1.
Packaging, label claims. Regulatory aspects of
nutraceutical products in india
Prepared By:
MOHAMMAD KHALID
(Assistant Professor)
Krishna Pharmacy College, Bijnor (UP)

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contentINTRODUCTION (Packaging)
TYPES OF PACKAGING
Objective of Packaging
Consideration for packaging
FUNCTIONS OF PACKAGING
Factors for package design in international market
Introduction (Labelling)
Function of labels
Objective of labeling
Which Information Is Mandatory
Contents in a Nutraceutical label
Definition of Nutrition Claim/s
Definition of Health Claim/s
New FDA Labeling Requirements
Regulation of Nutraceuticals in India
Food Safety and Standards Authority of India (fssai)
Regulatory Requirements in India
Registration Process in India

3.
INTRODUCTION
Packaging is a process of covering,
wrapping of goods into a package.
Packaging involves designing & producing
the wrapper for a product.
Packaging is next to grading and branding
Packaging is essential for Offering goods in
safe, and secured position to consumer

4.
TYPES OF PACKAGING
Primary Packaging: 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: Secondary packaging is outside
the primary packaging, perhaps used to group primary packages
together.
Tertiary packaging: 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.

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TYPES OF PACKAGING
Designed for consumer-
convenience & appeal,
marketing consideration
& display
The main emphaises-
Is on marketing
CONSUMER PACKAGING INDUSTRIAL PACKAGING
• Industrial packaging is-
focuses on the handling
convenience & protection
during transportation
• The main emphaises-
is on logistics

6.
Objective of Packaging
Physical protection:
The objects enclosed in the package may require
protection from, among other things, shock,
vibration, compression, temperature etc. Eg : Egg,
Bottles.
Barrier protection:
A barrier from oxygen, water vapor, dust, etc., is
often required. Controlled atmospheres are also
maintained in some food packages, keeping the
contents clean & fresh. Eg: Fruits, Vegetables

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Continue…..
Containment or Agglomeration:
Small objects are typically grouped together in
one package for reasons of efficiency.
Eg: Chocolates, Biscuits
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 a important
phenomenon. Eg: Chips, Biscuits

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Continue…..
Security:
Packages can be made with improved tamper
resistance to deter tampering and also can have
tamper evident features to help indicate
tampering. Eg: Coke drinks, water bottles.
Convenience:
Packages can have features that add
convenience in distribution, handling, stacking,
display, sale, opening, reclosing, use,
dispensing, and reuse. Eg: Sauce, Jam

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Continue….
Portion control:
Single serving
packaging has a
precise amount of
contents to control
usage. Commodities
can be divided into
packages that are a
more suitable size for
individual
households. Eg: Milk,
Ice creams

10.
Consideration for packaging
Prevention - Use packaging where needed
Minimization – Minimize mass & Volume
Reuse - Encourage reuse of packages
Recycling - Reprocess materials into new
products
Disposal - Use disposable, eco-friendly
packages

11.
FUNCTIONS OF PACKAGING
PRIMARY
FUNCTION
Presentation
Convenience
Economy
Preservation
Protection

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Primary functions………
PRESENTATION:
Presentation of product should be attractive &
eye catching.

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PROTECTION:
Protection increases life cycle of a product
PRESERVATION:
It preserves original colours, Quality, favour etc.
ECONOMY:
Packaging of a product should be economy
CONVENIENCE:
Packaging should be light to handle

14.
Secondary
Function
Identification
Labeling
SuitabilityHandling
Containment

15.
Secondary function
Containment:
Premeasured, preweight and then placed in box
Identification:
Packaging helps to indentify the products easily
Labeling:
It helps to promote the sale of goods
Handling:
When package is light in weight it facilitate easy handling of
cargo
Suitability:
Packaging should be match with the product

16.
Factors for package design in international
market
Physical characteristics
Language, colour and size
Economy
Container
Convenience

17.
Indian institute of packaging
The Indian institute of packaging was setup in
Mumbai on 14th may 1966.
Indian institute of packaging is a registered body
under the societies registration Act
Laboratories are in Delhi , Chennai & Kolkata

18.
Role of IIP in export packaging
Grapes

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Labeling

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Introduction
Labeling is any written, electronic, or graphic
communications on the packaging or on a
separate but associated label. Display of
information about a product on its container,
packaging, or the product itself.

