1. Overview of FSS Act, Rules and
Regulations
New Food Regulatory Regime in INDIA
CHANGES ! CHALLAENGES ! AND WAY AHEAD
1 Oct 12, 2012

2. Postgraduate with 17 years Techno-‐Commercial Experience.
Native of Himalaya Foothills Dehradun, Uttrakhand.
Key Competencies :
Regulatory Affairs, QMS & FSMS, Quality Assurance/Quality Control
Manufacturing & Operations; Co-‐Manufacturing Operations
Certified QMS/FSMS/ISO 14000 LA Courses DNV/BVQI
Regulatory Affairs
South Asia QA/QC/RSA/
Co-Manufacturing
QA/QC/QMS/
FSMS/Manufacturing
Regulatory Affairs
Microbiologist/Chemist
/QMS
2

3. History & Evolution of FSSAI.
Why Change.
Paradigm Shift.
Difference between Act, Rule and Regulation.
Food Definition & Types of Food.
Offences under Food Law.
Organizational Structure.
Powers and Duties of Authority.
Food Safety and Standards Regulations, 2011.
Impact of FSSA on Industry.
Way forward.
3

4. By mid 1900s food processing sectors laws framed in a veritable grid of
regulation including a multitude of states law e.g. FPO, MMPO, Export
Act, Insecticide Act, MFPO, BIS, EPA, Infant Milk substitute, APA,
Essential commodity act, VOPO etc. etc.
1998 PM council on Trade & Industry suggested for unified single food
regulatory authority.
In 2002 National Non profit association has been constituted to
deliberate on subject.
In 2003 MoH expert group proposed to create new food law to
regulate functional food and dietary supplement.
In 2005 number of committees including standing committee on
parliament on agricultural submitted its 12th report where the need of
single food regulatory body and integrated food law has emphasized.
4

5. Finally Indian food safety standard bill 2005 is signed into law.
In 2006 Food Safety and Standards Act, 2006 came into enforcement
with two objective :
To introduce a single statute relating to food and
To provide for scientific development of the food processing industry
On 5th Aug 2008 FSSAI is constituted.
On 5th May 2011 FSS Rules are notified in to the Gazette.
On 5th Aug 2011 FSS Rules and Regulation came into enforcement.
5

6. 1 2 3 4 5
Ministry of Ministry of Food Ministry of
Ministry of
Health &
Ministry of
& Commerce Food Processing
Family Welfare Agriculture
Consumer Affairs (DGFT) Industries
Agricultural Produce Essential Com. Act Imports & Exports Fruit products
& Marking Act Standards of Weights Regulations order
(AGMARK) & Measures Act Export Inspection Meat & Meat
Packaged Commodities Agency (EIA) Products order
Rules Tea Board
Consumer Protection Act
B.I.S. Act
Milk and Milk
Product Order Coffee Board
(MMPO) Coffee Act & Rules
VOP Control Order
VOP (Std of Quality)
SEO Control Order
6 Contd..

7. 6 7 8 9
Ministry of Rural Ministry of Ministry of HRD Ministry of
Development Forest & (Department of Science &
(AMA) Environment Women& Child Welfare) Technology
Agricultural Trade in
Infant Milk Substitutes, Atomic Energy
Endangered
Produce Species Act Feeding Bottles & Act-­1962
Grading & InfantFoods (Regulation
Ecomark-­CPCB Control of Irradiation
Marking of production, supply & of Foods Rules,1991
Act 1937 distribution) Act & Rules GM & Organic foods
(AGMARK) Packaging
material
7

8. Industry wanted just one window to deal with all the food regulations.
Standards are rigid and non-­‐responsive to scientific advancements and
modernization.
Varied Quality/Safety standards restricting innovation in food products.
Integrated response to strategic issues like Novel foods, GM foods, international
trade etc.
Decentralization of licensing for food products .
Achieve high degree of consumer confidence in quality & safety of food.
Investors friendly regulatory mechanism with emphasis on self regulations and
capacity building.
Emphasis on gradual shift from regulatory regime to self compliance.
Consistency required between domestic and international food policy .
Mechanism for speedy disposal of cases (special courts/Special tribunals).
8

