FQA – 362 (2+0)

Lecture No. 0

Food Quality, Safety Standards and

Certification
Project
ProjectIdentification
Identification&&Screening
Screening

Samit Dutta, Associate Professor & Head,

Dept. of Food Business Management,
1
College of FPTBE, AAU
 Course Content - Theory
Unit Topics Lecture

1 Introduction :Definition, its role in food industry , Quality attributes 1

Physical properties: Color, visocisity, size and shape: 2
Definition, color measurement techniques by spectrophotometer, Muncell
color system and Lovibond tintometer; Role of viscosity and consistency in
food quality :Size and Shape :Size and shape, weight, volume, weight 2
volume ratio, length, width, diameter, symmetry, curvature, area;
2 Quality Defects: Classification, Genetic-physiological defects: Structural,
off color, character; Entomological defects: Holes, scars, lesions, off 3
coloring, curled aves, pathological defects; Mechanical defects, extraneous
or foreign material defects. Measurement of defects by different
techniques
3 Quality Assessment:
Quality assessment of food materials on the basis of sensory evaluation,
Physical, chemical microbiological methods ; 2
Quality of products during processing and after processing:
Factors influencing the food qualities: Soil, field practices, harvesting 1
practices, procedures, packaging, transportation, storage, conditions,
processing conditions, packaging and storage conditions of finished 2
Unit Topics Lecture

4 Role of QC and QA Quality: Quality Control, Quality Assurance, Concepts

of quality control and quality assurance functions in food industries. 2
Quality Improvement Total Quality management: Quality evolution,
quality gurus, defining TQM, principals of TQM, stages in implementation,
TQM road map. Quality improvement tools, customer focus, cost of quality 3
5 Food Laws
Food Laws and Standards: National and International food laws Mandatory 2
and voluntary food laws.
FSSAI
Indian Food Regulations and Certifications: Food Safety and Standards Act 2
FSSAI Rules, food adulteration, misbranding, common adulterants in foods,
Duties and responsibilities of Food Safety Authorities 2
6 AGMARK, BIS, FPO, Weights and Measures Act ,CODEX :
Agricultural Marketing and Grading Standards (AGMARK), Bureau of Indian 2
Standards(BIS) and their certification,
FPO –standards and certification process Weights and Measures Act and 2
Packaged commodity rules
Role of CODEX in food safety and standards ,Food safety issues and risk
analysis 2
Unit Topics Lecture

7 FSMS 22000 2
Food Safety Management Systems, ISO 22000 – 2005 and other Global
Food safety management systems. Principles, implementation;
documentation, types of records; Auditing, certification procedures,
certifying bodies, accrediting bodies
 Study Materials

• Ppt / Lecture note

• Published papers / articles / internet
resources
• Books
– Inteaz Alli. 2004. Food Quality Assurance: Principles and
Practices. CRC Press, Boca Raton, FL, USA.
– Ronald H. Schmidt and Gary E. Rodrick. 2003. Food Safety
Handbook. John Wiley & Sons, Inc., Hoboken. New Jersey,
USA.
– R.E. Hester and R.M. Harrison. 2001. Food Safety and Food
Quality. Royal Society of Chemistry, Cambridge, UK
 Course Administration
• Class Schedule
– Theory: Tue (09:00 – 10:00) / Fri (09:00 – 10:00)
– 26 Feb (Fri), 2021 – 2 Jul (Fri), 2021

• Exam Pattern - Theory

– Self study/Assignments = 10 marks (You are encouraged to study with friends,
but you are expected to compose your own reports )
– Mid term Exam = 40 marks
– Semester end exam = 50 marks

• Exam Schedule
– Mid term exam: 10-19 May, 2021
– Assignment Submission Date: 18 Jun, 2021 (Fri) (writeup &/or
ppt)
– Internal practical exam: 21-30 Jun, 2021
– Semester end exam: 5-14 Jul, 2021
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 1

Food Quality, Safety Standards and

Certification – An Introduction
Project Identification
ProjectDefinitions,
Identification &&Screening
Screening
Concepts, Overview

Samit Dutta, Associate Professor & Head,

Dept. of Food Business Management,
1
College of FPTBE, AAU
Quality: definitions
degree of excellence

faculty, skill, accomplishment

high rank or social standing

(logic) being affirmative or negative

distinctive character (of sound, voice etc.)

concerned with maintenance of high quality (quality

control)
What is Quality?

The quality of a product or service is a

customer’s perception of the degree to
which the product or service meets his or
her expectations.
Quality: definition
(ISO 8402/ISO 9000)

“Quality is the totality of

features and characteristics
of a product or service
that bear on its ability to
satisfy stated or implied needs”
 Managing quality: why?

⚫ Demand for fruits, vegetables and livestock products is

growing fast
⚫ Export markets can absorb high value added products and
bring high returns
⚫ One key factor is the ability to manage a constant level of
quality
⚫ Growing Consumer concern for food safety

2
Quality Standards
in International Trade
⚫ WTO / SPS Agreement: standards set by Codex
Alimentarius, O.I.E., I.P.P.C.
⚫ EU harmonization ( standards on raw material, process
and end product)
⚫ NAFTA requirements
⚫ Bilatéral requirements
⚫ ISO Standards

6
 Principle provisions of SPS
⚫ Applied only to the extent necessary to safeguard
plant, animal and human health
⚫ Harmonization, no discrimination
⚫ Equivalence: recognize different systems
⚫ Risk assessment and determination of « appropriate
level of protection »
⚫ Adaptation to Regional Conditions

7
 Differences in Policies
⚫ Large differences exist among similar countries:
⚫ hormones dispute
⚫ raw-milk cheese
⚫ animal welfare, child labor
⚫ Consumer values versus science-based standards

8
 Culture drives policy
⚫ Framing the problem:
⚫ «selective vision » of problems depends on culture
⚫ the example of Genetically Modified Organisms
(GMOs): the US focuses on the products while UK is
concerned with the process, Germany by both

9
 Culture drives policy (2)
⚫ Styles of regulation
⚫ differences in public participation
⚫ conflict resolution: political versus judicial
⚫ Acceptable evidence:
⚫ formal / quantitative versus qualitative appraisal
⚫ measurable risk versus precaution
⚫ Forms of expertise:
⚫ technical / neutral versus affiliation

10
 Two basic models

⚫ The old model:

⚫ one by one inspection at the end of the chain

⚫ zero tolerance

⚫ The new model:

⚫ quality management throughout the chain

⚫ standards based on risk assessment

11
Modern Chain Based
Quality Control Systems

⚫ Total quality control (ISO 9000 series)

⚫ Hazard Analysis and Critical Control Point system
(HACCP)
⚫ Standard operating procedures (e.g. GMP, GLP, ...)

12
 ISO 9000
A Quality Assurance System

⚫ ISO 9000 mandates that an organization:

⚫ defines appropriate quality standards,
⚫ documents its processes, and
⚫ proves that it consistently adheres to both.
⚫ ISO 9000 does not specify HOW a particular organization
should operate!

13
 ISO 9000 Certification

⚫ Companies can register for ISO 9000 certification.

⚫ Assures customers about suppliers capabilities and systems
to provide quality goods and services.
⚫ The US DoD is switching to ISO 9000
⚫ EU requires ISO 9000 registration for 35 product
categories.
⚫ Japan requires ISO 9000 registration for companies
wishing to market products and services.

14
ISO 9000 shortcomings

⚫ Does not always guarantee high-quality products.

⚫ ISO 9000 standards focus mainly on traditional
manufacturing businesses.
⚫ While improvements can lead to savings and higher
profits, the cost of ISO 9000 certification is over
$200,000

15
 Hazard Analysis and Critical Control Point
system

⚫ Control is transferred from end product testing to a

number of points of the manufacturing chain of foods
⚫ Testing for failure is replaced by preventing failure
⚫ Some end product testing still required for on-going
verification of the process.

16
 Key features of HACCP
⚫ It provides a more structured approach than traditional
procedures.
⚫ Developed in the 1960’s for NASA to guarantee total
food safety for astronauts
⚫ Now part of the Codex Alimentarius
⚫ Now required of all food businesses in Europe under
EC Directive 93/43.

17
 The 7 Components of HACCP

1: Conduct a hazard analysis

2: Identify the Critical Control Points
3: Establish target level(s) and tolerance(s) for keeping
each CCP under control
4: Establish a monitoring system of the CCPs
5: Establish corrective action to be taken when a
particular CCP is moving out of control
6: Document all procedures and keep records
7: Establish verification procedures

18
Managing food hazards
Elements of effective programs

⚫ Sound export / import regulations

⚫ Up-to-date active disease surveillance and information
systems
⚫ Efficiently functioning plant protection and veterinary
services
⚫ Alert field professionals and public health officials
⚫ Full cooperation of industries

19
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 2

Basics of food safety – elementary

knowledge
Project
Project
Basics Identification
of Food Identification
safety &&Screening
Screening

Samit Dutta, Associate Professor & Head,

Dept. of Food Business Management,
1
College of FPTBE, AAU
 What is food?
⚫ Food is one of the basic needs of the human being
⚫ Required for the normal functioning of the body parts and for
a healthy growth
⚫ Food is any substance, composed of carbohydrates, water,
fats and/or proteins that is either eaten or drunk by any
animal, including humans, for nutrition or pleasure
⚫ Items considered food may be sourced from plants, animals or
another kingdom such as fungus

⚫ Food science - a study concerned with all technical

aspects of food, beginning with harvesting or slaughtering, and
ending with its cooking and consumption. It is considered one
of the life sciences, and is usually considered distinct from the
field of nutrition
2
 Food science - a highly interdisciplinary applied
science
⚫ Food processing - The set of methods and techniques used to transform
raw ingredients into food or to transform food into other forms for
consumption by humans or animals either in the home or by the food
processing industry
⚫ Food safety - The causes, prevention and communication dealing with
food borne illness
⚫ Food microbiology - The positive and negative interactions between
micro-organisms and foods
⚫ Food preservation - The causes and prevention of quality degradation
⚫ Food engineering - The industrial processes used to manufacture food
⚫ Product development - The invention of new food products
⚫ Sensory analysis - The study of how food is perceived by the consumer's
senses
⚫ Food chemistry - The molecular composition of food and the involvement
of these molecules in chemical reactions
⚫ Food packaging - The study of how packaging is used to preserve food
after it has been processed and contain it through distribution
⚫ Food technology - The technological aspects of food
3 ⚫ Food physics - The physical aspects of foods (such as viscosity,
creaminess, and texture)
 Introduction to Food Safety
⚫ Concern for the supply of food that is safe for the consumer has
increased
⚫ Rising liberalization of agro-industrial markets and the world-wide
integration of food supply chains require new approaches and
systems for assuring food safety
⚫ Food processors and retailers are sourcing worldwide and it can be
hard to track the region let alone the producer of the ingredient
⚫ International trade in high-value food products (fresh and processed
fruits and vegetables, fish, live animals and meat, and nuts and
spices) has expanded enormously in the last twenty five years
⚫ It is in particular, these products for which food safety plays an
important role
⚫ With each food “scare” reported – from banned dyes in multiple
products to links between animal and human diseases – consumer
concern grows
⚫ In response, the public and the private sector have developed new
process standards and require suppliers of food products to follow
them
4 ⚫ Both, the market and legislations in importing countries demand for
comprehensive and transparent schemes reaching "from farm to
 Definition
⚫ The causes, prevention and communication dealing with
food borne illness

⚫ Food Safety can be defined as the assurance that food

will not cause harm to the consumer when it is
prepared and or eaten according to its intended use
(WHO)

⚫ All conditions and measures that are necessary during

production, processing, storage, distribution and
preparation of food that when ingested does not represent
an appreciable risk to health
5
 Global trends and their impact on food safety
⚫ The regional, national and global food chain has required
parallel changes in food science and technology, including
preservation
⚫ At the same time, there have been social changes such as an
increasing number of meals being consumed outside the home
environment and also an ageing population
⚫ Public exposure to a food-borne pathogen may change due to
changes in processing, changes in consumption patterns and
the globalization of the food supply chain

⚫ Many risk factors influence host (our) susceptibility to

infection:
⚫ Pathogen (microbes)-related : ingested dose, virulence
⚫ Host-related: age, immune status, personal hygiene, genetic
susceptibility.
6
⚫ Diet-related nutritional deficiencies, ingestion of fatty or highly
buffered foods
 Basics of Food Safety
⚫ The globalization of the food supply is recognized as a major
trend contributing to food safety problems
⚫ Pathogenic micro-organisms are not contained within a single
country's borders
⚫ Additionally, tourism and increased cultural interests may lead
to new eating habits, such as the consumption of 'sushi' (origin
in Japan) or our very own ‘tandoori tikka masala’ in Western
countries
⚫ The continuous increase in international trade has been
achievable partly through advances in food manufacturing and
processing technologies together with improvements in
transportation
⚫ Regional trade arrangements and the overall impact of the
Uruguay Round Agreements have reduced many tariff and
subsidy-related constraints to free trade, encouraging
increased production and export from the countries with the
most cost-effective production means
7 ⚫ However, many exporting countries do not have the
infrastructure to ensure high levels of hygienic food
 ⚫ The continuing integration and consolidation of agriculture
and food industries and the globalization of food trade are
changing the patterns of food production and distribution as
well as supply and demand
⚫ The pressure to produce food for export is very significant in
developing economics and can lead to improper agricultural
practices.

The consequences may include the following:

⚫ Accidental or sporadic low level microbial contamination of a
single product, which can result in a major epidemic of
food-borne illness
⚫ High levels of mycotoxins, often resulting from poor storage
and handling conditions
⚫ High pesticides residues food
⚫ Industrial contamination of food with metals and chemicals
8 such as polychlorinated biphenyls (PCBs) and dioxins
⚫ Eating away from home is a major trend of recent years
⚫ Many of the meals eaten away from home require extensive food
handling and /or are cold foods that are not cooked before
consumption
⚫ Subsequently this leads to the potential for transmission of food-borne
diseases from food handlers to consumers
⚫ Several studies have documented an increasing lack of knowledge
related to personal hygiene, the use of clean utensils and storage of
food at the correct temperature
⚫ Thus, the changing trend has increased the importance that food be
handled in a sanitary manner
⚫ With volume processing and preparation of food, effects of
contamination are accentuated if sanitary practices are not followed
⚫ Added mechanization and larger volume operations of food
processing and preparation have increased the need for workers in all
segments of the food industry to have an understanding of sanitary
practices and how hygienic conditions can be attained and maintained
⚫ Yet, if workers are expected to abide by these practices, it is necessary
to impart a certain amount of appreciation of the reasoning behind the
required practices and biological basis for the reasoning
9
 Food Safety Issues
Specific food safety concerns differ markedly and include:

⚫ Additives, colours and flavors

⚫ Drug residues
⚫ Fertilizers and other growing aids
⚫ Irradiation
⚫ Microbiological contamination
⚫ Naturally occurring food toxicants
⚫ Food supplements
⚫ Pesticides
⚫ Pollutants
⚫ Processing ,packaging and labeling
⚫ Adulteration and Misbranding
10
 ⚫ Consumers are most concerned about pesticides and additives as both
are linked in the consumer's mind to cancer
⚫ It is also interesting, perhaps even alarming, that most consumers are
not concerned about microbiological contamination, despite solid
evidence that, of all the hazards, it is the one most likely to occur
⚫ Many homes have unsafe food storage and preparation practices
⚫ Consumers rarely consider their own food practices a hazard
⚫ Food industry, however, is most concerned about the microbiological
safety of its products
⚫ In addition, many quality control checks are made to ensure that foods
are free of extraneous matter such as glass, machine fillings and insect
parts
⚫ Large food companies in many parts of the world adhere to a code of
manufacturing practice known as 'Good Manufacturing Practice
(GMP). This code helps to assure that products are manufactured
under conditions of proper storage and sanitation.
⚫ Many also employ an elaborate system known as 'Hazard Analysis
11
and Critical Control points (HACCP)' to make sure that there is no
chance of contamination or error during processing
 Factors Affecting Food Safety
⚫ Food hazards are the factors, which are the biggest threat to food
safety. A hazard is defined as: a biological, chemical, or physical
agent in a food, or condition of a food, with the potential to cause
an adverse health effect.

⚫ Biological hazards are living organisms, including bacteria, viruses,

fungi and parasites
⚫ Chemical hazards 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 are aflatoxins and shellfish poisons
⚫ The second group covers poisonous chemicals or deleterious
substances which are intentionally or unintentionally added to foods at
some point in the food chain. This group of chemicals can include
pesticides and fungicides and 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,
stones and metal which may cause illness and injury
12
 Examples of hazards associated with food
Biological Chemical Physical
Macro biological Veterinary residues, antibiotics Glass , Hair

Microbiological Growth stimulants Metal

Pathogenic Bacteria Plasticisers and packaging migration Stones

∙ Sporeforming
∙ Non sporeforming
Parasites and protozoa Chemical residues Wood

Viruses Pesticides Plastic

Mycotoxins Cleaning fluids Parts of pests

Allergens Insulation material

Toxic metals; Lead and cadmium Bone

Food chemicals; preservatives, processing Fruit pits

aids, polychlorinated biphenyls (PCBs),
13 printing inks, Prohibited substances
 ⚫ Because most foods are grown in the open environment, they can become
contaminated with natural and human-derived environmental toxicants
⚫ Lead, in most cases, is one such toxicant. PCBs, dioxin, and other pollutants
resulting from human activity are further examples.
⚫ In addition to environmental pollutants, foods become contaminated with trace
toxicants which are unintentionally or intentionally added to foods
⚫ The use of pesticides to control insects, unwanted plants, or fungi can result in
trace residues of the pesticide in the food
⚫ In some cases, components of packaging materials migrate from the package
to foods
⚫ Oils from processing machinery or other processing aids can leave trace
residuals in foods
⚫ These substances are sometimes called processing aids and are regulated for
safety
⚫ Traces of drugs which are given to food-producing animals to treat diseases in
these animals or make them grow more quickly could, under some
circumstances, remain in the food. Traces of antibiotics in milk are one
example. These are also considered trace toxicants
14⚫ Public concern on food safety has been raised due to well publicized
incidences such as food irradiation, BSE, E. coli O157:H7 and genetically
 Definition of Safe Food
⚫ What is "safe" food? This question invokes different answers
depending upon who is asked. Essentially, the different definitions
would be given depending upon what constitutes a significant risk.
⚫ The general public might consider that 'safe food' means zero risk (no
risk at all).
⚫ Whereas the food manufacturer would consider 'what is an acceptable
risk?’
⚫ The opinion expressed is that zero risk is not feasible given the range
of food products available, the complexity of the distribution chain
and human nature.
⚫ Nevertheless, the risks of food poisoning should be reduced during
food manufacture to an 'acceptable risk'. Unfortunately there is no
public consensus on what constitutes an acceptable risk.
⚫ A difficulty that arises in manufacturing 'safe' food is that the
consumer is a mixed population with varying degrees of susceptibility
and general life style. Additionally, food with ‘high’ levels of
preservatives to reduce microbial growth is undesirable by the
15
consumer and perceived as 'over processed' with 'chemical additives'!
 Manufacture of Safe Food
⚫ The manufacture of safe food is the responsibility of everyone in
the food chain, and food factory, from the operative on the
conveyor belt to the higher management

⚫ The production of safe food requires the following:

⚫ Control at source
⚫ Product design and process control
⚫ Good hygienic practice during production. processing,
handling and distribution, storage, sale, preparation and use
⚫ Preventatives approach because effectiveness of microbial
end-product testing is limited

⚫ Control of food borne pathogens at source is not always easy.

Many pathogens survive in the environment for long periods of
time. They can be transmitted to humans by a variety of routes –
water, soil, sewage, crops etc.
16
 Integrated Approach to Food Safety
⚫ The safe food production requires an all-encompassing approach
involving the food operatives at the shop floor through to the
management
⚫ Hence a number of management safety tools need to be implemented
⚫ Although industry and national regulators strive for production and
processing systems which ensure that all food is ‘safe and wholesome’,
complete freedom from risks is an unattainable goal
⚫ Safety and wholesomeness are related to a level of risk that society
regards as reasonable in the context, and in comparison with other risks
in everyday life

⚫ The safety of foods (especially microbiological) can be principally

assured by:
⚫ The application of good hygienic practices during production,
processing (including labeling), handling, distribution, storage, sale,
17 preparation and use
 Food safety management tools (adapted from Jouve et. al 1998)

18
 ⚫ Consideration of safety needs to be applied to the complete food
chain, from food production on the farm, or equivalent, through
to the consumer. To achieve this integration, following food
safety tools are required:
⚫ Good Hygienic Practice (GHP)
⚫ Good Manufacturing Practice (GMP)
⚫ Hazard Analysis Critical Control Point (HACCP)
⚫ Microbiological Risk Assessment (MRA)
⚫ Quality management: ISO series
⚫ Total Quality Management (TQM)

⚫ Last figure presents the food safety tools. These tools can be
implemented worldwide, which can ease communication with
food distributors and regulatory authorities especially at port of
entry.
19
 Importance of Safe Food
⚫ A safe food supply that will not endanger consumer health and
good quality food is essential for proper nutrition. It would ensure
prevention of food borne diseases, provide consumer
unadulterated food of good quality. It also promotes participation
in International trade in food products and stimulates economic
development.
⚫ Maintaining food safety and quality is essential in the entire chain
of food production ranging from
i. Primary food production at the level of farmers
ii. Primary food processing at the farm, dairy, abattoir and grain mills
iii. Secondary food processing level such as canning, freezing, drying
and brewing
iv. Food distribution, both at National and International level of
import/export
v. Food retailing and Food catering
20
vi. Domestic Food preparation level
 ⚫ During recent years, newer challenges such as globalization of
trade in food, urbanization, changes in life style, international
travel, environmental pollution, deliberate adulteration and
natural and man-made disasters have arisen which need to be
addressed to help ensure food safety and quality
⚫ For example, greater numbers of people go out and eat meals in
catering establishments including partaking street foods

⚫ The boom in food service establishments is not matched by

effective food safety education and control
⚫ Unhygienic preparation of food provides plenty of opportunity
for contamination, growth or survival of food borne pathogens
⚫ Also in the developed countries, a considerable public interest
has been shown with regard to genetically modified foods, and
the possible risk of transmission of “mad cow” disease through
the consumption of beef
21
 ⚫ Consumer confidence in the safety and quality of the food supply
is an important requirement and consumers are demanding
protection for the whole food supply chain from primary
producer to the end consumer, often described as from farm or
pond to the plate approach
⚫ It is absolutely essential for countries to protect the safety and
quality of their foods entering international trade
⚫ Also it is necessary to ensure that imported foods are of good
quality and safe to eat
⚫ The new world order and global environment for food trade
places considerable obligation on the part of both importing and
exporting countries to ensure safety and quality of food
⚫ The International agencies like Food and Agriculture
Organization and World Health Organization as well as the
Codex Alimentarius Commission, with a membership of 165
countries, recommends risk analysis approach which includes
22 risk assessment, risk management and risk communication
⚫ The perception of what constitutes a risk depends on a person’s
culture, education and past experience
⚫ But while what is perceived as a risk may differ, the basic
scientific principles for dealing with risk are the same

⚫ Education and Training plays an important role in improving the

safety and quality of food. It is essential to acquire the know-how
and skills necessary to understand and manage food safety
hazards.
⚫ Both education and training are needed for the purpose.
⚫ While education aims at influencing the way of life and
empowering people to make a choice, training is a process by
which one is enable to acquire a skill.
⚫ Any successful food safety programme will always need a shared
responsibility among producers, industry, trade, government and
23
the consumer
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 3

Basics of food safety & processing –

contaminants & adulterants
Project
Project
Food Identification
Identification&&Screening
Contaminants Screening
Food Adulteration
Food Additives
Food Packaging & Labelling

Samit Dutta, Associate Professor & Head,

Dept. of Food Business Management,
1
College of FPTBE, AAU
 Food Contamination
⚫ Food contamination refers to the presence of harmful
chemicals and microorganisms in food which can cause
consumer illness
⚫ A food contaminant has been defined as any substance not
intentionally added to food, which is present in such food as a
result of the production, manufacture, processing, preparation,
treatment, packing, transport or storage of such food as a result
of environmental contamination
⚫ It is important to protect food from risk of contamination to
prevent food poisoning and the entry of foreign objects
⚫ There are three main ways in which food can become
contaminated:
(i) Microbial Contamination;
2
(ii) Physical Contamination;
(iii) Chemical Contamination
 (i) Microbial Contamination
⚫ If food is consumed that has been contaminated by certain,
harmful bacteria (pathogenic bacteria) or their toxins (poisons
produced by some of these bacteria), food poisoning may
result
⚫ Bacteria are responsible for most food poisoning cases
⚫ Symptoms of food poisoning may include vomiting, diarrhea,
fever and abdominal pain. The symptoms may take some time
to occur depending on the type of bacteria (incubation period).
⚫ In general, the bacteria must grow in the food to produce
sufficient numbers to infect the body, multiply within the
intestine and cause illness. Alternatively, toxins may be
produced in the foodstuff or within the intestine, to produce
symptoms very soon after ingestion.
⚫ It is important to remember that foods contaminated with
pathogenic bacteria will look, taste and smell perfectly normal.
3 Steps must therefore be taken to prevent pathogenic bacteria
 Some of the foods borne diseases:

S. Causal organism Disease

No.
1. Staphylococcus aureus Gastroenteritis
2. Clostridium botulinum Botulism
3. Bacellus cereus Diarrhea
4. Salmonella typhi Enteric fever typhoid, food
borne salmonellosis
5. Escherichia coli Gastroenteritis, diarrhea

4
 Controls:
⚫ Prevent cross-contamination. Cross-contamination occurs
when bacteria are transferred onto food either directly
(e.g. when raw and cooked food come into direct contact,
sneezing or coughing onto food) or indirectly (e.g. via a
vehicle such as from dirty utensils, pests, hands etc.)
⚫ Prepared and cooked foods should be stored separate to
raw foods and unprepared vegetables to reduce the risk of
cross-contamination. If this is not possible, raw food and
unprepared vegetables should always be stored at the base
of the refrigerator.
⚫ Keep stored foods covered.
⚫ Prevent animals and insects entering the food room.
5 ⚫ Keep food preparation areas and utensils clean.
 ⚫ Wash hands frequently, particularly after using the toilet,
handling raw foods, handling refuse, blowing your nose,
combing your hair and after smoking.
⚫ Keep cuts, boils etc., covered with a waterproof dressing
(preferably coloured).
⚫ Do not handle food if suffering from symptoms of diarrhea or
vomiting and notify your supervisor immediately.
⚫ To multiply, bacteria require food, warmth, moisture and time.
By removing one or more of these criteria the growth of
bacteria can be slowed or even stopped. Therefore store foods
at safe temperatures (either cold below 8°C or hot above 63°
C); cook food thoroughly; do not prepare food too far in
advance; avoid keeping food at room temperature for any
longer than necessary, if food has to be reheated, heat
thoroughly and stir contents during heating; cool cooked food
within 1½ hours and refrigerate; prevent dry foods becoming
6 moist.
 Food can also be contaminated with fungus
⚫ Mycotoxin: Toxic substances produced by moulds or fungi are called as
Mycotoxin. Some mycotoxins are mutagenic and carcinogenic in nature. Of
these mycotoxins, Aflatoxin is of most common occurrence in the agricultural
produce/ food.
⚫ Aflatoxins are produced by a fungus – Aspergillus flavus and Aspergillus
parasiticus. At least 18 closely related toxins are known. Of these Aflatoxin
B1, B2, M1, M2, G1, G2 are most commonly occurring in the farm
produce/food. Most susceptible food grains are Maize, Paddy/Rice, Jowar,
Ground nut, Wheat, Barley, Soybean, and their products. These toxins are
heat labile, so their toxicity remains unaffected even after cooking at high
temperature. Other important mycotoxins are Citrinin, Ochratoxin, Patulin etc
which are produced by Penicillium species.
⚫ In general, maximum tolerance limit of mycotoxins including Aflatoxin in
stored food grains has been recommended at 30 micrograms per Kg (this
limit is considered by CWC/SWC/FCI).
⚫ Ergot :Ergotin is another mycotoxin produced by fungi Claviceps purpurea
on rye/bajra, where this fungus causes Ergot disease.
7⚫ Mycotoxins are produced at high moisture content and in temperature range
of 12°C to 40°C. Therefore, the best way of coming over this food hazard is
 (ii) Physical Contamination
⚫ Physical contamination can occur at any stage of the food
chain and therefore all reasonable precautions must be taken to
prevent this type of contamination.
⚫ While harvesting, farm produce comes into contact with
variety of external material called as physical contaminant.

⚫ Physical contamination consists of two major groups viz.,

organic matter and inorganic matter.
⚫ The former includes plant parts, debris, weed seeds, poisonous
seeds of Dhatura and Akra, other food grains, dead insects,
excreta, damaged grains, broken, fragments, nooks, rodent
hair, uric acid etc.
⚫ While the latter consists of lump of earth, pebbles, stones, dust
etc. The proportion of these contaminants in the sample
determines the quality of the produce and also the shelf life.
However, the produce must be cleaned, graded and packed in
8
suitable gunny bags/ packing material free from any
infestation before storing or marketing the same.
 Examples of physical contamination:
⚫ Pieces of machinery which can fall into food during
manufacture. Most manufacturers protect against this type
of contamination by installing metal detectors on the
production lines which reject food if anything metallic is
present

⚫ Stones, pips, bones, twigs, pieces of shell

⚫ Foreign objects can enter food during handling so care

must be taken to adhere to good food handling practices
(e.g. do not wear jewellery or smoke in a food room)

9
 (iii) Chemical Contamination
⚫ Contamination may occur through environmental
pollution of the air, water and soil, such as the case with
toxic metals, PCBs and dioxins, or through the intentional
use of various chemicals, such as pesticides, animal drugs
and other agrochemicals.
⚫ Chemicals, including pesticides, bleach and other
cleaning materials can contaminate food if not used
carefully. For example, store cleaning fluids separate to
foods to prevent tainting and contamination if there is a
spillage.
⚫ The impact of chemical contaminants on consumer health
and well-being is often apparent only after many years of
prolonged exposure at low levels (e.g. cancer).
10
⚫ Chemical contaminants present in foods are often
 ⚫ Chemical contaminants can be classified according to the
source of contamination and the mechanism by which
they enter the food product.
⚫ Agrochemicals are chemicals used in agricultural practices
and animal husbandry with the intent to increase crops and
reduce costs. Such agents include pesticides (e.g.
insecticides, herbicides, rodenticides), plant growth
regulators, veterinary drugs (e.g. nitrofuran,
fluoroquinolones, malachite green, chloramphenicol), and
bovine somatotropin (rBST).
⚫ Environmental contaminants are chemicals that are
present in the environment in which the food is grown,
harvested, transported, stored, packaged, processed, and
consumed. The physical contact of the food with its
environment results in its contamination
11
 Possible sources of contamination:
⚫ Air: radionuclides (137Caesium, 90Strontium), polycyclic aromatic
hydrocarbons (PAH).
⚫ Water: arsenic, mercury.
⚫ Soil: cadmium, nitrates, perchlorates. Polychlorinated biphenyls (PCB) ,
dioxins, and polybrominated diphenyl ethers (PBDE) are ubiquitous
chemicals, which are present in air, water, soil, and the entire biosphere.
⚫ Packaging materials: antimony, tin, lead, perfluorooctanoic acid (PFOA),
semicarbazide, benzophenone, isopropylthioxanthone (ITX), bisphenol A.
⚫ Processing/cooking equipment: copper, or other metal chips, lubricants,
cleaning and sanitizing agents.
⚫ Naturally occurring toxins: mycotoxins, phytohaemagglutinin,
pyrrolizidine alkaloids, grayanotoxin, mushroom toxins, scombrotoxin
(histamine), ciguatera, shellfish toxins (see shellfish poisoning),
tetrodotoxin, among many others.
⚫ Processing contaminants are generated during the processing of foods
(e.g. heating, fermentation). They are absent in the raw materials, and are
formed by chemical reactions between natural and/or added food
constituents during processing. Examples are: nitrosamines, polycyclic
aromatic hydrocarbons (PAH), heterocyclic amines, histamine,
12
acrylamide, furan, benzene, trans fat, monochloropropanediol (MCPD),
semicarbazide, 4-hydroxynonenal (4-HNE), and ethyl carbamate.
 ⚫ RESTRICTED PESTICIDES (India)

⚫ Aluminium phosphide 6. Ethylene dibromide

⚫ BHC/Lindane 7. Methyl bromide
⚫ Captafol 8. Phenyl mercuric acetate
⚫ DDT
⚫ Dieldrin

13
 Food Contaminants Rendering Food Unsafe For Human Consumption
PHYSICAL CHEMICAL BIOLOGICAL
INORGANIC ORGANIC
Foreign matter Lumps Heavy metals: Pesticide Residue Insects and Rodents
of earth, pebbles, Lead, Mercury, Water
Stones, dust, plant Arsenic, Cadmium
parts, Stem, chaff etc. Sulphur
Unhygienic Packaging Uric Acid Fungus
Material Excreta, Rodent hair
Unhygienic Processing Mycotoxins eg., Bacteria
Aflatoxin, ergot, and alkaloids
form, Karnal Bunt, Smut affected
grains
Moisture Human being suffering
from contagious
disease
Unhygienic handling B-Oxalyl Amino Acid(BOAA),
produced by Lathyrus sativus
(Khesari Dal) and
Alkaloids in the oil from
Argemone mexicana

14 Non food grade

Colour and
 ⚫ Emerging food contaminants While many food contaminants
have been known for decades, the formation and presence of
certain chemicals in foods has been discovered relatively
recently. These are the so-called emerging food
contaminants, e.g. acrylamide, furan, benzene, perchlorate,
perfluorooctanoic acid (PFOA),
3-monochloropropane-1,3-diol (3-MCPD), 4-hydroxynonenal
and (4-HNE).

