[Food allergen regulations in the EU]. / Lebensmittelrechtliche Regelungen für Allergene in der EU.

With the implementation of EU regulation 1169/2011 in December 2014, labelling of allergenic ingredients has been extended to non-prepacked foods. The member states of the European Union were authorised to lay down national rules for the labelling of allergenic ingredients in non-prepacked foods. In Germany, this was accomplished through the introduction of the Vorläufige Lebensmittelinformations-Ergänzungsverordnung (VorlLMIEV). Regulation 1169/2011 also changed the way allergenic ingredients are to be labelled on prepacked foods.This article provides an overview over the current regulations regarding the labelling of food allergens on prepacked and non-prepacked foods in the EU and Germany.

GMO analysis results from official food control laboratories in Germany from 2017 to 2021.

In Germany, genetically modified organisms (GMO) analysis of food samples collected within the official food control is performed by the laboratories of the Federal States. The present report shows GMO analysis results from food samples of the years 2017 to 2021, including contaminations by unauthorized GMO, as well as genetically modified (GM) plant events authorized in the European Union. In addition to previous publications, evaluation of the aggregated food samples analysed for GMO components is shown. During this timeframe, 1077 (7.1%) out of 15,145 samples contained genetic modification. In 43 samples, DNA sequences of unauthorized GM plants were found. Additionally, for food derived from soybean, evaluations according to different product categories and the agronomic production (conventional and organic farming) are shown. Whereas in products from organic farming and in conventional soybeans labelled "without genetic engineering" GM soybeans were detected in 6.1% and 8.9%, of all tested samples, respectively, nearly 30% of all conventional soy samples yielded positive results below 0.1%. However, only in 0.7% of the overall analysed 5424 soybean samples GMO percentages of more than 0.1% were obtained. Generally, authorized GM plants were only found at low contamination levels. The labelling threshold of 0.9% for GM ingredients was exceeded only in 0.2% (maize) and 0.1% (soybean) samples, respectively. For monitoring purposes and risk evaluation, the data collection shall be continued.

A practical approach to screen for authorised and unauthorised genetically modified plants.

In routine analysis, screening methods based on real-time PCR are most commonly used for the detection of genetically modified (GM) plant material in food and feed. In this paper, it is shown that the combination of five DNA target sequences can be used as a universal screening approach for at least 81 GM plant events authorised or unauthorised for placing on the market and described in publicly available databases. Except for maize event LY038, soybean events DP-305423 and BPS-CV127-9 and cotton event 281-24-236 x 3006-210-23, at least one of the five genetic elements has been inserted in these GM plants and is targeted by this screening approach. For the detection of these sequences, fully validated real-time PCR methods have been selected. A screening table is presented that describes the presence or absence of the target sequences for most of the listed GM plants. These data have been verified either theoretically according to available databases or experimentally using available reference materials. The screening table will be updated regularly by a network of German enforcement laboratories.

Action Levels for Food Allergens: An Approach for Official Food Control in Germany.

Official food control laboratories in Germany have established internal action values for the assessment of analytical results of food allergens especially obtained from samples without declaration of the specified allergen. A pragmatic approach was chosen considering the current situation for European food information legislation. Accordingly, when a positive result is obtained for an unlabeled allergen, it is not necessarily an irregularity if it can be demonstrated that the result was caused by cross-contamination. Action values take into account current analytical experiences as well as published allergologic reference doses. They are considered as internal de minimis thresholds by food control authorities that are used to support laboratories in the decision-making process and when a written expert opinion is requested by an enforcement authority. If only minor traces are detected at concentrations below the action values, further investigation of the issue and inspections at the location of manufacture can be abandoned. The present report includes a collection of results from official food control laboratories in Germany that have been evaluated in line with the aforementioned system of action levels.

Highly Sensitive Matrix-Independent Quantification of Major Food Allergens Peanut and Soy by Competitive Real-Time PCR Targeting Mitochondrial DNA.

The development of two competitive real-time PCR assays for the quantitative detection of trace amounts of two major food allergens, peanut and soybean, is reported. In order to achieve very low detection levels for both allergens, we established PCR primers and probes targeting mitochondrial DNA sequences. We were able to demonstrate that this approach led to an increase in detection sensitivity in the range of at least 1 order of magnitude compared with published assays targeting nuclear DNA. Furthermore, we generated corresponding competitor molecules, which were used as internal standards to compete with matrix effects that are evident during DNA extraction and PCR amplification in heterogeneous analytical matrixes like food. According to the recently described competitive quantitative PCR method published by Holzhauser et al. (2014), we performed threshold calibration against milk powder spiked with 10 ppm peanut and soy. Matrix-independent quantitative determination of peanut and soy could be demonstrated for three different calibrated food matrix standards in a range between 1 and 100 ppm. The data presented indicate that both assay concepts are powerful analytical tools for the quantitative detection of trace amounts of peanut and soy in commercial food products.

Combined chemometric analysis of (1)H NMR, (13)C NMR and stable isotope data to differentiate organic and conventional milk.

The increased sales of organically produced food create a strong need for analytical methods, which could authenticate organic and conventional products. Combined chemometric analysis of (1)H NMR-, (13)C NMR-spectroscopy data, stable-isotope data (IRMS) and α-linolenic acid content (gas chromatography) was used to differentiate organic and conventional milk. In total 85 raw, pasteurized and ultra-heat treated (UHT) milk samples (52 organic and 33 conventional) were collected between August 2013 and May 2014. The carbon isotope ratios of milk protein and milk fat as well as the α-linolenic acid content of these samples were determined. Additionally, the milk fat was analyzed by (1)H and (13)C NMR spectroscopy. The chemometric analysis of combined data (IRMS, GC, NMR) resulted in more precise authentication of German raw and retail milk with a considerably increased classification rate of 95% compared to 81% for NMR and 90% for IRMS using linear discriminate analysis.

Collaborative trial validation studies of real-time PCR-based GMO screening methods for detection of the bar gene and the ctp2-cp4epsps construct.

Polymerase Chain Reaction (PCR)-based screening methods targeting genetic elements commonly used in genetically modified (GM) plants are important tools for the detection of GM materials in food, feed, and seed samples. To expand and harmonize the screening capability of enforcement laboratories, the German Federal Office of Consumer Protection and Food Safety conducted collaborative trials for interlaboratory validation of real-time PCR methods for detection of the phosphinothricin acetyltransferase (bar) gene from Streptomyces hygroscopicus and a construct containing the 5-enolpyruvylshikimate-3-phosphate synthase gene from Agrobacterium tumefaciens sp. strain CP4 (ctp2-cp4epsps), respectively. To assess the limit of detection, precision, and accuracy of the methods, laboratories had to analyze two sets of 18 coded genomic DNA samples of events LLRice62 and MS8 with the bar method and NK603 and GT73 with the ctp2-cp4epsps method at analyte levels of 0, 0.02, and 0.1% GM content, respectively. In addition, standard DNAs were provided to the laboratories to generate calibration curves for copy number quantification of the bar and ctp2-cp4epsps target sequences present in the test samples. The study design and the results obtained are discussed with respect to the difficult issue of developing general guidelines and concepts for the collaborative trial validation of qualitative PCR screening methods.