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

Akshay Anand
Akshay AnandRegulatory Affairs Professional um ITC Limited
AKSHAY ANAND
FOODSAFETY
ANDSTANDARDS
AUTHORITYOF
INDIA
©2015
akshayanand
01
©2015
akshayanand
• 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 & StandardsAct 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
02
©2015
akshayanand
• 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.
03
©2015
akshayanand
• Ministry of Health & FamilyWelfare,
Government of India is the Administrative
Ministry for the implementation of FSSAI.
• The Chairperson and Chief Executive Officer of
Food Safety and StandardsAuthority of India
(FSSAI) have been appointed by Government of
India.
04
©2015
akshayanand
• 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.
05
©2015
akshayanand
• 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.
06
©2015
akshayanand
• Creating an information network across the country so that the
public, consumers, Panchayats etc receive 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.
07
©2015
akshayanand
1. Dairy products and analogues
2. Fats and oils, and fat emulsions
3. Edible ices, including sorbet
4. Fruits and vegetables (including mushrooms and fungi, roots and
tubers, fresh pulses and legumes, and aloe Vera), seaweeds, and
nuts and seeds
5. Confectionery
6. Cereals and cereal products, derived from cereal grains, from roots
and tubers, pulses, legumes (fresh pulses and legumes are covered
in category 4.2) and pith or soft core of palm tree, excluding bakery
wares of food category 07.0 .
7. Bakery products
8. Meat and meat products, including poultry and game
08
©2015
akshayanand
9. Fish and fish products, including molluscs, crustaceans, and
echinoderms
10. Eggs and egg products
11. Sweeteners, including honey
12. Salts, spices, soups, sauces, salads and protein products.
13. Foodstuffs intended for particular nutritional uses.
14. Beverages, excluding dairy products
15. Ready-to-eat savouries
16. Prepared Foods/dishes including Composite foods
17. Products not covered into category 1-16
18. Substances added to food which are ‘not for direct consumption as
food’
09
©2015
akshayanand
• 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
10
©2015
akshayanand
• 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
11
©2015
akshayanand
• Eligible Food Business Operators (FBO) need to procure a License from the
State Authority.They include,
• Manufacturers
• Storage
• Transporters
• Retailers
• Marketers
• Distributors
• After issuance of license, any Modification, Renewal, Duplicate
Request are carried out Online.
• State License is issued by the State Authorities operating in each
state in pursuant to the FSS Regulations, 2011.
• DOCUMENTS NEEDED
12
©2015
akshayanand
• 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
catering arrangements, food vendors like dabbawallas etc & Other food Business
Operator - INR 2000/Year
13
©2015
akshayanand
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
14
©2015
akshayanand
Issuance of unique application number
Require additional information on incomplete application
Manufacturer may apply for
manufacturing license in Form B
15
©2015
akshayanand
Inspection of premises after receiving
completed application & issue inspection
report
Either grant or reject the licenseWithin 60 days of
receipt of completed application or within 30 days of
inspection
Manufacturer may start the business after 60
days
16
©2015
akshayanand
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
17
©2015
akshayanand
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
18
©2015
akshayanand
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
19
©2015
akshayanand
• 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
20
©2015
akshayanand
• Causing food to be injurious
• Abstracting any constituent
• Deliberate adulteration
• Non-conformance in Label information etc.,
21
©2015
akshayanand
• Substandard food: Upto Rs. 2.00 lakhs
• Misbranded: Upto Rs. 3.00 lakhs
• Misleading advertisement : Upto Rs. 10.00 lakhs
• Food with extraneous matter: Upto Rs. 1.00 lakhs
• Fail to meet the requirements as directed by FSO: Upto Rs. 2.00 lakhs
• Unhygienic / unsanitary preparations: Upto Rs. 1.00 lakhs
• Adulterant not injurious to health: Upto Rs. 2.00 lakhs
• Adulterant injurious to health: Upto Rs. 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 : upto Rs.1.00 lakh
• Causing grievous injury : 6 years imprisonment with fine of Rs. 5.00 lakh
• Compensation in case for grievous injury : upto Rs.3.00 lakh
• Causing death : 7 years or life imprisonment and fine of Rs. 10.00 lakh
• Compensation in case of death : upto Rs. 5.00 lakh minimum
22
©2015
akshayanand
• 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.