⚫ Safety and regulation Acceptable Daily Intake (ADI) levels

and tolerable concentrations of contaminants in individual
foods are determined on the basis of the "No Observed
Adverse Effect Level" (NOAEL) in animal experiments, by
using a safety factor (usually 100). The maximum
concentrations of contaminants allowed by legislation are
often well below toxicological tolerance levels, because such
levels can often be reasonably achieved by using good
15
agricultural and manufacturing practices.
 Food Adulteration
⚫ Food adulteration takes into account not only the
intentional addition or substitution or abstraction of
substances which adversely affect the nature, substances
and quality of foods, but also their incidental
contamination during the period of growth, harvesting,
storage, processing, transport and distribution

⚫ A food adulterant may be defined as any material which

is added to food or any substance which adversely affects
the nature, substance and quality of the food

16
 When is Food Considered Adulterated?
⚫ If the article sold by a vendor is not of the nature, substance or quality
demanded by the purchaser or if not of the nature, substance or quality
which it ought to be. Thus for e.g. , if a sweet vendor leads his customer
to believe that his sweets are prepared in pure desi ghee and actually he
uses a mixture of hydrogenated vegetable oils and ghee his sweets will
be considered to be adulterated
⚫ If the article contains or processing has produced in it injurious
ingredients, for instance during the process of hydrogenating oil to
prepare vanaspati, nickel is used as a catalyst. If not properly removed,
this metal can prove to be hazard
⚫ If any inferior or cheap substance has been substituted holly or in par for
the article e.g. starch powder has been mixed in milk powder
⚫ If any constituent of the article has been wholly or in part abstracted e.g.
natural flavours or essential oils have been removed from spices before
selling them
⚫ If the article has been prepared, packed or kept under unsanitary
17 conditions or it has become contaminated or injurious to health
⚫ If the article has any filth, putrid rotten, decompose or diseased animal or
⚫ If the article is obtained from a diseased animal;
⚫ If the article contains any poisonous or other ingredient which render it
injurious o health;
⚫ If the container of the articles composed of poisonous or deleterious substances
which render its content injurious to health. For example, harmful chemicals
can leach into the food kept in the container made from poor quality plastics.
⚫ If it contains un-permitted colours or if he amount of the prescribed colouring
matter are not within the prescribe limits. For instance, only 100 ppm of colour
can be added to ice cream and the colour is to be chosen from a list of eight
approved by the PFA at.
⚫ If the article contains any prohibited preservatives or an excessive amount of
permitted ones.
⚫ If it does not satisfy the prescribed standards laid down by the authorities and
which makes the article injurious o health. For e.g. an article of food should not
have more than the permitted level of pesticides. If it does, the sugar is
adulterated but such an adulteration is not injurious to health.
⚫ If it does not satisfy the prescribed standards laid down by the authorities’ but
the article does not become injurious to health. For e.g. sugar should not have
18 more than 0.5 % by weight of moisture. If it does, the sugar is adulteration but
such an adulteration is not injurious to health
 COMMONLY ADULTERATED FOODS
⚫ Any commodity which is either expensive or sells more is a target for
adulteration.
⚫ Foods which are in a powder, minced or paste form are more likely to
be adulterated.
⚫ Adulteration of foods sold loose by the retailer is also more common
as compared to packaged foods.
⚫ Foods commonly adulterated include:
⚫ Food grains like wheat, rice, pulses and their products like wheat flour,
semolina, gram flour (besan).
⚫ Edible oils and fats e.g. sunflower oil, safflower oils, mustard oil, vanaspati.
⚫ Spices, both whole and ground, like red chilli powder, turmeric powder and
coriander powder.
⚫ Milk and milk products e.g ghee and milk powder.
⚫ Coffee and tea.
⚫ Sweetening agent like sugar and honey.
⚫ Non- alcoholic beverages like aerated rinks, squashes, juices, sherbets
⚫ Miscellaneous items like confectionary, jams, sauces, ice creams and
prepared foods items like sweets, ladoos, jalebi and burfi
19
 STAGES AT WHICH ADULTERATION OCCURS

⚫ There are three stages at which food gets adulterated:

1. Producer
2. Distributor
3. Retailer

∙ Poor agricultural ∙ Poor storage ∙ Poor hygiene and

practices conditions sanitation
∙ Improper processing, ∙ Improper conditions ∙ Improper storage
storage & packaging of transportation ∙ Intentional addition of
∙ Intentional addition ∙ Intentional addition adulterant or
of adulterant or of adulterant or substitution of cheaper
substitution with substitution with materials
cheaper materials cheaper materials
20
 Common Adulterants
detected in different food items (excluding microbial contaminants)

Food Category Adulterants

Milk Antibiotics residues, formalin, boric acid, pesticide
residues, neutralizers like sodium bi- carbonate, urea,
water, sugar, starch, foreign fat.
Milk powder Pesticide residues, sugar, starch, fat, deficiency,
excessive moisture
Ghee and Vanaspati Extraneous colour, animal body fat, hydrogenated
vegetable oils, excessive moisture
Edible oils Castor oils, mineral oil, argemone oil, triorthocresyl
phosphate, oil soluble colours, aflatoxin, pesticide
residues, and cheaper vegetable oils
Spices Non- permitted colours, mineral oil coating, husk
starch, foreign seeds/ resins, extraneous matter,
exhausted spices
21
 Food Category Adulterants
Non alcoholic beverages Saccharin, dulcin, brominates vegetable oil, non
permitted colours, and excessive permitted colours
Confectionary, sweets and Non- permitted colours, aluminium foil, permitted
savouries colour ore than prescribed limit
Coffee Chicory, date or tamarind seeds, artificial colour
Tea Colour, iron filings, foreign leaves, exhausted
leaves
Pulses and their products Foreign pulses like lathyrus sativus, vicia sativa,
like besan lens esculenta, artificial colours, talc, foreign
starch, extraneous matter
Cereals and their products Fungal infestation, pesticide residues, sand, dirt,
like maida, suji, flour foreign starch, powdered chalk, iron filings

22
 Harmful Effects of Adulterants
⚫ There are many adulterants which might prove to be a hazard to our
health especially if consumed over a long period of time.
⚫ Chemicals like urea, sodium carbonate, sodium hydroxide,
formaldehyde and hydrogen peroxide added to increased shelf life of
milk can be harmful when ingested. They can damage the intestinal
lining irritating it.
⚫ Un- permitted food additives or permitted food additives added in
excess; both can cause serious damage of health. Whether they are
flavouring, colourings, preservatives, antioxidants etc. They are all
chemicals which are safe only if eaten in very small quantities.
⚫ The use of certain colours has been banned as they are well known or
their toxicity in experimental animals. Non- permitted colours like
auramine, Rhodamine B, Sudan red, malachite green, Orange II lead
to retardation of growth and affects the proper functioning of vital
organs like liver, kidneys, heart spleen, lungs, bones and the immune
systems. The commonly used metanil yellow could be injurious to the
stomach, ileum, rectum, liver, kidney, ovary and testis. All he non-
permitted colours can also bring about changes in genes, most having
been identified as potential cancer- causing agents.
⚫ Toxicity of permitted colours is also well demonstrated as allergic
23
response to these colours e.g. Tartrazine
 Impact of Adulteration on Economic Sector

⚫ Economic losses involve value of food rendered unfit for

consumption. In addition there is the cost of treating people who
have fallen sick, been disabled or the heavy cost of lives lost

⚫ If exported foods do not meet rigorous quality standards, they

would have to be recalled, cases would be filed in court and the
product would loose credibility in the local and international
market

24
 Methods for Detection of Common Adulterants

There are three types of simple tests for detecting adulterants:

⚫ Simple visual tests

⚫ Simple physical tests
⚫ Simple chemical tests

25
 FOOD ADDITIVES
⚫ Food additives are substances added to food to preserve flavour or
improve its taste and appearance
⚫ Some additives have been used for centuries; for example,
preserving food by pickling (with vinegar), salting, as with bacon,
preserving sweets or using sulphur dioxide as in some wines
⚫ With the advent of processed foods in the second half of the 20th
century, many more additives have been introduced, of both natural
and artificial origin
⚫ A food additive may be defined as any substance or a mixture of
substances other than the basic foodstuff which is present in food as
a result of any aspect of production, processing, storage or
packaging
⚫ Food additives are added intentionally to foods and are not naturally
a part of the food
⚫ Different countries have different laws pertaining to which food
additives can be used and in which foods
⚫ These laws specify the amounts and names of food additives which
can be added to certain foods
26
 FUNCTIONS OF FOOD ADDITIVES

⚫ Maintaining product consistency

⚫ Improving or maintaining nutritive value
⚫ Maintaining palatability and wholesomeness
⚫ Improving flavour or imparting desired color
⚫ Providing leavening or controlling acidity
acidity/alkalinity

27
 CLASSIFICATION OF FOOD ADDITIVES
Food additives are classified based on their function in food
i.e. the purpose for which the additive has been added to the
food.
The various classes of food additives include:
⚫ Antioxidants
⚫ Preservatives
⚫ Food colors
⚫ Food flavours
⚫ Emulsifiers and stabilizers
⚫ Artificial sweeteners
⚫ Miscellaneous: Anti-caking agents; sequesterants; acids,
bases, and buffers; anti-foaming agents, enzymes,
28
leavening agents.
 Broadly speaking, these food additives can be classified as:
⚫ Direct food additives
⚫ Indirect food additives
⚫ Direct food additives are added to a food for a specific
purpose in that food e.g. synthetic color
⚫ Indirect food additives become part of the food in trace
amounts due to packaging, storage or other handling
⚫ Additives used in raw ingredients or any other material
with which foods may come in contact may find their way
into the finished food product
⚫ Antioxidants, for example, used in edible oil may be
found in chips or any food item prepared with this oil
⚫ This is known as the “carry over” principle
29
 Food additives classification as per Codex Alimentarius
Functional classes (for Definition Sub-classes (Technological
Labelling purposes) functions)
1. Acid Increases the acidity and/or Acidifier
imparts a sour taste to a food

2. Acidity Regulator Alters or controls the acidity acid, alkali, base, buffer,
or alkalinity of a food buffering agent, pH adjusting
agent
3. Anti caking agent Reduces the tendency of anticaking agent, antistick
particles of food to adhere to agent, drying agent, dusting
one another powder, release agent
4. Antifoaming agent Prevents or reduces foaming Antifoaming agent

5. Antioxidant Prolongs the shelf-life of Antioxidant, antioxidant

foods by protecting against synergist, sequestrant
deterioration caused by
oxidation, such as fat rancidity
and colour changes
30
 Functional classes (for Definition Sub-classes (Technological
Labelling purposes) functions)
6. Bulking agent A substance, other than air bulking agent, filler
or water, which contributes
to the bulk of a food
without contributing
significantly to its available
energy value

7. Colour Adds or restores colour in a Colour

food

8. Colour retention agent Stabilizes, retains or Colour fixative, colour stabilizer

intensifies the colour of a
food

9. Emulsifier Forms or maintains a emulsifier, plasticizer,

uniform mixture of two or dispersing agent, surface active
more immiscible phases agent, surfactant, wetting agent
31
such surface as oil and
 Functional classes (for Definition Sub-classes (Technological
Labelling purposes) functions)
10. Emulsifying salt Rearranges cheese proteins melding salt, sequestrant
in the manufacture of
processed cheese, in order
to prevent fat separation

11. Firming agent Makes or keeps tissues of firming agent

fruit or vegetables firm and
crisp, or interacts with
gelling agents to produce or
strengthen a gel

12. Flavour enhancer Enhances the existing taste flavour enhancer, flavour
and/or odour of a food modifier, tenderizer

13. Flour treatment agent A substance added to flour bleaching agent, dough
to improve its baking improver, flour improver
quality or colour
32
 Numbering
⚫ To regulate these additives, and inform consumers, each additive is assigned a
unique number
⚫ Initially these were the "E numbers" used in Europe for all approved additives
⚫ This numbering scheme has now been adopted and extended by the Codex
Alimentarius Commission to internationally identify all additives, regardless of
whether they are approved for use
⚫ E numbers are all prefixed by "E", but countries outside Europe use only the
number, whether the additive is approved in Europe or not
⚫ For example, acetic acid is written as E260 on products sold in Europe, but is simply
known as additive 260 in some countries
⚫ Additive 103, alkanet, is not approved for use in Europe so does not have an E
number, although it is approved for use in Australia and New Zealand
⚫ Since 1987 Australia has had an approved system of labelling for additives in
packaged foods
⚫ Each food additive has to be named or numbered
⚫ The numbers are the same as in Europe, but without the prefix 'E‘
⚫ The United States Food and Drug Administration listed these items as "Generally
recognized as safe" or GRAS and these are listed under both their Chemical Abstract
Services number and FDA regulation listed under the US Code of Federal
33 Regulations
 Safety Issues
⚫ A large number of substances in use today as food additives are “generally
recognised as safe” or GRAS substances. GRAS substances are those
whose use is generally recognized by experts as safe, based on their
extensive history of use in food or based on published scientific evidence.
Salt, sugar, spices, vitamins are classified as GRAS substances
⚫ Although most food additives are considered to be without any potential
adverse effects, there have been problems concerning the safety of some of
these chemicals.
⚫ The safety of the antioxidant BHA has been questioned in the light of the
fact that its consumption leads to cancer in rodents
⚫ Sensitive asthmatics have been reported to develop allergic responses to
the food color tartrazine. Allergies have been reported to cause even fatal
shock. Nitrites can form cancer-causing nitrosamines in foods in which
they are added as preservatives
⚫ MSG intake of 1.5g or more can result in acute illness characterized by
burning or tingling sensation on face, neck and head, tightness, stiffness or
34 pressure in chest and facial muscles. This is the “Chinese Restaurant
Syndrome” because these symptoms have been seen in people who had
 ⚫ High levels of erythrosine intake have been associated with thyroid
tumors
⚫ Ponceau 4R, Tartrazine and Sunset Yellow FCF have provoked allergic
reactions in several individuals even at loe levels of intake. The allergic
responses vary rashes to swelling and worsening of the condition of
patients with asthma
⚫ One should choose foods that are free of additives or at least select
those brands of processed foods which have a minimum number of
additives. Foods with artificial or synthetic colors and Class II
preservatives should specially be avoided. The label of the food
product declares the presence of the additives used in the product.
Hence only properly labelled foods should be selected
⚫ With the increasing use of processed foods since the 19th century,
there has been a great increase in the use of food additives of varying
levels of safety. This has led to legislation in many countries regulating
their use. For example, boric acid was widely used as a food
preservative from the 1870s to the 1920s, but was banned after World
35 War I due to its toxicity, as demonstrated in animal and human studies.
 ⚫ During World War II the urgent need for cheap, available food
preservatives led to it being used again, but it was finally banned in the
1950s. Such cases led to a general mistrust of food additives, and an
application of the precautionary principle led to the conclusion that only
additives that are known to be safe should be used in foods. In the USA,
this led to the adoption of the Delaney clause, an amendment to the
Federal Food, Drug, and Cosmetic Act of 1938, stating that no
carcinogenic substances may be used as food additives. However, after the
banning of cyclamates in the USA and Britain in 1969, saccharin, the only
remaining legal artificial sweetener at the time, was found to cause cancer
in rats.
⚫ There has been significant controversy associated with the risks and
benefits of food additives. Some artificial food additives have been linked
with cancer, digestive problems, neurological conditions in addition to
ADHD, and diseases like heart disease or obesity.
⚫ Even "natural" additives may be harmful in certain quantities (table salt,
for example) or because of allergic reactions in certain individuals. Safrole
was used to flavour root beer until it was shown to be carcinogenic. Due to
36 the application of the Delaney clause, it may not be added to foods, even
 Food Packaging and Labelling
⚫ Packaging is the science, art and technology of enclosing
or protecting products for distribution, storage, sale, and
use
⚫ Packaging also refers to the process of design, evaluation,
and production of packages
⚫ Packaging can be described as a coordinated system of
preparing goods for transport, warehousing, logistics,
sale, and end use
⚫ Packaging contains, protects, preserves, transports,
informs, and sells
⚫ In many countries it is fully integrated into government,
business, institutional, industrial, and personal use
⚫ Package labelling (en-GB) or labelling (en-US) is any
written, electronic, or graphic communications on the
37
packaging or on a separate but associated label
 ⚫ The first packages used the natural materials available at the
time: Baskets of reeds, wineskins (Bota bags), wooden boxes,
pottery vases, ceramic amphorae, wooden barrels, woven bags,
etc.
⚫ Processed materials were used to form packages as they were
developed: for example, early glass and bronze vessels
⚫ The study of old packages is an important aspect of archaeology
⚫ Iron and tin plated steel were used to make cans in the early
19th century
⚫ Paperboard cartons and corrugated fiberboard boxes were first
introduced in the late 19th century
⚫ Packaging advancements in the early 20th century included
Bakelite closures on bottles, transparent cellophane overwraps
and panels on cartons, increased processing efficiency and
improved food safety
⚫ As additional materials such as aluminum and several types of
38 plastic were developed, they were incorporated into packages to
improve performance and functionality
 Objectives/purposes of packaging and package labels

⚫ Physical protection - The objects enclosed in the package may

require protection from, among other things, shock, vibration,
compression, temperature, etc.
⚫ Barrier protection - A barrier from oxygen, water vapor, dust,
etc., is often required. Permeation is a critical factor in design.
Keeping the contents clean, fresh, sterile and safe for the
intended shelf life is a primary function.
⚫ Containment or agglomeration - Small objects are typically
grouped together in one package for reasons of efficiency. For
example, a single box of 1000 pencils requires less physical
handling than 1000 single pencils. Liquids, powders, and
granular materials need containment.

39
 ⚫ Information transmission - Packages and labels communicate
how to use, transport, recycle, or dispose of the package or
product. With pharmaceuticals, food, medical, and chemical
products, some types of information are required by
governments. Some packages and labels also are used for track
and trace purposes

⚫ Marketing - The packaging and labels can be used by marketers

to encourage potential buyers to purchase the product. Package
graphic design and physical design have been important and
constantly evolving phenomenon for several decades. Marketing
communications and graphic design are applied to the surface of
the package and (in many cases) the point of sale display

40
 ⚫ Security - Packaging can play an important role in reducing the
security risks of shipment. Packages can be made with improved
tamper resistance to deter tampering and also can have tamper-evident
features to help indicate tampering. Packages may include
authentication seals and use security printing to help indicate that the
package and contents are not counterfeit. Packages also can include
anti-theft devices, such as dye-packs, RFID tags, or electronic article
surveillance tags that can be activated or detected by devices at exit
points and require specialized tools to deactivate. Using packaging in
this way is a means of loss prevention
⚫ Convenience - Packages can have features that add convenience in
distribution, handling, stacking, display, sale, opening, reclosing, use,
dispensing, and reuse
⚫ Portion control - Single serving or single dosage packaging has a
precise amount of contents to control usage. Bulk commodities (such
as salt) can be divided into packages that are a more suitable size for
individual households. It is also aids the control of inventory: selling
41 sealed one-liter-bottles of milk, rather than having people bring their
own bottles to fill themselves.
 Types of Packaging
⚫ Packaging types Packaging may be looked at as being of several
different types

⚫ For example a transport package or distribution package can be the

shipping container used to ship, store, and handle the product or inner
packages

⚫ Some identify a consumer package as one which is directed toward a

consumer or household

⚫ Packaging may be described in relation to the type of product being

packaged: medical device packaging, bulk chemical packaging,
over-the-counter drug packaging, retail food packaging, military
materiel packaging, pharmaceutical packaging, etc.
42
 ⚫ It is sometimes convenient to categorize packages by layer or function:
"primary", "secondary", etc.
⚫ Primary packaging is the material that first envelops the product and
holds it. This usually is the smallest unit of distribution or use and is
the package which is in direct contact with the contents
⚫ Secondary packaging is outside the primary packaging, perhaps used
to group primary packages together
⚫ Tertiary packaging is used for bulk handling, warehouse storage and
transport shipping
⚫ The most common form is a palletized unit load that packs tightly into
containers. These broad categories can be somewhat arbitrary. For
example, depending on the use, a shrink wrap can be primary
packaging when applied directly to the product, secondary packaging
when combining smaller packages, and tertiary packaging on some
distribution packs
⚫ Symbols used on packages and labels Many types of symbols for
package labelling are nationally and internationally standardized. For
43
consumer packaging, symbols exist for product certifications,
 Symbols used on packages and labels

⚫ Many types of symbols for package labelling are nationally and

internationally standardized
⚫ For consumer packaging, symbols exist for product
certifications, trademarks, proof of purchase, etc.
⚫ Some requirements and symbols exist to communicate aspects of
consumer use and safety
⚫ Examples of environmental and recycling symbols include:
Recycling symbol, Resin identification code (below), and Green
Dot (symbol). Bar codes (below), Universal Product Codes, and
RFID labels are common to allow automated information
management in logistics and retailing
⚫ Country of Origin Labelling is often used

44
 LABELLING RULES

⚫ Consumers should be able to be confident with their choice of

foods and be able to buy according to their particular
requirements, be it for diet and health, personal taste and
preferences, or cost
⚫ They want to be able to make comparisons with similar products,
knowing the information on the label is correct
⚫ They have a right to expect that the food bought matches the
description given on the label and that they get what they pay for
⚫ Part of the Food Standards Agency's role is to help prevent
mislabelling or misdescription of foods
⚫ Mislabelling does not normally give rise to safety issues;
nevertheless, when done deliberately it constitutes the crime of
fraud
45
 ⚫ In some cases, the names of foods we buy are protected by law,
and must comply with certain compositional regulations
⚫ In other cases, such as fish fingers, there may be no such
standards, but the food still needs to be described accurately and
should not be misleading
⚫ Food authenticity is all about whether a food matches its
description
⚫ If food is misdescribed, not only is the consumer being deceived,
but it can also create unfair competition with the honest
manufacturer or trader
⚫ The description of food refers to the information given as to its
name, its ingredients, its origin or processes undergone
⚫ In the past, basic foods such as flour, spices and beer were
46 adulterated with cheaper ingredients
 FORMS OF Regulations:
⚫ FSS Act (2006) defines labelling as, “labelling” includes any
written, printed or graphic matter that is present on the label
accompanying the food. Regulation 4.1.1 explains the general
labelling requirements as:
1) Every prepackaged food to carry a label.
2) Prepackaged food shall not be described or presented on any
label or in any labelling manner that is false, misleading or
deceptive or is likely to create an erroneous impression regarding
its character in any respect.
3) Label in prepackaged foods shall be applied in such a manner
that they will not become separated from the container.
4) Contents on the label shall be clear, prominent, indelible and
readily legible by the consumer under normal condition of
purchase and use.
47
5) Where the container is covered by a wrapper, the wrapper
 As per FSS Act (2006); clause 23:
(1) No person shall manufacture, distribute, sell or expose for sale
or dispatch or deliver to any agent or broker for the purpose of sale,
any packaged food products which are not marked and labelled in
the manner as may be specified by regulations:
Provided that the labels shall not contain any statement, claim,
design or device which is false or misleading in any particular
concerning the food products contained in the package or
concerning the quality or the nutritive value implying medicinal
or therapeutic claims or in relation to the place of origin of the
said food products.
(2) Every food business operator shall ensure that the labelling and
presentation of food, including their shape, appearance or
packaging, the packaging materials used, the manner in which they
are arranged and the setting in which they are displayed, and the
48
information which is made available about them through whatever
medium.
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 4

Advances in
Food Safety & Quality Management
• Project
/ GHPIdentification
Project
GMP Identification&&Screening
Screening
• HACCP
• ISO 9001 QMS
• ISO 22000 FSMS
• TQM
Samit Dutta, Associate Professor & Head,
Dept. of Food Business Management,
1
College of FPTBE, AAU
 Good Manufacturing and Hygienic
Production
⚫ The food processing industry is one of the largest
industries in India having huge potential for uplifting
agricultural economy, creation of large scale processed
food manufacturing and food chain facilities
⚫ Food processing covers a spectrum of products from
sub-sector comprising agriculture, horticulture,
plantation, animal husbandry and fisheries

⚫ Essentially, the food industry involves the commercial

movement of food from field to fork

2
 ⚫ The foundation for Food Safety is infrastructure and
hygiene
⚫ Quality and food safety improvement and maintenance is
a continuous process
⚫ It can be achieved if primary production measures,
production operations, storage and packaging are
monitored properly with care
⚫ Food Regulations have substantial influence on the
manufacturer

⚫ Adoption of Good Hygienic Practice (GHP), Good

Manufacturing Practice (GMP), food safety management
systems based on HACCP/ISO 22000 and quality
3
management systems based on ISO 9001 help food
processing industries to maintain food quality and safety
 Good Hygiene Practices (GHP)
⚫ Good Hygienic Practices may be defined as all practices
regarding the conditions and measures necessary to
ensure the safety and suitability of food at all stages of the
food chain

⚫ GENERAL PRINCIPLE: Identify the essential principles

of food hygiene applicable throughout the food chain, to
achieve the goal of ensuring that food is safe and suitable
for human consumption

4
 Areas examined under GHP
⚫ i. Primary production
⚫ ii. Establishment: design and facilities
⚫ iii. Control of operation
⚫ iv. Establishment: maintenance and sanitation
⚫ v. Establishment: personal hygiene
⚫ vi. Transportation
⚫ vii. Product information and consumer awareness
⚫ viii. Training

5
 Good Manufacturing Practice (GMP)
⚫ A term that is recognized worldwide for the control and
management of manufacturing and quality control testing of
foods, pharmaceutical products, and medical devices
⚫ GMP takes the holistic approach of regulating the
manufacturing and laboratory testing environment itself
⚫ An extremely important part of GMP is documentation of
every aspect of the process, activities, and operations involved
with food, drug and medical device manufacturer

⚫ Additionally, GMP requires that all manufacturing and testing

equipment has been qualified as suitable for use, and that all
operational methodologies and procedures (such as
manufacturing, cleaning, and analytical testing) utilized in the
food and drug manufacturing process have been validated, to
demonstrate that they can perform their purported function

6
 Issues addressed under GMP
⚫ GMP regulations address issues including recordkeeping,
personnel qualifications, sanitation, cleanliness, equipment
verification, process validation, and complaint handling
⚫ Most GMP requirements are very general and open-ended,
allowing each manufacturer to decide individually how to best
implement the necessary controls
⚫ This provides much flexibility, but also requires that the
manufacturer interpret the requirements in a manner which
makes sense for each individual business
⚫ GMP is a good business tool which will help to refine both
compliance and performance at company
⚫ GMP requirements are largely common sense practices which
will help your company better itself as it moves toward a quality
approach using continuous improvement
7
 Good Manufacturing Practices (GMP) &
Good Hygiene Practices (GHP) for Food
Businesses

8
 1. Primary Production
⚫ The Food establishment shall exercise control
contamination of food produce / materials from air, soil,
water, feedstuffs, pests, fertilizers, pesticides, veterinary
drugs during production, handling, storage and transport, as
appropriate

⚫ Plant and animal health are controlled so that it does not

pose a threat to human health through food consumption

9
 2. Location and Surroundings
⚫ Food establishment shall be located away from
⚫ environmentally polluted areas and industrial activities
which produce disagreeable or obnoxious odour, fumes,
excessive soot, dust, smoke, chemical or biological
emissions and pollutants which pose a serious threat of
contaminating food;
⚫ areas subject to flooding;
⚫ areas prone to infestations of pests; and
⚫ areas where wastes, either solid or liquid, cannot be
removed effectively

10
 3. Layout and Design of Food Establishment Premises

⚫ The layout of the food establishment shall ensure a forward

food preparation / manufacturing process flow such that
cross-contamination from earlier steps in the process is
avoided in the later steps
3.1 Equipment
⚫ Equipment and containers that come in contact with food
and used for food handling, storage, preparation, processing,
packaging and serving shall be made of materials, which do
not impart any toxicity to the food material
⚫ Containers used to hold cleaning chemicals and other
dangerous substances shall be identified and where
appropriate, be lockable to prevent accidental contamination
11 of food
 3.2 Facilities
⚫ Water supply

Only potable water which meets the requirements of

specifications on drinking water, with appropriate facilities for
its storage, distribution and temperature control, shall be used,
if required as an ingredient and also for food handling,
washing, processing and cooking.

Water storage tanks shall be cleaned periodically and records

of the same shall be maintained.

12
 ⚫ Ice and steam

Ice and steam used in direct contact with food shall be made
from potable water and complying with requirements
specified.

Ice and steam shall be produced, handled and stored to protect

them from any contamination.

13
 ⚫ Drainage and waste disposal

The disposal of sewage and effluents (solid, liquid and gas) shall be in
conformity with requirements of Environment Pollution Control Board.
Adequate drainage, waste disposal systems and facilities shall be provided.

They shall be designed and constructed so that the risk of contaminating food or
the potable water supply is eliminated.

Waste storage shall be located in such place that it does not contaminate the food
process, storage areas, the environment inside and outside the food
establishment.

Waste shall be kept in covered containers and shall not be allowed to accumulate
in food handling, food storage, and other working areas.

14
 ⚫ Personnel facilities and toilets

Personnel facilities shall include adequate means of hygienically washing

and drying hands, including wash basins and a supply of hot and /or cold
water; separate lavatories of appropriate hygienic design for males and
females; and adequate changing facilities for personnel.