21.
Introduction……
Label :- ( As per IP)
Any printed packing material, including package
inserts that provide information on the article
The oxford dictionary defines a label as
“a slip of paper, card, liner, metal for attaching to an
object and indicating its nature, owner, name,etc

22.
Function of labels
To identify the product
Provide ingredients
Purpose /use of the product
Decoration as evidence
Child safety
Other information like maximum retail
price(MRP), Batch NO, Shelf-life, etc

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Objective of labeling
Brand Identification:
Labeling helps in the
identification and
principal place of
business of the person by
or for whom the
prepackaged product was
manufactured, processed,
produced or packaged for
resale

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CONTINUE…..
Description:
Labels provide the
information regarding
the food product. It
describes the contents,
nutritional values,
cost, product usage
methods, shelf life etc

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CONTINUE….
Promotion:
Finally labels helps
in promoting the
product through
attractive and bright
graphics replacing
paper labels glued
on cans and bottles.

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Who uses product labeling
Pharmaceutical
Food
Personal care
Bio-tech
Beverages
Cosmetics
Medical devices
Nutraceuticals

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Which Information Is Mandatory
Labeling of packaged food products shall
include the following information:

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Some international labeling symbols in use are as follows

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Contents in a Nutraceutical label
As per the Indian Regulations a food label must have-
Product name and category of food
An ingredient list in descending order of weight
Logo for Vegetarian / Non-Vegetarian food
Nutrition facts panel or information which includes energy,
protein, carbohydrate (sugar) & fat
The shelf life (Use by or Best before date)
Storage conditions
The name & address of the manufacturer, packer and / or seller
The country of origin (in case of imported foods)
The weight
Instructions for use.

30.
Example of simple nutraceutical label

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Definition of Nutrition Claim/s
Nutrition claim means any representation which states, suggests
or implies that a food has particular nutritional properties-
 Include energy value, protein, fat and carbohydrates, vitamins and minerals
 What does not constitute nutrition claims:
 Mandated - Listing of Ingredients - Nutrition Panel – QUID
Nutrient content claim is a nutrition claim that describes the
level of a nutrient contained in a food. (Examples: “source of
calcium”; “high in fibre and low in fat”.)
Nutrient comparative claim is a claim that compares the
nutrient levels and/or energy value of two or more foods.
(Examples: “reduced”; “less than”; “fewer”; “increased”; “more
than”.)

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Definition of Health Claim/s
Health claim any representation that states, suggests or implies of
relationship between
a Food or
a Constituent of that Food &
Health
Health claims include
Nutrient function claims - a nutrition claim that describes the
physiological role of the nutrient in growth, development and normal
functions of the body.
Other function claims - Specific beneficial effects of food
consumption on normal functions or biological activities of the body.
Reduction of disease risk claims - Linking consumption of a food
to the reduced risk of developing a disease or health- related condition

33.
New FDA Labeling Requirements
On May 20, 2016, the U.S. Food and Drug
Administration (FDA) finalized significant
changes to food, beverage, and supplement
labeling, including updates to daily values,
serving sizes, the Nutrition Facts chart, and
more.
The new rules become effective on July 26,
2016 and require most food manufacturers to
comply by July 26, 2018.

34.
Regulation of Nutraceuticals in India
No clear regulatory framework exists:
The prevention of Food Adulteration Act, 1954
Food Products Order
Drugs and Cosmetics Act
(Ayurvedic, Unani & Siddha Drugs Technical Advisory Board)
The Drugs And Magic Remedies (Objectionable
Advertisements) Act, 1954

35.
Food Safety and Standards Authority of India
(fssai)
General Requirements:
Every pre-packaged food shall carry a label containing
information
Label in pre-packaged food shall be applied in such a
manner that they will not become separated from the
container
The particulars of declaration required under these
regulations to be specified on the label shall be in English
or Hindi
Pre-packed food shall not be described or presented on
any label or in any label manner that is false, misleading

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continue.….
The disclosure of information on food labels in India is
primarily governed by the Prevention of Food Adulteration
Act of 1954, which focuses mainly on basic product
information with less emphasis on health and nutritional
information.
Recent amendments regarding Packaging and labeling of food
under part VII of the Prevention of Food Adulteration Rules
of 1955 mandate the disclosure of health and nutritional
claims on food labels along with basic information.
Chapter IV, paragraph 23 of the FSSAI clearly states that no
person shall manufacture, distribute, sell or expose for sale,
nor dispatch or deliver to any agent or broker for the purpose
of sale, any packaged food product that is not marked and
labelled in the manner of specific by regulation.

