Aggregated aluminium exposure: risk assessment for the general population.

Aluminium is one of the most abundant elements in earth's crust and its manifold uses result in an exposure of the population from many sources. Developmental toxicity, effects on the urinary tract and neurotoxicity are known effects of aluminium and its compounds. Here, we assessed the health risks resulting from total consumer exposure towards aluminium and various aluminium compounds, including contributions from foodstuffs, food additives, food contact materials (FCM), and cosmetic products. For the estimation of aluminium contents in foodstuff, data from the German "Pilot-Total-Diet-Study" were used, which was conducted as part of the European TDS-Exposure project. These were combined with consumption data from the German National Consumption Survey II to yield aluminium exposure via food for adults. It was found that the average weekly aluminium exposure resulting from food intake amounts to approx. 50% of the tolerable weekly intake (TWI) of 1 mg/kg body weight (bw)/week, derived by the European Food Safety Authority (EFSA). For children, data from the French "Infant Total Diet Study" and the "Second French Total Diet Study" were used to estimate aluminium exposure via food. As a result, the TWI can be exhausted or slightly exceeded-particularly for infants who are not exclusively breastfed and young children relying on specially adapted diets (e.g. soy-based, lactose free, hypoallergenic). When taking into account the overall aluminium exposure from foods, cosmetic products (cosmetics), pharmaceuticals and FCM from uncoated aluminium, a significant exceedance of the EFSA-derived TWI and even the PTWI of 2 mg/kg bw/week, derived by the Joint FAO/WHO Expert Committee on Food Additives, may occur. Specifically, high exposure levels were found for adolescents aged 11-14 years. Although exposure data were collected with special regard to the German population, it is also representative for European and comparable to international consumers. From a toxicological point of view, regular exceedance of the lifetime tolerable aluminium intake (TWI/PTWI) is undesirable, since this results in an increased risk for health impairments. Consequently, recommendations on how to reduce overall aluminium exposure are given.

Validation of a picture book to be used in a pan-European dietary survey.

OBJECTIVE: To validate a picture book for estimation of food portion sizes using two approaches: (i) 'perception' of food portions by comparison with a series of food photos; and (ii) 'conceptualization and memory', using the same photos to estimate the amount of served food one hour after self-served food portions. DESIGN: Each partner developed a country-specific picture book based on the so-called EPIC-Soft picture book. Representative and common photo series were chosen achieving approximately 25 % of the original picture book (n 23). Three portions from each photo series were randomly selected. SETTING: The study was performed within the Pilot study in the view of a Pan-European dietary survey - Adolescents, adults and elderly (PILOT-PANEU) project. SUBJECTS: A sample of adolescents and adults was recruited in five countries: Bulgaria (n 103), Finland (n 34), Germany (n 69), Hungary (n 62) and Portugal (n 77). RESULTS: Among the portions of the corresponding photo series and depending on the type of food, from 18 % (cheese) to 96 % (ratatouille) of participants chose the correct portions. In the perception study, agreement between the portions shown and reported was substantial (intraclass correlation coefficient (ICC)=0·805) and the mean difference was very low. In the memory study, agreement between the served and reported portions was lower than in the perception study (ICC=0·536). Agreement also seemed to decrease as the appearance of food on the plate differed from food in the picture. CONCLUSIONS: Overall, the picture series selected can be applied in future intake surveys to quantify foods similar to those depicted in the pictures.

[Dietary exposure assessment of substances in foods : The BfR MEAL study - the first German total diet study]. / Expositionsschätzung von Stoffen in Lebensmitteln : Die BfR-MEAL-Studie ­ die erste Total-Diet-Studie in Deutschland.

The dietary exposure of a population to chemical substances is estimated based on representative consumption data and data on the occurrence of substances in foods. Consumption data in Germany for different age groups are provided by the National Nutrition Survey ll, VELS, EsKiMo and the ongoing KiESEL study. The data for the levels of substances in foods is currently obtained from the German food monitoring programme (Lebensmittel-Monitoring) and the German Food Composition Table (Bundeslebensmittelschlüssel) and is not sufficient for a comprehensive evaluation of dietary exposure in Germany. More data is needed and, in particular, the range of analysed substances should be broadened to reduce the uncertainties of the exposure assessment. A representative data basis for concentrations of substances in foods will be established with the first German total diet study, called the BfR MEAL study. The study will markedly reduce major uncertainties in the dietary exposure assessment through its wide coverage of substances in food groups, the inclusion of prepared foods, the orientation on low measurement limits as well as the analysis of substances without a reliable data basis.

