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Ministry of Commerce& Industry
2021
Food Fortification
1
SUBBURAJ M
Deputy Director
DESIGNATED OFFICER/CENTRAL LICENSING
AUTHORITY, AUTHORISED OFFICER IMPORT
AND EXPORT OPERATIONS
FSSAI, Eastern Region
Ministry of Commerce& Industry
2021
2
Important Definitions
Fortification: Means deliberately increasing the content of essential micronutrients in a food so as to
improve the nutritional quality of food and to provide public health benefit with minimal risk to health.
Fortificant: Substance added to food to provide micronutrients but does not include nutraceuticals or
foods for Special Dietary Uses.
Fortified food: Food, as specified under the Food Safety and Standards (Food Products Standards and
Food Additives) Regulations, 2011, that has undergone the process of fortification as per the provisions of
these regulations.
Ministry of Commerce& Industry
2021
3
Fortified Processed Foods: Processed foods (i.e., foods that have been altered from its natural state by
industrial processing methods) that have undergone the process of fortification as per the provisions of
these regulations. The same may have fortified staples as raw materials and/or fortified with permitted
micronutrients and additives as specified under the Food Safety and Standards (Food Product Standards
and Food Additives) Regulation, 2011.
Micronutrients: Means essential dietary nutrients including vitamins, minerals or trace elements that are
required in very small quantities and are vital to development, disease prevention and wellbeing of human
beings.
Ministry of Commerce& Industry
2021
Food Fortification
• Food is any nutritious substance required by living organisms in order to maintain life and support
growth. Food is essential as it gives us the energy and nutrients to grow and develop.
• Nutrients can be defined as the substances found in food that help the body to function properly. Food
provides different nutrients to living organisms, which can be classified into two main groups:
• Macronutrients: There are three macronutrients that are required in large amounts and are essential
for good health. These are Carbohydrate, Protein and Fat. Macronutrients are measured in grams (g).
• Micronutrients: There are two types of micronutrients namely Vitamins and Minerals. Their amounts
are measured in milligrams (mg) and micrograms (μg).
4
Ministry of Commerce& Industry
2021
5
General Principles
1. Micronutrients may be appropriately added to foods for the purpose of contributing to any of
the following as mentioned schedule 1.
(a)Preventing or reducing the risk of, or correcting, a demonstrated deficiency of one or more micronutrients in
the population or specific population group.
(b)Reducing the risk of, or correcting, inadequate nutritional status of one or more micronutrients in the
population or specific population group.
(c) Meeting requirements or recommended intake of one or more micronutrients.
(d) Maintaining or improving health.
(e) Maintaining or improving the nutritional quality of foods.
5
Ministry of Commerce& Industry
2021
6
2. When fortification of a food is made mandatory, it shall be based on severity and extent of public health need as
demonstrated by generally accepted scientific evidence.
3. The Food Authority may, specify mandatory fortification of any staple food on direction of the Government of
India.
4. Wherever “Iron (As Fe)” is used as a source of nutrient, heme iron shall not be used in any form in any article of
food.
5. Fortified Processed Foods may be prepared from fortified food articles that may be cereals and/or milk;
6. The Fortified Processed Food shall provide 15-30% of the Indian adult RDA of micronutrient based on an average
calorie intake of 600 kcal from processed foods (approximately 1/3rd of daily energy requirement for an adult);
7. High Fat Sugar Salt (HFSS) Foods shall be excluded from Fortified Processed Foods category. The definition of
HFSS foods shall have the same meaning as specified under the Food Safety and Standards (Labelling and Display)
Regulations,2020.
Ministry of Commerce& Industry
2021
Fortification means
increasing the
content of essential
micronutrients to
provide health
benefits
It refers to providing
concentrated
sources of nutrients
in diet in the form of
capsules,pills,injecti
ons
Synonymous with
fortification refers to
addition of
micronutrient to the
food which are lost
during processing
Fortification Enrichment
Supplementation
Fortification v/s supplementation
Ministry of Commerce& Industry
2021
It does not change
the taste, odor, color
or texture of food
I
It does not require
manufacturers to
adapt to a new or
expensive
technology
It does not require
consumers to alter
their eating habits.
It is a safe and cost
effective method
Fortification means deliberately increasing the content of essential micronutrients in a food so as to
improve the nutritional quality of food and to provide public health benefit with minimal risk to
health
Benefits Of Fortification
Ministry of Commerce& Industry
2021
Why fortification?
9
Ministry of Commerce& Industry
2021
Commodity Fortificant
Rice Iron, Folic Acid, Vitamin B12
Wheat Flour, Maida Iron, Folic Acid, Vitamin B12
Milk Vitamin A, Vitamin D
Fruit juice Vitamin C
Edible Oil Vitamin A, Vitamin D
Salt Iron , Iodine
In India, fortification has been implemented for commodities which are consumed in fairly
consistent and sufficiently large amounts by the population
The optional Micronutrients for Rice and Wheat Flour are Zinc, Vitamin A, Thiamine (Vitamin B1),
Riboflavin (Vitamin B2), Niacin (Vitamin B3) and Pyridoxine (Vitamin B6). 10
Ministry of Commerce& Industry
2021
How to fortify ?
