A review on the role of food regulatory science for food safety in the era of Food-Tech innovation

Abstract

In the Republic of Korea, the Framework Act on Food Safety has been implemented to ensure public health and safety by focusing on the formulation and coordination of food safety policies. In response to the rapidly changing environment, the Regulatory Science Innovation Act on the Safety and Commercialization Support of Food, Drugs, and Other Products was recently introduced to establish an institutional foundation for the swift commercialization of innovative products and ensure their safety. However, many issues need to be discussed regarding the application of regulatory science in the field of food safety. This study aimed to review the principles and characteristics of food safety regulations and derive the concept and role of food regulatory science. Food regulatory science serves as a critical tool for translating the fundamental principles of food regulation into policy. Prioritizing the advancement of research and development, training on specialized human resources, and establishing a robust support system for commercialization are essential to achieving this objective. This approach will facilitate the development and implementation of policies based on food regulatory science in the Republic of Korea.

Introduction

According to Article 10 of the Constitution of the Republic of Korea, all people possess dignity and worth as human beings and have the right to pursue happiness through the safe consumption of food (Constitution of the Republic of Korea, Article 10). As set forth in Articles 36 and 37 of the Constitution, this right is fundamental and cannot be disregarded for reasons not enumerated in the Constitution. It is the State’s responsibility to ensure food safety throughout the food supply chain, as set forth in the Constitution, to promote the health and safety of its citizens (Wang, 2014).

The Government of the Republic of Korea is responsible for establishing and implementing food safety policies at all stages, from production to consumption, to ensure that citizens can maintain a healthy and safe diet (Framework Act on Food Safety, Article 1). To achieve this objective, the Framework Act on Food Safety clarifies the rights and duties of citizens for food safety and the responsibilities of state and local governments. It also regulates the fundamental principles governing the formulation and coordination of food safety policies. It emphasizes scientific rationality, consistency, transparency, promptness, and prevention in formulating policies (Framework Act on Food Safety, Article 4). The Act also mandates scientific standards for food production, processing, and distribution of food ingredients that prioritize public health and safety while aligning with international standards, including those of the Codex Alimentarius Commission (Codex) under the World Trade Organization (WTO) system.

The landscape of food safety policy is rapidly evolving due to technological advances, changing consumer needs and global environmental challenges. A wide range of Food-Tech products combining biotechnology and the Internet of Things are being developed, as well as functional foods based on novel foods and foods for special medical purposes (FSMPs) to improve health and prevent chronic diseases (NIFDS, 2022a). At the same time, environmental problems such as climate change have increased risks from pathogenic microorganisms, antibiotics, and endocrine-disrupting chemicals (MFDS, 2024). The globalization of food trade has increased the necessity for harmonized standards, as discrepancies in regulations between importing and exporting countries frequently result in disputes. The pandemic has emphasized the necessity for safe yet innovative products in the food sector, and these trends underscore the importance of regulatory science as a new paradigm for food safety management, including the development of safe and innovative products. (NIFDS, 2022b).

Several countries are strengthening food safety policies to ensure consumer confidence and public health. In the United States (US), the Food Safety Modernization Act (FSMA) emphasizes the precautionary principle, whereas the US Food and Drug Administration (FDA)’s “New Era of Smarter Food Safety-FDA’s Blueprint for the Future” presents a series of strategies for responding to the advent of novel food technologies and digital systems (FDA, 2018; FDA, 2020). The European Union’s integrated food safety management system, the “One Health” approach, integrates food safety with agricultural, veterinary, and environmental health to improve food quality and guarantee the food industry’s competitiveness (DG SANTE, 2020). The WHO Global Strategy for Food Safety 2022–2030, published by the World Health Organization (WHO), focuses on ensuring access to safe and healthy food through evidence-based, forward-looking, and cost-effective principles (WHO, 2022). Similarly, the FAO Strategic Framework 2022–2031, published by the Food and Agriculture Organization (FAO) of the United Nations, highlights strengthening national food safety systems by encouraging stakeholder participation, providing scientific evidence for decision-making, and promoting public–private collaboration for ongoing improvements (FAO, 2023). Codex continues to set internationally recognized standards that support the harmonization of regulations under the principles of free trade (Codex, 2019).

