UNIT-1

FSSAI
 What is food Safety
Food safety is a scientific discipline describing
handling, preparation, and storage of food in
ways that prevent food borne illness. This
includes a number of routines that should be
followed to avoid potentially severe health
hazards.
• Food safety is a global concern that covers a variety of different areas
of everyday life.
• The principles of food safety aim to prevent food from becoming
contaminated and causing food poisoning. This is achieved through a
variety of different avenues, some of which are:
• Properly cleaning and sanitising all surfaces, equipment and utensils
• Maintaining a high level of personal hygiene, especially hand-washing
• Use safe water and safe raw materials.
• Separate raw and cooked foods to prevent contaminating the cooked
foods.
• Cook foods for the appropriate length of time and at the appropriate
temperature to kill pathogens.
• 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
 Food Security
• According to FAO, Food security exists when
all people, at all times, have physical, social
and economic access to sufficient, safe and
nutritious food which meets their dietary
needs and food preferences for an active and
healthy life.
 Primary Objective of Food Safety
1. Food should be safe and suitable for human
consumption.
2. Ensuring fair trade practices in the food trade.
3. Follows the food chain – farm to fork.
4. Takes into account the wide diversity of Food
safety standards
5. Lays a firm foundation for ensuring food hygiene
with each specific code of hygiene practice
applicable to each sector
 Fact Sheet on Food Safety
• Access to sufficient amounts of safe and nutritious food
is key to sustaining life and promoting good health.
• Unsafe food containing harmful bacteria, viruses,
parasites or chemical substances, causes more than 200
diseases – ranging from diarrhoea to cancers.
• An estimated 600 million – almost 1 in 10 people in the
world – fall ill after eating contaminated food and
420 000 die every year.
• Children under 5 years of age carry 40% of the food
borne disease burden, with 125 000 deaths every year.
 Fact Sheet....
• Diarrhoeal diseases are the most common illnesses resulting
from the consumption of contaminated food, causing 550 million
people to fall ill and 230 000 deaths every year.
• Food safety, nutrition and food security are linked. Unsafe food
creates a vicious cycle of disease and malnutrition, particularly
affecting infants, young children, elderly and the sick.
• Food borne diseases impede socioeconomic development by
straining health care systems, and harming national economies,
tourism and trade.
• Food supply chains now cross multiple national borders. Good
collaboration between governments, producers and consumers
helps ensure food safety.
Food Safety & Standards Authority of
India
Pre – FSS Act Scenario in Food
Safety Regulation

10
 Multiplicity of food laws, standards setting and enforcement agencies
for different sectors of food
 Varied Quality/Safety standards restricting innovation in food
products
 Thin spread of manpower, poor laboratories infrastructure and other
resources restricting fixation of effective standards
 Standards are rigid and non-responsive to scientific advancements
and modernization
 Poor Information dissemination level to consumer level

11
 A Statutory Regulatory Body under Ministry of Health & Family
Welfare, Government of India

 Constituted on 5 Sep 2008 under FOOD SAFETY AND STANDARDS

ACT, 2006

 Mandate of 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.

12
 FOOD SAFETY AND STANDARDS ACT, 2006

An Act to consolidate the laws relating to food and

to establish the Food Safety and Standards
Authority of India 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 and for matters connected
therewith.
Thrust of the New Act

14
 Contd..

 Movement from multi-level and multi- department control to a single

line of command

 FSSAI as a single reference point for all matters relating to Food Safety
and Standards, Regulations and Enforcement

 Integrated response to strategic issues like Novel foods, GM foods,

international trade etc

 Decentralisation of licensing for food products, it empowers state to

issue registration and state license. Uniform licensing/registration
regime across the centre and the states.

 Achieve high degree of consumer confidence in quality & safety of food

 Envisages large network of food laboratories

15
 Effective, transparent and accountable regulatory framework

 Emphasis on gradual shift from regulatory regime to self compliance

 Consistency between domestic and international food policy measures with out

reducing safeguards to public health and consumer protection

 Adequate information dissemination on food to enable consumer to make informed

choices.

