EFSA Research Articles

Polyfluoroalkyl-Substances Detection in Junk Food Packing Materials Using Various Analytical Methods: A Review.

Per- and polyfluoroalkyl substances (PFAS) are unseen, dangerous organic compounds that can cause major health disorders. PFASs have been categorized as persistent, bioaccumulative, and toxic (PBT). This review provides knowledge about the PFASs present in junk food packaging materials, which can migrate into the food. Different types of samples were analyzed using the analytical methods. The most preferred method of extraction is ultrasonic-assisted extraction (UAE). It summarizes the analytical approaches of PFASs. The results of numerous studies show that perfluorooctanoic acid is the most often detected compound with high concentrations. The European Food Safety Authority (EFSA) announced that the tolerable weekly intake (TWI) of PFASs is 4.4 ng/kg. The US Environmental Protection Agency (EPA) has announced the limit for perfluorobutane sulfonic acid due to its toxicity level. These compounds have potential effects on both people's health and the biosphere. PFAS usage has to stop in the industries for a better future.

Bisphenols in daily clothes from conventional and recycled material: evaluation of dermal exposure to potentially toxic substances

Given the increasing concern about chemical exposure from textiles, our study examines the risks of dermal exposure to bisphenol A (BPA), bisphenol S (BPS), bisphenol B (BPB) and bisphenol F (BPF) from conventional and recycled textiles for adults, aiming to obtain new data, assess exposure, and evaluate the impact of washing on bisphenol levels. A total of 57 textile samples (33 from recycled and 24 from conventional material) were subjected to ultrasound-assisted extraction (UAE) followed by ultra-high performance liquid chromatography with tandem mass spectrometry analysis (UHPLC-MS/MS). The BPA and BPS concentrations varied widely (BPA: < 0.050 to 625 ng/g, BPS: 0.277–2,474 ng/g). The median BPA content in recycled textiles (13.5 ng/g) was almost twice as high as that of 7.66 ng/g in conventional textiles. BPS showed a median of 1.85 ng/g in recycled textiles and 3.42 ng/g in conventional textiles, indicating a shift from BPA to BPS in manufacturing practices. Simulated laundry experiments showed an overall reduction in bisphenols concentrations after washing. The study also assessed potential health implications via dermal exposure to dry and sweat-wet textiles compared to a tolerable daily intake (TDI) of 0.2 ng/kg bw/day for BPA set by the European Food Safety Authority (EFSA). Exposure from dry textiles remained below this threshold, while exposure from wet textiles often exceeded it, indicating an increased risk under conditions that simulate sweating or humidity. By finding the widespread presence of bisphenols in textiles, our study emphasises the importance of being aware of the potential risks associated with recycling materials as well as the benefits.

P20-31 The re-evaluation of sweeteners by the European Food Safety Authority (EFSA): the revised protocols for the assessment of hazard identification and hazard characterisation and exposure of sweeteners

P20-31 The re-evaluation of sweeteners by the European Food Safety Authority (EFSA): the revised protocols for the assessment of hazard identification and hazard characterisation and exposure of sweeteners

Peer review of the pesticide risk assessment of the active substance Bacillus velezensisRTI301.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance Bacillus velezensis strain RTI301 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. velezensis strain RTI301 as a fungicide for the control of soil-borne diseases in greenhouses (permanent) and walk-in tunnels (non-permanent) and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.

Peer review of the pesticide risk assessment of the active substance Bacillus subtilis strain RTI477.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Bacillus subtilis strain RTI477 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. subtilis strain RTI477 as a fungicide for the control of soil-borne diseases in greenhouses (permanent) and walk-in tunnels and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.

