EFSA Research Articles

A LC-MS/MS procedure for the analysis of 19 perfluoroalkyl substances in food fulfilling recent EU regulations requests

Perfluoroalkyl and polyfluoroalkyl substances (PFASs) are synthetic, stable, fluorinated molecules widely used in consumer products. They are non-biodegradable, persistent and bio-accumulating. In 2020 European Food Safety Authority (EFSA) lowered the Tolerable Weekly Intake (TWI) for the four PFASs (PFOA, PFOS, PFNA, PFHxS) and in 2022, the EU issued a Recommendation asking to monitor twenty-one PFASs in food. Since 1st January 2023 limits in food were set. Here we report a sensitive, straightforward and robust procedure enabling the determination of 19 PFAS in food matrices using a liquid chromatography mass spectrometer (LC–MS/MS). Few are the published methods applicable to the different food matrices and covering the molecules listed in Recommendation 2022/1431, fulfilling the LOQs requested. The method was satisfactory validated (UNI CEI EN ISO/IEC 17025:2018 and Regulation (EU) 2022/1428) and used to investigate hen egg samples, highlighting home-produced eggs as the more critical egg farming process for PFAS accumulation.

Use of harmonised epidemiological indicators (HEIs) for broilers in Europe

In 2012, the European Food Safety Authority (EFSA) proposed harmonised epidemiological indicators (HEIs) for poultry at different production stages: Salmonella, Campylobacter, extended-spectrum β-lactamase/AmpC β-lactamase (ESBL/AmpC) producing Enterobacteriaceae and generic Escherichia (E.) coli. The HEIs are based on existing monitoring systems or the sampling strategies provided by EFSA. To realise the full benefit of HEIs, risk managers should use them for farm and abattoir categorisation and for adapting the existing meat inspection systems. As HEIs are not legal requirements within the European Union (EU), it is unclear which HEIs are used in which country, to date. Therefore, an online survey was conducted in Europe to gather knowledge about the implementation, application and consequences following on from the HEIs in existing official and private monitoring and surveillance systems (MOSS).A total of 34 answer sets from participants working in the framework of official surveillance or as food business operators in broiler abattoirs were collected from eleven EU member states (EU-MS) and four non-EU countries.While all participants stated that testing for Salmonella is performed, HEI 4-Salmonella, which corresponds to the process hygiene criterion (PHC) for Salmonella was applied by 62% of the participants. In total, 94% of the participants reported that they test for Campylobacter. Among them, 71% stated that testing is performed for HEI 5-Campylobacter, which corresponds to PHC for Campylobacter. Although testing neck skin samples for Salmonella and Campylobacter after chilling are official and mandatory MOSS in the EU, not all participants from EU-MS (Salmonella: 6/11 EU-MS; Campylobacter: 8/11 EU-MS) confirmed to comply with. Altogether, 56% of the participants (from 6 EU-MS and 2 non-EU countries) stated that they test for E. coli. Ten of them reported that the testing is performed at the abattoir after chilling according to the suggested HEI for generic E. coli as a hygiene indicator. Consequences that result from the existing MOSS for the three examined pathogens (Salmonella, Campylobacter and E. coli) were mainly rising awareness, farm risk categorisation and feedback to the farmer.According to the answers from the participants, the HEIs suggested by EFSA for broilers are currently implemented in most EU-MS. One reason could be that some of the according MOSS are required by EU law. As intended by EFSA, the participants stated that they use HEIs for farm risk categorisation as one of the three top consequences following from MOSS for the three mentioned pathogens. For improving the knowledge and application of HEIs in the context of risk-based meat safety assurance systems, specific training could be helpful.

European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation.

