Food Safety Officer Guide

FOOD SAFETY OFFICER’S GUIDE
CONTENT
Chapter Page
1. What is Food Safety 3
2. Evolution of FSS Act 8

2.1 Overview of FSS Act 9
2.2 Structure of FSSAI 10
2.3 Structure of State Food
Safety Regulatory Body 13
2.4 Role & Responsibility 14
3. Integrating Food chain 16

3.1 Process: Farm to Fork 17
3.2 Risk Analysis 19
3.3 Hazard Identification 23
4. Food Safety Surveillance 27

4.1 Definition & Procedure 28
4.2 Food Borne Diseases 31
4.3 Investigation of an outbreak 34
4.4 Food Recall 38
5. Regulatory Compliance 39
5.1 General Inspection Procedures 40
5.2 Developing a Food Safety Plan 46
5.3 Monitoring & Evaluation of Food Safety 47
5.4 Product inspection (Packaging & labelling) 50
5.5 Sampling 61
5.6Formats & Checklist 85
6. Administration 90
6.1 Registration and Licensing 91
6.2 Procedure for Registration 93
6.3 Food Licensing Registration System (FLRS) 95
6.4 Licensing 101
6.5 Reports & Annexures 110
7. Important concepts under FSS Act 120
1
LEARNING OUTCOME
What we will learn from this book?
Integrating Food chain

Knowledge on Food Hazard
How to identify hazard?
Establishment Categorization
Risk Assessment
Surveillance Technique
How to verify compliance of

the mandate of Food Law?
How & When to take sample?
How to study report & make
documentation?
Structure of Food Authority

Food Safety & Standards Act,
Rules & Regulations
Registration & Licensing
Facilitator Role of a Food

Safety Officer
2
3
WHAT IS FOOD SAFETY
4
Chapter 1
What is Food Safety
Why Food Safety is Important?

Food Safety is one of the most important topic to talk about
these days.
If the food safety is not achieved, then it can harm the human
body from inside or outside.
10 exciting facts about the food

safety! (WHO)
Fact 1: more than 200 diseases are spread through
food
1 in 10 people fall ill every year from eating
contaminated food, and 420 000 people die each year as a
result. Children under 5 years of age are at particularly high
risk, with some 125 000 young children dying from
foodborne diseases every year. Proper food preparation can
prevent most foodborne diseases.
Fact 2: contaminated food can cause long term health

problems
The contaminated food can cause the long term health
problems. The contaminated food with naturally occurring
toxins or with heavy metals can be a reason for the long term
diseases including neurological disorders and cancer.
Fact 3: food borne diseases affect vulnerable people

harder than other groups
Infections caused by contaminated food have much
higher impact on population with poor or fragile health
status and can easily lead to serious illness and death.
For infants, pregnant women, the sick and the elderly
the consequences of foodborne diseases are usually
more severe and may be fatal.
Fact 4: There are opportunities for food contamination
to take place 5
Today’s food supply is complex and involves a range of
different stages including on-farm production,
slaughtering or harvesting, processing, storage,
Fact 5: Globalization makes food safety more

complex and essential
Globalization of food production and trade in
making the food chain and complicates
foodborne diseases outbreak investigation and
product recall in case of emergency.
Fact 6: Foods safety is multisectorial and
multidisciplinary
To improve food safety, multitude of different
professionals are working together, making use
of the best available science and technologies.
Different governmental departments and
agencies encompassing public health,
agriculture, education and trade, need to
collaborate and communicate with each other
and engage with the civil society including
consumer groups
Fact 7: food contamination also affects economy
and society as a whole
Food contamination has far reaching effects
beyond direct public health consequences – it
undermines food exports, tourism, livelihood of
food handlers and economic development, both
in developed and developing countries
Fact 8: some harmful bacteria are becoming
resistant to drug treatments
Antimicrobial resistance is a growing global
health concern. Overuse and misuse of
antimicrobials in agriculture and animal
husbandry in addition to human clinical uses, is
one of the factors leading to the emergence and
spread of antimicrobial resistance. Antimicrobial
resistant bacteria in animals may be transmitted
to humans via food
6
Fact 9: Everybody has a role to play in keeping

food safe
Food safety is a shared responsibility between
governments, industry, producers, academia,
and consumers. Everyone has a role to play.
Achieving food safety is a multi-sectoral effect
requiring expertise form a range a different
discipline – toxicology, microbiology,
parasitology, nutrition, health economics, and
human and veterinary medicine, local
communities, women groups and school
education also play an important role.
Fact 10: consumers must be well informed on
food safety practices
People should make informed and wise food
choices and adopt adequate behaviors. They
should know common food hazards and how to
handle food safety, using the information
provided in food labelling
What Are the Benefits of Food Safety?

The World Health Organization estimates foodborne and waterborne dysenteric diseases together
kill about 2.2 million people each year. Foodborne diseases are a public health risk. According to
the WHO, food safety procedures and programs can improve food safety from production to
consumption. The reason why food safety is important is that it:
 Reduce Food-Borne Illness
 Give confidence to Customers,
 Protects and enhances your business reputation leading to increased profits
 Enhance Consumer Confidence on domestic and international foods.
 Reduces food wastage and associated costs.
7
Safe & Nutritious food (SNF) – A way of Life

Food safety ensures that food consumption (according to its intended use) does not cause harm and / or
foodborne illness to the consumer. Food safety also includes the absence of harmful substances such as
environmental contaminants or residues of veterinary medicinal products. Nutritious food should have
all the nutrients needed in specific amount to ensure good health and wellbeing. FSSAI bouquet of
initiatives work on 360-degree approach to food safety and nutrition to prevent food borne infections
and disease sand for complete nutrition for citizen everywhere at all times
Safe & Nutritious food (SNF) initiatives of FSSAI

 Safe and Nutritious Food @ Home
 Safe and Nutritious Food @ School
 Safe and Nutritious Food @ Workplace.
 Safe and Nutritious food @when Eating Out
Safe and Nutritious Food @ Safe and Nutritious Food @

Home Workplace.
Safe and Nutritious Food @ Safe and Nutritious food

School @when Eating Out
8
EVOLUTION OF FOOD SAFETY &

STANDARD ACT
9
Chapter 2
Evolution of FSS Act

2.1 Overview
Evolution of the FSS Act had a long history. Prior to the enactment of FSS Act, food related legislation
were fragmented and there was lack of uniformity in approach & effect. Further the existing laws on
food had failed to match the rapid evolution of food related technologies and advancements in the
production, distribution & marketing of the food. No less than eight legislations prescribed the
minimum regulatory standards for various type of food and food products prior to FSS Act.
Contemporary in view of global environment, an integrated food law was enacted in August 2006 to
consolidate various laws governing food sector and to establish food safety authority of India for laying
down science based standards for articles of food and to regulate their manufacture, storage,
distribution, sale and import to ensure availability of safe and wholesome food for human
consumption.
The Executive Authority under the Act is assigned to the Ministry of Health & Family Welfare,
Government of India (MOHFW). On September 5, 2008, Government of India notified the
establishment of Food Safety & Standard Authority of India (FSSAI or the Authority) under Section 4
of the Act, which is the central authority for enforcement & implementation of the Act.
The Rule & Regulations to implement the Act have been notified by the Authority. The broad coverage
of such Rules & Regulations are stipulated under Section 91 & Section 92 of the Act. The Rules mainly
cover the administrative structure & functioning of FSSAI and various bodies under it. While the
Regulations cover the various regulatory aspects of the food industry like Licensing, labeling, use of
additives, food standards etc. Regulations have come in to force with effect from 5 th August 2011.
In addition, the Authority in exercise of powers conferred by Sub -Section 1 of Section 97 of the Act,
has also repelled the enactment and orders in the Second Schedule of the Act with effect from 5th
August 2011.
The Second Schedule of the Act contains all the earlier food related legislations which are as follows.
1. Prevention of Food Adulteration Act 1954 (Act No 37 of 1954)

2. Food Product’s Order 1955
3. The Meat Food Product’s Order 1973
4. The Vegetable Oil Products (Control) Order 1947
5. The edible oil’s packaging (Regulation) Order 1998
6. The Solvent Extracted Oil, de-oiled meal, & edible flour (Control) Order 1967
7. Milk & Milk Product’s Order 1992
8. Any Other Order issued under the essential commodities Act 1955 (10 of 1955) relating to food
Under Section 99 of the Act, Milk & Milk Product’s Order 1992 shall be deemed to be Regulation issued by the
Authority under this Act.
The intent of the Act lies in bringing almost all the food business areas within its scope & to promote the objective
of ‘’Food Safety’’ and not mere the’’ Prevention of Food Adulterations ‘’as was the case with the previous laws.
10
2.2 Structure of FSSAI

FSSAI has been established under the legal frame work of FSS Act 2006 with all its administrative and
technical structure. Food Authority consists of a Chairperson and 22 members of which one third
must be women. In their endeavor to carry out provisions of the Act, the Authority is assisted by
Central Advisory Committee (CAC), Scientific Panels and Scientific Committees each with specific
responsibilities.
Structure of FSSAI
FSSAI CHAIRPERSON
Finance
Vigilance
CEO Food Authority
CODEX Central Advisory

Committee (CAC)
Scientific
Committee/Panels
Director CMSO Advisor
Head CITO
Human Standard
Compliance
Quality Resources Development
Assurance/ Imports Information
Laboratories Communication Regulation Technology
FSMS and Public Development
Legal Relation
Research & Scientific
Development International Outreach
Relation
Risk Committee &
Assessment Capacity Panel Support
Building
11
Food Authority
Food Authority is a body corporate having a Chairperson with 22 members, of which one third shall be
women. All members of the Food Authority are appointed by the Central Government, except for seven
ex-officio members from various Departments of the Central Government who are selected by the
selection committee formed under Section 6 of FSS Act 2006. These members are from the various
Ministries like
 Agriculture
 Commerce
 Consumer Affairs
 Food Processing Industries
 Health
 Small Scale Industries and
 Legislative Affairs
These Ministries are directly or indirectly related to the food industry and consumers in one manner or
the other. Besides above said members the FSSAI Food Authority has the following other members
 two representatives from food industry of which one shall be from small scale industries
 two representatives from consumer organizations
 three eminent food technologists or scientists
 two persons to represent farmers’ organizations
 one person to represent retailers’ organizations
 Five members, one each from five zones specified in the First Schedule of the FSSA and to be
appointed by rotation every three years to represent the States and Union Territories.
The food Authority meets as per the directives of the Chairperson and decide on the questions coming
up before any meeting of the Food Authority, and takes decisions by a majority of votes of the members
present and voting and Chairperson will have a casting vote. Chief Executive Officer of FSSAI is the
member Secretary of the Food Authority.
Central Advisory Committee

The main purpose of CAC Institution is to ensure close cooperation between the Authority and the
Enforcement agencies operating in the field of food and specifically looks after prioritization of work
identifying potential risks, pooling ok knowledge etc. The CAC consists of two members each
representing from Food Industry, Agriculture, Consumers, relevant Research Bodies and Food
Laboratories, Commissioners of Food Safety and the Chairperson of the Scientific Committee. The CEO
of the Authority is the Ex- Officio Chairperson of the CAC.
Scientific Panel & Committee

As per Section 13 of the FSSA, FSSAI may establish as many scientific panels as deem necessary consisting
of independent scientific experts/scientists. The FSSAI however must establish scientific panels on:
 Food additives, flavorings, food additives, processing aids and materials in contact with food
 pesticides and antibiotics residues
 genetically modified organisms and foods
 functional foods, nutraceuticals, dietetic products and other similar products
 biological hazards
 contaminants in the food chain
 labelling
 methods of sampling and analysis
12
As per Section 14 of FSSA, FSSAI constitutes a scientific committee consisting of scientific experts.
Chairpersons of all the Scientific Panels shall also be its members. Besides the chairpersons of all the
Scientific Panels, it consists of six independent scientific experts who are not associated to any of the
Scientific Panels.
Scientific Committee is responsible for providing Scientific Opinion to the Authority and has a power to
hold public hearings where necessary.
Chairperson
The functional Head of the Food Authority is the Chairperson appointed for the period of three years
by the Government of India from amongst the persons of eminence in the field of food science or
amongst the person from the Administration holding or has held the position of not below the rank of
Secretary to the Government of India.
Chief Executive Officer
The Authority has a full time Chief Executive Officer appointed by Government of India who supervises
the day to day administrative work, draws up proposals for work in consultations with CAC, implements
those and ensures appropriate scientific technical and administrative support for the scientific panel
and the scientific committee. CEO is also the legal representative of the Authority and responsible for
the functions listed as in Section 10 of FSS Act. The statutory functional capacity of the CEO is of the
commissioner of food safety while dealing with the matters related to food safety
Role of FSSAI
The main role of Authority is to regulate and monitor, manufacture, processing, distribution, sale and
import of food while ensuring safe and wholesome food to the consumers. The Act lays down the
following main function for discharge by the Authority.
 Prescribing the Standards & Guidelines in relation to food and specified appropriate system
for enforcement.
 Specifying limits for Additives, Contaminants, Pesticides & Veterinary Drug Residues, Heavy
Metals, Processing Aids, Mycotoxins, Antibiotics and Pharmacological active substances and
Irradiated Foods.
 Lay down food labelling standards including claims on health, nutrition, special dietary uses
and food category system for foods.
 Lay down methods of sampling, analysis and exchange of information among enforcement
agencies prescribing procedures and guidelines for accreditation of certification bodies and
laboratories.
 Taking up, summarizing and analyzing relevant scientific and technical data on incidence
and prevalence of biological or emerging risk, residues of various contaminants,
introduction of rapid alert system among others.
 Prescribing the procedure, and the enforcement of quality control in relation to any
imported article of food in to India
 Creating an information network across the country to disseminate rapid reliable and
objective information about food safety and issues of concern.
 Providing Training Programs for persons who are involved or intent to get involved in food
businesses
 Promoting general awareness about food safety and food standards and promoting
coordination of work on food standards undertaken by International Governmental and
Non-Governmental Organization.
13
2.3 Structure of State Food Safety Regulatory Body

Food Authority
Chief Executive Officer
Commissioners of Food Safety
Adjudicating
Designated Officer Officer
Food Analyst
Food Safety Officer
The enforcement of the Act shall be through the state/UT Commissioner of Food Safety (CFS) and
Designated Officer, Food Safety Officer, Food Analyst and Panchayat Raj / Municipal bodies.
Commissioner of Food Safety
As per Section 30 of FSS Act, the State Government appoints the Commissioner of Food Safety not
below the rank of the Commissioner & Secretary to the State Government for efficient
implementation of Food Safety & Standards Act. The powers and duties of the Commissioner of Food
Safety are as follows
 Prohibit in public health interest, the manufacture, storage, distribution or sell of any article
or food in the whole of the State within a maximum time of one year.
 Carry out survey of the food industrial unit in the State for compliance.
 Organize Training Program for generating awareness on food safety.
 Sanction prosecution for offences punishable with imprisonment and also perform other
function prescribed by the State Government in consultation with the Food Authority.
Designated Officer
As per Section 36, the Commissioner appoints the Designated Officers (DO) to be in charge of Food
Safety Administration in a specified area. Further, as per Rule 2.1.2 Designated Officer shall be a
whole time officer not below the rank of Sub Divisional Officer or equivalent. Each district or a
specified area must have at least one DO who has the power to issue or cancel the license.
Food Safety Officer

As per Section 37, Commissioner of Food Safety appoints Food Safety Officers for such local areas as
the Commissioner may assign to them for the purpose of functioning under the Act & Rules &
Regulation made there under. The appointment will be according to the need and through issuance
of notification, once the FSO has successfully completed the Training as specified by Food Authority.
The State Government may authorize any officer of the State Government having the prescribed
qualification to perform the functions of the Food Safety Officers
14
Food Analyst
As per Section 45, Commissioner appoints Food Analysts for specified local areas as deemed fit by the
Commissioner, different Analysts may be appointed for different articles of food. However, any
person who has any financial interest in manufacture or sale of any article of food, cannot be
appointed as an Analyst. An Analyst is responsible for carrying out required analysis of the samples
as instructed by the Food Safety Officers along with the test method.
Adjudicating Officer
For the purpose of Adjudication, the State Government will notify Adjudicating Officers not below
the rank of Additional District Magistrate of the district. The Adjudicating Officer will have the power
of the civil court and all the proceedings before him shall be deemed to be judicial proceeding s within
the meaning of Section 193 & 228 of the Indian Penal Code.
2.4 Role & Responsibility of Food Safety Officer
Monitoring Facilitation &

Surveiallance Coordination
Promotion &
Capacity Building
INSPECTION FACILITATE FOOD

TRAINING OF FOOD BUSINESS OPERATOR TO
SAMPLING
BUSINESS OPERATOR INTRODUCE FOOD
FOOD SAFETY SAFETY MANAGEMENT
GENERAL AWARENESS
SURVEILLANCE SYSTEM
ON FOOD SAFETY FOR
COMPLIANCE & AUDIT CONSUMER FACILIATATE PANCHAYAT
& MUNCILAPLITY TO
INVESTIGATE
PREPARE FOOD SAFETY
COMPLAINTS
PALN
15
Food safety is a collective responsibility of the Regulators, Industry and Consumers. However, the
Regulators are responsible for carrying out measures to protect public health by ensuring availability
of safe and wholesome food to the consumers. The role of Food Safety Officers is more dynamic as
they are the one who will be working at the grass root level.
Besides having a thorough knowledge of food law and regulation, Food Safety Officers must know
and understand all the elements of their role in food safety.
FSO has to conduct inspections when:
1. Prescribed by the Designated Officers (DO) for Food

Establishment, to be licensed or renewal of license for
manufacturing, handling, packing or selling of an article of food to
satisfy himself that the conditions of licenses are being complied
by the Food Business Operators, carrying out the business within
his/her assigned area and submit the inspection report to DO.
2. As a registering authority, he/she can inspect for registration.
3. Surprise Inspections to investigate any complaints or inspecting
INSPECTION any premises or vehicle suspecting to contain any unsafe food or
foods which does not comply with the provision of the Acts &
Rules intended for sale or delivery for human consumption.
FSO has to take sample for the following purposes
1. For the Surveillance, survey and research which cannot be used

SAMPLING for prosecution.
2. Routine Sampling of any article of foods for prosecution
FSO has to carry out food safety surveillance to identify and address the
FOOD SAFETY safety hazards. It has to be achieved through programmed sampling
system that make an effective contribution to food law enforcement.
SURVEILLANCE
Food Surveillance will highlight foods that are of public health risk.
FSO has following facilitator role
1. In preparation of Food Safety Plans for Panchayat and

Municipalities in accordance with Schedule IV of Chapter 3 of
FACILITATION Regulations.
2. Coordinate with the Food Business Operators within his area of
operation and facilitate the introduction of Food Safety
Management System in accordance with Schedule IV
FSO will conduct or organize Training Programme as duties entrusted to

CAPACITY him by DO or Food Safety Commissioner for the personnels working in
BUILDING different segments of food chain and also work on generating
awareness on food safety.
16
FOOD PRODUCTION PROCESS
17
Chapter 3
Integrating food Chain
3.1 Process: Farm to Fork
Consumer confidence in the safety and quality of food supply is an important requirement and
consumers are demanding protection for whole food supply chain from Primary Producer to the End
Consumer often described as Farm to Fork approach. Maintaining food safety & quality is essential in
entire chain of food production.
 Primary Food Production at the level of farmers

 Primary Food Processing at the Farms, Dairy, Abattoir and Grain Mills
 Secondary Food Processing Level such as Canning, Freezing, Drying and Brewing
 Food Distribution both at National & International Level
 Food Retailing & Catering
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What is ‘SAFE FOOD’?

