Precautionary Allergen Labelling Research Articles

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.

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.

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.

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.

Allergen and precautionary allergen labeling of packaged foods in Türkiye

Allergen and precautionary allergen labeling of packaged foods in Türkiye

Rethinking precautionary allergen labelling – Threshold doses, risk assessment approaches and analytical implications

AbstractFood allergies became a major public health and food safety interest in the past decades as their prevalence is increasing, and their only available treatment is a strict elimination diet that necessitates appropriate food labelling regulations. While such regulations are available worldwide, most of them are not taking into account inadvertent allergen cross-contamination and they usually do not define threshold doses that could support the industry in their endeavour to provide reliable food labels for allergic consumers. This resulted in the proliferation of the “may contain” type precautionary allergen labelling (PAL), which is voluntary and is intended to warn consumers for potential unintended contamination with an otherwise undeclared allergen. As this kind of labelling is hardly ever based on actual risk assessment, it puts both the industry and the consumer into a difficult position. A promising tool towards the solution of this problem could be allergen threshold doses based on clinical data, which are becoming increasingly available. This review intends to present this process, the new ways of improved risk assessment it opens, and its implications for food analysis.

Clinically and industrially relevant incurred reference materials to improve analysis of food allergens, milk, egg, almond, hazelnut and walnut

Measurement of food allergen protein concentrations against thresholds can improve allergen risk management and precautionary allergen labelling. Such measurement suffers well known problems which could be ameliorated by well characterised reference materials (RMs) providing meaningful information for risk assessors. We investigated the preparation and characterisation of the first consensus informed industrially and clinically relevant multi-allergen matrix RM kit for five priority allergens. It is a medium analytical difficulty processed food chocolate paste matrix (a) devoid of allergens, and (b) incurred with five allergens at the clinically relevant concentration of 10 mg kg−1 expressed as protein. The allergen raw materials: hens’ egg white powder, skimmed cows’ milk powder, almond powder (full fat), hazelnut powder (partially defatted), and walnut powder (partially defatted), are also available as RMs. The preparation, gravimetric traceability to the SI, homogeneity, and stability were found to be fit-for-purpose and the RMs are now available to the analytical community.

Reactivity to allergenic food contaminants: A study on products on the market.

The frequency and severity of reactions in food-allergic consumers exposed to unintentional food allergen contamination during production is unknown. To warn allergic consumers, it has been suggested for pre-packaged foods to be precautionary labelled when the food allergen contamination may exceed the amount to which 1%-5% of the population could react (ED01-ED05). ED01 for hazelnut and milk have been estimated at 0.1 and 0.2mg, respectively, by the Voluntary Incidental Trace Allergen Labelling (VITAL) initiative. The respective reference doses recommended by the FAO/WHO Codex consultation are 3 and 2mg. We evaluated the reactivity to potential traces of milk and hazelnut allergens in allergen-free pre-packaged products by children affected by severe allergies to milk and hazelnuts. Oral Food Challenges with commercially available hazelnut-free wafer biscuits and milk-free chocolate pralines were administered to patients with severe food allergies to hazelnut and cow's milk, respectively. Contamination levels of milk or hazelnut allergens were measured using chromatographic separation interfaced with triple quadrupole mass spectrometry. No hazelnut allergic patient showed allergic reactions to exposure to biscuits, nor any milk allergic patient displayed allergic reactions to the dark chocolate praline. While no hazelnut trace was detected in biscuits, the praline was found to be contaminated by milk at concentrations ranging between 8 and 35mg total protein/kg food. In our dose model, these amounts exceeded 1.5-10 times the VITAL ED01 and reached the threshold suggested by the FAO/WHO Codex consultation. Upon the consumption of food products available on the market, many patients with severe food allergies tolerate significantly higher doses of allergen than reference doses indicated in the VITAL system used for precautionary allergen labelling. These doses support the safety of the FAO/WHO recommended reference doses.

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.

Precautionary allergen labeling: Current communication problems and potential for future improvements

Precautionary allergen labeling: Current communication problems and potential for future improvements

Precautionary Allergen Labeling: What Advice Is Available for Health Care Professionals, Allergists, and Allergic Consumers?

Precautionary Allergen Labeling: What Advice Is Available for Health Care Professionals, Allergists, and Allergic Consumers?

Accidental allergic reactions to food in adolescents and adults: An overview of the factors involved and implications for prevention.

