環保專案成果報告查詢系統

專案計畫編號
經費年度	111
計畫經費	14,570 千元
預算科目	化學物質評估與管理-化學物質登錄審查
專案開始日期	2022/02/16
專案結束日期	2022/11/30
專案主持人	賴允傑
主辦單位	化學局
承辦人	謝泊諺
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	化學物質登錄、危害及暴露評估、化學品分類及標示全球調和制度
英文關鍵字	Chemical Substances Registration, Hazard and Exposure Assessment, Globally Harmonized System of Classification and Labelling of Chemicals
協同主持人	洪偉毅；陳柏霖
共同主持人
計畫聯絡人	陳歆妤
計畫聯絡電話	02-77306566#158
計畫聯絡信箱	hsinyu@apollotech.com.tw

中文摘要	本年度主要協助辦理化學物質登錄風險評估資料審查與諮詢回覆，並研析既有化學物質標準登錄資訊應用，以及建立優先盤點物質之篩選與資訊蒐集模式等工作。完成7件新化學物質及147件既有化學物質標準登錄案件審查作業，作業期間彙整常見審查問題，並具體提出改善建議。為因應後續既有化學物質危害及暴露評估資訊登錄需求，提出資訊分級架構、繳交原則及優先繳交建議，並辦理3場次個案輔導，協助登錄人準備資料。於資料應用規劃方面，蒐研化學物質之次世代風險評估技術及國家整合性評估方法，提出篩選及層次性風險評估規劃，並完成甲苯試行工作及3場次專家諮詢會議，提出後續資料蒐集重點與應用建議。對於危害資訊的應用，完成30式的物質資訊公開檔案，並綜整登錄人繳交資訊與國際資料庫資訊完成3式危害摘要。對於評估所需的缺口資料，建立以環境轉化產物填補生態毒理資訊缺口的流程圖。為建立後續的物質評估策略，研析優先盤點物質的篩選模式，並完成候選清單中10種物質的資料盤點，提供資料缺口及建議。本年度以化學物質風險評估為主軸推動各工作項目，逐步完善危害與暴露所需資訊，祈建立我國完整的化學物質風險評估系統。
中文關鍵字	化學物質登錄、危害及暴露評估、化學品分類及標示全球調和制度

中文摘要

本年度主要協助辦理化學物質登錄風險評估資料審查與諮詢回覆，並研析既有化學物質標準登錄資訊應用，以及建立優先盤點物質之篩選與資訊蒐集模式等工作。完成7件新化學物質及147件既有化學物質標準登錄案件審查作業，作業期間彙整常見審查問題，並具體提出改善建議。為因應後續既有化學物質危害及暴露評估資訊登錄需求，提出資訊分級架構、繳交原則及優先繳交建議，並辦理3場次個案輔導，協助登錄人準備資料。於資料應用規劃方面，蒐研化學物質之次世代風險評估技術及國家整合性評估方法，提出篩選及層次性風險評估規劃，並完成甲苯試行工作及3場次專家諮詢會議，提出後續資料蒐集重點與應用建議。對於危害資訊的應用，完成30式的物質資訊公開檔案，並綜整登錄人繳交資訊與國際資料庫資訊完成3式危害摘要。對於評估所需的缺口資料，建立以環境轉化產物填補生態毒理資訊缺口的流程圖。為建立後續的物質評估策略，研析優先盤點物質的篩選模式，並完成候選清單中10種物質的資料盤點，提供資料缺口及建議。本年度以化學物質風險評估為主軸推動各工作項目，逐步完善危害與暴露所需資訊，祈建立我國完整的化學物質風險評估系統。

中文關鍵字

化學物質登錄、危害及暴露評估、化學品分類及標示全球調和制度

類型	檔名	檔案大小	說明	最新版公開日期
期末報告	化學物質風險評估技術建置輔導與資料盤點計畫成果報告_公開版.pdf	14MB		2023/2/1 上午 12:00:00

摘要	There are 3 main tasks in this project. First, we assisted in reviewing the risk assessment information of chemical substances and provided registrants with consulting services. A total of 7 cases of new chemical substances and 147 cases of existing chemical substances were reviewed completely this year. During the review, we summarized the frequently asked questions and provided suggestions. Furthermore, we clarified the essential information needed in risk assessment for different levels of standard registration and provided principles of the information submission. We also held 3 helpdesk meetings to assist registrants in preparing risk assessment dossiers. Second, we analyzed the international trends and proposed strategies for accelerating registration applications. The method for screening and the tiered approach of risk assessment were established based on the research results of integrated evaluation methods at the state level. In the meantime, toluene was used as an example to practice the risk assessment process. We held 3 expert consultation meetings in order to improve data collection and application in the future. To promote hazard information application, we established the information disclosure documents for 30 substances. The hazard information from registrant’s dossiers and international databases were also summarized, and the results were used to complete the abstracts of hazard information for 3 substances. For filling the data gaps, we provided a flow chart for ecotoxicology data from transformation products to explain the hazard of original substances. Third, we built a model for selecting the priority substances which needed further detailed information. We also completed the information dossiers for 10 substances which were selected from this model. The details of data gaps and the suggestions for data filling were also provided. This year, this project provided the necessary information for hazard and exposure evaluation and those results could help to build the risk assessment system of chemicals in Taiwan.
英文關鍵字	Chemical Substances Registration, Hazard and Exposure Assessment, Globally Harmonized System of Classification and Labelling of Chemicals

摘要

There are 3 main tasks in this project. First, we assisted in reviewing the risk assessment information of chemical substances and provided registrants with consulting services. A total of 7 cases of new chemical substances and 147 cases of existing chemical substances were reviewed completely this year. During the review, we summarized the frequently asked questions and provided suggestions. Furthermore, we clarified the essential information needed in risk assessment for different levels of standard registration and provided principles of the information submission. We also held 3 helpdesk meetings to assist registrants in preparing risk assessment dossiers. Second, we analyzed the international trends and proposed strategies for accelerating registration applications. The method for screening and the tiered approach of risk assessment were established based on the research results of integrated evaluation methods at the state level. In the meantime, toluene was used as an example to practice the risk assessment process. We held 3 expert consultation meetings in order to improve data collection and application in the future. To promote hazard information application, we established the information disclosure documents for 30 substances. The hazard information from registrant’s dossiers and international databases were also summarized, and the results were used to complete the abstracts of hazard information for 3 substances. For filling the data gaps, we provided a flow chart for ecotoxicology data from transformation products to explain the hazard of original substances. Third, we built a model for selecting the priority substances which needed further detailed information. We also completed the information dossiers for 10 substances which were selected from this model. The details of data gaps and the suggestions for data filling were also provided. This year, this project provided the necessary information for hazard and exposure evaluation and those results could help to build the risk assessment system of chemicals in Taiwan.

英文關鍵字

Chemical Substances Registration, Hazard and Exposure Assessment, Globally Harmonized System of Classification and Labelling of Chemicals