Good Practice Principles for Regulating Large‑Scale Food Fortification

Principle 4: LSFF supervision is carried out effectively and efficiently

 

Principle definition
Clear mandates, integrated systems, risk-based supervision, co-ordination, and laboratory capacity ensure effective fortification oversight.
Sub-principles	Criteria
4.1. Regulatory authorities supervising food fortification have clear mandates and responsibilities with fortification oversight fully integrated into the existing food safety control system.	Legal framework designates responsible authority(ies) for food fortification supervision. Enforcement powers cover inspections and compliance measures. Fortification supervision is embedded within existing food safety controls. Oversight mandates and powers are mapped and publicly communicated.
4.2. Proactive and risk-based approaches are used to supervise food safety and food fortification.	Inspections are planned using risk-based methodology. Businesses risk-classification is based on static and dynamic criteria. Majority of inspections are preventive and planned with a limited number conducted in response to incidents or serious complaints Inspections focus on high-risk operators and control points.
4.3. Operational mechanisms support co-ordination and communication among public authorities engaged in LSFF.	Horizontal and vertical co-ordination mechanisms are established and operational. Reporting is standardised across all relevant authorities. Inspection data are shared among authorities and are readily accessible. Aggregated data is used to identify trends and inform inspection planning.
4.4. Accredited laboratories exist and have capacity to test for fortification.	Laboratories are accredited to recognised standards. Approval criteria for laboratories are clear and aligned with ISO 17025. Standardised testing and sampling protocols are applied. Rapid and laboratory testing are used complementarily.

Even well-designed fortification laws and standards cannot deliver impact without effective oversight. Despite current fortification efforts, 38.6 billion instances of inadequate micronutrient intake persist globally. Improving compliance could prevent one-third of these (Friesen et al., 2026[152]). Where enforcement is uneven, compliance remains low and standards are not reliably met, undermining the effectiveness of fortification programmes. Despite global momentum to establish fortification programmes, weak regulatory oversight and compliance gaps have often jeopardised the achievement of intended public health outcomes. For example, in a review of 20 national fortification programmes across 12 countries, fewer than half of tested samples met relevant standards with weak regulatory oversight and compliance identified as the primary causes (Luthringer et al., 2015[153]). External evaluations frequently highlight constrained budgets, poorly equipped laboratories, overlapping institutional mandates, inconsistent training and guidance for inspectors, and weak co-ordination and communication as persistent barriers to effective oversight (GAIN, 2018[154]).

Principle 4 therefore turns from rule design to rule delivery: how governments organise, prioritise, co-ordinate, and technically support the supervision and enforcement of LSFF so that fortified foods placed on the market are safe, correctly dosed, and consistently available. It builds on the OECD’s regulatory enforcement and inspections toolkit (2018[155]), as well as key literature on LSFF – including GAIN’s policy guidance on regulatory monitoring of LSFF programmes (2018[154]), WHO guidelines on fortification (2006[156]) and specific guidance on monitoring flour fortification (2021[157]), and ASEAN guidelines for the implementation of mandatory LSFF (2024[25]).

Sub-principle 4.1 underscores the need to anchor food fortification oversight in clear legal mandates and to fully integrate it within existing food safety control systems, ensuring that responsibilities are neither fragmented nor unclear. Sub-principle 4.2 promotes proactive, risk-based inspections that focus limited public resources where risks to food safety and quality are greatest. Sub-principle 4.3 emphasises co-ordination and information-sharing across authorities and levels of government to prevent gaps, duplication, and inconsistent enforcement. Sub-principle 4.4 underpins the entire system with adequate laboratory capacity, reliable testing methods, and clear sampling protocols to verify that fortified foods contain what regulations require.

4.1. Regulatory authorities supervising food fortification have clear mandates and responsibilities with fortification oversight fully integrated into the existing food safety control system

Authorities responsible for supervising LSFF have clear mandates and responsibilities

When rules and policies governing LSFF enforcement clearly define roles and responsibilities without overlap, there is consistence, coverage, and predictability in how food fortification is enforced – avoiding supervision gaps and conflicting instructions to businesses that can ultimately weaken compliance and nutrition impact. For example, if both a food safety agency and a standards body assume the other is responsible for checking fortification levels, inspections may not occur; conversely, if multiple authorities inspect the same mill for the same requirement, resources are wasted, and businesses face unnecessary burdens. Clear delineation of mandates, responsibilities, and scopes of oversight among authorities involved in supervising LSFF, together with a shared understanding of these respective roles, can help prevent such instances. This also includes clarifying how different authorities interact and how responsibilities are divided between central authorities, and between national and subnational levels, where such a division exists.

In order to carry out enforcement and supervision, authorities need clearly defined powers to oversee compliance with LSFF, including through conducting inspections and taking enforcement actions when necessary. Each institution or structure with inspection and enforcement power will ideally have a mandate that specifies its role in managing risks and contributing to outcomes for social well-being. The mandates can be set in a variety of ways, typically through primary or secondary legislation, but they can also be supplemented through strategy documents approved by the supervisory board or ministry or other competent authority. (OECD, 2018[155]). In Guatemala for example, food safety and food fortification powers are centralised within the Ministry of Health with the aim to improve oversight consistency and reduce the risk of duplication and overlaps (Box 4.1).

Box 4.1. Centralised food enforcement: Ministry of Health and Social Assistance Guatemala

Guatemala operates a health-ministry-centred model of food safety and large-scale food fortification governance. Under the Code of Health (1997) and the General Law of Food Enrichment (1992), regulatory authority is vested in the Ministry of Health and Social Assistance of Guatemala. The Code of Health establishes the Ministry of Health and Social Assistance as the lead public health authority responsible for sanitary licensing, inspection, enforcement, and surveillance across the food chain. The General Law of Food Enrichment complements this framework by assigning responsibility for large-scale food fortification to the Ministry of Health and Social Assistance.

The Ministry of Health co-ordinates implementation through the National Commission for Fortification, Enrichment and Equipment of Foods (CONAFOR), an inter-institutional body composed by the Ministry of Health, other relevant ministries, private sector associations, and consumer representatives. Advisory participants include academia and international partners such as UNICEF, the Pan American Health Organization (PAHO), and the Central America and Panama Institute for Nutrition (INCAP).

