Dataset Information

Safety evaluation of the food enzyme containing endo-polygalacturonase and cellulase from the non-genetically modified Talaromyces cellulolyticus strain NITE BP-03478.

ABSTRACT: The food enzyme containing endo-polygalacturonase ((1-4)-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) and cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) activities is produced with the non-genetically modified Talaromyces cellulolyticus strain NITE BP-03478 by Meiji Seika Pharma Co., Ltd. It is intended to be used in eight food manufacturing processes: baking processes, brewing processes, fruit and vegetable processing for juice production, wine and wine vinegar production, fruit and vegetable processing for products other than juices, fruit and vegetable processing for refined olive oil production, coffee bean demucilation and grain treatment for starch production. Since residual amounts of total organic solids (TOS) are removed during three food processes (refined olive oil production, coffee bean demucilation and grain treatment for starch production), dietary exposure was not calculated for these food processes. For the remaining five food processes, dietary exposure was estimated to be up to 3.193 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 806 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 252. A search for the similarity of the amino acid sequences of the food enzyme to known allergens was made and six matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, especially in individuals sensitised to pollen. 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-EPMC9951331 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Safety evaluation of the food enzyme containing endo-polygalacturonase and cellulase from the non-genetically modified <i>Talaromyces cellulolyticus</i> strain NITE BP-03478.

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 Aguilera Jaime J Andryszkiewicz Magdalena M Liu Yi Y di Piazza Giulio G Rainieri Sandra S de Sousa Rita Ferreira RF Chesson Andrew A

EFSA journal. European Food Safety Authority 20230224 2

The food enzyme containing endo-polygalacturonase ((1-4)-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) and cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) activities is produced with the non-genetically modified <i>Talaromyces cellulolyticus</i> strain NITE BP-03478 by Meiji Seika Pharma Co., Ltd. It is intended to be used in eight food manufacturing processes: baking processes, brewing processes, fruit and vegetable processing for juice production, wine and wine vinegar prod ...[more]

PMID: 36846396

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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 containing endo-polygalacturonase and cellulase from the non-genetically modified Talaromyces cellulolyticus strain NITE BP-03478.

Publications

Safety evaluation of the food enzyme containing endo-polygalacturonase and cellulase from the non-genetically modified <i>Talaromyces cellulolyticus</i> strain NITE BP-03478.

Similar Datasets

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