Through its recent notification the FSSAI has proposed regulations, related to the fortification of foods. FSSAI has also asked all stake holders and WTO-SPS member countries for their comments and suggestions within a period of 60 days beginning 4 October 2016. Once notified in the Official Gazette these regulations will be called Food Safety and Standards (Fortification of Foods) Regulations 2016.
Chapter I: Defines “fortification” which 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. Similarly “fortificant” means a substance added to food to provide micronutrients but does not
include nutraceuticals or foods for Special Dietary Uses. Other words used in the regulations like atta, maida, fortified food, micronutrient, milk, nutrition claim, oils, rice, staple foods, wheat, salt etc. have also been defined.
Chapter 2 deals with Standards in Fortification
Under general principles the FSSAI says that essential nutrients may be added to foods for the purpose of
- preventing or reducing the risk of, or correcting, a demonstrated deficiency of one or more essential nutrients in the population or specific population group
- reducing the risk of, or correcting, inadequate nutritional status of one or more essential nutrients in the population or specific population group
- meeting requirements or recommended intake of one or more essential nutrients
- maintaining or improving health
- maintaining or improving the nutritional quality of foods
Mandatory fortification
FSSAI states that fortification of foods will be made mandatory based on severity and extent of public health need as demonstrated by generally accepted scientific evidence. The FSSAI may also specify mandatory fortification of any staple food if the Government of India gives directions to do so.
Compliance with Standards on Micronutrient Content in Fortified Food
Food manufacturers must keep in mind recognised international standards to ensure that the level of micronutrients in fortified foods do not
- fall below the minimum level specified in the schedule food
- exceed the highest amount of micronutrient that can safely be added to such food
CHAPTER 3: Provides for General Obligations
Quality Assurance: Every manufacturer and packer of fortified food shall ensure quality assurance and will also submit evidence of steps taken in this regard to the FSSAI.
The Quality assurance undertaking will comprise of
- Certification of a food laboratory notified by the FSSAI that the fortified food is in compliance with the provisions of the Act and Regulations and standards specified therein
- Up-to-date records of the continuous inventory of fortificants used in the manufacturing or packing process, including the source from where the fortificant was procured
- Appropriate monitoring procedures at different stages of manufacturing or packing process
- random testing of fortificants and fortified food
- regular audit of technical equipment and processes
- such good manufacturing practices, as may be specified by the FSSAI from time to time
Whether the food is voluntarily fortified or is fortified because of a mandatory fortification requirement it must be manufactured, packed, labelled, 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.
Packaging and Labelling Requirements
While all provisions under the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 all apply to the fortified foods there are some other provisions also like
- All fortified food must 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.
- Every package of fortified food shall carry the words on the label “fortified with ………… (name of the fortificant)”
- Every package of food, fortified with Iron shall carry a statement “Not recommended for people with Thalassemia and people on low iron diet”.
- No manufacturers and packers of fortified food shall be permitted to make a nutrition claim in relation to an article of fortified food under regulation 2.2.2(3) of the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
Promotion of Fortified Food
With a view to promote wholesome food in the country, the FSSAI will take steps to encourage the production, manufacture, distribution, sale and consumption of fortified food including fortification through conventional breeding/ hybridization, in cooperation with concerned government departments. Without prejudice to the generality of sub-regulation, the Food Authority shall endeavour to:
- advise and promote the use of fortified food in Government-funded programmes on distribution of food
- organise public awareness, education and advocacy campaigns on nutrition and fortified food
- conduct technical assistance programmes and provide technical expertise to small manufacturers to enable them to undertake fortification
- equip laboratories and research institutions notified under the Act to conduct the nutrient analysis of fortified food
- identify and recommend to the Central and State Governments, financial incentives, subsidies and loans to be provided to manufacturers and packers to encourage them to undertake fortification
Some important points
- Once these regulations are notified then 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.
- However the provisions of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 will continue to prevail and nothing in these regulations shall affect that provision.
Standards for fortification
Fortification of Salt
Salt needs to be fortified with Iodine and iron in combination with iodine at levels specified below
Component Level of Nutrients
Iodine content
manufacturer level – Not less than 30ppm on dry weight basis
distribution and retail – Not less than 15ppm on dry weight basis
Iron content (as Fe) – 850-1100ppm
Fortification of Vegetable Oil with Vitamin A or Vitamin D
Micronutrients to be used singly or in combination at levels given below
Nutrient Minimum level of nutrient Source of nutrient
Vitamin A 25 IU per gm of oil Retinyl acetate, Retinyl palmitate and Retinyl propionate
Vitamin D 4.5 IU per gm of oil. Cholecalciferol, Ergocalciferol
Fortification of Milk with Vitamin A or Vitamin D
Toned, double toned or skimmed milk may be fortified with the following micronutrients, singly or in combination, at the level given below
Nutrients Minimum Level of nutrient per litre Source of nutrient
of toned/double toned/skimmed milk
Vitamin A 770 IU Retinyl acetate, Retinyl palmitate and Retinyl propionate
Vitamin D 550 IU Cholecalciferol, Ergocalciferol
Standards for Fortification of Vanaspati
Nutrient Level of nutrient
Synthetic Vitamin A Not less than 25 International Units per gram at the time of packing. Should test positive when tested wit Antimony Trichloride (Carr-Price Reagent) as per IS:5886-1970
Standards for Fortification of Atta
Nutrient Minimum Level of Fortification
1.Iron 20mg
Sodium Iron (III) Ethylene diamine tetra Acetate,
Trihydrate (Sodium federate-Na Fe EDTA);
2. Folic acid 1300 µg
3. Vitamin B12- cyanocobalamine, hydroxycobalamine; 10 µg
In addition, atta may also be fortified with following micronutrients, singly or in combination, at the level in the table below:
Nutrient Minimum Level of Fortification per Kg
1.Zinc-Zinc Sulphate – 30 mg
2.Vitamin A-Retinyl acetate, Retinyl Palmitate,
Retinyl Propionate – 1500 μg RE
3.Thiamine (Vitamin B1)- Thiamine hydrochloride,
Thiamine mononitrate 3.5 mg
4.Riboflavin (Vitamin B2)- Riboflavin , Riboflavin
5’-phosphate sodium ; 4 mg
5.Niacin-Nicotinamide, Nicotinic acid; 42 mg
6.Pyridoxine(Vitamin B6)-Pyridoxine
hydrochloride; 5 mg
Standards for Fortification of Maida
Nutrient Minimum Level of Fortification per Kg
- Iron-
(a) Ferrous citrate, Ferrous lactate, Ferrous sulphate – 60mg
Ferrous pyrophosphate, electrolytic iron, Ferrous
fumarate
(b) Sodium Iron (III) Ethylene diamine tetra Acetate- 20mg
Trihydrate (Sodium federate-Na Fe EDTA);
- Folic acid 1300 µg
- Vitamin B12- cyanocobalamine, hydroxycobalamine 10 µg
In addition, maida may also be fortified with following micronutrients, singly or in combination, at the level given in the table below:
Nutrient Minimum Level of Fortification per Kg
- Zinc-Zinc Sulphate 30 mg
- Vitamin A-Retinyl acetate, Retinyl Palmitate,
Retinyl Propionate; 1500 μg RE
- Thiamine (Vitamin B1)- Thiamine
hydrochloride, Thiamine mononitrate 3.5 mg
- Riboflavin (Vitamin B2)- Riboflavin , Riboflavin
5’-phosphate sodium 4 mg
- Niacin-Nicotinamide, Nicotinic acid 42 mg
- Pyridoxine(Vitamin B6)-
Pyridoxinehydrochloride; 5 mg
Standards for fortification of Rice
Nutrient Level of Fortification per Kg
1.Iron- (a) Ferric pyrophosphate (b) Sodium Iron
(III) Ethylene diamine tetra Acetate, Trihydrate
(Sodium federate-Na Fe EDTA) 20 mg
- Folic acid-Folic acid; 1300 µg
- Vitamin B12- cyanocobalamine,
hydroxycobalamine; 10 µg
In addition, rice may also be fortified with following micronutrients, singly or in combination, at the level given in the table below:
Nutrient Level of Fortification per Kg
1.Zinc-Zinc Oxide 30 mg
2.Vitamin A- Retinyl Palmitate; 1500 μg RE
3.Thiamine (Vitamin B1)- Thiamine hydrochloride,
Thiamine mononitrate; 3.5 mg
4.Riboflavin (Vitamin B2)- Riboflavin , Riboflavin 5’-
phosphate sodium 4 mg
5. Niacin-Nicotinamide, Nicotinic acid 42 mg
6. Pyridoxine(Vitamin B6)-Pyridoxine hydrochloride 5 mg
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