Through a notification dated 15 February 2017 the FSSAI has operationalized the Food Safety and Standards (Licensing and Registration of Food Businesses) Amendment Regulations, 2018. These regulations contain amendments in respect of Food Safety and Standards (Licensing and Registration of Food Business)
Regulations, 2011 in the following sections:
- Section 1: Licensing and Registration of E-Commerce food business operator
- Section 2: Documents to be enclosed for a new application for a license to State/Central Licensing Authority for restaurant
- Section 3: Conditions of license for a restaurant
- Section 4: Part-II of Schedule 4 relating to general requirements on Hygienic and sanitary practices to be followed by all food business operators applying for a license
- Section 5:- Part IV of Schedule 4 relating to establishing a small slaughterhouse
- Section 6: Part V of Schedule 4 relating to good hygienic and manufacturing
- practices to be followed by licensed food business operators engaged in catering or food service operation
Some of the regulations under these sections are new and others have been revised and simplified so that they can be implemented easily. The food business operators shall follow these revised regulations with immediate effect and the enforcement of these regulations shall commence only after the final regulations are notified in the Gazette of India.
Some of the important highlights of the amendments in the various sections are as follows
Section I: Licensing and Registration of E-Commerce food business operator
In Chapter 1 under Definitions, the definitions related to e-commerce have been included which are
- Digital and electronic network which includes computers, TV channels, mobiles and internet applications, etc.
- E-commerce means buying and selling through a digital and electronic network
- E-commerce FBO means Food Business Operators carrying out business activity through information technology platform as described under “Marketplace based model of e-commerce FBO”
- “Inventory based model of e-commerce FBOs” means an e-commerce activity where an inventory of food products and food services is owned by e-commerce FBO and is sold to the customers directly.”
- “Marketplace based model of e-commerce FBO” means providing of an information technology platform by an e-commerce FBO on a digital and electronic network to act as a facilitator between the buyer and seller/brand owner/ manufacturer. E-Commerce marketplace includes entities providing support services to sellers/brand owners/product manufacturers in respect of warehousing, logistics, order fulfillment, payment selection, facilitator of delivery and other services.
LICENSING AND REGISTRATION OF FOOD BUSINESS
Registration and Licensing of E-Commerce Food Business (2.2.1) E-commerce FBOs need FSSAI license/ registration as follows
- E-commerce FBOs need to obtain registration and license from the concerned registration or licensing authority.
- E-commerce entities providing only listing/directory of FBO/food products may not be required to obtain license/registration provided they are not covered under the definition• “Marketplace based model of e-commerce FBO”
- However, those FBOs who also facilitate orders/transaction on their website besides providing listing/directory of food products also require FSSAI licenses.
Responsibilities of E-commerce Food Business Operators (2.2.2)
The sellers/brand owners/manufacturers on the eCommerce platform
- shall display their FSSAI License/Registration and hygiene grading as may be assigned by FSSAI
- who display or offer any ‘pre-packed food’ for sale on their own e-commerce platform or on the marketplace based model of e-commerce have to show clearly the ‘principal display panel’ of such pre-packed food except batch number/lot number, best before, expiry date, date of manufacturing/packing and MRP.
- dealing in fresh produce will provide an indicative image of the same product to the e-commerce FBOs for displaying on their platform to enable the consumers to recognize the product
- Mandatory food information mentioned in the FSS Act, Rules and Regulations shall be provided to the consumers without charging supplementary costs and should be available before the purchase is concluded.
All E-commerce FBOs
- must sign an agreement with the sellers/brand owners/manufacturers that they are compliant with FSS Act Rules and Regulations and the liabilities for the same will rest with these FBOs
- Food article delivered to consumers by them shall have a shelf life of 30 percent or 45 days before expiry at the time of delivery to the consumer
- Caters or restaurants receiving an order through electronic media only fresh food item shall be delivered to the consumer.
- The food products offered for sale by them shall be liable to sampling at any point of the supply chain.
