From January 1, 2026, FSSAI will require data-backed, standardised submissions for scientific risk assessments of food products, placing the burden of proof on applicants while keeping existing licensed products unaffected unless a review is sought.
India’s food regulator has introduced a significant procedural shift in how food safety decisions are evaluated. From January 1, 2026, the Food Safety and Standards Authority of India (FSSAI) will require robust scientific evidence, rather than assurances alone, when assessing the safety of food products.
Under the new framework, all applications seeking a scientific risk assessment or changes to existing food standards must follow a single, standardised submission format supported by comprehensive data. Officials said the move was prompted by earlier applications that often lacked critical information, making effective risk assessment difficult.
Importantly, the regulation does not automatically reopen safety reviews for products already available in the market. It will apply only when a manufacturer or other stakeholder requests a scientific evaluation, either to introduce a new product or to review an existing one. In such cases, the responsibility to demonstrate safety will rest squarely with the applicant.
The prescribed format will require detailed disclosures, including nutritional composition, typical consumption levels among Indian consumers, toxicological study results, evidence on safe intake limits, potential allergen risks, and supporting scientific literature. These submissions will be reviewed by FSSAI’s Science and Standards Division, along with expert panels, which will determine whether a product can be approved, continued without changes, restricted, or subjected to tighter regulatory limits.
Officials emphasised that a key focus of the revised process is alignment with Indian dietary habits. They noted that international data may not always reflect actual exposure levels in India, underscoring the need for locally relevant evidence.
“This is an important step to protect public health,” said Anjali Bhola, a dietician at the National Cancer Institute, Jhajjar, under the All India Institute of Medical Sciences. “Requiring evidence on long-term safety, consumption patterns, and allergy risks makes food regulation more relevant to Indian consumers.”
FSSAI also assured industry stakeholders that all submitted data would remain confidential and be used solely for scientific evaluation and policy decisions. For consumers, the change signals a clearer regulatory stance: when food safety is under scrutiny, decisions will now be driven by evidence.
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