 Regulation of food imported in the country

 Mechanism for speedy disposal of cases

 Provision of food recall

16
Prevention of Food Adulteration Act, 1954

Fruit Products Order, 1955

Meat Food Products Order, 1973

Vegetable Oil Products (Control) Order, 1947

Edible Oils Packaging (Regulation) Order, 1988,

Solvent Extracted Oil, De-oiled Meal and Edible Flour (Control)

Order, 1967
Milk and Milk Products Order, 1992

Any order under Essential Commodities Act, 1955 relating to

food food.

17
 FOOD
FOOD AUTHORITY
AUTHORITY
FSSAI Structure
Chief Executive Officer Finance Division

Central Advisory Committee

Vigilance Division

Scientific Committee and Panels Central Food Laboratories Codex Cell

Chief, Chief Chief Chief, Product Approvals,

Management Surveillance Enforcement Quality Assurance Chief Scientific Advisor
Services Officer Officer Officer

e
ns
ce
Li
Major Functionaries in FSSAI
FOOD
FOOD AUTHORITY
AUTHORITY

Central Advisory Committee Scientific Advisor

Chief Executive Officer
Scientific Committee and Panels Codex Cell

State/UT Food Commissioners Quality Enforcemen Import

Assurance t Clearance
Surveillanc Product
e Approval
Central Designated Authorised
Designated Food Labs Officer Officer
Officer
Adjudicating
Officer Referral Risk
Asst AO
Food
Lab
Framework Food Safety
Officer
Food Safety Safety
Appellate Officer Accredited Technical
Tribunal Lab Officer
Technical
Officer
Registering
Special Authorities Food
Courts Analyst
(wherever
required)
e
e ns
Lic
 Food Authority
Consists of chairperson and 22 members

STUDY FROM NOTES

 Commissioner of Food Safety
• Commissioner of Food Safety appointed by the
State Government for implementation of food
safety and standards and other requirement of
the act. Shall perform following functions -
• Prohibit manufacture/storage/ distribution /
sale of any article of food in the public interest.
• Carry out survey of food processing Units
• Conducting or organizing training
programmers for different segment of food
chain for generating awareness on food safety
• Ensure an efficient and uniform
implementation of standards
• Ensure high standards of objectivity,
accountability, practicability, transparence and
credibility
• Sanction prosecution for offences punishable
with imprisonment
DESIGNATED OFFICER
Powers and duties

 Issue or cancel license of Food Business Operator.

 Prohibit sale in contravention of this Act.

 Receive report and samples of articles of food from Food Safety Officer and get
them analyzed.

 Make recommendation to the Commissioner of Food Safety for sanction to

launch prosecutions

 Sanction prosecution

 Maintain record of all inspections made by Food Safety Officers

 Get investigated complaints in respect of any contravention of the provision of

this Act or against FSO

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FOOD SAFETY OFFICER

Powers and duties

• Power to take a samples of any food or any substance, to be intended for sale or to
have been sold for human consumption

 Seize any articles of food which appears to be in contravention of this Act.

 Enter and inspect any place where the food is manufactured, or stored for sale

 May after giving notice to the food business operator cause the food to be
destroyed which is unfit for human consumption

 Seize any adulterant found in possession of a manufacture or distributor of any

article of food

 Penalty for harassment of business operator and also for false complaint

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 Main Chapters & Clauses of The Food
Safety & Standards Act-2006
• The Act has 12 Chapters/sections and 2 schedules
• There are 101 main Clauses in the Act
The main chapters in the Act are :-
• Chapter I :Preliminary( Clause 1to 3)
• Chapter II: Food Safety & Standards Authority of India( Clause 4 to 17)
• Chapter III: General Principles of Food Safety (Clause 18)
• Chapter IV: General Provisions As To Articles of Food (Clause 19 to 24)
• Chapter V: Provisions Relating to Import (Clause 25)
• Chapter VI : Special Responsibilities As to Food Safety (Clause 26 to 28)
• Chapter VII :Enforcement of the Act (Clause 29 to 42)
• Chapter VIII : Analysis of Food (Clause 43 to 47)
• Chapter IX : Offences and Penalties (Clause 48 to 67)
• Chapter X: Adjudication & Food Safety Appellate Tribunal (Clause 68 to 80)
• Chapter XI: Finance, Accounts, Audit & Reports (Clause 81 to 84)
• Chapter XII: Miscellaneous( Clause 85 to 101)
• THE FIRST SHEDULE
• THE SECOND SHEDULE
• The FSSAI is headed by a non-executive Chairperson,
appointed by the Central Government, either holding or
has held the position of not below the rank of Secretary to
the Government of India.
• Rita Teotia is the current Chairperson for FSSAI
• Pawan Kumar Agarwal is the current Chief Executive
Officer for FSSAI.
• The FSSAI has its headquarters at New Delhi.
• The authority also has 6 regional offices located in Delhi, 
Guwahati, Mumbai, Kolkata, Cochin, and Chennai, 14
referral laboratories notified by FSSAI, 72 State/UT
laboratories located throughout India and 112 laboratories
are NABL accredited private laboratories notified by FSSAI
 PROVISIONS RELATING TO IMPORT
An imports of articles of food to be subject to this Act.-
No person shall import into India-
(i) Any unsafe or misbranded or sub-standard food or food
containing extraneous matter;
(ii) Any article of food for the import of which a licence is
required under any Act or rules or regulations, except in
accordance with the conditions of the licence and
(iii) Any article of food in contravention of any other
provision of this Act or of any rule or regulation made
there under or any other Act.
 SPECIAL RESPONSIBILITIES AS TO FOOD SAFETY
Responsibilities of the food business operator.-
(l) 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.

(2) No food business operator shall himself or by any person on his behalf manufacture,
store, sell or distribute any article of food-

(i) Which is unsafe; or

(ii) Which is misbranded or sub-standard or contains extraneous matter; or
(iii) For which a licence is required, except in accordance with the conditions of the
licence; or
(iv) Which is for the time being prohibited by the Food Authority or the Central
Government or the State Government in the interest of public health; or
 SPECIAL RESPONSIBILITIES AS TO FOOD SAFETY

(3) food business operator shall not employ any person who
is suffering from infectious, contagious disease.

(4) No food business operator shall sell or offer for sale any
article of food to any vendor unless he also gives a
guarantee in writing in the form specified by regulations
about the nature and quantity of such article to the
vendor e.g. bill, cash memo, or invoice etc.
 SPECIAL RESPONSIBILITIES AS TO FOOD SAFETY
Liability of Manufacturers, packers, wholesalers, distributors and sellers.-
(l) The manufacturer or Co-packer of an article of food shall be liable for
such article of food if it does not meet the requirements of this Act and the
rules and regulations made there under.

(2) The wholesaler or distributor shall be liable under this Act for any article
of food which is-
(a) supplied after the date of its expiry; or
(b) stored or supplied in violation of the safety instructions of the
manufacturer; or
(c) unsafe or misbranded, or
(d) unidentifiable of manufacturer from whom the article of food have been
received; or
(e) stored or handled or kept in violation of the provisions of this Act, the
rules and regulations made there under; or
(f) received by him with knowledge of being unsafe.
 SPECIAL RESPONSIBILITIES AS TO FOOD SAFETY
(3) The seller shall be liable under this Act, for any article of
food which is­

(a) sold after the date of its expiry; or

(b) handled or kept in unhygienic conditions; or
(c) misbranded; or
(d) unidentifiable of the manufacturer or the distributors
from whom such articles of food were received; or
(e) received by him with knowledge of being unsafe.
Food Recall for Food Safety
 SPECIAL RESPONSIBILITIES AS TO FOOD SAFETY
Food recall procedures.-
(l) If a food business operators considers or has reasons to
believe that a food which he has processed, manufactured or
distributed is not in compliance with this Act, or the rules or
regulations, made there under, he shall immediately initiate
procedures to withdraw the food in question from the market
and consumers indicating reasons for its withdrawal and inform
the competent authorities thereof.
(2) A food business operator shall immediately inform the
competent authorities and co-operate with them, if he
considers or has reasons to believe that a food which he has
placed on the market may be unsafe for the consumers.
 SPECIAL RESPONSIBILITIES AS TO FOOD SAFETY

(3) The food business operator shall inform the competent

authorities of the action taken to prevent risks to the
consumer and shall not prevent or discourage any person
from co-operating, in accordance with this Act, with the
competent authorities, where this may prevent, reduce or
eliminate a risk arising from a Food.