- The last mile delivery should be undertaken by trained delivery personnel and the safety of food product must not be compromised
- no misleading information/false claims to the product or misleading images of food products are made available or shown on their platform
- shall immediately delist any food products listed on their platform, which are not in compliance with the FSS Act or Rules or Regulations,
- All the FBOs i.e. sellers/brand owners, vendors, importers, manufacturers, restaurant, hotel etc. shall comply with the basic hygiene and sanitary practices mentioned in the Schedule 4 of Food Safety and Standards (Licensing and Registration of Food Businesses), Regulations 2011.
- Complaints relating to products efficacy, quality, or any other such issues shall be communicated immediately by e-commerce FBO to the sellers/brand owners/ importers/manufacturing company concerned for expeditious resolution.
- E-commerce entities providing listing/directory of FBO/food products on their platform shall list the rating/ranking of FBO, voluntary or mandatory, as may be specified by Food Authority.
E-commerce FBO includes any
- Entities providing listing services to sellers/brand owners/ /manufacturers/restaurants on their platform, thereby providing a platform for commerce to the sellers, manufacturers, restaurants etc.
- Sellers/brand owner/manufacturer, vendors, importers, processors, packagers or manufacturers who display or offer their food products, including food services, catering services, a sale of food or food ingredients for sale to the customers, through either the market-based model or the inventory based model of e-commerce.
- Operating and providing storage and/or distribution services to the sellers/brand owners, vendors, importers or manufacturers of the food products listed on their marketplace.\
- Providing transportation services to the sellers/brand owner, vendors, Importers or manufacturers of the food products and/or providing last mile delivery transportation to the end consumers.
The term ‘seller/brand owners/manufacturers ‘ means seller /brand owner/restaurant/ vendor/ importer/processor/packager/manufacturer responsible for the listing of their
product/offering on the e-commerce platform and will be visible to the end consumer as the ‘seller’ of the said product/offering.
In SCHEDULE 2 under ‘Form ‘B’ (Where kind of business has to be ticked) the option of ‘E-commerce’ has been added
Section II: Documents to be enclosed for a new application for a license to
State/Central Licensing Authority – regarding
Annexure-2 Under “Documents to be enclosed for a new application for a license to State/Central Licensing Authority”,-
The following documents are not applicable for restaurants
- 2 is Blueprint/layout plan of the processing unit showing the dimensions in meters/square meters and operation-wise area allocation”
- 4 Name and List of Equipment and Machinery, along with the number, installed capacity and horsepower used.”
- No 6 List of food category desired to be manufactured. (In case of manufacturers). (In case of manufacturers)
- 11 Copy of certificate obtained under Coop Act – 1861/Multi State Coop Act – 2002 in case of Cooperatives.
- No 12 NOC from a manufacturer in case of Re-labellers
- 17, Recall plan, wherever applicable, with details on whom the product is distributed.
Section III: Conditions of license – regarding
In Annexure-3 under “Conditions of License,’ the amendments for restaurants have been added to the following serial numbers
- No 1 “In case of restaurant display a Food Safety Display Board at all times at a prominent place in the premises.”
- No 4 “In case of restaurant employ at least one technical person or Food safety
- Supervisor trained by Food Safety and Standards Authority of India”
- No 8 Maintain daily records of production, raw materials utilization and sales separately is NOT applicable to the restaurant.
- No 14 “The restaurants shall buy food raw materials only from licensed/registered vendors and maintain record thereof”
- Serial Number 5, 7, 9, 10 and 11 shall be omitted
Under “Other conditions”, –
No 1 will read as – “Hotels, restaurants and other food establishments who sell or expose for sale savouries, sweets or other articles of food shall put up a notice board containing separate lists of the articles which have been cooked in ghee, edible oil, vanaspati and other fats for the information of the intending purchasers.
Section 4: Part-II of Schedule 4
relating to general requirements on Hygienic and sanitary practices to be followed by all food business operators applying for license.-
These requirements under Schedule 4 have been revised and simplified to facilitate the Industry to implement Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP) and to meet the regulatory requirements.
