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Safety of Herbal Preparations on the Dutch Market

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Safety of Herbal Preparations on the Dutch Market Safety of herbal preparations on the Dutch market Martijn J. Martena Thesis commiTTee Thesis supervisor Prof. dr. ir. I.M.C.M. Rietjens Professor of Toxicology, Wageningen University Thesis co-supervisor Dr. E.J.M. Konings Group Manager, Method Management Group - Quality and Safety department, Nestlé Research Center, Lausanne, Switzerland oTher members Prof. dr. R.F. Witkamp, Wageningen University Prof. dr. M.B. Katan, VU University Amsterdam Prof. dr. P.W.J. Peters, Den Haag Prof. dr. B.J. Blaauboer, Utrecht University This research was conducted under the auspices of the Graduate School VLAG (Nutrition, Food Technology, Agrobiotechnology, and Health Sciences) Safety of herbal preparations on the Dutch market Thesis submitted in fulfillment of the requirements for the degree of doctor at Wageningen University by the authority of the Rector Magnificus Prof. dr. M.J. Kropff, in the presence of the Thesis Committee appointed by the Academic Board to be defended in public on Wednesday 15 December 2010 at 1:30 p.m. in the Aula Martijn J. Martena Safety of herbal preparations on the Dutch market 224 pages. Thesis Wageningen University, Wageningen, NL (2010) With abstract, with references, with summaries in Dutch and English ISBN 978-90-8585-822-5 ABSTRACT The use and availability of herbal preparations covered by food law is increasing in the Netherlands and in other European Member States. Correspondingly, safety concerns relating to herbal preparations are growing as well. The aim of the present PhD project was therefore to review the toxicity of selected herbal preparations, to investigate the presence and actual levels of selected naturally-occurring toxic substances and contaminants in herbal preparations on the Dutch market and to estimate the associated risks. First, an overview is provided of the Dutch and European legal provisions for food commodities with botanical ingredients, the nature and mechanism of action of various toxic botanical ingredients specifically covered by these provisions, and the health concerns defined by risk assessors related to several botanicals for which no specific legal provisions exist. Secondly, data are presented on the actual occurrence in traditional herbal preparations (THPs) of a group of phytotoxins, i.e. aristolochic acids, which were banned by the Dutch Commodities Act Decree ‘Herbal preparations’. Aristolochic acids and derivatives are nephrotoxic, genotoxic and carcinogenic and are present in several plants from the Aristolochiaceae family. Aristolochic acids were found in 25 of 190 THPs used in Traditional Chinese Medicine (TCM) sampled on the Dutch market. This shows that testing for aristolochic acids of Chinese THPs at risk of contamination is essential in the framework of food safety. Thirdly, the presence of selected toxic contaminants in herbal preparations on the Dutch market was investigated. Lead, mercury and arsenic levels were analyzed in THPs used in several Asian traditional medicine systems, such as Ayurveda, TCM, and Traditional Tibetan Medicine (TTM). These metals and metalloids were present in 186 (64%) of 292 THPs and use at recommended dose levels of 59 THPs (20%) would result in intakes of these contaminants significantly above established toxicological safety limits. It was concluded that the mercury, arsenic and lead contents of these Asian THPs are cause for concern. Because metals such as mercury can exist in various defined chemical species with different toxic properties, a study was performed using selective acid extraction procedures to determine the presence or absence of the relatively non-toxic elemental form of mercury in 19 Ayurvedic THPs, which were shown in the previous study to result in mercury intakes above the safety limit for inorganic mercury when used at the recommended daily dose level. It was concluded that in these THPs the main part of the mercury content is not present in the elemental form, that the mercury detected in Ayurvedic THPs is likely to be present in the inorganic form and that therefore the estimation of the related risks based on the safety limits for inorganic mercury is justified. In the last study of this PhD thesis, polycyclic aromatic hydrocarbons (PAH) were determined in more than 1500 food supplements sampled on the Dutch market, many of which contained herbal ingredients. Herbal preparations can become contaminated with PAH through various processes including direct atmospheric deposition on plant surfaces and drying practices during manufacturing. Several PAH, such as benzo[a]pyrene are genotoxic and carcinogenic. Supplements containing herbal ingredients such as St. John’s wort and Ginkgo biloba, the phytochemical resveratrol