特定疾病配方食品之我國查驗登記現況及國際管理制度分析   全文下載

Analysis on the Current Status of Formula for Certa Disease in Taiwan and International Regulations

我國特殊營養食品之特定疾病配方食品係指因病人生理功能失調，致無法進食、消化、吸收或代謝一般食品或食品中特定營養成分，或醫學上認定有其他特殊營養需求，且不易透過日常飲食調整所獲取，而依據其適用對象特別加工或配製之食品。截至113年3月1日，經衛生福利部查驗登記核准之特定疾病配方食品共350件，國產產品較進口產品多，分別為260件及90件。在核准之特定疾病配方食品中，營養調整完整配方食品之適用對象以糖尿病患者為多數，營養調整補充配方食品則是針對癌症/腫瘤患者設計之產品為大宗。目前世界各國對特定疾病配方食品類似產品具有不同名稱、定義、標示要求及管理規範，本文除介紹我國現行特定疾病配方食品管理規範外，透過對Codex、美國、歐盟、澳紐、日本及中國等國家之管理規範研究，將有助於持續精進我國特定疾病配方食品之管理並期與國際接軌。

Formula for Certain Disease is intended for the dietary management of patients who have impaired capacity to ingest, digest, absorb or metabolize ordinary foods or certain nutrients, or who, for any medically-proven reason, have special dietary requirements that cannot be easily met with rebalancing daily diet. The food products in this category are processed or formulated according to the needs of the target users. As of March 1, 2024, a total of 350 items of Formula for Certain Disease have been permitted by the Ministry of Health and Welfare, including 260 domestic products and 90 imported products. Among them, the majority are intended for diabetes patients in terms of nutritionally complete foods with customized formula, while nutrition adjusted supplementary formula foods are primarily designed for cancer/tumor patients. This article not only introduce the management regulations for disease-specific formula foods in Taiwan, but also collects information on the definitions, labeling requirements, and regulatory standards for formula for certain disease from Codex, the United States, the European Union, Australia, New Zealand, Japan, and China. This aims to facilitate continuous improvement of Taiwan management regulations for disease-specific formula foods and alignment with international standards.