[Risk assessment of synephrine in dietary supplements]. / Gesundheitliche Risiken von Synephrin in Nahrungsergänzungsmitteln.

Synephrine is a sympathomimetic phenylethylamine derivative that occurs naturally in citrus fruits. It is often added to dietary supplements intended for weight loss and enhancement of sports performance, typically in the form of Citrus aurantium extracts and in many cases in combination with caffeine. The health risks of synephrine were evaluated on the basis of the available toxicological data and in accordance to the EFSA guidance on the safety assessment of botanicals and botanical preparations intended for use in food supplements. In animal studies, orally applied synephrine induced adrenergic effects on the cardiovascular system (increase of blood pressure, ventricular arrhythmias), which were enhanced by the concomitant application of caffeine as well as physical activity. Some human intervention studies investigating the acute effects of synephrine on blood pressure and heart rate of healthy, normotensive test persons indicate that synephrine can induce cardiovascular effects in humans. A series of published case reports of adverse cardiovascular effects (hypertension, cardiac arrhythmia, myocardial infarction) were associated with consumption of synephrine- and caffeine-containing dietary supplements. In conclusion, consumption of high amounts of synephrine, especially in combination with caffeine and physical exercise, is associated with an increased risk of adverse effects on the cardiovascular system. According to the assessment by the BfR (Bundesinstitut für Risikobewertung), daily intake of synephrine through dietary supplements should not exceed the median intake from conventional foods.

Dietary intake and food sources of choline in European populations.

Choline is an important nutrient for humans. Choline intake of the European population was assessed considering the European Food Safety Authority European Comprehensive Food Consumption Database and the United States Department of Agriculture Nutrient Database. Average choline intake ranges were 151-210 mg/d among toddlers (1 to ≤3 years old), 177-304 mg/d among other children (3 to ≤10 years old), 244-373 mg/d among adolescents (10 to ≤18 years old), 291-468 mg/d among adults (18 to ≤65 years old), 284-450 mg/d among elderly people (65 to ≤75 years old) and 269-444 mg/d among very elderly people (≥75 years old). The intakes were higher among males compared with females, mainly due to larger quantities of food consumed per day. In most of the population groups considered, the average choline intake was below the adequate intake (AI) set by the Institute of Medicine in the USA. The main food groups contributing to choline intake were meat, milk, grain, egg and their derived products, composite dishes and fish. The main limitations of this study are related to the absence of choline composition data of foods consumed by the European population and the subsequent assumption made to assess their intake levels. Given the definition of AI, no conclusion on the adequacy of choline intake can be drawn for most European population groups. Such results improve the knowledge on choline intake in Europe that could be further refined by the collection of choline composition data for foods as consumed in Europe.

How long can you store vitamins? Stability of tocopherols and tocotrienol during different storage conditions in broccoli and blueberries.

Differences between the stability of α-, ß-, γ-, and δ-tocopherol as well α-tocotrienol stored at -20 °C and -80 °C were studied in broccoli and blueberry samples. Before storage up to 28 days, they underwent different initializing processes such as freezing quickly with liquid nitrogen and freeze-drying, followed by homogenization. While α-tocopherol levels in blueberries did not significantly differ, levels in broccoli were substantially higher after homogenization of freeze-dried samples compared to fresh broccoli samples. This might be caused by higher extractability of α-tocopherol from the changed cell structure. Storage of fresh broccoli samples at -20 °C led to decreasing α-tocopherol levels. Nevertheless, the deviation between freeze-dried samples to the initial fresh samples and fresh samples frozen with liquid nitrogen stored at -20 °C for 7 days were in the same order of magnitude. In conclusion, storage up to 7 days for vitamin relevant samples before analysis seemed to be justifiable.

Assessment of long-term dietary cadmium exposure in children in Germany: Does consideration of data from total diet studies reduce uncertainties from food monitoring programmes?

