Proposal of 0.5 mg of protein/100 g 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

Zuberbier, Torsten; Dörr, Tamara; Aberer, Werner; Alvaro, Montserrat; Angier, Elizabeth; Arasi, Stefania; Arshad, Hasan; Ballmer‐Weber, Barbara; Bartra, Joan; Beck, Lisa A.; Bégin, Philippe; Bindslev‐Jensen, Carsten; Bislimovska, Jovanka Karadzinska; Bousquet, Jean; Brockow, Knut; Bush, Andrew; Cianferoni, Antonella; Cork, Michael J.; Čustović, Adnan; Darsow, Ulf; Jong, Nicolette de; Deleanu, Diana; Giacco, Stefano Del; Deschildre, A.; Galvin, Audrey Dunn; Ebisawa, Motohiro; Fernández‐Rivas, Montserrat; Ferrer, Marta; Fiocchi, Alessandro; Wijk, Roy Gerth van; Gotua, Maia; Grimshaw, Kate; Grünhagen, Josefine; Heffler, Enrico; Hide, Michihiro; Hoffmann‐Sommergruber, Karin; Incorvaia, Cristoforo; Janson, Christer; John, Swen Malte; Jones, Carla; Jutel, Marek; Katoh, Norito; Kendziora, Benjamin; Kinaciyan, Tamar; Knol, Edward F.; Курбачева, О М; Lau, Susanne; Loh, Richard; Lombardi, Carlo; Mäkelä, Mika; Marchisotto, Mary Jane; Makris, Michael; Maurer, Marcus; Mijakoski, Dragan; Минов, Јордан; Mullol, Joaquim; Nilsson, Caroline; Nowak‐Węgrzyn, Anna; Nwaru, Bright I.; Odemyr, Mikela; Pajno, Giovanni Battista; Paudel, Sushil; Papadopoulos, Nikolaos G.; Renz, Harald; Ricci, Giampaolo; Ring, Johannes; Rogala, Barbara; Sampson, Hugh A.; Senna, Gianenrico; Šitkauskienė, Brigita; Smith, Peter; Stevanovic, Katarina; Stoleski, Sasho; Szajewska, Hania; Tanaka, Akio; Todo‐Bom, Ana; Topal, Fatih Alexander; Valovirta, Erkka; Ree, Ronald van; Venter, Carina; Wöhrl, Stefan; Wong, Gary; Zhao, Zuo-Tao; Worm, Margitta

doi:10.1111/all.15167

Cited by 22 publications

(20 citation statements)

References 70 publications

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“…In this issue of allergy, Zuberbier et al report a systematic review in which they sought to assess the number of fatal cases of anaphylaxis to exposures below 5 mg protein for food allergens. They found only 8 cases of fatal anaphylaxis reported in which the level of exposure could be estimated; there were no reported fatalities to levels of exposure below 5 mg protein 14 . On the basis of these data, and a reasonable assumption that a portion size of 100 g is more typical than 1 000 g, the authors propose a cut‐off of 0.5 mg food protein due to UAP per 100 g food (5 ppm) to inform whether PAL is needed.…”

Section: Allergen Expected Rate Of Symptoms To a Level Of Allergen Ex...mentioning

confidence: 99%

“…Zuberbier et al propose a PAL statement of ‘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 0.5 mg per 100 g of this product’ as a voluntary declaration on prepacked foods 14 . This implies 5 ppm for the allergenic food, rather than total protein from that food (as stated in the review's title) and highlights the need for consistent communication across all stakeholders: consumers, risk assessors, risk managers and healthcare professionals.…”

Section: Allergen Expected Rate Of Symptoms To a Level Of Allergen Ex...mentioning

confidence: 99%

“…nut) at concentrations less than 0.5 mg per 100 g of this product' as a voluntary declaration on prepacked foods. 14 This implies 5 ppm for the allergenic food, rather than total protein from that food (as stated in the review's title) and highlights the need for consistent communication across all stakeholders: consumers, risk assessors, risk managers and healthcare professionals. Fourth, the assertion that a 5 ppm threshold 'can be readily detectable for all [14 EU priority] food allergens with the currently existing technology' is not uniformly true in practice.…”

Section: %-10%mentioning

confidence: 99%

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

Turner

Baumert

Beyer

et al. 2022

Allergy

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The disclosure of 'priority' allergens when present as an (intended) ingredient in foods is, in most countries, enshrined in legislation.However, the disclosure of unintended allergen presence (UAP) due to cross-contact or cross-contamination (e.g. through the use of shared production facilities) is not. 1 Many food businesses use precautionary allergen ('may contain') labels (PAL) to advise consumers as to the possibility of UAP; however, use of PAL is voluntary and not specifically regulated, and the presence/absence of PAL does not inform as to the actual level of risk that a particular food product

