provide FSSAI a list of existing and new manufacturers intending to export the above products to India prior to enforcement of the requirements on 1 February 2023.
The WTO notification acknowledges that registration of facilities will be done by FSSAI within a portal on receipt of list provided by the competent authority of exporting countries.
Definition of Nutraceutical products
Nutraceuticals are defined 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] 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.
Departmental request for details of nutraceutical manufacturing facilities
- Under the new registration requirement, FSSAI has requested the competent authority of the exporting country (i.e. the Department) submits details of foreign food manufacturing facilities that export nutraceuticals to India including:
- Details of the Food Manufacturer: Name: Address: Contact details.
- Approval/Licence no. issued by the competent authority.
- Name and HS Code of Product/s to be exported to India.
- Information on who should apply and how to apply refer to – Industry Advice Notice 2023-02.
- The information will be used to compile a list to provide to FSSAI to enable registration in the FSSAI portal.
- Exporters are requested to exercise caution when exporting nutraceuticals to India where product will arrive on or after 1 February 2023.
- The Department is currently working to understand the new requirements and impacts on Australian exporters, raising any relevant concerns. This includes formally responding to the WTO notification.
- The Department encourages all exporters to work closely with their importers to ensure that product meets India’s current importing country requirements
The information provided in this advice is current at the time of writing and is intended for use as guidance only and should not be taken as definitive or exhaustive. The Commonwealth endeavours to keep information current and accurate, however, it may be subject to change without notice. Exporters are encouraged to verify these details with their importers prior to undertaking production/exports. The Commonwealth will not accept liability for any loss resulting from reliance on information contained in this notice.