UNIT IV

FOOD SAFETY

Food safety refers to the proper food handling procedures applied

during food preparation, processing, storage, and distribution of
the products you deal with in your food business. The concern on
the integrity of food safety lingers within all of the parts of a food
supply chain. The concern for the food production life cycle
starts from agriculture to packaging of finished products and
delivery to the consumer's table.
MEANING OF FOOD SAFETY:

 Food safety is the absence, or safe, acceptable levels, of

hazards in food that may harm the health of consumers.
 It refers to limiting the presence of those hazards whether
chronic or acute, that may make food injurious to the health
of the consumer.
 Food safety refers to the process of reducing harmful impact
of food-borne illnesses through maintaining hygiene and
sanitation during harvest, processing, storage, distribution,
all the way to preparation and consumption.
 Food safety is increasing in magnitude as a public health
concern for health practitioners and the general public.
 Food safety is one of the crucial global concerns that covers
variety of different areas of daily life for health and well-
being.
 The “World Health Organization (WHO) five keys to safer
food” serve as the basis for educational programs to train
food handlers and educate the consumers. They are
especially important in preventing food-borne illness
IMORTANCE OF FOOD SAFETY:
Recent data released by the World Health Organization have
estimated that at least 600 million people all over the world
become inflicted with foodborne illnesses after consuming
unsanitary food. Of these people, at least 420,000 people die
every year. 
The majority of food safety issues are caused by pathogenic
microorganisms such as bacteria that cause food poisoning or
food intoxication. They can cause mild to fatal health
consequences that include watery diarrhea, vomiting,
abdominal pain, or even debilitating infections and long-term
diseases.
Some examples of foods involved in common illnesses include
high-risk ingredients and any perishable food such as eggs,
poultry, fresh fruits, raw meat or deli meats, deli seafood
salads, undercooked seafood, ground meat, raw sprouts, and
raw milk products.
 Protection from foodborne illnesses and other food-
related injuries. The main objective of food safety is to
protect consumers of food products from foodborne diseases
or injuries related to food consumption. Foodborne
illnesses are a major threat to food businesses and affect
everyone all over the world as a result of inadequate food
safety. These effects are mainly caused by foodborne
pathogens that may include harmful bacteria, fungi, yeasts,
parasites, or viruses. Additionally, chemical substances,
heavy metals, and excessive additives can also cause
foodborne illnesses and acute poisoning.
 Reduced cost from food safety issues. Unsafe food with
proven safety issues may be deemed unfit for consumption
and may merit being disposed of.
 Reduce waste. Food products that have been proven to
have food safety issues may be subjected to disposal. 
 A better way of living. Any foodborne illness affects
productivity in consumers. Once afflicted, consumers will be
able to function well and may even need hospitalization in
extreme cases. These events cause dramatic disruptions in
everyday activities.
 Safer food globalization. All laws about food safety are
designed to protect consumers from food safety issues.

IMPORTANCE OF FOOD SAFETY AND QUALITY IN

DEVELOPING COUNTRIES:
Food safety holds great significance both financially and ethically.
If food safety guidelines are violated by food manufacturers, it
can lead to disastrous consequences. The importance of ensuring
food safety is listed below

1. For food manufacturers

Food safety plays an important role in maintaining the reputation
of a food manufacturing company. Failing to implement an
effective food safety practice can lead to contaminated food
products entering the market. If defective food products are
discovered, it can cause dramatic disruptions in the operations of
the food manufacturing company. The company then had to
announce food recalls.
Food recalls cost can be a huge loss for companies. And the most
important thing is that it will leave a negative impact on your
brand among the people which will have a long-term effect. This
is perhaps more costly than the food recalls cost. Thus, any food-
producing company should not give up on food safety. It is an
important investment that cannot be missed out on.

2. For Human
The human cost of unsafe food is higher than anything. More
than 200 diseases are spread worldwide through food. It is
estimated that over 4,20,000 people die every year due to food
contamination, most of which are children belonging to the age
group of 1 to 5 years. Food contamination can lead to various
long-term health problems like neurological disorders, ulcers,
cancer, and more. The impact of foodborne diseases is severe in
infants, pregnant women, the sick, and the elderly. This might
lead to serious illness and sometimes death.

3. For government
Food safety is directly related to the socio-economic progress of
the country. A lack of food safety affects public health services,
tourism, food exports, livelihoods of food handlers, and more
people, which in turn leads to unstable economic development.
PREVALENCE OF FOOD BORNE ILLNESS:

Contaminated food causes 600 million cases of foodborne

disease a year and over 400,000 deaths, demonstrating the
clear connection between food safety and public health. Yet the
importance of food safety goes beyond direct impacts on health. It
is also fundamental for developing market economies,
maintaining livelihoods, and increasing trade – especially
for developing countries trying to break into growing global
markets in food and agriculture.

