Overview

The food industry in India is expected to witness an unprecedented growth in the years ahead due to multiple factors like an increase in health consciousness, changes in eating habits, and a general move towards a sedentary lifestyle. Despite market growth, Food Business Operators (FBOs) face multiple challenges in obtaining the Food Safety and Standards Authority of India (FSSAI) license, food import approval, and food product approval.

Over the years, the Indian food authority, FSSAI, has been trying to set up a self-compliant culture in the Indian food industry, where FBOs are responsible for product safety and information available on the product label. This requires backing by strong data on manufacturing, control, and claims. Although the regulations are for the FSSAI food license are in place, the challenge lies in comprehending food composition-related regional compliance requirements, ingredient sourcing, and advertising restrictions on special foods and infant foods. 

FSSAI has revised the regulations on nutraceuticals, which have come into effect since April 01, 2022. Under this revision, the classification of food supplements and other compliance criteria have been modified. Food supplements are categorized into six (06) categories of functional foods, which are the following:

• Health Supplements
• Nutraceuticals
• Food for Special Dietary Use (FSDU)
• Food for Special Medical Purposes (FSMP)
• Prebiotic food
• Probiotic foods

Food and food supplements must be validated in compliance with Indian regulations for them to make a compliant market entry. If the product is not a novel food and along with the product composition in terms of the ingredients used, additives, and their limits, it can comply with the requirements listed under the regulations, it can be easily launched in the Indian market without the need for an official product approval from the FSSAI.

Product approval is required for novel or non-specified foods. As per regulations, a non-specified food is one for which standards have not been specified under any FSSAI regulation. The novel categories for which a novel registration procedure is required are novel foods or novel food Ingredients processed with the use of novel technology, new additives, new processing aids, including enzymes, and food ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi, or algae. The FSSAI has also included alcoholic beverages under its jurisdiction; and it rolled out a separate regulation for this in 2018. Thus, manufacturers of alcoholic beverages need to comply with these regulations before launching their products in the Indian market.

Freyr, with an in-depth knowledge of FSSAI regulations, provides Regulatory support to food, food supplements, and alcoholic beverage manufacturers. Freyr’s Regulatory assistance spans various compliance requirements, ranging from food product classification, product compliance, label and claims compliance, to dossier submission for FSSAI product approval, obtaining of food license, food product approval, and food registration.