9. PFA FSSAI
Multiple Authorities Single Authority, Single Reference Point
Adulteration Food Safety
Inspection/Control (regulatory Monitoring Surveillance (self
regime) compliance)
Insufficient Full time Food Safety Officer and
Enforcement/Personnel Designated Officers Under FSC
Direct prosecution by court no Graded fine & penalties for offences
appeal before moving to court through adjudication process.
Food Safety Tribunals
No provisions of improvement Provision of improvement notices
notices
GMP/GHP Not mandate GMP/GHP Mandatory (Schedule -‐4)
Improper Control on Import Proper Import Control/Structure
Less Court Cases but HEAVY PANELTIES !
9

10. Act Rules/ Regulations
Primary legislation. Form of secondary legislation.
Are made to regulate the action of
Acts. REGULATION
Legal document (in written form) Rules are framed against the Act by the
Passed by Parliament, which is the authorized body of Parliament.
highest form of law in the land. Can be struck down by a court.
What to Regulate. FSS
REGULAT
Specify enforcement mechanism
ION 2011
How a Act will be Enforced.
FSS
RULES Who will enforce.
2011
Actionable points e.g. particular set of
FSSAI 2006
standards.
Frequent amendment is not These are by laws.
possible. Can be framed/amended (need based)
in line with particular section of the
Act. Outside the parliament.
10

11. The Food Safety And Standards Act, 2006
Passed by parliament with the intention:
to converge 08 different food laws in to one comprehensive act
to have single regulatory body
FSSAI
FSSAI Constituted on 5 Sep 2008
FSSAI is a Statutory Regulatory Body under Ministry of Health & Family
Welfare, Government of India
Mandate of 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.
11

12. 1. Legislations Replaced with New Food Act.
The Prevention of Food Adulteration Act, 1954.
The Fruit Products Order, 1955.
The Meat Food Products Order, 1973.
The Vegetable Oil Products (Control) Order, 1947.
The Edible Oils Packaging (Regulation) Order, 1998.
The Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control)
Order, 1967.
The Milk and Milk Products Order, 1992.
Any other order issued under the Essential Commodities Act, 1955 ( 10
of 1955) relating to food.
2. Compels the establishment of food recall procedures.
3. Mandatory licensing and registration of food business.
4. Only registration Petty FBO.
5. Mandatory to follow Food Safety System e.g. HACCP/FSMS
12

13. 6. Provision of Improvement Notice by DO.
7. Compounding and Adjudication of cases.
8. Special Tribunals -­‐ expedite the disposal of cases.
9. Prohibits advertisements which are misleading or deceiving or
contravenes the provisions of the Act (stakeholders at source may
be prosecuted).
10. All imports of articles of food are covered.
11. Self Regulation by FBOs to ensure that the articles of food
satisfy the requirements of this Act at all stages of production,
processing, import, distribution and sale within the businesses
under his control.
12. Provision for graded penalties where offenses like
manufacturing, storing or selling misbranded or sub-­‐standard food
is punished with a fine, and more serious offences with
imprisonment or both.
13

14. Food Authority:
means the Food Safety and Standards Authority of
India (FSSAI) established under Section 4.
the Central Government shall, by notification,
establish a body to be known as FSSAI to exercise
the powers conferred on, and to perform the
functions assigned to, it under the Act.
Local Area: means any area, whether urban or rural
notified by the Commissioner of Food Safety, to be a
local area for the purposes of this Act
14

15. Commissioner fo Food Safety: means the Commissioner of
Food Safety appointed under Section 30.
-­‐ The State Government shall appoint the Commissioner of
Food Safety for the state for efficient implementation of food
safety and standards and other requirements laid down under
this Act and the rules and regulations made there under.
Designated Officer: means the Officer appointed under
Section 36.
-­‐ The Commissioner of Food Safety shall, by order, appoint the
Designated Officer, who shall not be below the rank of a sub-­‐
divisional Officer, to be in-­‐charge of food safety administration
in such areas as may be specified by Regulations.
15

