Novel food approval process in India is regulated by the Food Safety and Standards Authority of India (FSSAI).
In order to regulate Novel food and provide the opportunity to Food Business Operators(FBOs) to innovate food products, FSSAI came up with Food Safety and Standards (Approval of Non-Specified Food and Food Ingredients) Regulations, 2017.
FSSAI drafts and implements regulations for the manufacture and sale of food products in India. Its approval is required for any food product to enter into the market. Only after its approval, the food product can be sold in Indian market.
But before you can do that, you need to know what is novel food and requirement for approval as per the FSSAI regulation
If you’re not sure don’t worry.
In this piece, we’ll explain what are novel food and approval process and why it’s important and then give you step-by-step guide.
Table of Content
- What are Novel Food and Non-specified food?
- What us covered under Novel Food or Non-specified Food category under the FSSAI regulation?
- Steps for seeking approval
- Steps after seeking approval
- Conclusion
Let us explore in detail.
What are Novel Food and Non-specified Food?
Novel Food is food or food ingredient which does not have any history of human consumption whereas,
Non-specified food is food or food ingredient which have a history of safe human consumption but not specified in the regulations of FSSAI.
What is covered under Novel Food or Non-specified Food category under the FSSAI regulation?
- Novel Foods/ Ingredients/ food processed with Novel technology
- New Additives
- New Processing Aids including Enzymes
- Articles of food or ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi or algae
- Any other non-specified food.
Steps for seeking approval
- Submit the application, documents and fee
- Application scrutiny by FSSAI maximum within 45 days
- Post assessment, FSSAI approve or seek additional documents
- Authority may accept or reject the application
Steps after seeking approval
- FSSAI Central License procurement under specific category
- Formulation/Ingredient review and claims validation
- Labelling and artwork compliances
- Regulatory intelligence and go-to-market strategy
- Post marketing surveillance
Food Business Operators(FBO) must verify whether the food falls under the scope and must follow the regulations before introducing the food product in the Indian market. Still, you have confusion-Is my product or ingredient present in my product Novel?
Read more: Common India Entry Challenges for Nutraceuticals and Dietary Supplement Manufacturers
Conclusion
You may find the solution with us at Shauryam.
Novel food approval is a rigorous procedure in India.
Our food regulatory consultants can help you understand the regulations related to Novel Food in India and fast-tracking the approval process.
