Good Practice Principles for Regulating Large‑Scale Food Fortification

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

 

Pillar definition
Regulatory requirements and processes to start a business are designed in a way that ensures fortified foods and premixes encounter minimal barriers to market access, without compromising food safety or public health protections.
Sub-principles	Criteria
3.1. Registration and authorisation requirements are risk-based and evidence-driven, and used only as necessary.	Systems for registration/authorization of fortified food and premixes are based on an evaluation of risk Registration and authorisation processes are proportionate to the level of risk Authorisation is limited to only when risks cannot be managed in any other way
3.2. Regulatory requirements for market entry are well-defined and integrated in existing systems with clearly defined regulatory responsibilities.	Existing registration and authorisation systems are extended to include fortified food and premixes Requirements and procedures for production, import, export, and trade are clearly defined, with regulatory responsibilities clearly allocated Processes are streamlined to reduce burden on businesses and facilitate formalisation
3.3. Registration and authorisation requirements are transparent and accessible.	Information on requirements and processes are easily accessible Whole-of-government approaches and digital tools help improve transparency and efficiency
3.4. An accessible register of food fortification businesses is maintained to facilitate informed decision-making.	Registration and authorisation information is used to establish a register of businesses engaged in food fortification activities Information in the register is accurate and maintained up-to-date Databases are coherent and interoperable with other systems to the extent feasible
3.5. Labelling requirements enable market access, consumer awareness, and traceability of fortified foods, including at the wholesale level.	Labelling requirements are clearly established in law and apply consistently across the supply chain Labels identify essential content, in line with Codex and other applicable guidance Labelling supports traceability and enforcement without being too burdensome Labelling and logos support consumer understanding and policy coherence

Regulatory requirements for market entry play a central role in shaping the effectiveness of LSFF programmes. When well designed, they help ensure that fortified foods placed on the market meet safety and quality standards, that responsible businesses can enter and operate with clarity and predictability, and that authorities have the information needed to supervise and enforce compliance. Risk-based and evidence-driven requirements can build trust in fortified foods, encourage industry participation, and support competition and supply. Conversely, overly complex, costly, or poorly co-ordinated requirements can discourage market entry – particularly for small and medium-sized enterprises – delay the availability of fortified foods, or push activities into informality. These outcomes can reduce coverage of LSFF programmes. By contrast, streamlined and accessible procedures for market entry can reduce barriers to entry, encourage compliance, bring more producers into the formal system, and ultimately improve oversight, market competition, prices, and access to fortified foods.

This Principle builds on the OECD’s Best Practice Principles for Licensing and Permitting (OECD, 2025[122]), which provide a broader reference point for authorities addressing licensing and permitting beyond the LSFF context. It combines these OECD principles with LSFF-specific literature, standards, and evidence from food systems to set out targeted, context-specific practices and guidance for food fortification. Importantly, as the OECD’s principles recognise, the terminology used to refer to rules, requirements, and instruments for market entry processes can vary across countries and policy areas; for the purpose of this publication and consistent with more familiar terminology in food fortification discussions, “authorisation” is used to refer to the tools and processes that provide formal approval for individuals or businesses to engage in an activity, provided before that activity begins (also known as licensing and permitting).

Depending on national frameworks, authorisation in LSFF can take different forms, including licensing, permitting or certification. A pre-market approval – such as a licence or certificate – may be required, particularly for higher-risk activities. Importers and exporters of fortified foods and premixes may also be subject to additional authorisation requirements, reflecting differences in national standards, trade rules, and the intended purpose of fortification. Where risks are considered lower, businesses may be able to begin operations after submitting a registration, a notification or a self-declaration, with compliance verified through inspections or monitoring at a later stage.

This chapter examines how regulatory requirements and processes for market entry can be designed to support effective and sustainable LSFF implementation. It sets out good practices for risk-based and evidence-driven registration and authorisation (Principle 3.1), for clearly defined and integrated market entry requirements with well-assigned regulatory responsibilities (Principle 3.2), and for ensuring that procedures and information are transparent and accessible to businesses (Principle 3.3). The chapter also highlights the importance of maintaining an up-to-date and accessible register of food fortification businesses to support informed public decision-making (Principle 3.4), and of establishing labelling requirements that enable market access, consumer awareness, and traceability of fortified foods across the supply chain, including at the wholesale level (Principle 3.5).

3.1. Registration and authorisation requirements are risk-based, evidence-driven, and used only as necessary

Regulatory requirements and processes governing market entry can act as a double-edge sword: they can support market creation, inducing entry and increasing competition, or distort the market, acting as barriers to entry and dampening competition, depending on how they are deployed. A rigorous authorisation process may in some cases maximise safety assurance, but when not risk-based it imposes disproportionate costs, by making market entry burdensome for businesses, discouraging participation in fortification, or demanding time and resources from public authorities that are not feasible to sustain. A risk-based authorisation framework helps balance these trade-offs by using available evidence to tailor requirements and procedures, streamlining oversight where risks are lower while maintaining robust controls where risks are higher (OECD, 2025[122]).