Ministry of Commerce& Industry
2021
Ferrous
sulphate
Premix
preparation
Salt
Addition of
Sodium
Hexa Meta
Phosphate
& blending
Double Fortified salt
Encapsulated
premix of
ferrous
fumarate
Blending
/Mixing
Double Fortified salt
Ministry of Commerce& Industry
2021
Pulverized
milled rice
Vitamin/
mineral
premix
Extrusion
processing
Fortified rice kernel
Fortified Rice Kernel
Ministry of Commerce& Industry
2021
Preblend
(premix + small
amt oil)
Refined oil
Mixing/
Blending
1.Batch
2.Continuous
Fortified oil
Fortified oil
Ministry of Commerce& Industry
2021
Micronutrients namely Iron,
Folic Acid and Vitamin B12
are added in the form of a
premix through a feeder
located towards the end of
the milling process
Fortified wheat flour
Fortified wheat flour
Ministry of Commerce& Industry
2021
Liquid milk is fortified
just prior to
pasteurization or ultra-
heat treatment, and it is
essential to ensure a
good distribution of the
nutrients in milk prior
to any heat treatment.
The simplest way to fortify
dried milk is to blend dry
forms of vitamins and
minerals with the dried
milk powder, although oily
forms can also be added
Fortified Milk
Ministry of Commerce& Industry
2021
Food Safety and Standards (Fortification of Foods)
Regulation, 2018
Standards
on
fortifications
General
obligations
General
definitions
17
Ministry of Commerce& Industry
2021
.
STANDARDS ON FORTIFICATIONS
Wherever “Iron (As Fe)” is used as a
source of nutrient, heme iron shall
not be used in any form in any
article of food.
Micronutrients may be
appropriately added to foods as
mentioned in Schedule-I
High Fat Sugar Salt (HFSS) Foods
shall be excluded from Fortified
Processed Foods category
The Fortified Processed Food shall
provide 15-30% of the Indian adult
RDA of micronutrient based on an
average calorie intake of 600 kcal
General
principles
18
Ministry of Commerce& Industry
2021
Compliance with Standards on Micronutrient Content in Fortified Food.
Any manufacturer who fortifies any food shall ensure that the level of added micronutrients on label of such
fortified food shall fall within the range specified in Schedule-I.
The tolerance of minus 10 percent of the declared total value on the label may be allowed for the purposes
of compliance and analysis at any point in time (max limit Schedule-I)
19
Ministry of Commerce& Industry
2021
GENERAL OBLIGATIONS
20
Ministry of Commerce& Industry
2021
QUALITY ASSURANCE
 Every manufacturer and packer of fortified food
shall give an undertaking on quality assurance
Quality
Assurance
Certification by a
food laboratory that
the fortified food is in
compliance with the
provisions of the Act
and regulations
Up-to-date record
keeping and
continuous
inventory of
fortificants
The undertaking
shall be given
twice a year
Random testing
of fortificants and
fortified food;
Regular audit of
technical equipment
and processes;
21
Ministry of Commerce& Industry
2021
Packaging and Labelling Requirements
Every package of fortified food
shall carry the words “fortified
with ………… (name of the
fortificant)” and the logo
It may also carry a tag line
“Sampoorna Poshan Swasth
Jeevan” under the logo.
Every package of food, fortified
with Iron shall carry a statement
“People with Thalassemia may
take under medical supervision
and persons with Sickle Cell
Anaemia are advised not to
consume iron fortified food
products
All fortified food shall be
packaged in a manner that takes
into consideration the nature of
the fortificant added and its
effect on the shelf life of such
food.
Fortified food shall be permitted
to make a nutrition claim in
relation to an article of fortified
food under the Food Safety and
Standards (Packaging and
Labeling) Regulations, 2011.
22
Ministry of Commerce& Industry
2021
SCHEDULE-I
23
Ministry of Commerce& Industry
2021
Iron fortified iodized salt
(Double Fortified Salt)
Iron fortified iodized salt (Double Fortified Salt) when fortified with Iron and Iodine Salt shall
be fortified with Iodine and may also be fortified with iron in combination with iodine, at the
level given
S. No. Component Level of nutrients Source of Nutrients
1. Iodine content
(a) Manufacture level
(b) Distribution channel
including retail level
15- 30 parts per
million(on dry
weight basis)
Potassium Iodate
2. Iron content (as Fe) 850-1100 parts per
million
Ferrous sulphate or
FerrousFumarate
24
Ministry of Commerce& Industry
2021
 Double fortified salt may contain Hydroxypropyl Methyl Cellulose, Titanium dioxide full
Hydrogenated Soybean oil and Sodium Hexametaphosphate (all food grade) and
anticaking agent not more than 2.0 percent. On dry weight basis
 the water insoluble matter wherein anticaking agent is used shall not exceed 2.2 percent.
25
Ministry of Commerce& Industry
2021
Fortified Oil
Vegetable Oil shall be fortified with the following micronutrients, at the level given
Note: Vitamin A (retinol): 1 IU= 0.3 μg RE (Retinol Equivalent); Vitamin D (Cholecalciferol or
Ergocalciferol): 1 IU= 0.025 μg
Sl.
No.
Nutrient Level of nutrient Source of nutrient
1. Vitamin A
6 µg RE - 9.9 µg RE per
gm.
of oil
Retinyl acetate or Retinyl
palmitate
2. Vitamin D
0.11 µg– 0.16 µg per gm. of
oil.
*Cholecalciferol or
*Ergocalciferol
(*Only from Plant Source)
26
Ministry of Commerce& Industry
2021
Fortified Milk
Toned, double toned, skimmed milk or standardized milk /milk powder shall be fortified with
the following micronutrients, at the level given
Fortified Milk Powder: shall only be used in the Government Funded Programs for the
purpose of preparation of ‘Reconstituted Fortified Milk’
Sr. No. Nutrients/Source
Level of nutrient per liter of
Milk
1.
