ABSTRACT Arsenic (As) is a metalloid, widely present in the environment, occurring naturally in soil, water and air. It occurs in nature and food in various chemical forms that differ considerably in their toxicity. Inorganic arsenic (iAs), comprising arsenite (As(III)) and arsenate (As(V)), is considered the most toxic form of arsenic and is therefore of greatest concern for human health risk assessment. Dietary exposure through the consumption of certain foods and drinking water is recognised as the principal source of chronic exposure to iAs, whereas exposure via inhalation generally contributes to a much lesser extent. Following oral ingestion, soluble forms of iAs are rapidly and efficiently absorbed from the gastrointestinal tract (45–80 %) and distributed via the bloodstream to virtually all tissues. During pregnancy, iAs readily crosses the placental barrier and reaches the fetus. Elimination occurs predominantly via urine, partly as unchanged inorganic arsenic and partly as methylated metabolites, with an elimination half‐life of around 2–3 days. As no comprehensive assessment of dietary exposure to iAs from different food categories had previously been conducted for children in Croatia, and taking into account the conclusions and recommendations of the scientific opinions published by the European Food Safety Authority (EFSA), together with national food consumption data for infants and young children, the Croatian Agency for Agriculture and Food (HAPIH), Centre for Food Safety (CFS), following a proposal from its Permanent Scientific Committee on Chemical Hazards in Food and Feed, conducted a study in 2025 entitled Determination of inorganic arsenic concentrations in food for infants and young children. The analytical results generated in this study (n = 101) constituted the primary occurrence dataset used to prepare the present Scientific Opinion. In addition, analytical results obtained from food samples collected within the national food monitoring programme during the period 2020–2024 (n = 65) were included. Overall, 166 food samples were analysed, of which 31 (18.67 %) contained iAs concentrations below the limit of quantification (LOQ). The highest mean concentrations of iAs were observed in the food category “Grains and grain‐based products”. For infants, mean concentrations ranged from 90.96 to 92.80 μg/kg using the lower bound (LB) and upper bound (UB) approach, while for toddlers and other children the corresponding concentrations ranged from 75.91 to 77.41 μg/kg (LB–UB). The lowest mean concentrations were found in the food category “Fruit and vegetable juices and nectars (including concentrates)”, ranging from 0.81 to 2.50 μg/kg (LB–UB) for infants and toddlers and from 0.85 to 2.44 μg/kg (LB–UB) for other children. As the adverse health effects associated with inorganic arsenic are primarily related to long‐term exposure, chronic dietary exposure was estimated for the following age groups: infants, toddlers and other children. The estimated mean chronic dietary exposure ranged from 0.028 μg/kg bw per day (LB) in other children to 0.065 μg/kg bw per day (UB) in infants. At the 95th percentile (P95), exposure ranged from 0.096 μg/kg bw per day (LB) in other children to 0.255 μg/kg bw per day (UB) in infants. The contribution of individual food categories to total dietary exposure to iAs showed that the category “Food products for young population” was the main contributor in infants (75.47 %) and toddlers (58.37 %), while its contribution in other children was 42.32 %. The contribution of the category “Grains and grain‐based products” increased with age, accounting for 22.12 % of total dietary exposure in infants, 37.62 % in toddlers and 49.22 % in other children. The categories “Fruit and vegetable juices and nectars (including concentrates) and “Products for non‐standard diets, food imitates and food supplements” made only a minor contribution to total dietary exposure across all age groups. In its 2024 Scientific Opinion, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) established a benchmark dose lower confidence limit (BMDL05) of 0.06 μg iAs/kg bw per day, based on a benchmark response (BMR) of 5 %, as the reference point. Risk characterisation was conducted using the Margin of Exposure (MOE) approach. An MOE of 1 corresponds to an exposure level that, based on the available evidence, is associated with a 5% increase in the incidence of skin cancer compared with the background incidence in the population. For infants, MOE values based on mean dietary exposure ranged from 0.93 (UB approach) to 1.02 (LB approach), while MOE values based on P95 exposure ranged from 0.24 (UB approach) to 0.25 (LB approach). For toddlers, MOE values based on mean dietary exposure ranged from 1.33 (UB approach) to 1.44 (LB approach), while MOE values based on P95 exposure ranged from 0.36 (UB approach) to 0.38 (LB approach). For other children, MOE values based on mean dietary exposure ranged from 1.98 (UB approach) to 2.17 (LB approach), whereas MOE values based on P95 exposure ranged from 0.59 (UB approach) to 0.62 (LB approach). For mean dietary exposure, MOE values exceeded 1 in all age groups and for all substitution approaches (LB, MB and UB), with the exception of infants under the MB and UB approaches, for whom MOE values were below 1. This result indicates on a potential public health concern for this age group. For P95 dietary exposure, all estimated MOE values were below 1 across all age groups and substitution approaches, indicating a potential health concern due to high intake of foods from the categories “Food products for young population” and “Grains and grain‐based products”. Within the framework of this Scientific Opinion, a number of recommendations were developed to reduce children's dietary exposure to inorganic arsenic in the Republic of Croatia. These recommendations include raising awareness among parents and healthcare professionals about the health risks associated with iAs, promoting a diverse and balanced diet, and limiting frequent consumption of foods that contribute substantially to iAs exposure, particularly rice‐based products (food category “Grains and grain‐based products”) and foods intended for infants and young children (food category “Food products for young population”). The Opinion also emphasises the importance of appropriate rice preparation practices, and avoiding rice drinks as a substitute for milk in the diets of young children, except where medically indicated. Furthermore, continued systematic monitoring of iAs concentrations in food is recommended, together with use of the resulting occurrence data to support planning of future monitoring programmes, development of national food‐based dietary guidelines, and implementation of risk management measures aimed at protecting the most vulnerable population groups.
