{"title":"The Paramount Importance of Technical Equivalence Assessment for Active Substances in Crop Protection and Biocidal Products","authors":"Hanna Skarpos","doi":"10.21552/ICRL/2019/1/5","DOIUrl":null,"url":null,"abstract":"This article outlines the importance of assessing the technical equivalence regarding the chemical composition and hazard profile for different new sources of an active substance compared to the reference source of the same active substance used for the initial risk assessement. The legal provisions of past directives and two current regulations as last amended, Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and Regulation (EU) No 528/2012 concerning the placing on the market and use of biocidal products, are addressed in detail. Moreover, the harmonised procedures for assessing technical equivalence of different sources, based on the information presented in different supporting guidelines, are portrayed and discussed. Following the presentation of all legal provisions, a two-tiered approach as proposed for assessing the equivalence of different sources of active substances is presented in detail.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"100 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Chemical Regulatory and Law Review","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.21552/ICRL/2019/1/5","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
This article outlines the importance of assessing the technical equivalence regarding the chemical composition and hazard profile for different new sources of an active substance compared to the reference source of the same active substance used for the initial risk assessement. The legal provisions of past directives and two current regulations as last amended, Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and Regulation (EU) No 528/2012 concerning the placing on the market and use of biocidal products, are addressed in detail. Moreover, the harmonised procedures for assessing technical equivalence of different sources, based on the information presented in different supporting guidelines, are portrayed and discussed. Following the presentation of all legal provisions, a two-tiered approach as proposed for assessing the equivalence of different sources of active substances is presented in detail.
本文概述了与用于初始风险评估的同一种活性物质的参考来源相比，评估一种活性物质的不同新来源的化学成分和危害概况的技术等效性的重要性。详细阐述了过去指令和最近修订的两个现行法规的法律规定，即关于植物保护产品投放市场的法规(EC) No 1107/2009和关于生物杀灭剂产品投放市场和使用的法规(EU) No 528/2012。此外，还描述和讨论了根据不同的辅助准则所提供的资料评估不同来源的技术等效性的统一程序。在介绍了所有法律规定之后，详细介绍了评估不同来源活性物质等效性的两层方法。
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