In the Republic of Korea, the Act on Regulatory Science Innovation for Supporting Food and Drug Safety and Commercialization (hereafter referred to as the Regulatory Science Innovation Act) was newly implemented in February 2024 to address the rapid advancements and transformations occurring across various fields. This Act aims to enhance public safety and well-being by implementing reasonable safety management practices for food, drugs, and other products based on regulatory science, thereby ensuring their safe use and expeditious commercialization. Consequently, novel evaluation criteria and methodologies for the safety, efficacy, and quality of innovative products have been established through research and development (R&D) projects. The Act also provides for training specialized personnel, enabling the application and development of these new evaluation criteria by regulatory authorities and industry. This creates a virtuous support system cycle that facilitates rapid commercialization from the early stages of innovative product development (Fig. 1). When the core concept of regulatory science, as legally defined, is applied to the food sector, food regulatory science can be defined as all activities related to safety management. This includes technologies, standards, and approaches based on evaluating the safety, efficacy, quality, and performance of food products, from approval and licensing to their use (Lee et al., 2024). However, the broad scope of food regulatory science, encompassing all aspects of food safety management, presents significant challenges in practical application, highlighting the necessity for further discourse on the implementation and methodologies of regulatory science in the food industry (Health and Welfare Committee, 2023). Future R&D endeavors on the creation of novel food products, the training of regulatory science professionals in the food sector, and the expeditious commercialization of these products must align with the tenets of the Regulatory Science Innovation Act.

Fig. 1.

The framework of regulatory science innovation in the Republic of Korea

This study had three primary objectives: first, to review the regulatory principles and concepts that have shaped food safety policies over time; second, to discuss the concept of food regulatory science to be applied broadly to the entire food sector; and third, to clarify the role of food regulatory science in all areas of food safety management, including the development of innovative products. The food safety system is a complex and dynamic scientific activity continuously influenced by several factors, including the environment and climate, global political and socioeconomic conditions, scientific and technological advancements, and consumer attitudes. This paper is intended to guide establishment and implementation food safety policies based on food regulatory science, thereby ensuring that the public can exercise their right to consume safe and secure food.

Characteristics of food safety regulation in the Republic of Korea

Key principles of food safety regulation

The Republic of Korea’s Framework Act on Food Safety presents the fundamental principles for establishing and implementing national food safety policies. In alignment with the WTO Sanitary and Phytosanitary Measures (SPS) Agreement, Codex adopted the “Working Principles of Risk Analysis” for implementing Codex standards and guidelines during its 26th session in 2003. This provided fundamental definitions and directions for applying food safety (Codex, 2003). The regulatory principles of food safety are utilized not only in the Republic of Korea but also by regulatory agencies globally and international organizations such as the WHO and FAO under the WTO system. While the terminology may vary slightly, the fundamental principles and core concepts of food regulation remain consistent, and their primary elements can be summarized as follows.

Scientific rationality

The initial principle is scientific rationality. The principle of risk analysis is a system designed to prevent or minimize the potential harmful effects on human health when exposed to hazardous elements in food and other products. This process entails not only a scientific assessment of the hazards but also an examination of social and economic factors to ensure a suitable risk management strategy. It is based on the principles of scientific rationality and consists of three fundamental, risk-based approach elements: risk assessment, risk management, and risk communication. In the WTO/SPS system, which supports a market-oriented free trade order, risk analysis has been pivotal to decision-making regarding international food safety regulatory policies over the past two decades (WTO, 1995).

Worldwide, the most challenging issue in food safety is the establishment of science-based food safety policies. The Republic of Korea also applies the principle of risk analysis based on scientific rationality when establishing standards and specifications for food. During this process, the appropriate level of protection and the principle of as low as reasonably achievable (ALARA) are applied (MFDS, 2023). The term “appropriate level of protection” describes the sanitary or phytosanitary protection level established to safeguard human, animal, and plant life and health. A fundamental tenet of the Codex approach to standard-setting and product specification is the adherence to the requisite level of protection as determined through risk assessment under the WTO/SPS Agreement. This is defined in Article 5 of the Agreement. Furthermore, the ALARA principle, initially proposed by the International Commission on Radiological Protection in 1976, is applied internationally in food and environmental safety (Cho and Cho, 2018; Jo, 1995; WTO, 1995). According to the “Guidance for Risk Assessment of Human-Use Products,” revised and published by the Ministry of Food and Drug Safety (MFDS) in 2023, the ALARA principle is defined as maintaining the exposure level of harmful substances to humans at a reasonably achievable level, considering the benefits and risks in terms of hazards, socioeconomic, technological, and public policy factors. In the Republic of Korea, this principle is applied when setting standards for harmful contaminants in foods, such as heavy metals. The Korean Food Code mandates that standards be established under the ALARA principle, considering the contamination levels of harmful substances in food, total human exposure, risk levels, and share of exposure (MFDS, 2023).