Accidental allergic reactions to food are one of the major problems in adult patients diagnosed with food allergy. Such reactions occur frequently, are often severe and are associated with higher medical and non-medical costs. The aim of this Perspective is to provide insight into the different factors involved in the occurrence of accidental allergic reactions and to present an overview of practical implications for effective preventive measures. Several factors affect the occurrence of accidental reactions. These factors are related to the patient, health care, or food. The most important patient-related factors are age, social barriers to disclosing their allergy and non-adherence to the elimination diet. With regards to healthcare, the degree to which clinical practice is tailored to the individual patient is an important factor. The major food-related factor is the absence of adequate precautionary allergen labeling (PAL) guidelines. Since many factors are involved in accidental allergic reactions, different preventive strategies are needed. It is highly recommended that health care be tailored to the individual patient, with regard to education about the elimination diet, support on behavioral and psychosocial aspects, usage of shared decision-making and taking into account health literacy. In addition, it is crucial that steps are taken to improve policies and guidelines for PAL.

Knowledge, Attitudes, and Practices of Consumers on Food Allergy and Food Allergen Labeling: A Case of Lebanon.

The epidemiology of food allergies is increasing worldwide. International labeling standards were developed to enhance consumers' awareness of allergen-free foods. The main objective of the present study is to assess the characteristics of allergen labeling and consumers' knowledge, attitudes, and purchasing habits of food products with allergens in Lebanon. We evaluated the allergen labeling of 1000 food products form Lebanese supermarkets. A random sample of 541 consumers was recruited through an online survey (November 2020-February 2021). Descriptives and regression analysis were conducted. Results showed that wheat represents the largest group of food allergens on food labels, followed by milk and soybean. Furthermore, 42.9% of supermarket food products had a precautionary allergen labeling with "may contain traces of allergens". The majority of food products complied with local regulations for locally manufactured and imported products. One-quarter of survey respondents had a food allergy or were caregivers of food-allergic individuals. Regression analyses showed that "previous experience of a severe reaction" was negatively associated with food allergy-related knowledge and attitude scores respectively (β = -1.394, 95% CI: (-1.827, -1.034) and β = -1.432, 95% CI: (-2.798, -0.067)). The findings of this study provide practical insights on food allergy labeling issues for stakeholders and policymakers in the food supply chain.

Socioeconomic and Clinical Factors Associated with Knowledge and Approach to Precautionary Allergen Labeling (PAL) in Food Allergy

Caregivers may take different approaches to heeding PAL for children with food allergy (FA). There are limited data on knowledge and response to PAL labeling among those with different socioeconomic status (SES), education level, or time since diagnosis.

Simulated Use of Thresholds for Precautionary Allergen Labelling in the Canadian Food Market: Impact on Prevalence and Risk

Allergen avoidance warrants accurate food labelling. The lack of requirements for the use of precautionary allergen labelling (PAL) by food manufacturers limits allergic consumers’ food choices. Allergen thresholds based on population eliciting doses (ED) could standardize the use of PAL and reduce its occurrence in the Canadian food market.

Bayesian statistics and modeling approaches for estimating allergic reactions to foods and evaluating quantitative risk assessment in Japan

Japan is one of the few countries that legally prohibits precautionary allergen labelling (PAL) by establishing official methods for detecting the protein of allergenic ingredients (allergens) and setting the threshold of protein content for the national labeling system. This study was conducted to develop the quantitative risk-assessment methods for allergic-reactions to foods containing allergenic ingredients and to verify the validity of the evaluation criteria of Japan's food allergy-labeling system.

Precautionary Allergen Labeling: What Advice Is Available for Health Care Professionals, Allergists, and Allergic Consumers?

In most countries, the use of precautionary allergen labelling (PAL) is not governed by regulation. PAL was initially identified as a judicious risk management measure to address instances of « unavoidable » cross-contact with priority food allergens during food processing. However, PAL has gradually been devalued, in part due to overuse and inconsistent application by the food industry. Currently, most food products do not contain detectable allergen residue or contain only low concentrations of residue of the allergens declared using PAL; however, occasionally high concentrations of allergen residue are reported, rendering it an ineffective risk communication tool for allergic consumers. In this context, several reasons exist which make the consumption of products bearing a PAL statement not advisable for people with food allergies. The main reason is that the risk is generally not correlated with the statement used by manufacturers. Due to the increased use of PAL on prepackaged food products, and in order to maximize food choices for allergic individuals, healthcare professionals increasingly advise some patients considered to be "not highly allergic" to consume products bearing a PAL statement. This article explains why consumption of products with PAL is not advisable without having a full clinical evaluation and knowledge that an allergen risk assessment has been conducted. It also discusses the perspectives for a better use of PAL on the basis of the recent FAO/WHO recommendations on food allergens.

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.