FSSAI - Food Safety and Standards Authority of India - by Akshay Anand

A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015

1. FOODSAFETY
ANDSTANDARDS
AUTHORITYOF
INDIA
©2015
akshayanand
AKSHAY ANAND M
I Year –Master of Pharmacy
Pharmaceutical Regulatory Affairs
JSS College Of Pharmacy
Mysuru570015, Karnataka

2. 01
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•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
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, storage distribution, sale
and import, to ensure availability of safe
and wholesome food for human
consumption and for matters connected
therewith or incidental thereto.
•Food Safety Standards
Act 2006
•Food Safety Standards
Regulations 2011

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•The FSSAI has been established under Food Safety and
Standards Act, 2006.
•This act consolidates various acts & orders that have
hitherto handled food related issues in various Ministries
and Departments.
•FSSAI has been created 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.

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•Ministry of Health & Family Welfare,
Government of India is the Administrative
Ministry for the implementation of FSSAI.
•The Chairperson and Chief Executive Officer of
Food Safety and Standards Authority of India
(FSSAI) have been appointed by Government of
India.

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•Framing of Regulations to lay down the Standards and
guidelines in relation to articles of food and specifying
appropriate system of enforcing various standards thus
notified.
•Laying down mechanisms and guidelines for accreditation of
certification bodies engaged in certification of food safety
management system for food businesses.
•Laying down procedure and guidelines for accreditation of
laboratories and notification of the accredited laboratories.

6. 05
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•To provide scientific advice and technical support to Central
Government and State Governments in the matters of framing
the policy and rules in areas which have a direct or indirect
bearing of food safety and nutrition.
•Collect and collate data regarding food consumption, incidence
and prevalence of biological risk, contaminants in food,
residues of various, contaminants in foods products,
identification of emerging risks and introduction of rapid alert
system.
•Provide training programmes for persons who are involved or
intend to get involved in food businesses.

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•Creating an information network across the country so that the
public, consumers, Panchayatsetcreceive rapid, reliable and
objective information about food safety and issues of concern.
•Contribute to the development of international technical
standards for food, sanitary and phyto-sanitary standards.
•Promote general awareness about food safety and food
standards.

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1.Dairyproductsandanalogues
2.Fatsandoils,andfatemulsions
3.Edibleices,includingsorbet
4.Fruitsandvegetables(includingmushroomsandfungi,rootsand
tubers,freshpulsesandlegumes,andaloeVera),seaweeds,and
nutsandseeds
5.Confectionery
6.Cerealsandcerealproducts,derivedfromcerealgrains,fromroots
andtubers,pulses,legumes(freshpulsesandlegumesarecovered
incategory4.2)andpithorsoftcoreofpalmtree,excludingbakery
waresoffoodcategory07.0.
7.Bakeryproducts
8.Meatandmeatproducts,includingpoultryandgame

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9.Fishandfishproducts,includingmolluscs,crustaceans,and
echinoderms
10.Eggsandeggproducts
11.Sweeteners,includinghoney
12.Salts,spices,soups,sauces,saladsandproteinproducts.
13.Foodstuffsintendedforparticularnutritionaluses.
14.Beverages,excludingdairyproducts
15.Ready-to-eatsavouries
16.PreparedFoods/dishesincludingCompositefoods
17.Productsnotcoveredintocategory1-16
18.Substancesaddedtofoodwhichare‘notfordirectconsumptionas
food’

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•The process of application starts with identification of
the premise.
•Depending on the installed capacity in case of
manufacturers and/or turnover for businesses and/or
location, the premise may be eligible for any of the
following categories.
•Central License
•State License/Registration

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•Eligible Food Business Operators (FBO) need to procure a License from the
Central Authority. They include,
•Importers
•100% EoUs
•Manufacturers
•Operators in
•Central Govt. Agencies
•Airports
•Seapors
•After issuance of license, any Modification, Renewal, Duplicate
Request are carried out Online.
•Central License is issued by the FSSAI Regional Offices across the
nation in pursuant to the FSS Regulations, 2011.
•DOCUMENTS NEEDED

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•Eligible Food Business Operators (FBO) need to procure a License from the
Central Authority. They include,
•Manufacturers
•Storage
•Transporters
•Retailers
•Marketers
•Distributors
•After issuance of license, any Modification, Renewal, Duplicate
Request are carried out Online.
•Central License is issued by the FSSAI Regional Offices across the
nation in pursuant to the FSS Regulations, 2011.
•DOCUMENTS NEEDED

