Estimated reading time: 28 minutes
1. Introduction
In 2021, more than half the people affected by hunger in the world (425 million) lived in Asia (1). The factors that can contribute to the micronutrient deficiency burden across various life stages include limited access to diverse and healthy diets due to non-affordability or poor dietary choices resulting from limited knowledge, socio-cultural norms, preferences, and convenience (2). In South Asia, micronutrient deficiencies are at levels that can only be addressed through policy solutions (3).
Addressing these deficiencies through targeted interventions can help improve public health outcomes and reduce the burden of disease in the region. While improving diets through dietary diversification is the ideal solution to addressing micronutrient gaps, food fortification is recognized as a low-cost, effective complementary strategy. Fortification is defined by the World Health Organization (WHO) as: “The practice of deliberately increasing the content of essential micronutrients (i.e., vitamins and minerals) in a food, so as to improve the nutritional quality of the food supply and provide a public health benefit, with minimal risk to health”. Large-scale food fortification involves enhancing the vitamin and mineral content of widely consumed foods during post-harvest processing. Essential micronutrients (vitamins and minerals) that are often added during food fortification include iron, zinc, vitamin A, folic acid and other vitamins, either as single compounds or as a blend of several micronutrients (i.e., premix).
The main goal of a fortification programme is to correct inadequate micronutrient intakes; it can be defined as the practice of deliberately increasing the content of essential micronutrients in a food so as to improve the nutritional quality of the food supply and provide a public health benefit, with minimal risk to health.
Figure 1: Food fortification interventions
2. Food fortification regulatory framework
The need for fortification regulatory frameworks
The regulatory framework for food fortification refers to the set of rules, regulations and guidelines established by government authorities to govern food fortification practices within a country or region. It provides the legal and administrative structure for implementing food fortification initiatives.
The food fortification regulatory framework is essential to ensure the safety, efficacy and consistency of fortified foods. It is important for food manufacturers, producers and regulators to follow a set of guidelines to ensure that fortified foods are beneficial and not harmful to health.
In the case of large-scale food fortification programmes, fortification of any staple food must be implemented in coordination and harmonization with other staples that are being fortified, and it must be in line with international practices and guidelines.
Food fortification standards
Standards are an essential component of the regulatory framework for food fortification. They provide the technical specifications and criteria that must be followed by food manufacturers and producers when adding essential nutrients. They need to be country- and context-specific and align with national laws and regional regulations. Standards can encompass various aspects, including:
Nutrient levels (quantities): Specify the permissible levels of fortification for each essential nutrient in different food categories. These levels are determined based on scientific evidence and the specific nutritional needs of the target population.
Nutrient forms: Define the acceptable forms of nutrients that can be used for fortification, such as specific vitamins or minerals.
Food categories: Identify the food categories that are eligible for fortification. This ensures that the selected foods are appropriate for delivering the fortified nutrients to the target population.
Labelling requirements: Dictate the information that must be included on the product labels of fortified foods, such as the nutrient content, serving size and health claims.
Monitoring and compliance: Establish protocols for monitoring the nutrient levels in fortified foods to ensure that they meet the prescribed requirements. Compliance mechanisms are also put in place to address any deviations from the standards.
Food fortification is implemented through two
main approaches: mandatory fortification, where the government or regulatory authorities require specific food products to be fortified with certain nutrients, or; voluntary fortification, which allows food manufacturers to choose whether to add specific nutrients to their products.
Fortification standards play a crucial role in supporting both mandatory and voluntary fortification of food products and facilitating regional and global trade.
In the case of mandatory fortification, standards set
the minimum and maximum requirements for the fortification of specific foods to ensure that they meet the targeted nutrient levels needed to improve the health of the population. They also provide guidance on the forms of nutrients that should be added, the concentration of these nutrients, and the methods used for fortification.
In the case of voluntary fortification, standards are essential to ensure that the fortified products meet the quality and safety requirements necessary for consumer protection. These standards provide a reference for manufacturers to produce high quality fortified products that meet specific nutrient levels without compromising the safety and quality of the food.
Aligning fortification standards with national and international guidelines
Guidelines provide recommendations and best practices for the addition of nutrients to food products and are typically issued by public health authorities or international organizations. They aim to offer guidance to food manufacturers and fortification programmes.
The global source for food standards, guidelines and codes of practice is the Codex Alimentarius Commission established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex sets international food guidelines and codes of practice to protect the health of consumers and ensure fair trade practices within and outside a given country. The adoption of the recommendations is voluntary but they are often used as a basis for national food standards, including fortified foods. Codex has developed guidelines for the fortification of foods with vitamins and minerals to ensure that they are safe, effective and provide the intended nutritional benefits (5).
FAO and WHO have also published a set of guidelines for food fortification with micronutrients (6). These provide recommendations on the selection of nutrients, levels of fortification, and monitoring and evaluation of fortification programmes. WHO has also published guidelines for fortification of wheat flour with vitamins and minerals (7), which provide recommended fortification levels based on estimated average per capita wheat flour consumption. These guidelines are used as a benchmark to set standards for other foods, including rice.
In addition, many countries have their own regulations and guidelines for food fortification. For example, in the United States of America, the Food and Drug Administration (FDA) regulates the fortification of foods with nutrients, including vitamins and minerals. The FDA has established a list of nutrients that can be added to foods and sets specific levels of fortification.
Harmonizing standards at the regional level
The adoption of consistent fortification practices helps prevent trade barriers and disparities in food quality and promotes the free flow of fortified food products across borders, benefiting both producers and consumers. Harmonization of standards with neighbouring countries or surrounding regional trading blocs needs to be considered as countries adopt or update national fortification standards, in particular
in countries where import levels of fortified/fortifiable foods are high to allow for an efficient allocation of resources and expertise, to reduce duplication of efforts and costs through leveraging economies of scale. It encourages countries to collaborate and share best practices in fortification, helps strengthen institutional frameworks and ultimately leads to more effective and cost-efficient programs.