16. Food Business: means any undertaking, whether for profit or not
and whether public or private, carrying out any of the activities
related to any stage of manufacture, processing, packaging,
storage, transportation, distribution of food, import and includes
food services, catering services, sale of food or food ingredients.
Package: means a pre-­‐packed box, bottle, casket, tin, barrel, case,
pouch, receptacle, sack, bag, wrapper, or such other things in which
an article of food is packed.
Premises: include any shop, stall, hotel, restaurant, airline services
and food canteens, place or vehicle or vessel where any article of
food is sold or manufactured or stored for sale.
16

17. means any substance, whether processed, partially
processed or unprocessed, which is intended for human
consumption and includes primary food to the extent defined in
clause (zk), genetically modified or engineered food or food
containing such ingredients, infant food, packaged drinking
water, alcoholic drink, chewing gum, and any substance,
including water used into the food during its manufacture,
preparation or treatment but does not include any animal feed,
live animals unless they are prepared or processed for placing
on the market for human consumption, plants, prior to
harvesting, drugs and medicinal products, cosmetics, narcotic
or psychotropic substances :
Provided that the Central Government may declare, by notification in the
Official Gazette, any other article as food for the purposes of this Ac having
regards to its use, nature, substance or quality;
17

18. Standardized Food -­‐ for which standards is provided in
FSS(Food Product Standards & Food Additives) Regulations,
2011 under FSSA.
Primary Food (zk) -­‐ Any article of food, being a produce
of agriculture or horticulture or animal husbandry and
dairying or aquaculture in its natural form, resulting from
the growing, raising, cultivation, picking, harvesting,
collection or catching in the hands of a person other than a
farmer or fisherman.
Proprietary Food -­‐
an article of food for which standards have not been
specified but is not unsafe.
18

19. Genetically modified foods -­‐
food and food ingredients
composed of or containing genetically modified or
engineered organisms obtained through modern
biotechnology, or food and food ingredients produced from
but not containing genetically modified or engineered
organisms obtained through modern biotechnology
Organic foods -­‐ means food products that have been
produced in accordance with specified organic production
standards.
19

20. Functional foods-­‐
means:
(a) foods which are specially processed or formulated to satisfy
particular dietary requirements which exist because of a
particular physical or physiological condition or specific diseases
and disorders and which are presented as such, wherein the
composition of these foodstuffs must differ significantly from the
composition of ordinary foods of comparable nature, if such
ordinary foods exist, and may contain one or more of the
following ingredients, namely:-­‐
(i) plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or
hydro alcoholic extract, single or in combination;
(ii) minerals or vitamins or proteins or metals or their compounds or aminoacids (in amounts not exceeding
the Recommended Daily Allowance for Indians) or enzymes (within permissible limits);
(iii) substances from animal origin;
(iv) a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake;
20

21. ( (b) (i) a product that is labelled Food for special dietary uses or
functional foods or nutraceuticals or health supplements or similar
such foods use as a conventional food
and whereby such products may be formulated in the form of
powders, granules, tablets, capsules, liquids, jelly and other dosage
forms but not parenterals, and are meant for oral administration;
(ii) such product does not include a drug as defined in clause (b) and
ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of
section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and
rules made thereunder;
(iii) does not claim to cure or mitigate any specific disease, disorder
or condition (except for certain health benefit or such promotion
claims) as may be permitted by the regulations made under this Act;
(iv) does not include a narcotic drug or a psychotropic substance as
defined in the Schedule of the Narcotic Drugs and Psychotropic
Substances Act, 1985 (61 of 1985) and rules made thereunder and
substances listed in Schedules E and EI of the Drugs and Cosmetics
Rules, 1945;
21

22. Penalty for substandard food Rs 5 lacs
Penalty for misbranded food Rs 3 lacs
Penalty on misleading advertisement Rs 10 lacs
Food containing extraneous matter Rs 1 lac
Penalty for failure to comply with food Three months of
safety officer/False & Misleading Info imprisonment/Rs 2 lacs
Penalty for unhygienic processing of food Rs 1 lacs
Punishment for unsafe food -­‐ Which
Does not result in injury 6 Months Imp and 1 lakhs
Non-­‐grievous injury 1 Year Imp and 3 Lakh
Grievous injury 6 Y Imp and 5 Lakh
Death 7Y or Life Imp and 10 Lakh
Unhygienic or unsanitary conditions 1 lakh rupees
Not having valid license 6 M Imp and 5 Lakhs
Compensation to consumer
Death 5 lakh rupees
Grievous injury 3 Lakh
Injury 1 Lakh 22

23. Consisting of 23 members including
Central Government
one chairperson
Food Authority
Secretariat
Central Advisory
Scientific Panel Scientific Committee Enforcement
Committee
Consisting of 48 members 8-numbers need based 1 from each scientific panel
+ 6 expert members
State Food Safety
Authority
State Food Safety
Food Analyst
Commissioner
Designated Officer
Food Safety Officer
23

24. Food Authority
Consists of 22
members and
Chairperson Agriculture
Retailer (1) Commerce
Organization
(1)
(1)
Farmer Consumer
Organization Affairs
(2) (1)
Food
State & UT
Processing
(5)*
Chairperson (1)
Food
Health
Technologist
(1)
(3)
Consumer Legislative
Organization Affairs
(2) Food Small scale (1)
Industry Industries
(2) (1)
* On rotation basis for every three years
24

25. Some duties and functions
Prepare the standards and guidelines to regulate safety of food.
Setting of Limits for food additives, contaminants, Residues,
processing aids etc.
Accreditation of certification bodies engaged in certification of FSMS.
Procedure and the enforcement of quality control.
Accreditation of laboratories and their notification to stakeholders.
Method of sampling, analysis and exchange of information among
enforcement authorities.
Food labeling standards including claims on health, nutrition, special
dietary uses and food category systems for foods.
25

26. Some duties and functions
CAC ensures close co-­‐operation
between Food Authority and the
enforcement agencies. CEO (1)
BIS, ICMR, Food
Farmer Org Industry
(3) (2)
Advise to Food Authority on
Proposal for work program.
Invitees Agriculture
Prioritization of work. (5) (2)
Identifying potential risks. Central
advisory
Knowledge Pooling. committee
such other functions as may be Chairperson
Scientific
Consumer
Organization
specified by regulations. Committee
(1)
(2)
CAC meet regularly -­‐ min thrice a Coommissioners R&D
Of Food Institutes
year or upon invitation. Safety (28) (2)
Food Labs
(2)
26

27. Some duties and functions
Method of
FA constitutes need based Scientific Sampling (1)
Food additives,
panel. flavorings,
Labeling
(1)
processing aids &
materials in contact
Consist of independent Scientific with food (1)
expert.
Provide Science based opinion on Contaminants in
Food
Pesticides and
respective subject to FA. the food chain
(1)
Authority
Antibiotics residues
(1)
Scientific panel can invite relevant
industry and consumer organizations.
Genetically
Biological hazards modified
FA time to time may re-­‐constitute the (1) Organisms & Food
scientific panel by adding new Functional foods,
Nutraceuticals,
(1)
members or by omitting the existing dietetic pdts & other
or by changing name of panel as the similar products
case may be. (1)
27

28. Some duties and functions
Responsible for providing scientific opinion Independent
to Food Authority. Scientific Experts
(6)
Provide opinion on multi-­‐sector issues falling
within the scope of more than one scientific
panel or beyond the scope of any panel.
Food
Authority
Set up working group for establishing
scientific opinion particularly in the case of
subjects where Scientific Panel does not exist.
E.g Fisheries Products; vegetable products etc.
Chairpersons of
Scientific Panels
28

