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Food Safety & Standard Act
FSSAI
Presented By: Nikita Vinayak Khaire
F.Y.M.Pharm. (Regulatory Affairs)
Semester: 2nd
Guided by : Dr. Lokesh P. Kothari
( M. Pharm., Ph.D. )
CONTENTS
 Introduction
 Scope of the Act
 Need for the new act
 Salient features of the act
 Chapters of FSS act
 FSS act rules, 2011
 FSSAI
Function of FSSAI
Department of FSSAI
FSSAI Notified laboratories
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 2
INTRODUCTION
• The Food Safety & Standards Act, 2006 is 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, distribution, sale and import, to ensure
availability of sale and wholesome food for human consumption.
• The Food Safety and Standards Act, 2006 was passed by parliament with
the intention:
* To converge 8 different laws into one comprehensive act.
*To have single regulatory body.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 3
FSS ACT : INTEGRATES
Food
Safety &
Standards
Act, 2006
Prevention
of food
Adulteration
Act, 1954
Fruit
products
order, 1955
Meat Food
product
order, 1973
Vegetable
oil Products
(control)
order,1947
Edible oils
packaging
(regulation)
order, 1998 Solvent Extracted
oil, Deoilded meal
& edible flour
(control)
order,1967
Milk & milk
products
order, 1992
Any other order
under essential
commodities
Act, 1955
relating to food
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 4
SCOPE OF THE ACT
• The Act covers activities throughout the food distribution chain,
from primary production through distribution to retail and
catering.
• The Act gives the government powers to make regulations on
matters of food safety.
• The Food Safety & Standards Authority of India is the principal
Government Authority responsible for preparing specific
regulations under the Act.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 5
NEED FOR THE NEW ACT
FSSA initiates harmonization of India’s food regulations as per
international standards.
 It establishes a new national regulatory body, the Food Safety and
Standards Authority of India (FSSAI) to develop science based standards.
 All food imports will therefore be subject to the provisions of the FSSA
and rules and regulations which as notified by the Government on 5th of
August 2011 will be applicable.
 FSSAI department is controlled directly by the Ministry of Health and
Family Welfare.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 6
SALIENT FEATURES OF THE ACT
To ensure that all food meets consumers expectations in terms of
nature, substance and quality and is not misleading.
To provide legal powers and specify offences in relation to public
health and consumers interest.
 To shift from regulatory regime to self compliance through Food
Safety Management system.
 Science based standards.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 7
CHAPTERS OF THE FSS ACT
 Chapter I – Preliminary (Section 1-3).
 Chapter II – Food safety & standards Authority of India (Section 4-
17).
 Chapter III – General principles of Food Safety (Section 18).
 Chapter IV – General provisions as to articles of food (Section 19-24).
 Chapter V – Provisions relating to import (Section 25).
 Chapter VI – Special responsibilities as to food safety (Section
26,27,28).
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 8
CONT……
 Chapter VII – Enforcement of the act (Section 29-42).
 Chapter VIII – Analysis of food (Section 43-47).
 Chapter IX – Offences & Penalties (Section 48-67).
 Chapter X – Adjudication & Food Safety Appellate Tribunal
(Section 68- 80).
 Chapter XI – Finance, Accounts, Audit and Reports (Section
81-84).
 Chapter XII – Miscellaneous (Section 85-101).
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 9
FSS ACT RULES, 2011
Under section 91, it empowered the central government to make rules by
notification in the official gazette, for carrying out provisions of the act.
Some of them are namely:
→ Qualifications of Food Safety officer.
→ Qualifications of Food analysts.
→ Procedure to be followed in adjudication of cases.
→Any other matter relating to procedure and powers tribunal under
clause.
→ The fee to be paid for preferring an appeal to the high court.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 10
IMPORTANT REGULATIONS OF FSS ACT
FSSAI Business Transaction Regulations, 2010.
 FSS (Licensing and Registration) Regulations, 2011.
 FSS (Packaging and Labelling) Regulations, 2011.
 FSS (Food Product Standard & Food Additive) Regulations, 2011.
 FSS (Prohibition and Restriction on sales) Regulations, 2011.
 FSS (Contaminants, Toxins and Residues) Regulations, 2011.
 FSS (Laboratory and sampling analysis) Regulations, 2011.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 11
CONT….
