Recalls of Pyrrolizidine Alkaloid-Containing Spices and Food Supplements in Europe

In the time period between March and June 2019, alerts for 19 products containing botanical ingredients contaminated with potentially toxic pyrrolizidine alkaloids (PAs) have been issued by the European Commission on its Rapid Alert System for Food and Feed (RASFF) portal.¹ Eight of the alerts were due to oregano (Origanum vulgare subsp. hirtum, and O. onites, Lamiaceae) herb sold as a spice, while four concerned St. John’s wort (Hypericum perforatum, Hypericaceae) food supplements. Other ingredients with PA concentrations exceeding the acceptable limit of PAs included thyme (Thymus spp., Lamiaceae) herb, nettle (Urtica dioica, Urticaceae) leaf, and rooibos (Aspalathus linearis, Fabaceae) leaves. PA levels ranged from 0.363 mg/kg in nettle tea to 17.9 mg/kg in oregano herb.

The St. John’s wort alert was based on an investigation by the Dutch Food and Consumer Products Safety Authority (NVWA), finding between 3.20 and 4.85 mg PAs/kg in four food supplement products.² Regulatory action included informing the recipients, a public warning about the products, and destruction of the products in question. This is the second time that a European regulatory agency has recalled St. John’s wort food supplements.³

Comment: Based on the increased number of alerts for products contaminated with PAs, it appears that European authorities have started to enforce certain limits on these alkaloids. For food supplements, the maximum daily intake has been set to 1 μg/day.⁴ For herbal teas, Germany and Switzerland have adopted action limits of 350 μg/kg for rooibos, 310 μg/kg for green and black tea (Camellia sinensis, Theaceae), 270 μg/kg for chamomile (Matricaria chamomilla, Asteraceae), 160 μg/kg for herbal tea mixtures, 120 μg/kg for peppermint (Mentha × piperita, Lamiaceae), and 110 μg/kg for fennel (Foeniculum vulgare, Apiaceae).⁵ It is highly important to note that these species do not naturally contain PAs. The presence of PAs in these is due to accidental contamination, usually during the harvesting process with respect to PA-containing plants, primarily common groundsel (Senecio vulgaris, Asteraceae) and other species of the genus Senecio, growing in close proximity to the target plants. Botanical ingredient suppliers and dietary and food supplement manufacturers should be aware of the tolerance limits and take precautionary measures to keep PA levels below the permitted maximum concentrations.

References

1. Rapid Alert System for Food and Feed (RASFF). Brussels, Belgium: European Commission; 2019. https://webgate.ec.europa.eu/rasff-window/portal/index.cfm?event=notificationsList&StartRow=1. Accessed June 26, 2019.
2. Belangrijke veiligheidswaarschuwing Sint Janskruid diverse producenten. Utrecht, Netherlands: Netherlands Food and Consumer Products Safety Authority (NVWA); 2019. https://www.nvwa.nl/documenten/waarschuwingen/2019/03/01/belangrijke-veiligheidswaarschuwing-sint-janskruid-diverse. Accessed June 26, 2019.
3. Gafner S. British Medicines and Healthcare Products Regulatory Agency issues recall of St. John’s wort tablets. Botanical Adulterants Monitor. 2016;7.
4. Wilson A. Pyrrolizidine alkaloids (PAs) in herbal medicinal products. Letter to holders of a Traditional Herbal Registration (THR). London: Medicines and Healthcare Products Regulatory Agency; 2016.
5. Ruge W, Kapp T. Pyrrolizidinalkaloide in Kräutertee. Karlsruhe, Germany: Chemisches und Veterinäruntersuchungsamt Karlsruhe; 2016. http://www.ua-bw.de/pub/beitrag.asp?subid=2&Thema_ID=2&ID=2286&Pdf=No&lang=DE. Accessed June 26, 2019.