29. Food Safety Commissioner
Food Safety Special Courts
Referral Appellate (whenever
Lab Tribunal required)
Accredited
Lab Designated
Officer Adjudicating Officer
Food
Analyst Food Safety
Officer
29

30. MISBRANDED
AND UNSAFE
SUBSTANDARD FOOD
FOOD
ADJUDICATING COURTS
Fine with
FINE
Punishment
30

31. Powers & Duties
Prohibit in the interest of public health, the manufacture, storage,
distribution, or sale of any article of food.
Carry out survey of the food processing units in the state to find
out compliance of standards.
Conduct training programs for the personnel engage in the food
safety.
Ensure efficient and uniform implementation of the standards
and other requirements.
Sanction prosecution for offences punishable with imprisonment
under this Act.
31

32. Powers & Duties
Issue or cancel license of Food Business Operator.
Prohibit sale in contravention of this Act.
Receive report and samples of articles of food from Food Safety
Officer and get them analyzed.
Make recommendation to the Commissioner of Food Safety for
sanction to launch prosecutions.
Sanction prosecution.
Maintain record of all inspections made by Food Safety Officers.
Get investigated complaints in respect of any contravention of the
provision of this Act or against FSO.
32

33. Powers & Duties
Power to take a samples of any food or any substance, to be
intended for sale or to have been sold for human consumption.
Seize any articles of food which appears to be in contravention of
this Act.
Enter and inspect any place where the food is manufactured, or
stored for sale.
May after giving notice to the food business operator cause the
food to be destroyed which is unfit for human consumption.
Seize any adulterant found in possession of a manufacture or
distributor of any article of food.
Penalty for harassment of food business operator and also for
false complaint.
33

34. Food Safety & Standards Regulations (FSSR),
2011 is divided into six parts:
FSS (Licensing and Registration) Regulations, 2011
FSS (Packaging and Labeling) 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) Regulation, 2011
34

35. Every FBO is covered.
Licensing and registration segregated.
Petty food business operators need to apply for Registration only.
Conversion of existing Licenses is extended till Feb, 2013.
25.06.2012 -­‐ A Table containing food categorization and food codes
is uploaded on FSSAI website.
Food Categorization is based on harmonization of CODEX and
Indian products.
Two tier system of licensing Central & State
60 days time limit for processing of license / 30 days for
Registration.
Introduction of exhaustive Safety, Sanitary and Hygienic conditions
mandatory for registration/licensing
35

36. Necessary access to licensing authority.
Communicate any change in the documents or Mfg lines.
One Technical person for Production with Science degree.
Periodic Annual Return to be submitted before 31st of May.
Comply with Schedule 4 (GMP/GHP).
Maintain Daily Record of Production/Purchase and Sales.
Source and Standards of RM of Optimum Quality.
36

37. Testing of RM/PM/FG for Physical, Chemical and Microbiological
Parameters once in a six months/Own or NABL recognised lab.
Required Temperature conditions Throughout the supply chain.
Buy or Sale from only licensed or registered vendors.
CIP to be followed for cleaning and sanitation of equipment.
Well equipped laboratory facility.
Register for edible oil RM , Nature, Purchase/Produced/Sold
records.
Can not sold/offer/distribute edible oil without packaging/Marking
and Labeling.
37

38. 38

39. Product approval process is simplified.
Only Broader category wise product approval is required.
If one FBO has taken approval, other FBOs need not to be
applied for the exact same product (with permitted variations).
For Novel/new products whose safety is not established need
product approval before applying for license.
Product approval not required for Traditional foods.
If product has safe history of use in other countries will be
accepted (Case to case basis).
NOC will be issued for 1 Year.
In case of Novel food, application will be sent to scientific
committees for approval.
No claim will be made on novel food without prior approval.
39

