Good Practice Principles for Regulating Large‑Scale Food Fortification

Principle 2: LSFF rules are designed to achieve impact

 

Principle definition
Policy and regulatory frameworks for LSFF are designed and updated to ensure requirements are informed by evidence, coherent, and capable of delivering nutrition impact.
Sub-principles	Criteria
2.1. LSFF is integrated in an overarching national policy on public health and/or sectoral policies.	National nutrition policies define evidence-based objectives, outcomes, and measurable milestones Micronutrient goals are integrated across health, food, agriculture, and development policies Roles, responsibilities, and links between LSFF policy and regulation are clearly defined
2.2. Technical standards follow international instruments and best practices; countries adopt international standards when appropriate and include required content.	LSFF technical standards follow international best practices and instruments, tailored to local context as appropriate Countries adhere to international and regional standards when appropriate LSFF technical standards include required content
2.3. Regulation is established at the appropriate level within legal hierarchy and integrated into the existing legal framework.	LSFF requirements are placed in appropriate legal instruments within existing food law frameworks Relevant authorities are empowered to issue detailed rules and carry out enforcement of fortification requirements Fortification rules clearly define scope, responsibilities of different authorities, and cover the full value-chain Regulations and standards are aligned and cross-referenced for coherent implementation
2.4. Rules are regularly reviewed and updated, as needed, to ensure they remain relevant.	Monitoring systems track LSFF progress using defined indicators and data collection strategies Reviews use nutrition, coverage, and compliance evidence, as well as data on impact and stakeholder feedback to assess policy effectiveness and efficiency Evaluation findings are used to update and adjust LSFF-related rules, policies, and programmes

Clear, coherent, and well-designed legal frameworks act as the bridge between policy ambition and real-world impact. The way rules are written, structured, and embedded in existing legal systems determines whether businesses understand what is required, regulators can enforce consistently, and fortified foods reach people at the right quality and scale. When this translation is weak – for example, when provisions are vague, fragmented across instruments, or misaligned with institutional capacity – implementation can stall, compliance can become uneven, and nutrition gains can fall short despite sound policy intent.

This chapter sets out practical principles and criteria to support impact-oriented rule design and review. It highlights how integration into national policy frameworks supports coherence and buy-in for LSFF (sub-principle 2.1), how alignment with international standards can support quality and trade (sub‑principle 2.2), how legal provisions can be comprehensive and well-structured to strengthen implementation across the value chain (sub-principle 2.3), and how built-in monitoring and review mechanisms allow rules to adapt over time (sub-principle 2.4). The aim is to help policymakers design LSFF frameworks that are not only technically sound, but also workable, coherent, and responsive to evidence.

2.1. LSFF is integrated in an overarching national policy on public health and/or sectoral policies

An LSFF programme, by its nature, is a targeted policy intervention – typically just one element within a much wider national agenda spanning nutrition, public health, agriculture, economic development and other policy priorities. If LSFF is treated as a siloed intervention rather than a key part of realising national policy goals, it can easily lose impact, priority, and momentum. Maximising the impact of LSFF, therefore, requires that it is integrated into the broader national policy framework. This section explores how LSFF can be aligned with the national policy framework, as part of national policies to which LSFF rules link back, providing a clear legal and policy foundation for effective implementation.

National objectives and measures to reduce/prevent micronutrient deficiencies are integrated into national policies

The reduction and prevention of micronutrient deficiencies can be reflected across a wide range of national policy frameworks, including and beyond nutrition, supporting both policy coherence and commitment. Policies on agriculture and food security, public health, access to safe water and sanitation, education, infrastructure, and gender equality all link to the levels of nutrition in a population (Food and Agriculture Organization of the United Nations, 2004[84]). Food and nutrition objectives can also be mainstreamed into national economic policies to support development, resilience, and recovery – supporting prioritisation of nutrition goals and coherence with the national economic policy agenda. Box 2.1 illustrates how Indonesia has linked fortification to national development policy and planning.

Box 2.1. Indonesia’s Integration of Fortification into National Development Policy and Planning

Indonesia’s development planning system operates through a 20-year long-term plan – the National Long-Term Development Plan 2025-2045 – that acts as the core policy document setting the country’s overarching vision. The long-term plan is supported by 5-year medium term plans that sets out whole-of-government implementing strategies.

The policy direction in the Long-Term Plan addresses nutrition problems through focused interventions to fortify food, ensure access to food, and sustain nutrition through LSFF. Indonesia has established a National Food and Nutrition Action Plan (RAN-PG) as a strategic planning and policy instrument supporting the achievement of National Priorities outlined in the 2025–2029 National Medium-Term Development Plan (RPJMN). The plan recognises LSFF as a key intervention for achieving the strategic objective of enhancing the consumption of diverse, balanced, safe, and climate-resilient foods, while strengthening the delivery of essential nutrition services.

Source: (Government of Indonesia, 2024[85]).

As outlined in Principle 1, national policies are most effective when they are based on comprehensive scientific and economic evidence, clearly articulating the context for the policy, the problem it seeks to address, and the basis for corresponding objectives. Objectives and desired outcomes typically flow from the problems identified through evidence, but they are more useful in national policies when they go beyond broad goals such as “reduce malnutrition.” The acronym SMART (specific, measurable, attainable, relevant, and timely) is a common framework used to guide objective-setting. Clear objectives with precise medium- and long-term milestones make it easier for policymakers to monitor progress, seeing whether implementation is on track or whether course-corrections are needed. Following this framework, a more operational objective may be framed as “reduce the prevalence of iron deficiency anaemia among women of reproductive age from X% to Y% by 2035 and Z% by 2040 through fortified staple foods and complementary nutrition interventions”.

Linking objectives to concrete actions and resources can make it more likely that they will be implemented in practice. Achieving national public health and nutrition objectives can also include defining comprehensive, multi-intervention plans that also work to address underlying drivers of deficiencies through various nutrition and socioeconomic measures – such as social protection schemes, targeted food vouchers, support for farmers, or measures to improve market access in underserved areas. This works in two ways: clear underlying actions and measures help ensure that objectives are realistic, and it helps ensure that performance indicators, mechanisms, and programmes are aligned with those objectives.