and the bee product propolis showed the highest mean PAH levels. It was shown that individual food supplements can contribute significantly to PAH exposure, whereas on average PAH intake resulting from food supplement use will be at the lower end of the range of contributions of main food groups to PAH exposure. From the work described in this thesis it can be concluded that for herbal preparations ‘natural’ does not equal ‘safe’. Given that uncertainty exists whether additional European legal measures will be taken in the near future to restrict or prohibit the use of specific toxic herbal substances in foods and the fact that several herbal preparations for which specific provisions are absent in Dutch food safety law raise toxicological concern, would suggest that it is prudent to keep the Dutch Decree ‘Herbal preparations’ and other national legislation up to date in order to protect consumers from serious risks resulting from use of botanicals in food products such as herbal preparations. CONTENTS Chapter 1 General introduction 9 Chapter 2 The Dutch and European regulatory framework for selected food commodities 19 with botanical ingredients Chapter 3 Molecular mechanisms of toxicity of important food-borne phytotoxins 45 Chapter 4 Determination of aristolochic acids in Chinese traditional herbal preparations on 97 the Dutch market Chapter 5 Monitoring of mercury, arsenic and lead in traditional Asian herbal preparations 121 on the Dutch market and estimation of associated risks Chapter 6 Detection of elemental mercury in selected traditional Ayurvedic herbal 149 preparations Chapter 7 Monitoring of Polycyclic Aromatic Hydrocarbons (PAH) in food supplements with 161 botanicals and other ingredients on the Dutch market Chapter 8 Summary and general discussion 187 Samenvatting en discussie 203 Dankwoord 219 Curriculum vitae 221 List of publications 222 CHAPTER 1 General introduction Introduction This PhD thesis focuses on the safety of selected herbal preparations on the Dutch market. It concerns exclusively herbal preparations that are used orally and which are regulated by Dutch food law. Because a significant part of the research included in the project involves official controls by the Voedsel en Waren Autoriteit (VWA) – the Dutch Food and Consumer Safety Authority – safety concerns regarding herbal preparations are also approached from a legal perspective. The European Food Safety Authority (EFSA) recognized in 2004 that a large number of botanical materials and botanical preparations obtained from these materials by various processes were finding their way onto the food supplement market and that safety concerns existed for several of these products. The safety concerns related to botanicals and botanical preparations essentially relate to i) the presence of naturally-occurring toxic substances in plants, ii) the intentional addition or accidental occurrence of toxic contaminants and iii) interactions of botanical ingredients with active ingredients from medicinal products (herbal food-drug interactions) [1]. In the Netherlands, safety concerns related to specific herbal preparations including several issues referred to by EFSA such as the presence of toxic pyrrolizidine alkaloids or aristolochic acids in herbal preparations were addressed in 2001 by the Commodities Act Decree ‘Herbal preparations’ [1, 2]. Furthermore, the Decree prohibits the placing on the market of any herbal preparation that contains herbal substances in amounts that are detrimental to health [2]. The aim of the present PhD project was to review the toxicity of selected herbal preparations, to investigate the presence and actual levels of selected contaminants and naturally-occurring toxic substances in herbal preparations on the Dutch market and to estimate the associated risks. Legal framework for herbal preparations and related botanical products The Dutch Commodities Act and its subordinate Decrees and Directives fall under the responsibility of the Ministry of Health. The Act regulates foods and a wide array of other commodities. The Commodities Act Decree ‘Herbal preparations’ (in Dutch: ‘het Warenwetbesluit Kruidenpreparaten’) covers herbal preparations that are brought on the market as foods and non-food products [2]. The Decree defines herbal preparations as ‘herbal substances, subjected to treatment or not, including herbal extracts, which are intended to be used by humans’. In addition, ‘herbal substances’ are defined as ‘substances that are composed of plant material’. According to EFSA, the term ‘botanical’ includes all botanical materials (e.g. whole, fragmented or cut plants, plant parts, algae, fungi and lichens) and the term ‘botanical preparation’ includes all preparations obtained from botanicals by various processes (e.g. pressing, squeezing, extraction, fractionation, distillation,
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