This question invokes different answers depending up on who is asking….
The Consumer might consider that Safe Food means “Zero Risk” or “No Risk at all”.
A food manufacturer would consider Safe Food as “what is an acceptable risk?”
Opinion express that zero risk is not feasible given the range of food product available, the
complexity of the distribution chain and human nature. The difficulty that arises in manufacturing
“safe” food is, that, the consumer is the mixed population with varying degree of susceptibility and
general life style. During production, use of Pesticide to control insects, unwanted plant or fungi
used on Primary Crop can result in trace residues of pesticide in the food. Traces of drugs given to
food producing animals to treat diseases in animal under some circumstances may remain in the
food. During Processing, use of preservatives to reduce microbial growth can be perceived as
undesirable by the consumers. These trace toxicants which come in to the food chain
unintentionally are regulated for safety for example MRL setting for Pesticides & Antibiotics.
How Risk can enter in to the food chain?

 Production: Poor Agriculture Practices
 Processing: Improper Handling & Processing, Storage & Packaging
 Transportation: Improper unhygienic transportation
 Retail: Poor Hygiene & Sanitation
19
3.2 Risk Analysis

In order to manage safe food production, it is important to have thorough knowledge on the
occurrence of risks associated with foods that can enter at any stage in the food production chain.
International Agencies like Food & Agriculture Organisation (FAO) & World Health Organisation
(WHO) as well as Codex Alimentarius Commission with its member countries recommend Risk
Analysis Approach for managing the risk in the food production process.
What is Risk?
Hazard
Risk
Exposure
Hazard can become a risk only when there is an exposure to that particular
hazard. If there is a hazard but there is no exposure, it cannot become a risk.
What is Hazard?
As shown in the Picture, there is a nail embedded in the food, chemical used for vegetables and
microbes. These are the Hazards and when any one will consume this food, these will become a
Risk for consumer.
20
Food hazards are the biggest threat to food safety
Hazard is defined as a biological, or chemical or physical agent in a food or condition of the food,
with the potential to cause an adverse effect.
Biological Hazard: are living organisms, including microbiological organisms, bacteria, viruses,
fungi and parasites.
Chemical hazard: are in two categories: naturally occurring poisons and chemicals or deleterious
substances. The first group covers natural constituents of foods that are not the result of
environmental, agricultural, industrial or other contamination, examples being aflatoxins and shell
fish poison. The other group covers poisonous chemicals or deleterious substances, which are
intentionally or unintentionally added to food at some point in the production chain, examples are
pesticides and fungicides as well as lubricants and cleaners.
Physical Hazard: is any physical material not normally found in food which causes illness or
injury. physical hazards include glass, wood, stone, bone and metal, which may cause illness and
injury.
Table showing examples of Hazards
Hazards associated with food

Biological Chemical Physical
Macro biological Veterinary residues Glass
Example: Pests, Pest part, Example: Veterinary Hair
Insects dead or alive Drugs
Microbiological Growth Stimulants Metals
 Pathogenic Bacteria Plasticisers and packaging Stones
Spore forming & migration Wood
Non spore forming Plastic parts of pests
 Parasites and Allergens Insulation material
protozoa Toxic metals Bone
 Viruses Example: lead and
cadmium
Mycotoxins Food Chemicals Fruit pits
Example: Example: Preservatives,
processing Aids,
Polychlorinated
biphenyls(PCBs)
Printing inks, prohibited
substances.
Chemical residues
Example: Pesticide,
Cleaning Fluid
21
Risk Analysis Approach

Risk analysis plays an important role for National Food Control System. It is a powerful tool to carry
out science based analysis and to achieve a sound and consistent solution to food safety problems.
It provides information on hazard in food to be linked directly to data on the risk to human health,
and to improve food safety decision making process.
It comprises of three stages:
 Risk Assessment
 Risk Management
 Risk Communication
Risk analysis involves identifying the risk and weighing their likelihood and impact
on health and then establish system to reduce or mitigate the risks.
22
Risk assessment is a scientifically based process consisting of four steps: hazard identification,
hazard characterization, exposure assessment and Risk Characterisation. Risk assessment is carried
out by the independent scientific panels and Scientific committee to provide scientific inputs on the
risk and potential adverse effect of the risk to the health of the consumers. These inputs are based
on sound scientific principle, data and evidence.
Risk management is a process of assessing various policy alternatives in consultation with all
relevant stakeholders, considering risk assessment and other factors relevant for the health
protection of consumers and for the promotion of fair trade practices
Risk Communication is the interactive exchange of information and opinions throughout the risk
analysis process concerning hazards and risks, risk related factors and risk perceptions, among risk
assessors, risk managers, consumers, industry, the academic community and other interested
parties.
Why FSO must know Risk Analysis?
A well established and integrated information and data generation system across the food chain on
the occurrence of risk is very essential to complete the cycle of Risk Analysis. Information & Data
generated should be of quality and precision, that minimizes uncertainty in the risk estimate to the
extent possible. Such activity in our Regulatory System to find out the risk associated with the foods
are being carried out by Food Safety Officers under the terms “Monitoring’” and “’ Surveillance ‘”.
Identify & address the safety

hazards
Draw samples for the purpose of

Surveillance, Survey & Research Risk Assessment
To respond to the incidence of

Food Poisoning in his area
Food Safety
Surveillance
Powers & Duties of FSO
Risk Communication
Monitoring
Carry Out Inspections in food
establishments
Draw samples for the purpose of Risk Management

Monitoring to be used for
Prosecution if required
Maintain the database of all the

food businesses within the area Standards & Guidelines
23
It has been described that, how hazard can enter in to the food chain at any point of time and
subsequently, on exposure to that hazard, consumer faces risk with unsafe food. to the consumers
Therefore, four Steps of Risk Assessment are always necessary to ensure food safety.
Through
Food Safety
Surveillance
&
Monitoring
Risk Management
Risk Control & Mitigation Guidance
Food Safety is being Ensured!!!!
The role of FSO in hazard identification becomes one of the important source of input for risk
assessors in completing the steps of Risk assessment. Risk Analysis is the foundation on which food
control policy and consumer protection measures are based. The scientific inputs from risk
assessment will provide basis for policy decisions to risk managers for developing standards and
guidelines to minimize or control the risks.
3.3 How to identify Hazard?

Hazard identification will be predominately a qualitative process and Food Safety Officers will help
in hazard identification and address this by carrying out Food Safety Surveillance. In an attempt to
identify potential hazards, it is necessary to follow the process as mentioned below.
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Hazard identification
Categorize the food Establishments
Change of focus Consider hazards

from end product associated with the food.
testing.
Review the control
Focus on the Look for the
measures in place
compliance possible hazard
Target high risk
Inspect the establishments with
premises & Grade them according to available resources
processes for the risk after inspection
compliance with
hygienic & other
requirements of
standards/ Establishment categorization
regulations High, medium or low risk based on risk
factors
Low risk Medium &High risk
Inspection frequency will depend on:

 History of compliance
 Product risk profiles
25
Categorization of Food Establishments
Food risks in food establishments depend on types of foods handled- process and
products:
Establishments producing food to be cooked prior to consumption/ producing ready to eat products
Products like raw chicken/ meat and fish products are high risk because they naturally carry a high
load of pathogenic bacteria. For such products, practices related to cross contamination & cooking
are priority during inspection.
Products having wide distribution & large consumption, those meant for children, infants,
vulnerable segment of population pose more risk
Decision tree for risk categorization in the secondary food business sector
Check if the primary product is High or Low-Risk Food
Could the food sector

introduce a hazard to the
No Yes
food, or fail to control the
level of a hazard that could be
present?
Low-Risk Food Food sector need to take

Establishment action(s) to eliminate, reduce
or control a hazard critical to
NO
the safety of product when it
is consumed?
YES
NO
Medium Risk Food Business
Will/could the presence of the
YES hazard lead to “severe” public
High-Risk Food Business health consequences?
26
Prioritization for Inspection
 When number of establishments to be inspected is more prioritization is necessary.

 Based on process/ product-related set of risk factors for food-borne disease - By
identifying high risk foods or high risk food preparation processes Food Safety Officers
can focus on those foods or processes that are most likely to cause food-borne disease
if uncontrolled
 Record of compliance
 History of compliance by the establishment with its quality and safety management
system & pertinent regulations
 The establishment profile and grading as “High” or “Low” based on establishment
records
 The products are profile on the level of food borne disease risk factors they present
(e.g. inherent toxins) or marketing characteristics (reaching more populations/
vulnerable segments)
Matrix to Assign a Priority Ranking to Establishments
Establishment Product risk profile Inspection priority profile

compliance profile (e.g. (e.g. new products, new
non-compliance and violations formulas, new processes)
are reported)
Low High Top priority

Low Low Medium priority
High High Medium priority
High Low low priority
The establishment categorization or priority level for inspection thus obtained should be reviewed
and updated after each inspection.
Benefits of risk-based food inspection

 Emphasizes on a preventative approach rather than corrective actions
 Places responsibility on various stakeholders specially producer/ processor rather than
government of producing a safe food.
 Promotes partnerships between inspecting officers and processors for purpose of
improving food safety
 Uses limited resources in a more effective manner.
 Investigate & apply enforcement action proportionate to risk.
 Provide advice & information to food industry workers & management
27
FOOD SAFETY SURVEILLANCE
28
Chapter 4
Food Safety Surveillance
4.1 Definition & Procedure
Food Safety Surveillance is a system that collects the data regarding all types of contaminants in
foods. It has to be conducted in a structured and planned manner with the purpose to understand
the spectrum of food safety, timely identifying of food safety hazards and then provide relevant data
for food safety monitoring, risk assessment and standard setting.
As a part of duties and responsibilities in food safety & standards rules and regulation 2011, Food
Safety Officer has to conduct surveillance activities at both the retail and wholesale level (at all stages
of production, processing and distribution)
Microbiological Surveillance is a system for collecting data on food borne diseases and is critical in
the performance of food safety systems. Surveillance of human illness and epidemiological
investigation of outbreaks can identify previously unknown hazards and provide feedback on the
effectiveness of the existing control measures.
Requirements for an Effective Surveillance and Monitoring?

The object of food safety surveillance system is to ensure that the food supplied in the market is safe.
In the absence of an effective system, the consumer can be exposed chemical and microbiological
contaminants, causing a variety of food borne diseases caused by agents such as Mould, Yeast, E. coli,
Coliform, Salmonella, Staphylococcus Aureus, Vibro Cholera, etc., and chemical contaminants like
pesticide residues, heavy metals, aflatoxins, etc. The effectiveness of the food safety system can be
judged by the frequency and extent of such diseases. In the absence of requisite data, it is not possible
to assess the present state and size of the problem
Under the Food Safety and Standards Act it is planned that the Food Authority will derive the work
program from the Advisory Committee and scientific inputs from the Scientific Committee. This will
enable prioritization of work and taking decisions on the basis of science. More specifically, the Food
Authority will –
 Set standards and limits for contaminants

 Prescribe labeling requirements
 Devise procedures and guidelines
 Indicate methods of analysis
 Set out guidelines for accreditation of laboratories
 Conduct surveys
 Maintain data
 Organize training programs
29
A number of decisions of the Food Authority will require information and data. These decisions have
to be taken with the help of natural databases of hazards in foods, testing of food for chemical and
biological agents, dietary intake surveys, epidemiological surveys of consumer populations, and
investigations of food borne disease outbreaks. Monitoring and surveillance data allow the
identification of potential area of focus to be listed for subsequent action by the Food Authority and
the evaluation of the effectiveness of sanitary measures that have been implemented in all food safety
frameworks.
For an effective food safety

surveillance system follow
these eight steps
 Ensure the authenticity of foods.
 Provide data for risk assessment and risk management activities by

identifying the hazards in foods for the purpose of monitoring trends of
food safety hazards.
 Remove contaminated products from the market.
 Enforce compliance at all levels in the food chain --by farmers,

manufacturers, distributors, importers, and other stakeholders.
 Take decisions based on science.
 Empower authorities to detect sources of contamination and take

necessary action to prevent contaminated foods from reaching the
consumer.
 Be transparent and promote public confidence.
 Detect outbreaks and assist with their investigation.
30
5 steps for Food Safety Surveillance to be

conducted by Food Safety Officer
State Food Authority & FSSAI will use

1 5 the data for Hazard identification and other risk
assessment activities
Upload Laboratory Analysis Report into the

1 4 database for further analysis & interpretation
Get the samples analyzed in food laboratories. In

1 3 FSSAI organized surveillance projects, the samples have to be
tested in prescribed laboratories.
Start Sampling on targeted food products and the number of

1 2 samples to be lifted has to be statistically calculated.
Prepare a food safety surveillance plan for identification and

1 1 addressing safety hazards in their jurisdiction. The plan should be based on
focused commodities to be taken up for survey.
In case of food borne outbreak Microbiological Surveillance is to be

conducted by FSO to assist outbreak investigation
The Microbiological Surveillance is an extremely important aspect of food safety. It becomes

important for the Food Authority to ensure that all sectors of the food chain control their
procedures effectively to prevent harmful microorganisms form contaminating the food, and
one of the ways how this can be achieved is through microbiological surveys.
The survey has to be carried out on regular basis to establish the current situation in the microbial
contamination in a range of foods and focus should be on high risk foods and processed foods.
However, the survey sampling can also be done to support an investigation of food borne illness
with other agencies (Public Health Departments)
Learning from food safety surveillance

 Points of contamination
 Areas for improvement in food production
 Knowledge on common & emerging pathogens associated with food borne illnesses
 Trend in food borne disease outbreaks
31
4.2 Food borne diseases

Food borne diseases are more critical in developing countries due to various reasons, such as use
of unsafe water for cleaning and processing of food, poor food production processes and food
handling, absence of adequate food storage infrastructure and inadequate enforced regulatory
standards.
Foodborne diseases are diseases caused by consuming contaminated food or drinks. Many
microbes and toxic substances can contaminate foods. The majority are infectious and are caused
by bacteria, viruses, and parasites. Other foodborne diseases are essentially poisonings caused by
toxins, chemicals contaminating the food. All foodborne microbes and toxins enter the body
through the gastrointestinal tract and often causes the first symptoms there. Nausea, vomiting,
abdominal cramps and diarrhoea are frequent in foodborne diseases. Foodborne and waterborne
diarrheal diseases are a problem for every country in the world but they can be prevented. Food
borne diseases are usually either infectious or toxic in nature caused by agents that enter body
through the ingestion of food. Although most foodborne illnesses are sporadic, there have been
alarming outbreaks of salmonellosis, cholera, enter hemorrhagic E Coli infections, hepatitis A and
other diseases in both developed and developing countries. The symptoms of food borne diseases
range from mild and self-limiting (nausea, vomiting and diarrhoea with or without blood) to
debilitating and life threatening (such as kidney and liver failure, brain and neural disorders,
paralysis and potential cancers) leading to long period of absenteeism form work and premature
deaths.
Hazards and the food borne diseases

Hazards Food borne disease
Diarroheal Disease Virus Norovirus

Agents
Bacteria Campylobacter sp, Enteropathogenic E coli(EPEC),
Non typhoidal Salmonella, shigella, vibrio cholera
Protozoa Cryptosporidium , Entamoeba histolytica , Giardia

Invasive infectious Virus Hepatitis A
disease agents
Bacteria Brucella , Listeria monocytogenes, mycobacterium
bovis , Salmonella typhi and para typhi
Protozoa Toxoplasma gondii
Helminths Cestodes Echinococcus granulosus, Echinococcus

multilocularis, Taenia solium
Ascaris , Trichinella
Nematodes
Trematodes Clonorchis sinensis, Fasciola , Opisthorchis ,
intestinal flukes
Chemical Toxins and Aflatoxin, Cassava cyanide, dioxin
poisons
32
Food Borne illness caused by Microorganism. Microorganism

remains in food in small number and when it grows in certain condition it
causes illness
Microorganism loves FATTOM to grow!!
Microorgani Different Microorga