Regulators who prioritise their oversight and allocate resources based on the level of risk posed by different activities are able to operate far more efficiently. They make better use of limited resources and ultimately deliver more effective and proportionate supervision. For example, an importer of fortified foods from a country with equivalent standards and reliable certification may not warrant the same level of scrutiny as an importer from a jurisdiction without comparable controls. Similarly, a premix manufacturer – where a small formulation error can affect large volumes of food and potentially lead to widespread over- or under-fortification – poses a different risk profile from a small, fortified food processor using established methods to supply local market. These examples reflect an understanding of the technical definition of risk as “the combination of the likelihood of an adverse event (hazard, harm) occurring, and of the potential magnitude of the damage caused” (OECD, 2014[123]). Clear and consistently applied risk-based criteria and evidence are essential to determine why some activities require closer scrutiny than others. This subsection examines how risk-based business registration and authorisation for fortified foods and premixes helps target regulatory efforts and resources where they are most needed, while reducing unnecessary, costly, and difficult-to-comply-with requirements for both businesses and public administrations.

Risk-based system for registration/authorisation of fortified foods and premixes

In a risk-based system, the decision on the type of market entry requirement that applies to a business (e.g. notification, registration, licensing or permitting) is based on a sound and proportionate assessment of evidence. The transparent use of evidence minimises the risk of arbitrary or biased decisions on market entry requirements that can distort the LSFF market, promoting a sense of fairness and stakeholder confidence. Clearly communicating to the public how risks are weighed in these decisions is also a core part of risk management, and it falls upon governments and licensing authorities to relay a suitable level of information on risks, trade-offs, and public concerns in a simple, transparent, and accessible manner (OECD, 2025[122]).

To determine the proportionate requirements for starting a business or activity, authorities need to evaluate and classify associated risks. A risk-based system employs a consistent framework to determine whether a business or activity falls in high risk, medium risk, or low risk categories. In making this judgement, authorities can apply tools such as risk ratings and risk matrices (OECD, 2025[122]) to analyse the combined probability and magnitude of harm (OECD, 2021[124]) associated with different fortification activities. For example, the potential magnitude of harm increases where errors could affect large volumes of staple foods, or where vulnerable populations may be exposed. In the context of LSFF, risk ratings can consider factors such as the scale of production or distribution, the type of fortification technology used, the complexity of processes (e.g. handling concentrated premixes), the novelty of the formulation/method/staple food vehicle, the geographic reach, and the degree of human intervention involved.

In selecting applicable instruments for LSFF, authorities are encouraged to assess whether the level of risk justifies requiring approval before a product or activity enters the market, or whether risks can be managed after market entry through inspections, monitoring, and corrective action without endangering public health. Prior authorisation is only necessary for high, uncertain, or hard-to-manage risks where ex ante safeguards are essential (OECD, 2025[122]). Requiring authorisation on a precautionary rather than a risk basis can impose unnecessary burdens on businesses and hinder growth with potential negative effects on employment. Focusing resources on ongoing oversight, while providing guidance to businesses, can be more effective than making it difficult to start production, especially when risks are low.

For low-risk businesses, regulators may consider alternative, less burdensome processes which may include simplified administrative procedures and information requirements, such as self-declaration, notification, registration, or a rule-based system where businesses can operate by following specified requirements without needing permits (OECD, 2025[122]). Where there is no clear evidence that a fortification activity poses a high likelihood of serious harm – for example, where standard methods are used at small/medium scale – allowing market entry subject to notification or registration and post-market oversight can be both effective and proportionate. Box 3.1 illustrates how Indonesia employs a risk-based framework for licensing food businesses and activities.

Box 3.1. Indonesia’s Digital Risk-Based Business Licensing

On 1 April 2021, Indonesia issued Government Regulation 5 of 2021 to introduce a risk-based approach to the issuance of business licences across 16 sectors, including food and agriculture. Government Regulation 28 of 2025 then replaced the original Government Regulation 5 of 2021, retaining the same risk classification system while introducing reforms to address challenges identified in implementation. These include a prohibition on additional subnational requirements beyond those set out in OSS, ensuring uniform procedures across all regions of Indonesia.

Under this framework, the government conducts an analysis of each business licence application that assesses the level and likelihood of hazards associated with relevant business activities. Based on this analysis, businesses are classified into the following categories: low risk, medium-low risk, medium-high risk, and high risk.

This framework builds upon Indonesia’s Online Single Submission (OSS) system, which acts as a one- stop shop for authorisation processes (one-stop shops are further discussed later in this chapter). The OSS integrates multiple ministries and agencies across various levels of government including national, provincial, and municipal.

All businesses must first obtain a Business Registration Number through the OSS system, providing core information (tax ID, business activity code, business profile, capital structure, location). The Business Registration Number serves as the business identity and enables preparatory activities. Additional requirements vary depending on the risk level of the business:

• Low-risk: Business Registration Number only.

• Medium-low risk: Business Registration Number plus Certificate of Standards (self-declared via OSS).

• Medium-high risk: Business Registration Number plus Certificate of Standards verified by government.

• High-risk: Business Registration Number plus operating licence, issued after meeting and verifying specified conditions (e.g. technical and environmental assessments).

For low-risk businesses that can commence operations by obtaining a Business Registration Number alone, this can be achieved through OSS within 30 minutes. For all higher-risk businesses subject to additional scrutiny, all processes can be managed through OSS. For instance, where a business’s application requires obtaining multiple permits (e.g. location permit, environmental permit, construction permit), all applications can be submitted and managed through OSS. The licence to operate is also issued automatically through OSS once the application is approved.

Amendments made by the 2025 Regulation include establishing maximum processing timeframes for each licensing stage, so if a government agency fails to respond within the stipulated period, the licence is deemed automatically approved. The 2025 Regulation also links the risk level of business activities to proportionate supervision requirements.

Source: (Government of Indonesia, 2021[125]), Government Regulation No. 5 of 2021 on Implementation of Risk-Based Business Licensing, Indonesia’s Omnibus Law: Risk Based Business Licensing; Indonesia - Introduced Risk Based Business Licensing | Investment Policy Monitor | UNCTAD Investment Policy Hub; (Government of Indonesia, 2025[126]), Government Regulation No. 28 of 2025 on the Organization of Risk-Based Business Licensing; Indonesia OSS (One Single Submission) System – Electronically Integrated Business Licensing System, https://oss.go.id/en; Indonesia OSS Integrated BPOM RI application, https://ereg-rba.pom.go.id/.

A risk-based framework can significantly streamline the market entry process for businesses. Brazil’s health regulator, for instance, introduced a risk-based system – under which lower-risk products require only notification rather than full registration – to reduce average time to market for those lowest-risk products from 288 days to as little as 0 days (ANVISA, 2022[127]). The amount of information or documentation that businesses are required to submit to begin operation should also be proportionate to the level of risk, so as to avoid unnecessary burden. For SMEs in particular in many low- and middle-income countries, balanced market entry processes that entail less administrative burden make it more feasible to engage in supplying fortified foods (OECD, Forthcoming[70]). Premix manufacturing can involve additional risk factors compared to other parts of the LSFF value chain because it concentrates micronutrients in highly potent forms, where small formulation or dosing errors can lead to significant under- or over-fortification at scale. Production often requires specialised equipment, strict quality control systems, traceability of raw inputs, and validated blending processes to ensure homogeneity and stability (PATH & GAIN, 2015[128]). Where these controls are weak, errors can cascade across many batches of fortified foods. Accordingly, jurisdictions may choose to place greater scrutiny on premix producers in authorisation processes. India’s FSSAI, for example, classifies fortified rice kernels (a premix) as a high‑risk food category requiring systematic inspection before licensing and during operations, reflecting a higher level of regulatory oversight for specialised fortified food inputs such as premixes. (India FSSAI, 2022[129])

3.2. Regulatory requirements for market entry are well-defined and integrated in existing systems with clearly defined regulatory responsibilities

Streamlined requirements and integrated systems for notification, registration and authorisation

When authorisation processes are overly complex, costly, or time-consuming, smaller or informal operators may choose to remain outside the regulatory system or avoid fortification altogether, limiting monitoring and coverage of LSFF programmes. By contrast, procedures that are streamlined, predictable, and accessible can facilitate market entry and encourage compliance with regulatory requirements. This can also increase the participation of smaller producers in the formal sector, strengthen the capacity of authorities to monitor and enforce fortification standards, and support competitive markets while improving the availability and affordability of fortified foods.

Regulatory requirements for fortified foods and premixes need to be integrated into the existing regulatory framework governing the production, import, and export of food products – rather than in a separate or standalone framework. Incorporating food fortification requirements within already established food safety and quality control systems, ensures that the same principles naturally extend to food fortification, and makes use of existing regulatory structures, processes and mechanisms. Integration helps avoid duplication and confusion for both regulators and businesses, making compliance easier and supporting consistent, efficient oversight.

Clear and well-defined requirements and procedures for producing, importing, exporting, and trading fortified foods and premixes are essential for a smooth functioning of LSFF. Regulations clearly set out, for example which authority oversees premix production, food processors, and which is responsible for import controls. When these responsibilities are clearly delineated businesses can move fortified products through the supply chain with minimal delays and misunderstandings. Regulatory clarity prevents overlaps between food safety, customs, and standards authorities. It also helps to avoid duplicative information requirements across agencies, making it easier for actors in the LSFF value chain – including producers, importers, exporters – to comply with fortification requirements while meeting broader food regulations.

Proportionate administrative processes and information requirements throughout production, import, and trade help align effort from businesses and regulators with LSFF outcomes. This means limiting the type and amount of information required to what is justified and balanced, both proportionate to the level of risk and necessary to achieve LSFF policy objectives – rather than what may be needed “just in case” (OECD, 2025[122]). In practice, digital tools can support integration – for instance, a data exchange platform can help ensure that information obtained through registration or authorisation processes is seamlessly integrated and shared across various authorities involved in food authorisation and oversight. Practically, streamlining administrative requirements is in the interest of both businesses and regulators, as it reduces unnecessary burden, speeds up approvals, and allows authorities to focus oversight where errors would have the greatest public health impact. Box 3.2 presents the example of Finland illustrating the application of risk-proportionate requirements for fortified food production.

Box 3.2. Food fortification registration in Finland

There is no specific authorisation requirement for fortifying food in Finland. Food producers just need to submit a notification to the Finnish Food Authority of the vitamins and/or minerals being added to fortify foods. Such notification can be done electronically though an online service. Mandatory information in the notification includes: i) commercial product name, ii) name of foodstuff, iii) food group (e.g. Fruit and vegetable juices and nectars), iv) country of origin, v) list of ingredients, vi) nutrition labelling/declaration, and vii) a copy of the label.