According to the World Health Organization, the illness,

disability, and premature deaths resulting from unsafe foods led
to productivity losses of about USD 95 billion in 2016 in low-
and middle-income countries.

Despite the prevalence of unsafe food and related problems,

however, policymakers in these countries have generally paid
little attention to and made little investment in the addressing
the issue of food safety. In order to encourage further
improvements in food safety, a new report from the World Bank
provides examples of effective food safety management practices
from around the world. The report also includes a strong call to
action, emphasizing the need for the creation of cohesive and
well-funded domestic food safety management systems and
public-private partnerships (including public agencies,
businesses, and consumers) in low- and middle-income
countries.

According to the report, food safety results from the actions or

inactions of a wide variety of stakeholders, including farmers,
food handlers and distributors, food manufacturers, food service
operators, consumer, regulators, scientists, educators, and the
media. The behavior of these stakeholders is often shaped by
their awareness of food safety hazards and their capacity
(technical or financial) to apply proper food safety practices, as
well as by rules and incentives in place to encourage such
practices.

In developing countries, food safety has been hampered by two

main groups of factors. First, weak empirical knowledge (i.e., a
lack of good quality data) regarding the country-level incidence of
foodborne diseases, the economic costs of unsafe food, and the
efficacy of domestic food safety interventions means that
policymakers and researchers often do not know the extent of the
problem in their country. Second, institutional challenges, such
as fragmented food value chains and policies, have made it
difficult to establish comprehensive, cohesive programs to
address food safety issues across the board.

The report uses the term “food safety life cycle” to describe how
the burden of unsafe food changes alongside economic
development. At the traditional stage of the food safety life cycle
(characterized by consumption of starchy staple foods and
policies focused on food availability and affordability), food
production practices are fairly effective at controlling food-borne
hazards, the report says; most foodborne illness at this stage
stems from poor hygiene practices and limited access to clean
water and proper sanitation facilities. Therefore, at this stage,
demand and incentives for food safety tend to be low.

As food systems modernize and incomes increase, however,

countries reach the transitional stage of the food life cycle. At this
stage, food safety hazards become broader, as consumers’ dietary
preferences shift rapidly and populations become more
urbanized. At this stage, most foodborne hazards stem from
changes in the production and consumption practices of fresh
foods, such as meat products and fruits and vegetables. In
addition, food imports, particularly of perishable fresh products,
tend to increase at this stage, opening consumers up to new
foodborne hazards. Governmental regulatory bodies and systems,
as well as emerging private sector actors, can become
overwhelmed in this scenario of rapidly increasing and changing
food safety risks, and food safety concerns tend to increase faster
than the ability of existing tools to address those challenges.

As countries’ food systems reach the modernizing stage of the

food safety life cycle, agri-food value chains often undergo
significant restructuring. Producers, processors, and distributors
tend to become more formalized, and retail sectors become
modernized, even in rural areas. While foodborne hazards still
exist at this stage, more effective monitoring and regulatory
systems make it easier to establish and enforce minimum food
safety standards in both the public and the private sector. As a
result, consumer trust in the ability of systems to deliver safe
food increases.

Often, governments attempt to reach these later life cycle stages

through strict regulations enforced through the inspection of food
facilities and products and the penalization of failures to meet
certain standards. However, this system may not be effective in
low- and middle-income countries, where food systems are
dominated by smallholder farmers, micro and small enterprises,
and informal food channels. To better help these countries move
through the food safety life cycle and achieve improved food
safety outcomes, the report recommends the establishment of a
more shared management model. Under such a model,
governments would work to incentivize and facilitate the safe
production, processing, and distribution of foods through the
establishment of minimum food safety standards; in turn, food
businesses would retain a certain degree of flexibility in attaining
these standards and would be able to draw on government
support and resources to comply with standards. In this way,
various stakeholders would be able to better coordinate and work
together.

In addition, investments need to focus not just on food safety

interventions but also on environmental interventions, such as
reducing contamination of soil and water supplies. The report
also calls for a shift to a more proactive focus on identifying and
reducing or avoiding potential future food safety risks; in this
way, policymakers will be able to not only respond to food safety
incidents but actually prevent such incidents.
WHO Five keys for food safety:
 Keep food surfaces clean. Wash all utensils, plates, platters,
and cutlery as soon as used.
 Separate raw food from cooked food.

 Cook food thoroughly, to the appropriate temperature.

 Keep food at safe temperatures, both for serving and

storage.
 Use safe water and raw materials.

PRINCIPLES OF FOOD SAFETY

The principles of food safety intend to avoid food from becoming
unhygienic and causing food poisoning. This is acquired through
a variety of different guidelines, some of which are:

 Properly cleaning and sanitizing all surfaces, equipment,

and utensils.
 Maintaining a high level of personal hygiene, especially
hand-washing.
 Storing, chilling and heating food correctly with regards to
temperature, environment, and equipment.
 Implementing effective pest control.
 Comprehending food allergies, food poisoning and food
intolerance.

PATENTS

Introduction:

The IP laws are all about protecting ‘innovation’ and ‘creativity’,

Food industry is covered under the IP laws likeany other
industry. For instance, if we consider Coca-Cola brand, we find
that the process of making Coca-Cola is a trade secret; the
name, the artistic way it is written as well as the shape of the
bottle is a registered trademark; and the ads and jingles used for
its promotion are protected under copyright.

An industry as competitive as the food industry where one has to

come up with innovative ideas in order to survive on a regular
basis should find IP to be a source of solace as it extends
protection to their innovation from imitation.

DEFINITION:

A patent is a set of exclusive rights granted by the government to

an inventor or assignee for a limited period of time in exchange
for detailed public disclosure of an invention. An invention is a
solution to a specific technological problem and is a product or a
process.

INVENTION:

Under the Patents Act, inventions are defined as those that are
either products or processes, are novel, have an inventive step,
and are industrially applicable. When seen through the lens of
patent law, inventions are only those products and processes
that satisfy patentability requirements.
The definition of invention however includes only three of the
patentability requirements, and inventions must satisfy two
additional requirements to be eligible for patent grant. One of
them relates to the list of subjects that are not patentable even if
they are inventions, and the other reviews the description and
workability of the invention.
REQUISITIES/REQUIREMENTS OF A PATENT:

An invention will be eligible for a patent grant in India only if it

satisfies the patentability requirements. To be patentable, the
invention must satisfy all of the requirements, which check
worthiness of the invention for patent grant from different
perspectives. Some of the requirements are relatively easy to
satisfy when compared to others, but all of them are equally
important for purposes of patentability assessment.

The five (5) requirements for patentability of inventions in India

are:

A. Patentable Subject Matter;

B. Industrial Applicability;
C. Novelty;

D. Inventive Step; and

E. Specification.

Patentability requirements may be viewed as filters arranged in

succession for purposes of analysing patentability of inventions.
Only inventions that pass through all the filters will be eligible for
patent grant, and those that get filtered out will be refused. The
picture below provides a view of the patent filter model.

A.PATENTABLE SUBJECT MATTER:

Patentable subjects are provided in broad terms in the definition

of invention, which states that an invention under the Act must
either be a product or process. In other words, in order to be
considered for patentability an invention must either be a
product or process. Patent eligible subjects are therefore
products and processes without any limitation of field,
technology, or any other. At a general level, every invention is
either a product and/or process, and patentability objections at
this level are not very common. However, the Patents Act
provides a long list of inventions not patentable, which form
material part of the patentable subject matter requirement.

NON PATENTABLE INVENTIONS:

 New Forms
 Computer Programs Per Se
 Plants and Animals and
 Traditional Knowledge

New Forms:

The mere discovery of a new form of a known substance which

does not result in the enhancement of the known efficacy of that
substance or the mere discovery of any new property or new use
for a known substance or of the mere use of a known process,
machine or apparatus unless such known process results in a
new product or employs at least one new reactant.
Explanation. —For the purposes of this clause, salts, esters,
ethers, polymorphs, metabolites, pure form, particle size,
isomers, mixtures of isomers, complexes, combinations and other
derivatives of known substance shall be considered to be the
same substance, unless they differ significantly in properties with
regard to efficacy;”

Computer Programs Per Se:

It excludes mathematical algorithms, mathematical methods,

business methods and computer programs per se from
patentability 

Plants and Animals:

The clause excludes the following subjects:
1. Plants as a whole and their parts;
2. Animals as a whole and their parts;
3. Seeds;
4. Plant and animal varieties;
5. Plant and animal species; and
6. Essential biological processes for production and
propagation of plants and animals.
Traditional knowledge:

Three types of inventions are excluded from patentability under

the clause:

 Inventions that are in effect traditional knowledge;

 Aggregation of known properties of traditional knowledge
components; and
 Duplication of known properties of traditional knowledge
components.

It excludes inventions that claim traditional knowledge and its

components, but does not bar inventions that are based on
traditional knowledge. In other words, an invention is not
excluded under the clause merely because it relates to traditional
knowledge. Specific phrases such as “in effect traditional
knowledge” and “aggregation or duplication of known properties,”
provide sufficient scope for interpreting inventions out of the
scope of the exclusion.

The Council of Scientific and Industrial Research (CSIR)

maintains a database of traditional knowledge called as the
Traditional Knowledge Digital Library, which has 2.5 lakh
formulations pertaining to Ayurveda, Unani and other ancient
medicinal systems in India. It documents information relating to
traditional knowledge with the objective of preventing patent
grants over subject matter covered in TKDL. As of date, nine (9)
patent offices including those of India, US and Europe have
access to the library, and efforts are in progress to provide access
to other patent offices. The information in TKDL is available to
Indian patent examiners to search for traditional knowledge and
assess patentability of traditional knowledge-based inventions.

