Human dietary exposure to dioxins and dioxin-like PCBs through the consumption of Atlantic herring from fishing areas in the Norwegian Sea and Baltic Sea

The concentrations of dioxins [polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)], and dioxin-like polychlorinated biphenyls (DL-PCBs) in Atlantic herring depend on the fishing area. These substances originate from various anthropogenic sources and accumulate in the environment and in food. The influence of country-specific contaminant concentrations on human dietary exposure was studied exemplary for herring to show the influence of fish origin. PCDD/F and DL-PCB concentrations in herring from the Norwegian Sea and the Baltic Sea were combined with country-specific herring consumption. Herring concentrations showed geographical variation. For herring consumers, the 50th percentile dietary exposure to the total sum of PCDD/Fs and DL-PCBs amounted to 1.2 and 8.9 pg WHO-2005-TEQ/kg BW/week for Norway and Germany, respectively. The different exposure was mainly related to higher concentrations in herring from the Baltic Sea, rather than in herring from the Norwegian Sea. If contaminant concentrations are influenced by geographical origin, this should be integrated into the dietary exposure assessments. For herring, relevant fishing areas should be integrated into the sampling strategy to generate concentration data. The usage of country-specific data could refine exposure assessments.publishedVersio

Risks of pyrrolizidine alkaloids in tea and herbal infusions

Pyrrolizidinalkaloide (PA) sind sekundäre Pflanzeninhaltsstoffe, die von einer Vielzahl von Pflanzen gebildet werden und u. a. zur Abwehr von Fraßfeinden dienen. Toxikologisch bedeutsam sind die PA, die eine Doppelbindung in 1,2-Position aufweisen. Diese können zu gesundheitlichen Schäden bei Mensch und Tier führen, wobei die Leber das Hauptzielorgan darstellt. Neben den bekannten hepatotoxischen Effekten können 1,2-ungesättigte PA auch die DNA schädigen und krebserzeugend wirken. Die Verbindungen gelangen in erster Linie über Wild- und Beikräuter in die Lebensmittelkette. In der im Jahr 2016 durch das Bundes­institut für Risikobewertung (BfR) veröffentlichten Bewertung stellte der Verzehr von kontaminiertem Tee und Kräutertee die wesentliche Expositionsquelle für die Bevölkerung gegenüber 1,2-ungesättigten PA in Deutschland dar; aber auch andere Lebensmittel können zur Aufnahme beitragen. In der vorliegenden Arbeit, in der ausschließlich Tee und Kräutertee berücksichtigt werden, zeigt sich, dass die Gehalte an 1,2-ungesättigten PA in dieser Lebensmittelgruppe im Vergleich zu 2016 deutlich gesunken sind. Dennoch kann es insbesondere bei Personen, die langfristig hohe Mengen Kräutertee bzw. Rooibostee verzehren, auch gegenwärtig noch zu Aufnahmemengen kommen, die in einem Margin of Exposure von unter 10.000 resultieren, weshalb es auch weiterhin angezeigt scheint, Maßnahmen zur Senkung der Gehalte durchzuführen.Pyrrolizidine alkaloids (PA) are secondary plant metabolites which are produced by a large number of plants, e. g. to ward off herbivores. PA with a double bond in the 1,2-position are of toxicological relevance. These derivatives can cause adverse health effects in humans and animals, with the liver being the major target organ. Besides the known hepatotoxic effects, 1,2-unsaturated PA may also damage DNA and may be carcinogenic. The occurrence of these compounds in foods is primarily caused by contamination with wild herbs. In the assessment published in 2016 by the German Federal Institute for Risk Assessment (BfR), consumption of contaminated tea and herbal tea was the main source of exposure for the population to 1.2-unsaturated PA in Germany; however, other foods can also contribute to intake. The present study, which focuses exclusively on tea and herbal tea, shows that levels of 1,2-unsaturated PA in this food group have decreased significantly compared to 2016. Nevertheless, persons who consume high amounts of herbal tea or rooibos tea in the long term may still be exposed to intakes that result in a margin of exposure of less than 10,000, which is why it still seems appropriate to implement measures to reduce the levels

Towards a Harmonised Total Diet Study Approach: a guidance document:joint guidance of EFSA, FAO and WHO

