環保專案成果報告查詢系統

專案計畫編號
經費年度	108
計畫經費	5,570 千元
預算科目	綜合企劃-毒物及化學物質科學研究
專案開始日期	2019/07/11
專案結束日期	2019/12/15
專案主持人	賴允傑
主辦單位	化學局
承辦人	崔君至
執行單位	瑞昶科技股份有限公司
專案分類	化學物質管理
中文關鍵字	化學物質風險評估、化學物質風險評估模式、化學物質生態風險評估試驗
英文關鍵字	Risk assessment of chemical substances, Models for chemical substances risk assessment, Ecotoxicological risk assessment of chemical substances
協同主持人	賴弘智；陳慎德
共同主持人
計畫聯絡人	李依庭
計畫聯絡電話	02-77306566#168
計畫聯絡信箱	ytlee@apollotech.com.tw

中文摘要	本年度已蒐集歐盟、美國與日本化學物質管理主管機關所發布之化學物質風險評估作業準則規範資料與相關評估案例清單，並分別針對美國環保署N-甲基吡咯啶酮（N-methylpyrrolidone，NMP）、三氧化二銻（antimony trioxide，ATO）評估案例，以及歐盟化學局萘（naphthalene）評估案例進行探討分析；另針對國內化學物質風險評估制度發展及執行現況，則盤點分析環保署、衛福部、勞動部、農委會及經濟部等單位之法令制度、作業規範、歷年調查評估案例和參數資料調查建置情形等，研析未來資源整合運用可行性，並綜整參酌前述國內外相關資料之研析成果，據以研提我國化學物質風險評估作業流程架構之規劃。在化學物質風險評估技術部份，已蒐集經濟合作暨發展組織（Organization for Economic Co-operation and Development，OECD）開發並由歐盟化學總署（European Chemicals Agency，ECHA）推廣使用之定量構效關係工具箱（quantitative structure-activity relationships Toolbox，QSAR Toolbox）和歐盟化學總署開發之歐盟物質評估系統（European Union System for the Evaluation of Substances，EUSES）模式，以及美國環保署發展之生態構效關係模式（Ecological Structure Activity Relationships，ECOSAR）、評估專案介面套裝軟體（Estimation Programs Interface Suite，EPI Suite）及暴露及宿命評估篩選工具（Exposure and Fate Assessment Screening Tool，E-FAST）模式，並以國內列管毒化物－雙酚A（bisphenol A，BPA）和富馬酸二甲酯（dimethyl fumarate，DMFu）為例進行各項模式之試行運用，據以提出國內參採使用建議；另亦蒐集國內外化學物質生態風險評估試驗方法，選定小球藻、水蚤和鯉魚等水生生物做為試驗物種，以NMP和1-溴丙烷（1-bromopropane，1-BP）為例進行試驗，並運用試驗結果試算化學物質生態風險評估所需之預測無作用濃度（predicted no-effect concentrations，PNEC）參數，做為未來我國執行相關評估作業之參考。化學物質風險評估參數資料庫規劃則首先彙整分類化學物質風險評估所需參數資料項目，並蒐集國內外政府為利於化學物質風險評估作業所建置之資料庫系統，據此提出我國化學物質風險評估參數資料庫之規劃構想。最後綜整前述各項工作成果，及透過兩場次專家諮詢會議蒐集各界建議，提出化學物質風險評估納入我國化學物質管理政策或法規之建議及未來中長期工作發展建議。
中文關鍵字	化學物質風險評估、化學物質風險評估模式、化學物質生態風險評估試驗