Transparency

The second principle is transparency, a fundamental tenet of the WTO system that has been agreed upon by most of the WTO member states. The objective is to enhance the predictability of international trade rules and ensure the effectiveness of agreements by preventing the arbitrary interpretation and application of trade-related rules. This principle requires that domestic laws, judicial and administrative decisions, and policies related to trade be transparent and publicly disclosed (Cho and Cho, 2018; Yang, 2005). Article 7 of the SPS Agreement addresses the principle of transparency, stipulating that all laws and regulations affecting food trade must be publicly disclosed intelligibly. In cases where this is not feasible, the relevant information must be made accessible through alternative channels (WTO, 1995). The transparent accessibility of domestic matters related to SPS measures allows interested parties, including other nations, to become aware of and offer input before new SPS measures are enacted or existing ones are amended. This approach enhances the rationality and predictability of SPS measures and helps prevent potential future trade disputes. The Republic of Korea also adopted the principle of transparency as a key regulatory principle in its food safety policy (Article 4, Paragraph 2 of the Framework Act on Food Safety). By maximizing the openness of its domestic food safety system and governance, the Republic of Korea maintains regulatory transparency in its food safety policies, thereby increasing predictability and consistency.

Precautionary principle

The third principle is the precautionary principle. This principle states that when significant or irreversible environmental damage is anticipated, the lack of scientific certainty should not be used to delay the implementation of regulatory measures to prevent environmental harm. The precautionary principle has been established as a theoretical framework through various international discussions, justifying preemptive regulatory actions even in scientific uncertainty within environmental norms. Notably, the European Commission adopted a communication from the Commission on the Precautionary Principle in February 2000, explicitly stating that the EU would apply the precautionary principle in environmental protection and public health (Commission of the European Communities, 2000; Song, 2021). Similarly, the Codex considers the precautionary principle an integral component of risk analysis, advising that standards should not be established in cases where there is evidence of potential harm to human health but scientific data is insufficient or incomplete (FAO, 2003). In food safety, which is fundamentally prevention-oriented, an unforeseen incident resulting from scientific uncertainty can lead to rapid and widespread damage. Consequently, the precautionary principle should be prioritized for newly developed food products derived from novel materials, functional foods utilizing these materials, and genetically modified foods, particularly when there is scientific uncertainty and a scarcity of prior experience with these foods.

Food safety regulatory framework and the introduction of regulatory science

The food safety regulations in the Republic of Korea have significantly transformed from a reactive, post-management system to a proactive safety management approach that emphasizes the precautionary principle. Concerted efforts have been made to enhance consumer participation and establish a rapid crisis response system. All food policies aim to ensure food safety and secure public health.

Historically, food safety regulations in the Republic of Korea have been based on the Food Sanitation Act. However, a multifaceted food safety management system has been in place in practice. For example, the responsibility for managing food safety in the Republic of Korea is distributed among different authorities based on the type of food product, such as processed foods, agricultural products, livestock products, and seafood products. The safety and quarantine of imported foods are managed separately, and tasks related to food safety and the food industry are distinctly divided, challenging integrated management. The diversification of food management policies has led to several issues, including blind spots in food safety management, unclear accountability, and inefficiencies in the food safety management system due to overlapping regulations. The Framework Act on Food Safety was enacted and implemented in 2008 to address these issues. This legislation established the Food Safety Policy Committee, chaired by the Prime Minister, as a national body for the comprehensive coordination of food safety policies in the Republic of Korea.

The Framework Act on Food Safety clarifies the rights and obligations of citizens regarding food safety, outlines the responsibilities of state and local governments, and provides the fundamental principles and plans for the formulation and coordination of food safety policies. As a result, numerous food safety regulations have been enacted with the public interest in mind, aiming to safeguard the lives, safety, and health of the public. The legislation oversees the production, manufacture, and distribution of potentially hazardous foods by food business entities. Under the oversight of the central government agency, the MFDS, the State maintains significant control over food safety at all stages, from production and manufacturing to distribution and consumption. In contrast, the Food Sanitation Act prescribes specific policies for implementing and enforcing actual regulations within the basic framework of food safety regulation. This legislation specifies measures for food hygiene management and the response to food safety and hygiene-related incidents. Beyond these two core laws, the food safety management system is also governed by other legislative provisions. For instance, the legislative framework encompasses a range of specific laws, including the Functional Foods Act, the Agricultural and Fishery Products Quality Control Act, the Livestock Products Sanitary Control Act, and the Special Act on Safety Management of Children’s Dietary Lifestyle. With regard to the regulatory framework, notable laws include the Special Act on Imported Food Safety Control, the Act on Labeling and Advertising of Foods, the Act on the Establishment and operation of the Korea Agency of HACCP Accreditation and Services, and the recent Act on Assistance in Ensuring Meal Service Safety in Social Welfare Facilities for Senior Citizens and Persons with Disabilities are of particular note. Other common areas of legislation include the Act on Testing and Inspection in the Food and Drug Industry, the Cleansing and Hygiene Products Control Act, the Act on Risk Assessments of Products for Human Use, and the Act on Regulatory Science Innovation for Supporting Food and Drug Safety and Commercialization (Regulatory Science Innovation Act). According to Article 2, Paragraph 5 of the Framework Act on Food Safety, 32 laws are classified as food safety-related laws, illustrating the intricate and multifaceted nature of the food safety legal system. A summary of the current food safety regulatory framework in Korea is presented in Fig 2.

