New Delhi | December 31, 2025, 8:15 AM IST: In a major regulatory overhaul aimed at strengthening consumer protection, the Food Safety and Standards Authority of India (FSSAI) has announced that all food product approvals and food standard change requests must be backed by comprehensive scientific evidence from January 1, 2026.
The move marks a decisive shift in India’s food regulatory framework, transitioning from largely descriptive submissions to a strict, science-driven evaluation system. Officials say the reform will bring greater transparency, accountability, and international credibility to India’s food safety approvals.
The new mandate applies to food business operators, research institutions, industry associations, and other stakeholders seeking approval for new food products, ingredients, additives, or amendments to existing food standards.
Scientific Rigor Becomes Mandatory
Under the revised framework, applicants will be required to submit detailed scientific dossiers rather than general explanations or industry claims.
These submissions must include:
- Complete nutritional composition and ingredient profiles
- Peer-reviewed scientific studies supporting product safety
- Indian dietary consumption patterns and portion-size data
- Toxicological risk assessments and safe intake limits
- Allergenicity data and long-term exposure studies
FSSAI officials have repeatedly flagged that earlier applications often lacked sufficient data, making robust risk assessment difficult.
“This reform embeds science into every food decision,” an FSSAI official involved in the transition said. “No product or claim will move forward without credible evidence. Scientific integrity must underpin what reaches the Indian consumer.”
Burden of Proof Now on Applicants
The new rule places the entire responsibility of proving food safety on applicants, not the regulator.
Once dossiers are submitted, the Science and Standards Division of FSSAI, supported by expert scientific panels, will evaluate the evidence. Based on the findings, products may be:
- Approved without conditions
- Approved with restrictions or labeling requirements
- Sent for further safety testing
- Rejected if risks are identified
Officials say this change will significantly reduce ambiguity and discretionary approvals while improving regulatory consistency.
Focus on Indian Dietary Patterns
A critical pillar of the new framework is the mandatory inclusion of India-specific dietary data.
FSSAI has repeatedly warned that foreign consumption models often underestimate actual intake levels in India, especially for additives, sweeteners, and processed food ingredients.
“As food habits evolve rapidly, understanding how Indians consume and metabolize foods is essential,” a senior FSSAI scientist said. “What is safe in Europe or the U.S. may not be appropriate for Indian consumption levels.”
This localized approach is expected to result in more realistic exposure assessments, particularly as packaged and ultra-processed foods gain popularity across urban and semi-urban India.
Confidentiality of Proprietary Data Assured
To address industry concerns, FSSAI has assured that confidential business information and proprietary scientific data submitted during evaluations will remain protected.
Officials clarified that submitted data will be used solely for scientific assessment and regulatory decision-making, not for public disclosure or competitive review.
Part of a Larger Food Regulatory Reform
The evidence mandate is part of FSSAI’s broader modernization agenda for India’s food safety ecosystem.
Throughout 2025, the authority has undertaken multiple reforms, including updates to:
- Food additive standards
- Labeling and compliance norms
- Product safety and ingredient thresholds
Notably, the Food Products Standards and Additives (Amendment) Regulations, 2025 are scheduled to take effect in February 2026, reinforcing India’s shift toward evidence-based policymaking.
Industry and Consumer Impact
For consumers, the reform promises higher safety assurance, improved transparency, and stronger trust in food products available in the market.
For businesses, the change signals a need for early investment in scientific research, nutrition studies, and toxicological evaluations before launching or reformulating products.
Industry experts view the move positively.
“Global food companies have long sought regulatory clarity in India,” said a senior executive at a multinational food firm. “This evidence-based approach improves predictability and aligns India with global best practices.”
As India’s packaged food sector expands rapidly, FSSAI’s science-first approach is expected to reshape how food safety is assessed, regulated, and communicated.
From 2026 onward, when food safety is questioned, only evidence will decide what stays on the Indian plate.
