An International First: Stakeholder Consensus Statement for Food Allergen Management in Packaged Foods and Food Service for Australia and New Zealand.

Food-allergic consumers encounter inadequate, confusing, and ambiguous allergen information for packaged and unpackaged foods. Key Australian and New Zealand allergy organizations convened multiple forums to facilitate discussions among consumers, food manufacturers, food retailers, regulatory bodies, researchers, and health professionals to develop a unified approach to improving food allergen management. The following stakeholder consensus statement provides a foundation for advocacy for improved food allergen management and safety. It is the responsibility of consumers to: 1. declare their food allergies and read food labels (including ingredient lists and allergen declaration statements), and 2. ultimately make their own judgment about the foods they choose to consume. We consider that to enable consumers to make informed decisions about their safety, It is the responsibility of packaged food manufacturers to: 1. follow robust allergen management practices including quantitative risk assessment, and 2. use clear, consistent labeling to inform consumers about that food's allergen content, including the possible presence of unintended allergens. It is the responsibility of food service establishments and providers to: 1. follow robust allergen management practices, and 2. ensure that staff understand and can inform consumers about the allergen content of the food they provide, including the possible presence of unintended allergens.

Anaphylaxis to foods purchased from food establishments in Australia.

AIM: Food establishments that sell non-packaged foods are not required to have a food label directly on the food product detailing the ingredients. This practice could increase the risk of anaphylaxis among individuals with food allergy. The aim of the study is to understand whether anaphylaxis occurs commonly in individuals with food allergy as a consequence of eating food products purchased from food establishments. METHODS: We undertook an anonymous on-line cross-sectional survey of food allergic individuals over a 9-month period. Anaphylaxis was defined as reported symptoms consistent with the Australasian Society of Clinical Immunology and Allergy definition of anaphylaxis. RESULTS: A total of 268 responses were received over the study period and 264 consented and completed the questionnaire. Among our survey participants, the rate of anaphylaxis to food purchased from establishments was 27% (n = 67/246, 95% confidence interval 21.8-33.3%). Of those who reported an anaphylaxis (n = 67), 87% reported informing staff of their/their dependents food allergy/s. Most (81%) reported that they would like to see additional information, such as listing of allergen information next to dishes on the menu and 61% reported that staff pro-actively asking about food allergies would be beneficial. CONCLUSION: Anaphylaxis from food purchased at food establishments is not uncommon despite a high proportion of individuals declaring their food allergy to staff. Consumers with food allergy would like to see allergen information listed on the menus and for staff to proactively enquire about food allergies. A food allergen matrix that is regularly checked/updated so staff and consumers have easy access to information on menu items and common allergens is required.

Anaphylaxis to packaged foods in Australasia.

AIMS: To examine reports of anaphylaxis in Australasia from consumption of packaged food products with or without precautionary allergen labelling (PAL), where the known allergen triggers were not a listed ingredient. METHODS: A questionnaire was sent to all members of the Australasian Society of Clinical Immunology and Allergy (n = 548). Participants were asked to complete a survey reporting whether they have had seen any patients over the last 3 months reporting anaphylaxis following ingestion of a packaged food where the suspected food allergen was not a listed ingredient. RESULTS: Of the n = 548 members approached, n = 198 responded (response rate 36.1%).There were 14 reports of anaphylaxis to packaged foods (where the suspected allergen was not a listed ingredient), which met the case definition from a total of 198 respondents over the 9-month period. Of those reactions, 50.0% (confidence interval 95% 21-78) were reported from foods that did not have a PAL statement, and 50.0% (confidence interval 95% 21-78) were due to peanuts. CONCLUSION: Anaphylaxis to undeclared allergens was not rare and did not appear to depend on whether the product was labelled with precautionary advice. There is currently no reliable labelling system that can inform food-allergic consumers of safer food choices. Improvements in the regulation of food labelling with PAL are required.

Are food allergic consumers ready for informative precautionary allergen labelling?

Precautionary allergen labelling (PAL) has resulted in consumer confusion. Previous research has shown that interpretive labels (using graphics, symbols, or colours) are better understood than the traditional forms of labels. In this study, we aimed to understand if consumers would use interpretive labels (symbol, mobile phone application and a toll-free number) with or without medical advice that was advocated by the food industry rather than the normal PAL. This is relevant information for industry and clinicians as it provides an insight into the food allergic perception regarding PAL.

Peanut Allergen Threshold Study (PATS): Novel single-dose oral food challenge study to validate eliciting doses in children with peanut allergy.