Fig. 2.

The food safety management system and regulations in the Republic of Korea

Recent international regulatory developments have demonstrated the effectiveness of policy decisions in addressing issues arising in modern society, including food safety. This is referred to as evidence-based regulation, a legislative approach that aims to develop more rational and desirable regulatory methods based on the most current scientific evidence. This is achieved by integrating human behavior and judgment into the scientific process, thereby enhancing the efficiency of scientific evidnece informing policy outcomes using scientific data (Lee et al., 2023). The field of regulatory science represents a relatively recent addition to the regulatory framework, with a growing prevalence across a range of policy domains. It is an academic discipline that identifies problem areas, verifies the effectiveness of specific regulations, and improves the alignment between data-driven scientific evidence and policy outcomes. In the Republic of Korea, the Regulatory Science Innovation Act defines regulatory science, establishes fundamental plans for regulatory innovation, supports research and development projects, and reviews regulatory coherence to enhance the effectiveness of innovative products and expedite their market entry. Additionally, it provides for the training and designation of specialized human resources and institutions, as well as the conduct of domestic and international surveys on regulatory science innovation and the promotion of public–private cooperation.

Thus, the core of the Republic of Korea’s food safety regulatory system must be the Framework Act on Food Safety, which presents the fundamental tenets requisite for applying food safety regulations across the full spectrum of food production, importation, manufacturing, processing, distribution, and consumption. Furthermore, the Regulatory Science Innovation Act should be employed to facilitate the expeditious commercialization of novel food materials or foods developed using innovative technologies. This approach is founded upon an efficient and evidence-based regulatory science management strategy. These two acts should be mutually reinforcing to ensure that the public can maintain a healthy and safe diet. Consequently, when formulating the basic plans for food safety control under the Framework Act on Food Safety, the “Master Plans for Regulatory Science Innovation,” upon which it is based, must be integrated.

Paradigm shift in food safety policy focused on the Regulatory Science Innovation Act

Definition of food regulatory science

According to the definition specified in Article 2, Paragraph 2 of the Regulatory Science Innovation Act, the term “regulatory science for foods, drugs, etc.” means science related to technologies, standards, and approaches in all aspects of safety management, ranging from the evaluation of safety, efficacy, quality, performance of foods, drugs, etc. to authorization, permission, and use. The Republic of Korea is the only country where food regulatory science is legally defined in such a manner (Lee et al., 2024).

However, since the concept of regulatory science originated in the pharmaceutical field and the Republic of Korea’s definition was adapted from the US FDA’s definition of regulatory science, its direct application in the food sector has several limitations. Firstly, unlike pharmaceuticals, food is generally perceived as safe, and food safety is often defined using terms similar to those in hygiene or public health. Therefore, a clear definition of food safety must be established in food regulatory science. This is particularly important at this time to facilitate the rapid commercialization of innovative products derived from novel foods with no prior food experience. Furthermore, unlike pharmaceuticals, the concept of efficacy does not apply to food. Nevertheless, Article 3 (Definitions), Paragraph 2 of the Functional Foods Act defines “functionality” as controlling nutrients for the structure or functions of the human body or providing beneficial effects for health purposes, such as physiological effects. Despite its use in the context of functional foods, it poses a challenge when defining food regulatory science. Nevertheless, as consumer demand and interest in preventing diseases and improving health through food consumption have rapidly increased both domestically and internationally, interest in and the consumption of functional foods has grown. This trend has led to the need for a clear definition of food efficacy or functionality. However, the task of establishing specific criteria and application areas for broadly defined technologies, standards, and approaches to food safety management remains.

An examination of cases from abroad revealed that food regulatory science is defined at the level of regulatory agencies or associations (Table 1). In examining cases from the US, Europe, and Australia, where regulatory agencies define food regulatory science, the US FDA defines it as the science of developing new tools, standards, and approaches to evaluate the safety, efficacy, quality, and performance of FDA-regulated products (FDA, 2022a). The scope of applications is comprehensive, encompassing all products regulated by the FDA, including food and medical products. In Europe, the European Food Safety Authority (EFSA), a scientific advisory body responsible for food-related risk assessment, characterizes regulatory science as transdisciplinary scientific information that supports science-based policy. Furthermore, The EFSA conveys consistent and transparent messages in risk communication strategies, empowering consumers to make informed decisions (EFSA, 2021). In Australia and New Zealand, Food Standards Australia New Zealand is responsible for developing and managing food-related standards and regulations, defining regulatory science as applying scientific knowledge to integrate various scientific fields, and quantifying risks to support policies and regulations. The integrated model of risk assessment, risk management, and risk communication, as used in Codex (FSANZ, 2019), is a key example of this approach. At the association level, the Global Food Regulatory Science Society (GFoRSS) offers further insight. It defines food regulatory science as the science that forms the basis of regulatory decisions through a multidisciplinary approach, encompassing a wide range of areas from food risk analysis to the economic impact assessment of regulatory actions (GFoRSS, 2024).