To be followed by all FBOs
The establishment in which food is being handled, processed, manufactured, packed, stored and distributed by the food business operator and the persons handling them should conform to the sanitary and hygienic requirement, food safety measures and other standards as specified below. It shall also be deemed to be the responsibility of the food business operator to ensure adherence to necessary requirements. In addition to the requirements specified below, the food business operator shall identify steps in the activities of the food business, which are critical to ensuring food safety, and ensure that safety procedures are identified, implemented, maintained and reviewed periodically
ESTABLISHMENT – DESIGN & FACILITIES
- Location and surroundings
- Premises and rooms
- Internal Structure & fittings
- Walls and partitions
- Ceilings and overhead fixtures
- Windows doors
- Equipment and Containers
- Food control and monitoring equipment – Equipment used to cook, heat treat, cool, store or freeze food shall be designed to achieve the required food temperatures as rapidly as necessary to meet the food safety requirements, and maintain them effectively.
- Containers for chemicals and hazardous substances -Containers for chemicals (eg. cleaning materials, lubricants, fuels, boiler chemicals etc.) or hazardous substances, shall be specifically identifiable and suitably constructed, closable, made of impervious material, be easy to clean, and where necessary to disinfect.
- Water supply
- Waste disposal and drainage
- Personnel hygiene and employee facilities
- Temperature control – Depending on the nature of the food operations undertaken, adequate facilities shall be available for heating, cooling, cooking, refrigerating and freezing food, for storing refrigerated or frozen foods, monitoring & recording food temperatures, and when necessary, controlling ambient temperatures to ensure the safety and suitability of food.
- Air quality and ventilation
- Storage Facilities
- Compressed air and other gases o Compressed air, carbon dioxide, nitrogen and other gas systems wherever required used in manufacturing and/or filling shall be constructed and maintained so as to prevent contamination.
CONTROL OF OPERATION
Food Receipt (Procurement of raw materials and ingredients)
- No raw material or ingredient or any other material used in processing products\ shall be accepted by a food business operator if it is known to contain chemical, physical or microbiological contaminants which would not be reduced to an acceptable level by normal sorting and/or processing.
- Packaged raw materials must be checked for ‘expiry date’/ ‘best before’/ ‘use by’ date, packaging integrity and storage conditions
- Records of raw material or ingredient or any other material to be maintained
- Receiving temperature of potentially hazardous food must be 50C or below; or 600C or above. Receiving temperature of frozen food shall be -18 0C or below and records maintained
- Ingredients containing allergens must be identifiable and stored appropriately to prevent cross-contamination
Food and packaging materials storage including warehousing
- FBOs shall store food and packaging materials in appropriate areas for effective protection from dust, condensation, drains, waste and other sources of contamination during storage.
- Storage areas shall be dry and well ventilated.
- Segregation shall be provided for the storage of raw, processed, rejected, recalled or returned materials or products and shall be clearly marked.
Food processing and preparation
- Systems shall be in place to prevent contamination of foods by foreign bodies such as glass, metal shards from machinery and dust. Procedures must be in place to follow in case of breakages
- Whenever frozen food / raw materials are used/ handled/transported, adequate care shall be taken so that defrosted/thawed material are not re-frozen for future use.
The packaging design and materials shall provide protection for products in order to prevent contamination, damage and accommodate required labeling as laid down under the FSS Act & the Regulations thereunder. Only Food grade and non-toxic packaging materials shall be used. Packaging materials like aluminum, tin, and plastic shall conform to the Indian standards as mentioned in the FSS Regulations.
Rework and control of non-conforming products
- Stored rework materials shall be protected from exposure to microbiological, chemical or extraneous matter contamination.
- Rework shall be clearly identified and/or labeled to allow traceability and records maintained
- Conveyance and containers used for transporting foodstuffs shall be clean and maintained. Where direct contact with food may occur, materials used in carrier construction should be suitable for food contact.
- Bulk foodstuffs in liquid, granulate or powder form shall be transported in receptacles and/or containers/tankers reserved for the transport of foodstuffs and will be clearly marked to show they are for transporting foodstuff.
Food Traceability and recall
- The FBO shall have a documented and effective product recall plan in place in accordance with the Food Safety & Standards (Food Recall) Regulations, 2017. Such a plan shall allow the FBO to effectively locate all affected food products that may cause a potential threat to public health and enable the complete, rapid recall of the implicated lot of the product from the market.
- The food business operator shall have a quality control programme in place to include inspection and testing of incoming, in-process and finished products.
- In case adequate in-house test facilities are not available, a system shall be in place for testing these materials in a NABL accredited external laboratory/ laboratory notified by FSSAI.
