The FSSAI had framed the Food Safety and Standards (Fortification of Foods) Regulations 2016 and thereafter the draft notifications were notified in the Gazette of India. These draft regulations had been operationalized up to 18 April 2018.
The Final Regulation for food fortification has now been approved by the Food Authority in its 24th meeting and they are in the process of notification. 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 with effect from 19 April 2018.
The operationalized regulations are available on Food Safety Helpline but have been summarised below for ready reference.
Chapter 1 GENERAL
This chapter 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 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
- exceed the highest amount of micronutrient that can safely be added to such food, keeping in mind recognized international standards
Chapter 3 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 from time to time
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 as specified in Schedule II of these regulations on the label
- Every package of food, fortified with Iron shall carry a statement “Not recommended for people with Thalassemia and people on a 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.
This schedule contains the standards for the following foods. The standards contain the level of nutrients, source of the nutrient and the minimum level of fortification as the case might be Standards for Fortification of Salt with Iodine
- Standards for the Fortification of Vegetable Oil with Vitamin A or D
- Standards for the Fortification of Milk with Vitamin A or D
- Standards for the fortification of Vanaspati -may be fortified with Synthetic Vitamin A and micronutrients
- Standards for the fortification of Atta – Atta may be fortified with iron, folic acid, Vitamin B-12 and micronutrients
- Standards for the fortification of Maida – may be fortified with iron, folic acid, Vitamin B-12 and micronutrients
- Standards for the fortification of Rice – may be fortified with iron, folic acid, Vitamin B-12 and micronutrients
Schedule –II contains the food fortification logo that has to be displayed on all fortified foods.