Chemical Food Research Articles

Generic kinetic and kinetic‐dynamic modelling in human subgroups of the population and animal species to support transparency in food and feed safety: Case studies

Abstract The present report describes the work performed in the EFSA‐project ‘Data collection, update and further development of biologically‐based models for humans and animal species to support transparency in food and feed safety’. Here, Focus is given to case studies for food and feed chemicals to predict kinetic parameters and profiles using generic and substance‐specific physiologically‐based kinetic (PBK) models for humans, including human subgroups, laboratory animal species, farm animals and a kinetic‐dynamic model in salmon. For humans, five case studies were conducted to compare kinetic predictions using the human generic PBK 6‐compartment COSMOS/TKPlatewith i) in vivo data from human clinical or biomonitoring studies, ii) substance‐specific model predictions using molecules relevant to food safety. Another five case studies assessed the impact of physiological variability (including pregnancy, renal excretion, metabolism variability, or ontogeny) and their impact on biomarkers of exposure. Case studies on laboratory and farm animals focused on theophylline, caffeine, cannabinoids, alkaloids and mycotoxins using the generic 11/12 PBK compartment models integrated in EFSA's TKPlate to assess predicted and experimental parameters i.e. plasma concentrations, excretion via milk or eggs. Overall, predictions from the human generic and substance‐specific PBK models for parameters of chronic exposure were similar and robust compared to the available experimental data. For test species and farm animals, model predictions from the generic TKPlate PBK models also performed well and were mostly within 2‐fold compared to available experimental in vivo data. In addition, 3D molecular modelling case studies were also conducted to investigate transport of chemicals (ochratoxin A, perfluoroalkyls) and cytochrome P450 metabolism (ochratoxin A, safrole and other alkenylbenzenes) as a useful tool to generate metabolism information at the molecular level. Conclusions and recommendations for future work are formulated to further develop generic PBK models for parent compounds and metabolites and further guidance to use and parameterise these models in next generation risk assessment.

A Study on the Automatic IoT Based Multiple Solid Mixing and Product Measurement System

Abstract: This project presents an automated system for mixing multiple solid materials and measuring the final product, using Internet of Things (IoT) technology. The system automatically mixes different solid ingredients in the right proportions, ensuring consistency and accuracy. It uses sensors to monitor the mixing process in real-time, sending data to a central control system that makes adjustments as needed. The system also measures the weight and volume of the final product to ensure it meets the required specifications. With IoT integration, the system allows remote monitoring, data tracking, and performance analysis, reducing human error and improving efficiency. This technology is flexible and can be used in industries like food processing, pharmaceuticals, and chemicals, offering a more precise and automated approach to solid mixing and product measurement.

Integration of National Chemical Hazards Monitoring, Total Diet Study, and Human Biomonitoring Programmes for Food Safety Exposure Assessment in Singapore

Food safety and food security can impact the quality of human life, and these two aspects are interrelated alongside many influencing external factors. Global stressors such as climate change, recent pandemic, and geopolitical tensions have demonstrated tangible impacts on food security and safety. Food and food system innovation is a key strategy towards feeding the world in a more sustainable and climate-resilient manner. This paper highlights the use of a science-based risk assessment and management in Singapore’s food safety system, specifically in the integration of exposure assessment approaches to support evidence-based food safety risk analysis and decision-making. The use of complementary top-down and bottom-up exposure assessment approaches through the market monitoring programme, total diet study and human biomonitoring forms a comprehensive integrated exposure assessment strategy which can ultimately inform policy and measures in ensuring and securing a supply of safe food. The discussion on such application for chemical food safety in Singapore offers additional insights into the synergistic inter-relationships contributing to the exposure assessment associated with chemicals in food.

Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals.

