India's FSSAI Food Fortification Regulations: Key Amendments and Impact

Introduction

The Food Safety and Standards Authority of India (FSSAI) issued an important notification on September 22, 2021, revising the Food Safety and Standards (Fortification of Foods) Regulations, 2018. These revisions are part of India's continuous crusade against micronutrient deficiency and reinforcing the safety and proper indication of fortified foods among consumers.

Background: The Importance of Food Fortification in India

Micronutrient undernourishment remains a pressing problem in India, impacting tens of millions of citizens, with the most at-risk groups being children, women, and vulnerable groups. Food fortification— intentional addition of essential vitamins and minerals to food commonly consumed— is an effective, affordable step that can be taken against this public health challenge. FSSAI regulations aim to standardize and regulate the process, ensuring nutritional value and public health effects.

Major Provisions of the 2021 Amendment

1. Title and Effective Date

Official Title: It has been named the Food Safety and Standards (Fortification of Foods) Second Amendment Regulations, 2021.
Enforcement Date: The regulations were effective from the date of publication in the Official Gazette, and compliance was mandated by food business operators (FBOs) from April 1, 2022.

2. Amended Compliance Specifications for Micronutrient Content

Core Requirement: Food manufacturers fortifying food must see to it that the labeled quantities of micronutrients on the product label adhere to the specified ranges laid out in Schedule-I of the regulations.
Tolerance Clause: Up to 10% tolerance of the total declared value on the label for inspection at any time is permitted. But the upper tolerance limit for added micronutrients must not be exceeded.
Illustration: For a fortified wheat flour product declaring 30 mg of iron per 100g, the low limit shall be not less than 27 mg (10% reduction) and shall not exceed the amount specified in Schedule-I.

3. Extended Coverage and Definitions

Processed Fortified Foods: Changes categorize processed foods produced from fortified staples (e.g., baked goods or breakfast cereal) that enter if they use accepted micronutrients as per the Food Product Standards and Food Additives Regulations, 2011.
Exclusion of HFSS Foods: Exclusion is made for High Fat, Sugar, Salt (HFSS) foods from being classified as fortified processed foods so that fortification cannot promote unhealthy foods.

4. Quality Assurance and Monitoring

Voluntary Quality Assurance: The manufacturers will submit a quality assurance declaration to FSSAI every six months. This will include certifications by recognized food laboratories, records of inventory of fortificants, monitoring schemes, and random test reports.
Standards for Purity: Micronutrients are to be of purity standards acceptable to well-known pharmacopoeias or international standards (Indian Pharmacopoeia, CODEX Alimentarius).

5. Packaging and Labelling Requirements

+F Logo: The '+F' logo should be displayed on every food that is fortified along with the indication statement so that the consumers can easily identify.
Special Warnings: Foods containing added iron should warn patients with Thalassemia and Sickle Cell Anemia either to consume the food under medical supervision or to strictly avoid.
Tagline: A tagline like "Sampoorna Poshan Swasth Jeevan" can come after the logo for the health emphasis.
Example Products: Aashirvaad Chakki Atta and Tata Salt Plus are some examples of compliance with the +F logo specifications.

6. Promotion and Public Awareness

Government Initiatives: FSSAI actively encourages the consumption of fortified foods in government-run programs like the Public Distribution System (PDS), Mid-Day Meal Scheme, and Integrated Child Development Services (ICDS).
Awareness Campaigns: Activities encompass public awareness, technical assistance to small manufacturers, and capacity building of nutrient analysis laboratories.

Step-by-Step Detailed Descriptions of Key Points

A. Fortification Standards and Schedules

Schedule-I: Prescribes minimum and maximum levels of micronutrient levels (e.g., iron, iodine, vitamin A, vitamin D, folic acid, zinc) on staple food products such as wheat flour, rice, edible oil, milk, and salt.
Schedule-III: Prescribes processed foods with standards to deliver 15-30% of the Recommended Dietary Allowance (RDA) for adults in an average serving.

B. Regulatory Process and Stakeholder Engagement

Public Consultation: The amendment followed an open process, for which a draft was placed in August 2019 for comments from the public, for objections and suggestions against which 30 days were made available. Every comment was kept in view while finalizing the final regulations,
Legal Authority: Amendments are brought into force under Section 92 of the Food Safety and Standards Act, 2006, for which strong legal support exists.

C. Compliance and Enforcement

Transition Period: FBOs were given a stipulated time to transition, with a deadline for compliance established as April 1, 2022, allowing reformulation, relabeling, and quality assurance enhancements.
Certification: FBOs must secure the +F Endorsement Certificate through FSSAI’s Food Safety Compliance System (FoSCoS), submitting laboratory test reports from NABL-accredited labs to substantiate fortification claims.

D. Real-World Impact and Examples

Fortification of Rice: Under the Centrally Sponsored Pilot Scheme, fortified rice is supplied via PDS to reduce anemia and micronutrient deficiency in vulnerable sections.
Milk and Edible Oil: Major companies like Mother Dairy and ADM Healthfit Oil have already begun fortification, supplementing their products with vitamins A and D.
Wheat Flour: Aashirvaad Chakki Atta is a readily available fortified wheat flour, enriched with iron, folic acid, and vitamin B12.

Conclusion

The 2021 fortification regulations of FSSAI are an important step forward in India's nutritional policy. By simplifying compliance norms, enhancing the accuracy of labeling, and expanding the range of fortified foods, the FSSAI is making safe, nutritious, and transparently labeled products more accessible. FBOs will have to focus on compliance to create a healthier India from April 1, 2022.