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Chapter 3: Novel Food Technologies and Regulatory Framework in Food Technologies

The document discusses the historical development of food regulations in India, including key acts and regulatory bodies. It outlines four major Acts: the Prevention of Food Adulteration Act of 1954, the establishment of the Food Safety and Standards Authority of India in 2006, the Food Safety and Standard Act of 2006, and the Food Safety and Standards (Packaging and Labeling) Regulations of 2011. It also discusses international regulatory bodies like the Codex Alimentarius Commission and World Health Organization.

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0% found this document useful (0 votes)
65 views22 pages

Chapter 3: Novel Food Technologies and Regulatory Framework in Food Technologies

The document discusses the historical development of food regulations in India, including key acts and regulatory bodies. It outlines four major Acts: the Prevention of Food Adulteration Act of 1954, the establishment of the Food Safety and Standards Authority of India in 2006, the Food Safety and Standard Act of 2006, and the Food Safety and Standards (Packaging and Labeling) Regulations of 2011. It also discusses international regulatory bodies like the Codex Alimentarius Commission and World Health Organization.

Uploaded by

infotechedge10
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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Chapter 3: Novel Food Technologies and Regulatory Framework in Food Technologies

Introduction

India's food regulations have changed significantly throughout the years, which is indicative

of the nation's dedication to guaranteeing food safety, quality, and consumer protection.

Numerous legislative initiatives and regulatory organisations have been set up to discuss the

various issues that the food business is facing. Let's examine the major turning points in the

evolution of Indian food laws throughout history.

3.1 Historical Development of food regulations in India

Act 1. The prevention of food adulteration act, 1954

On June 15, 1955, the Prevention of Food Adulteration Act, 1954, which covers the entirety

of India, went into force. The following situations are included by the act's definition of

adulteration:

● if the vendor's product fails to live up to the buyer's expectations or the article's stated

requirements.

● if there is anything in the item that detracts from the article's quality.

● if the item was produced or kept in an unsanitary environment.

● if the item includes any components that are inappropriate for ingestion by humans,

such as rotten, decayed, or putrid plant or animal materials.

● if a component of the merchandise was obtained from an animal that was ill.

● if any harmful or toxic materials are present in the article.

● if the article's container is composed of any harmful material.

● if the article contains colouring agents other than those that are recommended.
● whether any illegal preservatives or preservative quantities above recommended

limits are present in the item.

● Whether or not the article is harmful to health, it does not fulfil the committee's

standards for quality and purity.

Act 2. Establishment of food safety and standards authority of India (FSSAI)

The FSSAI was established in 2006 in order to bring together several food-related regulations

and actions. It combined the provisions of the Fruit Products Order, the Meat Food Products

Order, and the Prevention of Food Adulteration Act. The SSAI is in charge of creating and

implementing the nation's food standards.

Key Points of the 2006 Food Safety and Standards Act

● Many federal laws, including the Prevention of Food Adulteration Act of 1954, the

Fruit Products Order of 1955, the Meat Food Products Order of 1973, the Vegetable

Oil Products (Control) Order of 1947, the Edible Oils Packaging (Regulation) Order

of 1988, the Solvent Extracted Oil, De-oiled Meal and Edible Flour (Control) Order

of 1967, and the Milk and Milk Products Act of 1968 Order, 1992, etc., shall be

revoked upon the implementation of the FSS Act, 2006.

● The Act also intends to replace multi-level, multi-departmental control with a single

line of command, creating a single point of reference for all issues pertaining to food

safety and standards. In order to do this, the Act creates the Food Safety and

Standards Authority of India, an independent statutory body with its headquarters


located in Delhi. The State Food Safety Authorities and the Food Safety and

Standards Authority of India (FSSAI) will implement the Act's numerous sections.

Act 3: The Food safety and standard act 2006:

A committee was formed by the Food Safety Standard Authority of India (FSSAI) in May

2023 to investigate and pinpoint new problems concerning highly processed foods and

nutraceuticals. The chairs of the 21 scientific committees and six independent specialists

comprise the Scientific Committee. Section 13 of the Food Safety and Standards Act of 2006

(FSS Act) established it.