P25-10 Update of European Food Safety Authority (EFSA)'s work on cumulative risk assessment of pesticide residues targeting the thyroid

P25-10 Update of European Food Safety Authority (EFSA)'s work on cumulative risk assessment of pesticide residues targeting the thyroid

Outcome of the stakeholder consultation on the reasoned opinions for azocyclotin, bifenthrin, chlorfenapyr, cyhexatin, diazinon, dicofol, endosulfan, fenarimol, fenpropathrin and profenofos

Abstract In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission has requested the European Food Safety Authority (EFSA) to organise a stakeholder consultation on the reasoned opinions for the following active substances, non‐approved for use as plant protection products in the European Union: azocyclotin, bifenthrin, chlorfenapyr, cyhexatin, diazinon, dicofol, endosulfan, fenarimol, fenpropathrin and profenofos. This technical report presents the outcome of the consultation, an appraisal of the data received and a conclusion on whether a reconsideration of the previous assessments will be needed based on the additional data collected.

Peer review of the pesticide risk assessment of the active substance flufenacet.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Poland and co-rapporteur Member State France for the pesticide active substance flufenacet are reported. In addition, the assessment of the confirmatory data following the Article 12 maximum residue limit (MRL) review of Regulation (EC) No 396/2005 is also reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of flufenacet as a herbicide on winter cereals. Confirmatory data following the Article 12 MRL review were assessed. The reliable end points, appropriate for use in regulatory risk assessment and the assessment of confirmatory data following the Article 12 MRL review, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Energy Content, Moisture Content, and Energy Assimilation Efficiency by Birds and Mammals of Oil-Containing Seeds and Implications for Seed Treatment Risk Assessments for Birds and Mammals.

Energy content, moisture content, and energy assimilation efficiency are essential parameters in the food intake rate (FIR) and exposure calculations for bird and mammal risk assessments. The updated European Food Safety Authority guidance document on risk assessment for birds and mammals summarizes these parameters for different food items. For seed treatments, values for cereal seeds are proposed as surrogates for other crops. Oil-containing seeds are expected to have a higher energy content than cereal seeds. This would result in lower FIR and, thus, exposure from consuming such seeds. To be able to calculate reliable exposure values for risk-assessment purposes, we conducted a systematic literature review to collect information on these three parameters for oil-containing seeds (sunflower, oilseed rape, soybean, peanut, sesame, safflower, linseed [flax], white mustard, and castor bean). The search yielded 401 papers, of which 151 contained values for at least one of the parameters of the crops in focus. The overall average energy content value of oil-containing seeds was 24.25 kJ/g (n = 124, SD = 3.00), whereas that for moisture content was 6.57% (n = 296, SD = 1.15). Energy assimilation values were only available for peanut, oilseed rape, soy, linseed, and sunflower for a limited number of bird and mammal species. Mean energy assimilation efficiency for mammals was 82.69% (n = 4, SD = 1.55), whereas values for birds were 57.54% (n = 2, SD = 6.77) for Galliformes and 79.25% (n = 2, SD = 1.82) for Passeriformes. The values presented can be used to calculate appropriate FIR values for future bird and mammal risk assessments. Environ Toxicol Chem 2024;43:2080-2085. © 2024 The Author(s). Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Health risk assessment for dietary exposure to 3-monochloropropane-1,2-diol, 2-monochloropropane-1,2-diol, and glycidol for Italian consumers

3-Monochloropropane-1,2-diol (3-MCPD), 2-monochloropropane-1,2-diol (2-MCPD) and 2,3-epoxy-1-propanol (glycidol), in their free form or esterified to fatty acids, are food contaminants formed during the refinement of oils and fats. We conducted a survey to quantify the levels of these compounds in 130 food items, in order to assess the exposure to them in food and the consequent health risk for consumers. Food samples, including infant formula, were analysed by gas-chromatography mass spectrometry with the indirect method, and we used the latest open access food consumption database for the Italian population for a probabilistic assessment of exposure. We adopted an in silico approach to fill the gap for the toxicity of 2-MCPD. The occurrence values for the three contaminants in food were in most cases lower than or comparable to those reported in previous surveys. Exposure assessment for the most exposed individuals (95thpercentiles of consumers only) of different age groups, gave values below the tolerable daily intake recommended by the European Food Safety Authority for 3-MCPD and below the simulated or predicted toxicity thresholds for 2-MCPD, indicating a negligible risk due to dietary exposure to these contaminants. For glycidol, however, estimated exposure indicated a non-negligible increase in cancer risk, and a margin of exposure <25,000 for younger population groups, indicating a potential health concern.

