Food Safety and Standards (Fortification of Foods) Regulation, 2018

The Food Safety and Standards Act, 2006

Official text

MINISTRY OF HEALTH AND FAMILY WELFARE

(FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA)

NOTIFICATION

New Delhi, the 2nd August, 2018

F. No. 11/03/Reg/Fortification/2014.—Whereas the Food Safety and Standards (Fortification of Foods)

Regulations, 2016 were published as required under sub section (1) of section 92 of the Food Safety and Standards Act,

2006 (34 of 2006), vide notification No. 11/03/Reg/Fortification/2014, dated the 23rd December, 2016, in the Gazette of

India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely to be affected

thereby, before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the

said notification were made available to the public;

And whereas copies of the said Gazette were made available to the public on the 3rd January, 2017;

And whereas objections and suggestions received from the public in respect of the said draft regulations have

been considered by the Food Safety and Standards Authority of India;

Now, therefore, in exercise of the powers conferred by clause (e) of sub- section (2) of section 92 of the said

Act, the Food Safety and Standards Authority of India hereby makes the following regulations, namely:-

PART 1: GENERAL

1. Short title and commencement. - (1) These regulations may be called the Food Safety and Standards (Fortification of

Foods) Regulations, 2018.

(2) They shall come into force on the date of their publication in the Official Gazette and Food Business Operator shall

comply with all the provisions of these regulations by 1st January, 2019.

(3) The provisions of these regulations shall supersede standards on fortification of food set out in any regulations,

orders, or guidelines issued under the Act thereunder save as regards regulations on nutraceuticals and foods for Special

Dietary Uses.

2. Definitions. – (1) In these regulations, unless the context otherwise requires: -

(a) “Act” means the Food Safety and Standards Act, 2006 (34 of 2006);

(b)“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;

for Special Dietary Uses;

(d) “fortified food” means a 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;

(e) “Government-funded programme” means any programme, policy, scheme or other provision under which food is

sold, distributed or otherwise made available to the public by the Central or State Governments;

(f) “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;

(g) “quality assurance” means the systematic measures applied and steps taken by manufacturers and packers of

fortified food throughout the manufacturing or packing process to ensure that the finished food complies with the

provisions of the Act and regulations and standards specified thereunder;

(h) “staple foods” means articles of food intended for mass consumption on a daily basis and include rice, wheat, wheat

flour, atta, maida, oil, salt, milk, and such other articles of food as may be designated staple foods under these

regulations;

(2) All other words and expressions used and, not defined in these regulations shall have the meanings assigned to them

in the Act, rules or regulations made thereunder.

PART 2: STANDARDS ON FORTIFICATION

3. General principles.-(1) Micronutrients may be appropriately added to foods for the purpose of contributing to any of

the following as mentioned in Schedule-I:

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(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;

(d) maintaining or improving health;

(e) maintaining or improving the nutritional quality of foods.

(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.

4. Compliance with Standards on Micronutrient Content in Fortified Food.-

(1) Any manufacturer who fortifies any food shall ensure that the level of micronutrient in such fortified food does not

fall below the minimum level specified in Schedule- I.

PART 3: GENERAL OBLIGATIONS

5. Quality Assurance.- (1) Every manufacturer and packer of fortified food shall give an undertaking on quality

assurance and submit evidence of steps taken in this regard to the Food Authority or such other authority which the Food

Authority may designate.

(2) The undertaking shall be given twice a year and shall include, the following, namely:-

(a) certification by a food laboratory notified by the Food Authority that the fortified food is in compliance with

the provisions of the Act and regulations and standards specified therein;

(b) up-to-date record keeping and continuous inventory of fortificants used in the manufacturing or packing

process, including the source of its procurement;

(d) random testing of fortificants and fortified food;

(e) regular audit of technical equipment and processes;

(f) such good manufacturing practices, as may be specified by the Food Authority from time to time.

(g) provisions for the reference of the purity criteria of micronutrients, generally accepted by pharmacopoeias,

namely, Indian Pharmacopoeia, British Pharmacopoeia, Food Chemical Codex, Joint Food and Agriculture

Organization or World Health Organisation Expert Committee on Food Additives or CODEX Alimentarius may

be adopted by food Business operators.

6. Compliance with the generally applicable provisions of the Act, Regulations and Standards.- All fortified food,

whether voluntarily fortified or required to undergo mandatory fortification shall be manufactured, packed, labeled,

handled, distributed and sold, whether for profit or under a Government-funded programme, only in compliance with the

standards specified under the provisions of the Act and regulations made thereunder.

7. Packaging and Labeling Requirements. – (1) 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.

(2) Every package of fortified food shall carry the words “fortified with ………… (name of the fortificant)” and the logo,

specified in Schedule-II of these regulation, on its label. It may also carry a tag line “Sampoorna Poshan Swasth

Jeevan” under the logo.

(3) provisions of the Food Safety and Standards (Packaging and Labeling) Regulations, 2011, shall also apply to the

fortified foods.

(4) Every package of food, fortified with Iron shall carry a statement “People with Thalassemia may take under

medical supervision”.

10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]

(5) All manufacturers and packers of fortified food complying with the provisions of the Act and rules or regulations

made thereunder on 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.

8. Promotion of Fortified Food. - (1) The Food Authority shall take steps to encourage the production, manufacture,

distribution, sale and consumption of fortified food including fortification through conventional breeding or

hybridization, in cooperation with concerned departments of the Government of India/Government of States/UTs.

(2) Without prejudice to the generality of sub-regulation (1), the Food Authority shall endeavor to:

(a) advise and promote the use of fortified food in Government-funded programmes on distribution of food;

(b) organise public awareness, educate and advocate campaigns on nutrition and fortified food;

them to undertake fortification;

(d) equip laboratories and research institutions notified under the Act to conduct the nutrient analysis of fortified

food; and

SCHEDULE-I

STANDARDS FOR FORTIFICATION OF FOODS

[See sub-regulation (1) of regulation 4]

1. 1) Iodized salt (when fortified with Iodine)

2) 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 in the table below:

Sl.No. Component Level of nutrients Source of nutrients

1. Iodine content

(a) Manufacture level

(b) Distribution channel

including retail level

20-30 parts per million (on dry

weight basis)

15-30 parts per million (on dry

weight basis)

Potassium Iodate

2. Iron content (as Fe) 850-1100 parts per million Ferrous sulphate or Ferrous

Fumarate

The total matter insoluble in water where an anticaking agent has been added shall not exceed 2.2 per cent. and Sodium

Chloride content on dry basis shall not be less than 97.0 per cent. by weight and it shall also conform other parameter as

mentioned under clause (1) of sub-regulation 2.9.30 of the Food Safety and Standards (Food Product Standards and

Food Additives) Regulations, 2011.

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 per cent. On dry weight basis

and the water insoluble matter wherein anticaking agent is used shall not exceed 2.2 per cent.

2. Fortified Oil: Vegetable Oil shall be fortified with the following micronutrients, at the level given in the table below:

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)

Note : Vitamin A (retinol): 1 IU= 0.3 µg RE (Retinol Equivalent); Vitamin D (Cholecalciferol or Ergocalciferol): 1 IU=

0.025 µg

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3. Fortified Milk

Toned, double toned, skimmed milk or standardized milk shall be fortified with the following micronutrients, at the level

given in the table below:

Sl. No. Nutrients Level of nutrient per litre of

toned/double toned/skimmed

milk/ Standardized Milk

Source of nutrient

1. Vitamin A 270 µg RE - 450 µg RE Retinyl acetate or Retinyl palmitate

2. Vitamin D 5 µg -7.5 µg *Cholecalciferol or *Ergocalciferol

(*Only from Plant source)

Note : Vitamin A (retinol): 1 IU= 0.3 µg RE (Retinol Equivalent); Vitamin D (Cholecalciferol or Ergocalciferol):

1 IU= 0.025 µg

4. Fortified Atta

Atta, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given in the table below:

Sl.No. Nutrient

Level of fortification

per Kg

Iron-

Ferrous citrate or Ferrous lactate or Ferrous sulphate or

Ferric pyrophosphate or electrolytic iron or Ferrous

fumarate or Ferrous BisGlycinate;

28 mg- 42.5 mg *

Sodium Iron (III) Ethylene diamine tetra Acetate

Trihydrate (Sodium feredetate-Na Fe EDTA);

14 mg- 21.25 mg

2. Folic acid

75 µg- 125 µg

3. Vitamin B12- Cyanocobalamine or

Hydroxycobalamine;

0.75 µg- 1.25 µg

Note: * added at a higher level to account for less bioavailability

In addition, atta may also be fortified with following micronutrients, singly or in combination, at the level in the table

below:

Sl.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

Thiamine (Vitamin B1)- Thiamine hydrochloride or

Thiamine mononitrate;

1 mg- 1.5 mg

Riboflavin (Vitamin B2)- Riboflavin or Riboflavin 5’-

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

5. Fortified Maida

Maida, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given in the table below:

Sl.No. Nutrient Level of fortification per Kg

Iron-

(a)Ferrous citrate or Ferrous lactate or Ferrous sulphate

or Ferric pyrophosphate or electrolytic iron or Ferrous

fumarate or Ferrous BisGlycinate;

28 mg- 42.5 mg *

(b) Sodium Iron (III) Ethylene diamine tetra Acetate

Trihydrate (Sodium feredetate -Na Fe EDTA);

14 mg- 21.25 mg

2. Folic acid 75 µg- 125 µg

Vitamin B12- Cyanocobalamine or

Hydroxycobalamine;

0.75 µg- 1.25 µg

Note: *added at a higher level to account for less bioavailability

12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]

In addition, maida may also be fortified with following micronutrients, singly or in combination, at the level given in the

table below:

Sl.No. Nutrient Level of fortification

per Kg

1. Zinc- Zinc Sulphate; 10 mg- 15 mg

2. Vitamin A- Retinyl acetate or Retinyl Palmitate; 500 µg RE- 750 µg RE

3. Thiamine (Vitamin B1)- Thiamine hydrochloride or

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 Nicotinic acid; 12.5 mg- 20 mg

6. Pyridoxine(Vitamin B6)-Pyridoxine hydrochloride; 1.5 mg- 2.5 mg

6. Fortified Raw Rice

Rice, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given in the table below:

Sl.No. Nutrient Level of fortification per Kg

Iron- (a)Ferric pyrophosphate 28 mg- 42.5 mg *

(b) Sodium Iron (III) Ethylene diamine tetra Acetate

Trihydrate (Sodium feredetate -Na Fe EDTA);

14 mg- 21.25 mg

2. Folic acid-Folic acid; 75 µg- 125 µg

Vitamin B12- Cyanocobalamine or

Hydroxycobalamine;

0.75 µg- 1.25 µg

Note: *added at a higher level to account for less bioavailability

In addition, rice may also be fortified with following micronutrients, singly or in combination, at the level given in the

table below:

Sl.No. Nutrient Level of fortification per Kg

1. Zinc-Zinc Oxide; 10 mg- 15 mg

2. Vitamin A- Retinyl Palmitate; 500 µg RE- 750 µg RE

Thiamine (Vitamin B1)- Thiamine hydrochloride or Thiamine

mononitrate;

1 mg- 1.5 mg

Riboflavin (Vitamin B2)- Riboflavin or Riboflavin 5’-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

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SCHEDULE-II

[See sub-regulation (2) of regulation 7]

PAWAN AGARWAL, Chief Executive Officer

[ADVT.-III/4/Exty./168/18]

Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064

and Published by the Controller of Publications, Delhi-110054.

Fortified with….

SAMPOORNA POSHAN

SWASTHA JEEVAN

…. स ेफो�टफाइडस ेफो�टफाइडस ेफो�टफाइडस ेफो�टफाइड स�पूण� पोषणस�पूण� पोषणस�पूण� पोषणस�पूण� पोषण �व�थ जीवन�व�थ जीवन�व�थ जीवन�व�थ जीवन

2018-08-09T10:02:59+0530

ALOK KUMAR