The scientific committee had to focus on more recent advancements to provide better food

options for future generations, in addition to creating sustainable standards. Along with

suggestions for lowering adulteration, the committee will also offer fast testing and methods

for detecting food diseases.

Act 4: Food Safety and Standards (Packaging and Labeling) Regulations, 2011:

Governmental organisations everywhere have strict guidelines regarding the designs of food

packaging. You must make sure you follow these policies each time a new product is

introduced or the packaging is updated. Food packaging regulations in India are set by the

Food Safety and Standards Authority of India (FSSAI). For instance, the FSSAI mandates

that labels include a list of ingredients, nutritional data, a notice of non-vegetarian goods, and

other information.

The FSSAI Regulations are a thorough collection of rules that all producers and brands of

food products need to abide by. Twelve main labelling requirements are enforced by the

FSSAI for all food packaging. These are the following:

● The food's name

● The component list


● Nutritional data

● Indicate whether or whether the food item is vegetarian.

● An explanation of the utilised food additives

● Name and full address of the producer

● Information about customer service,

● Number

● The price at retail for sale

● FSSAI licence number and emblem,

● Nation of origin, date of marketing, and batch identifying number

● The use guidelines

Food Safety Mitra Scheme

FSSAI launched the Food Safety Mitra project in recognition of the need to support small

FBOs. FBOs will receive assistance with training, licensing and registration, and hygiene

rating. A person with professional training and FSSAI certification, known as a "Food Safety

Mitra," aids in compliance with the FSS Act and its rules and regulations. Digital Mitra,

Trainer Mitra, and Hygiene Mitra are provided under the Food Safety Mitra Scheme:-

● Digital Mitra: To help FBO comply with FSSAI's internet portals.

● Trainer Mitra: To instruct FBOs on the application of the Food Safety Act and its

regulations.

● Hygiene Mitra: To rate FBOs' hygiene.

The Food Safety Mitra Scheme, which supplements the efforts of FSSAI and the State Food

Authorities, strives to establish a last-mile self-driven and self-employed compliance

structure through this multi-layered ecosystem that is responsive to the demands of FBOs.

Rapid alert system for food and feed (RASFF)


Notifications from RASFF are posted online. The European Commission runs the "RASFF

Window" to give stakeholders, businesses, and consumers access to notifications from the

European Rapid Alert System for Food and Feed. The RASFF Window shows the most

recent notifications in English, and you can utilise the data for independent assessments of

the RASFF.

3.2 International and National Regulatory Bodies

i. Codex Alimentarius Commission

The Codex Alimentarius Commission (CAC) has approved a set of global dietary guidelines

known as the Codex Alimentarius. All of the major food categories—processed, semi-

processed, and raw—are covered by the Codex Standards. The hygienic and nutritional

quality of food is addressed by Codex requirements, which also cover food additives,

pesticide and veterinary medicine residues, pollutants, labelling and presentation, sampling

techniques, and risk assessment methodologies. In May 1963, the Codex Alimentarius

Commission was founded.

● The Food and Agriculture Organisation and the World Health Organisation share

management of it.

● The European Union is one of the 189 Codex Members of the Codex Alimentarius

Commission as of 2021, along with 188 Member Countries.

● In 1964, India joined Codex Alimentarius.

● All Member Nations and Associate Members of FAO and WHO who are interested in

global food standards are eligible to join the Commission.

● Every year, the Commission convenes in a regular session in Geneva or Rome.

● The six official languages of the United Nations (UN) are Arabic, Chinese, English,

French, Russian, and Spanish. CAC operates in these languages.

● WHO and FAO manage all fiscal problems jointly.


