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Ferimzone (Third Edition) (Pesticides).
Pub Date : 2025-03-21 eCollection Date: 2025-03-01 DOI: 10.14252/foodsafetyfscj.D-25-00007

Food Safety Commission of Japan (FSCJ) conducted a risk assessment of ferimzone (CAS No. 89269-64-7), a pyrimidine hydrazone fungicide, based on submitted documents. A request for reevaluation was made under the Agricultural Chemical Regulation Act. Additional information was submitted by the Ministry of Agriculture, Forestry and Fisheries, which included data on residues in crops (paddy rice) and in livestock products (cattle and chickens), fate in livestock (goats and chickens), and also related published scientific literatures. Major adverse effects of ferimzone were observed in the liver (including centrilobular hypertrophy of hepatocytes) and blood (anemia). Adverse effects were observed on neither fertility, teratogenicity, nor genotoxicity. The lowest no-observed-adverse-effect level (NOAEL) obtained from these studies was 1.94 mg/kg bw per day in the two-year combined chronic toxicity/carcinogenicity study in rats. FSCJ specified an acceptable daily intake (ADI) of 0.019 mg/kg bw per day by applying a safety factor of 100 to this NOAEL. The lowest value was a NOAEL of 30 mg/kg bw per day in the general pharmacological study in mice and rats, as well as the one-year chronic toxicity study in dogs. FSCJ specified an acute reference dose (ARfD) of 0.3 mg/kg bw by applying a safety factor of 100 to this NOAEL.

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引用次数: 0
Revised Guidelines for the Risk Assessment of Food Additives in Japan. 日本食品添加剂风险评估修订指南》。
Pub Date : 2025-03-21 eCollection Date: 2025-03-01 DOI: 10.14252/foodsafetyfscj.D-24-00018
Takahiro Inoue, Daisuke Ikeda, Maako Sugiyama, Asami Suenaga, Minoru Kawashima, Emiko Kondo, Takashi Umemura

In September 2021, the Food Safety Commission of Japan (FSCJ) revised its 2010 guidelines for the risk assessment of food additives. The revised guidelines, titled Guidelines for the Risk Assessment of Food Additives, incorporate updated international trends in toxicity testing and reflect the experience gained from prior assessments. The revised guidelines are composed of the following 4 chapters: Chapter 1. General Provisions; Chapter 2. Detailed Exposition; Chapter 3. Approach for the risk assessment of processing aids; and Chapter 4. Approach for the risk assessment of additives in foods used as breast milk substitutes for infants under four months old. A central feature of the revised guidelines is the organization of risk assessment into four distinct steps: hazard identification, hazard characterization (toxicological assessment), exposure assessment, and risk characterization. These steps, based on the Codex Alimentarius principles, ensure a thorough and systematic evaluation of food additives. The guidelines also introduce the Threshold of Toxicological Concern (TTC) approach for processing aids and guideline for assessing the additives used as breast milk substitutes for infants under four months old, considering their specific characteristics. This paper provides an overview of these key updates, and offer a structured approach to enhance transparency and consistency risk assessment practices for food additives in Japan.

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引用次数: 0
Per- and Poly-fluoroalkyl Substances (PFAS) (Chemicals and Contaminants).
Pub Date : 2025-03-21 eCollection Date: 2025-03-01 DOI: 10.14252/foodsafetyfscj.D-25-00009

Food Safety Commission of Japan (FSCJ) conducted a self-tasking risk assessment of per- and poly-fluoroalkyl substances (PFAS) in food. Scientific findings and risk evaluation data regarding PFAS, of international organizations, government agencies in other countries, etc., were reviewed in the current risk assessment. The scientific literature related to three major compounds of PFAS, perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA) and perfluorohexane sulfonate (PFHxS), was surveyed and served for the discussion. Reference doses were derived from two animal experiments* described below. To determine the reference dose, dose estimation models developed by overseas evaluation institutions were adopted for conversion of POD (point of departure) in animal experiments to PODHED (Human Equivalent Dose). Based on the discussions and estimation, the tolerable daily intake (TDI) was appropriately set as 20 ng/kg body weight/day (2×10-5 mg/kg body weight/day) for PFOS and as 20 ng/kg body weight/day (2×10-5 mg/kg body weight/day) for PFOA. Insufficient scientific findings precluded the evaluation to specify a reference dose of PFHxS. The average daily intake in Japan was obtained from the Total Diet Study conducted in a limited number of regions during the fiscal years 2012-2014: PFOS (Lower Bound to Upper Bound (LB-UB)** 0.60-1.1 ng/kg body weight/day, and PFOA (LB-UB) 0.066-0.75 ng/kg body weight/day. These values were lower than the TDIs. Due to the lack of sufficient data on PFAS concentrations and their distribution in various foods, it is necessary to be aware of these intake estimates carrying considerable uncertainty.

