Statement of the Prolamin Working Group on the Determination of Gluten in Fermented Foods Containing Partially Hydrolyzed Gluten

Abstract

On August 12, 2020, the U.S. Food and Drug Administration (FDA) has finalized a rule related to gluten-free labeling for foods containing fermented, hydrolyzed ingredients. The FDA believes that there is no scientifically valid analytical method effective for determining gluten in fermented or hydrolyzed foods. In the absence of an analytical method, the FDA has decided to evaluate gluten-free claims on these foods based only on evidence that the food or ingredient used is gluten-free before fermentation or hydrolysis. For example, barley-based beers from which gluten is removed during brewing using special filtration, adsorption and/or enzymatic treatment are therefore excluded from bearing a gluten-free label. The Prolamin Working Group (PWG) acknowledges that the FDA rule is a regulatory act and might have to take into consideration several aspects other than scientific evidence, including risk assessment. Nevertheless, the PWG thinks that science has to be the most important driver for regulatory acts in risk management. In contrast, in the EU such beers are currently allowed to bear a gluten-free label. As required by Regulation (EU) No 1169/2011 of 25 October 2011 on the provision of food information to consumers, the ingredients list must include “barley malt” in highlighted lettering, because gluten-containing cereals are listed in Annex II of the Regulation as substances or products causing allergies or intolerances. The maximum gluten level to bear a gluten-free claim is set in Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food. On this legal basis, non-governmental Organizations such as the Association of European Coeliac Societies (AOECS) have developed the European Licensing System with guidelines that have to be met to allow using the crossed grain symbol for gluten-free food on the label.