Such facilities shall be suitably located so that they do not open directly into
food process areas.

Rest and refreshments rooms shall be separate from food process and service
areas.

These areas shall not lead directly to food production, service and storage
areas.

15
 ⚫ Air quality and ventilation

Ventilation systems, natural or mechanical, including air filters, wherever

required, shall be designed and constructed so that air does not flow from
contaminated areas to clean areas; minimize air-borne contamination of food;
control odours; control ambient temperatures and humidity, where necessary, to
ensure the safety and suitability of food.

⚫ Lighting

Adequate natural or artificial lighting shall be provided to enable the undertaking

to operate in a hygienic manner. Lighting fixtures should, where appropriate, be
protected to ensure that food is not contaminated by breakages

16
 4. Food Operations and Controls
4.1 Procurement of raw materials
⚫ No raw material or ingredient shall be accepted by an
establishment if it is known to contain parasites, undesirable
micro-organisms, pesticides, veterinary drugs or toxic,
decomposed or extraneous substances, which would not be
reduced to an acceptable level by normal sorting and/or
processing.

4.2 Storage of raw materials and food

⚫ Food storage facilities shall be designed and constructed to
enable food to be effectively protected from contamination
during storage; permit adequate maintenance and cleaning;
17
and avoid pest access and harbourage.
 4.3 Food Processing, Packaging and Distribution, Temperature
control
The Food establishment shall develop and maintain system to ensure that
time and temperature is controlled effectively where it is critical to the
safety and suitability of food. Such controls shall include time and
temperature of receiving, processing, cooking, cooling, storage,
packaging, distribution and food service upto the consumer, as
applicable.

⚫ Precautions against contaminants and cross-contamination

Systems shall be in place to prevent contamination of food materials and
foods by physical, chemical and microbiological contaminants.
Microbiological and chemical analysis, suitable detection devices for
foreign objects shall be used, where necessary.
Access to food preparation / processing / manufacturing facility shall be
controlled.
18
Further, staff from raw processing areas shall not be allowed to go to
 ⚫ Food Packaging
Packaging materials shall provide adequate protection for processed food
products to prevent contamination, damage and accommodate proper labelling.
Packaging materials or gases where used shall be non-toxic and not pose a threat
to the safety and suitability of food under the specified conditions of storage and
use.

⚫ Food Distribution / Service

Processed, packaged / ready-to-eat food shall be adequately protected during
transport and service. Temperatures and humidity necessary for sustaining food
safety and quality shall be maintained during transport and service.
The conveyances /containers shall be designed, constructed and maintained such
that they can effectively maintain the requisite temperature, humidity,
atmosphere and other conditions necessary to protect food.

19
 5. Management and Supervision
⚫ The Food establishment shall ensure that managers and
supervisors have appropriate qualifications, adequate knowledge
and skills of food hygiene principles and practices to be able to
⚫ ensure food safety and quality of its products,

⚫ judge food hazards,

⚫ take appropriate preventive and corrective action, and

⚫ ensure that effective monitoring and supervision takes place.

20
 6. Documentation and Records
⚫ Appropriate records of food processing / preparation, production
/ cooking, storage, distribution, service, food quality assurance,
cleaning and sanitation, pest control and product recall shall be
kept and retained for a period that exceeds one year or the
shelf-life of the product, which ever is more.

7. Traceability and Food Products Recall

⚫ The Food Business shall ensure that effective traceability
procedures are in place from raw material to finished product and
to the consumer so as to deal with any food safety hazard and to
enable the complete, rapid recall of any implicated lot of the food
product from the market.

21
 8. Sanitation and Maintenance of Establishment Premises
8.1 Cleaning and maintenance
⚫ Food premises shall be kept clean and where possible dry, maintained
in good repair and condition and have an adequate supply of hot and
cold water.
⚫ Work surfaces and surfaces of equipment in contact with food shall be
maintained in a sound condition, cleaned and, where necessary,
disinfected at frequent intervals.

8.2 Pest Control Systems

⚫ Food establishment shall be kept in good repair and condition to
prevent pest access and to eliminate potential breeding sites.
⚫ Holes, drains and other places where pests are likely to gain access
shall be kept sealed or fitted with mesh / grills / claddings as required.
⚫ Animals and pets shall not be allowed into the food establishment
premises.
22
⚫ Records of pesticides / insecticides used shall be maintained.
 8.3 Personal Hygiene
⚫ Health Status
Personnel known, or suspected, to be suffering from, or to be a carrier of a
disease or illness likely to be transmitted through food, shall not be allowed to
enter any food handling area if there is a likelihood of their contaminating food.
The Food establishment shall develop system whereby any person so affected
shall immediately report illness or symptoms of illness to the management.
Medical examination of a food handlers shall be carried out if clinically or
epidemiologically indicated.

⚫ Personal Cleanliness
Food handlers shall maintain a high degree of personal cleanliness.
The Food establishment shall provide to all food handlers adequate and suitable,
clean protective clothing, head covering and footwear.
The Food operators shall ensure that the food handlers at work wear only clean
protective clothes, head covering and footwear every day.
23
 ⚫ Personal Behaviour

Food handlers engaged in food handling activities shall refrain from smoking;
spitting; chewing or eating; sneezing or coughing over unprotected food and
eating in food preparation and food service areas
Food handlers shall not wear any personal effects such as rings, bangles,
jewellery, watches, pins and other items that pose a threat to the safety and
suitability of food.

⚫ Visitors

The Food establishment shall ensure that visitors to its food manufacturing,
cooking, preparation, storage or handling areas should, where appropriate, wear
protective clothing and adhere to the other personal hygiene provisions in this
section.

24
 9. Product Information and Consumer Awareness

⚫ All packaged food products shall carry a label and requisite

information as specified under regulatory bodies so as to ensure

that adequate and accessible information is available to the next
person in the food chain to enable them to handle, store, process,
prepare and display the food products safely and correctly and

that the lot or batch can be easily traced and recalled if necessary.

25
 10. Training

⚫ The Food establishment shall ensure that all food handlers are

aware of their role and responsibility in protecting food from

contamination or deterioration.

⚫ Food handlers shall have the necessary knowledge and skills

relevant to the food processed / manufactured, packed, stored and

served so as to ensure the food safety and food quality.

26
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 5

Advances in
Food Safety & Quality Management
• Project
ProjectIdentification
HACCP Identification&&Screening
Screening

Samit Dutta, Associate Professor & Head,

Dept. of Food Business Management,
1
College of FPTBE, AAU
 HACCP
⚫ HACCP stands for Hazard Analysis and Critical Control Point.
⚫ Hazard is a biological, chemical or physical agent that is
reasonably likely to cause illness or injury in the absence of its
control.
⚫ Hazards can be harmful microorganisms or chemical and/or
physical contaminants.
⚫ To ensure safe food, HACCP system is designed to identify
hazards, establish controls and monitor these controls.
⚫ HACCP is a preventive system of hazard control rather than a
reactive one.
⚫ Food processors can use it to ensure safer food products for
consumers.

2
 ⚫ The Pillsbury Co. pioneered the application of the HACCP
concept to food production during its efforts to supply food for
the U.S. space program in the early 1960s.
⚫ It is not a zero-risk system, but it is designed to minimize the
risk of food-safety hazards.
⚫ In an assessment of the effectiveness of food regulation in the
United States, the National Academy of Sciences (NAS)
recommended in 1985 that the HACCP approach be adopted by
all regulatory agencies and that it be mandatory for food
processors. Since then globally this system has been adopted to
ensure safety of foods.

⚫ HACCP is a preventive system for ensuring food safety, but it is

not a stand-alone system. HACCP must be built upon current
food-safety programs such as Good Manufacturing Practices
3 (GMPs) and others to make it work.
 ⚫ Codex has defined HACCP as a system which identifies,
evaluates, and controls hazards which are significant for food
safety.
⚫ More broadly it is a scientific and rational approach to food
safety which analyzes potential hazards, determines the critical
control points in a food process and develops monitoring
procedures to determine if the hazards identified are being
effectively controlled.
⚫ It enhances food safety besides better use of resources and
timely response to problems.
⚫ HACCP has signaled a shift in emphasis from resource
intensive end-product inspection and testing to preventive
control of hazards at all stages of food production.
⚫ This is the reason why HACCP system is now widely embraced
by the food industries and by the government regulatory
4
agencies around the world as a most cost-effective means of
minimizing the occurrence of identifiable food borne biological,
 ⚫ It is a system which targets critical areas of processing and in
doing so reduces the risk of manufacturing and selling unsafe
products.

⚫ HACCP can be applied throughout the food chain from the

primary production to final consumption and its implementation
should be guided by scientific evidence of risks to human health
to enhance food safety and provide other significant benefits.

⚫ In addition, the application of HACCP systems can aid

inspection by regulatory authorities and promote international
trade by increasing confidence in food safety.

5
 HACCP Plan
⚫ To perform a hazard analysis for the development of a
HACCP plan, food processors must gain a working knowledge
of potential hazards.

⚫ The HACCP plan is designed to control all reasonably likely

food-safety hazards.

⚫ Such hazards are categorized into three classes: biological,

chemical and physical.

6
 Biological Hazards
⚫ These hazards can come from raw materials or from
food-processing steps used to make the final product.
Microorganisms live everywhere: air, dirt, fresh and salt water,
skin, hair, animal fur and plants.
⚫ Microorganisms are classified into various groups. A few
groups important in foods include yeasts, molds, bacteria,
viruses and protozoa. Although thousands of kinds of
microorganisms exist, only a few pose hazards to humans.
⚫ Without adequate food, water and temperature, microorganisms
stop growing and multiplying. Some die and others stop
functioning until they get the elements they need.

⚫ Some preservation methods, such as drying or smoking, control

of water or nutrients in food, make these essential elements
7
unavailable to microorganisms.
 Chemical Hazards
⚫ Chemical contamination can happen at any stage in food
production and processing.
⚫ Chemicals can be helpful and are purposefully used with some
foods, such as preservatives.
⚫ The presence of a chemical may not always represent a hazard.
The amount of the chemical may determine whether it is a
hazard or not. Some may require exposure over prolonged
periods to have a toxic effect. Regulatory limits are set for
some of those contaminants.

⚫ Chemical hazards can be separated into three categories:

⚫ Naturally occurring chemicals
⚫ Intentionally added chemicals

8
⚫ Unintentionally or incidentally added chemicals
 Physical Hazards
⚫ Physical hazards include any potentially harmful extraneous
matter not normally found in food.

⚫ When a consumer mistakenly eats the foreign material or

object, it is likely to cause choking, injury or other adverse
health effects.

⚫ The source of the hazard is often easy to identify.

9
 Guidelines for the Application of the HACCP
System
⚫ Prior to application of HACCP to any sector of the food chain,
that sector should be operating according to the Codex General
Principles of Food Hygiene, the appropriate Codex Codes of
Practice and appropriate food safety legislation like FSSAI.
⚫ Management commitment is necessary for implementation of
an effective HACCP system.

⚫ During hazard identification, evaluation and subsequent

operations in designing and applying HACCP systems,
consideration must be given to the impact of raw materials,
ingredients, food manufacturing practices, role of
manufacturing processes to control hazards, likely end-use of
the product, categories of consumers of concern, and
epidemiological evidence relative to food safety.
10
 Principles
The HACCP system consists of the following seven principles:

⚫ Principle 1 : Conduct a hazard analysis.

⚫ Principle 2 : Determine the Critical Control Points (CCPs).
⚫ Principle 3 : Establish critical limit(s).
⚫ Principle 4 : Establish a system to monitor control of the CCP.
⚫ Principle 5 : Establish the corrective action to be taken when
monitoring indicates that a particular CCP is not under control.
⚫ Principle 6 : Establish procedures for verification to confirm
that the HACCP system is working effectively.
⚫ Principle 7 : Establish documentation concerning all
procedures and records appropriate to these principles and their
application.
11
 Logic Sequence for Application of HACCP
The application of HACCP principles consists of the following
tasks as the Logic Sequence for Application of HACCP:
1. Assemble the HACCP Team
2. Describe the Product
3. Identify Intended Use
4. Construct Flow Diagram
5. On‑site Confirmation of Flow Diagram
6. List All Potential Hazards Conduct a Hazard Analysis Determine Control
Measures
7. Determine CCPs
8. Establish Critical Limit for Each CCP
9. Establish a Monitoring System for Each CCP
10. Establish Corrective Action for Deviations that May Occur
11. Establish Verification Procedures
1212. Establish Documentation and Record Keeping
 1. Assemble HACCP team
⚫ The food operation should assure that the appropriate product
specific knowledge and expertise is available for the
development of an effective HACCP plan.

⚫ This is accomplished by assembling a multidisciplinary team

consisting production, QA, engineering, marketing, purchase,
HR personnel.

⚫ The scope should describe which segment of the food chain is

involved and the general classes of hazards to be addressed.

13
 2. Describe product
⚫ A full description of the product should be drawn up, including
relevant safety information such as: composition,
physical/chemical structure (including aw, pH, etc.), microcidal
/ static treatments (e.g. heat-treatment, freezing, brining,
smoking, etc.), packaging, durability and storage conditions and
method of distribution.
3. Identify intended use
⚫ The intended use should be based on the expected uses of the
product by the end user or consumer.
⚫ In specific cases, vulnerable groups of the population, e.g.
institutional feeding may have to be considered.

14
 4. Construct flow diagram
⚫ The flow diagram should be constructed by the HACCP team.
⚫ The flow diagram should cover all steps in the operation.
⚫ When applying HACCP to a given operation, consideration
should be given to steps preceding and following the specified
operation.

5. On‑site confirmation of flow diagram

⚫ The HACCP team should confirm the processing operation
against the flow diagram during all stages and hours of
operation and amend the flow diagram where appropriate.

15
 6. List all potential hazards associated with each
step, conduct a hazard analysis and consider any
measures to control identified hazards
⚫ The HACCP team should list all of the hazards that may be
reasonably expected to occur at each step from primary
production, processing, manufacture, and distribution until the
point of consumption.

⚫ The HACCP team should conduct a hazard analysis to identify

for the HACCP plan which hazards are of such a nature that
their elimination or reduction to acceptable levels is essential to
the production of a safe food.
⚫ The team must then consider what control measures, if any,
exist which can be applied for each hazard.
16
 7. Determine Critical Control Points
⚫ There may be more than one CCP at which control is applied to
address the same hazard.

⚫ The determination of a CCP in the HACCP system can be

facilitated by the application of a decision tree which indicates a
logic reasoning approach.

⚫ Application of a decision tree should be flexible, given whether

the operation is for production, slaughter, processing, storage,
distribution or other.

⚫ It should be used for guidance when determining CCPs.

17
 8. Establish Critical Limits for each CCP

⚫ Critical limits must be specified and validated if possible for

each critical control point. In some cases more than one critical
limit will be elaborated at a particular step.

⚫ Criteria often used include measurements of temperature, time,

moisture level, pH, Aw, available chlorine and sensory
parameters such as visual appearance and texture.

18
 9. Establish a Monitoring System for each CCP

⚫ Monitoring is the scheduled measurement of a CCP relative to

its critical limits.
⚫ The monitoring procedures must be able to detect loss of
control at the CCP.
⚫ Data derived from monitoring must be evaluated by a
designated person with knowledge and authority to carry out
corrective actions when indicated.
⚫ Physical and chemical measurements are often preferred to
microbiological testing because they may be done rapidly and
can often indicate the microbiological control of the product.
⚫ All records and documents associated with monitoring CCPs
must be signed by the person doing the monitoring and by a
responsible reviewing official of the company.
19
 10. Establish a Corrective Actions

⚫ Specific corrective actions must be developed for each CCP in

the HACCP system in order to deal with deviations when they
occur.
⚫ The actions must ensure that the CCP has been brought under
control.
⚫ Actions taken must also include proper disposition of the
affected product.
⚫ Deviation and product disposition procedures must be
documented in the HACCP record keeping.

20
 11. Establish a Verification Procedures

⚫ Verification and auditing methods, procedures and tests,

including random sampling and analysis, can be used to
determine if the HACCP system is working correctly.

⚫ Examples of verification activities include:

⚫ Review of the HACCP system and its records
⚫ Review of deviations and product dispositions
⚫ Confirmation that CCPs are kept under control

21
 12. Establish a Documentation and Record Keeping
⚫ Efficient and accurate record keeping is essential to the
application of a HACCP system.
⚫ HACCP procedures should be documented.
⚫ Documentation and record keeping should be appropriate to the
nature and size of the operation.

⚫ The HACCP system is to focus control at Critical Control

Points (CCP).
⚫ Redesign of the operation should be considered if a hazard
which must be controlled is identified but no CCPs are found.
⚫ HACCP should be applied to each specific operation separately.
⚫ The HACCP application should be reviewed and necessary
changes should be made when any modification is made in the
22
product, process, or any step.
 Terminology
Term Description
Control (verb): To take all necessary actions to ensure and maintain
compliance with criteria established in the HACCP plan.
Control Measure: Any action and activity that can be used to prevent or
eliminate a food safety hazard or reduce it to an acceptable
level.
Corrective Action: Any action to be taken when the results of monitoring at the
CCP indicate a loss of control.
Critical Control A step at which control can be applied and is essential to
Point (CCP): prevent or eliminate a food safety hazard or reduce it to an
acceptable level.
Critical Limit: A criterion which separates acceptability from
unacceptability.
23
 Term Description
Deviation: Failure to meet a critical limit.
HACCP: A system which identifies, evaluates, and controls hazards
which are significant for food safety.
HACCP Plan: A document prepared in accordance with the principles of
HACCP to ensure control of hazards which are significant for
food safety in the segment of the food chain under
consideration.
Hazard: A biological, chemical or physical agent in, or condition of,
food with the potential to cause an adverse health effect.
Hazard Analysis: The process of collecting and evaluating information on
hazards and conditions leading to their presence to decide
which are significant for food safety and therefore should be
addressed in the HACCP plan.
24
 Term Description
Monitor: The act of conducting a planned sequence of observations or
measurements of control parameters to assess whether a CCP
is under control.
Validation: Obtaining evidence that the elements of the HACCP plan are
effective.
Verification: The application of methods, procedures, tests and other
evaluations, in addition to monitoring to determine
compliance with the HACCP plan.

25
26
27
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 6

Advances in
Food Safety & Quality Management

• ISO 22000 FSMS

• ISO 9001 QMS

Samit Dutta, Associate Professor & Head,

Dept. of Food Business Management,
1
College of FPTBE, AAU
 Introduction
⚫ ISO (the International Organization for Standardization) is a
worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International
Standards is carried out through ISO technical committees.
⚫ Food safety is related to the presence of food-borne
hazards in food at the point of consumption. As the food
safety hazards can occur at any stage of the food chain,
adequate control throughout the food chain is essential.
Thus, food safety is ensured through the combined efforts
of all the parties participating in the food chain.
⚫ The International Standard ISO 22000:2005 specifies the
requirements for a food safety management system that
combines the following generally recognized key elements
to ensure food safety along the food chain, up to the point
of final consumption.
2
 ⚫ The International Standard integrates the principles of
the Hazard Analysis and Critical Control Point (HACCP)
system and application steps developed by the Codex
Alimentarius Commission. By means of auditable
requirements, it combines the HACCP plan with
prerequisite programmes (PRPs). Hazard analysis is the
key to an effective food safety management system,
since conducting a hazard analysis assists in organizing
the knowledge required to establish an effective
combination of control measures.

⚫ Since ISO 22000 is a generic food safety management

standard, it can be used by any organization directly or
indirectly involved in the food chain. It applies to all
organizations in the food chain. It doesn't matter how
complex the organization is or what size it is, ISO 22000
3 can help ensure the safety of its food products.
 ⚫  The food chain consists of the entire sequence of
stages and operations involved in the creation and
consumption of food products. This includes every
step from initial production to final consumption.
More precisely, it includes the production, processing,
distribution, storage, and handling of all food and
food ingredients.

⚫ The food chain also includes organizations that do

not directly handle food. These include organizations
that produce feed for animals. It also includes
organizations that produce materials that will
eventually come into contact with food or food
ingredients.

4
 Advantages of ISO 22000: 2005
⚫ ISO 22000 will help you to achieve the following objectives:
⚫ a) To establish a food safety management system (FSMS).
⚫ b) To ensure that products do not cause adverse health
effects.
⚫ c) To demonstrate compliance with external safety
requirements.
⚫ d) To evaluate customers' food safety requirements.
⚫ e) To provide safe products and enhance customer
satisfaction.
⚫ f) To export food products and penetrate international
markets.
⚫ g) To communicate safety issues throughout the food
chain.
⚫ h) To ensure compliance with company’s food safety policy
5
 Key Elements of ISO 22000
• Interactive communication: Communication is essential along
the food chain to ensure all relevant food safety hazards are
identified and adequately controlled at each step within the food
supply chain. This implies for both upstream and down steam in
organizations.

• System Management: The most effective food safety systems

are to be designed, operated within the framework of structured
management system then and incorporated into the overall
management activities of the organization.

6
 • Prerequisite Program: The prerequisite programmes are

classified into 2 subcategories. The Infrastructure and

Maintenance programs which cover permanent features in
food safety. The Operational prerequisite programs are
designed to reduce the risk of hazards in the product or
processing environment.

• HACCP Principles: The HACCP plan is used to manage the

critical control points determined to eliminate, prevent or

reduce specific food safety hazard from the product, as
determined during hazard analysis.
7
 Interactive Communication

8
 ISO 22000 requires that interactive communication (i.e.
proactive, open, continuous dialogue with the stake holders)
to ensure that:

• a) all relevant food safety hazards are identified and

adequately controlled at each step within the food chain

through communication to all parties in the food chain.

• b) Communication with customers and suppliers, based

on the information generated through systematic hazard

analysis is maintained to establish customer and supplier
requirements in terms of feasibility, need and impact on
the end product.
9
10
 Prerequisite Programme
• Prerequisite programs (PRPs) are the conditions that must be
established throughout the food chain and the activities and
practices that must be performed in order to establish and
maintain a hygienic environment.

• PRPs are also referred to as good hygienic practices, good

agricultural practices, good production practices, good
manufacturing practices, good distribution practices, and good
trading practices.

• Operational prerequisite programs (OPRPs) are prerequisite

programs (PRPs) that are essential. They are essential because
11 a hazard analysis has shown that they are necessary in order to
 HACCP Principles
• ISO 22000 integrates the HACCP 7 principles developed by the
Codex Alimentarius Commission and dynamically combine it
with PRPs necessary to control and reduce any food safety
hazards identified for the end products delivered to the next step
in the food chain to acceptable levels.

12
 ISO 22000 Food Safety Management System
• FSMS is a set of interrelated activities to establish policy and
objectives and to achieve those objectives used to direct and
control an organization with regard to food safety.
• An effective FSMS should be well-established, documented,
implemented, maintained and continually improved / updated
and has its products / services that actually meet its intended
usage and are safe and is proactive and innovative, scientific,
risk-avoiding and prevention-oriented

Model of the ISO 22000

• The ISO 22000 model is a continuous improvement

process-based FSMS with systematic approach for developing,
13
planning, validating, establishing, implementing, monitoring,
14
 Key Requirements of the ISO 22000: 2005

• The ISO 22000 standard is a management system

standard that sets requirements for results without
setting requirements for resources. This standard sets
out specific requirements for the five areas shown in
the figures

15
 Clause wise requirements of ISO 22000

16
 Implementation model for food safety control measures
• ISO 22000 requires that organizations to plan and
develop processes needed for realization of safe
product, implement, operate and ensure effectiveness
of planned activities.
• This includes PRP’s, Operational PRP’s and/or HACCP
plan.
• The organization uses a dynamic and systematic
process approach to develop the food safety
management system.
• This is achieved through effective development,
implementation, monitoring of planned activities,
maintenance and verification of control measures,
updating the food processes and process environment,
17
and through appropriate actions in the event of the
production of nonconformities.
 ISO 22000 groups control measures into three groups:
• i) Prerequisite programmes (PRPs) that manage the basic
conditions and activities; the PRPs are not selected for the
purpose of controlling specific identified hazards but for
the purpose of maintaining a hygienic production,
processing and/or handling environment;
• ii) Operational prerequisite programmes (OPRPs) that
manage those control measures that the hazard analysis
identifies as necessary to control identified hazards to
acceptable levels, and which are not otherwise managed
by the HACCP plan; and
• iii) HACCP plan to manage those control measures that
the hazard analysis identifies as necessary to control
identified hazards to acceptable levels, and which are
applied at critical control points (CCP’s).

18
 Food Safety Management System Plan
• Constitution of a multidisciplinary food safety team
• Gathering information for prerequisites
• Gathering information for hazard analysis
• Recommended International Code of Practice General Principles
of Food Hygiene (CAC/RCP1(1969)Rev-4 ( 2003)
• Product characteristics
• a) Raw materials, ingredients and product-contact materials
• b) Characteristics of end products
• Industry specific guidelines /codes
• Intended use
• Statutory & regulatory requirements in that specific area

19 • Flow diagrams, onsite verification.

 ISO 22000 Certification
• ISO 22000 is designed to be used for certification/registration
purposes.
• In other words, once company has established a FSMS that
meets ISO's requirements, it can apply for certification to a
certification agency to audit the system.
• If certification agency find after audit that the implemented
system meets the ISO 22000 requirements, it will issue an
official certificate that states that company’s FSMS meets the
food safety requirements.
• However, it is not mandatory to go for certification.
• A company can be in compliance without being formally certified
by an accredited certification agency.
• It can self assess the system implemented and declare ISO
22000 compliant company.
20
• But company customers and business partners are not likely to
 Benefits of ISO 22000 for users
Organizations implementing the standard will benefit from:
• Organized and targeted communication among trade partners,
• Optimization of resources (internally and along the food chain);
• Improved documentation;
• Better planning, less post process verification;
• More efficient and dynamic control of food safety hazards;
• All control measures subjected to hazard analysis;
• Systematic management of prerequisite programmes;
• Wide application because it is focused on end results;
• Valid basis for taking decisions;
• Increased due diligence;
21
• Control focused on what is necessary, and
 QUALITY MANAGEMENT SYSTEM ISO 9001

22
 ⚫ ISO is the most important of international standard
setting organizations.
⚫ It is a world federation of national standards bodies,
an international non-governmental organization with a
mandate to prepare and propagate voluntary
consensus based international standards.

⚫ ISO develops standards through technical committee

represented by concern stakeholder.
⚫ All its standards are voluntary in nature.
⚫ However, given its credibility as the most
internationally accepted organisation, ISO standards
have considerable trade affects due to their wide use
in international trade.
23
 Introduction to ISO 9001
⚫ In pursuit of excellence, quality has taken a tangible form with the
advent of ISO 9000 series of standards.

⚫ It is recognized internationally as a bench mark for measuring quality.

⚫ It provides measures of an organization's ability to consistently deliver a

product or service that meets the requirements of its customers.

⚫ It also provides a framework for continuous improvement in quality.

⚫ This is the reason why ISO 9000 series of standards have become the
subject of intense focus the world-wide.

⚫ It is becoming increasingly important both as a potential market place

requirement and as a marketable company feature.

⚫ ISO 9000 series is generic in nature and are relevant to all types of
business whether it be manufacturing industries or service
establishments . The fist version of ISO 9001 was published in 1987 and
since then it has undergone revisions and the latest one is ISO 9001
24 2015 version. In 1998, ISO published eight QMS principles on which are
embedded into the elements of the ISO 9001
 ISO 9001:2008 Clauses
The standard is divided in eight main clauses as listed
below:
⚫ 1) Scope
⚫ 2) Normative references
⚫ 3) Terms and definitions
⚫ 4) Quality Management System
⚫ 5) Management Responsibility
⚫ 6) Resource Management
⚫ 7) Product realization
⚫ 8) Measurement, analysis and improvements

25
 Documentation Structure of ISO 9001: 2008

26
 1. Quality policy

The quality policy of the organization should:

a) Be appropriate to the purpose of the organization;

b) Include a commitment to comply with requirements
and continually improve the effectiveness of quality
management system;
c) provide a framework for establishing and reviewing
quality objectives;
d) be communicated and understood within the
organization; and
e) be reviewed for continuing suitability.

27
 2. Quality Objective

⚫ The organization establishes quality objectives

including those needed to meet requirements for
products at relevant functions and levels within the
organization.

⚫ The Quality objectives should be consistent with the

quality policy and be SMART
⚫ Specific

⚫ Measurable

⚫ Acceptable

⚫ Realistic

⚫ Time
28
 3. Quality Manual
⚫ Quality manual is a document which explains
how the requirements of ISO 9001:2000 are
planned to be fulfilled by the organization
taking into consideration
⚫ the type of product/service offered,

⚫ complexity of processing methods,

⚫ competence of operating personnel and

⚫ number of sites where the Quality Management

System is implemented.

29
 ⚫ The manual also contains the general information about the

organization like:

⚫ Establishment and evolution over the years

⚫ The position in the supply chain

⚫ The suppliers and customers in the chain

⚫ The site related details

⚫ Quality policy and related objectives

⚫ Organization chart

⚫ Applicable statutory and regulatory requirements

⚫ The structure of QMS documentation

⚫ The site map from external and internal point of view

⚫ Roles and responsibilities

30
⚫ Details of external resources utilized.
 ⚫ The manual gives reference to or contains all the
elements of the QMS documentation.

⚫ It acts as a reference document for training of new

team members of the organization, communicating
the QMS overview to National and International
customers and as a supporting document during any
statutory and regulatory interaction.

⚫ The manual is required to be reviewed periodically by

the top management in management review
meetings.

31
 4. Procedures
⚫ The procedures in ISO 9001 fall in two categories- the
documented procedures which are mandatory and
procedures needed by the organization depending on
its activities.

⚫ The mandatory procedures are:

⚫ Control of documents

⚫ Control of records

⚫ Internal audit

⚫ Control of non-conformity

⚫ Corrective action

⚫ Preventive action
32
 ⚫ Control of documents: This procedure
contains information related to approval of
documents, re-approval of documents,
identification of changes, identification of
current revision status, availability of relevant
versions at points of use, legibility, documents
of external origin and management of
obsolete documents.
⚫ A master list of documents is prepared which gives
details like document name, document number,
issue date, current revision number and date,
information about preparation, review and approval
33
of the documents.
 ⚫ Control of records: This procedure defines controls
needed for the identification, storage, protection,
retrieval, retention time and disposal of records.
⚫ A master list of records is prepared which gives details like -

record name, associated format number and issue date,

version of record (soft/hard), record originating process, etc.

⚫ Internal audits: This procedure contains the

responsibility and requirements for planning and
conducting audits, and for reporting results and
records.
⚫ It also contains the details of competence of the internal audit
34
team members.
 ∙ Control of non-conforming product: This procedure contains the
information about the identification and assessment of
potentially non-conforming end products to determine their
proper handling and review of the corrections carried out. It also
specifies the records required to be maintained.

∙ Corrective action: This procedure contains information related to

review of non-conformities (including customer complaints),
review of trends in monitoring results, determination of causes of
non-conformities, evaluating the need for the action,
determining and implementing the actions needed, recording the
results and reviewing corrective actions taken.