Microorgan Microorganis
Microorgani sms Microorgani nisms
m need
sm easily typically do isms grow sm have grow well
sufficient
grows in not grow in best different in moist
time to grow.
highly acidic between Oxygen food
Contaminate
PROTEINS or alkaline requirement
the d food
& food. remains in to grow
temperatur
They grow e of 41-141 the
CARBO
best in temperature
HYDRATE
foods which
DEGREE F danger zone
are FOR 4 HOURS
NEUTRAL & OR MORE
SLIGHTLY can cause
ACIDIC illness.
33
Food borne disease are preventable

WHO built the Five Keys to Safer Food Programme to assist Member States in promoting safe food
handling behaviors and educate all food handlers, including consumers, with tools easy to adopt
and adapt. The Five Keys to Safer Food explain the basic principles that each individual should
know all over the world to prevent foodborne diseases. Over 100 countries have reported using
the Five Keys to Safer Food. As a result, billions of food handlers, including consumers, are
empowered to prevent foodborne diseases, make safe and informed choices and have a voice to
push for a safer food supply.
34
4.3 Investigation of an outbreak

What is a food borne outbreak?
A disease outbreak is the occurrence of cases of disease in excess of what would normally be
expected in a defined community, geographical area or season. An outbreak may occur in a
restricted geographical area, or may extend over several countries. It may last for a few days or
weeks, or for several years. A foodborne disease outbreak is defined as two or
more illnesses caused by the same organism (e.g., a toxin, virus or bacteria) which are linked to
eating the same food. When a foodborne disease outbreak is detected, public health and
regulatory officials work quickly to collect as much information as possible to find out what is
causing it, so they can take action to prevent more people from getting sick.
Key players in investigation of an outbreak
National Authorities State Authorites State Laboratories

(Health & (Health & (Public Health &
Regulatory) Regulatory) Food)
Food Safety &

Standard State Health Public Health
Authority of India Departments Laboratories
[FSSAI]
National Centre
for Disease Regulatory
Control Compliance Food Laboratories
Department
[NCDC]
Steps of Investigation
Foodborne disease outbreaks are investigated to prevent both ongoing transmission of disease
and similar outbreaks in the future. Investigating an acute food borne outbreak may primarily be
Deductive (i.e., reasoning from premises or propositions proved previously), Inductive (i.e.,
reasoning from particular facts to a general conclusion) or it may be a combination of both.
Important considerations in investigating an acute outbreak of infectious diseases include
determining that outbreak has in fact occurred and defining the extent of the population at risk,
determining the measure of spread and reservoir, and characterizing the agent. The scale of an
outbreak may range from a local outbreak of a small number of linked cases with mild disease to
a nationwide or international outbreak of severe disease involving the mobilization of public
health resources from all levels irrespective of the scale.
A full investigation of a foodborne disease outbreak will normally include Epidemiological

investigation, Environmental and food investigations, Laboratory investigation.
35
Three components of the Investigation of an outbreak
Epidemiological Investigation
 Patterns in where and when people got
sick, and past outbreaks caused by the
same organism.
 Interviews with sick people to look for
foods or other exposures occurring
more often than expected.
 Finding the clusters of unrelated sick
people who ate at the same food,
shopped at the same grocery store, or
Trace back Investigation

 A common point of contamination in
the distribution chain from farm to
fork, to be identified by reviewing
records collected from restaurants or
stores where sick people ate or
shopped.
 Inspections in food production
facilities and in restaurants with
identified food safety risks
36
Environmental Health Investigation
 Sampling and testing of the food and

the environment.
 The organism that caused illness is
found in a food item collected from a
sick person’s home, a retail location,
or in the food production
environment.
Steps that are commonly used in investigating an outbreak, however these may vary and differ in
order, depending upon the outbreak.
37
Identifying food borne outbreak: A Team Approach

Notification of Food Poisoning
Under Section 35 of the FSS Act it requires the Food Authority to notify registered medical
practitioners carrying on their profession in any local area specified in the notification, to report
all occurrences of food poisoning coming to their notice to such officer as may be specified.
When a foodborne disease outbreak is detected, public health and regulatory officials shall have
to work quickly to collect as much information as possible to find out the cause of the outbreak,
so as to prevent more people from getting sick. The data is then collated, analyzed to establish the
likely source of the outbreak and with a convincing information to link the illness with the
contaminated food. In some cases, the health officials can decide to alert the public directly
through electronic media, and regulatory authorities can recall the food product and can impose
temporary ban on the sale, distribution or import of the food implicated in the outbreaks.
Outbreak Investigation Team
Epidemiologists Microbiologists
Regulatory
Public Health Division
Specialists Officers &
Inspectors
Food Safety Officer has to be a part of Rapid Response Team (RRT) for
outbreak Inspection
38
4.4 Food Product recall:
Recall” means and refers to action taken to remove ‘unsafe food’ under
recall from distribution, sale and consumption as appropriate. Unsafe
food is defined under Section 3 (1) (zz) of the Act.
Food recall is an action taken to remove from sale, distribution and consumption foods, which may pose
a safety risk to consumers. A food recall may be initiated as a result of a complaint from a variety of
sources − manufacturers, wholesalers, retailers, government agencies and consumers. It may also occur
as a result of a food business’s internal testing and/or auditing. Recalls are conducted by food businesses
to ensure that potentially hazardous or unsafe foods are not consumed. A recall plan should strive to
achieve the following goals:
A recall plan should strive to achieve the following goals:

 Protect consumer health
 Comply with existing rules and regulations
 Minimize the cost of the recall.
 Regain and improve the company’s reputation
Food Recall Procedure (Section 28)

Section 28 of the Food Safety and Standards Act, 2006, emphasizes the need for product recall, if a food
business operator considers or has reasons to believe that a food which he has processed, manufactured
or distributed is not in compliance with this Act, or the rules or regulations, made thereunder, he shall
immediately initiate withdrawal of the food product from market and inform competent authorities of
the risk and also the action taken.
39
REGULATORY COMPLIANCE
40
5.1 General Inspection Procedures

The Food Safety Officers are empowered by law and regulation to conduct inspections so it is necessary for the
FSO to have a thorough knowledge about these laws and regulations and about the scope of the authority
vested in him/her. They should have copies of all the pertinent law(s) and regulations for consultation in case
of any disagreement. In absence of laws and regulations to allow an FSO to implement a risk based approach to
food inspection, areas for improvement identified during the inspection can be raised as recommendation
instead of noncompliance while legislation is reviewed.
Knowledge and skill requirements

for
Food Safety Officers
1. Thorough knowledge of food law(s) and pertinent regulations.

2. Background information on the field of safety and quality.
3. Prerequisite sanitation, hygiene and pest control practices.
4. HACCP principles.
5. Inspection techniques.
6. Sampling techniques for product testing
7. Compliance verification skills.
8. Skill of creating awareness about food safety and quality among
food producers and processors for compliance verification.
9. Dissemination of concept of continuous improvement of the
quality and safety management system.
10.Recognition of organization or agency for food safety audit
(Section 44)
41
What Inspections are to be done by the Food Safety Officer?
Routine
Follow up
Establishments
FSMS plan
Inspection Types
Complaint
Product
Pre Licensing
License Renewal
Food Safety Officer need to change

their attitude from regulators to that
of food safety professional
42
Procedural flow of inspection at a food processing facility
Prepare for inspection Inspection opening meeting:

 Pre announcement inspection  FSO and team identification
(except if inspection in response to  Explain regulation and objectives
compliant/ violation. scope procedure and confidentiality
 Review inherent risk factors/ of inspection.
products  Request management collaboration.
 Prepare for inspection (time, dress,  Seeking questioning of operators.
tools)
 Schedule opening meeting.
 Examine Records.
 Foresee food borne disease risk
factors. Process flow chart
 Review facility’s quality and safety
management system(documents)  Obtain / prepare operation flow
chart.
 Method of monitoring & validation
 Anticipate CCPs
Counter – Flow walk through:  Focus on risk factors
 Check CCPs critical limits
 Storage / transportation of finished
products, Packaging and labelling
 Product characteristics/ labelling/
sampling
 Processing – verify control measures Closing Meeting (Caution)
 Facility assessment  Discuss finding (especially
 Equipment assessment noncompliance & violation).
 Employee/ staff health / hygiene &  Agree on time lines for corrective
Training action.
 Sick employee facilities  Sign report, give copy to management
 Examine employee facilities.  Discuss possible improvements
 Check raw material reception / storage  File report and schedule follow-up
 Additives and non-food chemicals
 Packaging material specifications/
storage
 Sanitation and pest control
 Site & surrounding environment
assessment Follow up Inspection
43
Inspection Requirements
for Food Business Operators
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 should also be deemed to be responsibility of the food business operator
to ensure adherence to necessary requirements. in addition to the requirements specified
below, the FBO shall identify steps in the activities of food business, which are critical to
ensuring food safety, and ensure that adequate safety procedures are identified,
implemented, maintained and reviewed periodically.
Inspectional requirements for all Food Business Operators:

1. Location and surrounding
2. Layout and design of food establishment premises.
3. Equipment.
4. Facilities:
 Water supply (potable and non-potable)
 For cleaning Utensils /equipment
 Washing raw materials.
 Ice and steam.
 Drainage and waste disposal
 Personal hygiene
 Air quality and ventilation
 Lighting.
5. Food operation and Control:
 Procurement of raw materials
 Storage of raw materials and food.
 Food processing / preparation, packaging and distribution /services.
 Time and temperature control
 Food packaging
 Food distribution/ service.
6. Management and supervision
7. Food testing facilities
8. Audit, documentation and records.
9. Sanitation and maintenance of establishment premises
 Cleaning and maintenance
 Pest control system
10. Personal Hygiene
11. Product information and consumer awareness
44
Biological inspection of establishment:

While conducting inspection following parameters to be taken into consideration to address
microbial contamination / microbial hazards in the food establishment.
Manufacturing
Storage
Area
Finished Personal
Product Hygiene
Raw material storage – refrigerated and Non

refrigerated
 Free form insect, rodent infestation and

contamination from other sources.
 Microbial load of the raw material should be
within the acceptable limits at receiving as well
as during storage.
 Depending upon the nature of food,
refrigeration, monitoring of temperature and
controlling of ambient temperature has to be
ensured.
 Swabs should be taken from the crates, tanks
in which the material is kept and stored, to
check their microbiological suitability for the
purpose.
45
Manufacturing Area
 All pieces of food contact equipment should be clean
and in good repair.
 All the equipment and their surrounding should be free
from evidence of rodent and insect activity.
 Working area as well as washing facilities should be
clean and adequate.
 In meat processing units’ carcass form diseased
animals should be removed from the processing unit
and disposed of accordingly.
 Swabs from machines, tables, utensils and other food
contact surfaces should be taken at regular intervals to
ensure microbial safety for food use.
 Air contamination should be adjusted by checking the
microbial quality of Air.
Packaging and storage of finished Products:

 Packaging material should be kept and stored under
hygienic conditions in a room intended for that
purpose.
 Packaging material/bottles/ closures should be
sanitized before use.
 All the products should be labelled according to the
food labelling regulation.
 After packaging the temperature has to be maintained
in the storage area to prevent any spoilage.
Personal Hygiene:
Health status
 Arrangements for getting the employees of the

establishment medically examined once in a year to
ensure that they are free form any infectious
contagious and other communicable diseases.
 The staff shall be compulsorily vaccinated against the
enteric group of diseases once a year and a record
towards that shall be kept for inspection.
 In case of an outbreak or epidemic, all workers to be
vaccinated irrespective of the yearly vaccination
46
Personal Cleanliness
 Food handlers should maintain a high degree of

personal cleanliness and should wear head gear,
gloves clean protective clothing while handling the
food.
 Food handlers with any cut or wounds in their
person, shall not come in direct contact with food
and food contact surfaces.
 Food handlers shall always wash their hands with
soap and clean water at the beginning of the food
handling activities
 Food handlers shall refrain from smoking, spitting,
chewing, sneezing and coughing which preparing
food.
 Food handlers should trim their nails periodically.
5.2 Developing a Food Safety Plan

What is a food safety Plan?
The FSS Act 2006 puts lot of emphasis on development of food safety plans at all levels to ensure food
safety. A food safety plan means adoption of all activities necessary to ensure food safety. A food safety
plan is a written document that describes how you can control food safety hazards in your food
processing establishment. The goal of the plan is to identify biological, chemical, and physical hazards
and then to prevent or control these hazards, or reduce hazards to acceptable levels throughout your
food process. A Food Safety Plan, includes, GMP (good manufacturing practices), a HACCP Plan (Hazard
Analysis Critical Control Point) and such other activities.
Under Food Safety and Standards Regulation 2011(schedule IV), the Food Premises of every food
business operator where food is processed or prepared must develop, maintain and follow a Food Safety
Plan to ensure that a health hazard does not occur in the operation of the facility. FSO has to facilitate
in preparation of Food Safety Plans for Panchayat and Municipalities in accordance with the parameters
and guidelines given in Schedule IV of regulation 2.1.2. Food Safety Plans should focus on the critical
steps within the preparation of the food to prevent hazards from entering the food chain.
Components of Food Safety Plan
Identification
Taking
of Potentially Set Critical Set Critical
Corrective
Hazardous Control Point Limit
Action
Foods
47
Before venturing into preparing a food safety plan, one needs to have baseline data on
food safety issues, one needs to address in his jurisdiction or panchayat or municipality
etc. If a road map is made covering all the components of the food safety plan half of the
job is completed and implementation becomes easy.
General food safety plan for panchayat and municipalities;

1. Identification and categorization of food business.
2. Inspection of the premises of food business operator.
3. Taking samples of food for analysis.
4. Evaluation and determination of the quality drinking water used
5. Reviewing the arrangements for disposal of waste by the public in general and the
food business operators in particular.
6. Investigation of food poisoning and follow up.
7. Interaction with industries and consumers to create awareness among them on
food safety.
8. Dissemination of information on food safety to general public.
5.3 Monitoring & Evaluation of Food Safety

Good Manufacturing Practices (GMP) and HACCP (Hazard Analysis &
Critical Control Points)
In any food operation, food safety management is achieved through the application of HACCP.
Prior to implementation of HACCP, Food processors must operate in accordance with good
hygiene practices(GHP) and good manufacturing practices(GMP). HACCP principles are not
required under the regulation, but are strongly recommended and may be incorporated in the
Food Safety Plan developed by the Food Safety Officer. The prerequisites are important as they
can often be used to reduce or eliminate a hazard. Good manufacturing Practices ( GMP) is a
process of food control wherby the requirements for mainataing the quality and safety of products
are written down in a GMP mannual which becomes a key reference for the operation of a food
manufacturing buisness. HACCP may form part of GMP requirements but, where HACCP focuses
on product and their manufacturing processes, GMP takes a wider perspective and covers all
aspects of the buisness which may impinge on food quality and safety.
Key aspects of GMP

 Consideration of requirements for the premises and maintenance of their
suitability for food manufacturing operations.
 The facilities and their adequacy for involvement in food manufacturing
 The manufacturing, storage and distribution operations and their
appropriateness for the manufacture and supply of food safety management.
Requirements for hygiene and food safety management.
 Management responsibility for the quality and safety of foods including the
maintenance of good manufacturing practices
48
HACCP (Hazard Analysis & Critical Control Points) system
49
HACCP system for food safety control was initially developed for the US Space Programme.
HACCP provides a means of ensuring that food eaten by astronauts was safe and did not contain
any food poisoning organisms which may have added to the difficulties of space mission. The
FSS Act 2006 also encourages all food services establishments, industry to follow HACCP
principles to ensure food safety.
There are seven HACCP principles that will be a part of your food safety plan. Principles one
through five are required, and principles six and seven are highly recommended:
1. Identifying hazards
2. Identifying Critical Control Points (CCPs)
3. Establishing Critical Limits at the CCPs
4. Establishing Monitoring Procedures for CCPs
5. Establishing Corrective Actions
6. Establishing Verification Procedures to ensure that the system is effective
7. Keeping Records
Implementation of HACCP
50
Benefits of HACCP
Many varied benefits have been described including:
 Better understanding of the processes and rationale for food safety controls.
 Personnel understand their roles better and are better trained.
 Provides a systematic approach;
 Control is tightened up, which may also lead to quality benefits.
 Proactive strategy means that controls are built in to prevent problems and these
continuously managed.
 Real time monitoring so problems are quickly identified and actioned straight
away, and
 Cost effective by targeting resources to the essential areas.
5.4 Product Inspection

Food Safety & Standards (Packaging and Labelling) Regulation 2011)
Section 38 (2) & (5) empowers the Food Safety Officer, to inspect any establishment and to
conduct the visual inspection of the products manufactured, or stored for sale or stored for the
manufacture of any other food article, or exhibited for sale.
As per the Food Safety& Standards Act 2006, every pre-packaged food article has to be labelled and
it has to be labelled in accordance to the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011.
General Labelling Requirements:
 The particulars of declaration on the label shall be in English or Hindi in Devnagri Script.
 Pre-packaged food shall not contain any label that is misleading or deceptive or creating any
erroneous impression regarding its character in any respect.
 Label in pre-packaged foods shall be applied in such a manner that they will not become
separated from the container.
 Contents of the label shall be clear, prominent, indelible and readily legible by the consumer
under normal conditions of Purchase and use.
 Where the container is covered by a wrapper, the wrapper shall carry the necessary
information or the label on the container shall be readily legible through the outer wrapper
and not obscure by it.
 FSSAI License Number shall be displayed on the principal Display Panel.
51
What information is required to be on Food label?
In order to safe guard the interest of the consumer, the packaged food article has to be labelled
and it shall provide the following information:
1. The name of Food

2. FSSAI License Number
3. List of Ingredients,
4. Nutritional Information,
5. Declaration regarding Veg or
non-veg,
6. Declaration regarding Food
Additives,
7. Name and complete address of
the manufacturer or packer
8. Net Quantity,
9. Code No, /Lot No./Batch No.,
10. Date of manufacture or packing,
11. Best Before and Use by Date,
12. Country of Origin for imported
food and
13. Instructions for use
In addition to the above information the manufacturer or the packer has to also ensure that the
label complies with the general requirements of labelling prescribed under the regulations.
LABELLING REQUIREMENTS FOR FOOD IMPORTS INTO INDIA
 All products should have a minimum of 60% shelf life remaining on each product at the time
of entry into India - Mandatory requirement
 All information should be in English
 The consignments shall comply with the provision of Labelling and Packaging Regulation,
2011.
 The consignment of multiple food or food falling under different categories packed in a
single container shall be packed in such a manner so as to facilitate the inspection and
collection of samples from the consignment.
 Special exemptions on labelling for information on name and address of the importer, FSSAI
logo, Non-Veg/Veg logo can be affixed by the importer upon arrival of imported food
consignment in the custom bonded warehouse.
 Such deficiency shall be rectified by affixing a single non detachable sticker or by any other
non-detachable method. Upon such rectification by the food importer, AO shall carry out a
re-inspection.
52
What the Food Safety Officer has to do during product Inspection?
As discussed before the focus needs to be changed from product testing to compliance. However, to
verify the regulatory compliance for labelling and packaging the product is checked by visual
inspection by the Food Safety Officer and other inspecting Officers. The FSO can very easily notice
the defect in labelling through visual inspection provided he/ she has through knowledge about the
Act and relevant regulations. There may be no need for send a sample for analysis to identify the
labelling defects. If the food product is not labelled in accordance to the regulations or it does not
provide the required complete information or the food product is promoted for sale with false,
misleading or deceptive claims then it is considered as misbranded food and attracts the penalties as
per Law.
What the FSO has to check on visual inspection of the product?

