Blog

You are currently viewing Novel Food Approval Process In India

Novel Food Approval Process In India

 Novel food approval process in India is regulated by the Food Safety and Standards Authority of India (FSSAI).

Innovative formulations, new ingredients and advanced nutrition concepts are shaping the future of India’s food and nutraceutical market. But when your product doesn’t fit into existing FSSAI standards, you enter the world of novel foods and non-standardized products.

Under India’s food law, many of these products fall into Non-Specified Food (NSF),  and require prior FSSAI approval before they can be manufactured or imported.

In order to regulate Novel food and provide the opportunity to Food Business Operators(FBOs) to innovate food products, FSSAI came up with Food Safety and Standards (Approval of Non-Specified Food and Food Ingredients) Regulations, 2017.

FSSAI drafts and implements regulations for the manufacture and sale of food products in India. Its approval is required for any food product to enter into the market. Only after its approval, the food product can be sold in Indian market. 

But before you can do that, you need to know what is novel food and requirement for approval as per the FSSAI regulation

If you’re not sure, don’t worry.

In this piece, we’ll explain what novel foods are and approval process, and why it’s important, and then give you a step-by-step guide.

FSSAI Approval is Mandatory for Novel Food Sales and Manufacturing in India

Table of Content

  • What are Novel Food and Non-specified food?
  • What us covered under Novel Food or Non-specified Food category under the FSSAI regulation?
  • Steps for seeking approval
  • Steps after seeking approval
  • Conclusion & Solutions
  • People Also ask (FAQs with answers)

Let us explore in detail.

What are Novel Food and Non-specified Food?

Novel Food is food or food ingredient which does not have any history of human consumption whereas,

Non-specified food is food or food ingredient which have a history of safe human consumption but not specified in the regulations of FSSAI.

What is covered under Novel Food or Non-specified Food category under the FSSAI regulation?

  • Novel Foods/ Ingredients/ food processed with Novel technology
  • New Additives
  • New Processing Aids including Enzymes
  • Articles of food or ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi or algae
  • Any other non-specified food.

Steps for seeking approval

  • Submit the application, documents and fee
  • Application scrutiny by FSSAI maximum within 45 days
  • Post assessment, FSSAI approve or seek additional documents
  • Authority may accept or reject the application

Steps after seeking approval

  • FSSAI Central License procurement under specific category
  • Formulation/Ingredient review and claims validation
  • Labelling and artwork compliances
  • Regulatory intelligence and go-to-market strategy
  • Post marketing surveillance

Food Business Operators(FBO) must verify whether the food falls under the scope and must follow the regulations before introducing the food product in the Indian market. Still, you have confusion-Is my product or ingredient present in my product Novel?

Read more: Common India Entry Challenges for Nutraceuticals and  Dietary Supplement Manufacturers

Conclusion

You may find the solution with us at Shauryam.

Novel food approval is a rigorous procedure in India.

Our food regulatory consultants can help you understand the regulations related to Novel Food in India and fast-track the approval process.

Why Shauryam Solutions Private Limited for FSSAI approval for novel foods?

Shauryam Solutions Private Limited is widely recognised as a dedicated regulatory and compliance partner for food, nutrition, cosmetic, ayurveda and allied sectors in India.

For FSSAI Non-Specified Food approval and FSSAI approval for novel foods, Shauryam offers:

  • 10+ years of specialised experience in FSSAI regulations and product approvals.
  • A multi-disciplinary team covering regulations, science, documentation and lab coordination.
  • End-to-end support – from product classification and data gap analysis to Form I filing, query handling and final approval.
  • Fully online processes that support clients across India and worldwide.
  • Integrated help on licensing, labelling, claims, audits, and ongoing compliance.

Whether you are a startup, established brand ,or global supplier entering Indian market, Shauryam acts as your FSSAI Non-Specified Food approval consultant so you can focus on innovation while staying legally safe.

Check this blog to learn all about NSF product approval:

NSF product approval

Source: FSSAI

What is Non-Specified Food under FSSAI?

FSSAI approval for novel foods is the prior authorisation required for foods and ingredients that have no existing standards, may lack a history of human consumption or use new ingredients/processes. Under Indian law, most such products are handled as Non-Specified Food and must go through the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.

What is meant by Non-Specified Food under FSSAI?

Non-Specified Food means any food or food ingredient (including additives, processing aids and enzymes) for which no standards are laid down in any FSSAI regulation, and which is not classified as proprietary food. Such products require FSSAI Non-Specified Food approval before they can be manufactured or imported.

When do I need Approval for non-standardized food FSSAI?

You need Approval for non-standardized food FSSAI when your product: Does not fall under any existing FSSAI standard; Cannot be treated as proprietary food; and Uses novel ingredients or processes that require safety assessment. This is common for innovative nutraceuticals, new functional ingredients, and certain imported specialty products.

How do I apply for FSSAI Non-Specified Food approval?

You apply via ePAAS, FSSAI’s electronic Product & Claim Approval Application System. The manufacturer or importer submits Form I with all required documents and the prescribed fee. The application is scrutinised, queries may be raised and scientific panels evaluate safety before a decision is made.

What documents are required for FSSAI Non-Specified Food approval?

Typically, FSSAI expects: Product composition and specifications Manufacturing process and flow chart Safety/toxicology data and history of use Stability and shelf-life data Intended use, target population, and intake levels Draft label and claims For imports: country-of-origin approvals, Certificates of Analysis and free sale certificates An FSSAI Non-Specified Food approval consultant can help prepare this dossier in the format FSSAI expects.

How long does FSSAI Non-Specified Food approval usually take?

There is no fixed published timeline. Actual duration depends on product complexity, quality of documentation and the number of queries raised. FSSAI’s published status lists show that some applications move faster, while others take longer due to additional assessments or data requirements.

Does every imported novel ingredient need Non-Specified Food approval?

Not every imported product needs NSF approval. However, if the ingredient or product is not covered by any existing Indian standards, or FSSAI explicitly indicates that it is Non-Specified Food, then FSSAI Non-Specified Food approval may be required in addition to normal import compliance. Import FAQs and guidance also mention product approval as a conditional document in some cases.

Is the Non-Specified Food approval process fully online?

Yes. FSSAI uses ePAAS for Non-Specified Food and ingredient approvals, and FoSCoS for licence/registration payments and related services. Applications, document uploads and fee payments are processed digitally, allowing both Indian and overseas businesses to work remotely with an FSSAI Non-Specified Food approval consultant (shauryam).

After getting FSSAI Non-Specified Food approval, do I still need an FSSAI licence?

Yes. Non-Specified Food approval is a product/ingredient-level authorisation, not a substitute for your FSSAI licence or registration as a Food Business Operator. After approval, you must still obtain the correct licence (manufacturing, import, etc.) under the regular FSSAI licensing system.

Why should I hire a FSSAI Non-Specified Food approval consultant?

The process involves complex scientific data, regulatory interpretation and portal management. A specialised consultant such as Shauryam Solutions Private Limited can: - Determine whether your product truly needs NSF approval - Identify data gaps early and help you generate or source missing information - Prepare a strong, compliant dossier and manage ePAAS filing - Handle FSSAI queries professionally and efficiently - Integrate NSF approval with your broader licensing and compliance strategy This improves your chances of a successful FSSAI approval for novel foods while protecting timelines and investment.
Tags: , , , , , , , , , , , , , ,

Leave a Reply