Opinion of the Scientific Panel on Dietetic products, nutrition and allergies [NDA] related to a notification from AAC on wheat-based glucose syrups including dextrose pursuant to Article 6, paragraph 11 of Directive 2000/13/EC
Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Andreu Palou, Hildegard Przyrembel, Seppo Salminen, John (Sean) J Strain, Stephan Strobel, Inge Tetens, Henk van den Berg, Hendrik van Loveren and Hans Verhagen.
Acknowledgment
The Scientific Panel on Dietetic Products, Nutrition and Allergies wishes to thank Taraneh Dean, Martin Stern and Jean-Michel Wal for their contributions to the draft opinion.
No abstract available
Since wheat is relevant both as a source of epitopes known to induce coeliac disease and as a source of allergens triggering wheat allergy, it is appropriate to investigate wheat products, namely wheat starch hydrolysates, for their potential to induce coeliac disease or trigger wheat allergy.
The applicant provides information on wheat starch hydrolysates, particularly concerning the potential effects of wheat-based glucose syrups including dextrose in coeliac disease and wheat allergy. The history of safe use of wheat-based glucose syrups including dextrose is claimed based on the safe use of wheat starch-based gluten-free diet in coeliac disease. Similar data do not exist on wheat-allergic individuals. Low amounts of residual gluten and peptides were found by mass spectrometry and high-pressure liquid chromatography analysis in wheat starch glucose syrups including dextrose (0.3-1.4 mg/kg).
A biopsy-controlled clinical study in 27 adult patients with coeliac disease shows no deterioration of coeliac disease after a wheat starch-based glucose syrup challenge over 24 weeks. Two challenge studies in 32 wheat allergic individuals examining clinical allergic reactions to wheat starch-based glucose syrups are considered by the Panel to be inconclusive regarding the likelihood that the product may trigger an allergic reaction in susceptible individuals.
Wheat-based glucose syrups including dextrose may contain low levels of proteins and peptides. It is not known at which levels of intake glucose syrups including dextrose would cause allergic reactions in wheat-allergic individuals. Nevertheless, taking into account all the scientific information provided and in particular the levels of wheat proteins reported in glucose syrups including dextrose, the Panel considers that it is not very likely that this product will trigger a severe allergic reaction in susceptible individuals.
For coeliac disease, assessment of the evidence provided including a new clinical study indicates that wheat-based glucose syrup is unlikely to cause an adverse reaction in individuals with coeliac disease provided that the (provisional) value of gluten considered by Codex Alimentarius for foods rendered gluten-free is not exceeded.