 FSS (Food or Health Supplements, Nutraceuticals, Foods for
special dietary uses, Foods for special medical purpose,
Functional Foods and novel food) Regulations, 2016.
 FSS (Food Recall Procedure) Regulation, 2017.
 FSS (Import) Regulation, 2017.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 12
FSSAI
 FSSAI full form is the Food Safety and Standards Authority of India (FSSAI)
which is an autonomous body established under the Ministry of Health &
Family Welfare, Government of India.
Meaning of FSSAI-
FSSAI is an authority to provide a food license to every food business in India.
FSSAI makes sure that the food business runs with appropriate license and a
quality check. The food businesses are required to follow the FSSAI rules and
guidelines.
FSSAI is in entirely responsible for setting the standard and principles and
controls for the welfare of food businesses in India.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 13
FSSAI PORTAL
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 14
FSSAI REGISTRATION ( FOOD LICENSE)
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 15
Filing of Application
Unique Application
Reference Number
Required additional
information on
incomplete Application
Unique Application ID
Inspection of premises
after receiving application
& issue inspection report
Grant of license if all
formalities completed
within 60 days
APPLICATION FORM B DOCUMENTS + FEE
FBO May
start the
business
after 60
days
Improvement Notice
No Improvement
Suspension
No Improvement
Cancellation
Fresh application after
90 days
If no response
No Inspection
If inspection report
not processed
Form B
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 16
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 17
FORMS AND REGULATIONS
 Form A: Application for registration / Renewal of Registration under Food
safety and Standards Act, 2006
 Form B: Application for license / Renewal of license under Food Safety and
Standards Act, 2006
 Form of Self Declaration (Form 9)
 Form of Nomination
 Affidavit for FSMS (Food Safety Management System) plan
 Food licensing & Registration Regulations, 2011
 Notification regarding time extension of Sub-Regulation
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 18
FSSAI –ADMINISTRATIVE STRUCTURE
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 19
Ministry of Health & Family Welfare, Government of India is the
Administrative Ministry for the implementation of FSSAI.
 Headquarter : New Delhi
 Location: FSSAI is located in 5 region
• Northern Region –With head office at New Delhi
• Eastern Region – Kolkata
• North Eastern Region – Guwahati
• Western Region – Mumbai
• Southern Region – Chennai
New Delhi Headquarter
FSSAI ADMINISTRATIVE STRUCTURE
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 20
Western Region – Mumbai Southern Region – Chennai
GOVERNING STRUCTURE Of FSSAI
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 21
Food authority
chairperson &
22 members
Food standard
Scientific committee
CP& member of the
scientific panel & 6
independent
members
17 Scientific
panels
Compliance &
inspection
Central
Advisory
committee
State level
steering
committee
District level
Advisory
committee
FSSAI DEPARTMENT
 Import division
 International Co-operation
 Regulatory Compliance Division (RCD)
 Food Safety Management System (FSMS) Division.
 Risk Assessment and R&D division (RARD)
 Information Education Communication Division (IEC)
 Regulation and Codex Division
 Quality Assurance/ Lab Division
 HR Division
 Standards Division
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 22
FSSAI NOTIFIED LABORATORIES
FSSAI notified laboratories that are classified as
1. FSSAI notified NABL (National accreditation board for testing
and calibrating laboratories) accredited labs - 112
2. State labs - 72
3. Referral labs - 14 FSSAI notified laboratories
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 23
FUNCTIONS OF FSSAI
• Framing of regulations to lay down food safety standards.
• Laying down guidelines for accreditation of laboratories for
food testing.
• Providing scientific advice and technical support to the
Central Government.
• Contributing to the development of international technical
standards in food.
• Collecting and collating data regarding food consumption,
contamination, emerging risks etc.
• Disseminating information and promoting awareness about
food safety and nutrition in India.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 24
APPLICABLE FSSAI LICENSE
• FSSAI issues three types of license based on nature of food business and
turnover:-
1. Registration: For turnover less than 12 Lakh.
2. State License: For turnover between 12 Lakh to 20 Crore.
3. Central License: For turnover above 20 Crore .
• Other criteria like the location of the business, number of retail stores etc. is
needed while evaluating the nature of license applicable.