BACKGROUND: Eliciting doses (EDs) of allergenic foods can be defined by the distribution of threshold doses for subjects within a specific population. The ED05 is the dose that elicits a reaction in 5% of allergic subjects. The predicted ED05 for peanut is 1.5 mg of peanut protein (6 mg of whole peanut). OBJECTIVE: We sought to validate the predicted peanut ED05 (1.5 mg) with a novel single-dose challenge. METHODS: Consecutive eligible children with peanut allergy in 3 centers were prospectively invited to participate, irrespective of previous reaction severity. Predetermined criteria for objective reactions were used to identify ED05 single-dose reactors. RESULTS: Five hundred eighteen children (mean age, 6.8 years) were eligible. No significant demographic or clinical differences were identified between 381 (74%) participants and 137 (26%) nonparticipants or between subjects recruited at each center. Three hundred seventy-eight children (206 male) completed the study. Almost half the group reported ignoring precautionary allergen labeling. Two hundred forty-five (65%) children experienced no reaction to the single dose of peanut. Sixty-seven (18%) children reported a subjective reaction without objective findings. Fifty-eight (15%) children experienced signs of a mild and transient nature that did not meet the predetermined criteria. Only 8 (2.1%; 95% CI, 0.6%-3.4%) subjects met the predetermined criteria for an objective and likely related event. No child experienced more than a mild reaction, 4 of the 8 received oral antihistamines only, and none received epinephrine. Food allergy-related quality of life improved from baseline to 1 month after challenge regardless of outcome (η2 = 0.2, P < .0001). Peanut skin prick test responses and peanut- and Ara h 2-specific IgE levels were not associated with objective reactivity to peanut ED05. CONCLUSION: A single administration of 1.5 mg of peanut protein elicited objective reactions in fewer than the predicted 5% of patients with peanut allergy. The novel single-dose oral food challenge appears clinically safe and patient acceptable, regardless of the outcome. It identifies the most highly dose-sensitive population with food allergy not otherwise identifiable by using routinely available peanut skin prick test responses or specific IgE levels, but this single-dose approach has not yet been validated for risk assessment of individual patients.

Is advising food allergic patients to avoid food with precautionary allergen labelling out of date?

PURPOSE OF REVIEW: Precautionary allergen labelling (PAL) continues to be used by the food manufacturing industry to alert the food allergic consumer that cross-contact may have occurred during the supply chain for ingredients or the manufacturing process. This review will summarize recent evidence regarding use and interpretation of precautionary labels by industry, healthcare professionals, and food allergic consumers. Consumers find precautionary labels difficult to interpret and often distrust them as disclaimers of product liability. It is unclear from a clinician's perspective how healthcare professionals should advise their patients regarding these statements. RECENT FINDINGS: Recent studies suggest that consumers do not always read food labels and that these labels are difficult to interpret and are often distrusted by consumers as disclaimers of liability. There is evidence to suggest that this behaviour occurs in all countries assessed that use PAL. The healthcare professional remains confused about the interpretation and value of the current PAL system as it is unclear whether foods that contain no advisory labels are safe to consume. There is a need for improvement in the value and use of precautionary labelling for allergen risk assessment for allergic consumers. SUMMARY: New studies have shown the confusion that currently exists in regard to PAL for the healthcare professional and the consumer alike. The studies have also highlighted certain gaps in the literature that, once addressed, will improve the uniformity of PAL and provide the healthcare professional with appropriate advice which they can in turn relay to the allergic consumer. Because of the global supply of food products there is a need for an international approach in improving PAL.

Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol.

BACKGROUND: The eliciting dose (ED) for a peanut allergic reaction in 5% of the peanut allergic population, the ED05, is 1.5 mg of peanut protein. This ED05 was derived from oral food challenges (OFC) that use graded, incremental doses administered at fixed time intervals. Individual patients' threshold doses were used to generate population dose-distribution curves using probability distributions from which the ED05 was then determined. It is important to clinically validate that this dose is predictive of the allergenic response in a further unselected group of peanut-allergic individuals. METHODS/AIMS: This is a multi-centre study involving three national level referral and teaching centres. (Cork University Hospital, Ireland, Royal Children's Hospital Melbourne, Australia and Massachusetts General Hospital, Boston, U.S.A.) The study is now in process and will continue to run until all centres have recruited 125 participates in each respective centre.A total of 375 participants, aged 1-18 years will be recruited during routine Allergy appointments in the centres. The aim is to assess the precision of the predicted ED05 using a single dose (6 mg peanut = 1.5 mg of peanut protein) in the form of a cookie. Validated Food Allergy related Quality of Life Questionnaires-(FAQLQ) will be self-administered prior to OFC and 1 month after challenge to assess the impact of a single dose OFC on FAQL. Serological and cell based in vitro studies will be performed. CONCLUSION: The validation of the ED05 threshold for allergic reactions in peanut allergic subjects has potential value for public health measures. The single dose OFC, based upon the statistical dose-distribution analysis of past challenge trials, promises an efficient approach to identify the most highly sensitive patients within any given food-allergic population.