23
©2015
akshayanand
• 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
thankyou!axayanand@gmail.com
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FSSAI - Food Safety and Standards Authority of India - by Akshay Anand

  • 2. 01 ©2015 akshayanand • 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 & StandardsAct 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
  • 3. 02 ©2015 akshayanand • 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.
  • 4. 03 ©2015 akshayanand • Ministry of Health & FamilyWelfare, Government of India is the Administrative Ministry for the implementation of FSSAI. • The Chairperson and Chief Executive Officer of Food Safety and StandardsAuthority of India (FSSAI) have been appointed by Government of India.
  • 5. 04 ©2015 akshayanand • 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 ©2015 akshayanand • 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.
  • 7. 06 ©2015 akshayanand • Creating an information network across the country so that the public, consumers, Panchayats etc receive 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.
  • 8. 07 ©2015 akshayanand 1. Dairy products and analogues 2. Fats and oils, and fat emulsions 3. Edible ices, including sorbet 4. Fruits and vegetables (including mushrooms and fungi, roots and tubers, fresh pulses and legumes, and aloe Vera), seaweeds, and nuts and seeds 5. Confectionery 6. Cereals and cereal products, derived from cereal grains, from roots and tubers, pulses, legumes (fresh pulses and legumes are covered in category 4.2) and pith or soft core of palm tree, excluding bakery wares of food category 07.0 . 7. Bakery products 8. Meat and meat products, including poultry and game
  • 9. 08 ©2015 akshayanand 9. Fish and fish products, including molluscs, crustaceans, and echinoderms 10. Eggs and egg products 11. Sweeteners, including honey 12. Salts, spices, soups, sauces, salads and protein products. 13. Foodstuffs intended for particular nutritional uses. 14. Beverages, excluding dairy products 15. Ready-to-eat savouries 16. Prepared Foods/dishes including Composite foods 17. Products not covered into category 1-16 18. Substances added to food which are ‘not for direct consumption as food’
  • 10. 09 ©2015 akshayanand • 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
  • 11. 10 ©2015 akshayanand • 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
  • 12. 11 ©2015 akshayanand • Eligible Food Business Operators (FBO) need to procure a License from the State Authority.They include, • Manufacturers • Storage • Transporters • Retailers • Marketers • Distributors • After issuance of license, any Modification, Renewal, Duplicate Request are carried out Online. • State License is issued by the State Authorities operating in each state in pursuant to the FSS Regulations, 2011. • DOCUMENTS NEEDED
  • 13. 12 ©2015 akshayanand • 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 catering arrangements, food vendors like dabbawallas etc & Other food Business Operator - INR 2000/Year
  • 14. 13 ©2015 akshayanand 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
  • 15. 14 ©2015 akshayanand Issuance of unique application number Require additional information on incomplete application Manufacturer may apply for manufacturing license in Form B
  • 16. 15 ©2015 akshayanand Inspection of premises after receiving completed application & issue inspection report Either grant or reject the licenseWithin 60 days of receipt of completed application or within 30 days of inspection Manufacturer may start the business after 60 days
  • 17. 16 ©2015 akshayanand 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
  • 18. 17 ©2015 akshayanand 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
  • 19. 18 ©2015 akshayanand 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
  • 20. 19 ©2015 akshayanand • 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
  • 21. 20 ©2015 akshayanand • Causing food to be injurious • Abstracting any constituent • Deliberate adulteration • Non-conformance in Label information etc.,
  • 22. 21 ©2015 akshayanand • Substandard food: Upto Rs. 2.00 lakhs • Misbranded: Upto Rs. 3.00 lakhs • Misleading advertisement : Upto Rs. 10.00 lakhs • Food with extraneous matter: Upto Rs. 1.00 lakhs • Fail to meet the requirements as directed by FSO: Upto Rs. 2.00 lakhs • Unhygienic / unsanitary preparations: Upto Rs. 1.00 lakhs • Adulterant not injurious to health: Upto Rs. 2.00 lakhs • Adulterant injurious to health: Upto Rs. 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 : upto Rs.1.00 lakh • Causing grievous injury : 6 years imprisonment with fine of Rs. 5.00 lakh • Compensation in case for grievous injury : upto Rs.3.00 lakh • Causing death : 7 years or life imprisonment and fine of Rs. 10.00 lakh • Compensation in case of death : upto Rs. 5.00 lakh minimum
  • 23. 22 ©2015 akshayanand • 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.
  • 24. 23 ©2015 akshayanand • 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