A Total Diet Study (TDS) can be a complementary approach to traditional monitoring and surveillance programs, which instead of focusing on compliance is designed to provide a solid basis for calculating population dietary exposure and assessing potential impact on public health. A TDS includes the selection of foods based on food consumption data to represent a large portion of a typical diet, their preparation to food as consumed and the subsequent pooling of related foods before analysis. There is already a wealth of international TDS data available, but to better enable comparisons it is important that methods are harmonised to the extent possible. The Working Group of experts provides a definition of the TDS approach highlighting its inherent value; it gives guidance for a harmonised methodology starting from the TDS planning to the collection of analytical results, exposure assessment calculation and communication of TDS results; and it proposes a general approach to facilitate the use of TDS information at international level. A TDS can be used for screening purposes or as a more refined exposure assessment tool. It provides background concentration and exposure levels of chemical substances in a range of representative foods prepared for consumption, while monitoring and surveillance programs can better capture highly contaminated individual food items. Their complementarities would allow the identification of the relative importance of individual sources of chemical substances from the whole diet. In conclusion, a TDS is considered to be a good complement to existing food monitoring or surveillance programs to estimate population dietary exposure to beneficial and harmful chemical substances across the entire diet. Harmonising the TDS methodology will enhance the value of these programs by improving the comparability at international level

Refined exposure assessment of polyethylene glycol (E 1521) from its use as a food additive

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the refined exposure assessment of polyethylene glycol (E 1521) when used as a food additive. Polyethylene glycols were evaluated by several international bodies and the AFC Panel previously adopted scientific opinions on the safety polyethylene glycol (E 1521). In 2006, the Panel concluded that based on all the data, consumption of PEG through use as plasticisers in film‐coating formulations for food supplement tablets and/or capsules at the intended use level are not of safety concern. In 2007, in another opinion of the AFC Panel related to d‐alpha‐tocopheryl polyethylene glycol 1000 succinate (TPGS) in use for food for particular nutritional purposes, the Panel noted that TPGS intakes would correspond to intake to PEG 1000 at levels equivalent to 3.3–8.5 mg/kg body wieght (bw) per day which are within the range of group acceptable daily intakes (ADIs) of the SCF (1997) and JECFA (1980). This assessment could only take into account the use of polyethylene glycol (E 1521) in food supplements and thus the food supplements consumers only scenario was performed. It resulted in exposure estimates of polyethylene glycol (E 1521) up to 3.5 mg/kg bw per day at the mean and up to 6.1 mg/kg bw per day at the high level. The current exposure assessment is based on the methodology used in the re‐evaluation of food additives together with reported use levels received following a call for data in 2017. Considering the uncertainties of the exposure assessment, these estimates very likely overestimated the real exposure to polyethylene glycol (E 1521). The Panel also noted that the highest calculated exposure estimate falls within the range of the group ADI previously established by SCF (5 mg/kg bw per day for PEG 300–4000) and of the one set by JECFA (10 mg/kg bw per day for PEG 200–10000)

Refined exposure assessment of extracts of rosemary (E 392) from its use as food additive

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the refined exposure assessment of extracts of rosemary (E 392) when used as a food additive. Extracts of rosemary (E 392) was evaluated by the AFC Panel in 2008. Following this EFSA evaluation, extracts of rosemary (E 392) was authorised for use as a food additive in the EU in several food categories with maximum levels. In 2015, the ANS Panel provided a scientific opinion on the safety of the proposed extensions of use for extracts of rosemary (E 392) in fat-based spreads. In 2016, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated this food additive and established a temporary acceptable daily intake (ADI) of 0–0.3 mg/kg body weight (bw) for rosemary extract, expressed as carnosic acid plus carnosol. Based on the data provided by food industry, the Panel was able to refine the exposure estimates of extracts of rosemary (E 392). The highest mean refined exposure estimate (non-brand loyal scenario) was 0.09 mg/kg bw per day in children (3–9 years) and the highest 95th percentile of exposure was 0.20 mg/kg bw per day in children. Taking uncertainties into account, the Panel concluded that these exposure estimates very likely overestimate the real exposure to extracts of rosemary (E 392) from its use as a food additive according to Annex II. Margins of safety were estimated for children and adults using the refined exposure estimate; these are higher than the ones calculated in 2015. Intake of carnosic acid and carnosol from natural diet (herbs) was estimated. It was maximally 1.66 mg/kg bw per day (p95)

