3.

WITE-UP

SANITARY AND HYGIENIC REQUIREMENTS OF FOOD MANUFACTURING

ESTABLISHMENTS

One of the conditions of FSSAI license is to maintain sanitary and hygienic requirements laid
down under Schedule 4 of the Licensing & Registration of Food Business Regulations. These
requirements are nothing but Food Safety Management System (FSMS) which include Good
Hygienic Practices (GHP), Good Manufacturing Practices, HACCP etc. The establishment in
which food is handled, processed, manufactured, stored, distributed by the food business
operator should be as per norms laid down under the Regulations. It is the responsibility of the
food business operators to ensure compliance of the requirements.

General requirements on hygienic and sanitary practices to be followed by all food business
operators applying for license or who are already licensed, as laid down under Part II, Schedule
4 of the aforesaid Regulations, are given below:

1. LOCATION AND SURROUNDINGS:

(i) Food establishment shall be located away from environmental pollution and
industrial activities that produce obnoxious odour, fumes, smoke, chemical or
biological emissions and pollutants which may pause threat of contaminating food
(ii) The surroundings shall be clean, free from infestation of pests, wastes- solid or
liquid
(iii) Manufacturing premises should not have direct access to any residential
premises/area

2. LAY-OUT AND DESIGN:

(i) Installation of machinery & equipment to be in such a way so that flow of process
operation is unidirectional and it should permit free movement of men and
materials and not amenable to cross-contamination
(ii) Floor, walls, ceiling, doors and windows etc. should be suitably laid and so
designed as to permit hygienic production
(iii) There should be efficient internal and external drainage systems with adequate measures
to prevent entry of pests, rodents etc.
(iv) Doors, windows and other openings suitably screened to prevent entry of flies

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3. EQUIPMENT AND CONTAINERS :
(i) All equipment should be non-corrosive, made from food grade materials that do
not impart any toxic substance to food
(ii) No equipment and containers made up of iron or galvanized iron to be used in
food handling, preparation and storage
(iii) Equipment to be suitably designed and placed so as to permit easy cleaning and
disinfection
(iv) The containers for preparation and storage of food shall not be used for other
purposes like cleaning and waste disposal
(v) Equipment and containers for wastes, by-products and cleaning chemicals shall be
properly identified
(vi) All equipments and containers should be kept in good condition, properly clean
and disinfected
(vii) Every container for preparation and storage of food shall be fitted with suitable
cover/lid.
4. FACILITIES :
(a) Water supply:
(i) There shall be provision for potable water as per BIS specifications and overhead
tanks for storage of the same, which to be regularly cleaned
(ii) There should be separate pipelines for potable and non-potable water
(iii) Adequate facilities for cleaning of utensils, raw materials with hot and cold water
provided
(iv) Water used for preparation of ice and steam should be of potable quality

(b) Drainage and waste disposal:

(i) There should be efficient drainage system for quick disposal of effluents and
adequate facility for disposal of solid wastes from the processing premises
(ii) Disposal of liquid and solid wastes shall be in conformity with Environment and
Pollution Control Board norms
(iii) The storage of solid wastes shall be away from processing premises which shall be
disposed off quickly so that it does not contaminate processing and storage areas

(c) Personal facilities:

(i) There should be sufficient number of toilets, urinals for each sex, located away
from manufacturing premises
(ii) Facilities for hand and foot wash with disinfectants at the entrance of the
manufacturing premises and change room for workers

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 (iii) There should be display board at prominent places indicating DOs and DON’Ts for
workers both in English and local language

(d) Ventilations and lighting:

(i) Provision for natural and artificial ventilations and lighting
(ii) The intensity of lights should be as per the requirement of operation
(iii) All fixtures should be properly protected

5. FOOD OPERATION CONTROL:

(a) Procurement of raw materials:
(i) All raw materials including ingredients and additives should be procured from
reliable sources and record maintained for traceability
(ii) No raw material should be procured from a source which is known to
contaminated with undesirable micro-organisms, pesticides, veterinary drugs or
toxic or decomposed or extraneous substances which cannot be reduced to an
acceptable level by normal sorting or processing
(iii) All raw materials should be physically checked while receiving and cleaned before
use
(iv) Packaged raw materials to be checked for expiry or best before date
(v) Receiving temperature for high risk raw materials like raw milk, meat, fish should
be below 5˚C.
(b) Storage & use of raw materials:

(i) Raw materials to be properly stored on pallets or racks to protect from hazards
(ii) Edible and non-edible materials are to be stored separately with proper identification