The European Food Safety Authority (EFSA) has revised their estimate of the toxicity of bisphenol A (BPA) and, as a result, have recommended reducing the tolerable daily intake (TDI) by 20 000-fold. This would essentially ban the use of BPA in food packaging such as can liners, plastic food containers, and in consumer products. To come to this conclusion, EFSA used a systematic approach according to a pre-established protocol and included all guideline and nonguideline studies in their analysis. They found that Th-17 immune cells increased with very low exposure to BPA and used this endpoint to revise the TDI to be human health protective. A number of regulatory agencies including the European Medicines Agency (EMA) have written formal disagreements with several elements of EFSA's proposal. The European Commission will now decide whether to accept EFSA's recommendation over the objections of EMA. If the Commission accepts EFSA's recommendation, it will be a landmark action using knowledge acquired through independent scientific studies focused on biomarkers of chronic disease to protect human health. The goal of this Perspective is to clearly articulate the monumental nature of this debate and decision and to explain what is at stake. Our perspective is that the weight of evidence clearly supports EFSA's proposal to reduce the TDI by 20 000-fold.

Quantitative determination of BPA, BPB, BPF and BPS levels in canned legumes from Italian market.

The levels of bisphenol A (BPA), bisphenol B (BPB), bisphenol F (BPF) and bisphenol S (BPS) were monitored in twenty-three samples of canned legumes from popular brands marketed in Italy. BPB, BPS and BPF were not detected in any samples, while BPA was found in 91 % of the samples in the concentration range 1.51-21.22ng/mL. The risk associated with the human exposure to BPA was categorized using the Rapid Assessment of Contaminant Exposure (RACE) tool promoted by the European Food Safety Authority (EFSA). The results showed that there is no risk for any of the population groups when the current TDI value for BPA of 4μg/kg bw/day was used as toxicological reference point. In contrast, using the new TDI value for BPA of 0.04ng/kg bw/day, proposed by EFSA in December 2021, the existing risk was found to be real for all population groups.

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

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 Austria and co-rapporteur Member State Italy for the pesticide active substance folpet and of confirmatory data following the MRL review under Article 12 of Regulation (EC) No 396/2005. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of folpet as a fungicide on barley, wheat and wine grape (field uses) and tomato (field and greenhouse uses). The reliable end points, appropriate for use in regulatory risk assessment and the confirmatory data, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Tetrodotoxin in bivalve mollusks: An integrated study towards the comprehension of the influencing factors of a newly native phenomenon

Tetrodotoxins (TTXs) are potent neurotoxins named after the Tetraodontidae fish family. The ingestion of TTX-contaminated flesh can cause neurotoxic symptoms and can lead to death. In 2017 symptoms the European Food Safety Authority (EFSA) recognized the threat to food safety resulting from TTX exposure via food consumption and, thus, proposed a safety limit of 44 μg/kg of TTX in marine gastropods and bivalves. To date, however, TTXs have not yet been included in the list of biotoxins to be monitored within the European Union, even though, in a few cases, levels of TTX found were higher than the EFSA limit. The origin of TTX production is debated and the roles of both biotic and abiotic factors on TTX-mediated toxic events remain unclear. In order to meet these knowledge requests the present study was aimed to investigate the role of seawater temperature, pH, water conductivity, and oxygen saturation, along with the marine phytoplankton community and the bacterial community of mussels and oysters on the accumulation of TTX and analogues in the bivalves. Abiotic parameters were measured by means of a multi-parametric probe, phytoplankton community was analyzed by optic microscopy while microbial community was described by amplicon metataxonomic sequencing, TTXs concentration in the collected matrices were measured by HILIC-MS/MS.A possible role of seawater pH and temperature, among the investigated abiotic factors, in regulating the occurrence of TTXs was found. Regarding biotic variables, a possible influence of Vibrio, Shewanella and Flavobacteriaceae in the occurrence of TTXs was found. Concurrently, Prorocentrum cordatum cell numbers were correlated to the incidence of TTX in mussels. The results herein collected suggest that environmental variables play a consistent part in the occurrence of TTX in the edible bivalve habitats, and there are also indications of a potential role played by specific bacteria taxa in association with phytoplankton.