Total diet studies (TDS) and food monitoring programmes are different approaches for collecting occurrence data on substances in food. This case study evaluated the practical applicability of TDS data (BfR MEAL Study) and monitoring data for the assessment of long-term cadmium exposure in children in Germany. Cadmium data from both programmes were combined with food consumption data from the KiESEL study. Uncertainties associated with both assessments were systematically described. Using monitoring data resulted in cadmium intakes approximately 3 times higher than the use of BfR MEAL Study data. Incomplete data and neglect of market shares and consumption weights were considered by conservative data adjustments to the monitoring data and mainly explain the higher estimates. Fewer data adjustments were necessary for BfR MEAL Study data, which covered almost the entire diet and considered consumer behaviour during sample collection and sample preparation. In sum, the use of the BfR MEAL Study data resulted in less uncertainty and more reliable exposure estimates for chronic assessments over the entire diet. However, description of variability and upper tails of substance distributions in food remain essential features of monitoring data. The integration of both programmes into a complementary system further improves food safety.

Results of the BfR MEAL Study: Acrylamide in foods from the German market with highest levels in vegetable crisps.

Acrylamide (AA) is formed in foods due to thermal processes. AA was analysed in 230 foods in the first German Total Diet Study and the highest mean levels of AA were found in vegetable crisps (1430 µg/kg), followed by potato pancakes (558) µg/kg) and pan-fried potatoes (450 µg/kg). In various foods, e.g. French fries and sweet potatoes, AA was also tested for different browning degrees and cooking methods. French fries cooked to a browning degree of 3 in all cooking methods exceeded the benchmark level set by the European Union. French fries prepared in the oven and sweet potatoes in the air fryer had the lowest AA levels. In foods from the German market, AA was found also in foods such as popcorn (243 µg/kg), salty sticks (190 µg/kg), and dark chocolate (130 µg/kg). Levels of AA found in our study may support future dietary exposure and food safety assessments.

Germany's first Total Diet Study - Occurrence of non-dioxin-like polychlorinated biphenyls and polybrominated diphenyl ethers in foods.

The occurrence of persistent organic pollutants like polychlorinated biphenyls (PCBs) and polybrominated diphenyl ethers (PBDEs) in food represents a public health concern. The BfR MEAL Study was initiated to generate a comprehensive data base of occurrence data for chemicals in the most consumed foods in Germany. Non-dioxin-like PCBs (NDL-PCBs) and PBDEs were analysed in 300 foods, purchased and prepared representatively for the eating behaviour of the population in Germany. Highest levels of NDL-PCBs and PBDEs were detected in spiny dogfish, cod liver, herring, and eel. High NDL-PCB and PBDE levels were observed in other oily fish, wild boar meat, sheep liver, and high-fat dairy products. The comparison of food from conventional and organic production revealed higher NDL-PCB values in the food group 'meat and meat products' if produced organically. Occurrence data of this study will improve future dietary exposure and risk assessments in Germany.

Reusability of Germany´s total diet study food list upon availability of new food consumption data-comparison of three update strategies.

BACKGROUND: The German total diet study (TDS)-BfR MEAL Study-established its food list in 2016 based on food consumption data of children (0.5-<5 years) and adults (14-80 years). The list consists of 356 foods selected for analysis in order to ensure ≥90% coverage of the diet. Recently, new food consumption data for children (0.5-<6 and 6-<12 years) in Germany became available, which raised the opportunity to evaluate the applicability of the MEAL food list 2016 on new data. OBJECTIVE: We tested the hypotheses that the MEAL food list 2016 also covers ≥90% of the diet of the new collected food consumption data, and that the selection of foods from younger children and adults was sufficient to also cover the middle age group (6-<12 years). Strategies for updating the existing food list were assessed. METHODS: Three approaches evaluated the reusability and potential adjustment strategies of the existing food list. Approach 1 applied the existing food list to new food consumption data. Approach 2 allowed the extension of the existing food list to improve coverage of food consumption. Approach 3 set up a new food list based on the new data. RESULTS: The MEAL food list 2016 covered 94% of the overall diet of the new collected food consumption data. The diet of the middle age group was sufficiently covered with 91%. However, coverage on main food group or population subgroup level was <90% in some cases. Approach 3 most accurately identified relevant modifications to the existing food list. 94% of the MEAL food list 2016 could be re-used and 51 new foods were identified as potentially relevant. SIGNIFICANCE: The results suggest that a high investment in the coverage of a TDS food list will lower the effort and the resources to keep data updated in the long-term. IMPACT: There is no established approach to update a TDS food list. This study provides comparative approaches to handle newly collected food consumption data for follow-on TDS activities. The results provide useful information for institutions planning or updating a TDS. Furthermore, new food consumption data for children in Germany recently became available and are here presented for the first time.

