EFSA Research Articles

Classification of substances by health hazard using deep neural networks and molecular electron densities

In this paper we present a method that allows leveraging 3D electron density information to train a deep neural network pipeline to segment regions of high, medium and low electronegativity and classify substances as health hazardous or non-hazardous. We show that this can be used for use-cases such as cosmetics and food products. For this purpose, we first generate 3D electron density cubes using semiempirical molecular calculations for a custom European Chemicals Agency (ECHA) subset consisting of substances labelled as hazardous and non-hazardous for cosmetic usage. Together with their 3-class electronegativity maps we train a modified 3D-UNet with electron density cubes to segment reactive sites in molecules and classify substances with an accuracy of 78.1%. We perform the same process on a custom food dataset (CompFood) consisting of hazardous and non-hazardous substances compiled from European Food Safety Authority (EFSA) OpenFoodTox, Food and Drug Administration (FDA) Generally Recognized as Safe (GRAS) and FooDB datasets to achieve a classification accuracy of 64.1%. Our results show that 3D electron densities and particularly masked electron densities, calculated by taking a product of original electron densities and regions of high and low electronegativity can be used to classify molecules for different use-cases and thus serve not only to guide safe-by-design product development but also aid in regulatory decisions.Scientific contributionWe aim to contribute to the diverse 3D molecular representations used for training machine learning algorithms by showing that a deep learning network can be trained on 3D electron density representation of molecules. This approach has previously not been used to train machine learning models and it allows utilization of the true spatial domain of the molecule for prediction of properties such as their suitability for usage in cosmetics and food products and in future, to other molecular properties. The data and code used for training is accessible at https://github.com/s-singh-ivv/eDen-Substances.

Ambient air concentrations of plant protection products: Data collection for the combined air concentration database and associated risk assessment

CropLife Europe collected literature values from monitoring studies measuring air concentrations of Plant Protection Products (PPPs) that may be inhaled by humans located in rural areas but not immediately adjacent to PPP applications. The resulting “Combined Air Concentration Database” (CACD) was used to determine whether air concentrations of PPPs reported by the French “Agency for Food, Environmental and Occupational Health & Safety” (ANSES) are consistent with those measured by others to increase confidence in values of exposure to humans. The results were put into risk assessment context. Results show that 25–90% of samples do not contain measurable PPP concentrations. Measured respirable fractions were below EU default air concentrations used for risk assessment for resident exposure by the European Food Safety Authority. All measured exposures in the CACD were also below established toxicological endpoints, even when considering the highest maximum average reported concentrations and very conservative inhalation rates. The highest recorded air concentration was for prosulfocarb (0.696 μg/m³ measured over 48 h) which is below the EFSA default limit of 1 μg/m³ for low volatility substances. In conclusion, based on the CACD, measured air concentrations of PPPs are significantly lower than EFSA default limits and relevant toxicological reference values.

Proposals for new transfer coefficient (TC) values for worker re-entry activities in grape vineyards

New transfer coefficient (TC) values were derived for vineyard workers handling treated grapevines during harvesting and crop maintenance activities. Re-entry exposure and dislodgeable foliar residue (DFR) studies were performed in Europe, covering hand harvesting, pruning/training, pruning/tying and pruning/shoot lifting. Foliar applications of fungicides (iprovalicarb, dimethomorph, dithianon, pyrimethanil and fenbuconazole) were made and 73 workers at 16 sites were monitored over one working day. Exposure was measured on inner and outer dosimeters, face/neck wipes and hand washes. In concurrent DFR studies, leaf punches were taken at each site during the time of worker re-entry. Potential exposure values correlated well with DFR values. TC values were derived for various re-entry activities for potential and actual exposure, with and without gloves. The harvesting task resulted in lower TC values than the other crop maintenance tasks. Additional TC values reflecting the use of protective gloves can be derived from the results. The TC values are much lower than current European Food Safety Authority (EFSA) default values. This project addresses a data gap identified by EFSA for specific EU TC values to permit more realistic and reliable re-entry worker exposure estimates for grapes.