46. Create Your ID & Password
Fill in Form B
Upload Required Documents
Online Fill in DD Details
Acknowledgement No. Will be Generated
Print Out Ackn No. sheet
Online Printout online filled Form -‐ B
Prepare DD of Required Fees
Collect all the required documents (e.g.
Blue Print or Layout Plan, Form B, DD,
HACCP Certificate, Affidavit, Nomination
Details, Recall Plan, Water Testing Report,
Memorandum of Article, Source Details for
Milk and Meat Processing, NOC from PCB,
List of Directors, Equipment List and their
Physical
Installed Capacity, Photo ID of Authorized
Signatory or Nominee, List of Food
Category desired to be Manufactured,
Proof of possession of Premises, NOC from
Manufacturers in case of Re-‐labelers.
Submit to the DO of your Region

47. Go to Licensing Portal
Go to Modification Tab
Select Lic. No. to be Modified.
Online Revise Form B
Upload Revised Documents
Print Out Ackn No. sheet
Printout online filled Form -‐ B
Online
Prepare DD of Required Fees (for one
year only)
Collect all the required documents
(e.g. changed blue Print or Layout
Plan, Form B, Fee -‐ DD, HACCP
Certificate, Affidavit, Nomination
Physical Details, Recall Plan, Water Testing
Report, Equipment List and their
Installed Capacity, List of Food
Category desired to be
Manufactured.
Changes in nominations and Directors
details, Capacities etc. Needs to be
communicated to the FSSAI.

48. Trade/ Brand name & FSSR category/ Food Descriptor
Ingredients in descending order.
Vegetarian Symbol.
Non Veg Symbol.
Net Weight
Date of manufacturing or packing
Best Before
Manufactured and Marketed By
Lot No.
MRP
Nutritional information
Consumer contact details
48

49. Best Before: mmm/yyyy in CAPS up to which the product is best for
consumption needs to be mentioned
Manufacturing date:
mmm/yyyy: Best Before Date > 3 months
dd/mmm/yyyy: Best Before Date < 3 months
Use by date/recommended last consumption date/expiry date:-‐
The use by date/recommended last consumption date/expiry
date shall be given,-‐
in case of package of Aspartame, which shall be not more than
three years from the date of packing;
in case of infant milk substitute and infant foods.
49

50. Height of any numeral in the declaration
required under rules, on the principal display
panel shall not be less than.
Sl. No Net Quantity in Minimum height of
weight/Volume numeral
1 Upto 50g/ml 1
2 Above 50g/ml upto 200g/ml 2
3 Above 200g/ml upto 1kg/litre 4
4 Above 1Kg/litre 6
50

51. Nutritional Information:
Nutrient Unit Value*
Energy kcal 0 decimal
Protein g 1 decimal
Carbohydrate g 1 decimal
Sugar g 1 decimal
Fat g 1 decimal
Claims
No food should be described or presented in a manner that is
false, misleading or deceptive
Claims should be justifiable.
No health claim on proprietary/Novel food/Functional foods
without FSSAI approval.
51

52. Chapter 1 title and commencement, Definitions
Chapter 2 Food Product Standards
Regulation 2.1 Dairy Products and Analogues
Regulation 2.2 Fats, Oils and Fat Emulsions
Regulation 2.3 Fruit & Vegetable Products
Regulation 2.4 Cereals and Cereal Products
Regulation 2.5 Meat and Meat Products
Regulation 2.6 Fish and Fish Products
Regulation 2.7 Sweets & Confectionery
52

53. Regulation 2.8 Sweetening Agents including Honey
Regulation 2.9 Salt, Spices, Condiments and Related
Products
Regulation 2.10 Beverages (other than Dairy and Fruits
& Vegetables based)
Regulation 2.11 Other Food Products & Ingredients
Regulation 2.12 Proprietary Food
Regulation 2.13 Irradiation of Food
53

