Compliances under Food Safety and Standards (Licensing and Registration of Food Businesses), Regulations 2011

Background

The Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011(FSSR), were notified by the Food Safety and Standards Authority of India (FSSAI) under the powers granted by Section 31 read with clause (o) of sub-section (2) of Section 92 of the Food Safety & Standard Act, 2006 (FSS). The draft regulations were first published in October 2010, and after considering public suggestions, they were officially enforced to streamline the licensing and registration process for food businesses in India.

Compliance Duties as per FSSR:

  1. Essential Licensing Compliance:

a. Display of License in the premises [Reg. 2.1.4(6)]:Display a true copy of the license granted in Form C shall at all times at a prominent place in the premises.In case of restaurant, display a Food Safety Display Board at all times at a prominent place in the premises.

b. Intimation of Modifications, Expansion or Changes in premises of food business [Reg. 2.1.9]:The Licensing Authority must have up-to-date information on food business operators’ operations. Prior to implementation, they must disclose any modifications to the product category, layout, closure, expansion, or other significant elements. Prior approval, the original license, and a cost equal to one year’s license charge are required for changes that alter license details.

c. Transfer of registration certificate or License in case of death [Reg. 2.1.11]:If the holder of a registration certificate or license passes away, the certificate or license will remain valid for the benefit of the deceased’s legal representative or any family members, or until either

(a) 90 days have passed since the holder’s death, or

(b) the longer period that the designated officer may permit for reasons that must be documented in writing.

The dead holder’s family member or legal representative must apply to the relevant authority to have the registration certificate or license transferred in his favour.
The registration or license will remain valid once the transfer application is filed and until the authority makes a decision.

d. Form D-2: Annual Return by Food Business Operator engaged in manufacturing of milk/ milk products [Reg. 2.1.13]:

  • Every licensee shall on or before 31st May of each year, submit a return electronically or in physical form as may be prescribed by the concerned Food Safety Commissioner, in ‘Form D-1 (as per schedule 2)’.
  • Every licensee engaged in manufacturing of milk and/or milk products shall file half yearly returns for the periods 1st April to 30th September and 1st October to 31st March of every financial year in the Form D-2, as provided in Schedule-2 of these regulations. Such returns will be filed within a month from the end of the period.

Note: A separate return shall be filed for every license issued under the Regulations, irrespective of whether the same Food Business Operator holds more than one license.

e. Form E: Guarantee for sale of food article to a vendor [Reg. 2.1.14(2)]: 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 in Form E.

Conditions of License:

All Food Business Operators shall ensure that the following conditions are complied with at all times during the course of its food business:

  1. Display a true copy of the license granted in Form C shall at all times at a prominent place in the premises.
  2. Give necessary access to Licensing Authorities or their authorised personnel to the premises.
  3. Inform Authorities about any change or modifications in activities /content of license.
  4. Employ at least one technical person to supervise the production process. The person supervising the production process shall possess at least a degree in Science with Chemistry/Bio Chemistry/Food and Nutrition/ Microbiology or a degree or diploma in food technology/ Dairy technology/ dairy microbiology/ dairy chemistry/ dairy engineering/ oil technology /veterinary science /hotel management & catering technology or any degree or diploma in any other discipline related to the specific requirements of the business from a recognized university or institute or equivalent.
  5. Furnish periodic annual return (1st April to 31st March), within upto 31st May of each year. For collection/ handling/ manufacturing of Milk and Milk Products half yearly returns also to be furnished as specified (1st April to 31st September before 30th November and 1st October to 31st March).
  6. Ensure that no product other than the product indicated in the license/ registration is produced in the unit.
  7. Maintain factory’s sanitary and hygienic standards and worker’s Hygiene as specified in the Schedule – 4 according to the category of food business.
  8. Maintain daily records of production, raw materials utilization and sales separately.
  9. Ensure that the source and standards of raw material used are of optimum quality.
  10. Food Business Operator shall not manufacture, store or expose for sale or permit the sale of any article of food in any premises not effectively separated to the satisfaction of the licensing authority from any privy, urinal, sullage, drain or place of storage of foul and waste matter.
  11. Ensure Clean-In-Place systems (wherever necessary) for regular cleaning of the machine & equipments.
  12. Ensure testing of relevant chemical and/or microbiological contaminants in food products in accordance with these regulations as frequently as required on the basis of historical data and risk assessment to ensure production and delivery of safe food through own or NABL accredited /FSSA notified labs at least once in six months.
  13. Ensure that as much as possible the required temperature shall be maintained throughout the supply chain from the place of procurement or sourcing till it reaches the end consumer including chilling, transportation, storage etc.
  14. The manufacturer/importer/distributor shall buy and sell food products only from, or to, licensed/registered vendors and maintain record thereof.