⚫ Preventive action: This procedure contains information related to

review of potential non-conformities (including customer
complaints), review of trends in monitoring results, determination
of causes of potential non-conformities, evaluating the need for
the action, determining and implementing the actions needed,
35 recording the results and reviewing corrective actions taken.
 Procedures required for planning, operation & control
These procedures vary with the operational complexities of the
organization. These normally include:
⚫ Procedure for management review

⚫ Procedure for competence, creating awareness and providing training

⚫ Procedure for maintenance of machinery and equipment

⚫ Procedure for determination, review and communication of customer

requirement
⚫ Procedure for purchase of product and services

⚫ Procedure for evaluation, selection and re-evaluation of suppliers

⚫ Procedure for verification of purchased product

⚫ Procedure for identification and traceability

⚫ Procedure for receipt, storage and dispatch of finished goods,

⚫ Procedure for control and calibration of measuring devices

36
⚫ Procedure for determination of customer satisfaction level
 5. Work Instructions
⚫ The work instructions provide instructional guidance to operational

personnel for carrying out micro-activities outlined in different

procedures.

⚫ The details of the contents depend on the competence of the operating

personnel, complexity of the process and the nature of product/service.

⚫ These are normally in imperative form of English.

⚫ These should be accessible to the operating personnel preferably near

their work area.

⚫ Work instructions should be available in the (local) language, which the

operational workforce understands.

37 ⚫ These documents are to be drafted with the help of the operational

 6. Formats and Records
⚫ Records are established to provide evidence of conformity to requirements
and of effective operation of the quality management system.

⚫ The records are required to be maintained in pre-determined formats as

an evidence of activities carried out as per defined quality management
system:

∙ Current competence of all concerned ∙ Corrections of non-conforming product

∙ ∙ Verification of purchased product
Calibration of measuring and monitoring instruments
∙ Outcome of internal audits ∙ Identification of product where traceability
∙ Output of management review is a requirement
∙ Corrective actions ∙ Release of end product
∙ Training and effectiveness of training given ∙ Receipt and issue of material/products in
∙ Product design input determination stores
∙ Product design review ∙ Maintenance (breakdown and preventive)
∙ Product design verification ∙ Quality objective tracking
∙ Product design validation ∙ Document change control
∙ Product design change review ∙ Document distribution

38
 Accreditation of certification bodies
⚫ Food safety and quality management systems are
widely implemented and certified by certification
agencies for acceptance of the products and services
in the world market.

⚫ This implies that certification agencies must be

credible. How does this credibility come?

⚫ To exercise control over the operation of certification

bodies, accreditation system has been established.

⚫ There is an International Accreditation Forum (IAF)

whose member accreditation bodies in respective
countries enjoy acceptance in the world market.
39
 ⚫ In India Quality Council of India, the national
accreditation body has been established to oversee
the functioning of client certification bodies complying
with the ISO/IEC 17021:2006 Conformity Assessment:
Requirements for bodies providing audit and
certification of management systems.

⚫ QCI is a member of IAF.

⚫ Though accreditation of certification bodies is

voluntary, most of the certification bodies operating in
India are accredited due commercial compulsions in
the market place.
40
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 6

Advances in
Food Safety & Quality Management
• TQM

Samit Dutta, Associate Professor & Head,

Dept. of Food Business Management,
1
College of FPTBE, AAU
 Introduction
⚫ What is quality?
Dictionary has many definitions: “Essential characteristic,”
“Superior,” etc.
⚫ Some definitions that have gained wide acceptance in various
organizations: “Quality is customer satisfaction”, “Quality is
Fitness for Use.”

⚫ The American National Standards Institute (ANSI) and the

American Society for Quality (ASQ) define quality as:
⚫ “The totality of features and characteristics of a product or
service that bears on its ability to satisfy given needs.”

2
 ⚫ What is a customer?
Anyone who is impacted by the product or process
delivered by an organization.
External customer: The end user as well as intermediate
processors. Other external customers may not be
purchasers but may have some connection with the
product.
Internal customer: Other divisions of the company that
receive the processed product.

⚫ What is a product?
The output of the process carried out by the
organization. It may be goods (e.g. automobiles,
missile), software (e.g. a computer code, a report) or
service (e.g. banking, insurance)
3
 ⚫ How is customer satisfaction achieved?
Two dimensions: Product features and Freedom from
deficiencies.

⚫ Product features – Refers to quality of design.

Examples in manufacturing industry: Performance,
Reliability, Durability, Ease of use, Esthetics etc.
Examples in service industry: Accuracy, Timeliness,
Friendliness and courtesy, Knowledge of server etc.

⚫ Freedom from deficiencies – Refers to quality of

conformance.
Higher conformance means fewer complaints and
increased customer satisfaction.
4
 Reasons for quality becoming a cardinal priority for
most organizations:
⚫ Competition – Today’s market demand high quality
products at low cost. Having `high quality’ reputation
is not enough! Internal cost of maintaining the
reputation should be less.

⚫ Changing customer – The new customer is not only

commanding priority based on volume but is more
demanding about the “quality system.”

⚫ Changing product mix – The shift from low volume,

high price to high volume, low price have resulted in a
5
need to reduce the internal cost of poor quality.
 ⚫ Product complexity – As systems have become more
complex, the reliability requirements for suppliers of
components have become more stringent.

⚫ Higher levels of customer satisfaction – Higher

customers expectations are getting spawned by
increasing competition.

Relatively simpler approaches to quality viz. product

inspection for quality control and incorporation of
internal cost of poor quality into the selling price,
might not work for today’s complex market
environment.

6
 ⚫ The quality control discipline is constantly developing
with growing importance of the quality aspects in
food processing operation.

⚫ Earlier the quality control was primarily concerned

with maintaining the quality standards.

⚫ The need to produce and sell high quality products

and increase the efficiency of the production process,
has led to the development of quality assurance
systems and then total quality management systems.

7
 ⚫ Quality control is the evaluation of a final product prior to its
marketing, i.e. it is based on quality checks at the end of a
production chain for maintenance of prescribed standards .
Since, at the end of the production chain, there is no way to
correct production failures or upgrade the quality of the final
product, the non-marketable products have to be discarded.
Thus, quality control has only a limited potential to increase the
quality and efficiency of a multi-step production procedure.

⚫ Quality Assurance: In contrast to quality control, the quality

assurance includes the planning and surveillance of everything
to do with the quality throughout the company. It is the
implementation of quality checks and procedures to
immediately correct any failure and mistake that is able to
reduce the quality of the interim products at every production
step.
8
 ⚫ Total Quality Management (TQM) The
management approach to long-term success through
customer satisfaction, based on the participation of all
members of an organization (suppliers and distributors
included) in improving processes, products, services
and the working culture.

⚫ A comprehensive, organization-wide effort to improve

the quality of products and services, applicable to all
organizations.

9
 History of Total Quality Management
⚫ Before Industrial Revolution, skilled craftsmen served both as
manufacturers and inspectors, building quality into their
products through their considerable pride in their
workmanship.

⚫ Industrial Revolution changed this basic concept to

interchangeable parts. Likes of Thomas Jefferson and F. W.
Taylor (“scientific management” fame) emphasized on
production efficiency and decomposed jobs into smaller work
tasks. Holistic nature of manufacturing rejected!

⚫ Statistical approaches to quality control started at Western

Electric with the separation of inspection division. Pioneers
like Walter Shewhart, George Edwards, W. Edwards Deming
10
and Joseph M. Juran were all employees of Western Electric.
 ⚫ After World War II, under General MacArthur's Japan
rebuilding plan, Deming and Juran went to Japan.
⚫ Deming and Juran introduced statistical quality control theory
to Japanese industry.

⚫ The difference between approaches to quality in USA and

Japan: Deming and Juran were able to convince the top
managers the importance of quality.

⚫ Next 20 odd years, when top managers in USA focused on

marketing, production quantity and financial performance,
Japanese managers improved quality at an unprecedented rate.
⚫ Market started preferring Japanese products and American
companies suffered immensely.

11
 ⚫ America woke up to the quality revolution in early 1980s. Ford
Motor Company consulted Dr. Deming to help transform its
operations.
(By then, 80-year-old Deming was virtually unknown in USA.
Whereas Japanese government had instituted The Deming
Prize for Quality in 1950.)
⚫ Managers started to realize that “quality of management” is
more important than “management of quality.” Birth of the
term Total Quality Management (TQM).
⚫ TQM – Integration of quality principles into organization’s
management systems.
⚫ Early 1990s: Quality management principles started finding
their way in service industry. FedEx, The Ritz-Carton Hotel
Company were the quality leaders.
⚫ TQM recognized worldwide: Countries like Korea, India, Spain
12 and Brazil are mounting efforts to increase quality awareness.
 The Pioneers of Scientific Quality Management
⚫ Frederick Taylor: A highly regarded consultant whose name was
synonymous with “scientific management,”. He proposed the
reduction of waste through careful study.
⚫ Walter A. Shewhart: Introduced production process into a state of
statistical control to manage a process economically.
⚫ W. Edwards Deming: Deming defined quality as a predictable
degree of uniformity and dependability, at low costs and suited to the
market. He produced his 14 Points for management in order to help
people understand and implement for transformation in industry.
⚫ Joseph M. Juran: Defines quality as “fitness for use” in terms of
design, conformance, availability, safety, and field use.
⚫ Philip B. Crosby Coined the word Quality Is Free He stated that
quality is free because the small costs of prevention will always be
lower than the costs of detection, correction, and failure. Crosby’s
name is perhaps best known in relation to the concepts of “Do It
13
Right the First Time” and “Zero Defects.”
 Total Quality Management
⚫ TQM is a management philosophy, a paradigm, a continuous
improvement approach to doing business through a new
management model.
⚫ TQM expands beyond statistical process control to embrace a
wider scope of management activities of how we manage
people and organizations by focusing on the entire process, not
just simple measurements.

14
 TQM is a comprehensive management system which:
⚫ Focuses on meeting customers’ needs by providing quality
services at a cost that provides value to the customers
⚫ Is driven by the quest for continuous improvement in all
operations
⚫ Recognizes that everyone in the organization has
owners/customers who are either internal or external
⚫ Views an organization as an internal system with a common
aim rather than as individual departments acting to maximize
their own performances
⚫ Focuses on the way tasks are accomplished rather than simply
what tasks are accomplished
⚫ Emphasizes teamwork and a high level of participation by all
employees
15
 Need of implementing TQM
Organization Reality
⚫ Industrial disputes, climate of distress
⚫ Increased competition – domestic / International
⚫ Conservative management
⚫ Monopoly situation

Organization Self Evaluation

⚫ Where are we as an organization?
⚫ Where do we want to go?
⚫ How do we get there?
⚫ How TQM help to get there?
⚫ How will we know when we get there?
16
 Immediate Objectives
⚫ Trust and harmony
⚫ Awareness of organization reality
⚫ Waste identification
⚫ Team building
⚫ Success measures

17
 Implementation Process
1. Obtain CEO Commitment
2. Educate Upper-Level Management
3. Create Steering Committee
4. Outline the Vision Statement, Mission Statement, & Guiding
Principles
5. Prepare a Flow Diagram of Company Processes
6. Focus on the Owner/Customer (External) & Surveys
7. Consider the Employee as an Internal Owner/customer
8. Provide a Quality Training Program
9. Establish Quality Improvement Teams
10. Implement Process Improvements
11. Use the Tools of TQM
1812. Know the Benefits of TQM
 1 Obtain CEO Commitment, and
2 Educate Upper-Level Management

⚫ The first step in implementing TQM is to obtain the total

commitment, involvement, and leadership of the CEO and
upper-level management.
⚫ The second step is to teach the CEO and upper-level
management how to conduct the following:
⚫ Undergo quality training
⚫ Commit to TQM and provide the necessary resources of time
and money to permit improvement
⚫ Assist in the development of the corporate vision statement,
mission statement, guiding principles, and objectives

19
 3 Create a Steering Committee
Upon completion of upper management’s commitment and
training, a steering committee to be created to guide the company
through the process of implementing TQM. The role of the
steering committee would be:

⚫ Review and evaluate customer surveys.

⚫ Determine processes to be improved, based on customer and
employee recommendations, surveys, and a knowledge of
existing problems.
⚫ Monitor process improvement.
⚫ Oversee employee recognition for quality improvement.
⚫ Communicate successes and progress.

20
 4 Outline the Vision Statement, Mission Statement,
& Guiding Principles

In developing the fourth step, important principles to consider

including in the company’s vision statement, mission statement,
and guiding principles are:

⚫ Reputation as the best in the field

⚫ customer Satisfaction
⚫ Improved Safety
⚫ Elimination of errors and defects
⚫ Continuous Improvement
⚫ Employee Empowerment

21
 5 Prepare a Flow Diagram of Company Processes

Prepare a TQM flow diagram illustrating in the figure to

implement quality processes within the company.

22
 6 Focus on the Customer (External) & Surveys
The best ways of accomplishing quality improvement is by
focusing on customers’ concerns, and by learning what those
concerns are through customer surveys. Several areas to survey,
and operating
Safe to take care to provide are: Degree of communications
procedures
Accident experience Planning
Attitude Administrative procedures
Professional competence of the project Appearance and conduct of the work
manager, superintendent, and project force
engineers Condition of equipment
Technical competence of the work force Coordination and supervision of
Overall responsiveness to subcontractors
owner/customer requests Appearance of the jobsite
Timeliness
23
 7 Consider the Employee as an Internal Owner/
Customer
In order to conduct an analysis of the internal processes within
the company, the following steps should be applied to the internal
processes within a company:
⚫ List several of your internal owners/customers within your
company
⚫ Choose one of these owners/customers to focus on for the
application of this technique
⚫ Determine the Outputs (products, services, information) that
must be provided to this internal owner/customer
⚫ Determine the work Processes your company uses to produce
these Outputs
⚫ Learn how your customer’s expectations are met and how
satisfaction is measured
24
 8 Provide a Quality Training Program

The training program must begin with upper management, then

training must be provided for the remaining management, and the
in-house trainers and facilitators:

⚫ Upper Management
⚫ Remaining Management
⚫ In-House Trainers & Facilitators
⚫ Front-Line Supervisors
⚫ Non-Supervisory Employees
⚫ Team Training
⚫ Training of Subcontractors & Suppliers

25
 9 Establish quality improvement teams
In establishing quality improvement teams, a smaller company
might assign one quality improvement team. Larger firms might
assign several, possibly with one quality lead team as a guide for
the other teams. Areas where quality improvement teams could
begin investigating for possible improvement are:
⚫ Increased Employee Value
⚫ Technical Training
⚫ Quality Training
⚫ Employee Suggestions
⚫ Employee Participation
⚫ Personal Development
A quality improvement team (QIT) meets on a regular basis, once
per week for 3 to 5 hours. After the TQM implementation plan is
26
complete and underway, the QIT should meet once or twice per
month.
 10 Implement Process Improvements

⚫ Identification of areas needing improvement

⚫ Cooperative attitude between elements of the company
⚫ Viewing every person who is on the receiving end of a process
as a customer
⚫ Fear driven from the company
⚫ A system for selecting processes to be improved
⚫ Training for all employees in quality awareness
⚫ Improved communications outside the company

27
 11 Use the Tools of TQM

Seven classical tools of quality and process improvement are

presented below:
⚫ 1.Flowchart
⚫ 2.Control Chart
⚫ 3. Cause and Effect Diagram
⚫ 4. Histogram
⚫ 5. Check Sheet
⚫ 6. Pareto Diagram
⚫ 7.Scatter Diagram

28
 12 Know the Benefits of TQM

⚫ Improve competitiveness
⚫ Reduce Operational costs
⚫ Increase sales
⚫ Enhance customer satisfaction
⚫ Reduce wastes
⚫ Improve efficiency
⚫ Improve human relations
⚫ Improve internal and external customer relation
⚫ Integrates with ISO

29
 7 QC TOOLS
FOR
QUALITY IMPROVEMENT

30
 Introduction
⚫ The 7 QC Tools are simple statistical tools used for problem
solving.
⚫ Kaoru Ishikawa developed seven basic visual tools of quality
so that the average person could analyse and interpret data.
⚫ In terms of importance, these are the most useful. Kaoru
Ishikawa has stated that these 7 tools can be used to solve 95
percent of all problems.

⚫ These tools were widely introduced to Japan by the Quality

Gurus such as Deming and Juran.
⚫ These tools have been the foundation of Japan's astonishing
industrial resurgence after the second war.
⚫ These tools have been used worldwide by companies,
managers of all levels and employees.
31
 7 QC Tools :

1. Check Sheets
2. Stratification (alternatively, flow chart or run
chart)
3. Control Charts
4. Histogram
5. Pareto Chart
6. Cause & Effect Diagram
7. Scatter Diagram

32
 1. Check Sheets

⚫ As measurement and collection of data forms the basis for any

analysis, this activity needs to be planned in such a way that
the information collected is both relevant and comprehensive.
⚫ Check sheets are tools for collecting data.
⚫ They are designed specific to the type of data to be collected.
⚫ The check sheet is a form (document) used to collect data in
real time at the location where the data is generated. The data it
captures can be quantitative or qualitative. When the
information is quantitative, the check sheet is sometimes called
a tally sheet.
⚫ Some examples of check sheets are daily maintenance check
sheets, attendance records, production log books, etc.

33
 ⚫ As measurement and collection of data forms the basis for any
analysis, this activity needs to be planned in such a way that
the information collected is both relevant and comprehensive.
⚫ Check sheets are tools for collecting data.
⚫ They are designed specific to the type of data to be collected.
⚫ Some examples of check sheets are daily maintenance check
sheets, attendance records, production log books, etc.

34
 Kaoru Ishikawa identified five uses for check sheets in quality control:

⚫ To check the shape of the probability distribution of a process

⚫ To quantify defects by type

⚫ To quantify defects by location

⚫ To quantify defects by cause (machine, worker)

⚫ To keep track of the completion of steps in a multistep

procedure (in other words, as a checklist)

35
 2. Stratification (alternatively, flow chart or run
chart)
⚫ Data collected using check sheets needs to be meaningfully
classified. Meaningful classification of data is called
stratification.
⚫ Stratification is a way to organize data, and in particular of
separating data into meaningful groups. Stratification is also
known as a flow chart or run chart.
⚫ In stratification, you should include each data point in only one
group, and you should leave no data point(s) out.
⚫ Stratification may be by group, location, type, origin, symptom,
etc. for example:
a) Data on rejected product may be classified either machine
wise or operator wise or shift wise.
b) Data of production of food grains may be classified nation
wise, state wise or district wise, etc.
36
 ⚫ Graphs of various types are used for pictorial representation of
stratified data. Pictorial representation enables the user or
viewer to quickly grasp the meaning of the data.
⚫ Different graphical representation of data are chosen depending
on the purpose of the analysis and preference of the audience.
⚫ The different types of graphs used are:
⚫ Bar Graph To compare sizes of data,
⚫ Line Graph To represent changes of data,
⚫ Gantt Chart To plan and schedule,
⚫ Radar Chart To represent changes in data (before and after),
⚫ Band Graph Same as above,
⚫ Pie Chart Used to indicate comparative weights

37
 Flow chart
⚫ A flowchart is a type of diagram that represents a workflow or
process.
⚫ A flowchart can also be defined as a diagrammatic
representation of an algorithm, a step-by-step approach to
solving a task.
⚫ The flowchart shows the steps as boxes of various kinds, and
their order by connecting the boxes with arrows.
⚫ This diagrammatic representation illustrates a solution model to
a given problem.

⚫ Creating a Flow Chart

⚫ First, familiarize the participants with the flow chart
symbols.
⚫ Draw the process flow chart and fill it out in detail about
38
each element.
 A simple flowchart representing a process for dealing with a
non-functioning lamp.

39
 Run chart
⚫ A run chart, also known as a run-sequence plot is a graph that
displays observed data in a time sequence.
⚫ Run charts are used to analyze processes according to time or
order.
⚫ Often, the data displayed represent some aspect of the output or
performance of a manufacturing or other business process.
⚫ It is therefore a form of line chart.
⚫ Creating a Run Chart:
⚫ Gathering Data
⚫ Some type of process or operation must be available to take measurements for
analysis.
⚫ Organizing Data
⚫ Data must be divided into two sets of values X and Y. X values represent time
and values of Y represent the measurements taken from the manufacturing
process or operation.
⚫ Charting Data
⚫ Plot the Y values versus the X values.
40
⚫ Interpreting Data
 An Example of Using a Run Chart
⚫ An organization’s desire is to have their product arrive to
their customers on time, but they have noticed that it doesn’t
take the same amount of time each day of the week.
⚫ They decided to monitor the amount of time it takes to
deliver their product over the next few weeks.

41
 3. Control Charts
⚫ Control charts (also, Shewhart chart, statistical process control
chart) was developed by Dr. Walter A. Shewhart during 1920's
while he was with Bell Telephone Laboratories.
⚫ Control chart makes possible the diagnosis and correction of
many production troubles and brings substantial improvements
in the quality of the products and reduction of spoilage and
rework.
⚫ It tells us when to leave a process alone as well as when to take
action to correct trouble.
⚫ Control charts are used to determine whether a process will
produce a product or service with consistent measurable
properties.
⚫ An Example of When to Use a Control Chart
⚫ Counting the number of defective products or services
42 ⚫ Do you count the number of defects in a given product or service?
⚫ Is the number of units checked or tested constant?
 Steps Used in Developing Process Control Charts
⚫ Identify critical operations in the process where inspection
might be needed.
⚫ Identify critical product characteristics.
⚫ Determine whether the critical product characteristic is a
variable or an attribute.
⚫ Select the appropriate process control chart.
⚫ Establish the control limits and use the chart to monitor and
improve.
⚫ Update the limits.

43
 4. Histogram

⚫ Histograms or Frequency Distribution Diagrams are bar charts

showing the distribution pattern of observations grouped in
convenient class intervals and arranged in order of magnitude.

⚫ Histograms are useful in studying patterns of distribution and

in drawing conclusions about the process based on the pattern.

⚫ Histograms provide the easiest way to evaluate the distribution

of data.

44
 Procedure to prepare a Histogram consists of the following steps:
1. Collect data (preferably 50 or more observations of an item).
2. Arrange all values in an ascending order.
3. Divide the entire range of values into a convenient number of
groups each representing an equal class interval. It is customary
to have number of groups equal to or less than the square root of
the number of observations. However one should not be too rigid
about this. The reason for this cautionary note will be obvious
when we see some
examples.
4. Note the number of observations or frequency in each group.
5. Draw X-axis and Y-axis and decide appropriate scales for the
groups on X-axis and the number of observations or the
frequency on Y-axis.
6. Draw bars representing the frequency for each of the groups.
45
7. Provide a suitable title to the Histogram.
 Examples of How Histograms Can Be Used

⚫ Histograms can be used to determine distribution of sales.

⚫ Say for instance a company wanted to measure the revenues of

other companies and wanted to compare numbers.

46
 5. Pareto Chart
⚫ Pareto charts are used to identify and prioritize problems to be
solved.
⚫ Pareto Chart is a tool that arranges items in the order of the
magnitude of their contribution, thereby identifying a few items
exerting maximum influence.
⚫ The origin of the tool lies in the observation by an Italian
economist Vilfredo Pareto that a large portion of wealth was in
the hands of a few people. He observed that such distribution
pattern was common in most fields.
⚫ Pareto principle, also known as the 80/20 rule, is used in the
field of materials management etc.
⚫ They are actually histograms aided by the 80/20 rule adapted
by Joseph Juran. Remember the 80/20 rule states that
approximately 80% of the problems are created by
47 approximately 20% of the causes.
 A Pareto Chart for the defects in shirts.

48
The steps in the preparation of a Pareto Chart are :
1. From the available data calculate the contribution of each individual
item.
2. Arrange the items in descending order of their individual
contributions. If there are too many items contributing a small
percentage of the contribution, group them together as "others". It is
obvious that "others" will contribute more than a few single individual
items. Still it is kept last in the new order of items.
3. Tabulate the items, their contributions in absolute number as well as
in percent of total and cumulative contribution of the items.
4. Draw X and Y axes. Various items are represented on the X-axis.
Unlike other graphs Pareto Diagrams have two Y-axes - one on the left
representing numbers and the one on right representing the percent
contributions. The scale for X-axis is selected in such a manner that all
the items including others are accommodated between the two Y axes.
The scales for the Y-axes are so selected that the total number of items
49
on the left side and 100% on the right side occupy the same height.
 5. Draw bars representing the contributions of each item.
6. Plot points for cumulative contributions at the end of each item.
A simple way to do this is to draw the bars for the second and each
subsequent item at their normal place on the X-axis as well as at a
level where the previous bar ends. This bar at the higher level is
drawn in dotted lines. Drawing the second bar is not normally
recommended in the texts.
7. Connect the points. If additional bars as suggested in step 6 are
drawn this becomes simple. All one needs to do is - connect the
diagonals of the bars to the origin.
8. The chart is now ready for interpretation. The slope of the chart
suddenly changes at some point. This point separates the 'vital few'
from the 'useful many' like the A,B and C class items in materials
management.

50
 An Example of How a Pareto Chart Can Be Used
⚫ Pareto Charts are used when products are suffering from different
defects but the defects are occurring at a different frequency, or
only a few account for most of the defects present, or different
defects incur different costs.

⚫ What we see from that is a product line may experience a range of

defects.

⚫ The manufacturer could concentrate on reducing the defects

which make up a bigger percentage of all the defects or focus on
eliminating the defect that causes monetary loss.

51
 6. Cause and Effect Diagrams
⚫ The cause and effect diagram is also called the Ishikawa
diagram or the fishbone diagram.
⚫ It is a tool for discovering all the possible causes for a
particular effect.
⚫ The major purpose of this diagram is to act as a first step in
problem solving by creating a list of possible causes.
⚫ A Cause-and Effect Diagram is a tool that shows systematic
relationship between a result or a symptom or an effect and its
possible causes.
⚫ It is an effective tool to systematically generate ideas about
causes for problems and to present these in a structured form.
⚫ This tool was devised by Dr. Kouro Ishikawa and as
mentioned earlier is also known as Ishikawa Diagram.

52
 Structure
⚫ Another name for the tool, as we have seen earlier, is Fish-Bone
Diagram due to the shape of the completed structure.
⚫ The symptom or result or effect for which one wants to find
causes is put in the dark box on the right.
⚫ The lighter boxes at the end of the large bones are main groups in
which the ideas are classified.
⚫ Usually four to six such groups are identified.
⚫ In a typical manufacturing problem, the groups may consist of
five Ms - Men, Machines, Materials, Method and Measurement.
The six M Money may be added if it is relevant. Important
subgroups in each of these main groups are represented on the
middle bones and these branch off further into subsidiary causes
represented as small bones.
⚫ The arrows indicate the direction of the path from the cause to the
53
effect.
 The steps in the procedure to prepare a cause-and-effect diagram are:
1. Agree on the definition of the 'Effect' for which causes are to be
found. Place the effect in the dark box at the right. Draw the spine
or the backbone as a dark line leading to the box for the effect.
2. Determine the main groups or categories of causes. Place them in
boxes and connect them through large bones to the backbone.
3. Brainstorm to find possible causes and subsidiary causes under
each of the main groups. Make sure that the route from the cause to
the effect is correctly depicted. The path must start from a root
cause and end in the effect.
4. After completing all the main groups, brainstorm for more causes
that may have escaped earlier.
5. Once the diagram is complete, discuss relative importance of the
causes. Short list the important root causes.

54
 An Example of When a Cause and Effect Diagram Can Be Used

⚫ This diagram can be used to detect the problem of incorrect

deliveries.

⚫ When a production team is about to launch a new product, the

factors that will affect the final product must be recognized. The
fishbone diagram can depict problems before they have a chance
to begin.

55
 Diagram of the Incorrect Deliveries Example

56
 7. Scatter Diagram
⚫ Scatter Diagrams are used to study and identify the possible
relationship between the changes observed in two different sets
of variables.
⚫ When solving a problem or analyzing a situation one needs to
know the relationship between two variables. A relationship
may or may not exist between two variables. If a relationship
exists, it may be positive or negative, it may be strong or weak
and may be simple or complex. A tool to study the relationship
between two variables is known as Scatter Diagram.
⚫ It consists of plotting a series of points representing several
observations on a graph in which one variable is on X-axis and
the other variable in on Y-axis. The way the points lie scattered
in the quadrant gives a good indication of the relationship
between the two variables.

57
 Constructing a Scatter Diagram

⚫ First, collect two pieces of data and create a summary table of the
data.

⚫ Draw a diagram labeling the horizontal and vertical axes.

⚫ It is common that the “cause” variable be labeled on the X axis
and the “effect” variable be labeled on the Y axis.

⚫ Plot the data pairs on the diagram.

⚫ Interpret the scatter diagram for direction and strength.

58
 Ice cream sell versus the noon temperature

⚫ A random distribution of points

all over the quadrant. Such a
distribution or scatter indicates
a lack of relationship between
the two variables being studied.

⚫ The points appear scattered closely along a line ("Line of Best Fit“ or "Trend
Line") travelling from the Southwest to the Northeast direction indicating that
if the variable on X-axis increases, the variable on Y-axis also increases. This
is a positive relationship.
⚫ If the points are scattered closely around a line sloping in Northwest to
Southeast direction, indicates a strong negative relationship. A negative
relationship means that the variable on Y-axis goes down as the variable on
X-axis goes up.
⚫ A scatter of points loosely spread around lines indicates a weak positive
59
 An Example of When a Scatter Diagram Can Be Used

⚫ A scatter diagram can be used to identify the relationship

between the production speed of an operation and the number
of defective parts made.

⚫ Displaying the direction of the relationship will determine

whether increasing the assembly line speed will increase or
decrease the number of defective parts made. Also, the
strength of the relationship between the assembly line speed
and the number of defective parts produced is determined.

60
 Six Sigma

61
 Introduction

⚫ Business improvement approach that seeks to find and eliminate

causes of defects and errors in processes by focusing on outputs
that are critical to customers.

⚫ The term Six Sigma is based on a statistical measure that equates

3.4 or fewer errors or defects per million opportunities.

⚫ Motorola pioneered the concept of Six Sigma.

⚫ The late Bill Smith, a reliability engineer is credited with
conceiving the idea of Six Sigma.
⚫ GE (specifically CEO Jack Welch) extensively promoted it.

62
 Core philosophy based on key concepts:

⚫ Think in terms of key business processes and customer

requirements with focus on strategic objectives.
⚫ Focus on corporate sponsors responsible for championing
projects.
⚫ Emphasize quantifiable measures such as defects per million
opportunities (dpmo).
⚫ Ensure appropriate metrics is identified to maintain
accountability.
⚫ Provide extensive training.
⚫ Create highly qualified process improvement experts -“belts”.
⚫ Set stretch objectives for improvement.

63
 Contrasts between traditional TQM and Six Sigma (SS):

⚫ TQM is based largely on worker empowerment and teams; SS is

owned by business leader champions.

⚫ TQM is process based; SS projects are truly cross-functional.

⚫ TQM training is generally limited to simple improvements tools

and concepts; SS is more rigorous with advanced statistical
methods.

⚫ TQM has little emphasis on financial accountability; SS requires

verifiable return on investment and focus on bottom line.

64
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 4

Food Safety – A Global Perspective

• Project Identification & Screening

WTO
• FAO
• WHO
• OIE / IPPC
• CODEX
Samit Dutta, Associate Professor & Head,
Dept. of Food Business Management,
1
College of FPTBE, AAU
 FOOD SAFETY: DRIVERS OF
CHANGE

FAO

2 Changing food safety systems

 FOOD SAFETY AND QUALITY
Fundamental Principle

Consumer is entitled to safe, sound/pure

and wholesome food free from any
physical, chemical and microbiological
hazards

3
 PURE-SAFE-NUTRITIOUS:WHY
STANDARDS?
Quality Produced with
good practices Safety
Free from abnormal
colour/off-flavour/ • Free from debris,
bad taste sediment, physical
Good objects
Purity/Quality Quality/ • Safe levels of
Safe Milk antibiotics,
•Not subject to
pesticides and
unnatural addition/
other chemical
extraction
contaminants
•Normal composition
• Free from
and acidity
pathogens when
•Low number of consumed
bacteria

Wholesome and should not cause illness or injury when

4
consumed
 MORE QUESTIONS THAN
ANSWERS!

