Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments.

EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal.

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-, β-, 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.

Results of the BfR MEAL Study: The food type has a stronger impact on calcium, potassium and phosphorus levels than factors such as seasonality, regionality and type of production.

The BfR MEAL Study aims to provide representative levels of chemical substances in foods consumed by the population in Germany for dietary exposure assessment. Calcium, potassium and phosphorus (Ca, K, P) are essential to obtain physiological functions in humans. Levels were investigated in 356 foods.

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.

Analysis of German BSE Surveillance Data: Estimation of the Prevalence of Confirmed Cases versus the Number of Infected, but Non-Detected, Cattle to Assess Confidence in Freedom from Infection.

Quantitative risk assessments for Bovine spongiform encephalopathy (BSE) necessitate estimates for key parameters such as the prevalence of infection, the probability of absence of infection in defined birth cohorts, and the numbers of BSE-infected, but non-detected cattle entering the food chain. We estimated three key parameters with adjustment for misclassification using the German BSE surveillance data using a Gompertz model for latent (i.e.

Exposure assessment of methylmercury in samples of the BfR MEAL Study.

The BfR MEAL Study is the first German total diet study and will establish a representative and comprehensive database for dietary exposure assessment in Germany. The present study reports first results of the BfR MEAL Study regarding methylmercury in fish, seafood and mushrooms. In total, 34 MEAL foods were purchased nationally or regionally according to a defined sampling plan, prepared in a representative way for German households, pooled into 49 samples, homogenized and subjected to ICP-MS analysis.

Comparison of Bayesian and frequentist methods for prevalence estimation under misclassification.

Background: Various methods exist for statistical inference about a prevalence that consider misclassifications due to an imperfect diagnostic test. However, traditional methods are known to suffer from truncation of the prevalence estimate and the confidence intervals constructed around the point estimate, as well as from under-performance of the confidence intervals' coverage.

Methods: In this study, we used simulated data sets to validate a Bayesian prevalence estimation method and compare its performance to frequentist methods, i.

Analysis of consumer behavior for the estimation of the exposure to chemicals in personal care products.

In this study, the main objective was to implement an integrative modelling framework in order to support the prioritization and screening of chemicals present in personal care products (PCPs) regarding their potential to expose users across multiple possible pathways. Here, we implemented an exposure-based framework based on product intake fractions (PiFs) calculated using a two-compartment model reproducing the skin uptake and the competing volatilization of chemicals applied on skin during PCP use. The implemented framework enabled to simultaneously and comprehensively accommodate coupled chemical specific parameters (i.

Use of meat juice and blood serum with a miniaturised protein microarray assay to develop a multi-parameter IgG screening test with high sample throughput potential for slaughtering pigs.

Background: Serological screening of pig herds at the abattoir is considered a potential tool to improve meat inspection procedures and herd health management. Therefore, we previously reported the feasibility of a miniaturised protein microarray as a new serological IgG screening test for zoonotic agents and production diseases in pigs. The present study investigates whether the protein microarray-based assay is applicable for high sample throughput using either blood serum or meat juice.

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.

Refining animal research: The Animal Study Registry.

The Animal Study Registry (ASR; www.animalstudyregistry.org) was launched in January 2019 for preregistration of animal studies in order to increase transparency and reproducibility of bioscience research and to promote animal welfare.

Dietary exposure assessment of aluminium and cadmium from cocoa in relation to cocoa origin.

Cocoa contains aluminium and cadmium as environmental contaminants while concentrations are supposed to be country of origin-related. Integrating origin in dietary exposure assessment could refine calculations. Averages or higher percentiles of concentrations in cocoa powder from German Food Monitoring (GFM) and cocoa consumption from the German National Nutrition Survey II (NVS II) were combined in standard scenarios.

Development of a miniaturized protein microarray as a new serological IgG screening test for zoonotic agents and production diseases in pigs.

In order to monitor the occurrence of zoonotic agents in pig herds as well as to improve herd health management, the development of new cost-effective diagnostic methods for pigs is necessary. In this study, a protein microarray-based assay for the simultaneous detection of immunoglobulin G (IgG) antibodies against different zoonotic agents and pathogens causing production diseases in pigs was developed. Therefore, antigens of ten different important swine pathogens (Toxoplasma gondii, Yersinia enterocolitica, Salmonella spp.

The disease burden associated with Campylobacter spp. in Germany, 2014.

