Allergen Labeling Research Articles

Evaluation of Label Compliance to Allergens in Imported Asian Food Sold in Northern Italy

Abstract Background The import of Asian food is strongly increasing in the EU. In Italy, the Asian market has expanded over the last 3 decades. Unfortunately, the labelling of these products often implies errors, mainly due to linguistic differences. Consequently, it can become a consistent problem regarding food safety, in particular for allergens declaration. According to EU Reg. 1169/2011 (Annex II), allergens must be labelled in bold and translated in the current language of the Member State. Asian food non-compliant labelling could enhance the probability of allergic consumers to get adverse events; accordingly, it is important to increase controls on the imported products. The present work investigates the label compliance to allergens on Asiatic products imported in Northern Italy. Methods Totally, 39 foodstuffs were tested for gluten, 93 for white egg proteins and 118 for milk proteins by commercial ELISA kits according to manufacturers’ instructions. Samples were considered non-compliant when the results were above 20 mg/Kg, the law limit for gluten, or above the milk LOD (10 µg/Kg) and the egg LOD (0.4 mg/Kg). Results Data showed 18% (CI 95% 0.09-0.32) of non-compliant samples for gluten: 6 samples > 80 mg/Kg (snacks and ready to eat meal) and 1 sample containing 48 mg/Kg (snack). In addition, 19.4 % (CI 95% 0.13-0.28) showed presence of egg proteins (noodles, snacks, patties and pasty). Finally, 13.6% (CI 95% 0.08-0.21) samples were irregular for undeclared milk (noodles and snacks). Conclusions Products label report their content and represent an important element for food trading and tracing. The results obtained confirm a high percentage of non-compliant labels, underlining how the consumption of imported products can represent a health risk for allergic consumers. The present work highlights the importance of imported food monitoring to guarantee the consumers health, and of the implementation of standardized/international regulated labelling rules. Key messages • Many non-compliant labels about allergens was observed on Asiatic products. • Correct labelling of allergens in imported food should be monitored to avoid adverse events.

Development and Validation of a Loop-Mediated Isothermal Amplification (LAMP) Method for the Rapid, Sensitive, and Specific Detection of Hazelnut as an Allergen in Food Matrix.

Analytical verification of hazelnut in food supports risk-based approaches for proper allergen labeling to prevent unwanted allergic reactions or to quality control diagnostic or therapeutic allergen preparations for allergic subjects. We present the development and validation of a loop-mediated isothermal amplification (LAMP) assay for rapid detection of hazelnut by targeting the internal transcribed spacer 2 gene. The qualitative method requires neither sophisticated analytical equipment nor antibodies, allowing an easy-to-use application with no ethical concern related to the use of animals. It demonstrated a limit of detection at or below 10 mg/kg hazelnut in various food matrices, making it also suitable for verifying hazelnut at levels of clinically relevant eliciting doses. Validation against proficiency test samples and testing of applicability with commercial food items confirmed its usefulness in processed foods. The simplicity of the method, including visual colorimetric detection, combined with high specificity and sensitivity, represents an advancement over existing qualitative methods.

The changing food allergen landscape in Europe calls for harmonised food allergen monitoring: Position paper

With the changing food allergen landscape in Europe, there is an increasing need for the monitoring of (non-)prepacked food products to improve the protection of consumers with food allergies. Although food allergy is a condition affecting up to 10 % of the consumers worldwide, a European harmonised approach for the management of precautionary allergen labelling, allergen reference doses, analytical methods or food product monitoring is not in place. This leads to limited food choices for consumers with food allergies but can also result in the occurrence of serious allergic incidents. The current state of non-harmonised and unregulated food allergen monitoring in Europe means risks and considerable costs for the individual consumer, but also for society in general. In this position paper, we argue for the introduction of harmonised guidelines for food allergen monitoring on the European level based on a discussion of the wide-ranging implications their lacking entails. We believe that there is a pressing need to update the European legislation on food allergens, including the introduction of harmonised monitoring programmes, which will lead to improved overall food safety, and better protection and options for consumers with food allergies.