Record your name, the date of inspection, the name and address of the facility being inspected, and the
product description.
 Check the food packaging labels for compliance

against the relevant food packaging & labelling
regulations.
 Prepare a checklist of components to be verified for
a particular product and compare it with the
standards, this exercise helps to strengthen the label
verification process and provides evidence that this
activity has been completed during the inspection
process.
 The ingredient list should be verified at this stage
and if any non-compliance issue is found make sure
that you document the corrective action and directs
the FBO to rectify the non-conformance (if
rectifiable).
 If during food inspection the FSO notices any
labelling defect that creates doubt in the mind of the
FSO about the quality of the food product also, then
invariably the sample of such food product is taken
and sent for analysis for the check of its quality. if on
analysis the sample is found non-complying to the
standards then the food product is declared as
substandard besides misbranding and prosecution is
launched for substandard and also for misbranding
i.e. labelling defect. And if the sample is found
confirming to standards on analysis, the prosecution
is launched for misbranding.
53
What is the Principal Display Panel of a Food Product?

According to the Food Safety and Standards (Packaging and Labelling) Regulations, 2011,
Principal Display Panel means that part of the container or package that the customers will first read
if it is on display in a shop or which they will pick up to read and examine if they want to purchase that
commodity. The principal display is what the salesperson will show to the customer if the customer
has asked to buy that particular packaged product.
According to regulations the Principal Display Panel normally gives the identity of the food like, Jam,
Pickle in a specific way, where the letters have to be of specific height. It also mentions the net quantity
or amount of the product in the specific container of package, the numerals for which have to be of
specific height as mentioned in regulations. The information on the Principal Display Panel has to be
clear, easily readable and cannot be obscured by design, vignettes, or crowding. For the packages of
the same size the quantity of the contents need to be in uniform size as directed by regulations.
The space occupied by the Principal Display Panel
 In case the container is rectangular then the

space occupied by the Principal Display Panel
must be in 40% of the available space when
height is multiplied by width of the package in
the area where the package is the broadest.
 In case the container is cylindrical or nearly

cylindrical, round or nearly round, oval or
nearly oval container then the Principal
Display Panel must be on 20% of the available
space when the height of the container is
multiplied by the average circumference.
 In case the container/ package is of any other

shape then 20% of the total surface area will
contain the Principal Display Panel but only if
there is no label affixed securely to the
container. If a label has been affixed, then the
surface area of the label that works as the PDP
must not be less than 10% of the total surface
area of the container. Principal Display Panel
can be must be tape or card affixed to the
package or container if it has the capacity of
only 5 cubic centimeters and must bear all the
required information according to regulations.
54
Specific requirements on manner of labelling

Food category Labelling requirement
Infant milk substitutes Prior Approval of the food and the label form the Authority label
and infant foods shall contain “IMPORTANT NOTICE” for statements namely:
MOTHERS MILK IS BES FOR YOUR BABY”
Infant food only used on the advice of a health worker
Infant food or infant substitute is not the sole source of
nourishment of an infant
Warnings and cations about the use and storage of these foods.
Label on infant milk substitutes or infant food shall have NO
picture of infant or women or both.
The label shall indicate the additional information if recommended
as PREMATURE BABY, LOW BIRTH WEIGHT and TO BE TAKEN
UNDER MEDICAL ADVICE in capital letters
Infant milk substitutes or infant food for lactose intolerant infant
the label shall indicate “LACTOSE FREE or SUCROSE FREE
statements
Infant milk substitutes or infant food for infants allergic to cows/
buffalo milk or soy protein shall have label with statement “
HYPOALLERGNIC FORMULA
Edible Oils and Fat Label shall not use the expressions which are an exaggeration of
the quality of the product ( Extra refined, Ultra refined , Anti-
Cholesterol etc.)
Permitted food Label shall state the word “ Food Colours” with complete
colours chemical and the common name and colour index of the dye stuff
Irradiated foods The label shall have bear the Declaration “PROCESSED BY
IRRADIATION METHOD DATE OF IRRADIATION and the Logo
License Number of Irradiation Unit and
purpose of Irradiation.
The other food products with specific requirements are mentioned in sub-section
2.4.5 of Food Safety & Standards (Packaging and Labelling) Regulation 2011.
55
Specific Restrictions on product labels

Specific restriction Explanation
Labels not to contain reference to Act or rules No reference of the Act, Rules or Regulations
or regulations contradictory to required is permitted to be made on the labels. Which
particulars will directly or by implication , contradicts
qualifies or modifies such particular or
declaration
Labels not to use words implying The words “recommended by the medical
recommendations by medical profession profession” or any words which suggest that
the food is recommended, prescribed, or
approved by medical practitioners or
approved for medical purpose, are not
allowed to be mentioned on the labels.
Unauthorized use of words showing imitation The word ‘imitation’ or any word, or words
prohibited indicating that the article is a substitute for
any food, are not to be mentioned on the
label
Imitation not to be marked “Pure” The word “pure” or any word or words of the
same significance shall not be included in the
label of a package that contains an imitation of
any food.
Labelling prohibitions for Drinking Water No claims regarding medicinal effects shall be
(Both Packaged and Mineral Water) made. The name of the locality, or specified
place should not be associated with the trade
name unless the packaged water is collected
from that particular place.
The use of any statement or of any pictorial

device which may create confusion in the
mind of the public or in any way mislead the
public about the nature, origin, composition,
and properties of such waters put on sale is
prohibited.
Restriction on advertisement Advertisement of any food, which is
misleading or contravening the provisions of
Food Safety and Standards Act, or the rules /
regulations, is prohibited
Unauthorized use of the words or any

misinterpretation with an intention to pull the
sales of the product will be an offense under
the regulations of the FSS act, hence the above
has to be strictly be followed to avoid
penalties.
56
57
Some important food labelling logos
58
The Bureau of Indian Standards

(BIS) Act 1986
The quality standards are voluntary in
nature, however some of the
standards are mandatory for some
food products:
 Infant foods, infant formula
and milk cereal based weaning
food, processed cereal based
weaning food and follow up
formulas
 Condensed milk sweetened,
skimmed milk powder, partly
skimmed milk powder, partly
skimmed sweetened
condensed milk etc.
 Packaged drinking water
Agricultural Produce (Grading

and Marking) Act 1937
AGMARK standards are fixed quality
standards notified for 181 agricultural
and allied commodities
Under FSS (Prohibition & Restriction on

sales) Regulation
AGMARK is mandatory for
 Sealed packages of blended

edible Oils.
 Sealed packages of ghee,
 Sealed packages of Fat spread
59
Exemptions from Labelling

Requirements (2.6.1)
Under sub-section 2.6.1 of FSS (Packaging and Labelling) Regulations, certain cases where one or more of the
mandatory information required to be given on the labels such as list of ingredients, Lot Number or Batch
Number or Code Number, nutritional information, the ‘date of manufacture’ or ‘best before date’ or ‘expiry
date’ and instructions for use, need not be given on the labels. Such cases are as given below:
Food Category Label declaration Exemptions
If the surface area of the list of ingredients,

package is not more than 100 Lot Number or Batch Number or Code Number,
square centimeters. Nutritional information and
Instructions for use, need not be given on the labels. but this
information shall be given on the wholesale packages or multi piece
packages, as the case may be.
If the surface area of the List of ingredients,

package is less than 30 square Lot Number or Batch Number or Code Number,
centimeters. Nutritional information
The ‘date of manufacture’ or ‘best before date’ or ‘expiry date’ and
Instructions for use, need not be given on the labels, but these
information shall be given on the wholesale packages or multi-piece
packages, as the case may be.
In case of liquid products List of ingredients need not be given on the label.
marketed in bottles and the If the glass bottles have been manufactured after March 19, 2009,then
bottle is intended to be reused the list of ingredients and nutritional information are required to be
for refilling. given on the bottle.
In case of food with shelf-life The ‘date of manufacture’; need not to be mentioned on the label of
of not more than seven days. packaged food articles, but the ‘use by date’ is required to be
mentioned on the label by the manufacturer or packer.
On the wholesale packages ( List of ingredients.

Multi piece Packages) Date of manufacture/ packing,
Best before or expiry date
Labelling of irradiated food and,
Vegetarian logo/non vegetarian logo, need not to be specified.
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Search and Seizure

Section 41(2) states the provision of CrPC relating to search and shall apply to all the actions taken by the Food
Safety Officer under the FSS Act2006.
Under this provision the Food Safety Officer may search any place, seize ant article of food or adulterant, if there
is a reasonable doubt about the involvement of the FBO in commission of any Offense related to food. On demand
of the FSO, if the person against whom action is sought to be taken does not provide access to the place the food
safety Officer acting under sub section 2 of section 100 read with subsection 47 of CrPC can break open any outer
or inner door or window of any premises. However, if such premises is an apartment and the occupant is a female
(not being a person against whom action is sought to be taken) who, according to the customs of the country does
not appear in public, the FSO must allow her to withdraw and give her reasonable facility to withdraw, and then
may break open the apartment and enter it.
Other principles to be kept in mind:

 If any person is “reasonable suspected” of concealing in his person any article for search needs
to be made, the FSO may search that person expect if the person is a woman than the search
should be made by a woman with strict regard to decency.
 Before making the search the FSO has to call upon two or more independent witness of the
locality and if none comes forward issue an order in writing to them to do so and the search
should be made in their presence.
 A list of all things seized in the course of the search and the places in which they are respectively
found should be prepared by the FSO and signed by the witness.
 The occupants of the palace searched or the attendants should be all the time present at the time
of search and the copy of the list prepared by the FSO signed by the witness should be given to
him/ them.
Seizure
Section 38(1) empowers the Food Safety Officer to seize any article of food which appears to be in
contravention of the Act or the regulations made thereunder. Section 42(2) further states the provisions
of CrPC relating to seizures shall apply to all actions taken by the FSO under this FSS Act.
This power can be exercised against both licensed and unlicensed persons under the Act. Further the
FSO has to thereafter inform the Designated Officer of the actions taken by him in writing. Every FSO has
the discretionary power to seize (in suitable cases) and carry away any article of food which is found
under circumstances which create suspension of the commission of any offence.
61
5.4 Sampling
Food sampling is a process used to check that a food is safe and that it does not contain
harmful contaminants, or that it contains only permitted additives at acceptable levels, or that it
contains the right levels of key ingredients and its label declarations are correct, or to know the
levels of nutrients present. Food sampling involves the selection of a certain portion of container
and product units from a particular lot of the same food. It must be a representative as possible of
the whole consignment or from lot.
Objective:
1. Protecting public health
2. Detecting fraudulent activities
3. Giving customers sufficient information to make informed choices.
4. Ensuring that food standards are maintained
5. Informing the enforcement approach
6. Providing product quality advice to the producer
7. Promoting fair trade and deterring bad practice
Authorized person for taking Food Samples:

Food Safety Officer may take samples of food for analysis under clause A of sub
section 1 of section 38 and clause (c) of sub section (1) of section 47 of the Act or
An Authorized Officer can take samples of imported article of food for analysis
under sub section (5) of section 47 of the Act shall, follow the procedure specified
for taking samples and sending them for analysis.
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TYPE OF SAMPLES
Regulatory (Formal) Sample:
Regulatory/ Formal samples are picked for evaluation in case of certain concerns, issues. The reports of these
analyses are filed for legal actions. The sample integrity, homogeneity, and representativeness is vital for a fair
and meaningful inference and subsequent actions. Formal samples will be taken where formal enforcement
action may be required if an adverse report is received following examination or analysis. Hence formal samples
have to be purchased or procured by the Food Safety Officer /Authorized officers.
Monitoring or Surveillance Sample:

Samples are drawn for the monitoring or surveillance purpose as well. Monitoring activity is an ongoing process
and samples picked for this activity are large in number and should be preferably in the range of 5 to 8 samples
per location/product. Such sampling will also be initiated as a part of survey initiated by the Food Authority, to
monitor the quality and safety of foods manufactured, distributed and retailed.
SAMPLING PLAN
Sampling plans are required to ensure that fair and valid procedures are used when food is being controlled for
compliance with a particular commodity standard. FSO/ Authorized Officer is responsible for sampling should
select sampling plans appropriately for inspections under specifications laid down in standards. The sampling
plans have to be designed to ensure foods safety and are to collect samples for testing to decide whether a food
lot complies with relevant food safety standards and is fit or unfit for human consumption. The plans will vary
according to food commodities and hazards involved, each sampling plan should specify the number of samples
to be randomly collected from a suspect food lot for testing; the plans also guide how to divide large food lots to
smaller sub lots for sampling.
Criteria to be considered in formulating a Sampling plan

 Type of food product
 The size of food articles to be sampled (production units, cans, packages etc.)
 The nature of the defect.
 The degree of hazard to human health.
 The potential for fraud.
 Acceptance and rejection criteria
 Degree of confidence required so that the test result is valid
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Principles adopted in designing the sampling

plans
The sampling plans have been adopted after making reference
to the following international and national food authorities:
(a) Codex Alimentarius Commission (Codex) guidelines or code

of practice on sampling.
(b) When Codex documents are not available or not applicable

to sampling of the considered products, reference can be made
to regulations or food standard in FSS Act 2006.
Methods of sampling
Method Characteristics
Random sampling Samples are collected in a way that ensures that any one unit has an equal chance
of being included into sample to be analysed.
Stratified sampling Units of sampling are taken from defined strata (subparts) of the parent population.
Within each stratum the samples are taken randomly. The sampling of branded
foods can be stratified according to manufacturing plant. Where different brands of
the same food are not expected to show significant variation, the sample can be
weighted according to market share. Strata may be regional, seasonal, retail sale
point, etc., as defined by knowledge of the food being sampled
Selective sampling Samples are taken according to a Sampling plan that excludes food products with
certain characteristics or selects only those with defined characteristics. This
method is often legitimately used in the analysis of contamination, where the
objective may be to identify maximal exposure to contaminants.
Samples of foods prepared in a unit can be regarded as selective samples. Generally,
samples collected from cooks working in domestic or industrial kitchens are to be
preferred, as they can be regarded as more representative of foods generally
available for consumption.
Systematic when a complete list of sample units is not available, but when samples are
sampling distributed evenly over time or space, such as on a production line. The first sample
is selected at random and then every nth unit after that.
Convenience Samples are taken on the basis of accessibility, expediency, cost or other reason not
sampling directly concerned with sampling parameters and samples obtained by using this
method should be regarded as low quality. Convenience sampling may be the option
in the case of wild or uncultivated foods; provided the sources of the samples are
fully documented the values can be used in a database.
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Procedure of Sampling
Requirements of Good Sampling methods:
Samples are useful for their intended purpose when they are taken in a manner consistent with
generally recognized good sampling techniques and good sampling practices. This requires the
following
 Inspection of the lot before sampling

 Use of suitable sampling devices for the
particular commodity and type of sample
desired.
 Use of suitable containers to hold the sample.
 Maintenance of the integrity of the sample and
associated records.
 Use of adequate precautions in preserving,
packing and delivery of the sample to the lab in
a timely manner.
 Packing, sealing and marking of samples and
sample containers for identification of units
and to establish chain-of-custody.
 Provision of appropriate storage conditions for
the sample both prior to and following
analysis.
Importance of Sample Collection:

The reliability of analytical data obtained depends on several factors, sampling being the major
factor. Current analytical methods require only few grams of food sample to analyse. Thus, it is
necessary that a sample be as representative of the population as possible.
There are three basic activities involved in analysis of food products:
 Collection of representative sample.
 Sample preparation.
 Analysis using appropriate methods and instruments.
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General Guidelines for Sampling

Samples should be stored in a container that
protects the sample from moisture and other
environmental factors that may affect the sample
(e.g., heat, light, air).
 To protect against changes in moisture

content, samples should be stored in an
airtight container.
 Light sensitive samples should be stored in
containers made of opaque glass, or the
container wrapped in aluminium foil.
Oxygen sensitive samples should be stored
under nitrogen or an inert gas. Refrigeration
or freezing may be necessary to protect
chemically unstable samples, and freezing
should be avoided when storing unstable
emulsions.
 Preservatives (e.g., mercuric chloride,
potassium dichromate, and chloroform) can
be used to stabilize certain food substances
during storage.
 Samples should be clearly identified by

markings on the sample container in a
manner such that markings will not be
removed or damaged during storage and
transport. For example, plastic bags that are
to be stored in ice water should be marked
with water-insoluble ink.
 If the sample is a legal sample the container

must be sealed to protect against tampering
and the seal mark easily identified. Such
samples also must include the date of
sampling with the name and signature of
the Food Safety Officer. The chain of
custody of such samples must be identified
clearly.
66
Sampling procedure
The sampling procedures involve the selection of a sample (or samples) from a lot, the inspection or analysis
of the sample, and the classification of the lot (as ‘acceptable’ or ‘not acceptable’) based upon the result of the
inspection or analysis of the sample. Sampling procedures should be performed in accordance with
appropriate ISO Standards related to the commodity of concern (for example ISO 707 for sampling of milk and
milk products). Sampling for analysis should be done by trained Food Safety Officer/ Authorized Officer.
What is required for Sampling?

