Starting in 2003 when the Food Safety Basic Act was established in Japan, risk analysis for food safety was based on scientific data and was carried out at the Cabinet Office of the Food Safety Commission. The Food Safety Commission is independent of other ministries of risk management, such as the Ministry of Health, Labor and Welfare, the Ministry of Agriculture, Forestry and Fisheries, the Ministry of the Environment and the Consumer Affairs Agency. Risk analysis of food safety is comprised of 3 steps, i.e., 1) risk assessment, 2) risk management and 3) risk communication.
Six specialists for food safety risk analysis, (Drs. Y. Kawamura and A. Tada (National Institute of Health Sciences, NIHS), M. Honma (NIHS), K. Seguro (Japan Food Additives Association), K. Ogawa (NIHS), C. Uneyama (NIHS)), contribute in this special issue. They explain these food safety matters including international risk assessment and regulation for the global standard at the Codex Alimentarius Commission (CAC), the Joint FAO/WHO Expert Committee Food Additives (JECFA) , and the International Agency for Research on Cancer (IARC), as well as the Food Safety Commission in Japan.
I hope that this special issue contributes to further understanding the risk analysis of food.

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The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international expert scientific committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The committee evaluates the safety of food additives and residues of veterinary drugs in animal products, and the risk of food contaminants. Moreover, it establishes specifications and analytical methods for food additives. JECFA is not a component of the Codex Alimentarius Commission (CAC) and invited JECFA specialists are independent scientists who serve in their individual capacities. JECFA has evaluated more than 2,500 food additives including flavouring agents and has established their specifications. The outline of the specifications for food additives and the process of their establishment are introduced. All information for JECFA is placed on the home pages of FAO and/or WHO. It is not difficult to propose the establishment of new specifications or the revision of specifications. JECFA is freely available.

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Because a genotoxicity test is usually a qualitative method to identify the genotoxic hazard of chemical substances, the result is considered “positive” or “negative.” On the other hand, toxic chemical health risk assessments generally use a dose-response model, which includes a threshold below which no adverse health effects are detected. This allows us to establish an Acceptable Daily Intake (ADI). However, this becomes challenging when a chemical has been found to be carcinogenic and is then detected to have genotoxicity. Unlike other toxicities, genotoxicity is considered to have no threshold. Therefore, no ADI can be set because the theory states that the health risk does not become zero unless intake becomes zero. This is the specificity of risk assessments for genotoxic carcinogens. There is another method of risk assessment/management that is based on the following concept : “even if a substance has genotoxicity, it can be considered virtually safe as long as the exposure dose is sufficiently low to result in extremely low carcinogenicity with an acceptable level of risk”. This dose is called the virtually safe dose (VSD), and it adopts an acceptable risk level of 10^–5– 10^–6. Based on carcinogen databases, it is possible to conclude that the majority of chemicals would cause little virtual health hazard even if they are mutagenic carcinogens as long as their daily intake is below 1.5 μg/person. Such a comprehensive threshold is called the “threshold of toxicological concern (TTC)”. In this paper, I discuss the use of VSD and TTC for risk assessment and management of chemicals contained in foods (e .g ., food additives, eluents from plastic containers, flavoring substances, residual pesticides). More than 40 years ago in Japan, 2-(2-furyl)-3-(5- nitro-2-furyl)-acrylamide (AF-2) was widely used as a food preservative for tofu, ham, sausage, fish paste etc. Later, discovery of the potent genotoxicity (mutagenicity) of AF-2 initiated extraordinarily heated discussions, and finally the use of AF-2 was banned in 1974. I re-assess the carcinogenic risk of AF-2 based on the current risk assessment method.

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The Codex Alimentarius Commission (CAC) was established as an international intergovernmental organization by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO) in 1963. The CAC is responsible for establishment of global standards for foods and food additives. The principle objectives of CAC are to protect the health of consumers, ensure fair food trade practices, and coordinate all food standard operations carried out by both governmental and non-governmental organizations. In 1995, the World Trade Organization (WTO), replacing General Agreement on Tariffs and Trade (GATT), was established and one of its agreements, namely, “WTO Agreement on Application of Sanitary and Phytosanitary Measures (SPS agreement)” demands that all members base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, unless there is scientific justification to do otherwise. In this regard, Codex food standards should be followed as international standards.
International standards for food additives are prepared by Codex Committee on Food Additives (CCFA) with scientific advisory input from the Joint FAO / WHO Expert Committee on Food Additives (JECFA). CCFA is one of CAC's General Committees and is responsible for policy-making and proposal-making to CAC on food additives. JECFA is an international scientific expert committee administered jointly by FAO and WHO and is responsible for safety assessment of food additives, pollutants, veterinary medicines, etc. CAC applies risk analysis principles in its decision-making and thus, together with JECFA as a risk assessor, CCFA as a risk manager makes and updates international standards.

