FSSAI License for Food Supplements and Nutraceuticals in India - Form B & Form C
CliniExperts is a 360-degree regulatory solutions provider in India for food supplements and nutraceuticals industries. We help you with the entire process of getting the FSSAI Food Supplement License / FSSAI Registration for Nutraceuticals in Form C. Contact our experts to get your FSSAI License for Nutraceuticals, Health Supplements, and novel foods.
FSSAI Registration For Food Supplements & Nutraceuticals In From C – Overview
FSSAI License For Food Supplements & Nutraceuticals In Form C {Manufacturing License/ Marketing/ Importing (central)/ Storage/ Distribution/ Wholesaler/ Retailer/ Transporter/ Exporter} -
The regulatory body that supervises food-related licensing in India is the Food Safety and Standards Authority of India (FSSAI). Any manufacturer, importer, distributor or wholesaler of food supplements and nutraceuticals must hold a valid FSSAI License.
Many Food Business Operators (FBOs) have been accused of non-compliance with FSSAI regulations, indulging in practices such as adulteration, sale or manufacture of substandard food and use of unsafe ingredients. The FBOs holding a valid FSSAI License for manufacturing, supplying, distributing or importing food products into India are prevented from such activities if they follow the FSSAI guidelines to obtain the licenses.
The purpose is that the food which is licensed is verified and hence, safe to consume. Furthermore, FSSAI License ensures the FBOs are registered with FSSAI, which makes it easier to maintain the records of their licenses and related compliances such as food safety audits, annual returns, product testing, recalls, etc. It provides a medium for FBOs to make sure all compliances and works are as per FSSAI guidelines of licensing. Finally, compliance with regulations ensures the food is safe for consumption, has no adverse health consequences and helps consumers make informed choices with fair competition for the FBOs.
The following process needs to follow to apply for the FSSAI License:
- The applicant should apply in Form B and submit the required documents and pre-requisite FSSAI Licensing fees to the Food Authority.
- After applying, the FBOs receive a Unique Application Reference Number.
- The Food Authority further scrutinises the submitted application.
- In case of incomplete information in the application or non-compliance, the Licensing Authority directs the FBOs to rectify and complete the application form by submitting the required details within thirty days of receiving the notice to avoid rejection.
- After scrutinising the application and documents, the Licensing Authority appoints a Food Safety Officer to inspect the premises and direct them to issue an inspection report.
- After satisfactory scrutiny, the Licensing Authority grants the FSSAI License to the applicant within 60 to 90 days.
Who Can Apply?
Any Indian-based manufacturer, importer, distributor, retailer, wholesaler, or transporter involved in food-related business can apply for FSSAI License.
How To Apply?
The Applicant must follow the following process:
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The applicant must visit the FoSCoS website for food licensing and registration.
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The applicant is required to register on the FoSCoS and log in with a username, password and captcha.
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The applicant must select Apply for New License/Registration" from the dashboard.
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The applicant should fill in the required details based on the premise and KoBs.
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The applicant completes Form B and attaches the required documents, such as an Aadhaar Card, Form IX, proof of premise, etc.
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Preview the application and submit it to proceed with the payment.
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Upon completing the payment, a receipt is generated with a 17-digit reference number for future reference.
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After satisfactory scrutiny of the application and the submitted documents, the Food Authority grants the license. · The FBOs must follow the conditions laid down in the granted license.
Validity
The FSSAI Central License remain valid for 1 to 5 years, depending on the application request.
Fee Involved
The per-year charge of FSSAI Central License is 7500 rupees plus taxes.
Important Documents
The essential documents involved are:
- Duly filled Form B
- Names of Directors with full address and contact details.
- Photo I.D and address proof of the applicant
- Authority letter with name and address of the responsible person.
- Blueprint of the manufacturing unit.
- Address proof of premises (Sale deed/ Rent agreement/ Electricity bill, etc.)
- List of equipment/machinery with registration number, installed capacity and horsepower used
- Photographs of the production unit
- Partnership Deed/Affidavit/Memorandum; Articles of Association Export towards the constitution of the firm.
- Copy of certificate obtained under Coop Act - 1861/Multi Multi-State Act - 2002 in case of Cooperatives.
- If applicable, a No-Objection Certificate from the manufacturer.
- NOCs from Municipality or local body and State Pollution Control Import Code document Board except in case of notified industrial area.
- List of categories of food
- Statement of ingredients and additives in case of manufacture of supplements
- Complete Analysis report (Chemical, Bacteriological and Pesticide residues) of water.
- Form IX
- Recall Plan
- If applicable, product approval document
- Case-specific documents applicable to the manufacturer/importer /distributor etc., depending upon the kind of business.
- Food Safety Management System plan or certificate, if any (ISO, BRC, HACCP etc.)
Timeline to get
Form C
from Central Drugs Standard Control Organisation
2 to 3
MONTHSEssential Tips
The following are a few essentials tips that may benefit during the application process:
- The applicant must correctly fill out Form B and submit the completed copy.
- The product should be compliant with FSSAI guidelines for that food category.
- Complete details of the authorised person, technical person and form IX person.
- The applicant must select the correct business and product categories. A few problems may be faced during the application process:
- If the applicant submits insufficient or incorrect documents.
- If the applicant applies to the incorrect category.
- If the licensing personnel transfers or is a recruit.
- If the products filed in the application are non-compliant
Expert Advise
CliniExperts provides technical advice to ensure smooth application approval:
The applicant must upload all self-attested documents by the authorised signatory/proprietor while applying for the license/registration. The applicant must ensure the product submitted in the application are compliant to avoid queries and rejection.
The applicant should make sure to reply to the query within 30 days.
The applicant must ensure the accuracy and backup of the information filled in Form B.
Related Services
Frequently Asked Questions
Are different Licenses required to conduct a different kinds of food business activities at the same premise?
FSSAI license is based on the premise. All kinds of food business activities that are being conducted at the same premise can be applied for in a single FSSAI license.
What is the FSSAI License requirement to run a food business in more than one state with the same name of the company or organisation?
If a Food Business Operator (FBO) has his food business premises located in two or more States, he is required to obtain a Central License for his Registered Office or Head Office in addition to the license/registration for each unit/premise. A separate license or registration has to be obtained for each unit/premise depending upon that unit's capacity or turnover, from the concerned Central or State licensing authorities.
At which points, an inspection of my food business will be conducted
Inspections are conducted on the points of Sanitary and Hygienic Requirements as mentioned in Schedule 4 of FSS (Licensing and Registration of Food Businesses) Regulations, 2011. Kind of Business wise standardised inspection checklists used by inspectors are based on Schedule 4.
How will I know about the stages/status of my application?
An applicant is informed by SMS/Email alert at many application processing stages. Moreover, the applicant can obtain the status by using the "Track Application Status" facility on FoSCoS.
Is the FSSAI License under Importer KoB sufficient to carry out further food Business activities of Imported Food Products?
No, FSSAI License under Importer KoB is only for importing food Items into the Country. Therefore, for carrying out further food business activities of that imported food products, as defined under clause 3(n) of the Food Safety and Standards Act, 2006, FBOs need to endorse all such relevant Kind of Business categories in the issued license by applying modification of license.