For herbal drugs used for the production of medicinal products, the European Pharmacopoeia has established limits for pesticide residues in Chapter 2.8.13. For pesticide substances not listed in this chapter and whose presence is suspected the limits set by Regulation (EC) No. 396/2005 are applicable. This publication presents an evaluation of a database which includes 3.398.655 sets of data collected between 2011 and 2016 on the occurrence of pesticide residues in 376 herbal drugs. Based on such up-to-date information this contribution aims to support manufacturers of plant-based medicinal products in their individual risk assessment. This may include considerations on which substances are relevant for analysis and which testing frequencies are appropriate. The data show that a number of substances not listed in Ph.Eur. Chapter 2.8.13 can be considered relevant and therefore deserve particular attention within the risk assessment of the manufacturer. Vice versa, some Ph.Eur. substances did not show any positive results in a large number of analyses. For some further substances, the respective Ph.Eur. limits are exceeded only in a few cases. For herbal drugs from organic cultivation a remarkably lower number of positive findings was observed than for conventional cultivation. Regarding positive results for certain substances in organic products, sources other than the application of pesticides, e.g. from environment, packaging material or cross-contamination may be discussed.

对于用于生产药品的草药，《欧洲药典》在第2.8.13章中规定了农药残留限量。对于本章未列出且怀疑存在的农药物质，适用第（EC）396/2005号规定所设定的限值。该出版物提出了对数据库的评估，该数据库包括2011年至2016年之间收集的376.655套关于376种草药中农药残留的数据。基于此类最新信息，此贡献旨在为植物性药品制造商的个人风险评估提供支持。这可能包括考虑哪些物质与分析有关以及哪些测试频率合适。数据显示许多未在Ph.Eur中列出的物质。2.8。13应该被认为是相关的，因此在制造商的风险评估中值得特别注意。反之亦然，有些博士。大量分析中这些物质未显示任何阳性结果。对于某些其他物质，请参见相应的Ph.Eur。仅在少数情况下会超出限制。对于来自有机栽培的草药，观察到的阳性结果明显少于常规栽培。关于有机产品中某些物质的积极结果，可以讨论除农药施用以外的其他来源，例如来自环境，包装材料或交叉污染的来源。大量分析中这些物质未显示任何阳性结果。对于某些其他物质，请参见相应的Ph.Eur。仅在少数情况下会超出限制。对于来自有机栽培的草药，观察到的阳性结果明显少于常规栽培。关于有机产品中某些物质的积极结果，可以讨论除农药施用以外的其他来源，例如来自环境，包装材料或交叉污染的来源。大量分析中这些物质未显示任何阳性结果。对于某些其他物质，请参见相应的Ph.Eur。仅在少数情况下会超出限制。对于来自有机栽培的草药，观察到的阳性结果明显少于传统栽培。关于有机产品中某些物质的积极结果，可以讨论除农药施用以外的其他来源，例如来自环境，包装材料或交叉污染的来源。