Vitamins and essential minerals are micronutrients that are required for the normal functioning of the human body. However, they may lead to adverse health effects if consumed in excess. A tolerable upper intake level (UL) is a science-based reference value that supports policy-makers and other relevant actors in managing the risks of excess nutrient intake. EFSA's principles for establishing ULs for vitamins and minerals were originally developed by the Scientific Committee on Food in 2000. This guidance from the EFSA Panel on Nutrition, Novel Foods and Food Allergens provides an updated framework for UL assessments. A draft was published in 2022 and underwent a 2-year piloting period. The present document incorporates revisions based on the experience gained through its practical implementation. It covers aspects related to the planning of the risk assessment (problem formulation and definition of methods) and its implementation (evidence retrieval, appraisal, synthesis, integration, uncertainty analysis). As in the previous framework, the general principles developed for the risk assessment of chemicals in food are applied, i.e. hazard identification, hazard characterisation, intake assessment, risk characterisation. Specific to nutrients are their biochemical and physiological roles and the specific and selective mechanisms that maintain the systemic homeostasis and accumulation of the nutrient in the body. Such considerations must also be taken into account when conducting risk assessments of nutrients.

Health consequences of harmful chemicals in foods: insights from the WHO Global Burden of Foodborne Disease Study

Abstract Foods can be an important source of human exposure to harmful chemicals. Contamination can occur at any stage of the food chain; with chemicals that occur naturally or by anthropogenic pollution in the environment and during production processes from farm level to the kitchen of the consumer. The variety of chemicals in foods is broad and associated with a wide range of adverse health effects. Where toxicological risk assessment of chemicals in foods serves the purpose of protecting populations from exposure levels constituting a health concern, burden of disease methodology provides a quantitative snapshot of the current impact of chemicals on disease occurrence and population health. This allows for the comparison across hazards, health effects and foods and eventually prioritized allocation of resources to maximize health benefits. Following the advice by the World Health Organization Foodborne Disease Burden Epidemiology Reference group (WHO/FERG), WHO published in 2015 the first estimates of the global burden of foodborne disease. More than 400,000 deaths and 33 million disability-adjusted life years were estimated due to unsafe foods in 2010; the largest proportion due to foodborne pathogens, as the contribution of only 3 chemical hazards (dioxins, aflatoxin B1 and cassava cyanide) was included. WHO, once more under the advice by the re-established WHO/FERG (2021-2025), is currently working to update the 2010 estimates. Besides applying updated data and methodological improvements in managing data gaps and time series analysis, WHO’s ambition is to consider a wider range of chemicals and associated health effects for the year of 2020. In this presentation, we will share insights on the WHO estimates of the global burden of foodborne chemicals, and explore the methodological opportunities and challenges that estimating the burden of foodborne chemicals provides for informing policies.

Experimental Study on the Effect of Skin Friction Drag and Convective Heat Transfer for Viscoelastic and Pseudoplastic Fluid Flow

Drag Reducing Agents (DRAs) have a huge impact and major concern in engineering and industrial applications. It makes the fluid flow turbulent to laminar, dampens eddy reduces head loss by up to a certain limit, and saves pumping energy costs. Viscosity is the property that dampens eddy due to the viscous effect, which increases the fluidity up to a certain limit. Pseudoplasticity is the shear thinning effect that decreases viscosity when the flow rate increases. So, for the viscoelastic effect, we can increase the concentration up to a certain limit to reduce head loss. Still, during flow due to the pseudoplastic effect, the viscosity will start decreasing which is a negative effect. So, these combined effects are studied to reduce skin friction drag in the pipeline and save energy costs which will be convenient for the food industry, chemical, and medicine industries. In this investigation, investigation is carried out for 0.3 g/L, 0.2 g/L, and 0.15 g/L of xanthan gum in turbulent flow to observe the pressure drop and heat transfer rate. The study reveals that after increasing viscosity the pressure drop reduced significantly. Conversely, the heat transfer rate was also reduced due to the poor mixing effect. A higher performance and less vibration of the pump was also observed. It was concluded that the frictional pressure drop was reduced up to 85 % and the heat transfer rate was reduced by up to 90% by increasing the concentration of the DRA up to 0.3 g/L at 10 LPM than the pure water or base fluid as a working substance on the double pipe heat exchanger. As the heat transfer rate reduced up to 90% with reducing pressure drop another aim of the study was to establish a concentration and flowrate for which the heat transfer rate is maximum and it was found at a concentration of 0.15 g/L of DRAs (drag reducing agents) at 22 LPM (maximum flowrate at this setup).

