India’s apex food safety regulator, the Food Safety and Standards Authority of India (FSSAI), has significantly strengthened its approval framework for food products by making it mandatory for companies to submit detailed scientific evidence when seeking clearance for new products or requesting a scientific review of existing ones. The revised norms came into force on January 1 and are aimed at curbing unsubstantiated or misleading safety and health claims in the food sector.
Under the updated framework, food businesses must now take full responsibility for proving the safety of their products. FSSAI clarified that the burden of demonstrating safety will rest with the applicant, rather than the regulator attempting to assess risks based on incomplete or insufficient data. The move follows repeated instances where earlier submissions were found to be inadequate or not aligned with established scientific assessment standards, making it difficult for authorities to conduct thorough risk evaluations.
While the regulator has raised the bar for scientific scrutiny, it has assured industry stakeholders that all submitted data will remain strictly confidential and will not be made public. The information will be used solely for scientific evaluation and policy-related decisions. FSSAI also emphasised that products already available in the market will not be disrupted unless a formal scientific review is specifically requested.
As part of the new requirements, companies must provide comprehensive details including nutritional composition, Indian consumption pattern data, toxicological studies, safe intake levels, allergy risk assessments and relevant scientific literature. To streamline the process and ensure consistency, FSSAI has also introduced a standardised format for submissions.
A key highlight of the revised norms is the strong emphasis on Indian dietary habits. The regulator noted that safety data derived from international studies may not always be suitable for India, as local portion sizes, frequency of consumption and population sensitivities can vary significantly. This is particularly relevant as the consumption of packaged and processed foods continues to rise across the country.
Once applications are submitted, they will be examined by FSSAI’s Science and Standards Division and, where necessary, reviewed by independent expert panels. Based on scientific evaluation, these panels may approve a product, allow its continued use with specific conditions, impose restrictions, or recommend stricter usage limits.
From a consumer perspective, FSSAI believes the strengthened framework will enhance confidence in food safety claims, reduce allergy-related risks and ensure that approved intake levels are more realistic for Indian eating patterns. At the same time, the regulator expects the new norms to push food manufacturers towards greater scientific accountability and more robust product substantiation.