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引用次数: 0
Announcement on Use of AI.
Pub Date : 2025-03-21 eCollection Date: 2025-03-01 DOI: 10.14252/foodsafetyfscj.D-25-00010

In recent years, as significant progress has been made in artificial intelligence (AI) technology, various peer-reviewed journals have been extending the policies on use of AI. Considering this situation, Food Safety felt the need to address concerns about the use of the technologies such as Large Language Models (LLMs), chatbots, or image creators in the writing and reviewing of manuscripts. Food Safety , thus, has compiled a tentative and preliminary guideline for responsible use of AI tools based on the ICMJE Recommendations. Authors and reviewers are expected to refer to this guideline during the manuscript preparation and peer-review process. Guide for Authors for Food Safety will be updated in response to the comments from authors and reviewers, as well as updates on the ICMJE Recommendations and policies of other journals. Please feel free to contact Editorial Office of Food Safety if you have any comments or questions about the guideline.

近年来,随着人工智能(AI)技术的长足发展,各种同行评审期刊也在不断扩展人工智能的使用政策。考虑到这种情况,《食品安全》认为有必要解决在撰稿和审稿过程中使用大语言模型(LLM)、聊天机器人或图像创建器等技术的问题。因此,《食品安全》根据 ICMJE 建议汇编了一份关于负责任地使用人工智能工具的暂定初步指南。希望作者和审稿人在稿件准备和同行评审过程中参考本指南。食品安全作者指南》将根据作者和审稿人的意见以及 ICMJE 建议和其他期刊的政策更新。如果您对本指南有任何意见或问题,请随时联系《食品安全》编辑部。
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引用次数: 0
Rapid and Conventional Freezing Conditions of Fish for the Prevention of Human Anisakiasis.
Pub Date : 2025-03-21 eCollection Date: 2025-03-01 DOI: 10.14252/foodsafetyfscj.D-24-00015
Yukihiro Kodo, Rie Murata, Kohji Mori, Jun Suzuki, Kenji Sadamasu

In recent years, rapid freezers have been used to freeze and preserve seafood, with advances in freezing technology. However, limited studies have examined the effect of rapid freezing on the viability of Anisakis larvae in fish muscle. In this study, freezing experiments were conducted on Anisakis larvae alone (bare group) and on larvae embedded in mackerel fish (embedded group) using an air-blast freezer (rapid freezing) as the most popular rapid-freezing method, passing through the zone of maximum ice crystal formation within 30 min, and a natural convection freezer (conventional freezing) set at -20 °C. In the bare group experiments, all larvae died after 8 min of rapid freezing and after more than 2 h of conventional freezing. In the rapid-freezing experiments on the embedded group, only a few larvae were alive when the core temperature of the fish reached -20 °C, whereas all larvae died when the core temperature reached -35 °C. With conventional freezing, only a few larvae were alive for 24 h after freezing at -20 °C. In contrast, all larvae died after freezing at -20 °C for 24 h after the fish core temperature reached -20 °C under both rapid and conventional freezing conditions. In the embedded group, the standard deviation of the time taken for the fish core temperature to reach -20 °C was <15 min for rapid freezing and 171 min for conventional freezing. The results showed that the time taken for the core temperature to reach -20 °C varies by several hours in conventional freezing, depending on the fish size. Thus, the most crucial freezing conditions to avoid anisakiasis are either rapidly freezing the fish to a core temperature of -35 °C or keeping the fish core temperature at -20 °C for at least 24 h.

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引用次数: 0
Acknowledgment of Reviewers. 审稿人致谢。
Pub Date : 2024-12-20 eCollection Date: 2024-12-01 DOI: 10.14252/foodsafetyfscj.D-24-00017
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引用次数: 0
Construction of a CYP2J2-Template System and Its Application for Ligand Metabolism Prediction. cyp2j2模板体系的构建及其在配体代谢预测中的应用
Pub Date : 2024-12-20 eCollection Date: 2024-12-01 DOI: 10.14252/foodsafetyfscj.D-24-00010
Yasushi Yamazoe, Norie Murayama

A Template system for the understanding of human CYP2J2-mediated reactions was constructed from the assembly of the ligands with the introduction of ideas of allowable width, Trigger-residue and the residue-initiated movement of ligands in the active site, which were in common with other Template* systems for human CYP1A1, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C18, CYP2C19, CYP2E1, CYP3A4, CYP3A5, and CYP3A7 (Drug Metab Pharmacokinet 2016, 2017, 2019, 2020, 2021, 2022, 2023, 2024, and in press 2024). CYP2J2 system also includes ideas of bi-molecule binding of ligands on the Template. From their placements on the Template and rules for interaction modes, verifications of good and poor substrates, regio/stereo-selectivity, and inhibitory interaction became available faithfully for these ligands. The refined CYP2J2-Template system will thus offer reliable estimations of this human CYP catalysis toward ligands of diverse structures, together with their deciphering information to lead to judgments.