The mission has objective of

● To safeguard consumer health and uphold ethical standards in the food industry;

● To encourage worldwide governmental and non-governmental organisations working

on food standards to coordinate their efforts;

ii. World Health Organisation (WHO)

Leading the way among intergovernmental organisations in the fight against foodborne

illnesses and to enhance food security and safety worldwide is the World Health Organisation

(WHO). In the area of food safety, WHO has also aided in the development and

dissemination of new policy ideas. These ideas include the introduction of the new risk

analysis paradigm, the holistic, "One Health" approach to food production, which considers

food production from farm to fork, and, lastly, the emphasis on effective and straightforward

messaging that aims to prevent food risks by improving knowledge of safe food preparation

practices across all sectors. The WHO plays a normative role in food safety and other public

health domains, facilitating risk assessment and worldwide standard setting. The adoption of

a formalised system to create and use science-based risk assessments to enhance food safety

at the national and international levels has been the most significant normative development

in the food safety field during the past few decades. The World Health Organisation has been

advocating for the use of risk analysis as a framework for managing food production and

safety for nearly two decades. According to WHO data, a significant fraction of foodborne

disease episodes worldwide are caused by a limited number of food handling-related factors.

Typical mistakes consist of:

● food prepared several hours before consumption and stored at temperatures that

encourage the growth of harmful microorganisms and/or the production of toxins;

● inadequate food preparation or reheating to minimise or eradicate germs;


● cross-contamination; and food being handled by those who don't wash their hands

well.

In response to these mistakes, the Ten Golden Rules provide guidance that can lower the

likelihood that foodborne pathogens will be able to contaminate, survive, or multiply. The

rules should be viewed as a paradigm for the creation of culturally appropriate educational

solutions, despite the fact that these causes are universal across a variety of cultural

situations. Therefore, users are urged to modify these guidelines to convey signals that are

unique to food preparation customs in a particular cultural context. Their ability to alter

ingrained behaviours will be amplified.

iii. European Food Safety Authority (EFSA)

Located in Parma, Italy, EFSA is a decentralised agency under the European Union. In

response to many food crises in the late 1990s, the organisation was founded in 2002 with the

goal of providing scientific opinions and guidance on hazards related to the food chain.

Regarding dangers associated with food, independent scientific advice is provided by the

European Food Safety Authority (EFSA).

EFSA provides guidance on current and potential food hazards. This guidance helps shield

consumers from hazards in the food chain by informing European laws, regulations, and

policymaking. Its purview includes food and feed safety, nutrition, animal welfare, plant

health, and plant protection. The work of EFSA includes:

● collecting information and knowledge from scientists

● provide unbiased, current scientific guidance on matters pertaining to food safety

● educating the public about its scientific work engaging with other stakeholders,

international organisations, and EU member states enhancing confidence in the EU's

food safety system by offering solid guidance.

iv. Food and Agriculture Organization (FAO)


The food and agriculture organisation FAO allows supporting gender equality in the

agriculture sector with an effort to raise levels of nutrition in local communities and improves

agricultural productivity. These agencies work pretty hard so that a correct effort is made to

defeat hunger. The goal is to achieve food and security for people so that they can live

healthy lives and manage hunger and malnutrition. FAO has a decentralised network of

regional, sub regional and Liaison offices.

3.3 Legislative Framework for Novel Food Technologies

i. Food Safety and Standards Authority of India (FSSAI) - India

Role: This was established in 2008 so that a welfare mandate can be laid down on science

based standards of articles and food in India while ensuring the availability of the sales

standard implementation. This regulatory body does a proper inspection of food producing

and manufacturing companies so that it is ensured of meeting all the standards as per

guideline. This act sets up the formulation and enforcement of food safety standards in India

and allows quality of food products to be delivered to the customers.

ii. Food and Drug Administration (FDA) - United States:

Role: Regulates and oversees the safety of foods, including novel food technologies, in the

United States. Evaluates and approves new food ingredients and technologies before they

enter the market. FDA is funded by the user fees and budget appropriations. The FDA is an

independent federal agency that controls the production and distribution and conservation of

food. All FDA-approved goods come with the following full guarantees: Their effectiveness

and safety have been evaluated. Food is labelled correctly, wholesome, safe, and hygienic.

