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

food enzyme, lactase, β‐d‐galactosidase galactohydrolase, beta‐galactosidase, EC, Bacillus sp. M3‐1
First published in the EFSA Journal
22 ottobre 2019
17 settembre 2019
Scientific Opinion

Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.


The food enzyme β‐d‐galactosidase galactohydrolase (EC 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.

Panel members at the time of adoption

José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, Vittorio Silano, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn.
Panel on Food Contact Materials, Enzymes and Processing Aids
fip [at]
EFSA Journal 2019;17(10):5827
Question Number
On request from
European Commission