5/6 June 2024
Following the draft chapter 2.8.2 Foreign Matter in herbal drugs (Pharmeuropa 33.3) the final version has been published in the European Pharmacopoeia (Ph. Eur.) 11.1. The supplement is now available and will become applicable as of 1 April 2023.
In particular, the requirements for other foreign elements like moulds, insects and other animal contamination have been further specified:
Foreign matter is material consisting of any or all of the following:
Furthermore, it has been clarified that the quantitative limits for foreign matter that are specified in general Ph. Eur. monographs (e. g. Herbal drugs, max. 2 %) or in an individual monograph, only apply to foreign organs and foreign elements; other foreign elements as defined in 2.8.2 are not covered by the limit but should, as far as possible, be absent.