New approach methodologies to enhance human health risk assessment of immunotoxic properties of chemicals - a PARC (Partnership for the Assessment of Risk from Chemicals) project.

As a complex system governing and interconnecting numerous functions within the human body, the immune system is unsurprisingly susceptible to the impact of toxic chemicals. Toxicants can influence the immune system through a multitude of mechanisms, resulting in immunosuppression, hypersensitivity, increased risk of autoimmune diseases and cancer development. At present, the regulatory assessment of the immunotoxicity of chemicals relies heavily on rodent models and a limited number of Organisation for Economic Co-operation and Development (OECD) test guidelines, which only capture a fraction of potential toxic properties. Due to this limitation, various authorities, including the World Health Organization and the European Food Safety Authority have highlighted the need for the development of novel approaches without the use of animals for immunotoxicity testing of chemicals. In this paper, we present a concise overview of ongoing efforts dedicated to developing and standardizing methodologies for a comprehensive characterization of the immunotoxic effects of chemicals, which are performed under the EU-funded Partnership for the Assessment of Risk from Chemicals (PARC).

Global guidelines recommendations for dietary sodium and potassium intake.

Non-communicable diseases (NCDs) cause a significant global health challenge, with unhealthy diets identified as a major risk factor. Sodium and potassium, which are essential minerals for human health, play important roles in various bodily functions, and an imbalance in their intake can have significant health implications, particularly concerning hypertension and cardiovascular diseases. This review compiles dietary sodium and potassium intake recommendations from prominent global health organizations and compares global guidelines to Japan's Dietary Reference Intake (DRI) guidelines. Sodium and potassium intake guidelines from organizations such as the World Health Organization (WHO), American College of Cardiology (ACC) and American Heart Association (AHA), Dietary Guidelines for Americans (DGA), European Food Safety Authority (EFSA), and DRI for Japanese exhibit variations. Compared to other Asian countries, Japan's historically higher sodium goal aligns with Southeast Asia where traditional preserved foods contribute to high sodium intake. Contrarily, Japan's lower potassium goal contrasts with other countries in Asia promoting a diet rich in fruits and vegetables. The ongoing effort by Japan to align with global recommendations reflects a gradation approach considering social habits. While harmonizing international efforts is essential, appreciating regional diversities is paramount through tailoring guidelines to cultural and dietary habit practices. Implementing context-specific guidelines informed by scientific research can contribute to global efforts in promoting healthy diets and reducing the burden of NCDs. Global guidelines that recommended the daily dietary intake goal for sodium and potassium exhibit variations. These disparities are influenced by diverse factors, including cultural dietary habits, socioeconomic status, health priorities, and available scientific research. Each population should follow the recommendations of their region.

Optimizing Antimicrobial Efficacy: Investigating the Impact of Zinc Oxide Nanoparticle Shape and Size.

Zinc oxide nanoparticles (ZnO NPs) have been investigated due to their distinct properties, variety of structures and sizes, and mainly for their antimicrobial activity. They have received a positive safety evaluation from the European Food Safety Authority (EFSA) for packaging applications as transparent ultraviolet (UV) light absorbers based on the absence of significant migration of zinc oxide in particulate form. ZnO NPs with different morphologies (spherical, flower, and sheet) have been synthesized via different sol-gel methods and extensively characterized by several solid-state techniques, namely vibrational spectroscopy, powder X-ray diffraction (XRD), scanning electron microscopy/energy dispersive X-ray spectroscopy (SEM/EDS), Fourier Transform Infrared Spectroscopy (FTIR), ultraviolet-visible spectroscopy (UV-VIS), electron paramagnetic resonance (EPR), and nitrogen adsorption-desorption isotherms. The ZnO NPs were assessed for their antibacterial activity against Escherichia coli (gram-negative bacteria) and Staphylococcus aureus (gram-positive bacteria) to study the influence of morphology and size on efficacy. ZnO NPs with different morphologies and sizes demonstrated antimicrobial activity against both bacteria. The highest microbial cell reduction rate (7-8 log CFU mL-1 for E. coli and 6-7 log CFU mL-1 for S. aureus) was obtained for the sheet- and spherical-shaped NPs as a result of the high specific surface area. In fact, the higher surface areas of the sheet- and spherical-shaped nanoparticles (18.5 and 13.4 m2 g-1, respectively), compared to the flower-shaped NPs (5.3 m2g-1), seem to promote more efficient bacterial cell reduction. The spherical-shaped particles were also smaller (31 nm) compared with the flower-shaped (233 × 249 nm) ones. The flower ZnO NP resulted in a 4-5 log CFU mL-1 reduction for E. coli and 3-4 log CFU mL-1 reduction for S. aureus. The lower apparent antibacterial activity of the flower-shaped could be associated with either the lack of defects on the particle core or the shape shielding effect. Compared to S. aureus, E. coli seems to be less resistant to ZnO NPs, which may be explained by the characteristics of its cell membrane. With simple synthesis techniques, which do not allow the size and shape of the nanoparticles to be controlled simultaneously, it is a challenge to elucidate the effect of each of these two parameters on antibacterial performance.

