Precautionary Allergen Labelling Research Articles

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.

EXPLORING PARENTAL INTEREST IN IDENTIFYING THE ELICITING DOSE OF PEANUT FOR THEIR PEANUT ALLERGIC CHILD

<h3>Introduction</h3> The eliciting dose (ED) of a food allergen, or minimum dose at which a patient is likely to react, is increasingly being used to inform precautionary allergen labeling (PAL), assess individual risk, and improve management of food allergies. However, conducting a low-dose oral food challenge to determine a patient's ED is not commonly done as part of the diagnostic work-up. Limited literature exists on parental desire to know their food-allergic child's ED. <h3>Methods</h3> We performed a prospective survey of parents with peanut-allergic children to determine their interest in performing a single-dose 10mg peanut challenge and explore variables that may be related to their interest. <h3>Results</h3> Parents of 51 peanut-allergic children were surveyed to date. Demographics of children are as follows: 62% male, 59% African American, median age of 7 years, 73% were insured by Medicaid, and 76% reported other food allergies. 69% reported avoiding foods with PAL for peanut allergy. Of all respondents, 69% reported interest in performing a one-time 10mg challenge to peanut (understanding peanut content in products with PAL likely contain less than 1mg of peanut). No variable correlated with interest in performing the challenge. <h3>Conclusion</h3> In this study to date, the majority of parents express interest in performing a low-dose challenge to peanut. Further research is needed to explore this area as it may have an impact on anxiety, social limitations, and desire to pursue therapy if parents know their child is at low risk of reaction to accidental ingestion of small amounts of peanut.

Transitioning peanut oral immunotherapy to clinical practice.

Peanut allergy is on the rise in industrialized countries, affecting 1%–4.5% of children and generally persisting into adulthood. It is associated with a risk of severe anaphylaxis and is one of the major causes of food allergy-induced deaths. Health-related quality of life is significantly impaired for patients and affected families due to food restrictions attributable to omnipresent precautionary allergen labeling, constant risk of potentially life-threatening reactions, and limitation of social activities. Oral immunotherapy (OIT) has emerged as a valid treatment option for patients with IgE-mediated peanut allergy, with randomized controlled trials and real-life studies showing a high rate of desensitization and a favorable safety profile, especially in young children. Ultimately, the decision to initiate peanut OIT relies on a multidisciplinary shared decision-making process, involving open, personalized and evidence-based discussions with patients and their caregivers.

A Chinese-Specific Reference Amounts Study With TNO Food Allergen Risk Assessment Models - China, 2022.

What is already known about this topic?There are no consistent regulations on possible unintended allergen presence in food. The Netherlands Organization for Applied Scientific Research (TNO) has been committed to developing a quantitative risk assessment methodology for the unintentional intake of allergens.What is added by this report?This study aims to derive the optimal food consumption point for a deterministic food allergy risk assessment under the TNO framework based on Chinese national consumption data. A case study has been presented as an illustration.What are the implications for public health practice?A robust evidence-based food consumption input in quantitative risk assessment of unintended allergens is necessary for future public policy on Precautionary Allergen Labeling for specific products to meet the safety objectives and to be adequately conservative.

Spent fowl as a source of unintentional egg proteins exposure in Canadian food products

The occurrence of egg proteins in products containing spent fowl manufactured under current practices was studied to assess the risk these food products may pose to egg-allergic consumers and to determine if Precautionary Allergen Labelling (PAL) was recommended. Spent fowl slaughtering and processing operations in 2 Canadian facilities were observed. Raw hen pieces (n = 134), coming from 2 facilities, and intermediate and processed products containing spent fowl (n = 57), coming from one facility, were analyzed using ELISA. All samples tested positive for egg proteins. Raw pieces were tested using a qualitative method (i.e., swabbing); estimated egg proteins concentrations suggest the presence of highly contaminated samples (>600 mg/kg in 2 hen wing samples). Swabbing was found to be efficient for rapid detection of eggs in raw hen pieces, but not for quantification. A comparison between swab and grind results showed that egg proteins concentration is underestimated by at least a factor 2 for whole carcasses and a factor 10 for breast, wings and drumsticks, when using the swab protocol. For intermediate and processed products, quantitative measurements indicate that egg protein levels were below 16 mg/kg. Additionally, 88 water samples from chiller tanks were analyzed and indicate that this step could be the cause of the global contamination observed with an increase in egg protein concentrations overtime during the production schedule. As egg contamination is not adequately controlled under the current good production practices, the use of PAL would be recommended for raw spent fowl products.

