‘Too high, too low’: The complexities of using thresholds in isolation to inform precautionary allergen (‘may contain’) labels

Turner, Paul J.; Baumert, Joseph L.; Beyer, Kirsten; Brooke‐Taylor, Simon; Comberiati, Pasquale; Crevel, René; Gerdts, Jennifer; Gowland, M. Hazel; Houben, Geert F.; Hourihane, Jonathan; Konstantinou, George N.; Vieille, Sébastien La; Moya, Beatriz; Muraro, Antonella; Mills, E. N. Clare; Patel, Nandinee; Podestá, Márcia Helena Miranda Cardoso; Pöpping, Bert; Reese, Imke; Roberts, Graham; Said, Maria; Santos, Alexandra F.; Schnadt, Sabine; Taylor, Steve L.; Vlieg‐Boerstra, Berber; Remington, Benjamin C.

doi:10.1111/all.15202

Cited by 14 publications

(8 citation statements)

References 25 publications

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“…Subjective symptoms, although not necessarily indicating an actual reaction, 35,40 may be stressful. Naturally, it is of interest for the food industry not only to verify food safety but also a perception of safety for the customers 41 . In this study, there was no safe dose in terms of subjective symptoms as 27 patients reported subjective symptoms to doses ≤1 mg sesame protein.…”

Section: Discussionmentioning

confidence: 83%

Sesame eliciting and safe doses in a large sesame allergic population

Nachshon,

Westerhout,

Blom

et al. 2023

Allergy

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BackgroundSesame is a significant food allergen causing severe and even fatal reactions. Given its increasing prevalence in western diet, sesame is listed as an allergenic food requiring labeling in the United States and EU. However, data on the population reaction doses to sesame are limited.MethodsAll sesame oral food challenges (OFCs), performed either for diagnosis or for threshold identification before the beginning of sesame oral immunotherapy (OIT) between November 2011 and July 2021 in Shamir medical center were analyzed for reaction threshold distribution. Safe‐dose challenges with 90–120 min intervals were also analyzed.ResultsTwo hundred and fifty patients underwent 338 positive OFCs, and additional 158 safe‐dose OFCs were performed. The discrete and cumulative protein amounts estimated to elicit an objective reaction in 1% (ED01) of the entire cohort (n = 250) were 0.8 mg (range 0.3–6.3) and 0.7 mg (range 0.1–7.1), respectively, and those for 5% of the population (ED05) were 3.4 mg (range 1.2–20.6) and 4.5 mg (range 1.2–28.8), respectively. Safe‐dose OFCs showed similar values of ED01 (0.8, 0.4–7.5 mg) and ED05 (3.4, 1.2–22.9 mg). While doses of ≤1 mg sesame protein elicited oral pruritus in 11.6% of the patients, no objective reaction was documented to this amount in any of the challenges, including safe‐dose OFCs.ConclusionsThis study provides data on sesame reaction threshold distribution in the largest population of allergic patients studied, with no right or left censored data, and with validation using a safe‐dose OFC. It further supports the current methods for ED determination as appropriate for establishing safety precautions for the food industry.

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Section: Discussionmentioning

confidence: 83%

Sesame eliciting and safe doses in a large sesame allergic population

Nachshon,

Westerhout,

Blom

et al. 2023

Allergy

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“…Moreover, studies reveal that the presence of PAL does not necessarily correlate with the actual presence or severity of UAP in products, further diminishing its reliability as a risk communication tool [15]. Analytical studies assessing UAP in food products underscore the variability in allergen concentrations, indicating that PAL alone may not accurately reflect the potential risk levels [16 ▪▪ ,17]. Additionally, products without PAL may still harbour UAP, challenging the assumption that absence of PAL implies safety [16 ▪▪ ].…”

Section: Precautionary Allergen Labellingmentioning

confidence: 99%

Perspectives in precautionary allergen labelling of prepackaged foods after the FAO/WHO consultation

Fierro,

Mazzuca,

Urbani

et al. 2024

Current Opinion in Allergy &Amp; Clinical Immunology

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Purpose of review 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. Recent findings 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. Summary 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.

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“…The final decision on an acceptable level of contamination in manufactured foods lies with the authorities, and therefore, the data presented here on Danish food allergic patients may facilitate the ongoing debate on how to improve allergen labeling and at the same time protect patients against allergic reactions. 37,38 There is not necessarily a parametric function which both gives a good fit to the total number of dose-responders and fits the lower part of the function (low dose respondents) as well. Several of the allergens had few observations in the low-doses regime and consequently had a large uncertainty in this part.…”

Section: 4mentioning

confidence: 99%

Challenge‐verified thresholds for allergens mandatory for labeling: How little is too much for the most sensitive patient?

Mortz,

Eller,

Garvik

et al. 2023

Allergy

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BackgroundIt is mandatory to label food products with the 14 main allergens in the EU. Reasonable allergen labeling requires knowledge of population‐based thresholds derived from food challenges. The aim of this study was to evaluate the threshold‐distribution in clinically verified food allergic patients for allergens mandatory for labeling.MethodsAll positive open oral food challenges and double‐blind placebo‐controlled food challenges (DBPCFC) performed at the Allergy Center, Odense University Hospital, Denmark (2000–2022) were included. For each included challenge, the cumulative threshold (LOAEL) was obtained and NOAEL estimated. Data were modelled as an interval censored log‐normal distribution.ResultsOverall, 38 of all 2612 challenges (1.5%) in 1229 patients (717 male, 986 children) reacted to <5 mg protein. The majority of the most sensitive patients reacted with a Sampson severity score of 2–3. Using interval censored log‐normal models only five groups (hens´ egg, fish, peanut, milk, tree‐nuts) elicited reactions after ingestion of 0.5 mg protein and in low frequencies of the population. Hen's egg was the most potent allergen, with reactivity to <0.5 mg protein in 0.24% [0.13–0.44%] of egg allergic patients while the estimated fraction of allergic patients reacting to a eliciting dose on 0.5 mg protein for most other allergens were below 0.04%.ConclusionOur data demonstrates that the majority of food allergic patients as expected tolerating traces of allergenic foods without developing severe allergic symptoms and signs. Hen's egg appears to be the food most likely to elicit reactions in the most sensitive individuals at very low doses.

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‘Too high, too low’: The complexities of using thresholds in isolation to inform precautionary allergen (‘may contain’) labels

Cited by 14 publications

References 25 publications

Sesame eliciting and safe doses in a large sesame allergic population

Sesame eliciting and safe doses in a large sesame allergic population

Perspectives in precautionary allergen labelling of prepackaged foods after the FAO/WHO consultation

Challenge‐verified thresholds for allergens mandatory for labeling: How little is too much for the most sensitive patient?

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