Metabolic and Biochemical Effects of Pyrroloquinoline Quinone (PQQ) on Inflammation and Mitochondrial Dysfunction: Potential Health Benefits in Obesity and Future Perspectives.

Obesity is defined as a complex, systemic disease characterized by excessive and dysfunctional adipose tissue, leading to adverse health effects. This condition is marked by low-grade inflammation, oxidative stress, and metabolic abnormalities, including mitochondrial dysfunction. These factors promote energy dysregulation and impact body composition not only by increasing body fat but also by promoting skeletal muscle mass atrophy. The decline in muscle mass is associated with an increased risk of all-cause mortality in individuals with this disease. The European Food Safety Authority approved pyrroloquinoline quinone (PQQ), a natural compound, as a dietary supplement in 2018. This narrative review aims to provide a comprehensive overview of the potential role of PQQ, based on its anti-inflammatory and antioxidant properties, in addressing dysfunctional adipose tissue metabolism and related disorders.

Artificial intelligence-based data extraction for next generation risk assessment: Is fine-tuning of a large language model worth the effort?

To underpin scientific evaluations of chemical risks, agencies such as the European Food Safety Authority (EFSA) heavily rely on the outcome of systematic reviews, which currently require extensive manual effort. One specific challenge constitutes the meaningful use of vast amounts of valuable data from new approach methodologies (NAMs) which are mostly reported in an unstructured way in the scientific literature. In the EFSA-initiated project ‘AI4NAMS’, the potential of large language models (LLMs) was explored. Models from the GPT family, where GPT refers to Generative Pre-trained Transformer, were used for searching, extracting, and integrating data from scientific publications for NAM-based risk assessment. A case study on bisphenol A (BPA), a substance of very high concern due to its adverse effects on human health, focused on the structured extraction of information on test systems measuring biologic activities of BPA. Fine-tuning of a GPT-3 model (Curie base model) for extraction tasks was tested and the performance of the fine-tuned model was compared to the performance of a ready-to-use model (text-davinci-002). To update findings from the AI4NAMS project and to check for technical progress, the fine-tuning exercise was repeated and a newer ready-to-use model (text-davinci-003) served as comparison. In both cases, the fine-tuned Curie model was found to be superior to the ready-to-use model. Performance improvement was also obvious between text-davinci-002 and the newer text-davinci-003. Our findings demonstrate how fine-tuning and the swift general technical development improve model performance and contribute to the growing number of investigations on the use of AI in scientific and regulatory tasks.

Dietary exposure assessment to mycotoxins from traditional meat products in Croatia

Mycotoxins may be present in traditional meat products (TMPs) due to production of moulds overgrowing their surface during ripening or due to contaminated spices or meat used in their production. The aim of this study was to evaluate the human exposure to the mycotoxins, including aflatoxins (AFs) B1, B2, G1 and G2 (AFB1, AFB2, AFG1, AFG2), ochratoxin A (OTA), cyclopiazonic acid (CPA), citrinin (CIT) and sterigmatocystin (STC), which may be present in TMPs, using 288 samples available on the market in relation to the consumption data of Croatian citizens. AFs and CIT weren't detected in any sample, so the exposure to these mycotoxins in TMP can be considered negligible. The determined exposure to STC was 0.011–0.020 ng/kg bw/day far below the exposure of low health concern set by the European Food Safety Authority (EFSA). The determined exposure to CPA was up to 5.75 ng/kg bw/day, but there isn't yet a health-based guideline value (HBGV) for the consumer risk associated with CPA in food. The determined exposure to OTA was 0.043–0.121 ng/kg bw/day, and according to the margin of exposure (MoE) approach, in the case of the upper bound (UB) scenario, for neoplastic effects a low concern was identified in 0.12% of consumers, while for non-neoplastic effects a potential health concern was identified in 4.15% of consumers. Among the TMP categories, dry-fermented sausages contributed the most to consumer exposure for all three mycotoxins detected. Results indicate that mycotoxins presence should be monitored over a longer period of time where different data can be expected in order to observe the trend of human exposure.

