LAUSR

Abstract 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.