The standards for assessing patentability of inventions relating to

traditional knowledge are high compared to other inventions, and
it is relatively difficult to convince the IPO and Courts to grant
patents on modifications or improvements over traditional
knowledge.

For Example, In a case involving a traditional basket for hauling

farm produce called ‘Kilta,’ the Himachal Pradesh High Court
held that an invention claiming a plastic long basket instead of
the traditional one made of bamboo with adjustable straps is not
patentable. The Court came to the said conclusion because mere
replacement of bamboo with plastic and addition of straps, which
are known in the prior art, does not make the invention an
enhancement over traditional knowledge. Though the inventor in
the case increased the size of the traditional basket, made it
lighter and easy to carry, the Court placed the invention within
the scope of mere aggregation and duplication of traditional
knowledge components and revoked the patent.

B. INDUSTRIAL APPLICABILITY

Industrial applicability requirement checks if an invention is

capable of being made or used in an industry. If a product can be
manufactured repeatedly and has at least one use in an industry,
it will be considered as industrially applicable. A process must be
capable of being used in an industry to satisfy this requirement.
Uncertain, vague, futuristic or non-specific use is not considered
as valid use. The same is the case with insubstantial or non-
credible use of a product or process.

In a case between Cipla and Roche, the Delhi High Court

reviewed some Indian and foreign cases relating to the utility or
industrial applicability requirement and observed that an
invention must be commercially viable. It must have a
commercial use, and commercial success need not be proved. At
a basic level, the invention must have a practical use and has to
be useful for the purpose claimed in the patent specification.
Nothing more will be required to prove utility of an invention for
patentability.

C. NOVELTY

Novelty simply means newness based on what is existing as of

the priority date of the patent application. An invention will be
considered to be novel if it is different from what is already
existing, which is referred to as ‘prior art.’ Novelty is always
assessed in the light of a single prior art reference at a time, and
prior art references are not combined for novelty analysis. Having
said that, general knowledge of   the art not expressly provided in
a prior art reference may be read into the reference.

Novelty has not been defined under the Patents Act, and is
provided under different sections pertaining to examination,
anticipation, opposition and revocation. For purposes of novelty
as well as inventive step analysis, prior art includes the following:

i. Prior patents relating to the invention, which include patent

applications and granted patents in India, whose priority date
precedes that of the patent application;
ii. Prior Publications relating to the invention, which include any
document published before the priority date of the patent
application;

iii. Prior commercial working of the product or process in India

before the priority date of the patent application;

iv. Prior communication of the product or process to the

Government before the priority date of the patent application;

v. Prior display of the product in an exhibition before the priority

date of the patent application;

vi. Prior public working of the invention in India, before the

priority date of the patent application; and

vii. Prior use of the invention in India before the priority date of
the patent application.

D. INVENTIVE STEP

The inventive step requirement is the most subjective and

complex of all patentability requirements.
Under the Indian Patents Act, the assessment of inventive step
includes two aspects, technical advance or economic
significance; and non-obviousness.

An “inventive step” means a feature of an invention that involves

technical advance as compared to the existing knowledge or
having economic significance or both and that makes the
invention not obvious to a person skilled in the art;”

To satisfy this requirement, an invention has to:

1. have technical advance over existing knowledge; or

2. have economic significance; and

3. Must not be obvious to a person skilled in the art.

E. SPECIFICATION
To obtain a patent, the inventor has to file a patent application
containing a specification The object of the specification is to
provide complete information to the public about the invention
and the mode of carrying it out and to define the boundaries of
the invention. The specification has to contain a written
description of the invention and of the manner and process of
making and using it. The written description may contain
drawings where and when required to clearly describe the
invention. A model or sample may have to be submitted if the
patent office requires such a model or sample as an illustration of
the invention. However, such a model or sample will not form
part of the specification. If the invention involves biological
materials, the biological materials may be deposited at a
recognized depository in order to describe the invention and such
materials would form part of the specification.

The specification has to enable the invention, which means it

must fully and particularly describe the invention and its
operation or use and the method by which it is to be performed.
It must describe the embodiment of the invention claimed in each
of the claims. The description of the invention must be so clear
that any person in the field can carry it out and no further
experimentation must be required to practice the invention. The
specification must also disclose the best method of performing
the invention which is known to the applicant at the time of filing
the patent application.

Furthermore, the specification has to end with a claim or claims

defining the scope of the invention for which protection is
claimed. The function of the claims is to define the metes and
bounds of the invention claimed in the patent application. Claims
in a specification have to relate to a single inventive concept, and
be clear and succinct. The claims must mark out with adequate
distinctiveness, the boundary of the territory of the invention
sought to be protected. The principle idea in the invention has to
be presented in the claims and must not be left for general review
of the specification. All claims in the patent have to be supported
by the matter provided in the written description of the
specification.