ESTABLISHMENT – MAINTENANCE AND SANITATION
- Cleaning and sanitation – food premises and equipment must be cleaned to prevent any kind of contamination
- Cleaning procedures and methods – cleaning must remove residue and dirt that could cause contamination
- Cleaning procedures and methods have been given in detail
- Cleaning methods and programmes – A cleaning and disinfection programmes shall be drawn up, observed and records of the same shall be maintained for all parts of the establishment and equipment
- Preventive maintenance of equipment and machinery shall be carried out regularly as per the instructions of the manufacturer including calibration of devices
- Corrective maintenance shall be carried out in such a way that production on adjoining lines or equipment is not at risk of contamination
Pest Control Systems
- Must prevent access
- Storage must prevent harbourage and infestation
- Monitoring and detection – establishments and surrounding areas must be regularly examined for evidence of infestation and traps must be laid in key locations to identify pest activity
- Eradication – Pest infestations shall be dealt with immediately by a competent person and without adversely affecting food safety or suitability. Treatment with permissible chemical, physical or biological agents, within the appropriate limits, shall be carried out by trained operatives.
Waste disposal management
- Accumulation of food waste, non-edible by-products, and other refuse shall not be allowed in food handling or storage areas
- No waste to be kept open inside the premises
- Proper disposal of sewage and effluents
ESTABLISHMENT – PERSONAL HYGIENE
FBOs must ensure
- Health status of food handlers
- During illness and injuries no food handling and employees to report illness to management
- Personal hygiene of the highest standard to be maintained and hand washing display notices to be posted in the requisite food preparation areas
- Personal behavior and hygiene practices to be implemented by FBOs strictly
Product information and labeling – All packaged food products shall carry a label and requisite information as per provisions of Food Safety and Standards Act, 2006 and Regulations
Appropriate Consumer awareness and complaint handling programme to be in place
ESTABLISHMENT – TRAINING AND MANAGEMENT
- All personnel should be aware of their role and responsibility in protecting food from contamination or deterioration. The Food Business operators shall ensure that all food handlers have the necessary knowledge and skills to enable them to handle food hygienically.
- Those who handle strong cleaning chemicals or other potentially hazardous chemicals should be instructed in safe handling techniques
Management and supervision
- The Food Business Operator shall supervise and monitor all operations appropriately.
- The FBO management shall provide and maintain documented standard operating procedure for FSMS systems compliance and its supervision at a site through records/checklists on the routine basis to control any possible hazards throughout the supply chain
ESTABLISHMENT – AUDIT, DOCUMENTATION AND RECORD KEEPING
- Self-evaluation and review- The FBO shall conduct a self-evaluation of the process to verify the effectiveness of the implemented food safety system
- Documentation and records – Appropriate documentation & records of processing, production, and distributions shall be maintained in a legible manner, retained in good condition for a period of one year or the shelf-life of the product, whichever is more
Section V: Part IV of Schedule 4
(amendment includes the following
Sanitary and hygienic requirements for establishing a small slaughterhouse (which are under State license/registration)
No Objection Certificate from the Municipality or Panchayat and State Pollution Control Board to be obtained.
All other parameters must be maintained in the same way as for the bigger slaughterhouses
Section VI: Part V of Schedule 4 – regarding
Good Hygienic and Manufacturing Practices to be followed by licensed Food Business Operators engaged in catering or food service operations
Catering/ food establishment in which food is being handled, processed/prepared,
stored, distributed and ultimately sold to the customers and the persons handling
them should conform to the sanitary and hygienic requirement, food safety
measures and other standards as specified below. It shall also be deemed to be the
responsibility of the food business operator to ensure adherence to the necessary
requirement. It includes premises where the public is admitted for repose or for consumption of any food or drink or any place where cooked food is sold or prepared for sale. It includes:
(a) Eating Houses
(b) Restaurant and Hotels
(c) Snack Bars
(d) Canteen and mess (Schools, Colleges Office, Institutions)
(e) Food Service at religious places
(f) Rail and Flight catering
(g) Hospital Catering
(h) Event caterings
(All other parameters for establishment design, location maintenance, fittings, water waste disposal, pest control, personal hygiene etc. are the same as given above)
This article only provides the main highlights and a synopsis of the amended regulation