Comparison of commercial DNA kits for allergen detection of celery in food matrices

For correct allergen risk management by industry, retail and food safety authorities, sensitive and reliable fast allergen detection methods are required, even more when precautionary allergen labelling based on reference doses will be implemented in legislation.This study aimed to perform a comparative assessment of three commercially available quantitative or qualitative test kits, for DNA analysis of celery in food products. Five product groups, representing different sectors of the AOAC food-matrix triangle, being (plant-based) meat products, snacks, sauces, dried herbs and spices, and smoothies, were identified to potentially contain celery. From each group, blank and incurred (labelled to contain celery) food products were selected, of which the blank food products were additionally spiked with low protein levels of celery prior to qPCR assessment.Results show that the assessed test kits perform according to their specifications, however, a clear influence of the matrix on the detection ability of celery was observed. In addition, quantification of the amount of celery in the different food products showed to be challenging in all food product groups using the two quantification kits.

Simulated use of thresholds for precautionary allergen labeling: Impact on prevalence and risk

Heterogeneity and overuse of precautionary allergen labelling (PAL) in prepackaged foods have eroded its risk communication efficacy. Experts recommend applying PAL based on allergen concentration thresholds, but adoption remains limited. The aim of this study was to quantitatively assess the potential impact of this approach using Monte Carlo risk simulations. Four allergens and 9 food categories were considered in 2 scenarios: (1) consumption of products currently carrying PAL in Canada where individuals with food allergy (FA) are assumed to consume them, and (2) consumption of products without PAL, in a hypothetical context where PAL is applied based on thresholds that would protect 99 % (ED01) and 95 % (ED05) of individuals with FA, and individuals with FA systematically avoid products with PAL. In scenario (1), although several cases studied would cause <10 reactions/10 000 eating occasions (e.o.), there were also many that would cause >20 reactions/10 000 e.o. Cross-contact milk posed the highest risk (max. 1120 reactions/10 000 e.o.), and peanut, the least (max. 10 reactions/10 000 e.o.). In scenario (2), consumption of products without PAL, when using thresholds for PAL based on ED01, could lead to a maximum of 15 reactions/10 000 e. o. for all studied cases, and based on ED05, to 57 (if excluding dark chocolate with milk PAL). In most cases, the estimated number of reactions per 10 000 e.o. attributed to products with PAL currently on the market would be higher (p < 0.05) than that attributed to products without PAL, if PAL is applied based on the simulated thresholds. Thus, a threshold driven approach to adopt PAL on prepackaged foods, while advising consumers to avoid these products, could be beneficial for individuals with FA in Canada, as products without PAL would result in very few and generally mild adverse reactions.

Development of a rapid and reliable method to simultaneously detect seven food allergens in processed foods using LC-MS/MS

Rapid analysis of multiple food allergens is required to confirm the appropriateness of food allergen labelling in processed foods. This study aimed to develop a rapid and reliable method to simultaneously detect trace amounts of seven food allergenic proteins (wheat, buckwheat, milk, egg, crustacean, peanut, and walnut) in processed foods using LC-MS/MS. Suspension-trapping (S-Trap) columns and on-line automated solid-phase extraction were used to improve the complex and time-consuming pretreatment process previously required for allergen analysis using LC-MS/MS. The developed method enabled the simultaneous detection of selected marker peptides for specific proteins derived from seven food ingredients in five types of incurred samples amended with trace amounts of allergenic proteins. The limit of detection values of the method for each protein were estimated to be <1 mg/kg. The developed analytical approach is considered an effective screening method for confirming food allergen labelling on a wide range of processed foods.

Techno-Functions and Safety Concerns of Plant-Based Peptides in Food Matrices.

