Good Practice Principles for Regulating Large‑Scale Food Fortification

Overview

Billions of people globally suffer from inadequate micronutrient intakes and related deficiencies (Passarelli et al., 2024[1]) (Stevens et al., 2022[2]) – referred to as “hidden hunger” and contributing to poor health outcomes and socioeconomic disparities (Burchi, Fanzo and Frison, 2011[3]). These deficiencies are linked to increased mortality and morbidity, poor pregnancy outcomes, stunting in children, and reduced productivity and cognitive function in adulthood (Tam et al., 2020[4]). Deficiencies are especially widespread in low and middle-income countries, and disproportionately affect poorer households where diets are often dominated by low-cost staple foods (such as flour, rice, and edible oils) with insufficient nutrient density (Wanyama et al., 2019[5]). The economic burden of micronutrient malnutrition and its associated health effects is also substantial, costing nations billions in healthcare and lost productivity (Burchi, Fanzo and Frison, 2011[3]) – with the World Bank estimating that inaction on undernutrition would amount to an estimated USD 21 trillion in lost economic productivity over the next 10 years (eds., 2024[6]). Addressing micronutrient deficiencies is therefore an imperative for people, countries, and economies to grow equitably and sustainably.

Large-scale food fortification (LSFF) – the practice of adding vitamins and minerals to commonly consumed foods during processing to increase their nutritional value (Olson et al., 2021[7]) – is widely employed as an intervention to help address micronutrient deficiencies. As of 2023, more than 100 countries mandate salt iodisation, and about half of the countries worldwide require wheat flour fortification. Several countries also mandate the fortification of edible oil, maize flour and a few mandate rice fortification. Many countries also employ voluntary fortification programmes, either on its own or alongside mandatory fortification (Karapanou, Arndt-Bascle and Toktosunova, 2024[8]; Global Fortification Data Exchange, n.d.[9]).

LSFF as a strategy has its strengths, limitations, and risks. Research suggests that LSFF offers cost‑effectiveness, with every USD 1 of investment estimated to generate USD 27 of economic return through disease prevention, improved earnings, and enhanced productivity (UNICEF, Gates Foundation and USAID, 2021[10]). Food fortification also does not rely on behaviour change in order to be directly effective. However, LSFF is not a silver bullet to singlehandedly address micronutrient deficiencies and should be used alongside other strategies like dietary diversification (i.e. helping people consume a wider variety of nutritious foods) or supplementation (i.e. providing essential micronutrients through pills, powders, syrups, etc. (Tam et al., 2020[4])). Food fortification should not substitute a healthy, balanced diet, and excessive consumption of certain food vehicles including salt, oils and sugar, which are associated with diet-related diseases such as diabetes and hypertension should be avoided. It should also not be used to induce consumers to buy unhealthy foods, such as high-sugar breakfast cereals or ultra-processed snacks (Giner, Rodriguez and Elasri, 2023[11]).

This publication sets out Good Practice Principles for Regulating Large-Scale Food Fortification. It responds to a policy need: while many countries have adopted fortification standards, challenges persist in translating policy commitments and programmes into sustained, measurable improvements in nutrient intake and health outcomes. Fragmented regulation, unclear institutional roles, weak enforcement, unnecessary regulatory burden, insufficient evidence use, and inadequate consideration of economic and market realities limits impact. At the same time, fortification programmes that are governed by effective and simple rules and policies can support industry compliance, foster consumer confidence, and ensure fortified foods get to the people who need them – and by advancing nutrition, can ultimately foster improved public health, productivity, and economic growth. This report aims to provide clear guidance on how to get there.

The Good Practice Principles (hereafter, the “Principles”) in this publication are designed to be applied pragmatically and progressively. Importantly, most countries are also not starting from a blank canvas. Existing food safety laws, standards bodies, inspection services, customs controls, public health programmes, and statistical systems already provide a foundation that can be built upon and adapted to support the delivery of LSFF programmes. Applying these Principles may therefore mean strengthening, aligning, and better connecting what already exists – rather than building something entirely new from scratch. Where resources are limited, governments may gain more impact by first focusing on select high‑leverage actions rather than attempting to implement a fully comprehensive system at once. For instance, collecting basic data on the prevalence of micronutrient deficiencies and using proxy data sources, establishing clear and accessible fortification standards, aligning requirements with industry and enforcement capacity, or introducing simple risk-based monitoring tools can establish essential building blocks for an effective fortification framework. Over time, more advanced elements – such as digital licensing and registration systems and more sophisticated data-driven supervision – can be layered in as capacity grows. Countries establishing new systems may also adopt digital and data-driven approaches from the outset, in parallel with the development of the necessary regulatory and institutional frameworks.