Though the specification requirement is normally not listed as

one of the patentability requirements, it is as important as other
requirements. If the invention is not fully described, claimed,
supported or enabled in the specification, the patent application
will be rejected. Through the specification, the inventor has to
show that he is not only in possession of the invention, but also
that the invention is workable without undue experimentation.

PATENTABLE INVENTIONS:

The main categories of food patents include:

1. Food Composition
2. Process/Method for making a product or creation of recipes
3. A novel microorganism, plant or animal that has been
genetically modified toproduce a particular chemical (e.g. a food
ingredient or additive).
4. Substitution of matter: a new and improved composition, or a
method or apparatus for making or testing a composition
5. Bioactive compounds
6. A new synthetic process, a molecule produced by that process,
or the use of that molecule to produce a particular effect, for
example, a flavour, aroma, texture or stability
7. Machines for making food items
8. Packaging of food products

1.Food Composition:

Food compositions are patentable wherein new compositions, for

example in an invented sauce, the steps of formulating a sauce
and the sauce itself is patentable; if it fulfills all the criterions of
patentability.

Example:

US5885644 provide a composition of combining a garlic sauce

without exogenous starch, where garlic sauces are not
spreadable because of their runny consistency, similar in
consistency to salad dressing. This runny consistency is therefore
not suitable for spreading on a cracker or for dipping vegetables.

The most common solution includes use of starch, like bread or

potato. However, the most prominent drawback is that it
diminishes or obscures the nut and garlic flavour of the sauce.
The starch containing sauces of the prior art have a bread-like
taste and a pasty or starchy texture that imparts a gooey or tacky
texture to the sauce.

Several other recipes had a pungent, bitter, tart or vinegary flavor

that detracts from the enjoyment of the natural flavor of garlic.
The colors of prior art garlic sauces vary, for example, from white,
almost white, to a grey, purplish, "dirty water" color. These color
variations will also detract from the overall visual presentation of
the sauce.

Therefore a garlic sauce, comprising the following ingredients: a)

garlic; b) chunks of nuts, c) vinegar; d) water; e) oil; and f)
salt, wherein said ingredients are combined without the addition
of exogenous starch is claimed and patented.

2. Process/Method of Cooking:

Process of cooking an ingredient or the peculiar sequence in

which the ingredients are added. The processes that make a
recipe patentable may include: heating, frying, grilling, stirring,
sautéing, baking, poaching, grinding, bottling, whipping, mixing,
canning, molding, aging, separating, soaking, cutting, blanching,
smoking, chilling, freezing, melting, dehydrating, layering,
stamping, and poaching.

3. A novel Microorganism:

Plant or animal that has been genetically modified to produce a

particular chemical

4. Substitution of Matter: For health reasons many people avoid

rich food and the food that may cause allergy e.g. Butter and egg.
Therefore, if a substitute in a particular composition is claimed to
produce a desirable taste and provide desirable qualities then
this recipe can be patented, as it is novel and provides a solution
to a particular problem.

5. Bioactive Compounds: Usual food items that are consumed

as part of a normal diet can be imparted to have physiological
benefits and/or reduce the risk of chronic disease, thereby
performing beyond basic nutritional functions, by adding certain
bioactive compounds are patentabl.

6. A New Synthetic product:

A molecule produced by that process, or the use of that molecule

to produce a particular effect, for example, a flavour, aroma,
texture or stability. Jp61202678 provides Modified Japanese
SAKE. To obtain a modified Japanese SAKE having excellent
taste and flavour quite different from those of normal Japanese
SAKE, by mixing the extract of plum, apple, etc., together with
acetic acid to Japanese SAKE. Japanese SAKE produced by
brewing process, synthetic process, etc., is added with (A)
preferably one or more components selected from extract of plum,
concentrated extract of plum, extract of apple, concentrated
extract of apple, and apple vinegar in an amount of preferably 1-
20% and (B) acetic acid or an acetic acid-containing substance
such as vinegar, in an amount of preferably about 0.05-0.5% in
terms of acetic acid.

7. Machines for making food items: e.g. toaster, oven, robots or

other machines used for performing tasks. US 7156642 provides
a Dough rolling apparatus and method

8.Packaging with added functions beyond containment and

protection also known as active packaging extends shelf-life, thus
ensuring prolonged food quality and safety. The active packaging
includes features such as gas, moisture, UV absorbers, flavor,
antioxidants, and antimicrobial releasers etc.
US8341925 provides a Method of packing a food product with
extended shelf-life - A method of packing and heat treating a
solid or semi-solid food product in a packaging container of paper
or paperboard, the method comprising, prior to filling of the solid
or semi-solid food product, filling the packaging container with a
foam containing a non-oxidising gas and, after the filling, sealing
the packaging container by thermo sealing and subjecting the
packed solid or semisolid food product to a heat treatment for
purposes of extending the shelf-life of the packed solid or semi-
solid food product in the sealed packaging container.