54. Definitions and Standards of Quality e.g.
Atta
54

55. Natural Coloring Matter (Regulation 3.1.2:2): Natural Coloring
matters which may be used:
Beta-‐carotene No Restriction except
Chlorophyll Annatto specifically mentioned
Riboflavin Saffron in standards
Caramel Curcumin
Allowed Synthetic Food Colors (Regulation 3.1.2:4)
Ponceau 4R Sunset Yellow FCF
Carmoisine Indigo Carmine
Erythrosine Brilliant Blue FCF
Tartrazine Fast Green FCF
Restricted Usage: Provisions for specific use in FSS
(Food Product Standards & Food Additives) Regulations,
Chapter 3 and Appendix A
55

56. Preservative: Means a substance which when added to food, is
capable of inhibiting, retarding or arresting the process of
fermentation, acidification or other decomposition of food.
Class I Preservatives:
*Addition of Class I Preservative
Common Salt Spices allowed in any food is not
Sugar Vinegar restricted, unless otherwise
provided in the rules
Dextrose Honey
Glucose Syrup Edible Vegetable Oil
Class II Preservatives:
Restricted Usage: Provisions for specific use in Chapter 2 and
Appendix A.
Use of more than 1 class 2 preservatives in a food NOT
ALLOWED, unless provided specifically.
56

57. Antioxidant: Means a substance which when
added to food retards or prevents oxidative
deterioration of food and does not include sugar,
cereal oils, flours, herbs and spices.
Allowed Antioxidants in any food:
Lecithin
Ascorbic acid
Tocopherol
Other antioxidants: Restricted Usage-‐ Provisions
for specific use in FSS (Food Product Standards &
Food Additives) Regulations, Chapter 2 and
Appendix A of this Regulation.
57

58. Regulation 3.1.6: 1: Definition: substances, which when
added to food are capable of facilitating a uniform
dispersion of oils and fats in aqueous media or vice versa
Regulation 3.1.6: 2: No emulsifying and stabilizing agent
shall be used in any article of food, except where use is
specifically permitted.
Regulation 3.1.6:3: Use of Starch Phosphate.
Regulation 3.1.6:4: Use of modified starches.
Regulation 3.1.6:5: Use of emulsifier and stabilizer in flavours.
Regulation 3.1.6:6: Use of emulsifier and stabilizer in fruit products.
Regulation 3.1.6:7: Use of emulsifier and stabilizer in frozen
desserts.
58

59. Flavoring agents may be of following three types:
Natural Flavors and Natural Flavoring Substances: are flavor
preparations and single substance respectively, acceptable for
human consumption, obtained exclusively by physical processes
from vegetable, for human consumption.
Nature Identical Flavoring Substances: are substances
chemically isolated from aromatic raw materials or obtained
synthetically; they are chemically identical to substances present
in natural products intended for human consumption, either
processed or not.
Artificial Flavoring Substances: are those substances which have
not been identified in natural products intended for human
consumption either processed or not.
The Flavoring agents may contain permitted anti-‐oxidants,
emulsifying and stabilizing agents and food preservatives as per
Regulation 3.1.10 (3).
59

60. For the purpose of the standards specified in FSS (Food Product
Standards & Food Additives) Regulations, Chapter 2, the "Carry Over"
principle applies to the presence of additives such as colours,
flavouring agents, antioxidants, anti-‐caking agents, emulsifying and
stabilizing agents, and preservative in food, as a result of the use of
raw material or other ingredients in which these additives were used.
The presence of contaminants is not covered for this purpose.
The presence of an additive in food through the application of the
carry over principle is admissible in general unless otherwise
specifically prohibited in any FSSR or in FSS (Food Product Standards
& Food Additives) Regulations, Chapter 2 provided the total additive
including the carry over through the raw material or other
ingredients does not exceed the maximum amounts so
permitted.
60

