| 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.
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