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In 2015, the International Agency for Research on Cancer (IARC) celebrated its 50-year anniversary. In the memorial book of “International Agency for Research on Cancer: The first 50 years”, the history and policies of this unique organization, that is both independent and included within the WHO, are described. This agency engaged in a “fight for life” in several series of publications including WHO/IARC Classification of Tumors, IARC Scientific Publications and IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Among these, the IARC Monographs on the Evaluation of Carcinogenic Risks to Humans has become an international standard for evaluation of cancer hazard identification. This activity was started in 1972 under the leadership of Dr. Lorenzo Tomatis. Since then, 113 monographs have been published as of October 2017. In the monographs, the description of a hazard is followed by a measure of uniformity and a grading of the evidence of carcinogenicity. Since 1988 the short general Preamble that introduces each Monograph has been expanded to explain procedures and “Group 1, 2A, 2B, 3 and 4” classifications of carcinogenic risk to humans. In 2006, the Preamble was revised, making it clear that the Monograph focuses on the identification of “Cancer Hazard” that is capable of causing cancer under some circumstances, while a cancer “risk” is an estimate of the carcinogenic effects expected from exposure to a cancer hazard. The Monographs identify cancer hazards even when risks are very low at current exposure levels, because new uses or unforeseen exposures could produce risks that are significantly high. At its inception, the scope of the program was limited to chemicals. Since its reshaping in 1987-1988, the scope was widened to cover physical, chemical, and biological agents as well as mixtures of compounds (like tobacco smoke) and circumstances not specifiable more precisely (like some occupations). In this article, the general procedure for the preparation of Monographs and recent trends are presented.

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Following passage of the Food Safety Basic Act in 2003, food safety risk analysis has become a basic component of food safety in Japan. As a component of risk analysis, risk communication plays a major role in protecting consumers from food-borne diseases. However, for almost all parts of the food chain, achieving people's understanding and the practice of effective communications are still insufficient and misinformation about food safety prevails. Here, I present some of my experiences in food safety risk communication from an event jointly sponsored by four Japanese competent authorities in 2016-2017. We all need to recognize the fact that food is not risk-free and know how to keep food safe. Presenting or focusing only on a specific risk is sometimes inadequate, so we have to use “risk scales” such as Margin of Exposure (MOE) or Disability Adjusted Life Years (DALYs). Risk should be perceived in the context of effect on individual life, the value of the food, etc. Armed with commonly described and well-used “risk scales”, we can foster food safety risk communication for improved food safety.

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To explore the features that make a food delicious tasting, food companies often compare specific ingredients in food with the results of sensory evaluations. The process of food recognition starts with the generation of a food signal in the oral cavity with transmission of the signal to the brain. Different features of the food signals are sorted, amplified, and suppressed during signal transduction. Therefore, we need to understand this process in detail. In this study, we attempt to compare the data between input and output of sweet taste signal transduction of 6 sweeteners using molecular physiological and sensory evaluation methods. We used responses of human sweet taste receptor hT1r2/hT1r3 expressing culture cells as the input signal for sweet taste signal transduction, and the sweetness intensity, sweetness preferences, and the salivary secretion in human subjects as the output signals. We compare results using concentration-response graphs regardless of the methods. Our results support the view that salivary secret ion in response to sweet stimuli is an unconditioned reflex, apparently not a subjective response. These findings suggest that the sweet taste intensity of non-nutritive sweeteners can be evaluated by salivary secretion. Thus, using this method, it would be feasible for untrained persons to evaluate taste quality without bias.

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Characteristic ingredients in fermented rice noodles and the microorganisms used in making these noodles were investigated. Microorganisms including Bacillus species, yeast, fungus, and lactobacillus are present in the process in which fermented rice noodles are made. In the traditional processing of fermented rice noodles, protein and free amino acids are flushed out with hot water, decreasing these components in these rice noodles. Improvements in the noodle making process now prevent the loss of protein and amino acids. Fermented rice noodles now contain large amounts of functional components such as γ-aminobutyric acid and branched-chain molecules. In addition, the improved processing procedures for producing noodles results in a low level of allergens that could trigger immune responses in people with rice allergies. Bacillus subtilis has high potential for application in production of hypoallergenic fermented rice noodles with high nutrient availability. Here we provide proposals for production and development of fermented rice noodles using Japanese rice.

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Following the cultivation of barley, millet, rice and other field crops, barley porridge from Korea was introduced to Japan in 1000 BC. In the following years, barley porridge and medley soup (Zosui) mixed with vegetables and millet became the stable food for people, especially for farmers. During these times rice was the special dietary cereal for the upper classes such as peers and priests, was treated as money and became the foundation of the social economy. This system continued until the Edo era (1868 AD). Subsequently the condition of the country changed owing to opening the country to foreign interactions during the Meiji era. As a result, the staple foodstuff for the people changed from barley and millet to rice. Presently, there are no Japanese porridges like the Chinese or Korean porridges previously used for traditional events; rather, Japanese people enjoy porridges as common and convenient foods.

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