Source: Government of Guatemala (1992), Ley General de Enriquecimiento de Alimentos (Decreto Número 44‑92), 24 November 1992, https://comercioeinversionguate.gob.gt/media/uploads/2021/02/09/decretono44-92.pdf.

Overlaps and inefficiencies are not uncommon in LSFF supervision and enforcement, and present real challenges for both authorities and businesses. A systematic review and mapping exercise of regulatory functions in LSFF can help to detect, prevent, and address potential overlaps, duplications and gaps in supervision. In food policy more broadly, WHO and FAO’s national food control system assessment tool, for instance, provides a methodology for such an exercise; Dimension A (2019[158]) involves identifying relevant institutional and legal frameworks alongside available resources and detecting overlaps, while Dimension B (2019[159]) comprises routine domestic import, and export control activities as well as monitoring, surveillance, and response functions. FAO has supported over 30 countries in using the tool,

By clarifying institutional mandates, roles and accountability across agencies, such exercises reveal co-ordination failures and areas of weak oversight, enabling more effective enforcement. This is not only a point-in-time exercise; inefficiencies and insufficiencies may also stem from outdated or static institutional mandates, and evolving dynamics as rules, powers, and institutions are created or amended over time. Greece, for example, introduced a horizontal legislative framework for inspections in 2018 providing a legal basis for long-term inspection reform and enabling authorities to review oversight across all inspection domains, including food control (Hellenic Parliament, 2018[160]).

Publicising the roles and responsibilities of regulatory authorities enhances transparency, predictability, and co-operation. Making mandates visible through one-stop-shop platforms, official publications, or stakeholder engagement forums helps businesses understand which authority to approach and reduces confusion and delays. Greater visibility also strengthens accountability and co-ordination among the different institutions involved in fortification oversight, as regulators have a clear understanding of who is responsible for what.

Defining mandates and powers for oversight ideally occurs early in regulatory design – rather than as an afterthought in implementation. A common pitfall is that regulatory proposals assume supervision and enforcement will naturally follow and be effective but, in practice, this is not automatic. During the policy design process, policymakers need to explicitly think through which authorities have the relevant competencies to carry out the required level of inspections, as well as whether and how any new responsibilities will be allocated, being mindful to avoid unnecessary proliferation of inspecting institutions and to prevent conflicting responsibilities (OECD, 2018[155]). For LSFF supervision, the responsible authorities may be dedicated food control bodies or supervision may be carried out by authorities operating in broader areas, such as industry or standards oversight.

Supervision is integrated into food safety control

Integrating fortification supervision into existing food safety control systems strengthens both efficiency and impact. Fortification is not a standalone activity; it occurs within the same production lines, storage facilities, and supply chains that are already subject to food safety control. When fortification monitoring is embedded within established food safety inspection protocols, authorities can verify nutrient addition, dosage accuracy, and premix handling alongside hygiene, traceability, and contamination controls during a single visit. For example, an inspection that checks sanitation conditions in a flour mill can simultaneously verify dosifier calibration and premix reconciliation, ensuring that fortified products are both safe and nutritionally compliant.

For food producers, integration means that fortification becomes part of routine internal control and quality management systems rather than an additional parallel requirement. This encourages producers to manage premix storage, dosage records, staff training, and corrective actions within their broader food safety management frameworks – enabling a more cost-efficient and comprehensive approach to ensuring fortification safety and quality. Maintaining a single, unified food safety and quality system ensures that food safety and fortification are prioritised together.

For food safety authorities, an integrated approach to food control implies that compliance with food fortification requirements is assessed alongside with general food safety standards during inspections. This approach ensures consistent application of the risk-based approach across all activities in food control, including the supervision of both food safety and fortification. It also promotes efficient use of public resources by optimising the deployment of staff and technical capacity.

4.2. Proactive and risk-based approaches are used to supervise food safety and food fortification

Risk-based inspections are essential to ensure that limited public resources are used where they matter most for nutrition and food safety outcomes. In LSFF systems, not all actors, products, or processes pose the same level of risk. Without a risk-based approach, authorities may spend equal time inspecting low-risk operators while overlooking high-impact facilities where dosing errors, premix mismanagement, or labelling inaccuracies could affect millions of consumers. This can lead to inefficient use of inspection time, delayed detection of serious non-compliance, and weak overall coverage – even when a lot of inspection activity is taking place. By contrast, risk-based inspections allow governments to optimise time, budget, manpower, and technical expertise by focusing supervision on higher-risk products, processes, and operators those most likely to undermine food safety and fortification with negative impact on public health.

Risk is the underlying foundation of all supervision activities, including inspections

The legal and policy framework underpinning inspections and enforcement activities should adopt a risk-based approach, whereby inspections are planned proactively and are targeted based on the level of risk attributed to businesses. Despite empirical evidence corroborating the effectiveness of risk-based inspection approaches, there remains systematic legal barriers across countries with over half of OECD members explicitly disallowing regulatory enforcement authorities from basing their activities on risk criteria (OECD, 2025[60]). Italy illustrates a shift from deterrence-based food safety oversight to a structured risk-based system, though OECD-supported reforms at regional level, which rely on a formal risk categorisation of establishments based on criteria such as the type of activity, structural and organisational characteristics and compliance history (OECD, 2021[124]) In other regions, authorities actively encourage risk considerations in their policy documents – demonstrated by the East, Central and Southern Africa Health Community’s updated inspection manual (Box 4.2).

Box 4.2. Updated food fortification inspection manual from the East, Central and Southern Africa Health Community

In 2020, the East, Central and Southern Africa Health Community updated its food fortification inspection manual to strengthen risk-informed supervision. The revised guidance encourages authorities to plan inspections based on contextual risk factors — including high population density areas, where non-compliance could affect larger numbers of consumers, and regions near borders with countries where fortification is not mandatory, where the risk of non-fortified imports entering the market may be higher. By incorporating geographic and market-based risk indicators into inspection planning, the updated manual supports more strategic allocation of limited inspection resources and helps enhance the overall effectiveness of fortification monitoring systems.

Source: East, Central and Southern Africa Health Community (ECSA‑HC) (2021), Manual for Inspection of Fortified Foods at the Points of Entry and in Market, https://ecsahc.org/wp-content/uploads/2021/11/ECSA-Manual-for-Inspection-of-Fortified-Foods-at-the-POEs-and-Markets.pdf.