Standards for quality control and manufacturing procedures have been followed.

iii. European Food Safety Authority (EFSA) - European Union:

Role: Assesses the safety and nutritional aspects of novel foods and food ingredients before

they can be authorised for use within the EU. Ensures a high level of protection for
consumers in the European Union. European food safety authority is actually helping with the

food sustainability systems through transparent, independent and trustworthy scientific

advice. Before regulating food improvement agents are approved for use on the European

market, EFSA assesses their safety. Chemicals employed as food additives, food enzymes,

flavourings, and smoke flavourings are known as food enhancement agents.

3.4 Emerging Food Technologies and Innovations

Since the study is a comparative analysis between different nations the nationwide

regulations are explained.

UK

i. 2022 - EU Regulation (EU) 2015/2283 Implementation - European Union

It establishes guidelines for novel foods to be sold in the European Union (EU). These are

made to offer a high degree of protection for consumer interests and human health.

ii. 2021 - UK Novel Food Regulations - United Kingdom

Novel foods are those which do not have a history of consumption and hence the novel food

act of the UK allows the management of food so that people are eating healthy. Establishing

that a food or ingredient is safe to consume under the suggested circumstances and that

regular consumption would not have a negative nutritional impact is the main objective of a

novel foods application.

India

i. 2019 - FSSAI Guidelines on Approval of Novel Foods - India:

The nation's approved food regulator is the Food Safety and Standards Authority of India

(FSSAI). It creates and carries out laws pertaining to the production and marketing of food

items in India. Before any food product can be sold, it must be approved. The food product

cannot be offered in the Indian market unless it has been approved. Food goods were divided

into two categories under the previous regulations: standard and non-standard.
Standardised food items are governed by set standards, and permission is only needed once

when launching a new firm in order to manufacture, distribute, sell, or import them. This

implies that these products can be easily sold in the Indian market if approval is given for

them. Conversely, non-standard food products lack established safety standards and

necessitate authorization for production, retail, import, or distribution.

Food Safety and Standards (Approval of Non-Specified Food and Food Ingredients)

Regulations, 2017 were created by FSSAI in order to regulate such products, including

innovative food, and to give food business operators the chance to expand their product

offerings.

The following food items or substances are covered by the regulation: new cuisine or

innovative cuisine components or processed using cutting-edge technologies Innovative

additions new tools for processing, such as enzymes food-related products and ingredients

that are made of, or separated from, bacteria, yeast, fungi, algae, or microorganisms.

ii. 2006 - Food Safety and Standards Act - India:

Under the Food Safety and Standards Act of 2006, the Food Safety and Standards Authority

of India is a statutory agency. The main legislation governing the regulation of food items is

the Food Safety and Standards Act (FSS), 2006. The establishment and implementation of

food safety regulations in India are also facilitated by this act. This act was received as the

assent of the president on 23rd August 2006. There is generalised information that will

consolidate the laws relating to food and establish the food safety standards of India for

managing the manufacturing, sales, distribution and imports of human consumable food.

United States

i. 1958 - Federal Food, Drug, and Cosmetic Act (FFDCA) - United States:

Section 408 of this act limits the uses of pesticides, and denotes the absence of tolerance for a

pesticide residue. The tolerance's residual level serves as the catalyst for enforcement
measures after it has been set. That is, the commodity may be seized if residues are

discovered above that threshold.

When EPA establishes tolerances, it must determine if the tolerance is "safe." According to

the definition of safe, there is a "reasonable certainty that no harm will result from aggregate

exposure to the pesticide residue." The EPA takes into account a number of factors before

reaching a safety conclusion, including the pesticide's toxicity and the products that break it

down; cumulative exposure to the pesticide through food and other sources; and any unique

concerns that may be present for young children and babies.