Abstract Seaweed is seen as an important source of alternative proteins for a sustainable food system and food security. The cultivation of seaweed is therefore encouraged by the European Union (EU) and also by the Dutch government. In the Netherlands, seaweed is farmed on small scale in the Southwest Delta, the Wadden Sea and the North Sea. Despite the fact that the cultivation of seaweed in Dutch waters is stimulated, not all the risks resulting from this cultivation are yet in the picture. Seaweed may be contaminated with chemical, microbiological or physical contaminants that may pose a risk to food safety. And the cultivation of seaweed in open water may have adverse effects on the natural ecosystem. Therefore, the Office for Risk Assessment and Research (BuRO) of the Netherlands Food and Consumer Product Safety Authority (NVWA) has assessed the risks on food safety and Dutch waters. The food safety risk from the consumption of processed seaweed is assessed as low for chemical, microbiological and physical hazards. Although seaweed may be contaminated with chemical, microbiological or physical hazards, the processing of seaweed for consumption (e.g. by washing and heating) is expected to reduce the presence of these hazards. Cultivating alien seaweed species in open water or open aquaculture facilities poses a risk to nature. The use of starting material from another area can have an impact on nature as well, regardless whether it is native or alien. Alien species can hitchhike with the material and establish or expand their distribution. The actual impact of an alien species on nature depends on the species involved and the local circumstances in the area of cultivation.
Abstract Between January 2020 and December 2024, the Swiss poison information centre Tox Suisse responded to 1'303 enquiries relating to cases of poisoning or suspected poisoning involving food supplements, slimming foods and sports nutrition foods. The number of enquiries increased over the reporting period, and also compared with previous years. The most common enquiries concerned products containing vitamin D, iron or iron salts, and caffeine. Clinical follow‐up reports were received on 88 cases, of which 32 were asymptomatic, and 56 were symptomatic and with a probable causal relationship between product and symptoms. The severe (5) and moderate (15) cases primarily concerned products containing caffeine, 7 of which were associated with a suicide attempt. No deaths were reported. Overall, the report concludes that the unintentional intake of small quantities of food supplements by children results in either no or only mild symptoms, while intentional overdoses in adults – primarily of caffeine – can lead to severe symptoms requiring surveillance and treatment, sometimes even in intensive care units.
Abstract Hereditary Fructose Intolerance (HFI), also known as aldolase B deficiency, is an inherited metabolic disorder caused by the deficiency of that enzyme, which participates in the fructose metabolism in the liver, kidneys and small intestine. Aldolase B deficiency brings about the accumulation of fructose‐1‐phosphate in these organs, which can lead to a series of symptoms such as nausea, vomiting, abdominal pain, hypoglycaemia, liver dysfunction, kidney failure, growth retardation in children and even death, as a result of metabolic toxicity. On the other hand, fructose malabsorption (intestinal fructose intolerance), a disorder that is increasingly frequent in our society, occurs when there is a deficiency, in the intestinal mucosa, of the transporter protein that allows its absorption in the small intestine, so that the excess of non‐assimilated sugars passes to the colon, where the bacteria break them down forming acids, gas and water, which are what cause symptoms such as flatulence, abdominal pain/distension or diarrhoea. These are disorders in which the metabolism and absorption of fructose, a sugar present in fruits, vegetables and honey, in sucrose or table sugar and in processed foods that contain sources of fructose, such as, for example, sorbitol, maltitol or glucose syrup, used in the food industry for their sweetening properties, are compromised. Both conditions require dietary restrictions to control symptoms and prevent complications, which implies the elimination of fructose from the diet. However, this dietary restriction that involves eliminating, for example, fruits, vegetables and other sources of fructose, can lead to nutritional deficiencies and affect the quality of life of affected people. The lack of information on the fructose content and its sources in food labelling, especially of processed foods, poses a direct risk of accidental ingestion, with consequences that can be serious. Providing this information would be key to allowing consumers to make informed choices about the foods they buy and consume and, therefore, for the appropriate monitoring of an adequate fructose‐restrictive diet. The Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) concludes that, to improve the health and wellbeing of people with HFI and fructose malabsorption, it is important to educate and raise awareness among consumers, health professionals and the food industry about the health risks of these disorders; perform adequate personalised dietary guidance by competent health professionals in the field of nutrition; conduct research to understand the mechanisms and treatment of these conditions; and provide information on fructose and its sources, in food labelling, which allows people affected by these intolerances to safely choose foods. The fact that there is insufficient scientific evidence regarding the fructose intake levels that are safe for people with HFI or fructose malabsorption means that the limits of detection and quantification of analytical techniques can be a reference value to establish the conditions of use of a possible mention of the absence of fructose, and its sources, in the labelling of food products.
Abstarct Copper is an essential trace mineral that plays a vital role in human health, contributing to energy production, iron metabolism, and the proper functioning of the nervous and immune systems. It is naturally present in a variety of foods, including nuts, seeds, whole grains, legumes, seafood, and organ meats, making it relatively easy to obtain adequate amounts through a balanced diet. While small quantities are necessary for normal body functions, excessive copper intake can be harmful, particularly when it enters food through contamination from sources such as unlined copper cookware, water pipes, or agricultural chemicals. In the current report the dietary exposure of the target population is studied using ImproRisk model v.0.6.2. The aim of this risk assessment study was to estimate the dietary copper intake of the population in Cyprus, to carry out the necessary risk characterization and to calculate the contribution rate of the major food groups to the copper exposure. Mean and 95th percentile exposure were calculated as 17.0 and 40.8 μg/kg b.w. per day (Table 4.2). It was found that approximately 0.8 % of the whole population was exposed over the ADI value of 70 μg/Kg b.w. per day, as also shown in Figures 4.1 and 4.2. The results of the exposure assessment study were comparable with the results observed for the pan‐European population according to EFSA's opinion. In all areas the highest exposure was observed for infants and toddlers. The exposure of the different population classes seemed to be independent of the geographical area. For infants and toddlers, the consumption of infant formula and commercial baby foods contributes significantly to the daily copper intake. In the case of adults, the main contributor to copper exposure was coffee with 28.7%, followed by potatoes (9.1%), pulses (7.0%) and mammal liver (5.9%) and meat (4.5%).
