FOOD AND NUTRACEUTICALS REGULATION IN INDIA, FSSAI ( FOOS SAFETY AND STANDARD AUTHORITY OF INDIA)

1. REGULATIONS FOR
NUTRACEUTICALS AND
FUNCTIONAL FOOD IN INDIA
PREPARED BY,
Mr. CHANDAN B V
1st YEAR M.PHARM
DEPT. OF PHARMACEUTICS
REGULATORY AFFAIRS GROUP
JSS COLLEGE OF PHARMACY,
MYSURU
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2. NUTRACEUTICALS
• Nutraceutical a portmanteau of the words “NUTRITION”
and “PHARMACEUTICAL”
•Dr Stephen L. DeFelice coined the term “Nutraceutical” in
1989.
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3. • They have Physiological and health benefits just like the
pharmaceuticals
• These are not a complete diet but just a dietary supplement
• These are provided in measurable quantities(unit quantities)
• Nutraceuticals are those products in which the ingredients
specified in schedule VI in food safety and standard (Health
supplements, food for special dietary use, food for special
medical purpose, functional food and novel food) regulations,
2016
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4. 4

5. Examples for nutraceuticals
Examples of nutraceuticals are natural foods, including
• Antioxidants - Carotenoids, ascorbates, lipoic acids
• dietary supplements – energy drinks, energy bars
• fortified dairy products - Milk, yogurt, powder milk, and
cheese
• citrus fruits – orange, lemon, grape fruit
• Vitamins – vitamins A, B, C, D, E, K
• minerals
• Herbals - glucosamine from Genseng, Omega-3 fatty acids
from linseed, lycopene from tomato
• cereals
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6. Are these drugs?
DRUG
What drugs do?
Drugs claim to prevent, treat or
Cure a human disease
Whereas nutraceutical
products can not
make these claims
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7. FUNCTIONAL FOOD
• Functional food is a food where a new ingredient(s) has been
added to a food and the new product has an additional function
• Functional food is the generic term for food that has been
linked to health benefits.
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8. • Functional foods are foods that offer health benefits beyond
their nutritional value. In addition to nutrient-rich ingredients
like fruits and veggies, the category also
includes foods fortified with vitamins, minerals, probiotics,
and fiber.
• These claim to have an additional function by adding new
ingredients or more of existing ingredients.
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9. Classification of functional food
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10. HISTORY OF FOOD REGULATIONS IN INDIA
• India is the world’s 2nd largest producer of fruits and
vegetables
• By the mid-1990s the food processing sector laws were
framed in a veritable grid of regulation including a multitude
of state laws as well as the following national laws:
• Export (Quality Control and Inspection) Act 1963
• Solvent Extracted Oil Control Order 1967
• The Insecticide Act 1968
• Meat Food Products Order 1973
• Prevention of Food Adulteration Act (PFA) 1954 rules (Ministry
of Health and Family Welfare) with last amendments in 1986
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11. • Bureau of Indian Standards Act 1986
• Environmental Protection Act 1986
• Pollution Control Act 1986
• Milk and Milk Products Order 1992
• The Infant Milk Substitutes Feeding Bottles and Infant Food (Regulation
of Production, Supply) Act 1992 and Rules 1993
• Fruit Product Order 1955
• Agriculture Produce Act
• Essential Commodities Act 1995 (Ministry of Food and Consumers
Affairs)
• Industrial license
• Vegetable Oil Product Control order 1998
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Continued……….

12. TIMELINE OF FOOD LAWS IN INDIA
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13. FOOD SAFETY AND STANDARD ACT 2006
• The Food Safety and Standard Act 2006 aims to establish a
single reference point for all matters relating to Food Safety
and Standards, by moving from multilevel, multidepartment
control to a single line of command.
• It incorporates the salient provisions of the Prevention of Food
Adulteration Act 1954 and is based on international
legislations, Instrumentalities and the Codex Alimentarius
Commission.