A multi-year strategic planning framework linked with budgeting instruments such as annual budget and multi-year budget frameworks, can help align policy ambition with realistic timelines and available resources (OECD, 2020[86]). The OECD Recommendation of the Council on Budgetary Governance (2015[87]) highlights the importance of closely aligning budgets with governments’ medium-term strategic priorities, including by structuring budget allocations around national objectives and linking expenditure to expected policy deliverables. Funding can then be dedicated to support the achievement of specific policy goals, finance fortification-related projects and activities, or support the capacity of institutions charged with realising fortification objectives.

Because a comprehensive approach to reducing or preventing micronutrient deficiencies often implicate multiple sectors and institutions, national policies are more effective when they clearly identify which public authorities are involved and what role each is expected to play. This includes preventing gaps or unnecessary overlaps, and including sub-national governments where needed to support last-mile delivery and community outreach. The national statistical office, for instance, may be responsible for collecting data on food market and intake patterns. Ministries of health may be responsible for education campaigns promoting a balanced diet. Ministries of industry or agriculture may be responsible for the domestic production of fortified foods. Ministries of education or social welfare may deliver school feeding or safety‑net programmes. Viet Nam’s national nutrition strategy allocates local-level responsibilities, charging the Provincial People’s Committees to develop, resource, and implement annual nutrition action plans (Viet Nam Ministry of Health, 2022[88]). Box 2.2 illustrates how India’s national nutrition plan allocates responsibilities among various authorities.

Box 2.2. National Nutrition Mission of India – POSHAN 2.0

In India, fortification is largely covered by the National Nutrition Mission, referred to as the Prime Minister’s Overarching Scheme for Holistic Nutrition (POSHAN). The revised version of the programme (POSHAN 2.0) seeks to address the challenges of malnutrition in children, adolescent girls, pregnant women and lactating mothers and has identified a road map for the short (6 to 12 months), medium (1 to 3 years) and long term (3 to 5 years). POSHAN 2.0 also identifies the roles and responsibilities of the key ministries and departments involved in implementation. The Ministry of Women and Child Development is the leading public authority for POSHAN along with the support of other public authorities defined under guidelines released by the government. For instance, the Food Safety and Standards Authority of India (FSSAI), which is under the Ministry of Health and Family Welfare, is responsible for setting food-related standards and ensuring their compliance, while the Ministry of Rural Development is responsible for grass root level infrastructures spreading awareness around nutrition issues. The integration of India’s Public Distribution System, the country’s largest safety net programme into POSHAN 2.0 provides for the distribution of fortified foods across the country. The POSHAN 2.0 includes the ‘POSHAN Tracker’, an application for real-time monitoring that should provide feedback to programme managers on the impact of the scheme.

Source: (Ministry of Women and Child Development of India, 2022[89]).

In federal or highly decentralised systems, national nutrition policies may not automatically bind or guide states, provinces or regions that hold responsibility for food and LSFF regulation. Yet progress towards national targets, like reductions in stunting and anaemia, often depends on effective action at these levels. National strategies may therefore build in practical arrangements for harmonisation, co-ordination, communication and capacity-building. Arrangements can be binding, such as legislation or formal intergovernmental agreements, or softer, such as joint committees, policy networks and regular platforms for dialogue. Arrangements are most effective when they improve coherence while leaving room for policies to reflect local needs and conditions (OECD, 2012[12]). Pakistan’s Multi-Sectoral Nutrition Strategy 2018-2025, for example, includes specific actions on developing training and providing technical services – such as national labs for nutrition and food analysis and centralised procurement for nutrition commodities and equipment – to support provincial nutrition interventions (Ministry of Planning, Development & Reform and World Food Programme, 2018[90]). In the Philippines, national legislation assigns local governments specific roles in monitoring local access to and consumption of fortified foods, and reporting on the distribution of fortified products. Local governments also incorporate fortification into local nutrition plans, adopt supporting ordinances, allocate resources and undertake information and education activities (National Nutrition Council, 2025[91]). Although involving sub-national governments in policy and regulation-making requires additional time and resources, early and meaningful engagement builds buy-in, brings local knowledge into policy design and reduces the longer-term costs of inconsistent rules, uneven implementation and later corrective action.

Government cannot address MNDs on their own – national policies that clearly define the roles and expectations of different private actors help align public and private efforts and support more effective collaboration toward shared nutrition goals. For example, Sri Lanka’s national nutrition plan identifies specific roles for various non-government actors, including: 1) media and civil society organisations supporting the design and delivery of national nutrition communication campaigns; 2) food manufacturers and distributors applying rules on the marketing of foods and milk products for infants and young children; and 3) formal and informal food vendors complying with rules that limit the availability of unhealthy foods near schools (Sri Lanka Ministry of Health, 2022[92]). Particularly when policies substantially impact or require investment from the private sector, acknowledging their role encourages understanding, participation, and compliance. OECD work has also highlighted various policy tools governments can use to work with industry to encourage healthier food choices, including regulatory and fiscal measures (Giner and Brooks, 2019[93]). This publication further explores collaboration with industry in the regulatory governance of LSFF, including through guidance for food businesses (Principle 5) and policy approaches that support sustainable supply and demand of fortified foods (Principle 6).

Regulatory framework on LSFF includes clear references to relevant national policies to ensure alignment and coherence

In some countries, the constitution or supreme law explicitly recognises rights to food, health, nutrition security, or general well-being, providing a strong legal foundation for food fortification regulations. For example, the Philippines’ implementing law for the food fortification programme specifically cites that “Section 15 of Article II of the Constitution provides that the State shall protect and promote the right to health of the people and instil health of the people and instil health consciousness among them” (Philippines Department of Health, 2021[94]). Where such provisions are absent, a national policy that explicitly identifies food fortification as a priority intervention to address MNDs can provide a strong legal foundation that makes it easier to introduce a regulatory framework and requirements for fortification. In turn, the regulatory framework should include clear links and references to the relevant policy basis. Regulatory frameworks that are grounded in national policy demonstrate consistency with the goals and objectives of the government and therefore enjoy enhanced legitimacy and provide a more stable and coherent legal environment. This perceived legitimacy and coherence is not merely symbolic but carries practical value. For example, clearly anchoring requirements on fortification levels in national policy can help show to businesses that requirements are predictable and justified, rather than ad hoc or excessive – which can then support higher levels of voluntary compliance.