Abstract Food allergies are an important public health problem with an increasing prevalence in the population and have a significant impact on the lives of allergic patients and their families. The Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) has reviewed and compiled the available information on those food allergens that are not declarable but that could be relevant in Spain, in particular, fruits of the Rosaceae family, legumes, kiwi and pine nuts, in order to support, in the event that the review of declarable allergens in the European Union is addressed, their inclusion in said list, if relevant. The Scientific Committee of the AESAN concludes that Rosaceae allergy is one of the most frequent among patients suffering from food allergy, representing, in Spain, approximately 23.6 % of the diagnosed food allergy reactions. Of particular importance is peach allergy, followed by apple allergy; and, in terms of symptom severity, allergic reactions to Rosaceae are related to a high frequency of anaphylaxis. With regard to legume allergy (without taking into account peanuts or soybeans), it has been noted that it affects approximately 7 % of the Spanish population with food allergies, with lentils being the most implicated legume, and that they can produce serious symptoms, such as anaphylaxis. Furthermore, kiwi allergy is a major paediatric allergy and is associated with severe gastrointestinal symptoms and anaphylaxis. And finally, pine nut allergy is not a very common food allergy, although it has been found to be related to a high probability of developing anaphylaxis at low food concentrations.
Abstract Biogenic amines are low molecular weight organic bases that come from the enzymatic decarboxylation of amino acids. They are present in many types of food, with the highest concentrations usually found in fish and their derived products, as well as in beverages and fermented foods of plant, meat and dairy origin. In general, the concentration of these amines increases as the hygienic quality decreases, so the presence and levels of biogenic amines provide indirect information on the degree of contamination and on food production, handling and storage practices. Meat and meat products are a group of foods that, due to their high protein content and the high probability of microbial contamination during slaughter and processing processes, favour the formation of biogenic amines that can appear in a wide range of concentrations. A high concentration of one or more biogenic amines suggests high microbial growth and, with it, poor food quality. As a result of the appearance of a number of foodborne outbreaks in nursery schools in Spain, associated with the consumption of chicken meat with the presence of biogenic amines by children under 3 years of age, the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) has assessed the available information on the factors that can influence the appearance of this type of outbreaks; the acceptable levels of biogenic amines in chicken meat; those aspects related to the production of chicken meat that have an influence on the level of biogenic amines; the influence of the expiration time and storage temperature from the time of the slaughter of the chickens and the measures that can minimise the risk in the canteens that use this type of meat when the recipients are children under 3 years of age. The Scientific Committee concludes that, due to its structure and protein composition, chicken meat is, after fish, the most susceptible to developing biogenic amines, with factors such as the use of a raw material of low hygienic quality and inadequate or very long transport and/or storage conditions having an influence on their appearance. There is no consensus on the levels of biogenic amines that could be used as a guide in foods. There are also a number of uncertainties regarding the toxicity of histamine and tyramine, such as the concurrence of both in the same food, or the potentiating effect that the presence of other biogenic amines may have. Therefore, it is difficult to establish safe maximum levels in this population group. The primary production systems of chicken rearing do not seem to have a decisive influence on the levels of biogenic amines in meat. However, meat production and processing systems can have a great influence on the microbiological contamination of carcasses, which is a critical factor for the formation and accumulation of these amines in meat during its conservation and storage. It would be advisable not to use chicken meat with a storage time of more than 5 days after slaughter of the birds in the diet of children under 3 years of age, and that the meat is always kept at a suitable temperature from slaughter (0‐4°C). The effective prevention of the risk from biogenic amines from chicken meat in children's canteens requires a chain of control measures that include a careful selection of raw materials and their proper treatment until their consumption, with special attention to maintaining a suitable refrigeration temperature and storage for a limited time.
Abstract Menopause is the time when a woman transitions from the reproductive stage of life to the non‐reproductive state. It is characterised by significant hormonal changes, which can affect a woman's physical, emotional, mental and social well‐being. This transition also includes peri‐menopause (the stage before menopause) and post‐menopause (the phase after the menopause). According to the most recent data from the National Institute of Statistics (INE), in Spain women aged 50 or over (which is the usual age of onset of natural menopause) account for approximately half the female population. The World Health Organization (WHO) believes that support for women's social, psychological and physical health during the menopausal transition and after menopause, should be an integral part of health care, in order to promote women's healthy ageing and a good quality of life before, during and after menopause. The Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) has studied the factors that influence the age of onset and symptomatology of the menopause and has evaluated the nutritional risks that women present during the menopausal and post‐menopausal transition, including obesity and its associated complications, vascular risk, osteoporosis and sarcopenia. The Committee has concluded that adopting a healthy diet, in which certain nutrients acquire special relevance at this stage of life, avoiding toxins such as tobacco and alcohol and performing physical activity on a regular basis, can influence these factors and help mitigate these risks and improve quality of life.
Abstract Royal Decree 1021/2022, which regulates certain hygiene requirements for the production and marketing of foodstuffs in retail establishments, establishes that, in retail establishments, food made with raw egg subjected to heat treatment where a temperature equal to or greater than 70°C is reached for 2 seconds in the centre of the product or any other combination of time and equivalent temperature conditions and which are not stable at room temperature, as well as foodstuffs made with egg products to be consumed without undergoing heat treatment, must be stored at a temperature equal to or lower than 8°C and must be consumed within a maximum of 24 hours following their preparation. Also, in our country's retail establishments, the use of raw eggs for foodstuffs that are not going to be subjected to heat treatment is not allowed. Against this background, the Scientific Committee of the Agency for Food Safety and Nutrition (AESAN) has been requested to evaluate the safety of conservation of foodstuffs made with raw eggs and subjected to a heat treatment, as well as those foods that are not subjected to a heat treatment made with pasteurized egg products at storage temperatures of prepared meals (in particular, at 4°C if their shelf life is greater than 24 hours, considering that Royal Decree 1021/2022 already allows storage at a temperature equal to or lower than 8°C for a maximum of 24 hours). Furthermore, it has been requested to evaluate the risk of foodborne infection, in the field of catering, due to the consumption of raw eggs contaminated both internally and externally with S. Enteritidis and S. Typhimurium. The AESAN Scientific Committee, through the application of predictive models, concludes that the refrigeration conservation conditions stipulated in Royal Decree 1086/2020 for prepared foods (4°C if their shelf life is more than 24 hours and 8°C if their shelf life is less than 24 hours) are sufficiently safe with respect to the risk of proliferation of Salmonella spp. in foods made with raw eggs and subjected to heat treatment, as well as in those not subjected to heat treatment made with pasteurized egg products, provided that the starting microbiological quality is guaranteed, as well as good hygiene and handling practices. Moreover, although the prevalence of S. Enteritidis and S. Typhimurium in operations involving laying hens is currently low, the risk associated with the consumption of raw egg preparations can be considered low but not negligible. In the context of catering, the combination of a reduced but persistent prevalence, together with the high capacity to spread the pathogen and the severity of the associated cases, makes it necessary to maintain a preventive management approach based on the strict application of good hygiene practices, continuous refrigeration and the preferential use of pasteurised egg products.
ABSTRACT The Croatian Agency for Agriculture and Food (HAPIH), through the work of the Centre for Food Safety in preparing scientific opinions on risks in food and feed, provides scientific and technical support to the authorities responsible for food and feed safety in making informed risk‐management decisions. This activity is based on national legislation, among which the Ordinance on Feed Safety and the Official Controls Act are particularly important in the context of preparing this scientific opinion, as well as on alignment with relevant European Union regulations. In this context, the assessment of risks posed by mycotoxins is especially important, with zearalenone (ZEN) standing out as one of the significant contaminants in animal feed. ZEN is an estrogenic mycotoxin produced as a secondary metabolite of moulds of the genus Fusarium, most commonly contaminating cereals and plant‐derived products. Its presence poses a risk to animal health, particularly to pigs, which are the most sensitive species, but also to fattening lambs, broiler chickens, and fattening turkeys. Indirectly, ZEN may also affect the safety of food of animal origin. Given its frequent occurrence and potential consequences, its monitoring and risk assessment are important components of the animal feed safety system. The scientific opinion on ZEN was prepared based on an analysis of national data on feed contamination collected during the period 2020–2024. The data included the results of laboratory analyses of feed samples taken during official controls and analysed at the Croatian Veterinary Institute (HVI), as well as the results of laboratory analyses carried out at HAPIH within the implementation of Measure 14 – Animal Welfare and Intervention 70.06. A total of 815 samples from official controls were analysed, of which 677 were included in the assessment, and 674 samples from HAPIH, of which 521 were included. The reduction in the number of processed samples resulted from the need to harmonise feed categories, exclude insufficiently defined samples, and ensure a minimum number of samples per category. Data analysis revealed significant inconsistencies in feed naming and categorisation, requiring additional processing and manual harmonisation. A relatively high proportion of left‐censored (LC) data, i.e. results below the limit of quantification, was also observed, which further increased the uncertainty of the assessment. The proportion of such data varied – in official controls it reached up to approximately 70%, while in HAPIH data it reached up to 80% in certain categories. The assessment of animal exposure to ZEN was carried out according to the methodology of the European Food Safety Authority (EFSA), combining data on ZEN concentrations in feed, daily feed intake, and body weight of animals. Three approaches (LB, MB, and UB) were applied to account for the uncertainty associated with left‐censored data. The assessment covered fattening piglets, fattening pigs/gilts, broiler chickens, fattening turkeys, and fattening lambs. The results showed that ZEN levels in all analysed samples, both from official controls and HAPIH analyses, were below the guidance values established by legislation. Furthermore, the estimated exposure of animals was significantly lower than the toxicological reference values (NOAEL) established by EFSA. In most cases, exposure ranged from 0% to a maximum of about 20% of the NOAEL, indicating a low risk to animal health during the observed period. A comparison of the two datasets revealed certain differences in estimated exposure. In general, exposure levels were slightly higher in the results from official controls than in HAPIH data, except in the case of fattening lambs, where the opposite trend was observed. However, these differences were not significant in terms of risk assessment. They were likely influenced by factors such as the geographical origin of samples, climatic conditions, and differences in sampling patterns and data collection systems. An important limitation of the assessment is the unequal representation of different feed categories. While basic feed components (e.g. maize, wheat, barley) were well represented, data for compound feeds and certain specific categories were limited. Given that compound feeds often constitute a key component of animal diets, this imbalance may affect the representativeness of the exposure assessment. Despite the estimated low level of risk, the results confirm the continuous presence of ZEN in animal feed, which is consistent with the known influence of climatic and storage conditions on mould growth and mycotoxin production. Therefore, continuous monitoring is necessary to ensure timely detection of potential changes in contamination levels. Given the low exposure to ZEN and its limited transfer to muscle and other tissues, very low or non‐detectable levels are expected in meat; therefore, the potential risk to consumer health is considered negligible. Based on the obtained results, the need to improve the monitoring system was highlighted, including better sampling design, standardisation of feed categorisation, reduction of left‐censored data through the use of more sensitive analytical methods, and inclusion of information on the geographical origin of samples. Strengthening coordination between different data collection systems and further incorporation of actual animal diets into exposure assessment were also recommended. Although current levels of ZEN in animal feed in the Republic of Croatia do not pose a significant risk to animal health, maintaining and further improving monitoring systems remains essential for ensuring a high level of feed safety and protecting both animal and human health in the future.