61. Appendix A
Additives which can be added to different category of food
Appendix B
Microbiological Requirements
61

62. Appendix A lists down various food additives allowed in different
categories of food
Table 1 List of food additives for use in Bread & Biscuits
Table 2 List of food additives for use in Foods
Table 3 List of food additives for use in foods not specified
Table 4 List of food additives for use in edible oils & fats
Table 5 List of food additives for use in fish & fish products
Table 6 List of food additives for use in Thermally Processed
Fruits
Table 7 List of food additives for use in Thermally Processed
Vegetables
Table 8 List of food additives for use in food products
Table 9 -‐ List of food additives for use in food products (Fruits &
Veg)
62

63. Appendix A lists down various food additives allowed in
different categories of food
Table 10 -‐ List of food additives for use in food products (Fruits &
Vegetables)
Table 11 -‐ List of food additives for use in food products (Fruits &
Vegetables)
Table 12 -‐ List of food additives for use in Sugars & Salt
Table 13 -‐ List of food additives for use in Cocoa Powder,
Chocolate, Sugar Boiled Confectionery, Chewing Gum/Bubble
Gum.
Table 14 -‐ List of food additives for use in Milk products
Table 15 -‐ List of food additives for use in individual variety of
cheese
63

64. Appendix B lists microbiological requirements in different
categories of food:
Table 1 Microbiological requirements for sea foods
Table 2 Microbiological parameters for milk products
Table 3 Microbiological parameters for spices
Table 4 Microbiological requirements for food products
(Fruits & Vegetables)
64

65. Chemicals described in monographs of the Indian
Pharmacopeia when used in foods, shall not contain
metals contaminants beyond the limit specified in
the appropriate monographs of the Indian
Pharmacopeia for the time being in force.
List of Metal Contaminants as per FSSR:
Lead Cadmium
Copper Mercury
Arsenic Methyl Mercury
Tin Chromium
Zinc Nickel
65

66. Crop contaminants: Means any substance not intentionally
added to food, but which gets added to articles of food in
the process of their production (including operations
carried out in crop husbandry, animal husbandry and
veterinary medicine), manufacture, processing,
preparation; treatment, packing, packaging, transport or
holding of articles of such food as a result of
environmental contamination.
Naturally occurring toxic substances
mg/kg
(Regulation 2.2.2)
Agaric acid Max 100
Hydrocyanic acid Max 5
Hypericin Max 1
Safrole Max 10
Aflatoxin (Regulation 2.2.1) 0.03mg/kg
66

67. Residues: no insecticides shall be used directly on articles of
food.
Provided that nothing in this regulation shall apply to the
fumigants which are registered and recommended for use as
such on articles of food by the Registration Committee,
constituted under section 5 of the Insecticides Act, 1968 (46
of 1968).
67

68. Major benefits:
Broad based product standards.
Additives if allowed in Codex, may be easily requested to be
allowed in local standards.
Single authority instead of multiple ministries controlling the food
industry.
Possible disadvantages:
Stringent contaminant limits (e.g.: pesticide residues, antibiotics,
mycotoxins etc..)
Higher penalties along with imprisonment in case of standard
violations.
68

69. FSSI proposes 12th Five year plan 2012-­‐2017 which includes :
Food safety needs to be the part of Education System -­‐ NCERT
Foods for Special Dietary Use (FSDU) Regulation.
Specify standards and guidelines in relation to food items, limits for
food additives, Labeling & Quality control.
Designate and finalise upgradation plans for Referral labs and food
laboratory infrastructure.
Regulation for Safety and Quality of Water/Milk & Meat Industry.
Trans Fats and Saturated Fats Standards.
Regulations for Labeling and claims especially for functional foods.
69

70. Develop procedures for establishment and working of
Adjudicating officers and Food Safety Tribunals.
Food Safety Surveillance Mechanism, Recall Mechanism.
Review standards for Organic Food, GAP and GMP.
Harmonization of standards with other Food Regulations and
CODEX.
Consumer awareness for food safety, disaster management.
Critical studies on (e.g. through NIN)
Diet Surveys,
Data-­‐base for Food Safety Regulations, Trans Fatty Acids
Import regulation regime etc.
70

71. 72