Food Safety Hazards

There are four primary categories of food safety hazards to

consider: biological, chemical, physical, and allergenic.
Understanding the risks associated with each can dramatically
reduce the potential of a foodborne illness. Each have their own
unique characteristics, but all can be avoided through a robust
food safety management system (FSMS).

Biological Hazards

Biological hazards are characterized by the contamination of food

by microorganisms found in the air, food, water, animals, and in
the human body. These incredibly tiny organisms are not
inherently unsafe – many provide benefits to our anatomy.
Despite this, foodborne illness can occur if harmful
microorganisms make their way into the food we eat. There are
several types of microorganisms, each of which can negatively
impact health: bacteria, viruses, and parasites

Biological Commonly found in

Hazard

Salmonella Eggs, poultry, meat, unpasteurized milk or

juice, cheese, fruits and vegetables, spices,
and nuts

Norovirus Produce, shellfish, ready-to-eat foods

Campylobacter Raw and undercooked poultry, unpasteurized
milk, contaminated water

E. coli Undercooked ground beef, unpasteurized milk

or juice, raw milk cheeses, raw fruits and
vegetables, contaminated water

Listeria Ready-to-eat deli meats and hot dogs,

unpasteurized milk or juice, raw milk cheeses

Clostridium Beef, poultry, gravies

perfringens

Chemical Hazards
Chemical hazards are identified by the presence of harmful
substances that can be found in food naturally, or
unintentionally added during processing. Some chemical hazards
include naturally occurring chemicals, such as mycotoxins,
intentionally added chemicals, including the preservative sodium
nitrate, and unintentionally added chemicals, like pesticides.

Chemical Hazard Examples

Mycotoxins Produced by fungi and can be toxic to
humans and animals. They are formed
by moulds which grow on crops and
foods under certain conditions.
Natural Toxins Biochemical compounds produced by
plants in response to certain conditions
or stressors.
Marine Toxins Decomposition or microscopic marine
algae accumulated in fish and shellfish.
Environmental Accidentally or deliberately enter the
Contaminants environment. Typically manufactured for
 industrial use.
Food Additives Any chemical substance that is added to
food during preparation or storage.
Processing-induced Undesirable chemicals can be formed in
Chemicals certain foods during processing as a
result of reactions between compounds
that are natural components of the food.
Pesticides/ Used to control, destroy, or repel a pest,
Agricultural Products or to mitigate the effects of a pest.
Veterinary Drug Used in food-producing animals to
Residues control and/or prevent illness in the
animal.

INDIAN PATENT LAW: OVERVIEW

 The history of Patent law in India starts from 1911 when the
Indian Patents and Designs Act, 1911 was enacted.
 The Patents Act, 1970 is the legislation that till date governs
patents in India. It first came into force in 1972.
 The Patents Act has been repeatedly amended in 1999,
2002, 2005, 2006 respectively. These amendments were
required to make the Patents Act TRIPS compliant. TRIPS
stands for Trade-Related Aspects of Intellectual Property
Rights.
 The major amendment in the Patent Act was in 2005, when
product patents were extended to all fields of technology like
food, drugs, chemicals and microorganisms. The Rules
under Patent Act were also amended in 2012, 2013, 2014.
 The Office of the Controller General of Patents, Designs and
Trade Marks or CGPDTM is the body responsible for the
Indian Patent Act
 The Office of the Controller General of Patents, Designs &
Trade Marks (CGPDTM) is located
at Mumbai.
  The Head Office of the Patent office is at Kolkata and its
Branch offices are located at Chennai, New Delhi and
Mumbai.
 The Offices of The Patent Information System (PIS) and
National Institute of Intellectual Property Management
(NIIPM) are at Nagpur.
 The Controller General supervises the working of the
Patents Act, 1970, as amended, the Designs Act, 2000 and
the Trade Marks Act, 1999 and also renders advice to the
Government on matters relating to these subjects.

Patent Law Amendment Act 2005 

Salient features of the Patents (Amendment) Act 2005

related to product patents:
1. Extension of product patent protection to products in
sectors of drugs, foods and chemical.
2. Term for protection of product patent shall be for 20 years.
3. Introduction of a provision for enabling grant of compulsory
license for export of medicines to countries which have
insufficient or no manufacturing capacity; provided such
importing country has either granted a compulsory license
for import or by notification or otherwise allowed
importation of the patented pharmaceutical products from
India (in accordance with the Doha Declaration on TRIPS
and Public Health)
4. Section 3 (d) regarding patentability.
Effects of Patent Amendment Act 2005
1. Due to the new patent regime, increased prices of products
was considered to be a major hindrance during the time.
However, the government has taken proactive measures to
ensure low prices for essential drugs, and has used
compulsory licensing as a tool to keep exorbitant prices
under check.
2. The amendment intended to make Indian drug and
pharmaceutical industries competitive at par with
multinational companies. 
3. Despite initial reservations, Indian pharmaceutical
companies manufacturing generic drugs have flourished in
the last decade. 
4. Also, MNCs have opened Research and Development
Centres in India.
Patents (Amendment) Rules, 2021:

