Pestizidrückstände in Arzneidrogen und deren Zubereitungen
Lothar Kabelitz
PhytoLab, GmbH & Co. KG, Vestenbergsgreuth
Pesticide Residues in Herbal Medicinal Drugs and Their Formulations Regulations for pesticide residues in herbal medicinal drugs are included in the monograph “Pesticide Residues” of the European Pharmacopoeia (Ph.Eur.). According to the monograph limits applying to pesticides not listed in the table of the monograph comply with the limits set by the EC directives 76/895 and 90/642 including their annexes and successive updates. The limits indicated in the mentioned EC directives that have been adopted in German legislation within the Maximum Residue Level Regulation (Rückstands-Höchstmengenverordnung, RHmV) are not appropriate. They refer to certain product groups only, they are generally too low and therefore they are not practicable.
According to the Contaminants Working Group of the Federal Association of Pharmaceutical Product Manufacturers (Bundesverband der Arzneimittelhersteller, BAH) 67 pesticides respectively substance groups are relevant to a selection of 205 herbal medicinal drugs which were given a positive assessment by the E Commission or ESCOP or a monograph by the Ph.Eur.
The table of substances and limits in the Ph.Eur. monograph „Pesticide Residues“ should be amended. Maximum limits for 70 pesticides, calculated on the positive findings and the 90th percen-tiles or adjusted to the quantitation limits for a number of pesticides, should be adopted as maximum levels of the Ph.Eur. in those cases where the actual limit is fixed at a lower value.
As the analytical method provided by the Ph.Eur. is not suited to check the limits of the 70 relevant pesticides the DFG S 19 procedure, which has been adopted in the § 35 method collection of the German Food and Commodities Act (Lebensmittel- und Bedarfsgegenstände-Gesetz, LMBG) as procedure L 00.00-34, is proposed as appropriate analytical method for the Ph. Eur. monograph “Pesticide Residues”.
