1. FSSAI and impact to
industry: Licensing and
Registration

2. 




Multiplicity of food laws, standard 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 non-conducive to
effective fixation of standards
Standards rigid and non-responsive to scientific
advancements and modernization
Poor Information dissemination to consumer level

3. 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.
3

4. FSS Act – New Features
• Covering Health Foods, supplements, nutraceuticals
• Issuing Licenses within a time frame of 2 months
• Provision of Improvement Notice by Designated
Officers
• Compounding and Adjudication of cases – to reduce
Court’s workload and expedite the disposal of cases
• Prosecution, if to be launched, should be within 1 year
time frame
4

5. FSS Act – New Features
• Constitution of Special Courts for summary trials
• Special Tribunals
• Compensation to Victims (for any case of Injury/
Grievous injury/ Death)
• Reward to informer (informing about the violators –
adulteration etc.) by State Govt.
• One composite license for unit(s) falling under one area
5

6. FSS Act – New Features
• Training and Awareness programmes for Food
Business Operators as well as Regulators;
• Ensuring representation in the Authority from
different regions by grouping States into 5 Zones;
• Recognition of Food Safety Audit Agencies to verify
the compliance of Food Safety and Management
systems;
• Encouraging Self regulation through introduction of
Food Recall Procedures; and,
• No License for small food business operators; only
registration is mandatory;
6

7. 
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Section 91- provides for Central Government to
make Rules for carrying out provisions of the Act.
Section 92 (1)- provides Food Authority with the
previous approval of Central Government and after
previous publication, by notification, make
regulations consistent with this Act and Rules made
thereunder.
FSSAI drafted Rules and Regulations through
extensive consultation and deliberations/meetings
with various stakeholders.
Final Rules have been notified in the gazette of
India on 5th May, 2011.
Final Regulations have been notified in the gazette
of India on 1st August, 2011.

8. 
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Describe the qualification and duties of
Food Safety commissioner, Designated
Officer and Food Safety Officer.
Sampling procedure, manner of taking
samples
Function of Food analyst and the analysis
report
Adjudication procedure, appeal
Food Safety Appellate Tribunal, Special courts

9. COMMISSIONER OF FOOD SAFETY OF
THE STATE
FUNCTIONS







Prohibit the manufacture, storage, distribution or sale
of any article of food.
Survey of the Industrial Units.
Conduct or organise training programmes.
Uniform implementation of the standards and other
requirements as specified.
Ensure a high standard of objectivity, accountability,
practicability, transparency and credibility.
Sanction of prosecution for offences punishable with
imprisonment under this Act.
Other functions.

10. DESIGNATED OFFICER
Issue or cancel licence.
 Prohibit the sale of any article of food.
 Receive report and samples of article of foods.
 Recommend to the Commissioner of Food
Safety for sanction to launch prosecutions.
 Sanction or launch prosecutions.
 Maintain record of all inspections made by
Food Safety Officers and action taken by them
in the performance of their duties;
 Investigate any complaint.
 Other duties.


11. FOOD SAFETY OFFICER
Powers

Take sample.

Seize any article of food.

Can enter and inspect any place.

May destroy, deteriorated, perishable product after giving notice in
writing.

May seize any article of food and books of account or other
documents found in position of manufacturer, distributor and
dealer where position of adulterant found.

In case of non availability of the FBO, the FSO may seize the
adulterant food and seal the premises for investigation after taking
a sample of such adulterant or food for analysis.

May cause a person to be examined by a qualified medical
professional duly authorized by the Designated Officer.