中文摘要

本年度已蒐集歐盟、美國與日本化學物質管理主管機關所發布之化學物質風險評估作業準則規範資料與相關評估案例清單，並分別針對美國環保署N-甲基吡咯啶酮（N-methylpyrrolidone，NMP）、三氧化二銻（antimony trioxide，ATO）評估案例，以及歐盟化學局萘（naphthalene）評估案例進行探討分析；另針對國內化學物質風險評估制度發展及執行現況，則盤點分析環保署、衛福部、勞動部、農委會及經濟部等單位之法令制度、作業規範、歷年調查評估案例和參數資料調查建置情形等，研析未來資源整合運用可行性，並綜整參酌前述國內外相關資料之研析成果，據以研提我國化學物質風險評估作業流程架構之規劃。在化學物質風險評估技術部份，已蒐集經濟合作暨發展組織（Organization for Economic Co-operation and Development，OECD）開發並由歐盟化學總署（European Chemicals Agency，ECHA）推廣使用之定量構效關係工具箱（quantitative structure-activity relationships Toolbox，QSAR Toolbox）和歐盟化學總署開發之歐盟物質評估系統（European Union System for the Evaluation of Substances，EUSES）模式，以及美國環保署發展之生態構效關係模式（Ecological Structure Activity Relationships，ECOSAR）、評估專案介面套裝軟體（Estimation Programs Interface Suite，EPI Suite）及暴露及宿命評估篩選工具（Exposure and Fate Assessment Screening Tool，E-FAST）模式，並以國內列管毒化物－雙酚A（bisphenol A，BPA）和富馬酸二甲酯（dimethyl fumarate，DMFu）為例進行各項模式之試行運用，據以提出國內參採使用建議；另亦蒐集國內外化學物質生態風險評估試驗方法，選定小球藻、水蚤和鯉魚等水生生物做為試驗物種，以NMP和1-溴丙烷（1-bromopropane，1-BP）為例進行試驗，並運用試驗結果試算化學物質生態風險評估所需之預測無作用濃度（predicted no-effect concentrations，PNEC）參數，做為未來我國執行相關評估作業之參考。化學物質風險評估參數資料庫規劃則首先彙整分類化學物質風險評估所需參數資料項目，並蒐集國內外政府為利於化學物質風險評估作業所建置之資料庫系統，據此提出我國化學物質風險評估參數資料庫之規劃構想。最後綜整前述各項工作成果，及透過兩場次專家諮詢會議蒐集各界建議，提出化學物質風險評估納入我國化學物質管理政策或法規之建議及未來中長期工作發展建議。

中文關鍵字

化學物質風險評估、化學物質風險評估模式、化學物質生態風險評估試驗

類型	檔名	檔案大小	說明	最新版公開日期
期末報告	我國化學物質風險評估與管理研析計畫期末報告(定稿本).pdf	20MB	期末報告(定稿本)	2020/1/22 上午 12:00:00