(4) Every food business operator shall follow such

conditions and guidelines relating to food recall procedures
as the Food Authority may specify by regulations.
 LICENCING
• All Food Businesses in the country will be
registered or licensed in accordance with the
procedures laid down herein under without
prejudice to availability of safe and
wholesome food for human consumption or
affecting the interest of the consumer
• Any person desirous to commence or carry on
any food business shall make an application for
grant of a License to the Designated Officer along
with fees.
• In case a license is not issued within two months
from the date of making the application or his
application is not rejected, the applicant may start
his food business after expiry of the said period.
 Contd..
• No food business can be started without License.
– Existing businesses need to obtain License within one year of the rules being
notified.
• Non-compliance will attract a penalty which may extend to Rs 2 Lakhs. Licensing
Authority may give appropriate directions for compliance, or improvements.
• Large food businesses, listed in Schedule 1, will need to obtain license from
Central Licensing Authority.
• Others will obtain License from State Licensing Authority.

– Format for application is given in Schedule 2-Form B.

– Annual Fee to be paid is Rs 10000 for licenses issued by Central Licensing

Authority, and between Rs 2000 and Rs 5000 for licenses issued by State
Licensing Authority.
 Registration
• The provision of obtaining a license for
carrying on any food business shall not apply
to a petty retailer, hawker, itinerant vendor or a
temporary stall holder or small scale or cottage
or such other industries relating to food
business or tiny Food Business Operator.
But they shall have Registration with the
Designated Officer.
Ways to apply for License/Registration
• Web based application Lisence .pptx
– FBO to submit application online
– DO/FSO to process application online
– Inspection report entered online
– Additional documentation (if required by FBO) submitted
online
– Issue License/Registration Certificates online

• Manual application
– FBO could optionally submit manual application
– concerned Authority to enter the application online
Online Application: http://foodlicensing.fssai.gov.in
Support: Ph:1800-112100
e-Mail: licensing@fssai.gov.in
  Following documents are required by the Food Business
Operators who are applying for the central or state license

1. Application Form-B duly completed and signed (in duplicate) by the

proprietor/partner or the authorized signatory.
2. Blueprint or Layout Plan of the processing unit in complete dimension
with an allocated area dedicated for operations activities.
3. List of directors with their complete address and contact details
4. Name and list of equipments and machinery along with the installed
capacity (in case of manufacturing/processing units)
5. Photo ID and address proof issued by the concerned Govt authority
(Optional)
6. List of food category to be manufactured (For manufacturers only)
7. Authority letter with the name and letter of the responsible person
nominated by the manufacturer along with the alternative responsible
person
8. Analysis report (Chemical & Bacteriological) of the water to be used as an ingredient in
food product, through a Govt recognized laboratory on food testing.
9. Proof of possession of the premises (Could be a sale deed, rent agreement, electricity
bill etc)
10.Partnership Deed/affidavit/memorandum & articles of association conferring
constitution of the firm.
11.Copy of certificate obtained under the Co-operative acts (In case of co-operatives only)
12.NOC from the manufacturer in case of re-labellers
13.Food Safety Management System plan or certificate (If any)
14.Source of milk or procurement plan for milk and milk products processing units
(Including details of the milk collection centres)
15.Details on source of raw material for meat and meat processing plants.
16.Pesticide residues report of water in case of manufacturer of packaged drinking water,
mineral Water, carbonated water from a govt recognized lab.
17.Recall plan wherever applicable with details on whom the product is distributed
(Optional)
18.NOCs from Municipality or the local body and from the State Pollution Control Board
except in case the unit is established in the notified industrial area for a particular food
business (Optional)
Food Businesses that require to apply to Central Licensing Authority