Implementing a risk-based approach requires a clear and standardised methodology that uses evidence to assess the level of risk posed by different food business operators. A risk-based inspection strategy recognises that food safety and fortification risks are not evenly distributed across the supply chain. They vary depending on factors such as the nature of the production process, the scale of operations, past compliance history, and the vulnerability of the consumers reached. Inspection planning is therefore grounded in reliable data, scientific evidence, and ongoing risk evaluation, rather than intuition or static annual plans. Higher-risk businesses receive more frequent and intensive supervision while lower-risk operators are inspected less often, helping optimise the use of human resources and budget, and reduce inspection burden.

Risk criteria

Risk-based criteria are measurable factors used by regulatory authorities to assess the level of risk posed by regulated businesses. These criteria guide inspection planning and help allocate enforcement resources more efficiently. Indicators can be either static or dynamic, and experience suggests that inspection targeting is more effective when greater weight is given to dynamic criteria in overall risk scoring.

Table 4.1. Illustration of static and dynamic criteria for food fortification inspections

Static criteria (inherent risk factors)	Dynamic criteria (performance and behaviour over time)
Types of products, activity, or process: Nature of food vehicle, fortificant used, processing complexity, shelf life, frequency of consumption, product impact on health and safety	Compliance history: Results and trends from previous inspections; recurrence of violations; implementation of corrective actions.
Built-in controls: Incorporation of voluntary safety management procedures, industry standards, and other voluntary standards indicating better quality and risk management	Severity of violations: Nature and seriousness of past violations, including sanctions imposed.
Scale and distribution: Size of facility, volume of production, number of consumers reached, geographic reach, and export exposure including potential economic impact of non-compliance,	Management reliability: Demonstrated safety culture, staff competence, internal quality control, and understanding of fortification requirements.
Characteristics of people exposed to risk: Risk is aggravated if the product is consumed by vulnerable consumer groups	Complaints and external signals: Frequency and gravity of consumer complaints or relevant non-compliance in other regulatory domains.

Source: (OECD, Forthcoming[161]).

Static criteria are characteristics that can be identified before an inspection takes place and are used to classify facilities initially. They are typically based on objective information such as the type of activity performed, the nature of the product, production volume, or certification status. Data to inform static criteria are often available from licensing procedures, business registration systems, or certification records.

Dynamic criteria are informed by inspection findings and reflect how a business manages risks in practice. They capture compliance history, implementation of corrective actions, internal control systems, staff competence, and overall food safety and fortification culture. Because dynamic indicators reflect actual behaviour and performance over time, they allow authorities to reclassify businesses and adjust inspection frequency accordingly. For this reason, many risk-based systems assign greater weight to dynamic criteria than to static ones when determining inspection priorities, as illustrated with the example from the Singapore Food Agency in Box 4.3.

Box 4.3. Grading based on track record: Singapore

The Singapore Food Agency announced in 2026 a new framework for grading food establishments that rewards businesses with a track record of compliance. Food establishments with consistent good food safety track records will attain higher grades, while those with poor food safety track records will attain lower grades, and be subjected to more frequent inspections. Establishments categorised as being involved in significant processing, such as food manufacturers, are required to meet additional requirements to receive a top grade.

Illustrating transparency, consumers and establishments alike can directly check track records on an online platform where grade changes are reflected within 3 working days.

Source: Singapore Food Agency (2026), Understanding the Safety Assurance for Food Establishments (SAFE) Framework, https://www.sfa.gov.sg/regulatory-standards-frameworks-guidelines/understanding-the-safety-assurance-for-food-establishments-framework#overview-0.

By combining static and dynamic criteria, authorities can classify businesses into risk categories such as low, medium, or high risk, with each category linked to a defined minimum inspection frequency (OECD, 2018[155]). This structured approach ensures that higher-risk operators receive closer supervision while lower-risk businesses are not over-inspected. Establishing minimum inspection frequencies helps maintain credibility and predictability in the system, ensuring that all operators remain subject to reasonable oversight while resources are focused where they are most needed.

Clear communication of risk criteria and inspection methodologies strengthens both compliance from businesses and credibility of government (OECD, 2025[60]). When food business operators understand how risk is assessed, through published guidelines, workshops, or online portals, they are better positioned to self-evaluate and improve their internal controls. Box 4.4. Self-assessment of risk in Italy illustrates a tool launched in Italy to educate food business operators and the public and improve compliance. Engagement with industry associations, consumer groups, and other stakeholders can further refine risk frameworks and foster a preventive culture. Greater transparency reduces adversarial dynamics, while targeted training and guidance help businesses strengthen compliance and improve their risk profile over time.

Box 4.4. Self-assessment of risk in Italy

As part of its food safety strategy, the Campania region of Italy has launched a self-assessment tool to reinforce business compliance, called GISA Self-assessment. The web-based application allows companies to autonomously access and complete the official inspection checklist. This enables them to identify the strengths and weaknesses of their facilities from the health authorities’ perspective. The tool is also available to “guest users”, enabling individuals to learn more about food and veterinary requirements before setting up a business, depending on its future characteristics. The result of the self-simulated inspection is expressed as a risk level. The purpose of this tool is to educate; it is, therefore, not a mandatory self-monitoring or self-reporting tool. Advances in the use of predictive techniques may in the future allow the tool to also indicate the occurrence of potential risks to profiled companies by enhancing their historical data.

Source: (OECD, 2025[60]), OECD Regulatory Policy Outlook 2025, OECD Publishing, Paris, https://doi.org/10.1787/56b60e39-en.

Inspections focus on key control points

A risk-based inspection system enables authorities to concentrate oversight on the most critical inspection points in the fortified food value chain, including premix production facilities, points of import, fortified food production sites, and retail markets, as illustrated in Figure 4.1. As products move downstream, they become more widely dispersed across numerous retail outlets, making official controls increasingly labour-intensive and resource demanding. Accordingly, the World Health Organization recommends focusing inspections on production and import stages, where risks can be addressed earlier and at scale (WHO, 2021[157]). Strategic, risk-based prioritisation across the value chain therefore supports earlier risk mitigation, strengthens compliance, and reduces the need for more burdensome downstream market controls.

