環境資源報告成果查詢系統

111年環境用藥劑型管理及檢測規範計畫

中文摘要 有關檢視有效環境用藥許可證、國內既有劑型,進行分析、彙整,並提出適當之劑型重新歸類方案部分,根據110年環境用藥品質檢測及管理計畫 (110A016)提出之50種環境用藥之劑型種類及定義建議,檢視國內目前有效環境用藥許可證共1356張、國內既有劑型共39種,進行分析、彙整,經統計,結果發現約有59%的許可證無劑型變動建議,但有約41%的許可證建議需重新檢視其物化特性及使用方法,以歸類至新的調和劑型項目之中。 本計畫根據110年環境用藥品質檢測及管理計畫 (110A016) 並參考JMPS及我國農藥標準規格準則之規格項目、檢驗方法及通過標準,將業者可能會有的劑型納入研析,更新擬定40種劑型規格檢驗項目及其暫訂通過標準。目前亦參考現行農藥標準規格之檢驗項目及檢驗費之收費數額,列出40種環境用藥劑型規格檢驗項目及相關檢驗費用資訊。另外,亦建議上準環境科技股份有限公司及22家GLP符合性登錄的物理─化學測試的實驗室,可供未來實施規格檢驗時的檢測單位。 在與5家環境用藥業者分別舉行座談會部分,提供業者新劑型調和建議方案,讓業者對調和劑型的調整方向更有概念,再對業者提出的問題做說明與討論。業者對於劑型之調整皆表示支持之意向,但由於劑型變動所牽涉到工廠登記證等法規部分,相關的地方主管機關之標準不一,希望未來能由中央主管機關統一審核及有足夠之寬限期可執行相關變更。另外藥劑規格檢驗之規模連帶提升之成本也為業者所關心,此為未來執行劑型變更時需一併考量之因素。 有關分析國內既有環境用藥副成分種類之現況部分,本計畫根據110年環境用藥品質檢測及管理計畫(110A016),行政院環境保護署民國 109 年12月10日公告環境衛生用藥成分禁止含有之化學物質種類共80種,在既有環境用藥之副成分中均未含有公告禁用之化學物質種類。行政院環境保護署民國111年7月29日公告環境衛生用藥成分禁止含有之化學物質種類共82種,新增甲基陶斯松和陶斯松。在既有環境用藥中有效成分含有陶斯松之環境用藥許可證共有78張。 歐盟委員會在2021 年 3 月 3 日頒布(EU)2021/383號法規,修訂(EC)1107/2009號條例之附件三,列出植物保護產品中不被接受的配方副成分種類共有143 種,在既有環境用藥之副成分中含有12種歐盟禁用於植保產品之副成分,而既有環境用藥含有歐盟禁用於植保產品之副成分之許可證張數為123張。美國EPA 在2016 年 12 月 20 日,宣布從其批准用於農藥產品的化學品清單中刪除 72 種惰性成分,在既有環境用藥之副成分中含有2種美國禁用化學物質,而既有環境用藥含有美國禁用化學物質之許可證張數為4張。中國農業部農藥檢定所於2015年7月發佈了徵求「農藥助劑禁限用名單」意見稿之文書,列出9種擬禁用副成分,在既有環境用藥之副成分中含有1種中國擬禁用化學物質,而既有環境用藥許可證含有中國擬禁用化學物質之許可證張數為2張。含有國際上禁用化學物質的既有環境用藥許可證總共有129張,需進行檢討副成分資料。 我國行政院農業委員會106年4月14日發布農藥其他成分之限量規格修正規定,列出50 種農藥其他成分限量規格清單,在既有環境用藥之副成分中含有8種我國農藥之限量化學物質,其中7種限量化學物質含量超過限量基準,既有環境用藥含有我國農藥之限量化學物質之許可證張數為195張,其中62張許可證所含有之限量化學物質含量超過限量基準。西班牙在2022年9月更新訂定植物保護產品不可用之副成分清單共列出15種限用成分清單,在既有環境用藥之副成分中含有3種西班牙限用成分,其中2種限用化學物質含量超過限量基準,既有環境用藥含有西班牙限用成分之許可證張數為16張,其中2張許可證所含有之限用化學物質含量超過限量基準。中國農業部農藥檢定所於2015年7月發佈了徵求「農藥助劑禁限用名單」意見稿之文書,列出75種擬限用成分清單,在既有環境用藥之副成分中含有8種中國農藥擬限用成分,其中4種限用化學物質含量超過限量基準,既有環境用藥含有中國農藥擬限用成分之許可證張數為78張,其中41張許可證所含有之限用化學物質含量超過限量基準。含有國際上限用化學物質的既有環境用藥許可證總共有105張,需進行檢討副成分資料。 在有關完成15張製造許可證依據劑型重新分類與技術規範部分,選定18張有效之環境用藥許可證,包含乳劑8張、液劑10張(其中1個產品建議重新歸入溶液、3個產品建議歸入防蚊液、3個產品建議歸入水分散性乳劑、3個產品建議可歸入微乳劑或水基乳劑),根據劑型歸類定義,設定建議檢驗項目。本計畫完成8個乳劑產品檢驗,乳化安定性合格率為87.5%、起泡性合格率為100%、耐熱試驗合格率為62.5%、耐冷試驗合格率為100%。耐熱試驗不合格的產品都是有效成分-亞特松含量不合格,推測可能與亞特松成分安定性不佳有關。 本計畫完成10個液劑產品檢驗,在起泡性檢驗部分,不合格率高達50%偏高,檢測不合格產品包括1個建議重新歸入溶液的產品、1個建議歸入水分散性乳劑的產品和3個建議可歸入微乳劑(ME)或水基乳劑(EW))的產品。其餘液劑產品檢驗項目皆檢測合格如溶液產品之耐熱試驗與耐冷試驗、防蚊液產品之耐熱試驗、水分散性乳劑產品之細度、分散安定性、耐熱試驗與耐冷試驗、微乳劑或水基乳劑產品之乳化安定性、耐熱試驗與耐冷試驗。
中文關鍵字 環 境 用 藥 , 劑 型 , 規 格