Allergen action levels for food industries as risk management tools for a better use of precautionary Allergen labelling

Providing guidance to generate allergen action levels for food industries is important to assess the need for precautionary allergen labelling (PAL). Allergen action levels (in mg of allergen per kg of food commodity) were computed based on the eliciting dose (ED) of each selected allergen divided by consumption distribution data. Canadian consumption data was extracted from the Canadian Community Health Survey of 2015, representative of the general Canadian population. High-risk food categories selected included baked goods, baking mixes, bread products, candies, cereal products, chocolate products, cookies, energy bars, sauces, savory biscuits, and snacks. The ED inducing an allergic reaction in 1% and 5% of the allergic population (ED01, ED05) for nine allergens (milk, egg, peanut, hazelnut, cashew, walnut, wheat, sesame, soy) were extracted from Houben et al., 2020. Action levels for the median (P50), 75th and 97.5th percentile consumption (P75, P97.5) of any food category investigated could be detected by commercial allergen detection kits when the ED05 was used. The P75 and ED05 were preferred to determine action levels because they were less conservative and more flexible. Allergen action levels set for use by food business operators (FBOs) as risk management tools in Canada would help standardize PAL use and make PALs more meaningful for Canadian FBOs and consumers. These values must be interpreted considering their limitations and assumptions and should accompany all efforts of prevention and management of allergen cross-contact.

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.

Low dietary adherence after a positive food challenge in food allergic adults.

BackgroundAfter a positive food challenge (FC), patients receive dietary advice regarding avoidance of the culprit food. We examined the frequency and variables associated with dietary adherence after a positive FC in adults.MethodsIn this prospective daily practice study, adults with a positive FC were included. After every FC, dietary advice was given consisting of three options: (1) strict avoidance, (2) avoidance but products with precautionary allergen labelling (PAL) allowed and (3) (small) amounts allowed. Questionnaires about dietary adherence and associated variables were completed prior to and 6 months after the FC(s).Results41 patients (with 58 positive FCs) were included. Overall, patients adhered to the advised diet after 31% of the FCs. After 33 FCs, the advice was strict avoidance, whereof 82% followed a less strict diet. After 16 FCs, the advice was avoidance but products with PAL allowed, whereof 19% followed a less strict and 25% a stricter diet. In 9 FCs with the least strict advice, “(small) amounts allowed’’, 67% followed a stricter diet. Three variables were associated with adherence: misremembering dietary advice, impaired health‐related quality of life (HRQL) on domain “Emotional impact’’ and the need for dietary change after the FC.ConclusionAfter one third of the positive FCs, patients adhered to the dietary advice. Variables associated with adherence were misremembering dietary advice, impaired HRQL on domain “Emotional impact’’ and the need for dietary change after the FC. It seems important that healthcare professionals should more frequently apply adherence‐enhancing strategies to improve dietary adherence.

Analysis of Clinical Food Allergen Thresholds by Comparing Threshold Dose Distributions

Approaches to establish thresholds provided by oral food challenge (OFC) for food allergen labeling are held to be more important. Japan is one of the few countries that enables precautionary allergen labeling to be legally restricted by setting strict standards for total protein concentration (<10 μg/g). We collected OFC data and compared them using several different models to scientifically verify the validity of this labeling system.

Allergen's labeling of food products: regulatory practices in Morocco

PurposeAllergenic substances cause food allergy, which represents a major health issue in most countries. This underlines the importance of considering the products' labeling as well as applying related regulatory practices. The objective of this study was to assess the labeling practices of allergens in food products in Morocco.Design/methodology/approachThis cross-sectional survey was conducted on 156 food products collected from four supermarkets in a Moroccan megacity. The data related to the allergen substances (allergen declared, emphasis characters, precautionary allergen labeling) were collected from labels of food products.FindingsThe number of foods included in this research was 156, of which 7 (4.5%) did not mention the allergy alert. The analysis of the allergy alert in the others sample (149) showed 266 nonconformities, noticed in 112 (71.8%) products. The labeling emphasis characters were observed in 33.3% of products, and only 13.5% mentioned “contains allergen” as a mandatory statement to declare the presence of allergens. Allergic alerts found in places concealed, removable by the opening of the seal or difficult to see were observed in 28.9%. The use of a precautionary allergen labeling statement was noticed in 40.4% of products.Originality/valueMoroccan regulations on food allergens are demanding like those of the European Union and more demanding than those of most African countries. However, the application of this regulation remains unsatisfactory and 266 non-conformities were found in 112 (71.8%) products. The absence of emphasis characters and the declaration in inappropriate places represent the most observed non-conformities. Therefore, Moroccan manufacturers must strictly adhere to regulations to avoid exposure of predisposed consumers to potentially threatening allergenic substances.

Labeling food allergens in the packaged food pyramid groups in Brazil: analysis of descriptions, ambiguities, and risks.

ABSTRACTObjective:The aim of this study was to evaluate allergenic labeling components of packaged foods for “What is the quality of food labels?” and “What is the group of Brazilian Food Pyramid that ‘May contain’ is predominant?.”Methods:The photographs of 916 products were obtained, of which 518 were analyzed. Data from each label were evaluated according to Brazilian Food Pyramid Groups (i.e., Cereals, Fruits, & Vegetables; Soybean & products; Milk & dairy products; Meat & eggs; Fats & oils; and Sugars & sweets). Ten items were analyzed in each label, namely, the presence of a list of ingredients, alert phrase for allergy sufferers, grouping of the alert phrase, phrase location, uppercase phrase, the phrase in bold, the color of alert phrase contrasting to the background, adequate font size, do not claim the absence for any allergen with the ingredients, and others factors that make it difficult to read. For the second question, a structured questionnaire was completed, and products were classified into two categories, namely, “Contain” and “May contain.”Results:The quality of the label was appropriate, and 69% of packaged foods had at least one allergen. The information “May contain” were higher in cow’s milk (Cereals and Meat & eggs), soy (Soybean & products), and egg protein (Cereals). Soybean & products were the highest insecurity group.Conclusions:Brazilian health professionals can count on good-quality labeling of packaged products. Consequently, they could promote patients’ and parents/caregivers’ education to consult the labels and manage the risks in processed foods about precautionary allergen labeling. Soybean & products were the most significant insecurity for food choices between Brazilian Pyramid Groups.

Threshold of Reactivity and Tolerance to Precautionary Allergen-Labelled Biscuits of Baked Milk- and Egg-Allergic Children

Extremely sensitive food-allergic patients may react to very small amounts of allergenic foods. Precautionary allergen labelling (PAL) warns from possible allergenic contaminations. We evaluated by oral food challenge the reactivity to a brand of PAL-labelled milk- and egg-free biscuits of children with severe milk and egg allergy. We explored the ability of proteomic methods to identify minute amounts of milk/egg allergens in such biscuits. Traces of milk and/or egg allergens in biscuits were measured by two different liquid-chromatography-mass spectrometry methods. The binding of patient’s serum with egg/milk proteins was assessed using immunoblotting. None of the patients reacted to biscuits. Egg and milk proteins were undetectable with a limit of detection of 0.6 µg/g for milk and egg (method A), and of 0.1 and 0.3 µg /g for milk and egg, respectively (method B). The immunoblots did not show milk/egg proteins in the studied biscuits. Milk/egg content of the biscuits is far lower than 4 µg of milk or egg protein per gram of product, the minimal doses considered theoretically capable of causing reactions. With high sensitivity, proteomic assessments predict the harmlessness of very small amount of allergens in foods, and can be used to help avoiding unnecessary PAL.