• Food processing units with installed capacity more than 2 metric tones
per day, except grains, cereals and pulses milling units.
• Re-packers and re-labelers are included in this category
• Businesses above specified capacity in dairy, Vegetable oil, and meat
processing
• Businesses in export and import
• Retail chains operating in 3 states or more
• Central government agencies
 License Validity and Renewal
• License validity will be for 1 or 5 year at the desire of Food Business
operator, by paying the required fee at one time
• License form will list items of food products with authorized capacity to
manufacture, re-pack or relabel
• Renewal application must be submitted 60 days prior to expiry, in the
same form as original application. Up to period of validity , late fee of
Rs100 per day is payable.
• If application is not made within the period of validity for which license
was issued, it will be treated as expired. All business
• must stop, and fresh application made as for a new license.
 Suspension or Cancellation of License

• Normally no inspection will be ordered for food business that

holds a valid certificate of a Food Safety Management System
from an accredited certifying agency.
• Licensing Authority may after giving reasonable opportunity,
and reasons in writing, suspend a license, if there has been a
noncompliance of conditions or action has not been taken on
improvement notice within specified time
• Within 15 days of suspension, inspection will be ordered if
defects are not rectified, license may be cancelled.
• Authority may in interest of public health, suspend or cancel
license by a written order
• Fresh application can be made after improvements have been
carried out, only after 3 months from cancellation of license
 Modifications, Expansion or Changes in Premises for which license has been
issued

• Operator shall notify changes, modifications, and additions in

– Premises
– Products
– Layout
– Expansion
– Food Business Operator
– Any information based on which license was granted
• Any change that alters the information contained in license
Certificate, shall need prior approval
• One year fee will need to be paid for effecting changes in License
Certificate, and Authority will consider all aspects of change
before approval, within 30 days
 Conditions of License
All FBO shall ensure that conditions given are complied with at all
times during the course of its food business

Sertain conditions are given. For example

– Production process must be supervised by at least one
technical person, with degree in science or diploma
– Submit periodic returns

– Inform authorities of any change or modifications in activities

– Maintain daily records of production, material usage,& sale

– Ensure quarterly testing of all food products

 Offences and Penalty
• Sub-standard food (Section 51) -five lakh rupees
• Misleading advertisement (Section 53) -Ten lakh rupees
• Food containing extraneous matter (Section 54) -One lakh rupees
• Failure to comply with the directions of Food Safety Officer (Section 55) -Two lakh
rupees
• Unhygienic or unsanitary processing or manufacturing of food (Section 56) -One
lakhrupees
• Penalty for possessing adulterant (Section 57)
– where such adulterant is not injurious to health, to a penalty not exceeding two
lakh rupees;
– where such adulterant is injurious to health, to a penalty not exceeding ten lakh
rupees.
 Contd..

• Punishment for interfering with seized items (Section 60) -imprisonment

up to six months and fine upto to two lakh rupees.
• Punishment for false information (Section 61) -imprisonment upto three
months and fine upto to two lakh rupees.
• Punishment for obstructing or impersonating a Food Safety Officer
(Section 62) -imprisonment upto three months and fine upto to one lakh
rupees.
• Punishment for carrying out a business without license (Section 63)
-imprisonment upto six months and fine upto to five lakh rupees.
 Quality & Safety Regulations
The Path of Convergence of the Prevention of Food Adulteration Act 1954
to the Food Safety and Standards Act 2006.

# Subject to content Provision under the FSS Act 2006

1 Total sections `101 Sections
2 Rules Published, 5th of Aug, 2011
3 Central Advising authority FSSAI and Central Advisory Commt.
4 Chairman
Duties & functions of Food
5
Authority

6 State Authority 36 State and UT Food Commissioners

7 Local Health Authority Designated Officer

8 Enforcing staff Food Safety Officer

9 Sample Analizer Food Analyst
 Quality & Safety Regulations
The Path of Convergence of the Prevention of Food Adulteration Act 1954
to the Food Safety and Standards Act 2006.

