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Zum Verzehr ungeeignete Botanicals wie Cannabis und Kurkuma in Lebensmitteln – Anwendung des § 12 LFGB in Abgrenzung von Artikel 14 der Basis-Verordnung
Abstract and Figures
The assessment of foods containing botanicals above toxicological thresholds poses challenges, as administrative court decisions have set high barriers for the application of Art. 14 para. 2a or 2b of the General Food Law Regulation (EC) No 178/2002. If the application of Art. 14 para. 2b of the General Regulation is restricted by a narrow interpretation of para. 5 to contamination, putrefaction, spoilage or decomposition, a regulatory loophole emerges. The examples of tetrahydrocannabinol in hemp products with cannabidiol and curcumin in food supplements with turmeric illustrate the challenge of food regulatory evaluation, as there is no contamination by definition in the products mentioned. In such cases, where Art. 14 of the General Regulation cannot be applied, an assessment as unfit for consumption according to § 12 food and feed law (LFGB) has to be considered. The legal basis transferred to German national § 12 LFGB was historically used for the assessment of so-called disgust cases. However, § 12 LFGB is not explicitly limited to these, but is openly formulated for cases that are not subject to Art. 14 of the General Regulation. Accordingly, in the opinion of the authors, a food regulatory assessment of products containing botanicals that exceed toxicological threshold values is possible under § 12 LFGB.
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Gewürze zählen zu den am häufigsten verfälschten Lebensmitteln. In Kurkuma aus Bangladesch, einem der Hauptanbauländer, wurden laut einer aktuellen Studie Bleikontaminationen mit gesundheitlich bedenklichen Gehalten von bis zu 1 g/kg vorgefunden. Als mögliche Ursache wird eine Farbschönung mit gelbem Bleichromat (PbCrO4) angegeben. Damit kann die Farbe der getrockneten bzw. gemahlenen Kurkumawurzel der Verbrauchererwartung entsprechend verändert und gleichzeitig die Gewinnmarge erhöht werden. Aus Untersuchungen von 43 in Baden-Württemberg untersuchten Proben ergab sich bisher keinerlei Hinweis auf erhöhte Bleiwerte im Bereich der in Bangladesch beobachteten Gehalte von 1 g/kg. Alle analysierten Produkte würden der Bangladesh Standards and Testing Institution (BSTI) Höchstmenge von 2,5 mg/kg, sowie der europäischen Höchstmenge von 3,0 mg/kg für Nahrungsergänzungsmittel entsprechen.
Zusammenfassung
Seit dem 1996 aufgehobenen Anbauverbot für Pflanzen der Spezies Cannabis sativa L. (sog. Faserhanf) mit geringem Gehalt des psychoaktiven Inhaltsstoffs Δ9-Tetrahydrocannabinol (THC) wird eine Vielzahl daraus hergestellter Lebensmittel angeboten. Als Beurteilungshilfe für die amtliche Lebensmittelüberwachung werden in dieser Übersichtsarbeit alle Aspekte von Hanf als Lebensmittel diskutiert, eine Einführung in die Botanik der Hanfpflanze gegeben und die aktuelle Gesetzeslage in Deutschland und der Europäischen Union dargestellt. Forensisch-toxikologische Aspekte insbesondere hinsichtlich des Einflusses von Hanflebensmitteln auf Drogentests werden beschrieben und eine Übersicht über die analytischen Möglichkeiten zur Absicherung der THC-Richtwerte gegeben. Abschließend werden Vorschläge für die lebensmittelchemische und rechtliche Beurteilung von Hanflebensmitteln gemacht. Neue Aspekte in diesem Update betreffen insbesondere sog. Cannabidiol (CBD)-Öle und deren Novel-Food-Status. Seit 1998 wurde ein Rückgang der THC-Konzentrationen für mehrere Produktgruppen beobachtet. Die von der EU vorgeschriebene Verwendung von zertifiziertem Hanfsamen und die verstärkte Kontrolle der Hersteller haben offensichtlich zu einem deutlichen Rückgang der THC-Konzentrationen in Hanflebensmitteln geführt. Der maximale THC-Gehalt in derzeit verfügbaren traditionellen Hanflebensmitteln ist zehn- bis hundertfach niedriger als in den Studien der 1990er-Jahre. Es ist zu beachten, dass frühere GC-Studien immer die Summe von THC und THC-Säuren bestimmten. In den letzten Jahren liefern LC-MS-Methoden Informationen über den spezifischen Gehalt an THC in Hanfprodukten. Dennoch wurden seitdem immer noch Lebensmittel mit inakzeptablen THC-Gehalten vorgefunden, was zu einer ganzen Reihe von öffentlichen Warnungen im EU-Schnellwarnsystem für Lebens- und Futtermittel (RASFF) führte. Daher ist eine kontinuierliche Qualitätskontrolle erforderlich, um den THC-Wert niedrig zu halten. Dazu gehört sowohl die Verwendung von Sorten mit niedrigem THC-Gehalt als auch die richtige Saatgutreinigung. Jüngstes Interesse gilt dem CBD, das wegen seiner vermeintlich günstigen gesundheitlichen Eigenschaften vermarktet wird. Während natürliche Gehalte in den oben genannten Lebensmitteln toleriert werden, werden reine CBD-Extraktprodukte entweder als Arzneimittel oder als sogenanntes Novel Food behandelt, die beide vor dem Inverkehrbringen zugelassen werden müssen. Nicht-traditionelle Hanf-Extraktprodukte weisen zudem häufig so hohe THC-Konzentrationen auf, dass die Produkte als gesundheitsschädlich beurteilt werden müssen.