Patent Fees for Educational Institutions Reduced:

 Educational institutions engage in many research

activities, where professors and teachers and students
generate several new technologies which need to be
patented for facilitating commercialization of the same.
 At the time of applying for patents, the innovators have
to apply these patents in the name of the institutions
which have to pay fees for large applicants, which are
very high and thus work as a disincentive.
 In this regard and to encourage greater participation of
the educational institutions, official fees payable by
them in respect of various acts under the Patents
Rules, 2003, have been reduced by way of the Patents
(Amendment) Rules, 2021.
 Benefits related to 80% reduced fee for patent filing &
prosecution have been extended to all educational
institutions.

 This benefit was earlier available to all recognised

educational institutions owned by the government.
Extension of Expedited Examination System:

The fastest granted patent is the one which was granted in 41

days after filing of such request. This facility of Expedited
Examination system was initially provided for patent applications
filed by Startups.

It has been now extended to 8 more categories of Patent

Applicants:

SME (Small and Medium Enterprises), Female applicants,

Government Departments, Institutions established by a Central,
Provincial or State Act, Government Company, an Institution
wholly or substantially financed by the Government and
applicants under Patents Prosecution Highway.
The Patent Prosecution Highway (PPH) is a set of initiatives for
providing accelerated patent prosecution procedures by sharing
information between some patent offices.

Term of Patent:

The term of every patent in India is twenty years from the date
of filing the patent application, irrespective of whether it is filed
with provisional or complete specification.

Advantages of patents

 A patent gives you the right to stop others from copying,

manufacturing, selling or importing your invention without
your permission. See protecting intellectual property.
 You get protection for a pre-determined period, allowing you
to keep competitors at bay.
 You can then use your invention yourself.

Alternatively, you can license your patent for others to use it or

you can sell it. This can provide an important source of revenue
for your business. Indeed, some businesses exist solely to collect
the royalties from a patent they have licensed - perhaps in
combination with a registered design and trade mark.

Disadvantages of patents

Your patent application means making certain technical

information about your invention publicly available. It might be
that keeping your invention secret may keep competitors at bay
more effectively.

Applying for a patent can be a very time-consuming and lengthy

process (typically three to four years) - markets may change or
technology may overtake your invention by the time you get a
patent.

Cost - it will cost you money whether you are successful or not -
the application, searches for existing patents and a patent
attorney's fees can all contribute to a reasonable outlay. The
potential for making a profit should outweigh the time, effort and
money it takes to get and maintain a patent. Not all patents have
financial value.

You'll need to remember to pay your annual fee or your patent

will lapse.

You'll need to be prepared to defend your patent. Taking action

against an infringer can be very expensive. On the other hand, a
patent can act as a deterrent, making defence unnecessary. Read
more about patent protection and enforcement.

PATENT PROCEDURES:

