History of Consumption & International Regulatory Status

Your Strongest Asset — If You Document It Correctly

Founder & CEO, CE Group of Companies  |  Forbes Business Council Member

Regulatory Affairs Expert | Clinical Trials Advisor | Medtech & Food Regulatory Consultant

 

The Evidence the Panel Finds Most Persuasive

Ask any experienced FSSAI regulatory consultant which section of the NSF dossier carries the most weight with the Scientific Panel, and the answer is almost always the same: History of safe consumption in Humans.

The reason is straightforward. Toxicology studies tell the Panel what happens to rodents at high doses in controlled conditions whereas Human consumption history tells the Panel what has happened to real people consuming this ingredient over years and decades. For ingredients with a robust international safety track record — 20 years of safe use across the US, EU, Japan, and Australia — History of consumption can be the most persuasive element in the entire dossier.

The challenge is that most applicants do not document their consumption history with the rigour the Panel needs. A paragraph stating ‘this ingredient has been sold in the US for over 15 years’ is not substantial evidence to document for history of safe consumption. A structured, sourced, population-specific evidence package that demonstrates global regulatory acceptance and quantifies human exposure is.

Evidence Hierarchy

#	Evidence Type	Source / Reference	Weight with FSSAI Panel
E1	History of safe consumption — countries, population, duration, estimated intake	Market data, regulatory approval history	★★★★★ Highest. 30+ years safe use across multiple countries is the strongest single evidence in establishing history of safe consumption
E2	FDA GRAS Notice — non-objection letter + full GRAS determination	GRAS Notice database (FDA)	★★★★★ Highest. Full documentation required — GRN number alone is insufficient.
E3	EU Novel Food authorisation — Commission Implementing Regulation	EUR-Lex / Official Journal of the EU	★★★★★ Highest. Attach full regulation text including conditions of use, maximum levels and population groups.
E4	JECFA / CODEX Alimentarius safety evaluation/WHO	WHO/FAO JECFA monographs	★★★★★ Highest. Carries significant weight as independent international safety assessment.
E5	Health Canada, FSANZ, KFDA, MHLW approvals	National regulatory agency publications	★★★★ High. Each additional national approval strengthens international safety track record.
E6	Indian EDI — Estimated Daily Intake for Indian population	NNMB / ICMR-NIN dietary databases	★★★★★ Critical. Must use Indian dietary data. Non-Indian EDI calculations are a guaranteed Panel query.
E7	Traditional Indian use documentation records	Classical usage of the ingredient as traditional Indian food with ethnobotanical data	★★★★★ Highest for qualifying ingredients. Significantly accelerates Panel review if documented comprehensively.

 Table 1

Building Each Evidence Element Correctly

E1 — History of Safe Consumption: Structure It Like a Brief 

The consumption history document should be structured as a standalone brief — not a paragraph buried in the executive summary. It should state: which countries (at least 3) the ingredient is commercially available in, since when, in what product categories and dosage forms, at what typical daily intake levels, and what the estimated number of consumer exposures is. Where post-market surveillance data exists — adverse event reports, pharmacovigilance records — include it with appropriate context.

For global supplement ingredients, choose the markets that offer the longest commercial history. Document this with Regulatory standards data references, import/export records, or commercially available and trusted market intelligence reports.

E2 — GRAS: Full Documentation, Not Just the GRN Number 

A GRAS Notice number is a reference, not a submission. FSSAI’s Scientific Panel needs the full GRAS determination package: the FDA’s non-objection letter, the complete GRAS determination document with the safety assessment, the expert panel composition, and all supporting scientific literature. Self-affirmed GRAS — where the determination was not submitted to FDA — is accepted by FSSAI but requires the complete self-affirmation dossier to be submitted, including the names and qualifications of the expert panel.

E3 — EU Novel Food: Attach the Full Regulation Text 

EU Novel Food authorisation is among the most influential international approvals in FSSAI’s review process. When submitting EU authorisation evidence, include the full text of the relevant Commission Implementing Regulation from EUR-Lex — not a summary, not a third-party article about the authorisation. The Panel needs to see the exact conditions of use, maximum levels, population groups and any labelling requirements imposed by the EU authorisation. These conditions contextualise how your proposed Indian conditions of use compare to the EU framework.

E6 — The Indian EDI: The Calculation Most Applicants Get Wrong

The Estimated Daily Intake for the Indian population must be calculated using Indian dietary data. This is the single most common query raised in the NSF applications — not because applicants omit the EDI, but because they calculate it using US NHANES or EU EFSA dietary consumption data, which do not reflect Indian dietary patterns.

Indian EDI calculations must draw from the National Nutrition Monitoring Bureau (NNMB) surveys or the ICMR-NIN dietary assessment databases. The calculation must document all assumptions — serving size, consumption frequency, ingredient concentration per serving — and present the resulting daily exposure estimate in mg/day and mg/kg bodyweight/day (using standard Indian adult bodyweight of 60 kg). Compare the EDI explicitly against the ADI from Section D to demonstrate the safety margin.

E7 — Traditional Indian Use: A Significant Accelerant

If your ingredient has a documented history of traditional use in India as a traditional food ingredient — this is one of the most powerful elements you can add to strengthen the history of consumption. Traditional Indian use documented in classical texts, or peer-reviewed ethnobotanical literature signals to the Panel that the ingredient is not foreign to the Indian food system and significantly reduces the novelty risk perception.

One Common Mistake: Assuming International Approval Equals India Approval

EU Novel Food authorisation, FDA GRAS status, and JECFA evaluation are powerful evidence — but they are not India approvals. FSSAI’s Scientific Panel will consider them as evidence of international regulatory acceptance, not as automatic approval. India has its own risk assessment framework, its own dietary patterns, and its own regulatory mandate. The Panel may reach the same conclusion as its international counterparts — but it needs to reach that conclusion through its own process, supported by your dossier.

The role of History of consumption is to give the Panel the confidence that this ingredient has been carefully evaluated globally and found safe — so that India’s review can be efficient and well-informed rather than starting from zero.

Conclusion

History of consumption is often the most influential part of an NSF dossier because it demonstrates real-world human safety through documented consumption history and international regulatory acceptance. However, its strength depends on the quality and completeness of evidence, including global approvals, safe-use data, Indian EDI calculations, and traditional use records. While international authorizations such as FDA GRAS and EU Novel Food approvals provide strong support, FSSAI requires a well-structured, India-specific assessment to independently establish the ingredient’s safety for the Indian population