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 25
REFERENCES
1. https://www.slideshare.net/JwalaJayadeep/food-safety-
standards-authority-of-india-fssai
2. https://www.slideshare.net/SanthiNori1/fss-and-fssai-act
3. https://www.slideshare.net/GauriGatade/fssai-108111959
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 26
13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 27

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FSSAI.ppt Food safety standards act in RAFN

  • 1. Food Safety & Standard Act FSSAI Presented By: Nikita Vinayak Khaire F.Y.M.Pharm. (Regulatory Affairs) Semester: 2nd Guided by : Dr. Lokesh P. Kothari ( M. Pharm., Ph.D. )
  • 2. CONTENTS  Introduction  Scope of the Act  Need for the new act  Salient features of the act  Chapters of FSS act  FSS act rules, 2011  FSSAI Function of FSSAI Department of FSSAI FSSAI Notified laboratories 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 2
  • 3. INTRODUCTION • The Food Safety & Standards Act, 2006 is 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, distribution, sale and import, to ensure availability of sale and wholesome food for human consumption. • The Food Safety and Standards Act, 2006 was passed by parliament with the intention: * To converge 8 different laws into one comprehensive act. *To have single regulatory body. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 3
  • 4. FSS ACT : INTEGRATES Food Safety & Standards Act, 2006 Prevention of food Adulteration Act, 1954 Fruit products order, 1955 Meat Food product order, 1973 Vegetable oil Products (control) order,1947 Edible oils packaging (regulation) order, 1998 Solvent Extracted oil, Deoilded meal & edible flour (control) order,1967 Milk & milk products order, 1992 Any other order under essential commodities Act, 1955 relating to food 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 4
  • 5. SCOPE OF THE ACT • The Act covers activities throughout the food distribution chain, from primary production through distribution to retail and catering. • The Act gives the government powers to make regulations on matters of food safety. • The Food Safety & Standards Authority of India is the principal Government Authority responsible for preparing specific regulations under the Act. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 5
  • 6. NEED FOR THE NEW ACT FSSA initiates harmonization of India’s food regulations as per international standards.  It establishes a new national regulatory body, the Food Safety and Standards Authority of India (FSSAI) to develop science based standards.  All food imports will therefore be subject to the provisions of the FSSA and rules and regulations which as notified by the Government on 5th of August 2011 will be applicable.  FSSAI department is controlled directly by the Ministry of Health and Family Welfare. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 6
  • 7. SALIENT FEATURES OF THE ACT To ensure that all food meets consumers expectations in terms of nature, substance and quality and is not misleading. To provide legal powers and specify offences in relation to public health and consumers interest.  To shift from regulatory regime to self compliance through Food Safety Management system.  Science based standards. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 7
  • 8. CHAPTERS OF THE FSS ACT  Chapter I – Preliminary (Section 1-3).  Chapter II – Food safety & standards Authority of India (Section 4- 17).  Chapter III – General principles of Food Safety (Section 18).  Chapter IV – General provisions as to articles of food (Section 19-24).  Chapter V – Provisions relating to import (Section 25).  Chapter VI – Special responsibilities as to food safety (Section 26,27,28). 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 8
  • 9. CONT……  Chapter VII – Enforcement of the act (Section 29-42).  Chapter VIII – Analysis of food (Section 43-47).  Chapter IX – Offences & Penalties (Section 48-67).  Chapter X – Adjudication & Food Safety Appellate Tribunal (Section 68- 80).  Chapter XI – Finance, Accounts, Audit and Reports (Section 81-84).  Chapter XII – Miscellaneous (Section 85-101). 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 9
  • 10. FSS ACT RULES, 2011 Under section 91, it empowered the central government to make rules by notification in the official gazette, for carrying out provisions of the act. Some of them are namely: → Qualifications of Food Safety officer. → Qualifications of Food analysts. → Procedure to be followed in adjudication of cases. →Any other matter relating to procedure and powers tribunal under clause. → The fee to be paid for preferring an appeal to the high court. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 10
  • 11. IMPORTANT REGULATIONS OF FSS ACT FSSAI Business Transaction Regulations, 2010.  FSS (Licensing and Registration) Regulations, 2011.  FSS (Packaging and Labelling) Regulations, 2011.  FSS (Food Product Standard & Food Additive) Regulations, 2011.  FSS (Prohibition and Restriction on sales) Regulations, 2011.  FSS (Contaminants, Toxins and Residues) Regulations, 2011.  FSS (Laboratory and sampling analysis) Regulations, 2011. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 11
