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:
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]:
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:
General Requirements on Hygienic and Sanitary Practices to be followed by all Food Business Operators applying for License:
A. Location And Surroundings:
B. Layout And Design Of Food Establishment Premises:
C. Equipment & Containers:
D. Water Supply:
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:
H. Personnel Facilities And Toilets:
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:
L. Storage Of Raw Materials And Food:
M. Time And Temperature Control:
N. Food Packaging:
O. Management And Supervision:
P. Food Testing Facilities:
Q. Audit, Documentation And Records:
R. Cleaning And Maintenance:
S. Pest Control Systems:
T. Health Status:
U. Personal Cleanliness:
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:
Registration of E-Commerce Food Business Operator:
A. Registration:
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:
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.
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.
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