Updated Risk Assessment of Cannabidiol in Foods Based on Benchmark Dose-Response Modeling.

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.

Risk Assessment of Pulegone in Foods Based on Benchmark Dose-Response Modeling.

This study presents a new risk assessment of pulegone, a substance classified as possibly carcinogenic to humans (Group 2B) by the WHO International Agency for Research on Cancer (IARC). The analysis used data from a two-year carcinogenicity studies in rats and mice conducted by the National Toxicology Program (NTP) in 2011. Because of the absence of a no-observed adverse effect level (NOAEL) in these studies, the benchmark dose (BMD) approach was employed as an alternative risk assessment method. The lowest BMD lower confidence level (BMDL) of 4.8 mg/kg b.w./day among the eight endpoints served as the point of departure for calculating an acceptable daily intake (ADI) of 48 µg/kg b.w./day. This new ADI is significantly lower than the previously established tolerable daily intake of 0.1 mg/kg b.w./day set in 1997. The analysis also considered various genotoxicity studies, which indicate that pulegone's effects follow a nongenotoxic, thresholded mechanism. The estimated intake levels of pulegone in the European Union and USA were below the newly calculated ADI, suggesting a low health risk based on current consumption patterns.

The Paradox of Alcohol and Food Affordability: Minimal Impact of Leading Beer and Cachaça Brands on Brazilian Household Income Amid Hazardous Drinking Patterns.

Alcohol consumption, associated with various cancers, mental disorders, and aggressive behavior, leads to three million deaths globally each year. In Brazil, the alcohol per capita consumption among drinkers aged 15 and over is 41.7 g of pure alcohol/day (~1 L beer/day), which falls into the risky consumption category and exceeds the global average by almost 30%. An effective way to mitigate alcohol-related harm is to increase its retail price. This study assesses the costs of consuming leading brands of beer and sugarcane spirit cachaça (Brazil's most popular alcoholic beverages) against the expenditure on staple foods. Data on food and alcoholic beverage prices were collected in João Pessoa, Brazil, for 2020 and 2021. The cost per gram of pure alcohol and food were considered to establish consumption patterns of 16.8 g/day (moderate), 41.7 g/day, and 83.4 g/day (heavy), distributed in three scenarios involving the beverages alone or combined (64% beer and 36% cachaça), and a balanced 2000 kcal/day staple diet. The study finds that all heavy consumption scenarios cost less or significantly less (cachaça alone) than a 2000 kcal/day staple diet, highlighting an urgent need for fiscal policies, such as a minimum unit pricing for alcohol, to address public health concerns.

Influence of short-term chronic oral cannabidiol application on muscle recovery and performance after an intensive training protocol - a randomized double-blind crossover study.

BACKGROUND: Rapid regeneration after intense exercise is essential for competitive athletes. Based on this assumption, supplementation strategies, focusing on food supplements, are increasing to improve the recovery processes. One such supplement is cannabidiol (CBD) which is gaining more attention in competitive sports. However, the evidence is still lacking and there are no data available about the effect of a short-term chronic application. METHODS: A three-arm double-blind cross-over study was conducted to determine the effects of two different CBD products on performance, muscle damage and inflammatory processes in well-trained athletes. In total 17 subjects took successfully part in this study. Each subject underwent the six-day, high-intensity training protocol three times. After each training session, each subject took either a placebo or a CBD product (60 mg of oil or solubilisate). Between the intervention phases, at least four weeks of washout period was conducted. Before and after the training protocols the performance capacity in countermovement jump (CMJ), back squat (BS), bench press (BP) and 1-mile run were measured and biomarkers for muscle damage (creatine kinase, myoglobin), inflammatory processes (interleukin 6 and 10) and immune cell activity (ratios of neutrophil granulocytes, lymphocytes and, platelets) were analyzed. For statistical analyses, the current version of R and a linear mixed model was used. RESULTS: It could identify different effects of the training protocol depending on performance level (advanced or highly advanced athletes) (p < .05). Regardless of the performance level, muscle damage and a reduction in performance could be induced by the training protocol. Only CBD oil was associated with a reduction in myoglobin concentration (p < .05) in advanced athletes. Concerning immune activity, a significant decrease in platelets lymphocyte ratios was observed in advanced athletes after placebo treatment (p < .05). CBD oil application showed a slight inhibitory effect (p < .10). Moreover, the reduction in performance differs between the performance levels. A significant decrease in CMJ was observed in advanced athletes and a decreasing trend in BS was observed in highly advanced athletes after placebo treatment (p < 0.10). Both CBD products do not affect performance parameters. For inflammatory parameters, no effects were observed. CONCLUSION: It was found that the performance level of the subjects was a decisive factor and that they responded differently to the training protocol and the CBD application. However, no clear effects of either CBD product were found and further research is needed to identify the long-term effects of CBD application.

