Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with PAs

This document provided transitional recommendations for control of pyrrolizidine alkaloids levels due to contamination in herbal medicinal products.

Contamination aspects, partially updated, were later included in the revised version of Public statement EMA/HMPC/893108/2011 (Rev 1 adopted July 2021). For current recommendations, the Public statement on Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) should be followed, including its recommendations on contamination of herbal medicinal products with pyrrolizidine alkaloids.

Keywords: Herbal medicinal products, pyrrolizidine alkaloids

Current version

Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids

Adopted Reference Number: EMA/HMPC/328782/2016 Summary:

Pyrrolizidine alkaloids (PAs) are nitrogen containing compounds that occur naturally in plants. Several hundred structurally distinct PAs have been found in low concentrations in several thousand different plant species. Many of these plants are common weeds.

Document history

Call for scientific data for use in HMPC assessment work on ‘Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids (EMA/HMPC/328782/2016)’

Draft: consultation closed Consultation dates: 28/02/2019 to 31/08/2019 Reference Number: EMA/HMPC/37920/2019