Citing or cross-referencing relevant national policy goals within regulatory text supports alignment and coherence in implementation. They help responsible authorities interpret in-text requirements in light of policy goals, support co-ordination across ministries and agencies, and signal to stakeholders that there is coherence and continuity in the government’s agenda. This alignment can also make future updates easier, as both policy and regulatory frameworks can be reviewed and adjusted in tandem to reflect new evidence, evolving nutrition priorities, and implementation experience. Sub-principle 2.4 further discusses the process of evaluating and updating the regulatory framework on fortification post-implementation.

2.2. Technical standards follow international instruments and best practices; countries adopt international standards when appropriate and include required content

Although technical in nature, standards are most effective when written in clear, accessible language. Clear standards reduce confusion and inconsistent interpretation, support more predictable compliance, and help ensure that fortified foods placed on the market meet defined nutrition and quality objectives. By contrast, ambiguous or incomplete standards can lead to inconsistent formulations from producers, varied enforcement across jurisdictions, and barriers for importers and exporters.

Food fortification technical standards set out the detailed requirements for how essential micronutrients are added to selected foods. They serve as a common reference point for producers, importers, exporters, laboratories, and inspectors.

While there is no universal definition of what constitutes a standard – as this can vary depending on country, sector, and context – a food fortification standard can be understood as a document:

1. developed by a recognised body

2. for common and repeated use

3. based on scientific evidence

4. that outlines requirements and characteristics for producing a fortified food or food category.

This understanding is consistent with definitions employed by the International Organisation for Standardisation (ISO) (2019[95]) and the OECD (2025[35]). Standards, with a few exceptions, are generally voluntary in nature and lack legal enforceability on their own. International instruments such as non-binding technical standards, guidelines and codes of practice may be adopted through intergovernmental consensus, expert-based processes, or public-private partnerships, and vary in their legal status, institutional context, and mechanisms for implementation (OECD, 2021[96]). Ideally, micronutrient fortification standards for specific food products or food categories are developed first and then, if needed, made mandatory through adoption in regulation (discussed under 2.3).

Food fortification technical standards include essential content to improve health outcomes

As set out through an illustrative example in Box 2.3, a robust technical food fortification standard:

• identifies the foods and food categories to be fortified;

• clearly names the micronutrients to be added to the food;

• defines the minimum and/or maximum levels of the micronutrients to be added in the food; and,

• lists the permitted micronutrient compounds to be used for fortification including their name and level.

Box 2.3. Mexico’s fortified edible salt technical standard

Mexico’s mandatory technical standard for fortified edible salt illustrates the importance of robust standard development and comprehensive content in maximising health outcomes. Its development was undertaken in co-ordination with various government bodies including health, industry, and trade agencies, as well as university research centres and industry associations.

In addition to clarifying the objective (i.e. preventing diseases caused by iodine and fluoride deficiencies in the population) and the scope/applicability (i.e. mandatory for all persons who produce, process, package, distribute, import, or market iodised salt, iodised–fluoridated salt, or iodised salt for consumption), this standard clearly sets out essential technical requirements for fortification. This includes:

• Foods subject to fortification: Fortification applies to edible salt for human consumption, distinguishing between iodised salt and iodised-fluoridated salt, and further differentiates between unrefined and refined salt. It also covers iodised salt for animal consumption, while explicitly excluding salt intended for industrial non-food uses.

• Micronutrients required: Iodine is mandatory for all edible salt within scope, while fluoride is required only for iodised-fluoridated salt intended for human consumption.

• Minimum and maximum fortification levels: Iodine must be present at 30 mg/kg, with an allowable range of ±10 mg/kg, and fluoride must be present at 250 mg/kg, with an allowable range of ±50 mg/kg. Notably, the technical standard prohibits fluoride fortification in geographic areas where levels of fluoride in drinking water exceed a defined threshold.

• Permitted micronutrient compounds: For iodine, potassium iodate, sodium iodate, potassium iodide, and sodium iodide are authorised. For fluoride, sodium fluoride and potassium fluoride are permitted.

Source: Mexico, NOM-040-SSA1-1993, https://platiica.economia.gob.mx/normalizacion/nom-040-ssa1-1993/; (OECD, 2020[97]).

The inclusion of minimum and/or maximum levels is consistent with Codex Principle 3.1.3 (Codex Alimentarius Commission, 1987[42]). WHO guidelines further elaborate on the definition of regulatory parameters including the legal minimum and maximum tolerable levels (WHO and FAO, 2006[43]). The decision on whether to prescribe either or both minimum and maximum levels includes factors like potential health risks associated with overconsumption of certain micronutrients, the stability of specific fortificants, and industry technical capacity. Some experts have also raised, as an alternative option, the use of an average level of fortification (instead of a minimum/maximum range); this may support fortification at a level closer to the ideal, but may also challenge enforcement without a clearly-defined range of what is acceptable.

A structured and transparent process to standard development helps ensure that resulting standards are both technically sound and practical to implement. This typically includes reviewing scientific evidence on micronutrient deficiencies, dietary and consumption patterns, complementary nutrition programmes, and public health needs; working with technical experts in nutrition and food science to determine suitable nutrient levels and compounds for given food vehicles; consulting relevant stakeholders; and aligning with international guidance where appropriate to support regulatory coherence and trade.

Food fortification standards are usually developed by a national standardisation body, responsible for developing and promoting standards. In some countries, a cross-sector institution such as the Uganda National Bureau of Standards develops standards across many product areas. In other countries, a sector‑specific authority such as India’s Food Safety and Standards Authority develops fortification standards. National standardisation bodies can be government agencies established by legislation or independent organisations endorsed by government.

