Electrochemical immunosensor for point-of-care detection of soybean Gly m TI allergen in foods.

Soybean is a legume with high technological functionality, commonly used by the food industry as an ingredient in different products. However, soybean is an allergenic food whose undeclared presence in processed foods may represent a public health risk. In this work, it was developed an efficient electrochemical immunosensor, targeting the soybean trypsin inhibitor (Gly m TI) allergen using commercial anti-Gly m TI IgG, aiming at detecting/quantifying minute amounts of soybean in different food formulations. For this purpose, model mixtures of different foods (sausages, cooked-hams, biscuits) were prepared to contain known amounts of soybean protein isolate (100,000-0.1 mg kg-1) and submitted to specific thermal treatments (autoclaving, oven-cooking, baking). The electrochemical immunosensor allowed quantifying down to 0.1 mg kg-1 of soybean in the three food matrices, raw and processed (0.0012 mg of Gly m TI/kg of matrix). Accordingly, the immunosensor is suitable for detecting traces of soybean in raw, processed, and complex foods, thus protecting 99 % of soybean-allergic patients.

The 50th percentile of the general population single eating occasion intake of food is optimal for the calculation of action levels for precautionary allergen labelling.

Lack of guidance regarding selection of food intake values for allergen risk assessment can lead to different outcomes for similar levels of allergens in food products. Several food consumption survey databases (United States, North-West Europe, and Netherlands) were analyzed to identify optimal food intake percentiles using a sensitivity analysis. Deterministic risk assessment scenarios using the 50th percentile up to the maximum intake per food group were compared with probabilistic risk assessment outcomes. The optimal intake percentile is the lowest percentile that results in a deterministic risk assessment outcome compliant with the predefined safety objective, i.e., the predefined risk of an objective allergic reaction at ED01, ED2.5, ED05 or ED10 doses of 14 allergenic foods. The P50 intake met these criteria in more than 99.9% of all 28,784 scenarios tested. The P50 is therefore recommended for deterministic allergen risk assessment and calculation of action levels for precautionary allergen labelling. In case a P50 value is not available, the mean is a good alternative, as analyses of the intake data showed that the mean generally is between the P50 and P65.

Allergen management under a voluntary PAL regulatory framework - A survey of Canadian food processors.

Canadian regulations require food business operators (FBOs) to implement preventive controls to manage allergens and ensure their accurate declaration. However, the use of precautionary allergen labelling (PAL) is voluntary and competent authorities provide limited guidance on its use. The objective of this study was to present an overview of Canadian FBOs' current allergen management practices, including the mechanisms used to evaluate the need for PAL in finished products, and to investigate potential areas for improvement. Canadian FBOs were invited to answer an online survey of 48 questions covering allergen management practices and perceptions. Eighty-four full survey responses (margin of error of 9% at a 90% confidence level) were obtained. Differences in responses to multiple choice questions per company size were determined using chi-square and Fisher's exact tests. Kruskal-Wallis tests were used to analyse responses to rating or forced ranking questions. Survey respondents' allergen management practices were based on a combination of recognized best practices, third-party quality systems' standards, and regulatory requirements. Concerning practices related to the criteria used to reach PAL decisions were noted, which could be addressed with increased awareness and use of risk-based approaches and a clearer regulatory policy. Analytical testing applicability and interpretation, access to information on unintentional allergen presence in raw materials, and clarity on the expectations related to the current regulatory framework on food allergens and its enforcement, were identified as challenges faced by Canadian FBOs. The results of this survey and its analysis could be used by regulators - to inform potential policy changes, by FBOs - to map industry practices, and by allergic consumers - to better understand how manufacturers manage allergens in their operations.

Sensitivity analysis to derive a food consumption point estimate for deterministic food allergy risk assessment.

One of the input parameters in food allergy risk assessment is the amount of a given food consumed at an eating occasion. There is no consensus on how to use food consumption data when assessing the risk from unintended allergen presence in food products. A sensitivity analysis was performed to establish the optimal food consumption estimate for a deterministic food allergy risk assessment. Exposure was calculated for consumption percentiles (50th percentile, P50 to maximum) using the iFAAM consumption database in conjunction with an allergen concentration range from 1 to 1000 ppm. The resulting allergen intakes were compared to the allergic population reference doses proposed by Taylor et al. (2014) for 10 major allergenic foods. Optimal consumption percentiles were defined as those which predicted an intake below the relevant reference dose and met the defined acceptable risk level confirmed by probabilistic risk assessments. Analysis showed that, for 99% of the food groups, the P50 consumption met our criteria, while the P75 did so for 100% of the food groups. We suggest that the P75 is the optimal point estimate for use in deterministic food allergy risk assessment. It meets the safety objective and is adequately conservative for a public health context.