To support this reality, the Principles include practice examples drawn from the experiences of countries in a diverse range of resource contexts. These examples illustrate how governments have advanced LSFF programmes under real-world constraints through pragmatic approaches, such as phased implementation timelines, simple spreadsheet databases, shared laboratory arrangements, or public-private collaboration. These practices are intended as learning tools, rather than models to be copied wholesale. They provide a practical basis for understanding what has worked, under what conditions, and why. Policymakers can then reflect on what may be transferable to their own national context and how approaches can be adapted based on local capacity, institutions, traditions, and market conditions. The aim is to support steady progress and learning, recognising that effective governance is built iteratively, and that workable solutions implemented today can create the foundation for stronger systems over time.

Regulatory policy in action drives nutrition, public health, social, and economic impact of LSFF

Regulatory policy and governance may be misunderstood simply as the act of making a rule, and in the context of LSFF, may be treated as technical or secondary to nutrition science. However, this dimension can make or break the success of LSFF policies and their real-world results. Regulatory policy encompasses the full system through which policies are selected, designed, implemented, enforced, reviewed, and adapted (OECD, 2012[12]). This includes i) core policies i.e. government statements defining the orientation for regulating and governing; ii) actors, institutions, and capacities responsible for designing, implementing, monitoring and enforcing regulations; and iii) systems, processes and tools ensuring regulatory delivery through specific practices (OECD, 2014[13]).

This report is structured according to a six-pillar framework that sets out how regulatory policy and governance applies to LSFF, starting from determining whether LSFF may be a suitable policy response, and extending through to its effective design and delivery. The framework builds on broader OECD practical and normative work around effective regulatory policy and governance, and is structured as follows:

• Principle 1: Evidence is used to identify micronutrient gaps and inform policy responses;

• Principle 2: LSFF rules are designed for impact;

• Principle 3: Fortified foods and premixes encounter minimal barriers to market access;

• Principle 4: LSFF supervision is carried out effectively and efficiently;

• Principle 5: Tools for behaviour change and capacity building enhance LSFF compliance; and,

• Principle 6: Coherent policies strengthen supply and demand for fortified foods.

Following these steps, regulation and governance can directly shape whether LSFF delivers real nutrition gains. For instance, rules that are practical and feasible to implement are more likely to be followed, thereby achieving the intended policy impact. When rules are aligned with industry and enforcement capacity – for example, phased in while smaller producers and laboratories build capability – compliance becomes more achievable and coverage more reliable.

In this framework, evidence is used throughout the policy cycle to inform interventions that deliver impact in practice. Micronutrient status, health outcomes, and dietary data help identify micronutrient gaps and priority population groups. Information on industry structure, administrative capacity, and programme performance enables policymakers to compare feasible policy options and choose approaches that are both impactful and workable. Where evidence is lacking, policies can misfire – for example, choosing a food vehicle not widely consumed by the target population or setting fortification levels without intake data, leading to under-dosage. During implementation, data from registration systems, inspections, laboratory testing, and compliance reporting support targeted supervision, risk-based enforcement, and the identification of bottlenecks. Without this information, governments and businesses risk investing in programmes that appear good on paper but fail to achieve meaningful coverage or nutrition impact. Over time, monitoring and evaluation data enable course-correction – showing whether objectives are being met, at what cost, and where requirements and procedures can be simplified – so that LSFF and nutrition policies remain effective, proportionate, and responsive to changing conditions.

Regulatory governance directly impacts how fortified foods are delivered. Clear, risk-based registration and licensing rules integrated into food safety frameworks help ensure that fortified foods are produced consistently and safely. These rules determine which businesses may fortify foods and under what technical conditions. Inspections that are risk-based and focused on key control points (such as calibration of equipment to ensure correct dosage, premix reconciliation through tracking inventory, usage and fortified output) help determine whether foods contain the required nutrients at safe levels while targeting the use of enforcement resources where they matter most. Laboratory testing, reporting requirements, and digital inspection tools further support quality assurance. When governance is weak or impractical (e.g. through unclear standards, weak labelling and traceability, or inconsistent enforcement) fortified foods may be poorly dosed, inconsistently available, or unsafe, undermining the health objectives of LSFF.

Beyond health outcomes, regulatory governance also shapes social and economic effects of LSFF. For example, complex or costly registration or licensing requirements can push small producers out of the market and limit access to fortified foods in the rural or low-income areas they serve, whereas streamlined and digitalised procedures make it easier for businesses to participate. Administrative simplification and burden-reduction measures – such as risk-based requirements for market entry and digital one-stop shops – can lower compliance costs and help strengthen the business case for companies to engage in fortification. Business registers and inspection databases affect how efficiently authorities work and how much trust the public and industry place in the system. Supportive instruments – such as training for millers and inspectors, and clear guidance for small firms – can widen coverage and improve compliance. Public procurement and social safety net programmes that buy and distribute fortified foods can create steady demand and encourage producers to invest in fortification infrastructure, while also setting an example for private actors to align their own procurement practices with government standards. Together, these governance choices influence the supply of fortified foods, prices, competition, jobs, market viability, and confidence in fortification programmes.

