Safety evaluation of the food enzyme subtilisin from the genetically modified Bacillus licheniformis strain NZYM‐CB
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PROVIDER: S-EPMC10995817 | biostudies-literature | 2024 Apr
REPOSITORIES: biostudies-literature
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| S-EPMC10665993 | biostudies-literature
Project description:The food enzyme acetolactate decarboxylase (α-acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM-JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distillation; consequently, dietary exposure was not calculated for distilled alcohol products. For other brewery products, based on the maximum use level recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-TOS was estimated to be up to 0.003 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic 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 at the highest dose of 1,018 mg TOS/kg bw per day. When compared with the dietary exposure, this results in a sufficiently high margin of exposure (at least 300,000). The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
| S-EPMC7009408 | biostudies-literature
Project description:The food enzyme pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced with the genetically modified Bacillus licheniformis strain NZYM-LU by Novozyme A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in brewing processes and in starch processing for production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the brewing processes. It was estimated to be up to 0.59 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. The similarity of the amino acid sequence 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 for this to occur is low. Based on the data provided, the QPS status of the production strain and the absence of issues of concern arising from the production process, the Panel concluded that the food enzyme pullulanase produced with the genetically modified B. licheniformis strain NZYM-LU does not give rise to safety concerns under the intended conditions of use.
| S-EPMC9194765 | biostudies-literature
Project description:The food enzyme glutaminase (l-glutamine amidohydrolase EC 3.5.1.2) is produced with the genetically modified Bacillus licheniformis strain NZYM-JQ by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme is free from viable cells of the production organism and its DNA. The enzyme under assessment is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 0.148 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concern resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search was made for the similarity of the amino acid sequence to those of known allergens and one match with a pollen allergen was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, particularly for individuals sensitised to birch and oak pollen. The Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.
| S-EPMC11009860 | biostudies-literature
Project description:The food enzyme α-amylase (1,4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM-AC by Novozymes A/S. The genetic modifications do not give rise to safety concerns and the production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of glucose syrups and other starch hydrolysates, cereal-based products other than baked, brewed products and distilled alcohol; processing of fruits and vegetables for the production of juices and products other than juices; production of refined and unrefined sugars. Since the residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of concerns resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found with a respiratory allergen. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is 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.
| S-EPMC10667960 | biostudies-literature
Project description:The food enzyme β-galactosidase (β-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Bacillus licheniformis strain NZYM-BT by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for the hydrolysis of lactose. Based on the assumption that all selected milk and milk products are enzymatically treated, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.34 mg TOS/kg body weight (bw) per day in European populations. Toxicological data were reported and were considered as supporting evidence of the safety of the food enzyme. 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 672 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 1,950. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one 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, especially in individuals sensitised to galactosidase or to the matching allergen of pollen from Platanus. 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.
| S-EPMC9251851 | biostudies-literature
Project description:The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase; EC 3.2.1.8) is produced with a genetically modified Bacillus licheniformis (strain NZYM-CE) by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal-based processes. Based on the maximum use levels recommended for the respective food processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.012 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a genotoxic concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of at least 1,020 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure, this results in a margin of exposure (MoE) of at least 85,000. Similarity of the amino acid sequence 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 upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that based on the data provided and the derived MoE, this food enzyme does not give rise to safety concerns under the intended conditions of use.
| S-EPMC7009109 | biostudies-literature
Project description:The food enzyme α-amylase (4-α-d-glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM-BC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain was shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, cereal-based processes, refined and unrefined sugar production and fruit and vegetable processing for juice production. Since the residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food manufacturing processes. For the remaining four processes, the dietary exposure to the food enzyme-TOS was estimated to be up to 0.05 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise safety concern. The similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and one 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 was 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.
| S-EPMC9247866 | biostudies-literature
Project description:The food enzyme glucan 1,4-α-maltohydrolase (4-α-d-glucan α-maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM-SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4-α-maltohydrolase produced with the genetically modified B. licheniformis strain NZYM-SD does not give rise to safety concerns under the intended conditions of use.
| S-EPMC9200369 | biostudies-literature
Project description:The food enzyme glucan 1,4-α-maltohydrolase (4-α-d-glucan α-maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM-CY by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the baking and brewing processes. Dietary exposure was estimated to be up to 0.45 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4-α-maltohydrolase produced with the genetically modified B. licheniformis strain NZYM-CY does not give rise to safety concerns under the intended conditions of use.
| S-EPMC9202445 | biostudies-literature