General Requirements on Hygienic and Sanitary Practices to be followed by all Food Business Operators applying for License:

A. Location And Surroundings:

  • Food establishments should be situated away from environmental pollution and industrial operations that emit unpleasant odours, fumes, soot, dust, smoke, or harmful chemical/biological pollutants. The location must prevent contamination risks to food areas, avoid pest infestations, and ensure effective removal of solid or liquid waste.
  • If nearby industries pose contamination risks, adequate protective measures must be implemented.
  • Manufacturing premises should not have direct access to residential areas.

B. Layout And Design Of Food Establishment Premises:

  • Floors, ceilings, and walls should be made of impervious materials, maintained in good condition to avoid the accumulation of dirt or mold. They must be smooth, easy to clean, and free from flaking paint or plaster.
  • Doors must be constructed with smooth, non-absorbent surfaces to ensure easy cleaning and disinfection when needed.
  • Food processing or service areas should have effective drainage systems, with sloped floors designed to direct flow away from food preparation zones to prevent contamination.
  • Proper measures should be in place to prevent insects and rodents from entering processing areas through drains.
  • All external openings such as windows and doors should be fitted with wire mesh or insect-proof screens. Doors must have automatic closing systems, and screens should be removable for cleaning.
  • No food-related activity should take place in premises that are not adequately separated from toilets, drains, or waste storage areas, in order to maintain hygiene and prevent contamination.

C. Equipment & Containers:

  • Equipment and utensils that come in contact with food must be made of non-toxic, corrosion-resistant materials and should be easy to clean or disinfect.
  • All equipment must be kept clean, in good condition, and used solely for food-related purposes.
  • Food containers must have proper lids or covers to prevent exposure to dust, flies, and other contaminants.
  • Utensils and food containers should not be stored in areas exposed to impure air or harmful gases/substances that can contaminate food.
  • Equipment must be designed and placed in a way that allows easy maintenance and promotes good hygiene practices.
  • Appropriate facilities must be provided for cleaning and disinfecting equipment. Where possible, a Cleaning in Place (CIP) system should be used.
  • Separate, identifiable containers should be used for waste, by-products, and dangerous or inedible substances.
  • Cleaning chemicals and other hazardous materials must be stored in labelled containers away from food items to prevent contamination.
  • A wastewater disposal or effluent treatment system should be installed if necessary.
  • All items that touch food must:
  1. Be maintained to allow proper cleaning and disinfection.
  2. Avoid chipped enamelware; instead, use stainless steel, aluminium, glass, or lined brass utensils.

D. Water Supply:

  • Only potable water should be used in cooking and processing, with proper storage and distribution facilities in place.
  • Water used for washing or handling food must be of a quality that prevents contamination or health hazards.
  • Water storage tanks must be cleaned regularly, and cleaning records should be maintained.
  • Non-potable water can be used only for cleaning equipment that does not come into contact with food, steam production, firefighting, or refrigeration systems—provided that the piping system ensures there’s no risk of contamination to food or ingredients.
  • Pipes carrying non-potable water must be clearly distinguishable from those used for potable water.

