Revised Ph. Eur. Chapter on Foreign Matter

Recommendation

6/7 June 2023

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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:

• Foreign organs: matter coming from the source plant but not defined as the herbal drug;
• Foreign elements: matter not coming from the source plant and of either vegetable or mineral origin;
• Other foreign elements: matter such as moulds and animal contamination (e. g. insects, their eggs or larvae, spiders, rodents and excreta) and any other unwanted matter (e. g. glass, metal, plastics).

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.