‘Free’ = Normal=?
Really?

Unnatural=?
‘Low’ =?

‘Safe Good=???
level’=?

What is the objective description of requirement /

practice?

5
REGULATIONS ARE THE ANSWER!
• Objective expression of requirements
• Plan to control hazards
• Checking the status of control
• Demonstrating product safety
• Trade facilitation

Food regulations/standards are

yardsticks that facilitate business and
consumer confidence

6
 International Regime: Food Safety

FAO, WHO, WTO, CAC, OIE, IPPC including SPS, TBT

1. Consumer Safety (Prime Importance)
2. Fair Trade Practice (Fraud/Adulteration)

⚫ Dual Challenge of International Food Trade

⚫ confidence in the safety and quality of food being imported

⚫ food products consider to be of inferior quality may be “
dumped”

7
 Global trade scenario

⚫ Changed scenario
⚫ Open markets, Increasing demand
⚫ Stiff competition : Price competitiveness / Quality and
safety competitiveness
⚫ Need to meet international standards

• The World Trade Organization (WTO): Specifies modalities

for international trade – various agreements

• WTO-SPS Agreement
⚫ International benchmark standards: CODEX, OIE
⚫ Emphasis on harmonization of domestic standards with
international standards.
8
 What is the World Trade Organization?
⚫ The World Trade Organization (WTO) deals with the
rules of trade between nations at a global or near-global
level.
⚫ It’s an organization for liberalizing trade.
⚫ It’s a forum for governments to negotiate trade
agreements.
⚫ It’s a place for them to settle trade disputes.
⚫ It operates a system of trade rules.

⚫ (But it’s not Superman, just in case anyone thought it

could solve — or cause — all the world’s problems!)
9
 ⚫ Above all, it’s a negotiating forum … Essentially, the WTO is a place
where member governments go, to try to sort out the trade problems they
face with each other.

⚫ It’s a set of rules … At its heart are the WTO agreements, negotiated and
signed by the bulk of the world’s trading nations. These documents
provide the legal ground-rules for international commerce. They are
essentially contracts, binding governments to keep their trade policies
within agreed limits. It also means ensuring that individuals, companies
and governments know what the trade rules are around the world, and
giving them the confidence that there will be no sudden changes of policy.
In other words, the rules have to be “transparent” and predictable.

⚫ And it helps to settle disputes … This is a third important side to the

WTO’s work. Trade relations often involve conflicting interests. The most
harmonious way to settle these differences is through some neutral
procedure based on an agreed legal foundation. That is the purpose behind
the dispute settlement process written into the WTO agreements.

⚫ Born in 1995, but not so young … The WTO began life on 1 January
1995, but its trading system is half a century older. Since 1948, the
General agreement on Tariffs and Trade (GATT) had provided the rules
10 for the system.
 Functions
⚫ The WTO’s overriding objective is to help trade flow
smoothly, freely, fairly and predictably. It is done by:

Administering trade agreements

Acting as a forum for trade negotiations
Settling trade disputes
Reviewing national trade policies
Assisting developing countries in trade policy issues,
through technical assistance and training programmes
Cooperating with other international organizations

11
 Structure
⚫ The WTO has 164 members, accounting for 98% of world trade. A
total of 25 countries are negotiating membership.
⚫ Decisions are made by the entire membership. This is typically by
consensus. A majority vote is also possible but it has never been used
in the WTO, and was extremely rare under the WTO’s predecessor,
the GATT. The WTO’s agreements have been ratified in all members’
parliaments.
⚫ The WTO’s top level decision-making body is the Ministerial
Conference which meets at least once every two years.
⚫ Below this is the General Council which meets several times a year in
Geneva headquarters. The General Council also meets as the Trade
Policy Review Body and the Dispute Settlement Body.
⚫ At the next level, the Goods Council, Services Council and Intellectual
Property (TRIPS) Council report to the General Council.
⚫ Numerous specialized committees, working groups and working
12 parties deal with the individual agreements and other areas, such as the
 WTO Secretariat
⚫ The WTO Secretariat, based in Geneva, has around 620 staff and
is headed by a Director- General. It does not have branch offices
outside Geneva. Since decisions are taken by the WTO’s
members, the Secretariat does not itself have a decision-making
role.

⚫ The Secretariat’s main duties are to supply technical support for

the various councils/ committees and the ministerial conferences,
to provide technical assistance for developing economies, to
analyse world trade and to explain WTO activities to the public
and media.

⚫ The Secretariat also provides some forms of legal assistance in

the dispute settlement process and advises governments wishing
13 to become members of the WTO. The annual budget contributed
by members is roughly 197 million Swiss francs.
 Principles of the trading system

⚫ The WTO agreements are lengthy and complex because they are
legal texts covering a wide range of activities.

⚫ They deal with: agriculture, textiles and clothing, banking,

telecommunications, government purchases, industrial standards
and product safety, food sanitation regulations, intellectual
property, and much more.

⚫ But a number of simple, fundamental principles run throughout

all of these documents.
⚫ These principles are the foundation of the multilateral trading
system.
14
 A closer look at these principles:
⚫ Trade without discrimination

⚫ 1. Most-favoured-nation (MFN): treating other people equally- The trading system

should be without discrimination — a country should not discriminate between its
trading partners (giving them equally mostfavoured- nation” or MFN status); and it
should not discriminate between its own and foreign products, services or nationals
(giving them “national treatment”). Some exceptions are allowed. For example,
countries can set up a free trade agreement that applies only to goods traded within the
group — discriminating against goods from outside. Or they can give developing
countries special access to their markets. Or a country can raise barriers against
products that are considered to be traded unfairly from specific countries.

⚫ 2. National treatment: Treating foreigners and locals equally Imported and locally
produced goods should be treated equally — at least after the foreign goods have
entered the market. The same should apply to foreign and domestic services, and to
foreign and local trademarks, copyrights and patents. National treatment only applies
15
once a product, service or item of intellectual property has entered the market.
 ⚫ Freer trade: gradually, through negotiation

⚫ Lowering trade barriers is one of the most obvious means of encouraging trade. The barriers
concerned include customs duties (or tariffs) and measures such as import bans or quotas that restrict
quantities selectively. At first these focused on lowering tariffs (customs duties) on imported goods.
As a result of the negotiations, by the mid-1990s industrial countries’ tariff rates on industrial goods
had fallen steadily to less than 4%. The WTO agreements allow countries to introduce changes
gradually, through “progressive liberalization”. Developing countries are usually given longer to fulfil
their obligations

⚫ Predictability: through binding and transparency

⚫ Foreign companies, investors and governments should be confident that trade barriers (including
tariffs and non-tariff barriers) should not be raised arbitrarily; tariff rates and market-opening
commitments are “bound”in the WTO. With stability and predictability, investment is encouraged,
jobs are created and consumers can fully enjoy the benefits of competition — choice and lower prices.
The multilateral trading system is an attempt by governments to make the business environment stable
and predictable. In the WTO, when countries agree to open their markets for goods or services, they
“bind” their commitments. For goods, these bindings amount to ceilings on customs tariff rates. The
system tries to improve predictability and stability in other ways as well. One way is to discourage the
use of quotas and other measures used to set limits on quantities of imports — administering quotas
can lead to more red-tape and accusations of unfair play. Another is to make countries’ trade rules as
16 clear and public (“transparent”) as possible.
 ⚫ Promoting fair competition

⚫ The WTO is sometimes described as a “free trade” institution, but that is not entirely accurate.
The system does allow tariffs and, in limited circumstances, other forms of protection. More
accurately, it is a system of rules dedicated to open, fair and undistorted competition. The rules
on non-discrimination — MFN and national treatment — are designed to secure fair conditions
of trade. So too are those on dumping (exporting at below cost to gain market share) and
subsidies. The issues are complex, and the rules try to establish what is fair or unfair, and how
governments can respond, in particular by charging additional import duties calculated to
compensate for damage caused by unfair trade.

⚫ Encouraging development and economic reform

⚫ The WTO system contributes to development. On the other hand, developing countries need
flexibility in the time they take to implement the system’s agreements. And the agreements
themselves inherit the earlier provisions of GATT that allow for special assistance and trade
concessions for developing countries. Over three quarters of WTO members are developing
countries and countries in transition to market economies.

⚫ The case for open trade

⚫ The economic case for an open trading system based on multilaterally agreed rules is simple
enough and rests largely on commercial common sense. But it is also supported by evidence: the
experience of world trade and economic growth since the Second World War. Tariffs on
industrial products have fallen steeply and now average less than 5% in industrial countries.
During the first 25 years after the war, world economic growth averaged about 5% per year, a
17 high rate that was partly the result of lower trade barriers. World trade grew even faster,
averaging about 8% during the period.
 10 Benefits of WTO
⚫ 1. The system helps promote peace- Peace is partly an outcome of two of the most
fundamental principles of the trading system: helping trade to flow smoothly, and providing
countries with a constructive and fair outlet for dealing with disputes over trade issues. It is
also an outcome of the international confidence and cooperation that the system creates and
reinforces.

⚫ 2. Disputes are handled constructively- There could be a down side to trade liberalization
and expansion. More trade means more opportunities for disputes to arise. Left to themselves,
those disputes could lead to serious conflict. But in reality, a lot of international trade tension
is reduced because countries can turn to organizations, in particular the WTO, to settle their
trade disputes.

⚫ 3. Rules make life easier for all- The WTO cannot claim to make all countries equal. But it
does reduce some inequalities, giving smaller countries more voice, and at the same time
freeing the major powers from the complexity of having to negotiate trade agreements with
each of their numerous trading partners.

⚫ 4. Freer trade cuts the costs of living- Protectionism is expensive: it raises prices. The
WTO’s global system lowers trade barriers through negotiation and applies the principle of
non-discrimination. The result is reduced costs of roduction (because imports used in
production are cheaper) and reduced prices of finished goods and services, and ultimately a
lower cost of living.

18
 ⚫ 5. It provides more choice of products and qualities- Think of all the things we can now have
because we can import them:fruits and vegetables out of season, foods, clothing and other products
that used to be considered exotic, cut flowers from any part of the world, all sorts of household goods,
books, music, movies, and so on.

⚫ 6. Trade raises incomes- Lowering trade barriers allows trade to increase, which adds to incomes—
national incomes and personal incomes. The WTO’s own estimates for the impact of the 1994
Uruguay Round trade deal were between $109 billion and $510 billion added to world income
(depending on the assumptions of the calculations and allowing for margins of error).

⚫ 7. Trade stimulates economic growth- Trade clearly has the potential to create jobs. In practice there
is often factual evidence that lower trade barriers have been good for employment.

⚫ 8. The basic principles make life more efficient- Trade allows a division of labour between
countries. It allows resources to be used more appropriately and effectively for production. But the
WTO’s trading system offers more than that. It helps to increase efficiency and to cut costs even more
because of important principles enshrined in the system.

⚫ 9. Governments are shielded from lobbying- The GATT-WTO system which evolved in the second
half of the 20th Century helps governments take a more balanced view of trade policy. Governments
are better placed to defend themselves against lobbying from narrow interest groups by focusing on
trade-offs that are made in the interests of everyone in the economy.

⚫ 10. The system encourages good government- Under WTO rules, once a commitment has been
made to liberalize a sector of trade, it is difficult to reverse. The rules also discourage a range of
unwise policies. For businesses, that means greater certainty and clarity about trading conditions. For
governments it can often mean good discipline.

19
 The SPS and TBT Agreements
⚫ International trade in food is as old as nations
⚫ Trade in agricultural products provides clear economic benefits
⚫ Agriculture remains a cornerstone of many economies

⚫ One fundamental requirement is that imported (as well as domestic)

agricultural products are safe, and do not pose risks to human, animal and
plant health. To ensure food safety, and to avoid the introduction of diseases
and pests through trade, countries impose regulations to protect human and
animal health (sanitary measures) and plant health (phytosanitary measures)

⚫ GATT 1947 recognized the need to introduce trade restrictions to protect

health. GATT members had the right to take these measures as long as they
were not applied in a manner which would be a means of arbitrary or
unjustifiable discrimination between countries, or a disguised restriction on
international trade
⚫ Through successive rounds of negotiations, tariffs were reduced, and
temptation to use non-tariff barriers to protect domestic industries increased.
Included in these non-tariff barriers were sanitary and phytosanitary
20
measures. There was thus a growing need to give precision to the exceptions
 ⚫ Among many other concerns, sanitary and phytosanitary measures
were one of the areas addressed by the Uruguay Round of trade
negotiations, which resulted in the creation of the WTO in 1995

⚫ The Marrakesh Agreement Establishing the World Trade

Organization contains a number of trade agreements in its annexes,
including
⚫ Agreement on the Application of Sanitary and Phytosanitary
Measures (SPS Agreement)
⚫ Agreement on Agriculture deals mainly with issues of market
access, domestic support and export subsidies for agricultural
products
⚫ Agreement on Technical Barriers to Trade (TBT Agreement) covers
technical regulations not covered by the SPS Agreement

⚫ In addition, the WTO Agreement contains a dispute settlement

21 mechanism and a mechanism through which member’s trade policies
are regularly reviewed
 WORLD TRADE
ORGANIZATION

AGREEMENT ON THE
APPLICATION OF SANITARY AGREEMENT ON TECHNICAL
AND PHYTOSANITARY BARRIERS TO TRADE
MEASURES TBT AGREEMENT
SPS AGREEMENT

22
 SANITARY AND PHYTOSANITARY MEASURES AND
TECHNICAL BARRIERS TO TRADE
⚫ SPS allows member nations to take scientifically based measures to protect
public health
⚫ on internationally established guidelines and risk assessment procedures
⚫ in the case of particularly stringent measures, countries must present
scientific justification
⚫ SPS Agreement is a compromise that permits countries to take measures to
protect public health within their borders so long as they do so in a manner
that restricts trade as little as possible.
⚫ TBT Agreement strikes a delicate balance between the policy goals of trade
facilitation and national autonomy in technical regulations
⚫ covers all technical requirements, voluntary standards and the procedures
to ensure that these are met , except when these are SPS measures as
defined by the SPS Agreement
⚫ The agreement attempts to extricate the trade-facilitating aspects of
standards from their trade-distorting potential by obligating countries to
ensure that technical regulations and product standards do not
23 unnecessarily restrict international trade.
 The TBT Agreement works toward this end in three ways:
∙ The agreement encourages 'standard equivalence' between
countries, in other words, the formal acceptance of the standards
of other countries through explicit agreements.

∙ It also promotes the use of international standards.

⚫ Lastly, it mandates that countries establish enquiry points and

national notification authorities (the two may be the same body)
in order to answer questions about SPS regulations and notify
other nations of new regulations respectively. Enquiry points
compile all available information in that country on product
standards and trade regulations and provide it to other members
upon request.
24
 Differences between SPS and TBT Measures:

SPS measures typically deal with: TBT measures typically deal with:
⚫ additives in food or drink ◻ labelling of composition or quality of
⚫ contaminants in food or drink food, drink and drugs
⚫ toxic substances in food or drink ◻ quality requirements for fresh food
⚫ residues of veterinary drugs or pesticides in ◻ volume, shape and appearance of
food or drink
packaging
⚫ certification: food safety, animal or plant
health ◻ packaging and labelling for dangerous
⚫ processing methods with implications for
chemicals and toxic substances,
food safety pesticides and fertilizer
⚫ labelling requirements directly related to ◻ regulations for electrical appliances
food safety ◻ regulations for cordless phones, radio
⚫ plant/animal quarantine equipment etc.
⚫ declaring areas free from pests or disease ◻ textiles and garments labelling
⚫ preventing disease or pests spreading to or in
a country
◻ testing vehicles and accessories
⚫ other sanitary requirements for imports (e.g. ◻ regulations for ships and ship
imported pallets used to transport animals) equipment
25
◻ safety regulations for toys
The WTO Agreement on the Application of Sanitary and Phyto-sanitary
Measures (SPS Agreement) – Annex A: Definition

⚫ 1. Sanitary or phytosanitary measure — Any measure

applied:

⚫ (a) to protect animal or plant life or health within the territory of

the Member from risks arising from the entry, establishment or
spread of pests, diseases, disease-carrying organisms or
disease-causing organisms;
⚫ (b) to protect human or animal life or health within the territory
of the Member from risks arising from additives, contaminants,
toxins or disease-causing organisms in foods, beverages or
feedstuffs;
⚫ (c) to protect human life or health within the territory of the
Member from risks arising from diseases carried by animals,
26
plants or products thereof, or from the entry, establishment or
spread of pests; or
⚫ 2. Harmonization — The establishment, recognition and application of
common sanitary and phytosanitary measures by different Members.
⚫ 3. International standards, guidelines and recommendations:
⚫ (a) for food safety, the standards, guidelines and recommendations
established by the Codex Alimentarius Commission relating to food
additives, veterinary drug and pesticide residues, contaminants, methods
of analysis and sampling, and codes and guidelines of hygienic practice;
⚫ (b) for animal health and zoonoses, the standards, guidelines and
recommendations developed under the auspices of the International
Office of Epizootics;
⚫ (c) for plant health, the international standards, guidelines and
recommendations developed under the auspices of the Secretariat of the
International Plant Protection Convention in cooperation with regional
organizations operating within the framework of the International Plant
Protection Convention; and
⚫ (d) for matters not covered by the above organizations, appropriate
standards, guidelines and recommendations promulgated by other
27 relevant international organizations open for membership to all
 ⚫ 4. Risk assessment — The evaluation of the likelihood of entry,
establishment or spread of a pest or disease within the territory of an
importing Member according to the sanitary or phytosanitary measures
which might be applied, and of the associated potential biological and
economic consequences; or the evaluation of the potential for adverse
effects on human or animal health arising from the presence of
additives, contaminants, toxins or disease-causing organisms in food,
beverages or feedstuffs.
⚫ 5. Appropriate level of sanitary or phytosanitary protection — The
level of protection deemed appropriate by the Member establishing a
sanitary or phytosanitary measure to protect human, animal or plant
life or health within its territory.
⚫ 6. Pest— or disease-free area — An area, whether all of a country, part
of a country, or all or parts of several countries, as identified by the
competent authorities, in which a specific pest or disease does not
occur.
⚫ 7. Area of low pest or disease prevalence — An area, whether all of a
28
country, part of a country, or all or parts of several countries, as
identified by the competent authorities, in which a specific pest or
 Why do standards matter for trade?
⚫ Government regulations or industry standards for goods can impact trade in at least
three ways:

∙ They can facilitate exchange by clearly defining product characteristics and improving
compatibility and usability.
∙ They also advance domestic social goals like public health by establishing minimum
standards or prescribing safety requirements.
∙ Finally, they can hide protectionist policies.

⚫ During the Uruguay Round of multilateral trade negotiations, member nations

established The Agreement on the Application of Sanitary and Phytosanitary (SPS)
Measures and the Agreement on Technical Barriers to Trade (TBT) to address the
emerging debate over the use of standards in international trade. The SPS and TBT
Agreements can be interpreted as an attempt to balance the first two uses of standards
and to minimize the third. In other words, these Agreements balance the competing
demands for domestic regulatory autonomy and the global harmonization of product
standards. At the same time, the agreements attempt to prevent standards from
becoming a protectionist device.

29
 Developing Countries
⚫ Developing countries take issue with the agreements because
they make intensive use of multilaterally established standards
that are determined by a process that is both politically and
economically skewed.

⚫ Thus, implementing the SPS and TBT Agreements often requires

developing countries to adhere to standards more appropriate for
their industrialized counterparts.

⚫ The lack of developing country input in the formation of

standards translates into what some observers have called
techno-imperialism, or the imposition of standards by the rich
countries upon the poor ones.

30
 What is the Food and Agriculture
Organization?
⚫ The Food and Agriculture Organization of the United
Nations (FAO) is a specialised agency of the United
Nations that leads international efforts to defeat hunger.
⚫ Serving both developed and developing countries, FAO
acts as a neutral forum where all nations meet as equals to
negotiate agreements and debate policy.
⚫ FAO is also a source of knowledge and information, and
helps developing countries and countries in transition
modernize and improve agriculture, forestry and fisheries
practices, ensuring good nutrition and food security for all.
⚫ Its Latin motto, fiat panis, translates into English as "let
there be bread“.
⚫ As of now, FAO has 194 members states, works in over
31
130 countries worldwide.
 ⚫ A specific priority of the Organization is encouraging
sustainable agriculture and rural development, a long-term
strategy for increasing food production and food security
while conserving and managing natural resources.

⚫ The aim is to meet the needs of both present and future

generations by promoting development that does not
degrade the environment and its technically appropriate,
economically viable and socially acceptable.

32
 Structure and finance
⚫ FAO was established on 16 October 1945 in Quebec City, Quebec, Canada. In
1951 its headquarters were moved from Washington, D.C., United States, to
Rome, Italy.

⚫ The agency is directed by the Conference of Member Nations, which meets

every two years to review the work carried out by the organization and to
approve a Programme of Work and Budget for the next two-year period.

⚫ The Conference elects a council of 49 member states (serve three-year rotating

terms) that acts as an interim governing body, and the Director-General, that
heads the agency.

⚫ FAO is composed of eight departments: Agriculture and Consumer Protection,

Climate, Biodiversity, Land and Water Department, Economic and Social
Development, Fisheries and Aquaculture, Forestry, Corporate Services and
Technical Cooperation and Programme Management.

33⚫ Beginning in 1994, FAO underwent the most significant restructuring since its
founding, to decentralize operations, streamline procedures and reduce costs.
 FAO World headquarters
⚫ The world headquarters are located in Rome, in the former seat of the
Department of Italian East Africa.

⚫ One of the most notable features of the building was the Axum Obelisk which
stood in front of the agency seat, although just outside of the territory
allocated to FAO by the Italian Government.

⚫ It was taken from Ethiopia by Benito Mussolini's troops in 1937 as a war

chest, and returned on 18 April 2005.

⚫ It has various regional, sub-regional and Liaison offices also.

34
 What it does?
⚫ Development assistance
FAO considerations included in the formulation of giving practical help to
developing countries through a wide range of technical assistance projects. The
organization encourages an integrated approach with environmental, social and
economic development projects.

⚫ Information
FAO collects, analyses, interprets and disseminates information relating to
nutrition, food, agriculture, forestry and fisheries. The Organization serves as a
clearing-house, providing farmers, scientists, traders and government planners
with the information they need to make rational decisions on planning,
investment, marketing, research or training.

⚫ Advice to Governments
Drawing on its widespread information networks and the skills and experience of
its technical staff, FAO provides independent advice on agricultural policy and
planning, and the administrative and legal structures needed for development. It
includes national strategies towards rural development, increased food security
35and the alleviation of poverty.
 ⚫ Neutral forum
FAO provides a neutral forum where all nations can meet to discuss and formulate
policy on major food and agriculture issues. FAO approves international standards and
helps frame international conventions and agreements and regularly hosts major
conferences, technical meetings and consultations of experts.

⚫ FAO in India
For the last decades FAO has continuously been a partner in India’s development from
a food deficit country to a net food exporting country. FAO concentrates on its
technical assistance in a relatively small number of catalytic areas where high quality
technical assistance can be effectively leveraged into a large quantum of ultimate
development.
FAO’s current focus in India is mainly on plant production activities, forestry, fisheries,
nutrition, and food quality & safety.

⚫ Regular Support
The FAO in India provides regular support to many activities within its mandate,
particularly in the field of Food Security and Nutrition. Household food security
through small and large scale production activities, community nutrition, nutrition
education, street foods, food safety and quality control are examples of issues FAO
supports through its elaborate technical services in its Head Quarters in Rome and
Regional Office in Bangkok. A special interests lies in the field of vulnerability
mapping through the establishment of a Food Insecurity and Vulnerability Information
and Mapping System (FIVIMS ) and the preparation of a Nutrition Country Profile for
36India. In addition, under its Special Programme for Food Security, FAO supports the
design of a large scale maize production scheme.
 ⚫ Technical Cooperation Programme
The FAO’s own Technical Cooperation Programme (TCP) is funded from the
organizations Regular Programme, and is used to respond rapidly to urgent and
unforeseen requests for technical and emergency assistance. By its very nature,
the TCP is unprogrammed. Other characteristics are its limited project duration;
low costs; practical orientation; and catalytic role and complementarity to other
sources of assistance.

⚫ Examples of TCP projects in India are:

⚫ Transfer of technology for vegetative propagation of walnuts in Jammu &
Kashmir
⚫ Assistance to apiculture in Karnataka
⚫ Development of integrated plant nutrition systems methodology
⚫ Training in sea safety development programmes
⚫ Greenhouse technology for floriculture
⚫ Food quality control

37
 ⚫ Trust Fund projects
Trust Funds are set up and administered by FAO on behalf of the countries and
institutions that donate them and on behalf of the recipient countries that benefit
from them.

The twelve current Trust Fund projects cover a wide range: forestry, fisheries,
local fibre industries, animal genetic resources, integrated pest control, watershed
management, population and development dynamics and wood energy
development

Four World Bank funded Trust Fund projects specifically emphasize capacity
building through fellowships and study tours.

⚫ UNDP funded projects

FAO provides technical assistance to the execution of UNDP funded projects.
The current areas of involvement are: establishment of a phytotron facility, plant
quarantine and inspection facilities, oilseeds & pulses, biovillage demonstration,
and forestry.
38
 ⚫ Biosecurity in Food and Agriculture
Biosecurity is a key requirement for achieving the goals set out in the FAO
Strategic Framework by promoting, developing and re-enforcing policy and
regulatory frameworks for food, agriculture, fisheries, and forestry. Biosecurity
has direct relevance to food safety, the conservation of the environment
(including biodiversity), and sustainability of agriculture.

Biosecurity encompasses all policy and regulatory frameworks (including

instruments and activities) to manage risks associated with food and agriculture
(including relevant environmental risks) including fisheries and forestry and
constitutes three sectors (namely food safety, plant life and health, and animal
life and health).

These sectors include food production in relation to food safety, the introduction
of plant pests, animal pests and diseases and zoonoses, the introduction and
release of Genetically Modified Organisms (GMOs) and their products and the
introduction and safe management of invasive alien species and genotypes.

39
 Growing interest in Biosecurity is a result of major international developments
such as globalization of the world economy, the rapid increase in volume of
communications, transport and trade, technological progress and growing
awareness of problems faced by biological diversity and environment.
Members require effective, efficient, improved and updated international
frameworks and standards to support appropriate national action. Members also
require national frameworks to regulate, manage and control biosecurity for food
and agriculture including forestry and fisheries, thus permitting practical
implementation increasing cost effectiveness and improving consistency across
sectors.

Recent developments related to biosecurity in food and agriculture include the

tendency toward integration of and cooperation across sectors. Internationally
this tendency is demonstrated in the WTO Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS Agreement) and the Convention on
Biological Diversity (CBD) and its Cartagena Protocol on Biosafety. It is further
addressed in the FAO/WHO Codex Alimentarius, the International Plant
Protection Convention (IPPC) and the FAO Code of Conduct for Responsible
Fisheries. The IPPC makes a key contribution to biosecurity by reducing the
40risks of introduction of plant pests that may affect agriculture and the
environment.
 World Health Organization
⚫ The World Health Organization (WHO) is a specialized
agency of the United Nations (UN) that acts as a coordinating
authority on international public health.
⚫ Established on 7 April 1948, and headquartered in Geneva,
Switzerland, the agency inherited the mandate and resources of
its predecessor, the Health Organization, which had been an
agency of the League of Nations.

⚫ Constitution and history: The WHO's constitution states that

its objective "is the attainment by all people of the highest
possible level of health ." Its major task is to combat disease,
especially key infectious diseases, and to promote the general
health of the people of the world. The World Health
Organization (WHO) is one of the original agencies of the
United Nations, its constitution formally coming into force on
41 the first World Health Day, (December 21 2012), when it was
ratified by the 26th member state.
 Structure
⚫ WHO is working with 194 Member States, across six regions, and
from more than 150 offices.
⚫ The WHO Headquarters is in Geneva.
⚫ WHO Member States appoint delegations to the World Health
Assembly, WHO's supreme decision-making body.
⚫ All UN member states are eligible for WHO membership, and,
according to the WHO web site, “Other countries may be admitted as
members when their application has been approved by a simple
majority vote of the World Health Assembly.”
⚫ The WHO Assembly generally meets in May each year. The Assembly
elects 34 members, technically qualified in the field of health, to the
Executive Board for three-year terms.
⚫ The main functions of the Board are to carry out the decisions and
policies of the Assembly, to advise it and to facilitate its work in
general.
42⚫ The WHO has various regional, liaison and country offices.
 The WHO agenda
⚫ WHO operates in an increasingly complex and rapidly
changing landscape.
⚫ The boundaries of public health action have become
blurred, extending into other sectors that influence
health opportunities and outcomes.
⚫ WHO responds to these challenges using a six-point
agenda.
⚫ The six points address two health objectives, two
strategic needs, and two operational approaches.
⚫ The overall performance of WHO will be measured by
the impact of its work on women's health and health in
Africa.
43
 1. Promoting development
⚫ During the past decade, health has achieved unprecedented
prominence as a key driver of socioeconomic progress, and more
resources than ever are being invested in health. Yet poverty
continues to contribute to poor health, and poor health anchors
large populations in poverty.
⚫ Health development is directed by the ethical principle of equity:
Access to life-saving or health-promoting interventions should
not be denied for unfair reasons, including those with economic
or social roots.
⚫ Commitment to this principle ensures that WHO activities aimed
at health development give priority to health outcomes in poor,
disadvantaged or vulnerable groups.
⚫ Attainment of the health-related Millennium Development Goals,
preventing and treating chronic diseases and addressing the
44
neglected tropical diseases are the cornerstones of the health and
development agenda.
 2. Fostering health security
⚫ Shared vulnerability to health security threats demands collective
action. One of the greatest threats to international health security arises
from outbreaks of emerging and epidemic-prone diseases.
⚫ Such outbreaks are occurring in increasing numbers, fuelled by such
factors as rapid urbanization, environmental mismanagement, the way
food is produced and traded, and the way antibiotics are used and
misused.
⚫ The world's ability to defend itself collectively against outbreaks has
been strengthened since June 2007, when the revised International
3. Health Regulations
Strengthening came systems
health into force.
⚫ For health improvement to operate as a poverty-reduction strategy,
health services must reach poor and underserved populations.
⚫ Health systems in many parts of the world are unable to do so, making
the strengthening of health systems a high priority for WHO.
⚫ Areas being addressed include the provision of adequate numbers of
appropriately trained staff, sufficient financing, suitable systems for
45 collecting vital statistics, and access to appropriate technology
 4. Harnessing research, information and evidence

⚫ Evidence provides the foundation for setting priorities, defining

strategies, and measuring results.
⚫ WHO generates authoritative health information, in consultation
with leading experts, to set norms and standards, articulate
evidence-based policy options and monitor the evolving global
heath situation.
5. Enhancing partnerships
⚫ WHO carries out its work with the support and collaboration of
many partners, including UN agencies and other international
organizations, donors, civil society and the private sector.
⚫ WHO uses the strategic power of evidence to encourage partners
implementing programmes within countries to align their
activities with best technical guidelines and practices, as well as
with the priorities established by countries.
46
 6. Improving performance
⚫ WHO participates in ongoing reforms aimed at improving its
efficiency and effectiveness, both at the international level and
within countries. WHO aims to ensure that its strongest asset - its
staff - works in an environment that is motivating and rewarding.
WHO plans its budget and activities through results-based
management, with clear expected results to measure performance
at country, regional and international levels.
⚫ Activities: Coordinating international efforts to monitor
outbreaks of infectious diseases, such as SARS, malaria,
Tuberculosis, swine flu, and AIDS . Sponsors programs to
prevent and treat such diseases. Supports the development and
distribution of safe and effective vaccines, pharmaceutical
diagnostics, and drugs. After over two decades of fighting
smallpox, the WHO declared in 1980 that the disease had been
eradicated – the first disease in history to be eliminated by
47
human effort. The WHO aims to eradicate polio within the next
 ⚫ The WHO also carries out various health-related campaigns — for
example, to boost the consumption of fruits and vegetables worldwide
and to discourage tobacco use.
⚫ The WHO also promotes the development of capacities in Member
States to use and produce research that addresses national needs, by
bolstering national health research systems and promoting knowledge
translation platforms such as the Evidence Informed Policy Network
-EVIPNet.
⚫ WHO also conducts health research in communicable diseases,
non-communicable conditions and injuries; for example, longitudinal
studies on ageing to determine if the additional years we live are in
good or poor health, and, whether the electromagnetic field
surrounding cell phones has an impact on health.

⚫ The World Health Organization's suite of health studies is working to

provide the needed health and well-being evidence through a variety
of data collection platforms, including the World Health Survey
covering 308,000 respondents aged 18+ years and 81,000 aged 50+
48
years from 70 countries and the Study on global AGEing and adult
health (SAGE)) covering over 50,000 persons aged 50+ across almost
 Programs and Projects
⚫ African Programme for Onchocerciasis Control (APOC)
⚫ Yellow Card or Carte Jaune, is an international certificate of
vaccination (ICV) issued by the WHO. It is recognised internationally
and may be required for entering certain countries where there are
more health risks for travellers. The Yellow Card should be kept in the
holder's passport as it is a medical passport of sorts.
⚫ Collaborating centres are institutions designated by the
director-general that work to support WHO programs.
⚫ Global Burden of Disease project (GBD)
⚫ Global Initiative for Emergency and Essential Surgical Care
⚫ Global Malaria Programme (GMP)
⚫ Household Water Treatment and Safe Storage (HWTS)
⚫ Prequalification of Medicines Programme (PMP page)
⚫ International Programme on Chemical Safety (IPCS), with ILO and
UNEP
⚫ International Radon Project
49
⚫ World Health Day is celebrated every year on 7 April.
 What is Office International des Epizooties
(OIE) / World animal Health Organization
⚫ The OIE was created in 1924 by 28 countries, and thus predates
the United Nations.
⚫ The founding countries wished to implement an international
agreement that would enable them to work together to try to put
an end to the epizootics that were devastating their livestock.
⚫ In particular, they sought an undertaking from infected
countries to inform the others in case of an important sanitary
event, thereby enabling them to take protective action. They
also wished to have information on the most effective methods
of controlling the most dangerous animal diseases.
⚫ The need to fight animal diseases at global level led to the
creation of the Office International des Epizooties through the
international Agreement signed on January 25th 1924.
⚫ In May 2003 the Office became the World Organization for
Animal Health but kept its historical acronym OIE.
50
⚫ The OIE is the intergovernmental organization responsible for
improving animal health worldwide.
⚫ The headquarter of the organization is located in Paris.

⚫ It is recognized as a reference organization by the World Trade

Organization (WTO).
⚫ In 1994, the Agreements that led to the creation of the World
Trade Organization (WTO) included specific measures on the
management of sanitary and phytosanitary problems (SPS
Agreements) relating to the risks posed by trade in animals and
animal products.
⚫ The standards, guidelines and recommendations issued by the
OIE were designated as the international reference in the field of
animal diseases and zoonoses.
⚫ The WTO's choice of the OIE stems mainly from the fact that
51 this organization's decisions are exclusively science-based.
 Objectives
⚫ To improve the health and the welfare of animals all over the
world regardless of the cultural practices or the economic
situations in member countries.

⚫ The objectives of sanitary and scientific information in the

veterinary field are among the priority missions of this
organisation, both for diseases solely affecting animals and those
also transmissible to humans.

52
 Members
⚫ In 2018 had a total of 182 member states.

⚫ The OIE maintains permanent relations with 45 other

international and regional organizations and has Regional and
sub-regional Offices on every continent.

⚫ In the original agreement establishing OIE there were 28

European countries enrolled as members.

53
 Working
⚫ The organization is placed under the authority and control of a
World Assembly of Delegates consisting of Delegates designated
by the Governments of all Member Countries.
⚫ The day-to-day operation of the OIE is managed at the
Headquarters situated in Paris and placed under the responsibility
of a Director General elected by the World Assembly of
Delegates.
⚫ The Headquarters implements the resolutions passed by the
International Committee and developed with the support of
Commissions elected by the Delegates:
⚫ Council
⚫ Regional Commissions (5)
⚫ Specialist Technical Commissions (4)

54
 ⚫ The OIE's financial resources are derived principally from compulsory
annual contributions backed up by voluntary contributions from Member
Countries and Territories.
⚫ There is a sliding scale of fees structured into six different categories.
Members have the option to decide the category according to the size of their
economy. There is one vote for each country and generally decisions are
made through consensus.
⚫ An International Committee (IC) comprising permanent delegates appointed
by the governments of the member countries is the apex decision making
body in OIE. The permanent delegates are expected to be animal health
professionals in their country.

⚫ At the operational level, activities of OIE are conducted by a Central Bureau.

The Chief Executive is called Director-General, who is appointed by the
International Committee. The Central Bureau is the implementing wing for
all resolutions of IC, the Regional Commissions and the Specialist
Commissions. Depending upon the topical exigencies, OIE has provisions
for Working Groups. Similarly, the standard setting processes begin as and
when a need is felt. Usually, the Central Bureau is the pivotal point in any
exercise on the standard setting.
⚫ The OIE maintains Representations in the following regions: Africa,
Americas, Asia and the Pacific, Eastern Europe, Middle East.
55⚫ The goal of these Representations is to provide regionally adapted services
to OIE Members so that they may strengthen the surveillance and control of
 What is International Plant Protection
Convention (IPPC)?
⚫ The International Plant Protection Convention (IPPC) is a 1951 multilateral
treaty overseen by the United Nations Food and Agriculture Organization
that aims to secure coordinated, effective action to prevent and to control the
introduction and spread of pests of plants and plant products. The
Convention extends beyond the protection of cultivated plants to the
protection of natural flora and plant products. It also takes into consideration
both direct and indirect damage by pests, so it includes weeds.
⚫ The Convention created a governing body consisting of each party, known
as the Commission on Phytosanitary Measures, which oversees the
implementation of the convention. As of August 2017, the convention has
183 parties, which includes 180 United Nations member states, the Cook
Islands, Niue, and the European Union.

⚫ The convention is recognized by the World Trade Organization's (WTO)

Agreement on the Application of Sanitary and Phytosanitary Measures (the
SPS Agreement) as the only international standard setting body for plant
health.

⚫ The IPPC is one of the "Three Sisters" recognized by the World Trade
56 Organization's (WTO) Sanitary and Phytosanitary Measures (SPS)
Agreement, along with the Codex Alimentarius Commission for food safety
 Implementing the IPPC: Governing bodies and structure
⚫ The Commission on Phytosanitary Measures (CPM) was established in 2005
building on the Committee of Experts on Phytosanitary Measures (CEPM),
whose first session was held in 1993. The CPM is the IPPC main governing
body, holding its sessions annually. The CPM promotes the full
implementation of the Convention’s objectives, including reviewing the state
of plant protection in the world and actions to control the international
spread of pests and their introduction into endangered areas; establishing and
keeping under review the necessary institutional arrangements and
procedures for the development and adoption of international standards; and
adopting international standards.

⚫ The CPM Bureau was established in 2005 as the executive body of the
Commission. It provides guidance to the IPPC Secretariat on activities,
particularly those related to financial and operational management, between
CPM sessions and meets at least five times per year including one virtual
meeting. The CPM Bureau is composed of seven members, one per FAO
region.

⚫ The Standards Committee (SC) is composed of 25 members and of

57 observer(s) from the seven FAO regions. Its primary role includes
overseeing the IPPC standard setting process to develop international
 ⚫ The Implementation and Capacity Development Committee (IC) is
composed of 12 members, plus one RPPO representative and one SC
representative. It provides technical guidance to enhance the capacity of
contracting parties to implement the IPPC and meet its strategic objectives.

⚫ The Strategic Planning Group (SPG) is an informal working group, which

undertakes specific activities on behalf of the CPM, relating to the planning
and prioritization of the various elements of the work programme including a
focus on strategic issues. Its meetings are open to IPPC contracting parties
and observers.
⚫ The Financial Committee (FC) was established in 2012 and its core function
is to secure financial transparency and appropriateness and to ensure the
integration of the IPPC Strategic Framework into financial issues throughout
planning and budgeting processes. The FC contributes to resource
mobilization by assisting in the framing and developing of relevant
documents.

⚫ The IPPC Secretariat, established in 1992 and hosted at FAO headquarters in

Rome, coordinates the work of IPPC contracting parties to achieve the
Convention’s goals. It develops a variety of resources to provide technical
58 guidelines, it implements plant health related projects and organizes the
CPM and other major committee meetings, and is responsible for the
 Regional Plant Protection Organizations
⚫ The IPPC boasts a network of international partners from all over the
world. These include ten Regional Plant Protection Organizations
(RPPOs) working to secure plant health and environmental protection
in their regions. The IPPC specifies the functions of RPPOs as:
⚫ coordinating National Plant Protection Organizations (NPPOs) and
participating in activities to promote and achieve the objectives of
the IPPC;
⚫ cooperating with other regions to promote harmonized phytosanitary
measures;
⚫ gathering and disseminating information, in particular in relation to
the IPPC; and
⚫ cooperating with the CPM and the IPPC Secretariat in developing
and implementing International Standards for Phytosanitary
Measures.

⚫ Each RPPO has its own action plan and programme. However, each
year the IPPC Secretariat organizes a Technical Consultation
59 (TC-RPPO) where all RPPOs gather to discuss common challenges,
share information and look for synergies.
 Functions and Objectives
⚫ International travel and trade are greater than ever before — and
as people and commodities move around the world, organisms
that present risks to plants travel with them.

⚫ Pest introductions and outbreaks cost governments, farmers and

consumers billions every year. Once pest species are established
their eradication is often impossible, and controlling them takes
up a significant percentage of the cost of producing food.

⚫ The IPPC allows countries to analyze risks to their national plant

resources and to use science-based measures to safeguard their
cultivated and wild plants.

60
 ⚫ By protecting plant resources from pests and diseases, the IPPC
helps:
⚫ protect farmers from economically devastating pest and
disease outbreaks;
⚫ protect the environment from loss of species diversity;
⚫ protect ecosystems from loss of viability and function as a
result of pest invasions; and
⚫ protect industries and consumers from the costs of pest control
or eradication.

⚫ Contracting parties to the IPPC share the same goal: to protect

the world's cultivated and natural plant resources from the
spread and introduction of plant pests while minimizing
interference with the international movement of goods and
61 people.
 ⚫ The IPPC also provides information exchange related to import
and export requirements, pest status and regulated pest lists
provided by each member country.
⚫ Developing countries also receive technical assistance to support
their ability to implement the Convention and the ISPMs.

⚫ While the IPPC’s primary focus is on plants and plant products

moving in international trade, the convention also covers
research materials, biological control organisms, germplasm
banks, containment facilities and anything else that can act as a
vector for the spread of plant pests — for example, containers,
packaging materials, soil, vehicles, vessels and machinery.

62
 ⚫ The IPPC is governed by the Commission on Phytosanitary
Measures (CPM), which meets annually to promote cooperation
to help implement the objectives of the IPPC. In particular, the
CPM:

⚫ reviews the state of plant protection around the world;

⚫ identifies action to control the spread of pests into new areas;
⚫ develops and adopts international standards;
⚫ establishes rules and procedures for resolving disputes;
⚫ establishes rules and procedures for the sharing of
phytosanitary information; and
⚫ cooperates with international organizations on matters covered
by the Convention.

63
 ⚫ Contracting parties participate in implementing the IPPC
through:

⚫ involvement in standard setting activities;

⚫ the implementation of standards and ISPMs;
⚫ involvement in Commission on Phytosanitary Measures
meetings;
⚫ membership of international organizations;
⚫ membership of Regional Plant Protection Organizations;
⚫ participation through National Plant Protection Organizations;
⚫ involvement in phytosanitary capacity building;
⚫ sharing of technical information, experience and expertise; and
⚫ supporting the IPPC Secretariat by making financial or in kind
donations.

64
 IPPC and International Trade
⚫ The IPPC has always played an important role in international
trade. The Convention has encouraged countries to ensure
through phytosanitary certification that their exports are not the
means for introducing new pests to their trading partners.
Likewise importing countries strive to ensure that measures they
have in place for protection are technically justified.
⚫ The relationship of the IPPC to international trade is
strengthened by the WTO-SPS Agreement which names the
IPPC as the international organization responsible for
phytosanitary standard-setting and the harmonization of
phytosanitary measures affecting trade. Both agreements are
distinct in their scope purpose and membership. Neither
agreement is supplementary to the other. Instead they are
complementary in the areas where they overlap. The SPS
Agreement makes provision for plant protection in a trade
65
agreement and the IPPC makes provision for trade in a protection
 ⚫ The IPPC is a legally binding international agreement but the
standards developed and adopted by the Convention are not legally
binding under the IPPC. However WTO members are required to base
their phytosanitary measures on international standards developed
within the framework of the IPPC. Phytosanitary measures that
conform to the ISPMs are presumed to be consistent with the relevant
provisions of the SPS Agreement.
⚫ Measures that deviate from international standards or measures that
exist in the absence of international standards must be developed
through the assessment of the risk to plant life or health and must be
based on scientific principles and evidence. Emergency (or
provisional) measures may be taken without such analyses but must be
reviewed in a timely manner for their scientific justification and
modified accordingly to be legitimately maintained.

⚫ The IPPC also has dispute settlement procedures in the instance where
measures may be challenged as unjustified barriers to trade. The
dispute settlement process under the IPPC offers possibilities for
examining controversial issues at a technical level. Although the
dispute settlement process in the IPPC is non-binding the results of the
process can be expected to have substantial influence in disputes that
66
may be raised to the WTO level under the SPS Agreement.
 CODEX ALIMENTARIUS COMMISSION
(CODEX)
⚫ Adequate, safe and wholesome food is a vital element for the
achievement of acceptable standards of living. There is
increasingly worldwide concern about food safety and animal
and plant health.

⚫ The WTO Agreement on Sanitary and Phytosanitary Measures

sets out the basic rules for food safety and animal and plant
health regulations. It applies to all such measures which may,
directly or indirectly, affect international trade.

⚫ All countries have the right to adopt or enforce necessary

measures to protect human, animal or plant life or health,
subject to the requirement that these measures are not applied in
a manner which would constitute a means of arbitrary or
67
unjustifiable discrimination between Members where the same
 ⚫ The major objectives of the work of Codex Alimentarius
Commission [CAC] are to protect the health of the consumers and
ensure fair practices in the food trade as well as to facilitate
international trade in food.

⚫ The National Codex Contact Point (NCCP) in the Ministry of Health

and Family Welfare acts as the liaison office to coordinate with the
other concerned government departments (at central and state level),
food industry, consumers, traders, research and development
institutions to ensure fulfill this objective.

⚫ Article 7 of the Agreement requires the members to provide

information on Sanitary or Phytosanitary requirements in the
country.

⚫ For this purpose each Member is required to ensure that one Enquiry
Point exists which is responsible for answering all reasonable
68
questions from interested Members as well as to provide relevant
 ⚫ The Codex Alimentarius Commission was created in 1963 by
Food and Agriculture Organization of the United Nations
(FAO) and the World Health Organization (WHO) to develop
food standards, guidelines and related texts such as codes of
practice under the Joint FAO/WHO Food Standards
Programme.
⚫ The main purpose of this Programme is to protect the health of
consumers, ensure fair practices in the food trade, and promote
coordination of all food standards work undertaken by
international governmental and non-governmental
organizations.
⚫ These standards are accepted by World Trade Organization
(WTO) in settling disputes in international trade.
⚫ Latin for “Food Law” or “Food Code”
69 ⚫ Currently the Codex Alimentarius Commission has 189 Codex
Members made up of 188 Member Countries and 1 Member
 ⚫ Codex Alimentarius is a collection of standards, codes of
practice, guidelines and other recommendations.

⚫ The Codex General Principles of Food Hygiene introduces the

use of the Hazard Analysis and Critical Control Point
(HACCP), being the prime food safety management system.

⚫ Several significant issues, vital to fulfilling the objectives of the

Codex Alimentarius Commission, namely, protecting the health
of consumers, ensuring food safety and promoting fair global
trade practices are under discussion across several Codex
Committees that focus on Food Safety Objectives.

70
 Standards, codes of practice, guidelines and other
recommendations
⚫ Codex standards usually relate to product characteristics and may deal with
all government-regulated characteristics appropriate to the commodity, or only
one characteristic. Maximum residue limits (MRLs) for residues of pesticides
or veterinary drugs in foods are examples of standards dealing with only one
characteristic.

⚫ Codex general standards for food additives and contaminants and toxins in
foods that contain both general and commodity- specific provisions. The
Codex General Standard for the Labelling of Prepackaged Foods covers all
foods in this category. Because standards relate to product characteristics, they
can be applied wherever the products are traded.

⚫ Codex methods of analysis and sampling, including those for contaminants

and residues of pesticides and veterinary drugs in foods, are also considered
Codex standards.

71
 ⚫ Codex codes of practice – including codes of hygienic practice – define the
production, processing, manufacturing, transport and storage practices for
individual foods or groups of foods that are considered essential to ensure the
safety and suitability of food for consumption. For food hygiene, the basic text
is the Codex General Principles of Food Hygiene, which introduces the use of
the Hazard Analysis and Critical Control Point (HACCP) food safety
management system.

⚫ Codex guidelines fall into two categories:

⚫ principles that set out policy in certain key areas; and

⚫ guidelines for the interpretation of these principles or for the interpretation

of the provisions of the Codex general standards.

⚫ Interpretative Codex guidelines include those for food labelling, especially

the regulation of claims made on the label. This group includes guidelines for
nutrition and health claims; conditions for production, marketing and labelling
of organic foods; and foods claimed to be “halal”.
72
 The Commission’s operations : Compiling the Codex Alimentarius

⚫ As stated in Article 1 of the Commission’s Statutes, one of the principal

purposes of the Commission is the preparation of food standards and their
publication in the Codex Alimentarius.

⚫ The legal base for the Commission’s operations and the procedures it is
required to follow are published in the Procedural Manual of the Codex
Alimentarius Commission. Like all other aspects of the Commission’s work,
the procedures for preparing standards are well defined, open and transparent.

⚫ In essence they involve:

⚫ The submission of a proposal for a standard to be developed by a national

government or a subsidiary committee of the Commission. This is usually
followed by a discussion paper that outlines what the proposed standard is
expected to achieve, and then a project proposal that indicates the time
frame for the work and its relative priority.

73
 ⚫ A decision by the Commission or the Executive Committee that a
standard be developed as proposed. “Criteria for the Establishment of
Work Priorities” exist to assist the Commission or Executive Committee in
their decision-making and in selecting the subsidiary body to be responsible
for steering the standard through its development. If necessary, a new
subsidiary body – usually a specialized task force – may be created.

⚫ The preparation of a proposed draft standard is arranged by the

Commission Secretariat and circulated to member governments for
comment.

⚫ Comments are considered by the subsidiary body that has been allocated
responsibility for the development of the proposed draft standard, and this
subsidiary body may present the text to the Commission as a draft
standard. The draft may also be referred to the Codex Committees
responsible for labelling, hygiene, additives, contaminants or methods of
analysis for endorsement of any special advice in these areas.

⚫ Most standards take a number of years to develop. Once adopted by the

74 Commission, a Codex standard is added to the Codex Alimentarius.
 Revising and adapting: keeping the Codex Alimentarius up to date

⚫ The Commission and its subsidiary bodies are committed to

keeping the Codex standards and related texts up to date to
ensure that they are consistent with current scientific knowledge
and with the needs of the member countries.

⚫ The procedure for revision or consolidation follows that used for

the initial preparation of standards.

75
 General Subject Committees

⚫ These Committees are so called because their work has relevance for
all Commodity Committees and, because this work applies across the
board to all commodity standards, General Subject Committees are
sometimes referred to as “horizontal committees”.

⚫ General Subject Committees develop all-embracing concepts and

principles applying to foods in general, specific foods or groups of
foods; endorse or review relevant provisions in Codex commodity
standards; and, based on the advice of expert scientific bodies, develop
major recommendations pertaining to consumers’ health and safety.

⚫ Six of the General Subject Committees have the responsibility of

ensuring that specific provisions in Codex commodity standards are in
conformity with the Commission’s main general standards and
guidelines in their particular areas of competence.
76
 ⚫ They are:

⚫ Committee on General Principles

⚫ Committee on Food Labeling
⚫ Committee on Methods of Analysis and Sampling
⚫ Committee on Food Hygiene(CCFH)
⚫ Committee on Pesticide Residues(CCPR)
⚫ Committee on Food Additives and Contaminants
⚫ Committee on Import/Export Inspection and Certification Systems
⚫ Committee on Nutrition and Foods for Special Dietary Use (A General Committee
for the purpose of Nutrition)
⚫ Committee on Residues of Veterinary Drugs in Food (CCRVDF)
⚫ These Committees may also develop standards, maximum limits for additives
and contaminants, codes of practice or other guidelines for either general
application or in specific cases where the development of a complete
commodity standard is not required. For example, the Committee on Food
Hygiene has developed a Code of Hygienic Practice for Spices and Dried
Aromatic Plants, and the Committee on Food Additives and Contaminants
77 (divided into two committees in 2006) has developed a Standard for
Maximum Levels of Lead in Foods.
 ⚫ The Committees on Food Labelling and on Nutrition and Foods
for Special Dietary Uses have worked together to prepare the
Codex Guidelines on Nutrition Claims.

⚫ The Committee on Pesticide Residues and the Committee on

Residues of Veterinary Drugs in Foods prepare MRLs for these
two categories of chemicals used in agricultural production.

⚫ The Committee on Food Import and Export Inspection and

Certification Systems deals with the application of standards to
foods moving in international trade, in particular to the
regulatory measures applied by governments to assure their
trading partners that foods and their production systems are
correctly regulated to protect consumers against foodborne
hazards and deceptive marketing practices.

78
 Commodity Committees

⚫ The responsibility for developing standards for specific foods or

classes of food lies with the Commodity Committees.

⚫ In order to distinguish them from the “horizontal committees” and

recognize their exclusive responsibilities, they are often referred to as
“vertical committees”.

⚫ Commodity Committees convene as necessary and go into recess or are

abolished when the Commission decides their work has been
completed.

⚫ New Committees may be established on an ad hoc basis to cover

specific needs for the development of new standards.

79
 Current status of Commodity Committees

CCFFP Codex Committee on Fish and Fishery Products Active

CCFFV Codex Committee on Fresh Fruits and Vegetables Active
CCFO Codex Committee on Fats and Oils Active
CCSCH Codex Committee on Spices and Culinary Herbs Active
CCCPC Codex Committee on Cocoa Products and Chocolate Adjourned sine die
CCCPL Codex Committee on Cereals, Pulses and Legumes Adjourned sine die
CCMMP Codex Committee on Milk and Milk Products Adjourned sine die
CCMPH Codex Committee on Meat Hygiene Adjourned sine die
CCNMW Codex Committee on Natural Mineral Waters Adjourned sine die
CCPFV Codex Committee on Processed Fruits and Vegetables Adjourned sine die
CCS Codex Committee on Sugars Adjourned sine die
CCVP Codex Committee on Vegetable Proteins Adjourned sine die
CCIE Codex Committee on Edible Ices Abolished
CCM Codex Committee on Meat Abolished
CCPMPP Codex Committee on Processed Meat and Poultry Products Abolished
CCSB Codex Committee on Soups and Broths Abolished
CXTO Joint CODEX/IOOC Meeting on the Standardization of Table Olives Abolished

80
 Applying Codex standards

⚫ The harmonization of food standards is generally viewed as contributing to the

protection of consumer health and to the fullest possible facilitation of
international trade. For this reason, the Uruguay Round Agreements on the
Application of Sanitary and Phytosanitary Measures and on Technical Barriers
to Trade (SPS and TBT Agreements) both encourage the international
harmonization of food standards.

⚫ Differing legal formats and administrative systems, varying political systems

and sometimes the influence of national attitudes and concepts of sovereign
rights impede the progress of harmonization and deter the acceptance of
Codex standards.

⚫ Despite these difficulties, however, the process of harmonization is gaining

impetus by virtue of the strong international desire to facilitate trade and the
desire of consumers around the world to have access to safe and nutritious
foods.

81
⚫ An increasing number of countries are aligning their national food standards,
 Codex Maximum Limits for Pesticides Residues in Food & TBT Agreement

⚫ A country which accepts a codex maximum limit for pesticides residues in

foods according to the provision of General Principles of the Codex
Alimentarius should be prepared to offer advice and guidance to exporters and
processors of food for export to promote understanding of and compliance
with the requirements of importing countries.

⚫ Technical barriers to trade (TBT) generally result from the preparation,

adoption and application of different technical regulations and conformity
assessment procedures.

⚫ If a producer in an exporting country ‘A' wants to export to an importing

country ‘B'; he will be obliged to satisfy the technical requirements that apply
in country ‘B', with all the financial consequences this entails.

⚫ The importing country agreeing Codex MRLs have a right to reject

consignment on different technical regulations.

82
 National Codex Contact Point (NCCP)

⚫ The Food Safety and Standards Authority of India, (Ministry of

Health and Family Welfare) has been designated as the nodal
point for liaison with the Codex Alimentarius Commission.

⚫ The National Codex Contact Point (NCCP) has been constituted

by the Food Safety and Standards Authority of India for keeping
liaison with the CAC and to coordinate Codex activities in India.

83
 Core Functions of NCCP-INDIA
• Act as a link between the Codex Secretariat, National Codex Committee and
Shadow Committee;
• Coordinate all relevant Codex activities within India;
• Receive all Codex final texts (standards, codes of practice, guidelines and
other advisory texts) and working documents of Codex Sessions and ensure
that these are circulated to those concerned;
• Send comments on Codex documents or proposals to the CAC or its
subsidiary bodies and /or the Codex Secretariat within the time frame;
• Work in close cooperation with the National Codex Committee and its Shadow
Committees;
• Act as a channel for the exchange of information and coordination of activities
with other Codex Members;
• Receive invitations to Codex Sessions and inform the relevant Chairpersons
and the Codex Secretariat of the names of participants representing India;
• Maintain a library of Codex standards, Code of Practice, Guidelines and any
other documents and publications on or related to Codex; and
• Promote Codex Activities throughout India
• Build capacity in country to effectively take up Codex work.

84
 Responsibilities of NCCP -INDIA
• Undertake secretariat responsibilities to the National Codex
Committee;
• Act as the contact point for the country for maintaining liaison with
the Codex Secretariat in elaborating international food standards;
• Collect, procure and analyze data for elaborating international food
standards;
• Keep track of international food standards work and give comments
and data to ensure that international food standards elaborated are
practicable for local manufactures and do not hinder exports of food;
• Undertake study and research work to solve any problem resulting
from the elaboration of international food standards;
• Encouragefood manufacturers to improve quality and hygiene
management to meet requirements of international food standards;
and
• Disseminate information of food standards and food laws to relevant
government agencies, primary producers, manufacturers, exporters,
consumers and concerned organizations.

85
 National Codex Committe (India)

⚫ The National Codex Committee has been constituted by the Food

Safety and Standards Authority of India for keeping liaison with
the CAC.
Core Functions of NCC-INDIA
• To advise government on the implications of various food standardization,
food quality and safety issues which have arisen and related to the work
undertaken by the CAC so that national economic interest is taken into
account, or considered, when international standards are discussed;
• To provide important inputs to the government so as to assist in ensuring
quality and safety of food to the consumers, while at the same time
maximizing the opportunities for development of industry and expansion of
international trade;
• To appoint Shadow Committees on subject matters related to the
corresponding Codex Committees to assist in the study or consideration of
technical matters; and
• To meet as and when necessary to formulate national position.
86
 Responsibilities of NCC -INDIA
• To cooperate with the Joint FAO/WHO Food Standards Programme
and to nominate delegates to attend Codex meetings;
• To formulate national position in consultation with the members of
NCC in the matters of Codex and recommend action to government;
• To study Codex documents, collect and review all relevant
information relating to technology, economics, health and control
systems, so as to give supporting reasons to the government for the
acceptance of Codex Standards or otherwise;
• To identify organizations to take action and where necessary
commission studies for generation of data base or preparation of
base papers projecting the country's interest and for interacting with
the CAC; and
• To cooperate with other local/regional or foreign organizations
dealing with activities relating to food standardization.

87
 Shadow Committees of NCC-INDIA

⚫ The Food Authority has appointed the Shadow Committees of

the NCC on subject matters corresponding to the Codex
Committees to assist the NCC in the study or consideration of
technical matters.

⚫ Officers in the rank of Joint Secretary or above in the concerned

Department/Ministry / Food Authority who handle the subject at
the policy level and also serve as the members of the NCC may
be nominated as the Chairpersons of these Shadow Committees.
Specialized experts in the relevant field may be nominated as
members of these Shadow Committees.

⚫ These lists of experts may be reviewed from time to time to

ensure that they meet the ongoing requirements of the NCC.
88
 Currently, the Shadow Committees assist the National Codex
Committee in the following areas:
• Codex Alimentarius Commission • Food Export and Import and Certification
Systems
• Executive Committee of the Codex
Alimentarius Commission • Nutrition and Foods for Special Dietary Uses
• Regional Coordinating Committee (including • Fish and Fishery Products
Coordinating Committee for Asia) • Fats and Oils
• General Principles • Fresh Fruits and Vegetables
• Food labelling • Processed Fruits and Vegetables
• Methods of Analysis and Sampling • Milk and Milk Products
• Pesticides Residues • Spices & Culinary Herbs
• Veterinary drugs
• Food Hygiene
• Food Additives
• Contaminants in Foods

89
 Terms of Reference of Shadow Committees
⚫ To review and advise on the agenda documents including the Code of
Hygienic Practices and Codex Guidelines for the respective Codex
Committees;

⚫ To advise on the composition of the Indian Delegation;

⚫ To coordinate with the other Shadow committees and concerned Departments

for seeking comments and finalise the India?s view point on different agenda
items under consideration of the respective Codex Committees;

⚫ To advise the concerned Government Department on all matters relating to

Codex procedure and working process for elaboration of Codex Standards,
Codex Code of Practices and Codex Guidelines;

⚫ To advise on Capacity Building, food safety, food regulations and technical

assistance;

⚫ Any other work assigned by the National Codex Committee and the
90
Chairman, National Codex Committee, from time to time
 Functions of Shadow Committees

⚫ To advise the NCCP / NCC on the implications of various food

standardization, food quality and safety issues which have arisen
and related to the work undertaken by the relevant Subsidiary
Body/Task Force so that national economic interest is taken into
account or considered when international standards are
deliberated by the relevant committee; and

⚫ To follow the Codex agenda of the relevant Subsidiary Body and

provide inputs to the government so as to assist in ensuring
quality and safety of food to the consumers while at the same
time safeguard national interests and maximize the opportunities
for development of industry and expansion of international trade.

