Dataset Information

Safety evaluation of the food enzyme cellulase from the genetically modified Trichoderma reesei strain AR-852.

ABSTRACT: The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified Trichoderma reesei strain AR-852 by AB Enzymes GmbH. The genetic modifications did not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in five food manufacturing processes: baking processes, brewing processes, distilled alcohol production, wine and wine vinegar production, and fruit and vegetable processing for juice production. As residual amounts of total organic solids (TOS) are removed by distillation, dietary exposure was only calculated for the other four food processes. Dietary exposure to the food enzyme TOS was estimated to be up to 0.1 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 10,000. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this 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.

SUBMITTER: EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)

PROVIDER: S-EPMC9247864 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety evaluation of the food enzyme cellulase from the genetically modified <i>Trichoderma reesei</i> strain AR-852.

Lambré Claude C Barat Baviera José Manuel JM Bolognesi Claudia C Cocconcelli Pier Sandro PS Crebelli Riccardo R Gott David Michael DM Grob Konrad K Lampi Evgenia E Mengelers Marcel M Mortensen Alicja A Rivière Gilles G Steffensen Inger-Lise IL Tlustos Christina C Van Loveren Henk H Vernis Laurence L Zorn Holger H Glandorf Boet B Herman Lieve L Aguilera Jaime J Andryszkiewicz Magdalena M Liu Yi Y Nielsen Elsa E Norby Karin K di Piazza Giulio G Chesson Andrew A

EFSA journal. European Food Safety Authority 20220701 7

The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified <i>Trichoderma reesei</i> strain AR-852 by AB Enzymes GmbH. The genetic modifications did not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in five food manufacturing processes: baking processes, brewing processes, distilled alcohol production, wine and wine v ...[more]

PMID: 35795293

Similar Datasets

Project description:The food enzyme containing cellulase (EC 3.2.1.4), endo-1,3(4)-β-glucanase (EC 3.2.1.6) and endo-1,4-β-xylanase (EC 3.2.1.8) is produced with the non-genetically modified Trichoderma reesei strain AR-256 by AB-Enzymes GmbH. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, cereal-based processes, brewing processes, fruit and vegetable processing for juice production, wine and wine vinegar production, distilled alcohol production and grain treatment for production of starch and gluten fractions. Since the residual amounts of total organic solids (TOS) are removed during grain treatment and distilled alcohol production, dietary exposure was estimated for the remaining five processes and amounted up to 3.92 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an endo-1,4-β-xylanase from T. reesei ■■■■■, considered by the Panel as a suitable substitute, because the genetic differences between the strains are well characterised and of no concern. Additionally, several strains derived from the production strain are considered safe by EFSA and the manufacturing of both food enzymes is similar. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity rat study. The no observed adverse effect level of 939 mg TOS/kg bw per day, the highest dose tested, compared with the estimated dietary exposure, resulted in a margin of exposure above 239. In the search for the similarity of the amino acid sequences to known allergens, one match (salmon) was found. The Panel considered that, under the intended conditions of use (except distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, in particular for individuals sensitised to salmon. The Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Dataset Information

Safety evaluation of the food enzyme cellulase from the genetically modified Trichoderma reesei strain AR-852.

Publications

Safety evaluation of the food enzyme cellulase from the genetically modified <i>Trichoderma reesei</i> strain AR-852.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets