Precautionary Allergen Labeling: Avoidance for All?

PURPOSE OF REVIEW: 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. RECENT FINDINGS: 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.

Habits and Perspectives on Reading Allergy Food Labels of Parents of Children with Food Allergies.

Study Objective: Food allergy is an essential growing public health concern that affects the quality of life of children and their parents. This study aimed to identify the parents' awareness and daily practice about food labels and allergy warnings on packaged foods. Materials and Methods: The study investigated the parents of children with food allergies who applied to the pediatric allergy outpatient clinic between October 01, 2020 and March 30, 2021. A total of 106 questionnaires were collected and statistically analyzed. Results: One hundred six parents with an average age of 31.6 ± 5.17 years were questioned. Most of the participants were mothers (88.7%). The most common food allergens observed in children were hen's egg (75%), cow's milk (56%), nuts (24.5%), peanuts (19.8%), walnuts (11.3%), and wheat (10.4%). Of the children, 39.6% rarely consumed packaged products, and the proportion of children who did not consume packaged products at all was 32.1%. All parents reported that they read the labels. Of them, 65.1% stated that allergy food labels were inadequate and it could be more noticeable if symbols (53.6%) or bold text (39.1%) were used for labeling. Conclusion: This study shows that parents with a diagnosis of food allergy in their child were highly aware of labels that indicate the content of the product. However, they thought that food labels are insufficient in scope and shape and needed to be improved. Parents preferred allergen labels with both symbols and bold text.

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

In most countries, the use of precautionary allergen labeling (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 that 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. Because of the increased use of PAL on prepackaged food products, and to maximize food choices for allergic individuals, health care professionals increasingly advise some patients considered to be "not highly allergic" to consume products bearing a PAL statement. This article explains why the 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 Food and Agricultural Organization/World Health Organization recommendations on food allergens.

Precautionary Allergen Labelling in Serbia: Market Audit and Consumers' Perception.

Background: Precautionary allergen labels (PAL) should be used to indicate the possibility of allergen presence in the food. This study aimed to determine the prevalence and types of precautionary labeling statements on different pre-packaged food products in retail stores in Belgrade, Serbia, as well as to assess consumers' attitudes and behavior towards PAL statements. Methods: This was a descriptive study. The following characteristics of 1404 pre-packaged foods were analyzed: prevalence of PAL, listed food allergens on PAL, and the types of the advisory terminology. In the group of 275 participants (94 with food allergies, and 181 persons who purchasing food for a household member with food allergy) reading practice of PAL, purchasing practice based on PAL, and the opinion about PAL statements credibility were evaluated. Results: Overall, 33.9% of products had precautionary statements for one or more allergens. "Tree nuts" were the most common allergens listed in the PAL. The most common type of PAL was "May contain traces of x [allergen]" (52.7%). The PAL was always read by half of the participants. Less than half (43.3%) of the participants incorrectly believed that PAL is regulated by national law. A quarter of participants thought that the PAL statements are trustworthy. Conclusion: PAL statements frequently are not user-friendly and are not providing sufficient protection for food allergic patients. To gain buyers' confidence, protect health and provide security, the necessity for the strategies that would regulate PAL by the law exists.

Reproducibility of food challenge to cow's milk: Systematic review with individual participant data meta-analysis.

BACKGROUND: Cow's milk (CM) is an increasingly common cause of severe allergic reactions, but there is uncertainty with respect to severity of reactions at low-level CM exposure, as well as the reproducibility of reaction thresholds. OBJECTIVE: We undertook an individual participant data (IPD) meta-analysis of studies reporting double-blind, placebo-controlled food challenges in CM to determine the rate of anaphylaxis to low-level exposures and the reproducibility of reaction thresholds. METHODS: We performed a systematic review and IPD meta-analysis of studies reporting relevant data. Authors were contacted to provide additional data and/or clarification as needed. Risk of bias was assessed using the National Institute for Clinical Excellence methodologic checklists. RESULTS: Thirty-four studies were included, representing data from over 1000 participants. The cumulative ED01 and ED05 (cumulative doses causing objective symptoms in 1% and 5% of the at-risk allergic population) were 0.3 (95% confidence interval [CI], 0.2-0.5) and 2.9 (95% CI, 1.6-5.4) mg, respectively. At meta-analysis, 4.8% (95% CI, 2.0-10.9) and 4.8% (95% CI, 0.7-27.1) of individuals reacting to ≤5 mg and ≤0.5 mg of CM protein had anaphylaxis (minimal heterogeneity, I2 = 0%). Then 110 individuals underwent repeat double-blind, placebo-controlled food challenges; the intraindividual variation in reaction threshold was limited to a ½-log change in 80% (95% CI, 65-89) of participants. Two individuals initially tolerated 5 mg CM protein but then reacted to this dose at a subsequent challenge, although neither had anaphylaxis. CONCLUSIONS: About 5% of CM-allergic individuals reacting to ED01 or ED05 exposure might have anaphylaxis to that dose. This equates to 5 and 24 anaphylaxis events per 10,000 patients exposed to an ED01 or ED05 dose, respectively, in the broader CM-allergic population. Most of these anaphylactic reactions would be mild and respond to a single dose of epinephrine.

Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis.

Regional and national legislation mandates the disclosure of "priority" allergens when present as an ingredient in foods, but this does not extend to the unintended presence of allergens due to shared production facilities. This has resulted in a proliferation of precautionary allergen ("may contain") labels (PAL) that are frequently ignored by food-allergic consumers. Attempts have been made to improve allergen risk management to better inform the use of PAL, but a lack of consensus has led to variety of regulatory approaches and nonuniformity in the use of PAL by food businesses. One potential solution would be to establish internationally agreed "reference doses," below which no PAL would be needed. However, if reference doses are to be used to inform the need for PAL, then it is essential to characterize the hazard associated with these low-level exposures. For peanut, there are now published data relating to over 3000 double-blind, placebo-controlled challenges in allergic individuals, but a similar level of evidence is lacking for other priority allergens. We present the results of a rapid evidence assessment and meta-analysis for the risk of anaphylaxis to a low-level allergen exposure for priority allergens. On the basis of this analysis, we propose that peanut can and should be considered an exemplar allergen for the hazard characterization at a low-level allergen exposure.

Using data from food challenges to inform management of consumers with food allergy: A systematic review with individual participant data meta-analysis.

BACKGROUND: Eliciting doses (EDs) (eg, ED01 or ED05 values, which are the amounts of allergen expected to cause objective symptoms in 1% and 5% of the population with an allergy, respectively) are increasingly being used to inform allergen labeling and clinical management. These values are generated from food challenge, but the frequency of anaphylaxis in response to these low levels of allergen exposure and their reproducibility are unknown. OBJECTIVE: Our aim was to determine (1) the rate of anaphylaxis in response to low-level peanut exposure and (2) the reproducibility of reaction thresholds (and anaphylaxis) at food challenge. METHODS: We conducted a systematic review and individual participant data meta-analysis of studies that reported at least 50 individuals with peanut allergy reacting to peanut at double-blind, placebo-controlled food challenge (DBPCFC) and were published between January 2010 and September 2020. Risk of bias was assessed by using National Institute for Clinical Excellence methodologic checklists. RESULTS: A total of 19 studies were included (covering a total of 3151 participants, 534 of whom subsequently underwent further peanut challenge). At individual participant data meta-analysis, 4.5% (95% CI, 1.9% to 10.1%) of individuals reacted to 5 mg or less of peanut protein with anaphylaxis (moderate heterogeneity [I2 = 57%]). Intraindividual thresholds varied by up to 3 logs, although this variation was limited to a half-log change in 71.2% (95% CI, 56.2% to 82.6%) of individuals. In all, 2.4% (95% CI, 1.1% to 5.0%) of patients initially tolerated 5 mg of peanut protein but then reacted to this dose at subsequent challenge (low heterogeneity [I2 = 16%]); none developed anaphylaxis. CONCLUSION: Around 5% of individuals reacting to an ED01 or ED05 level of exposure to peanut might develop anaphylaxis in response to that dose. This equates to 1 and 6 anaphylaxis events per 2500 patients exposed to an ED01 or ED05 dose, respectively, in the broader population of individuals with peanut allergy.

Understanding Precautionary Allergen Labeling (PAL) Preferences Among Food Allergy Stakeholders.

BACKGROUND: Food allergy (FA) is an increasing public health concern in the United States, affecting approximately 8% of children and 11% of adults. The United States currently lacks clear requirements for the use of precautionary allergen labeling (PAL) on packaged foods, such as "may contain" or "made on shared equipment." This lack of specific governmental policy results in inconsistent labeling practices and confusion. OBJECTIVE: This study aimed to understand current knowledge and preferences for PAL statements among FA stakeholders. METHODS: A cross-sectional survey was sent to FA stakeholders. Descriptive statistics and associations from logistic regressions were used to assess respondents' knowledge of PAL policy, shopping habits, and preferences around PAL. RESULTS: Of 3008 respondents, 24.2% were able to correctly answer 4 questions surrounding PAL policies. When asked about their shopping habits, the majority of respondents never purchase products with a "May contain traces of allergen" label (85.5%) in comparison with never purchasing products with a "Good manufacturing practices used to segregate ingredients in a facility that also processes allergen" label (35.0%). Their top preferences for a PAL statement were "Not suitable for people with 'blank' allergy" (29.3%) and "May contain" (22.1%). Health care provider discussions around PAL varied and were strongly associated with purchasing behaviors. CONCLUSIONS: These results suggest that FA consumers are not aware of PAL policies and make decisions based on the words in the PAL. They prefer having clearer, more specific, and consistent labeling on products, indicating that explicit PAL policies are needed to allow customers to easily identify safe foods.

