The European Food Safety Authority (EFSA) has concluded that the food enzyme α-galactosidase from genetically modified Saccharomyces cerevisiae strain CBS 615.94 does not pose safety concerns when used in three food manufacturing processes, including two newly requested applications. In a scientific opinion adopted on 24 June 2026 and published on 7 July 2026, EFSA's Panel on Food Enzymes estimated the highest dietary exposure at 0.402 mg Total Organic Solids per kg body weight per day for toddlers and children at the 95th percentile, based on revised intended uses. The enzyme is produced by Kerry Ingredients & Flavours Ltd.
The opinion updates a previous safety evaluation from January 2024, which had assessed the enzyme for use in one process — production of enzymatically hydrolysed guar gum. The applicant subsequently requested an extension to include two additional processes: production of refined and unrefined sugar from sugar beets, and production of plant-based analogues of milk and milk products. In sugar production, the enzyme hydrolyses raffinose to increase yield, and is not carried into the final product due to crystallisation. In plant-based milk analogues, it breaks down galacto-oligosaccharides to improve sensory properties and digestibility, and the enzyme remains in the final food. The panel noted that the enzyme is inactivated in all processes, as its activity decreases above 40°C with no residual activity at 60°C.
The dietary exposure assessment used the FEIM webtool with consumption data from 51 dietary surveys across 27 European countries, covering infants, toddlers, children, adolescents, adults, and the elderly. The highest mean exposure was 0.259 mg TOS/kg bw per day in toddlers, and the highest 95th percentile was 0.402 mg TOS/kg bw per day in toddlers and children. The panel concluded that, based on the revised exposure and the previous evaluation, the food enzyme does not give rise to safety concerns under the intended conditions of use. The opinion will inform the European Commission's decision on whether to update the Union list of authorised food enzymes.