Dellaglioa Algida Cell-Free Supernatant Inhibits Pseudomonas Fluorescence and Pseudomonas Fragi by Destroying Cell Membranes.

The aim of this study was to examine the components of the cell-free supernatant (CFS) derived from a novel strain of psychrophilic Lactobacillus, Dellaglioa algida, and to further elucidate the impact of this CFS on various cellular processes. Specifically, we sought to understand its effects on the cell membrane, protein and DNA release, protease activity, and metabolites of Pseudomonas fluorescens and Pseudomonas fragi, thereby clarifying the antibacterial mechanism involved. The CFS components were analyzed using Gas Chromatography-Mass Spectrometry (GC-MS), the Coomassie Brilliant Blue method, and the phenol-sulfuric acid method. The inhibitory effect of the CFS on Pseudomonas fluorescens and Pseudomonas fragi was assessed using the ethidium bromide (EB) assay, Oxford cup assay, and ultramicroassay. Additionally, we analyzed the metabolites produced by Pseudomonas fluorescens and Pseudomonas fragi when treated with the CFS. The findings reveal that the CFS of Dellaglioa algida contains 94 volatile components, with protein and sugar concentrations of 32.857 ± 0.9705 mg/mL and 98.250 ± 4.210 mg/L, respectively. The CFS induces varying degrees of damage to the cell membranes of both Pseudomonas fluorescens and Pseudomonas fragi, leading to the release of intracellular proteins and DNA. Furthermore, the CFS reduced the protease activity and metabolic capacity of Pseudomonas fluorescens and Pseudomonas fragi. These results enhance our understanding of the mechanism by which psychrophilic Dellaglioa algida inhibits Pseudomonas fluorescens and Pseudomonas fragi, confirming that its inhibitory effect predominantly occurs through damage to the biological cell membranes of Pseudomonas. Dellaglioa algida is a newly identified cold-adapted inhibitor of Pseudomonas, indicating that its CFS is an effective microbial inhibitor in cold environments. This discovery suggests potential applications in inhibiting the growth and reproduction of Pseudomonas fluorescens and Pseudomonas fragi in food, pharmaceuticals, perfumes, and other chemicals, providing a valuable new reference for industrial preservation.

The Golden Discovery of Camelina Sativa: A Pivotal Study of Its Unique Components and Its Multiple Uses in Various Applications in Science and Industry

Camelina [Camelina sativa L. Crantz] is an oily plant from the Brassicaceae family that has been cultivated for thousands of years for its importance. Camelina seeds are rich in protein (27–32%) and oil (38–43%). Camelina oil contains many components like phytosterols, phenolic compounds, tocopherols, and fatty acids. The most are omega 3 and omega 6. In the agriculture sector, the growing of this crop is of interest due to its short growth cycle and little need for water and fertiliser. Due to its resistance to drought and cold, camelina is a great crop for dry regions. Interest has increased in recent years due to its economic importance and use in various fields, especially medical ones. In the United States of America and Europe, Camelina has been grown as a rich crop to use as an alternative to current fuels. Future studies seek to improve agricultural characteristics and consider it an alternative to current fuels. In this review, camelina and its oil, its components, and properties, as well as application areas such as food, biofuel, animal feed, and agricultural chemicals are mentioned.