91
 Responsibilities of Shadow Committees
⚫ To study Codex documents, collect and revise all relevant information relating
to technology, economics, health and control systems so as to give supporting
reasons to the government in the acceptance of Codex Standards or otherwise;

⚫ To formulate national position in consultation with the members of the

Shadow Committee with respect to the agenda for the forthcoming session /
meeting of the Subsidiary Body of the CAC and forward the same to NCCP
for sending it to Codex Secretariat after approval by government.

⚫ To finalize the delegation for the meeting of the Codex in consultation with
the NCC / NCCP and transmit the names to the host secretariat through the
NCCP; and

⚫ To recommend to the NCCP the position to be taken during the Sessions of

the Commission with respect to agenda items relevant to the terms of
reference of the Shadow Committees.

92
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 9

Food Safety – A National Perspective

FSSAI
Project Identification & Screening
BIS, AGMARK (DMI)
Legal Metrology Act, 2009
Consumer Protection Act 1986
Export Inspection Council
APEDA, MPEDA, Commodity Boards
Samit Dutta, Associate Professor & Head,
Dept. of Food Business Management,
1 College of FPTBE, AAU
 Food Safety and Standards Act , 2006
⚫ To protect health and safety of consumers, an effective
food control systems are essential.
⚫ This will facilitate countries to assure the safety and quality
of their foods for own citizens and global trade.
⚫ The governments have great responsibility for food safety
and consumer protection.
⚫ Responsibility for food control in our country is shared by
Government of India and its agencies/departments through
various food laws for protecting public health.
⚫ The Food Safety and Standards Authority of India (FSSAI)
has been created 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.
2
 Salient Features of FSS Act, 2006
⚫ Movement from multi-level and multi-department control to a
single line of command.
⚫ FSSAI as a single reference point for all matters relating to Food
Safety and Standards, Regulations and Enforcement.
⚫ Integrated response to strategic issues like Novel foods, Health
Foods, Nutraceuticals, GM foods, international trade etc.
⚫ Adequate information dissemination on food to enable consumer
to make informed choices.
⚫ Compounding and Adjudication of cases – to reduce Court’s
workload and expedite the disposal of cases.
⚫ Graded penalty depending upon the gravity of offences.
⚫ Adequate representation of government, industry organizations,
consumers, farmers, technical experts, retailers etc.
⚫ Enforcement of the legislation by the State Governments/ UTs
through the state Commissioner for Food Safety, his officers and
Panchayati Raj/Municipal bodies.
3
Single Food Law

The Act, incorporates the salient provisions of the Prevention of Food Adulteration Act,
1954 and is based on international legislations and instrumentalities. Act takes care of
international practices and envisages a overreaching policy framework and provision of
single window to guide and regulate persons engaged in manufacture, marketing,
processing, handling, transportation, import and sale of food.
Vegetable Oil Edible Oils
Products Packaging
(Control) Order, (Regulation)
1947 Order, 1998
Solvent Extracted Oil,
Meat Food
Deoilded Meal, and
Products Order,
Edible Flour (Control)
1973
Order, 1967

Milk and Milk

Fruit Products
Products Order,
Order, 1955
1992

Food Any other order

Prevention of
Food Safety and under Essential
Commodities
Adulteration
Act, 1954 Standards Act, 1955
relating to food
4
Act, 2006
 Scope & Excludes
Scope of Act: Includes all types of foods for human consumption
⚫ Primary Foods
⚫ Unprocessed/ semi processed/ processed foods
⚫ Genetically engineered foods
⚫ Organic foods
⚫ Substances and water used in foods
⚫ Packaged drinking water etc.

Excludes:
⚫ Produce of farmers at farm level and plants
⚫ Animal feeds
⚫ Live animals
⚫ Any farmer or farming operations, crops, supplies used in or
5
produced in farming or products of crops produced by farmer at
fam level.
 New Provisions in the Act
⚫ Covering Health Foods, supplements, nutraceuticals
⚫ Issuing Licenses within a time frame of 2 months
⚫ Provision of Improvement Notice by Designated Officers
⚫ Prosecution, if to be launched, should be within 1 year time frame
⚫ Special Courts for summary trials
⚫ Compensation to Victims (for any case of Injury/ Grievous injury/
Death)
⚫ Reward to informer (informing about the violators – adulteration etc.)
by State Govt.
⚫ One composite license for unit(s) falling under one area
⚫ Training and Awareness programmes for Food Business Operators as
well as Regulators;
⚫ Encouraging Self regulation through introduction of Food Recall
Procedures
6
⚫ No License for small food business operators; only registration is
 Some of the important definitions of the act:
a. Adulterant
⚫ Any material which is or could be employed for making the food
unsafe or sub-standard or mis-branded or containing extraneous matter
⚫ Misbranded: Means an article of food with
i) False, misbranding or deceptive claims either on the label of the
package, or through advertisement,
ii) If the article is sold as an imitation of, or is a substitute for, or is
likely to deceive, or
iii) The package bears statement, design or device regarding the
ingredients or the substances contained therein, which is false or
misleading or
iv) Manufacturers name and address is false or
v) Contains any artificial flavouring, colouring or chemical
preservative and is not labelled properly as per the requirements of
the law
7
 ⚫ Substandard: An article of food shall be deemed to be sub-standard
if it does not meet the specified standards but does not render the
food unsafe
⚫ Unsafe: Means an article of food which is injurious to health:-
i) by the article itself, or its package thereof, or
ii) consists wholly or in part, any filthy, putrid, rotten, decomposed or
diseased animal substance or vegetable substance; or
iii) is processed unhygienically or the article of food has harmful
substance in it or is infected or infested with worms, weevils or
insects; or
iv) has been substituted by inferior or cheaper substance whether
wholly or in part; or
v) uses a substance directly or as an ingredient or as additive which is
not allowed under the law; or
vi) by virtue of its being prepared, packed or kept under unsanitary
conditions; or
vii) by virtue of its being mis-branded or sub-standard or food
8 containing extraneous matter; or
viii) by virtue of containing pesticides and other contaminants in
 b. Food
⚫ Any substance, whether processed, partially processed or unprocessed, which
is intended for human consumption and includes primary food i.e. all raw
produce except those in hands of the grower, farmer, fisherman etc.,
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 medical 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
c. 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,
9 processing, packaging, storage, transportation, distribution of food, import an
includes food services, catering services, sale of food or food ingredients
 d. Food business operator
⚫ 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 there-under

e. Manufacture
⚫ Means a process or adoption or any treatment for conversion of ingredients
into an article of food, which includes any sub-process, incidental or ancillary
to the manufacture of an article of food

f. Manufacturer
⚫ Means a person engaged in the business of manufacturing any article of food
for sale and includes any person who obtains such article from another person
and packs and labels it for sale or only labels it for such purposes
10
 Chapters of FSS Act, 2006
The Act consists of 12 chapters:
1. Preliminary: definitions
2. Food Safety and Standards Authority of India
3. General principles of food safety
4. General provisions as to food: prohibitions
5. Provisions relating to import
6. Special responsibilities as to food safety
7. Enforcement of the act
8. Analysis of food: laboratories, sampling and public analysts
9. Offences and penalties
10. Adjudication and food safety appellate tribunal
11. Finance, accounts , audits and reports
11
12. Miscellaneous
 Regulations under the FSS Act: 5 August 2011
Food Safety and Standards (Licensing and Registration of Food
Businesses) Regulations, 2011
Food Safety and Standards (Food Products Standards and Food
Additives) Regulations, 2011
Food Safety and Standards (Contaminants, Toxins and
Residues) Regulations, 2011
Food Safety and Standards (Prohibition and Restrictions on
Sales) Regulations, 2011
Food Safety and Standards (Packaging and Labelling)
Regulations, 2011
Food Safety and Standards (Laboratory and Sample Analysis)
12 Regulations, 2011
 Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulations, 2011
⚫ Every food business operator to be licensed or registered as
appropriate:
⚫ Registration: Petty food business operator (FBO)
⚫ License : Other than petty FBO

⚫ Salient features:
⚫ Unified Licensing procedures.
⚫ Common application forms and procedures.
⚫ Registration of food Businesses to cover all petty food
businesses.
⚫ Distinction between ‘registration’ and ‘licensing’. Cut off
limits for registration and licensing.
⚫ Sectors which have high Installed Capacity are covered
under central licensing.
1
3
⚫ Safety, Sanitary and Hygienic conditions.
 Licensing & Registration of FBOs

Central Licensing
Authority
State Licensing
Authority Registering
Authority

Designated Officer
appointed by the Chief Food Safety Officer
Designated Officers
Executive Officer of appointed under or any official in
the Section 36(1) of the Panchayat, Municipal
Food Authority of India Act by the Food Safety Corporation or any
Commissioner of a other local body in an
in his capacity of Food
State or UT for the area, notified as such
Safety Commissioner purpose of licensing and by the State Food
monitoring. Safety Commissioner
for the purpose of
registration
14
 Food Safety and standards (Food Products Standards and
Food Additives) Regulations, 2011
Microbial standards have been introduced
First part- There are 13 product categories (377 products)
⚫ Dairy products and analogues
⚫ Fats, oils and fat emulsions
⚫ Fruits and Vegetable products
⚫ Cereals and cereal products
⚫ Meat and meat products
⚫ Fish and fish products
⚫ Sweets and confectionary
⚫ Sweetening agents including honey
⚫ Salt, spices and related products
⚫ Beverages ( other than dairy and fruits & vegetables based )
⚫ Other food products and ingredients
⚫ Proprietary food
⚫ Irradiated food
15
 The second part of the Regulation basically deals with use of
food additives in various foods and specifies their limits as
well as specifies some specific label declarations with respect
to certain food additives.

The third part is on Microbiological Criteria

16
 Food Safety and Standards (Contaminants, Toxins and
Residues) Regulations, 2011

This Regulation contains 3 clauses that specify the limits in

various foods.

METAL CONTAMINANTS: This regulation prescribes the

limits for Heavy metals and Metal contaminants for various
foods and commodities.

CROP CONTAMINANTS AND NATURALLY

OCCURING TOXINS
This regulation defines Crop Contaminants and specifies their
limits for foods. Also for 4 naturally occurring toxins.

17 RESIDUES: This clause lists down limits for 149 Insecticide

Residues and 5 Antibiotics in foods
 Food Safety and Standards (Prohibition and Restrictions on
Sales) Regulations, 2011

This Regulation deals with the restrictions and Prohibitions on

sale of certain food products. Contains 3 clauses:
⚫ Sale of certain admixtures prohibited

⚫ Restrictions on use of certain ingredients

⚫ Prohibition and restriction on sale of certain products

The Regulation covers 15 products and 22 conditions of sale

that are either restricted or prohibited.

18
 Food Safety and Standards (Packaging and Labelling)
Regulations, 2011
Packaging Requirements
General Requirements:
⚫ Following materials/metals shall not be used for packaging of
food-
⚫ containers which are rusty
⚫ enameled containers which have become chipped and rusty
⚫ copper or brass containers which are not properly tinned
⚫ containers made of aluminum not conforming in chemical
composition to IS:20 specification

✔ All containers should be securely packed and sealed

✔ Exterior of the Cans should be Free from Rust, Dents, perforations
and Seam Distortions
19✔ Cans shall be Free from Leaks
 Label Must Carry…

1. Name of the food

2. List of ingredients in descending order
3. Nutritional information
4. Veg/ Non Veg logo of appropriate dimensions
5. Specific declaration of food additives and colours/flavors
6. Name and complete address of manufacturer
7. Net content and drained weight by weight or Volume
8. Lot no/ code no/Batch identification
9. Date of Manufacturing /Packing
10. Best Before Date and use by date
11. Country of Origin for Imported food
2012. Instructions for use
 Nutritional Information
✔ Nutritional information is the declaration of the
nutritional composition of the food. It provides an idea
of the nutrition that can be derived from that particular
article of food
✔ Nutritional information should always be stated in
numerical terms. The nutrition information for a
particular food article is declared per 100g or 100ml
or per serving of the food on the label

This declaration should compulsorily comprise of the following information:

⚫ Energy value in kcal
⚫ Protein, fat and carbohydrate along with sugar quantity in g
⚫ Amount of any other nutrient for which a nutrition / health claim is
made

21
 Food Safety and Standards (Laboratory and Sample
Analysis) Regulations, 2011
Salient features

These Regulations:
⚫ Defines the Referral laboratory and notified laboratories.
⚫ Describes the function of the referral laboratories.
⚫ Prescribes the notified laboratories for import and Referral
Laboratories and their area of jurisdiction.
⚫ Prescribes the quantity of the sample of various food products
and their method of preservation.
⚫ Prescribes the formats for the certificate of analysis by the
Referral food laboratories and food analysis report by the Food
analyst.
22
 Bureau of Indian Standards
⚫ BIS is the National Standard Body of India established under the
BIS Act 2016 for the harmonious development of the activities
of standardization, marking and quality certification of goods
and for matters connected therewith or incidental thereto.
⚫ BIS certification scheme is voluntary and aims at providing
quality, safety and dependability to the ultimate consumer.
⚫ Presence of certification mark known as Standard Mark on a
product is an assurance of conformity to specifications
⚫ The activities of Bureau of Indian Standards (BIS) are
formation of Indian Standards in the processed food sector and
the implementation of standards through promotion, voluntary
and third party certification systems.
⚫ In general these standards cover raw materials and their quality
parameters, hygienic conditions under which products are
manufactured and packaging and labeling requirements.
23
 ⚫ Manufacturers complying with standards laid down by the BIS
can obtain the ISI Mark that can be exhibited on product
packages.
⚫ These standards have higher quality specifications than those
prescribed under AGMARK and FSSAI.

⚫ The BIS has laid down specification for mineral water and
packaged drinking water and is the licensing authority for the
manufacture of mineral water and packaged drinking water in
India.
⚫ IS Standards have been laid down for fruit and vegetable
products, spices and condiments, animal products and processed
foods.

⚫ The products are checked for quality by the BIS in their own
network of testing laboratories or in several public and private
laboratories recognized by them.
⚫ Under BIS many of the standards are laid down based upon ISO
24 (International Organization for Standardization) standards which
is a worldwide federation of National Standard Bodies.
 BIS Standard
Mark
⚫ Main areas:
• Standards development
• Product certification
• International cooperation
• HACCP certification

⚫ Standards development in 14 different areas including food

and agriculture
• Each area has a division council
• Each divisional council has sectional committees

25
 Activities of BIS:

⚫ Standards Formulation
⚫ Product Certification Scheme
⚫ Compulsory Registration Scheme
⚫ Foreign Manufacturers Certification Scheme
⚫ Hall Marking Scheme
⚫ Laboratory Services
⚫ Laboratory Recognition Scheme
⚫ Sale of Indian Standards
⚫ Consumer Affairs Activities
⚫ Promotional Activities
⚫ Training Services, National & International level
⚫ Information Services

26
 Constitution of the Bureau:
⚫ The Bureau consist members such as the Minister in charge of
the Ministry, Minister of State, the Director-General of the
Bureau, persons representing the Ministries, state Governments,
recognized consumer organizations, farmers, industry and trade,
research institutions, technical, educational and professional
organizations etc.

Powers and Functions of the Bureau

⚫ Establishment, Publication and Promotion of Indian
Standards : For the purpose of formulation of Indian Standards
in respect of articles or processes, technical committees of
experts are constituted.
⚫ Such committees may include Division Councils, Sectional
Committees, Sub-committees and Panels and each of these
27
councils have specified functions .
 ⚫ Procedure for Establishment of Indian Standards: Any Ministry of
Central or State Government, consumer organizations, industrial units,
industry-associations, professional bodies, can submit proposals to the
Bureau for establishing a standard or for revising, amending, a standard
by making a request in writing.
⚫ Division Council concerned will assign the task of formulating the
standard to an appropriate Technical Committee.
⚫ Later a draft standard prepared and duly approved by a Committee shall
be issued and widely circulated for a period of not less than one month
amongst the various interests concerned for critical review and
suggestions for improvement.
⚫ The appropriate Technical Committee shall thereafter finalize the draft
standard giving due consideration to the comments that may be received.
⚫ The draft standard shall be submitted to the Chairman of the Division
Council concerned for adoption.
⚫ All established standards shall be reviewed periodically, at least once in
five years, to determine the need for revision or withdrawal.
28 ⚫ Standards which there is need to revise or amendment shall be reaffirmed.
 ⚫ Grant of License: Manufacturing units can apply for BIS
license on a prescribed form along with application fee and other
documents such as location map of factory and factory layout,
land documents, list of manufacturing and testing equipments,
flow charts of the process, details of the technical staff etc and
an undertaking to follow BIS terms and conditions including
stop marking procedure.

⚫ BIS office will do a preliminary inspection verify all documents

and process.

⚫ The product samples are drawn and sent for analysis at BIS
certified lab.

⚫ After satisfactory inspection and sample report of the product,

29
license is granted 1 to 2 years which can renewed periodically.
 ⚫ Inspection : The certified units are inspected by inspecting
officers.
⚫ The may be done at manufacturing place, dispatch place or at
the place where it is used.
⚫ At manufacturing place the inspection will also be for the QA
systems, verification and validation.
⚫ The Bureau shall designate such of the officers of the Bureau as
Inspecting Officers

30
 ⚫ STOP Marking: If there is evidence that the product is not as
per the conforming standards and agreed clauses, the licensee
will be directed to stop marking.

⚫ The reasons can be Non conformance of products at

manufacturing place or at market place, Non implementation of
Scheme of Testing of the products, Non availability of testing
staff, Significant modification of plant and machinery with out
informing BIS, Relocation of plant and machinery, Prolonged
closure of the unit, Marking non conformed product, Marking
standard mark other than that are included in the license.

⚫ The licensee can resume only after re inspection and satisfactory

compliance.

31
 Agricultural Produce (Grading and
Marking) Act 1937 (as amended in 1986)
⚫ Popularly known as “AGMARK”
⚫ The word Agmark is derived from Agricultural Marketing.
⚫ Quality standards for grading, packing and marking of
agricultural and animal husbandry products – mainly
compositional and adulteration - not microbial.
⚫ The Directorate of Marketing and Inspection (DMI) , an
attached Office of the Department of Agriculture, Cooperation
and Farmers Welfare under Ministry of Agriculture & Farmers
Welfare, was set up in the year 1935 to implement the
agricultural marketing policies and programmes for the
integrated development of marketing of agricultural and other
allied produce in the country with a view to safeguard the
interests of farmers as well as the consumers.
⚫ It maintains a close liaison between the Central and the State
32
Governments.
 ⚫ Under this Act Grade standards are prescribed for agricultural
and allied commodities.
⚫ Agmark grading means grading of an article in accordance with
grade/standards prescribed under the provisions of the act.
⚫ These are known as AGMARK standards.
⚫ Grading under the provision of this Act is voluntary.

⚫ Any person or body of persons desirous of being authorized to

grade and mark an article under the provisions of the act shall
apply to the agricultural marketing advisor or any other officer
of the Central Government or State Government authorized by
Agricultural Marketing Advisor.
⚫ Manufacturers who comply with standard laid down by DMI are
allowed to use "AGMARK" labels on their products.

33
 ⚫ The grade designation marks shall be applied only to the articles
mentioned in the certificate of authorization during the validity
period.
⚫ The certificate of authorization is issued by agricultural
marketing advisor or any other officer of the central or state
government authorized by the Agricultural Marketing Advisor.
⚫ The grade designation characteristics vary from product to
product.

⚫ The quality of the product is determined with reference to the

size, variety, weight, color, moisture, fat content and other
factors are taken in to account.
⚫ It covers quality assurances of unprocessed, semi processed and
processed agricultural commodities.
⚫ Blended edible vegetable oils and fat spread are compulsorily
34
required to be certified under Agmark.
 ⚫ The inspecting officer shall analyze the sample for quality
factors as laid down in grading and marketing rules of the
specific commodity in respect of produce.
⚫ The inspecting officer shall also ensure that all the food article
graded and certified under Agmark shall satisfy the mandatory
requirements laid down under FSS act & rules.
⚫ The rules for affixation of AGMARK labels, method of packing
and marking, check sampling and certificate of grading rules are
also given under this act.

35
 Salient features of Agmark standard:
(1) Quality standards for Agricultural commodities are framed based on
their intrinsic quality.
(2) Food safety factors are being incorporated in the standards to
compete in world trade.
(3) Standards are being harmonized with international standards keeping
in view the WTO requirements.
(4) Check is kept on the quality of certified products through 23
laboratories and 43 offices spread all over the country
⚫ The grades incorporated are grades 1, 2, 3 and 4 or special, good, fair
and ordinary.
⚫ Agmark products are subjected to continuous inspection.
⚫ The certificate of “Authorization” is granted only to those in the trade
having adequate experience and standing in the market.
⚫ The staff of the DMI or of the state Government is generally present at
the time of selection of goods, their processing, grading and packing
36 before applying the appropriate AGMARK labels.
 ⚫ Products available under AGMARK are pulses, wheat products,
vegetable oils, ground spices, whole spices, milk products,
honey, compounded asafetida, rice, tapioca sago, seedless
tamarind and gram flour; grading of these commodities is
voluntary.

⚫ On the other hand grading of commodities like tobacco, walnut,

spices, basmati rice, essential oils, onion, potatoes are meant for
export is compulsory under AGMARK.

⚫ The Directorate of marketing and inspection of central

government has 21 laboratories and 50 sub offices spread all
over the country.
⚫ The central AGMARK laboratory at Nagpur continuously
carries out research and development works in this field.
37
 Legal Metrology Act, 2009
⚫ Metrology is the scientific study of measurement.
⚫ Legal metrology” means that part of metrology which treats
units of weighment and measurement, methods of
weighment and measurement and weighing and measuring
instruments, in relation to the mandatory technical and legal
requirements which have the objects of ensuring public
guarantee from the point of view of security and accuracy
of the weighments and measurements.
⚫ With respect to provide uniform standards of weights and
measures, the Legal Metrology Act, 2009 enforced in India.
⚫ The Act was implemented with effect from 1st April, 2011.
⚫ It repeals and replaces the Standard of Weights and
Measures Act, 1976 and the Standards of weights and
Measures (Enforcement) Act, 1985.
38
 ⚫ The Act came into force with the following objectives:
⚫ To regulate trade and commerce in weights and measures
⚫ To set and enforce the standards of weight and measure
⚫ To regulate the manufacture, sale and use of goods by
weights, measures or numbers
⚫ To rationalize the Metric system (meter, kilogram etc.) to be
used in India

⚫ The provisions of Legal metrology applies to:

⚫ Persons who are using any weight or measure in any transaction or
Industrial Production or Protection
⚫ Manufacturer, Retailer, Wholesaler, trader, Repairer of any weight
or measure, Importer and/or Packer of any item related to weight,
measure and numbers.

39
 ⚫ The Major Stakeholders under the Legal Metrology Act are:
⚫ Manufacturer: A person who manufactures weight or measure, any
commodity in packaged form, one or more parts, and acquires other
parts, of such weight or measure and, after assembling those parts,
claims the end product to be a weight or measure manufactured by
himself
⚫ Dealer: A person who, carries on, directly or otherwise, the business
of buying, selling, supplying or distributing any weight or measure for
a valuable consideration
⚫ Packer: A person / Firm, who which pre-packs any commodity in any
bottle, tin, wrapper or otherwise, in units suitable for sale whether
wholesale or retail
⚫ Importer: Any individual, firm or legal entity that brings goods, or
causes goods to be brought from a foreign country into a customs
territory
⚫ Repairer: A person who repairs a weight or measure and includes a
40
person who adjusts, cleans, lubricates or paints any weight or measure
or renders any other service to such weight or measure to ensure such
 ⚫ Important Legislations/Regulations:
⚫ Legal Metrology (Packaged Commodities) Rules, 2011
⚫ Legal Metrology (General) Rules, 2011
⚫ Legal Metrology (Approval of Models) Rules, 2011
⚫ Legal Metrology (National Standards) Rules, 2011
⚫ Legal Metrology (Numeration) Rules, 2011
⚫ Indian Institute of Legal Metrology Rules, 2011
⚫ Legal Metrology (Packaged Commodities) Rules, 2011

⚫ Under the Act, there are various rules, but a crucial arm of the
act is the Packaged Commodities Rules, i.e. Legal Metrology
(Packaged Commodities) Rules, 2011 (hereinafter referred to as
“Rules”).

41
 ⚫ The Department of Legal Metrology falls under the Department of
Consumer Affairs and is therefore concerned with fair and honest
practices in relation to all aspect of the trade.
⚫ The Rules deal with goods that are packaged and provide inter
alia how declarations are to be made and what declarations are to be
contained in a packaged commodity that is meant to be for sale.

⚫ The Legal Metrology (Packaged Commodities)Rules ,2011were

prescribed in order to regulate pre-packaged commodities. Under the
said rules, pre-packaged commodities are required to comply with
certain mandatory labeling requirements w.r.t net quantity, MRP and
Customer care information.
⚫ With view to encourage ease of business operations, amendments in
packaged commodity rules have been notified in 2017, harmonizing
the labeling provisions w.r.t Food products with the Regulations as
laid down under the Food Safety & Standard Regulations (FSSR)
2017.
42
 ⚫ Packaged commodities rules are applicable for all the products like
food products, electronic gadgets, consumer durable as well as
non-durable goods. Following are few things which every product
manufacturer, or repacker or the person who put labels on products or
marketer needs to follow :

⚫ PRICE: Pricing details to be mentioned on the actual product as well

as at the online display of the product. (basically, the maximum retail
price needs to be mentioned)
⚫ ORIGIN: Origin of the product (name of country) where the product
was manufactured, processed or assembled.
⚫ Expiry Date: Expiry date, use by date should be mentioned on each
product. Consumers should be aware of what they are consuming or
use it is safe or not.
⚫ Swachh Bharat though the label is not mandatory, you are welcome
to print this as well. (quality assurance purpose).
43 ⚫ Barcodes, QR Codes, E-Codes on Product for quality assurance
purpose.
 Who Needs to Comply with this Packaged Commodities rules?
⚫ Both online and offline sellers, so in case you are selling online or
offline any product please make sure it complies with the above
norms. Additionally FSSAI Licence number should be printed on the
food products.
Why this Packaged Commodities Rules came into the picture?
⚫ Suppose you are buying any product online at some discount,
previously what used to happen was that no actual price was
mentioned on the product, which means the discount you used to get
was not legitimate.
⚫ Also to make sure the discounts that you are getting are correct and to
promote fair practice in the e-commerce ecosystem. As per the data
last year 50,760 complaints were made compared to last year 23,955.
Most of the complaints were based on “payment refunds issues”.
⚫ However, we as Indian citizen looking for positive changes in the
online ecosystem, complying to this will save from unnecessary
44
hassles and penalties. As not complying to this includes fines ranging
between 5-50 thousand and in some cases imprisonment, depending
 Are all packaged commodities covered under the Rules?
⚫ Yes and no. While certain provisions are applicable for all packaged
commodities there are certain rules that do not apply to certain kinds of
commodities. Chapter II of the Rules, for example, deal with packages that
are meant for retail sale, these provisions would not be applicable to certain
kind of commodities.
⚫ Beyond the obvious, these rules would not be applicable for products meant
for institutional or industrial consumers, i.e. those institutions who directly
purchase from the manufacturer for use by the said institution OR consumers
who buy the products directly from the manufacturer for use in that industry.
⚫ For example, a hospital buying packaged paint directly from a paint company
would amount to an institutional consumer, and the products would not
require the declarations that otherwise are required had the products been sold
in the retail market.
⚫ Similarly, an automobile company that buys packaged paint and consumes it
for the purposes of painting the vehicles would amount to an industrial
consumer and the packaged paint would similarly not require the declarations
otherwise required.
45 ⚫ Further, commodities which contain the quantity of more than 25 kg or 25
liters (50 respectively in case cement and fertilizers) are exempted from the
 ⚫ Additionally, the Rules do not apply to certain packages even if
they satisfy all other criteria if:
⚫ The package is sold by weight or measure and amounts to less
than 10 ml or 10 gm (provided the product is not tobacco); or
⚫ Package contains fast food items and is packed by
hotels/restaurant/similar body; or
⚫ Contains scheduled drugs and non scheduled drugs covered by
the Drugs (Price Control) Order, 1995; or
⚫ Agricultural farm produce in packages above 50 kgs; or
⚫ A thread which is sold in the form of the coil to handloom
weavers.

46
 Which declarations are mandated under the Rules?
⚫ RULE 6 OF THE RULES DICTATE THE DECLARATIONS THAT MUST
BE PRESENT IN EVERY PACKAGING. THEY INCLUDE
(a) The name and address of the manufacturer/importer/packer, as may be applicable.
Note that if the manufacturer and packer are separate entities then their names are to be
mentioned separately. Also it is to be noted that address to be mentioned is registered
office address (this is a departure from the Weights and Measurements Act as well as the
earlier iteration of the rules – this clarification and amendment came into being vided
GSR 385 – E, dated 14th May 2015, with effect from 1st January 2016). It is to be noted
that this declaration is waived if the product is or contains a food article, instead of the
specific provision under the Food Safety and Standards Act, 2006 will be applicable.
(b) The generic name of the commodity being sold.
(c) Price at which the product is being sold, inclusive of all taxes. Note that there is a
specified format at which the same is to be declared, viz. “Maximum Retail Price
……………… Inclusive of all taxes” or “MRP ……………… Inclusive of all taxes”.
The symbol of the currency is to be mentioned, i.e. the Rupee symbol, or Rs., or INR.
Price is to be declared up to two decimal places.
(d) Date of manufacture/packaging/import, as the case may be, viz. the month and year.
If the date of packaging and manufacture differ, separate declarations are to be given.
(e) The quantity of the commodity (explained in further detail later on)
47
(f) Name, address, telephone number, an e-mail address of the person or office who can
 Consumer Protection Act, 2019
⚫ The Consumer Protection Act, 1986 is repealed after three decades and replaced by
the Consumer Protection Act, 2019. The Consumer Protection Act, 2019 has been
enacted with a view to widen the scope of consumer rights and cover the field of
e-commerce, direct selling, tele-shopping and other multi levels of marketing in the
age of digitization.
⚫ This act aims at revamping the settlement and administration process by imposing
stricter penalties.

⚫ Who is a 'Consumer' under the 2019 Act?

⚫ As per Section 2(7) of the 2019 Act, consumer is any person who buys goods or
avails any service for a consideration and includes any user except for the person
who has availed such services or goods for the purpose of resale or commercial use.
The explanation to the definition specifically states that the expression "buys any
goods" and "hires or avails any services" includes all online transactions conducted
through electronic means or direct selling or teleshopping or multi-level marketing.
Online transactions is an exclusive feature of this act and added keeping in mind the
growing e-commerce business and advancement in technology.

48
 Consumer Rights
Under the Act, consumers have six main rights, which are listed as
follows:

⚫ the right to be protected against the marketing of goods, products or

services which are hazardous to life and property;
⚫ the right to be informed about the quality, quantity, potency, purity,
standard and price of goods, products or services, as the case may
be, so as to protect the consumer against unfair trade practices;
⚫ the right to be assured, wherever possible, access to a variety of
goods, products or services at competitive prices;
⚫ the right to be heard and to be assured that consumer's interests will
receive due consideration at appropriate fora;
⚫ the right to seek redressal against unfair trade practice or restrictive
trade practices or unscrupulous exploitation of consumers; and
49 ⚫ the right to consumer awareness
 ⚫ The law provides for redress of consumer complaints arising out of
violation of these rights, through consumer forums constituted at
the district, state and the national level.
⚫ The same rights apply to food consumers too. Simply put, food
consumers have a right to safe food, right to information about the
food - so as to facilitate informed choice, they have a right to a
choice of foods at competitive prices, they have a right to be heard,
right to be protected against unfair and restrictive trade practices ,
right to consumer education and right to grievance redress.