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14. 14
FSSAI PORTAL (Home page)

15. INTEGRATES OF FSS ACT 2006
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16. SALIENT FEATURES
• Decentralization of licensing for food products
• Easy issue of license with time frame of two months
• No license for small food business operators ; only registration
is mandatory
• The act ensures safety of consumers and assures full
compensation to victim in case of injury or death
• The act emphasizes on training and awareness program
regarding food safety for food business operators , consumers
and regulators
• The act encourages self regulations through introduction of
food recall procedures.
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17. BENEFITS OF IMPLEMENTING THE ACT
• Unification of eight laws, i.e., steps to harmonization
• Alignment of international regulations
• Science-based standards
• Clarity and uniformity on novel food areas
• Help to curb corruptions
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18. WHO NEEDS FSSAI LICENSE…..
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19. Functions of Food Authority
• Food Authority to regulate and monitor the manufacture,
processing, distribution, sale and import of food so as to
ensure safe and wholesome food.
• It will provide scientific advice and technical support to the
Central Government and the State Governments in matters of
framing the policy and rules in areas which have a direct or
indirect bearing on food safety and nutrition; Other works as
mentioned in the act.
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20. HOW FSSAI WORK…
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21. LICENSING AND REGISTRATION REQUIRMENT
• Every food business operator in the country will have to obtain
registration and license in accordance with the procedure laid
down in FSSAI (licensing and registration of food business)
regulation 2011.
• A manufacturer cannot commence business unless he is
registered or has a valid license.
• Petty food manufacturers (annual turnover less than Rs.12
lakhs) have to register with the commissioner and
manufacturers whose turnover is greater than 12 lakhs to
obtain a food license from FSSAI office.
• Existing licenses/registration should be converted into FSSAI
license/ registration.
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22. • An application for the grant of a license shall be made in form
B of schedule 2 to the concerned licensing authority; the
license shall be issued within 60 days from the date of issue of
an application ID number.
• After the issue of application ID number the licensing
authority may direct the food safety officer to inspect the
premises in the manner prescribed by the FSSAI in accordance
with these regulations.
• The licensing authority shall issue a license in form C under
schedule 2 of these regulations.
• Registration or license granted under these regulations shall
be valid and subsisting, unless otherwise specified, for a
period of 15 years.
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23. 23

24. Licensing /Registration System for
Nutraceuticals under FSSAI
• Everyone in the food sector is required to get a license or a
registration that would be issued by the local authorities.
• Temporary stall holders are exempted from the license, but
need to get their businesses registered with the local
municipality or panchayat.
• Import licensing, manufacturing licensing and other national
level clearances/licenses required from the regulatory side
need to be taken care of before launching these products in
India.
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25. • The FSSAI promises to simplify the licensing and registration
processes for nutraceuticals since the actual process varies with a
number of parameters.
• For product registration in India, a number of licenses (almost 4 -
5) might be required, depending on the actual product status like:
1. Whether the company wants to sell bulk drug or finished
formulation
2. Whether the company is importing finished product or bulk
goods
3. Whether product to be imported is with or without India
specific label
4. Will the claims be developed in India
5. Whether the company has a packaging license
6. Whether it requires manufacturing license
7. Whether it requires marketing license
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26. Responsibilities of the Food Business Operator
Every food business operator shall ensure that the articles of
food satisfy the requirements of this Act and the rules and
regulations made there under at all stages of production,
processing, import, distribution and sale within the businesses
under his control.
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27. Restrictions of advertisement & prohibition as to
unfair trade practice
• No advertisement shall be made of any food which is
misleading or deceiving or contravenes the provisions of this
Act, the rules and regulations made there under.
• No person shall engage himself in any unfair trade practice for
purpose of promoting the sale, supply, use and consumption of
articles of food or adopt any unfair or deceptive practice
including the practice of making any statement, whether orally
or in writing or by visible representation.