Crop Contamination and Human Exposure to Per- and Polyfluoroalkyl Substances around a Fluorochemical Industrial Park in China.

Due to their significant environmental impact, there has been a gradual restriction of the production and utilization of legacy per- and polyfluoroalkyl substances (PFAS), leading to continuous development and adoption of novel alternatives. To effectively identify the potential environmental risks from crop consumption, the levels of 25 PFAS, including fourteen perfluoroalkyl acids (PFAAs), two precursor substances and nine novel alternatives, in agricultural soils and edible parts of various crops around a fluoride industrial park (FIP) in Changshu city, China, were measured. The concentration of ΣPFAS in the edible parts of all crops ranged from 11.64 to 299.5 ng/g, with perfluorobutanoic acid (PFBA) being the dominant compound, accounting for an average of 71% of ΣPFAS. The precursor substance, N-methylperfluoro-octanesulfonamidoacetic acid (N-MeFOSAA), was detected in all crop samples. Different types of crops showed distinguishing accumulation profiles for the PFAS. Solanaceae and leafy vegetables showed higher levels of PFAS contamination, with the highest ΣPFAS concentrations reaching 190.91 and 175.29 ng/g, respectively. The highest ΣAlternative was detected in leafy vegetables at 15.21 ng/g. The levels of human exposure to PFAS through crop consumption for various aged groups were also evaluated. The maximum exposure to PFOA for urban toddlers reached 109.8% of the standard value set by the European Food Safety Authority (EFSA). In addition, short-chained PFAAs and novel alternatives may pose potential risks to human health via crop consumption.

Temporal variation in the concentrations and profiles of paralytic shellfish toxins and tetrodotoxin in scallop (Mizuhopecten yessoensis) and bloody clam (Anadara broughtonii) collected from the coast of Miyagi Prefecture, Japan

For food safety, the concentrations and profiles of paralytic shellfish toxins (PSTs) and tetrodotoxin were examined in economically important scallops and bloody clams collected from the coast of the Miyagi Prefecture, Japan. PSTs were the major toxins in both species. The tetrodotoxin concentration in scallops increased in summer, although the highest value (18.7 μg/kg) was lower than the European Food Safety Authority guideline threshold (44 μg/kg). This confirmed the safety for tetrodotoxin in this area.

Nutritional Assessment of Children and Adolescents with Atypical Anorexia Nervosa: A Preliminary Longitudinal Investigation Using the 24-h Dietary Recall.