The value of introducing separate premix standards is a point of discussion among LSFF stakeholders and depends upon the market and regulatory context. Premixes are commercially prepared, customised blends of vitamins and/or minerals in which each nutrient component is pre-scaled and precision blended into a form that is then added to food vehicles (Access to Nutrition Initiative, 2025[98]). Only a limited number of countries currently have domestic premix manufacturing capacity, involving the manufacturing of premixes from individual vitamin and mineral ingredients and other inputs, while premix blending occurs in a larger number of countries. Introducing separate premix standards may provide clear benchmarks for composition and quality, ensuring that premixes are assessed against the same requirements. The decision to introduce separate premix standards will also be influenced by the capacity to enforce and test those standards. This includes the ability to conduct oversight at the appropriate control points (e.g., production and import), the availability of appropriate enforcement measures, opportunities for collaboration between industry and regulators, and the availability, affordability and reliability of testing methods. Such standards would support supervision where local premix production or blending exists and can facilitate monitoring in specific cases such as fortified rice kernels where kernel-based compliance checks can simplify oversight. Premix standards may also facilitate trade in cases where regions have harmonised premix standards. However, where food fortification standards already clearly specify the nutrient content required in the final product, separate premix standards may duplicate existing requirements, increase compliance, testing and enforcement costs and create implementation challenges especially where premix and fortified food standards are not well aligned. Highly prescriptive premix standards may also limit flexibility and innovation by restricting the use of new formulations, technologies, nutrient compounds or delivery systems that could otherwise improve product stability, affordability or effectiveness.

Dedicated premix standards represent one of several approaches that can be used to strengthen premix quality assurance and regulatory oversight. Other approaches include well-designed food fortification standards supported by clear implementation guidance, the use of pre-qualified supplier systems, and quality-assured procurement mechanisms (Guinot et al., 2012[99]). Contract and commercial law can also support quality assurance by making premix specifications enforceable and providing remedies when premix supplied to a food business does not meet agreed-upon or advertised specifications. These approaches can be supported by tools such as certificates of analysis, premix reconciliation during inspections of fortified food products, and laboratory testing of premix and fortified food products. Risk-based inspection approaches that focus oversight on critical control points in the supply chain (see Principle 4), including premix manufacturers, blenders and importers where appropriate, can further strengthen quality assurance while making efficient use of resources. Countries will need to assess the relative benefits and costs of introducing dedicated premix standards alongside these approaches, taking into account their regulatory capacity, market structure and policy objectives.

Countries can ensure the credibility and quality of their standard-setting processes by following ISO’s Good Standardization Practices and other recognised best practices for producing standards that are relevant, technically robust, and widely accepted. ISO, like Codex, promotes standards based on clear objectives, evidence, and consistent methods and terminology so they are easy to interpret and interoperable. The Practices also encourage open and well-documented engagement processes to support the participation of interested stakeholders – including regulators, industry, consumers, and academia (ISO, 2019[95]). Altogether, these practices help ensure that resulting standards are credible, effective, and widely applicable.

Technical food fortification standards can also include prescribed mechanisms for regular review and revision to keep standards current, in line with ISO’s Good Standardization Practices – which note that good practice is to review standards every five years, and based on the findings of the review, the standard may be upheld, adjusted, or withdrawn altogether (see also section 2.4. on post-implementation reviews).

National technical standards reflect international and regional benchmarks

Where possible and suitable, countries benefit from harmonising with international instruments and adopting international and regional technical standards on food fortification. The reference and use of regional standards can yield better outcomes for consumers and trade, minimise unnecessary regulatory burden and help to ensure the quality of both the standards and the standard-setting processes. It limits the cost and complexity of compliance for industry actors operating regionally by reducing regulatory fragmentation and supporting economies of scale in the production and distribution of fortified foods and premixes. Furthermore, the use of international standards also enhances the legitimacy and effectiveness of domestic regulations and standards and helps countries meet their obligations under multilateral agreements, including those under the World Trade Organization (WTO).

Countries can ensure a common basis by following the Codex Alimentarius which provides a key reference point, particularly the General Principles for the Addition of Essential Nutrient to Foods. These principles emphasise how food fortification should aim to prevent or correct demonstrated nutritional deficiencies in the population and consider safety concerns and efficacy, in other words, standards should have a clear intended purpose and intended outcomes. The Codex Alimentarius recommends countries to consider national contexts, even when aligning with international instruments, for instance by recommending that food fortification levels should be based on dietary intake patterns locally. Table 2.1 sets out relevant WHO guidelines and regional standards by food vehicle, which also serve as a reference for policymakers.

Table 2.1. WHO guidelines and regional standards by food vehicle

Food vehicle	WHO guidelines, guidance	Regional standards
General	WHO/FAO guidelines on food fortification with micronutrients (“Orange Book”)	ASEAN Guidelines and Minimum Standards for Implementation of Mandatory Large-scale Food Fortification (2024)
Edible oils	WHO guidelines on fortification of edible oils and fats with vitamins A and D (2025)	ARSO: ARS 862:2016(E), Fortified cooking oils — Specification ECOWAS: ECOSTAND 008 EAC: EAS 769:2019 SADC Minimum Standards for Food Fortification (2022)
Rice	WHO guidelines on fortification of rice (2018)	EAC: Draft standard DEAS 1236: 2024 (Fortified milled rice – specification) [as of 2025, a final standard has not yet been published]
Wheat flour	WHO guidelines on fortification of wheat flour with vitamins and minerals as a public health strategy (2022) Monitoring Flour Fortification to Maximize Health Benefits: A manual for millers, regulators and program managers (2021)	ARSO: ARS 860:2016(E), Fortified wheat flour — Specification ECOWAS: ECOSTAND 047 EAC: EAS 767: 2019 SADC Minimum Standards for Food Fortification (2022)
Maize flour	WHO guidelines on fortification of maize flour and corn meal (2016)	ARSO: ARS 861:2016(E), Fortified maize flour — Specification EAC: EAS 35:2021 SADC Minimum Standards for Food Fortification (2022) ECOWAS: ECOSTAND 066:2017 (Fortified milled maize products – specification)
Salt	WHO guidelines on fortification of food-grade salt with iodine (2014) Guideline: Sodium intake for adults and children (2012)	ARSO: ARS 471:2016(E), Food grade salt — Specification EAC: EAS 35:2021 ECOWAS: ECOSTAND 048:2015 SADC Minimum Standards for Food Fortification (2022)
Sugar		ARSO: ARS 863:2016 (E), Fortified sugar — Specification ECOWAS: ECOSTAND 055:2017 (Fortified sugars – specification) EAC: EAS 770:2022

Source: (WHO and FAO, 2006[43]); (Nyumuah and Ojomo, 2025[100]); (South African Development Community, 2020[101]); (ARSO, 2025[102]).

