Pesticide testing according to the European Pharmacopoeia (Ph.Eur.) – legal requirements and practical approach

In 1996 the monograph „Pesticide residues (2.8.13.)“ in herbal drugs has been implemented to the European Pharmacopoeia (Ph.Eur.). There were „definition“, „limits“, „sampling“, „qualitative and quantitative analysis of pesticide residues“ and a „Test for pesticides“ described in the monograph.

Refering to the publication in PHARMEUROPA Vol.17 No.1, January 2005 (Pesticide Residues in medicinal Drugs and Preparations) the Ph.Eur. Pesticide Expert Group has been mandated to update the monograph Ph.Eur 2.8.13. The revised monograph (Ph.Eur. 6.2) has been published in 2008.

The revision includes following changes: The new harmonised European Pesticide Regulation (EU 396/2005) replaced old European Directives (EC 76/895 and EC 90/642); the list of pesticides has been extended from 34 to 115 substances frequently observed in herbal drugs; limits has been set in view of toxicology and according to a 90 per cent percentile approach; the formula for the calculation of pesticide limits in extracts and other herbal drug preparations has been modified; more details for method validation procedure has been given (cross reference to document SANCO/10232/2006); the method for determination of pesticides („Test for pesticides“) has been deleted.

With the updated monograph a framework for quality control of pesticide analysis in herbal drugs has been given. For the frequently found 115 substances pesticides in herbal drugs and herbal drug preparation limits could be found or calculated easily. The allocation from product to limit of all other (not listed) pesticides according to the new harmonised European Pesticide Regulation (EU 396/2005) remains difficult.

The scope of testing depends on the methods of analyses used. Using additionally new analytical technics based on LC-MS/MS detection more than 500 substances could be detected analysing pesticide residues in herbal drugs.