How to Get a FSSAI License To Sell Nutraceuticals & Health Supplements in India

Businesses producing or marketing health products must obtain an FSSAI License for Nutraceuticals to comply with India’s food safety regulations. Recently, the Food Safety and Standards Authority of India (FSSAI) has proposed some substantial modifications to Food Business Operators (FBOs) who have their products produced by third party manufacturers. Such businesses will now have to acquire an FSSAI License in the category of Kind of Business called Relabeller. Businesses operating under contract manufacturing now most commonly use the Relabeller license, as the Supplier and Marketer classes no longer accept new license applications.

Definition of Relabeller: – 

The regulations of FSSAI consider relabellers to be manufacturers but they do not possess manufacturing premises. A relabeller can receive the products produced or packed by the manufacturers with valid FSSAI licenses only. The classification also provides the businesses with adequate food safety standards despite outsourcing production.

FSSAI License of Relabeller: – 

FSSAI uses a single license to relabellers that have to operate in several premises. In the case of businesses which conduct operations in more than one state, the registered office or head office can obtain a single central license according to the FSS licensing and registration regulation, 2011.

Under the Licensing Regulations 2011 the prescribed application form contains the Kind of Business (KOB) of re-labeling (manufactured by third party under own packaging and labeling). Food business operators can apply through the Food Safety and Compliance System (FoSCoS), which provides detailed licenses for different KOB types.

Requirements to grant FSSAI License to Relabeller: –

Applicants must fulfill the following conditions to receive an FSSAI License for Relabeller.

1. Arrangements on manufacturing: – Relabellers cannot independently manufacture their products, they have to sign or enter into an agreement/contract with third-party manufacturers who manufacture their products.

2. Compliance Responsibility: – Relabellers should make sure that the implementation of all conditions of the Schedule 4 (General Hygienic and Sanitary Practices) is done by their contracted manufacturers.

3. Accountability on product safety: – The relabeller has the responsibility of the safety and standards of all products that it manufactures and packs under its license.

4. Multi-Category Coverage: – A relabeller has the right to seek and acquire one license incorporating various types of food.

5. Dual Labeling Requirement: – Product labels should have the addresses and license numbers of the relabeller and the manufacturer/processor on these labels.

6. Complete License Annexure: – The license annexure should also contain the information about all manufacturing/processing sites, product category, processing capacity, and FSS licensing numbers.

7. Change Notifications: – The changes of either the location, capacity of working or a change in the type of product should be reflected in the license immediately.

8. Compliance Officer: – The relabeller should appoint one officer who would be the compliance officer with regard to compliance with the conditions of licensing at all relabeling units.

9. FSMS Maintenance: – It is the mandate of each manufacturing/processing unit to maintain Food Safety Management System (FSMS) conditions.

10. Recall and Traceability Plan: –  There should be a detailed recall and traceability plan in the license applications.

Fee Structure for FSSAI License for Nutraceuticals: – 

The fee structure for obtaining an FSSAI License for Relabeller is as follows: –

Documents Required for FSSAI License for Nutraceuticals: – 

Applicants must submit the following documents to obtain an FSSAI License for Relabeller.

1. Financial Documentation: –

• Proof of expected annual turnover

2. Personal Information: –

• Full address and contact details of directors
• Photo ID and address proof issued by government authority of proprietor/partner/director(s)/authorized signatory

3. Premises Documentation: –

• Proof of possession of premises (sale deed/rent agreement/electricity bill, etc.)
• Business Constitution: – Partnership deed/self-declaration for proprietorship/memorandum & articles of association

4. Authorization Documents: –

• Nomination of persons by company along with board resolution
• No Objection Certificate (NOC) and copy of license from manufacturer

Application Procedure: – 

The FSSAI has simplified the process of application by use of the Food Safety and Compliance System (FoSCoS). Notably, one needs not to create FoSCoS user ID prior to application of a license or registration. Applicants can make applications directly on the FoSCoS home page.

Step-by-Step Application Process:

1. Create an Account on FoSCoS

• Go to the FoSCoS web site (foscos.fssai.gov.in).
• Register with your email address
• Create a secure password
• Verify your email address

2. Choose the Correct Application Type

• Log into your FoSCoS account
• The dashboard will provide the option of choosing New License/Registration.
• Select Relabeller as Your Kind of Business (KOB).
• When choosing the type of licenses, choose on the basis of your annual turnover.

3. Complete the Application Form

• Enter all necessary business information.
• Inform the authority about your manufacturing partners.
• Upload all required documents in the given format.
• Include detailed information about products and types.
• Specify manufacturing location parameters clearly.

4. Upload Required Documents

• Ensure all documents are in PDF format and within size limits.
• Arrange files according to the sequence in the application.
• Confirm that every required paper is included.
• Review each upload for clarity and completeness.

5. Pay the License Fee

• Pay the applicable fee based on your business turnover.
• Use the secure online payment gateway.
• Save the payment receipt for your records.
• Note the transaction reference number for future tracking.

6. Submit and Finalize Your Application

• Review all entered details carefully.
• Correct any inaccurate information.
• Submit the completed application online.
• Record the application reference number.
• Print and save the acknowledgment receipt.

Post-Application Process: – 

1. Application Processing: Your application and supporting documents would be reviewed by the appointed officer within the stipulated time.
2. Checking (when necessary): Depending on your business nature, an inspection of your premises can be done.
3. Response to the query: You will be informed via the FoSCoS portal in case of any clarifications or other documents.
4. Re-issue of License: In case of a successful verification, your FSSAI Relabeller license will be issued and can be downloaded in the FoSCoS portal.

Things to Keep in Mind: – 

1. Timeline: The time would be between 30 and 60 days depending on how complete your application was and the inspection requirements.
2. Validity: depending on the type of the license that is obtained, FSSAI issues licenses which have a tenure of 1-5 years.
3. Compliance: This should guarantee continued adherence to all FSSAI regulations and should keep good records to be audited regularly.
4. Renewals: Have license renewed long before expiry so as not to create any disruption to the business.

Conclusion

Securing a license of FSSAI Relabeller is a mandatory requirement among the businesses operating in the nutraceuticals and health supplements industry that depend on outsourcing their manufacturing. Online processes with the help of FoSCoS are simpler to apply to, however, it is very important to guarantee that all requirements are adhered to and that relevant documentation is done to ensure successful acquisition of the license and continued operation.