Safety evaluation of an extension of use of the food enzyme glucan 1,4‐α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BF
strain NZYM-BF by Novozymes A/S. The safety of this food enzyme was evaluated previously and it did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of three food manufacturing processes. As the food enzyme-Total Organic Solids (TOS) are removed from the final foods in one process, the dietary exposure to the food enzyme-TOS was estimated for the remaining two food manufacturing processes. It was calculated to be up to 4.431 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1306 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 307. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
Authors
- Francesco Catania (ORCID: https://orcid.org/0000-0002-2652-9397)
- José Manuel Barat Baviera
- Laurence Vernis
- Daniele Cavanna
- Baltasar Mayo
- Henk Van Loveren
- Alessandro Manghi
- Claudia Bolognesi
- Holger Zorn
- Alicja Mortensen
- Ralf Greiner
- Gabriele Gadermaier
- Yi Liu
- Marize L. M. Solano
- Yrjö Henrik Roos
- EFSA Panel on Food Enzymes (FEZ)
Publication Details
- Journal
- EFSA Journal
- Published
- 2026-05-01
- DOI
- https://doi.org/10.2903/j.efsa.2026.10080
- Primary Topic
- Agricultural safety and regulations
- Type
- article
- Field-Weighted Citation Impact
- 0.00