There are several insecticides that are not required to have a tolerance. When there is a

reasonably foreseeable possibility that the pesticide residues won't be harmful to human

health, the EPA may grant an exemption.

ii. 2016 - Amendment to FFDCA - United States

This amendment included the inspection of different acts including federal meat inspection

act, poultry products inspection act and egg products inspection act. There is also a utilisation

of humane methods of slaughter act. To make sure imported goods fulfil American food

safety regulations, FSIS reexamines imported goods and inspects all meat products sold in

interstate commerce. To make sure imports fulfil American food safety regulations, FSIS

reexamines imported goods and inspects all poultry products marketed in interstate

commerce. To make sure imported goods fulfil American food safety regulations, FSIS

reexamines imported goods and inspects egg products sold in interstate commerce. According

to the Humane Methods of Slaughter Act of 1978 (7 USC 1901–1906), only humane

techniques may be used when handling and killing animals.

Chapter 4: Challenges and Gaps in the Regulatory Framework

4.1 Legal Rights and Interests of Consumer

i. Right to Information (RTI)


Legal protection: The Consumer Protection Act, 2019.

Fundamental right: The Right to Information Act, 2005 (RTI)

Justification: One of the most significant pieces of legislation enabling common people to

scrutinise the government and how it operates is this one. The public and media have utilised

this extensively to expose corruption, the state of government operations, and information

about spending. Consumers have the proper rights of accessing information through the

portal of regulatory bodies like FSSAI. This is a basic human right to know about the product

being consumed.

ii. Right to Safety

Legal protection: The consumer protection act of 2019.

Fundamental right- Article 21- Rights to life and personal liberty

Justification: These ensure that consumers are protected by laws which show safety standards

of food products. Different emerging technologies are applied to get the correct information

so that consumers' life and personal liberty is never compromised. In addition to food safety

the safety act allows having rights to be protected against those goods and services which is

hazardous to people.

iii. Right to Choice

Legal protection: The consumer protection act of 2019.

Fundamental rights: Article 19(1)(g)- Right to Practise Any Profession, or to Carry on Any

Occupation, Trade or Business. High courts are interpreting article 21 to give people enough

liberty to live life normally and have enough privacy to make their own choices. Laws

promoting an excess of fair competition allows people to make choices of their preferences.

The economic activities are managed under this act alongside enabling the choices of

accessing various products, goods or services at competitive price points.

iv. Right to privacy


Legal Protection: The Digital Data protection Act 2022.

Fundamental Right: The Right to Privacy

Justification: Consumer data is often shared with companies and companies are bound to

safely protect the data alongside minimising the data leakage. The consumer privacy needs to

be safeguarded under this data protection law where no data is supposed to be shared with

third parties.

v. Right to redress

Legal Protection: The Consumer Protection Act, 2019.

Fundamental Right: Access to Justice under Article 21.

Justification: Consumers have the right to seek redressal from the company and get their due

compensation if they are not satisfied with the food products. Justice is hence identified as an

important part of the process where the right compensation is gained.

vi. Right to health

Legal protection: under the Food Safety and Standards Act of 2006,

Fundamental right: Article 21 within the right to Life and Personal liberty

Justification: Allows understanding the facts that consumers might have to face potential

health risks if they consume novel food. The goal of healthcare law is to safeguard the

welfare and rights of patients. It guarantees that patients receive safe, efficient, and moral

healthcare. Informed consent, access to medical records, confidentiality of medical

information, and protection from medical negligence are all rights that patients enjoy.

vii. Right to Sustainable Practices

Legal protection: under the Food Safety and Standards Act of 2006

Fundamental right: Article 21 of Right to Life and Personal Liberty

Justification: Laws and regulations that support environmental conservation and protection

must be enacted and enforced by the government cited under section 21. This includes the
rights of being in a healthy environment while adhering to sustainable approaches. Eco-

friendly concepts of food products are the new normal and all people should get the benefit of

it.

viii. Right to Non-Discrimination

- Legal Protection: The Consumer Protection Act, 2019.

- Fundamental Right: Article 14 - Right to Equality.