Food for thought — Paving the way for a UK roadmap towards optimum consumer safety: Development, Endorsement and Regulatory acceptance of New Approach Methodologies (NAMs) in Chemical Risk Assessment and Beyond

Advances in biosciences, chemistry, technology, and computer sciences have resulted in the unparalleled development of candidate New Approach Methodologies over the last few years. Many of these are potentially invaluable in the safety assessment of chemicals, but very few have been adopted for regulatory decision making. There is an immediate opportunity to use NAMs in safety assessment where the vision is to be able to predict risk more rapidly, accurately, and efficiently to further assure consumer safety.In order to achieve this, the UK Food Standards Agency (FSA) and the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) have developed a roadmap towards acceptance and integration of these new approach methodologies into safety and risk assessments for regulatory decision making. The roadmap provides a UK blueprint for the transition of NAMs from the research laboratory to their use in regulatory decision making. This will require close collaboration across disciplines (chemists, toxicologists, informaticians, risk assessors and others), and across chemical sectors, to develop, verify and utilise appropriate models. Linking up internationally, and harmonization will be fundamental.

The U.S. Food and Drug Administration (FDA) Food Disaggregation Database (FDA-FDD): a new tool for U.S. dietary exposure assessment

Dietary exposure to a food chemical (e.g. contaminant, nutrient, or other natural constituent) is a function of the concentration of the chemical in foods and the quantity of each food consumed. Exposures to food chemicals can be estimated using intake data from What We Eat in America (WWEIA), the food consumption survey portion of the National Health and Nutrition Examination Survey (NHANES). To estimate exposures to chemicals in foods consumed by NHANES/WWEIA respondents, the consumption data must be mapped to chemical concentration data on the same or similar foods. However, food chemical data are generally not available on all the foods and food mixtures that are reported in NHANES/WWEIA. To address this, we developed the FDA Food Disaggregation Database (FDA-FDD), a ‘recipe’ database with estimates of ingredient percentages. FDA-FDD allows mapping to food chemical data based on ingredients in NHANES/WWEIA foods rather than on food mixtures, resulting in more accurate exposure estimates. Using FDA-FDD, FDA mapped over 11,000 NHANES/WWEIA foods to FDA’s Total Diet Study (TDS) foods. FDA-FDD is available as part of a publicly available interactive application that also allows access to the TDS mapping.

High Sugar and Fat Additives in Fast Food Restaurants: Is Whether Addiction or Consumer Loyalty?

The article will describe how chemicals in fast food and consumer loyalty to consume in high frequency. The chemical reality of fast food is suspected to cause addiction so that on the other hand consumers will appear loyal. This research applies a systematic review to examine studies exploring customer loyalty in the context of fast-food restaurants. The systematic review was chosen as the most appropriate method because its aim is to collect, critically evaluate, integrate, and present findings from various research studies relevant to the research question or topic. The findings offer significant theoretical implications for future research in this field and practical implications for practitioners in the fast-food industry. The initial relevance of each manuscript was determined based on its title. Manuscripts that appeared to discuss customer loyalty within the fast-food industry were selected for further evaluation. This study collected comprehensive information from these selected studies, including the author, year, title, and abstract. It’s noteworthy that all references utilized in this study are derived exclusively from English-language literature. The research contributes to the existing literature by providing a comprehensive and updated summary of the antecedents and their effects, and it offers actionable insights and recommendations on how to enhance customer loyalty, thereby providing a competitive advantage in the fast-food industry.

Safety Assessment on Product E 401 (Sodium Alginate) Used as a Surface Treatment in Entire Fruits and Vegetables (RP290)

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2021 from Bio Natural Solutions – BNS S.A.C. (‘the Applicant’) for the modification of the conditions of use of sodium alginate (CAS: 9005-38-3), which is an already authorised food additive (E 401), to the surface of entire fresh fruit and vegetables, as a coating to preserve them. The Applicant intends to extend the use of the sodium alginate (E 401) as a coating material within the food category: 4.1.1 ‘Entire fresh fruit and vegetables to include citrus fruit, melons, pineapples, bananas, papayas, mangoes, avocados, pomegranates’ at the level of quantum satis. To support the FSA and FSS in evaluating the dossier the Joint Expert Group on Additives, Enzymes and other regulated products (AEJEG) were asked to review the dossier and the supplementary information from the Applicant. The AEJEG concluded that no risk to health would be presented from this extension of use of E 401 on the basis that the additive was considered of low toxicological concern, as indicated by the European Food Standards Agency’s (EFSA) decision that a numerical ADI was not required. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) also reviewed the AEJEG safety assessment agreeing with the conclusions of the AEJEG. The views of the AEJEG and COT have been taken into account in this safety assessment which represents the opinion of the FSA and FSS on the extension of use of the sodium alginate (E 401) as a coating material in entire fresh fruit and vegetables.