Summary Lead is a ubiquitous environmental contaminant that occurs naturally and, to a greater extent, from anthropogenic activities. People are exposed to lead through food, water, air, soil and dust. Food is the major source of exposure for the adult population. The Centre for Food Safety, Croatian Agency for Agriculture and Food initiated the production of a Scientific Opinion on the exposure of children and adolescents in the Republic of Croatia to lead from different types of food in order to gain insight into the state of exposure to lead of this particularly vulnerable population and consequently assess the health risk. The lead occurrence data were derived from analytical results of food samples collected during the monitoring program in 2020, 2021, 2022 and 2023, in accordance with the Multiannual National Plan of Official Controls of the Republic of Croatia. The lead occurrence data in tap water were derived from analytical results of samples from water supply network, which were collected during the national monitoring of water for human consumption in 2020, 2021, 2022 and 2023, according to the Annual Plans of State Monitoring of Water Intended for Human Consumption in the Republic of Croatia. After this data cleaning process, 339 data were excluded, while 5613 data on lead concentrations in food and water samples were taken into account for further calculations. The analyzed food was divided into groups according to the FoodEx2 classification. The highest number of analysed samples was in the food group “Water and water‐based beverages”, followed by “Vegetables and vegetable products” and “Fruit and fruit products”, as well as “Fish and seafood” and “Sugars and the like, confectionery and water‐based desserts”. Majority of the results that are above the limit of quantification are found in categories “Coffee, cocoa, tea and other infusions”, “Composite dishes” and “Water and water‐based beverages” around 50%, followed by “Isolated food ingredients, food additives, flavourings and processing aids”, “Spices and sauces” and “Cereals and cereal products” with around 40%. The mean values of lead concentration in the LB approach range from 0.41 in the group “Foodstuffs for the younger population” to 93.96 μg/kg in the group “Coffee, cocoa, tea and other infusions”, with the results for this group being expressed for the dry product. In the MB approach, mean concentrations range from 0.83 μg/kg in the “Water and water‐based beverages” group to 96.87 μg/kg in the “Coffee, cocoa, tea and other infusions” group. In the UB approach, mean concentrations range from 1.18 μg/kg in the “Water and water‐based beverages” group to 99.78 μg/kg in the “Coffee, cocoa, tea and other infusions” group. The highest concentration of lead was found in the group “Coffee, cocoa, tea and other infusions” 783 μg/kg in mint tea. Food consumption data were obtained from national surveys, the first of which was conducted in the period 2017 ‐ 2022 on the population of children aged 3 months to 9 years, and the second in the period 2019 ‐ 2023 on the population aged 10 to 99 years. As with the lead occurrence data, the food was divided into groups according to EFSA's FoodEx2 classification. The food inside the recipes is recalculated into ingredients. Given the long half‐life in the human body, the potentially harmful effect of lead is a consequence of long‐term exposure, and therefore chronic exposure for infants, toddlers, other children and adolescents was calculated. To assess exposure, the mean lead concentration in the LB, MB, and UB approaches for a certain food group at level 2 according to the EFSA FoodEx2 classification was taken into account, along with the average daily consumption of the corresponding food for each individual consumer at the lowest level at which it was reported, which most accurately describes that food, and individual body mass. Since BMDL values were set as toxicological reference points for lead, the MOE approach was applied to assess the risk of lead to human health. The MOE was calculated for BMDL01 of 0.5 μg/kg bw/day for the effect of developmental neurotoxicity in all age groups included in this assessment. The mean exposure ranges from 0.05 μg/kg bw/day on the LB approach for adolescents to 0.48 μg/kg bw/day on the UB approach for young children. The 95th percentile of exposure estimation ranges from 0.11 μg/kg bw/day on the LB approach for adolescents to 0.97 μg/kg bw/day on the UB approach for young children. For infants, the group “Food products for the young population” has the highest contribution to the total exposure with 31%, followed by “Fruit and fruit products” with 28%, and “Vegetables and vegetable products” and “Milk and milk products” with 11% and 9% respectively. In toddlers, the group “Fruit and fruit products” contributes the most to the total exposure to lead, followed by “Milk and dairy products” with 27%. A similar situation was observed in the age category of other children, where “Fruit and fruit products” had the largest contribution with 27%, followed by “Milk and milk products” with 22%. Among adolescents, the “Water and water‐based beverages” group has the highest contribution with 21%, followed by “Milk and dairy products” with 17%. The MOE value for the mean exposure value ranges from 1.05 for the UB approach for toddlers to 9.12 for the LB approach for adolescents. The MOE value for the 95th percentile of exposure ranges from 0.51 for the UB approach for toddlers to 4.36 for the LB approach for adolescents. The obtained MOE values at the mean exposure value indicate low concern for the health of children and adolescents in the Republic of Croatia from lead through food groups that were taken into account in this scientific opinion. However, taking into account the MOE values obtained for the 95th percentile of exposure in the MB and UB approach for infants (0.90, 0.56) and toddlers (0.81, 0.51) and the UB approach for other children (0.72), a possible adverse effect of lead on these population groups cannot be excluded. There are certain uncertainties associated with the estimation of exposures that may lead to an underestimation or overestimation of exposure. Other foods not included in this assessment also contribute to the total exposure to lead.