However, just like other businesses, food businesses (including those engaged in food fortifications) need to register their businesses before starting operations, either by notifying food control authority at the location municipality (which can be done online) or apply for an approval from food control authority (for food premises that handle foodstuffs of animal origin before delivering to retail sales).

Source: Finnish Food Authority, Questions about fortified foods.

Clear and streamlined authorisation requirements are particularly important for SMEs with limited resources, which play a major role in workforce employment, as well as food production and distribution (OECD, forthcoming). When registration or authorisation processes are complex or unclear, these businesses may need to spend disproportionate time and money on understanding requirements, navigating procedures, or hiring external experts – resources that they cannot invest in fortification itself. For example, requiring formal third-party certification as a condition for authorisation in a country where accredited certification bodies are scarce or non-existent can make compliance prohibitively expensive or practically impossible for small mills or processors, effectively excluding them from LSFF and discouraging formalisation. If authorisation is required to manage risks effectively, regulatory requirements need to remain proportionate, with simpler and more streamlined requirements applied to SMEs compared with those imposed on larger businesses.

Fees are a common part of authorisation schemes in many countries – however, the motivation behind authorisation should be mitigating risk and not revenue generation. When authorisation requirements are necessary to address risk, then fees can be set proportionately to the administrative costs of processing applications, maintaining registers, and conducting oversight to help ensure that authorisation systems support compliance and participation in LSFF.

Producers may use independent certification schemes to demonstrate that manufacturing processes, quality-control systems and traceability arrangements meet defined industry standards. For instance, suppliers of single vitamins and premix blends are required by GAIN Premix Facility, a qualified supplier and quality-assured procurement mechanism (discussed further in Box 6.1. under Principle 6), to comply with recognised certification schemes such as the Food Safety System Certification 22000, to provide assurance that they operate effective systems for quality control, traceability and the identification and management of food safety hazards throughout the production process (Guinot et al., 2012[99]). 

Co-operation and harmonisation can facilitate market entry for fortified foods and fortification inputs across jurisdictions. Broader than the context of fortification, OECD considers the use of mutual recognition in combination with international instruments as a best practice for international regulatory co-operation. Where regulatory objectives are comparable, mutual or unilateral recognition of another jurisdiction’s rules, conformity assessment procedures or enforcement results may avoid undue costs to business and enforcement clogging (OECD, 2021[130]). In the context of LSFF, this may mean reducing duplicative testing, certification and other conformity-assessment requirements, lowering costs and shortening time-to-market. Closer regulatory alignment among countries can help minimise delays at borders through more efficient and predictable trade facilitation procedures (OECD, 2025[131]). More efficient regional trade can also strengthen food-system resilience by allowing countries to draw on a wider range of suppliers when domestic supply is disrupted (Deconinck et al., 2023[132]). However, recognition arrangements can require significant resources and ongoing regulatory co-operation, and are generally facilitated by high levels of trust and confidence in each jurisdiction’s regulatory and administrative systems (Correia de Brito, Kauffmann and Pelkmans, 2016[133]) (OECD, 2021[130]).

3.3. Registration and authorisation requirements are transparent and accessible

Registration and authorisation systems that are transparent and aligned with regulatory objectives, strengthen public trust, and promote good governance. When procedures are clear, predictable, and proportionate to the risks imposed by a business, they reduce administrative burdens and encourage compliance. Conversely, overly complex and opaque procedures can create confusion, generate distrust in administrative procedures and open opportunities for abuse or corruption. Transparent requirements and straightforward procedures including clearly defined steps, published timelines and consistent criteria, enable businesses to plan effectively, while reinforcing confidence in government oversight.

Easy access to requirements and digitalised processes improve transparency and efficiency

Making information on authorisation requirements freely and publicly available is critical for transparency and effective compliance in LSFF. When businesses can easily access up-to-date information on registration and licensing procedures, required documentation, applicable standards, and responsible authorities, they are better able to understand what is expected of them and how to comply. Ensuring this information is comprehensive and easy to navigate further supports compliance, particularly in complex or niche regulatory environments like LSFF.

Clear explanations written in plain language, supported by checklists, flowcharts, or step-by-step guidance, help businesses identify which requirements apply to their specific activities, whether premix production, food processing, or import. In countries without online systems to support market entry, the notification or authorisation process can be simplified by creating a standardised application form with clear instructions and a checklist of required documentation (if applicable). To assist potential applicants, the relevant agency can offer pre-application consultations where food businesses can meet with licensing officials to discuss requirements and obtain clarification on their specific situation. This is especially important for SMEs, which may lack the capacity to interpret complex legal texts or engage legal advisors. Accessible, well-structured information in turn lowers compliance costs, reduces errors and delays, and supports broader participation in food fortification programmes.

Transparency that extends to different types of information and data on the operation of registration and authorisation systems can further bolster trust and credibility. In practice, this can include the publication of annual activity reports including information about approval rates, processing times and justification for denials, enforcement data, and information about the different mandates and responsibilities of the various authorities involved in authorisation processes (OECD, 2025[122]).

