Scientific publications

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. Scientific Publication

Nov 6, 2021 | Magazine: Allergy

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.

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