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28. Food Recall Procedures
- Initiate process for recall if food is not in compliance of the
act.
- Immediately inform competent authorities.
- Food business operator will follow guidelines relating to food
recall procedure.
(“Food recall” means the action to remove food from the
market at any stage of the food chain, including that possessed
by consumers)
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29. Authorities responsible for enforcement of Act
• The Food Authority and the State Food Safety Authorities
shall be responsible for the enforcement of this Act.
• They shall monitor and verify that the relevant requirements of
law are fulfilled by food business operators at all stages of
food business.
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30. Designated Officer
The Commissioner of Food Safety shall appoint Designated
Officer for each district.
Functions
• Issue or cancel licensee of food business operators.
• Prohibit the sale of any article of food which is in
contravention of the provisions of this act.
• To make recommendation to the Commissioner of Food Safety
for sanction to launch prosecution in case of contraventions
punishable with imprisonment.
• To maintain record of all inspections made by Food Safety
Officers and actions taken by them in the performance of their
duty.
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31. Commissioner of the Food Safety
State Govt. shall appoint the Commissioner of Food Safety for
the state for efficient implementation of food safety and
standards.
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32. Food Safety Officer
The Commissioner of Food Safety shall appoint Food Safety
Officers. The State Govt. may authorize any officer of the state
govt. to perform the functions of a Food Safety Officer.
Powers
Take sample of any food, seize any article of food, enter in
premises of food operators and inspect. FSO will follow the
guidelines issued by Commissioner of Food Safety from time
to time.
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33. Purchaser may have food analyzed
• Purchaser also can get food analyzed by food analyst on
payment of prescribed fees.
• Provided that such purchaser inform Food Business Operator
at time of purchase of his intention to have such article so
analyzed.
• If food analyst found that food is not in compliance with the
Act or rules or regulations, the purchaser shall be entitled to
get refund of the fees paid.
• Food Analyst find the sample in contravention of provisions of
this act and rules and regulations, the food analyst shall
forward the report to the Designated Officer for prosecution
under Section 42.
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34. FOOD SAFETY AND STANDARDS (PACKAGING AND
LABELLING) REGULATIONS, 2011
General Requirements (Packaging)
 A utensil or container made of the following materials or
metals, when used in the preparation, packaging and storing of
food shall be deemed to render it unfit for human
consumption:—
(a) Containers which are rusty;
(b) Enameled containers which have become chipped and rusty;
(c) Copper or brass containers which are not properly tinned
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35.  Containers made of plastic materials should conform to the
following Indian Standards Specification
(i) IS : 10146 (Specification for Polyethylene in contact with
foodstuffs)
(ii) IS : 10142 (Specification for Styrene Polymers in contact
with foodstuffs)
(iii) IS : 10151 (Specification for Polyvinyl Chloride (PVC), in
contact with foodstuffs);
(iv) IS : 10910 (Specification for Polypropylene in contact with
foodstuffs)
(v) IS : 11434 (Specification for Ionomer Resins in contact with
foodstuffs)
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36. (vi) IS: 11704 Specification for Ethylene Acrylic Acid (EAA)
copolymer.
(vii) IS: 12252 - Specification for Poly alkylene terephathalates
(PET).
(viii) IS: 12247 - Specification for Nylon 6 Polymer
(ix) IS: 13601 - Ethylene Vinyl Acetate (EVA)
(x) IS: 13576 - Ethylene Metha Acrylic Acid (EMAA)
(xi) Tin and plastic containers once used, shall not be re-used for
packaging of edible oils and fats.
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37. General packaging requirements for Canned
products
i) All containers shall be securely packed and sealed.
(ii) The exterior of the cans shall be free from major dents, rust &
perforations.
(iii) Cans shall be free from leaks.