Digital tools

Digital tools can transform the efficiency and transparency of registration and authorisation processes. In India, for example, the FSSAI has launched the Food Safety Compliance System (FoSCoS). FoSCoS is an integrated, multi-purpose online system that is used by both businesses and government agents. One use of FoSCoS is that food business operators may apply for licences and registration certificates and track the progress of their application through the system. FoSCoS also contains a list of the mandatory requirements needed to apply for a licence or registration certificate per type of business. A list of conditions that businesses must comply with during the course of their operations is also available on the platform.

Digital tools can also be employed to support users in more easily and efficiently navigating licensing requirements and process. For instance, the Canadian Food Inspection Agency operates a “Licensing Interactive Tool” to help businesses identify whether they require a Safe Food for Canadians licence based. Users can identify activities that apply to their business, including the type of food and level of trade, and the tool then identifies licensing requirements to those activities (Canadian Food Inspection Agency, n.d.[134]). The Singapore Food Agency also offers a live chat service for general enquiries and to check statuses of food retail licence applications and food import licence applications and permits (Singapore Food Agency, n.d.[135]).

When deploying digital tools for authorisation procedures, portals and websites benefit from being authoritative, comprehensive, user-friendly, and regularly updated. Clear navigation, a strong search function, and intuitive categorisation improve usability and portal designs that accommodate diverse users, including multilingual access, with plain-language content, and accessible formats can broaden accessibility. Before rollout, it is crucial to assess user needs, plan long-term sustainability, allocate resources for updates, and involve users in testing. A clear user interface and straightforward requirements can facilitate a smoother experience for SMEs, and businesses in rural or remote areas. Assigning a responsible authority can improve oversight, promotion and ongoing improvement of digital tools. Efforts should be made to ensure that information is asked only once – a principle that can be put into practice through one-stop shops.

Whole of government approach: one-stop shops

Whole-of-government co-ordination is an essential element for efficient market entry processes for businesses looking to engage in LSFF – an activity that can fall under several policy areas and responsibilities. For example, a flour mill seeking to produce fortified flour may need to notify multiple authorities separately: registering the business with the general food authority, filing a production activity notification with an industry ministry, submitting a fortified product notification to the food safety regulator, declaring premix imports to customs authorities, and separately notifying or validating labels with a consumer protection body – often submitting overlapping information and documents each time, and having to check multiple websites to understand the different requirements under each authority’s framework. Without co-ordination between authorities at both national and subnational levels, this fragmented process can lead to duplicated paperwork, inconsistent guidance, more resources invested in compliance, and longer delays to market entry, which can discourage the flour mill from participating in the fortification programme altogether, even if the actual technical standards are clear.

One-stop shops can serve as a valuable administrative tool to make market entry easier for businesses engaged in LSFF or other regulated activities. A one-stop shop provides a single, co-ordinated interface through which businesses can complete procedures that would otherwise involve separately applying to multiple authorities. These systems can also extend beyond initial authorisation to cover ongoing regulatory interactions throughout the lifecycle of a business. When designed and delivered well, one-stop shops make requirements easier to find and follow, reduce repeated submissions of the same information, and simplify navigation of procedures. Through consolidation, they can also help to streamline requirements and processes – to the benefit of both regulators and businesses. They can further benefit regulators by facilitating ongoing co-ordination, communication, and data-sharing among participating agencies (OECD, 2020[136]) – as is the case in Indonesia where the Online Single Submission system enables multiple agencies to access information provided through the notification and authorisation process.

It is important that procedures and requirements are reviewed and streamlined upfront; the efficiency gains of a consolidated system are limited if complexity, overlap or unclear documentation requirements persist (OECD, 2025[122]). The experience of the renewable energy one-stop shop in Cyprus illustrates this point, as the digital platform was introduced alongside efforts to map, simplify and align procedures across authorities to ensure the system is effective and delivers administrative efficiency (Ministry of Energy, Commerce and Industry, 2023[137]).

There is no universal one-stop shop model for all circumstances, and governments may need to adapt the approach to be feasible based on available resources and the existing infrastructure (OECD, 2020[136]). For instance, a one-stop shop may be a physical location instead of an online platform. It may be strictly informational, consolidating‑ requirements and even guidance, but lacking the functionality for service delivery. It may be limited to a specific activity (such as starting a business), a specific policy area (such as food systems), or a specific level of government. Over time, simpler models can be expanded as capacity grows. Box 3.3 further elaborates on Viet Nam’s experience in consolidating authorisation information and functions – alongside other public services – in a digital tool. Further guidance and information on the application of one-stop shops beyond the specific context of LSFF authorisation is available in the OECD’s Best Practice Principles on One-Stop Shops for Citizens and Business (2020[136]).

Box 3.3. Viet Nam’s Online Systems for Business Registration and Authorisation

Viet Nam’s National Business Registration Portal provides a consolidated online platform for company registration and serves as a practical example of a digital “one-stop” entry point for businesses. Through the Portal, firms can submit registration applications online, upload required documents, and authenticate using digital signatures. Once approved, businesses receive a registration certificate and must upload their registration information to a searchable public database of registered enterprises. The system delivered measurable efficiency gains: average registration time fell from around 15 days in 2007 to about 2.3 days in 2018, and IFC estimates reported by the government in 2014 indicated approximately USD 4 million in annual cost savings for newly registered enterprises.

