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Novel Food Catalogue "Cannabinoids"
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Zusammenfassung
Im Novel-Food-Katalog der Europäischen Kommission sind Cannabidiol (CBD) und Hanfextraktprodukte als neuartig eingestuft und benötigen somit vor dem ersten Inverkehrbringen eine Zulassung. Vonseiten der Lebensmittelunternehmen wird aber eine Vielzahl derartiger Produkte ohne Zulassung in den Verkehr gebracht und von der amtlichen Ü...
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Objectives
Use of Cannabis is common amongst athletes and the U.S. population at large. Use of Cannabinoid Oil is being increasingly utilized for a number of different pathologies, injuries, and ailments due to anecdotal evidence of its efficacy. Due to the current United States Opioid crisis, Δ9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD), th...
Citations
... The novelty of a food is determined by the absence of a significant history of consumption prior to 15 May 1997 [2]. Extracts and derived products containing cannabinoids, such as cannabidiol (CBD), as well as isolated or fully synthetic cannabinoids, are considered novel foods [3]. Therefore, CBD products intended to be marketed as food or food supplements in the EU require prior authorisation. ...
In the European Union (EU), cannabidiol (CBD) products extracted from Cannabis sativa L. require pre-marketing authorisation under the novel food regulation. Currently, 19 CBD applications are being assessed by the European Food Safety Authority (EFSA). During the initial assessment of the dossiers, the EFSA Panel on Nutrition, Novel Foods, and Food Allergens (NDA) identified several knowledge gaps that need to be addressed before the evaluation of CBD can be finalised. The effects of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system need to be clarified. The contribution of this research is to provide an evidence-based assessment of the potential risks associated with CBD products, and to provide recommendations for risk management in the European Union while awaiting the finalisation of novel food applications. The available literature allows for a benchmark dose (BMD)-response modelling of several bioassays, resulting in a BMD lower confidence limit (BMDL) of 20 mg/kg bw/day for liver toxicity in rats. Human data in healthy volunteers showed increases in the liver enzymes alanine aminotransferase and aspartate aminotransferase in one study at 4.3 mg/kg bw/day, which was defined by the EFSA NDA panel as the lowest observed adverse effect level (LOAEL). The EFSA NDA panel recently concluded that the safety of CBD as a novel food cannot be assessed, resulting in a so-called clock stop for the applications until the applicants provide the required data. The authors suggest that certain CBD products still available on the EU market as food supplements despite the lack of authorisation should be considered "unsafe". Products exceeding a health-based guidance value (HBGV) of 10 mg/day should be considered "unfit for consumption" (Article 14(1) and (2)(b) of Regulation No. 178/2002), while those exceeding the human LOAEL should be considered "injurious to health" (Article 14(1) and (2)(a) of Regulation No 178/2002).
... An excellent example to highlight several deficits of the novel food regulation, its implementation and enforcement, is the case of cannabidiol (CBD) products based on hemp extracts from Cannabis sativa plant parts or on chemically synthesised CBD. According to the novel food catalogue and numerous administrative court decisions, these products are clearly assigned as being novel foods because the food business operators failed to provide evidence regarding a history of consumption before 15 May 1997 [13]. All novel food applications of CBD are currently in a clock stop because the data submitted to the European Food Safety Authority were insufficient for safety assessment [14]. ...
The current novel food regulation in the European Union (EU) is not an adequate barrier to prevent manufacturing and the market appearance of unapproved novel food products, such as cannabidiol products. However, the novel food regulation appears to be an effective barrier against the import of traditional foods from third countries into the EU. Apart from climate change, the global food system is currently experiencing an unprecedented series of crises, first due to coronavirus SARS-CoV-2 (COVID-19) pandemic and second due to the ongoing Russia–Ukraine war. The novel food regulation of the European Union (EU) provides a barrier to rapid reactions in such times of crises, e.g. from substituting traditional carbohydrate and protein sources with agricultural products from third countries such as coffee by-products. These and several other aspects necessitate another revision of the regulation. Specifically, the approval of traditional foods from third countries should not unnecessarily be bound to certain food categories, and traditional foods from third countries should not be penalised compared to traditional foods from within the EU.
... At present, foods containing cannabidiol (CBD) and other cannabinoids are internationally being widely advertised and sold in increasing quantities [9]. In the European Union (EU), these products require pre-marketing authorization under the novel food regulation, so all available CBD oils and CBD-containing food supplements in the EU are currently placed on the market with an infringement of food laws [10]. Currently, 19 CBD applications are being evaluated by the European Food Safety Authority (EFSA) [11]. ...