Table 1.

Examples of various definitions of food regulatory science

Institution	Definition
MFDS	Regulatory science for foods, drugs, etc. means science related to technologies, standards, and approaches in all aspects of safety management, ranging from the evaluation in terms of safety, efficacy, quality, and performance, etc. of foods, drugs, etc. to authorization, permission, and use
FDA	Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products
EFSA	Regulatory science refers to the transdisciplinary scientific information, including risk/safety assessments, methods, tools, models, and scientific advice, to support sound and transparent science-based policies
FSANZ	Regulatory science is a broad discipline, grounded in a fundamental knowledge of science and regulation. It consists of the application of science to support policy, notably regulatory objectives. It requires the integration of a large variety of scientific fields, the development of new methods, and the ability to synthesize information from many sources to quantify risk and support regulatory and other policy objectives
GFoRSS	The sciences underpinning food regulatory decisions, as a multi-disciplinary field of food science, including, but not limited to, the application of food risk analysis and associated disciplines, the development of food laws, and the assessment of economic impacts of food regulatory measures

MFDS Ministry of Food and Drug Safety, FDA Food and Drug Administration, EFSA European Food Safety Authority, FSANZ Food Standards Australia New Zealand, GoFRSS Global Food Regulatory Science Society

Although the clarity of its definition has been debated, as seen in various cases, food regulatory science is both an academic and practical concept that encompasses the entire spectrum of safety management activities from evaluating safety, efficacy, quality, and performance to approving, licensing, and using food products. Food regulatory science can be a highly effective methodological tool for establishing and implementing evidence-based food safety policies. By addressing the needs of stakeholders, including food policymakers, the food industry, consumers, and academia, the scope of the applications and effectiveness of food regulatory science can be maximized in the future.

The necessity of regulatory science in food safety and the commercialization of Food-Tech products

The current food safety management system establishes the fundamental principles of food safety regulations in the Framework Act on Food Safety. These principles are further defined and elaborated upon by general laws such as the Food Sanitation Act, which provides detailed guidance on the specific execution and management of food safety (Ahn, 2022; Joint Ministries, 2021). More precise and targeted methods for food safety management are urgently needed to respond to the rapid evolution of food safety policies due to the changing environment, including climate change, technological and digital innovations, population aging and its related increase in disease burden, and shifts in consumer behavior. For instance, the evaluation of the safety of novel foods with no prior consumption history, adjustments and decision-making regarding food safety policy activities in response to changes in consumer and industry behavior, and the effective resolution, prediction, detection, and enhancement of the response capabilities for food safety incidents like foodborne illnesses, which continue to rise despite technological advances, necessitate the development of a methodological tool to rationally translate food safety management principles into concrete food safety policies. In addition, Food-Tech, which refers to the scientific field that enhances and changes food production, processing, distribution, and consumption in innovative ways through the convergence of food and technology, contributes to improving work efficiency at the food processing stage, optimizing production processes, and producing a variety of foods through the development of innovative ingredients (Jang, 2020; Yong et al., 2021). It can also be used to develop personalized food and precision nutrition, which will benefit consumers and the food industry and is expected to lead to innovation (Park et al., 2019). Incorporating advanced science and technology into legislation and institutional frameworks is a time-consuming process, during which the public may experience delays in benefiting from these advancements. Furthermore, as science and technology continue to evolve, responsive tools to facilitate incorporating the latest scientific developments and their impact on the regulatory framework are needed. This is why countries like the US, the EU, and Australia/New Zealand have introduced the concept of regulatory science into food and drug safety management.

The emergence of regulatory science in response to changes in food safety, along with the enactment of the Regulatory Science Innovation Act based on this concept, has laid the foundation for implementing evidence-based regulations that can swiftly adapt to shifts in food safety management. Food safety regulatory activities aimed at ensuring the provision of safe food to the public and protecting consumer safety can effectively achieve food safety policy objectives, namely the promotion of healthy and safe dietary habits, by utilizing innovative food regulatory science tools.