By complying with the WTO’s Agreement on Technical Barriers to Trade, countries can prevent unnecessary obstacles to trade. Under the Agreement, members are encouraged to base their technical regulations and conformity assessment procedures on relevant international standards when possible. This includes ensuring that domestic regulations and standards are not more trade-restrictive than necessary and are developed through transparent, inclusive and evidence-informed processes. In the context of food fortification, this can help to balance public health goals with the facilitation of trade and market access while mitigating negative economic impacts in the food sector. Finally, both the WTO and ISO stress alignment with international norms to support global trade, and the avoidance of unnecessary barriers.

Establishing a conducive institutional environment with sufficient technical and administrative capacity is critical to supporting alignment with regional LSFF standards. To enable the effective use of international instruments when developing standards, countries need to ensure they have mechanisms for co-ordination across the various ministries and agencies involved, access to international expertise, and capacity to engage in international standard-setting bodies (OECD, 2022[103]). In federal or highly decentralised systems, national endorsement of a standard may not automatically result in its adoption or implementation by states, provinces or regions that hold the relevant jurisdiction; mechanisms for institutional co-ordination and dialogue with the subnational level therefore become critical (Rodrigo, Allio and Andres-Amo, 2009[104]). Early involvement of these authorities can support buy-in and the necessary capacity-building, avoiding standard adoption gaps in which standards may be endorsed at the national level but are not effectively adopted, implemented or enforced by the responsible authorities.

As needed and appropriate, international and regional standards are tailored to local needs

When adopting international standards countries need to carefully consider their local context. National Standardisation Bodies (NSBs) assess whether international standards are compatible with domestic realities and, where necessary, adapt them to ensure relevance and feasibility. Technical standards for food fortification must reflect the country’s specific nutritional needs, dietary patterns, legal frameworks, industrial capacity, and institutional arrangements. This may involve modifying certain parameters, such as the type and levels of micronutrients added, while maintaining alignment with the underlying principles and objectives of the regional standard. In emergency and humanitarian contexts, governments are encouraged to allow importation of foods fortified following international standards as applied in international humanitarian assistance programmes such as the United Nations World Food Programme, to support the timely delivery of safe and nutritionally adequate food during crises.

It is important to be mindful of the risks and trade-offs that may be associated with adapting international standards to local contexts. As noted in the World Bank’s 2025 World Development Report, stakeholders may capture the process, watering down standards, making them hard to reverse or improve over time – which, in turn, risks locking countries into low-quality norms and limited trade prospects. Deviating from international standards to accommodate limited firm capacity to meet those standards should therefore be a last resort, used only when firms’ capacity cannot yet be strengthened. As countries and firms increase their capacity for compliance, they should align standards for the domestic market with international standards (World Bank, 2025[105]).

ASEAN, in its 2024 Guidelines and Minimum Standards for Implementation of Mandatory Large-scale Food Fortification, provides further specific guidance. It directs Member States to consider WHO guidelines for suggested micronutrient levels and recommended compounds applicable for national consumption level of the food vehicle (Table 2.1 above outlines WHO guidelines). If the food vehicle is rice, Member States are encouraged to review the WHO guidelines for how to set rice fortification levels. If another food vehicle is being considered, and to use the Food Fortification Formulator (a series of spreadsheets from USAID that include dietary parameters for different gender and age groups, the price of commonly used fortificants, and the usual stability of vitamins and minerals during production, distribution, and marketing of fortified foods). If global guidelines are not followed, the government ideally document reasons why global recommendations were not applicable and how national food fortification requirements were developed (ASEAN and UNICEF, 2024[25]).

Several East African countries have harmonised LSFF regulatory frameworks by adopting technical standards produced by the East Africa Community EAC, an intergovernmental organization that supports regional integration among its eight member countries. Uganda, a member country, introduced mandatory requirements on LSFF by transposing East African Standards into their domestic legislation. The process to do so was by referring to the standards from the Ugandan National Standardisation Body in the Official Gazette. Economic Community of West African States (ECOWAS) standards for fortified wheat flour, vegetable oil, and iodised salt have been adopted by all member countries of the West African Economic and Monetary Union, as well as by Gambia, Guinea, and Cape Verde – however, select ECOWAS countries remain exceptions, having yet to align their domestic fortification standards with ECOWAS.

Countries should engage proactively in regional standards development processes to ensure technical standards reflect their own context. Active participation by national standards bodies and relevant ministries in regional technical committees and working groups allows member states to shape regional LSFF standards in ways that reflect shared priorities and national interests. Such participation can also build national ownership of the standards and facilitate smoother implementation and enforcement once adopted. For further discussion on how standards, regulations, and quality infrastructure systems work together, see the OECD’s report on Reinforcing Regulatory Frameworks through Standards, Measurements and Assurance (OECD, 2025[35]).

2.3. Regulation is established at the appropriate level within legal hierarchy and integrated into the existing legal framework

Anchoring policies and requirements for food fortification in law is not a one-size-fits-all exercise. Typically, a regulatory framework for LSFF will include a mix of primary laws, subordinate implementing regulations and technical standards, all of which are properly integrated into existing food law frameworks (Karapanou, Arndt-Bascle and Toktosunova, 2024[8]). This mix, as well as how each instrument is designed, is shaped largely by a country’s specific legal system and traditions, as well as a balance of considerations – like the need for rules to be authoritative and comprehensive, while simultaneously being sufficiently clear and flexible. This sub-principle practically sets out how countries can balance their national context and various considerations to design an impactful and coherent legal framework for LSFF.

As a note for clarity, this section refers specifically to subordinate regulations. Unless a distinction is specifically made, the term “regulation” throughout this publication encompasses the broad set of instruments that governments can use to set requirements, including but not limited to primary laws, subordinate regulations, formal and informal orders, and administrative formalities (OECD, 2021[106]).