Figure 4.1. Inspection points in the food fortification value chain

Note: The points in the value chain in this figure represent a standard food fortification system. These points may vary depending on the national context.

Source: Author's own elaboration.

Once an inspection point has been selected, the inspection methodology applies sequential steps to verify compliance and manage risk. Pre-inspection preparation includes reviewing the risk-profile of the site or activity, relevant business documentation and prior inspection reports, which helps inform the inspection strategy and identify focus areas based on compliance history. The inspection then proceeds in a stepwise approach, illustrated in Figure 4.2, from document review to process audit, followed by qualitative checks to quantitative testing where necessary.

Figure 4.2. Steps of an inspection

Source: (ASEAN and UNICEF, 2024[25]), (WHO and FAO-UN, 2006[156]), (WHO, 2021[157]), (GAIN, 2018[154]), (OECD, Forthcoming[161]).

Process audit is the most important inspection step as it involves systematic examination of the manufacturing operations to verify that fortification is implemented in accordance with regulatory requirements and documented procedures. It includes the inspection of critical control points, including premix storage conditions, calibration of equipment to ensure correct dosing and others, where errors could lead to over- or under-fortification, or unsafe products. Premix reconciliation is an important part of process audit as it compares the quantity of micronutrient premix purchased or imported by a producer with the volume of fortified food produced over a given period. By assessing whether premix inputs align with expected fortification rates and output volumes, inspectors can quickly identify discrepancies that may indicate under-fortification, over-fortification, or diversion (GAIN, 2018[154]).

Qualitative and quantitative testing of food samples may complement process audit to confirm whether the food produced at the inspected facility is fortified and whether fortification level complies with applicable standards. Qualitative testing confirms the presence of micronutrient in food but not its specific level, while quantitative testing measures the level of micronutrient added (see Section 4.4 below for more information on food testing). This stepwise approach optimises inspection resources as detection of non-compliance at any step constitutes evidence of non-compliance for the inspected site or activity and, where permitted by the legal framework, may allow the inspection to conclude with the appropriate enforcement action.

Inspections are planned proactively

A proactive inspection system is grounded in a clear, structured plan to provide predictability for both regulators and industry. An annual inspection plan sets out the expected number, scope and focus of inspections, aligned with available resources and current risk assessments. It ensures that oversight is not driven solely by crises, media attention or complaints. The plan does not provide specific details on when and where inspections will take place to avoid subversive actions.

Within this framework, most inspections are preventive. Risk data, business classification, and mapping of the large-scale food fortification value chain help identify where oversight is likely to have the greatest impact – focusing on the criteria and control points discussed above.

But no preventive system eliminates risk entirely, and incidents or complaints may still arise. In such cases, complaints are assessed to determine their seriousness. Low-risk complaints can be addressed through the regular inspection cycle, while serious or substantiated complaints may trigger targeted ad hoc inspections. These reactive activities remain proportionate in number and are integrated back into the overall risk assessment process. Information generated through complaints and incident-driven inspections helps refine risk profiles and improve the targeting of future preventive actions.

Leveraging digital technologies and AI for monitoring, supervision, and planning

Technology plays a pivotal role: after establishing the risk assessment framework, agencies may develop or adopt IT systems for data management and to support risk classification of businesses. Building on these foundations, more advanced digital tools, including big data analytics and AI applications, can be deployed to further refine inspection planning. Inspection IT systems use data compiled from business registration, licensing procedures and certification records, such as the type of activity and scale of operations, to enable the initial classification of businesses into specific risk categories forming the basis for inspections planning. Subsequently, they may also systematically record inspection outcomes, including levels of compliance and sanctions imposed, and integrate complaints, to automatically update the risk level of businesses and sharpen future targeting. Such a system has been developed in Georgia, as illustrated in Box 4.5, to support risk scoring, strengthening both the effectiveness and efficiency of inspections.

Data analysis can substantially enhance the application of risk-based approaches by improving the use of available information to refine risk assessments (OECD, 2025[162]). New technologies and applications of AI, allow supervision authorities to analyse vast amounts of data in real-time to monitor how risks evolve in practice and to support a more accurate prioritisation of inspections and more efficient use of resources. Machine learning techniques can be used to validate and continuously refine risk criteria by identifying the most predictive risk factors and recalibrating parameters as new data become available, (OECD, 2025[162]). In addition, AI-driven predictive analytics can forecast risks based on historical trends such as seasonal pathogen surges, and natural language processing can extract insights from inspection reports. Together, these tools can help authorities leverage data to prioritise higher-risk cases, balance workloads, automate scheduling, optimise resources and improve supervision outcomes. See Box 4.5 for an example from Canada.

Box 4.5. New technologies and applications of Artificial Intelligence for Inspection Strengthening

Digitalising food safety inspections in Georgia

Until 2017, Georgia’s National Food Agency received food control results from the regions on spreadsheets and text files. Authorities experienced problems in receiving timely data throughout the food chain including information of registrations of food businesses, inspection results and any other relevant food safety data. To address this, the Agency identified active food business operators from different authority registers to include them in a new consolidated online database. Digitalization was extended to the whole inspection process. Food control inspectors were equipped with portable tablets and printers, which permitted the electronic documentation of the inspection results immediately on-site, handing over a printout to the food business operator (FBO) and instant data transfer to the National Food Agency’s online database. The software program scores the FBOs based on the food type, type of activity, turn over (describing the size of the activities) and history of compliance. The scoring is used to generate a risk-based inspection plan for the regions. The system is also used for monitoring food control outputs at regional and inspector level. Planned activities such as number of inspections are followed, and reminders are sent to regional divisions when necessary.

Canadian Food Inspection Agency and the Establishment-based Risk Assessment

The Canadian Food Inspection Agency uses the Establishment-based Risk Assessment model as a risk‑based, algorithmic tool to prioritise inspections of federally regulated food establishments. It assigns risk categories to establishments using scientific and compliance data, allowing inspection resources to focus where risk is highest.