从配体的组装出发,引入了与其他人类CYP1A1、CYP1A2、CYP2B6、CYP2C8、CYP2C9、CYP2C18、CYP2C19、CYP2E1、CYP3A4、CYP3A5和CYP3A7的模板系统相同的允许宽度、触发残基和残基引发的配体在活性位点的运动等思想,构建了一个用于理解人类cyp2j2介导反应的模板系统(Drug Metab Pharmacokinet 2016、2017、2019、2020、2021、2022、2023、2024、2024年出版)。CYP2J2系统还包括模板上配体双分子结合的思想。根据它们在模板上的位置和相互作用模式的规则,对这些配体进行了良好和不良底物、区域/立体选择性和抑制相互作用的验证。因此,改进的CYP2J2-Template系统将提供可靠的估计,这种人类CYP对不同结构配体的催化作用,以及它们的解码信息,从而导致判断。
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引用次数: 0
On the Present Guideline-Focusing Points on FSCJ's Revised Guideline for the Risk Assessment of the Effects of Food on Health for Foodborne Microorganisms and Others (Viruses, Parasites) and Its Supplemental Technical Guidance. 关于本指南——FSCJ修订的《食品对食源性微生物和其他(病毒、寄生虫)的健康影响风险评估指南》及其补充技术指南的要点
Pub Date : 2024-12-20 eCollection Date: 2024-12-01 DOI: 10.14252/foodsafetyfscj.D-24-00013
Noriko Mizutani, Tamao Mizuno, Masako Waki

Food Safety Commission of Japan (FSCJ) has recently revised the Guideline for the Risk Assessment of the Effects of Food on Health for Foodborne Microorganisms and Others (Viruses, Parasites) and newly issued its supplemental manual as the "Technical Guide for the Risk Assessment of the Effects of Food on Health for Foodborne Microorganisms and Others (Viruses, Parasites)". These documents are based recent evidence and according to the Microbiological Risk Assessment Guidance for Food, Microbiological Risk Assessment Series 36 published by FAO/WHO. This short review describes the main structures and characteristics of these documents.

日本食品安全委员会(FSCJ)最近修订了《食品对食源性微生物和其他(病毒、寄生虫)健康影响风险评估指南》,并新发布了补充手册《食品对食源性微生物和其他(病毒、寄生虫)健康影响风险评估技术指南》。这些文件基于最近的证据,并根据粮农组织/世卫组织出版的《食品微生物风险评估指南》,微生物风险评估系列36。这篇简短的综述描述了这些文档的主要结构和特征。
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引用次数: 0
Cadmium (Third Edition) (Chemicals and Contaminants). 镉(第三版)(化学品和污染物)。
Pub Date : 2024-09-27 eCollection Date: 2024-09-01 DOI: 10.14252/foodsafetyfscj.D-24-00011

Exposure to cadmium tends to be higher in Japan than in other countries due to the wide spreading of ore deposits and many mines throughout Japan. The proximal tubule of the kidney is recognized as the most susceptible site to be affected by cadmium exposure. Food Safety Commission of Japan (FSCJ) considered it appropriate to investigate studies of the effects of cadmium intake on renal proximal tubular function using urinary β2-microglobulin concentration of 1,000 μg/g creatinine as a criterion for the dysfunction. Based on these epidemiological studies, FSCJ established a tolerable weekly intake (TWI) of 7 µg/kg bw per week for cadmium. This value is derived from the results of actual dietary surveys and urinary β2-microglobulin concentrations in Japan, and not from the results of application of blood or urinary cadmium levels to theoretical models. Therefore, no uncertainty factor is required. The estimated dietary intake of cadmium in 2022 was 2.03 µg/kg bw per week, approximately 30% of the TWI of 7 µg/kg bw per week. Therefore, it is unlikely that dietary cadmium intake in the general Japanese population would cause adverse health effects.