Sampling Equipment:
Tools such as a scoop, dipper, borer, knife or spear, agitator
and zone sampler (for oils and other similar products), are
required to remove a unit from bulk material, from packages
(such as drums, large cheeses) or from units of meat or
poultry which are too large to be taken as primary samples.
Containers:
When selecting the container for sampling, some general
requirements are to be kept in mind:
 Cleanliness of the container

 Quality of the container in particular its robustness to
withstand any condition of storage, transportation,
suitability of preserving the sample unchanged for the
necessary period.
 Containers and closures must be such as not to
influence the odour, flavour, pH or composition of the
sample products.
For liquids, clean water proof and grease proof material
including glass, stainless-steel and plastic material which can
be sterilized by heat when necessary can be used.
For solids and semi solids clean dry, wide mouth cylindrical
receptacles of suitable water proof, greaseproof material
should be used. the containers may also need to be sterilized.
All containers must have air tight closures. Suitable plastic
bags may also be used although plastic bags or containers
should not be used for pesticide samples
Sampling equipment required for microbiological sampling
must be sterilized before sampling process.
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Other requirements for sampling:

 Disposable gloves
 Official seal
 Sealing wax and thread
 Official paper slips (bearing signature of Designated Officer)
 Official label seal
 Refrigerator (0-40C)
 Freezer (- 18 0C)
 Cool box
 Insulated container (for transportation or holding chilled or frozen samples)
 A camera for recording both the premises and details of the samples taken when appropriate.
 Writing material- pen, markers note pads, log/ record book, formats and other annexures as specified in
the Act.
The list is the general guide for food sampling activities, and it can vary with specific sampling activities.
Sampling and analysis (Section 47 of FSS Act 2006)
Food safety officer
Food Business Operator
FSO must pay FBO at the Signature or thumb impression of

rate sold to public FBO or witness if FBO declines signing
Lifting the
sample
Authorized officer Purchaser can lift
lifts 2 parts sample (2 parts)
FSO will lift 4 samples or divide into 4 parts
NABL Accredited laboratory Two parts will Food Analyst of State

(if FBO demands) remain with DO Food Laboratory
Referral laboratory Analysis and reporting (4 copies)
Appeal Analysis
Food business Designated Officer Referral laboratory

operator FA Report
RFL report
Food safety Officer
Adjudication
FBO appeals
State Government to launch prosecution/penalty if Tribunal Special court
sample is unsafe, substandard or misbranded
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Sampling Guidelines for Microbiological testing

The sampling for different microbiological testing
parameters proposed in the standards is to be ensured
aseptically by Food Safety Officer at manufacturing units
following guidelines given in IS 11546:1999/ ISO 707:1985
(reaffirmed 2010).
 The samples shall be stored and transported
under appropriate temperature conditions and
insulation within 24 hours of sampling to
accredited laboratory for analysis as per the
approved test methods.
 A large sample size may be drawn according to the
tests required and the type of products.
 Preservatives shall not be added to samples
intended for microbiological examination.
 Three sample set shall be taken form full
production batches and each batch shall comprise
of a minimum of five samples of 100 grams each
taken randomly form throughout the batch.
 A set of five samples shall be tested form three
different accredited laboratories and final decision
shall be drawn based on three test results.
 There will be no provision for retesting or
resampling for microbiological testing.
Sample collection for analysis of Pesticide

Residues:
Set of problems that must be considered when submitting a
food sample for pesticide analysis
 For pesticide analysis of fresh produce, agricultural
products, and milk or animal products a selective sample
should collected to substantiate inspection or other
evidence of suspected misuse of a specific pesticide for a
particular crop, grower or growing area.
 Stability of the pesticide must be considered, as
transport and storage could permit the residues to
diminish, giving results which do not reflect conditions at
the time of sampling.
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To Maintain the Integrity of the Sample, Food Authority Regulation timely notify:
 Quantity of sample for analysis
 Testing Microbiological Parameters
 The method of lifting sample
 Type of container
 Temperature to be maintained
 Method of transportation
 Preservatives- Nature and Quantity (not added in sample for microbiological testing/analysis) &
same to be noted on the label affixed to the container.
Do you know how many and how much of sample will be needed?
What is Sample size? (Quantity)

Sample size means the number of items or units, or quantity of material, constituting the sample
drawn from a lot or production. The sample size can be the smallest discrete portion of the whole
lot or production which will have all the characteristics of that food products and should represent
the whole lot or production as adequately as possible. If the sample collected is not representative,
then there will be sample-to-sample variation in results. The reliability of sampling is dependent
more on the sample size than on the population size.
Generally, if each part of a formal sample is about 300 - 500 grams then this should be sufficient for analysis.
The quantity of samples to be lifted and sent for analysis to the food laboratory is specified in Sub-
Section 2.3.1 ( table I) in Food Safety and Standards Regulations (Laboratory and Sample Analysis)
2011.
Foods sold in packaged condition (seal container/ package) shall be sent for analysis in its original
condition without opening the package as far as practicable, to constitute approximate quantity
along with original label. In case of bulk packages wherever preservatives to be added, as per the
requirement, the sample shall be taken after opening sealed container or package and the contents
of the original label shall also be sent along with the sample for analysis. However, such samples
shall not be fit for microbiological analysis.
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Table 1
The FSO must lift the following quantity of samples to be sent to the Food Analyst for analysis:
Article of Food Quantity to be supplied for analysis

Milk 500 ml
Sterilized Milk / UHT Milk 500 ml
Malai / Dahi 200 gms
Yoghurt / Sweetened Dahi 500 gms
Chhana / Paneer / Khoya / Shrikhand 250 gms
Cheese/Cheese spread 200 gms
Evaporated Milk/Condensed Milk 200 gms
Ice-cream/ Softy/ Kulfi/ Ice candy/ Ice lolly 300 gms
Milk Powder/Skimmed Milk Powder 250 gms
Infant Food/Weaning Food 500 gms
Malt Food/Malted Milk Food 300 gms
Butter/Butter Oil/Ghee/Margarine/ Cream/Bakery Shortening 200 gms
Vanaspati, Edible Oils/Fats 400 gms
Carbonated Water 3 litre
Baking Powder 100 gms
Arrow root/Sago 250 gms
Corn flakes/Macaroni Products/Corn Flour/Custard Powder 200 gms
Spices, Condiments and Mixed Masala (Whole) 500 gms
Spices, Condiments and Mixed Masala (Powder) 500 gms
Nutmeg/Mace 250 gms
Asafoetida 100 gms
Compounded Asafoetida 150 gms
Saffron 20 gms
Gur/jaggery, Icing Sugar, Honey, Synthetic Syrup, Bura 250 gms
Cane Sugar/Refined Sugar/Cube Sugar, Dextrose, Misri/Dried 200 gms
Glucose Syrup
Artificial Sweetener 100 gm
Fruit Juice/Fruit Drink/Fruit Squash 1 ltr.
Tomato Sauce/Ketch up/Tomato Paste, jam/ Jelly/ Marmalade/ 300 gms
Tomato Puree/Vegetable Sauce
Non Fruit Jellies 200 gms
Pickles and Chutneys 250 gms
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Oilseeds / Nuts /Dry Fruits 250 gms

Tea/Roasted Coffee/Roasted Chicory 500 gms
Instant Tea/Instant Coffee/Instant Coffee-Chicory Mixture 100 gms
Sugar Confectionery/Chewing Gum/Bubble Gum 200 gms
Chocolates 200 gms
Edible Salt 200 gms
Iodised Salt/Iron Fortified Salt 200 gms
Food Grains and Pulses (Whole and Split) 1 kg
Atta/Maida/Suji/Besan/Other Milled Product/Paushtik Fortified 500 gms
Atta/Maida
Biscuits and Rusks 200 gms
Gelatin 150 gms
Bread/Cakes/Pasties 250 gms
Catechu 150 gms
Vinegar/Synthetic Vinegar 300 gms
Food Colour 25 gms
Food colour preparation (Solid/Liquid) 25 gm. Solid/100 ml liquid
Natural Mineral Water/Packaged Drinking Water 4000ml in three minimum original sealed
packs
Silver Leafs 2 gm
Prepared Food 500 gms
Proprietary Food, (Non Standardised Foods) 500 gms
Canned Foods 6 sealed cans
Food not specified 500 s
The quantity of sample of food packaging material to be sent to the Food Analyst / referral lab
for analysis must be:
Name of food packaging material Approximate quantity/surface area
to be supplied
1. Food packaging material when sample is taken 8 x 1000 x 9 sq.cm. surface area."
from manufacturer.
2. When sample is taken from small consumer Complete packaging material used for
packages. one container.
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What FSO should follow before taking samples

The Food Safety Officer while taking sample of food for analysis, shall also follow the
procedure specified hereunder; -
1. Shall call one or more witnesses at the time of lifting of the samples
2. Obtain the signatures from the witnesses in all the forms and documents prepared
3. Serve the notice in Form V A to the business operator then and there.
4. in case the food business operator discloses that the product has been obtained from the
manufacturer, the distributor or supplier, a notice shall also be given to such manufacturer, distributor or
supplier,
5. In case where the sample is drawn from an open container, the person drawing the sample shall also
draw a sample from a container in original condition of the same article bearing the same declaration, if
such container is available, and intimate the same to the Food Analyst.
6. Where a Food Safety Officer or the purchaser takes a sample of an article of food for analysis, he shall
pay, the cost of such sample, to the person from whom the sample is taken, calculated at the rate at
which the article is sold to the public
Before collecting any sample, the Food Safety Officer/ Authorized

Officer must observe the lot from which the sample is to be
collected and record relevant observations. Information obtained
should include the following as appropriate:
 Name of the food.

 Lot size
 Type of packing
 container size or sizes
 Product code or control number 1.Code number
 Number of consignments 2.Name of the sender with his
official designation and signature
 Labelling information
3.Date and place of collection
 Condition of the lot (broken packages, evidence of rodent 4.Nature of articles being sent for
analysis
or insect infestation, debris)
5. Nature and quantity of
 General condition of the area or building in which the lot preservative, if any, added
is stored.
 If the subsamples for packaged food are drawn from
boxes or crates, the sample units should be marked with
numbers. Corresponding numbers should be written
inconspicuously on the boxes or crates, together with the
FSO/ Authorized officers initials and the date.
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 In case the sample is drawn from an open

If it is not possible to
container, another sample of the same commodity control the temperature of
should also be drawn from a sealed container of milk, preservatives like
the said commodity and also sent to Food Analyst formalin may be added to
and it will be informed to the Food Analyst that this extend shelf life.
particular sample is from a sealed container.
 In case the sample from the open container is

found to be non-conforming and the sample from
the sealed container is found to be conforming the Perishable -Sample storage
retailer is liable to explain this discrepancy. under chilled or frozen
condition as the product
demands. Ice packs can be
 Foods sold in packaged condition (sealed container
used during transportation
or package) can be sent for analysis in its original
and temperature is to be
condition without opening the package, as far as maintained between 4-6⁰C.
practicable, to constitute approximate quantity
along with the original label.
 If it is not possible to maintain the sample in a
condition to render it suitable for analysis the FSO
may add a preservative to it as prescribed from
time to time in the regulations, for the purpose of
maintaining it in a condition suitable for analysis. Non-perishable - Storage of
This should not be done in cases where the sample non-perishables should
is meant for microbiological testing/analysis. maintain the originality of
Whenever any preservative is added to a sample, the sample as is during the
the nature and quantity of the preservative added sampling conditions.
must be specified. Transportation should be
done at temperatures not

more than 40C. Care
 Where food is sold or stocked for sale or for
should be taken to provide
distribution in sealed containers having identical
maximum protection from
label declaration, the contents of one or more of
pilferage.
such containers as may be required to satisfy the
quantity prescribed, will be treated to be a part of
the sample.
The Food Safety Officer may undertake sampling under the following
circumstances:
a. Sampling for surveillance
b. Sampling for analysis and possible launch of prosecution
c. Sampling of possible adulterants
d. Sampling of any food product or books of account or other document for use as evidence
during proceedings.
74
Sampling of possible adulterants

 FSO has been given the powers with respect to search, seizure and sampling for adulterants.
The process for search, seizure, sealing of premises (in limited cases) and sampling of
adulterants is the same as prescribed
 If any adulterant is found in the possession of a manufacturer or distributor of, or dealer in, any
article of food or in any of the premises occupied by him and such FBO is unable to explain why
he is in possession of such adulterant, the FSO can seize such adulterants and take samples of it
for analysis.
 It is also recommended that the FSO record in writing any such decision to seize adulterants
and provide a copy of such written record to the FBO if appropriate
 The FSO must exercise caution and must base his decision on the actual activities of the FBO as
there are instances where a food article could be used as an adulterant in another a food article
but by itself does not constitute an adulterant. For e g – if water is mixed with milk, it will be
considered an adulterant but water by itself is not an adulterant
.
 Apart from this, all other processes, forms, reports etc. with respect to the search, inspection,
seizure and sampling of the adulterants is the same as for any other food article.
75
Sampling of any food product or books of account or other

document for use as evidence during proceedings.
 FSO has been empower to lift samples of any food, substance, books of account or any other
document if he has reasons to believe that such food, substance, books of account or any
other document may be required as evidence in proceedings under the FSS Act or the Rules
or any of the Regulations.
 The FSO may seize them if they have been found in the possession or control of a
manufacturer, distributor or dealer in any food.
 The FSO must be certain that such documents will be of use as evidence for a proceeding
under the FSS Act.
 FSO can also lift extracts of such documents if they will be pertinent to an investigation under
the FSS Act. In any event, it is very important that when the FSO is seizing such documents,
the prior written consent of the DO or the Commissioner be obtained. The seized documents
are then to be kept in the safe custody of FBO.
 The FSO can take copies or extracts from the documents by providing a written
communication to this effect to the FBO. Once the person from whom the documents were
seized receives this communication, he must provide all copies and extract requested
authenticated by the FBO accompanied by an affidavit in Form I.
 In the event the FBO refuses to certify or authenticate the copies or extracts and a prosecution
has been instituted against him under the FSS Act, the FSO must return the documents only
after the court has certified it
 The FSO must then return the seized documents to the FBO from whom it was seized within
a period of 30 (thirty) days from the date of seizure.
 Suring the whole process the FSO must keep the FBO informed of all procedures and
actions to follow. This will help in obtaining the FBO’s co-operation.


76
Role of Food Safety Officer in Adjudication
Entire prosecution process depends Food Safety Officer should have complete clarity
on the sampling and analysis process. about sampling process and must take it in
compliance with the procedures laid down.
Sampling and analysis process must
Any Procedural lapse in the sampling process
be undertaken to determine if there
could lead to deficiencies in the adjudication
has been any contravention of the
process
provisions of the FSS Act
On the directions of Designated Officer in writing,
Food Safety Officer will file adjudication
immediately with the Adjudicating Officer.
The application for filing of adjudication must

carry the following information:
 Name, address and license number of the

Analytical report findings analyzed by
FBO
DO, if Do believes offence has been  Copy of the Food Analyst Report
committed and will decide whether  Copy of the DO’s directions to launch the
the office is to go for adjudication. adjudication
 Details of the alleged offence with
provisions of the FSS Act, Rules or
Regulations contravened.
Liability of Food Safety Officers in Certain Cases (Section 39 of FSS Act2006)))
Penalties can be imposed against a Food Safety Officer if

 FSO vexatiously and without any reasonable ground seizes any article of food or
adulterant.
 FSO commits any other act to the injury of any person without having reason to believe
that such act is necessary for the execution of his duty.
 In such cases, the FSO will be guilty of an offence and will be liable to a penalty which
may extend to INR 1,00,000.
 Provided, if it is found that complaint against the FSO is False, the complainant will be
guilty of an offence and will be punishable with a fine of INR 50,000 to INR 1,00,000.
The actions of the FSO will have a direct impact on the level of safe and wholesome food that
reaches the end consumer and the liability that may be attached to FBOs for committing any
offense or non-compliance under the FSS Act.
77
Major Sources of errors in sampling