Can my child with IgE-mediated peanut allergy introduce foods labeled with "may contain traces"?

Peanut IgE-mediated food allergy is one of the most common food allergies in children with a prevalence that has increased in the past decades in Westernized countries. Peanut allergies can trigger severe reactions and usually persist over time. Peanut-allergic children and their families are often confronted to processed foods with precautionary allergen labeling (PAL) such as "may contain traces of peanuts," which are frequently used by the food industry. Patients are generally confused as to whether eating such foods entails a risk of allergic reaction, which can ultimately lead to dietary restrictions and decreased quality of life. Thus, guidance toward eviction of foods with PALs such as "may contain traces of peanuts" is a recurring problem that peanut-allergic patients address during pediatric allergy consultations with varying attitudes among allergists. Many studies have evaluated peanut contamination in foods with PALs, with generally less than 10% of foods containing detectable levels of peanuts, albeit heterogeneous amounts, with in rare occasions levels that could trigger allergic reactions in certain patients. The risk of reacting to foods with traces varies significantly with threshold, with patients with the lowest reaction thresholds at highest risk, and a dramatic reduction of risk as threshold increases. Thus, risk stratification based on individual reaction threshold may help stratify patients' risk of reacting to foods with PAL. In clinical practice, a single-dose 30 mg peanut protein oral food challenge may be an option to stratify peanut-allergic patients' risk when introducing foods with PAL, as illustrated by three clinical cases.

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.

Economic Factors Impacting Food Allergen Management: Perspectives from the Food Industry.

Food allergies affect up to 8% of children in the United States and may occasionally lead to severe life-threatening reactions. Because there is currently no cure for food allergies, strict avoidance of the allergen-containing foods is the only means of preventing an allergic reaction. Consumers rely on food manufacturers to reliably track and declare the presence of food allergens in products. Over the past 10 to 20 years, the food industry has increasingly adopted allergen control approaches in its processing facilities. However, the major industry costs related to food allergen management have not been fully described. The objective of this study was to characterize the factors that contribute to the economic impact of food allergen control practices on the food industry. A focus group (n = 100) was conducted with food industry professionals to identify key areas of cost for food allergen management. A survey based on the domains identified was then developed and disseminated to a convenience sample (n = 50) of quality control food industry specialists with knowledge of their company's food allergen management practices. Nearly all companies (92%) produced food products containing one or more of the top eight allergenic foods recognized by the U.S. Food and Drug Administration or sesame seeds. Cleaning procedures, employee training, and the potential for a recall due to allergen cross-contact were most frequently rated as the important factors in food allergen management. Recalls due to food allergen cross-contact, cleaning procedures, equipment and premises design, and employee training were ranked as the greatest allergen management expenses. Although 96% of companies had a food allergen control plan in place, nearly half (42%) had at least one food allergen-related recall within the past 5 years. The industry appears to endorse a willingness to unify precautionary allergen labeling to communicate a clear message more effectively to consumers.

Assessing food allergy risks from residual peanut protein in highly refined vegetable oil.

Refined vegetable oils including refined peanut oil are widely used in foods. Due to shared production processes, refined non-peanut vegetable oils can contain residual peanut proteins. We estimated the predicted number of allergic reactions to residual peanut proteins using probabilistic risk assessment applied to several scenarios involving food products made with vegetable oils. Variables considered were: a) the estimated production scale of refined peanut oil, b) estimated cross-contact between refined vegetable oils during production, c) the proportion of fat in representative food products and d) the peanut protein concentration in refined peanut oil. For all products examined the predicted risk of objective allergic reactions in peanut-allergic users of the food products was extremely low. The number of predicted reactions ranged depending on the model from a high of 3 per 1000 eating occasions (Weibull) to no reactions (LogNormal). Significantly, all reactions were predicted for allergen intakes well below the amounts reported for the most sensitive individual described in the clinical literature. We conclude that the health risk from cross-contact between vegetable oils and refined peanut oil is negligible. None of the food products would warrant precautionary labelling for peanut according to the VITAL® programme of the Allergen Bureau.

[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.