12. MANNER OF DISPATCHING CONTAINERS OF SAMPLE
To analyst
1
Two parts to
Designated Officer
2
3
4
Remaining part, if FBO
Request send to accredited Lab

13. Fourth
part
First
part
On request FBO
Send to
food analyst
Send to
accredited
laboratory
Analysis
report
Analysis
report
2 &3rd
part DO
Send to
Referral
Laboratory
Report shall
be final
If at variance
Analysis
report fails
FBO can Appeal
Analysis
report fails
(form VIII)
Punishment with fine or
imprisonment

14. Prosecution
Designated
Officer
Sample Pass
Punishable with
imprisonment
with/without fine
Sample Fail
Punishable with
Fine

15. Prosecution
Punishable with
Fine
Other FBO’s
Petty
Manufacturer
Compounding u/s.
69
Order by
Adjudication
Officer
Enforcement
Appeal to
Appellate
Tribunal

16. Prosecution
Punishable with
imprisonment
with/without fine
Commissioner
Appeal to High
Court
Case filed
Court order
Enforcement

17. 
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
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Integrates the erstwhile acts/rules/orders, no new
standards being introduced.
New chapter scheme to facilitate scientific approach
in regulatory framework, & scientific developments,
provide specificity and traceability of content, easy to
digitalized.
Unified Licensing Procedures and application forms
Clear line of distinction between licensing and
registration
Standards have been systematically arranged taking
into consideration Codex classification

18. 





Food Safety and standards (Licensing and
registration)Regulations, 2011
Food Safety and standards (packaging and
labeling)Regulations, 2011
Food Safety and standards (Food products standards
and Food Additives) Regulations, 2011.
Food Safety and standards (Prohibition and
restriction for sale) Regulations, 2011
Food Safety and standards (contaminants, toxins and
Residues )Regulations, 2011.
Food Safety and standards (Referral laboratories and
sampling) Regulations, 2011

19. The present Regulation
integrates the Licensing
provisions in the following
Orders relating to food
products :






Fruit Products Order, 1955
Prevention of Food
Adulteration Act, 1954
Milk and Milk Products Order,
1992
Vegetable Oil Products
(Control) Order, 1947
Edible Oils Packaging
(regulation ) Orders, 1998
The Solvent Extracted Oil, De
oiled Meal and Edible flour
(Control) Order, 1967
Meat Food Products Orders,
1973

20. 





Unified Licensing procedures.
Common application forms and procedures.
Registration of food Businesses to cover all
petty food businesses.
Distinction between ‘registration’ and
‘licensing’. Cut off limits for registration and
licensing.
Sectors which have high Installed Capacity
are covered under central licensing.
Safety, Sanitary and Hygienic conditions.

21. Registering
Authority
State Licensing
Authority
Central Licensing
Authority
Designated Officer
Food Safety Officer
or any official in
Panchayat,Municipal
Corporation or any
other local body in an
area, notified as such
by the State Food
Safety Commissioner
for the purpose of
registration
Designated Officers
appointed under
Section 36(1) of the
Act by the Food Safety
Commissioner of a
State or UT for the
purpose of licensing and
monitoring.
appointed by the Chief
Executive Officer of the
Food Authority of India
in his capacity of Food
Safety Commissioner

22. FRAMEWORK FOR REGISTRATION/ LICENSING/MONITORING OF FOOD BUSINESS
ESTABLISHMENTS
CHIEF EXECUTIVE OFFICER, FSSAI
CENTRAL
FOOD
AUTHORITY
STATE FOOD SAFETY
COMMISSIONER
34 STATES/UT
REGISTRATION AUTHORITY
• City Municipal
Corporation,
• Town Panchayat,
• Gram Panchayat
LICENSING
FSSAI
Head Quarters
(Licensing)
AUTHORITY
DESIGNATED OFFICER
LICENSING AUTHORITY
FOOD SAFETY OFFICER
(for Inspection and
Monitoring Food Business
operators)
ZONAL DIRECTORS
& OTHER OFFICERS
(for inspections &
Monitoring)

23. 
means any Food manufacturer, who

Manufactures or sells any article of food himself or a
petty retailer, hawker, itinerant vendor or
temporary stall holder; or

24. 
such other industries including small scale or
cottage or tiny food businesses with an
annual turnover not exceeding 12 lakhs and
whose
 production capacity of food (other than milk and
milk products and meat and meat products) does
not exceed 100 kg/ltr per day or
 procurement or collection of milk is up to 500 litres
of milk per day or
 slaughtering capacity is 2 large animals or 10 small
animals or 50 poultry birds per day or less