基本資訊

專案計畫編號 經費年度 111 計畫經費 2076 千元
專案開始日期 2022/02/25 專案結束日期 2022/11/30 專案主持人 黃紹毅
主辦單位 化學局 承辦人 林涵君 執行單位 國立中興大學

成果下載

類型 檔名 檔案大小 說明
期末報告 111成果報告定稿版1214(加密版本).pdf 16MB 111年環境用藥劑型管理及檢測規範計畫期末報告

2022 Formulation Management and Quality Inspections of Public Health Pesticide

英文摘要 Regarding the inspection of valid Environmental agents licenses, existing domestic formulations, analysis and compilation, and the proposal of an appropriate formulation reclassification plan, according to the 2021 Environmental agents Quality Inspections and Management Project (110A016), it proposed 50 environmental pesticide formulations Types and suggested definitions. After reviewing a total of 1,356 valid Environmental agents licenses in Taiwan and 39 existing formulations in Taiwan and after analyzing and compiling statistics, it was found that about 59% of the licenses have no suggestion for changing formulations, but there are About 41% of the license proposals need to re-examine their physicochemical properties and methods of use to classify them into the new blended formulation items. This plan is based on the 2021 Environmental agents Quality Inspections and Management Project (110A016) and refers to the specifications, inspection methods and passing standards of JMPS and Taiwan's pesticide standards, and includes the formulations that the industry may have. Various dosage form specifications inspection items and their tentative approval standards. At present, with reference to the inspection items and inspection fees of the current pesticide standard specifications, the inspection items and relevant inspection fee information for 40 environmental pharmaceutical formulations are listed. In addition, it is also recommended that Eurofins Sun Dream Environmental Technical Corporation and 22 GLP compliance-registered physical-chemical testing laboratories be used as testing units for future standard inspections. In the part of symposiums held with 5 Environmental agents manufacturers, the proposed plans for the manufacturers' new formulations are provided, so that the manufacturers can have a better idea of the adjustment direction of the formulations, and then explain and discuss the problems raised by the manufacturers. The industry has expressed their intention to support the adjustment of dosage forms. However, due to the changes in formulation form involved in regulations such as factory registration certificates, the relevant local competent authorities have different standards. It is hoped that the central competent authority will review uniformly in the future with sufficient grace period. The relevant changes can be implemented. In addition, the scale of pharmaceutical specification inspection and the cost of increasing the cost are also concerned by the industry, which is a factor that needs to be considered when implementing formulation changes in the future. Regarding the analysis of the current status of the types of existing Environmental agents sub-components in Taiwan, this plan is based on the 2021 Environmental agents Quality Inspections and Management Project (110A016), the Environmental Protection Administration Executive Yuan announced on December 10, 2020 that the environment sanitation medicine ingredients are prohibited. There are a total of 80 types of chemical substances contained, and none of the auxiliary ingredients of existing Environmental agents contain the types of chemical substances that are banned by announcement. The Environmental Protection Administration Executive Yuan announced on July 29, 2022 that there are 82 types of chemical substances that are prohibited from being contained in environment sanitation pharmaceutical ingredients, including Chlorpyrifos-methyl and Chlorpyrifos. There are a total of 78 environmental agents licenses that contain Chlorpyrifos as the active ingredient in existing environment medicine. The European Commission promulgated Regulation (EU) No. 2021/383 on March 3, 2021, amending Annex III of Regulation (EC) No. 1107/2009, listing a total of 143 types of unacceptable auxiliary ingredients in plant protection products. The existing environmental agents contain 12 by-components banned from plant protection products in the EU, and123 licenses for existing environmental agents to contain by-components banned from plant protection products in the EU. On December 20, 2016, the US EPA announced that 72 inert ingredients were removed from its list of chemicals approved for use in pesticide products, and there were 2 US-banned chemicals in the by-components of existing environmental agents, while existing environmental pesticides , the number of licenses for the use of drugs containing