Bacteria of the genus Campylobacter are an important cause of human illness worldwide. Campylobacter infections are expressed as gastroenteritis and can lead to severe sequelae like reactive arthritis, Guillain-Barré syndrome, irritable bowel syndrome and inflammatory bowel disease. In Germany, Campylobacter-associated gastroenteritis cases are notifiable but there is no reporting obligation for the sequelaes and the disease burden is clearly underestimated.

Refinement of dietary exposure assessment using origin-related scenarios.

Global sourcing of food may lead to variability in concentrations of contaminants or pesticide residues. It would be important to incorporate origin influences in dietary exposure assessment. To characterise uncertainties, substance concentrations from GFM (German Food Monitoring), chosen based on the highest CV (coefficient of variation), and food consumption from NVS II (German National Nutrition Survey II) were combined in standard scenarios.

[Health reporting of poisoning in Germany-a scientific investigation into the establishment of national poisoning monitoring in Germany : Background, preliminary work, requirements].

As a result of decentralized and non-harmonized documentation of poisoning cases within Germany, in comparison to other countries (e.g. the USA, Switzerland, Sweden, and the Netherlands), there is a substantial lack of harmonized national data, in particular for the early detection and risk assessment at the German Federal Institute for Risk Assessment (BfR).

Design, statistical analysis and reporting standards for test accuracy studies for infectious diseases in animals: Progress, challenges and recommendations.

The quality of diagnostic accuracy studies (DAS) for infectious diseases of animals has improved over the last 20 years because of international educational efforts, use of design and reporting standards to guide researchers and test developers, and acceptance of the use of latent class models to account for imperfect reference tests. In this review, we focus on measurement of diagnostic sensitivity and specificity as a measure of clinical validity, describe the leadership role of the World Organisation of Animal Health (OIE) in setting standards for test validation in the context of fitness-for-purpose, and describe how design and reporting quality have facilitated the increased use of systematic reviews and meta-analysis of DAS. Ongoing challenges for design, conduct, analysis and reporting of DAS are identified; and we make recommendations for improvements in these areas for OIE-listed and non-listed infectious diseases.

Simple changes of individual studies can improve the reproducibility of the biomedical scientific process as a whole.

We developed a new probabilistic model to assess the impact of recommendations rectifying the reproducibility crisis (by publishing both positive and 'negative' results and increasing statistical power) on competing objectives, such as discovering causal relationships, avoiding publishing false positive results, and reducing resource consumption. In contrast to recent publications our model quantifies the impact of each single suggestion not only for an individual study but especially their relation and consequences for the overall scientific process. We can prove that higher-powered experiments can save resources in the overall research process without generating excess false positives.

Lead content in wild game shot with lead or non-lead ammunition - Does "state of the art consumer health protection" require non-lead ammunition?

The toxicity of lead has been known for a long time, and no safe uptake level can be derived for humans. Consumers' intake via food should therefore be kept as low as possible. Game meat can contain elevated levels of lead due to the use of lead ammunition for hunting.

Updated quantitative risk assessment (QRA) of the BSE risk posed by processed animal protein (PAP).

EFSA was requested: to assess the impact of a proposed quantitative real-time polymerase chain reaction (qPCR) 'technical zero' on the limit of detection of official controls for constituents of ruminant origin in feed, to review and update the 2011 QRA, and to estimate the cattle bovine spongiform encephalopathy (BSE) risk posed by the contamination of feed with BSE-infected bovine-derived processed animal protein (PAP), should pig PAP be re-authorised in poultry feed and vice versa, using both light microscopy and ruminant qPCR methods, and action limits of 100, 150, 200, 250 and 300 DNA copies. The current qPCR cannot discriminate between legitimately added bovine material and unauthorised contamination, or determine if any detected ruminant material is associated with BSE infectivity. The sensitivity of the surveillance for the detection of material of ruminant origin in feed is currently limited due to the heterogeneous distribution of the material, practicalities of sampling and test performance.

Methodology and preliminary results of a systematic literature review of ante-mortem and post-mortem diagnostic tests for bovine tuberculosis.

A systematic review was conducted to identify studies with data for statistical meta-analyses of sensitivity (Se) and specificity (Sp) of ante-mortem and post-mortem diagnostic tests for bovine tuberculosis (bTB) in cattle. Members of a working group (WG) developed and tested search criteria and developed a standardised two-stage review process, to identify primary studies with numerator and denominator data for test performance and an agreed range of covariate data. No limits were applied to year, language, region or type of test in initial searches of electronic databases.

Disease burden of methylmercury in the German birth cohort 2014.

This study aimed to estimate the disease burden of methylmercury for children born in Germany in the year 2014. Humans are mainly exposed to methylmercury when they eat fish or seafood. Prenatal methylmercury exposure is associated with IQ loss.