Perceptions of precautionary labelling among parents of children with food allergy and anaphylaxis.

OBJECTIVE: To examine the behaviour and perception of parents of food-allergic children with and without a history of anaphylaxis in relation to precautionary labelling on packaged foods and to understand consumers' perception of the "may be present" statement advocated by VITAL (voluntary incidental trace allergen labelling). DESIGN, SETTING AND PARTICIPANTS: Questionnaire-based study of parents of a consecutive series of 497 children who attended the Department of Allergy and Immunology at the Royal Children's Hospital, Melbourne, from 1 August to 31 October 2011, of whom 293 met our criteria of having an existing medically diagnosed food allergy, and of whom 246 had enough information provided to be included in our analysis. MAIN OUTCOME MEASURES: Parents' responses about their behaviour and perceptions relating to precautionary food labels, and a comparison between parents of children with a past history of anaphylaxis and those with a past history of mild to moderate IgE allergic reactions. RESULTS: Avoidance of foods with precautionary labels differed depending on the wording of the precautionary statement, with 74 parents (65%) ignoring the statement "made in the same factory" compared with 24 (22%) for "may be present". There was no evidence of a difference in participants' behaviour or perceptions depending on whether or not their child had a history of anaphylaxis. CONCLUSIONS: Consumers are choosing a gradient level of risk based on the wording of the precautionary statements and appear to be complacent about precautionary labelling. Many statements are now being disregarded by a sizeable proportion of parents of food-allergic children, including those caring for children with a past history of anaphylaxis. This may be due to inadequacies in food labelling legislation. Policies that promote greater clarity and consistent use of precautionary statements may help to deal with this complacency.

Precautionary allergen labelling following new labelling practice in Australia.

AIMS: We aimed to assess the prevalence and types of precautionary labelling statements for common food allergens on the packages of products for which these allergens were not listed as an ingredient and to investigate the uptake of the Voluntary Incidental Trace Allergen Labelling, a new risk management tool developed in Australia to assist with declaring the possible presence of allergens in food products by manufacturers. We also aimed to examine changes in the prevalence of precautionary labelling for egg, peanuts and tree nuts over a 3-year period. METHODS: All packaged processed goods in a large supermarket in Melbourne, Australia, were examined for precautionary labelling between May and July 2011. RESULTS: In total, 1355 products were investigated. Overall, 882 products (65%) had a precautionary statement for one or more allergens. The most common allergens listed on precautionary statements were tree nuts (36.2%) and peanuts (34.1%), followed by sesame (27.5%) and egg (22.6%). Of those that had precautionary statements, 'May contain traces of …' was the most common type of precautionary label used on 392 products (29.0%). This was followed by 'May be present' on 172 products (12.7%). CONCLUSIONS: The use of precautionary labelling for peanut, tree nuts and egg remained high. The uptake of the Voluntary Incidental Trace Allergen Labelling 'May be present' statement was low in comparison with other precautionary statements, but there has been an increase since 2009.

Hidden allergens in foods and implications for labelling and clinical care of food allergic patients.

The prevalence of precautionary labelling remains high. This prevalence restricts food choices, in some cases perhaps unnecessarily, for food allergic consumers. During processing, cross-contamination does often occur in food products due to the way that modern processing facilities operate; however, zero risk of cross contamination is not a realistic expectation. There is evidence to suggest that threshold levels below which reactions are not provoked in allergic individuals do exist and these have been established in the literature for peanuts. Additional information such as understanding threshold levels will be important to this field of research. The data that will be obtained from future clinical trials will help to underpin action plans for precautionary labelling. This paper will review the current literature that is available regarding: consumer behaviour and attitudes regarding precautionary labelling; risk to the consumer and analytical results of products that bear advisory labelling; the current debate regarding whether a tolerable level of risk can be obtained in food allergy; and finally, the newly introduced Voluntary Incidental Trace Allergen Labelling (VITAL) system operating in Australia.