FSSAI Compliance

Streamlining Food Safety Compliance Ecosystem in India



Delivering trust, meeting standards

The Food Safety and Standards Act, 2006 (FSS Act), and the rules and regulations under the act form the legal bases for food safety in India and elaborate food safety compliance requirements of FSSAI. FSSAI lays down food safety standards in the country with periodic checks in the form of audits, testing and inspections; more recently, it has empanelled third party auditors for food businesses and training of food handlers, which indicates a push for self-compliance as a salient feature of food safety regulations.

Responsibilities of Food Business Operators
  • FSSAI Registration & Licensing
  • Conducting regular Food, Beverage, Air & Swab (Hand & Food contact surfaces) Tests
  • Conducting Hygiene Audits or Inspection
  • Vendor Audits or Inspection
  • Pre – Transportation & Dispatch Audits
  • Food Safety Standards System Plan (FSMS)
  • Regular Medical Check-ups of Food Handlers
  • Documentation
  • Penalties
  • Implementation of solutions provided
  • Form C, format of License
  • Form E, guarantee of quality
  • Compliance of Packaging and Label Declaration
  • Advertisement Standards Council of India (ASCI)
  • Compliance with Laws on Weights & Measures
  • Compliance with other laws applicable to food industry

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  • FSSAI Registration & Licensing-
  • All FBOs require either a Registration or License under the Act to carry on the business of manufacturing, packing, sale, storage, transport of food.
    FSSAI Basic registration- Food businesses whose turnover is below 12 Lakhs Annually.
    FSSAI State license- Food businesses whose turnover is more than 12 lakhs but below 20 crores annually.
    FSSAI Central license- Food businesses whose turnover is more than 20 crores annually. If FBO is operating in more than two states, he is required to have a Central license and one for every state as the central license can cover a maximum of two states.

  • Conducting regular Food, Beverage, Air & Swab (Hand & Food contact surfaces) Tests-
  • It is most prominent way of finding out whether the food that has been prepared or served is safe. It also helps you to track back into the chain & conduct an analysis of where exactly the FBO faltered or what the problem is & what can be done to resolve it and prevent it from recurring. This is also essential for every FBO to submit a water analysis report where water is used as an ingredient in the food being prepared, to secure a license.

  • Conducting Hygiene Audits or Inspection–
  • This is a root cause analysis & check of all the processes & systems in place. Scrutinizing the processes & finding out GAPs within the system where food is served or processed is one of the most significant step to provide big measures to prevent hazards that may occur.

  • Vendor Audits or Inspection –
  • This helps you to establish controls on your vendor, the processes & practices. Verifying the methods of monitoring and tracking if the errors are at the vendor site or the manufacturing or service site is an important aspect.

  • Pre – Transportation & Dispatch Audits-
  • Transportation is a stage that increases the probability of introducing a food hazard or can cause a food to become a toxin rather than a nutrient. Inspection of dispatch procedures, condition of the transportation vehicle, the containers used for transportation, temperature control during transportation etc is imperative.

  • Food Safety Standards System Plan (FSMS) –
  • The FSMS Plan is a must for licensing. It is based on ISO 22000 & also incorporates the Food Safety Standards Regulations 2011, Schedule IV guidelines. Irrespective of whether you need to get a license or not, as FSMS plan is a must for every organization in the food sector as it brings in along with it a structure, uniformity and systematic follow-through of all that is expected from an FBO and all that they need to ensure or put into place to abide by the law as well to safeguard themselves as well as their consumers.

  • Regular Medical Check-ups of Food Handlers –
  • It is the one of the safest ways to ensure that your food handlers do not only contaminate food but also do not transmit any infectious diseases to other staff as well as people who consume the food. FSSAI advises that all food handlers have at least a yearly check-up to detect any kind of infectious diseases & to track the overall fitness. The check-up can be conducted by any authorized/registered medical practitioner. The Medical Performa certificate is must that has to be submitted along with medical test records of food handlers for licensing purposes.

  • Documentation –
  • Regular Audit Reports done by an Internal Auditor (Trained Admin/Facility Manager), and monthly/quarterly Audit Reports by a Food Safety/Hygiene Auditor, coupled with monthly/quarterly Food, Water and Hygiene Swab testing reports, and documentation of the steps taken for rectification of errors in case of any non-compliance to the standards found would complete the documentation required. Such documentation is needed to be maintained at the Food Vendor’s end, as well as the Corporate Canteen’s too.

  • Penalties –
  • Any Company found to have contracted a Food Vendor, without the FSSAI License/ Registration will be prosecuted by FSSAI / FDA. The responsible managers handling F&B/ Catering/Canteen/Cafeteria will be held responsible. In case of any unfortunate incidents like food poisoning, outbreak of food borne diseases, etc., and if proper documentation is not maintained, the Authorities will prosecute the responsible person with monetary penalties ranging between Rs. 1,00,000/- up to Rs. 10,00,000/- and/or imprisonment from 6 months up to lifetime, depending upon the severity of the case and the documentation maintained.

  • Implementation of solutions provided –
  • There are suggestions & solutions provided for all analysis & inspections conducted. Implementation of these will help close all non-conformities & resolve issues that lead to any contamination & any law suits.

  • Form C, format of License –
  • Every FBO shall display the license, the format of which is given in Form C, at all times at a prominent location.

  • Form E, guarantee of quality –
  • Every manufacturer, distributor or dealer selling an article of food to a vendor shall give either separately or in the bill, cash memo or label, a warranty or guarantee of quality, the format of which is in Form E.

  • Compliance of Packaging and Label Declaration-
  • Every FBO to ensure that the labelling of foods should conform to the regulations and does not mislead the consumers.

  • Advertisement Standards Council of India (ASCI)-
  • Caution and care should be observed in advertising of F& B especially ones containing high fat, Sugar and Salt (HFSS). Advertisements should not be misleading or deceptive Advertisements for food or beverages unless nutritionally designed as such should not be promoted or portrayed as meal replacement.

  • Compliance with Laws on Weights & Measures-
  • Legal Metrology Act, 2009-
    Manufacturing, packing, selling or importing any pre-packaged commodity is prohibited unless it is in standard quantity and carries all prescribed declarations.
    Any advertisement mentioning the retail price of packaged commodity should also contain the net quantity thereof.
    Legal Metrology (Packaged Commodities) Rules, 2011-
    It is punishable if any pre-packaged commodity is packed with error in net quantity beyond the limit prescribed in the Rules.
    Declarations under the Act and Rules should be legible and prominent. For example, the Net Content and MRP must be very clear. The language has to be English or Hindi in Devnagari script. Regional languages may be used in addition only and not as a replacement.

  • Compliance with other laws applicable to food industry-
  • Export (Quality Control and Inspection) Amendment Act, 1984- The Act facilitates export trade through quality control and inspection before the products are sold to international buyers.
    Environment Protection Act, 1986- This Act incorporates rules for the manufacture, use, import and storage of hazardous microorganisms / substances / cells used as foodstuff.
    The Bureau of Indian Standards (BIS)- BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto.

1] Regulatory Compliance
FSSAI ensures that the law and provisions of FSSAI Act are complied.

2] Improvement & Prohibition Notices
Improvement Notices
– Issued by Designated Officer – Failure to comply results in suspension / cancelation of license
– Appeal to Commissioner of Food Safety

Prohibition Notices
– Court can issue prohibition notice if:

  • Food Business Operator is convicted of any offence under this Act and
  • Health risk exist with respect to that business


– Prohibition as to:

  • Use of process or treatment
  • Use of premises or equipment
  • Participation of any FBO in the management of any food business

– Application can be made for lifting of prohibition order

3] Sampling of Food

    • The Food Safety Officer is authorized to pick samples of food for analysis by following the procedure:

– Shall call one or more witnesses while lifting of samples – Obtain signatures from the witnesses in all documents
– Serve the notice in Form VA to the FBO regarding the same
– Serve notice to the manufacturer/ distributor/ supplier in case the FBO obtains the product from them
– In case of drawing sample from an open container, to be drawn in original condition

– Pay the cost of such sample to the person concerned calculated at the rate at which article is sold to public
– Take samples in clean, dry bottles or jars which shall be closed to prevent leakage and ensure that it is sealed
– The bottles and jars should be properly labelled carrying code no. of the sample, name of the sender with official designation, date and place of collection, nature of articles being sent for analysis, nature and quantity of preservatives, if any and parcel shall be properly addressed

  • The sample is then sent to the Food Analyst for testing


4] Food Recall

    • All Food Business Operators (FBO) to have up-to-date Food Recall Plan
    • Recall Plan to be in written form
    • Available to the Food Authorities on request
    • Initiation of Food Recall

– By FBO if food is unsafe or non-compliant
– May be initiated as a result of reports / complaints by manufacturers, wholesalers, importer, exporter, distributors, retailers, consumer, media, government agencies, Food Authorities
– If FBO does not initiate food recall, consumer / complainant may report to the Food Authorities who can direct food recall
– Food Authorities may on its own direct recall of food that is unsafe or non-compliant.
– FBO in the entire distribution chain to implement recall instructions of the recalling FBO and report to recalling FBO
– Recall of imported food products can also be initiated
– Food Authority to monitor recall of exported food products

Do you have any queries?

This information is in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Mind Sync does not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any information provided herein. On any specific matter, reference should be made to the appropriate advisor.



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