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3. Zum Verzehr ungeeignete Botanicals wie Cannabis und Kurkuma in Lebensmitteln – Anwendung des § 12 LFGB in Abgrenzung von Artikel 14 der Basis-Verordnung: Foods containing botanicals such as cannabis and turmeric that are unsuitable for consumption – application of § 12 LFGB in demarcation from article 14 of the general food law regulation

Author

Beisel, Julia M., Schaumann, Theresa, Bock, Verena, Rajcic de Rezende, Tabata, Sproll, Constanze, Walch, Stephan G., and Lachenmeier, Dirk W.

Published
2023
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5. Updated Risk Assessment of Cannabidiol in Foods Based on Benchmark Dose–Response Modeling.

Author

Wisotzki, Eva, Franke, Heike, Sproll, Constanze, Walch, Stephan G., and Lachenmeier, Dirk W.

Subjects
CANNABIS (Genus), GRAY market, CONFIDENCE intervals, CONSUMER protection, RISK assessment, CANNABIDIOL
Abstract

Cannabidiol (CBD), a non-psychotropic main component of the Cannabis plant, has been approved as a drug in the European Union (EU) under the name "Epidyolex". However, its approval process as a food ingredient under the Novel Food Regulation was paused by the European Food Safety Authority (EFSA) due to a lack of safety data. Nevertheless, there is a growing, unregulated market in which CBD is advertised with various health claims and dosage instructions. Of particular concern is its toxic effect on the liver and possible reproductive toxicity in humans. Studies suitable for calculating the benchmark dose were identified from the available data. Animal studies yielded a benchmark dose lower confidence limit (BMDL) of 43 mg/kg bw/day, which translates into a safe human dose of approximately 15 mg/day. Only the Lowest-Observed-Adverse-Effect Level (LOAEL) of 4.3 mg/kg bw/day could be identified from the human data. This updated risk assessment confirmed a health-based guidance value (HBGV) of 10 mg/day based on human LOAEL. Despite the existing data gaps, preliminary regulation appears advisable because the current form of the gray CBD market is unacceptable from the standpoint of consumer safety and protection. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Cannabidiol (CBD) in Lebensmitteln - Beurteilung der Sicherheit: Gesundheitsschädlich bei über 300 mg/Tag

Author

Dietz, Tabea, Gerstenlauer, Janin, Sproll, Constanze, Walch, Stephan G., and Lachenmeier, Dirk W.

Subjects
food safety, tetrahydrocannabinol, food supplements, cannabidiol, benchmark dose, health-based guidance value, risk assessment, reference dose, Cannabis sativa, liver toxicity
Abstract

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.

Published
2022
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28. The Novel Food Regulation: A Major Obstacle to Sustainability in the Coffee Industry †.

Author

Lachenmeier, Dirk W. and Walch, Stephan G.

Subjects
*COFFEE industry, *AGRICULTURAL wastes, *TRADE regulation, *SUSTAINABILITY, *INSECT-plant relationships
Abstract

The global shortage of agricultural source products and the rising need for sustainability in supply chains have led to an effort to replace current sources, such as those for energy or protein, with novel foods. These include by-products from agricultural production that are currently being wasted or completely new plant or insect sources. Unfortunately, the novel food regulation of the European Union (EU) creates a hindrance to rapidly adjusting in times of crisis, and it particularly poses an unfair barrier against traditional foods from third countries. These might include some agricultural coffee by-products or the use of silverskin as a coffee roasting by-product. This presentation argues that the novel food regulation creates a significant trade barrier for applying novel foods, such as coffee by-products, to replace sources affected by current crises, like grains from Ukraine, or to improve sustainability in the industry at large. Furthermore, it is suggested that the approval requirements for traditional foods of third countries are overly strict and do not consider the practical realities of an agricultural food product. In conclusion, it is necessary to revise the EU novel food regulation to eliminate these barriers and allow a rapid and flexible introduction of novel foods. This should include traditional foods from third countries. Such a revision would assist in upholding food security and sustainability in the EU. [ABSTRACT FROM AUTHOR]

Published
2023
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32. Hanfhaltige Lebensmittel. Weiteres Update zur Verkehrsf��higkeit nach Entscheidungen des EuGH und BGH

Author

Lachenmeier, Dirk W., Golombek, Patricia, and Walch, Stephan G.

Subjects
narcotic, risk assessment, hemp, Cannabis sativa
Abstract

Produkte mit Hanfextrakt sind als neuartige Lebensmittel ohne Zulassung weiter nicht verkehrsf��hig. Der Europ��ische Gerichtshof schlie��t aber die Einstufung von Cannabidiol als Bet��ubungsmittel aus. F��r Hanfbl��tter und -bl��ten muss laut BGH ein Missbrauch zu Rauschzwecken ausgeschlossen werden, jedoch ist dann gegebenenfalls eine Abgabe auch an Endverbraucher m��glich.

Published
2021
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35. Rapid Approach to Determine Propionic and Sorbic Acid Contents in Bread and Bakery Products using ¹H NMR Spectroscopy

Author

Scharinger, Marwa, Kuntz, Marcel, Scharinger, Andreas, Teipel, Jan, Kuballa, Thomas, Walch, Stephan G., and Lachenmeier, Dirk W.

Subjects
analytical_chemistry, digestive, oral, and skin physiology, food and beverages
Abstract

The food additive sorbic acid is considered as an effective preservative for certain cereal products, and propionic acid is commonly added in bakery wares, e.g. bread and fine bakery wares. The aim of this study is to develop and validate a new nuclear magnetic resonance spectroscopy (¹H NMR) method for routine screening and quantification of sorbic and propionic acids in bread and several bakery products for quality control purposes. Results showed that none of the screened samples contained higher concentrations than regulatory maximum limits. However, for some samples, labelling of preservatives was lacking or they were used in food categories, for which the use is not approved. It can be concluded that the developed NMR method can be used for routine screening of bakery products.

Published
2021

39. Application of 1H Nuclear Magnetic Resonance Spectroscopy as Spirits Screener for Quality and Authenticity Control

Author

Teipel, Jan C., Hausler, Thomas, Sommerfeld, Katharina, Scharinger, Andreas, Walch, Stephan G., Lachenmeier, Dirk W., and Kuballa, Thomas

Subjects
food_chemistry
Abstract

Due to legal regulations, the rise of globalised (online) commerce and the need for public health protection, the analysis of spirits (alcoholic beverages > 15 % vol) is a task with growing importance for governmental and commercial laboratories. In this article a newly developed method using nuclear magnetic resonance (NMR) spectroscopy for the simultaneous determination of 15 substances relevant for the quality and authenticity assessment of spirits is described. The new method starts with a simple and rapid sample preparation and does not need an internal standard. For each sample a group of 1H-NMR spectra is recorded, among them a 2D spectrum for analyte identification and 1D spectra with suppression of solvent signals for quantification. Using the Pulse Length Based Concentration Determination (PULCON) method, concentrations are calculated from curve fits of the characteristic signals for each analyte. The optimisation of the spectra, their evaluation and the transfer of the results are done fully automatically. Glucose, fructose, sucrose, acetic acid, citric acid, formic acid, ethyl acetate, ethyl lactate, acetaldehyde, ethanol, methanol, n-propanol, isobutanol, isopentanol, 2-phenylethanol and 5-(hydroxymethyl)furfural (HMF) can be quantified with an overall accuracy better than 8 %. This new NMR-based targeted quantification method enables the simultaneous and efficient quantification of relevant spirits ingredients in their typical concentration ranges in one process with good accuracy. It has proven to be a reliable method for all kinds of spirits in routine food control.

Published
2020

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