# Subject to content Provision under the FSS Act 2006

Food sample analytical
10 5 CFL and 90+ NABL Acc and FSSAI Authorized lab in India
laboratory
No. of days for
11 Rsults 14 days from the date of receipt
analysis
12 Food Recall Procedure Yes
13 Prohibition of Food Yes, Article 26
Not to sale, expired, misbranded articles and store the food
14 Liability of Food Seller artcle in safe and hygenic condition as per the directions from
manufacturer
16 Food sampling Food Safety will do the sampling and collect 4 samples
 Quality & Safety Regulations
The Path of Convergence of the Prevention of Food Adulteration Act 1954
to the Food Safety and Standards Act 2006.
Subject to
# Provision under the FSS Act 2006
content
18 Dispatch of 1st sample to – Food analyst
sample 2nd sample to Designated officer
3rd to for his own purpose
4th sample – to NABL Acc lab –if desired By FBO

19 Penalty Penalty for selling food not of the nature or quality demanded, or substandard food (up
to 5 lakh Rs.)
Misbranded food (up to 3 lakh Rs.)
Misleading advertisement (upt o 10 Lakh Rs.),
Food containing extraneous matter (up to 1 lakh Rs.),
Failure to comply with the directions of FSO (upto 2 lakh Rs.),
Unhygienic processing (up to Rs. 1 lakh),
possessing adulteration :
* Not injurious up to 2 lakh
* injurious up to 10 lakh
For no specific provision (up to 2.0 lakh Rs.)

20 Punishment Punishment for Unsafe food :-

* Not injurious - Jail up to six months & fine up to 1 lakh.
* Non grievous injury- Jail up to 1 year & fine up to 3 lakh.
* Grievous injury- Jail up to 6 years and fine up to 5 lakh.
* Death - Jail more than 7 year & up to life term and fine not less than 10 lakh.
 Quality & Safety Regulations
The Path of Convergence of the Prevention of Food Adulteration Act 1954
to the Food Safety and Standards Act 2006.
# Subject to content Provision under the FSS Act 2006
22 Licensing Registration Central Level, or at state level or Reg. only
23 Improvement notice Provision made under Section-32. DO shall give the notice to FBO to comply with the
provision of the act.
24 Prohibition orders Any Food business operator is convicted of an offence the court may issue prohibitory
order after hearing of FBO regarding use process, equipment, premises.
25 Surveillance Section 30(2) (b) Commissioner empowered - to carryout survey of industrial units.
26 Sanction for prosecution Sanction to be given by Commissioner of Food safety in offences punishable with
imprisonment (Section 30 (2) (e)
 Quality & Safety Regulations
The Path of Convergence of the Prevention of Food Adulteration Act 1954
to the Food Safety and Standards Act 2006.
# Subject to content Provision under the FSS Act 2006
28 Appeal for Retest An appeal for against the report of Food Aalyst shall lie before the D.O. who shall decide
that the sample be send to the referral laboratory or not for opinion. ( Section 46 (4) )
30 General provisions - Fine upto Rs. 1.0 lakh & relieve of custody.
relating to penalty. Guideline is given for quantum of penalty based on nature of contravention ( Section 49 )
31 Adjudication - The adjudicating officer after giving opportunity of hearing in the matter and if on such
inquiry believes that the person has committed offence may impose such penalty as per
section 49.
- Adjudicating officer shall have the powers of a civil court.

32 Food Safety To hear the appeals against the decision of the Adjudicating officer under Section 68.
Appellate Tribunal
33 Civil Court not to No Civil court shall have jurisdiction to entertain any suit or proceeding in respect of
have jurisdiction matter which an Adjudicating officer or the Tribunal is empowered under FSSA Act.
( Section-72)
34 Provision of special State / Central Government empowered for it. ( Section 74 )
court & public
prosecution
 What is Product Approval?
• Any food product for which the standards
have not been defined under FSS Act/Rules &
Regulations, first of all has to be sent for the
prior approval to FSSAI to evaluate the safety
& other parameters. The process of getting
approval from the regulatory body is called
‘Product Approval’.
 And/Or
• If the food product is manufactured by using
the ingredients and additives for which there
are no guidelines issued under FSS Act/Rules
& Regulations, then such food products must
be verified and approved by FSSAI, only then
shall be allowed to be put in the market for
consumption.