The purpose of the conference session summarized in this article was to bring together international experts on food toxicology and food safety and share the current scientific knowledge on these topics. The presentations covered a wide range of interdisciplinary issues, including (i) the impact of diet on body weight and health outcomes including results from animal models of carcinogenesis, (ii) methods for microbial oil extraction, (iii) food processing and its impact on food safety and health, (iv) novel compounds to avoid mycotoxin contamination of agricultural products, and (v) the safety of cannabidiol in food supplements based on Cannabis sativa extracts. Some of the conclusions of the presentations included that correct food choices may impact on the risk of non-communicable diseases such as cancer, that food processing may have an influence on health, by either reducing or increasing risks, and that research regarding novel compounds is important, which may have preventive but also detrimental effects on health.
... Regarding the hemp plant Cannabis sativa L., only the seeds and seedderived products have a history of consumption and are treated as "not novel". In contrast, extracts and derived products containing cannabinoids, such as cannabidiol (CBD), but also synthetic cannabinoids are considered novel foods [3]. Hence, CBD products, which are intended to be marketed as foods or food supplements in the EU, need prior 2 of 8 authorisation. ...
In the European Union (EU), cannabidiol products require pre-marketing authorisation under the novel food regulation. Currently, 19 CBD applications are under assessment at the European Food Safety Authority (EFSA). During the initial assessment of the application files, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) located several knowledge gaps in their 07 June 2022 statement on safety of cannabidiol as a novel food that need to be addressed before the evaluation of CBD can be concluded. Namely, the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system needs to be clarified. Nevertheless, the available literature allows a benchmark dose (BMD)-response modelling of several bioassays, resulting in a BMD lower confidence limit (BMDL) of 20 mg/kg bw/day for liver toxicity in rats. Human data in healthy volunteers found increases in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in a study at 4.3 mg/kg bw/day, which was defined by EFSA NDA panel as a lowest observed adverse effect level (LOAEL). The EFSA NDA panel currently concluded that the safety of CBD as a novel food cannot be evaluated, leading to a so-called clock stop of the applications until the applicants provide the required data. Meanwhile, the authors suggest that CBD products still available as food supplements on the EU market despite the lack of authorisation must be considered as “unsafe”. Products exceeding a health-based guidance value of 10 mg/day must be considered as being “unfit for consumption” (Article 14(1) and (2) (b) of Regulation No 178/2002), while the ones in exceedance of the human LOAEL must be considered “injurious to health” (Article 14(1) and (2) (a) of Regulation No 178/2002).
... Bei der Hanfpflanze Cannabis sativa L. haben nur die Samen und die daraus gewonnenen Produkte eine Verzehrsgeschichte und werden als "nicht neuartig" angesehen. Im Gegensatz dazu werden Extrakte und daraus hergestellte Produkte, die Cannabinoide wie CBD, aber auch synthetische Cannabinoide enthalten, als neuartige Lebensmittel eingestuft [9]. Daher benötigen CBD-Produkte, die in der EU als Lebensmittel oder Nahrungsergänzungsmittel vermarktet werden sollen, eine vorherige Zulassung. ...
Die EFSA hat aktuell die Bewertung sämtlicher Novel-Food-Anträge zu CBD ausgesetzt (sog. Clock-Stop), da der Behörde keine ausreichenden Daten über die Sicherheit von CBD in Bezug auf zahlreiche Organsysteme des Menschen vorgelegt wurden, die im Tierversuch festgestellte Gefahren gesundheitsschädlicher Wirkungen widerlegen würden. Dieser Beitrag schlägt toxikologische Schwellenwerte vor, bei deren Überschreitung CBD-Produkte bereits zu diesem Zeitpunkt als nicht sichere Lebensmittel beurteilt werden können.
... Regarding the hemp plant Cannabis sativa L., only the seeds and seedderived products have a history of consumption and are treated as "not novel". In contrast, extracts and derived products containing cannabinoids, such as cannabidiol (CBD), but also synthetic cannabinoids are considered novel foods [3]. Hence, CBD products to be marketed as foods or food supplements in the EU, need prior authorisation. ...