Fortification regulations are integrated into the existing legal framework at the appropriate levels

Fortification requirements are generally most effective when they are built into the existing food legal framework rather than treated as a standalone system. Leveraging established food safety laws and enforcement mechanisms helps avoid duplication and creates a more coherent and predictable legal environment for businesses. In practice, this can mean drafting fortification regulations to explicitly cross-reference existing legal provisions and authorities – for example, relying on inspection powers, labelling requirements, or penalty clauses already defined in the general food law instead of recreating separate ones.

Legal frameworks for large-scale food fortification typically operate across multiple levels of the legal hierarchy, combining primary laws and subordinate regulations. Primary laws – such as a food or health law adopted by parliament – usually establishes the overall legal basis and authority for food fortification. Subordinate regulations – such as ministerial decrees or implementing rules issued by the government – then set out more detailed requirements needed to operationalise LSFF. Table 2.2 illustrates how different countries employ a mix of instruments across levels of the legal hierarchy to establish a framework for food fortification.

Table 2.2. The LSFF legal hierarchy in practice: Country examples

	Costa Rica	Tanzania
Primary laws	Law 5395 (1973) covers elements competency of the Ministry, enforcement tools and sanctions, among other elements.	Standards Act (2009), and Finance Act (2019) provide the Tanzania Bureau of Standards (TBS) competency over standardisation of all commodities (incl. foods), as well as enforcement tools and sanctions.
Subordinate regulations	Executive Decrees issued by the Ministry of Health cover fortified food parameters (incl. compounds, fortification levels, type of mandate) as well as some of the elements related to health claims for specific food vehicles.	Through Standards (Registration of Premises and Certification of Products) Regulations (2021), establishes the certification and registration of pre-packaged foods.
Other	Central American Technical Regulations cover elements such as labelling for pre-packaged products, and sanitary registry and inscription requirements.	The TBS through Technical Standards establishes both fortified food parameters and rules related to labelling of foods and packaging.

Source: Costa Rica: Law 5395 (1973), Executive Decree 27021-S (1998), SICA COMIECO, RTC 67.01.15:07 (2007):

Tanzania: Standards Act (2009), Finance Act (2019), Standards (Registration of Premises and Certification of Products) Regulations (2021).

The choice of whether a particular fortification requirement or provision is best-suited for primary law or subordinate regulation depends largely on country-specific legal and administrative factors. Relevant factors include the hierarchy of laws, how rule-making powers are distributed across institutions, and practical considerations about how easily rules can be updated and implemented in practice (Karapanou, Arndt-Bascle and Toktosunova, 2024[8]). Primary laws generally provide a strong and stable legal foundation because they sit high in the legal hierarchy and are adopted through formal legislative procedures that often involve consultation, political approval, and visibility – but they are typically also slower and more demanding to amend. Subordinate regulations help operationalise the framework set in primary laws by setting technical requirements. Compared to primary laws, they tend to be more detailed but can also be easier to update. As noted under 2.2, subordinate regulations can endorse and make technical fortification standards mandatory – a decision that requires first weighing the suitability of voluntary versus mandatory fortification approaches within the national context, as discussed under Principle 1. In some cases, standards can be incorporated by reference directly into subordinate regulations, so that future updates to the standard automatically take effect without requiring a full legal amendment, helping keep technical requirements current while maintaining legal clarity. Table 2.3 summarises what the various pros and cons mean for how different LSFF provisions may be distributed effectively between primary and subordinate levels.

Table 2.3. Typical LSFF provisions across primary legislation and subordinate regulations

Primary legislation May also be known as: statutes, acts, laws, legislation, code	Subordinate regulations May also be known as: decrees, guidelines, rules, regulations, standards, notifications
Establishes the legal foundation for food-related policies (food security, population nutrition, public health, food safety and quality, food trade etc.)	Endorse or adopt LSFF technical standards as mandatory
Mandates food fortification as a strategy to combat micronutrient malnutrition (applies only to mandatory fortification)	Provide technical specifications and implementation guidelines and timelines
Sets out institutional mandates, roles, and powers related to LSFF – including for enforcement	Define roles and responsibilities for regulatory agencies
Empowers relevant government agencies to develop, issue, and enforce regulations relevant to LSFF	Introduce requirements for food businesses, importers, exporters, and other non-government actors
If relevant, defines provisions relevant to the competencies of subnational jurisdictions	Set tools and mechanisms for supervision and enforcement

Source: Elaborated from Measurement Framework; Primer on public law and regulation.

Placing requirements at the wrong level can interfere with the operation of the framework. For example, prescribing micronutrient compounds, fortification levels or production methods directly in primary legislation can leave outdated technical requirements in force long after evidence or production practices have changed, because legislative amendment may be slow or politically difficult (FAO, WHO, 2019[107]). At the same time, placing essential legal obligations only in non-binding guidance can create uncertainty over what authorities can enforce (Melnick, 2017[108]) (Potts, 2021[109]). A layered approach can avoid these problems: law provides the authority and core obligations, subordinate instruments contain requirements that need legal force but may require regular adjustment, and guidance explains practical ways to comply. Guidance can provide the detail and clarity needed by businesses with limited technical capacity – through examples, recommended procedures or templates – without preventing other businesses from using different methods that achieve the same regulatory outcome (OECD, 2004[110]). Because guidance can be updated more easily, it also allows implementation practices to adapt over time without repeatedly amending the legal framework. Guidance is discussed further under Principle 5.3.

Fortification rules are comprehensive, providing coverage and clarity

Ensuring the content of LSFF regulations are comprehensive – covering the full fortification value chain, from premix production and food processing through distribution, import/export, and retail – helps translate policy decisions into consistent, practical actions by both businesses and regulators across the food system. When regulations provide incomplete or fragmented coverage, gaps like enforcement that overlooks distributors or unclear importer obligations can arise that weaken compliance, disrupt fortification supply chains, and ultimately reduce the nutrition impact of LSFF regulations. Box 2.4 summarises the essential contents of comprehensive fortification regulations, serving as a checklist basis for policymakers.

Box 2.4. Food fortification regulation content checklist

Food fortification regulations are most effective when they provide clear, complete, and operational requirements for both authorities and businesses covering the full fortification value chain. A practical checklist of core elements includes:

• Define the scope and technical requirements: Identify the specific foods or food categories subject to fortification requirements; specify approved micronutrients and permitted compounds; set minimum and/or maximum fortification levels and tolerances; and either describe key technical procedures or formally reference the applicable fortification standard.