This experimental study investigates the occurrence of Bacillus cereus in dried mushrooms available on the Czech market and assesses the potential health risks associated with the production of the emetic toxin cereulide. Thirty samples of dried mushrooms of various species and origins were analyzed. The study includes a microbiological analysis of Bacillus cereus counts, monitoring of growth dynamics during rehydration, molecular detection of the ces gene responsible for cereulide synthesis, and analytical determination of the toxin itself. The results show that Bacillus cereus is a relatively common contaminant in dried mushrooms (70% of samples), but its concentrations do not exceed legislatively established limits. During rehydration, there is no significant multiplication above recommended values, and subsequent heat treatment reliably eliminates vegetative forms of the bacteria. The ces gene was not detected in any of the 79 tested isolates, indicating a very low prevalence of emetic Bacillus cereus strains in dried mushrooms. Analytical determination of cereulide also did not confirm its presence in any sample. Based on these findings, it can be concluded that the risk of emetic syndrome after consumption of dishes containing rehydrated dried mushrooms is relatively low. The study recommends following proper handling procedures: rehydrate at room temperature for 2 hours, drain and rinse the mushrooms with clean water, and thoroughly cook dishes for at least 10 minutes. These measures significantly reduce the probability of foodborne intoxication and contribute to the safety of dishes in everyday culinary practice.
In the coming decades, there is expected to be a sharply increased demand for dietary proteins for humans and animals. As a result, there is an increasing focus on reared insects as a new source of protein. According to the Ministry of Agriculture, Nature and Food Quality (LNV), the use of food chain residual flows such as former foodstuffs as a rearing ground (substrate) for insects, which are subsequently used as raw material for animal feed for food-producing animals, is a sustainable and innovative development that must be further explored. However, this development may entail risks to animal and public health. The Ministry of LNV has asked the Office for Risk Assessment & Research (BuRO) of the Netherlands Food and Consumer Product Safety Authority (NVWA) to assess the animal and public health risks of insects reared on former foodstuffs as raw material for animal feed. Based on the outcome of this risk assessment, the Minister of LNV will then be able to propose to the European Commission (EC) to make a further adjustment in the legislation that applies to the rearing of insects and the use of insects as raw material for animal feed. BuRO advises the Dutch Minister of LNV to propose to the EC to make a further adjustment in the legislation that applies to the use of insects as raw material for animal feed and the substrates for rearing the insects. This can allow that a number of insect species can be used as raw material for animal feed for all non-ruminant farm animals and that adequate germ reducing treatments other than those currently prescribed in the Animal By-Products Regulation may be used. Moreover, BuRO sees opportunities to allow insects to be reared on former foodstuffs containing meat from non-ruminant farm animals, fish, crustaceans and shellfish under the condition that the proteins in the former foodstuffs are not derived from the same animal species that is fed with the animal feed consisting of insects. BuRO also gives the Inspector-General of the NVWA three recommendations. First to ensure specifically that the insect-based products used as raw material for animal feed comply with the microbiological safety standards applicable to processed animal proteins and other feed materials derived from animal by-products. Second to ensure the traceability of the animal species in former foodstuffs. Third to monitor developments in the insect sector to maintain a good overview of potential new risks arising from the introduction of multiple types of insects and production methods.
Phytopharmacovigilance consists in identifying signals of adverse effects on human, animal and plant populations and the environment associated with the use of plant protection products, and reporting them to the various bodies responsible for assessing and managing risks. To do this, the PPV scheme collects and analyses data, and classifies the nature of the signals accordingly. These data come from the network of phytopharmacovigilance partners and the literature monitoring conducted by ANSES, which mainly focuses on research into chronic health effects. The PPV scheme also receives reports directly from professionals and private individuals. On several occasions, signals of adverse effects assessed by phytopharmacovigilance have led ANSES to amend the conditions for use in marketing authorisations (MAs), or even to withdraw the MAs, in application of Article 44 of European Regulation (EC) No 1107/2009. Phytopharmacovigilance produces summaries of the surveillance and vigilance data available for active substances, in particular when their MAs are periodically re-examined and in addition to the a priori assessments updated in this context. These summaries can help highlight any specific problematic situations that were not identified through the representative uses predefined at European level for conducting European re-assessments of active substances. Phytopharmacovigilance also funds research in situations where the data collected as mentioned above are not sufficient for analysing and classifying signals of adverse effects. The funded projects concern the production of surveillance data for a given environment, or the analysis of existing data. They may also investigate ways to improve how the phytopharmacovigilance partners operate. Phytopharmacovigilance can also inform its partners of the needs that have been identified in terms of surveillance data, for example, based on its work to prioritise the substances to be monitored. This document presents a review of all the phytopharmacovigilance activities concerning all the aspects mentioned above, carried out since the scheme became operational on 1 July 2015. France's phytopharmacovigilance scheme is the only one of its kind in Europe. Its extension to the other Member States, with the aim of sharing surveillance data and improving the identification of adverse effect signals at European level, is one of the strategic orientations of the phytopharmacovigilance scheme for the period 2024–2028.
