|
The Path to Innovation: FSSAI’s Guide to Approving Non-Specified Foods in India
|
|---|
|
The Food Safety and Standards Authority of India (FSSAI) introduced the Non-Specified Food (NSF) Regulations in 2017 to manage the growing variety of new food products and ingredients not covered under existing food laws. These products could include novel ingredients, bioactive compounds, fermentation-based proteins, or plant-based innovations that aren't listed in current FSSAI regulations. If your product doesn’t fall under established categories, you need to seek regulatory approval before it can be sold in India. The NSF approval process requires food business operators (FBOs) to submit detailed applications through FSSAI’s online portal. The application includes product details, ingredient breakdown, safety data, and a manufacturing process description. There is a non-refundable fee of ₹50,000 per product. FSSAI's expert panels then evaluate the product based on scientific evidence, safety data, and Indian dietary norms. Products that pass this review may be approved with usage conditions. Once approved, products must comply with FSSAI's regulations, including specific labeling, usage guidelines, and post-market monitoring. If there are any changes to the product formulation, claims, or ingredients, it requires prior notification or re-approval from FSSAI. Mistakes like incomplete applications or outdated data can lead to delays or rejection, so it’s crucial to ensure that all documentation is accurate and up-to-date. |
INTRODUCTION
The Indian food industry is experiencing a wave of innovation: novel ingredients, advanced processing techniques, and imported functional foods are reshaping how consumers eat. However, not every new product fits into the established food standards defined by India’s food regulator, the Food Safety and Standards Authority of India (FSSAI). To accommodate this growing wave of food innovation while ensuring public health, FSSAI introduced the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. Commonly known as the Non-Specified Food (NSF) Regulations, this framework provides a formal approval mechanism for foods that fall outside the purview of existing standards.
WHAT IS A NON-SPECIFIED FOOD OR INGREDIENT?
A non-specified food or food ingredient is any product that is not covered under existing FSSAI regulations such as:
- Food Product Standards and Food Additives Regulations (FPSFA),
- Nutraceutical Regulations,
- Contaminants and Toxins Regulations,
- Packaging and Labelling Regulations,
- or other codified food standards.
These could include:
- Newly developed compounds or extracts (e.g., monk fruit juice concentrate),
- Bioactives or microbial strains (e.g., probiotics not previously approved),
- Nanomaterials and enzyme blends,
- Novel combinations of permitted ingredients,
- Fermentation-based proteins, synthetic forms of natural ingredients, or emerging plant-based innovations.
Essentially, if your product has no explicit mention in FSSAI’s approved list or compendia, it is treated as “non-specified” and requires regulatory clearance before marketing in India.
WHY WERE THE NSF REGULATIONS INTRODUCED?
Before 2017, FSSAI operated under a Product Approval System which was struck down by the Supreme Court due to lack of a legal framework. This left a regulatory void for food products not defined in existing laws.
To fill this gap, FSSAI issued the Non-Specified Food Regulations, notified on 11th September 2017, which came into force with the objective to:
- Ensure scientific evaluation of new foods and ingredients,
- Create a legal basis for granting approval,
- Support innovation and global trade without compromising consumer safety,
- Provide clarity and predictability for food business operators.
The regulation gave rise to a transparent, step-by-step process to evaluate such products based on global scientific evidence and Indian safety standards.
WHO NEEDS TO APPLY UNDER NSF REGULATIONS?
Any food business operator (FBO) manufacturer, importer, brand owner, or distributor needs to apply for NSF approval if their product:
- Contains a new ingredient not listed under any existing Indian regulation,
- Combines ingredients in a new composition or concentration,
- Utilizes new food processing aids or packaging technologies,
- Is imported from a country where it is legal but has no regulatory precedent in India,
- Uses novel claims, delivery forms (oral strips, soft gels), or unapproved strains.
Even if your product is approved in the US, EU, Australia, or Japan, you still need FSSAI’s separate approval to enter the Indian market.
STEP-BY-STEP NSF APPROVAL PROCESS
FSSAI has laid out a structured and formalized process for obtaining approval of non-specified foods and ingredients.
Step 1: Filing the Application
Applicants must submit Form I via the FSSAI online portal or physically at FSSAI HQ, along with the following:
- Product details and intended use
- Ingredient breakdown and concentrations
- Certificates of analysis and purity
- Manufacturing process with flowcharts
- Scientific safety data (toxicological, allergenic, ADI/NOAEL)
- Country of origin
- Product label specimen
Step 2: Payment of Application Fee
- A non-refundable fee of ₹50,000 is required per product application. This fee supports the evaluation process.
Step 3: Technical Review by FSSAI
FSSAI assigns the application to a Scientific Panel or Expert Committee, which evaluates:
- Scientific data and technical dossier
- Human safety exposure levels
- Past approvals in Codex, EFSA, US FDA, or JECFA
- Indian dietary patterns and risk assessment
Step 4: Approval/Rejection/Queries
Post-review, the authority may:
- Approve the product with usage conditions (e.g., dosage, category),
- Seek clarifications or request additional information,
- Reject the application with reasons,
- Mark it closed or withdrawn if the applicant fails to respond or requests withdrawal.
POST-APPROVAL COMPLIANCE AND OBLIGATIONS
Once a product is approved, it must still adhere to:
- Labelling requirements: Claims must match what was approved. No therapeutic or misleading claims are permitted.
- Usage restrictions: Dosage, mode of use, and target consumers must follow FSSAI’s conditions.
- Surveillance: FSSAI may conduct post-market monitoring, especially for imported or high-risk ingredients.
- Change Notification: Any modification to formulation, source, or claims requires prior notification and sometimes re-approval.
EXAMPLES OF REJECTED APPLICATIONS
Some products fail to meet safety or documentation criteria. Reasons for rejection include:
- Insufficient or outdated safety data
- Poorly defined formulation
- Conflicts with Indian dietary norms
- Use of banned or restricted substances
Rejected examples:
- Lactogen 2 with L. Reuteri – rejected due to strain concerns
- Cordyceps extract capsules – due to incomplete dossier
- Ganoderma lucidum (Reishi mushroom extract) – insufficient safety backing
Even globally used ingredients may be rejected if Indian regulations find the data inadequate.
COMMON MISTAKES TO AVOID
Many applications are delayed, rejected, or closed due to avoidable mistakes:
- Submitting incomplete documentation
- Missing or outdated scientific studies
- Failing to match label claims with product dossier
- Ignoring existing FSSAI regulations or dosage norms
CONCLUSION
The Non-Specified Food Regulations provide a well-structured approval mechanism for any food product or ingredient that falls outside FSSAI’s standard rules.
Key Benefit | Description |
Encourages Innovation | Enables launch of new-age food and health products |
Ensures Safety | Based on robust scientific evaluation |
Offers Transparency | Publicly available approval lists |
Harmonizes Global Trade | Recognizes data from global authorities (Codex, EFSA, etc.) |
HOW MORULAA CAN HELP
Morulaa offers end-to-end support for FSSAI’s Non-Specified Food approvals, including dossier preparation, scientific data review, and submission coordination. We help both Indian and global manufacturers navigate the complex regulatory process smoothly, ensuring faster approvals with full compliance without tying you to a single distributor.