While the Portal centralises core registration functions, firms engaging in specific activities may still need to obtain additional permits from specialised agencies – such as food safety or import-export permits. In practice, the submission and assessment of applications for registration and licences also involves unstructured data (e.g. uploaded scanned documents and PDFs), which can be burdensome to process compared to structured data directly inputted into online forms.

The Government continues advancing reforms to support integration and digitalisation. Viet Nam has adopted legal Decrees with provisions promoting the “once-only” principle (i.e. government agencies co-ordinate so businesses do not have to submit the same information repeatedly) and data-sharing across public authorities. In 2025, the Government also launched the National Legal Portal, which consolidates all legal documents and requirements in one searchable online portal. The Government also announced efforts to phase out ministerial and subnational administrative service platforms in favour of a consolidated national public service platform.

Source: (World Bank, 2024[138]); (Nhan Dan, 2025[139]); (United Nations in Viet Nam, 2019[140]); (Agency for Business Registration, 2014[141]).

3.4. An accessible register of food fortification businesses is maintained to facilitate informed decision-making

As part of notification, registration, or authorisation processes, food businesses submit a wide range of information to public authorities, such as details on their location, ownership, activities, and compliance arrangements. A business register provides a structured way to manage this information and maximise its value. What a register looks like in practice can vary widely, based on the resources and systems available to authorities in a country – from a paper-based list to an integrated and online IT-platform that allows for real-time updates and extracting data-based insights. A dedicated register that includes producers, premix manufacturers, importers, and other relevant actors gives authorities a clear overview of who is involved in fortification activities within their jurisdiction.

Information from up-to-date business registers supports effective decision-making by public authorities

A well-functioning register supports day-to-day regulatory decision-making by helping authorities track where fortification is taking place and at what scale. For example, knowing the location of fortified food producers and importers allows inspection authorities to plan and prioritise site visits, while information on ownership and the nature of operations helps identify links between businesses or supply chains. This visibility is particularly important in LSFF, where fortified foods may move across regions and where a single operator can supply large segments of the population.

It is also important to manage data properly to keep it accurate and reliable. Technology can help handle large amounts of data, but it only works well if the data going into the system is complete and correct. A small, high-quality dataset is better than a large one full of gaps. While licensing data often reflects static risks such as those related to type of an activity, size of operations and production capacity, data collected from other sources including inspection visits, reflect the operational aspects of a business, such as compliance history and internal control processes, and can inform dynamic risk criteria. Principle 4 further discusses the type of data that can inform risk classification of businesses.

Information contained in the register also feeds directly into risk-based approaches to supervision and enforcement. Data such as production volumes, types of fortified foods, use of premixes, or past compliance history can help authorities distinguish between higher- and lower-risk operators and allocate inspection resources accordingly. To remain accurate over time, the register needs to be regularly updated, reflecting changes such as new entrants, closures, changes in ownership, or shifts in production activities. However, updating a register should not impose unnecessary additional burdens on businesses and – to the extent feasible – should be done using existing sources.

The value of a business register increases when databases are coherent, consistent, and interoperable. Standardised data collection and storage enable information to be shared across licensing, inspection, customs, and food safety systems, reducing duplication and improving co-ordination among authorities. In practice, this can mean linking business registers with inspection management systems or import databases, allowing regulators to draw on the same information for multiple regulatory tasks.

Where information is incomplete or difficult to collect through registration alone, such as in settings with limited resources or high levels of informality, additional data sources can strengthen the register. Publicly available information from company websites, trade platforms, or procurement records can be used to supplement official data. Data-driven and AI-enabled tools, such as web scraping, can help identify active fortification businesses or changes in operations, improving coverage and accuracy over time. In Italy, for example, a regional environmental protection agency used an automated web scraper to identify thousands of businesses that had not applied for required licences that allowed the agency to monitor pollution activities. The programme used public search engines like Google and Bing to identify businesses’ web pages (e.g. searching “car repair Trentino”), then compared business identification numbers from web pages with the list of licenced operators (OECD, 2025[60]).

3.5. Labelling requirements enable market access, consumer awareness, and traceability of fortified foods, including at the wholesale level

Appropriate labelling requirements are established as a prerequisite for market placement of fortified food, enhancing consumer awareness, and supporting enforcement and traceability

Labels on fortified foods are used to convey important information to consumers, retailers, wholesalers, and regulators. Food labels should include the name and contact details of the manufacturer, list of ingredients, nutrient values, allergen information, expiry date, storage instructions, usage directions, and any claims or certifications (e.g., nutrition claims, logos). The role of labelling requirements for fortified foods is multifaceted and serves three primary functions: i) a prerequisite for market placement of fortified food to ensure consistent industry communications about food products, ii) a means to enhance consumer awareness about fortified foods, and iii) a tool for supporting traceability, which is crucial for the enforcement of LSFF regulations.

Labelling requirements are typically incorporated into food laws, food safety and quality legal frameworks, or other relevant legal documents, clarifying which labelling requirements are mandatory for businesses and which can be voluntarily applied. Importantly, labelling requirements are relevant for all fortified food products at the retail and the wholesale trade level, irrespective of mandatory or voluntary fortification. In addition, co-ordinating broader food and product labelling oversight across relevant ministries and agencies supports alignment and reduces duplication of efforts, thus helping to ensure consistent application across the supply chain.