Vitamin A (μg RE)- Retinylacetate or
Retinyl palmitate 270 - 450
2.
Vitamin D (μg) *Cholecalciferol
or*Ergocalciferol (*Only fromPlant
source)
5-7.5
27
Ministry of Commerce& Industry
2021
 In addition to the labelling provisions mentioned under Food Safety and Standards
Regulations, the label of Fortified Milk Powder shall also carry the following statement:
(a) NOT RECOMMENDED FOR DIRECT CONSUMPTION;
(b) ONLY FOR USE UNDER ______________ (Name of the Government Funded
Programme);
(c) TO BE CONSUMED ONLY AFTER RECONSTITUTION OF THE ENTIRE
CONTENT AS PER THE DIRECTIONS ON THE LABEL.
(d) PACK ONCE OPENED, TO BE CONSUMED ON THE SAME DAY.]
Fortified Milk Powder labelling
28
Ministry of Commerce& Industry
2021
Fortified Atta
Atta, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given
Sr.No. Nutrient
Level of
Fortification per
Kg
1.
Iron-Ferrous citrate or Ferrous lactate or Ferroussulphate or
Ferric pyrophosphate or electrolyticiron or Ferrous fumarate or
Ferrous BisGlycinate;or
Sodium Iron (III) Ethylene diamine tetraAcetateTrihydrate
(Sodium feredetate-Na Fe EDTA);
28 mg- 42.5 mg
2. Folic acid 75 µg- 125 µg
3. Vitamin B12- cyanocobalamine or hydroxycobalamine 0.75 µg- 1.25 µg
29
Ministry of Commerce& Industry
2021
 In addition atta may also be fortified with following micronutrients, singly or in
combination, at the level in the table below
S.No. Nutrient Level of Fortification per Kg
1. Zinc-Zinc Sulphate 10 mg- 15 mg
2. Vitamin A-Retinyl acetate or
RetinylPalmitate,;
500 µg RE- 750 µg RE
3. Thiamine (Vitamin B1)- Thiamine
hydrochlorideor Thiamine
mononitrate;
1 mg- 1.5 mg
4. Riboflavin (Vitamin B2)- Riboflavin or
Riboflavin 5'-phosphate sodium ;
1.25 mg- 1.75 mg
5. Niacin(Vitamin B3)- Nicotinamide or
Nicotinicacid;
12.5 mg- 20 mg
6. Pyridoxine(Vitamin B6)- Pyridoxine
hydrochloride;
1.5 mg- 2.5 mg
30
Ministry of Commerce& Industry
2021
Maida, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given in the
table
S.No. Nutrient Level of Fortification per Kg
1.
Iron
(a) Ferrous citrate or Ferrous lactate or Ferrous
sulphate or Ferric pyrophosphate or
electrolyticiron or Ferrous fumarate or
Ferrous bis glycinate
or
(a) Sodium Iron (III) Ethylene diamine tetra
Acetate Trihydrate (Sodium feredetate -Na Fe
EDTA)
28 mg- 42.5 mg *
14 mg- 21.25 mg
2. Folic acid 75 µg- 125 µg
3.
Vitamin B12- cyanocobalamineor
hydroxycobalamine 0.75 µg- 1.25 µg
31
Ministry of Commerce& Industry
2021
 In addition, Maida may also be fortified with following micronutrients, singly or in
combination, at the level in the table below
S.No. Nutrient Level of Fortification per Kg
1. Zinc-Zinc Sulphate 10 mg- 15 mg
2. Vitamin A-Retinyl acetate or
RetinylPalmitate,;
500 µg RE- 750 µg RE
3. Thiamine (Vitamin B1)- Thiamine
hydrochlorideor Thiamine
mononitrate;
1 mg- 1.5 mg
4. Riboflavin (Vitamin B2)- Riboflavin or
Riboflavin 5'-phosphate sodium ;
1.25 mg- 1.75 mg
5. Niacin(Vitamin B3)- Nicotinamide or
Nicotinicacid;
12.5 mg- 20 mg
6. Pyridoxine(Vitamin B6)- Pyridoxine
hydrochloride;
1.5 mg- 2.5 mg
32
Ministry of Commerce& Industry
2021
Fortified Rice
Rice, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level
given in the table below:
S.No. Nutrient Level of Fortification per Kg
1.
Iron- (a)Ferric pyrophosphate
or
(b) Sodium Iron(III) Ethylene diamine
tetra Acetate Trihydrate(Sodium
feredetate -Na Fe EDTA);
28 mg- 42.5 mg *
14 mg- 21.25 mg
2. Folic acid-Folic acid; 75 µg- 125 µg
3. Vitamin B12- cyanocobalamine or
hydroxycobalamine;
0.75 µg- 1.25 µg
33
Ministry of Commerce& Industry
2021
In addition, rice may also be fortified with following micronutrients, singly or in
combination, at the level given in the table below:
S.No. Nutrient Level of Fortification per Kg
1. Zinc-Zinc Oxide 10 mg- 15 mg
2. Vitamin A- RetinylPalmitate; 500 µg RE- 750 µg RE
3. Thiamine (Vitamin B1)- Thiamine
hydrochlorideor Thiamine mononitrate;
1 mg- 1.5 mg
4. Riboflavin (Vitamin B2)- Riboflavin or
Riboflavin5'-phosphate sodium ;
1.25 mg- 1.75 mg
5. Niacin(Vitamin B3)-Nicotinamide or
Nicotinic acid;
12.5 mg- 20 mg
6. Pyridoxine(Vitamin B6)-Pyridoxine
hydrochloride;
1.5 mg- 2.5 mg
34
Ministry of Commerce& Industry
2021
Fortified food logo
35
Ministry of Commerce& Industry
2021
+F logo has been developed to be used on the packs of
fortified food products to increase consumer awareness
and assist consumers in making healthier choices.
