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
Torsten Zuberbier 1 , Tamara Dörr 1 , Werner Aberer 2 , Montserrat Alvaro 3 , Elizabeth Angier 4 , Stefania Arasi 5 , Hasan Arshad 6 7 8 , Barbara Ballmer-Weber 9 10 , Joan Bartra 11 12 , Lisa Beck 13 , Philippe Bégin 14 , Carsten Bindslev-Jensen 15 , Jovanka Bislimovska 16 , Jean Bousquet 1 17 18 , Knut Brockow 19 , Andrew Bush 20 , Antonella Cianferoni 21 , Michael J Cork 22 , Adnan Custovic 23 , Ulf Darsow 19 , Nicolette de Jong 24 , Diana Deleanu 25 , Stefano Del Giacco 26 , Antoine Deschildre 27 28 , Audrey Dunn Galvin 29 30 31 , Motohiro Ebisawa 32 , Montserrat Fernández-Rivas 33 , Marta Ferrer 34 , Alessandro Fiocchi 5 , Roy Gerth van Wijk 24 , Maia Gotua 35 , Kate Grimshaw 36 , Josefine Grünhagen 1 , Enrico Heffler 37 38 , Michihiro Hide 39 , Karin Hoffmann-Sommergruber 40 , Cristoforo Incorvaia 41 , Christer Janson 42 , Swen Malte John 43 44 , Carla Jones 45 , Marek Jutel 46 , Norito Katoh 47 , Benjamin Kendziora 48 , Tamar Kinaciyan 49 , Edward Knol 50 51 , Oksana Kurbacheva 52 , Susanne Lau 53 , Richard Loh 54 , Carlo Lombardi 55 , Mika Mäkelä 56 , Mary Jane Marchisotto 57 58 , Michael Makris 59 , Marcus Maurer 1 , Rosan Meyer 60 , Dragan Mijakoski 16 , Jordan Minov 16 , Joaquim Mullol 61 , Caroline Nilsson 62 63 , Anna Nowak-Wegrzyn 64 , Bright I Nwaru 65 , Mikela Odemyr 66 , Giovanni Battista Pajno 67 , Sushil Paudel 68 , Nikolaos G Papadopoulos 69 , Harald Renz 70 71 , Giampaolo Ricci 72 , Johannes Ring 19 73 , Barbara Rogala 74 , Hugh Sampson 75 76 77 , Gianenrico Senna 78 , Brigita Sitkauskiene 79 , Peter Kenneth Smith 80 , Katarina Stevanovic 1 , Sasho Stoleski 16 , Hania Szajewska 81 , Akio Tanaka 82 , Ana Todo-Bom 83 , Fatih Alexander Topal 1 , Erkka Valovirta 84 , Ronald Van Ree 85 , Carina Venter 86 , Stefan Wöhrl 87 , Gary W K Wong 88 , Zuotao Zhao 89 , Margitta Worm 1
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 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.
CITATION Allergy. 2022 Jun;77(6):1736-1750. doi: 10.1111/all.15167. Epub 2021 Nov 24.