Through a notification dated 22 November 2017, the FSSAI has issued directions for the re-operationalization of the Food Safety and Standards (Fortification of Foods) Regulation, 2016. Since this was a draft regulation the FSSAI had invited comments and suggestions for the same and had also meanwhile operationalized these regulations up to the time period of 17 October 2017 only.
The Final Regulation for food fortification has now been approved by the Food Authority in its 24th meeting. Since the process of notification is likely to take some time and so as not to disrupt the on-going fortification of foods the FSSAI has decided to re-operationalize the fortification regulations and will be known as the Food Safety and Standards (Fortification of Foods) Regulations 2017.
Chapter 1 contains the definitions of terms that are used in the regulation like atta, fortification, fortificant, fortified foods, government-funded programme, international standards, maida, micronutrients, milk, nutrition claim, oils, quality assurance, rice, salt, staple foods, and wheat.
Chapter 2 contains STANDARDS ON FORTIFICATION
General principles state that essential nutrients may be added to food to
- Prevent or reduce the risk of or to correct, a demonstrated deficiency of one or more essential nutrients in the population or specific population group
- Reduce the risk of or correct inadequate nutritional status of one or more essential nutrients in the population or specific population group
- Meet the requirements or recommended intake of one or more essential nutrients
- Maintain and improve health
- Maintain and improve the nutritional quality of foods
- In case 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.
- The Food Authority may specify mandatory fortification of any staple food on the directions of the Government of India.
Compliance with Standards on Micronutrient Content in Fortified Food
Manufacturers and processors that fortify any food shall ensure that the level of micronutrient in fortified foods does not
- Fall below the minimum level specified in the Schedule I.
- Exceed the highest amount of micronutrient that can safely be added to such food, keeping in mind recognized international standards
Chapter 3 contains GENERAL OBLIGATIONS
FBOs must ensure Quality Assurance and give evidence of steps taken to FSSAI or any authority FSSAI may designate. Undertaking shall include
- Certification from 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 record keeping and continuous inventory of fortificants used in the manufacturing or packing process and source of fortificant used
- 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
- Follow good manufacturing practices as may be specified by the FSSAI
Compliance with the 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.
Packaging and Labelling Requirements
- All fortified food shall be packaged so as to take into consideration the nature of the fortificant and its effect on shelf life.
- Every package of fortified food shall carry the words
“Fortified with ………… (Name of the fortificant)” and the fortification logo
- Every package of food, fortified with Iron shall carry a statement
“Not recommended for people with Thalassemia and people on the low iron diet”.
- All other provisions of the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, shall also apply to the fortified foods.
- All 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
To promote wholesome food in the country, FSSAI shall 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.
The Food Authority shall endeavor to
- advise and promote the use of fortified food in Government-funded programmes
- organize 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
Consolidation of regulations and standards on fortified food
- 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.
- Provisions of the Infant Milk Substitutes, Feeding Bottles, and Infant Foods (Regulation of Production, Supply, and Distribution) Act, 1992 to prevail. Nothing in these regulations shall affect the provisions of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply, and Distribution) Act, 1992 (41 of 1992) or any rules, regulations or orders framed thereunder.
SCHEDULE- I STANDARDS FOR FORTIFICATION OF FOODS
Fortification of Salt with 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:
S. No | Component | Level of Nutrients |
1. | Iodine Content | |
(a) Manufacture level
(b) Distribution channel including retail level |
Not less than 30 parts per million on
dry weight basis Not less than 15 part per million on dry weight basis. |
|
2. | Iron content (as Fe) | 850-1100 parts per million |
Fortification of Vegetable Oil with Vitamin A or Vitamin D: Vegetable Oil may be fortified with the following micronutrients, singly or in combination, at the level given in the table below:
S. No | Nutrient | Minimum level of nutrient | Source of Nutrient |
1. | Vitamin A | 25 IU per gm. of oil | Retinyl acetate, Retinyl Palmitate and Retinyl propionate |
2. | Vitamin D | 4.5 IU per gm. of oil. | Cholecalciferol,
Ergocalciferol |
Fortification of Milk with Vitamin A or Vitamin D: Standardized, Toned, double toned or skimmed milk may be fortified with the following micronutrients, singly or in combination, at the level given in the table below
S. No | Nutrients | Minimum Level of nutrient
per litre of toned/double toned/skimmed milk |
Source of Nutrient |
1. | Vitamin A | 770 IU | Retinyl acetate, Retinyl Palmitate and Retinyl propionate |
2. | Vitamin D | 550 IU | Cholecalciferol,
Ergocalciferol |
Fortification of Vanaspati: Vanaspati shall be fortified with the following micronutrient at the level given in the table below
S. No | Nutrient | Level of Nutrient |
1. | Synthetic Vitamin A | Not less than 25 International Units per gram at the time of packing.
Should test positive when tested with Antimony Trichloride (Carr-Price Reagent) as per IS:5886-1970 |
Fortification of Atta: Atta, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given in the table below
S. No | Nutrient | Minimum Level of Fortification per Kg |
1. | Iron
Sodium Iron (III) Ethylene diamine tetra Acetate, Trihydrate (Sodium federate-Na Fe EDTA) |
20mg |
2. | Folic Acid | 1300 µg |
3. | Vitamin B12 cyanocobalamine,
hydroxocobalamin |
10 µg |
In addition, atta, maida, and rice may also be fortified with following micronutrients, singly or in combination, at the level in the table below
S No | 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. |
Fortification of Maida: Maida, when fortified, shall contain added iron, folic acid and Vitamin B-12 at the level given in the table below
S. No | Nutrient | Minimum Level of
Fortification per Kg |
1. | Iron
(a) Ferrous Citrate, Ferrous Lactate, Ferrous Sulfate, Ferrous pyrophosphate, electrolytic iron, Ferrous fumarate (b) Sodium Iron (III) Ethylene diamine tetra Acetate, Trihydrate (Sodium federate-Na Fe EDTA) |
60 mg
20 mg |
2. | Folic Acid | 1300 µg |
3. | Vitamin B12 cyanocobalamine,
hydroxocobalamin |
10 µg |
Fortification of 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 (b) Sodium Iron (III) Ethylene diamine tetra Acetate, Trihydrate (Sodium federate-Na Fe EDTA) |
20 mg |
2. | Folic acid | 1300 µg |
3. | Vitamin B12 cyanocobalamine,
hydroxocobalamin |
10 µg |
This is only the summary, so one can access the complete text on FSS (Fortification of Foods) regulation on FSSAI.Gov.In
Errol Prince says
I am presently working on a product that I would very much like to package therefore I would like to learn more about all this
Errol Prince says
I am presently trying to research the possibility of how to find the best way to package my Idea