The fortification logo (+F) indicates that the food has
been fortified with micronutrients as per standards
mandated by FSSAI. It is surrounded by a square
which represents completeness.
 The half ring below the +F sign symbolizes good
health, protection for an active and healthy life.
The FBOs fortifying their product, shall undertake an
endorsement by logging in the FoSCoS.
36
Fortified food logo
Ministry of Commerce& Industry
2021
SCHEDULE-II
Specifications for logo
37
Ministry of Commerce& Industry
2021
38
Ministry of Commerce& Industry
2021
39
Ministry of Commerce& Industry
2021
SCHEDULE-III
Standards for processed fortified foods
40
Ministry of Commerce& Industry
2021
Cereal products include Breakfast cereals, Pasta and Noodles, when fortified, shall contain
added iron, folic acid and Vitamin B12 at the level given in the table below, namely:-
S. No.
Nutrients/Source
Level of
nutrient per
100 g
1
Iron (mg) Ferrous citrate or Ferrous lactate or Ferrous
sulphate or Ferric pyrophosphate or electrolytic iron or
Ferrous fumarate or Ferrous bis glycinate; or SodiumIron
(III) Ethylene diamine tetra acetate, trihydrate (Sodium
feredetate -Na Fe EDTA);
1.4-2.7
2 Folic acid (μg) 8-16
3 Vitamin B12 (μg) - Cyanocobalamine, or
Hydroxycobalamine
0.08-0.16
Fortified Cereal Products
41
Ministry of Commerce& Industry
2021
In addition, fortified cereal products, when fortified, may also be fortified with following
micronutrients, singly or in combination, at the level in the table below, namely
Fortified Cereal Products
S. No. Nutrients/Source Level of nutrient per 100 g
1. Zinc (mg): Zinc Sulphate 1.0-1.9
2. Vitamin A (μg RE): Retinyl acetate or Retinyl Palmitate, 48-96
3. Thiamine (Vitamin B1) (mg): Thiamine hydrochloride or
Thiamine mononitrate;
0.1-0.19
4. Riboflavin (Vitamin B2) (mg): Riboflavin or Riboflavin
5’-phosphate sodium ;
0.11-0.22
5. Niacin(Vitamin B3) (mg): Nicotinamide or Nicotinic
acid;
1.3-2.6
6. Pyridoxine (Vitamin B6) (mg): Pyridoxine
hydrochloride;
0.2-0.3
42
Ministry of Commerce& Industry
2021
In addition, fortified bakery wares, when fortified may also be fortified with following
micronutrients, singly or in combination, at the level in the table below:
Fortified Bakery Products
S. No. Nutrients/Source
Level of nutrient per 100
g
1. Zinc (mg): Zinc Sulphate 1.0-1.9
2. Vitamin A (μg RE): Retinyl acetate or Retinyl Palmitate, 48-96
3.
Thiamine (Vitamin B1) (mg): Thiamine hydrochloride or
Thiamine mononitrate;
0.1-0.19
4.
Riboflavin (Vitamin B2) (mg): Riboflavin or Riboflavin
5’-phosphate sodium ;
0.11-0.22
5.
Niacin(Vitamin B3) (mg): Nicotinamide or Nicotinic
acid;
1.3-2.6
6.
Pyridoxine (Vitamin B6) (mg): Pyridoxine
hydrochloride;
0.2-0.3 43
Ministry of Commerce& Industry
2021
Bakery wares includes bread, biscuits, rusks and buns ,when fortified, shall contain added iron,
folic acid and Vitamin B12 at the level given in the table below, namely:-
S. No. Nutrients/Source
Level of nutrient per
100 g
1
Iron (mg): Ferrous citrate or Ferrous lactate or
Ferrous sulphate or Ferric pyrophosphate or
electrolytic iron or Ferrous fumarate or Ferrous
bisglycinate; or Sodium Iron (III)Ethylene
diamine tetra acetate, trihydrate
(Sodiumferedetate -Na Fe EDTA);
1.4-2.7
2 Folic acid (μg) 8-16
3
VitaminB12(μg)-Cyanocobalamine,or
Hydroxycobalamine;
0.08-0.16
44
Ministry of Commerce& Industry
2021
Fruit juices, when fortified, shall contain Vitamin C at the level given in the table below
Fortified Fruit Juices
Sr.
No.
Nutrients/Source Level of nutrient per 100
m L
1. Vitamin C (mg): Ascorbic acid 6-12
45
Ministry of Commerce& Industry
2021
Health Claims
In order to have uniformity in claims, the following scientifically substantiated health claims
are suggested, which may be used in broader form for the above fortified foods against
respective micronutrients fortified in accordance with the above said regulations:
Nutrients Claims
Vitamin A Helps against night blindness
Vitamin D Supports strong bones
Vitamin B 12 Important for maintaining normal functioning of nervous
system and blood formation
Folate & Folic acid Important for foetal development and blood formation
Iron FightsAnaemia
Iodine Required for normal growth, thyroid and brain function
Zinc Supports a healthy immune system
Thiamine Required for normal nerve and heart function
Riboflavin Necessary to release energy from food
Necessary to release energy from food
Necessary to release energy from food
Niacin
Pyridoxine
46
Ministry of Commerce& Industry
2021
47

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FOOD FORTIFICATION

  • 1. Ministry of Commerce& Industry 2021 Food Fortification 1 SUBBURAJ M Deputy Director DESIGNATED OFFICER/CENTRAL LICENSING AUTHORITY, AUTHORISED OFFICER IMPORT AND EXPORT OPERATIONS FSSAI, Eastern Region
  • 2. Ministry of Commerce& Industry 2021 2 Important Definitions Fortification: Means deliberately increasing the content of essential micronutrients in a food so as to improve the nutritional quality of food and to provide public health benefit with minimal risk to health. Fortificant: Substance added to food to provide micronutrients but does not include nutraceuticals or foods for Special Dietary Uses. Fortified food: Food, as specified under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, that has undergone the process of fortification as per the provisions of these regulations.
  • 3. Ministry of Commerce& Industry 2021 3 Fortified Processed Foods: Processed foods (i.e., foods that have been altered from its natural state by industrial processing methods) that have undergone the process of fortification as per the provisions of these regulations. The same may have fortified staples as raw materials and/or fortified with permitted micronutrients and additives as specified under the Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011. Micronutrients: Means essential dietary nutrients including vitamins, minerals or trace elements that are required in very small quantities and are vital to development, disease prevention and wellbeing of human beings.
  • 4. Ministry of Commerce& Industry 2021 Food Fortification • Food is any nutritious substance required by living organisms in order to maintain life and support growth. Food is essential as it gives us the energy and nutrients to grow and develop. • Nutrients can be defined as the substances found in food that help the body to function properly. Food provides different nutrients to living organisms, which can be classified into two main groups: • Macronutrients: There are three macronutrients that are required in large amounts and are essential for good health. These are Carbohydrate, Protein and Fat. Macronutrients are measured in grams (g). • Micronutrients: There are two types of micronutrients namely Vitamins and Minerals. Their amounts are measured in milligrams (mg) and micrograms (μg). 4
  • 5. Ministry of Commerce& Industry 2021 5 General Principles 1. Micronutrients may be appropriately added to foods for the purpose of contributing to any of the following as mentioned schedule 1. (a)Preventing or reducing the risk of, or correcting, a demonstrated deficiency of one or more micronutrients in the population or specific population group. (b)Reducing the risk of, or correcting, inadequate nutritional status of one or more micronutrients in the population or specific population group. (c) Meeting requirements or recommended intake of one or more micronutrients. (d) Maintaining or improving health. (e) Maintaining or improving the nutritional quality of foods. 5
  • 6. Ministry of Commerce& Industry 2021 6 2. When fortification of a food is made mandatory, it shall be based on severity and extent of public health need as demonstrated by generally accepted scientific evidence. 3. The Food Authority may, specify mandatory fortification of any staple food on direction of the Government of India. 4. Wherever “Iron (As Fe)” is used as a source of nutrient, heme iron shall not be used in any form in any article of food. 5. Fortified Processed Foods may be prepared from fortified food articles that may be cereals and/or milk; 6. The Fortified Processed Food shall provide 15-30% of the Indian adult RDA of micronutrient based on an average calorie intake of 600 kcal from processed foods (approximately 1/3rd of daily energy requirement for an adult); 7. High Fat Sugar Salt (HFSS) Foods shall be excluded from Fortified Processed Foods category. The definition of HFSS foods shall have the same meaning as specified under the Food Safety and Standards (Labelling and Display) Regulations,2020.
  • 7. Ministry of Commerce& Industry 2021 Fortification means increasing the content of essential micronutrients to provide health benefits It refers to providing concentrated sources of nutrients in diet in the form of capsules,pills,injecti ons Synonymous with fortification refers to addition of micronutrient to the food which are lost during processing Fortification Enrichment Supplementation Fortification v/s supplementation
  • 8. Ministry of Commerce& Industry 2021 It does not change the taste, odor, color or texture of food I It does not require manufacturers to adapt to a new or expensive technology It does not require consumers to alter their eating habits. It is a safe and cost effective method Fortification means deliberately increasing the content of essential micronutrients in a food so as to improve the nutritional quality of food and to provide public health benefit with minimal risk to health Benefits Of Fortification
  • 9. Ministry of Commerce& Industry 2021 Why fortification? 9
  • 10. Ministry of Commerce& Industry 2021 Commodity Fortificant Rice Iron, Folic Acid, Vitamin B12 Wheat Flour, Maida Iron, Folic Acid, Vitamin B12 Milk Vitamin A, Vitamin D Fruit juice Vitamin C Edible Oil Vitamin A, Vitamin D Salt Iron , Iodine In India, fortification has been implemented for commodities which are consumed in fairly consistent and sufficiently large amounts by the population The optional Micronutrients for Rice and Wheat Flour are Zinc, Vitamin A, Thiamine (Vitamin B1), Riboflavin (Vitamin B2), Niacin (Vitamin B3) and Pyridoxine (Vitamin B6). 10
  • 11. Ministry of Commerce& Industry 2021 How to fortify ?
  • 12. Ministry of Commerce& Industry 2021 Ferrous sulphate Premix preparation Salt Addition of Sodium Hexa Meta Phosphate & blending Double Fortified salt Encapsulated premix of ferrous fumarate Blending /Mixing Double Fortified salt
  • 13. Ministry of Commerce& Industry 2021 Pulverized milled rice Vitamin/ mineral premix Extrusion processing Fortified rice kernel Fortified Rice Kernel
  • 14. Ministry of Commerce& Industry 2021 Preblend (premix + small amt oil) Refined oil Mixing/ Blending 1.Batch 2.Continuous Fortified oil Fortified oil
  • 15. Ministry of Commerce& Industry 2021 Micronutrients namely Iron, Folic Acid and Vitamin B12 are added in the form of a premix through a feeder located towards the end of the milling process Fortified wheat flour Fortified wheat flour
  • 16. Ministry of Commerce& Industry 2021 Liquid milk is fortified just prior to pasteurization or ultra- heat treatment, and it is essential to ensure a good distribution of the nutrients in milk prior to any heat treatment. The simplest way to fortify dried milk is to blend dry forms of vitamins and minerals with the dried milk powder, although oily forms can also be added Fortified Milk
  • 17. Ministry of Commerce& Industry 2021 Food Safety and Standards (Fortification of Foods) Regulation, 2018 Standards on fortifications General obligations General definitions 17
  • 18. Ministry of Commerce& Industry 2021 . STANDARDS ON FORTIFICATIONS Wherever “Iron (As Fe)” is used as a source of nutrient, heme iron shall not be used in any form in any article of food. Micronutrients may be appropriately added to foods as mentioned in Schedule-I High Fat Sugar Salt (HFSS) Foods shall be excluded from Fortified Processed Foods category The Fortified Processed Food shall provide 15-30% of the Indian adult RDA of micronutrient based on an average calorie intake of 600 kcal General principles 18
  • 19. Ministry of Commerce& Industry 2021 Compliance with Standards on Micronutrient Content in Fortified Food. Any manufacturer who fortifies any food shall ensure that the level of added micronutrients on label of such fortified food shall fall within the range specified in Schedule-I. The tolerance of minus 10 percent of the declared total value on the label may be allowed for the purposes of compliance and analysis at any point in time (max limit Schedule-I) 19
  • 20. Ministry of Commerce& Industry 2021 GENERAL OBLIGATIONS 20
  • 21. Ministry of Commerce& Industry 2021 QUALITY ASSURANCE  Every manufacturer and packer of fortified food shall give an undertaking on quality assurance Quality Assurance Certification by a food laboratory that the fortified food is in compliance with the provisions of the Act and regulations Up-to-date record keeping and continuous inventory of fortificants The undertaking shall be given twice a year Random testing of fortificants and fortified food; Regular audit of technical equipment and processes; 21
  • 22. Ministry of Commerce& Industry 2021 Packaging and Labelling Requirements Every package of fortified food shall carry the words “fortified with ………… (name of the fortificant)” and the logo It may also carry a tag line “Sampoorna Poshan Swasth Jeevan” under the logo. Every package of food, fortified with Iron shall carry a statement “People with Thalassemia may take under medical supervision and persons with Sickle Cell Anaemia are advised not to consume iron fortified food products All fortified food shall be packaged in a manner that takes into consideration the nature of the fortificant added and its effect on the shelf life of such food. Fortified food shall be permitted to make a nutrition claim in relation to an article of fortified food under the Food Safety and Standards (Packaging and Labeling) Regulations, 2011. 22
  • 23. Ministry of Commerce& Industry 2021 SCHEDULE-I 23
  • 24. Ministry of Commerce& Industry 2021 Iron fortified iodized salt (Double Fortified Salt) Iron fortified iodized salt (Double Fortified Salt) when fortified with Iron and Iodine Salt shall be fortified with Iodine and may also be fortified with iron in combination with iodine, at the level given S. No. Component Level of nutrients Source of Nutrients 1. Iodine content (a) Manufacture level (b) Distribution channel including retail level 15- 30 parts per million(on dry weight basis) Potassium Iodate 2. Iron content (as Fe) 850-1100 parts per million Ferrous sulphate or FerrousFumarate 24
  • 25. Ministry of Commerce& Industry 2021  Double fortified salt may contain Hydroxypropyl Methyl Cellulose, Titanium dioxide full Hydrogenated Soybean oil and Sodium Hexametaphosphate (all food grade) and anticaking agent not more than 2.0 percent. On dry weight basis  the water insoluble matter wherein anticaking agent is used shall not exceed 2.2 percent. 25
