植物萃取物作為食品添加物之風險評估與標準增訂──以迷迭香萃取物為例   全文下載

Risk Assessment and Standard Revision of Plant Extracts as Food Additives Extracts of Rosemary as an Instance

植物萃取物可能因其具有特定指標性成分，並經萃取分離純化該指標性成分，且符合食品安全衛生管理法第3條之「食品添加物」定義，而可作為食品添加物使用。我國「食品添加物使用範圍及限量暨規格標準」屬正面表列管理，其參考動物安全性試驗資料、國際間相關法規標準與准用情形、各種食品添加物加工用途及其使用之必要性等文獻資料，並依據國人膳食習慣進行風險評估據以訂定。本研究以迷迭香萃取物為例，說明如何進行國人膳食習慣風險評估及訂定食品添加物標準。本研究參考歐盟規範之迷迭香萃取物最大允許濃度，代入所建立之臺灣食品添加物攝取模式應用系統（Taiwan food additives intake model, TFAIM），評估國人在保守估計下攝取迷迭香萃取物最大允許濃度之暴露劑量，再根據迷迭香萃取物之每日可接受劑量（Acceptable daily intake, ADI）計算風險，其風險結果顯示，暴露劑量僅占ADI之14.5-78.0%，為可接受風險。衛生福利部已參考本研究成果，於110年1月25日發布修正「食品添加物使用範圍及限量暨規格標準」，於第（三）類「抗氧化劑」增列「迷迭香萃取物」，並訂定其使用食品範圍、限量標準、使用限制及規格標準。

Plant extracts could be used as food additives because they carry specific index components, which have been extracted and purified, and comply with the definition of ''food additives'' as defined in Article 3 of ''Act Governing Food Safety and Sanitation''. ''Standards for specification, scope, application and limitation of food additives'' in Taiwan is a positive list management, which refers to documents concerning animal safety test data, relevant international regulations, standards and permitted conditions, processing uses of various food additives and the necessity of their use, etc. A risk assessment was formulated based on the dietary habits of Taiwanese. In this study, the antioxidant extracts of rosemary were taken as an example to illustrate how the food additive standards were amended and the risk of Taiwanese dietary habits was assessed. The maximum allowable concentration of extracts of rosemary in EU regulations was referred, and substituted into the Taiwan food additives intake model (TFAIM) to evaluate the consumption under conservative estimates by Taiwanese. The exposure dose of the maximum allowable concentration is calculated based on the acceptable daily intake (ADI) of extract of rosemary. The results showed that the exposure dose only accounts for 14.5 - 78.0 % of the ADI, which is an acceptable risk. On January 25, 2021, the Ministry of Health and Welfare has issued an amendment to the ''Standards for specification, scope, application and limitation of food additives'', augmented extracts of rosemary into the category (3) ''Antioxidant'' , and set standards for the specification, scope, application and limitation of rosemary extracts.