摘要	This project has collected the data of chemical substance assessment standard announced by European Union, the United States, and Japan, including the list of relevant assessment cases. After relevant data was collected, this project has analyzed the assessment cases about N-Methylpyrrolidinone（NMP）and Antimony Trioxide（ATO）from US EPA, and the assessment cases about Naphthalene from European Chemicals Agency. To research the development and status of risk assessment for chemical substances in Taiwan, this project has analyzed the regulations, operation procedures, historical investigation and assessment cases, and parameters investigation data from Environmental Protection Administration, Ministry of Health and Welfare, Ministry of Labor, Council of Agriculture, and Ministry of Economic Affairs in Taiwan for the estimation of resource integration and feasibility research in the future. After the research, the results and data were summarized as the reference for planning the chemical substance risk assessment operation procedures. As for the methods for the chemical substance risk assessment, this project has researched the details from quantitative structure-activity relationships Toolbox（QSAR Toolbox）and European Union System for the Evaluation of Substances（EUSES）model developed by European Chemicals Agency, and also the details from Ecological Structure Activity Relationships（ECOSAR）, Estimation Programs Interface Suite （EPI Suite）and Exposure and Fate Assessment Screening Tool（E-FAST） model developed by US EPA. By applying the controlled chemical substances in Taiwan such as Bisphenol A（BPA）and Dimethyl Fumarate（DMFu）as the samples for testing each mode, this project has also proposed suggestions in accordance with the testing results for Taiwan to precede these modes. With NMP and 1-Bromopropane（1-BP）as testing substances, this project has selected some aquatic creatures such as Chlorella vulgaris, Daphnia magna, and Cyprinus carpio for testing the collected ecological risk examination methods from domestic and abroad. A trial calculation for the Predicted no-effect concentration (PNEC) for making a chemical substance ecological risk assessment has been made according to the testing results, which could be as the reference parameters for the relevant assessment works in the future. For the database planning of chemical substance risk assessment parameters, this project has firstly summarized and categorized all necessary items for chemical substance risk assessment. Second, this project has collected the database which government of Taiwan and other countries have built for chemical substance risk assessment. After the above process, this project has proposed an initial model for the database of chemical substance risk assessment in Taiwan. Integrating the works and results mentioned above with professional suggestion from twice profession consultation conference, this project has eventually summarized the suggestions for the policy and regulation establishment in Taiwan about chemical substance risk assessment, and the advice for medium- to long-term development in the future.
英文關鍵字	Risk assessment of chemical substances, Models for chemical substances risk assessment, Ecotoxicological risk assessment of chemical substances

摘要

This project has collected the data of chemical substance assessment standard announced by European Union, the United States, and Japan, including the list of relevant assessment cases. After relevant data was collected, this project has analyzed the assessment cases about N-Methylpyrrolidinone（NMP）and Antimony Trioxide（ATO）from US EPA, and the assessment cases about Naphthalene from European Chemicals Agency. To research the development and status of risk assessment for chemical substances in Taiwan, this project has analyzed the regulations, operation procedures, historical investigation and assessment cases, and parameters investigation data from Environmental Protection Administration, Ministry of Health and Welfare, Ministry of Labor, Council of Agriculture, and Ministry of Economic Affairs in Taiwan for the estimation of resource integration and feasibility research in the future. After the research, the results and data were summarized as the reference for planning the chemical substance risk assessment operation procedures. As for the methods for the chemical substance risk assessment, this project has researched the details from quantitative structure-activity relationships Toolbox（QSAR Toolbox）and European Union System for the Evaluation of Substances（EUSES）model developed by European Chemicals Agency, and also the details from Ecological Structure Activity Relationships（ECOSAR）, Estimation Programs Interface Suite （EPI Suite）and Exposure and Fate Assessment Screening Tool（E-FAST） model developed by US EPA. By applying the controlled chemical substances in Taiwan such as Bisphenol A（BPA）and Dimethyl Fumarate（DMFu）as the samples for testing each mode, this project has also proposed suggestions in accordance with the testing results for Taiwan to precede these modes. With NMP and 1-Bromopropane（1-BP）as testing substances, this project has selected some aquatic creatures such as Chlorella vulgaris, Daphnia magna, and Cyprinus carpio for testing the collected ecological risk examination methods from domestic and abroad. A trial calculation for the Predicted no-effect concentration (PNEC) for making a chemical substance ecological risk assessment has been made according to the testing results, which could be as the reference parameters for the relevant assessment works in the future. For the database planning of chemical substance risk assessment parameters, this project has firstly summarized and categorized all necessary items for chemical substance risk assessment. Second, this project has collected the database which government of Taiwan and other countries have built for chemical substance risk assessment. After the above process, this project has proposed an initial model for the database of chemical substance risk assessment in Taiwan. Integrating the works and results mentioned above with professional suggestion from twice profession consultation conference, this project has eventually summarized the suggestions for the policy and regulation establishment in Taiwan about chemical substance risk assessment, and the advice for medium- to long-term development in the future.

英文關鍵字

Risk assessment of chemical substances, Models for chemical substances risk assessment, Ecotoxicological risk assessment of chemical substances