The model considers three types of factors: inherent risk factors, mitigation factors, and compliance factors. Inherent risks relate to the specific food commodity, operation, or process, and feed into initial Disability-Adjusted Life Years calculations and risk adjustments. Mitigation factors capture measures implemented by the establishment to control these risks, such as quality assurance personnel or microbiological sampling plans. Compliance factors assess the establishment’s track record in following its preventive control plan and regulatory requirements, drawing on inspection reports, complaints, recalls, and enforcement actions. Automated IT systems extract and process these inputs, reducing manual work.

By integrating data such as compliance history, pathogen impact, production volume, and mitigation measures into a deterministic algorithm, the Establishment-based Risk Assessment produces scores that guide inspection planning.

Source: (OECD, 2025[60]), https://openknowledge.fao.org/server/api/core/bitstreams/015dc325-07c9-44c4-a955-04024e582316/content; Canadian Food Inspection Agency, Audit of Establishment‑based Risk Assessment model, Internal Audit Directorate, July 2025, https://inspection.canada.ca/en/about-cfia/transparency/corporate-management-reporting/audits-reviews-and-evaluations/establishment-based-risk-assessment-model.

More generally, digital tools can strengthen supervision by bringing together data from across the fortification value chain and making it easier for regulators to identify emerging trends and potential areas requiring follow-up – and can also offer benefits for industry, as demonstrated by the DFQT+ system (Box 4.6). The information generated could, in turn, act as input into a more systematically data-driven supervision framework.

Box 4.6. Digital Fortification Quality Traceability (DFQT+) System

The DFQT+ system was developed by GAIN and partners as a digital tool to enable food producers, government authorities, and other actors along the fortification value chain to generate and share traceable data across the fortification supply chain.

Food producers can enter information on production, premix use and quality-control results – selecting information to share directly with government through the platform. while government authorities can contribute data generated through inspections, sampling or other monitoring activities. Other actors, such as premix suppliers or laboratories, can contribute relevant information where they participate in the system. Rather than remaining in separate company records, government databases or paper files, these data can be brought together in a shared digital platform and made available to authorised users. Together, these records provide a digital trail from inputs such as premix and micronutrients through to the fortified product.

The platform presents this information through dashboards, reports, and traceable records, allowing different users to draw on it for their respective functions. Producers can use the data to monitor their own production and quality-control practices, identify problems and prepare for regulatory audits. Regulators can use information from across participating producers to monitor trends and identify possible compliance concerns, supporting informed monitoring by allowing them to review producer compliance directly through the platform. The platform has also supported communication and data sharing between different ministries and agencies in a pilot country. It is also designed to allow regulators to communicate directly with producers on issues such as missing batches or failed inspections, giving producers a chance to address concerns and potentially avoid or mitigate penalties for issues that can be easily corrected. In Nigeria, for example, producers participating in the 2024 pilot reported that the system made it easier to verify premix quality, prepare for audits and maintain consistent fortification practices, while regulators used dashboards to monitor trends and identify areas for follow-up inspections.

In Bangladesh, introducing the system depended heavily on stakeholder buy-in and capacity building. The pilot for fortified edible oil was led by the Ministry of Industries, with support from partners including GAIN and participation from nutrient and premix suppliers and major edible-oil refineries. Between 2023 and 2025, around 60 demonstration, onboarding and training sessions were conducted, reaching more than 200 participants from industry and regulatory agencies. These activities helped familiarise users with the system and build the practical capacity and buy-in needed for its use. On 19 August 2026, the Bangladesh Standards and Testing Institution made use of the system mandatory as part of its licensing and registration process for producers, scaling it to a routine part of regulatory practice rather than a parallel or optional tool.

Source: https://www.gainhealth.org/digital-fortification-quality-traceability; https://www.gainhealth.org/blogs/hand-hand-data-sight-how-gains-digital-platform-unlocking-new-era-food-fortification-nigeria; slide deck from GAIN Bangladesh; https://bangladeshpost.net/posts/bsti-makes-digital-traceability-system-mandatory-for-edible-oil-refineries-172497.

Continuous evaluation and improvement

Risk profiles and enforcement strategies require regular reviews, incorporating new evidence such as epidemiological data on deficiencies, technological innovations like new dosifiers, shifts in supply chains and changes in fortification coverage. Reviews of risk profiles and enforcement strategies should ideally be integrated with performance evaluation of inspection authorities enabling assessment of how evidence-based adjustments contribute to improved compliance outcomes. Performance evaluation of inspection authorities can improve inspection outcomes both in short and long term. It can also prevent risk-regulation-reflex, where authorities adopt new rules and enforcement measures as an immediate response to an incident or new risk (OECD, 2018[155]). It also helps in better managing the risks posed by business operations (Dobrolyubova, 2018[163]). Evaluation of inspections also enables inspectorates to balance their resources ensuring inspections remain a resource-efficient exercise (see the example in Box 4.7).

Box 4.7. Greece’s inspection evaluation system

Greece is overhauling its inspection system to boost efficiency, transparency, and international alignment, with guidance from the OECD. The reforms focus on risk-based inspections, prioritising high-risk areas while reducing oversight for low-risk entities. Processes are streamlined, inspections co‑ordinated across agencies, and digital tools introduced to ensure transparency. Inspectors now follow standardised training, including guidance on evaluation and best practices.

OECD supports these reforms with a comprehensive evaluation framework, enabling inspection authorities to set long- and short-term goals, monitor activities and outputs, and measure performance against targets. This framework allows policymakers to assess regulatory outcomes, repurpose ineffective regulations, and establish a long-term vision for inspection activities. Inspectorates can systematically record results and track progress, fostering continuous improvement in enforcement.

These changes are part of Greece’s broader regulatory modernization. The overarching goal is to enhance efficiency, increase transparency, create a more business-friendly environment, and align domestic practices with international standards—all while embedding a culture of evaluation and evidence-based regulatory management. The reforms span Public Health, Occupational Health and Safety, Environment, and Infrastructure, marking a comprehensive effort to modernise inspection and regulatory practices across sectors.

Source: (OECD, Forthcoming[161]).