These Good Practice Principles translate evidence and guidance to create an enabling policy environment for LSFF

Many of the countries significantly affected by micronutrient deficiencies also operate with constrained resources, limited laboratory and inspection capacity, fragmented and informal markets, and incomplete data systems. In these settings, strengthening LSFF regulatory governance can seem overly complex or resource-intensive, and “good practice principles” may seem difficult to apply. However, experience shows that regulatory systems do not need to be fully mature, nor resources unlimited, to begin delivering measurable improvements.

The Principles, alongside practices set out in this publication, build upon work that the OECD Regulatory Policy Division has undertaken to examine how regulatory policy is applied effectively to the context of LSFF, across diverse regional and socioeconomic contexts. This includes the foundational Measurement Framework, itself based upon a comprehensive literature review and pilot studies, that consolidated key regulatory and institutional factors required for LSFF within a comprehensive six-pillar framework (Karapanou, Arndt-Bascle and Toktosunova, 2024[8]). Since the Framework, the OECD has also undertaken light-touch investigation to identify common challenges and practices in the regulatory governance of LSFF across over 20 jurisdictions globally and deep-dive analysis to investigate select jurisdictions in-depth using a robust indicator framework to identify specific strengths and bottlenecks. Over several years, this data collection has been complemented by dialogue and engagement with nutrition and development stakeholders, both at a global and country-specific level. This has informed thematic products on the integration of small and medium-sized enterprises and risk-based inspections in the context of LSFF, as well as products on high-level and country-specific analysis, all of which culminate in this comprehensive publication.

A range of key publications and guidance on LSFF also greatly informed these Principles. These include the World Health Organisation and the Food and Agricultural Organisation of the United Nation’s Guidelines on food fortification with micronutrients, the forthcoming edition of which includes a chapter on regulatory frameworks for food fortification, authored by the OECD, as well as relevant World Health Organisation and Codex Alimentarius guidelines on fortification. WHO, for instance, has specific guidelines for fortification of various foods, including edible oils and fats (2025[14]), rice (2018[15]), flour (2022[16]), and salt (2014[17]). Relevant Codex guidelines include the Codex Principles for the Addition of Essential Nutrients to Foods (2015[18]), Codex General Standard for the Labelling of Pre-packaged Foods (2024[19]), the Codex General Standard for the Labelling and Claims for Pre-packaged Foods for Special Dietary Uses (2009[20]), the Codex General Guidelines on Claims (2009[21]), the Codex Guidelines on Nutrition Labelling (2024[22]), and the Codex Guidelines for Use of Nutrition and Health Claims (2013[23]). These remain essential references for fortification policies. The Principles are intended to provide a regulatory policy and governance perspective that complements the technical and public health guidance developed by WHO, FAO and Codex, promoting the consistent application of international guidance across diverse regulatory settings. The Principles are also informed by Nutrition International’s Blueprint for the Design and Implementation of Large-Scale Food Fortification (2026[24]); ASEAN and UNICEF Guidelines and Minimum Standard for Implementation of Mandatory Large-scale Food Fortification (ASEAN and UNICEF, 2024[25]); the Global Alliance for Improved Nutrition’s guidance on Regulatory Monitoring of National Food Fortification Programs (2018[26]); the World Food Programme’s guidance on food fortification (2022[27]); the World Bank’s Investment Framework for Nutrition 2024 (eds., 2024[6]); and several other reports and products referenced throughout.

These Principles also build on a broader OECD body of practical and normative work around effective regulatory policy and governance, starting with the Recommendation on Regulatory Policy and Governance. They reflect the series of Best Practice Principles for Regulatory Policy, including on Regulatory Impact Assessment, One-stop Shops, Licensing and Permitting, Regulatory Enforcement and Inspections, Governance of Regulators, among others. The Principles are also informed by lessons and practical experience drawn from the OECD’s role in working with countries to implement hundreds of regulatory reform projects globally, across diverse country contexts, translating normative guidance into workable, real-world approaches to regulatory design and delivery. They complement and draw from other relevant OECD legal instruments – including the Recommendation for Agile Regulatory Governance to Harness Innovation and the Recommendation on Human-Centred Public Administrative Services – and reports, such as the Toolkit on Regulatory Enforcement and Inspections. Given the multidisciplinary implications of LSFF, this report also draws from OECD work in other policy areas, such as trade facilitation, food policy, consumer protection, lobbying, public procurement, SME growth, and more – including the Recommendation on Transparency and Integrity in Lobbying; Recommendation on Public Procurement; Recommendation on SME and Entrepreneurship Policy; Declaration on Trade; and the Declaration on Transformative Solutions for Sustainable Agriculture and Food Systems, as well as associated principles and reports.

The Good Practice Principles that follow consolidate work on LSFF and evidence-based regulatory governance, translating it into a practical framework for action. The subsequent six chapters cover the full policy cycle – through instrument choice, policy design, implementation, monitoring, and review – and are illustrated with international experiences, setting the stage for governments to enhance their approach to addressing micronutrient deficiencies.