The toxic effects of Helicobacter pylori and benzo(a)pyrene in inducing atrophic gastritis and gut microbiota dysbiosis in Mongolian gerbils.

Food chemical and microbiological contamination are major global food safety issues. This study investigated the combined effects of the food-borne pathogen Helicobacter pylori (H. pylori) and the pollutant benzo(a)pyrene (Bap) on atrophic gastritis and gut microbiota in Mongolian gerbils. The results demonstrated that simultaneous administration of H. pylori and Bap caused more severe weight loss, DNA damage, and gastritis in Mongolian gerbils compared with those exposed to H. pylori or Bap alone. The combination also significantly increased the serum level of proinflammatory cytokines, including IL-1β (p < .05), IL-6 (p < .0001), and TNF-α (p < .05). Additionally, the H. pylori and Bap combination altered the composition of gut microbiota in Mongolian gerbils: the relative abundance of Lactobacillus and Ligilactobacillus at the genus level (p < .05) was significantly reduced while the relative abundance of Allobaculum and Erysipelotrichaceae enhanced (p < .0001, p < .05). Our study revealed that the synergy of H. pylori and Bap can boost the development of atrophic gastritis and lead to gut microbiota dysbiosis in Mongolian gerbils, which provides essential implications for preventing contaminated foods to sustain life and promote well-being.

Determination of Phytochemicals and Some Elemental Compositions of Watermelon from Sokoto, Nigeria

Currently, many people are battling with infectious and chronic diseases in the country. More especially, the chronic diseases are associated with the level of ingredients in the food we take in, therefore, the easiest way to remedy our challenges is to monitor levels of chemicals in foods, especially the ones around us at affordable prices. Watermelon is a typical fruit that is conspicuous in the state, and can be a source of important natural chemicals for body health. The objective of this study was to perform a phytochemical and an elemental analysis of water melon grown in Sokoto state, Nigeria. The phytochemicals were determined with appropriate methods and chemicals of analytical grade, and elements are determined using atomic absorption spectroscopy. Regarding phytochemicals, flavonoids, alkaloids, saponins, and steroids were determined. Sodium levels in the seed, pulp, and peel reveals 0.40±0.02 (ppm), 3.0±0.01 (ppm), 2.00±0.01(ppm) respectively; potassium levels in the seed, pulp, and peel reveals, 5.000 ±0.04(ppm), 0.15±0.02 (ppm), 3.00±0.02 (ppm) respectively. Calcium determination shows values 20±1.0 (ppm), 20.0±1.00 (ppm), 20.30±0.3 (ppm) in seed, pulp, and peel respectively; and magnesium levels in seed, pulp, and peel are, 2.20±0.001 (ppm), 6.0±0.01 (ppm), and 0.40±0.03 (ppm) respectively. Iron levels of seed, pulp, and peel of watermelon reveals, 1.01±0.02 (ppm), 0.10±0.01(ppm), 15.00±0.2 (ppm) respectively; and Zinc 15±0.20 (ppm), 20.0±2.0 (ppm), and 10.00±1.05 (ppm) respectively. The watermelon contains significant amount of phytochemicals like flavonoids, alkaloids, saponins, and steroids useful in many purposes such as antimicrobial agents in neutralising the infectious diseases, a burden in the state. Also, the fruit contains useful elements in significant amount like, sodium, potassium, calcium, magnesium, iron, and zinc, that can be used in people that suffers specific nutritional problems.

Safety Assessment RP1190 2-Hydroxyethyl Methacrylate Phosphate

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in January 2021 by Keller and Heckman LLP for the authorisation of 2-hydroxyethyl methacrylate phosphate (HEMAP) as a monomer in a commercial product for use in the manufacture of kitchen countertops and sinks that are intended for contact with all types of food. All components of the commercial product are listed in assimilated Regulation EU No 10/2011 on plastic materials and articles intended to come into contact with food. The application and the following assessment are for HEMAP only, not the commercial product. Satisfactory information regarding the identity of substance, physical and chemical properties, intended application of substance, data on migration of substance and toxicological data were submitted. To support the FSA and FSS in evaluating the dossier, the Joint Expert Group on Food Contact Materials (FCMJEG) were asked to review the dossier submitted by the Applicant and the subsequent additional information requested. The FCMJEG concluded that the there was no concern to human safety from the use of HEMAP in the commercial product to be used in the manufacture of kitchen countertops and sinks. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) also reviewed the FCMJEG safety assessment agreeing with the conclusions of the FCMJEG. The views of the FCMJEG and COT have been taken into account in this safety assessment which represents the opinion of the FSA and FSS on the authorisation of HEMAP as a monomer for use in the manufacture of kitchen countertops and sinks.

Climate Effects on Ergot and Ergot Alkaloids Occurrence in Italian Wheat.

In recent years, there has been an intensification of weather variability worldwide as a result of climate change. Some regions have been affected by drought, while others have experienced more intense rainfall. The incidence and severity of moldy grain and mycotoxin contamination during the growing and harvesting seasons have increased as a result of these weather conditions. Additionally, torrential rains and wet conditions may cause delays in grain drying, leading to mold growth in the field. In July 2023, a wheat field in Lecco (Lombardy, Italy) was affected by torrential rains that led to the development of the Claviceps fungi. In the field, dark sclerotia were identified on some ears. Wheat ears, kernels, and sclerotia were collected and analyzed by LC-MS/MS at IZSLER, Food Chemical Department, in Bologna. The wheat ears, kernels, and sclerotia were analyzed for 12 ergot alkaloids (EAs) according to (EU) Regulation 2023/915 (ergocornine/ergocorninine; ergocristine/ergocristinine; ergocryptine/ergocryptinine; ergometrine/ergometrinine; ergosine/ergosinine; ergotamine/ergotaminine), after QuEChERS (Z-Sep/C18) purification. The analyzed sclerotia showed significant differences in total alkaloid content that vary between 0.01 and 0.5% (w/w), according to the results of the 2017 EFSA scientific report. EAs detected in sclerotia were up to 4951 mg/kg, in wheat ears up to 33 mg/kg, and in kernels were 1 mg/kg. Additional mycotoxins, including ochratoxin A, deoxynivalenol, zearalenone, fumonisins, T2-HT2 toxins, and aflatoxins, were investigated in wheat kernels after purification with immunoaffinity columns (IAC). The analysis revealed the presence of deoxynivalenol in wheat kernels at a concentration of 2251 µg/kg. It is expected that climate change will increase the frequency of extreme weather events. In order to mitigate the potential risks associated with mycotoxin-producing fungi and to ensure the protection of human health, it is suggested that official controls be implemented in the field.

DeepRA: A novel deep learning-read-across framework and its application in non-sugar sweeteners mutagenicity prediction

Non-sugar sweeteners (NSSs) or artificial sweeteners have long been used as food chemicals since World War II. NSSs, however, also raise a concern about their mutagenicity. Evaluating the mutagenic ability of NSSs is crucial for food safety; this step is needed for every new chemical registration in the food and pharmaceutical industries. A computational assessment provides less time, money, and involved animals than the in vivo experiments; thus, this study developed a novel computational method from an ensemble convolutional deep neural network and read-across algorithms, called DeepRA, to classify the mutagenicity of chemicals. The mutagenicity data were obtained from the curated Ames test data set. The DeepRA model was developed using both molecular descriptors and molecular fingerprints. The obtained DeepRA model provides accurate and reliable mutagenicity classification through an independent test set. This model was then used to examine the NSSs-related chemicals, enabling the evaluation of mutagenicity from the NSSs-like substances. Finally, this model was publicly available at https://github.com/taraponglab/deepra for further use in chemical regulation and risk assessment.