Comparative study of dietary selenium sources on gilthead seabream (Sparus aurata): Growth, nutrient utilization, stress response and final product quality

Selenium (Se) is a crucial trace mineral in human nutrition, known for its various health benefits, including the enhancement of antioxidant defenses. Enrichment of fish fillets with Se is seen as an interesting strategy to reduce the risk of Se deficiency in human diets. While inorganic sources have been traditionally used to supplement Se in fish diets, organic Se forms have demonstrated superior bioavailability and efficacy in managing oxidative stress and tissue retention rates compared to their inorganic counterparts.The main objective of this study was to assess the performance, stress resistance, and product quality of gilthead seabream (Sparus aurata) in response to diets supplemented with 0.2 mg kg−1 of Na2SeO3 (CTRL), Zn-L-SeMet (AVSe) or OH-Se-Met (ORGSe), complying therefore with the European Food Safety Agency (EFSA) maximum allowed supplementation of organic Se (0.2 mg kg−1). Diets were formulated to be similar in their protein (48% DM) and lipid content (17% DM), and hand-fed to apparent satiety to quadruplicate groups of 20 fish (initial body weight ∼ 75 g) gilthead seabream juveniles for 137 days. Fish were kept in a recirculating saltwater system (salinity 35‰, 22 ± 1 °C) until they reached commercial size (>250 g). At the end of the growth trial, all fish were individually weighed and measured, with 4 fish per tank sampled for whole-body composition analysis. Fillet yield, muscle lipid and mineral composition, and hepatic oxidative stress indicators were assessed (n = 12). Lipid peroxidation, muscle pH, water-holding capacity (WHC), color, and texture were evaluated on days 7 and 14 (n = 8), while sensory analysis was conducted on 20 fish. Additionally, 12 fish per treatment were subjected to overcrowding (100 kg m−3) for 5 min and air exposure for 1 min. After a 1-h recovery period, plasma and liver samples were collected from these fish, and results were compared to those of the non-stress group. All diets yielded equivalent growth performance, ensuring low feed conversion ratio. Fish fed the AVSe diet exhibited higher whole-body protein content compared to those fed the CTRL diet. Regarding mineral utilization, increased Se retention and gain in fish fed AVSe and ORGSe diets led to higher Se content in these fish compared to the CTRL. Additionally, the AVSe diet has also resulted in significantly increased Se deposition in the muscle compared to the other tested Se sources, contributing with 34% of the Se Daily Recommended Intake (DRI). The assessed flesh quality parameters and overall consumer acceptance did not reveal significant differences among the groups. Exposure to an acute stress was found to decrease the activities of Glutathione reductase and glutathione peroxidase, which in turn has increased the level of oxidized glutathione, particularly in the AVSe group. Compared to OH-Se-Met and Na2SeO3, Zn-L-SeMet was more effective in promoting response to stress and nutritional value of gilthead seabream as an important source of protein and Se in human diet.

Health Hazard Associated with the Presence of Clostridium Bacteria in Food Products.

Clostridium bacteria were already known to Hippocrates many years before Christ. The name of the Clostridium species is owed to the Polish microbiologist, Adam Prażmowski. It is now known that these Clostridium bacteria are widespread in the natural environment, and their presence in food products is a threat to human health and life. According to European Food Safety Authority (EFSA) reports, every year, there are poisonings or deaths due to ingestion of bacterial toxins, including those of the Clostridium spp. The strengthening of consumer health awareness has increased interest in consuming products with minimal processing in recent years, which has led to a need to develop new techniques to ensure the safety of microbiological food, including elimination of bacteria from the Clostridium genera. On the other hand, the high biochemical activity of Clostridium bacteria allows them to be used in the chemical, pharmaceutical, and medical industries. Awareness of microbiological food safety is very important for our health. Unfortunately, in 2022, an increase in infections with Clostridium bacteria found in food was recorded. Knowledge about food contamination should thus be widely disseminated.