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38. Packaging requirements for Edible oil/ fat
Tin Plate used for the manufacture of tin containers for
packaging edible oils and fats shall conform to the standards of
prime grade quality contained in B.I.S. Standards No. 1993 or
13955 or 9025 or 13954 as amended from time to time and in
respect of Tin containers for packaging edible oils and fats
shall conform to IS No. 10325 or 10339 as amended from time
to time.
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39. Packaging requirements for Drinking Water (Both
Packaged and Mineral Water)
It shall be packed in clean, hygienic, colorless, transparent and
tamperproof bottles/containers made of
> Polyethylene (PE) (conforming to IS:10146 or polyvinyl
chloride (PVC) conforming to IS : 10151 or poly alkylene
> Terephthalate (PET and PBT) conforming to IS : 12252 or
polypropylene conforming to IS : 10910 or food grade
> Polycarbonate or sterile glass bottles suitable for preventing
possible adulteration or contamination of the water.
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40. General Requirements Labeling
1. Every prepackaged food shall carry a label containing
information as required
2. The particulars of declaration required under these Regulations
to be specified on the label shall be in English or Hindi
3. Label in pre-packaged foods shall be applied in such a manner
that they will not become separated from the container
4. Contents on the label shall be clear, prominent, indelible and
readily legible by the consumer under normal conditions of
purchase and use.
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41. Labeling of Pre-packaged Foods
1. The Name of Food
2. List of Ingredients
3. Nutritional information
4. Declaration regarding Non veg
5. Declaration regarding Veg
6. Declaration regarding Food Additives
7. Net quantity
8. Lot/Code/Batch identification
9. Date of manufacture or packing
10. Best Before and Use By Date
11. Country of origin for imported food
12. Instructions for use 41

42. Labeling of edible oils and fats
1. The package, label or the advertisement of edible oils and fats
shall not use the expressions “Super-Refined”, “Extra-
Refined”, “Micro- Refined”, “Double-Refined”, Ultra-
Refined”, “Anti-Cholesterol”, “Cholesterol Fighter”,
“Soothing to Heart”, “Cholesterol Friendly”, “Saturated Fat
Free” or such other expressions which are an exaggeration of
the quality of the Product.
2. Every container in which solvent-extracted oil or de-oiled meal
or edible flour is packed for sale shall, at the
> time of sale by the producer, bear the following
particulars in English or Hindi :—the name, trade name, if any,
or description of the solvent-extracted oil or de-oiled meal or
edible flour. 42

43. 3. Every container of refined vegetable oil shall bear the
following label, namely,— Refined (name of the Oil) Oil.
Provided that the container of imported edible oil shall also
bear the word, “Imported”, as prefix.
4. Every package containing an admixture of palmolein with
groundnut oil shall carry the following label, namely,—
BLEND OF PALMOLEIN AND GROUNDNUT OIL
Palmolein......per cent
Groundnut oil....per cent
5. A package containing annatto color in vegetable oils shall bear
the following label namely :—
Annatto colour in oil (Name of oil/oils)
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44. REGULATORY REQUIRMENTS FOR ENTRY IN INDIA
In order to enter the Indian nutraceutical market, some of the very
important areas to focus include;
1. Product evaluation
2. Licenses
3. Health and label claims
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45. Product evaluation
Various steps in the product evaluation include:
• Developing extracts of documents and authenticating the
same by concerned authority
• Sample collection (in the presence of witnesses)
• Sample dispatch to concerned authority (different process for
bulk package and single package)
• Food analysis
• If analysis is not complete within stipulated period of time,
further action plan by designated officer
• Adjudication proceedings (holding enquiry, appeal
procedure, hearing, etc.)
