By S&S Co. Advocates & Solicitors · Published 20 February 2026 · Informational content, not legal advice: see our disclaimer
What Qualifies as a Novel Food
A 'novel food' under FSSAI's framework broadly covers a food or food ingredient that does not have a significant history of consumption in India, or that has been produced by a process not previously used for that food, such that its safety profile cannot simply be assumed from established prior use. This can include newly developed ingredients, foods derived from novel processing technologies, and, where applicable, foods or ingredients derived from genetically modified sources.
The Dossier a Business Must Prepare
Before marketing a novel food product, the applicant is expected to compile a safety dossier addressing the product's composition, manufacturing process, intended use and expected consumption levels, and available safety and toxicological data, together with, where a GM component is involved, the specific risk assessment material relevant to that component. A dossier that is incomplete on any of these fronts is a common source of delay, since the regulator will typically pause a review to request the missing material rather than proceed on an incomplete record.
Coordination With Other Regulators for GM Components
Where a novel food product involves a genetically modified component, the approval process has historically required coordination with the environment ministry's Genetic Engineering Appraisal Committee in addition to FSSAI's own review. The 2026 consolidation of the novel food approval process aims to streamline this coordination through a single dossier filed with FSSAI, with FSSAI managing the inter-agency reference internally, though an applicant should still expect the GM-specific component of the review to add materially to the overall timeline compared to a non-GM novel food application.
Practical Timeline Expectations
Because novel food review necessarily involves a case-by-case safety assessment rather than a checklist confirmation against an existing standard, businesses should build a realistic runway into their product launch planning: engaging with the regulatory process well before an intended launch date, rather than treating novel food approval as a final formality to be completed once manufacturing and marketing plans are otherwise finalised.
Frequently Asked Questions
What makes a food product 'novel' for FSSAI regulatory purposes?
Broadly, a food or ingredient without a significant history of consumption in India, or produced by a process not previously used for that food, such that its safety cannot simply be assumed from established prior use.
What does a novel food safety dossier need to cover?
Composition, manufacturing process, intended use and expected consumption levels, and available safety and toxicological data, plus GM-specific risk assessment material where a genetically modified component is involved.
Does a GM-derived food ingredient require approval beyond FSSAI?
Historically, coordination with the environment ministry's Genetic Engineering Appraisal Committee was required for the GM-specific component; the 2026 consolidation channels this through a single FSSAI dossier with internal inter-agency coordination.
How early should a business start the novel food approval process before a planned launch?
Well before the intended launch date. Novel food review involves a case-by-case safety assessment rather than a fixed-timeline checklist confirmation, so businesses should build a realistic runway into launch planning.
References & Further Reading
This article references the following statutory provisions. Readers should always verify current rules, fees and timelines against the applicable statute and rules as amended, since these are revised from time to time.
- Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.
- FSSAI circular on the revised novel food and GM-derived ingredient approval framework, 2026.