Atypical Anorexia Nervosa (AAN) is a Feeding and Eating Disorder characterized by fear of gaining weight and body image disturbance, in the absence of significantly low body weight. AAN may present specific clinical and psychopathological features. Nonetheless, the literature lacks data concerning the nutritional characteristics and body composition of children and adolescents with AAN and their variation over time. Case series, including 17 children and adolescents with AAN. All the patients were assessed at the first evaluation (T0) with a standardized dietary assessment (24 h Dietary Recall, 24 hDR). Nutritional data were compared with European dietary reference values (DRVs). Body composition parameters (weight, fat mass, fat-free mass) and their changes over time at two (T1) and six (T2) months were collected as well, using a Bioelectrical impedance analysis (Wunder WBA300 with four poles and foot contact; impedance frequency 50 kHz 500 μA; impedance measurement range 200~1000 Ω/0.1 Ω). The included individuals presented eating behaviors oriented towards significantly low daily energy intake (p < 0.001) compared with DRVs set by the European Food Safety Authority (EFSA) (with low carbohydrates and fats), and increased proteins (p < 0.001). A longer latency before observation (illness duration before observation) correlated with a negative change in weight. Body composition parameters were described, with no significant changes across the six-month outpatient assessment. This is the first research to systematically assess the body composition and nutritional features of a group of individuals with AAN in the developmental age. Further research should assess the effect of targeted treatment interventions on body composition and nutritional features.

Making way for the implementation of automated bee counters in regulatory risk assessment

AbstractMeasuring adverse effects on honey bees and their colonies requires a suitable methodology. For example, due to the large number of bees in a hive and the foraging activity, measuring the mortality of individuals is a difficult task that has not yet been adequately addressed. Knowing the natural daily mortality rate of a bee colony would be of great benefit in assessing whether and to what extent external influences and stress factors affect mortality. More precise mortality data could in turn help refining specific protection goals for regulatory purpose. The European Food Safety Authority recently published a document that estimated such mortality rates based on a systematic literature review, but none of these rates were assessed from continuous monitoring of colonies. Currently, bee mortality is routinely evaluated with various types of dead bee traps that prevent deceased bees from being removed from the colony. Both the literature review and the dead bee traps are relevant to regulatory risk assessment, but in our opinion are not describing the total mortality. Bee counters capable of precisely determining daily loss rates meet the above points and combine them with generating automated and continuous monitoring data. Lately, the field has gained a lot of importance in research and technological advances offer new possibilities in regulatory risk assessment. We will highlight these possibilities and discuss their future application in practice.

The Conflict between Regulatory Agencies over the 20,000-Fold Lowering of the Tolerable Daily Intake (TDI) for Bisphenol A (BPA) by the European Food Safety Authority (EFSA).

The European Food Safety Authority (EFSA) recommended lowering their estimated tolerable daily intake (TDI) for bisphenol A (BPA) 20,000-fold to . BPA is an extensively studied high production volume endocrine disrupting chemical (EDC) associated with a vast array of diseases. Prior risk assessments of BPA by EFSA as well as the US Food and Drug Administration (FDA) have relied on industry-funded studies conducted under good laboratory practice protocols (GLP) requiring guideline end points and detailed record keeping, while also claiming to examine (but rejecting) thousands of published findings by academic scientists. Guideline protocols initially formalized in the mid-twentieth century are still used by many regulatory agencies. EFSA used a 21st century approach in its reassessment of BPA and conducted a transparent, but time-limited, systematic review that included both guideline and academic research. The German Federal Institute for Risk Assessment (BfR) opposed EFSA's revision of the TDI for BPA. We identify the flaws in the assumptions that the German BfR, as well as the FDA, have used to justify maintaining the TDI for BPA at levels above what a vast amount of academic research shows to cause harm. We argue that regulatory agencies need to incorporate 21st century science into chemical hazard identifications using the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) nonguideline academic studies in a collaborative government-academic program model. We strongly endorse EFSA's revised TDI for BPA and support the European Commission's (EC) apparent acceptance of this updated BPA risk assessment. We discuss challenges to current chemical risk assessment assumptions about EDCs that need to be addressed by regulatory agencies to, in our opinion, become truly protective of public health. Addressing these challenges will hopefully result in BPA, and eventually other structurally similar bisphenols (called regrettable substitutions) for which there are known adverse effects, being eliminated from all food-related and many other uses in the EU and elsewhere. https://doi.org/10.1289/EHP13812.

The 2022 European Union report on pesticide residues in food.