Iodine intake and excretion from sheep supplemented with macroalgae (Laminaria hyperborea) by-product

Macroalgae, or seaweeds, have potential for use as feed ingredients and are currently unexploited despite their content of vitamins, minerals, and protein. Brown species can accumulate iodine from seawater and there are strict limits set by the European Food Safety Authority and the FDA regarding iodine content in animal feeds. Iodine can cause health problems for consumers if over or under-consumed and its presence in end food products is strictly regulated. The aim of the present experiment was to gain knowledge on intake, distribution, and excretion of iodine in sheep supplemented with Laminaria hyperborea by-product known to contain iodine. Twelve Norwegian White Sheep male lambs, four months of age, were blocked according to initial live weight (average 37.8 kg) and randomly allocated to two diet groups. Animals were fed gras silage and concentrate, without (CTR) and including the alga by-product at a 6% inclusion rate (HYP). The iodine concentrations were 4.1 and 476 mg/kg dry matter in the CTR and HYP concentrate, respectively. After 26 days of adaptation in a barn, animals were placed in metabolism crates for three consecutive days (Period 1) with collection of rumen fluid (via esophagus), grass silage, feces, urine, and blood for iodine content. After 5 weeks in the barn, animals returned to the metabolism crates for a subsequent three consecutive day sampling and iodine analyzes (Period 2). Data were analyzed via ANOVA using a repeated measure mixed model procedure. Dry matter intake (P = 0.001) and live weight (P = 0.001) increased from Period 1 to Period 2. Lambs fed CTR had higher daily growth rate than those fed HYP (P = 0.001). Iodine intake and excretion in feces and urine increased from Period 1 to Period 2 (P < 0.001, P = 0.010, P = 0.007, respectively). Iodine excreted in feces was 37% and 67% for lambs in fed the CTR and HYP diets, respectively. None of the animals showed signs of iodine poisoning during ten the experiment. We found that most of the iodine excreted from lambs fed the HYP diet was in feces.

Food Risk Analysis: Towards a Better Understanding of "Hazard" and "Risk" in EU Food Legislation.

For risk communication, it is important to understand the difference between "hazard" and "risk". Definitions can be found in Codex Alimentarius and the European Union (EU) General Food Regulation (EC) No. 178/2002. The use of these terms as synonyms or their interchange is a recurrent issue in the area of food safety, despite awareness-raising messages sent by EFSA (European Food Safety Authority) and other interested entities. A quick screening of the EU's food regulations revealed several inconsistencies. Hence, it was considered necessary to further investigate if regulations could act as a source for this problem. A software tool was developed to support the detection and listing of inconsistent translations of "hazard" and "risk" in certain EU food regulations. Subsequently, native-speaking experts working in food safety from each EU country were asked to provide their individual scientific opinion on the prepared list. All data were statistically analysed after applying numerical scores (1-5) describing different levels of consistency. Results showed that the most common problem was the interchange of "hazard" with "risk" and vice versa. This lack of consistency can create confusion that can further translate into misjudgments at food risk assessment and communication levels.

Draft genome sequence and probiotic functional property analysis of Lactobacillus gasseri LM1065 for food industry applications

Probiotics are defined as live organisms in the host that contribute to health benefits. Lactobacillus gasseri LM1065, isolated from human breast milk, was investigated for its probiotic properties based on its genome. Draft genome map and de novo assembly were performed using the PacBio RS II system and hierarchical genome assembly process (HGAP). Probiotic properties were determined by the resistance to gastric conditions, adherence ability, enzyme production, safety assessment and mobile genetic elements. The fungistatic effect and inhibition of hyphae transition were studied using the cell-free supernatant (CFS). L. gasseri LM1065 showed high gastric pepsin tolerance and mild tolerance to bile salts. Auto-aggregation and hydrophobicity were measured to be 61.21% and 61.55%, respectively. The adherence to the human intestinal epithelial cells was measured to be 2.02%. Antibiotic-resistance genes and putative virulence genes were not predicted in the genomic analysis, and antibiotic susceptibility was satisfied by the criteria of the European Food Safety Authority. CFS showed a fungistatic effect and suppressed the tricarboxylic acid cycle in Candida albicans (29.02%). CFS also inhibited the transition to true hyphae and damaged the blastoconidia. This study demonstrates the essential properties of this novel probiotic, L. gasseri LM1065, and potential to inhibit vaginal C. albicans infection.