Shaping the Future of Coffee: Climate Resilience, Liberica's Rise, and By-Product Innovation-Highlights from the International Coffee Convention 2023 (ICC2023).

The International Coffee Convention 2023 comprehensively addressed the contemporary challenges and advancements in the coffee industry, emphasizing sustainability, health, and innovation. This convention gathered experts and stakeholders to explore diverse aspects of coffee, ranging from the potential of underutilized species like Coffea liberica in terms of climate resilience to the innovative use of coffee by-products. The convention featured presentations and discussions, employing both empirical research and analytical reviews to explore various topics, including the health benefits of coffee, the advancements in traceability and authentication methods, and the impact of global regulatory changes on coffee production and trade. The key findings highlighted the importance of biodiversity in coffee production as a response to climate change, the significant health benefits and sustainability potential of coffee by-products, and the evolving landscape of coffee consumption patterns driven by technological innovations. The convention also stressed the need for alignment in global coffee trade regulations, particularly concerning deforestation and traceability. The 2023 convention underscored the complexity and interconnectivity of the coffee industry's challenges and opportunities. It concluded with a forward-looking perspective, emphasizing the need for continued research, sustainable practices, and collaborative efforts to shape the future of the coffee industry. The community is looking forward to furthering these discussions at the next International Coffee Convention in 2024.

Quantitative NMR Spectrometry of Phenylpropanoids, including Isoeugenol in Herbs, Spices, and Essential Oils.

Isoeugenol (2-methoxy-4-(1-propenyl)phenol) has been recently classified as possibly carcinogenic to humans (Group 2B) by the International Agency for Research on Cancer (IARC). This study conducted an analysis of isoeugenol in common herbs and spices, including basil, cinnamon, ginger, and nutmeg, using 1H nuclear magnetic resonance (NMR) spectrometry. Additionally, over 1300 coffee samples were analysed by 1H-NMR for isoeugenol, but it was not detected in any of the analysed samples. Various essential oils, including nutmeg, basil, clove, sweet flag, and ylang-ylang oils, were examined for isoeugenol content. Out of the twelve nutmeg oils tested, four contained isoeugenol, with concentrations ranging from 3.68 ± 0.09 g/kg to 11.2 ± 0.10 g/kg. However, isoeugenol was not detected in the essential oils of calamus, basil, ylang-ylang, and clove using NMR spectrometry. These findings warrant critical evaluation of the previous literature, given reports of high isoeugenol levels in some of these matrices. A toxicological assessment has determined that there is no risk to human health by exposure to isoeugenol via nutmeg essential oils.

Convention on Biological Diversity (CBD) and the Nagoya Protocol: Implications and Compliance Strategies for the Global Coffee Community.