Any people should not be judged or discriminated against on their food choice. Specifically

the food choice of the Novel category must be given equal importance like others. Non-

discrimination of food choices are part of human rights. The foundation of a world that is

peaceful, prosperous, and sustainable is human rights. The UNDP's support for achieving the

2030 Agenda, the Sustainable Development Goals, and other agreements made by Member

States is centred on human rights and non-discrimination.

4.2 Identified Challenges in Regulating Novel Food Technologies

i) Technology integration and interdisciplinary nature

Novel food technologies have been getting rapid promotion and these include several

synthetic biology, cellular agriculture and rapid evolving nature. The updated regulatory

framework sometimes finds it challenging to keep pace with these advancements. Novel food

technologies often span multiple disciplines. Integrating the correct technology to manage

livestock and produce fewer emissions. Some examples of food which needs novel labelling

and protection includes: “Japani Phal (Persimmon), Ambarella (Indian hog plum), Jangli

Jalebi or Kodukkapuli (Camachile), Karonda (Carandas cherry), and Buddha's hand

(Fingered citron).” The regulator needs to collaborate across various fields for ensuring

comprehensive understanding of the environment and technology so that an improved novel

food journey is achieved.

ii) Understanding the consumer perception and acceptance criteria


It is very important that consumer’s specific choices regarding food are kept in mind so that a

transparent communication is established. Sometimes evaluation of novel food becomes

complex and needs to adapt their methodologies to address the effects of new technology to

serve human beings without affecting nature. Novel food technologies are transcending

national borders and that is why establishment of global harmonisation becomes important.

Businesses that are operating in multiple jurisdictions might face more challenges due to

different regulatory approaches.

iii) Risk assessment of Novel foods

Hazard identification and understanding the methods of novel food consumption is one of the

most important aspects. This challenge can be divided into two distinct parts where:

Hazard Characterisation: When determining whether there is sufficient evidence to show that

a chemical has the potential to cause harm, risk assessors examine scientific data.Six When it

is feasible, they determine a safe level of exposure and research the nature of these health

impacts.

Exposure Assessment: When taking into account both dosage and duration, experts estimate

the amount of food or ingredient that consumers as a whole, population groupings (such as

infants, children, and adults), or sub-populations (such as vegetarians, and vegans), are likely

to be exposed to in real-life situations. To ascertain whether a hazard actually poses a risk, the

exposure must be assessed. The danger rises in proportion to the increased exposure.

iv) Ethics related to novel foods

The EU regulations on novel food have come into force in the year 1990’s. It has become one

of the most important aspects to create laws that will address ethical challenges related to

novel food consumption. Novel food concepts came from the threats of feminine and food

crisis in the 90’s in Europe. Now the concept has been changing people’s food habits and

giving replacement products that can serve as an additional source of nutrition. Although the
idea behind novel food was to find replacement of animal protein, sugar and reduce hunger

the ethical standards coming in the pathway of it. Environmental barriers such as greenhouse

effect and deforestation often are considered to be contributed by Novel foods.

4.3 Ethical and Societal Considerations

The novel food industry is based on the principles that are valid for acceptable food treatment

of others in association with food. On the other hand, the moral implications of dietary

choices, made by both humans and animals, are referred to as ethical eating or food ethics.

Genetically modified organisms such as GMO’s are raising some social and ethical concerns.

The regulators have to go through these concerns so that right standardisation and

accessibility is gained. High expectations from industry players might create ethical concerns

for novel foods. Sometimes the regulatory agencies face resource constraints and they need to

encourage innovation while ensuring safety. However, the absence of any prior information

on the safe consumption of novel foods makes it difficult to conduct thorough assessment and

stay ahead of the latest technological developments. Managing funds becomes a significant

challenge in this domain.

i) Long-term health issues: Food which is genetically modified often is not found to be

giving the right health statistics. There are major health issues generated afterwards

consuming the novel foods. Regulators and industry players should provide clear and

accessible information to the public so that they get an understanding of the technology

benefits which have been taken. To ensure that none of the consumers are falling ill after

consuming novel foods one needs to essentially monitor the consumer's well being. The fair

distribution of security components are essential in terms of understanding the changes and

organising correct food technologies.