An effective evaluation framework for inspections should clearly link inputs, outputs, and outcomes. Inputs, such as operational budgets, staffing and IT systems, enable risk-based inspection and targeted outreach activities that improve awareness and reduce administrative burdens. These outputs support intermediate outcomes like enhanced safety, and reduced contamination and accident risks. By linking these elements to strategic goals and systematically measuring progress, inspection agencies can enhance their performance and better protect public health and safety (World Bank, 2018[164]). This iterative process ensures adaptability, with post-enforcement evaluations feeding back into training and policy updates to sustain a proactive mindset focused on prevention and continuous improvement (IOM and NRC, 2010[165])

4.3. Operational mechanisms support co-ordination and communication among public authorities engaged in LSFF

Effective supervision and enforcement of large-scale food fortification depend not only on clear rules, but on how well public authorities co-ordinate and communicate in practice. In many countries, LSFF oversight involves multiple institutions: ministries of health, food safety authorities, standards bodies, customs agencies, competition or consumer protection authorities, and subnational inspection services. Without clear co-ordination and information-sharing mechanisms, enforcement can become fragmented, compliance gaps may emerge, and businesses may receive inconsistent instructions. Well-designed operational mechanisms help ensure that fortification requirements are supervised consistently across the value chain, from premix importation to retail distribution.

Information integration and sharing between authorities engaged in LSFF

If supervision and enforcement of LSFF is distributed across multiple actors, clear co-ordination arrangements are essential to ensure that fortification requirements are monitored coherently. For example, one agency may oversee inspections at production sites, another may manage border controls for imported premix, while regional or local authorities carry out routine market surveillance. Clarifying which authority leads on enforcement, how inspection findings are communicated across institutions, and how joint responses are organised when non-compliance or safety risks are identified is essential for coherent and effective supervision.

Co-ordination must operate both horizontally and vertically. Horizontal co-ordination aligns sectoral authorities at the same level of government implicated in food safety enforcement. Box 4.8 illustrates how horizontal co-ordination of food safety enforcement is performed in Viet Nam. Vertical co-ordination ensures consistency between central authorities that design enforcement frameworks and subnational authorities that carry out day-to-day inspections. In Bangladesh for instance, under the Act mandating salt iodization, the national government has established district-level management committees as necessary to support supervision of salt production, refining, iodization, processing, labelling, and other relevant activities; these district-level committees co-ordinate, in turn, with the National Salt Committee (Ministry of Industries, 2021[166]). Clear reporting lines, shared enforcement protocols, and regular co-ordination meetings help prevent duplication of inspections, conflicting directives, or gaps in oversight across regions.

Box 4.8. Inter-ministerial co-ordination on food safety enforcement: Viet Nam

In Viet Nam, food safety management is carried out by the Ministry of Health, Ministry of Agriculture and Rural Development and the Ministry of Industry and Trade; co-ordination of food safety enforcement among the three is overseen by the Central Inter-Ministerial Steering Committee for Food Safety, led by the Deputy Prime Minister and Minister of Health. The committee provides a platform for aligning inspection targets, consolidating reports on national inspection targets, and overseeing joint activities. For products under the control of more than one ministry, inter-ministerial inspection teams are commissioned and overseen by the committee. Inter-ministerial inspections are also conducted when there are complaints or food safety incidents or during special occasions/functions.

Source: Decree No. 15/2018/ND‑CP on the Elaboration of Some Articles of the Law on Food Safety, adopted 2 February 2018, Government of Viet Nam. Article 41, https://faolex.fao.org/docs/pdf/vie214418.pdf.

Standardised communication and reporting mechanisms further strengthen enforcement consistency. Inspection templates, sampling procedures, and compliance reporting formats should be harmonised across agencies and regions. Inspection results, including, where applicable, laboratory findings on micronutrient levels and labelling compliance, should be accessible to relevant enforcement authorities when needed. Informing enforcement agencies operating in other parts of the country helps reduce the risk that a non-compliant operator continues operating undetected in another jurisdiction. Where appropriate, sharing findings with inspected businesses also supports timely corrective action and promotes compliance. At international and regional levels, co-ordinated information-sharing platforms and mutual notification systems enable authorities to align practices, exchange risk information and address cross-border compliance issues as illustrated by the examples in Box 4.9.

Box 4.9. Mechanisms for communication and co-ordination on food safety

International

The International Food Safety Authorities Network serves as a hub of communication where information on food safety incidents and emergencies related to internationally traded foods is shared, facilitating rapid access to relevant information. It is a global, voluntary network of national food safety authorities from almost all FAO and WHO Member Nations, co-ordinated by a joint FAO/WHO Secretariat. Each member state has national, specialised contact points, the so-called “INFOSAN Focal Points”, for example for health, fisheries management, or agriculture. In 2012, the Network’s Secretariat established a community website as a secure online platform allowing members to connect and share information with each other – it includes a chat feature that allows real-time communication with other members.

Regional

Based on the European Union’s system, member countries of the Association of Southeast Asian Nations established a rapid alert system for food and feed. Thailand serves as system administrator, overseeing co-ordination and technical maintenance of the tool used by national regulatory authorities from 10 countries in south-east Asia. The web-based platform allows national authorities to directly notify authorities from the other nations once an incident is detected and once action has been taken. Key information in a notification includes the product name, category, and origin; distribution status; hazard; results of analysis; and outcome of investigations.

Source: World Health Organization & Food and Agriculture Organization of the United Nations (2020), INFOSAN Members’ Guide, https://www.who.int/publications/b/52506; (Savelli et al., 2021[167]); United Nations Industrial Development Organization (UNIDO) (2025), ARASFF – A Digital Solution for Enhancing ASEAN Food Safety, https://www.unido.org/sites/default/files/files/2025-07/arasff%20-%20a%20digital%20solution%20for%20enhancing%20asean%20food%20safety.pdf?_token=3828548.

Digital tools can significantly facilitate co-ordination in supervision and enforcement – but can look very different depending on available resources and digital infrastructure. Local inspectors in lower-resource settings, for example, may use a secure mobile app to co-ordinate with and report back directly to central levels. This system can be formalised and bolstered through integrated IT systems that enable secure sharing of inspection reports, laboratory data, and authorisation records across agencies. They can also include external access functions, allowing food business operators to access inspection outcomes and track required corrective actions. Where comprehensive digital systems are not yet feasible, inspection records should still be stored in a structured and retrievable manner to ensure continuity, follow-up, and institutional memory.