Under European Union legislation (Article 32, Regulation (EC) No 396/2005), the European Food Safety Authority provides an annual report assessing the pesticide residue levels in foods on the European market. In 2022, 96.3% of the overall 110,829 samples analysed fell below the maximum residue level (MRL), 3.7% exceeded this level, of which 2.2% were non-compliant, i.e. results in a given sample exceeded the MRL after taking into account the measurement uncertainty. For the EU-coordinated multiannual control programme subset, 11,727 samples were analysed of which 0.9% were non-compliant. To assess acute and chronic risk to consumer health, dietary exposure to pesticide residues was estimated and compared with available health-based guidance values (HBGV). Continuation of the probabilistic assessment methodology was consolidated to all pesticides listed in the 2022 EU Regulation providing the probability of a consumer being exposed to an exceedance of the HBGV. Overall, the assessed risk to EU consumer's health is low. Recommendations to risk managers are given to increase the effectiveness of European control systems and to ensure a high level of consumer protection throughout the EU.

Lactobacilli - Probiotic as well as an Uncommon Pathogen – Current Status Regarding the “Two Sides of the Same Coin:” An Overview

Abstract Lactobacilli are nonsporing, lactic acid producing, anaerobic bacilli, classified under the phylum Firmicutes that form part of the normal flora in specific areas of the human body inclusive of the oral cavity, gastrointestinal tract, and the urogenital system. This genus, for instance contains Lactobacillus acidophilus, Lactiplantibacillus plantarum, Lacticaseibacillus rhamnosus, and others, when they are involved in the breakdown of glucose, they release lactic acid. It plays a major role in the production of fermented foods and in addition, it can serve as a probiotic which can be good to the host in that it can help in digestion, synthesis of vitamins, and can prevent colonization by pathogens. Lactobacilli are in association, although, in a commensal manner in large numbers during puberty and pregnancy and are also acidity maintainers, thereby preventing the pathogens to occupy the vaginal tract. They have also been declared to influence antiviral functions together with the suppression of virulence factors of pathogens based on recent studies. However, some categories of strains have been associated with life-threatening conditions such as endocarditis, meningitis, liver abscess, and bacteremia, particularly in immunocompromised clients. Regarding Lactobacilli, speciation has grown with methods such as MALDI-TOF, as it is faster and accurate than biochemical assays. Because their fermentative metabolism differs, they are grouped into the obligate homofermentative, facultative heterofermentative, and the obligate heterofermentative lactobacilli that assists in their identification and functionality. Lactobacilli being the probiotics are known to be safe and effective as endorsed by such bodies as the US Food and Drug Administration and European Food Safety Authority. Prebiotics are most effective in preterm infants and neonates where they help in strengthening the Gut barrier and Immunity. Thus, two probiotic strains like L. rhamnosus, and L. acidophilus have shown some positive impacts against different infections such as Helicobacter pylori, Clostridium difficile-associated diarrhea, and periodontitis. Nevertheless, one cannot disregard the possible pathogenicity of Lactobacilli as a number of strains are known to produce enzymes and organic acids which are hazardous to the human body. These examples of invasive infections stemming from strict regard for the use of probiotics only serve to enforce the prospect of heedful application of probiotics, especially to the vulnerable groups of people. Furthermore, diseases such as vaginal lactobacillosis are created to focus on the need for moderation in the consumption of probiotics. In summary, it can be seen that both, the roles and effects of Lactobacilli are twofold, as positive components with great potential for benefiting health as well as negative aspects that need further assessment.

Assessment of genetically modified maize MON 89034 × 1507 × NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (application GMFF-2022-3670).

Following the submission of dossier GMFF-2022-3670 under Regulation (EC) No 1829/2003 from Corteva Agriscience Belgium BV and Bayer Agriculture BV, the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant and insect-resistant genetically modified maize MON 89034 × 1507 × NK603, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and a search for additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × NK603 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-3670 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × NK603.

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2022-9170).

