{"title":"关注FSCJ最近制定的指南:食品接触材料的风险评估。","authors":"Masahiro Nakamoto","doi":"10.14252/foodsafetyfscj.D-21-00029","DOIUrl":null,"url":null,"abstract":"<p><p>In Japan, the Positive List (PL) system was introduced (Enforcement: June 1, 2020) in the regulative field of Food Apparatus, Containers, and Packaging (ACP) by the recent amendment of the Food Sanitation Act. Under this situation, continuous requests for the risk assessments from the Ministry of Health, Labour and Welfare (MHLW) to the Food Safety Commission of Japan (FSCJ) will be expected. To enhance fairness and transparency and to clarify the data required for the risk assessment, the FSCJ established its \"Guidelines for the Risk Assessment of Food Apparatus, Containers, and Packaging\" on May 28, 2019. The Guidelines apply to new Food Contact Materials or Substances (FCMs) after enforcement of the PL system (June 1, 2020). The subject material is synthetic resins, because the PL system was first introduced to them in Japan. In general, the substances that are migrated from ACP are not intended to migrate into foods, and their technological effects on foods are not expected. It can be supposed that the migration of these substances is generally very limited. Therefore, as adopted in the USA and the EU, the Guidelines also adopt the tiered approach for the toxicological data requirement that depend on the estimated migration levels (Tier of Dietary Concentration (Tier of DC)) on the subject substance. The greater the exposure to the substance through migration, the more toxicity test results will be needed. The risk assessment steps by the tiered approach in the Guidelines are (1) migration assessment, (2) toxicity assessment, (3) exposure assessment, and (4) risk characterization. These steps are aimed to harmonize with the general 4 steps of risk assessments: hazard identification, hazard characterization, exposure assessment, and risk characterization. In this review, we will introduce the overview of the Guidelines and details of the above 4 steps.</p>","PeriodicalId":73044,"journal":{"name":"Food safety (Tokyo, Japan)","volume":"10 2","pages":"57-69"},"PeriodicalIF":0.0000,"publicationDate":"2022-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9233751/pdf/","citationCount":"0","resultStr":"{\"title\":\"Focusing Points on FSCJ's Guideline Recently Established: Risk Assessment of Food Contact Materials.\",\"authors\":\"Masahiro Nakamoto\",\"doi\":\"10.14252/foodsafetyfscj.D-21-00029\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>In Japan, the Positive List (PL) system was introduced (Enforcement: June 1, 2020) in the regulative field of Food Apparatus, Containers, and Packaging (ACP) by the recent amendment of the Food Sanitation Act. Under this situation, continuous requests for the risk assessments from the Ministry of Health, Labour and Welfare (MHLW) to the Food Safety Commission of Japan (FSCJ) will be expected. To enhance fairness and transparency and to clarify the data required for the risk assessment, the FSCJ established its \\\"Guidelines for the Risk Assessment of Food Apparatus, Containers, and Packaging\\\" on May 28, 2019. The Guidelines apply to new Food Contact Materials or Substances (FCMs) after enforcement of the PL system (June 1, 2020). The subject material is synthetic resins, because the PL system was first introduced to them in Japan. In general, the substances that are migrated from ACP are not intended to migrate into foods, and their technological effects on foods are not expected. It can be supposed that the migration of these substances is generally very limited. Therefore, as adopted in the USA and the EU, the Guidelines also adopt the tiered approach for the toxicological data requirement that depend on the estimated migration levels (Tier of Dietary Concentration (Tier of DC)) on the subject substance. The greater the exposure to the substance through migration, the more toxicity test results will be needed. The risk assessment steps by the tiered approach in the Guidelines are (1) migration assessment, (2) toxicity assessment, (3) exposure assessment, and (4) risk characterization. These steps are aimed to harmonize with the general 4 steps of risk assessments: hazard identification, hazard characterization, exposure assessment, and risk characterization. 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引用次数: 0
摘要
在日本,通过最近修订的《食品卫生法》,在食品器械、容器和包装(ACP)监管领域引入了正面清单(PL)制度(实施日期:2020年6月1日)。在这种情况下,预计卫生、劳动和福利部(MHLW)将不断要求日本食品安全委员会(FSCJ)进行风险评估。为了提高公平性和透明度,并澄清风险评估所需的数据,FSCJ于2019年5月28日制定了《食品器具、容器和包装风险评估指南》。该指南适用于PL系统(2020年6月1日)实施后的新的食品接触材料或物质(fcm)。主题材料是合成树脂,因为PL系统是首先介绍给他们在日本。一般来说,从ACP迁移的物质不打算迁移到食品中,也不期望它们对食品产生技术影响。可以假定,这些物质的迁移通常是非常有限的。因此,正如美国和欧盟所采用的那样,该指南也采用了基于估计迁移水平的毒理学数据要求分层方法(膳食浓度层(Tier of Dietary Concentration, DC))。通过迁移接触到的物质越多,需要的毒性测试结果就越多。指南中采用分层方法的风险评估步骤是:(1)迁移评估,(2)毒性评估,(3)暴露评估,(4)风险表征。这些步骤旨在与风险评估的一般4个步骤相协调:危害识别、危害表征、暴露评估和风险表征。在本检讨中,我们将介绍指引的概览及上述四个步骤的详情。
Focusing Points on FSCJ's Guideline Recently Established: Risk Assessment of Food Contact Materials.
In Japan, the Positive List (PL) system was introduced (Enforcement: June 1, 2020) in the regulative field of Food Apparatus, Containers, and Packaging (ACP) by the recent amendment of the Food Sanitation Act. Under this situation, continuous requests for the risk assessments from the Ministry of Health, Labour and Welfare (MHLW) to the Food Safety Commission of Japan (FSCJ) will be expected. To enhance fairness and transparency and to clarify the data required for the risk assessment, the FSCJ established its "Guidelines for the Risk Assessment of Food Apparatus, Containers, and Packaging" on May 28, 2019. The Guidelines apply to new Food Contact Materials or Substances (FCMs) after enforcement of the PL system (June 1, 2020). The subject material is synthetic resins, because the PL system was first introduced to them in Japan. In general, the substances that are migrated from ACP are not intended to migrate into foods, and their technological effects on foods are not expected. It can be supposed that the migration of these substances is generally very limited. Therefore, as adopted in the USA and the EU, the Guidelines also adopt the tiered approach for the toxicological data requirement that depend on the estimated migration levels (Tier of Dietary Concentration (Tier of DC)) on the subject substance. The greater the exposure to the substance through migration, the more toxicity test results will be needed. The risk assessment steps by the tiered approach in the Guidelines are (1) migration assessment, (2) toxicity assessment, (3) exposure assessment, and (4) risk characterization. These steps are aimed to harmonize with the general 4 steps of risk assessments: hazard identification, hazard characterization, exposure assessment, and risk characterization. In this review, we will introduce the overview of the Guidelines and details of the above 4 steps.