Finally, aggregated inspection and compliance data can strengthen enforcement strategy. Consolidated data allow authorities to identify recurring non-compliance patterns, regional disparities, or emerging risks in fortification practices. Data-driven approaches — including dashboards or analytical tools — can support risk-based inspection planning and highlight priority areas for enforcement. In this way, co-ordination and communication mechanisms enhance not only operational efficiency, but also the overall effectiveness and credibility of LSFF supervision systems. For example, through the online Harpya Laboratory Sample Management System, Brazil integrates results from its National Network of Sanitary Surveillance Laboratories, to track fortification levels and labelling compliance across different States, providing health authorities with a clear identification of regions and actors with elevated non-compliance (ANVISA, 2022[168]).

4.4. Accredited laboratories exist and have capacity to test for fortification

Lab accreditation and capacity

Laboratories are central to the credibility and effectiveness of food fortification monitoring systems. Testing fortified foods verifies not only the presence of added micronutrients but also whether they are present at the required levels to comply with relevant standards and ensure safety and public health impact. Through accreditation, labs are certified as meeting international benchmarks for their technical competence, impartiality, and consistency of test results; results from accredited labs are better accepted by stakeholders and the international community, and have the credibility required by a competent authority and in the event of a dispute. Box 4.10 further explains what constitutes laboratory accreditation.

Box 4.10. What are accredited laboratories?

ISO/IEC 17025:2017 is the internationally recognised standard that sets out the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories of any size and in any sector. It covers general requirements such as impartiality and confidentiality; resource requirements including qualified staff, suitable facilities, calibrated equipment, and measurement traceability; process requirements addressing method validation, sampling, quality control, data handling, and reporting; and management system requirements focused on internal audits, corrective actions, and continual improvement. Accreditation to ISO/IEC 17025 therefore means that a laboratory has been independently assessed and confirmed to have the qualified personnel, appropriate equipment, validated analytical methods, and robust quality systems needed to produce accurate, reliable, and reproducible test results.

How accreditation works: Labs can apply for and receive accreditation from national or regional accreditation bodies that are themselves recognised under the International Laboratory Accreditation Cooperation framework – for example, the South African National Accreditation System or the Nigeria National Accreditation System. Where no accreditation body exists locally, labs may seek accreditation from recognised bodies in other countries that are validated under the framework – such as the American National Accreditation Board or Cofrac in France.

Source: International Organization for Standardization & International Electrotechnical Commission (2017), ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories, International Standard 66912, https://www.iso.org/standard/66912.html.

The scope of the accreditation ideally covers all relevant analytical methods and food matrices required for testing compliance with national fortification standards. Where cost of accreditation is an issue, the scope can be limited to test methods for priority micronutrients of highest public health significance. For instance, most countries include multiple micronutrients in the standard for fortified wheat flour. The laboratory can for example prioritise the accreditation for iron and folic acid analytical methods, while trying to build the capacity for accreditation of other micronutrients, using globally validated analytical methods.

Existence of accredited laboratories at national and, where feasible, regional or local levels, support timely testing by enabling sample analysis close to the point of collection, reducing transport and processing delays that may compromise sample integrity. Such infrastructure can strengthen the responsiveness of inspection systems and ensure that enforcement decisions are based on robust evidence.

It is important that public authorities publish and regularly update the list of approved and accredited laboratories specialising in micronutrient analysis to enable businesses and inspection authorities to identify authorised facilities and promptly submit their samples for testing. India’s National Accreditation Board for Testing and Calibration Laboratories, for instance, maintains a public online and searchable database of accredited labs, as well as labs whose accreditation has been suspended or withdrawn. Accreditation alone may also have its limits, and authorities can further strengthen confidence in testing and manage risks by encouraging ongoing appropriate staff competency assessment, equipment calibration and maintenance, and internal and external quality-control procedures.

Addressing the lack of accredited labs and resource constraints

In settings with a shortage of accredited labs for micronutrient testing, some flexibility may be needed to involve non-accredited laboratories, approved by public authorities. A study on laboratory capacity in Africa highlighted the scarcity of well-equipped local laboratories, pushing countries to seek partnerships with foreign entities capable of meeting accreditation standards. The study underscored that regulatory bodies often turn to international laboratories to comply with the necessary health regulations when domestic laboratories cannot fulfil these requirements (Mfuh, Abanda and Titanji, 2023[169]) (Alemnji et al., 2014[170]). This is particularly notable in regions like East Africa, where harmonising regulatory processes could significantly reduce delays associated with accessing accurate diagnostic products (Rugera et al., 2014[171]).

In settings where fully accredited laboratories are not available, temporary use of competent non-accredited laboratories operating under an internal quality management system aligned with ISO/IEC 17025 requirements may be permitted under clearly defined conditions. The regulatory framework should establish minimum approval criteria, including having adequate supplies and equipment, and appropriately trained staff. Non-accredited laboratories used for official testing will need to adhere to good laboratory practices, employ globally validated analytical methods, ensure staff competence and ongoing training, maintain equipment to required standard, and implement data management and traceability systems. The laboratories and their quality management system should be approved by public authority, with a transition plan in place toward accreditation. The regulatory framework should outline approval criteria aligned with ISO 17025 to the extent possible. Laboratories that are approved to conduct micronutrient testing could play a role in routine testing while accredited laboratories can be used to verify findings and provide feedback to public authorities.

In settings where national laboratories are unavailable or lack the necessary capacity, co-operation with global and regional testing laboratories can be pursued. If no suitable laboratories exist within the country, samples can be shipped abroad to laboratories with required capacities and accreditations. Regulation should therefore allow using accredited laboratories in neighbouring countries, especially in countries where accredited laboratories do not exist. While this approach provides a practical interim solution, it may introduce longer processing times, higher costs and potential risks to sample integrity, emphasising the importance of developing in-country laboratory capacity.

The use of rapid testing methods can be considered to detect the presence of micronutrients – both qualitatively and quantitatively. Rapid testing kits are portable, field-ready tools used to assess vitamin and mineral levels in staple foods quickly on-site without complex regulatory equipment. Examples include rapid testing kits for iodine in salt, vitamin A in edible oil and zinc in fortified flour and rice (Zeb et al., 2025[172]) (Meyer et al., 2025[173]) (Lamborn et al., 2025[174]). This is especially relevant in settings with limited resources and accredited laboratory capacity. Rapid testing methods could be employed by businesses for self-checks and by public authorities for official use in the supervision of food fortification to detect presence of micronutrients through qualitative testing. Rapid screening methods can also be deployed as a resource-efficient approach for qualitative and quantitative testing – but it is important that the conditions under which rapid testing kits can be used in supervision by inspectors needs to be clarified in existing legal framework or guidance (see Box 4.11). While rapid testing may be efficient and useful for field monitoring, they should not replace validated procedures.