• Reference applicable technical standards: Explicitly link the regulation to recognised national or international fortification standards where feasible to ensure consistency, clarity, and ease of updating technical parameters when standards are revised.

• Delineate institutional roles and powers: Clearly assign the roles, responsibilities, and legal powers of competent authorities at central and sub-national levels in a manner that avoids gaps or overlaps, including standard-setting, authorisation, inspection, laboratory testing, and enforcement functions (Principle 4 further discusses how clear co-ordination and communication mechanisms between implicated authorities can support effective supervision). Where this includes responsibilities for setting subordinate requirements, assign who is responsible for doing so and, where appropriate, by when.

• Set business obligations across the value chain: Specify risk-based requirements for notification, registration, licensing (where applicable), and labelling for all relevant operators, including producers, premix suppliers, importers, exporters, transporters, and distributors – discussed further in Principle 3.

• Establish quality assurance and control requirements: Include obligations for internal quality control by businesses, premix traceability, record-keeping, and clear sampling and laboratory testing procedures.

• Provide supervision and enforcement provisions: Define inspection powers, monitoring approaches (including risk-based supervision where relevant), corrective actions, and proportionate penalties for non-compliance.

• Clarify reporting and documentation duties: Set out what production, import, or compliance data businesses must maintain or submit, and in what format and frequency.

• Include enabling and support measures: Where relevant, describe available incentives, transition measures, technical assistance, or capacity-building support for producers and importers.

• Specify exemptions and special cases: Clearly state any exemptions (e.g., for export-only products or small-scale operators where justified), with objective criteria and public health justification, ensuring non-discrimination between domestic and imported products.

Source: Elaborated from (Karapanou, Arndt-Bascle and Toktosunova, 2024, p. 19[8]).

In practice, how this checklist is employed in a given national context can vary and evolve over time as rules are amended. For instance, in Brazil, the initial 2002 regulation introducing mandatory wheat and maize flour fortification was relatively limited. The regulation required mandatory addition of iron and folic acid to all pre-packaged wheat and corn flours for consumer sale and industrial use, including bakery use and flour premixes, at prescribed minimum levels. The regulation noted exemptions were allowed in cases where iron or folic acid demonstrably interfered with a processed food product, with the company required to keep supporting studies available for health authorities. The choice of compounds was generally left to producers, with a broad requirement for producers to ensure stability and bioavailability (Brazil ANVISA, 2002[111]). Over two decades, requirements set in regulation evolved to clarify key elements such as: maximum fortification levels, linking fortification enforcement to broader sanitary infractions, labelling requirements, and clarifying exemptions (Brazil ANVISA, 2022[112])

Comprehensive regulations also need to strike a balance between clarity and flexibility, so that they are not so prescriptive that they create operational conflicts or unnecessary barriers for industry. For instance, rules specifying the exact processing stage at which vitamin D has to be added to liquid milk may later prove incompatible with standard sterilisation processes, making it difficult for producers to meet both safety and fortification requirements (Chile Ministry of Health, 2024[113]). As needed, requirements set out in regulation can be further elaborated or clarified through additional guidance or policy documents provided to policymakers, inspectors, business operators, or other actors involved in LSFF (see also Principle 5).

Making rules accessible – both in how they are written and how easily they are available – ensures that businesses and authorities alike can interpret and apply them consistently. Well-structured rules written using clear and easy-to-understand language avoids confusion and misinterpretation. Accessibility also matters in practical terms. A practical baseline step is to make all laws and regulations available through a consolidated and searchable online portal, as illustrated by Viet Nam’s National Legal Portal launched in 2025. Technical standards incorporated into regulation can present a greater challenge. For example, where compliance depends on consulting a technical standard, but that standard is only available at a prohibitive cost or through hard-to-access channels, smaller producers and importers may struggle to understand what is required, leading to avoidable errors or non-compliance. As an example of how to address this, Canada’s health regulator maintains an online Incorporation by Reference Inventory that directly links to all documents incorporated in regulations and/or provides a contact point that directs stakeholders to where incorporated documents can be obtained (Health Canada, 2025[114]). Guidance is also provided to Canadian policymakers on navigating the cost of standards that are incorporated into regulations (Box 2.5).

Box 2.5. Canada’s approach to considering cost when incorporating standards

Government of Canada guidance for policymakers recognises that many standards incorporated into regulation are copyrighted and may require payment to access. Policymakers are therefore encouraged to assess whether the cost of accessing an incorporated standard is reasonable in practice, since affordability is a key element of accessibility. This assessment can be made case-by-case with legal counsel, and regulators are expected to monitor costs over time to ensure they remain proportionate.

Guidance also highlights the need to consider accessibility cumulatively: where multiple standards are incorporated into a single regulation, the total cost of accessing all referenced documents should be taken into account. Regulators are encouraged to favour standards that offer view-only or read-only free access where possible, and to consult with the Standards Council of Canada and standards bodies on access options.

Additional practical measures can also improve accessibility, such as providing clear links and contact points, and – where copyright permits – making incorporated documents available for review online or at designated locations, including in machine-readable formats.

Source: (Treasury Board of Canada Secretariat, 2024[115]).

To keep fortification frameworks effective over time, review mechanisms can be prescribed directly within a law, subordinate regulation, or in administrative processes – discussed in the next sub-principle.

2.4. Rules are regularly reviewed and updated, as needed, to ensure they remain relevant

Regularly reviewing and updating LSFF rules, policies, and programmes ensures that regulatory frameworks remain responsive and suited to changing nutritional needs, scientific developments, and implementation realities. As populations, diets, industry practices, and fortification technologies evolve, the effectiveness and efficiency of LSFF regulatory frameworks can likewise evolve over time. Static or outdated rules risk undermining public health goals, creating compliance challenges, or missing opportunities for improvement. A structured and periodic review process helps maintain relevance, supports continuous improvement, and ensures that LSFF interventions continue to deliver intended health outcomes efficiently and equitably.

