The Committee on Herbal Medicinal Products (HMPC) published new recommendations for risk management and quality control of herbal medicinal products (HMPs) and traditional HMPs. The additional control measures issue the contamination of HMPs with toxic pyrrolizidine alkaloids (PAs) which can cause liver hemangiosarcoma in humans. The view of HMPC is that patient exposure to PAs from HMPs should be as low as possible and should not exceed a daily intake of 0.35 μg. However, for a limited transitional period an intake up to 1.0 μg per day can be accepted.
Contamination of herbal products (food and medicines) cannot be a new phenomenon, but today new, sensitive analytical methods can detect very low levels of PAs in foods and medicines . As a result, Marketing Authorization Holders (MAHs) are advised to implement suitable testing procedures to ensure PA levels are controlled in line with limits agreed. Also measures to avoid or reduce PA contamination in HMPs are recommended to be implemented.
Based on these recommendations, an analytical variation type II with the results of a risk analysis, a risk management plan and the implementation of routine testing of toxic PAs should be submitted to FAMHP if the (traditional) HMPs contain at least 1 of the specified herbal ingredients or derived preparations at highest risk of contamination. MAHs of other (traditional) HMPs should keep a risk analysis and risk management plan available to FAMHP.
More information on these recommendations can be found here.