Chronic dietary exposure to total arsenic, inorganic arsenic and water-soluble organic arsenic species based on results of the first German total diet study.

For risk assessment purposes, the dietary exposure to total arsenic and inorganic arsenic was estimated within the first German total diet study (BfR MEAL Study) for the whole population in Germany. Therefore, occurrence data of 356 different foods from the BfR MEAL Study were combined with consumption data from German nutrition surveys. Due to the different toxicological potentials of other water-soluble organic arsenic species present in rice-based foods, fish and seafood, dietary exposure to dimethylarsinic acid, monomethylarsonic acid and arsenobetaine was assessed in consumers in Germany through such foods for the first time. Related to the bodyweight, dietary exposure to total arsenic and inorganic arsenic in infants and young children (0.5-<5 years) were higher than in adolescents/adults (≥14 years). The highest median exposure estimates to inorganic arsenic resulted for the age group of infants from 0.5 to <1 year under modified lower bound conditions and for young children from 1 to <2 years under upper bound conditions (0.17 µg kg-1 bodyweight day-1-0.24 µg kg-1 bodyweight day-1 and 0.26 µg kg-1 bodyweight day-1-0.34 µg kg-1 bodyweight day-1, respectively). 'Grains and grain-based products' (especially rice) were identified as the main contributors for dietary exposure to total arsenic and inorganic arsenic for all age classes. Especially, for infants and young children, high consumption of rice-based foods and fish fingers is driving the dietary exposure to dimethylarsinic acid. The dietary exposure calculations indicate that a further reduction of dietary exposure to inorganic arsenic and further investigations to water-soluble organic arsenic species are necessary.

Corrigendum to "The first German total diet study (BfR MEAL Study) confirms highest levels of dioxins and dioxin-like polychlorinated biphenyls in foods of animal origin title of article" [Food Chem.: X 16 (2022) 100459].

[This corrects the article DOI: 10.1016/j.fochx.2022.100459.].

Long-term dietary exposure to copper in the population in Germany - Results from the BfR MEAL study.

The German Total Diet Study (BfR MEAL Study) measured copper in 356 foods. In 105 of these foods copper was determined separately for conventionally and organically pooled samples. Mammalian liver, nuts, oilseeds, cocoa powder and chia seeds contained the highest copper levels. Organically produced foods tended to have higher levels compared to conventionally produced foods. Children's copper exposure was between 0.04 mg/kg body weight per day (mg/kg bw/day) and 0.07 mg/kg bw/day (median). High exposure (95th percentile) ranged between 0.07 mg/kg bw/day and 0.11 mg/kg bw/day. Adult's exposure ranged between 0.02 mg/kg bw/day (median) and 0.04 mg/kg bw/day (95th percentile). Grains and grain-based products were main contributors for all age groups. Copper intake was about 10% higher in a scenario where consumers select the organically produced variants. Children's median and high exposure was above the acceptable daily intake (ADI) of 0.07 mg/kg bw/day set by the European Food Safety Authority (EFSA). However, according to EFSA's evaluation this is not of concern due to higher requirement related to growth. For adults, frequent consumers of mammalian liver exceeded the ADI in median and 95th percentile. Intake of copper-containing dietary supplements may also lead to exceedance of the ADI in all age groups.

Re-evaluation of the existing health-based guidance values for copper and exposure assessment from all sources.

