2011-03-022024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/652605摘要:目前健康食品查驗登記為雙軌制,第一軌(個案審查)健康食品其安全性評估是由健康食品審議委員會針對申請廠商所提供之安全性毒理試驗報告進行審查,而第二軌(規格標準)健康食品為針對科學上已相當確知具有保健功效的成分開放規格標準審查,無須進行安全性及功效性試驗,產品只要符合公告的規格標準,並提供申請產品符合公告之規格標準等檢驗報告。第二軌制度是在96年12月31日開始施行,目前已有魚油健康食品和紅麴健康食品兩種規格標準。   本計畫旨在蒐集整理燕麥健康食品之功效成分與規格標準相關研究文獻報告資料,包含國外 PubMed, Agricola, Web of Science 等文獻檢索資料庫,以及美、日、歐盟、大陸、香港、新加坡等國外健康食品規範,和網際網路拓樸資料檢索,基於客觀之科學證據,針對可行性、燕麥原料、功效成分含量、達到功效需要劑量、功效訴求、其他條件等方面,深入進行文獻整理、比較探討、訂定結果建議以及燕麥成分規格標準,並依據結果擬定其中、英文草案,據以提供中央主管機關訂定第二軌(規格標準審查)燕麥健康食品的成分規格標準,以擴大健康食品項目種類,嘉惠產業與國人健康。 <br> Abstract: The current registration and management systems of health food in Taiwan can be achieved by two approaches. In the first approach, the product should be examined as an independent case on the basis of the studies of its functional activity and toxicity. Reviewers would scrutinize the results for the consideration of approval. On the other hand, the second approach does not require the experimental studies of a product’s functional activity and toxicity. For subject whose major bioactive component has been known and already validated by scientific researches, specification standard for this bioactive component can be established. Products with their bioactive component committing the specification standard can be approved through the second approach. Since December 31 2007, the currently available specification standards are for fish oil and Monascus food products. The aim of this project is to collect, analyze and compile the worldwide research data and information (e.g. PubMed, Agricola, Web of Science) regarding the bioactive component, available standard and standardization methods of oat-based health food. Information available in USA, Japan, European Union, Mainland China, Hong Kong, and Singapore will be collected and analyzed. The feasibility of setting a standard for oat-based health food will then be accessed base on the evaluation and comparison of scientific literature, data, bioactive compound, dosage, and other criteria in relation to oat and its products. The final goal is to establish a specification standard for oat-based health food, and to increase the availability of standards of the second registration approach.健康食品燕麥膳食纖維Health foodOatSpecification StandardDietary fiber100年度「評估研訂健康食品規格標準」委託辦理計畫-分項計畫一:評估研訂「燕麥」之健康食品規格標準