Box 4.11. India’s regulatory amendment on rapid analytical food testing

Rapid analytical food testing kits and methods in India have substantially improved the speed and efficiency of food safety surveillance, enabling on-the-spot screening by Food Safety Officers and mobile laboratories and delivering results within hours. These tools support informed regulatory decisions at the point of testing, while conventional laboratory methods remain the standard for confirmatory analysis.

Under the Food Safety and Standards Authority of India’s (FSSAI) Rapid Analytical Food Testing scheme, applications for such kits are reviewed by a dedicated technical committee, with recommendations ratified by the Scientific Panel on Methods of Sampling and Analysis and approved by the competent authority. Approved kits are validated against international standards and aligned with national food safety regulations, ensuring reliability and consistency. The regulatory framework, established following 2019 amendments, explicitly authorises the use of rapid testing equipment and methods, emphasising their primary role in screening and monitoring while complementing traditional laboratory testing.

Source: Food Safety and Standards Authority of India. (2022). Annual report 2020–21. Section 5.8 (p. 65), https://fssai.gov.in/upload/uploadfiles/files/FSSAI_Annual_Report_2020_21_Eng_01_08_2022.pdf.

Validated testing methods and sampling protocols

All laboratories should use analytical methods validated by recognised authorities such as AOAC, ISO, Codex and regional guidelines (see Box 4.12). Before implementation, laboratories need to verify standard methods or validate in-house or non-standard methods to ensure they are fit-for-purpose within their specific operational context, including equipment and staff capacity. Any new or adapted methods needs to be validated or verified in the local context to confirm performance characteristics such as accuracy, selectivity, linearity, repeatability, sensitivity, limits of detection/quantification and robustness.

Box 4.12. Sources for approved or validated lab methods for testing micronutrients

International sources

• International Organization for Standardization (ISO) – offers internationally recognised methods for micronutrient analysis in food matrices (iron, vitamin A, folic acid, iodine, etc.).

• Codex Alimentarius Commission — provides General Methods of Analysis and references to analytical procedures for vitamins and minerals in fortified foods.

• Association of Official Analytical Collaboration, Official Methods of Analysis – subscription-based compendium of validated methods widely used in labs for food fortification testing and official control.

• ISO/IEC 17025 accredited labs – national reference laboratories often publish or provide access to methods they use under accreditation.

Regional and national sources

• ECSA-HS (East, Central and Southern African Health Community) – fortification testing guidelines and protocols tailored to regional inspection capacity.

• European Committee for Standardization (CEN) – detailed methods for micronutrients in food where applicable in Europe or referenced internationally.

• National standardisation bodies (e.g., Bureau of Indian Standards, US FDA) methods can also list validated analytical methods or references.

Source: East, Central and Southern African Health Community (ECSA‑HC) (2024), Manual of Laboratory Methods for Fortified Foods (Part III: Methods for Iron, Vitamin A and Riboflavin in Flours), https://ecsahc.org/ecsa-documents/?_sf_s=Laboratory%20methods%20for%20fortified%20foods.

Clear regulatory guidance outlining when and how samples are taken, how they are handled, and which analytical methods are applied reduce variability and strengthen the evidentiary basis for enforcement decisions. For example, vitamin A in fortified foods is highly sensitive to light, particularly in fats and oils, where exposure to ultraviolet rays accelerates degradation. Using opaque or dark containers and storing samples in cool, dry conditions away from sunlight helps preserve nutrient content and ensures that laboratory results reflect the true composition of the product at the time of sampling. Referring to established and recognised testing protocols that detail the specific methods and procedures to be followed for micronutrient analysis within guidance further bolsters credibility and consistency for inspectors, laboratories and food business operators alike.

Grounding sampling frameworks in recognised standards, such as the Codex Alimentarius General Guidelines on Sampling (2023[175]), strengthens confidence in inspection findings and supports comparability across jurisdictions. A sound sampling design considers appropriate stringency, practicality, and the homogeneity characteristic of the product. Stringency refers to a sampling plan's ability to control the risk of incorrectly accepting or rejecting a product at a given quality level. Cost and ease of use are also relevant, since a plan that monitoring bodies cannot afford or apply consistently offers little practical value. Variation across manufactured products is unavoidable. Statistical modelling of within-lot variation and measurement uncertainty makes it possible to quantify the risk of accepting a non-compliant lot or rejecting a compliant one (FAO/WHO Codex Alimentarius Commission, 2023[175]). In the case of iodised salt, washed salt in practice shows wide variation in iodine content, making composite sampling a relevant option. Evidence from Mexico shows that composite samples combining at least five samples increased homogeneity and narrowed the range of non-compliant results (Dary and Yusufali, 2025[176]). A recent study in Ethiopia found that combining household salt samples into composite samples produced similar estimates of average iodine content to testing individual samples, while requiring fewer laboratory analyses (Tefera et al., 2026[177]). Codex guidelines (2023[175]) note that composite sampling may be used for bulk materials that could be considered inhomogeneous and FAO similarly observes that the method is frequently used in food composition studies (Greenfield and Southgate, 2003[178]). Composite sampling requires careful consideration, since specialised protocols are needed to ensure that the composite is representative of the overall lot and authorities adopting this approach may wish to adjust the acceptance criterion accordingly (FAO/WHO Codex Alimentarius Commission, 2023[175]). Ultimately, the choice between discrete and composite sampling should be guided by the monitoring objective, the characteristics of the product, and the resources available, rather than treated as a default preference for either method (Sharma et al., 2021[179]).

Close co-ordination between regulatory authorities and laboratories reinforces the link between field inspections and laboratory verification, enhancing the overall effectiveness of supervision. Agreed sampling frequencies, clear reporting channels and structured feedback mechanisms help ensure that test results are communicated promptly and that identified non-compliances are addressed in a timely and proportionate manner.