Updated full range of Eliciting Dose values for Cow's milk for use in food allergen risk assessment

Blom, W. Marty; Westerhout, Joost; Baumert, Joseph L.; Meima, Marie Y.; Turner, Paul J.; Ebisawa, Motohiro; Yanagida, Noriyuki; Remington, Benjamin C.; Houben, Geert

doi:10.1016/j.fct.2022.113381

Cited by 3 publications

(5 citation statements)

References 12 publications

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“…During milk OFCs, the ED05 was reported at 2-7 mg of protein [13][14][15][16]; however, a previous systematic review showed that approximately 5% of individuals with a cow's milk allergy react to less than 2.9 mg of protein and that 5% of those with allergic reactions will experience anaphylaxis [15 && ]. Furthermore, children who are allergic to raw milk or egg but are tolerant to baked products containing milk or egg have higher thresholds than those who cannot tolerate baked products [17].…”

Section: Recent Studies Regarding the Threshold Dosementioning

confidence: 99%

Relationship between eliciting doses and the severity of allergic reactions to food

Yanagida

Sato

Ebisawa

2023

Current Opinion in Allergy &Amp; Clinical Immunology

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Purpose of reviewFood allergies with low thresholds are associated with frequent accidental allergic reactions. Severe reactions attributable to accidental ingestion often result in a poor quality of life. Nevertheless, no evidence of a relationship between a low threshold dose and the severity of symptoms exists. Therefore, we evaluated recent data regarding the threshold of food allergies based on the oral food challenge (OFC). We also proposed a stepwise OFC method to identify threshold and consumable doses. Recent findingsA higher specific IgE level and a history of food-induced anaphylaxis were related to low threshold doses and severe reactions during the OFC. In addition, a low threshold dose was not directly correlated with severe reactions. Performing a stepwise OFC may help safely clarify consumable doses and prevent the complete avoidance of allergy-causing foods. SummarySevere food allergies with high specific IgE levels are associated with lower thresholds and more severe reactions. However, the threshold is not directly related to the severity of food-induced allergic symptoms. Identifying a well tolerated consumable dose using a stepwise OFC may help manage food allergies.

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Section: Recent Studies Regarding the Threshold Dosementioning

confidence: 99%

Relationship between eliciting doses and the severity of allergic reactions to food

Yanagida

Sato

Ebisawa

2023

Current Opinion in Allergy &Amp; Clinical Immunology

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“…Under this uncertainty frame, studies are lacking aiming at defining the frequency and severity of reactions in severe food‐allergic patients exposed to doses below the FAO/WHO reference dose, the ED01 threshold set by VITAL, the GA2LEN threshold, or the recent reference dose of 0.3 mg (ED01) recommended for total milk proteins for risk assessment and management purposes 13 …”

Section: Introductionmentioning

confidence: 99%

“…This choice substantially adopted the approach proposed by the Allergen Bureau's Voluntary Incidental Trace Allergen Labelling (VITAL) Programme, 10 reducing the number of priority allergens. Elaborating on the concept of a minimum amount able to determine allergic reactions, VITAL defined the ‘eliciting doses’ (EDs) for specific food allergens, indicating the dose (mg) predicted to provoke reactions in a defined proportion of the allergic population 11–13 . The VITAL EDs were derived from the dose distribution of individual minimum EDs, based on the results of the Oral Food Challenges (OFCs) performed for diagnostic purposes and published in the scientific literature 14 .…”

Section: Introductionmentioning

confidence: 99%

“…23 Under this uncertainty frame, studies are lacking aiming at defining the frequency and severity of reactions in severe foodallergic patients exposed to doses below the FAO/WHO reference dose, the ED01 threshold set by VITAL, the GA2LEN threshold, or the recent reference dose of 0.3 mg (ED01) recommended for total milk proteins for risk assessment and management purposes. 13 The present study is an attempt to contribute to fill this lack of knowledge. In a 'real life' setting, we aimed to verify the reactivity to potential traces of milk and hazelnut allergens in milk and hazelnutfree products in a group of children affected by severe allergies to milk and hazelnuts.…”

mentioning

confidence: 98%

“…Elaborating on the concept of a minimum amount able to determine allergic reactions, VITAL defined the 'eliciting doses' (EDs) for specific food allergens, indicating the dose (mg) predicted to provoke reactions in a defined proportion of the allergic population. [11][12][13] The VITAL EDs were derived from the dose distribution of individual minimum EDs, based on the results of the Oral Food Challenges (OFCs) performed for diagnostic purposes and published in the scientific literature. 14 The Codex expert committee proposed thresholds based on the published ED05 values (the dose predicted to provoke reactions in 5% of the at-risk allergic population) 11 as the most appropriate reference doses to guarantee the transparency of information to the consumer and safeguard his safety.…”

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confidence: 99%

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

Fiocchi,

Monaci,

De Angelis

et al. 2023

Clinical & Translational All

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BackgroundThe 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 0.2 mg, respectively, by the Voluntary Incidental Trace Allergen Labelling (VITAL) initiative. The respective reference doses recommended by the FAO/WHO Codex consultation are 3 and 2 mg. 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.MethodsOral 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.ResultsNo 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 35 mg 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.ConclusionsUpon 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.

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