Documents required for FSSAI registration of Health supplements, Nutraceuticals and Novel foods

FSSAI Registration for Health supplements, Nutraceuticals and Novel foods

Any food business operator that is in the business of manufacturing, processing, storing, distributing and sale of food must mandatorily apply for and have an FSSAI Registration / License. Same way all businesses relating Health supplements, Nutraceuticals and novel foods require to get FSSAI registration/ license. In this article we have discussed about the documents required for FSSAI registration for Health Supplements, Nutraceuticals and Novel Foods.

• Health Supplements: The health supplements shall contain concentrated source of one or more nutrients and substances from animal origin or other similar substances with known and established nutritional or beneficial physiological effect, which are presented as such and are offered alone or in combination, but are not drugs.
• Nutraceuticals: Nutraceutical is a combination of ‘nutrition’ and ‘pharmaceutical’, and refers to a food or 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 benefit and helps maintain good health.
• Novel food: Novel food is a food that may not have a history of human consumption or may have any ingredient used in it which or the source from which it is derived, may not have a history of human consumption or a food or ingredient obtained by new technology with an innovative engineering process, where the process may cause significant change in the composition or structure or size of the food or food ingredients which may alter the nutritional value, metabolism or level of undesirable substances.

Documents required for FSSAI registration of Health supplements, Nutraceuticals and Novel foods

The following are the basic documents required for FSSAI License:

• Photo Identity of the Food Business Operator.
• Proof of the complete possession of premises (e.g. Rental Agreement ).
• A Partnership Deed or a Certificate of Incorporation.
• List of food products (that would be inputs as well as the final menu) to be dealt with.
• A detailed food safety management plan.

The following are the documents required for FSSAI registration of Health supplements, Nutraceuticals and Novel foods:

• Blueprint/layout plan of the processing unit showing the dimensions in meters/square meters and operation-wise area allocation (mandatory for manufacturing and processing units only).
• List of Directors with full address and contact details (mandatory for companies only.
• Name and List of Equipment and Machinery along with the number, installed capacity and horse power used.
• Analysis report (Chemical & Bacteriological) of water to be used as ingredient in food from a recognized/ public health laboratory to confirm the potable.
• Upload Production unit photograph
• Photo I.D and address proof issued by the Government authority of Proprietor / Partner / Director(s) / Authorized Signatory.
• Proof of possession of premises. (Sale deed/ Rent agreement/ Electricity bill, etc.).
• Partnership Deed/Self Declaration for Proprietorship/Memorandum & Articles of Association towards the constitution of the firm.
• Form IX: Nomination of Persons by a Company along with the Board Resolution.
• Category of the product as per Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 and List of Ingredients.

Note: In case of water is ground water then NOC from CGWA is necessary to be submitted accordingly.

Validity of FSSAI Registration

• FSSAI licenses issued to food businesses are valid for a period of 1 to 5 years as chosen by the Food Business Operator.
• It is mandatory to apply for license renewal 30 days before the expiry of the existing license.
• Non-renewal of licenses can fetch a fine of Rs.100 per day until the renewal is done .
• Any lapse in renewal within the stipulated date can result in the old license becoming deactivated and businesses will have to apply for a fresh license.

Suggested Read: The process for FSSAI registration for Health Supplements, Nutraceuticals and Novel Foods.