New food labelling requirements or changes to existing requirements can impose adjustment costs on businesses, including label redesign, verification of information, changes to printing or production systems, staff time, and the write-off of existing packaging. A 2022 Canadian regulatory proposal for a new mandatory front-of-package nutrition symbol estimated the cost of changing a label at CAD 23 146 per stock keeping unit; with around 46 000 products expected to require the symbol, the one-off industry cost was estimated at approximately CAD 1.07 billion assuming a three-and-a-half year transition period (Government of Canada, 2022[142]). The timing of labelling changes can also have substantive impact: Food Standards Australia New Zealand estimated that a five-year transition period for new allergen labelling requirements could reduce relabelling costs by around 70% by allowing businesses to incorporate mandatory changes into their normal label-update cycles (Food Standards Australia New Zealand, 2020[143]). Where logos are a choice in a voluntary fortification framework, cost has also been identified as a barrier to uptake; smaller manufacturers in one country case identified that they may not use the voluntary logo programme due to the associated costs, such as the cost of analysis of nutrients by accredited labs (The George Institute for Global Health, 2024[144]).

It is important to ensure policy coherence between fortification labelling and broader national health and nutrition policies. That is, fortification claims should not be used to market otherwise unhealthy products, and labelling requirements should align with national health policies including those on the prevention of non-communicable diseases. Consumers also need to be provided with accurate information free from misleading claims. Fortification claims or symbols should, for example, be consistent with front-of-pack nutrition labelling systems and should not inadvertently dilute or contradict information intended to help consumers identify healthier food choices. (The George Institute for Global Health, 2024[144]). Misuse of fortification labelling can actively undermine health policies – for instance, fortification of high-calorie snack foods and carbonated drinks may create the false impression that these products are healthy, with research showing that nutrition claims on less healthful fortified snacks can increase consumer beliefs about the presence of a wide range of healthful nutrients (Iles, Nan and Verrill, 2017[145]). It is important, therefore, that fortification labels support consumers in choosing fortified foods over non-fortified alternatives, rather than encouraging the consumption of unhealthy fortified foods. Other OECD reports discuss how food labelling can be employed to support coherence with nutrition and health policies for better nutrition outcomes (Giner, Rodriguez and Elasri, 2023[11]). The George Institute for Global Health’s paper on nutrition labelling to support LSFF (2024[144]) also includes a framework for nutrition labelling practices.

Appropriate labelling requirements support consumer awareness

In developing labelling requirements for fortified foods, governments can draw on guidance provided by the Codex Alimentarius Commission (Codex) via published guidelines, including the Codex General Standard for the Labelling of Pre-packaged Foods, the Codex General Standard for the Labelling and Claims for Pre-packaged Foods for Special Dietary Uses, the Codex General Guidelines on Claims, the Codex General Guidelines on Nutrition Labelling, and the Codex Guidelines on Nutrition and Health Claims. The collective of Codex guidelines aims to ensure information presented on food labels is technically accurate and clear for consumers. They serve to promote health and fair-trade practices by providing standardised guidelines for nutrition labelling and nutrition and health claims.

Fortified food labelling may include nutrient declarations, nutrition claims, and health claims (see Codex, 1985 for definitions). Though content and language should align with global guidance via Codex, how the language is used, whether it is mandatory or voluntary, and specific messaging content varies by country. At a minimum, labels of fortified foods should contain essential information in line with Codex guidelines, clearly indicating that the food is fortified and specifying the name and micronutrient content added. However, additional language that conveys nutrition or health claims can increase consumer awareness and may influence purchasing decisions (Codex Alimentarius Commission, 1985[146]).

A nutrient declaration uses standardised statement language or listing to list the nutrient content of food, and is typically provided on the back or side of a pack (The George Institute for Global Health, 2024[144]). At a minimum, Codex guidelines recommend mandatory nutrient declarations on pre-packaged foods, including values for energy, protein, available carbohydrate, fat, saturated fat, sodium, total sugars, and any nutrient considered to be relevant for maintaining a good nutritional status according to national guidance or legislation (Codex Alimentarius Commission, 1985[146]; The George Institute for Global Health, 2024[144]). For example, if folic acid is a concern in a country, the folic acid content of the food should be listed on the nutrition label when it is part of mandatory or voluntary food fortification efforts.

A nutrient declaration is also necessary whenever nutrition or health claims about a food are made and must indicate the amount of the nutrient included in the claim. These claims may include energy, protein, fat, carbohydrates, vitamins, or minerals. Nutrition claims indicate a link between the food and any specific nutritional properties or contents (e.g., whether a food is a good source of a specific vitamin or mineral). For example, a food can be a “good source of vitamin A” or an “excellent source of iron” as defined by national nutrition standards. Health claims may be used to convey a link between a food or nutrient and health-promoting properties (e.g., lower risk of disease, promotion of growth and development). For example, for foods that meet national criteria, health claims stating “Calcium and vitamin D reduce the risk of osteoporosis” (U.S Food and Drug Administration, 2026[147]) or “Vitamin A contributes to the normal function of the immune system” may be used (EFSA Panel on Dietetic Products, Nutrition and Allergies, 2013[148]). Nutrition and health claims must be made based on scientific evidence and should be reviewed and reevaluated as new evidence becomes available. Requirements to provide standardised nutrition information on food packaging – e.g., ‘iodised for better health’ based on food containing a required level of a micronutrient – can also help to simplify compliance and establish a level playing field for manufacturers, increase the efficiency of regulatory governance, and support consumer understanding (The George Institute for Global Health, 2024[144]).

