Food safety (Tokyo, Japan)最新文献

Aseptically filled Tofu was necessary to be refrigerated under the previous standards for tofu. Food Safety Commission of Japan (FSCJ) was requested by the Ministry of Health, Labour and Welfare (MHLW) to assess a food safety risk to human health on changing the standards to ambient temperature storage. Clostridium botulinum and Bacillus cereus can be significant hazards. Assuming that manufacturing procedures including sterilizing processes follow the MHLW-indicated condition, under a full hygienic control, C. botulinum and B. cereus would not exist in the final products. Therefore, FSCJ concludes that there are no substantial risks of human health irrespective of the change in the storage standard for aseptically filled Tofu.

This is a summary report of FSCJ (Food Safety Commission of Japan) workshop entitled "Future Challenges and Opportunities in Developing Methodologies for Improved Human Risk Assessments, which held in November 2018. Scientific advancements have facilitated the development of new methods for chemical risk assessments with the expansion of toxicological databases. They are promising tools to overcome challenges, such as situations of data insufficiency, estimation of internal exposure and prediction of hazard, and enable us to improve our human health risk assessment in food safety. In this review, current understandings on developments in chemical risk assessments, especially focusing on Threshold of Toxicological Concern (TTC) approach, non-testing and in-silico approaches (e.g. read-across), and physiologically based pharmacokinetics (PBPK) modeling are discussed as possible promising tools. It also discusses future challenges and opportunities regarding social environment buildings in which all stakeholders including scientific experts, risk managers and consumers are able to accept these new risk assessment technologies. International collaboration would increase and enhance the efficiency in forming innovative ideas and in translating them into regulatory practices. It would strengthen technical capacity of experts who contribute to regulatory decisions and also promote acceptance of new methodologies among stakeholders. Cross-sectional collaboration such as making good use of human data of pharmaceutical drugs will facilitate a development of fresh tools for food safety domains. Once a new methodology is recognized in risk assessment agencies as implementable, it needs to be acknowledged and accepted by wider range of different stakeholders. Such stakeholders include scientific experts who conduct risk assessment for the risk assessment agencies, food industries and consumers. Transparency in the risk assessment work performed by regulatory agencies should strengthen their credibility and promote the acceptance of risk assessment including the new methodologies used in it. At the same time, efforts should be continued by regulatory agencies to further communicate with consumers about the concept of risk-based assessment as well as the concept of uncertainty.

Food Safety Commission of Japan (FSCJ) conducted a risk assessment of aluminium ammonium sulfate and aluminium potassium sulfate. This evaluation was requested from Ministry of Health, Labour and Welfare (MHLW) to revise the standards for use of additives. Aluminium ammonium sulfate and aluminium potassium sulfate as additives are assumed reasonably to behave as ions after dissociation, such as aluminium, ammonium, potassium, and sulfate ions, in digestive tract prior to their absorption. FSCJ thus evaluated the safety of aluminium ammonium sulfate and aluminium potassium sulfate used as additives, in considering the substances that are composed of ammonium ion, sulfate ion, potassium ion and aluminium ion. FSCJ concluded that there were no safety concerns of sulfate, ammonium and potassium ions as the use of aluminium ammonium sulfate and aluminium potassium sulfate for food additives. FSCJ specified the lowest no-observed-adverse-effect level (NOAEL) of 30 mg/kg bw/day for aluminium ion based on the reproductive developmental toxicity studies in rats. FSCJ also recognized no carcinogenicity of aluminium additives. FSCJ judged no clear relationship of dietary intake of aluminium with the influences on the bone, mainly due to the insufficient amounts of evidence. FSCJ judged no sufficient evidence to indicate a causal relationship between dietary intake of aluminium and neurological diseases including Alzheimer's disease. FSCJ confirmed that no human data exist to indicate the clear association of the dietary intake with human health effects of aluminium. FSCJ specified this metal (Al) to be 1.0 mg/kg bw/week for the children (1 to 6 years) and 0.57 mg/kg bw/week for the general population. A safety factor of 100 was applied to the NOAEL of 30 mg/kg bw/day obtained in a developmental toxicity study in rats. Converting the value thus obtained to the aluminium intake per a week, FSCJ established a tolerable weekly intake (TWI) of 2.1 mg/kg bw/week (as Al) for aluminium.

