Proprietary Food vs Non-Specified Food

The Distinction That Determines Your India Market Entry Timeline

By Dr. Ashwini Kumar

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

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

The Mistake That Costs Global Brands 18 Months

Every week, international food and Nutraceutical companies approach the Indian market with one assumption: “Our product is approved in the US or EU — India entry should be straightforward.”

That assumption is wrong. And the regulatory classification error that follows — confusing a Proprietary Food with a Non-Specified Food (NSF) and Food Ingredients – is one of the most costly mistakes a Foreign companies can make when planning India market entry.

First, a Critical Correction the Industry Gets Wrong

The terms ‘Proprietary Food‘ and ‘Non-Specified Food’ are frequently used interchangeably — even by regulatory professionals. They are not the same thing. They are governed by different regulations, carry different compliance obligations, and lead to dramatically different timelines.

The authoritative definition makes this clear: Non-Specified Food or Food Ingredients are products that are neither standardised nor fall under the proprietary food category stated under the Food Safety and Standard Regulations.

Proprietary Food — The ‘No Standard Exists, But All Ingredients Are Permitted’ Category

A Proprietary Food is a composite food product for which no specific FSS standard exists, but where every individual ingredient it contains is already on FSSAI’s permitted lists. This is the easier pathway.

Non-Specified Food (NSF) — The ‘Prior Approval Mandatory’ Category

A Non-Specified Food is a product or ingredient that goes beyond the Proprietary Food definition — it is neither standardised under FSSAI regulations nor does it fit neatly into the proprietary food framework. This typically happens when:

• The product contains an ingredient with no history of safe use in India
• The ingredient has not been consumed traditionally in India or its region of origin
• The product has been produced using novel technology or engineering techniques
• The ingredient is derived from microorganisms, fungi, or algae not covered under existing FSSAI regulations
• The product is a global brand that complies with US, EU, or other standards but has no Indian regulatory equivalent

Side-by-Side Comparison: What You Actually Need to Know

 

Parameter	Proprietary Food	Non-Specified Food (NSF)
Legal Definition	Composite product with no existing FSS standard — but all ingredients are individually FSSAI-permitted	Food or ingredient that is neither standardised nor fits the proprietary food category under FSS Regulations
Prior Approval	NOT required	MANDATORY — from FSSAI HQ before manufacture or import
Application Fee	No product-level fee	The government fees is around ₹50,000 per product/ingredient (excluding GST).
Timeline to Market	With standard FBO/Import license —relatively fast	12–24 months (scientific review by FSSAI’s Scientific Panels)
Ingredients	All on FSSAI permitted list; no novel/unapproved ingredient	May contain novel or unclassified ingredient — that’s why approval is needed
Label Declaration	Must declare ‘Proprietary Food’ on label	Must reflect approval conditions and FSSAI-permitted claims only
Health Claims	Not permitted	Not permitted — and very conservatively reviewed
Governing Regulation	FSS (Food Products Standards & Food Additives) Regulations, 2011 — Regulation 2.12.1	FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017
Risk of Port Rejection	Low — if ingredients verified and label compliant	HIGH — if imported without prior FSSAI approval

Table 1

The NSF Approval Process: What Foreign Companies Face

For foreign manufacturers and foreign Companies whose products fall into NSF territory, the approval process under FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 is a structured dossier-based review. Here is what it requires:

Documentary Requirements

FSSAI requires robust scientific evidence demonstrating product safety. Your dossier must include:

• Complete product formulation and ingredient specifications
• Certificate of Analysis (CoA) — chemical, nutritional, microbiological, heavy metals, pesticide residues, naturally occurring toxicants
• History of consumption globally — which countries, for how long, regulatory approvals received
• International approvals such as GRAS (Generally Recognized as Safe) status, WHO/FAO/CODEX listing
• Human clinical safety data in prescribed format where available
• Proposed label with India-compliant claims (note: your global label claims will almost certainly need revision)
• FSSAI Central License or Import License copy

The Scientific Panel Review

Once submitted, your application undergoes risk analysis by FSSAI’s Scientific Panels. The Panel may request additional information, comparative studies, or clarifications. This iterative process is where most timelines extend — applicants who are unprepared for Panel queries can see their 12-month process stretch to 24 months or beyond.

FSSAI publishes a running status list of all NSF applications — approved, rejected, closed, withdrawn, or under process. As of March 2026, this list runs to 61 pages, giving you a sense of the volume of applications being processed and the categories being reviewed.

How CliniExperts Can Help

At CliniExperts and Innovation Bridge Healthcare (IBH), we have built India’s most integrated food regulatory and commercialization platform for foreign companies. Our food regulatory services include:

• Product classification advisory — Proprietary Food vs NSF determination with written regulatory opinion
• Ingredient mapping against FSSAI permitted schedules
• NSF dossier preparation and FSSAI HQ application filing
• India-compliant label development under FSS (Labelling & Display) Regulations 2020
• Foreign Food Manufacturer Facility ( FFMF) registration on the ReFoM portal
• Import License (Central) application and FICS clearance support
• End-to-end India market entry strategy for food, Nutraceutical, and health supplement foreign companies.

If you are a global food or Nutraceutical brand evaluating India entry, the regulatory classification question is the right place to start. We can help you answer it — accurately, quickly, and with full regulatory backing.