Regulatory Aspects concerning PA contamination in medicinal plants

Abstract

The first reports on the occurrence of PA contamination in herbal teas were published in 2013, followed shortly afterwards by reports on the contamination of herbal medi­cinal products with PA. As a result, various national regulatory authorities and the Committee for Herbal Medi­cinal Products of the European Medicines Agency requested marketing authorisation holders of herbal medi­cinal products in Europe to carry out risk assessments and risk reduction measures with regard to pyrrolizidine alkaloids. Both, national authorities and the HMPC introduced limits for PA as a contaminant. In addi­tion, the HMPC had endorsed the European Pharmacopoeia to develop a suitable PA determination method in the field of trace analysis. This is currently available as a draft for public consultation.