Source examples precautions
Food sample identification Poor labelling of sample Maintenance of documentation
throughout sampling and
analytical process
Nature of Sample Samples do not conform to Explicit instructions/ sampling
the defined sampling protocol, training of Food Safety
protocol and is not the Officers
representative sample
Transport and handling Sampling contaminated , Protocol specifies condition to

degraded or depleted during be maintained , supervision
transport , loss of sample
Analytical sample preparation Incorrect mixing or Proper supervision in laboratory

homogenization , laboratory quality assurance
Analytical sample storage Incorrect storage of sample Proper laboratory techniques

and supervision
78
PACKING AND SEALING THE SAMPLES
In order to maintain the integrity, packages containing

exhibits should be secured or sealed to prove their
authenticity i.e., is to ensure that they have not been
tampered or changed from the time the sample left the
FSO/ Authorized Officer’s hands until they were 1 2 3 4
received at the laboratory. 2 3 4
 The stopper shall first be securely fastened so 2 3
as to prevent leakage of the contents in transit. 2 3
3
 The bottle, jar or other container shall then be 3
completely wrapped in fairly strong thick 3
paper. The ends of the paper shall then be 3
neatly folded in and affixed by means of gum or 3
3 1
other adhesive.
3 SAMPLE
3
A paper slip (NOT required in case an
 A paper slip of the size that goes around
Authorized Officer draws the
completely form the bottom to top of the
container, bearing the signature of the sample) affixed from the bottom to
designated officer and code number of the top of the container, bearing:
sample, shall be pasted on the wrapper, the
 Signature of the DO/officer
signature or thumb impression of the person
authorized by Food Safety
from whom the sample has been taken, shall
be affixed in such a manner that the paper slip commissioner.
and the wrapper both carry a part of this  Code number of the sample.
signature or the thumb impression.  The signature/thumb
impression of the person
 The paper cover shall be further secured by from where the sample is
means of strong twine or thread both above
procured.
and across the bottle, or container and the
 The signature/thumb
twine or thread shall then be fastened on the
paper cover by means of sealing wax on which impression of one or more
there shall be distinct and clear impression of witnesses (if required).
the seal of the sender, of which one shall be at
An additional sheet/s of paper can
the top of the packet, one at the bottom and
be affixed so as to cover the
the other two on the body of the packet. The
knot of the twine or thread shall be covered by container completely, duly signed by
means of sealing wax bearing the impression FSO for purpose of identification.
of the seal of the sender (FSO/ Authorized
Complete sample to be wrapped in
Officer).
fairly strong thick paper.
 The outer covering of the packet shall also be
marked with code number of the sample. Use of Twine or Thread on bottle
(above and across).
 The outer covering of the packet shall also be 79

marked with code number of the sample.
Dispatch of Sample
After packaging and sealing of the sample it has to be dispatched to an authorized laboratory for
analysis. The sample must be handled and packaged in such a manner that subsequent handling
will not change the identity or cast doubt on its integrity.
 All samples packaged for dispatch must be secured with shock absorbing material to protect
them from damage en route.
 Samples of frozen food may be packed in insulated cartons containing dry ice that will last
for the length of time.
 When frozen, perishable or dangerous items are sent, the receiving laboratory should be
notified of the dispatch either telephonically or by email, with all the information pertinent
to the sample product. This is important for the laboratory to perform analysis at the
earliest.
Documentation at the time of sampling
Seizure of articles of food by Food Safety Officer

 Seizure Memo (receipt) in Form II (Rule 2.3.1 of FSS Rules 2011), for every article of food seized
by the Food Safety Officer and the matters connected therewith (as per 2.3 of food Safety &
Standards Rules 2011).
 Form of order/ bond (Rule 2.3.2 FSS Rules 2011). He shall after affixing the seal, on the article of
food make an order in Form III to the food business Operator not to dispose of the stock and
may require the FBO to execute a surety bond in Form IV
 Issue Notice in writing in form V A, to the food business operator whose name, address and
other particulars have been disclosed, of his intention to have the sample analyzed.
Documents to be dispatched with the sample:

 Memorandum to Food analyst (Form VI) with one part of the sample shall be sent in a
sealed packet to the food analyst.
 Memorandum to Designated Officer (Form VI) two copies to be sent to the designated
officer by any suitable means along with second and third part of the sample.
 Memorandum to accredited laboratory (Form VI) a copy shall be sent to an accredited
laboratory along with the fee prescribed by the Authority, if so requested by the food
business operator under intimation of the designated officer
80
ANALYSIS OF FOOD SAMPLES BY FOOD ANALYST
Sample delivered at the Authorized laboratory
Food Analyst Checks Condition of the Seal
Seal broken / unfit sample Seal intact
Sample to be analysed
Within 7 days from
within 14 days from its
the date of receipt
Receipt (if fails, Food
Inform Designated Officer Analyst to inform the DO
Sample Analysis Report (As per

Form VII A)
Request DO to  Result.
send the Second  Method of analysis
part of the
 Signatures of Food
sample for
Analyst
analysis.
Four copies of the

The manuals of the method of analysis, as analysis report
amended / adopted by the Authority from
time to time, shall be used for analyzing the
samples of food articles. The Manuals of analysis analysis analysis analysis
methods of Analysis of food as issued by the report
report report report
Director General of Health services, Ministry
of Health & Family Welfare, government of 1 2 3 4
India, New Delhi has been adopted.
Authority has developed a Manual on
General Guidelines on Sampling.
Designated Officer Food Safety Officer FBO
81
Action by Designated Officer on the report (Rule 2.4.3 of FSS Rules 2011)
Designated Officer shall keep the two copies of the Analysis Report for
further action
If Designated Officer finds the report delivered by the Food Analyst is

erroneous (to be recorded in writing)
Shall forward one part of the sample, have kept by

Sample
him to referral laboratory
part (2)
If analysis report indicates food as unsafe /sub-standard /

2nd and third part of
Misbranded /containing extraneous matter, the provisions of
the Sample with DO
Rule 3.1 (adjudication proceedings) shall, apply.
FOOD BUSINESS OPERATOR’S RIGHT TO HAVE THE FOOD ANALYSED
FBO in writing, can request FSO for sending the fourth part of
sample for analysis to any NABL accredited / FSSAI notified
laboratory
Sample send to NABL accredited/ FSSAI notified laboratory (which

should be within the state or the neighbouring state wherever available
Food Business Operator to borne the Cost of testing by the accredited

laboratory where the FSO will send the sample
Food Analyst sends four copies of the analysis report to the DO (Form VII A) indicating the
method of analysis
Analysis should complete within fourteen days from the date of the receipt of the sample
82
WILL
FOCUS
ON
PURPOSE NATURE EQUIPMENTS & DOCUMENTS
MANPOWER
Inspection for pre-informed Sampling Copies of the documents submitted by
Licensing equipments, the FBO with application, Form VI [ in
camera,other logistic case of sampling] Checklist for Inspection
Routine surprise Sampling Checklist for Inspection

Inspection Equipments, Improvement Notice
Camera,other Form VA [Notice in writing]
logistic, Form I [Seizure of Books of
Witness, Police, accounts & other documetns]
Team for assistants, Form II & III [Seizure Memo &
Vehicle Order of Seizure]
Form IV [Bond]
Form VI[Memorandum]
Inspection for pre-informed Same As Routine Apart from above Forms, Copies of the
Renewal/modi or surprise * Inspection Documents submitted for renewal
fication need based /any modification in the Unit
Inspection surprise Same As Rotine Same As in Routine Inspection
against Inspection
Complaint
83
WILL SEE
NOT
FAULT
PROCESS PRODUCT ENVIRONMENT
VISUAL INSPECTION & VISUAL VISUAL INSPECTION Location

RECORD CHECKING INSPECTION OF Premises or infrastructure
Procurement of raw Facilities (air, light, ventilation,
PRODUCT toilets, lab etc.)
material, food additives &
(packaged, unpacked, Equipment
ingredients, storage of
prepared food, raw Pest Management
raw materials & food,
time & temp control, material used in Drainage & Disposal
food packaging, food preparation of food Personal Hygiene
distribution/service product etc Waste Disposal System
Management & whichever is RECORDS CHECKING
supervision, food testing applicable) For pest control, cleaning,
facilities for sanitation, health status of
manufacturing unit SAMPLING & employees, registration or
Related records SENDING TO LAB licensing
84
WILL
DO
• Suggestion/ Direction in writing

• Counselling to FBO
• Capacity Building of FBO

• Follow up Inspection
Recommend to DO to issue
Improvement Notice
• Prosecution
85
FORM III
FORM OF ORDER OF SEIZURE
[Refer Rule 2.3.2.(1)]
To
(Name and address of the Food Business Operator)
………………………………….
………………………………….
………………………………….
Whereas below mentioned articles of food…. intended for sale which is in your possession
appears to me to be adulterated/misbranded under in violation of section—————————
———————of FSS Act:
Sl.No. Name of the products Batch No. No of units Qty in kgs .

1.
2.
3.
4.
5.
Now therefore under clause (c) of sub-section (1) of section 38 of the Food Safety and
Standards Act, 2006 (34 of 2006), I hereby direct you to keep in your safe custody the said
sealed stock subject to such orders as may be issued subsequently in relation thereto.
Food Safety Officer
Area……....................……
Place:
Date:
86
Refer Rule 2.3.2. (2)]

FORM OF SURETY BOND
Know all men by these present that we (i) ………………. son of ……………resident of …….and (ii) …… son of
………. resident of ……………. proprietors/partners/employees of Messrs ………. hereinafter called the Food
Business Operator (s) and (iii)…………..son of ………..resident of …….and (iv) ………son of ……….resident
of………….hereinafter called the surety/sureties are held and firmly borne up to the President of
India/Governor of………hereinafter called the government in the sum of …………..rupees to be paid to the
government, for which payment will and truly be made.
We firmly bind ourselves jointly and severally by these presents.
Signed this …………day of ………………. whereas Shri……………Food Safety Officer has seized………. (here, insert
the description of materials together with number/quantity and total price hereinafter referred to as the
said article) from ………..(specify the place);
Whereas on the request of the Food Business Operator(s) the government has agreed to keep the said article
in the safe custody of the Food Business Operator(s) executing a bond in the terms hereinafter contained and
supported by surety/two sureties which the Food Business Operator(s) has/have agreed to do. Now the
condition of the above written obligation is such that if in the event of the Food Business Operator(s) failure
to produce intact the said article before such court or Authority and on such dates(s) as may be specified by
the said Food Safety Officer from time to time the Food Business Operator(s) and /or the surety/sureties
forthwith pay to the government on demand and without a demur sum of ………rupees and there after the
said bond will be void and of no effect. Otherwise the same shall be and remain in full force and virtue.
These presents further witness as follows:
(i) The liability of the surety/sureties hereunder shall not be impaired or discharged by reason of time being
granted
by or any forbearance, act or omission of the government whether with or without the knowledge or consent
of the sureties or either of them in respect of or in relation to all or any of the obligations or conditions to be
performed or discharged by the Food Business Operator(s). Nor shall it be necessary for the government to
sue the Food Business Operator(s) before suing the sureties or either of them for the amount due, hereunder.
(ii) This Bond is given under the Food Safety and Standards Act,2006 for the performance of an Act in which
the public are interested.
(iii) The government shall bear the stamp duty payable on these presents.
In witness whereof these presents have been signed by the Food Business Operator(s) and the
surety/sureties the day
hereinabove mentioned and by Shri……………on behalf of the President of India on the date appearing below
against his signature.
Witnesses:
1.……………………. (Signature)
(Name and address) …………………..
2……………………. (Signature)
(Name and address) …………………..
Signature………………… (Food Business Operator)………
Signature………………… (Food Business Operator)………
Signature………………….. (Surety)………
Signature………………….. (Surety)………
for and on behalf of the President of India / governor of state of.
Signature………………………...
( Designation)………
87
DETENTION/SEIZURE MEMO
In exercise of the power delegated to me under section 38 of the FSS Act, I ---------------------
------- hereby seize/detain the under mentioned food products/documents which
contravene the provision of section------------------------------------ of this Act at the premises
of M/S----------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------
Sl.No. Name of the products Batch No. No of units Qty in kgs .
1.
2.
3.
4.
5.
-------------------------------------------------------------------------------------------------------------------------
----- The detention/seizure has been made and the inventory has been prepared in
presence of the following witness.
Name and address of the witness signature.
1.
2.
The products detained have been duly sealed and are left in the custody of Shri. --------------
-----------------------------------------------------------------------------------------------------------with the
instruction not to temper with the seals and not to dispose of the products till further
order.
Signature of Manufacturer/dealer Signature of Food Safety

Officer
Name-----------------------------------
-
Place----------------------------
Date: -----------------------------------
88
FORM V A
FORM OF NOTICE to the Food Business Operator
(Refer Rule 2.4.1. (3))
To
………………..
……………….
Dear Sir/s/ Madam:
I have this day taken the samples of food from premises/shop/market of ……………….situated at
……………..as
specified below to have the same analysed by the Food Analyst for _______.
Details of food:
Code number:
Parameter to be tested:
1. As per the FSSAI Standards for the specific products

2. Any additional test to be performed if any
Place: (Sd/-) Food Safety

Date: Officer/Authorized Officer.
Address:
Acknowledgement:
Sign of Food Business Operator
Witnesses
Witnesses
89
FORM VI
MEMORANDUM TO FOOD ANALYST
[Refer Rule 2.4.1.10]
From:
……………..
…………….. Date: _____
To
Food Analyst
………………
……………..
MEMORANDUM
(Refer Rule 2.4.1(11))
1. The sample described below is sent herewith for analysis under ___ of ___ of section ____ of Food
Safety and
Standards Act, 2006
(i) Code Number

(ii) Date and place of collection
(iii) Name/Nature of articles submitted for analysis
(iv) Name/Nature and quantity of preservative, if any, added to the sample.
2. A copy of this memo and specimen impression of the seal used to seal the packet of sample are being
sent separately by post/courier/hand delivery (strike out whichever is not applicable)
(Sd/) Food Safety Officer

Address:
90
ADMINISTRATION
91
6.1 Licensing & Registration of Food Business
Under the Section 31 of Food Safety and Standards Act 2006 and (Licensing/ Registration of Food Businesses is
mandatory, and food safety and standards (Licensing/ Registration of Food Businesses) Regulation 2011 lays
down Licensing and Registration conditions which are compulsory for any food business. All Food Business
Operators in the country will be registered or licensed in accordance with the procedures laid down in the Act
and regulation made thereunder. As mandated by the Act, distinction has been introduced between
“Registration” and “Licensing” as per the annual turnover and the capacity of production. Some food sectors
have been put under the central licensing (Schedule 1)
Authorities responsible for Licensing & Registration of Food

Business
Central Licensing
Authority
State Licensing
Authority
Registration Authority
Food safety Officer or Designated Officer Designated Officer

Appointed under appointed by the Chief
Any Official in Section 36 (1) of FSS Act
Executive Officer of the
Panchayat, Municipal by the Food Safety
Food Authority of India
Corporations or any Commissioner of the in his capacity as Food
other local body or state or UT for the
Safety Commissioner.
panchayat Area purpose of Licensing
and Monitoring
notified by the State
Food Commissioner for
the purpose of
Registration
92
FLRS (Food Licensing / Registration system)

Food Licensing & Registration System (FLRS) has been developed under the guidelines laid down under Food
Safety and Standards (Licensing & Registration of Food Businesses) Regulation, 2011. FLRS is a web based system
to facilitate Food Business Operators across the country to apply for License/Registration Certificate online and
track their application status through the various stages of processing. FLRS is being used by FSSAI Regional and
Sub-Regional Offices and all State Governments to process applications online. FLRS system (Food Licensing /
Registration system) allows the FBOs to check their premises eligibility according to the location or the activity
being conducted on that premise and it sends automatic alerts on email or SMS to the FBOs at different intervals
to facilitate faster processing of applications and allowing the FBOs to maintain continuity of their license/
registration certificate.
Registration of Food Business Operator under FSS Act 2006
Registration is meant for petty food manufacturers. Petty food Businesses are defined under the
food safety and standards Regulation as any Food Business Operator who:
 Food Business Operator who manufactures or sells any article of food himself or a petty
retailer, hawker, itinerant vendor or temporary stall holder.
 Some other Food Businesses including small scale or cottage or such other industries
relating to food business or tiny food businesses with an annual turnover not exceeding Rs
12 lakhs and / or whose:
 Production capacity of food (other than milk or milk products and meat
and meat products) does not exceed 100kg/lbs per day or
 Production or procurement or collection of milk is up to 500 litres of milk
per day or
 Slaughtering capacity is two large animals or ten small animals or 50
poultry birds per day or less.
Based on above definition even a temple that distributes Prasad or food must be registered as a
petty FBO. This provision is indicative of the very wide regulatory scope of the FSS Act.
93
6.2 Procedure for Registration of Food Businesses
Filing of Application
Application
Form A
fee Rs 100/-
Processing of Application
Either grant or Reject

Within 7 days
Registration certificate, issue
of receipt of
notice for inspection
Application
If no response
After the inspection grant the Within a period

Registration of 30 days
Food Business’ Operator may

start business
Mode and Days of  Demand draft

Payment  Online transfer
 Within 15 days of submission of
online Application
94
Role of Food Safety Officer in Registration
1. The Food Safety Officer is an appropriate registering authority for petty Food Businesses.
2. Every petty FBO applying for registration must submit an application in Form A (format in Annexure 2)
together with the INR 100 as the fees. The petty FBO is also expected to submit a self-attestation (in
prescribed format) stating that he is complying with the prescribed hygiene and safety requirements.
3. The FSO must scrutinize the Form A, ensure it is completed and all the information is written in a legible
manner. The FSO must ensure all the required documents (ID proof etc.) have been provided, the self-
attestation is in order and that the complete fee has been submitted. In case any information is missing on
the Form A or the petty FBO is unable to obtain certain information, the FSO must guide the petty FBO to
ensure that all the formalities are completed.
4. After ensuring that the application is complete in all respects, the FSO must make a decision to either grant
the registration or reject it within 7 days of the receipt of an application. If the FSO cannot make a decision,
he may inspect the premises before deciding. In any event, whatever decisions are taken, they must be
recorded in writing and the FSO must provide detailed reasons for the decision taken.
5. If the application is to be rejected, the applicant should be given an opportunity of being heard and the
reasons for rejecting the application should be recorded in writing. This has several purposes. For e.g – let’s
assume an application of a petty FBO was rejected because his location was close to an open sewer and he
refused to relocate to a cleaner location. By creating a written record, future FSOs will have a ready
reference if the same petty FBO applies again. The FSOs will be able to carry out a more informed risk
assessment before grating registration.
6. If the FSO orders an inspection, he must ensure that the hygiene and safety conditions that the petty FBO is
supposed to comply with are being followed (please see Annexure 4 for the conditions to be followed by the
petty FBO). The FSO should also use this opportunity to increase awareness and proper hygiene habits
amongst the petty FBOs. If the FSO sees any inconsistencies in the hygiene and safety requirements, then
he can caution the petty FBO and provide an opportunity for rectification instead of immediately rejecting
the application for registration.
7. After this process, once the FSO is satisfied that the safety and hygiene requirements are met he must grant
the registration within 30 days. This 30-day time period has been prescribed by law and should not be
deviated from. In the rare event that the FSO is unable to meet this timeline, he must inform the DO
immediately and must record reasons in writing for any such delay.
8. If registration is not granted, or denied, or inspection not ordered within 7 days or no decision is
communicated within 30 days after inspection, the petty FBO may start his food business, provided that it
will be the responsibility of the FBO to comply with any improvement suggested by the FSO in the future.
95
9. After granting registration, the FSO must also issue a photo ID card which the petty FBO will have to
display in a prominent place on his premises. For eg – if the petty FBO is a food street vendor, he must
display his license on the cart or stall from which he sells his food.
10. Food safety inspection of registered establishments must be carried out at least once in a year. The
only exception is for a producer of milk who is a registered member of a dairy Cooperative Society and
supplies or sells the entire milk to the Society. The discussion on inspections will follow in the later
sections.
6.3 Understanding Registration Process through FLRS
Food Safety Officer has to understand the process

of flow of Food Licensing and registration from the
initiation of an application scrutiny to submission
of inspection process in FLRS (Food Licensing &
registration System)
To access the system they have to use the link
https://foodlicensing.fssai.gov.in using any
standard browser and will be able to login to the
system with the user name and password.
Food Safety Officer / Inspecting Officer Login to FLRS
96
Food Licensing & Registration System (FLRS)
Application Process by the FBO