Plant-based peptides (PBPs) benefit functional food development and environmental sustainability. Proteolysis remains the primary method of peptide production because it is a mild and nontoxic technique. However, potential safety concerns still emanate from toxic or allergenic sequences, amino acid racemization, iso-peptide bond formation, Maillard reaction, dose usage, and frequency. The main aim of this review is to investigate the techno-functions of PBPs in food matrices, as well as their safety concerns. The distinctive characteristics of PBPs exhibit their techno-functions for improving food quality and functionality by contributing to several crucial food formulations and processing. The techno-functions of PBPs include solubility, hydrophobicity, bitterness, foaming, oil-binding, and water-holding capacities, which subsequently affect food matrices. The safety and quality of foodstuff containing PBPs depend on the proper source of plant proteins, the selection of processing approaches, and compliance with legal regulations for allergen labeling and safety evaluations. The safety concerns in allergenicity and toxicity were discussed. The conclusion is that food technologists must apply safe limits and consider potential allergenic components generated during the development of food products with PBPs. Therefore, functional food products containing PBPs can be a promising strategy to provide consumers with wholesome health benefits.

Gluten migration from biodegradable food contact materials poses a risk to celiac disease patients

Due to the ban of certain single-use plastics in the European Union, food contact materials (FCM) from biobased and/or biodegradable polymers are increasingly being used. Some FCM are made from wheat or rye and therefore contain gluten, which is a food allergen and known to cause celiac disease. Legislation currently does not require allergen labelling on FCM and there is only some first information that gluten from FCM can migrate into gluten-free foods. Our aim was to analyze the extent of gluten migration from six different FCM into a variety of liquid and solid foods to assess the risk of exposure for wheat allergy and celiac disease patients. We show that the extent of gluten migration depended on the properties of the material, the liquid or solid food it comes into contact with and contact time. There was no clear effect of temperature or pH value. Of the six FCM studied, wheat bran-based plates had the highest potential to release gluten with concentrations of up to 203.0 mg/L of gluten in deionized water after 30 min. To protect patients, it is important to raise awareness of the risk of gluten migration from such FCM and help patients identify and avoid gluten-containing FCM. Further, legislation needs to be adapted urgently to include mandatory labelling of allergens on these biodegradable FCM.

Investigating Food Allergen Labeling in Commercially Packaged Food Products

Background: In 2017, Turkey introduced Turkish Food Codex Regulation on labeling and providing food information to customers, which has been revised on a regular basis ever since. The purpose of this study was to survey food allergen information regarding foods and beverages sold in Turkey and the extent to which food allergens and precautionary allergen labeling (PAL) are emphasized in the products. Method: Thirteen food and drink categories were reviewed in five physical food stores and three online stores. A total of 1,010 foods and beverages were checked for allergens according to their labels. Results: 1,116 allergenic foods were identified in 59.7% of foods and beverages,. Gluten-containing cereals were clearly labelled in every food category, and milk received the highest number of declarations (30.55%), followed by gluten (27.42%), and tree nuts (9.67%). Snacks contained the most number of allergens (14.8%), followed by dairy products (13.8%), and baked products (12.4%). Conclusions: Accurate and understandable food allergy labeling is essential in avoiding food allergies. Food allergy labeling legislation especially The EU Regulation No. 1169/2011 establishes uniform rules for allergen labeling, which is one of the most stringent food regulations in the world. Current allergen labeling restrictions and policies need to be improved to reduce the risk of food hypersensitivity.

Assessing precautionary allergen labeling management in China: A comprehensive analysis of unintended allergen presence and VITAL® 3.0 evaluation