Shift in food safety policy governance

Historically, food safety policy governance in the Republic of Korea has been centered around the MFDS, with the Framework Act on Food Safety and the Food Sanitation Act serving as the primary legislative frameworks. However, in the fourth industrial revolution era, with technological advancements in the food sector and a liberalized international market environment, the fundamental responsibility for the rapid commercialization of innovative food products and the assurance of safe food from regulatory agencies should shift to private operators involved in food production, importation, and distribution. Enhancing the autonomy and responsibility of the private sector by leveraging the exceptional infrastructure and self-regulatory capabilities it has already established is crucial.

The transformation of food safety policy governance based on food regulatory science can be summarized in three key points. First, the government should revise and streamline regulations, removing content unrelated to food safety from food safety laws and transferring straightforward enforcement tasks, such as inspections and the implementation of penalties for non-compliant businesses, to private institutions. Second, the primary responsibility for food safety lies with business entities, which must be clarified. They should manage this through a precautionary management system. Supplementing the post-market food safety management system based on the framework of regulatory science and developing support measures for small businesses, which constitute the majority of the food industry in the Republic of Korea, is essential to prevent the weakening of food safety management areas traditionally led by the State. Third, the government should leverage the enhanced administrative capacity gained from transferring enforcement tasks to private institutions to reinforce its role as a guiding authority in food safety management. Systems must be established to ensure that entities maintain autonomy and fulfill their responsibility for safety management based on food regulatory science. Additionally, the government should support the development of private sector capacity so that private entities can independently make policy decisions. Special attention should be given to providing educational opportunities and strengthening support systems for small business entities, thereby minimizing differences in management capabilities based on the size of the food industry. These measures will ensure that the public can confidently and safely consume food.

Food is a matter of great public health importance as it is consumed daily. Thus, any related incidents can have significant social repercussions. Considering these considerations, the significance of state-led regulations in food administration remains a matter of considerable importance (Wang, 2014). Over the past five decades, the paradigm of the State’s responsibility for food safety has guided the country’s approach to food safety. The transition to a paradigm where the private sector assumes responsibility for food safety represents a significant challenge. During this transition period, maintaining public trust by ensuring the participation, communication, and transparency of all relevant stakeholders is paramount. Although there is public trust in and preference for the State’s responsibility for food safety, providing a comprehensive explanation of the rationale and timing for transitioning to a policy emphasizing private sector responsibility is essential. Highlighting the social benefits of this shift, such as promoting food safety awareness and expanding the safety infrastructure by reinforcing private sector autonomy and accountability, is equally important. Moreover, furnishing food businesses and consumers with transparent, real-time, and tailored food safety data by integrating artificial intelligence, big data, and other technologies is crucial. By employing these strategies, public confidence can be strengthened, and a more secure and streamlined food safety management system can be established.

Research and development projects in food regulatory science

When considering research projects within the food sector, those focused on developing core technologies for high-value food products, fundamental research, and industry promotion based on researcher demand are often the first to come to mind. In particular, with the recent activation of the Food-Tech sector, research projects aimed at strengthening the competitiveness of the food industry and driving the growth of Korean Food have focused on supporting the development of industrialization technologies for promising future food sectors and laying the groundwork for creating new industries (MAFRA, 2022). In contrast, the MFDS R&D projects fundamentally differ in that they are aimed at providing scientific evidence to support food safety management policies. The MFDS, responsible for ensuring the safety of the food supply, has conducted R&D projects focused on developing safety technologies. These include establishing standards and specifications for safe food, developing human risk assessment technologies, and creating safety evaluation technologies to assess the safety and quality of food (NIFDS, 2022b).

R&D projects, which have a regulatory focus to ensure public safety, must evolve under the introduction of food regulatory science. This evolution should result in a shift from the traditional MFDS-centered approach to developing standards and specifications to a model in which the private sector assumes a leading role in developing proactive evaluation technologies, standards, and methods. In the past, the MFDS developed specific evaluation technologies to verify food safety, applying these technologies to product safety evaluations. Developing proactive testing and analysis methods that can evaluate innovative products utilizing advanced technologies, such as novel foods, is necessary to meet future challenges. Private entities with advanced technologies should develop various testing methods, standards, and specifications to assess the safety of innovative products. The MFDS should then assume the responsibility of verifying that the safety of these privately developed methods does not differ from existing methods. Research should be conducted to establish food safety policies that reflect the changing food industry and consumer behavior. The use of big data and digital technologies is an example. Applying technologies that collect, store, process, and analyze big data in the food supply chain enables production optimization while maintaining safety and quality standards at every stage (Cangyu et al., 2020). Since the Republic of Korea is establishing various data platforms using digital technologies, big data technology research that standardizes data and links and utilizes this data to provide a policy basis for preventing and responding to food-related incidents is needed.

