Proprietary And Novel Food

Food & Drug Regulatory Licenses

Proprietary and Novel Foods are defined as those foods and food ingredients which do not have a significant history of human consumption in India or have undergone substantial changes in the processing or have been introduced into the country for the first time. As per FSSAI regulations, the Proprietary Food and Novel Food products require prior approval from the FSSAI before being marketed in India.

To obtain a FSSAI license for Proprietary and Novel Foods, the manufacturer or importer must submit a detailed dossier containing information regarding the safety and efficacy of the food product, including the composition, specifications, method of manufacture, quality control measures, and results of safety assessment studies. The dossier is evaluated by a panel of experts appointed by FSSAI, and the approval is granted based on their recommendations.

Once the approval is granted, the product can be marketed and sold in India with a label that meets the labeling requirements specified by FSSAI. The label must include all relevant information about the product, including the ingredients, nutritional value, usage instructions, and safety warnings.

It is important to note that Proprietary and Novel Foods are subject to regular monitoring and surveillance by FSSAI to ensure their safety and efficacy. Any violation of FSSAI regulations can result in penalties or revocation of the license.