Both nutrition and health claims are voluntary, though they may be used by manufacturers to support consumers in differentiating between non-fortified and fortified foods and highlight the potential benefits of fortified staples. Some countries have introduced standardised, generic claims for fortified foods that meet local fortification standards. For example, in South Africa, the national food fortification logo includes the statement “Fortified for better health,” that generally suggests that fortified foods that meet the government’s criteria are health-promoting. Regulators must clearly detail when nutrition and health claims may be used on food products and oversight should ensure claims are not used to promote unhealthy foods (Giner, Rodriguez and Elasri, 2023[11]). Prioritising standardised claims may increase the efficiency of regulatory governance and support consumer understanding and use (The George Institute for Global Health, 2024[144]). Figure 3.1 illustrates the voluntary fortification logo that can be obtained through compliance with relevant Kenyan fortification standards and application with the Kenyan Bureau of Standards.

Figure 3.1. Voluntary fortification logo in Kenya

Source: https://qualityassurance.kebs.go.ke/fortification-mark/.

Food labelling has been shown to influence consumers’ purchasing behaviours (Turk and Spohrer, 2016[149]; Jahn, Tsalis and Lähteenmäki, 2019[150]). In the case of food fortification, the objective should be to support informed consumer choice on fortified products and awareness regarding the role of fortified foods in a healthy diet. It is important that label information is accessible for all populations, recognising that low literacy levels may exist in vulnerable groups that may be most likely to benefit from food fortification. Logos, food group signals, coloured images, or graphical elements can support consumer decision-making for populations with limited literacy or nutrition-related knowledge. However, the benefits of fortified foods should not be overstated, nor should they imply that consumption of fortified staples may replace a balanced diet, including fruits, vegetables, legumes, and protein-rich foods. Consumer messaging on fortified foods should employ health claims that convey the health benefits of fortified foods as part of a diverse, balanced diet.

A distinctive logo as part of the label helps consumers easily differentiate fortified products from non-fortified products. When logos are endorsed by regulatory bodies monitoring fortification quality and standards and consumers are informed about fortified foods through public awareness campaigns or educational initiatives, logos can foster trust and consumer confidence. In a voluntary fortification system, logos make it easier for consumers to make informed choices and differentiate between fortified and non-fortified products. However, misuse of fortification labels and logos can undermine the credibility of the market. If products display a fortification mark without meeting the required nutrient levels, consumers may be misled and compliant producers placed at a competitive disadvantage. Robust oversight is therefore important to verify that only eligible products use such claims or logos, require their removal where conditions are not met, and apply proportionate enforcement where misuse is repeated or deliberate.

Several countries have mandatory requirements for fortification logos, while others have voluntary schemes where a producer can apply for a logo after meeting certain criteria. Regulatory requirements and oversight for placement of fortification logo ideally provide detailed guidance on the logo’s format, design, placement on the label to ensure consistency and clarity. As noted previously, careful consideration is needed to ensure the logo design is clear for low literacy populations. Oversight can help prevent false advertising or misuse, including displaying a logo on products with sub-standard nutritional quality (e.g., under-fortified foods that do not meet the national targets) or unfortified staple foods. Ideally, regulatory requirements and the logos themselves are aligned with regional logos and labelling requirements to facilitate cross-border trade and regional harmonisation.

Labelling supports enforcement and traceability

Traceability allows regulatory bodies to monitor and track fortified foods throughout production, processing, and distribution systems, ensuring compliance with fortification standards and reinforcing consumer trust in these products (FAO, 2017[151]). If there is a contamination or a quality issue or non-compliance with requirements with a specific batch of fortified food, traceability helps authorities to recall the product swiftly, minimising the risk of ingesting harmful food products and protecting public health.

Labelling requirements must be clear, adequate, and durable enough to enable traceability, ensuring that noncompliant fortified foods can be traced back to their sources for accountability and enforcement. Batch numbers, lot numbers, or production codes are commonly used to trace food products in the supply chain. Comprehensive food labelling regulations should include all of the following elements to ensure traceability: the food business identification number and the name of the brand owner; a description of the type of item by brand name and variety; the product manufacturer, producer or processor; a batch number, lot number, or production code; a code for date marking, as required by relevant legislation; and quantity (FAO, 2017[151])

In countries where food products, including fortified food, are sold without standard packaging or in bulk, regulators should consider and offer alternatives to support traceability. For example, transport documents, commonly known as waybills, could be required to include, in addition to standard details such as origin, destination, quantity, and type of foods, specific standardised information on nutrient content. This would help authorities track fortified foods even when sold and transported in bulk. Other strategies to enhance traceability may include placing unique identifiers on drums or other forms of bulk packaging, requiring distributors to maintain detailed documentation for all suppliers, and introducing digital tracking systems to monitor foods across the supply chain. Principle 4 further discusses effective monitoring and supervision of LSFF regulatory frameworks.