REGULATIONS FOR APPLICATION OF HEALTH FOOD PERMIT Article 21

The items and content of the identification report of ingredients with health care effect in the product in Subparagraph 7 of Paragraph 1 of Article 2 shall include qualitative and quantitative results of the ingredients with health care effect in the product.The items and content of the identification report of ingredients with health care effect in the product pursuant to Article 2 for the health foods in Article 3 shall meet the standards designated by the central competent authority in the Specification Standards for Health Foods.The testing method for the identification of ingredients with health care effect in the product in the preceding two paragraphs shall be the announced or recommended methods by the central competent authority preferentially; otherwise, scientific evidence and comparative reports indicating non-inferiority or superiority to the announced or recommended methods shall be required for using other testing method.The documents and information of the standard operating procedures and validation for the testing methods shall also be provided with the identification report submitted by applicants pursuant to Paragraph 1 and 2.If situation in the latter part of Subparagraph 1 of Paragraph 1 of Article 3 of the Act, the identification report of each ingredient with health care effect in the product shall be issued by applicants.
中文原文 健康食品申請許可辦法第21條
第二條第一項第七款產品保健功效成分鑑定報告,其項目及內容應包括保健功效成分之定性及定量試驗結果。
第三條健康食品,其依第二條應檢附之產品保健功效成分鑑定報告,其項目及內容應符合中央主管機關所定之健康食品規格標準。
前二項鑑定使用之檢驗方法,應優先使用中央主管機關公告或公開建議者;採其他方法者,應檢具無差異或優於公告或公開建議檢驗方法之科學性依據及比對說明文件或參考資料。
廠商提出第一項及第二項鑑定報告時,應一併檢具有關檢驗方法標準作業程序及其查證或確效之文件、資料。
有本法第三條第一項第一款後段情形者,廠商應提出具該保健功效各項原料之鑑定報告。

English translation for reference only; the Chinese text prevails. Not legal advice.