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46. Licenses
To get the product registered in India, the number of licenses
will be required depending on the actual product status such
as whether:
• The company wants to sell bulk drug or finished formulation
• The company is importing finished product or bulk ingredient
• The product to be imported is with or without an India-specific
label and will
the claims be developed in India
• The company has packaging license
• It requires a manufacturing license
• It requires a marketing license
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47. The number of documents will have to be furnished by the
food importer to the government authority along with
registration application. The interlink through its regulatory
product offerings provides regulatory support for the following
licensing procedures, which need to be taken care of before
launching these products in India:
• Import licensing
• Manufacturing licensing
• Marketing licensing
• Other state and national level clearances/licenses required from
the regulatory side
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48. Health and label claims
• Developing health and label claims specific to Indian
regulatory guidelines is the major element to be focused on
while entering Indian market.
• International as well as national clients have a number of
questions about Indian labeling and packaging requirements,
packing of consignment, need for sample material and
declaration for registration, composition of consignment and
approach for the same, label content, and structure function
claim and label claim.
• Based on the results of a regulatory assessment of the product,
India-specific label content and claims are developed
• New entrants should also consider some of the health claims
used in India and the requirements to be met to make specific
product claims. 48

49. IMPORT PROCESS OF FOOD IN INDIA
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50. IMPORT PROCESS OF NUTRACEUTICALS IN INDIA
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Importer
Apply for importer license in form
A and B along with supporting
documents and fee to FSSAI
Apply for IEC number to
DGFT
Gets importer license Receives IEC number
Import

51. FORM A
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52. 52

53. FORM B
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54. Forms
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66. Penalty for sub-standard food
Any person who whether by himself or by any other person on
his behalf manufactures for sale or stores or sells or distributes
or imports any article of food for human consumption which is
sub-standard, shall be liable to a penalty which may extend to
5 lakh rupees.
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67. Penalty for misleading advertisement
Any person who publishes, or is a party to the publication of an
advertisement, which –
(a) falsely describes any food; or
(b) Is likely to mislead as to the nature or substance or quality of
any food or gives false guarantee, shall be liable to a penalty
which may extend to 10 lakh rupees.
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68. Penalty for unhygienic or unsanitary
processing or manufacture of food
Any person who, whether by himself or by any other person
on his behalf, manufactures or processes any article of food for
human consumption under unhygienic or unsanitary
conditions, shall be liable to a penalty which may extend to 1
lakh rupees.
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69. Penalty for possessing adulterant
(1)Subject to the provisions of this chapter, if any person who
whether by himself or by any other person on his behalf,
imports or manufactures for sale, or stores, sells or distribute
any adulterant shall be liable –
(i) where such adulterant is not injurious to health, to a penalty
not exceeding 2 lakh rupees;
(ii) where such adulterant is injurious to health, to a penalty not
exceeding 10 lakh rupees.
(2) In a proceeding under sub-section (1), it shall not be a defense
that the accused was holding such adulterant on behalf of
any other person.
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71. Punishment for unsafe food
-Does not result in injury…
- imprisonment up to 6 moths & fine up to 1 lakh rupees.
- Non-grievous injury…
- imprisonment 1 year & fine upto 3 lakh rupees.
- Grievous injury…
- imprisonment 6 years & fine upto 5 lakh rupees.
- Death….
- not less than 7 years imprisonment may extend for life
and fine not less than 10 lakh rupees.
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72. Punishment for subsequent offences
If any person, after having been previously convicted of an
offence punishable under this Act subsequently commits and is
convicted of the same offence, he shall be liable to—
(i) Twice the punishment, which might have been imposed on a
first conviction, subject to the punishment being maximum
provided for the same offence;
(ii) A further fine on daily basis which may extend up to 1 lakh
rupees, where the offence is a continuing one; and
(iii) His license shall be cancelled.
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73. Compensation in case of injury or death of
consumer
If any person whether by himself or by any other person on his
behalf, manufactures or distributes or sells or imports any
article of food causing injury to the consumer or his death, it
shall be lawful for the Adjudicating Officer or as the case may
be, the court to direct him to pay compensation to the victim or
the legal representative of the victim, a sum—
(a) Not less than 5 lakh rupees in case of death
(b) Not exceeding 3 lakh rupees in case of grievous injury
(c) Not exceeding 1 lakh rupees, in all other cases of injury.