Simultaneous Salmonella and bacteriophage isolation on Modified Semisolid Rappaport Vassiliadis media

Salmonella represents a food safety concern worldwide. Despite the application of National Control Programs (NCP) against Salmonella, regulated by the European Union, every year the European Food Safety Authority reports new cases. On the look for new alternatives to antibiotics, bacteriophages, or phages, rise as a promising alternative to treat multidrug resistance infections. Although they are known to be ubiquitous in the environment, their high specificity to host cells hinders their isolation and usage for phage therapy. The ISO 6579-1:2017 is performed as a reference method in the NCP and uses an unspecific media to enrich the sample the same way most phage isolation protocols do. Later, the protocol uses a more selective media to isolate the Salmonella, Modified Semisolid Rappaport Vassiliadis (MSRV). This paper aims to find out whether, due to the similarity between phage isolation protocols and the ISO 6579-1:2017, this last one could be used as a protocol to also isolate phages against the same bacterium that is being simultaneously isolated. To do so, 2 experiments were performed to assess phage isolation from MSRV media in in-vivo conditions. The results from experiments 1 and 2 proved that the MSRV media was usable for simultaneous phage and pathogen isolation through a single procedure. Additionally, there is a correlation between the antigenic formulae from the bacteria and the phage's host range, seeming to be effective against bacteria with similar antigenic formulae.

Dietary micronutrient adequacies and adherence to the Mediterranean diet in a population of older adults with type 2 diabetes: A cross-sectional study

There are few data on micronutrient intake in older adults with type 2 diabetes (T2D) and their adherence to the Mediterranean diet, a dietary pattern rich in micronutrients. In this cross-sectional study, we evaluated the prevalence of adequacy in micronutrient intake according to the recommendations, and the adherence to the Mediterranean diet in older adults with T2D. One hundred thirty-eight patients (47 women and 91 men) with T2D aged over 65 years were included. Dietary habits were assessed by three 24-h dietary recalls. The micronutrient intake, expressed as mean daily intake, and adequacy were compared with the dietary recommendations proposed by the Italian Society of Human Nutrition (LARN) and the European Food Safety Agency (EFSA). Adherence to the Mediterranean diet was evaluated by the MEDI-quest score. An extremely low proportion of participants (∼1%) adhered to the recommendations for potassium and vitamin D intake. A low proportion of participants adhered to the recommendations for calcium (∼23%), magnesium (∼16%), selenium (∼17%), vitamin E (∼14%), riboflavin (∼28%), vitamin B6 (∼29%), folate (∼25%), and niacin (∼27%) intake. More than 60% of the population adhered to the recommendations for iron, copper, vitamin A and B12 intake. Only 53% of the population showed high adherence to the Mediterranean diet. Our data indicate that a very low proportion of older adults with T2D meet the recommendations for ten micronutrients (calcium, potassium, magnesium, selenium, vitamin D, vitamin E, riboflavin, vitamin B6, folate, and niacin) with an unsatisfactory adherence to the Mediterranean diet. Nutritional approaches aimed at favoring adherence to dietary recommendations and increasing the consumption of foods rich in micronutrients should be implemented in older adults.

Monthly distribution of lipophilic marine biotoxins and associated microalgae in the South Sea Coast of Korea throughout 2021