⚫ The Food Safety and Standards Act too protects consumers from
unsafe food through formulation of science based standards and
their enforcement through analysis of food and market surveillance.
The law also ensures informed choice through label information,
prohibits misleading claims or misrepresentation on labels and
advertisements. The law not only provides punishment to those
50 who violate the law, but also compensation to the victims of unsafe
 Export Inspection Council
⚫ The Export Inspection Council (EIC) is the official export
–certification body of India which ensures quality and safety of
products exported from India.
⚫ EIC was set up by the Government of India under Section 3 of the
Export (Quality Control and Inspection) Act, 1963 to ensure sound
development of export trade of India through quality control and
inspection and matters connected therewith.
⚫ The role of EIC is to ensure that products notified under the Export
(Quality Control and Inspection) Act 1963 are meeting the
requirements of the importing countries in respect of their quality and
safety.

⚫ The Export Inspection Council is located at Delhi and is headed by a

Chairman. The Executive Head of the Council is the Director of
Inspection & Quality Control who is responsible for day to day
51 functioning of the Council.
 ⚫ The assurance to quality and safety is provided through either a
consignment wise inspection or a quality assurance / food safety
management based certification through its field organization.
⚫ The Export Inspection Agencies (EIAs) located at Mumbai, Kolkata,
Kochi, Delhi and Chennai with a network of 30 sub offices backed by
the state of art, NABL accredited laboratories at various places.

⚫ EIC provides mandatory certification for various Food items namely

fish & fishery products, dairy product, honey, egg products, meat and
meat products, poultry meat products, animal casing, Gelatine, Ossein
and crushed bones and feed additive and pre-mixtures while other
food and non-food products are certified on voluntary basis.

⚫ With more than four decade experience in the field of inspection,

testing and certification of food items as per importing country’s
requirements, EIC is the only organization in India having global
acceptance.
52
 Services offered
⚫ Certification of quality of export commodities through installation of quality
assurance systems (In-process Quality Control and Self-Certification) in the exporting
units as well as consignment-wise inspection.
⚫ Certification of quality of food items for export through installation of Food Safety
Management Systems in the food processing units as per international standards.
⚫ Issue of different types of Certificates such as Health, Authenticity etc. to exporters
under various product schemes for export.
⚫ Issue of Certificates of Origin to exporters under various preferential tariff schemes
for export products.
⚫ Laboratory testing services.
⚫ Training and technical assistance to the industry in installation of Quality and Safety
Management Systems based on principles of Hazard Analysis Critical Control Point
(HACCP), ISO-9001: 2000, ISO: 17025 and other related international standards,
laboratory testing etc.
⚫ Recognition of Inspection Agencies as per ISO 17020 and Laboratories as per ISO
17025 and utilizing them for export inspection and testing.
⚫ In rendering the above services, EIAs are backed by qualified technical manpower,
having nearly forty years of diversified experience of quality control and inspection of
53 notified commodities including their testing as per international standards/importing
countries’ standards or the foreign buyers’ specifications.
 Export Inspection Council
⚫ The Export Inspection Council (EIC) is the official export
–certification body of India which ensures quality and safety of
products exported from India.
⚫ EIC was set up by the Government of India under Section 3 of the
Export (Quality Control and Inspection) Act, 1963 to ensure sound
development of export trade of India through quality control and
inspection and matters connected therewith.
⚫ The role of EIC is to ensure that products notified under the Export
(Quality Control and Inspection) Act 1963 are meeting the
requirements of the importing countries in respect of their quality and
safety.

⚫ The Export Inspection Council is located at Delhi and is headed by a

Chairman. The Executive Head of the Council is the Director of
Inspection & Quality Control who is responsible for day to day
54 functioning of the Council.
 APEDA
⚫ The Agricultural and Processed Food Products Export
Development Authority (APEDA) was established by the
Government of India under the Agricultural and Processed
Food Products Export Development Authority Act passed
by the Parliament in December, 1985.

⚫ The Authority, with its headquarters at New Delhi, is

headed by a Chairperson.
⚫ APEDA has been serving the agri-export community for 27
years.
⚫ In order to reach out to the exporters in different parts of
the Country, APEDA has set up 5 Regional offices at
Mumbai, Bangalore, Hyderabad, Kolkata & Guwhati and
55
13 Virtual Offices
 Assigned functions
⚫ Development of industries relating to the scheduled products for export by way of
providing financial assistance or otherwise for undertaking surveys and feasibility
studies, participation in enquiry capital through joint ventures and other reliefs and
subsidy schemes;
⚫ Registration of persons as exporters of the scheduled products on payment of such
fees as may be prescribed;
⚫ Fixing of standards and specifications for the scheduled products for the purpose of
exports;
⚫ Carrying out inspection of meat and meat products in slaughter houses, processing
plants, storage premises, conveyances or other places where such products are kept or
handled for the purpose of ensuring the quality of such products;
⚫ Improving of packaging of the Scheduled products;
⚫ Improving of marketing of the Scheduled products outside India;
⚫ Promotion of export oriented production and development of the Scheduled products;
⚫ Collection of statistics from the owners of factories or establishments engaged in the
production, processing, packaging, marketing or export of the scheduled products or
from such other persons as may be prescribed on any matter relating to the scheduled
products and publication of the statistics so collected or of any portions thereof or
56 extracts therefrom;
⚫ Training in various aspects of the industries connected with the scheduled products;
 Products monitored
APEDA is mandated with the responsibility of export promotion and development of the
following scheduled products:
⚫ Fruits, Vegetables and their Products.
⚫ Meat and Meat Products.
⚫ Poultry and Poultry Products.
⚫ Dairy Products.
⚫ Confectionery, Biscuits and Bakery Products.
⚫ Honey, Jaggery and Sugar Products.
⚫ Cocoa and its products, chocolates of all kinds.
⚫ Alcoholic and Non-Alcoholic Beverages.
⚫ Cereal and Cereal Products.
⚫ Groundnuts, Peanuts and Walnuts.
⚫ Pickles, Papads and Chutneys.
⚫ Guar Gum.
⚫ Floriculture and Floriculture Products.
⚫ Herbal and Medicinal Plants.
⚫
57 In addition to this, APEDA has been entrusted with the responsibility to monitor import
of sugar.
 MPEDA
⚫ The Marine Products Export Development Authority(MPEDA) was
set up under Section (4) of MPEDA Act, 1972 and became functional
from 20th April, 1972.
⚫ It is a statutory body functioning under the Department of Commerce.
The MPEDA, a statutory body, is responsible for development of the
marine products industry with special reference to exports.
⚫ It is headed by a Chairman. It has its headquarters at Kochi and has a
number of Regional and Sub- Regional Offices.

⚫ The Act empowers MPEDA to regulate exports of marine products

and take all measures required for ensuring sustained, quality seafood
exports from the country. MPEDA is given the authority to prescribe
for itself any matters which the future might require for protecting
and augmenting the seafood exports from the country.

⚫ It is also empowered to carry out inspection of marine products, its

raw material, fixing standards, specifications, and training as well as
take all necessary steps for marketing the seafood overseas.
58
 Commodity Boards
⚫ There are five statutory Commodity Boards under the
Department of Commerce. These Boards are responsible
for production, development and export of tea, coffee,
rubber, spices and tobacco.

59
 Tea Board
⚫ Tea Board was set up as a statutory body on 1st April, 1954 as
per Section (4) of the Tea Act, 1953.
⚫ As an apex body, it looks after the overall development of the
tea industry.
⚫ The Board’s Head Office is situated in Kolkata and there are
two Zonal offices and18 regional offices. For the purpose of tea
promotion, three overseas offices are located at London, Dubai
and Moscow.
⚫ The functions and responsibilities of Tea Board include
increasing production and productivity, improving the quality of
tea, market promotion, and welfare measures for plantation
workers and supporting Research and Development.
⚫ Collection, collation and dissemination of statistical information
to all stake holders are yet another important function of the
Board.
⚫ Being the regulatory body, the Board exerts control over the
producers, manufacturers, exporters, tea brokers, auction
60 organizers and warehouse keepers through various control
 Coffee Board
⚫ The Coffee Board is a statutory organization constituted
under Section (4) of the Coffee Act, 1942 and functions
under the administrative control of the Ministry of
Commerce and Industry, Government of India.
⚫ The Board is mainly focusing its activities in the areas of
research, extension, development, market intelligence,
external & internal promotion and welfare measures.
⚫ The Board has a Central Coffee Research Institute at
Balehonnur (Karnataka) along with a Sub-Station and
Regional Coffee Research Stations and the extension units
located in coffee growing regions of Karnataka, Kerala,
Tamil Nadu, Andhra Pradesh, Orissa and North Eastern
Region.
61
 Rubber Board
⚫ The Rubber Board is a statutory organization constituted
under Section (4) of the Rubber Act, 1947 and functions
under the administrative control of Ministry of Commerce
and Industry.
⚫ The Board’s headquarters is located at Kottayam in Kerala.
⚫ The Board is responsible for the development of the rubber
industry in the country by way of assisting and encouraging
research, development, extension and training activities
related to rubber.
⚫ It also maintains statistical data of rubber, takes steps to
promote marketing of rubber and undertake labour welfare
activities.
⚫ The activities of the Board are exercised through Five
Departments viz. General Services, Extension & Advisory
62 Services, Research Services (rubber Research Institute of
India), Training (Rubber Training Institute) & Finance.
 Spice Board
⚫ Spices Board is a statutory body constituted with effect
from 26.02.1987 under the Spices Board Act, 1986 (10 of
1986) by merging the erstwhile Cardamom Board and the
Spices Export Promotion Council under the administrative
control of the Department of Commerce.
⚫ Spices Board is responsible for the overall development of
cardamom industry and export promotion of 52 spices
listed in the schedule of the Spices Board Act, 1986.
⚫ The primary function of the Board includes development of
small and large cardamom, promotion, development,
regulation of export of spices and control on quality of
spices for export.
⚫ The Spices Board also undertakes research activities on
63
cardamom (small & large) under Indian Cardamom
 Tobacco Board
⚫ The Tobacco Board was constituted as a statutory body on
1st January, 1976 under Section (4) of the Tobacco Board
Act, 1975.
⚫ The Board is headed by a Chairman with its headquarters at
Guntur, Andhra Pradesh and is responsible for the
development of the tobacco industry.
⚫ While the primary function of the Board is export
promotion of all varieties of tobacco and its allied products,
its functions extend to production, distribution (for
domestic consumption and exports) and regulation of Flue
Cured Virginia (FCV) tobacco.

64
 Few other important legal provisions …..
⚫ Infant milk substitute, Feeding Bottles and Infant Foods
(Regulation of production, supply and distribution) Act,
1992 and Rules, 1993
⚫ Prohibits advertisements of infant foods and feeding bottles.

⚫ Livestock Importation Act, 1898

⚫ Mandatory to obtain an import permit before importing some
livestock products; milk and milk products included
⚫ Specific condition laid down that need to be met in respect of
the consignment including quarantine checks
⚫ Imports only through designated entry ports

65
 FQA – 362 (2+0)
Food Quality, Safety Standards and Certification
Lecture No. 10

Risk Analysis in Food Safety

Risk Analysis
Project Identification & Screening
Risk Assessment
Risk Management
Risk Communication

Samit Dutta, Associate Professor & Head,

Dept. of Food Business Management,
1 College of FPTBE, AAU
 Introduction
⚫ It is too expensive to guarantee that all food is safe. The
alternative is to identify the risk of unsafe food, pursue
management strategies to reduce the risk, and to discuss and
interact to assure the food industry, food regulators and
consumers appreciate (understand) the risks and strategies to
reduce the risk of unsafe food.

⚫ The goal is to reduce the risk of unsafe food!!

⚫ A food safety-risk analysis is essential not only to produce or

manufacture high quality goods and products to ensure safety and
protect public health, but also to comply with international and
national standards and market regulations.
⚫ With risk analyses food safety systems can be strengthened and
food-borne illnesses can be reduced.

⚫ Food safety risk analyses focus on major safety concerns in

2
manufacturing premises—not every safety issue requires a formal
 Risk analysis
⚫ Risk analysis is a powerful tool for carrying out science-based
analysis and for reaching sound, consistent solutions to food
safety problems. It provides information on hazards in food to be
linked directly to data on the risk to human health, to improve
food safety decision-making processes. It is a structured,
systematic, disciplined, decision-making process for food safety.
Risk analysis is defined by the Codex Alimentarius Commission
as "a process consisting of three components: risk assessment,
risk management and risk communication”.
⚫ The three components are essential, complementary parts of the
overall discipline. In the course of a typical food safety risk
analysis, almost constant interactions occur between risk
managers and risk assessors within an environment characterized
by risk communication. This approach has now gained wide
acceptance as the preferred choice for assessing possible links
between hazards in the food chain and actual risks to human
3 health, and takes into account a wide range of inputs to
decision-making on appropriate control measures.
 Principles for risk analysis

Risk analysis should:

⚫ follow a structured approach comprising the three distinct
components: risk assessment, management and communication
⚫ be based on all available scientific data
⚫ be applied consistently
⚫ be open, transparent and documented
⚫ be evaluated and reviewed as appropriate on the basis of new
scientific data

4
 Risk Analysis Process
⚫ Risk Assessment is the central scientific component of risk
analysis but risk management, defines the problem, articulates the
goals of the risk analysis and identifies the questions to be
answered by the risk assessment.
⚫ The science-based tasks of ‘measuring’ and ‘describing’ the
nature of the risk being analyzed (i.e. risk characterization) are
performed during the risk assessment.
⚫ Risk management and risk assessment are performed within an
open and transparent environment based on communication and
dialogue.
⚫ Risk communication encompasses an interactive exchange of
information and opinions among risk managers, risk assessors,
the risk analysis team, consumers and other stakeholders.
⚫ The process often culminates with the implementation and
5 continuous monitoring of a course of action by risk managers.
 General aspects of risk analysis
⚫ 1. The overall objective of risk analysis applied to food safety is to ensure
human health protection.
⚫ 2. Risk analysis principles apply equally to issues of national food control and
food trade situations and should be applied consistently and in a non
discriminatory manner.
⚫ 3. To the extent possible, the application of risk analysis should be established
as an integral part of a national food safety system.
⚫ 4. Implementation of risk management decisions at the national level should be
supported by an adequately functioning food control system/program.
⚫ 5. Risk analysis should be:
⚫ Applied consistently;
⚫ Open, transparent and documented; and
⚫ Evaluated and reviewed in the light of newly available scientific data.
⚫ 6. The three components of risk analysis should be documented fully and
systematically in a transparent manner. While respecting legitimate concerns to
preserve confidentiality of data and information should be accessible to all
interested parties.
⚫ 7. Effective communication and consultation with all interested parties should
6
be ensured throughout the risk analysis.
⚫ 8. It is recognized that national governments will use different approaches and
time frames in the application of these principles taking into account national
capacities and resources. For the purpose of the present document, the term
“interested parties” refers to “risk assessors, risk managers, consumers,
industry, the academic community and, other relevant parties and their
representative organizations”. However, it is recognized that interaction
between risk managers and risk assessors is essential for practical application.
⚫ 9. National governments should take into account relevant guidance and
information obtained from risk analysis activities pertaining to human health
protection conducted by Codex, FAO, WHO and other relevant international
intergovernmental organizations, including OIE and IPPC.
⚫ 10. With the support of international organizations where appropriate, national
governments should design and/or apply appropriate training, information and
capacity building programs that are aimed to achieve the effective application
of risk analysis principles and techniques in their food control systems.
⚫ 11. National governments should share information and experiences on risk
analysis with relevant international organisations, other national governments
(e.g. at the regional level through FAO/WHO Regional Coordinating
Committees) to promote and facilitate a broader and, where appropriate, more
7 consistent, application of risk analysis.
 Benefits of Food Safety Risk Analysis
⚫ Better identification and targeting of public health problems
ultimately facilitate improvements in managing food safety
⚫ Better utilization of resources by focusing the highest food safety
risks.

⚫ Trade opportunities- risk analysis provide a solid basis for

negotiating access to markets in other countries by objectively
demonstrating the absence of hazards or the effective control of
hazards to produce a safe food.

⚫ Risk analysis identifies gaps and uncertainties in scientific

knowledge on risks, which can help set research priorities
⚫ A community better informed about food safety issues, leading to
improving production, manufacturing and trading practices.
8
 Risk assessment
⚫ Risk Assessment is the central scientific component of risk
analysis and has evolved primarily because of the need to
make decisions to protect health in the face of scientific
uncertainty.
⚫ Risk assessment generally described as characterizing the
potential adverse effects to life and health resulting from
exposure to hazards over a specified time period.
⚫ Risk management and risk assessment are separate but
closely linked activities, and ongoing, effective
communication between those carrying out the separate
functions is essential.

9
 Principles of risk assessment
⚫ a) Risk assessment should be based upon sound scientific principles, data and evidence.
⚫ b) Risk assessment should be conducted according to a structured approach that
includes hazard identification, hazard characterization, exposure assessment, and risk
characterization.
⚫ c) A risk assessment should clearly state the purpose of the exercise, including the
report of risk estimate that will be the output.
⚫ d) A risk assessment should be transparent. This requires systematic documentation,
statement of assumptions and value judgments and rationale, and a formal record.
⚫ e) The risk estimate should contain a detailed description of uncertainty and where the
uncertainty arose during the risk assessment process.
⚫ f) The data generated should be of quality and precision that minimizes uncertainty in
the risk estimate to the extent possible.
⚫ g) A risk assessment, depending upon its purpose should explicitly consider the
dynamics of microbiological growth, survival, and death in foods, severity and
occurrence of chemical risk and the complexity of the interaction between human and
agent following consumption
⚫ h) Risk estimates should be re-assessed over time by comparison with independent
human health data where possible.
10
⚫ i) A risk assessment may need re-evaluation as new data and information becomes
 Basic components of risk assessment
⚫ The risk assessment process is generally represented as consisting of four steps,
described by Codex. Following identification of the hazard(s), the order in which
these tasks can be carried out is not fixed; the process is normally highly iterative,
with steps repeated as data and assumptions are refined.
1. Hazard identification
⚫ Specific identification of the hazard(s) of concern is a key step in risk assessment
and begins a process of estimation of risks specifically due to that hazard(s).
Hazard identification may have already been carried out to a sufficient level during
risk profiling; this generally is the case for risks due to chemical hazards. For
microbial hazards, the risk profile may have identified specific risk factors
associated with different strains of pathogens, and subsequent risk assessment may
focus on particular subtypes. Risk mana
2. Hazard characterization
⚫ During hazard characterization, risk assessors describe the nature and extent of the
adverse health effects known to be associated with the specific hazard. If possible,
a dose-response relationship is established between different levels of exposure to
the hazard in food at the point of consumption and the likelihood of different
adverse health effects. Types of data that can be used to establish dose-response
11 relationships include animal toxicity studies, clinical human exposure studies and
epidemiological data from investigations of illness.gers are the primary arbiters of
3. Exposure assessment
⚫ Exposure assessment characterizes the amount of hazard that is consumed by
various members of the exposed population(s). The analysis makes use of the
levels of hazard in raw materials, in food ingredients added to the primary food
and in the general food environment to track changes in levels throughout the
food production chain. These data are combined with the food consumption
patterns of the target consumer population to assess exposure to the hazard
over a particular period of time in foods as actually consumed.

4. Risk characterization
⚫ During risk characterization, outputs from the previous three steps are
integrated to generate an estimate of risk. Estimates can take a number of
forms and uncertainty and variability must also be described if possible. A risk
characterization often includes narrative on other aspects of the risk
assessment, such as comparative rankings with risks from other foods, impacts
on risk of various “what if” scenarios, and further scientific work needed to
reduce gaps. Risk characterization for chronic exposure to chemical hazards
does not typically include estimates of the likelihood and severity of adverse
health effects associated with different levels of exposure. A “notional zero
12
risk” approach is generally taken and where possible the goal is to limit
 General characteristics of food safety risk assessment:
a) A risk assessment should be objective, transparent, fully documented
and available for independent scrutiny.
b) The functions of risk assessment and risk management should be
carried out separately to the extent practicable.
c) Risk assessors and risk managers should engage in an iterative and
on-going dialogue throughout risk assessment.
d) Risk assessment should follow a structured and systematic process.
e) Risk assessment should be based on scientific data and should take into
account the whole “production-to-consumption” food pathway.
f) Uncertainties in risk estimates and their origins and impacts should be
clearly documented, and explained to risk managers.
g) A risk assessment should be subject to peer review if considered
appropriate.
h) A risk assessment should be reviewed and updated as new information
permits or requires.
13
 Approaches for risk Assessment
There are many situations at the national level where no risk assessment of
any form is available or feasible. In other situations, an active decision
may be taken to use a scientific approach that does not include risk
assessment. Obviously the advantages that flow from using risk
assessment to set food safety control measures cannot be realized in such
scenarios; nevertheless, choices to apply other scientific approaches are
likely to be reasonable and appropriate in their own right.

⚫ 1. Risk Assessment: The way four analytical steps are applied differs
somewhat for microbiological and chemical hazards. For
microbiological hazards, the occurrence and transmission of the hazard
at various stages from food production to consumption is evaluated,
thus moving "forward" through the various stages of the food chain to
arrive at an estimate of risk. In contrast, for chemical hazards, "safety
evaluation" is a standard risk assessment methodology. In that
approach, maximum exposure levels are identified to fit a "notional
14 zero risk" outcome.
⚫ 2. Use of Ranking Tools: Risk ranking, using tools that rely on knowledge of
risk factors to rank risks and prioritize regulatory controls, is often
commissioned by risk managers. Such rankings may or may not be based on
risk assessments. Some tools categorize a food business against specified risk
factors, e.g. by type of food, type of food preparation, type of business,
compliance record, food user subpopulation. Other tools are used to rank
hazard-food combinations in a national context by deriving a "comparative
risk" scoring system. Risk ranking methods not based on risk assessments are
not a good substitute for ranking methodologies that do incorporate risk
assessment.

⚫ 3. Epidemiology: is increasingly being used in food safety to study the links

between the frequency and distribution of adverse health effects in specific
populations and specific food-borne hazards. This includes observational
studies of human illness such as case-control, analysis of surveillance data, and
focused research. The usefulness of epidemiology depends on the availability
of data.

⚫ 4. Combination of Approaches: As a practical matter these various

15
approaches are often used in combination or feed into each other (e.g.
 How Risk assessment to be carried out at National, State and
Lower levels?
⚫ The Working Principles for Risk Analysis for Food Safety for Application by
Governments (Food safety regulatory authorities) are intended to provide
guidance to national governments for risk assessment, risk management and
risk communication with regard to food related risks to human health.

Risk assessment policy

⚫ a) Determination of risk assessment policy should be included as a specific
component of risk management.
⚫ b) Risk assessment policy should be established by risk managers in advance
of risk assessment, in consultation with risk assessors and all other interested
parties. This procedure aims at ensuring that the risk assessment is systematic,
complete, unbiased and transparent.
⚫ c) The mandate given by risk managers to risk assessors should be as clear as
possible.
⚫ d) Where necessary, risk managers should ask risk assessors to evaluate the
16
potential changes in risk resulting from different risk management options.
 Risk management

⚫ Risk Management is the process of weighing up the various

possible policies, taking account of the evaluation of risks
and other factors involved in the health protection of
consumers and the promotion of fair trade practices, and
taking decisions accordingly, i.e. choosing and
implementing the appropriate prevention and monitoring
measures.

⚫ The management of food-related risk therefore involves

balancing the recommendations formulated by the experts
commissioned to scientifically evaluate the risks, and the
resources of all types that social and commercial groups and
17 manufacturers can set aside for dealing with these risks.
 General Principles of Food Safety Risk Management
1. Protection of human health should be the primary objective in risk
management decisions.
2. Risk management should follow a structured approach.
3. Risk management decisions and practices should be transparent, consistent
and fully documented.
4. Risk management should take into account the whole food chain.
5. Risk management should ensure the scientific integrity of the risk
assessment process by maintaining the functional separation of risk
management and risk assessment.
6. Risk managers should take account of risks resulting from regional
differences in hazards in the food chain and regional differences in available
risk management options.
7. Risk management should include clear, interactive communication with
consumers and other interested parties in all aspects of the process.
8. Risk management should be a continuing process that takes into account all
18newly generated data in the evaluation and review of risk management
decisions.
 Risk Management Framework
⚫ A generic Risk Management Framework for food safety risk management must
be functional in both strategic, long term situations (e.g. development of
international and national standards when sufficient time is available) and in
the short term work of national food safety authorities (e.g. responding rapidly
to a disease outbreak). In all cases, it is necessary to strive to obtain the best
scientific information available.

There are four components of risk management frameworks:

⚫ a) Preliminary risk management activities comprise the initial process. It
includes the establishment of a risk profile to facilitate consideration of the
issue within a particular context, and provides as much information as possible
to guide further action. As a result of this process, the risk manager may
commission a risk assessment as an independent scientific process to inform
• Identify food safety issues
decision-making. • Establish risk assessment policy
• Develop risk profile • Commission risk assessment, if
• Establish goals of risk management necessary
• Decide on need for risk assessment • Consider results of risk assessment
19
• Rank risks, if necessary.
⚫ b) Evaluation of risk management options is the weighing of
available options for managing a food safety issue in light of scientific
information on risks and other factors, and may include reaching a
decision on an appropriate level of consumer protection. Optimization
of food control measures in terms of their efficiency, effectiveness,
technological feasibility and practicality at selected points throughout
the food-chain is an important goal. A cost-benefit analysis could be
performed at this
• Identify stage.options • Select preferred option (s)
possible
• Evaluate options • Rank risks, if necessary.

⚫ c) Implementation of the risk management decision will usually

involve regulatory food safety measures, which may include the use of
HACCP. Flexibility in the choice of individual measures applied by
industry is a desirable element, as long as the overall programme can be
objectively shown to achieve the stated goals. Ongoing verification of
the application of food safety measures is essential.
• Validate control (s) where • Verify implementation
20 necessary • Rank risks, if necessary
• Implement selected control (s)
⚫ d) Monitoring and review is the gathering and analyzing of data so as
to give an overview of food safety and consumer health. Monitoring of
contaminants in food and foodborne disease surveillance should
identify new food safety problems as they emerge. Where there is
evidence that required public health goals are not being achieved,
redesign of food safety measures will be needed.
⚫ Monitor outcome of control(s)
⚫ Review control (s) where indicated
⚫ External risk communication occurs between the risk analysis team and
external stakeholders.
⚫ Science and emotion define risks, and risk communication must address
both aspects. Although food safety experts focus on science, the general
public is usually more concerned about the emotional aspects of the
risk.
⚫ Risk communication should always have a clear goal.
⚫ Responsibility for risk communication should be clearly defined and
assigned to one or more members of the risk analysis team.
21
⚫ Risk communication provides a platform to actively involve external
 Risk communication
⚫ Risk communication is an interactive exchange of information
and opinions throughout the risk analysis process concerning risk,
risk-related factors and risk perceptions, among risk assessors,
risk managers, consumers, industry, the academic community and
other interested parties, including the explanation of risk
assessment findings and the basis of risk management decisions
⚫ Risk communication is an integral part of risk analysis together
with risk management and risk assessment. Risk communication
provides timely, relevant and accurate information to members of
the risk analysis team, as well as external stakeholders, in order to
improve knowledge about the nature and effects of a specific
food safety risk. Successful risk communication is a prerequisite
for effective risk management and risk assessment. The key
consideration in risk communication are:
⚫ Risk communication should facilitate an open and interactive
exchange of information, facts and opinions about food safety
22 risks.
⚫ Risk communication encompasses a continuous and interactive exchange of
information and opinions between risk assessors, risk managers, consumers,
industry, academic institutions and other interested stakeholders throughout the
risk analysis process.
⚫ Risk communication should involve a two-way dialogue. Risk communicators
must provide external stakeholders with clear and timely information about the
food safety risk and measures to manage it; this information should be
communicated in a way that stakeholders can easily understand and using a
media that they can easily access.
⚫ In addition, it is essential for risk communicators to solicit feedback from
external stakeholders and listen to their opinions in order to refine the key
message communicated and to fully and adequately address stakeholder
concerns.

⚫ The fundamental goal of risk communication is to provide meaningful, relevant

and accurate information in clear and understandable terms, targeted to a
specific audience. Risk communication may not resolve all the differences
between parties, but it should lead to a better understanding of those
differences.
23
⚫ Risk communication should also lead to more widely understood and accepted
 Goals of risk communication
a) To promote awareness and understanding among all participants of the
specific issues under consideration during the risk analysis process.
b) To promote consistency and transparency in arriving at and
implementing risk management decisions.
c) To provide a sound basis for understanding the proposed and/or
implemented risk management decisions.
d) To improve the overall effectiveness and efficiency of the risk analysis
process.
e) To contribute to the development and delivery of effective information
and education programmes, when they are selected as risk management
options.
f) To foster public trust and confidence in the safety of the food supply.
g) To strengthen working relationships and mutual respect among all
participants.
h) To promote the appropriate involvement of all interested parties in the
24
risk communication process.
⚫ Many different kinds of individuals and groups involved in all
aspects of the food chain from farm to fork (including production,
processing, distribution, sale and consumption) are affected by
food safety risks.
⚫ Risk communication is an integral and ongoing part of the risk
analysis exercise, and all stakeholders should be involved from
the start.

⚫ Risk communication makes stakeholders aware of the process at

each stage of the Risk Assessment.
⚫ This helps to ensure that the logic, outcomes, significance, and
limitations of the Risk Assessment are clearly understood by all
the stakeholders.

25
 Risk management and communication: Public comment
⚫ The risk managers submit your assessment for public comment
from stakeholders.
⚫ The most important replies are:
1. The seafood association denies completely that mercury has any
role in illness, other than the Minimata incident, where the exposure
was extremely high (daily or twice-daily consumption of products
extremely high in mercury). They also suggest that limiting
consumption of seafoods will have negative health aspects given the
unequivocal evidence linking polyunsaturated fatty acids with
reduced heart disease.
2. The Consumers' Association considers the assessment
underestimates the risk to the foetus and that the rating should be
"high". Even though evidence is not yet conclusive, the association
considers "the jury is still out" and that the assessment should be
26more conservative. They cite the NAS judgment in favor of the
more EPA level as evidence that the assessment should be more
 The risk managers make the following observations and decisions:
⚫ Given the consumption patterns, the risk is borne by around 25 000
pregnant consumers at any one time.
⚫ Warnings will be carried in every hospital and every doctor's surgery
that consumption of shark and game fish may lead to motor impairment
in the child and that these species should not be consumed more than
once a week during the first four months of pregnancy.
⚫ These warnings are based on levels recommended by JECFA.
⚫ Regulatory bodies in several countries, e.g. United States (FDA) and
Australasia (Food Standards Australia New Zealand) have decided to
follow JECFA recommendations.
⚫ The known benefits of seafood consumption outweigh the possible
negatives associated with (as yet unproven) motor impairment.
⚫ There are already size limits for sharks, which partially reduce the
hazard.
⚫ The topic will be kept under constant review and any new evidence will
27 be assessed.