chemical substances banned in the United States is 4. In July 2015, Institute for the Control of Agrochemicals of Ministry of Agriculture and Rural Affairs of the People's Republic of China issued a document soliciting opinions on the "List of Prohibited and Restricted Pesticide Adjuvants", listing 9 auxiliary ingredients to be banned. Proposed banned chemical substances, and the number of existing environment medicine licenses containing chemical substances to be banned in China is 2. There are a total of 129 existing environment medicine licenses containing internationally banned chemical substances, and it is necessary to review the sub-component information. On April 14, 2017, Council of Agriculture Executive Yuan issued the revised regulations on the limited specifications of other ingredients of pesticides, listing the limited specifications of 50 other ingredients of pesticides, including 8 kinds of limited chemical substances of pesticides in the by-components of existing Environmental agents. Among them, the content of 7 kinds of limited chemical substances exceeds the limit standard. The number of existing Environmental agents containing limited chemical substances of pesticides in my country is 195, of which 62 licenses contain limited chemical substances that exceed the limit standard. In September 2022, Spain updated the list of unusable auxiliary ingredients for plant protection products. A total of 15 restricted ingredients are listed. Among the auxiliary ingredients of existing environmental agents, there are 3 restricted ingredients in Spain, of which 2 are restricted. The content of chemical substances exceeds the limit standard. The number of licenses for existing Environmental agents containing restricted ingredients in Spain is 16, and the content of restricted chemical substances contained in 2 licenses exceeds the limit standard. In July 2015, Institute for the Control of Agrochemicals of Ministry of Agriculture and Rural Affairs of the People's Republic of China issued a document soliciting opinions on the "List of Prohibited and Restricted Pesticide Adjuvants", listing 75 ingredients to be restricted, including 8 of the by-products of existing Environmental agents. China's pesticides to be restricted ingredients, of which the content of 4 restricted chemical substances exceeds the limit benchmark, the number of existing Environmental agents containing the Chinese pesticides to be restricted ingredients is 78 licenses, of which 41 licenses contain restricted chemicals The substance content exceeds the limit benchmark. There are a total of 105 existing Environmental agents licenses containing chemical substances with international limits, and the information on sub-components needs to be reviewed. In the section about completing the reclassification of 15 manufacturing licenses based on dosage forms and technical specifications, 18 valid Environmental agents licenses were selected, including 8 emulsions and 10 liquids (among which 1 product is recommended to be reclassified as solution, 3 products It is recommended to be classified as anti-mosquito liquid, 3 products are recommended to be classified as water-dispersible emulsion, and 3 products are recommended to be classified as microemulsion or water-based emulsion). In this project, 8 emulsion product inspections have been completed. The qualified rate of emulsion stability is 87.5%, the qualified rate of persistent foaming is 100%, the qualified rate of accelerated storage procedure is 62.5%, and the qualified rate of stability at 0℃ is 100%. The products that failed the heat resistance test were all active ingredients - the content of pirimiphos-methyl failed, which may be related to the poor stability of pirimiphos-methyl. This project has completed 10 soluble concentrates product inspections. In test of persistent foaming, the unqualified rate is as high as 50%. The unqualified products include 1 product that is recommended to be reclassified into soluble concentrates, and 1 product that is recommended to be classified into dispersible concentrates; and 3 proposals can be classified as microemulsion (ME) or emulsion, oil in water (EW) products. All other liquid product inspection items are qualified, such as accelerated storage procedure and stability at 0℃ of solution products; accelerated storage procedure of mosquito repellent products; fineness, dispersion stability, accelerated storage procedure and stability at 0℃of water dispersible emulsion products,; emulsion stability, accelerated storage procedure and stability at 0℃ of microemulsion or emulsion, oil in water products.
英文關鍵字 Environmental agents, Formulation types, Specifications