Aquaculture farms have been established along the South Sea Coast of Korea, supplying most of the seafood consumed domestically. However, annual harmful algal blooms pose a potential threat to seafood safety. This study aimed to determine the spatial and seasonal distributions of 12 lipophilic marine biotoxins (LMTs) in phytoplankton and mussels in the region in 2021. Solid-phase adsorption toxin tracking (SPATT) was used to monitor the cumulative compositions of LMTs in seawater. LMT concentrations were also determined in twelve commercially available species of domestic shellfish to evaluate the potential risks to human health. Gonyaulux spinifera and Dinophysis acuminata, causative microalgae of yessotoxins (YTXs) and pectenotoxins (PTXs), respectively, showed high densities in the region from May to July. This period corresponded to high LMT concentrations in phytoplankton and mussels. Phytoplankton mainly contained PTX-2 and homo-YTX, with a maximum concentration of 2300 ng g−1 wet weight (ww) in May. In contrast, mussels mainly contained homo-YTX and YTX, with a maximum concentration of 1300 ng g−1 ww in July. LMTs-producing microalgae showed low densities and concentrations after July, whereas mussels accumulated toxins until September. In the SPATT sampler, more diverse LMTs were detected than in seawater, phytoplankton, and mussels. For example, dinophysistoxin-1 and azaspiracid-2 were detected only in SPATT. YTXs were detected in domestic seafood samples, including mussels, red scallops, and pen shells, but the concentrations were below the European Food Safety Agency recommended standard of 3.75 mg YTX-eq. kg−1. Moreover, the hazard quotient was less than 100 in all scenarios, indicating that the human health risk was not significant. This study provides valuable data on monthly distribution patterns of LMTs in the South Sea Coast of Korea and can serve as baseline data for future management policies of marine biotoxins.

Methodological approaches for the assessment of bisphenol A exposure

Bisphenol A (BPA) is an endocrine disruptor used in food contact materials, by the application of polycarbonate plastics and epoxy resins. The main objective of this study is to compare the estimate of daily BPA exposure at 13 years of age and in the adult Portuguese population, using different methodological approaches, and assess the associations between this exposure and sociodemographic characteristics. MethodologyCross-sectional data of 13-years follow-up from a population-based birth cohort Generation XXI (GXXI) (n = 2804) and from the National Food, Nutrition and Physical Activity Survey (IAN-AF 2015–2016) (n = 3845, ≥18 years old) was used. Dietary information was collected through three food diaries for adolescents and two non-consecutive 24-hour-recalls for adults.To estimate the daily exposure to BPA, three methodological approaches were used. “Food groups attribution” merged the food consumption data with the concentration of BPA in food groups. “Regression tree model” and “random forest” combined food consumption information with urinary BPA, measured in a subsample of 24-hour urine (in adolescents n = 216, and in adults n = 82), both used to predict BPA exposure in the remaining sample. The fit-index of the methodologies was assessed through the root mean square error (RMSE), mean absolute error (MAE) and Spearman correlation coefficient (ρ). Associations between BPA exposure and sociodemographic variables were tested by linear regression models, adjusted for sex, age groups (in adults) and educational level. Tolerable Daily Intake (TDI) of 0.2 ng/kg body weight (bw), recently proposed by the European Food Safety Authority (EFSA), was used for the risk characterization of BPA exposure. ResultsThe “random forest” was found as the best methodology to estimate the daily BPA exposure (adolescents: RMSE = 0.989, MAE = 0.727, ρ = 0.168; adults: RMSE = 0.193, MAE = 0.147, ρ = 0.250). The median dietary BPA exposure, calculated by “food groups attribution”, was 79.1 and 46.1 ng/kg bw/day for adolescents and adults, respectively, while “random forest” estimated a BPA exposure of 26.7 and 38.0 ng/kg bw/day. 99.9% of the Portuguese population presented a daily exposure above TDI. Male adolescents, females and higher educated adults, were those more exposed to BPA. ConclusionsThe estimated daily BPA exposure strongly depends on the methodological approach. Food groups attribution may overestimate the exposure while the random forest appears to be a better methodological approach to estimate BPA exposure. Nevertheless, for all methods, the Portuguese population presented an unsafe BPA exposure by largely exceeding the safe levels proposed by EFSA.