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

The United States does not have clear requirements for the use of food precautionary allergen labeling (PAL). The Food Allergen Labeling and Consumer Protection Act requires the names of 8 allergens (peanut, tree nuts, milk, egg, wheat, soy, fish, and shellfish), if present, to be listed in English on ingredient labels. Additional PAL, such as “may contain” or “made on shared equipment,” is voluntarily placed on products. In the current study, researchers aimed to understand patient and family knowledge of and preferences for PAL statements.Individuals with a personal history of food allergy (FA) or those with a relationship with a patient with FA (including caregivers, partners, and teachers) were invited to participate in the current study through a survey delivered through the Food Allergy Research and Education’s membership listserv. Researchers initially conducted a focus group to understand shopping experiences, understanding of PAL, and preferences for labeling language, format, and placement. A survey draft was sent to 9 additional stakeholders to refine survey reliability and comprehension. Of the ultimate recipients, 25 208 opened the e-mail, 3541 began the survey, and data from 3008 respondents were analyzed. Respondents were primarily female (84.7%), caregivers of a patient with FA (77%), non-Hispanic White (78.4%), had a graduate degree (40.6%), and had an annual household income >$100 000 (48.5%).Queried demographics included sex, race/ethnicity, education, household income, living location, relationship to FA, type of FA, number of FAs, severe adverse reaction history, and PAL knowledge. Survey domain outcomes included shopping habits, frequency of purchasing products with PAL, PAL preferences, confidence when purchasing PAL products, and PAL discussions with health care providers. Logistic regression analysis evaluated associations between respondent characteristics and PAL outcomes.Of respondents, 24.2% correctly answered 4 knowledge questions surrounding PAL. The majority of respondents never purchase products labeled “may contain traces of allergen” (85.5%), in comparison with never purchasing products labeled “good manufacturing practices used to segregate ingredients in a facility that also processes allergen” (35%). The top preferences for desired PAL statements were “not suitable for people with [blank] allergy” (29.3%) and “may contain” (22.1%). Respondents favor labeling with specific allergens versus a category of allergens. Most respondents favored PAL immediately after the ingredient list. Of individuals with FA, 32% were instructed to avoid foods with PAL, whereas 44.5% did not discuss PAL with their health care provider. Respondents who were told to avoid all PAL were 59% less likely to purchase products with PAL than patients who did not discuss PAL with their provider were.Responses revealed lack of awareness of PAL policies and suggest that consumers purchase products with PAL on the basis of specific language used. Consumers desire clarity, specificity, and consistency in labeling. Provider discussions influence purchasing.The authors acknowledge limitations of the current study to include potential bias in a sample of patients and caregivers from an advocacy group, which may not accurately represent all patients with FA. Inconsistent labeling practices currently cause confusion and may increase risk for patients with FA. Physician advocacy for improved labeling requirements may benefit patients and families.

A Synopsis of the Synopses, 2020–2021

A Synopsis of the Synopses, 2020–2021

Proposal of 0.5mg of protein/100g of processed food as threshold for voluntary declaration of food allergen traces in processed food-A first step in an initiative to better inform patients and avoid fatal allergic reactions: A GA²LEN position paper.

Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14main allergens used as ingredients in food products is mandatory in the EU, there is no legal definition of declaring potential contaminants. Precautionary allergen labeling such as "may contain traces of" is often used. However, this is unsatisfactory for consumers as they get no information if the contamination is below their personal threshold. In discussions with the food industry and technologists, it was suggested to use a voluntary declaration indicating that all declared contaminants are below a threshold of 0.5mg protein per 100g of food. This concentration is known to be below the threshold of most patients, and it can be technically guaranteed in most food production. However, it was also important to assess that in case of accidental ingestion of contaminants below this threshold by highly allergic patients, no fatal anaphylactic reaction could occur. Therefore, we performed a systematic review to assess whether a fatal reaction to 5mg of protein or less has been reported, assuming that a maximum portion size of 1kg of a processed food exceeds any meal and thus gives a sufficient safety margin. MEDLINE and EMBASE were searched until 24January 2021 for provocation studies and case reports in which one of the 14major food allergens was reported to elicit fatal or life-threatening anaphylactic reactions and assessed if these occurred below the ingestion of 5mg of protein. A Delphi process was performed to obtain an expert consensus on the results. In the 210studies included, in our search, no reports of fatal anaphylactic reactions reported below 5mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds. Based on the literature studied for this review, it can be stated that cross-contamination of the 14major food allergens below 0.5mg/100g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement "this product contains the named allergens in the list of ingredients, it may contain traces of other contaminations (to be named, e.g. nut) at concentrations less than 0.5mg per 100g of this product" for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged.

Controlling cross‐contamination by food allergens

Controlling cross‐contamination by food allergens

Peanut and hazelnut occurrence as allergens in foodstuffs with precautionary allergen labeling in Canada

Precautionary allergen labeling (PAL) is widely used by food industries. Occurrence studies revealed that few analyzed products contained the allergen(s) present in the statement, but little is known in Canada. To improve manufacturing practices and better manage allergen cross-contamination, occurrence data is needed to determine the exposure of allergic individuals eating those products. Samples were analyzed for peanuts (n = 871) and hazelnuts (n = 863) using ELISA methods. Within samples analyzed for peanuts, 72% had a PAL (n = 628), 1% had peanuts as a minor ingredient (n = 9) and 27% were claimed “peanut-free” (n = 234). Most hazelnut samples had a PAL for tree nuts/hazelnuts (94%; n = 807) with 6% claimed “nut-free” (n = 56). Peanuts and hazelnuts were found in 4% (0.6–28.1 ppm) and 9% (0.4–2167 ppm) of all samples, respectively. Chocolates were mostly impacted; they should be treated apart from other foods and used in risk assessments scenarios to improve manufacturing practices, reducing unnecessary PAL use.

Probabilistic risk assessment for milk in dark chocolate, cookies and other baked goods with PAL sold in Canada

The risk of having an allergic reaction in milk-allergic individuals consuming products with precautionary allergen labelling (PAL) for milk has been rarely studied in products such as dark chocolate, cookies, and other baked goods. A probabilistic risk assessment model was developed to estimate potential risks. Milk occurrence and contamination levels were reported in a previous article from our group. Dose-response curves for milk were constructed using values (n = 1078) from published double-blind placebo-controlled food challenges. Canadian consumption data was extracted from a national survey, and a homemade survey involving food-allergic Canadians. Milk eliciting doses (ED) were 0.23 (ED01), 1.34 (ED05), 3.42 (ED10), and 16.3 (ED25) mg of milk protein (Log-Normal distribution). Average exposures, per eating occasion, were 24 mg (dark chocolate), 3.9 mg (baked goods), and 0.20 mg (cookies) of milk proteins. The estimated risk of having a milk-induced allergic reaction by consuming foods with PAL for milk was higher for dark chocolate (16%; 15,881/100,000) than baked goods (3.8%; 3802/100,000) or cookies (0.6%; 646/100,000) in milk-allergic Canadians. Dark chocolate, cookies, and baked goods with PAL for milk, should be avoided by milk-allergic Canadians (consuming or not products with PAL) to prevent allergic reactions.