SUMMARYThe applicant provides information on the characteristics of hydrolysed wheat gluten and describes its use in the fining process of wines and musts. Laboratory data on residual levels and immunoreactivity of hydrolysed wheat gluten in treated wines and musts are also presented. It is stated that wines clarified with hydrolysed and non-hydrolysed wheat gluten do not represent any risk when consumed by coeliac patients and subjects allergic to wheat gluten. This statement is based on the applicant's interpretation of the results of in vitro studies, with emphasis on an ad hoc developed SDS-PAGE immunoblot method. The applicant plans to test wines in vitro for allergenic potential at various conditions and in all vinification stages. A clinical study with wheat allergic subjects will be considered only in case of ambiguous results of the laboratory studies.Clinical reactions to wheat isolates in food have been reported. Wines and musts treated with hydrolysed wheat gluten may contain low levels of allergenic proteins and peptides. However, the analytical data provided by the applicant are insufficient to determine the residual levels of gluten proteins and peptides in wines. It is not known at which levels of intake hydrolysed wheat gluten would cause allergic reactions in cereal allergic individuals. The scientific data provided by the applicant are insufficient to predict the likelihood of adverse reactions in cereal allergic individuals. Nevertheless, taking into account the levels of wheat proteins reported to cause allergic reactions in severely allergic individuals, the Panel considers that wines and musts treated with hydrolysed wheat gluten could trigger an allergic reaction. Clinical information and improved analytical data are needed with regard to the effects of wines and musts treated with hydrolysed wheat gluten in cereal allergic individuals. Appropriate clinical studies applying best clinical and laboratory practice should be carried out.For coeliac disease, assessment of the provided evidence indicates that wines and musts treated with hydrolysed wheat gluten are 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 (currently 200 mg/kg) is not exceeded.
KEY WORDSHydrolysed wheat gluten, coeliac disease, food allergy, musts, wines.