ii) Consumer acceptance


Public perception of novel food technologies is the pioneer of its cultivation. How the public

is actually seeing novel foods allows the scientist to innovate new methods of novel food

generation and emphasis on the transparency of information. The safety content is associated

with ethics about food, cultural dimension and shaping the way customers view the results.

iii) Equitable access

An ethical concern is ensuring that the advantages of new food technologies are accessible to

everybody. In order to prevent discrepancies in access to technologically advanced food

products, it entails addressing concerns of pricing, availability, and distribution.

iv) Environmental impact

It is one of the most important aspects to look after. Novel food technologies is identified as a

wide spread precision agriculture where the environmental impact of the technology is much

more. The well being of the animal kingdom has to be managed by the people. Some people

express concerns of the well being of animals used in the development process while in some

cultures it is completely extinct. The religious views should be focused while processing the

novel food technology concepts. None of the religious views should be hurt when the novel

food technologies are taken into action.

v) Regulatory oversight

Regulators may encounter difficulties getting enough information from industry participants,

and differences in data standards may make the evaluation procedure more difficult.Certain

modern food technology lack predecessors, making it difficult to draw on previous

encounters with regulations. It might be necessary for regulators to create completely new

frameworks, which calls for a careful balancing act between promoting innovation and

guaranteeing safety. Resources that regulatory bodies may not have enough of include money

and experience. Sufficient resources are necessary in order to carry out comprehensive
evaluations and keep up with the most recent advancements in technology. lengthy

procedures for regulatory approval, Long approval timelines for traditional regulatory

systems can stifle innovation because they are frequently labour-intensive. It's difficult to

streamline regulatory processes without sacrificing security.

4.4 Comparative Overview of Regulatory Approaches

Comparative overview of regulatory approaches of USA, INDIA,UK

USA

i) Novel food: FDA has been regulating a majority of the novel food and that too with an

understanding of the uses of colours, food additives and dietary supplements. The FDA

oversight is a must in novel food consumption while the department of agriculture also

associates with the same.

ii) Regulatory Agencies: Under the GRAS Notification Programme, manufacturers may

choose to voluntarily inform the FDA of their decision to designate a novel food component

as "generally recognised as safe" (GRAS). In order to do this, a GRAS notification dossier

proving the novel food ingredient's safety through expert consensus and scientific facts must

be submitted. Apart from this, FSMA (food safety modernization act) and Federal food, drug

and Cosmetic Act (FD&C) are also associated with novel food consumption.

iii) Biotechnology and GMOs: Consumer acceptance in case of novel foods is very important.

Since in the USA the cultural barriers are less in consumption of novel foods it becomes easy

for the people to go ahead and have those products consumed.

iv) Labelling requirements: In the industry the labelling requirements are more than anything.

Food makers are required by the USDA to disclose the use of bioengineered ingredients on

product labels through the use of language, symbols, or digital or electronic links, as part of

the National Bioengineered Food Disclosure Standard.


UK

i) Novel foods: Novel food products can only be sold in Great Britain in compliance with the

assimilated Regulation (EU) 2015/2283. Novel foods need to be authorised in the market so

that their consumption reactions can be found out.

ii) Regulatory Agencies: UK has some self regulatory approach of managing novel foods.

The main work is managed by FSA which evaluates the safety of novel food based on

scientific evidence and how the things are performing in the market. In the UK, FSA goes

into detail of each food being sold to people.

iii) Biotechnology and GMOs: UK has a more diverse food culture since it has a history of

immigration and globalisation. There is a high acceptance and consumption of novel food

seen in the UK by various people. Although the FSA in the UK assesses the safety standards

of GMO and checks the acceptance criteria before they are sold in the market for common

people’s consumption.

iv) Labelling requirements: Labelling requirement clearly indicates the name and variety,

ingredient list of the novel food used. By clearly indicating the descriptions of allergens UK

based novel food companies try to highlight the core ingredients. Each ingredient is

highlighted using a distinct font, style background colour and has a top most priority of being

shown. Each label should be given the storage instruction, country of origin and contact

information before selling any food.

