Last updated: October 22nd, 2022 5:41 PM

Central FSSAI License for Nutraceuticals and Health Supplements Business

Food Safety Standard Authority of India (FSSAI) issues an Order dated 16 September 2021 through which it informed that the Food Authority has placed food businesses manufacturing Nutraceuticals and Food/Health Supplements under the purview of Central Licensing Authorities. In this article, we will look at the Central FSSAI License for Nutraceuticals and Health Supplements Business in detail. Click here to know more about the Modification of the FSSAI License

Synopsis of FSSAI Notification

• All existing State Licensed Food Businesses involved in the Manufacturing of Nutraceuticals and Food/Health Supplements need to mandatorily modify their License to a Central License by 31st December 2021.
• Renewal Applications for existing State licenses for these products will not be allowed after 1st January 2022.

FSSAI Regulations Governing  Nutraceuticals and Health Supplements Business

Food businesses operators (FBOs) who manufacture Nutraceuticals and Food/Health Supplements need to get the FSSAI license under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Usc, Food for Special Medical Purposes, Functional Food, and Novel Food) Regulations, 2016. This regulation is known as 'Nutraceuticals Regulations'

FSSAI License for Nutraceuticals and Food/Health Supplements

At Present, the food business operators (FBOs) manufacturing products covered under 'Nutraceuticals Regulations' are being licensed by the State as well as the Central Licensing Authorities under General manufacturing.

• State License - FBOs having a production capacity of 2MT per day are issued with State License
• Central license - FBOs having a production capacity of more than 2MT per day are eligible for a Central license

Central FSSAI License for Nutraceuticals and Health Supplements Business

FSSAI has now announced that food businesses manufacturing products covered under the Nutraceuticals regulations will be licensed through Central Licensing Authorities only, irrespective of turnover of the FBOs. The Central License option shall only be available for manufacturers of food products covered under Nutraceuticals regulations.

Eligible Products for FSSAI License

These 'Nutraceuticals Regulations cover the following eight categories of Functional foods:

• Health Supplements
• Nutraceuticals
• Food for Special Dietary Use
• Food for Special Medical Purpose
• Specialty food containing plant or botanicals
• Foods Containing Probiotics
• Foods Containing Prebiotics
• Novel Foods

Nutraceuticals: Nutraceutical is a combination of ‘nutrition’ and ‘pharmaceutical’, and refers to a food product that reportedly provides health benefits. According to the Food Safety and Standards Authority of India (FSSAI), a nutraceutical is a food product that provides physiological benefits and helps maintain good health. Health Supplements: The health supplements contain concentrated sources of one or more nutrients and substances of animal origin or other similar substances with known and established nutritional or beneficial physiological effects.

Important Announcement for FBOs

• All existing State Licensed FBOs having licenses for the food products under Nutraceuticals regulations need to migrate from state to Central License by 31st December 2021
• State Licensed FBOs manufacturing products under Nutraceutical Regulations shall not be able to apply for renewal of their license after 31st December 2021
• All existing applications for new/modification licenses [under processing] with State Licensing Authorities shall stand rejected and the fee paid shall be refunded to the concerned FBOs in such cases. Such FBOs shall be required to resubmit the application with a full fee to the concerned Central Licensing Authorities.

Fee for Applying FSSAI Modification

The fee structure for applying the FSSAI Modification of the existing state license to the central license  is as follows:

Sl.No	Details	Fee
1	Modification of License and Certificate	Rs.1000 for the license and Rs.100 for the registration

The FBO needs to pay the differential amount between the State License fee and the Central License fee for the remaining number of complete years of validity of their existing licenses.

Procedure to Migrate From FSSAI State License to Central License

FSSAI has already notified the procedure to migrate/moodily their licenses from State License to Central license without change in existing license number with effect from 1st June 2021, thereby facilitating food businesses to save Overhead costs and undue hassle which otherwise, might have occurred due to change in existing license number and subsequently loss of pre-printed packaging material. Click here to know more about the Documents required, the Calculation of Fees, and the Procedure for Migrating from FSSAI State License to Central License. The official FSSAI Order Pertaining to the Central FSSAI License for FBOs Manufacturing Nutraceuticals and Food/Health Supplements is attached here for reference: Log onto www.indiafilings.com to learn more about FSSAI Licensing and the relevant compliances. Our team of FSSAI experts will guide you throughout the process.