Start
Meeting Eligibility
NO Meeting Eligibility NO
Criteria for
criteria for Central Eligible for state license
Registration
License
YES 1. FILL APPLICATION

2. UPLOAD SUBMIT SUPPORTING
DOCUMENTS
3. SUBMIT FEE
Generates Reference No
and send notification to
FBO via Mail and SMS FBO submit physical Documents verification to
Documents be done
YES
No Yes
A Inspection to be done
No
Generate License/ Registration

Certificate
B
Send Notification to FBO via mail or SMS
97
Food Licensing & Registration System FLRS)

Role of Food Safety Officer
Document verification
B FBO submit missing / required

Documents for licensing & registration
Documents cleared Send back to FBO for clarification
Inspection to
be done
The application as forwarded by CLA for document scrutiny would be listed for further processing in
document securitization bin under the heading processing.
15 days’ time limit is given to FSO to scrutinize the application and the documents
98
 Once the FSO clicks on processing, all the applications that are available for document
scrutinization would be displayed
 To process the application further for document scrutiny FSO will click on ‘Proceed’ for further
action
Completed Document Scrutiny

 FSO can View the application for which document scrutinization has been completed
FSO can also view Non form C Modification application for which scrutiny has been completed and can
accept or reject the modification
99
Food Licensing & Registration System( FLRS)

Role of Food Safety Officer
INSPECTION
FBO submit
DO will Assign Compliance Report
Food Safety within the time line
Officer
Inspection date YES Send back to FBO for

Food Safety Officer Submits
accepted by clarification
inspection report
Food Safety Officer
Inspection Report is OK No
Send inspection
notification to YES
FBO and
inspection team
Forward the inspection report DO Issue the
to Designated Officer License
Inspection process:
The applications that are forwarded for inspection by the Licensing Authority would be available to Food
Safety Officer in the Bin of “Acknowledge for inspection” under the head of inspection.
Once the FSO clicks on the link all the applications available for inspection would be displayed. The page
would also display the pre-inspection available applications and post inspection applications as well.
Submit inspection report: the inspection applications for which acknowledgement has been done by the
FSO would be displayed in “submit inspection report” bin under the head of inspection. The FSO will
submit the inspection report of the concerned application
Forward inspection report to Designated Officer: if found in order
Send back to FBO: if not found in order inspection report will be send back to FBO for clarification
100
Inspection Process
 Acknowledge for Inspection The applications that are forwarded for inspection by licensing Authority
would be available for FSO in the bin ‘Acknowledge for Inspection’ under the head Inspection as shown
in the fig below: -
 Once the FSO clicks on the link all the application available for Inspection would be displayed. The page
would display the pre-inspection available applications and if FSO has to check the applications for post
license inspection can select the option post license inspection available in the drop down menu of
Inspection type as shown in the fig below: -
Submit Inspection Report

 The inspection applications for which acknowledgement has been done by the FSO would be displayed in
“submit inspection report” bin under the head of inspection. The FSO will submit the inspection report of
the concerned application as shown in figure below:
If found in order, FSO will then forward the inspection report to Designated Officer (DO) for further action or
can send back to FBO for Clarification.
101
6.4 Licensing
Licensing of Food Businesses
Under Food Safety & Standards
Act 2006
(Section 31)
Licenses to be granted by Central Licensing Authority (Schedule 1)
 Diary units including milk chilling units equipped to handle or process more than 50 thousand
liters’ milk/day or 2500 MT of milk solid per annum.
 Vegetable oil processing units and units producing vegetable oil by the process of solvent
extraction and refineries including oil expeller unit having installed capacity more than 2 MT
per day.
 All slaughter houses equipped to slaughter more than 50 large animals or 150 or more small
animals including sheep and goats or 1000 or more poultry birds per day.
 Meat processing units equipped to handle or process more than 500 kg of meat per day or
150 MT per annum.
 All food processing units other than mentioned under (I) to (IV) including relabellers and
repackers having installed capacity more than 2 MT/day except grains, cereals and pulses
milling units.
 100 % Export Oriented Units.
 All Importers importing food items including food ingredients and additives for commercial
use.
 All food business operators manufacturing any article of food containing ingredients or
substances or using technologies or processes or combination thereof whose safety has not
been established through these regulations or which do not have a history of safe use or
food containing ingredients which are being introduced for the first time into the country.
 Food Business Operator operating in two or more states.
 Food catering services in establishments and units under Central Government Agencies like
Railways, Air and airport, Seaport, Defence etc.
Licenses to be granted by State Licensing Authority

License for commencing or carrying on food business, which are not covered under
Schedule 1, shall be granted by the concerned state Licensing Authority.
102
N o i m p r o v e m e
Procedure for grant of License to Food Business

n t
Filling of Application
Application
FORM B
Documents and Fee
Unique (ID) application Number
Require additional information on

incompletes application
Improvement
notice
No Improvement
Inspection of premises after
NO INSPECTION FBO may
receiving completed application &
start the
issue inspection report Suspension
business
after 60
days
No improvement
Cancelation
Either grant or reject the license
within 60days of receipt of
completed application or within 30
days of inspection FRESH
APPLICATION
AFTER 90 DAYS
103
Role of Food Safety Officer in Licensing Process
For other FBOs applying to the DO for a license, the process is a little more complex though the role of the
FSO is equally important in this case as well.
1. The FSO has the responsibility of carrying out the inspection of the FBO’s premises. This inspection
is of the sanitary and hygiene conditions. The FBO has to demonstrate compliance with these
conditions before the DO grants a license to the FBO.
2. The FSO should announce his intention to come for inspection to the FBO giving him adequate
notice, for e.g. – a FSO may inform a FBO seven days in advance of his inspection visit. The idea
here is to ensure that the FBO is as prepared as possible for the inspection thus making the
inspection more fruitful. Once at the premises, the FSO should take detailed notes and ensure
that all sanitary and hygiene conditions to be complied with are followed to the maximum extent
possible.
3. The FSO should develop a template or checklist of sanitary and hygiene conditions to be checked
during such inspections. This will help ensure that the inspection is objective and systematic. The
FSO should immediately record any additional observations made by him during the inspection. If
possible, the FSO should take the FBO’s signature on the checklist for inspection to ensure that
the FBO is also aware of the FSO’s inspection findings. Preparing these records in such a manner
will help with future risk assessment and will also help the FSO provide correct and relevant
guidance to each FBO during the licensing process.
4. Once the inspection is complete, the FSO must issue a notice to the FBO pointing out the lack of
compliance with the sanitary and hygiene conditions, wherever such deficiencies exist. In fact, the
checklist developed by the FSO will help identify the gaps in compliance, making it easier for the
FSO to issue the notice to the FBO.
5. The FSO may also counsel the FBO with the kinds of measures to be undertaken to ensure general
hygiene and safety and the expectation of the regulator in terms of on-going compliance. This will
be invaluable advice to the FBO and can ensure the FBO’s co-operation in the future.
104
IMPROVEMENT NOTICE (Section 32) of FSS Act 2006

The Act provided power to Designated Officer to issue improvement notice towards corrective
action if he has reasonable ground to believe that the FBO has failed to comply with the
regulation. Usually before the issuance or grant of license or grant of registration, the Licensing
Authority is required to inspect the unit or the establishment to check the compliance of the
applicable conditions if not satisfied, an Improvement Notice may be issued in accordance to
section 32 of the Act.
Role of Food Safety Officer in issuance of Improvement Notice
Food Safety officer after inspection can recommend designated officer to issue improvement
notices to the Food Business Operators whenever necessary.
Suspension or cancelation
Suspension or cancellation of license may happen only after the Improvement Notice has not
been complied with by the FBO. After issuance of the Improvement Notice, during inspection, if
it is proved that the FBO has not taken the corrective action as expected form him, his License /
registration may be suspended till the time he corrects the condition
Role of Food Safety Officer in suspension or cancellation of License / Registration
FSO can recommend to the designated officer giving specific grounds, suitable action in regard
to licenses issued to any Food Business Operator, if on Inspection the Food Safety Officer finds
that the Food Business Operator has violated the conditions for grant of license.
Appeal
A Food Business Operator aggrieved by the order of the Registrating or Licensing Authority may
appeal to the concerned Designated Officer or Food Safety Officer as per the regulation laid
down in the Section 31(8) & 32 (4) (5) of the Act.
Section 31(8) provides for Appeal against the order of Registration of grant of License /
Registration before the commissioner of Food Safety.
Section32(4) deals with appeal before the Food Safety commissioner against an Improvement
Notice served on the FBO or refusal to issue a certificate as to improvement or cancellation or
suspension or revocation of license.
Section 32(5) sets the time limit for appeal within 15 days of receiving the order. In case the
order is issued by the Designated Officer for many noncompliance or failure by the FBO then
the time frame is set out a mentioned in that order (if Any) or 15 days, whichever is earlier.
105
Modification after grant of License/ Registration

All FBOs have to intimate the Authority well in advance of their plan on any addition, extension/modification
within the business establishment including change in product category, layout, closure or any other
information based on the license /registration granted to them. Improvement Notices are served on account
of the belief with satisfactory proof by designated Officer that the FBO has failed to comply with any of the
regulations and/or conditions under FSS Act.
Prohibition Orders
If any food business operator is convicted of an offence under this Act; and the court by or before which he is
so convicted is satisfied that the health risk exists with respect to that food business, the court, after giving
the food business operator an opportunity of being heard, may by an order, impose the following prohibitions,
namely: -
 a prohibition on the use of the process or treatment for the purposes of the food business;
 a prohibition on the use of the premises or equipment for the purposes of the food business or any
other food business of the same class or description;
 a prohibition on the use of the premises or equipment for the purposes of any food business.
The court may, on being satisfied that it is necessary so to do, by an order, impose a prohibition on the food
business operator participating in the management of any food business, or any food business of a class or
description specified in the order. As soon as practicable after the making of an orders the concerned Food
Safety Officer shall serve
1. a copy of the order on the food business operator; and

2. in the case of an order under sub-section (1), affix a copy of the order at a conspicuous place on such
premises used for the purposes of the food business, and any person who knowingly contravenes such
an order shall be guilty of an offence and be punishable with a fine which may extend to three lakh
rupees.
A prohibition order shall cease to have effect upon the court being satisfied, on an application made by the
food business operator not less than six months after the prohibition order has been passed, that the food
business operator has taken sufficient measures justifying the lifting of the prohibition order.
The court shall give a direction on an application by the food business operator, if the court thinks it proper
so to do having regard to all the circumstances of the case, including in particular, the conduct of the food
business operator since the making of the order; but no such application shall be entertained if it is not made
–
(a) within six months after the making of the prohibition order; or
(b) within three months after the making by the food business operator of a previous application for such a
direction.
106
Emergency Prohibition Notice and Order
1. A Designated Officer has the power to recommend the Commissioner for the issue of emergency prohibition
notices. An emergency prohibition notice can be issued if the DO is satisfied that a health risk condition exists
with respect to any food business. The DO then makes a recommendation to the Commissioner to issue such
a notice. The commissioner of Food safety after being satisfied will impose Prohibition by order.
2. The day before the DO intends to make a recommendation to the Commissioner to issue an emergency
prohibition notice, he has to serve a notice on the food business in question stating his intention to make a
recommendation to the Commissioner Once the emergency prohibition order has been issued, it is the DO’s
responsibility, with the help of the Food Safety Officer , to serve a copy of the order on the FBO’s business or
affix a copy of the order at a conspicuous place on such premises used for the purposes of that business.
3. Once the FBO has taken corrective action, he may apply to the DO for a certificate stating that the health risk
has receded. If the DO is satisfied that the FBO has taken sufficient measures such that the health risk has
receded, he may issue a certificate to that effect.
4. This certificate must be issued within 7 days of an application by the FBO. Once the certificate is issued, the
emergency prohibition notice will cease. However, if the DO is not satisfied and does not issue such a
certificate, he must inform the FBO within a period of 10 days of receipt of application indicating reasons for
such decision.
107
General Principles for Food Safety Officers
1. The FSO has an important role to play, as they can be a counselor for FBOs in their effort to
comply with the provisions of the FSS Act. For eg – if the FSO, on inspection identifies any
contraventions by any FBO, then he can issue a caution stating the regulation to be followed
for the contraventions and can also counsel the FBOs for various preventive and corrective
actions to be taken for that contraventions. This is especially true for Petty FBOs who may not
be aware of the compliances required under the FSS Act.
2. The FSO must stay up to date with all the regulations, amendments, advisories etc that are
issued and notified under the FSS Act. This is a technical legislation and compliance under this
legislation involves scientific technical processes. The Act mandates scientific risk based
analysis. To ensure the best in class vigilance, the FSO should stay up to date with all such
relevant developments. The FSO should also stay in touch with allied legislations such as the
BIS Act, the Legal Metrology Act and other laws affecting safety of food such as environmental
laws and municipal sewage and water mechanisms. In this regard, the FSO may turn to the DO
and the Commissioner whenever he feels training may be beneficial or if any clarifications are
required.
3. It would be very beneficial to the FSO if he has a background in or at least some exposure to
food science and technology and in public health. This is because food processing and
manufacturing has become a highly specialized, technology intensive sector involving complex
physiological disciplines. There are also innumerable interactions between food components
and with multiple external factors that may have an effect on the quality and safety of food.
These factors may be microbiological, chemical, physical or sensory. Thus a technical
background will help the FSO understand the legislation and implement it better for the
ultimate benefit of the consumers.
108
4. It is also important for a FSO to have a thorough understanding of prerequisite programmes

requires prior knowledge of the properties of various types of cleaning and sanitizing
compounds, and their interactions with food matter, with each other and with other materials,
particularly those materials that equipment is made of (e.g. chlorine and steel).
5. The FSO should have a thorough knowledge about the Hazard Analysis and Critical Control
Point HACCP as its elements are useful for risk based inspections. Ideally, the FSO should have
taken courses and been certified in the application of HACCP.
6. The FSO should be well equipped to undertake risk analysis and risk communication. There
should be periodic studying of general risks that affect a category of food or food business. For
eg – by maintaining records of inspections etc, the FSO will be able to judge what the greatest
risks affecting a particular area or a particular food business are. This will help him understand
what his inspections should focus on and what areas FBOs may require guidance for.
7. The FSO should have good knowledge of testing techniques so that he/she can make informed
decisions about sampling methods and properly interpret the results of testing.
8. The FSO must possess good communication skills to enable him/her to adequately convey
technical and regulatory information regarding safe food handling to others. In addition, the
FSO must have professionalism and confidence.
109
6.5 Reports& Annexures
Relevant documents for Licensing / Registration?
Annexure 1: To access the general hygienic and sanitary practices, please visit the Food Safety and
Standards Authority of India website at http://www.fssai.gov.in/default.aspx
Annexure 2: FORM A (Application form for licensing)
Annexure 3: Self-Declaration for Registration and for Licensing
Annexure 4: General Hygienic and sanitary practices to be followed by petty FBOs when applying for
registration
Annexure 5: Format for Medical Examination (Performa for medical fitness certificate for food handlers)
Annexure 6: Improvement Notice

Annexure 7: Suggested Format for notice to FBO when food is to be destroyed [Refer Section 38 sub-
section 4 of the Food Safety and Standards Act 2006
110
Annexure 2
Form ‘A’
Application for Registration / Renewal of Registration under Food Safety and Standards Act,
2006
Kind of business:
Permanent/Temporary Stall holder

Hawker (Itinerant / Mobile food vendor))
Photograph of the Home based canteens/dabba wallas
Applicant
Petty Retailer of snacks/tea shops
Manufacturer/Processor
Re Packer
Food stalls/arrangements in Religious gatherings, fairs etc
Milk producers (who are not member of dairy co-operative
society)/ milk vendor
Dhaba
Fish/meat/poultry shop/seller
Other(s), please specify: ________
(a) Name of the Applicant/Company:

________________________________________________________
(b) Designation
Individual
Partner
Proprietor
Secretary of dairy co-operative society.
Others (Please specify)
(c) Proof of Identity of applicant:

_____________________________________________________________
[Note: Please submit a copy of photo ID like Driving License, Passport, Ration Card or
Election ID card]
(d) Correspondence address: ____________________________

Tel No:____________Mobile No.:____________
Fax No.:___________Email:________________________
111
[Note: In case the number(s) are a PP or common number(s), please specify the name
of the contact person as well]
(e) Area or Location where food business is to be conducted/Address of the premises:

___________________
(f) Description of the food items proposed to be Manufactured or sold:
S.No Name of Food category Quantity in Kg per day or M.T. per annum
Please attach separate sheet if required.