Precautionary allergen labeling (PAL) is used to warn consumers about potential unintended allergen presence (UAP) due to cross-contact in food processing. This study aimed to reveal the UAP levels in food products with PAL and to assess the current implementation of PAL in China based on Voluntary Incidental Trace Allergen Labeling (VITAL®) 3.0 program. A total of 127 pre-packaged snack foods containing egg PAL and 114 pre-packaged snack foods containing milk PAL were collected through stratified random sampling in Nanchang, Jiangxi, China, for subsequent detection and analysis. ELISA analysis indicated that 18.11 % of products had egg protein and 29.82 % had milk protein at levels exceeding 2.5 ppm, with the majority of these positives concentrated in baked products. Meanwhile, high UAP levels in certain products, particularly those from small and micro manufacturers, posed a non-negligible allergy risk. VITAL® 3.0 assessments found that over 80 % of these products were deemed risk-free and did not require PAL. These findings highlighted that the current PAL approach in China led to excessive labeling which diminished information and value for consumers. Therefore, it is necessary to strengthen the risk assessment and management of cross-contact allergens in food industry, establish a PAL system to effectively communicate risks to consumers, and ultimately build a more robust food management framework in China.

Ratiometric Fluorescence Aptasensor of Allergen Protein Based on Multivalent Aptamer-Encoded DNA Flowers as Fluorescence Resonance Energy Transfer Platform.

Life-threatening allergic reactions to food allergens, particularly peanut protein Ara h1, are a growing public health concern affecting millions of people worldwide. Thus, accurate and rapid detection is necessary for allergen labeling and dietary guidance and ultimately preventing allergic incidents. Herein, we present a novel ratiometric fluorescence aptasensor based on multivalent aptamer-encoded DNA flowers (Mul-DNFs) for the high-stability and sensitive detection of allergen Ara h1. The flower-shaped Mul-DNFs were spontaneously packaged using ultralong polymeric DNA amplicons driven by a rolling circle amplification reaction, which contains a large number of Ara h1 specific recognition units and has excellent binding properties. Furthermore, dual-color fluorescence-labeled Mul-DNFs probes were developed by hybridizing them with Cy3- and Cy5-labeled complementary DNA (cDNA) to serve as a ratiometric fluorescence aptasensor platform based on fluorescence resonance energy transfer. Benefiting from the combined merits of the extraordinary synergistic multivalent binding ability of Mul-DNFs, the excellent specificity of the aptamer, and the sensitivity of the ratiometric sensor to avoid exogenous interference. The developed ratiometric aptasensor showed excellent linearity (0.05-2000 ng mL-1) with a limit of detection of 0.02 ng mL-1. Additionally, the developed ratiometric fluorescence aptasensor was utilized for quantifying the presence of Ara h1 in milk, infant milk powder, cookies, bread, and chocolate with recoveries of 95.7-106.3%. The proposed ratiometric aptasensor is expected to be a prospective universal aptasensor platform for the rapid, sensitive, and accurate determination of food and environmental hazards.

Perspectives in precautionary allergen labelling of prepackaged foods after the FAO/WHO consultation.

The purpose of this review is to provide an overview of the perspectives regarding precautionary allergen labelling (PAL) of prepackaged foods following the consultation conducted by the Food and Agriculture Organization (FAO) and the WHO. The FAO/WHO consultation provided a comprehensive assessment of the current status and practices of PAL implementation worldwide. One of the key findings highlighted by the Expert Committee was the need for improvement in existing PAL systems. It was noted that many countries lacked uniformity in PAL practices, leading to inconsistencies in labelling and potentially misleading information for consumers. Furthermore, the consultation emphasized the importance of PAL being risk-based, taking into account both the amount and frequency of unintended allergen presence (UAP) in food products. The FAO/WHO consultation shed light on various perspectives and challenges associated with PAL of prepackaged foods. Key findings emphasized the need for improvement in existing PAL systems, including the adoption of a risk-based approach, standardized regulations, and enhanced transparency. Moving forward, collaborative efforts between regulatory agencies, food manufacturers, and consumer advocacy groups will be essential in developing effective PAL strategies that prioritize consumer safety and well being.