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•New License:-INR 7500/Year
•Renewal License:-INR 7500/Year
•Modification License:-INR 7500/Modification
•Duplicate License:-10% of the Applicable License Fee
•Note:-License can be issued / renewed for maximum 5 years
•Above 1MT per day Production -INR 5000/Year
•10,001 to 50,000 LPD of milk Or 501 to 2500 MT of milk solids per annum-INR 5000/Year
•Below 1 MT of Production-INR 3000/Year
•501 to 10,000 LPD of milk Or 2.5 MT to 500 MT of milk solids per annum -INR 3000/Year
•Hotels and Restaurants up to 4 Star-INR 5000/Year
•All Food Service providers including restaurants/boarding houses, clubs etc. serving food,
Canteens (Schools, Colleges, Office, Institutions), Caterers, Banquet halls with food
cateringarrangements, food vendors like dabbawallasetc& Other food Business
Operator-INR 2000/Year

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Apply for site registration in Form A
to State licensing authority
Processing of application
After 7 days
Issuance for inspection and
inspection done within 30 days
Approval
Rejection
for Site Registration and Manufacturing License

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Issuance of unique application number
Require additional information on incomplete application
Manufacturer may apply for
manufacturing license in Form B

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Inspection of premises after receiving
completed application & issue inspection
report
Either grant or reject the license Within 60 days of
receipt of completed application or within 30 days of
inspection
Manufacturer may start the business after 60
days

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for Import of Nutraceuticals
Importer
Apply for import license in
form A and B along with
supporting documents and fee
to FSSAI
Apply for IEC number
to DGFT
Receives IEC number
Importer
Gets import license

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Customs
Presents
required
documentation
Sends consignment
with required
documents
Foreign
Exporter
Requisite documents
are sent
Checks consignment documents,
conformance to FSS act and labeling
standards
Importer

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Not Ok Detailed/ re-exported Or
Appealed for
reconsideration
FSSAI authorized person/ port health officer
may collect the samples for testing
Ok
Not Ok Detailed/ re-exported and
quarantined Or Appealed
for
reconsideration
Customs
Ok
Domestic market
Checks consignment documents, conformance to FSS
act and labeling standards

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•FORM A -Application for Registration / Renewal of Registration under
Food Safety and Standards Act, 2006
•FORM B -Application for License / Renewal of license except importing
under Food Safety and Standards Act, 2006
•Form of Self Declaration (FORM IX)
•Form of Nomination
•Affidavit for FSMS (Food Safety Management System) Plan
•Condition of License
•Food Licensing & Registration Regulations, 2011
•Notification regarding time extension of Sub-Regulation
•Notification regarding usage of FSSAI License Number and Logo on the
Labels of Food Products

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•Causing food to be injurious
•Abstracting any constituent
•Deliberate adulteration
•Non-conformance in Label information etc.,

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•Substandard food: UptoRs. 2.00 lakhs
•Misbranded: UptoRs. 3.00 lakhs
•Misleading advertisement : UptoRs. 10.00 lakhs
•Food with extraneous matter: UptoRs. 1.00 lakhs
•Fail to meet the requirements as directed by FSO: UptoRs. 2.00 lakhs
•Unhygienic / unsanitary preparations: UptoRs. 1.00 lakhs
•Adulterant not injurious to health: UptoRs. 2.00 lakhs
•Adulterant injurious to health: UptoRs. 10.00 lakhs
•Unsafe food –but does not cause immediate injury : 6 months imprisonment with fine of
Rs.1.0 lakh
•Unsafe food causing non-grievous injury : 1 year imprisonment with fine of Rs. 3.00 lakh
•Compensation in case for injury : uptoRs.1.00 lakh
•Causing grievous injury : 6 years imprisonment with fine of Rs. 5.00 lakh
•Compensation in case for grievous injury : uptoRs.3.00 lakh
•Causing death : 7 years or life imprisonment and fine of Rs. 10.00 lakh
•Compensation in case of death : uptoRs. 5.00 lakh minimum

23. 22
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•A dietary supplement is a product intended for ingestion that contains a
"dietary ingredient" intended to add further nutritional value to
(supplement) the diet. A "dietary ingredient" may be one, or any
combination, of the following substances: a vitamin. a mineral. an herb or
other botanical. A dietary supplement is intended to provide nutrients
that may otherwise not be consumed in sufficient quantities.
•Nutraceutical, a portmanteau of the words “nutrition” and
“pharmaceutical”, was coined in 1989 by Stephen L. DeFelice, founder
and chairman of the Foundation of Innovation Medicine. The term is
applied to products that range from isolated nutrients, dietary
supplements and herbal products, specific diets and processed foods such
as cereals, soups, and beverages.

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•http://www.fssai.gov.in/
•http://www.fssai.gov.in/AboutFSSAI/introduction.aspx
•http://www.fssai.gov.in/AboutFSSAI/FSSAct.aspx
•http://foodlicensing.fssai.gov.in/index.aspx
•https://en.wikipedia.org/wiki/Food_Safety_and_Standards_Authority_of_I
ndia

25. thankyou!
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