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Section: Allergen Expected Rate Of Symptoms To a Level Of Allergen Ex...mentioning

confidence: 99%

Section: Allergen Expected Rate Of Symptoms To a Level Of Allergen Ex...mentioning

confidence: 99%

Section: %-10%mentioning

confidence: 99%

See 1 more Smart Citation

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

Turner

Baumert

Beyer

et al. 2022

Allergy

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“…mg/100 g for trace food allergen in processed food but acknowledges that this is not legally binding and is a first step towards this [35]. Therefore, a shared decision-making approach on how a family manages PAL on food labels forms an important component of food allergy patient education [33,36].…”

Section: Level Of Eliminationmentioning

confidence: 99%

Nutritional Management of Children with Food Allergies

Wright

Feeney

Yerlett

2022

Curr Treat Options Allergy

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Purpose of the Review The purpose of the review is to review the evidence for the nutritional management of paediatric food allergy and provide a practical approach for healthcare professionals working in this area. Recent Findings Dietary elimination remains the mainstay for management of food allergies in children. However, the elimination of food allergens increases the risk for growth faltering, micronutrient deficiencies and feeding difficulties. Breastmilk remains the ideal source of nutrition for infants, but when not available, the vast majority will tolerate an extensively hydrolysed formula, and rice hydrolysate has also been suggested as a suitable alternative. Only in severe cases, including anaphylaxis, eosinophilic oesophagitis and growth faltering, is an amino acid formula indicated. The early introduction of peanut and egg and avoiding the delay in the introduction of other allergens, when not already allergic, has been highlighted by recent studies. Summary Whilst the elimination of allergens increases the risk of developing poor growth, micronutrient deficiencies and feeding difficulties, optimal, early dietary input, including advice on active introduction of allergens and alternative feeds, ideally from a registered dietitian/nutritionist, may be prevent and improve outcomes.

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“…12 Foodallergic children with a high reactivity threshold may not be requested to avoid precautionary-labelled prepackaged foods. 13,14 The use of precautionary allergen labelling (PAL) is based on population-based threshold dose distributions for the different food allergens. 15,16 To this end, data from cohorts of subjects assessed in oral food challenges (OFCs) are used to calculate eliciting doses (EDs) and to specify the relation between EDs and symptoms.…”

Section: Introductionmentioning

confidence: 99%

Cow's milk and egg protein threshold dose distributions in children tolerant to beef, baked milk, and baked egg

Valluzzi

Riccardi

Arasi

et al. 2022

Allergy

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Background The use of eliciting doses (EDs) for food allergens is necessary to inform individual dietary advice and food allergen risk‐management. The Eliciting Dose 01 (ED01) for milk and egg, calculated from populations of allergic subjects undergoing oral food challenges (OFCs), are 0.2 mg total protein. The respective Eliciting Dose 05 (ED05) is 2.4 mg for milk and 2.3 mg for egg. As about 70% children allergic to such foods may tolerate them when baked, we sought to verify the EDs of that subpopulation of milk and egg‐allergic children. Methods We retrospectively assessed consecutive OFC for fresh milk and egg between January 2018 and December 2020 in a population of baked food‐tolerant children. Results Among 288 children (median age 56 ‐ IQR 36–92.5 months, 67.1% male) included, 87 (30.2%) returned positive OFC results, 38 with milk and 49 with egg. The most conservative ED01 was 0.3 mg total protein (IQR 0.03–2.9) for milk and 14.4 mg total protein (IQR 3.6–56.9) for egg. The respective ED05 was 4.2 (IQR 0.9–19.6) mg for milk and 87.7 (IQR 43–179) mg for egg. Such thresholds are, respectively, 1.5 (milk ED01), 1.75 (milk ED05), 72 (egg ED01), and 38.35 (egg ED05) times higher than the currently used thresholds. Conclusions The subpopulation of children allergic to milk and egg, but tolerant to baked proteins, displays higher reactivity thresholds than the general population of children allergic to milk and egg. Their risk stratification, in both individual and population terms, should consider this difference. In baked milk‐tolerant children, milk causes reactions at lower doses than egg in our group of egg‐tolerant children. This could be associated with the relative harmlessness of egg compared with milk in the determinism of fatal anaphylactic reactions in children.

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Proposal of 0.5 mg of protein/100 g 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

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Cited by 22 publications

References 70 publications

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

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

Nutritional Management of Children with Food Allergies

Cow's milk and egg protein threshold dose distributions in children tolerant to beef, baked milk, and baked egg

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