India

i) Novel foods: The FSSAI is the main regulatory body for novel food sold in India. FSSAI

collaborates with international food safety agencies so that global developments are done on

regulating the uses of certain products in India. The FSSAI in India periodically issues certain

guidelines in India that contain the ingredient and nutritional content and allergens to manage

consumer safety and transparency.


ii) Regulatory Agencies: Under the Environment Protection Act of 1986 and the Rules for the

Manufacture, Use, Import, Export, and Storage of Hazardous Microorganisms/Genetically

Engineered Organisms or Cells, 1989 (revised in 2007), the Ministry of Environment, Forest,

and Climate Change (MoEFCC) oversees the cultivation and release of GMOs in India. The

discharge of genetically modified crops into the environment requires approval from the

Genetic Engineering Appraisal Committee (GEAC).

iii) Biotechnology and GMOs: Novel foods and GMO consumption is increasing day after

day. However, in India due to cultural and social and ethnic beliefs the consumption is still

restricted. Although the GMO’s were developed for gaining enhanced nutritional profiles and

improved shelf life, it needs more research in India to come across as human consumable.

iv) Labelling requirements: Each labelling needs to address the level of allergenicity, toxicity

and nutritional composition. Every label must clearly focus on the name, origin and contact

information of the seller. Saturated fat, total or trans fat, cholesterol information has to be

given appropriately in the label of ingredients. Indian labelling also specifically focuses on

the features of date to be used by and net quantity along with the instruction of uses.

Summary of USA and India

From the above discussion, it is observed that there are significant differentiation in the

consumption of novels between the two countries. Both in developed and developing

counting the labelling requirements is must.

In the USA, the FDA regulates novel food consumption while the FSSAI is not regulating the

standards of novel foods.

Since, USA has a high disposable income and quite a well developed food industry, great

purchasing power is given so that novel foods are consumed more. There are pretty less

cultural barriers. On the other hand, India is still counted as a developing country and there

are cultural and economic boundaries that prevent people from purchasing novel foods.
The American diet is diverse in terms of including ingredients that are unpopular. While in

India the diet is very cultural and uses of traditional spices is more than the consumption of

GMO. In the USA technological advancement is more. There are pretty good researchers

created on the advancement of these food uses while in India there is a lack of awareness

among people and it will take more time to be improved.

Summary of UK and India

In the case of the UK the approval process is highly dependent on food authorities.

Assimilated Regulation (EU) 2015/2283 is the main controller of novel food consumption.

After Brexit, the UK created its own regulatory structure through the Food requirements

Agency (FSA) and modified its laws to conform to EU requirements. While in India the

FSSAI is the sole regulator of certain novel food consumption.

In case of labelling both the countries have similar types of constraints. There are similar

types of additions such as ingredient, net quantity, origin of source, allagents, nutritional facts

are expected to be mentioned in novel foods.

One of the main differences underlies cultural beliefs in novel food consumption. In order to

promote commerce and guarantee adherence to international best practices, the UK might

harmonise its new food legislation with international norms and principles. However, in India

there are social, racial, cultural, ethnic barriers that sometimes limit the people from

consuming novel food. The barriers can be identified in terms of economic stability as well.

The age-old dietary practices coming from Ayurveda, is the base of indian food habits.

However, the novel food and technology integrated food does not fit well with the process

and often is not talked about. While in the case of the UK, people are free to consume any

food that comes from a correct approval process with the correct ingredient list mentioned on

it.

Chapter 5 : - Comparative analysis of Domestic technologies with US and UK


5.1 Domestic case studies

5.2 Case studies from UK and US

5.3 Comparative Assessment of cases.

Chapter 6: Conclusion and Recommendations

6.1 Proposed Regulatory Reforms

6.2 Strengthening Consumer Protection

6.3 Policy Recommendations

6.4 Summary of Key Findings

6.5 Implications of the Research

6.6 Areas for Further Study

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