Giovanni Battista Pajno, Stefan Wöhrl, Sasho Stoleski, Caroline Nilsson, Mary Jane Marchisotto, Ronald van Ree, Carina Venter, Anna Nowak-Wegrzyn, Montserrat Fernandez-Rivas, Akio Tanaka, Barbara Rogala, Benjamin Kendziora, Michihiro Hide, Stefano Del Giacco, Katarina Stevanovic, Dragan Mijakoski, Enrico Heffler, Nikolaos G. Papadopoulos, Werner Aberer, Antoine Deschildre, Lisa A. Beck, Kate Grimshaw, M. Gotua, Torsten Zuberbier, Hugh A. Sampson, Marek Jutel, Mikela Odemyr, Carlo Lombardi, Erkka Valovirta, Antonella Cianferoni, Nicolette W. de Jong, Jovanka Karadzinska Bislimovska, Michael J. Cork, Christer Janson, Karin Hoffmann-Sommergruber, Gianenrico Senna, Jean Bousquet, Michael Makris, Carsten Bindslev-Jensen, Tamara Dörr, Joan Bartra, Ana Todo-Bom, Mika J. Mäkelä, Ulf Darsow, Margitta Worm, Richard Loh, Rosan Meyer, Giampaolo Ricci, Roy Gerth van Wijk, Audrey Dunn Galvin, Joaquim Mullol, M Alvaro, Alessandro Fiocchi, Zuotao Zhao, Stefania Arasi, Marta Ferrer, Norito Katoh, Philippe Bégin, Brigita Sitkauskiene, Sushil Paudel, Knut Brockow, Johannes Ring, Edward F. Knol, Susanne Lau, Gary W.K. Wong, Jordan Minov, Cristoforo Incorvaia, Marcus Maurer, Hasan Arshad, Fatih A Topal, Bright I Nwaru, Hania Szajewska, Andrew Bush, Tamar Kinaciyan, Adnan Custovic, Elizabeth Angier, O M Kurbacheva, Diana Deleanu, Harald Renz, Peter Smith, Motohiro Ebisawa, J. Grünhagen, Swen Malte John, Carla P. Jones, Barbara Ballmer-Weber, Ear, Nose and Throat, Experimental Immunology, AII - Inflammatory diseases, APH - Global Health, and APH - Personalized Medicine
Background\ud \ud 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.\ud \ud \ud \ud Methods\ud \ud 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.\ud \ud \ud \ud Results\ud \ud 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.\ud \ud \ud \ud Conclusion\ud \ud Based on the literature studied for this review, it can be stated that cross-contamination of the 14 major food allergens below 0.5 mg/100 g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement “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” for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged.