The Food Safety and Standards (Fortification of Foods) Regulations, 2018

class="separator" style="clear: both; text-align: left;">

 Food is integral for human survival and nutrients are a natural part of that foods. They can also be consumed in fortified foods, which are foods to which extra nutrients have been added. It can be carried out by food manufacturers or by governments as a public health policy which aims to reduce the number of people with dietary deficiencies within a population. Fortification is the process of adding micro-nutrients into foodstuff that do not already contain them. For example, milk is often fortified with additional vitamin D, to boost its nutritional value; breakfast cereal may be fortified with iron. The aim of fortification is to help people remedy their nutritional deficiencies. In order to promote fortification as a means to address micro-nutrient deficiencies, the Food Safety and Standards Authority of India (FSSAI) has operationalized (Fortification of Foods) Regulations, 2018.

§  According to the standards lay down by the Food Safety and Standards (Fortification of Foods) Regulation 2018, the fortification of the food products by FBO can use +F logo for enrichment foods.

§  According to the Food Safety and Standards (Prohibition and Restriction on sales) Regulations, 2018, adding iodine to commercial salt is mandatory in India.

§  +F logo was introduced to identify fortified foods.

§  The permitted dosage of nutrients provide a maxima & minima range for fortification of staple foods like wheat flour (atta or maida), rice, salt, milk and vegetables oil as  specified Standards (Fortification Regulations), 2018.

Significance of the +F logo.

Ø  When a certain food is fortified with specific levels of micro-nutrients as per the FSSAI in the Food Safety and Standards (Fortification Regulations), 2018 it should denoted by +F logo.

Fortification of Foods Law

FSSAI on August 2, 2018, brought forward the Food Safety and Standards (Fortification of Foods) Regulations 2018, to regulate the provisions regarding fortified food. Some of the important features of Food Fortification Regulations are as follows:

· It prescribes the standards of addition of micro-nutrients for the purpose of food fortification.

· The manufacturers of the fortified food are required to provide a quality assurance undertaking.

· Packaging and labelling of the fortified food must state the food fortificant added, logo and the tagline "Sampoorna Poshan Swasth Jeevan". Also, it should be in compliance to the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.

1. Short title and commencement. - These regulations may be called the Food Safety and Standards (Fortification of Foods) Regulations, 2018. Business Operator shall comply with all the provisions of these regulations by 1st January, 2019.

2. Definitions.

 "Fortification" means deliberately increasing the content of essential micro-nutrients in a food so as to improve the nutritional quality of food and to provide public health benefit with minimal risk to health.

"fortificant" means a substance added to food to provide micro-nutrients but does not include nutraceuticals or foods for Special Dietary Uses.

"Fortified food" means a food, as specified under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, which has undergone the process of fortification as per the provisions of these regulations.

"micro-nutrients" 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 well being of human beings.

"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.

3. General principles.

(1) Micro-nutrients may be appropriately added to foods for the purpose of contributing to any of the following as:

(a) Preventing or reducing the risk of, or correcting, a demonstrated deficiency of one or more micro-nutrients in the population or specific population group.

(b) Reducing the risk of, or correcting, inadequate nutritional status of one or more micro-nutrients in the population or specific population group.

(c) Meeting requirements or recommended intake of one or more micro-nutrients.

(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. Quality Assurance. - 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.

5. Packaging and Labelling 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, 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".

(5) All manufacturers and packers of 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 Labelling) Regulations, 2011.

 6. Promotion of Fortified Food

(1) The Food Authority shall take steps to encourage the production, manufacture, distribution, sale and consumption of fortified foods. The Food Authority shall endeavour to:

(a)  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.

(c) Conduct technical assistance programmes and provide technical expertise to small manufacturers to enable them to undertake fortification.

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

Standards for fortification of salt with iodine

Salt shall be fortified with iodine and may also be fortified with iron in combination with iodine, at level given in the table

Sr no.	Components	Level of nutrients
1.	Iodine content
	a) Manufacture level b) distribution channel including retail level	Not less than 30 ppm on dry wt. basis Not less than 15 ppm on dry wt. basis
2.	Iron content (as Fe)	850-1100 ppm

 Standards for fortification of vegetable oils with vit. A or vit. D

Vegetable oil may be fortified with following micronutrients, singly or in combination.

Sr. No.	Nutrients	Minimum level of nutrients	Source of nutrients
1.	Vitamin A	25 IU per gram of oil	Retinyl acetate, retinyl palmitate and retinyl proponiate
2.	Vitamin D	4.5 IU per gram of oil	Cholecalciferol, Eregocalciferol

 Standards for fortification of milk with vit. A or vit. D

Standardised, toned, double toned or skimmed milk may be fortified with micro-nutrients, singly or in combination.

Sr. No.	Nutrients	Minimum level of nutrients per litre of milk	Source of nutrients
1.	Vitamin A	770 IU	Retinyl acetate, retinyl palmitate and retinyl proponiate
2.	Vitamin D	550 IU	Cholecalciferol, Eregocalciferol

 Standards for fortification of Atta

Sr. No.	Nutrients	Minimum level of  fortification per kg
1.	Iron-Sodium iron (III) Ethylene Diamine tetra acetate, trihydrate (EDTA)	20mg
2.	Folic acid	1300µg
3.	Vitamin B12	10µg

 Standards for fortification of Maida

Sr. No.	Nutrients	Minimum level of  fortification per kg
1.	Iron a) Ferrous citrate, Ferrous lactate, Ferrous sulphate, Ferrous pyrophosphate, Electrolytic iron, Ferrous fumarate. b) Sodium Iron (III) (EDTA)	60mg  20mg
2.	Follic acid	1300µg
3.	Vitamin B12-Cyanocobalamaine, Hydroxy cobalamine	10µg

 Standards for fortification of Rice

Rice when fortified shall contain added iron, folic acid and vitamin B12

Sr. No.	Nutrients	level of  fortification per kg
1.	Iron-a)ferric pyrophosphate b) sodium iron(III) EDTA	20mg
2.	Folic acid	1300µg
3.	Vitamin B12	10µg

 Some of the benefits of fortified foods:

• Eliminate malnutrition and nutritional deficiencies.
• Provides extra nutrition at affordable costs.
• Wide scale production of fortified foods can help improve the overall nutritional problem of a country.
• The process of fortification is cost effective.

Downside of the fortified foods:

·   Only a handful of nutrients are added in the process of fortification. Other nutritional deficiencies remain untreated by the process.

·       Many times, fortified food products fail to reach the poorest segments of society,

·       Fortified foods could lead to a nutritional overdose.