Copper is an essential micronutrient and also a regulated product used in organic and in conventional farming pest management. Both deficiency and excessive exposure to copper can have adverse health effects. In this Scientific Opinion, the EFSA 2021 harmonised approach for establishing health-based guidance values (HBGVs) for substances that are regulated products and also nutrients was used to resolve the divergent existing HBGVs for copper. The tightly regulated homeostasis prevents toxicity manifestation in the short term, but the development of chronic copper toxicity is dependent on copper homeostasis and its tissue retention. Evidence from Wilson disease suggests that hepatic retention is indicative of potential future and possibly sudden onset of copper toxicity under conditions of continuous intake. Hence, emphasis was placed on copper retention as an early marker of potential adverse effects. The relationships between (a) chronic copper exposure and its retention in the body, particularly the liver, and (b) hepatic copper concentrations and evidence of toxicity were examined. The Scientific Committee (SC) concludes that no retention of copper is expected to occur with intake of 5 mg/day and established an Acceptable Daily Intake (ADI) of 0.07 mg/kg bw. A refined dietary exposure assessment was performed, assessing contribution from dietary and non-dietary sources. Background copper levels are a significant source of copper. The contribution of copper from its use as plant protection product (PPP), food and feed additives or fertilisers is negligible. The use of copper in fertilisers or PPPs contributes to copper accumulation in soil. Infant formula and follow-on formula are important contributors to dietary exposure of copper in infants and toddlers. Contribution from non-oral sources is negligible. Dietary exposure to total copper does not exceed the HBGV in adolescents, adults, elderly and the very elderly. Neither hepatic copper retention nor adverse effects are expected to occur from the estimated copper exposure in children due to higher nutrient requirements related to growth.

Re-evaluation of erythritol (E 968) as a food additive.

This opinion addresses the re-evaluation of erythritol (E 968) as food additive and an application for its exemption from the laxative warning label requirement as established under Regulation (EU) No 1169/2011. Erythritol is a polyol obtained by fermentation with Moniliella pollinis BC or Moniliella megachiliensis KW3-6, followed by purifications and drying. Erythritol is readily and dose-dependently absorbed in humans and can be metabolised to erythronate to a small extent. Erythritol is then excreted unchanged in the urine. It does not raise concerns regarding genotoxicity. The dataset evaluated consisted of human interventional studies. The Panel considered that erythritol has the potential to cause diarrhoea in humans, which was considered adverse because its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhoea of 0.5 g/kg body weight (bw) was identified as reference point. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) at the level of the reference point. An ADI of 0.5 g/kg bw per day was considered by the Panel to be protective for the immediate laxative effect as well as potential chronic effects, secondary to diarrhoea. The highest mean and 95th percentile chronic exposure was in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). Acute exposure was maximally 3531 mg/kg bw per meal for children at the 99th percentile. Overall, the Panel considered both dietary exposure assessments an overestimation. The Panel concluded that the exposure estimates for both acute and chronic dietary exposure to erythritol (E 968) were above the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Concerning the new application, the Panel concluded that the available data do not support the proposal for exemption.

KiESEL - The Children's Nutrition Survey to Record Food Consumption for the youngest in Germany.

BACKGROUND: With KiESEL, the Children's Nutrition Survey to Record Food Consumption, the German Federal Institute for Risk Assessment (BfR) collected representative food consumption data for children aged six months up to five years. KiESEL was one of five modules of KiGGS Wave2 (German Health Interview and Examination Survey for Children and Adolescents) conducted by the Robert Koch Institute (RKI). The objective was to update the consumption data for children in Germany and to fill a data gap for the age group of five-year-old children. The study provides an up-to-date and comprehensive database that will be used for exposure assessment, as part of risk assessment of Germany's youngest consumers. METHODS: In the years 2014 to 2017, 1104 children from all over Germany participated in KiESEL. During home visits, survey staff conducted a questionnaire-based interview including a food propensity questionnaire (FPQ) on seldom eaten foods and questions concerning consumption outside home, dietary habits and diet during first year. The interviewer measured the children's height and weight. Families and childcare workers filled out a food record, covering three consecutive days and one independent day. Data are based on the FPQ and present consumption frequencies. Depending on the question, socioeconomic status (SES) and migration background were considered. RESULTS: 1104 participants had an interview and filled out the questionnaire on usual food intake, seldom eaten foods and consumption away from home. They were included in sample1. 1008 of these participants additionally reported food consumption of at least three days (sample2). 91.2% of the children follow no special diet and 0.8% are vegetarians. 7% of the older children consuming soya-drink. For some foods differences in consumption across SES or migration status were noted. Children from families with higher SES consume more often soya-based substitute milk as families with lower SES (p < 0.00005). CONCLUSIONS: KiESEL gathered up-to-date consumption data for more than 1000 children living in Germany, aged six month up to including five years. The data will be used for risk assessments of the BfR and provided to national and international partners.

