Food License (FSSAI) Registration Decoded For Nutraceuticals
FSSAI License Decoded for Nutraceuticals in India
All individuals associated with the food business of Health Supplements and Nutraceuticals such as the manufacture, rebranding, repackaging, and importation are required to hold an appropriate 14 digit FSSAI License in accordance with the FOOD SAFETY AND STANDARDS ACT, 2006. While other food business activities are guided by a relatively simpler turnover based system, the category of Nutraceuticals (category 13.6) requires higher levels of compliance due to its nature.
What Is FSSAI’s Role In Regulating Nutraceuticals?
FSSAI is an acronym that stands for Food Safety and Standards Authority of India. The organization was formed under the provisions of Food Safety and Standards Act, 2006 to regulate and provide standards for FBOs.
As far as the Nutraceuticals industry is concerned, FSSAI has played a vital role in distinguishing between "food" and "drug." It makes sure that products such as Health Supplements, Nutraceuticals, Food for Special Dietary Use, and Functional Foods are fit for consumption without any misleading cure claims. Given the huge rise in the Indian dietary supplements market, the FSSAI has increased vigilance about compliance via FoSCoS.
FSSAI Registration for Health Food Supplements and Functional Foods Mandatory
As such, in a developing country like India, which has a market inundated with immunity booster and protein supplements, it becomes highly imperative for the Government to offer safe products to its citizens.
Nutraceutical manufacturers, relabellers/brand owners, importers, and marketers must obtain a FSSAI license. Unlike a small local store, the nutraceutical industry cannot function without the registration/license number.
Who Is Exempt From FSSAI Registration?
Are there any exceptions? Normally, No. Although the Food Safety and Standards (FSS) Act has some exceptions for "petty manufacturers," who are hawkers or temporary stallholders, the process of manufacturing of Nutraceuticals involves a certain level of hygiene and testing that petty businesses do not have. Thus, almost all Nutraceutical firms need to obtain a License.
Validity Of FSSAI Registration/ License
The validity period of a License issued under the Act shall extend to a minimum period of 1 year and a maximum period of 5 years. The choice of validity period shall be in the hands of the Food Business Operator.
The License shall be renewable for a period of 1 year to 5 years by applying through the FoSCoS Portal up to 30 days before the expiry of the license period.
Validity Period And Renewal Of FSSAI Nutraceutical Licenses
The fee system is dependent on the kind of license that you pick on the FoSCoS website. The fees for Nutraceuticals will be high because most companies come under State or Central category.
Category | New Registration / License Fee | Renewal Fee |
|---|---|---|
Registration (Basic) | ₹100 per year | ₹100 per year |
State License | ₹3,000 - ₹5,000 per year (depending on production capacity) | ₹3,000 - ₹5,000 per year |
Central License | ₹7,500 per year | ₹7,500 per year |
Step By Step Guide To Fssai Registration For Nutraceuticals On FOSCOS
The FLRS system has now been superseded by the Food Safety Compliance System (FoSCoS). The following is the decoding of the process for Nutraceuticals:
STEP 1: Login to the FoSCoS Portal.
STEP 2: Choose the State that the premises belong to.
Step 3: Pick “Kind of Business” (KoB).
Manufacturer: If you have your own factory.
Relabeler: If you have your brand name but manufacture the product outside India.
Importer: If you import the supplements to India.
Step 4: Choose the right “Food Category”.
This should be Category 13 (Foodstuffs intended for particular nutritional uses), i.e., 13.6 (Nutraceuticals).
STEP 5: Upload Mandatory Documents. In the case of Nutraceuticals, the level of inspection is high. You need to upload:
Form B (online form).
Blueprint/Layout Plan of Processing Unit (very important for Manufacturers).
Recall Plan: A mandatory document showing how you would recall defective batches.
Report on Water Analysis from NABL Lab.
List of Directors/Partners with contact details.
NOC from Manufacturer (if you are a Relabeller).
STEP 6: Scrutiny by Designated Officer (DO). They would verify whether the ingredients used by you comply with the FSSAI Nutraceuticals regulations of 2016.
STEP 7: Licensing Number Generation. On the fulfillment of all the documentation, the 14 digit licensing number would be generated.
Decoding The 14 Digit FSSAI License Number
Meaning of each digit in the FSSAI license number:
First Digit: Indicates status. "1" indicates License (State/Central), "2" indicates Registration.
Second & Third Digit: State Code (for Central License – "00").
Fourth & Fifth Digit: Year of Incorporation ("24" for 2024).
Sixth to Eighth Digit: Code of Registrar/Designated Officer
Ninth to Fourteenth Digit: Serial Number of FBO.
Mandatory Color Codes For Nutraceutical Manufacturing Units
FSSAI has brought into existence Food Safety Display Boards (FSDBs). Nutraceutical business operators must mandatorily display such boards on their premises.
Purple / Grey board: Generally allocated for Manufacturing / Processing units
Green board: For Retailers (like supplement stores).
Such boards inform about food safety and hygiene measures that should be undertaken by the FBO, along with their FSSAI license number.
Conclusion
Indian nutraceuticals are moving on from the era of “general wellness” to the era of “scientific compliance.” While using FSSAI’s digital way through FoSCoS, it may be that the difference between acceptance and rejection lies in choosing the correct category (13.6), verifying the ingredients against the schedule approved, and having iron clad documentation. Central License is not just a regulatory necessity, but it is a guarantee of safety and quality which consumers seek out from credible brands.
How Morulaa Can Help
Going by the complexity of FSSAI Category 13.6, one needs much more than paper work; they require scientific accuracy. Morulaa HealthTech is your trusted partner to de risk your market entry and guide you through the entire FoSCoS licensing cycle starting with formulation validation against ICMR limits and going all the way through NSF approvals for novel ingredients. We help you achieve it by managing your entire end to end application process and label compliance checks.
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