環保專案成果報告查詢系統

專案計畫編號
經費年度	113
計畫經費	18,635 千元
預算科目	風險管控-風險管控
專案開始日期	2024/02/06
專案結束日期	2024/11/30
專案主持人	洪偉毅
主辦單位	化學署評估管理組
承辦人	張容蓉
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	陳柏霖；陳歆妤
共同主持人
計畫聯絡人	吳睿元
計畫聯絡電話	(02)77306566#177
計畫聯絡信箱	juiyuan.wu@veolia.com

中文摘要	本年度工作包括︰協助化學物質登錄風險評估資料審查與輔導、研析危害及暴露評估資料繳交作法、建立化學物質特性資訊公開資料，以及優化既有化學物質後續登錄管理架構。主要成果涵蓋下列5項︰(1)完成13件新化學物質及830件既有化學物質標準登錄案件審查，並提供超過100家次危害及暴露評估輔導諮詢服務，另根據業者反饋意見，協助調修危害及暴露相關登錄系統工具項目欄位及教學影片。(2)為研擬第1期既有化學物質危害及暴露評估資料提交作法，調查共同登錄團體領導登錄人現有規劃及後續輔導需求，研析登錄資料及國際資訊，據以提出優先物質及提交期程建議，並完成2種物質之危害評估輔導教材。(3)對於登錄資料應用，提出階層式資料公開架構，完成30種既有化學物質資料蒐集與專家學者查核資料適用性，以及規劃並完成5種物質危害資訊圖像化呈現方式，內容包含定性危害、定量危害及非動物替代測試應用情形。(4)為持續完善既有化學物質登錄制度，提出後續物質篩選架構及優化方向，包含依物質危害資料完整度規劃不同的資料蒐集方式、參考歐盟和日本作法蒐集物質下游用途資訊、逐步篩選並強化高風險物質評估，以及配合管理需求傳遞物質資訊，此外進一步根據優化之篩選架構，綜整現有申報資料及國際危害資訊，分別提出下一批需評估之物質清單及替代測試評估物質清單各1式。(5)依據登錄輔導、制度研擬及政策宣導等業務需求，完成共15場危害及暴露評估相關會議，持續推動登錄制度及資料應用工作，以達到加速化學物質管理目的。
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

本年度工作包括︰協助化學物質登錄風險評估資料審查與輔導、研析危害及暴露評估資料繳交作法、建立化學物質特性資訊公開資料，以及優化既有化學物質後續登錄管理架構。主要成果涵蓋下列5項︰(1)完成13件新化學物質及830件既有化學物質標準登錄案件審查，並提供超過100家次危害及暴露評估輔導諮詢服務，另根據業者反饋意見，協助調修危害及暴露相關登錄系統工具項目欄位及教學影片。(2)為研擬第1期既有化學物質危害及暴露評估資料提交作法，調查共同登錄團體領導登錄人現有規劃及後續輔導需求，研析登錄資料及國際資訊，據以提出優先物質及提交期程建議，並完成2種物質之危害評估輔導教材。(3)對於登錄資料應用，提出階層式資料公開架構，完成30種既有化學物質資料蒐集與專家學者查核資料適用性，以及規劃並完成5種物質危害資訊圖像化呈現方式，內容包含定性危害、定量危害及非動物替代測試應用情形。(4)為持續完善既有化學物質登錄制度，提出後續物質篩選架構及優化方向，包含依物質危害資料完整度規劃不同的資料蒐集方式、參考歐盟和日本作法蒐集物質下游用途資訊、逐步篩選並強化高風險物質評估，以及配合管理需求傳遞物質資訊，此外進一步根據優化之篩選架構，綜整現有申報資料及國際危害資訊，分別提出下一批需評估之物質清單及替代測試評估物質清單各1式。(5)依據登錄輔導、制度研擬及政策宣導等業務需求，完成共15場危害及暴露評估相關會議，持續推動登錄制度及資料應用工作，以達到加速化學物質管理目的。

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與資料建置計畫.pdf	0MB		2024/12/30 上午 12:00:00

摘要	The project achieved 5 main outcomes, as follows: Firstly, it completed the review of 13 new chemical substances and 830 existing chemical substances for standard registration, provided over 100 consultations on hazard and exposure assessments, and based on the feedback from registrants, assisted in upgrading “Chemist New X 3.0” and educational videos related to hazard and exposure registration. Secondly, to develop the hazard and exposure assessment data submission for the designated list of existing chemical substances, a survey was conducted to understand the current plans and help needs of lead registrants in joint registration groups. Additionally, based on registration data and international information, priority substances and submission schedules were proposed, and training materials for hazard assessment of 2 substances were completed. Thirdly, for the application of registration data, a hierarchical framework for data disclosure was proposed, and data for 30 existing chemical substances were collected and reviewed by experts for applicability. Moreover, hazard information for 5 substances was graphically presented, covering qualitative and quantitative hazards, along with the application of non-animal alternative testing methods etc. Fourth, a framework for substance screening and optimization was proposed to further improve the regulations of existing chemical registration. This included planning different data collection methods based on hazard information, referencing practices from the EU and Japan to gather downstream usage information, prioritizing high-risk substances for evaluation, and communicating substance information to meet management needs. Based on this optimized framework, the annual report data and international hazard information were consolidated to propose two draft lists: one for substances requiring further evaluation and another for alternative testing assessment. Finally, 15 meetings related to hazard and exposure assessment were held based on the needs for registration, registration system planning, and policy promotion. These efforts continue to advance the registration system and data application to accelerate the management of chemical substances.
英文關鍵字	Chemical Substances Registration, Hazard and Exposure Assessment, Globally Harmonized System of Classification and Labelling of Chemicals

摘要

The project achieved 5 main outcomes, as follows: Firstly, it completed the review of 13 new chemical substances and 830 existing chemical substances for standard registration, provided over 100 consultations on hazard and exposure assessments, and based on the feedback from registrants, assisted in upgrading “Chemist New X 3.0” and educational videos related to hazard and exposure registration. Secondly, to develop the hazard and exposure assessment data submission for the designated list of existing chemical substances, a survey was conducted to understand the current plans and help needs of lead registrants in joint registration groups. Additionally, based on registration data and international information, priority substances and submission schedules were proposed, and training materials for hazard assessment of 2 substances were completed. Thirdly, for the application of registration data, a hierarchical framework for data disclosure was proposed, and data for 30 existing chemical substances were collected and reviewed by experts for applicability. Moreover, hazard information for 5 substances was graphically presented, covering qualitative and quantitative hazards, along with the application of non-animal alternative testing methods etc. Fourth, a framework for substance screening and optimization was proposed to further improve the regulations of existing chemical registration. This included planning different data collection methods based on hazard information, referencing practices from the EU and Japan to gather downstream usage information, prioritizing high-risk substances for evaluation, and communicating substance information to meet management needs. Based on this optimized framework, the annual report data and international hazard information were consolidated to propose two draft lists: one for substances requiring further evaluation and another for alternative testing assessment. Finally, 15 meetings related to hazard and exposure assessment were held based on the needs for registration, registration system planning, and policy promotion. These efforts continue to advance the registration system and data application to accelerate the management of chemical substances.

英文關鍵字

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