Food Safety & Standard Act
FSSAI
Presented By: Nikita Vinayak Khaire
F.Y.M.Pharm. (Regulatory Affairs)
Semester: 2
nd
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
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INTRODUCTION
•TheFoodSafety&StandardsAct,2006isacttoconsolidatethelaws
relatingtofoodandtoestablishtheFoodSafetyandStandardsAuthorityof
IndiaforLayingdownsciencebasedstandardsforarticlesoffoodandto
regulatetheirmanufacture,distribution,saleandimport,toensure
availabilityofsaleandwholesomefoodforhumanconsumption.
•TheFoodSafetyandStandardsAct,2006waspassedbyparliamentwith
theintention:
*Toconverge8differentlawsintoonecomprehensiveact.
*Tohavesingleregulatorybody.
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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, Deoildedmeal
& edible flour
(control)
order,1967
Milk & milk
products
order, 1992
Any other order
under essential
commodities
Act, 1955
relating to food
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SCOPE OF THE ACT
•TheActcoversactivitiesthroughoutthefooddistributionchain,
fromprimaryproductionthroughdistributiontoretailand
catering.
•TheActgivesthegovernmentpowerstomakeregulationson
mattersoffoodsafety.
•TheFoodSafety&StandardsAuthorityofIndiaistheprincipal
GovernmentAuthorityresponsibleforpreparingspecific
regulationsundertheAct.
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NEED FOR THE NEW ACT
FSSAinitiatesharmonizationofIndia’sfoodregulationsasper
internationalstandards.
Itestablishesanewnationalregulatorybody,theFoodSafetyand
StandardsAuthorityofIndia(FSSAI)todevelopsciencebasedstandards.
AllfoodimportswillthereforebesubjecttotheprovisionsoftheFSSA
andrulesandregulationswhichasnotifiedbytheGovernmenton5thof
August2011willbeapplicable.
FSSAIdepartmentiscontrolleddirectlybytheMinistryofHealthand
FamilyWelfare.
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SALIENT FEATURES OF THE ACT
Toensurethatallfoodmeetsconsumersexpectationsintermsof
nature,substanceandqualityandisnotmisleading.
Toprovidelegalpowersandspecifyoffencesinrelationtopublic
healthandconsumersinterest.
ToshiftfromregulatoryregimetoselfcompliancethroughFood
SafetyManagementsystem.
Sciencebasedstandards.
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CHAPTERS OF THE FSS ACT
ChapterI–Preliminary(Section1-3).
ChapterII–Foodsafety&standardsAuthorityofIndia(Section4-
17).
ChapterIII–GeneralprinciplesofFoodSafety(Section18).
ChapterIV–Generalprovisionsastoarticlesoffood(Section19-24).
ChapterV–Provisionsrelatingtoimport(Section25).
ChapterVI–Specialresponsibilitiesastofoodsafety(Section
26,27,28).
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CONT……
ChapterVII–Enforcementoftheact(Section29-42).
ChapterVIII–Analysisoffood(Section43-47).
ChapterIX–Offences&Penalties(Section48-67).
ChapterX–Adjudication&FoodSafetyAppellateTribunal
(Section68-80).
ChapterXI–Finance,Accounts,AuditandReports(Section
81-84).
ChapterXII–Miscellaneous(Section85-101).
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FSS ACT RULES, 2011
Undersection91,itempoweredthecentralgovernmenttomakerulesby
notificationintheofficialgazette,forcarryingoutprovisionsoftheact.
Someofthemarenamely:
→QualificationsofFoodSafetyofficer.
→QualificationsofFoodanalysts.
→Proceduretobefollowedinadjudicationofcases.
→Anyothermatterrelatingtoprocedureandpowerstribunalunder
clause.
→Thefeetobepaidforpreferringanappealtothehighcourt.
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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.
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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.
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FSSAI
FSSAIfullformistheFoodSafetyandStandardsAuthorityofIndia(FSSAI)
whichisanautonomousbodyestablishedundertheMinistryofHealth&
FamilyWelfare,GovernmentofIndia.
MeaningofFSSAI-
FSSAIisanauthoritytoprovideafoodlicensetoeveryfoodbusinessinIndia.
FSSAImakessurethatthefoodbusinessrunswithappropriatelicenseanda
qualitycheck.ThefoodbusinessesarerequiredtofollowtheFSSAIrulesand
guidelines.
FSSAIisinentirelyresponsibleforsettingthestandardandprinciplesand
controlsforthewelfareoffoodbusinessesinIndia.
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FSSAI PORTAL
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FSSAI REGISTRATION ( FOOD LICENSE)
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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
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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
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FSSAI –ADMINISTRATIVE STRUCTURE
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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
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Western Region –Mumbai
Southern Region –Chennai
GOVERNING STRUCTURE Of FSSAI
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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
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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
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FUNCTIONS OF FSSAI
•Framingofregulationstolaydownfoodsafetystandards.
•Layingdownguidelinesforaccreditationoflaboratoriesfor
foodtesting.
•Providingscientificadviceandtechnicalsupporttothe
CentralGovernment.
•Contributingtothedevelopmentofinternationaltechnical
standardsinfood.
•Collectingandcollatingdataregardingfoodconsumption,
contamination,emergingrisksetc.
•Disseminatinginformationandpromotingawarenessabout
foodsafetyandnutritioninIndia.
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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.
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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
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