Development of a field-deployable analytical workflow for determining current status and indicative human health risks at a historic dl-POPs hotspot

This paper introduces an integrated workflow that effectively evaluates environmental and health risks of dioxin-like Persistent Organic Pollutants (dl-POPs) at industrial hotspot regions. The developments of validated, cost effective and user-friendly analytical strategies which can be field deployable are quintessential for routine monitoring of dl-POPs, particularly in developing countries. This study addresses the lacunae by enabling an exclusive gas chromatography triple quadrupole mass spectrometer based analytical workflow substituting conventional magnetic sector high resolution mass spectrometer technique and validated the methodology as per the European Union regulation 644/2017. The viable monitoring utility of the methodology for predicting enviro-food-health nexus was field-tested by analyzing fish and sediment samples from the Eloor-Edayar industrial belt, a solitary POPs hotspot in India. The profiles of congeners indicate that dl-POPs were formed through precursor pathways, suggesting the potential release of chlorinated precursor species from surrounding industrial area as the root cause. Fish samples from hotspots were observed to have 8 times higher levels of polychlorinated dibenzo-p-dioxin/furans (PCDD/Fs) and 30 times higher levels of polychlorinated biphenyls (PCBs) than the control sites. A strong statistically significant (p < 0.05) positive correlation was observed between dl-POPs levels in fish and sediment samples at the study site and the Biota sediment accumulation factors for PCDD/Fs and dl-PCBs ranged from 0.019 to 0.092 and 0.004 to 0.671 respectively. The estimated weekly intake from fish consumption in the study region was observed to be 3 to 24 times higher than the maximum levels set by the European food safety authority (2 pgTEQ kg−1bwweek−1). Hence, the periodic surveillance of dl-POPs employing user friendly/validated confirmatory tools stands highly imperative to safeguard human health and environment. Keywords: Dioxin and PCBs, GC-MS/MS, POPs Hotspot, Biota-sediment accumulation factor, Correlation analysis, Health risk assessment.

Food processing contaminants: Dietary exposure to 3-MCPD and glycidol and associated burden of disease for Italian consumers

In this study we assessed Italian consumers’ dietary exposure to 3-MCPD and glycidol followed by risk characterization, potential cancer risk and the associated burden of disease. Consumption data was retrieved from the most recent Italian Food Consumption Survey (2017–2020), while contamination data was obtained from the European Food Safety Authority. The level of risk due to exposure to 3-MCPD was negligible, below the tolerable daily intake (TDI), except for high consumption of infant formulas. For infants, the intake level was higher than the TDI (139–141% of TDI), indicating a potential health risk. Exposure to glycidol indicated a health concern for infants, toddlers, other children, and adolescents consuming infant formulas, plain cakes, chocolate spreads, processed cereals, biscuits, rusks, and cookies (margin of exposure (MOE) < 25,000). The risk of cancer due to exposure to glycidol was estimated and the overall health impact was quantified in Disability-Adjusted Life Years (DALYs). The risk of cancer due to chronic dietary exposure to glycidol was estimated at 0.08–0.52 cancer cases/year/100,000 individuals depending on the life stage and dietary habits in Italy. The burden of disease quantified in DALYs varied from 0.7 to 5.37 DALYs/year/100,000 individuals. It is crucial to continuously gather consumption and occurrence data for glycidol over time to track patterns, assess potential health risks, identify exposure sources, and develop effective countermeasures, as long-term exposure to chemical contaminants can lead to an increased risk for human health. This data is critical for protecting public health and reducing the likelihood of cancer and other health issues related to glycidol exposure.

Assessment of exposure to perfluorinated industrial substances and risk of immune suppression in Greenland and its global context: a mixed-methods study