Following the joint submission of dossier GMFF-2022-9170 under Regulation (EC) No 1829/2003 from Bayer Agriculture B.V. and Corteva Agriscience Belgium B.V., the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant and insect resistant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations.

Glifosat – frakcja wdychalna [N-(fosfonometylo)glicyna]. Dokumentacja proponowanych wartości dopuszczalnych wielkości narażenia zawodowego

Glyphosate is an odorless solid in the form of white crystalline powder. It is an active ingredient in broad-spectrum herbicides, which used at lower doses is a plant growth regulator and desiccant. In Poland since 2001 the MAC value for glyphosate is 10 mg/m3 . Over the past 25 years many new research findings have been published regarding the potential fetotoxicity and carcinogenicity of glyphosate. The European Chemicals Agency (ECHA) reassessed the properties of glyphosate in order to presenting them to the European Food Safety Authority (EFSA). A new harmonized classification of glyphosate was also considered (in accordance with Regulation 1272/2008 of the Parliament and of the Council). In this context, it was necessary to verify the MAC value currently in force in Poland. The basis for calculating the MAC value was the dose of 155 mg/kg bw./day, considered as the NOAEL for systemic effects after oral exposure in mice. No basis for changing the current MAC value (10 mg/m3 ) were found. It should be considered that glyphosate has a very low vapor pressure – exposure occurs to glyphosate dust or aqueous solution only. There are no basis to establish the STEL value and the Biological Exposure Index (BEI). Glyphosate do not meet the criteria for "Skin" notation.

A novel method to derive a human safety limit for PFOA by gene expression profiling and modelling.

Perfluorooctanoic acid (PFOA) is a persistent environmental contaminant that can accumulate in the human body due to its long half-life. This substance has been associated with liver, pancreatic, testicular and breast cancers, liver steatosis and endocrine disruption. PFOA is a member of a large group of substances also known as "forever chemicals" and the vast majority of substances of this group lack toxicological data that would enable their effective risk assessment in terms of human health hazards. This study aimed to derive a health-based guidance value for PFOA intake (ng/kg BW/day) from in vitro transcriptomics data. To this end, we developed an in silico workflow comprising five components: (i) sourcing in vitro hepatic transcriptomics concentration-response data; (ii) deriving molecular points of departure using BMDExpress3 and performing pathway analysis using gene set enrichment analysis (GSEA) to identify the most sensitive molecular pathways to PFOA exposure; (iii) estimating freely-dissolved PFOA concentrations in vitro using a mass balance model; (iv) estimating in vivo doses by reverse dosimetry using a PBK model for PFOA as part of a quantitative in vitro to in vivo extrapolation (QIVIVE) algorithm; and (v) calculating a tolerable daily intake (TDI) for PFOA. Fourteen percent of interrogated genes exhibited in vitro concentration-response relationships. GSEA pathway enrichment analysis revealed that "fatty acid metabolism" was the most sensitive pathway to PFOA exposure. In vitro free PFOA concentrations were calculated to be 2.9% of the nominal applied concentrations, and these free concentrations were input into the QIVIVE workflow. Exposure doses for a virtual population of 3,000 individuals were estimated, from which a TDI of 0.15ng/kg BW/day for PFOA was calculated using the benchmark dose modelling software, PROAST. This TDI is comparable to previously published values of 1.16, 0.69, and 0.86ng/kg BW/day by the European Food Safety Authority. In conclusion, this study demonstrates the combined utility of an "omics"-derived molecular point of departure and in silico QIVIVE workflow for setting health-based guidance values in anticipation of the acceptance of in vitro concentration-response molecular measurements in chemical risk assessment.

A Review of Cyclic Imines in Shellfish: Worldwide Occurrence, Toxicity and Assessment of the Risk to Consumers.