(iii) Cold storage facility to be provided where necessary

(iv) Raw food, particularly meat, poultry, sea foods etc. and cooked food shall be
stored separately to avoid cross-contamination
(v) Raw materials should be used as per FIFO ( First in first out) or FEFO( First in first
expire) system

(c) Process control:

(i) There should be proper devices for time and temperature control
(ii) The food business should develop and maintain systems to ensure that time and
temperature are effectively controlled where it is critical to the safety of food

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 (iii) Whenever frozen foods/raw materials are used/handled ,proper care to be taken
so that defrosted/ thawed materials are not stored back for future use and only
required quantity is thawed

(d) Food Packaging:

(i) All packaging materials including packaging of ingredients, additives shall be used
which do not contaminate food
(ii) Packaging materials shall meet BIS specifications of food grade materials

(e) Distribution and service:

(i) All critical links in supply chain to be identified to minimize food spoilage during
transit
(ii) Temperature for products in cold chain to be maintained and containers for bulk
transport of food to be suitably designed
(iii) The vehicles for transporting food staffs shall not be used for transporting other
materials which may cause contamination to food or same vehicles for
transporting meat, poultry, fish or such foods which are repugnant to other type
of foods and may cause cross- contamination

6. MANAGEMENT AND SUPERVISION :

(i) Management and supervision are necessary for monitoring and taking control
measures in operations
(ii) All supervisory staffs for production and quality control should have appropriate
knowledge and skill to ensure food safety and quality
(iii) Detail standard Operating Procedure (SOP) for receiving raw materials, processing,
packing, storage and distribution to be developed for management and control

7. FOOD TESTING FACILITIES:

(i) In-house testing Laboratory with adequate facilities and qualified chemist to be
provided
(ii) If In-house facilities are not available for testing of chemical and microbiological
contaminants, these should be done from outside NABL accredited Laboratory

8. AUDIT, DOCUMENTATION AND RECORDS:

(i) Periodic audit of whole system according to SOP to be done to find out gap for
taking appropriate measures

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 (ii) Records of, raw materials, processing, preparation, cooking, quality control,
cleaning & sanitation, distribution, food recall etc. to be maintained and retained
for a period of at least one year or up to shelf life of the product

9. SANITATION AND MAINTENANCE:

(a) Cleaning and maintenance:

(i) Cleaning and maintenance of all machinery and equipment to be done as per
schedule specifying areas & equipment to be cleaned, frequency of cleaning,
cleaning chemicals used and their dozes
(ii) Cleaning chemicals to be handled carefully and stored properly with identifiable
containers

(b) Pest control:

(i) The food establishment to be kept in good repair so as to deny entry and harbour
of rodents, pests and insects
(ii) Holes and drainages to be adequately sealed to prevent entry of rodents
(iii) Treatment with permissible pesticides and insecticides with appropriate limits
shall be carried out carefully to ensure safety of food and person who handle the
chemicals

10. PERSONAL HYGIENE :

(a) Health status:
(i) No person suffering from infectious disease is allowed to work in food processing
establishment
(ii) Workers shall be medically examined before employed for work in processing
operations
(iii) All workers and factory staff shall be inoculated against enteric group of diseases
once in a year

(b) Personal cleanliness:

(i) All food handlers to be provided with clean and protective clothes, hand gloves
and foot wear
(ii) Their personal cleanliness to be maintained at all the times, they should wash their
hands with soap and disinfectant before every entry to processing premises and
after use of toilets
(iii) Supervisors shall ensure that their nails cut regularly and hair trimmed

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 (iv) No ornaments, except marriage bangles/ chains or such ornaments with proper
covering, shall be allowed during food handling
(v) Workers shall refrain from bad habits like chewing, smoking, scratching parts of
body, sneezing , coughing etc. during food handling

(c) Visitors:
Ideally no visitors should be allowed to enter to processing hall, if allowed they
should be provided with all protective wears.

11. PRODUCT INFORMATION I AND CONSUMER AWARENESS:

All packaged foods shall carry necessary and mandatory information on the packages
of food with a labels as per the regulations for consumers’ awareness and for proper
handling of food by the persons in supply chain for its safety.

12. TRAINING
(i) The food business shall ensure that food handlers and supervisory staff are aware
of food safety and hygiene
(ii) They should be given training periodically on food handling, food safety and
hygiene.
(iii) Effectiveness of training should be reviewed periodically by the management

REFERENCES:

1. Schedule 4, FSS Licensing & Registration of Food Business Regulations, 2011

2. www.fssai.gov.in
3. www.fao.org/fao-who-codexalimantarious
4. www.bis.org.in
5. www.moef.nic.in