Under the Regulatory Science Innovation Act, the objective of MFDS R&D projects is to develop novel evaluation technologies, standards, and methodologies to facilitate the expeditious commercialization of food and drug products and furnish scientific evidence for the rational implementation of food and drug safety management policies. R&D projects based on food regulatory science are expected to play a crucial role in ensuring food safety and supporting the market entry of innovative products, thereby strengthening competitiveness in the global market.

Support for the commercialization of innovative products in the food industry

In the food sector, new national R&D projects focused on product development must ensure the stability of project implementation by incorporating regulatory compliance diagnostics and evaluation from the planning stage, consistent with the Regulatory Science Innovation Act. This is because, even if relevant ministries develop products to advance the food industry, these products cannot enter the market if their safety is not assured, thereby undermining the success of national R&D projects. The scope of regulatory coherence examination covers a range of considerations, including whether the product is subject to regulation, its classification, applicable regulatory standards such as classification and labeling, and the need for regulatory science research on methods for evaluating safety, efficacy, and quality. If such collaboration is deemed necessary, regulatory agencies should participate in inter-ministerial national R&D projects to develop new innovative food products and conduct regulatory science research together. Businesses seeking to develop innovative products may receive support for commercialization under the auspices of the Regulatory Science Innovation Act. The content of this commercialization support is analogous to that of regulatory compliance review.

The rapidly expanding food technology market and food regulatory innovation targets, such as alternative meats, FSMPs, and functional foods, illustrate areas where food regulatory science must be actively utilized to promote the food industry. The support provided by the MFDS for commercializing products in the food sector, historically focused on functional foods, is anticipated to be extended to encompass these foods as well (MAFRA, 2019; MAFRA, 2020). In addition, national-level support is needed in various areas of functional foods, such as product commercialization support R&D projects that investigate functional ingredients, the standardization of ingredients, the verification of safety and functionality (e.g., mechanism research), and the creation of standardization guidelines for commercialization. Additionally, existing evaluation technologies should be advanced. The areas examined regarding regulatory coherence and commercialization support in the food sector are expected to expand gradually (MFDS, 2022).

The existing support for product commercialization has been primarily implemented based on existing legislation and regulatory frameworks. Rapid market entry through commercialization support has historically been challenging when a product does not align with the existing MFDS regulatory framework or lacks established standards for safety and functionality due to the introduction of new technologies. However, the support for innovative products based on regulatory science will shift toward rapidly coomercializing cutting-edge technologies in innovative products. The MFDS can proactively develop standards and testing methods through R&D projects conducted under the provisions of the Regulatory Science Innovation Act. If the MFDS cannot develop these standards and methods, the Act permits reviewing and applying those developed in the private sector. However, many challenges remain before such commercialization support can become a reality. While the Regulatory Science Innovation Act outlines the necessity for examining regulatory coherence and commercialization support for innovative products, including foods and drugs utilizing new technologies, the precise scope of these new technologies in the food sector remains uncertain. This lack of clarity will lead to significant resource expenditure while implementing regulatory coherence and commercialization support in the food sector. Therefore, promptly establishing detailed subordinate regulations to clarify the scope of these products is necessary. While revising subordinate regulations related to regulatory coherence and commercialization support is important, strengthening the capabilities and autonomy of MFDS staff to assess whether technologies developed by the private sector are appropriately compared to MFDS or international standards is even more crucial.

Training on specialized human resources in food regulatory science

The introduction of novel materials and next-generation foods has contributed to the growing complexity of the innovative product landscape within the food sector. Food science professionals have traditionally focused on developing and enhancing technologies for product development, production, and distribution. However, because regulatory science applies scientific principles to support policy, particularly regulatory objectives, food regulatory science professionals must integrate various scientific disciplines, develop new methods, synthesize information from diverse sources, quantify risks, and support regulatory and policy goals. This distinguishes them from traditional food science professionals (FSANZ, 2019).

Food regulatory science professionals must be able to respond expeditiously to the latest trends in innovative technologies and changes in related regulations to support the development and commercialization of innovative products such as functional foods utilizing new materials, alternative meats like cell-cultured foods, and FSMPs. Moreover, they must understand and be able to harmonize the legal and regulatory requirements of different countries. Thus, they must possess the capacity to conduct appropriate safety assessments and make regulatory decisions that ensure the expedient commercialization of developed products in the market. A solid understanding of global regulations related to food safety management, food standards, and specifications is essential. Additionally, if these professionals possess the communication skills necessary to effectively exchange evidence supporting regulatory policy decisions and the information required for risk management with various stakeholders, they will play a crucial role in improving the quality of food safety management and contributing to developing innovative products.

The advancement of food regulatory science is contingent upon the training of external professionals and enhancing the expertise of internal staff at the MFDS who are responsible for food safety regulation in the field of regulatory science. While developing technologies and platforms is crucial for advancing food regulatory science and implementing food safety policies, ensuring that regulatory agency personnel can make informed policy decisions based on these tools is equally important. For this reason, as part of its food safety regulatory science research, the US FDA engages in R&D activities to advance technology-based traceability systems and whole-genome sequencing (WGS) technology. The latter can potentially identify small outbreak clusters early in foodborne illnesses and prevent further spread. Moreover, the FDA offers its personnel training in the utilization, analysis, and comprehension of WGS technology and facilitates a range of internal educational programs designed to bolster regulatory review, policy, and regulatory decision-making through seminars that disseminate the findings of internal research programs (FDA, 2020; FDA, 2022b). Similarly, it is expected that the Republic of Korea will provide the necessary legal and institutional support to create an environment conducive to the continuous growth and development of new and existing personnel with expertise in food regulatory science (Fig. 3).

Fig. 3.

System of the talent cultivation project for regulatory science

Strategic directions for food safety management in the Republic of Korea

In the future, food safety management in the Republic of Korea will be organized around three principal systems. The Framework Act on Food Safety provides fundamental principles and direction for food safety management. The Food Sanitation Act and other related food safety laws establish specific requirements for maintaining food hygiene, promoting public health, and preserving order through implementing regulations. The Regulatory Science Innovation Act will establish a regulatory science foundation by developing methodologies for setting and enhancing standards and specifications for food safety management, as well as conducting R&D projects and training specialized personnel to ensure rational and effective operation (Fig. 4). Based on this foundation, a precautionary food safety policy strategy must be formulated to protect public health and safety. Particularly in the fields of functional foods, new material foods, alternative meats, and FSMPs, developing scientifically sound and rational standards, specifications, and methods for evaluating innovative products is essential. In cases where there are no existing regulatory standards for foods involving new technologies, developing standards, specifications, and evaluation techniques to promote the commercialization of innovative products actively should be proactively supported, with concentrated investment in related research projects. Furthermore, the government should proactively respond to international food trade, actively participate in global food regulatory policies, and provide regulatory services that help domestic companies navigate regulatory differences between countries and ensure international-level quality. This will facilitate the entry of domestic companies into global markets and enhance the Republic of Korea’s standing by leading international regulatory standards, thereby ensuring that our standards become global benchmarks. In addition to these efforts, the nation must prioritize strengthening public–private regulatory science capabilities and nurturing related talent, particularly in the vital and urgent areas of functional foods, novel foods, alternative meats, and FSMPs.

Fig. 4.

The institutional basis for food safety policy

The direction of the Republic of Korea’s food safety policy is centered on a regulatory innovation approach, which is evidence-based, science-driven, precautionary, people-centered, and future-oriented. This approach is designed to lead international standards. The key strategies include developing a digital-based smart food safety system, implementing proactive risk assessments of hazardous substances with a focus on human health, establishing a comprehensive food safety system that incorporates social values, improving tailored regulatory frameworks for emerging technology sectors, and strengthening the food industry through regulatory innovation to overcome global technical barriers and facilitate entry into international markets. The MFDS has established a policy direction for 2024 guided by the vision of “A world where the safety of food and drugs is a daily assurance.” This vision is supported by three core strategies: (1) science that adds trust to safety, (2) on-site actions that turn expectations into reality, and (3) partnerships that enhance safety synergies. In addition, nine practical initiatives are included. In the food sector, the focus is on innovating a digital-based smart food safety system, establishing a food safety environment that reflects social values, and improving tailored regulatory frameworks and regulatory innovation for promising new technology sectors. This includes establishing specific implementation procedures for the Regulatory Science Innovation Act, which will be fully implemented this year, and promoting the Regulatory Innovation 3.0 initiative to identify and address emerging issues.

Although the Regulatory Science Innovation Act established a legal framework to expedite the commercialization of food products, the specific methodologies and standards to guide this process remain undetermined. This highlights the need for further legislation despite the Act’s innovative content. Moreover, while the Act provides procedural regulations and support for food development through regulatory science methodologies for the private sector, it lacks clarity regarding the imposition of sanctions in the event of an incident, despite the principle that all rights are accompanied by obligations. Therefore, food regulatory science must fulfill its role in establishing laws and institutions, providing guidelines, training specialized personnel in food regulation, developing and evaluating food safety management systems utilizing fourth-industrial revolution technologies, and developing and disseminating food safety management technologies to enhance private sector capabilities. Furthermore, these areas must be interconnected and advanced without fragmentation. This is exactly why regulatory science must be introduced into food safety.

Declarations

Conflict of interest

The authors declared that they have no conflict of interest.