E. For Cleaning Utensils/Equipment:

Adequate facilities for cleaning, disinfecting of utensils and equipments shall be provided. The facilities must have an adequate supply of hot and cold water if required.

F. Washing Of Raw Material:

Adequate facilities for washing of raw food should be provided. Every sink (or other facilities) for washing food must have an adequate supply of hot and/or cold water. These facilities must be kept clean and, where necessary, disinfected. Preferably, sinks which are used for washing raw foods shall be kept separate and that should not be used for washing utensils or any other purposes.

G. Drainage And Waste Disposal:

  • Waste should be removed regularly from food handling areas to avoid accumulation. Covered, touch-free bins must be provided, cleaned, and disinfected daily.
  • Sewage and effluent disposal must comply with Factory/Environmental Board norms. Properly designed drainage and waste systems should be in place to prevent contamination of food and potable water.
  • Waste storage must be positioned to prevent contamination and kept in covered containers, emptied at regular intervals.
  • Waste must be disposed of regularly and not kept open inside the premises. Disposal should follow local regulations, including those for plastic and non-environment-friendly materials.

H. Personnel Facilities And Toilets:

  • Personnel facilities must include handwashing stations with hot/cold water, separate hygienic toilets for males and females, and changing areas that don’t open directly into food processing zones.
  • Adequate toilets should be provided based on staff count, and employees must be made aware of cleanliness practices.
  • Rest and refreshment areas should be separate and must not directly lead into food production or storage areas.
  • A display board with dos and don’ts should be placed prominently in English or local language for workers’ awareness.

I. Air Quality And Ventilation:

Ventilation systems natural and /or mechanical including air filters, exhaust fans, wherever required, shall be designed and constructed so that air does not flow from contaminated areas to clean areas.

J. Lighting:

Natural or artificial lighting shall be provided to the food establishment, to enable the employees/workers to operate in a hygienic manner. Lighting fixtures must wherever appropriate, be protected to ensure that food is not contaminated by breakages of electrical fittings.

K. Procurement Of Raw Materials:

  • Establishments must not accept any raw material or ingredient that contains parasites, harmful microorganisms, pesticides, veterinary drugs, toxins, or decomposed/ extraneous substances that cannot be removed through standard sorting or processing.
  • All ingredients and additives must meet the standards set under the Act.
  • Maintain proper records of ingredients and their sources for inspection.
  • Raw materials must be physically checked and cleaned thoroughly.
  • Purchase raw materials as per storage/preservation capacity.
  • Packaged raw material must be checked for ‘expiry date’/ ‘best before’/ ‘use by’ date, packaging integrity and storage conditions.
  • High-risk food must be received at or below 5°C.
  • Frozen food must be received at -18°C or below.

L. Storage Of Raw Materials And Food:

  • Food storage areas must be designed to prevent contamination, allow proper cleaning, and restrict pest entry.
  • Cold storage should be provided as per the type and need of raw, processed, or packed food.
  • Raw, processed, rejected, recalled, or returned materials must be stored separately with clear markings and secure handling. Raw food items must be kept apart from packaging, stationery, hardware, and cleaning chemicals to avoid contamination.
  • Meat, poultry, and seafood must be stored apart from other foods under correct temperature and humidity to extend shelf life.
  • Stock rotation practices like FIFO and FEFO must be followed for all food categories.
  • Non-toxic containers should be used, and food should be stored above the floor and away from walls to enable cleaning and pest control.

M. Time And Temperature Control:

  • Food businesses must maintain proper systems to control time and temperature throughout all critical stages like receiving, processing, cooking, cooling, storage, and distribution to ensure food safety.
  • Whenever frozen food / raw materials are being used / handled / transported, proper care should be taken so that defrosted / thawed material are not stored back after opening for future use.
  • If thawing is required then only required portion of the food should be thawed at a time.
  • Wherever cooking is done on open fire, proper outlets for smoke/steam etc. like chimney, exhaust fan etc. shall be provided.

N. Food Packaging:

  • Packaging materials must protect food from contamination or damage and comply with labelling requirements under the FSS Act and Regulations.
  • For primary packaging that comes in direct contact with food or ingredients, only food-grade materials must be used. Materials like aluminium, plastic, and tin should meet the standards specified under the FSS Regulations and related rules.
  • All packaging materials and gases used must be non-toxic and safe under the given storage and usage conditions.

O. Management And Supervision:

  • A detailed Standard Operating Procedure (SOP) must be developed for food processing, packing, dispatch, and storage to ensure effective management and quick identification of issues for faster corrective action.
  • Food businesses must ensure that technical managers and supervisors are adequately qualified and trained in food hygiene and safety to identify hazards, take corrective measures, and oversee operations effectively.

P. Food Testing Facilities:

  • Food establishments must have a well-equipped lab on the premises for regular testing of food materials for physical, microbiological, and chemical parameters as per FSSAI standards.
  • In case of suspected contamination, food must be tested before being dispatched from the facility.
  • If no in-house lab is available, testing must be conducted through FSSAI-notified or accredited laboratories, especially in case of complaints or quality concerns.

Q. Audit, Documentation And Records:

  • A periodic audit of the whole system according to the SOP shall be done to find out any fault/gap in the GMP/GHP system.
  • Proper records of all food-related activities—including production, storage, testing, cleaning, and recalls—must be maintained for at least one year or the product’s shelf life, whichever is longer.

R. Cleaning And Maintenance:

  • A documented cleaning and sanitation schedule must be followed, specifying areas to be cleaned, how often, and what procedures and materials will be used. Manufacturing equipment must be cleaned and sterilized regularly.
  • Cleaning chemicals must be handled as per manufacturer instructions and stored separately in clearly labelled containers to avoid any risk of food contamination.

S. Pest Control Systems:

  • Food establishments and equipment must be well-maintained to prevent pest entry and breeding. Openings should be sealed or covered, and animals or pets must be restricted from food areas.
  • Food should be stored in pest-proof containers, elevated above the ground and away from walls.
  • Any pest infestation must be addressed immediately using safe and permitted methods. Records of pesticides/insecticides used, along with dates and frequency, must be maintained.

T. Health Status:

  • Personnel with illnesses that can be transmitted through food must not enter food handling areas. The Food Business must have a system in place for immediate illness reporting and ensure medical examinations are conducted as needed, in addition to regular health checkups.
  • All food handlers must undergo annual medical checkups to ensure they are free from communicable diseases. Records signed by a registered medical practitioner should be maintained.
  • Factory staff must be vaccinated against enteric diseases as per the recommended schedule, with records kept for inspection.
  • In case of epidemics, all workers must be vaccinated regardless of prior schedules.

U. Personal Cleanliness:

  • Food handlers must maintain high personal hygiene and wear clean protective clothing, including head covering, gloves, and footwear during work.
  • Hands should be washed with soap and potable water, disinfected, and properly dried at the start of food handling and after any activity that may cause contamination, such as handling raw food or using the toilet.
  • Food handlers must avoid smoking, spitting, chewing, sneezing or coughing over food, and should not eat in food preparation or service areas to maintain hygiene and prevent contamination.
  • The food handlers should trim their nails and hair periodically, do not encourage or practice unhygienic habits while handling food.
  • Food handlers must:
  1. Avoid smoking, eating, or drinking in raw material or food handling/storage areas.
  2. Wash hands frequently—especially after coughing, sneezing, or using the restroom.
  3. Food handlers should avoid hand habits like scratching the nose, touching hair, rubbing eyes, or other body parts, as these actions can transfer bacteria to food. If such contact occurs, hands must be thoroughly washed before resuming food handling.

V. Visitors:

Visitors should generally be restricted from entering food handling areas. If entry is necessary, they must wear appropriate protective clothing and follow all personal hygiene requirements to ensure food safety is not compromised.

