In addition to the information submitted to obtain temporary exemption, the applicant provided further information regarding distillates made from cereals which include whisky, Kornbrand, gin,
vodka and “made wine” produced using vodka, liqueur and similar beverages.

The beverages in question are widely consumed in the European Union. A literature review that includes information up to April 2006 failed to reveal allergic reactions after consumption of
distillates made from cereals, although underreporting cannot be excluded. Further evidence of the unlikelihood of distillates made from cereals to elicit allergic reactions stems from
additional analytical data on potential residual proteins and their allergenicity in the distillates and the distillation process. The analytical methodology did not address the allergenic
activity of residual protein levels in the final product using appropriate human sera. Neither epidemiological studies nor double-blind placebo-controlled food challenge studies in clinical
settings have been carried out to address possible adverse allergic reactions to distilled spirit drinks due to cereal allergens.

Based on the data submitted by the applicant, the Panel notes that proteins and peptides are not carried over into the distillate during a properly controlled distillation process, at least not
in amounts higher than 1 mg/L for total proteins and 0.4 mg/kg for gluten. The Panel considers that distillates made from cereals are unlikely to trigger a severe allergic reaction in
susceptible individuals.

Opinion

Summary

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