環保專案成果報告查詢系統

專案計畫編號
經費年度	110
計畫經費	7,400 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	2021/02/01
專案結束日期	2021/11/30
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	化學物質登錄、危害及暴露評估工具、環境釋放參數
英文關鍵字	Chemical Substances Registration, Hazard and Exposure Assessment Tool, Environmental Release Factor
協同主持人	馬鴻文
共同主持人
計畫聯絡人	陳歆妤
計畫聯絡電話	02-77306566#164
計畫聯絡信箱	hsinyu.chen@veolia.com

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作業，並完善風險評估作業所需之撰寫指引、工具以及釋放參數研析等工作，合計共完成12件新化學物質及175件既有化學物質標準登錄案件審查作業，並有151件通過審查。為提升國內業者風險評估作業量能，協助辦理2場次教育訓練，並編撰實作訓練講義及提供教學協助。審查作業期間彙整常見的審查疑義與諮詢問答，後續可提供予業者參考以提升審查效率，或做為登錄作業檢討改善之依據。於完備登錄作業所需之工具方面，參考審查經驗與專家意見，完成既有化學物質危害與暴露評估撰寫指引草案修訂工作，另提出登錄資訊系統工具之調修建議，於參考研析國外現有危害及暴露評估工具之適用性後，完成我國化學物質危害評估工具及暴露評估工具之規劃建置與試行驗證等工作，並提出工具操作手冊，以利業者參考應用。考量國外暴露評估工具使用之預設釋放參數與國內現況差異較大，故辦理本土參數先期調查作業，已盤點國際環境釋放參數資料，包括歐盟化學物質風險評估報告、特定環境釋放類別、風險評估技術指引文件及釋放情境文件等，提出國內環境釋放參數建議援引使用原則、本土製程環境釋放參數建置之可行性評估及短中長期建置目標。
中文關鍵字	化學物質登錄、危害及暴露評估工具、環境釋放參數

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作業，並完善風險評估作業所需之撰寫指引、工具以及釋放參數研析等工作，合計共完成12件新化學物質及175件既有化學物質標準登錄案件審查作業，並有151件通過審查。為提升國內業者風險評估作業量能，協助辦理2場次教育訓練，並編撰實作訓練講義及提供教學協助。審查作業期間彙整常見的審查疑義與諮詢問答，後續可提供予業者參考以提升審查效率，或做為登錄作業檢討改善之依據。於完備登錄作業所需之工具方面，參考審查經驗與專家意見，完成既有化學物質危害與暴露評估撰寫指引草案修訂工作，另提出登錄資訊系統工具之調修建議，於參考研析國外現有危害及暴露評估工具之適用性後，完成我國化學物質危害評估工具及暴露評估工具之規劃建置與試行驗證等工作，並提出工具操作手冊，以利業者參考應用。考量國外暴露評估工具使用之預設釋放參數與國內現況差異較大，故辦理本土參數先期調查作業，已盤點國際環境釋放參數資料，包括歐盟化學物質風險評估報告、特定環境釋放類別、風險評估技術指引文件及釋放情境文件等，提出國內環境釋放參數建議援引使用原則、本土製程環境釋放參數建置之可行性評估及短中長期建置目標。

中文關鍵字

化學物質登錄、危害及暴露評估工具、環境釋放參數

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計畫_成果報告公開版.pdf	13MB		2022/1/3 上午 12:00:00

摘要	The purpose of the project was to assist the competent authority in reviewing and replying the risk assessment information on chemical substances in registration dossier, and to improve the writing guidelines, risk assessment tools and environmental release factors needed when evaluating the risk of chemical substances. A total of 12 cases of new chemical substances and 175 cases of existing chemical substances were reviewed, of which 151 cases have completed the registration dossier this year. In order to complete the risk assessment information required for registers, we assisted in holding 2 training courses and compiled practical training handout to provide teaching assistance. During the reviewing, we also completed the frequently asked questions about the review doubts and consultation, which can be offered to registers to improve the efficiency of the review, or can be used as a reference by the competent authority for improvement of the registration policy. In terms of completing the tools required for the registration, we referred to the review experience and expert opinions to complete the revision of the draft guidelines for writing the hazard and exposure assessment of existing chemical substances and proposed the adjustment suggestions for the registration tools. After studied the applicability of aboard existing hazard and exposure assessment tools, we completed planning, construction, testing and validation of the domestic hazard and exposure assessment tools and completed the user manuals for application by the registers. Because of the difference between the default value of the exposure assessment tools and actual situation in Taiwan, a preliminary local parameters investigation was conducted. We studied the international environmental release parameter information, including EU chemical risk assessment reports, specific environmental release category, technical guidance document on risk assessment and emission scenario document and then proposed the citation principle, the feasibility assessment of local environmental release parameter establishment and short-, medium- and long-term establishment targets.
英文關鍵字	Chemical Substances Registration, Hazard and Exposure Assessment Tool, Environmental Release Factor

摘要

The purpose of the project was to assist the competent authority in reviewing and replying the risk assessment information on chemical substances in registration dossier, and to improve the writing guidelines, risk assessment tools and environmental release factors needed when evaluating the risk of chemical substances. A total of 12 cases of new chemical substances and 175 cases of existing chemical substances were reviewed, of which 151 cases have completed the registration dossier this year. In order to complete the risk assessment information required for registers, we assisted in holding 2 training courses and compiled practical training handout to provide teaching assistance. During the reviewing, we also completed the frequently asked questions about the review doubts and consultation, which can be offered to registers to improve the efficiency of the review, or can be used as a reference by the competent authority for improvement of the registration policy. In terms of completing the tools required for the registration, we referred to the review experience and expert opinions to complete the revision of the draft guidelines for writing the hazard and exposure assessment of existing chemical substances and proposed the adjustment suggestions for the registration tools. After studied the applicability of aboard existing hazard and exposure assessment tools, we completed planning, construction, testing and validation of the domestic hazard and exposure assessment tools and completed the user manuals for application by the registers. Because of the difference between the default value of the exposure assessment tools and actual situation in Taiwan, a preliminary local parameters investigation was conducted. We studied the international environmental release parameter information, including EU chemical risk assessment reports, specific environmental release category, technical guidance document on risk assessment and emission scenario document and then proposed the citation principle, the feasibility assessment of local environmental release parameter establishment and short-, medium- and long-term establishment targets.

英文關鍵字

Chemical Substances Registration, Hazard and Exposure Assessment Tool, Environmental Release Factor