(g) Total Annual turnover from the food business, if existing, along with any supporting
document(s) showing proof of income (*In case of renewal):
_____________________________________________________
_____________________________________________________________________
_________________
(h) In case of new business - intended date of start:

_______________________________________________
(i) In case of seasonal business, state the opening and closing period of the year:
_______
(j) Source of water supply:
Public supply Private supply Any other source
(k) Whether any electric power is used in manufacture of the food items:
Yes No
If yes, please state the exact HP used or sanctioned Electricity load:
___________________________________
(l) I/We have forwarded a sum of Rs………towards registration fees according to the
provision of the Food Safety and Standards (Licensing and Registration) Regulations,
2011 vide:
Demand Draft no. (payable to ____________________)
Cash
(Signature of the Applicant)
112
Annexure 3
Self-Declaration for Registration and for Licensing
Refer Regulation 2.1.1 (2) and Regulation 2.1.3 of the Licensing and Registration Regulation
I, Mr./Ms./Mrs. _____________ S/o/D/o Mr. ______________, R/o _________________________

do hereby solemnly affirm and declare that all information and particulars furnished by me are true
and correct to the best of my knowledge. I further declare that the food business conducted or
proposed to be conducted by/through me conforms/ shall conform to the Food Safety and Standards
Act, Regulations/Bye-laws enacted thereunder, and specifically to the Guidelines on Hygiene and
Sanitary Practices provided under Schedule 4 of the Registration and Licensing Regulations published
by the Food Safety and Standards Authority of India or any person authorised on its behalf from time
to time.
113
Annexure 4
General Hygienic and sanitary practices to be followed by petty FBOs when applying for registration
Refer Regulation 2.1.1 of the Licensing and Registration Regulations
The FSO during inspection must confirm that the following measures are being carried out by the petty FBO
as far as possible:
The place where food is manufactured, processed or handled shall comply with the following requirements:
1. The premises shall be located in a sanitary place and free from filthy surroundings and shall maintain overall
hygienic environment. All new units shall set up away from environmentally polluted areas.
2. The premises to conduct food business for manufacturing should have adequate space for manufacturing
and storage to maintain overall hygienic environment.
3. The premises shall be clean, adequately lit and ventilated and sufficient free space for movement.
4. Floors, ceilings and walls must be maintained in a sound condition. They should be smooth and easy to
clean with no flaking paint or plaster.
5. The floor and skirted walls shall be washed as per requirement with an effective disinfectant the premises
shall be kept free from all insects. No spraying shall be done during the conduct of business, but instead fly
swats/flaps should be used to kill spray flies getting into the premises. Windows, doors and other openings
shall be fitted with net or screen, as appropriate to make the premise insect free The water used in the
manufacturing shall be potable and if required chemical and bacteriological examination of the water shall be
done at regular intervals at any recognized laboratory.
6. Continuous supply of potable water shall be ensured in the premises. In case of intermittent water supply,
adequate storage arrangement for water used in food or washing shall be made.
7. Equipment and machinery when employed shall be of such design which will permit easy cleaning.
Arrangements for cleaning of containers, tables, working parts of machinery, etc. shall be provided.
8. No vessel, container or other equipment, the use of which is likely to cause metallic contamination injurious
to health shall be employed in the preparation, packing or storage of food. (Copper or brass vessels shall have
proper lining).
9. All equipment shall be kept clean, washed, dried and stacked at the close of business to ensure freedom
from growth of mould/ fungi and infestation.
10. All equipment shall be placed well away from the walls to allow proper inspection.
11. There should be efficient drainage system and there shall be adequate provisions for disposal of refuse.
114
12. The workers working in processing and preparation shall use clean aprons, hand gloves, and head
wears.
13. Persons suffering from infectious diseases shall not be permitted to work. Any cuts or wounds shall
remain covered at all time and the person should not be allowed to come in direct contact with food.
14. All food handlers shall keep their finger nails trimmed, clean and wash their hands with soap, or
detergent and water before commencing work and every time after using toilet. Scratching of body parts,
hair shall be avoided during food handling processes.
15. All food handlers should avoid wearing, false nails or other items or loose jewellery that might fall into
food and also avoid touching their face or hair.
16. Eating, chewing, smoking, spitting and nose blowing shall be prohibited within the premises especially
while handling food.
17. All articles that are stored or are intended for sale shall be fit for consumption and have proper cover
to avoid contamination.
18. The vehicles used to transport foods must be maintained in good repair and kept clean.
19. Foods while in transport in packaged form or in containers shall maintain the required temperature.
20. Insecticides / disinfectants shall be kept and stored separately and `away from food manufacturing /
storing/handling areas.
Sanitary and hygienic requirements specifically for street food vendors:
1. Potential sources of contamination like rubbish, waste water, toilet facilities, open drains and stray
animals shall be avoided.
2. The surfaces of the vending carts which come in contact with food or food storage utensils shall be built
of solid, rust/ corrosion resistant materials and kept in clean and good condition They shall be protected
from sun, wind and dust. When not in use, food vending vans shall be kept in clean place and properly
protected.
3. Rubbish bin with cover shall be provided by food stall or vending cart owners for any waste generated
in the process of serving and eating by consumers.
115
4. Working surfaces of vending carts shall be clean, hygienic, impermeable and easy to clean (like
stainless steel), and placed at least 60 to 70 cm. from above ground.
5. Sale points, tables, awnings, benches and boxes, cupboards, glass cases, etc. shall be clean and
tidy.
6. Cooking utensils and crockery shall be clean and in good condition. It should not be broken/
chipped.
7. All containers shall be kept clean, washed and dried at the close of business to ensure that
there is no growth of mould/ fungi and infestation.
8. Water used for cleaning, washing and preparing food shall be potable in nature.
9. Transporting of drinking water (treated water like bottled water, boiled/ filtered water through
water purifier etc.) shall be in properly covered and protected containers and it shall be stored
in clean and covered containers in a protected area away from dust and filth.
10. Cooking, storage and serving shall not be done in utensils of, cadmium, lead, non-food grade
plastic and other toxic materials.
11. Utensils shall be cleaned of debris, rinsed, scrubbed with detergent and washed under
running tap water after every operation. Wiping of utensils shall be done with clean cloth.
Separate cloths shall be used for wiping hands and for clearing surfaces, cloth used for floor
cleaning will not be used for cleaning surfaces of tables and working areas and for wiping utensils
Person cooking, handling or serving food should use hand gloves and aprons, where necessary.
He shall wear head gear and cover his mouth always while at work.
12. Removing dust or crumb from plates or utensils shall be done by using cloth or wiper into
dustbin.
13. The person suffering from infectious disease shall not be permitted to work.
14. All food handlers shall remain clean, wear washed clothes and keep their finger nails
trimmed, clean and wash their hands with soap/ detergent and water before commencing work
and every time after touching food or using toilet.
15. All food handlers should avoid wearing loose items that might fall into food and also avoid
touching or scratching their face, head or hair.
16. All articles that are stored or intended for sale shall have proper cover to avoid
contamination. Food should be stored only in food grade plastic containers as steel containers
to prevent leaking.
116
17. Eating, chewing, smoking, spitting and nose blowing shall be prohibited within the premises.
18. Foods shall be prepared or cooked as per the day's requirement to avoid left over which
might be used in the next day without ascertaining its safety for consumption or use in food.
Consumables left over shall be kept in the refrigerator immediately after their intended use.
19. Adequate number of racks shall be provided for storage of articles of food, with clear identity
of each commodity. Proper compartment for each class shall also be provided wherever
possible so that there is no cross contamination.
20. Rubbish or garbage bin shall be with a tight cover and shall be cleaned everyday by
transferring contents into designated locations.
21. Vegetarian and non-vegetarian items should be segregated.
22. Fridge should be cleaned at least once a week to remove stains, ice particles and food
particles. The temperature in the fridge should be in the range of 4°C - 6°C.
23. The location of the vending unit should be in a place approved by the local authorities and
not blocking traffic or pedestrians or near unhygienic locations.
117
Annexure 6
Improvement Notice
Section 32 of the FSS Act
Reference Number: ..................................................
Name of the Food Business Operator

License/Registration number
Address
Date
Reference number of inspection report of FSO on the basis of which the improvement notice is issued
I have reasonable grounds for believing that you are failing to comply with the FSS Act, Rules and
Regulations made thereunder in connection with your food business:
S.No. Non-compliance Specific provisions of the Measures for

identified (please FSS Act, Rules or improvement
provide a description Regulations being to be
of non-compliance contravened undertaken
identified)
The improvement measure(s) must be undertaken by ____ (date), failing which your license may be
suspended.
It is an offence not to comply with this improvement notice by the date stated.
118
Annexure 7
Suggested Format for notice to FBO when food is to be destroyed

[Refer Section 38 sub-section 4 of the Food Safety and Standards Act 2006]
To
(Name and address of FBO)

------------------
------------------
In exercised of the power delegated to me under Section 38 sub-section 4 of the Food Safety and Standards
Act 2006, I hereby declare and inform you that the food articles seized by me on ----------- (dd/mm/year)
were found to be in a deteriorated state and unfit for human consumption based on the following
observations:
1
2
3
By reason of such deterioration, it has been decided that the food articles listed below must be destroyed.
SI No. Name of products Batch Number No. of units Qty in kgs. Reason for destruction
1
2
3
4
The food articles must be destroyed by ------------- (dd/mm/year) by way of -------------- (method of
destruction) at a safe location, such that the destruction will not cause harm to any living being, any
building or structure or equipment, in my presence or in the presence or any other person authorised in
this behalf.
Name of witness with signature

DO signature
Seal
119
7: Important Concepts under the FSS Act
There are some important definitions and concepts that the Food Safety Officer must keep
in mind while fulfilling his duties under the FSS Act:
1. Adulterant means any material which is or could be employed for making the food
unsafe or sub-standard or mis-branded or containing extraneous matter
2. Contaminant means any substance. whether or not added to food, but which is present
in such food as a result of the production (including operations carried out in crop
husbandry, animal husbandry or veterinary medicine), manufacture, processing,
preparation, treatment, packing, packaging, transport or holding, of such food or as a
result of environmental contamination and does not include insect fragments, rodent
hairs and other extraneous matter
3. Extraneous matter means any matter contained in an article of food which may be
carried from the raw materials, packaging materials or process systems used for its
manufacture or which is added to it, but such matter does not render such article of food
unsafe
4. Food means any substance, whether processed, partially processed or unprocessed,

which is intended for human consumption and includes primary food to the extent
defined in clause (Le), genetically modified or engineered food or food containing such
ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any
substance, including water used into the food during its manufacture, preparation or
treatment but does not include any animal feed, live animals unless they are prepared or
processed for placing on the market for human consumption, plants prior to harvesting,
drugs and medicinal products, cosmetics, narcotic or psychotropic substances:
Provided that the Central Government may declare, by notification in the Official
Gazette, any other article as food for the purposes of this Act having regards to its use,
nature, substance or quality
120
5. Food business means any undertaking, whether for profit or not and whether public or private,
carrying out any of the activities related to any stage of manufacture, processing, packaging,
storage, transportation, distribution of food, import and includes food services, catering services,
sale of food or food ingredients
6. Food business operator in relation to food business means a person by whom the business is
carried on or owned and is responsible for ensuring the compliance of this Act, rules and
regulations made thereunder
7. Ingredient means any substance, including a food additive used in the manufacture or
preparation of food and present in the final product, possibly in a modified form
8. Label means any tag, brand, mark, pictorial or other descriptive matter, written, printed,
stencilled, marked, embossed, graphic, perforated, stamped or impressed on or attached to
container, cover, lid or crown of any food package and includes a product insert
9. Misbranded food means an article of food

(A) if it is purported, or is represented to be, or is being-
(i) offered or promoted for sale with false, misleading or deceptive claims either;
(a) upon the label of the package, or
(b) through advertisement, or
(ii) sold by a name which belongs to another article of food; or
(iii) offered or promoted for 'sale under the name of a fictitious individual or company
as the manufacturer or producer of the article as borne on the package or containing
the article or the label on such package;
or
(B) if the article is sold in packages which have been sealed or prepared by or at the instance
of the manufacturer or producer bearing his name and address but-
(i) the article is an imitation of, or is a substitute for, or resembles in a manner likely to
deceive, another article of food under the name of which it is sold, and is not plainly and
conspicuously labelled so as to indicate its true character; or
121
(iii) the article is offered for sale as the product of any place or country which is false; or
(C) if the article contained in the package--
(i) contains any artificial flavouring, colouring or chemical preservative and the package
is without a declaratory label stating that fact or is not labelled in accordance with the
requirements of this Act or regulations made thereunder or is in contravention thereof;
or
(ii) is offered for sale for special dietary uses, unless its label bears such information as
may be specified by regulation, concerning its vitamins, minerals or other dietary
properties in order sufficiently to inform its purchaser as to its value for such use; or
(iii) is not conspicuously or correctly stated on the outside thereof within the limits of
variability laid down under this Act.
10. An article of food shall be deemed to be sub-standard if it does not meet the specified standards
but not so as to render the article of food unsafe
11. Unsafe food means an article of food whose nature, substance or quality is so affected as to
render it injurious to health: —
(i) by the article itself, or its package thereof, which is composed, whether wholly or in part, of
poisonous or deleterious substances; or
(ii) by the article consisting, wholly or in part, of any filthy, putrid, rotten, decomposed or
diseased animal substance or vegetable substance; or
(iii) by virtue of its unhygienic processing or the presence in that article of any harmful
substance; or
(iv) by the substitution of any inferior or cheaper substance whether wholly or in part; or
(v) by addition of a substance directly or as an ingredient which is not permitted; or
(vi) by the abstraction, wholly or in part, of any of its constituents; or
(vii) by the article being so colored, flavoured or coated, powdered or polished, as to damage
or conceal the article or to make it appear better or of greater value than it really is; or
(viii) by the presence of any colouring matter or preservatives other than that specified in
respect thereof; or
(ix) by the article having been infected or infested with worms, weevils or insects; or
(x) by virtue of its being prepared, packed or kept under insanitary conditions; or
(xi) by virtue of its being mis-branded or sub-standard or food containing extraneous matter;
or
(xii)by virtue of containing pesticides and other contaminants in excess of quantities specified
by regulations.
122
12. The Act prescribes various offenses and corresponding penalties for such offences. These offenses and
penalties have been prescribed in Section 48 to 67 of the Act. The penalties prescribed for the various
offenses vary from a fine of INR 1,00,000 to imprisonment for life depending on the severity of the
offense committed. On the one hand, the Act also prescribes for action to be taken against directors
and persons in control of a company when an offense has been committed by a company. On the other
hand, the Act also provides for a compounding provision whereby a Food Safety Commissioner
empowers a DO to compound a fine levied on a Petty FBO up to INR 1,00,000. This of course is not
applicable to any punishment of imprisonment against a Petty FBO.
123
To achieve foods safety and consumer protection, Self-Compliance by FBO
should be the focus of the FSO, so the Food Safety Officer should first act as a
counsellor to FBO for various preventive and corrective actions to be taken for
any contraventions. This is especially true for Petty FBOs who may not be aware
of the compliances required under the FSS Act.
The FSO must stay up to date with all The FSO should be able to provide food
the regulations, amendments, safety guidance to food Business
advisories etc. that are issued and Operators and must clarify the steps they
need to take control of all the risk of food
notified under the FSS Act The FSO
becoming contaminated.
should also have a knowledge about
The FSO should have good knowledge
other allied legislations such as the
of all the sampling techniques and
BIS Act, the Legal Metrology Act guidance notes on all enforcement and
and other laws affecting safety regulatory activities.
124

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FOOD SAFETY OFFICER’S GUIDE

2. Evolution of FSS Act 8

3. Integrating Food chain 16

4. Food Safety Surveillance 27

7. Important concepts under FSS Act 120

Integrating Food chain

How to verify compliance of

Structure of Food Authority

Facilitator Role of a Food

WHAT IS FOOD SAFETY

What is Food Safety

Why Food Safety is Important?

10 exciting facts about the food

Fact 2: contaminated food can cause long term health

Fact 3: food borne diseases affect vulnerable people

Fact 5: Globalization makes food safety more

Fact 9: Everybody has a role to play in keeping

What Are the Benefits of Food Safety?

 Reduce Food-Borne Illness

 Give confidence to Customers,

 Protects and enhances your business reputation leading to increased profits

 Enhance Consumer Confidence on domestic and international foods.

 Reduces food wastage and associated costs.

Safe & Nutritious food (SNF) – A way of Life

Safe & Nutritious food (SNF) initiatives of FSSAI

Safe and Nutritious Food @ Safe and Nutritious Food @

Safe and Nutritious Food @ Safe and Nutritious food

EVOLUTION OF FOOD SAFETY &

Evolution of FSS Act

1. Prevention of Food Adulteration Act 1954 (Act No 37 of 1954)

2.2 Structure of FSSAI

CODEX Central Advisory

Director CMSO Advisor

Central Advisory Committee

Scientific Panel & Committee

2.3 Structure of State Food Safety Regulatory Body

Chief Executive Officer

Commissioners of Food Safety

Commissioner of Food Safety

Food Safety Officer

2.4 Role & Responsibility of Food Safety Officer

Monitoring Facilitation &

INSPECTION FACILITATE FOOD

1. Prescribed by the Designated Officers (DO) for Food

FSO has to take sample for the following purposes

1. For the Surveillance, survey and research which cannot be used

FSO has following facilitator role

1. In preparation of Food Safety Plans for Panchayat and

FSO will conduct or organize Training Programme as duties entrusted to

FOOD PRODUCTION PROCESS

 Primary Food Production at the level of farmers

What is ‘SAFE FOOD’?

How Risk can enter in to the food chain?

3.2 Risk Analysis

Food hazards are the biggest threat to food safety

Table showing examples of Hazards

Hazards associated with food

Risk Analysis Approach

It comprises of three stages:

Why FSO must know Risk Analysis?

Identify & address the safety

Draw samples for the purpose of

To respond to the incidence of