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74. Latest announcement
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75. What is FoSCoS?
Food Safety Compliance System (FoSCoS) is built using latest
technology with a vision to have modern on stop pan-India IT
platform for food safety regulatory needs, its launched by
FSSAI. FoSCoS shall also be integrated with other platforms
of Government of India such as GST, PAN,MCA etc. further
ease out the processes for businesses and also ensure a 360
degree profiling of businesses.
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76. What are the types of FoSCoS food licenses?
Based on the annual turnover of the food business, the types of
FoSCos Food licenses are:
• Basic FSSAI Registration - Annual turnover of less than Rs.
12 Lakhs
• State FSSAI License - Annual turnover between Rs. 12 Lakhs
- Rs. 20 Crores
• Central FSSAI License - Annual turnover more than Rs. 20
Crores
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78. • Who is responsible for implementation & Enforcement of
FSSA, 2006? Or Who is the regulatory authority under the
Food Act in India?
Ans: Food Safety and Standards Authority of India and State
Food Authorities are jointly responsible for implementation &
enforcement of FSSA, 2006.
• Under what circumstances can the DO suspend the
license?
Ans:- If the food business operator fails to comply with an
improvement notice, his licence may be suspended.
• Under what circumstances can the DO cancel the license?
Ans:- If the food business operator fails to comply with the
improvement notice, the DO may, after giving the licensee an
opportunity to show cause, cancel the licence.
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79. • Are physical documents required to be submitted at
Regional Offices for Central License after submitting
online application?
Ans: No, there is no need to submit physical documents at
regional offices for central license.
• Are different Licenses required to conduct different kind
of food business activities at the same premise?
Ans: FSSAI license is based on premise. All kinds of food
business activities which are being conducted at the same
premise can be applied for in a single FSSAI license.
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80. • Do I need to obtain FSSAI License for utensils/packaging
material meant for serving or packaging of food?
Ans: No. FSSAI License/Registration is not required for
utensils or packaging material as these are not covered under
the definition of food
• My License was cancelled. Can I apply for fresh License?
Ans: After a period of 3 months from the date of cancellation,
the Food Business Operator may make a fresh application for
Registration or license to the concerned authority if all
observations made in the improvement notice have been
complied with.
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81. • Who will issue license to food business operators under
railways premises?
Ans: FSSAI license/Registration for food premises under
Railways are issued by the Indian Railways Designated
Officers/Registering Authorities as notified by Food Authority
from time to time.
• Who will issue the FSSAI license to food business
operators under Airport/Seaport premises?
Ans: FSSAI license for food premises at Airport/Seaport are
issued by Airport Health Officers (APHOs) or Port Health
Officers (PHOs) who are notified as Designated Officers
(DOs) by Food Authority. Airports/Seaports where
APHOs/PHOs are not notified as DOs, Central Licensing
Authority (CLA) of respective area would issue license.
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82. CONCLUSION
• As food is the most basic commodity for every living beings,
its exploitation should be checked so as to maintain proper
supply of food.
• Thus the food laws are forged so as to avoid the food
production and supply which are of sub-standard.
• These laws not only protect the interest of customers but also
of the producers, government and society. FSSAI is the best
example of such law.
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83. References
• https://www.fssai.gov.in/
• https://www.researchgate.net/publication/308111484_Ma
rketing_nutraceuticals_in_India_An_overview_on_current_
regulatory_requirements
• https://www.fssai.gov.in/cms/act-2006.php
• https://www.fssai.gov.in/cms/food-safety-and-standards-
rules--2011.php
• http://foodlicensing.org/index#procedure
• https://www.onlinelegalindia.com/services/fssai-
registration/?gclid=EAIaIQobChMIsM2766zX7QIVFR4rCh0E
hQ-ZEAAYASAAEgKFv_D_BwE
• https://foscos.fssai.gov.in/
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