Prevalence of perfluoroalkyl substances in paired batches of precooked and canned bovine meat and their implication on consumer safety

Meat is a highly nutritious food but there is a lot of significant evidence of negative health outcomes related to its excessive consumption, especially for processed one. Among the variety of emerging contaminants of concern for human health, a key role is played by poly- and per-fluoroalkyl substances (PFASs), which show adverse effects in humans who are exposed to them through diet. In the present study, for the first time, 70 paired batches of pre-cooked and canned bovine meat were analysed by Liquid Chromatography coupled to High Resolution Mass Spectrometry to evaluate the presence and concentration of 18 PFASs. These data were used to assess Italian consumers’ health risks by performing the PFAS intake evaluation. PFBA and PFOS were detected in the precooked and canned meat samples, with PFBA mean concentration of 0.22 ± 0.36 ng g−1, and <LOQ, respectively, and PFOS mean concentration of <LOQ in both. No PFASs were found in the jelly. The comparison between the PFBA levels in precooked and canned meat showed a significant difference. The PFAS intake evaluation showed an Estimated Daily Intake by far lower than the Tolerable Daily Intake for the average Italian consumer suggested by the European Food Safety Authority.

Development and Application of a Liquid Chromatography-Tandem Mass Spectrometry Method for the Analysis of 20 Perfluoroalkyl Substances in Fruit and Vegetables at Sub-Parts-per-Trillion Levels.

In response to the European Food Safety Authority's establishment of a tolerable weekly intake (TWI) for the sum of PFOA, PFNA, PFHxS, and PFOS, a method was developed to quantify and confirm 20 PFASs at the sub-parts-per-trillion level in fruit and vegetables. Improved sensitivity was achieved by (i) increasing the sample intake, (ii) decreasing the solvent volume in the final extract, and (iii) using a highly sensitive mass spectrometer. Except for PFTrDA, target PFASs could be quantitatively determined with an apparent recovery of 90-119%, limits of quantitation down to 0.5 ng/kg, and a relative standard deviation under within-laboratory reproducibility conditions of <28%. The method was successfully applied to 215 fruit and vegetable samples obtained from local grocery stores and markets. Leafy vegetables prove to be the main vegetable category responsible to PFAS exposure, mainly of PFOA, followed by PFHpA and PFHxA.

The Probiotic Enterococcus Lactis SF68 as a Potential Food Fermentation Microorganism for Safe Food Production.

Due to the reports describing virulent and multidrug resistant enterococci, their use has become a topic of controversy despite most of them being safe and commonly used in traditionally fermented foods worldwide. We have characterized Enterococcus lactis SF68, a probiotic strain approved by the European Food Safety Authority (EFSA) for use in food and feed, and find that it has a remarkable potential in food fermentations. Genome analysis revealed the potential of SF68 to metabolize a multitude of carbohydrates, including lactose and sucrose, which was substantiated experimentally. Bacteriocin biosynthesis clusters were identified and SF68 was found to display a strong inhibitory effect against Listeria monocytogenes. Fermentation-wise, E. lactis SF68 was remarkably like Lactococcus lactis and displayed a clear mixed-acid shift on slowly fermented sugars. SF68 could produce the butter aroma compounds, acetoin and diacetyl, the production of which was enhanced under aerated conditions in a strain deficient in lactate dehydrogenase activity. Overall, E. lactis SF68 was found to be versatile, with a broad carbohydrate utilization capacity, a capacity for producing bacteriocins, and an ability to grow at elevated temperatures. This is key to eliminating pathogenic and spoilage microorganisms that are frequently associated with fermented foods.

Assessment of the 2022 post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU.

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north-eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether 'very highly' and 'extremely' sensitive non-target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non-target lepidoptera to maize MON 810 pollen is reduced to levels of no concern.

Peer review of the pesticide risk assessment of the active substance Phthorimaea operculella granulovirus.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, The Netherlands for the pesticide active substance Phthorimaea operculella granulovirus are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Phthorimaea operculella granulovirus as an insecticide on tomato (field and greenhouse uses) and on potato (field use) via spraying (tractor drawn or knapsack sprayers) or overhead irrigation. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed.