Food Safety Compliance in India

  • What is FSSAI?

Food Safety and Standards Authority of India (“FSSAI”) is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. The FSSAI has been established under the Food Safety and Standards Act, 2006, which is a consolidating statute related to food safety and regulation in India. FSSAI is responsible for protecting and promoting public health through the regulation and supervision of food safety.  It ensures the food products undergo quality checks thereby curtailing the food adulteration and sale of sub-standard products. It is responsible for the registering and licensing of the Food Business Operators (FBO) in India and it lays down the rules and regulation for running the food business in India.

  • Why is FSSAI required?

Each food business administrator engaged with manufacturing, processing, storage distribution and sale of food products should necessarily acquire FSSAI Registration or License.  FSSAI Registration is not the same as FSSAI License as in relying upon the size and nature of the business, FBO ought to acquire the vital registration or license. It is a 14-digit registration or a license number which is imprinted on all the food packets. The 14-digit registration number gives insights regarding the collecting state and maker’s grant. This registration procedure is aimed to create more accountability on the FBO to maintain the quality of the food products. The permitting and registration strategy and prerequisites are controlled by Food Safety and Standards (Licensing and Registration of food Business) Regulations, 2011.

  • What is the procedure of FSSAI Registration/ License?

FSSAI registration or license is based on the business volume and premises. Depending upon the installed capacity or turnover or location, applicant premises are eligible for the license such as basic license, central license, and state license.

  • Types of food licenses
  1. FSSAI Registration: The FSSAI registration is needed for small businesses or start-ups which usually have annual turnover of less than Rs.12 Lakhs. The people who can apply for this process can be a petty retailer dealing in food products, stallholder or any person who manufactures or sells any food article by himself and cottage industries.
  2. FSSAI State License: The FSSAI state Licence is needed for mid-sized businesses that have an annual turnover between Rs. 12 lakhs to 20 crores. The people who can apply for this license are the FBOs like Manufacturing units, retailers, marketers, distributors, transporter and storage, etc. They all need to issue the license from the State Government.
  3. FSSAI Central License: The Central License is needed for big businesses that have an annual turnover of more than Rs. 20 crores. A central license is also needed when supply is to be made at the government offices. Moreover, the FBOs like 100% export-oriented units, large manufacturers, importers, food business operators in Central Government Agencies, airports, seaport, etc require to get FSSAI registration. The license is given by the Central government of India.
  • When does one have to apply for an FSSAI Registration or License?

OR

What is the time frame in which I need to apply for an FSSAI Registration or License?

Obtaining an FSSAI license is mandatory before starting any food business operation in India.

  • Documents required for FSSAI registration
  1. Photo of Food Business Operator;
  2. Document for Identity Proof like Ration Card, Voter ID Card, PAN Card, Driving License, Passport, Aadhar Card, Senior Citizen Card, Department Issued ID;
  3. Supporting Documents (if any) :- NOC by Municipality/Panchayat, Health NOC;
  4. Form ‘A’; and
  5. Fees of the license may vary according to the notification given by the FSSAI.
  • Documents required for State FSSAI registration
  1. Form B duly completed and signed;
  2. Plan of the processing unit showing the dimensions and operation-wise area allocation;    
  3. List of Directors/ Partners/ Proprietor with address, contact details, and photo ID;
  4. Name and list of equipment and machinery used with the number and installed capacity;
  5. List of food category to be manufactured;
  6. Authority letter from manufacturer nominated a responsible person name and address;
  7. Analysis report of water to be used in the process to confirm the portability;
  8. Proof of possession of premises;
  9. Partnership deed/ affidavit of proprietorship;
  10. NOC and copy of License from the manufacturer;
  11. Copy of certificate obtained under Coop Act 1861/Multi state Coop Act 2002; and
  12. Food safety management system plan or certificate.

There are different forms and documents which are required to be submitted for each conversion, renewal, and modification of license/s.

  • Documents required for Central FSSAI license
  1. Form B duly completed and signed;
  2. Plan of the processing unit showing the dimensions and operation-wise area allocation;    
  3. List of Directors/ Partners/ Proprietor with address, contact details, and photo ID;
  4. Name and list of equipment and machinery used with the number and installed capacity;
  5. List of food category to be manufactured;
  6. Authority letter from manufacturer nominated a responsible person name and address;
  7. Analysis report of water to be used in the process to confirm the portability;
  8. Source of raw material for milk, meat etc;
  9. Recall plan wherever applicable;
  10. Ministry of Commerce Certificate for 100% EOU;
  11. NOC/PA document issued by FSSAI;
  12. IE code document issued by DGFT;
  13. Form IX;
  14. Certificate from Ministry of Tourism;   
  15. Proof of possession of premises;
  16. Partnership deed/ affidavit of proprietorship;
  17. NOC and copy of License from the manufacturer;
  18. Food safety management system plan or certificate;
  19. NOC from the municipality or local body;
  20. Supporting document for proof of turnover and transportation; and
  21. Declaration form.
  22.  Benefits of procuring food license

Obtaining a license can provide the food business with legal benefits, build goodwill, ensure food safety, create consumer awareness, and assist in business expansion. Also, it helps to regulate, manufacture, store, distribute and sale of import food.