Evaluation of food allergen information, labelling and unintended food allergen presence in imported prepacked foods and drinks purchased online in the UK

Consumers have wide access to global food and drink products online and in store that require food allergen information and labelling. Frequent food and drink product recalls occur UK and worldwide due to incorrect labelling of food allergens and their unintended or undeclared presence. This research aims to evaluate the accuracy and compliance of information and labelling of substances or products causing allergies or intolerances in prepacked food and drink products imported from Asia and purchased online in the UK. The current study assessed 768 randomly selected prepacked products classified into 16 separate product categories, representative of items from 12 countries in Asia, sourced from 8 UK retailers. When screened for precautionary allergen labelling (PAL), 173 (22.5%) items provided PAL, with 24 phrasings being identified. Upon comparing food allergen information on pack and online, 36 products (36.0%) transferred inconsistencies on pack to online pages and 15 (15.0%) were not consistent. Additionally, laboratory studies were performed to detect milk and peanut allergens in a sub-group of 77 products. Following analysis, 24 (31.2%) contained unintended food allergens, with levels ranging from 0.2 to 6780.0 mg/kg. Of these items, 9 products (37.5%) had a risk ratio ≥ 1 exceeding action levels produced with the VITAL® 3.0 ED01 reference doses, recommending PAL, though 7 (29.2%) were found without PAL. A further 10 products (13.0%) overused PAL and 2 products (2.6%) used PAL correctly. This research indicates further refinement of policies to ensure adequate, accurate, clear and current food allergen information and labelling of products.

Analysis of the results of study allergens in food in 2021

One of the biggest problems in the world is allergy, the clinical manifestations of which can be of varying degrees of severity – from dermatitis to Quincke's edema and anaphylactic shock. More than 250 million people suffer from food allergies. It has been scientifically proven that more than 70 food products can cause allergies. The main allergens are products of plant and animal origin, such as nuts, cereals, fish and seafood, eggs, etc. Celiac disease is one of the manifestations of allergy or individual intolerance to cereal plants. This genetic, autoimmune disease manifests itself due to the consumption of gluten-containing products occurs with a frequency of 1:3000. According to the current Ukrainian legislation, product manufacturers are obliged to indicate on the packaging of products information about the presence of food allergens, but very often they do not do this, misleading buyers and putting people who have such a problem at risk. Considering the above, there is a need to conduct state control of food products for the presence of allergens to control manufacturers regarding the labeling of allergens. The work aims to analyze the results of real-time state control of allergens in food products by PCR. The analysis of the studies of allergens in food products showed that 25.4 % contained allergens not indicated on the product packaging. This means insufficient control by manufacturers and severely violates current legislation. According to the results of the State Allergen Control Program, undeclared allergens were found in 25.4 % of food products from the total number of tested samples: in 9.3 % of sweets, 6.9 % of bakery products, 2.3 % of beverages, 6.9 % of precise products. Considering the urgency of the problem, there is a need to develop and implement a state program for monitoring allergens in food products in order to control the requirements of the current legislation.

Performance Evaluation of a Commercial Real-Time PCR Method for the Detection of Lupin Traces in Food.

In accordance with U.S. FDA Foods Program Regulatory Science Steering Committee guidelines, with this study, we optimized and validated a commercial real-time PCR method for the detection of low amounts of lupin in four classes of food matrices: chocolate cookies, ragù, Olivier salad, and barley and rice flour. DNA extracted from blank (true negative) samples artificially contaminated with lupin (Lupinus albus) flour at 1000 ppm underwent dilutions with the DNA extracted from the true negative samples up to 0.5 ppm. The limit of detection for real-time PCR was 0.5 ppm in the complex matrices (range, Ct 26-34), making this a specific, robust, and rapid method for lupin allergen detection and labeling. Our validation data support the suitability of this commercially available real-time PCR method for this purpose.