Results of the BfR MEAL Study: In Germany, mercury is mostly contained in fish and seafood while cadmium, lead, and nickel are present in a broad spectrum of foods.

The BfR MEAL Study provides representative levels of substances in foods consumed in Germany. Mercury, cadmium, lead, and nickel are contaminants present in foods introduced by environmental and industrial processes. Levels of these elements were investigated in 356 foods. Foods were purchased representatively, prepared as consumed and pooled with similar foods before analysis. Highest mean levels of mercury were determined in fish and seafood, while high levels of cadmium, lead, and nickel were present in cocoa products and legumes, nuts, oilseeds, and spices. The sampling by region, season, and production type showed minor differences in element levels for specific foods, however no tendency over all foods or for some food groups was apparent. The data on mercury, cadmium, lead, and nickel provide a comprehensive basis for chronic dietary exposure assessment of the population in Germany. All levels found were below regulated maximum levels.

Collection of occurrence data in foods - The value of the BfR MEAL study in addition to the national monitoring for dietary exposure assessment.

Two different data sets of occurrence data are available in Germany at present: the German National Food Monitoring and the BfR MEAL Study. To determine the suitability of each data set for exposure assessment and to develop concepts for a target-oriented selection and application of data, possibilities, limitations and scope of substance as well as food selection is quantitatively compared. The National Monitoring data provides comprehensive information on the variability of substance levels. This enables short- and long-term exposure assessment and consumer-loyal scenarios. The BfR MEAL Study supplements the monitoring data set with > 100 substances or by complementing the food spectrum for substances already included in the National Monitoring. The study design benefits especially the long-term dietary exposure assessment for the German population including the total diet. Using both programmes enables case-dependent selection of the appropriate dataset and in combination both sets can contribute to enhanced consumer safety.

Results of the BfR MEAL Study: Highest levels of retinol found in animal livers and of ß-carotene in yellow-orange and green leafy vegetables.

This Total Diet Study (TDS) provides representative data on substance levels in foods, prepared as typically consumed by the population in Germany for future dietary exposure assessment. Vitamin A is essential and must be obtained from the diet, either as preformed vitamin A or as provitamin A carotenoids. Levels of retinol and ß-carotene were analysed in 333 and 271 foods, respectively. Highest mean retinol levels were found in cod liver (25,000 µg∙100 g-1), followed by other animal livers, liver-based products, butter, eel and fortified margarine. In contrast, highest mean ß-carotene levels were found in carrots (4,650 µg∙100 g-1), followed by other yellow-orange fruits and vegetables, green leafy vegetables and fortified fruit nectars. Sampling by production type and seasonality revealed differences in retinol and ß-carotene levels in individual foods. This TDS expands the existing data for ß-carotene and vitamin A extensively by providing representative data on most consumed foods.

The first German total diet study (BfR MEAL Study) confirms highest levels of dioxins and dioxin-like polychlorinated biphenyls in foods of animal origin.

The first German Total Diet Study, called the BfR MEAL Study, generated a comprehensive dataset of polychlorinated dibenzo-p-dioxins and -furans (PCDD/Fs) and dioxin-like polychlorinated biphenyls (dl-PCBs) in foods representative for the consumption habits in households in Germany. PCDD/Fs and dl-PCBs are persistent organic pollutants. Dietary intake is considered to be the most relevant exposure pathway for humans. Levels were examined in 300 foods that were prepared as typically consumed by the population in Germany. Highest PCDD/F and dl-PCB levels were detected in animal-based foods such as fish, butter, dairy products, liver, and meat. The comparison of conventionally and organically produced foods revealed a trend to slightly higher contents in organically produced foods. Sampling discriminated by region and season showed no major differences. Analysed occurrence data will improve future dietary exposure and food safety assessments in Germany.