  • Consequences of Non- compliance

Any registered or licensed person under the FSSAI has to adhere to the rules and regulations under the FSS Act, 2006. Food safety officer generally conducts the inspection of the food business operator’s facility and identifies the level of compliance with the regulation using a checklist. Based on the compliance level, the food safety officer marks it as:

  1. Compliance (C)
  2. Non-compliance (NC)
  3. Partial compliance (PC)
  4. Not applicable/Not observed (NA)

Based on the above, the Food Safety Officer (FSO) might issue an improvement notice where ever required per Section 32 of the FSS Act, 2006. If the business operator fails to comply with the improvement notice, the officer after giving the licensee an opportunity to show cause, may cancel his license. Any Food Business Operator aggrieved by an improvement notice can appeal to the State Commissioner of Food Safety. The decision thereon can be challenged through appealing to the Food Safety Appellate Tribunal/High Court.

  •   Penalty for Non-compliance
Sr No.ParticularsFine (INR)
1.Food quality not in compliance with the act2 Lakhs Petty Manufacturer-25,000/-
2.Sub- standard food5 Lakhs
3.Misbranded food3 Lakhs
4.Misleading advertisement or false description10 Lakh
5.Extraneous matter in food1 Lakh
6.Failure to comply with food safety officer direction2 Lakhs
7.Unhygienic processing or manufacture1 Lakh
  • Who are petty business food operators?

Petty Food Business Operators (FBO) who himself manufactures or sells any article of food or a petty retailer, hawker, itinerant vendor or a temporary stall holder or small scale or cottage or such other industries relating to food business or tiny food business operator having annual turnover up to Rs. 12 Lacs and/or whose:

  1. production capacity of food products does not exceed 100 kg or litres per day, or
  2. procurement or handling and collection of milk is up to 500 litres of milk per day, or
  3. slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or less.

These FBOs are required to obtain FSSAI Registration Certificate by applying on Food Licensing and Registration System. This Registration Certificate is embedded with QR code and has the image of FBO with 14-digit Registration number starting with 2 (2xxxxxxxxxxxxx).

  • Renewal of FSSAI license
  1. The FSSAI license is essential to commence the food business, similarly it is imperative to renew the license. The license is issued for a validity of 1 year or 5 years, so the business must apply for renewal 30 days prior to the expiry of current license. FSSAI has introduced an online application called Food Licensing and Registration System (FLRS) so businesses can apply online for the licenses.
  2. Registration or license granted under these Regulations shall be valid and subsisting, unless otherwise specified, for a period of 1 to 5 years as chosen by the Food Business Operator, from the date of issue of registration or license subject to remittance of fee applicable for the period and compliance with all conditions of license.
  3. Any application for the renewal of a registration or license granted under these Regulations shall be made in Form A or B of, as the case may be, not later than 30 days prior to the expiry date indicated in the license.
  4. The Registration or License shall continue to be in force till such time that the orders are passed on the renewal application which in no case shall be beyond 30 days from the date of expiry of registration or license.
  5. Any renewal application filed beyond the period mentioned under Regulation but before the expiry date, shall be accompanied by a late fee of Rs 100 per day for each day of delay.  Any Registration or license for which renewal has not been applied for within the period mentioned in Regulation shall expire and the Food Business Operator shall stop all business activity at the premises.
  6. The Food Business Operator will have to apply for fresh Registration or license as provided in Regulation as the case may be, if it wants to restart the business. Food Business Operator having valid certificate of an accredited food safety auditor or from an agency accredited by Food Authority or any other organization notified by food Authority for this purpose will not be normally required to be inspected before renewal of license. Provided that Designated Officer may order an inspection before renewal if considered necessary for reasons to be recorded in writing.
    The FLRS is utilized in five Regional Offices for the issue of licenses and entitlements. They are:
  7. Northern Region -New Delhi
  8. Eastern Region – Kolkata
  9. North Eastern Region – Guwahati
  10. Western Region – Mumbai and Kerala
  11. Southern Region – Chennai

The content of this article is intended to provide general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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