  • 12. CONT….  FSS (Food or Health Supplements, Nutraceuticals, Foods for special dietary uses, Foods for special medical purpose, Functional Foods and novel food) Regulations, 2016.  FSS (Food Recall Procedure) Regulation, 2017.  FSS (Import) Regulation, 2017. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 12
  • 13. FSSAI  FSSAI full form is the Food Safety and Standards Authority of India (FSSAI) which is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. Meaning of FSSAI- FSSAI is an authority to provide a food license to every food business in India. FSSAI makes sure that the food business runs with appropriate license and a quality check. The food businesses are required to follow the FSSAI rules and guidelines. FSSAI is in entirely responsible for setting the standard and principles and controls for the welfare of food businesses in India. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 13
  • 14. FSSAI PORTAL 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 14
  • 15. FSSAI REGISTRATION ( FOOD LICENSE) 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 15 Filing of Application Unique Application Reference Number Required additional information on incomplete Application Unique Application ID Inspection of premises after receiving application & issue inspection report Grant of license if all formalities completed within 60 days APPLICATION FORM B DOCUMENTS + FEE FBO May start the business after 60 days Improvement Notice No Improvement Suspension No Improvement Cancellation Fresh application after 90 days If no response No Inspection If inspection report not processed
  • 16. Form B 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 16
  • 17. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 17
  • 18. FORMS AND REGULATIONS  Form A: Application for registration / Renewal of Registration under Food safety and Standards Act, 2006  Form B: Application for license / Renewal of license under Food Safety and Standards Act, 2006  Form of Self Declaration (Form 9)  Form of Nomination  Affidavit for FSMS (Food Safety Management System) plan  Food licensing & Registration Regulations, 2011  Notification regarding time extension of Sub-Regulation 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 18
  • 19. FSSAI –ADMINISTRATIVE STRUCTURE 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 19 Ministry of Health & Family Welfare, Government of India is the Administrative Ministry for the implementation of FSSAI.  Headquarter : New Delhi  Location: FSSAI is located in 5 region • Northern Region –With head office at New Delhi • Eastern Region – Kolkata • North Eastern Region – Guwahati • Western Region – Mumbai • Southern Region – Chennai New Delhi Headquarter
  • 20. FSSAI ADMINISTRATIVE STRUCTURE 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 20 Western Region – Mumbai Southern Region – Chennai
  • 21. GOVERNING STRUCTURE Of FSSAI 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 21 Food authority chairperson & 22 members Food standard Scientific committee CP& member of the scientific panel & 6 independent members 17 Scientific panels Compliance & inspection Central Advisory committee State level steering committee District level Advisory committee
  • 22. FSSAI DEPARTMENT  Import division  International Co-operation  Regulatory Compliance Division (RCD)  Food Safety Management System (FSMS) Division.  Risk Assessment and R&D division (RARD)  Information Education Communication Division (IEC)  Regulation and Codex Division  Quality Assurance/ Lab Division  HR Division  Standards Division 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 22
  • 23. FSSAI NOTIFIED LABORATORIES FSSAI notified laboratories that are classified as 1. FSSAI notified NABL (National accreditation board for testing and calibrating laboratories) accredited labs - 112 2. State labs - 72 3. Referral labs - 14 FSSAI notified laboratories 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 23
  • 24. FUNCTIONS OF FSSAI • Framing of regulations to lay down food safety standards. • Laying down guidelines for accreditation of laboratories for food testing. • Providing scientific advice and technical support to the Central Government. • Contributing to the development of international technical standards in food. • Collecting and collating data regarding food consumption, contamination, emerging risks etc. • Disseminating information and promoting awareness about food safety and nutrition in India. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 24
  • 25. APPLICABLE FSSAI LICENSE • FSSAI issues three types of license based on nature of food business and turnover:- 1. Registration: For turnover less than 12 Lakh. 2. State License: For turnover between 12 Lakh to 20 Crore. 3. Central License: For turnover above 20 Crore . • Other criteria like the location of the business, number of retail stores etc. is needed while evaluating the nature of license applicable. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 25
  • 26. REFERENCES 1. https://www.slideshare.net/JwalaJayadeep/food-safety- standards-authority-of-india-fssai 2. https://www.slideshare.net/SanthiNori1/fss-and-fssai-act 3. https://www.slideshare.net/GauriGatade/fssai-108111959 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 26
  • 27. 13 May 2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nasik) 27