Accidental food allergy reactions: Products and undeclared ingredients.

BACKGROUND: Accidental allergic reactions to food are frequent and can be severe and even fatal. OBJECTIVE: We sought to analyze the culprit food products and levels of unexpected allergens in accidental reactions. METHODS: A prospective cohort study was conducted in adults (n = 157) with a physician-confirmed diagnosis of food allergy. During a 1-year follow-up, 73 patients reported accidental allergic reactions and the culprit food products. Food samples received (n = 51) were analyzed for a wide range of suspected noningredient allergens, and risk was quantified. RESULTS: A very diverse range of food products was responsible for the unexpected allergic reactions. Thirty-seven percent (19/51) of products analyzed had 1 to 4 culprit allergens identified that were not supposed to be present according to the ingredient declaration. Concentrations varied from 1 to 5000 mg of protein of the allergenic food per kilogram of food product and were greatest for peanut, milk, and sesame. Milk proteins posed the highest estimated risk for objective allergic reactions. The intake of culprit allergens by patients varied considerably. For those cases in which culprit allergens were detected, the intake of at least 1 allergen exceeded the reference dose or a culprit allergen with a yet unknown reference dose was present. Both patient neglect of precautionary allergen labeling statements and omission of using a precautionary allergen labeling statement by food manufacturers seem to contribute to accidental reactions. CONCLUSION: A wide range of food products are causing accidental reactions in patients with food allergy. Eight different allergens not declared on the ingredient lists were detected in the culprit food products, all of which were representative of allergens regulated in the European Union.

Using the Systems-Practice Framework to Understand Food Allergen Management Practices at College Catering Operations: A Qualitative Study.

BACKGROUND: The number of individuals with food allergies or intolerances attending catered university residential colleges is increasing, and safe dining options are required to minimize the risk of allergic reactions and food-induced death. OBJECTIVE: This qualitative research study sought to advance professional knowledge of the factors affecting allergen management practices, particularly pertaining to college foodservices. DESIGN: Three catered residential colleges affiliated with a major university in New Zealand were selected as research sites. The study used an ethnographic approach and systems-practice theory as a framework for data collection and organizing results. Data collection techniques included document analyses (3 hours per site), observations (6 to 8 hours per site), focus groups with foodservice workers (30 to 45 minutes per site, n=16), and interviews with foodservice managers (45 to 90 minutes per interview, n=5). Notes and transcripts were coded through the process of thematic analysis using NVivo for Mac software, version 11.1.1, to identify factors affecting allergen management practices. RESULTS: The main factors affecting allergen management practices at college foodservices included information provided by residents about dietary requirements; communication between residents and foodservice staff; systems for allergen management; attitude of foodservice staff; and college size. CONCLUSIONS: Detailed dietary information, effective communication with residents, sufficient resources, clarification of responsibilities, and thorough systems are required for staff to perform safe allergen management practices. Ultimately, successful implementation was predominantly determined by staff attitude. Foodservice managers are advised to identify motivators and address barriers of staff attitudes toward allergen management practices to promote successful implementation.

[Allergen management in the food industry]. / Allergenmanagement in der Lebensmittelindustrie.

Due to the lack of causative immunotherapies, individuals with food allergies have to rely on correct labelling for even minute amounts of allergenic constituents. It is not relevant to the allergic whether the source of the culprit food is an ingredient or an allergen that entered the food unintentionally, as is the case with so-called cross-contacts or hidden allergens.Efficient allergen management is the manufacturer's prerequisite for coping with allergenic foods in the food production environment and handling them in a way that avoids cross-contact. If it is technically not feasible to eliminate cross-contacts entirely, it must be ensured that these cross-contacts do not enter the final product without being detected.This article discusses measures that should be considered in allergen management. Examples include recording all relevant allergens in the production facility, staff sensitization and training, and taking into account all areas of production from incoming raw materials to outgoing goods.For the evaluation of unavoidable cross-contacts, it is possible today to draw on data from clinical trials for many of the substances that are subject to labelling. This data can be used to assess the risk of the final product.However, the data from threshold studies is not legally binding, so it is left to the manufacturer to assess the level up to which the food is safe for the allergic. In particular the non-harmonized approach of the EU member countries' food safety authorities currently represents a major obstacle, as this can lead to food recalls even though existing levels were evaluated as being safe according to the risk assessments performed.