Risks for human health related to the presence of pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements

Abstract

EFSA was asked by the European Commission to deliver a scientific opinion on the risks for human health related to the presence of pyrrolizidine alkaloids (PAs) in honey, tea, herbal infusions and food supplements and to identify the PAs of relevance in the aforementioned food commodities and in other feed and food. PAs are a large group of toxins produced by different plant species. In 2011, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) assessed the risks related to the presence of PAs in food and feed. Based on occurrence data limited to honey, the CONTAM Panel concluded that there was a possible health concern for those toddlers and children who are high consumers of honey. A new exposure assessment including new occurrence data was published by EFSA in 2016 and was used to update the risk characterisation. The CONTAM Panel established a new Reference Point of 237 lg/kg body weight per day to assess the carcinogenic risks of PAs, and concluded that there is a possible concern for human health related to the exposure to PAs, in particular for frequent and high consumers of tea and herbal infusions. The Panel noted that consumption of food supplements based on PA-producing plants could result in exposure levels causing acute/short-term toxicity. From the analysis of the available occurrence data, the CONTAM Panel identified a list of 17 PAs of relevance for monitoring in food and feed. The Panel recommended continuing the efforts to monitor the presence of PAs in food and feed, including the development of more sensitive and specific analytical methods. A recommendation was also issued on the generation of data to identify the toxic and carcinogenic potency of the PAs commonly found in food.

Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals

“…The exposure to the components of the mixture is summed and the value of 10,000 would again be applied. A recent application of this approach is illustrated in the Opinion of the Scientific Panel on Contaminants in the Food Chain on human risk assessment of pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements (EFSA CONTAM Panel, ). If BMDL values are available for all of the genotoxicants in the mixture, then the MOET can be calculated as the reciprocal of the sum of the reciprocals of the MOE of the individual chemical substances, applying the default assumption of dose addition.…”

“…In the human risk assessment field, recent examples include the Opinion of the Panel on Plant Protection Products and their Residues (PPR) dealing with an approach to group pesticides into ‘cumulative assessment groups’ based on the compounds’ toxicological properties (EFSA PPR Panel, ,b). The Panel on Contaminants in the Food Chain (CONTAM) published a number of Opinions involving case‐by‐case approaches to the human risk assessment of multiple contaminants using both whole mixture‐based and component‐based approaches (EFSA, , ; EFSA CONTAM Panel, , , , ). Finally, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) addressed the human risk assessment of combined exposure to rum ether [Flavouring Group Evaluation 500 (FGE.500)] for 84 reported constituents using component‐based approaches for 12 congeneric groups allocated based on structural and metabolic similarity (EFSA CEF Panel, ).…”

Analysis of Pyrrolizidine Alkaloids in Queensland Honey: Using Low Temperature Chromatography to Resolve Stereoisomers and Identify Botanical Sources by UHPLC-MS/MS

“…Various food products can contain toxic PAs either directly from plant origin (certain herbs, herbal medicines) or indirectly through natural transfer from floral nectar and pollen (e.g., some honey, pollen dietary supplements) or inadvertent cross-contamination (e.g., grains, herbs, teas) [4]. The Australian provisional tolerable daily intake of pyrrolizidine alkaloids is 1 µg/kg Bw/day [5], whilst the recommended European accepted intake is 150 times lower at 0.007 µg/kg Bw/day [6][7][8], although this has been recently revised [9,10].…”

“…The distribution of these PA containing plants varies throughout the country and different alkaloids would be expected in honey from tropical/sub-tropical Queensland regions as compared to honey originating from southern temperate states. Given that honey represents a significant food source of human exposure to PAs [10], identification of plant PA sources to reduce this exposure is crucial.…”

EFSA's activities on emerging risks in 2017

“…The EFSA session organised under the 2017 IAFP European Symposium on Food Safety (EFSA, 2017) highlighted that the successful identification of risks at their early inception is at the heart of public health protection and is becoming increasingly important in food safety management.…”