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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 GA(2)LEN position paper

Title: 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 GA(2)LEN position paper
Authors: Zuberbier, Torsten; Doerr, Tamara; Aberer, Werner; Alvaro, Montserrat; Angier, Elizabeth; Arasi, Stefania; Arshad, Hasan; Ballmer-Weber, Barbara; Bartra, Joan; Beck, Lisa; Begin, Philippe; Bindslev-Jensen, Carsten; Bislimovska, Jovanka; Bousquet, Jean; Brockow, Knut; Bush, Andrew; Cianferoni, Antonella; Cork, Michael J.; Custovic, Adnan; Darsow, Ulf; Jong, Nicolette; Deleanu, Diana; Del Giacco, Stefano; Deschildre, Antoine; Galvin, Audrey Dunn; Ebisawa, Motohiro; Fernandez-Rivas, Montserrat; Ferrer, Marta; Fiocchi, Alessandro; van Wijk, Roy Gerth; Gotua, Maia; Grimshaw, Kate; Gruenhagen, 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; Kurbacheva, Oksana; Lau, Susanne; Loh, Richard; Lombardi, Carlo; Mäkelä, Mika; Marchisotto, Mary Jane; Makris, Michael; Maurer, Marcus; Meyer, Rosan; Mijakoski, Dragan; Minov, Jordan; Mullol, Joaquim; Nilsson, Caroline; Nowak-Wegrzyn, Anna; Nwaru, Bright; Odemyr, Mikela; Pajno, Giovanni Battista; Paudel, Sushil; Papadopoulos, Nikolaos G.; Renz, Harald; Ricci, Giampaolo; Ring, Johannes; Rogala, Barbara; Sampson, Hugh; Senna, Gianenrico; Sitkauskiene, Brigita; Smith, Peter Kenneth; Stevanovic, Katarina; Stoleski, Sasho; Szajewska, Hania; Tanaka, Akio; Todo-Bom, Ana; Topal, Fatih Alexander; Valovirta, Erkka; Van Ree, Ronald; Venter, Carina; Woehrl, Stefan; Wong, Gary W. K.; Zhao, Zuotao; Worm, Margitta
Contributors: HUS Inflammation Center; Department of Dermatology, Allergology and Venereology; University of Helsinki
Publisher Information: Wiley Blackwell
Publication Year: 2023
Collection: Helsingfors Universitet: HELDA – Helsingin yliopiston digitaalinen arkisto
Subject Terms: anaphylaxis; food allergy; nutrition; EXERCISE-INDUCED ANAPHYLAXIS; COWS MILK; ORAL IMMUNOTHERAPY; PEANUT ALLERGY; CHALLENGE; CHILDREN; DIAGNOSIS; ADOLESCENTS; SESAME; TESTS; General medicine; internal medicine and other clinical medicine
Description: Background Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14 main 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 0.5 mg protein per 100 g 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. Methods MEDLINE and EMBASE were searched until 24 January 2021 for provocation studies and case reports in which one of the 14 major 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. Results In the 210 studies included, in our search, no reports of fatal anaphylactic reactions reported below 5 mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5 mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds. Conclusion Based on the literature ...
Document Type: article in journal/newspaper
File Description: application/pdf
Language: English
Relation: We thank the methodologist Alexander Nast for the important advice on the methodology of this paper. We also thank Graham Roberts for his help in revision of the manuscript and valuable feedback. We further thank many others especially members of patient organizations for their critical remarks, especially for pointing out that legally binding thresholds would be preferred. The authors certainly share this view. Open access funding enabled and organized by ProjektDEAL.; https://hdl.handle.net/10138/353409; 000721762600001
Availability: https://hdl.handle.net/10138/353409
Rights: cc_by_nc ; info:eu-repo/semantics/openAccess ; openAccess
Accession Number: edsbas.48FCEFE5
Database: BASE