Probiotic food supplements (FS) containing live bacteria cultures are widespread in Switzerland. The aim of the study conducted in 2024 was to evaluate the microbiological safety of these products and to review compliance with the legal requirements in accordance with the Ordinance on Food Supplements ( VNem , SR 817.022.14). The analysis looked at twenty products, mostly manufactured in the EU, containing three to sixteen probiotic bacteria strains, and in some cases combined with herbal ingredients, minerals or vitamins. The products underwent microbiological testing (microbial count as per ISO 15214) and molecular testing (sequencing using Oxford Nanopore Technology). In the majority of samples (n = 11), all requirements were met, while nine products were flagged as non-compliant. The main reasons for non-compliance were insufficient microbial counts per daily dose, discrepancies between the declared and actual bacterial composition, and various labelling deficiencies. No harmful microorganisms or transferable antimicrobial resistance genes (ARG) were detected. Detected ARGs (including aac(6’)-Ii, msr(C) and tet(W) ) are chromosomally coded and currently considered not horizontally transferable. However, products containing Enterococcus (E.) faecium or herbal ingredients (e.g. Chlorella powder) require special attention, as undesirable microorganisms or ARGs could potentially be introduced here. Non-compliant products were issued with conditions by the competent enforcement authorities, including having to present production documents, investigate causes, adapt their self-regulation systems and rectify labelling deficiencies. In three cases, sales bans were issued. The study also highlighted the potential of modern sequencing technologies for effective microbiological testing of the bacterial composition of probiotic food supplements. As recommendations, manufacturers and distributors must systematically check and document microbiological quality; mixtures containing E. faecium or herbal ingredients should be specifically tested for contaminants and ARGs; the combination of classical and molecular methods should be established as standard and the testing campaign should be repeated to check the long-term implementation of the self-regulation requirement. In conclusion, the tested probiotic food supplements are predominantly safe. The cases of non-compliance mainly affected quality management and declarations rather than product safety in the stricter sense. However, systematic self-regulation and improved product monitoring are key to ensuring microbiological quality and consumer safety.
Summary Perfluorooctanoic acid (PFOA) is a synthetic, perfluorinated carboxylic acid that has been widely used in industrial applications and consumer products. It is a persistent organic pollutant and a forever chemical, meaning it does not easily break down in the environment or human body. PFOA was primarily used in the manufacturing of: Non‐stick cookware (e.g., Teflon production), Waterproof and stain‐resistant coatings (e.g., for textiles, carpets, and upholstery), Firefighting foams (aqueous film‐forming foams, AFFF), Food packaging (e.g., grease‐resistant paper). PFOA does not degrade easily and accumulates in human and animal tissues. Its toxicity is linked to kidney and testicular cancer. PFOA exposure is associated with thyroid disease, liver damage, immune system dysfunction, and pregnancy complications. It can affect cholesterol levels and hormone regulation. In the current report the dietary exposure of the target population is studied using ImproRisk model v.0.6.2. The aim of this risk assessment study was to estimate the dietary intake of Perfluorooctanoic acid (PFOA) for the population in Cyprus, to compare this exposure estimate with the Tolerable Weekly Intake (TWI) of 0.006 μg/kg body weight (b.w.) per week and to calculate the contribution rate of the major food groups to the dietary PFOA exposure. Mean and 95th percentile dietary PFOA exposure of the Cypriot population was calculated as 0.002 and 0.005 μg/kg b.w. per week, respectively for the MB scenario. It was found that a range of 1.9 to 3.8 % of the whole population was exposed over the TWI value of 0.006µg/Kg b.w. per week, from LB to UB scenario. Much higher exposure was observed for infants, and toddlers due to their lower body weight and their high consumption of milk. There was a significant difference in PFOA intake between genders and different geographical areas among the population classes. Milk (40.6%), poultry meat (20.1%) and pig meat (11.1%) were the food categories with the highest contribution to the PFOA intake for the whole population. For infants, milk had the highest contribution (90%) in the exposure.
Summary Perfluorooctanesulfonic acid (PFOS) is a synthetic fluorinated organic compound that belongs to the class of per‐ and polyfluoroalkyl substances (PFAS). It is widely known for its persistence in the environment, bioaccumulative nature, and potential toxicity to humans and wildlife. PFOS was widely used in: Stain‐resistant coatings (for carpets, upholstery, and textiles), firefighting foams (aqueous film‐forming foams, AFFF), non‐stick coatings, pesticides and insecticides, metal plating and electronics manufacturing. Due to its environmental and health risks, many of its applications have been phased out or restricted under international regulations. PFOS is highly persistent in the environment and does not break down easily. It accumulates in water bodies, soil, and living organisms. It builds up in the tissues of animals and humans over time. PFOS toxicity is linked to liver damage, thyroid disorders, and immune system suppression. May affect fetal development and reproductive health. Possible carcinogenic effects (classified as a possible human carcinogen by the EPA). In the current report the dietary exposure of the target population is studied using ImproRisk model v.0.6.2. The aim of this risk assessment study was to estimate the dietary intake of Perfluorooctanesulfonic acid (PFOS) for the population in Cyprus, to compare this exposure estimate with the Tolerable Weekly Intake (TWI) of 0.013 μg/kg body weight (b.w.) per week and to calculate the contribution rate of the major food groups to the dietary PFOS exposure. Mean and 95th percentile dietary PFOS exposure of the Cypriot population was calculated as 0.002 and 0.007 μg/kg b.w. per week, respectively for the MB scenario. It was found that a range of 1.2 to 1.6 % of the whole population was exposed over the TWI value of 0.013μg/Kg b.w. per week, from LB to UB scenario. Much higher exposure was observed for infants, and toddlers due to their lower body weight and their high consumption of milk. There was no significant difference in PFOS intake between genders and different geographical areas. Milk (40.6%), poultry meat (20.1%) and pig meat (11.1%) were the food categories with the highest contribution to the PFOS intake for the whole population. For infants, milk had the highest contribution (90%) in the exposure.