  • 26. Ministry of Commerce& Industry 2021 Fortified Oil Vegetable Oil shall be fortified with the following micronutrients, at the level given Note: Vitamin A (retinol): 1 IU= 0.3 μg RE (Retinol Equivalent); Vitamin D (Cholecalciferol or Ergocalciferol): 1 IU= 0.025 μg Sl. No. Nutrient Level of nutrient Source of nutrient 1. Vitamin A 6 µg RE - 9.9 µg RE per gm. of oil Retinyl acetate or Retinyl palmitate 2. Vitamin D 0.11 µg– 0.16 µg per gm. of oil. *Cholecalciferol or *Ergocalciferol (*Only from Plant Source) 26
  • 27. Ministry of Commerce& Industry 2021 Fortified Milk Toned, double toned, skimmed milk or standardized milk /milk powder shall be fortified with the following micronutrients, at the level given Fortified Milk Powder: shall only be used in the Government Funded Programs for the purpose of preparation of ‘Reconstituted Fortified Milk’ Sr. No. Nutrients/Source Level of nutrient per liter of Milk 1. Vitamin A (μg RE)- Retinylacetate or Retinyl palmitate 270 - 450 2. Vitamin D (μg) *Cholecalciferol or*Ergocalciferol (*Only fromPlant source) 5-7.5 27
  • 28. Ministry of Commerce& Industry 2021  In addition to the labelling provisions mentioned under Food Safety and Standards Regulations, the label of Fortified Milk Powder shall also carry the following statement: (a) NOT RECOMMENDED FOR DIRECT CONSUMPTION; (b) ONLY FOR USE UNDER ______________ (Name of the Government Funded Programme); (c) TO BE CONSUMED ONLY AFTER RECONSTITUTION OF THE ENTIRE CONTENT AS PER THE DIRECTIONS ON THE LABEL. (d) PACK ONCE OPENED, TO BE CONSUMED ON THE SAME DAY.] Fortified Milk Powder labelling 28
  • 29. Ministry of Commerce& Industry 2021 Fortified Atta Atta, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given Sr.No. Nutrient Level of Fortification per Kg 1. Iron-Ferrous citrate or Ferrous lactate or Ferroussulphate or Ferric pyrophosphate or electrolyticiron or Ferrous fumarate or Ferrous BisGlycinate;or Sodium Iron (III) Ethylene diamine tetraAcetateTrihydrate (Sodium feredetate-Na Fe EDTA); 28 mg- 42.5 mg 2. Folic acid 75 µg- 125 µg 3. Vitamin B12- cyanocobalamine or hydroxycobalamine 0.75 µg- 1.25 µg 29
  • 30. Ministry of Commerce& Industry 2021  In addition atta may also be fortified with following micronutrients, singly or in combination, at the level in the table below S.No. Nutrient Level of Fortification per Kg 1. Zinc-Zinc Sulphate 10 mg- 15 mg 2. Vitamin A-Retinyl acetate or RetinylPalmitate,; 500 µg RE- 750 µg RE 3. Thiamine (Vitamin B1)- Thiamine hydrochlorideor Thiamine mononitrate; 1 mg- 1.5 mg 4. Riboflavin (Vitamin B2)- Riboflavin or Riboflavin 5'-phosphate sodium ; 1.25 mg- 1.75 mg 5. Niacin(Vitamin B3)- Nicotinamide or Nicotinicacid; 12.5 mg- 20 mg 6. Pyridoxine(Vitamin B6)- Pyridoxine hydrochloride; 1.5 mg- 2.5 mg 30
  • 31. Ministry of Commerce& Industry 2021 Maida, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given in the table S.No. Nutrient Level of Fortification per Kg 1. Iron (a) Ferrous citrate or Ferrous lactate or Ferrous sulphate or Ferric pyrophosphate or electrolyticiron or Ferrous fumarate or Ferrous bis glycinate or (a) Sodium Iron (III) Ethylene diamine tetra Acetate Trihydrate (Sodium feredetate -Na Fe EDTA) 28 mg- 42.5 mg * 14 mg- 21.25 mg 2. Folic acid 75 µg- 125 µg 3. Vitamin B12- cyanocobalamineor hydroxycobalamine 0.75 µg- 1.25 µg 31
  • 32. Ministry of Commerce& Industry 2021  In addition, Maida may also be fortified with following micronutrients, singly or in combination, at the level in the table below S.No. Nutrient Level of Fortification per Kg 1. Zinc-Zinc Sulphate 10 mg- 15 mg 2. Vitamin A-Retinyl acetate or RetinylPalmitate,; 500 µg RE- 750 µg RE 3. Thiamine (Vitamin B1)- Thiamine hydrochlorideor Thiamine mononitrate; 1 mg- 1.5 mg 4. Riboflavin (Vitamin B2)- Riboflavin or Riboflavin 5'-phosphate sodium ; 1.25 mg- 1.75 mg 5. Niacin(Vitamin B3)- Nicotinamide or Nicotinicacid; 12.5 mg- 20 mg 6. Pyridoxine(Vitamin B6)- Pyridoxine hydrochloride; 1.5 mg- 2.5 mg 32
  • 33. Ministry of Commerce& Industry 2021 Fortified Rice Rice, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given in the table below: S.No. Nutrient Level of Fortification per Kg 1. Iron- (a)Ferric pyrophosphate or (b) Sodium Iron(III) Ethylene diamine tetra Acetate Trihydrate(Sodium feredetate -Na Fe EDTA); 28 mg- 42.5 mg * 14 mg- 21.25 mg 2. Folic acid-Folic acid; 75 µg- 125 µg 3. Vitamin B12- cyanocobalamine or hydroxycobalamine; 0.75 µg- 1.25 µg 33
  • 34. Ministry of Commerce& Industry 2021 In addition, rice may also be fortified with following micronutrients, singly or in combination, at the level given in the table below: S.No. Nutrient Level of Fortification per Kg 1. Zinc-Zinc Oxide 10 mg- 15 mg 2. Vitamin A- RetinylPalmitate; 500 µg RE- 750 µg RE 3. Thiamine (Vitamin B1)- Thiamine hydrochlorideor Thiamine mononitrate; 1 mg- 1.5 mg 4. Riboflavin (Vitamin B2)- Riboflavin or Riboflavin5'-phosphate sodium ; 1.25 mg- 1.75 mg 5. Niacin(Vitamin B3)-Nicotinamide or Nicotinic acid; 12.5 mg- 20 mg 6. Pyridoxine(Vitamin B6)-Pyridoxine hydrochloride; 1.5 mg- 2.5 mg 34
  • 35. Ministry of Commerce& Industry 2021 Fortified food logo 35
  • 36. Ministry of Commerce& Industry 2021 +F logo has been developed to be used on the packs of fortified food products to increase consumer awareness and assist consumers in making healthier choices. The fortification logo (+F) indicates that the food has been fortified with micronutrients as per standards mandated by FSSAI. It is surrounded by a square which represents completeness.  The half ring below the +F sign symbolizes good health, protection for an active and healthy life. The FBOs fortifying their product, shall undertake an endorsement by logging in the FoSCoS. 36 Fortified food logo
  • 37. Ministry of Commerce& Industry 2021 SCHEDULE-II Specifications for logo 37
  • 38. Ministry of Commerce& Industry 2021 38
  • 39. Ministry of Commerce& Industry 2021 39
  • 40. Ministry of Commerce& Industry 2021 SCHEDULE-III Standards for processed fortified foods 40
  • 41. Ministry of Commerce& Industry 2021 Cereal products include Breakfast cereals, Pasta and Noodles, when fortified, shall contain added iron, folic acid and Vitamin B12 at the level given in the table below, namely:- S. No. Nutrients/Source Level of nutrient per 100 g 1 Iron (mg) Ferrous citrate or Ferrous lactate or Ferrous sulphate or Ferric pyrophosphate or electrolytic iron or Ferrous fumarate or Ferrous bis glycinate; or SodiumIron (III) Ethylene diamine tetra acetate, trihydrate (Sodium feredetate -Na Fe EDTA); 1.4-2.7 2 Folic acid (μg) 8-16 3 Vitamin B12 (μg) - Cyanocobalamine, or Hydroxycobalamine 0.08-0.16 Fortified Cereal Products 41
  • 42. Ministry of Commerce& Industry 2021 In addition, fortified cereal products, when fortified, may also be fortified with following micronutrients, singly or in combination, at the level in the table below, namely Fortified Cereal Products S. No. Nutrients/Source Level of nutrient per 100 g 1. Zinc (mg): Zinc Sulphate 1.0-1.9 2. Vitamin A (μg RE): Retinyl acetate or Retinyl Palmitate, 48-96 3. Thiamine (Vitamin B1) (mg): Thiamine hydrochloride or Thiamine mononitrate; 0.1-0.19 4. Riboflavin (Vitamin B2) (mg): Riboflavin or Riboflavin 5’-phosphate sodium ; 0.11-0.22 5. Niacin(Vitamin B3) (mg): Nicotinamide or Nicotinic acid; 1.3-2.6 6. Pyridoxine (Vitamin B6) (mg): Pyridoxine hydrochloride; 0.2-0.3 42
  • 43. Ministry of Commerce& Industry 2021 In addition, fortified bakery wares, when fortified may also be fortified with following micronutrients, singly or in combination, at the level in the table below: Fortified Bakery Products S. No. Nutrients/Source Level of nutrient per 100 g 1. Zinc (mg): Zinc Sulphate 1.0-1.9 2. Vitamin A (μg RE): Retinyl acetate or Retinyl Palmitate, 48-96 3. Thiamine (Vitamin B1) (mg): Thiamine hydrochloride or Thiamine mononitrate; 0.1-0.19 4. Riboflavin (Vitamin B2) (mg): Riboflavin or Riboflavin 5’-phosphate sodium ; 0.11-0.22 5. Niacin(Vitamin B3) (mg): Nicotinamide or Nicotinic acid; 1.3-2.6 6. Pyridoxine (Vitamin B6) (mg): Pyridoxine hydrochloride; 0.2-0.3 43
  • 44. Ministry of Commerce& Industry 2021 Bakery wares includes bread, biscuits, rusks and buns ,when fortified, shall contain added iron, folic acid and Vitamin B12 at the level given in the table below, namely:- S. No. Nutrients/Source Level of nutrient per 100 g 1 Iron (mg): Ferrous citrate or Ferrous lactate or Ferrous sulphate or Ferric pyrophosphate or electrolytic iron or Ferrous fumarate or Ferrous bisglycinate; or Sodium Iron (III)Ethylene diamine tetra acetate, trihydrate (Sodiumferedetate -Na Fe EDTA); 1.4-2.7 2 Folic acid (μg) 8-16 3 VitaminB12(μg)-Cyanocobalamine,or Hydroxycobalamine; 0.08-0.16 44
  • 45. Ministry of Commerce& Industry 2021 Fruit juices, when fortified, shall contain Vitamin C at the level given in the table below Fortified Fruit Juices Sr. No. Nutrients/Source Level of nutrient per 100 m L 1. Vitamin C (mg): Ascorbic acid 6-12 45
  • 46. Ministry of Commerce& Industry 2021 Health Claims In order to have uniformity in claims, the following scientifically substantiated health claims are suggested, which may be used in broader form for the above fortified foods against respective micronutrients fortified in accordance with the above said regulations: Nutrients Claims Vitamin A Helps against night blindness Vitamin D Supports strong bones Vitamin B 12 Important for maintaining normal functioning of nervous system and blood formation Folate & Folic acid Important for foetal development and blood formation Iron FightsAnaemia Iodine Required for normal growth, thyroid and brain function Zinc Supports a healthy immune system Thiamine Required for normal nerve and heart function Riboflavin Necessary to release energy from food Necessary to release energy from food Necessary to release energy from food Niacin Pyridoxine 46
  • 47. Ministry of Commerce& Industry 2021 47