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Continue….
Health claims establish a relationship between a food & disease
or medical condition.
For example claims like ‘Good for Heart’, ‘Good for Growing
Children’ etc.
Nutritional claims quickly inform a consumer of nutritional
value of a product for example ‘Low Fat’ or Zero Cholesterol’.

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Continue….
Food Safety and Standards Authority (FSSA), defines “foods for special
dietary uses or functional foods or nutraceuticals or health supplements”
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.
Health Claim: “Health claims” means a relationship between a food or a
constituent of that food and health. Health claims can further be grouped
into:
Nutrient content claim
Reduction of disease claim
Structure/Function claim

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Nutrition Content Claim: A nutritional claim suggests a
food has beneficial nutritional properties, such as “low
fat”, “no added sugar” and “high in fiber”. A Claim is a
statement that suggests a relationship between food and
health. For instance a Food can "help lower cholesterol",
"help reinforce the body’s natural defenses" or "enhance
learning ability"
Reduction of Disease Claim: Any claims states or implies
that the consumption of dietary supplements or one of its
constituents significantly reduce the risk factor in the
development of human disease.
Structure/Function Claim: Structure claim is a statement on
label of a food or dietary supplement about how that
product affects the human body structure

40.
Regulatory Requirements in India
1. Product Evaluation:
Examination of each active ingredients & additive.
Various steps in the product evaluation include:
Developing extracts of documents
Sample collection (in the presence of witnesses)
Sample dispatch to the concerned authority (different
processes for bulk package and single package)
Food analysis
If analysis is not complete within the stipulated period
of time, further action plan by the designated officer
Adjudication proceedings (holding enquiry, appeal
procedure, hearing, etc.)

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Continue….
2. Licenses:
To get Product registered in India, number of
licenses (almost 4 - 5) might be required which
include:
Import licensing
Manufacturing licensing
Marketing licensing and
Other state and national level clearances/licenses
required from the regulatory side, which need to be
taken care of before launching these products in
India.

42.
Continue….
3. Health and label claims:
“Health claims” means any representation that states,
suggests or implies that a relationship exists between a
food or a constituent of that food and health. This includes:
India specific labeling and packaging requirements
Packaging of the consignment composition of the
consignment and approach to market the same
Need for sample material and declaration for
registration
Label content and claim
Structure - function claim

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Registration Process in India
Apply to the state licensing Authority
for site registration in form A
Application is processed by the authority
7 days period
Inspection is done within 30 days Approval of the site Rejection of the application
Manufacture shall apply for manufacturing license in form B

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A unique application number has been issued
Queries are sent to the application on
the incomplete application
60 days 60 days
After receiving the missing information
Inspection is done on the premises
30 days 30 days
Granting of Licence Rejection of Licence
Manufacture shall
start the business

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References
https://www.slideshare.net/shraddhakurdekar/packaging-ppt-17317595
http://www.authorstream.com/Presentation/bristolmaverick-604326-
packaging-and-labeling-food-industries/
https://www.slideshare.net/GOVINDYADAV28/presentation-on-
nutraceutical-labeling?from_action=save
https://www.slideshare.net/Adrienna/nutrition-labeling-claims-india-2012
Regulation of nutraceuticals in India, http://www.gpo.gov/fdsys/pkg/FR-
1997-09-23/html/97- 24737.htm (Accessed on Feb 2014)pdf (Accessed
on march 2014)
Health claims in India, http://www.fssai.gov.in (Accessed on march 2014)
Regulatory_prespective_Nutraceuticals_whitepaper_Dec2011(Accessed
on march 2014)