Intellectual property is an intangible asset – one that can bestow

the world with an invention that can make life simple and also
contribute to the inventor or his company’s fiscal growth. An
Intellectual property brings with it a whole lot of benefits. It can
turn an idea into a profit making asset, enhance the market
value of a business and even help raise finances. Various
inventions such as solar power trees, solar water purifiers, cane-
based prosthetic limbs and self-repairing roads have all been
credited to Indian investors. These inventions have truly changed
the world.
If you have created or invented a process, product or service that
can be defined as an original invention, it is in your best interest
get it patented. Patenting your invention prevents your
competitors from profiting from something created by you. If you
need to file a patent, you can refer to this step-by-step guide
covering the entire patent process in India.
Steps to follow to file a patent
Thumb Rule:
Do not disclose your invention in public domain before filing
a patent application failing which the innovation loses its
novelty.
Inventors can file a patent in two ways:
 The inventor can file the patent on his/her own
 The inventor can take the help of a patent filing
professional or agency.
Since the patent filing process is long and complicated, most
inventors prefer to engage the services of patent filing
professionals or agencies. Such individuals or firms charge a fee
for since they have years if experience under their belt. They can
complete the necessary patent filing procedures on your behalf.
In case you choose to engage the services of a professional or
agency, you must complete all the formalities related to patent
filing, so that the agency does not pass off your invention as
theirs. To this effect, you need to draft a non-disclosure
agreement and have your agency professional sign it. This
formality needs to be completed before the inventor discloses
his/her invention to the professional or agency.
There are two ways to file for a patent – you can file it yourself or
seek the services of a patent-filing professional or agency. Since
you have to adhere to several deadlines, it is recommended that
you engage the services of a professional/agency with years of
experience. Also, ensure you make the professional sign a non-
disclosure agreement (NDA) before you disclose your invention.
Now let’s understand the patent filing procedure.
Step 1 – Check if your invention is patentable
Before you begin the patent registration process, you need to
check if your invention is patentable. This means that you need
to check if another individual has filed a patent for a similar
technology for which you are filing. Performing an in-depth
patentability search helps you understand whether or not you
have a chance of getting a patent. While this step is optional, it
can save time and help you understand whether or not you
should file for a patent in the first place.
Step 2 – Draft the patent application
You can now begin the patent application process. Indian
applicants need to fill Indian Patent Application Form 1. For
every patent you file, you need to mandatorily provide a Form 2
patent specification. You can choose between a provisional and
complete patent application, based on the stage of invention. This
means that if you are still testing your invention, you need to
apply for a provisional patent application. You get a period of 12
months to complete the invention and file for a complete patent.
You need to pay special attention when you are drafting your
patent application. Your patent application should include
clauses such as usability and outcome of the invention in detail.
You should also include the necessary clauses including your
intention to license your invention and preventing competition
from using and thereby, profiting from your invention. Ensure
caution while drafting your patent application, be meticulous and
include clauses that prevent the competition from using your
technology.
Step 3 – Filing the patent application:
Your patent application needs to be submitted with several
application forms. As per the patent filing procedure in India, you
need to submit all of the below mentioned forms. Links to all
forms and an applicable fee is http://www.ipindia.nic.in/form-
and-fees.htm
 Form 1 – Application for patent grant
 Form 2 – Patent specification form (provisional or complete)
 Form 3 – Undertaking and statement with regards to
foreign applications under section 8 (mandatory only in case
a corresponding application for patent is filed in a foreign
country)
 Form 5 – Declaration of invention to be filed with complete
application
 Form 26 – Form authorizing patent agent (applicable only if
you opt for an agent to help file the patent)
 Form 28 – Mandatory only if applicant is claiming small
entity or start-up status
 Priority Documents – You need to provide priority
documents only if priority is being claimed from a foreign
patent claim or application.
Step 4 – Publishing the patent application
After you submit all the documents, the patent application is
safely secured by the Indian Patent Office. The patent is then
published in an official patent journal after a period of 18 months
approximately. However, inventors who wish to have their patent
application published before this 18 month period can submit
Form 9. This is an automatic process but if an inventor wishes to
have his application published earlier, he needs to submit Form
9 (early publication request), in which case, the application will
be published in the official patent journal within 1 month of
making the request. However, there are certain scenarios in
which your patent application may not be published. These
include incomplete applications, withdrawal requests made by
the individual filing the patent and secrecy direction imposed
under Patent Act wherein the invention is against the nation’s
interests.
Step 5 – Examining the patent application
Before your patent is granted, it needs to be examined
substantively. As per rules of the patent application process in
India, your patent is thoroughly examined based on the merits of
your invention as claimed and described in the patent
specification form. Unlike the publication process, this is not an
automatic process and the applicant needs to make a request to
examine their patent application by submitting Form 18. The
patent office queues the application for examination only after a
formal request for examination is made. You can also expedite
this process by filling and submitting Form 18 (A).
The patent examiner is obligated to follow a few steps of his/her
own while examining your application. They are as under
 When the application lands on the examiner’s desk, it is
scrutinized according to the Patent Act and underlying
rules.
 The patent examiner searches for similar technologies to
ensure the invention satisfies patentability criteria.
 After reviewing the application, a first examination report
(FER) is submitted in which, grounds for objections, if any,
are also stated.
 The examiner lists his objections in detail. This can further
extend the application process by another 6- 9 months. Note
that examiner objections are quite common in case of
patents.
 If the inventor needs to make changes to his/her objection,
he/she can file a request for time extension by submitting
Form 4.
Step 6 – Decision to grant patent
Once the examiner finds no objections in the patent application,
he grants the patent. The patent is then published in the official
patent gazette.
Step 7 – Renewing the Patent
The patent holder also needs to renew his patent by paying an
annual renewal fee. In India, it is possible to renew your patent
for a period of 20 years at maximum, from the date the patent
was first filed.
Although the patent filing process is long and complex, one must
remember its importance in the long run. The entire process can
take anywhere between 3-5 years. However, Indian Patent Office
is hiring new examiners and also upgrading its offices to be able
dispose of patent applications in timely fashion. The process is
created with the intention of ensuring that the inventor gets
credit for his invention. It also ensures that no other individual
can claim rights over the invention. The legal rights you earn with
your patent can prevent competitors from using your invention
for financial benefits. You can also sue such individuals and
claim compensation for using your invention without your
approval.