Engineered lignocellulosic based biochar to remove endocrine-disrupting chemicals: Assessment of binding mechanism

The safety and health of aquatic organisms and humans are threatened by the increasing presence of pollutants in the environment. Endocrine disrupting chemicals are common pollutants which affect the function of endocrine and causes adverse effects on human health. These chemicals can disrupt metabolic processes by interacting with hormone receptors upon consumptions by humans or aquatic species. Several studies have reported the presence of endocrine disrupting chemicals in waterbodies, food, air and soil. These chemicals are associated with increasing occurrence of obesity, metabolic disorders, reproductive abnormalities, autism, cancer, epigenetic variation and cardiovascular risk. Conventional treatment processes are expensive, not environment friendly and unable to achieve complete removal of these harmful chemicals. In recent years, biochar from different sources has gained a considerable interest due to their adsorption efficiency with porous structure and large surface areas. biochar derived from lignocellulosic biomass are widely used as sustainable catalysts in soil remediation, carbon sequestration, removal of organic and inorganic pollutants and wastewater treatment. This review conceptualizes the production techniques of biochar from lignocellulosic biomass and explores the functionalization and interaction of biochar with endocrine-disrupting chemicals. This review also identifies the further needs of research. Overall, the environmental and health risks of endocrine-disrupting chemicals can be dealt with by biochar produced from lignocellulosic biomass as a sustainable and prominent approach.

Food Chemicals and Epigenetic Targets: An Epi Food Chemical Database.

There is increasing awareness of epigenetics's importance in understanding disease etiologies and developing novel therapeutics. An increasing number of publications in the past few years reflect the renewed interest in epigenetic processes and their relationship with food chemicals. However, there needs to be a recent study that accounts for the most recent advances in the area by associating the chemical structures of food and natural product components with their biological activity. Here, we analyze the status of food chemicals and their intersection with natural products in epigenetic research. Using chemoinformatics tools, we compared quantitatively the chemical contents, structural diversity, and coverage in the chemical space of food chemicals with reported epigenetic activity. As part of this work, we built and curated a compound database of food and natural product chemicals annotated with structural information, an epigenetic target activity profile, and the main source of the food chemical or natural product, among other relevant features. The compounds are cross-linked with identifiers from other major public databases such as FooDB and the collection of open natural products, COCONUT. The compound database, the "Epi Food Chemical Database", is accessible in HTML and CSV formats at https://github.com/DIFACQUIM/Epi_food_Chemical_Database.

New limits proposed for the management of non-mutagenic impurities

Multiple international guidelines exist that describe both quality and safety considerations for the control of the broad spectrum of impurities inherent to drug substance and product manufacturing processes. However, regarding non-mutagenic impurities (NMI) the most relevant ICH Q3A/B guidelines are not applicable during early phases of drug development leading to confusion about acceptable limits at this stage. Thus, there is need for more flexible approaches that ensure that patient safety remains paramount, while taking into consideration the limited duration of exposure. An EFPIA survey, which collected quantitative data from different types of studies applied to qualify impurities in accordance with ICH Q3A, shows that no toxicities could be attributed to any of the 467 impurities at any tested level in vivo. This data combined with earlier published toxicological datasets encompassing drug substances and intermediates, food related substances and chemicals provide convincing evidence that for NMIs, the application of a generic 5 mg/day limit for an exposure duration <6 months, and a 1 mg/day generic limit for life-long exposure, provides sufficient margins to ensure patient safety. Hence, application of these absolute limits to trigger qualification studies (instead of the relative limits described in Q3A/B), is considered warranted. This approach will prevent conduct of unnecessary dedicated impurity qualification studies and the resulting use of animals.