W. Training:

  • Food Business Operators (FBOs) must ensure that all food handlers are trained and aware of their responsibilities to maintain food safety and quality.
  • Food handlers must be trained in food hygiene, safety, and personal hygiene as per the nature of their duties and the type of food being handled, processed, prepared, packaged, stored, served, or distributed.
  • Periodic assessments of the effectiveness of training, awareness of safety requirements and competency level shall be made, as well as routine supervision and checks to ensure that food hygiene and food safety procedures are being carried out effectively.
  • Training programs should be reviewed and updated periodically.

Registration of E-Commerce Food Business Operator:

A. Registration:

  • E-commerce entities providing listing/directory of FBO/food products may not be required to obtain license under the Act, Rules & Regulations made thereunder, subject to the condition that they are not covered under the definition of food business as per section 3 (n) of FSS Act.
  • However, E-commerce entities providing listing/directory of FBO/food products and also facilitating orders/transaction on their website shall require FSSAI licenses.

 

B. Display Of FSSAI License:

The sellers/brand owners/manufacturers on the ecommerce platform shall be required to display their License/Registration obtained under the FSS Act and Regulations and hygiene grading of FBO as may be assigned by FSSAI.

 

C. Compliance Agreement:

All e-commerce FBOs are required to sign an agreement with the sellers/brand owners/manufacturers averring that the said ‘sellers/brand owners/manufacturers’ are compliant with FSS Act and Rules and Regulations made thereunder and the liabilities shall rest with these FBOs.

 

D. Display Panel Requirement:

The ‘sellers/brand owners/manufacturers’ who display or offer any ‘pre-packed food’ for sale to the customers, either on their own e-commerce platform or on the marketplace based model of e-commerce, shall ensure that legible and clear picture of the ‘principal display panel’ of such pre-packed food is made available for viewing by the customers, except batch number/lot number, best before, expiry date, date of manufacturing/packing and MRP.

 

E. Shelf Life Requirement For E-Commerce:

Any food article delivered to consumer by e-commerce FBO shall have shelf life of 30 percent or 45 days before expiry at the time of delivery to the consumer.

 

F. Display Of Indicative Image Of Fresh Food Articles:

The sellers/brand owners/manufacturers dealing in fresh produce will provide an indicative image of the same produce to the e-commerce FBOs for displaying on their platform to enable the consumers to recognize the product.

 

G. Safe Last Mile Delivery:

It shall be ensured by the e-commerce FBOs that the last mile delivery is undertaken by trained delivery personnel and the safety of food product is not compromised at the time of delivery.

 

H. Listing Only FSS-Compliant Products:

E-Commerce Food Operator is required to ensure that only those food articles can be listed on E-Commerce Platform which are in compliance with FSS Act or Rules or Regulations.

 

Employment of Trained Personnel:

In case of restaurant employ at least one technical person or Food safety Supervisor trained by Food Safety and Standards Authority of India.

 

Annual Self-Evaluation of Food Safety Processes:

Self-evaluation of process to verify the effectiveness of implemented food safety system at least once a year should be conducted through internal / external audits or other mechanisms. Necessary corrective actions based on self-evaluation results shall be taken.

Penalties:

  1. Non-Compliance of Annual Return Filing Requirement (Reg. 2.1.13):

Any delay in filing return beyond 31st May of each year shall attract a penalty of Rs 100 per day of delay with a maximum amount up to 5 times the annual license fees may be levied in case of delay or non-submission of annual returns.

  1. In case of Contravention of Compliances:

Non-compliance with FSSAI conditions can lead to serious consequences, starting with the issuance of an Improvement Notice under Section 32, giving the Food Business Operator (FBO) a time-bound opportunity to correct deficiencies. Failure to comply may result in suspension or cancellation of the license, requiring the FBO to stop operations. Monetary penalties for various non-compliances such as sub-standard food, misbranding, misleading ads or unhygienic handling may be levied. In severe cases, prosecution may follow, with imprisonment ranging from 6 months to life and fines up to ₹10 lakh, depending on the harm caused. Authorities may also seize or recall products and order temporary or permanent closure of the business.

Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article. 

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