The Nagoya Protocol on Access and Benefit-sharing (ABS) of the Convention on Biological Diversity (CBD) is a fundamental international agreement that plays a crucial role in the protection and equitable utilization of plant genetic resources. While this agreement is essential for conservation and sustainable use, it presents specific challenges to coffee research and industry. One major issue is the requirement to obtain prior informed consent (PIC) from the source country or community, which can be a complex and time-consuming process, especially in regions with limited governance capacity. Additionally, the mandates of this agreement necessitate benefit-sharing with the source community, a requirement that poses implementation challenges, particularly for small businesses or individual researchers. Despite these challenges, the importance of the Nagoya Protocol in the coffee sector cannot be overstated. It contributes significantly to the conservation of coffee genetic resources and the sustainable utilization of these resources, ensuring fair distribution of benefits. To address the complexities presented by this international framework, coffee researchers and industry need to engage proactively with source countries and communities. This includes developing clear and equitable benefit-sharing and implementing strategies for compliance. This article explores the impact of the Nagoya Protocol on the coffee industry, particularly emphasizing the need for balancing scientific investigation with the ethical considerations of resource sharing. It also discusses practical strategies for navigating the complexities of this agreement, including research focused on authenticity control and the challenges in conducting large-scale coffee studies. The conclusion underscores the potential for international collaboration, particularly through platforms like the International Coffee Organization (ICO), to harmonize research activities with the ethical imperatives of the Nagoya Protocol.

Risk Assessment of Isoeugenol in Food Based on Benchmark Dose-Response Modeling.

Isoeugenol has recently been evaluated as possibly carcinogenic (Group 2B) by the WHO International Agency for Research on Cancer (IARC). In light of this evaluation, an updated risk assessment of this common food constituent was conducted using the benchmark dose (BMD) approach as recommended by the European Food Safety Authority (EFSA) for point of departure (POD) determination, as an alternative to the no observed adverse effect level (NOAEL). This approach was specifically chosen, as for the relevant neoplastic endpoints only lowest observed adverse effect level (LOAEL) values are available. The toxicological endpoint from the animal studies with the most conservative BMD lower confidence limit (BMDL) value was identified. Using the obtained BMDL value of 8 mg/kg body weight/day as POD, an acceptable daily intake (ADI) of 16 µg/kg body weight/day was obtained, which-despite being more conservative than previous approaches-is still clearly above the estimated daily exposure level to isoeugenol in the USA and in Europe. These results confirm a low risk of the estimated daily exposure levels of isoeugenol.

Acetaldehyde as a Food Flavoring Substance: Aspects of Risk Assessment.

The Senate Commission on Food Safety (SKLM) of the German Research Foundation (DFG) has reviewed the currently available data in order to assess the health risks associated with the use of acetaldehyde as a flavoring substance in foods. Acetaldehyde is genotoxic in vitro. Following oral intake of ethanol or inhalation exposure to acetaldehyde, systemic genotoxic effects of acetaldehyde in vivo cannot be ruled out (induction of DNA adducts and micronuclei). At present, the key question of whether acetaldehyde is genotoxic and mutagenic in vivo after oral exposure cannot be answered conclusively. There is also insufficient data on human exposure. Consequently, it is currently not possible to reliably assess the health risk associated with the use of acetaldehyde as a flavoring substance. However, considering the genotoxic potential of acetaldehyde as well as numerous data gaps that need to be filled to allow a comprehensive risk assessment, the SKLM considers that the use of acetaldehyde as a flavoring may pose a safety concern. For reasons of precautionary consumer protection, the SKLM recommends that the scientific base for approval of the intentional addition of acetaldehyde to foods as a flavoring substance should be reassessed.

Risk Assessment of Chlorogenic and Isochlorogenic Acids in Coffee By-Products.

Chlorogenic and isochlorogenic acids are naturally occurring antioxidant dietary polyphenolic compounds found in high concentrations in plants, fruits, vegetables, coffee, and coffee by-products. The objective of this review was to assess the potential health risks associated with the oral consumption of coffee by-products containing chlorogenic and isochlorogenic acids, considering both acute and chronic exposure. An electronic literature search was conducted, revealing that 5-caffeoylquinic acid (5-CQA) and 3,5-dicaffeoylquinic acid (3,5-DCQA) are the major chlorogenic acids found in coffee by-products. Toxicological, pharmacokinetic, and clinical data from animal and human studies were available for the assessment, which indicated no significant evidence of toxic or adverse effects following acute oral exposure. The current state of knowledge suggests that long-term exposure to chlorogenic and isochlorogenic acids by daily consumption does not appear to pose a risk to human health when observed at doses within the normal range of dietary exposure. As a result, the intake of CQAs from coffee by-products can be considered reasonably safe.

Assessment of Aspartame (E951) Occurrence in Selected Foods and Beverages on the German Market 2000-2022.

This study examines the occurrence of the artificial sweetener aspartame (E951) in foods and beverages sampled by food control authorities in Germany between 2000 and 2022. The dataset was obtained through the Consumer Information Act. Out of 53,116 samples analyzed, aspartame was present in 7331 samples (14%), of which 5703 samples (11%) in nine major food groups were further evaluated. The results showed that aspartame was most commonly found in powdered drink bases (84%), flavored milk drinks (78%), chewing gum (77%), and diet soft drinks (72%). In the solid food groups, the highest mean aspartame content was detected in chewing gum (1543 mg/kg, n = 241), followed by sports foods (1453 mg/kg, n = 125), fiber supplements (1248 mg/kg, n = 11), powdered drink bases (1068 mg/kg, n = 162), and candies (437 mg/kg, n = 339). Liquid products generally had the highest aspartame content in diet soft drinks (91 mg/L, n = 2021), followed by regular soft drinks (59 mg/L, n = 574), flavored milk drinks (48 mg/kg, n = 207), and mixed beer drinks (24 mg/L, n = 40). These results suggest that aspartame is commonly used in some foods and beverages in Germany. The levels of aspartame found were generally within the legal limits set by the European Union. These findings provide the first comprehensive overview of aspartame in the German food market and may be particularly useful in informing the forthcoming working groups of the WHO International Agency for Research on Cancer (IARC) and the WHO/FAO Joint Expert Committee on Food Additives (JECFA), which are in the process of evaluating the human health hazards and risks associated with the consumption of aspartame.

Risk Assessment of Trigonelline in Coffee and Coffee By-Products.

Trigonelline is a bioactive pyridine alkaloid that occurs naturally in high concentrations in coffee (up to 7.2 g/kg) and coffee by-products (up to 62.6 g/kg) such as coffee leaves, flowers, cherry husks or pulp, parchment, silver skin, and spent grounds. In the past, coffee by-products were mostly considered waste and discarded. In recent years, however, the use of coffee by-products as food has attracted interest because of their economic and nutritional value and the environmental benefits of sustainable resource use. Their authorization as so-called novel foods in the European Union may lead to increased oral exposure of the general population to trigonelline. Therefore, the aim of this review was to assess the risk to human health of acute and chronic exposure to trigonelline from coffee and coffee by-products. An electronic literature search was performed. Current toxicological knowledge is limited, with few human data available and a lack of epidemiological and clinical studies. There was no evidence of adverse effects after acute exposure. No conclusion can be drawn on chronic exposure to isolated trigonelline due to the lack of data. However, trigonelline ingested as a component of coffee and coffee by-products appears to be safe for human health, based on the safe traditional use of these products.

Evaluation of the genotoxic potential of acrylamide: Arguments for the derivation of a tolerable daily intake (TDI value).

This opinion of the Senate Commission on Food Safety (SKLM) of the German Research Foundation (Deutsche Forschungsgemeinschaft, DFG) presents arguments for an updated risk assessment of diet-related exposure to acrylamide (AA), based on a critical review of scientific evidence relevant to low dose exposure. The SKLM arrives at the conclusion that as long as an appropriate exposure limit for AA is not exceeded, genotoxic effects resulting in carcinogenicity are unlikely to occur. Based on the totality of the evidence, the SKLM considers it scientifically justified to derive a tolerable daily intake (TDI) as a health-based guidance value.