Perfluoroalkyl substances (PFASs) are ubiquitous global contaminants that do not readily biodegrade and are therefore routinely found worldwide in wildlife, humans, and the environment. There is a paucity of global assessments to understand regional and continental differences in exposure to PFASs and the associated health risks, including those for Indigenous Arctic communities who consume high trophic marine diets. We aimed to estimate the long-term exposure of dietary PFASs from consumption of polar bear and ringed seal meat and establish its association with blood serum concentrations of PFASs in Inuit in Ittoqoortoormiit (Scoresby Sound), East Greenland. We also aimed to assess the risk of immune suppression on the basis of European Food Safety Authority (EFSA) thresholds for weekly intake and blood serum concentrations of PFASs. Last, we conducted a worldwide risk assessment based on blood concentrations of PFASs emphasising Arctic exposure in a global context. In this mixed-methods study, we conducted interviews to compare dietary exposure of PFASs in anonymous, non-pregnant, Inuit adults (aged ≥18 years) from full-time or part-time hunter families in Ittoqoortoormiit, East Greenland with ESFA toxic threshold values for tolerable weekly intake of the four most immunotoxic PFASs (∑4PFAS; perfluorooctanoic acid, perfluorononanoic acid, perfluorohexanesulfonic acid, and perfluorooctane sulfonate). Independent hospital staff from the local hospital randomly selected participants using simple randomisation using a telephone directory. Blood serum concentrations were then compared with EFSA risk categories: low (0·7-9·5 ng/mL), moderate (>9·5-17·5 ng/mL), high (>17·5-31·9 ng/mL), and severe (>31·9 ng/mL). We also reviewed the available scientific literature of ∑4PFAS concentrations in human blood to place the Inuit dataset in a broader global context. Between Sept 21, and Oct 2, 2015, 22 participants were enrolled in the study, of which 12 were male and ten were female. Sex data were obtained from personal social security numbers and options were male or female. As a result of a subsistence diet high in marine mammal muscle, 322 (92%) of 350 people in the Ittoqoortoormiit cohort exceeded the established immunotoxic thresholds of ∑4PFASs set by EFSA's tolerable weekly intake of 4·4 ng/kg, and 301 (86%) were in the most severe risk category (>31·9 ng/mL) based on blood serum concentrations. This Inuit cohort had the highest non-occupational long-term exposure to PFASs worldwide despite their remote location relative to industrial sources. Using country-wide average values across global studies, we found that blood serum concentrations of PFASs in populations from European countries, North America, the Arctic, and Australia were generally higher than those in South America, Africa, and mainland Asia, with the highest concentrations found in people from USA, Canada, Greenland, Faroe Islands, Denmark, Iceland, Norway, Sweden, the UK, Spain, Poland, and Australia. These high exposure countries all fall within the EFSA moderate-risk and high-risk categories. PFAS contamination of the environment and human populations occurs worldwide. This pollution not only poses substantial risks for immune system adverse events but also cardiovascular, cancerous, and reproductive endpoints. Data on such PFAS exposure is scarce in numerous countries. Therefore, it is important to also map out the exposure in these countries to enable a thorough global assessment of exposure and risks. Danish Cooperation for Environment in the Arctic.

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

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authorities of the rapporteur Member State, Germany, and co-rapporteur Member State, the Netherlands, for the pesticide active substance milbemectin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of milbemectin as an acaricide and insecticide in strawberry (field and greenhouse), berries and black and white currant (field and greenhouse), apple, pear, cherry and plum (field) and ornamentals (field and greenhouse). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

A Framework for Algae Modeling in Regulatory Risk Assessment.

The use of toxicokinetic-toxicodynamic (TKTD) modeling in regulatory risk assessment of plant protection products is increasingly popular, especially since the 2018 European Food Safety Authority (EFSA) opinion on TKTD modeling announced that several established models are ready for use in risk assessment. With careful adherence to the guidelines laid out by EFSA, we present a stepwise approach to validation and use of the Simple Algae Model Extended (SAM-X) for regulatory submission in Tier 2C. We demonstrate how the use of moving time windows across time-variable exposure profiles can generate thousands of virtual laboratory mimic simulations that seamlessly predict the effects of time-variable exposures across a full exposure profile while maintaining the laboratory conditions of the standard Organisation for Economic Co-operation and Development (OECD) growth inhibition test. Thus, every virtual laboratory test has a duration of 72 h, with OECD medium and constant light and temperature conditions. The only deviation from the standard test setup is the replacement of constant exposure conditions for time-variable concentrations. The present study demonstrates that for simulation of 72-h toxicity tests, the nutrient dynamics in the SAM-X model are not required, and we propose the alternative use of a simplified model version. For risk assessment, in accordance with the EFSA guidelines we use a median exposure profile of 10 as a threshold, meaning that if a time window within the exposure profile causes 50% growth inhibition when magnified by a factor of 10, the threshold will have been exceeded. We present a simplified example for chlorotoluron and isoproturon. The present case study brings to life our proposed framework for TKTD modeling of algae to establish whether a given exposure can be considered to be of low risk. Environ Toxicol Chem 2023;42:1823-1838. © 2023 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Oral nicotine pouches with an aftertaste? Part 1: screening and initial toxicological assessment of flavorings and other ingredients