25. Procedure of Registration
Filing of Application
Application
Form A
Fees Rs 100/-
Processing of
Application
Either grant or reject
Registration Certificate,
Issue notice for
inspection
After the Inspection
grant the registration
Within 7 days of
receipt of
application
If no response
Within a period
of
30 days
Food Business operator
may start business

26. Registration Procedure
•Registration shall not be refused without
giving the applicant an opportunity of being
heard.
•A registration certificate and a photo
identity card shall be issued which shall be
displayed at a prominent place.
•The Registering Authority or any officer or
agency specifically authorized for this
purpose shall carry out inspection.

27. No person (other than petty food businesses) shall
commence any food business without obtaining a valid
license.
 Existing Operator holding valid license/registration shall
CONVERT their license within one year of notification of
this Regulation
 No license fee for the remaining period of the validity.
 License for businesses mentioned under Schedule 1, shall
be granted by the Central Licensing Authority and all
others by State licensing Authority
 Licensing Authority shall ensure periodical food safety
audit and inspections of the licensed establishments.


28. More than 50,000
thousand lrs of
liquid milk/day
or
2,500 MT of milk
solid per annum

29. Installed capacity more than 2 MT per day

30. 50 large animals
150 or more small
animals,
1000 or more
poultry birds per
day.

31. More than 500 kg
of meat/day or
150 MT per annum

32. 2 MT/day except
grains, cereals
and pulses
milling units.

33. 
100 % Export Oriented Units

All Importers importing food items



Any article of Food which does not fall under
any of the food categories or deviates from
the prescribed specification for additives.
FBO s operating in two or more states
Food catering services in establishments and
units under Central government Agencies like
Railways, Airlines and airport, Seaport,
Defense etc.

34. Photo I.D and address proof. (optional)
 List of food category desired to be manufactured.
(In case of manufacturers)
 Authority letter with name and address of
responsible person nominated by the manufacturer
along with alternative responsible person. (wherever
applicable)
 Analysis report (Chemical & Bacteriological) of water
to be used as ingredient in food from a recognised/
public health laboratory to confirm the potability.
(mandatory only for manufacturing and processing units
only)


35. 
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Proof of possession of premises. (optional)
Partnership Deed/Affidavit/Memorandum &
Articles of Association towards the constitution of
the firm. (optional)
Copy of certificate obtained under Coop Act - 1861/Multi
State Coop Act - 2002 in case of Cooperatives. (optional;
wherever applicable)
NOC from manufacturer in case of Re-labellers
(mandatory)
Food safety management system plan or certificate (
if any)

36. 
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Source of raw material for meat and meat processing
plants (wherever applicable)
Pesticide residues report of water in case of units
manufacturing Packaged drinking water, packaged
Mineral water and/or carbonated water. (only for
packaged drinking water and mineral/ carbonated water)
Recall plan, if any (optional)
NOCs from Municipality or local body and from
State Pollution Control Board (optional)
Source of milk or procurement plan for milk
including location of milk collection centers etc in
case of Milk and Milk Products processing units.
(wherever applicable)

37. Procedure of Licensing
Filing of an Application
Application
Form B
Documents + Fees
unique application
number
Require additional
information on incomplete
Application
Inspection of premises
after receiving completed No inspection
application & issue
inspection report
Grant or reject within a
period of 30 days from
receipt of inspection
report excluding the time
taken by FBO.
Improvement
Notice
FBO
may
start the
business
after 60
days
No improvement
Suspension
No improvement
Cancelation
Fresh application
After 90 days

38. Modifications, Expansion or Changes
Food Business Operators Shall inform the Authority
Any modifications or additions or changes in product
category, layout, expansion, closure, or any other material
information based.
Any change that alters the information contained in the license
certificate shall require an approval or endorsement in license
prior to start of business with such changes.
Submit the original license along with a fee.
The Authority may approve and issue an amended license
within 30 days from the date of receipt of such information.

39. Return
Submit a return in Form ’D’ on or before 31st May of each
year, in respect of each class of food products handled by
FBO during the previous financial year.
1. Form D1 – Annual Return for businesses other than
Dairy
2. Form D2 – half yearly returns for businesses engaged in
manufacturing milk products for the period of 1st April
to 30th September and 1st October to 31st March of every
financial year.
Any delay in filing return beyond 31st May of each year
shall attract a penalty of Rs 100 per day of delay.

40. Validity and Renewal of Registration and License
i. For a period of 1 to 5 years as desired by the FBO,
from the date of issue of registration or license
ii. apply in Form A or B, not later than 30 days prior
to the expiry date indicated in the license.
iii. The Registration or License shall continue to be
in force till such time that the orders are passed
on the renewal application which in no case shall
be beyond 30 days from the date of expiry of
registration or license.
iv. Any renewal application filed beyond the period
mentioned above but before the expiry date, shall
be accompanied by a late fee of Rs 100 per day of
delay

41. 1. Fees for Registration
Rs 100
2. Fees for License issued by Central Licensing Authority:
Rs 7500
3. Fees for License issued by State Licensing Authority:
Manufacturer /Miller
Above 1MT per day Production or 10,001 to 50,000 LPD of milk
or 501 to 2500 MT of milk solids per annum
Rs. 5000/Below 1 MT of Production or 501 to 10,000 LPD of milk or 51 MT
to 500 MT of milk solids per annum
Rs.3000/Hotels – 3 Star and above
Rs. 5000/All Food Service providers including restaurants/boarding houses,
hotels below 3 star, clubs etc. serving food, Canteens (Schools, Colleges,
Office, Institutions), Caterers, Banquet halls with food catering
arrangements, food vendors like dabba wallas etc.
Rs. 2000/Any other Food Business Operator
Rs. 2000/-
The fees paid not refundable under any circumstances.
License lost, destroyed, torn, defaced or mutilated, licensee to apply for a duplicate copy
of the registration certificate or license during the validity period, accompanied with a
fee amounting to 10% of the applicable License fee. Duplicate license to have word
“Duplicate” word on it.

42. Liability for Compliance
Section 27
Manufacturer shall be liable for meeting all
requirements under this Act
Wholesaler/distributor shall be liable only for
Sale after expiry
stored or supplied in violation of the safety
instruction
Unsafe or misbranded
Manufacturer unidentifiable
Received with knowledge of being unsafe
Seller shall be liable only for
Sale after expiry
Handled or kept in unhygienic conditions
misbranded
Manufacturer unidentifiable

43. Inspection for New applicant/ Routine Inspection
On receiving the completed application licensing
authority directs Food Safety Officer or any other person
specially designated for such functions to inspect the
premises.
A prescribed inspection procedure being laid down in
Chapter Inspection of food establishments and
Inspection of Special Establishments.
A detailed Inspection Report to be prepared by the officer
as per the format A.
Copy of the same has to be handed to the applicant
suggesting compliance for improvements if any.
After confirming that all requirements have been
complied with the requirements a licence to be issued by
the Licensing Authority in format C provided under
Schedule 2 of the Regulations 2010.

44. FSSAI National
Licensing &
Registration
portal

45. Improvement Notices
Designated officer
Suspension
Improvement Notice
state the grounds
specify the matters
cancellation
specify the measures
which
require the food business
operator to take those
measures
Appeal to the
commissioner

46. 
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Single Window
Less inspections, more audit of system
Preventive rather than after the event
Independent regulator of safety
Transparent science based standards
and Procedures
Pooling of regulatory resources
Responsibility of Food Business
Operator

47. 
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Recall of unsafe food.
Small vendors exempted from licensing.
60 days time limit for processing of
license.
Adjudication and compounding
offences.
Quicker justice.
Penalty for harassment by Food safety
Officer.
Less inspector Raj.

48. THANK YOU
THANK YOU