Food Toxicology and Food Safety: Report of the 3rd International Electronic Conference on Foods: Food, Microbiome, and Health-A Celebration of the 10th Anniversary of Foods' Impact on Our Wellbeing.

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.

Risk Assessment of Coffee Cherry (Cascara) Fruit Products for Flour Replacement and Other Alternative Food Uses.

Coffee bean harvesting incurs various by-products known for their long traditional use. However, they often still end up being a waste instead of being used to their full potential. On the European market, coffee cherry (cascara) products are not yet common, and a novel food approval for beverages made from coffee cherry pulp was issued only recently. In this article, exposure and risk assessment of various products such as juice, jam, jelly, puree, and flour made from coffee cherry pulp and husk are reviewed. Since caffeine in particular, as a bioactive ingredient, is considered a limiting factor, safe intake will be derived for different age groups, showing that even adolescents could consume limited quantities without adverse health effects. Moreover, the composition can be influenced by harvesting methods and processing steps. Most interestingly, dried and powdered coffee cherry can substitute the flour in bakery products by up to 15% without losing baking properties and sensory qualities. In particular, this use as a partial flour substitute is a possible approach to counteract rising grain prices, transport costs, and disrupted supply chains, which are caused by the Russia-Ukraine war and changing climatic conditions. Thus, the supply of affordable staple foods could be partially ensured for the inhabitants of countries that depend on imported wheat and cultivate coffee locally by harvesting both beans and by-products.

Toxicological Assessment of Roasted Coffee Silver Skin (Testa of Coffea sp.) as Novel Food Ingredient.

Roasted coffee silver skin is a coffee by-product, the uses of which are currently limited, e.g., as fertilizer, for energy production, or animal feed. Due to a low content of fat and carbohydrates combined with a high content of fiber, polyphenols and proteins, roasted silver skin is a valuable possible food ingredient. Potential applications include partial flour replacement in bakery products, as antioxidant and providing protein or fiber sources in sports or functional foods. As no relevant consumption of isolated silver skin occurred before 1997 in the European Union (EU), it was classified as a novel food in need of premarketing approval. Novel food applications must meet legal requirements for compositional and toxicological information. This review presents information on silver skin composition and toxicological studies. Several in vitro studies and subchronic in vivo studies are available with negative results, not suggesting a need for further studies on carcinogenic effects, reproduction, or chronic toxicity. All available studies so far concluded that no toxic effects of silver skin were found or are to be expected. For a novel food application in the EU, further in vitro studies on mutagenic potential may be needed to close a formal data gap.

Lower Strength Alcohol Products-A Realist Review-Based Road Map for European Policy Making.

This paper reports the result of a realist review based on a theory of change that substitution of higher strength alcohol products with lower strength alcohol products leads to decreases in overall levels of alcohol consumption in populations and consumer groups. The paper summarizes the results of 128 publications across twelve different themes. European consumers are increasingly buying and drinking lower strength alcohol products over time, with some two fifths doing so to drink less alcohol. It tends to be younger more socially advantaged men, and existing heavier buyers and drinkers of alcohol, who take up lower strength alcohol products. Substitution leads to a lower number of grams of alcohol bought and drunk. Although based on limited studies, buying and drinking lower strength products do not appear to act as gateways to buying and drinking higher strength products. Producer companies are increasing the availability of lower strength alcohol products, particularly for beer, with extra costs of production offset by income from sales. Lower strength alcohol products tend to be marketed as compliments to, rather than substitutes of, existing alcohol consumption, with, to date, the impact of such marketing not evaluated. Production of lower strength alcohol products could impair the impact of existing alcohol policy through alibi marketing (using the brand of lower strength products to promote higher strength products), broadened normalization of drinking cultures, and pressure to weaken policies. In addition to increasing the availability of lower strength products and improved labelling, the key policy that favours substitution of higher strength alcohol products with lower strength products is an alcohol tax based on the dose of alcohol across all products.