Summary Dioxins are a group of chemically related compounds that are unintentional by‐products of various industrial processes, including the manufacturing of herbicides and pesticides, paper bleaching, and combustion processes such as waste incineration. The most toxic dioxin is 2,3,7,8‐Tetrachlorodibenzo‐p‐dioxin (TCDD). Dioxins are highly toxic and can cause reproductive and developmental problems, damage the immune system, interfere with hormones, and also cause cancer. Long‐term exposure to dioxins has been shown to result in severe skin disease (chloracne) and altered liver function. PCBs are a group of synthetic organic chemicals that contain 209 individual compounds (known as congeners) with varying levels of toxicity. PCBs were used in a variety of industrial applications, including as coolants and lubricants in transformers, capacitors, and other electrical equipment. Dioxin‐like PCBs are a subset of PCBs that have similar toxic effects and mechanisms of action as dioxins. Dioxin‐like PCBs can cause similar health effects as dioxins, such as cancer, immune system suppression, nervous system effects, reproductive and developmental problems, and endocrine disruption. Dioxins and dioxin‐like PCBs are mainly released into the environment through combustion processes, industrial activities, and as by‐products of chemical manufacturing. Human exposure occurs primarily through the food supply, particularly from animal fats in meat, dairy products, fish, and shellfish. They accumulate in the food chain due to their fat‐solubility and persistence in the environment. In the current report the dietary exposure of the target population is studied using ImproRisk model v.0.5.4. The aim of this risk assessment study was to estimate the dietary dioxins intake of the population in Cyprus, to compare this exposure estimate with the Tolerable Weekly Intake (TWI) of 2x10‐6 μg/kg body weight (b.w.) per week and to calculate the contribution rate of the major food groups to the dietary dioxin exposure. Mean and 95th percentile dietary dioxins and dioxin‐like PCBs exposure of the Cypriot population was calculated as 3x10‐6 and 1x10‐5 μg/kg b.w. per week, respectively. It was found that approximately 42 % of the whole population was exposed over the TWI value of 2x10‐6 μg/Kg b.w. per week. Much higher exposure was observed for infants, toddlers and other children due to their lower body weight and may be from the consumption habits. There was no significant difference in dioxins intake between genders and different geographical areas. Fish (29.6%), cheese (29.5%), meat (14.1) and milk (13.4%) were the food categories with the highest contribution to the dioxins intake for the whole population. For infants, milk had the highest contribution (72.7%) in dioxins exposure.
Plant pests, particularly non-native species, can have a profound impact on their host plants. Trees are the foundation of forest ecosystems and serve as important structures in agricultural landscapes and urban areas. In Sweden, forests cover around 70 % of Sweden's land area and serve as an important national resource for the economy and for biodiversity. Consequently, introductions of non-native tree pests can cause significant economic and environmental damage. Pest risk analysis (PRA) provides the foundation and scientific evidence to inform decisions to mitigate and manage the introduction of non-native plant pests into new areas. PRA involves structured and standardized procedures to assess the risks posed by non-native pests to a country or territory. There are general guidelines on the assessment of impact, including economic, environmental, and social aspects, as well as both direct and indirect effects. Regarding environmental impacts, two major constituents of a natural ecosystem are highlighted in environmental impact assessments of plant pest invasions; biodiversity and ecosystem services. However, there is no consensus of how environmental assessments in PRAs should be performed, and different methods are used in different assessments schemes. Overall, within pest risk assessments, there is a need for a more comprehensive understanding of the environmental consequences of plant pest invasions. The aim of this review is to summarize the main values provided by trees and compile the available information on the biodiversity and the ecosystem services to which trees contribute. All major tree species and genera found across various landscapes in Sweden were included in the report, including forests, agricultural land, and urban environments. In terms of biodiversity, we define values at risk based on the number of native species associated with individual tree species. We also identify valuable habitats where trees play an important structural role, such as old-growth forests, protected forest areas, and habitat types as defined in the Habitat Directive. Concerning ecosystem services, we summarize the contributions of trees within ecosystems identified as important for providing these services. These ecosystem services primarily cover provisioning, regulating, and cultural services. The contribution of trees for these services are described across various ecosystems, including forests, agro-ecosystems, semi-natural grasslands and urban areas. When possible, we present case studies that investigate the effects and magnitude of impacts that tree pests and pathogens have on biodiversity and the provisioning of ecosystem services. These examples, along with the reviews of the main ecosystem services provided by trees, aims to provide guidance for estimating risks in the context of pest risk assessments.
This document presents the opinion of the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), established from the work of its Working Group on “Risks associated with the consumption of Nitrites and Nitrates" (NiNa WG) and validated by its Expert Committees on “Assessment of the biological risks in foods” (CES BIORISK) and “Assessment of physico-chemical risks in food” (CES ERCA). Following a request from the Directorate General for Health, the Directorate General for Food and the Directorate General for Competition, Consumer Affairs and Fraud Control, ANSES was asked to deliver an opinion on the risks linked to nitrites and nitrates. Specifically, ANSES provided a scientific assessment associated with the following work themes regarding questions of (i) the impact of reducing nitrite/nitrate levels in foodstuffs on the fate of pathogenic bacteria in certain foods, (ii) the assessment of overall exposure to nitrates and nitrites from all sources in France and the proposal of actions that could help reduce this exposure, (iii) evaluating if new scientific knowledge could justify revisiting EFSA's ADIs/Health-Based Guidance Values (HBGVs) for nitrates and nitrites, and (iv) better characterizing their link to human cancer risk from meat product consumption. The opinion first presents the substances of interest, their origin and the regulatory framework. Then this opinion sets out the conclusions of the microbiological risk for three foodborne pathogens associated with reducing nitrate/nitrite levels as additives in three types of cured meats. This is followed by a presentation of the conclusions relating to the assessment of the available epidemiological and toxicological data in the light of recent scientific data. Finally, this enables the characterization of the risk associated with ingested nitrates and nitrites after exposure has been estimated. The opinion provides recommendations to continue epidemiological studies to confirm or refute suspected relationships for certain cancers and to conduct experimental studies for the establishment of ADIs considering the combined exposure to nitrates, nitrites and nitroso compounds. Furthermore, reducing the population's exposure to nitrites and nitrates involves collective and individual measures. As part of collective measures, in addition to controlling the quality of water intended for human consumption, a relevant measure would be to reduce the use of nitrites in processed meat products while implementing strict compensatory measures to address microbiological risk. This opinion finally emphasizes the importance of individual measures, by adhering to recommendations for processed meat consumption, limiting it to 150g/week, and diversifying the consumption of fruits and vegetables.