Summary
In 1996, the prohibition of the cultivation of plants of the species Cannabis sativa L. (so-called fibre hemp) with minor content of the psychoactive Δ9-tetrahydrocannabinol (THC) was lifted. Nowadays, a wide variety of hemp food products is offered on the market. As a help for evaluation of such products, this review article provides the official food control with information on all aspects of hemp as foodstuff. An introduction to the botany of the hemp plant and the current law situation in Germany and the European Union is presented. In particular, the forensic-toxicological aspects regarding the influence of hemp food on drug tests are described. Furthermore, an overview of the analytic techniques used to verify compliance with the guidance values is given. Finally, suggestions for the food regulatory and food chemical evaluation of hemp food products are made. New aspects in this update concern so-called cannabidiol (CBD) oils and their novel food status. Since 1998, a decrease in the THC concentrations for several product groups has been observed. The prescribed use of certified hemp seed by the EU and the increase of controls on manufactur-ers have obviously led to a significant decline of THC concentrations in hemp food products. The maximum THC content in currently purchasable traditional hemp food products is ten- to a hundred-fold lower than those found in the studies of the 1990s. It is of note that earlier GC studies always consider the sum of THC and THC-acids. In the last years, LC-MS methods provide information about the isolated content of THC in hemp products. Nevertheless, food products with inacceptable THC contents were still observed since then, which led to a series of public warnings in the EU Rapid Alert System for Food and Feed (RASFF). Therefore, ongoing quality control is needed to maintain low THC levels. This includes both the use of low THC varieties and proper seed cleaning. Recent interest surrounds CBD, which is purported for various health properties. While natural contents in the above-mentioned food products are tolerated, pure CBD extract products are either treated as medicines or as so-called novel food, which both need to be approved before being placed on the market. In addition, nontraditional hemp extract products often exhibited extreme THC concentrations, which must be evaluated as hazardous to health.
Background:
Food contaminants can pose a serious health threat. In order to carry out adequate risk communication measures, the subjective risk perception of the public must be taken into account. In this context, the breadth of the topic and insufficient terminological delimitations from residues and food additives make an elaborate explanation of the topic to consumers indispensable. A representative population survey used language adequate for lay people and a clear definition of contaminants to measure risk perceptions with regard to food contaminants among the general public.
Objectives:
The study aimed to assess public awareness of contaminants and the perceived health risks associated with them. In addition, people's current knowledge and need for additional information, their attitudes towards contaminants, views on stakeholder accountability, as well as compliance with precautionary measures, such as avoiding certain foods to reduce health risks originating from contaminants, were assessed.
Materials and methods:
A representative sample of 1001 respondents was surveyed about food contaminants via computer-assisted telephone interviewing.
Results:
The majority of respondents rated contaminants as a serious health threat, though few of them spontaneously mentioned examples of undesirable substances in foods that fit the scientific or legal definition of contaminants. Mercury and dioxin were the most well-known contaminants. Only a minority of respondents was familiar with pyrrolizidine alkaloids.
Conclusions:
The present findings highlight areas that require additional attention and provide implications for risk communication geared to specific target groups.
In 1996, the prohibition of the cultivation of plants of the species Cannabis sativa L. (so-called fibre hemp) with minor content of the psychoactive Delta(9)-tetrahydrocannabinol (THC) was lifted. Nowadays, a wide variety of hemp food products is offered on the market. As a help for evaluation of such products, this review article provides the official food control with information on all aspects of hemp as foodstuff. An introduction to the botany of the hemp plant and the current law situation in Germany and the European Union is presented. In particular, the forensic-toxicological aspects regarding the influence of hemp food on drug tests are described. Furthermore, an overview of the analytic techniques used to verify compliance with the guidance values is given. Finally, suggestions for the food regulatory and food chemical evaluation of hemp food products are made
The European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the risks for human health related to the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin. THC, more precisely delta-9-tetrahydrocannabinol (Δ⁹-THC) is derived from the hemp plant Cannabis sativa. In fresh plant material, up to 90 % of total Δ⁹-THC is present as the non-psychoactive precursor Δ⁹-THC acid. Since few data on Δ⁹-THC levels in foods of animal origin were available, the Panel on Contaminants in the Food Chain (CONTAM Panel) estimated acute human dietary exposure to Δ⁹-THC combining different scenarios for the presence of Δ⁹-THC in hemp seed-derived feed materials. Acute exposure to Δ⁹-THC from the consumption of milk and dairy products ranged between 0.001 and 0.03 µg/kg body weight (b.w.) per day in adults, and 0.006 and 0.13 µg/kg b.w. per day in toddlers. From human data, the CONTAM Panel concluded that 2.5 mg Δ⁹-THC/day, corresponding to 0.036 mg Δ⁹-THC/kg b.w. per day, represents the lowest observed adverse effect level. By applying an overall uncertainty factor of 30, an acute reference dose (ARfD) of 1 μg Δ⁹-THC/kg b.w. was derived. The exposure estimates are at most 3 % and 13 % the ARfD, in adults and toddlers, respectively. The CONTAM Panel concluded that exposure to Δ⁹-THC via consumption of milk and dairy products, resulting from the use of hemp seed-derived feed materials at the reported concentrations, is unlikely to pose a health concern. A risk assessment resulting from the use of whole hemp plant-derived feed materials is currently not feasible due to a lack of occurrence data. The CONTAM Panel could also not conclude on the possible risks to public health from exposure to Δ⁹-THC via consumption of animal tissues and eggs, due to a lack of data on the potential transfer and fate of Δ⁹-THC.
Recent jurisdiction confirms novel food status of hemp extracts and cannabidiol in foods - Classification of cannabis foods under narcotic law is still ambiguous
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