Edible insects present a potential solution to increasing global food insecurity. However, there is limited research on the microbial hazards they may pose. These include opportunistic pathogens like Cronobacter spp. (formerly Enterobacter sakazakii). In this study, nine types of ready-to-eat edible insect products purchased in the UK were examined for their microbial load (total aerobic count, total Enterobacteriaceae count), and screened for the presence of Cronobacter sakazakii (C. sakazakii) by selective enrichment and plating on chromogenic agar. While microbial load was generally low, presumptive Cronobacter spp. were detected in five of the edible insect products. Four of the isolates were identified as C. sakazakii, using the Remel RapID ONE biochemical test kit. Genotypic characterisation of the isolates by ITS-PCR, however, demonstrated that the isolates may be other species of Cronobacter instead. Further studies into understanding microbial hazards linked to edible insects for human consumption are required.

According to the annual food poisoning statistics compiled by the Ministry of Health, Labour and Welfare (MHLW) in Japan, Campylobacter replaced Salmonella and Vibrio parahaemolyticus as the leading bacterium responsible for food poisoning in 2003. Although in 2006 the number of cases of Campylobacter food poisoning was 3,439 on the basis of the MHLW statistics, it was estimated to be 1,545,363 on the basis of active surveillance, suggesting that passive surveillance yields an incidence about 450 times lower than that revealed by active surveillance. Epidemiological investigations of Campylobacter food poisoning in Japan have shown that chicken meat and its products are the most important sources of infection, as is the case in other industrialized nations. Over the last two decades, the consumption of fresh raw chicken meat and liver has been increasing in Japan. Although the MHLW recommends that chicken meat should only be eaten after thorough cooking, it is likely to account for much of the increased incidence of human campylobacteriosis. In response to this situation, the Expert Committee on Microorganisms/Viruses, Food Safety Commission of Japan, Cabinet Office, Government of Japan (FSCJ) has revised the previous risk profile of C. jejuni/coli in chicken meat by adding new findings for 2018. Moreover, the MHLW revised the Poultry Slaughtering Business Control and Poultry Meat Inspection Act in 2014 aiming at stepwise introduction of the Hazard Analysis Critical Control Point (HACCP) system into poultry processing plants. Subsequently, the Japanese government amended the Food Sanitation Act in 2018, requiring all food business operators to implement hygiene control based on HACCP principles as a general rule. This paper reviews the current status of Campylobacter food poisoning due to consumption of chicken meat in Japan and extracts the issues underlying each step of the food supply chain in order to examine the implementation of effective measures for risk management.

This study was conducted to give a preliminary estimation of deoxynivalenol (DON) dietary exposure in Japanese university students (n = 30, aged 22-25 years) using a biomarker approach and to examine the correlation between wheat food intake and DON exposure levels. Spot urine samples were collected from 30 students of Azabu University, Tokyo. Urine samples were treated with enzyme digestion (for total DON measurement) and without (for unconjugated DON analysis) before clean-up using an immuno-affinity column and analysis using an LC-MS method, with a ¹³C₁₅- DON internal standard used for accurate quantification. The limit of detection for this method is 0.5 ng/mL urine. The geometric mean (95% CI) of DON concentration was 2.03 (1.64 - 6.87) ng per mL urine. Ninety of the urine samples had detectable levels of urinary DON. The DON dietary intake exposure estimation suggested that one out of the 30 subjects had an intake of DON that exceeded Joint FAO/WHO Expert Committee on Food Additives (JECFA) provisional maximum tolerable daily intake (PMTDI) level. Mean ratio of free DON to total DON was determined to be 19%. Wheat intake assessed using a basic food frequent questionnaire method did not show a significant correlation with the urinary DON level.

