Safety evaluation of the food enzyme beta‐galactosidase from Bacillus sp. (strain M3‐1)

The food enzyme β‐d‐galactosidase galactohydrolase (EC 3.2.1.23) is produced with Bacillus sp. strain M3‐1 by GenoFocus Inc. The food enzyme β‐galactosidase is intended to be used in the manufacture of galactooligosaccharides (GOS). Since residual amounts of total organic solids are removed by the purification steps applied during the production of GOS, toxicological studies were considered not necessary and no dietary exposure was calculated. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.