Cyclic imines are a class of lipophilic shellfish toxins comprising gymnodimines, spirolides, pinnatoxins, portimines, pteriatoxins, prorocentrolides, spiro-prorocentrimine, symbiomines and kabirimine. They are structurally diverse, but all share an imine moiety as part of a bicyclic ring system. These compounds are produced by marine microalgal species and are characterized by the rapid death that they induce when injected into mice. Cyclic imines have been detected in a range of shellfish species collected from all over the world, which raises the question as to whether they present a food safety risk. The European Food Safety Authority (EFSA) considers them to be an emerging food safety issue, and in this review, the risk posed by these toxins to shellfish consumers is assessed by collating all available occurrence and toxicity data. Except for pinnatoxins, the risk posed to human health by the cyclic imines appears low, although this is based on only a limited dataset. For pinnatoxins, two different health-based guidance values have been proposed at which the concentration should not be exceeded in shellfish (268 and 23 µg PnTX/kg shellfish flesh), with the discrepancy caused by the application of different uncertainty factors. Pinnatoxins have been recorded globally in multiple shellfish species at concentrations of up to 54 times higher than the lower guidance figure. Despite this observation, pinnatoxins have not been associated with recorded human illness, so it appears that the lower guidance value may be conservative. However, there is insufficient data to generate a more robust guidance value, so additional occurrence data and toxicity information are needed.

Biosecurity measures for the prevention of African swine fever on German pig farms: comparison of farmers’ own appraisals and external veterinary experts’ evaluations

BackgroundSince its first introduction into the German wild boar population in 2020, African swine fever (ASF) has been spreading slowly from the eastern border westwards and has been introduced into eight domestic pig farms thus far. The European Food Safety Authority has named deficits in farm biosecurity and increased human activity as major risk factors for the introduction of the ASF virus into pig farms. Studies have shown that pig farms in Germany generally have a high level of biosecurity. However, veterinary practitioners and policy-makers have expressed concerns that not all pig farmers are appropriately prepared to deal with the threat of ASF. This study aimed to evaluate the level of biosecurity on pig farms in Lower Saxony and explore the reasons for deficits in the implementation of biosecurity measures. For this purpose, pig farmers were interviewed in open structured face-to-face interviews about their perception of ASF and biosecurity, and the implemented measures on their farms were assessed with a checklist. In the data analysis, the farmers’ answers and the results of the biosecurity check were compared to gain further insights into the factors influencing the implementation of biosecurity measures on the farms.ResultsThe biosecurity check showed that on most farms, a high level of biosecurity had been implemented. Nevertheless, deficits were found concerning the fences and the delimitation of clean and dirty areas on farm grounds and in the anteroom. Overall, the farmers were well informed about ASF and had a realistic perception of their own biosecurity. They considered the farm layout, financial means and practicality of hygiene measures to be the main barriers to implementing biosecurity measures against ASF. However, the results also suggested that farmers’ attitudes and legal regulations were major influencing factors.ConclusionThe results indicated a high level of biosecurity against ASF on most pig farms and a realistic perception of their own biosecurity by the farmers. Current knowledge transfer and information should focus on building upon the farmers’ own motivation and expertise and supporting them to put existing knowledge into practice.

Safety Assessment of Levilactobacillus brevis KU15006: A Comprehensive Analysis of its Phenotypic and Genotypic Properties.

Levilactobacillus brevis KU15006, isolated from kimchi, exhibits pathogen-antagonistic and anti-diabetic activities; however, the safety of this strain has not been assessed. In the present study, L. brevis KU15006 was evaluated to elucidate its safety as a probiotic strain using phenotypic and genotypic analyses. Its safety was assessed using a minimum inhibitory concentration test comprising nine antibiotics, 26 antibiotic resistance genes, a single conjugative element, virulence gene analysis, hemolysis, cell cytotoxicity, mucin degradation, and toxic metabolite production. L. brevis KU15006 exhibited equal or lower minimum inhibitory concentration for the nine antibiotics than the cut-off value established by the European Food Safety Authority. It did not harbor antibiotic resistance and virulence genes. L. brevis KU15006 lacked β-hemolysis, mucin degradation, cytotoxicity against Caco-2 cells, gelatin liquefaction, bile salt deconjugation, and toxic metabolite production abilities. Based on the results, L. brevis KU15006, which has antagonistic and anti-diabetic effects, could be marketed as a probiotic in the future.