A reliable enzyme-linked immunosorbent assay for the determining of sesame proteins in raw food ingredients and in processed foods

Sesame is a frequent cause of adverse food reactions in allergic patients. We developed a novel sandwich enzyme-linked immunosorbent assay (ELISA) using two monoclonal antibodies and a unique extraction buffer for the detection and quantification of sesame proteins in processed foods and in raw food ingredients to clarify the validity of sesame labeling and for precautionary allergen labeling. The developed sandwich ELISA method is highly specific for sesame proteins. The limit of detection (LOD) and limit of quantification (LOQ) are 0.013 µg/g and 0.025 µg/g, respectively. The recoveries for incurred food samples, such as dressing, breads, sauce and pudding, ranged from 67 % to 81 %, while the repeatability and reproducibility coefficients of variation were less than 4.7 % and 4.5 %, respectively. The developed method has applicability for food products and is a reliable tool for the detection of hidden sesame proteins in raw food ingredients and in processed foods.

Sesame seed allergy.

In the US, sesame was recognized as the ninth major food allergen in 2021, underscoring the importance of updated allergen labeling to facilitate effective prevention plans and anaphylaxis response. This article discusses the prevalence of sesame seed allergy among children in the US and outlines strategies for nurses to understand the assessment, treatment, and education of patients regarding this allergen.

Comprehensive Epitope Analysis of Monoclonal Antibodies Binding to Hen Egg Ovalbumin Using a Peptide Array

Food allergies are a significant health issue worldwide. In many countries, labeling of primary allergens in food products has been made mandatory to ensure consumer safety. In food manufacturing settings, the lateral flow immunoassay (LFI)—based on antigen–antibody reactions—is a rapid and accurate method for allergen testing and is widely used. Peptide arrays are tools that enable the synthesis of peptides of any sequence on a substrate and high-throughput analysis of their interactions with chemicals. This study aimed to investigate a new application of peptide arrays in the field of food technology, particularly in the development of antibodies for food allergen testing. First, monoclonal antibodies against hen egg ovalbumin, a major food allergen, were produced. Then, using a peptide array, the epitope and specificity of the antibodies were comprehensively and precisely analyzed. Finally, an LFI kit incorporating the antibodies demonstrated both high specificity and detection sensitivity for food allergen testing. These findings indicate that peptide arrays are valuable tools in the development of antibodies for food allergen testing, ensuring reliability and accuracy at the molecular level.

Precautionary Allergen Labeling: Avoidance for All?

Precautionary allergen labeling (PAL) suggests the risk of unintended allergen presence (UAP) in food but is unregulated in most countries and inconsistently applied by food manufacturers. This review evaluates the current use of PAL, its relevance to allergic consumers, and weighs possible advantages and disadvantages of avoiding products with PAL. In most countries, manufacturers are free to decide whether, when, and how to apply PAL resulting in inconsistencies and consumer confusion. Patients with food allergy often interpret PAL incorrectly and without guidance from their health care providers. Health care providers are also prone to misinterpreting PAL, indicating a need for better education. Consumers desire guidance on whether to avoid products with PAL or not. Until further regulatory guidance is available, shared decision-making between patient and provider is required to offer individualized, rather than one-size-fits-all, approaches to PAL.

Lateral Flow Immunochromatographic Assay for Competitive Detection of Crustacean Allergen Tropomyosin Using Phage-Displayed Shark Single-Domain Antibody.

The common food allergy crustacean tropomyosin (TM) poses a significant food safety challenge, which requires rapid and sensitive methods for screening TM in food. Herein, the variable new antigen receptor (VNAR) single-domain antibodies specific for the crustacean TM were isolated from a naïve phage-displayed shark VNAR library. Subsequently, a lateral flow immunochromatographic assay (LFIA) based on the gold nanoparticle-labeled phage-displayed shark VNAR (AuNPs@PSV) probe was developed for the detection of TM in food. The AuNPs@PSV-LFIA took 15 min for one test and had a visual limit of detection (vLOD) of 0.1 μg/mL and an instrumental LOD of 0.02 μg/mL. Good selectivity, accuracy, precision, and stability were confirmed for the AuNPs@PSV-LFIA. Moreover, the test results of 21 commercially available food products consisted of the allergen labels and were validated by a commercial ELISA kit. Therefore, this work demonstrated the great potential of VNAR for detecting TM in food by LFIA.