LSFF regulatory instruments are reviewed and updated based on scientific evidence and impact

Setting up effective monitoring and evaluation for after a rule has been put in place starts when the rule is being designed. As discussed under both Principles 1 and 2, when designing regulatory or policy interventions, it is important that policymakers define specific, measurable, attainable, relevant, and timely (SMART) objectives, along with performance indicators, means and programmes for achievement of the set objectives. What will constitute success of the regulatory intervention – and in turn, how will success be measured? The questions and benchmarks set out in the design process set the foundation for post-implementation review (OECD, 2020[116]). Evidence in LSFF is therefore not only an input to the initial decision to pursue fortification, but part of a continuous feedback loop that allows policymakers to test assumptions, monitor implementation and adjust the programme as new information becomes available.

No single indicator provides a complete picture of programme performance. Bringing together – or triangulating – different sources of evidence can help policymakers understand whether the right nutrients and food vehicles have been selected, whether standards remain appropriate and are being implemented, whether fortified foods meet required specifications, and whether they reach and are consumed in sufficient quantities by the populations expected to benefit. Establishing monitoring mechanisms and a clear data collection strategy makes it possible to understand whether LSFF rules are working as intended and delivering nutrition results in practice. This includes prescribing who is responsible for what data and evidence needs to be collected – which can be adjusted based on available resources. For instance, external partners whether in academia or in development organisations may be enlisted to carry out monitoring if internal government resources are limited. Monitoring systems can combine regulatory data (such as business registration, inspection findings, laboratory test results, and compliance reports) with nutrition and market data (such as coverage of fortified foods, household consumption patterns, and micronutrient status indicators) and stakeholder data (input received from standing or regular feedback mechanisms). In Nigeria, for instance, a 2012 study tested 293 fortified food samples across sugar, cooking oil, wheat and maize flour, semolina and salt, and found compliance levels so low as to – according to the authors – “generate doubt about the value of the entire fortification programme” (Ogunmoyela et al., 2013[117]). In response, efforts to improve compliance intensified, involving capacity-building for regulators, strengthening and accreditation of laboratory testing facilities, and, in 2017, the launch of a multi-sectoral initiative designed to increase compliance through partnerships with private-sector producers. (GAIN, 2022[118]).

Post-implementation reviews generally cover two dimensions: effectiveness and efficiency (OECD, 2020). “Effectiveness” focuses on whether LSFF rules are actually improving micronutrient intake and nutritional status in the population, and whether elements such as selected food vehicles, fortification levels, or target groups need adjustment based on observed results. This requires looking across the pathway from implementation to impact: whether the appropriate nutrients and food vehicles were selected, whether fortified foods comply with standards and achieve sufficient coverage and consumption; whether micronutrient intake and status improve, including among vulnerable groups; and, where data allow, the extent to which LSFF is contributing to broader public health improvements alongside other nutrition interventions. “Efficiency” focuses on how well the regulatory framework is functioning in practice – whether outcomes are being achieved with reasonable administrative effort and cost for both governments and businesses. This can be assessed using regulatory performance data such as compliance rates, inspection coverage and targeting, approval timelines, reporting obligations, and administrative costs for firms and authorities. Reviewing these elements can reveal duplication, delays, or overly complex procedures, and identify opportunities to simplify reporting, streamline authorisation and renewal processes, better target inspections, or better integrate LSFF oversight into existing food control systems.

Post-implementation reviews also support policy coherence, by examining how LSFF rules interact with other nutrition, food, and trade policies. This wider perspective is important when interpreting programme outcomes, as changes in micronutrient status or public health may reflect LSFF together with supplementation, dietary changes, social protection programmes or other interventions. As the policy landscape evolves, this process helps reveal overlaps, gaps, and unintended cumulative burdens, while highlighting opportunities for better alignment and co-ordination with complementary interventions such as supplementation programmes, public procurement and social safety nets. Principle 6 further discusses how systematic policy and regulation review can improve policy coherence and enhance fortified food supply.

Importantly, the value of review lies not only in generating findings, but in translating those findings into policy and regulatory action – and this is often a key challenge for governments. Reviews that are not linked to clear decision processes, responsible authorities, and follow-up timelines risk becoming purely informational exercises rather than drivers of improvement. Embedding review results into formal revision pathways, work plans, and accountability frameworks increases the likelihood that evidence leads to adjustments in standards, procedures, supervision approaches, or simplification measures. This closes the feedback loop between evidence, implementation and policy adjustment, making reviews practical tools for continuous improvement, rather than a one-off assessment. Box 2.6 sets out Guatemala and Brazil’s experience in employing post-implementation review to improve their LSFF regulatory framework. The OECD’s Best Practice Principles on Reviewing the Regulatory Stock further discusses and provides practical guidance for the systematic review of regulations beyond the specific context of LSFF (OECD, 2020[116]).

Box 2.6. Country experiences translating evaluation findings into policy change

Guatemala and evolving health landscape for sugar fortification

Over time, the burden of disease in the population changes and dietary patterns shift. Guatemala’s sugar fortification programme provides an illustrative example of why periodic review and adjustment of fortification rules is important. The programme began in the 1960s in response to widespread vitamin A deficiency, with fortification levels set based on sugar consumption patterns at that time. Decades later, deficiency rates declined significantly, but monitoring data showed elevated liver retinol levels in parts of the population, raising safety concerns. Rather than ending the programme outright, authorities reviewed updated dietary and intake evidence and adjusted fortification levels to reduce risk while maintaining protection for groups with limited alternative vitamin A sources – demonstrating how evidence-based review can recalibrate, rather than abandon, fortification measures.

Brazil and SME compliance with wheat flour fortification

In Brazil, post-implementation review of wheat flour fortification regulations helped to identify and ultimately address critical gaps in coverage. In 2016, a working group assessed programme performance and identified gaps, particularly among small and artisanal mills. Targeted inspections found that many small producers lacked technical knowledge, appropriate equipment, and access to suitable premix, and were often unaware of fortification obligations – even where products supplied public food programmes. Based on these findings, the review recommended differentiated compliance timelines and targeted technical support for smaller producers. ANVISA subsequently updated the wheat flour fortification requirements through a new resolution reflecting these recommendations and later refined the framework again following further evaluation – demonstrating how iterative review and adjustment can improve both regulatory feasibility and nutrition impact.

Source: (Brazil ANVISA, 2016[119]); (Bielderman et al., 2016[120]); (Presidency of Guatemala, 2000[121]).