Nicotine pouches are oral products that deliver nicotine without containing tobacco. Previous studies mainly focused on the determination of known tobacco toxicants, while yet no untargeted analysis has been published on unknown constituents, possibly contributing to toxicity. Furthermore, additives might enhance product attractiveness. We therefore performed an aroma screening with 48 different nicotine-containing and two nicotine-free pouches using gas chromatography coupled to mass spectrometry, following acidic and basic liquid–liquid extraction. For toxicological assessment of identified substances, European and international classifications for chemical and food safety were consulted. Further, ingredients listed on product packages were counted and grouped by function. Most abundant ingredients comprised sweeteners, aroma substances, humectants, fillers, and acidity regulators. 186 substances were identified. For some substances, acceptable daily intake limits set by European Food Safety Agency (EFSA) and Joint FAO/WHO Expert Committee on Food Additives are likely exceeded by moderate pouch consumption. Eight hazardous substances are classified according to the European CLP regulation. Thirteen substances were not authorized as food flavorings by EFSA, among them impurities such as myosmine and ledol. Three substances were classified by International Agency for Research on Cancer as possibly carcinogenic to humans. The two nicotine-free pouches contain pharmacologically active ingredients such as ashwagandha extract and caffeine. The presence of potentially harmful substances may point to the need for regulation of additives in nicotine-containing and nicotine-free pouches that could be based on provisions for food additives. For sure, additives may not pretend positive health effects in case the product is used.

Method Validation for Pesticide Residues on Rice Grain in Aceh Besar District, Indonesia Using Gas Chromatography-Electron Capture Detector (GC-ECD)

Analysis of pesticide residues in rice in Aceh Besar District using the Gas Chromatography – Electron Capture Detector (GC-ECD) method has been carried out. This study aims to validate the analytical method and determine the pesticide residue levels of Dichlorvos, Dimethoate, Bifenthrin, and λ-Cyhalothrin in rice samples. Rice samples in branded rice were taken from the Districts of Want Jaya, Indrapuri, Darussalam, Suka Makmur, Simpang Tiga, Kuta Baro, and ground using a grinder. The powder sample was extracted by the QuEChERS method and analyzed by GC-ECD. The results of the linearity test have met the requirements with the coefficient of determination (R2), which is an average of 0.98. The LOD values ranged from 0.013 to 0.017 mg/kg, while the LOQ ranged from 0.022 to 0.079 mg/kg. The results of precision and reproducibility (% RSD, n = 6) show the values of 0.56 - 1.26% and 1.14 - 2.19%, respectively, and the accuracy value (%Recovery) shows the results of 99.71 - 101.84%, with an RSD value of 2.42 - 3.59%, meet the requirement of 20%. The results of the analysis of the sample showed that sample A had a large %Recovery value in the Dichlorvos analyte, namely 139.10%, with the calculation that the Dichlorvos analyte contained 0.0206 mg/Kg. This value has not passed the MLR set by the European Food Safety Authority, which is 0.2 mg/Kg. In the other rice samples, no pesticide residue analytes were detected. The calculation of %Recovery of each analyte in the spiked sample ranged from 80-101%, which indicated that the pesticide residue analysis carried out had good accuracy, namely the requirement of 70-120%.