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FSSAI License for Food Supplements and Nutraceuticals in India - Form B & Form C


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    CliniExpert-usp test license

    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. Form C covers various licenses, including manufacturing, marketing, importing (central), storage, distribution, wholesaler, retailer, transporter, and exporter. -

    The Food Safety and Standards Authority of India (FSSAI) oversees food-related licenses in India. Anyone dealing with food supplements and nutraceuticals need a valid FSSAI License.

    Food Business Operators (FBOs) have faced accusations of violating the Food Safety and Standards Act (FSSAI). It can be adulterating, producing or selling inferior food, and using hazardous ingredients. Suppose the FBOs follow the guidelines to get the licences. In that case, they cannot manufacture, supply, distribute, or import food products into India without a valid FSSAI licence.

    Having an FSSAI License means the food is verified and safe to eat. It also means the food business is registered with FSSAI, making it easier to keep track of licenses and follow rules like safety audits, product testing, and recalls. This helps businesses ensure they're following FSSAI guidelines and making safe food. Following regulations ensures the food is safe, doesn't harm health, and lets consumers choose wisely while ensuring fair business competition.

    The following process needs to follow to apply for the FSSAI License:

    • The applicant should apply in Form B.
    • They can 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.
    • The Licensing Authority tells FBOs to fix and complete their application within 30 days. If not, it may be rejected.
    • The Licensing Authority reviews the application and documents. They then send a Food Safety Officer to inspect the premises and issue a report.
    • After satisfactory scrutiny, the Licensing Authority grants the FSSAI License to the applicant within 60 to 90 days.
    FSSAI Form A B C

    Who Can Apply?

    Any Indian-based manufacturer, importer, distributor, retailer, wholesaler, or transporter involved in food-related business can apply for FSSAI License.

    FSSAI Form C

    How To Apply?

    The Applicant must follow the following process:

    To obtain FSSAI License, the applicant must follow the following procedure:
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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.
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    Validity

    The FSSAI Central License remain valid for 1 to 5 years, depending on the application request.

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    Fee Involved

    The per-year charge of FSSAI Central License is 7500 rupees plus taxes.

    Important Documents

    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

    MONTHS

    Essential 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.

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    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 an FBO operates in multiple states, they need a Central License for their main office and separate licenses for each unit. Each unit needs a license based on its capacity or turnover from the relevant authorities.

    At which points, an inspection of my food business will be conducted

    Inspections are conducted on the points of Sanitary and Hygienic Requirements. They are mentioned in Schedule 4 of the 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, the FSSAI License under Importer KoB is only for importing food Items into the Country. Therefore, for carrying out further food business activities of imported food products, as defined under clause 3(n) of the Food Safety and Standards Act, 2006. FBOs need to endorse all such relevant Kinds of Business categories in the issued license by applying a modification of the license.