At present, foods containing cannabidiol (CBD) and other cannabinoids are internationally being widely advertised and sold in increasing quantities. In the European Union (EU), these products require pre-marketing authorisation under the novel food regulation, so that all available CBD oils and CBD-containing food supplements in the EU are currently placed on the market with an infringement of the food laws. Currently, 19 CBD applications are under assessment at the European Food Safety Authority (EFSA). During the initial assessment of the application files, EFSA located several knowledge gaps that need to be addressed before the safety evaluation of CBD can be concluded. Namely, the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system needs to be clarified. Nevertheless, the available literature allows a benchmark dose (BMD)-response modelling of several bioassays, resulting in a BMD lower confidence limit (BMDL) of 20 mg/kg bw/day for liver toxicity in rats. Human data in healthy volunteers found increases in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in a study at 4.3 mg/kg bw/day, which was defined by EFSA as a lowest observed adverse effect level (LOAEL). The EFSA panel currently concluded that the safety of CBD as a novel food cannot be evaluated, leading to a so-called clock stop of the applications until the applicants provide the required data. Meanwhile, the authors suggest that CBD products still available on the EU market despite the lack of authorisation must be considered as “unsafe”. Products exceeding a reference dose of 10 mg/day must be considered as being “unfit for consumption” (Article 14(1) and (2) (b) of Regulation No 178/2002), while the ones in exceedance of the human LOAEL must be considered “injurious to health” (Article 14(1) and (2) (a) of Regulation No 178/2002).
... Regarding the hemp plant Cannabis sativa L., only the seeds and seedderived products have a history of consumption and are treated as "not novel". In contrast, extracts and derived products containing cannabinoids, such as cannabidiol (CBD), but also synthetic cannabinoids are considered novel foods [3]. Hence, CBD products to be marketed as foods or food supplements in the EU, need prior authorisation. ...
At present, foods containing cannabidiol (CBD) and other cannabinoids are internationally being widely advertised and sold in increasing quantities. In the European Union (EU), these products require pre-marketing authorisation under the novel food regulation, so that all available CBD oils and CBD-containing food supplements in the EU are currently placed on the market with an infringement of the food laws. Currently, 19 CBD applications are under assessment at the European Food Safety Authority (EFSA). During the initial assessment of the application files, EFSA located several knowledge gaps that need to be addressed before the safety evaluation of CBD can be concluded. Namely, the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system needs to be clarified. Nevertheless, the available literature allows a benchmark dose (BMD)-response modelling of several bioassays, resulting in a BMD lower confidence limit (BMDL) of 20 mg/kg bw/day for liver toxicity in rats. Human data in healthy volunteers found increases in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in a study at 4.3 mg/kg bw/day, which was defined by EFSA as a lowest observed adverse effect level (LOAEL). The EFSA panel currently concluded that the safety of CBD as a novel food cannot be evaluated, leading to a so-called clock stop of the applications until the applicants provide the required data. Meanwhile, the authors suggest that CBD products still available on the EU market despite the lack of authorisation must be considered as “unsafe”. Products exceeding a reference dose of 10 mg/day must be considered as being “unfit for consumption” (Article 14(1) and (2) (b) of Regulation No 178/2002), while the ones in exceedance of the human LOAEL must be considered “injurious to health” (Article 14(1) and (2) (a) of Regulation No 178/2002).
... The most prominent representative among the class of these compounds is Δ 9 -tetrahydrocannabinol (Δ 9 -THC, Figure 1b), which is hydrogenated in positions 6a and 7 [1]. Due to the well-known psychotropic properties of Δ 9 -THC, only the cultivation of plant varieties with low contents of Δ 9 -THC is authorized in the European Union (EU) at the moment [2,3]. There is a discrepancy in terms of the legality of products derived from the hemp plant. ...
... Since then, so-called CBD extracts used as a food constituent, in cosmetic products or in the liquids for electronic cigarettes are found with a large variety in drug stores or in online shops [19][20][21]. According to the Novel Food Regulation (EU) 2015/2283, an approval of CBD extracts for the use in food requires a history of food consumption prior to May 1997 [3,22]. Thus, as such a history has not been demonstrated so far, CBD extracts are classified as Novel Food and are therefore not authorized in the EU. ...
Cannabidiol (CBD) is a naturally occurring, non-psychotropic cannabinoid of the hemp plant Cannabis sativa L. and has been known to induce several physiological and pharmacological effects. While CBD is approved as a medicinal product subject to prescription, it is also widely sold over the counter (OTC) in the form of food supplements, cosmetics and electronic cigarette liquids. However, regulatory difficulties arise from its origin being a narcotic plant or its status as an unapproved novel food ingredient. Regarding the consumer safety of these OTC products, the question whether or not CBD might be degraded into psychotropic cannabinoids, most prominently tetrahydrocannabinol (THC), under in vivo conditions initiated an ongoing scientific debate. This feature review aims to summarize the current knowledge of CBD degradation processes, specifically the results of in vitro and in vivo studies. Additionally, the literature on psychotropic effects of cannabinoids was carefully studied with a focus on the degradants and metabolites of CBD, but data were found to be sparse. While the literature is contradictory, most studies suggest that CBD is not converted to psychotropic THC under in vivo conditions. Nevertheless, it is certain that CBD degrades to psychotropic products in acidic environments. Hence, the storage stability of commercial formulations requires more attention in the future.