Food Safety Commission of Japan (FSCJ) conducted risk assessments of isobutylamine, isopropylamine, sec-butylamine, propylamine, hexylamine, pentylamine and 2-methylbutylamine, which are used as food additives (flavors) (hereinafter, referred to as "the flavoring agents"), based on the Guidelines for the Assessment of Flavoring Substances in Foods on Health (Decision of the Commission Dated May 2016, hereinafter, referred to as the Guidelines on Flavoring Substances), using various documents. Based on the structural and metabolic similarity, FSCJ regarded that the identical procedures are applicable for the risk assessments of all the flavoring agents. FSCJ judged that the seven flavoring agents have no genotoxicities relevant to human health on the basis of the evaluation of analogous compounds. FSCJ metabolized to innocuous products with no food safety concerns. The estimated daily intakes of all the flavoring agents are within the range of 0.02 μg/person per day to 2 μg/person per day, which are below the threshold of concern (i.e., 1,800μg/person per day for Class I), and therefore, FSCJ judged that the flavoring agents are considered to be of no concern for food safety. In summary, FSCJ concluded, as a result of the safety assessment, that there is no safety concern with the flavoring agents, isobutylamine, isopropylamine, sec-butylamine, propylamine, hexylamine, pentylamine, and 2-methylbutylamine, as long as they are used as flavorings in foods.

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of hexavalent chromium, hereinafter referred to as Cr (VI), related to the amendment of the standards for beverages established by the Ministry of Health, Labour and Welfare. Major toxicities induced by Cr (VI) were damages to small intestine and anemia in experimental animals. The finding observed at the lowest LOAEL was diffuse hyperplasia of mucosal epithelium in the duodenum in mice. Regarding to carcinogenicity, Cr (VI)-treatment by drinking water significantly increased incidences of tumors in the small intestine in mice and in the oral mucosa and tongue in rats. Therefore, FSCJ considered that Cr (VI) is carcinogenic. Cr (VI) showed positive results in many genotoxic studies in vitro, and in vivo after parenteral administration, whereas no clear positive results were obtained after the oral administration. These data indicate the genotoxic properties of Cr (VI), though genotoxicity by the oral administration including drinking water remains unclear. The mechanism of small intestinal tumors in mice is considered as follows: Continuous damage to mucosal epithelium in the small intestine by long-term exposure to Cr (VI) induces the hyperplasia in the crypt of small intestine, which would lead to the formation of tumor. In the in vivo gene mutation assays using transgenic rats and mice, no significant increases in mutant frequencies of the transgenes were observed in the carcinogenic target tissues, after exposure to Cr (VI) in drinking water for either 28 (rats) or 90 days (mice)^{1), 2)}. On the basis of these results, FSCJ judged that the carcinogenic mechanism of Cr (VI) intakes through drinking water was hardly attributable to the genotoxicity. FSCJ considered that the quantitative risk assessment of Cr (VI) through drinking water was difficult to conduct based on the results from epidemiological studies of non-occupational and occupational exposures in human population. Consequently, specifying a tolerable daily intake (TDI), based on the results of animal studies with oral exposure to Cr (VI) through drinking water, is rather feasible. FSCJ specified the TDI of Cr (VI) as 1.1 μg/kg bw/day after applying the uncertainty factor of 100 to BMDL₁₀ of 0.11 mg/kg bw/day, which was ascribed on the diffuse epithelial hyperplasia in the duodenum in male mice observed in the two-year oral exposure study. Since chromium in food is regarded to be present as trivalent chromium³⁾, FSCJ estimated daily intake of Cr (VI) from consumption of mineral water and tap water. The estimation gave the mean and high intakes as ca. 0.04 μg/kg bw/day and 0.290 μg/kg bw/day, respectively. Since both of these two values were lower than the TDI, 1.1 μg/kg bw/day, FSCJ concluded the risk of health effects from Cr (VI) at the current exposure through the consumption of mineral water and tap water to be extremely low.

[This corrects the article DOI: 10.14252/foodsafetyfscj.2018003.].