國際間持續對於食品添加物進行標準之增修訂，為能關注國際間最新管理趨勢，需暸解國際食品添加物標準調整之緣由、評估依據、及標準之調整內容，並進行相應之評估，以做為我國食品添加物管理規範精進之依據。根據食品安全衛生管理法規定，訂有「食品添加物使用範圍及限量暨規格標準」，規範食品添加物之品名、規格及其使用範圍、限量標準，該標準係為正面表列，僅表列之食品類別得依限量規定合法添加使用，非表列之品項及未准許之食品範圍，則不得使用。食品安全衛生管理法第18條第2項明訂，食品添加物標準之訂定，必須依據國人膳食習慣為風險評估，食品業者申請修正「食品添加物使用範圍及限量暨規格標準」時，亦需進行前述評估。食品業者若有增列或修正申請食品添加物使用標準之需求，應依申請項目，備齊「食品添加物使用範圍及限量暨規格標準增修訂申請表」資料，如涉及使用範圍及限量之修正，還需提供國人膳食風險評估資料，送予食藥署辦理審查及行政作業程序。本計畫擬審查與評估申請案件資料，經確認完整性後，提出審查資料摘要與審查結果，評估後如有攝食限制，建議攝食量與理由說明，檢討是否須修訂申請作業相關規範，並召開專家會議，提出建議修訂指引，以作為我國食品添加物管理規範精進之參考。 International organizations and national health agencies frequently revise the standards for food additives. This project aims to compile and review the latest international management trends and understand the reasons and basis for the adjustment of food additive standards. The Ministry of Health and Welfare has established the Standards for Specification, Scope, Application and Limitation of Food Additives in accordance with the provisions of the Act Governing Food Safety and Sanitation. The Standards regulate the product names, specifications, scope of use, and limits for food additives. The Standards is a positive list; only the food categories included in this list may legally be used as additives, and non-listed and unapproved products may not be used as food additives. Article 18, Section 2 of the Food Safety and Sanitation Management Law clearly states that the formulation of food additives standards must be based on the dietary risk assessment of Taiwanese. When the food industry applies to amend the "Scope of Use of Food Additives and Limits and Specifications" The aforementioned assessment is required. If there is any need to add to or amend the application standards for food additives, the relevant information must be included in the application form for changing the Application Range and Limits of Food Additives and Specification. The proposed amendments must also include information from a dietary risk assessment for the Taiwanese population, and they must be sent to the Food and Drug Administration to review and process. This project involves reviewing and evaluating these applications and, after confirming their completeness, submitting the review summaries and results. After the assessment, if there is a limitation on or recommended intake of the product in question, and reasons for these recommendations, we will review whether it is necessary to amend the relevant specifications for the application process. Experts will then meet to propose amendments as a reference for the improvement of the management of food additive regulations in Taiwan.
Act Governing Food Safety and Sanitation
Food Safety Risk Assessment