Re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive

The present opinion deals with the re-evaluation of neohesperidine dihydrochalcone (E 959) when used as a food additive. It is obtained by catalytic hydrogenation of a flavanone - neohesperidine - which is naturally occurring and thus isolated by alcohol extraction in bitter oranges (Citrus aurantium). Based on in vivo data in rat, neohesperidine dihydrochalcone is likely to be absorbed, also in humans, and to become systemically available. It does not raise a concern regarding genotoxicity. The toxicity data set consisted of studies on subchronic and prenatal developmental toxicity. No human studies were available. The data set was considered sufficient to derive a new acceptable daily intake (ADI). Based on the weight of evidence (WoE) analysis, the Panel considered unlikely that neohesperidine dihydrochalcone would lead to adverse effects on health in animals in the dose ranges tested. The Panel also considered that a carcinogenicity study was not warranted and that the lack of human data did not affect the overall confidence in the body of evidence. The Panel derived an ADI of 20 mg/kg bodyweight (bw) per day based on a no observed adverse effect level (NOAEL) of 4,000 mg/kg bw per day from a 13-week study in rat, applying the standard default factors of 100 for inter- and intraspecies differences and of 2 for extrapolation from subchronic to chronic exposure. For the refined brand-loyal exposure assessment scenario, considered to be the most appropriate for the risk assessment, the exposure estimates at the mean ranged from < 0.01 to 0.09 mg/kg bw per day and at the 95th percentile (P95) from 0.01 to 0.24 mg/kg bw per day. Considering the derived ADI of 20 mg/kg bw per day, the exposure estimates were below the reference value in all age groups. Therefore, the Panel concluded that dietary exposure to the food additive neohesperidine dihydrochalcone (E 959) at the reported uses and use levels would not raise a safety concern

Effect of surgical experience and spine subspecialty on the reliability of the {AO} Spine Upper Cervical Injury Classification System

OBJECTIVE The objective of this paper was to determine the interobserver reliability and intraobserver reproducibility of the AO Spine Upper Cervical Injury Classification System based on surgeon experience (&lt; 5 years, 5–10 years, 10–20 years, and &gt; 20 years) and surgical subspecialty (orthopedic spine surgery, neurosurgery, and "other" surgery). METHODS A total of 11,601 assessments of upper cervical spine injuries were evaluated based on the AO Spine Upper Cervical Injury Classification System. Reliability and reproducibility scores were obtained twice, with a 3-week time interval. Descriptive statistics were utilized to examine the percentage of accurately classified injuries, and Pearson’s chi-square or Fisher’s exact test was used to screen for potentially relevant differences between study participants. Kappa coefficients (κ) determined the interobserver reliability and intraobserver reproducibility. RESULTS The intraobserver reproducibility was substantial for surgeon experience level (&lt; 5 years: 0.74 vs 5–10 years: 0.69 vs 10–20 years: 0.69 vs &gt; 20 years: 0.70) and surgical subspecialty (orthopedic spine: 0.71 vs neurosurgery: 0.69 vs other: 0.68). Furthermore, the interobserver reliability was substantial for all surgical experience groups on assessment 1 (&lt; 5 years: 0.67 vs 5–10 years: 0.62 vs 10–20 years: 0.61 vs &gt; 20 years: 0.62), and only surgeons with &gt; 20 years of experience did not have substantial reliability on assessment 2 (&lt; 5 years: 0.62 vs 5–10 years: 0.61 vs 10–20 years: 0.61 vs &gt; 20 years: 0.59). Orthopedic spine surgeons and neurosurgeons had substantial intraobserver reproducibility on both assessment 1 (0.64 vs 0.63) and assessment 2 (0.62 vs 0.63), while other surgeons had moderate reliability on assessment 1 (0.43) and fair reliability on assessment 2 (0.36). CONCLUSIONS The international reliability and reproducibility scores for the AO Spine Upper Cervical Injury Classification System demonstrated substantial intraobserver reproducibility and interobserver reliability regardless of surgical experience and spine subspecialty. These results support the global application of this classification system

KiESEL – the children’s nutrition survey module in KiGGS Wave 2

Representative food consumption data for children are collected in KiESEL, the German nutrition survey for children aged 6 months up to five years conducted by the German Federal Institute for Risk Assessment (BfR). The data gained will update the consumption data for German children and will fill a data gap that existed for the age group of 5-year-old children. It will provide an actual and comprehensive data basis that will be used for exposure assessment, as part of risk assessment of Germany’s youngest consumers. In the years 2014 to 2017, around 1,000 children will participate in the context of the KiESEL module of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS). During home visits, survey staff conducts a questionnaire-based interview, measures the children’s height and weight and explains the weighing records for the family and the child care workers. The data will be used for risk assessments of the BfR and provided to national and international partners such as the World Health Organization. This article describes the background and objectives of the study as well as its methodology and survey instruments