在日本,由于矿床分布广泛,矿山遍布全国,因此镉的摄入量往往高于其他国家。肾脏近端小管被认为是最容易受镉影响的部位。日本食品安全委员会(FSCJ)认为,以尿β2-微球蛋白浓度达到每克肌酐 1,000 微克作为功能障碍的标准,调查镉摄入量对肾近曲小管功能的影响是适当的。根据这些流行病学研究,日本食品添加剂和污染物法典委员会把镉的每周可容忍摄入量(TWI)定为每周每公斤体重 7 微克。这个数值是根据日本实际膳食调查和尿液中β2-微球蛋白浓度的结果得出的,而不是将血液或尿液中的镉含量应用于理论模型的结果。因此,不需要不确定系数。2022 年的镉膳食摄入量估计为每周每公斤体重 2.03 微克,约为每周每公斤体重 7 微克的双位数的 30%。因此,一般日本人的镉膳食摄入量不太可能对健康造成不良影响。
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引用次数: 0
Geographical Variation of Antimicrobial Resistance of Salmonella in Japanese Chicken. 日本鸡沙门氏菌抗菌性的地域差异
Pub Date : 2024-08-30 eCollection Date: 2024-09-01 DOI: 10.14252/foodsafetyfscj.D-24-00002
Yoshimasa Sasaki, Tetsuya Ikeda, Yoshika Momose, Kenzo Yonemitsu, Masashi Uema, Tetsuo Asai

Chicken is a potent source of Salmonella infection in humans. Occasionally, patients with severe Salmonella enteritis require antimicrobial therapy. Antimicrobials are used to prevent and treat bacterial infections in broiler and breeder farms. Herein, we investigated the prevalence and antimicrobial resistance of Salmonella in 337 vacuum-packed chicken breast products manufactured in Japan between June and December 2021. Salmonella was isolated from 287 samples (85.2%). Among the products from Eastern Japan, the lowest Salmonella prevalence was observed in those processed in September (65.6%), which was significantly (p < 0.05) lower than that in November or December. Among the products from Western Japan, the lowest Salmonella prevalence was observed in those processed in August (61.9%), which was significantly (p < 0.05) lower than that in June, November, and December. The most frequent serovar was Salmonella Schwarzengrund (223 isolates), followed by S. Infantis (53 isolates), S. Manhattan (9 isolates), and S. Enteritidis (1 isolate). High rates of antimicrobial resistance were observed for streptomycin (64.5%), kanamycin (50.2%), tetracycline (65.2%), nalidixic acid (11.5%), and trimethoprim (35.9%). Resistance rates against these five antimicrobials in S. Schwarzengrund isolates were markedly higher in the isolates from Western Japan than in those from Eastern Japan. All 287 Salmonella isolates were susceptible to ciprofloxacin which belongs to fluoroquinolones and cefotaxime which belongs to third-generation cephalosporins. Salmonella prevalence in chicken products in Japan was found to be extremely high; therefore, chicken meat should be thoroughly heated before consumption. In Japan, fluoroquinolones and third-generation cephalosporins are recommended as the first- and second-choice antimicrobials for patients with severe Salmonella enteritis, respectively. The results of this study show that administering fluoroquinolones or third-generation cephalosporins is an effective option for patients with Salmonella enteritis caused by consuming chicken meat, and efficient strategies for Salmonella management on broiler farms and chicken-processing plants need to be developed.

鸡肉是人类感染沙门氏菌的重要来源。偶尔,严重的沙门氏菌肠炎患者需要接受抗菌治疗。在肉鸡和种鸡养殖场中,抗菌剂被用来预防和治疗细菌感染。在此,我们调查了 2021 年 6 月至 12 月期间日本生产的 337 种真空包装鸡胸肉产品中沙门氏菌的流行率和抗菌药耐药性。从 287 个样品(85.2%)中分离出了沙门氏菌。在东日本的产品中,9 月加工的产品沙门氏菌感染率最低(65.6%),明显低于 11 月或 12 月加工的产品(p < 0.05)。在日本西部的产品中,8 月份加工的产品沙门氏菌感染率最低(61.9%),明显低于 6 月份、11 月份和 12 月份(p < 0.05)。最常见的血清型是 Schwarzengrund 沙门氏菌(223 个分离株),其次是 Infantis 沙门氏菌(53 个分离株)、曼哈顿沙门氏菌(9 个分离株)和肠炎沙门氏菌(1 个分离株)。链霉素(64.5%)、卡那霉素(50.2%)、四环素(65.2%)、萘啶酸(11.5%)和三甲氧苄啶(35.9%)的抗菌率较高。日本西部沙门氏菌分离物对这五种抗菌药的耐药率明显高于日本东部。所有 287 个沙门氏菌分离株都对属于氟喹诺酮类的环丙沙星和属于第三代头孢菌素的头孢噻肟敏感。日本鸡肉产品中的沙门氏菌感染率极高,因此鸡肉在食用前应彻底加热。日本建议将氟喹诺酮类和第三代头孢菌素分别作为严重沙门氏菌肠炎患者的首选和次选抗菌药物。本研究结果表明,对于因食用鸡肉而导致沙门氏菌肠炎的患者,使用氟喹诺酮类或第三代头孢菌素是一种有效的选择,因此需要制定有效的策略来管理肉鸡养殖场和鸡肉加工厂中的沙门氏菌。
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引用次数: 0
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Food safety (Tokyo, Japan)
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