Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain LMG‐S 32676
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PROVIDER: S-EPMC10565612 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
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| S-EPMC11551588 | biostudies-literature
Project description:The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism Bacillus amyloliquefaciens strain BA by HBI Enzymes Inc. The enzyme under assessment is intended to be used in six food processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, production of dairy analogues and production of rice-based meals. Since residual amounts of total organic solids (TOS) are removed during distillation and during the production of glucose syrups and other starch hydrolysates, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 4.805 mg TOS/kg body weight (bw) per day in European populations. The applicant did not provide sufficient data to demonstrate that the production strain meets the qualified presumption of safety (QPS) criteria, or proof of absence of viable cells and DNA from the production organism in the food enzyme. Therefore, the Panel was not able to conclude on the safety of the microbial source. A margin of exposure could not be calculated in the absence of toxicological studies. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel could not conclude on the safety of this food enzyme, under the intended conditions of use.
| S-EPMC10388231 | biostudies-literature
Project description:The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified Bacillus amyloliquefaciens strain NZYM-WR by Novozymes A/S. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in nine food manufacturing processes: processing of cereals and other grains for the production of baked products, cereal-based products other than baked, glucose syrups and other starch hydrolysates, distilled alcohol and brewed products; production of refined and unrefined sugar, production of plant-based analogues of milk and milk products; processing of fruits and vegetables for the production of juices and fruit and vegetable products other than juices. Since residual amounts of total organic solids (TOS) are removed during two processes, a dietary exposure was calculated only for the remaining seven food manufacturing processes. Exposure was estimated to be up to 0.450 mg TOS/kg body weight per day in European populations. As the production strain qualified for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme 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-EPMC10701602 | biostudies-literature
Project description:The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified B. amyloliquefaciens strain BANSC by Advanced Enzyme Technologies Ltd. The α-amylase is intended to be used in brewing and baking processes and in starch processing for glucose syrups production and other starch hydrolysates. Since residual amounts of the food enzyme are removed during the starch processing for glucose syrups production, it is excluded from the dietary exposure estimation. Based on the maximum recommended use levels for brewing and baking processes, and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.468 mg TOS/kg body weight (bw) per day. The parental strain meets the required qualifications to be considered as a Qualified Presumption of Safety (QPS) organism and is therefore presumed to be safe. The conclusions on safety of the food enzyme are made following the QPS approach in relation to the production strain, with additional consideration of the conditions of manufacture. Consequently, the Panel considers no toxicological studies other than assessment of allergenicity necessary. Similarity of the amino acid sequence 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 upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
| S-EPMC7008862 | biostudies-literature
Project description:The food enzyme alpha-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Bacillus subtilis strain NBA by DSM Food Specialities B.V. This α-amylase is intended to be used in baking processes. The genetic modifications do not give rise to safety concerns and the food enzyme is free from viable cells of the production organism and recombinant DNA. The parental strain meets the required qualifications to be considered as a Qualified Presumption of Safety (QPS) organism and is therefore presumed to be safe. Since the production strain is not cytotoxic and since the introduced genetic modifications do not raise safety concerns, the presumption of safety made for the parental strain is extended to the production strain. The conclusions on safety of the food enzyme are made following the QPS approach in relation to the production strain, with additional consideration of the conditions of manufacture. However, the Panel considers no toxicological studies other than assessment of allergenicity necessary. This is based on the QPS status of the production strain and the absence of any hazards from the product and downstream processing. Based on the maximum use level recommended for the baking processes and individual data from the European Food Safety Authority (EFSA) Comprehensive European Food Consumption Database, dietary exposure was estimated to be up to 0.093 mg TOS/kg body weight per day in European populations. 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 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-EPMC7009207 | 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 strain Bacillus licheniformis DP-Dzb25 by Danisco US Inc. It is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, and in brewing processes. Since residual amounts of the food enzyme are removed by distillation and during starch processing, no dietary exposure was calculated for these food processes. Based on the maximum use levels recommended for brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.138 mg TOS/kg body weight (bw) per day. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene and consequently, it does not fulfil the requirements for the Qualified Presumption of Safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. Similarity of the amino acid sequence to those of known allergens was searched for and no match was found. The Panel notes that the food enzyme may contain a known allergen. Therefore, allergenicity cannot be excluded for uses other than distilled alcohol production. Apart from potential allergenicity, the Panel concluded that the food enzyme 4-α-d-glucan glucanhydrolase produced with the genetically modified B. licheniformis strain DP-Dzb25 does not give rise to safety concerns under the intended conditions of use.
| S-EPMC7008891 | biostudies-literature
Project description:The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus subtilis strain AR-651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1.19 mg TOS/kg body weight (bw) per day in European populations. The production strain carries known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were 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 considered to be low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns, under the intended conditions of use.
| S-EPMC9936607 | 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 α-amylase (1,4-α-D-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP-Dzb45 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of an antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this was not considered to be a risk. The α-amylase is intended to be used in brewing processes and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation, no dietary exposure was calculated for this intended use. Based on the maximum use levels recommended for the brewing 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 0.138 mg TOS/kg body weight per day in European populations. Toxicological tests with the food enzyme indicated that there was no concern with respect to genotoxicity or systemic toxicity. A no observed adverse effect level was identified in rats, which, compared with the dietary exposure, results in a margin of exposure of at least 484. Similarity of the amino acid sequence 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 can be excluded in distilled alcohol production but cannot be excluded when the enzyme is used in brewing. 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-EPMC7662087 | biostudies-literature