| 摘要: | 近年來國內外所發生之三聚氰胺人畜中毒事件，引起全世界對三聚氰胺的食品安全問題非常關注。我政府除了調查食品中三聚氰胺的污染之外，也關注到與食品接觸之美耐皿容器遷移三聚氰胺於食品中之問題。查我國現有之「食品器具容器包裝衛生標準」，針對美耐皿容器中三聚氰胺之遷移，尚無管制規定。爰委託本計畫，評估是否研訂我國美耐皿食品器具容器中三聚氰胺遷移之管制標準。本計畫於五個月期間，全部根據既有文獻資料完成了以下諸成果，用為協助衛生署檢討有關此項標準之訂定。 一、 蒐集國內外相關法規管理資訊及文獻報告實驗數據，表列三聚氰胺自美耐皿容器中遷移入食品模擬物之背景值資料。 二、 詳細說明歐盟及中國頒定之美耐皿容器中三聚氰胺遷移管制標準的規範，以供制定標準時之參考。國際間目前僅有歐盟及中國已頒定此類標準。此標準以兩種不同的單位呈現，mg/L和mg/dm2，兩者間須以容器之比表面積(dm2/L) 轉換。溶出試驗的規範為每1 cm2接觸面積使用2 mL溶媒。 三、 進行健康風險評估，計算美耐皿容器遷移三聚氰胺之安全上限，做為增訂三聚氰胺遷移之管制標準的參考值。 四、 彙整國際間有關美耐皿容器遷移三聚氰胺之遷移及試驗方法，以供政府參考採用。 五、 草擬美耐皿容器之商品標示要求及消費者正確使用方法，以供政府參考實施。 六、 列舉現有文獻資料欠缺之處，整理做為跟進研究、補足資訊之目標。 研究發現三聚氰胺自美耐皿容器遷移之速度受下列因素密切影響：美耐皿容器質料品質、美耐皿容器比表面積、遷移溶媒、溫度、及作用時間。故不同容器遷移濃度之比較以及遷移標準之制定，都必須明訂進行試驗時的溶媒、溫度、及作用時間條件。本計畫以1-6歲學齡前孩童為最高風險群，評估其暴露於自美耐皿容器遷移三聚氰胺之健康風險，從而計算美耐皿容器遷移三聚氰胺之安全上限。此安全上限因三聚氰胺之每人每日耐受量(TDI)之選值而定，以美國 FDA所提供之TDI = 0.06 mg/kg/day 為範例，計算所得之參考遷移安全上限值為0.69 mg/L或0.14 mg/dm2。而中國的相當標準為1.2 mg/L 或0.2 mg/dm2；歐盟的相當標準為30 mg/L 或5 mg/dm2。本研究所得之計算值大小，可由選用之TDI、美耐皿容器溶出三聚氰胺佔總三聚氰胺暴露之比例(%)、美耐皿容器盛裝率(%)和百分位數(Percentile)予以調整。 關鍵詞：三聚氰胺、美耐皿容器、每人每日耐受量、健康風險評估、特定遷移上限。
Abstract in English Melamine in foods has become a headline food safety issue due to mortalities in domestic animals and infants caused by exposure to this contaminant as an adulterant. In addition to surveillance on contamination of foods, our government is also concerned about migration of melamine from melamine containers that come in contact with foods. At present, there is no regulatory standard for controlling migration of melamine from plastic containers. This project was therefore commissioned to review the existing information and assess the health risk associate with migration of melamine from food containers. The results are aimed at assisting the Department of Health (DOH) in its effort to set up a regulatory standard for melamine migrated from food containers. In the last five months, we have accomplished the following tasks for this purpose. 1. Collection of information regarding regulation and experiments related to melamine migration from food containers. This baseline information was tabulated for the agency’s use. 2. Description of the specifics of the regulatory standards for melamine migrated from food containers as promulgated by the European Union and by China, the only two governments today having these standards. There are two kinds of units used in the standards, mg/L and mg/dm2, their inter-conversion is through the use of specific surface area of the containers in question. The specific migration limit (SML) of melamine must be determined with the equivalence of 2 mL medium per 1 cm2 of contact area. 3. Health risk assessment on the melamine from food containers to determine its health-based reference concentration (RSML) for use in the establishment of a specific migration limit (SML) of this country by DOH. 4. Compilation of methods of migration and analysis for melamine from food containers as a database for DOH’s future uses. 5. Preparation of a draft of proper labeling and user instructions to be used with melamine food containers for the future enforcement of similar labeling and instructions by DOH. 6. Identification of information gaps as a suggestion of areas of further studies. It was revealed in our studies that migration of melamine from food containers is a strong function of the quality of material of the containers, specific surface areas of the containers, migration media, temperature, and reaction time. Any comparison of migration results or enforcement of regulatory standards must be conducted under identical conditions in terms of medium, temperature, and time. Our health risk assessment was performed on the young pre-school children of 1-6 years old as the most sensitive sub-population. Selected values of melamine TDI were used to assess health risk and then to calculate RSML. For demonstration, using TDI given by the USFDA, i.e. 0.06 mg/kg/day, a RSML of 0.69 mg/L or 0.14 mg/dm2 was obtained. In comparison, the equivalent standard of China is 1.2 mg/L or 0.2 mg/dm2, while that of EU is 30 mg/L or 5 mg/dm2.Our calculated RSML value will change according to the values of TDI, portion (%) of malamine exposure from melamine containers, portion (%) of daily diet contained in melamine containers, and percentile chosen for calculation. Keywords: melamine, melamine containers, tolerable daily intake (TDI), health risk assessment, specific migration limit |
