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The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Saccharomyces cerevisiae strain LALL‐MA+ by Danstar Ferment AG. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for production of baked products. Dietary exposure was estimated to be up to 0.014 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the identity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found, three with respiratory allergens and one with an allergen from mosquito (injected). The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, 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. [ABSTRACT FROM AUTHOR]

Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Saccharomyces cerevisiae strain LALL‐MA+ by Danstar Ferment AG. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for production of baked products. Dietary exposure was estimated to be up to 0.014 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the identity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found, three with respiratory allergens and one with an allergen from mosquito (injected). The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, 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.

The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase, EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain BABSC by Advanced Enzyme Technologies Ltd. The requirements for the qualified presumption of safety (QPS) approach have not been met. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in baking processes and starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed, dietary exposure was not calculated for starch processing for the production of glucose syrups and other starch hydrolysates. For baking processes, the dietary exposure was estimated to be up to 0.101 mg TOS/kg body weight per day in European populations. No toxicological studies were provided by the applicant. 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 by dietary exposure cannot be excluded, but the likelihood is low. In the absence of appropriate data to fully characterise the production strain, the Panel was unable to conclude on the safety of the food enzyme under the intended conditions of use. [ABSTRACT FROM AUTHOR]

Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase, EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain BABSC by Advanced Enzyme Technologies Ltd. The requirements for the qualified presumption of safety (QPS) approach have not been met. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in baking processes and starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed, dietary exposure was not calculated for starch processing for the production of glucose syrups and other starch hydrolysates. For baking processes, the dietary exposure was estimated to be up to 0.101 mg TOS/kg body weight per day in European populations. No toxicological studies were provided by the applicant. 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 by dietary exposure cannot be excluded, but the likelihood is low. In the absence of appropriate data to fully characterise the production strain, the Panel was unable to conclude on the safety of the food enzyme under the intended conditions of use.

The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain MAMDSM by DSM Food Specialties. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked and brewed products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.204 mg TOS/kg body weight (bw) per day in European populations. The production strain meets the requirements for the QPS approach. As no concerns arising from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, 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. [ABSTRACT FROM AUTHOR]

The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐D‐glucan α‐maltohydrolase EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐513 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in four food manufacturing processes: processing of cereals and other grains for the production of baked products, other cereal‐based products and glucose syrups and other starch hydrolysates; processing of plant‐ and fungal‐derived products for the production of plant‐based analogues of milk and milk products. Since residual amounts of total organic solids (TOS) are removed in the production of glucose syrups and other starch hydrolysates, dietary exposure was not calculated for this process. For the remaining three food processes, exposure to the food enzyme‐TOS was estimated to be up to 0.2 μg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR‐513 meets the requirements for the qualified presumption of safety (QPS) approach and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and five matches with respiratory allergens and one with a mosquito allergen were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme did not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain MAMDSM by DSM Food Specialties. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked and brewed products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.204 mg TOS/kg body weight (bw) per day in European populations. The production strain meets the requirements for the QPS approach. As no concerns arising from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, 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.

Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐D‐glucan α‐maltohydrolase EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐513 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in four food manufacturing processes: processing of cereals and other grains for the production of baked products, other cereal‐based products and glucose syrups and other starch hydrolysates; processing of plant‐ and fungal‐derived products for the production of plant‐based analogues of milk and milk products. Since residual amounts of total organic solids (TOS) are removed in the production of glucose syrups and other starch hydrolysates, dietary exposure was not calculated for this process. For the remaining three food processes, exposure to the food enzyme‐TOS was estimated to be up to 0.2 μg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR‐513 meets the requirements for the qualified presumption of safety (QPS) approach and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and five matches with respiratory allergens and one with a mosquito allergen were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme did not give rise to safety concerns, under the intended conditions of use.

The food enzyme glucan‐1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐453 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure was estimated to be up to 0.262 mg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR‐453 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and six matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, 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. [ABSTRACT FROM AUTHOR]

Abstract The food enzyme glucan‐1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐453 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure was estimated to be up to 0.262 mg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR‐453 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and six matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, 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.

Abstract The food enzyme maltogenic α‐amylase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Saccharomyces cerevisiae strain LALL‐MA by Lallemand Baking Solutions. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in baking processes. Based on the maximum use level recommended for the baking processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure was estimated to be up to 0.059 mg total organic solids (TOS)/kg body weight per day in European populations. As the production strain of S. cerevisiae meets the requirements for a Qualified Presumption of Safety (QPS) approach, no toxicological data are required. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and six matches 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 concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

The food enzyme maltogenic α‐amylase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Saccharomyces cerevisiae strain LALL‐MA by Lallemand Baking Solutions. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in baking processes. Based on the maximum use level recommended for the baking processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure was estimated to be up to 0.059 mg total organic solids (TOS)/kg body weight per day in European populations. As the production strain of S. cerevisiae meets the requirements for a Qualified Presumption of Safety (QPS) approach, no toxicological data are required. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and six matches 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 concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

Abstract The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, baking and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these processes. Based on the maximum use levels recommended for baking and brewing 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 0.199 mg TOS/kg body weight (bw) per day. 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 at least 80 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 400. Similarity of the amino acid sequence to those of known allergens was searched and three matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure can be excluded in distilled alcohol production and is considered to be low in starch processing, baking and 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.

The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, baking and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these processes. Based on the maximum use levels recommended for baking and brewing 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 0.199 mg TOS/kg body weight (bw) per day. 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 at least 80 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 400. Similarity of the amino acid sequence to those of known allergens was searched and three matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure can be excluded in distilled alcohol production and is considered to be low in starch processing, baking and 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. [ABSTRACT FROM AUTHOR]

Abstract The food enzyme, a maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133), is produced with a genetically modified Escherichia coli strain BLASC by Advanced Enzyme Technologies Ltd. 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 maltogenic amylase is intended to be used in baking and brewing processes and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated for this food process. For baking and brewing processes, based on the maximum use levels recommended for food processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.107 mg TOS/kg body weight (bw) per day. 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 at the highest dose tested of 838 mg TOS/kg bw per day that, compared with the estimated dietary exposure, resulted in a sufficiently high margin of exposure (at least 7,800). Similarity of the amino acid sequence to those of known allergens was searched and one match was found with respiratory allergen produced by Aspergillus oryzae. The Panel considered that, under the intended conditions of use, the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reaction to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Abstract The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.649 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 in rats. The Panel identified a no observed adverse effect level at the mid‐dose of 371 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). Similarity of the amino acid sequence to those of known allergens was searched and three 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 Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organic Solids (TOS) was estimated to be up to 0.556 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 at the mid‐dose of 318.4 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). Similarity of the amino acid sequence to those of known allergens was searched and three 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 Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme considered in this opinion is a glucan 1,4‐α‐maltohydrolase (maltogenic α‐amylase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain MAM by the company DSM Food Specialties B. V. The food enzyme contains neither the production microorganism nor recombinant DNA; therefore, no environmental risk assessment is required. However, the Panel emphasises that this conclusion only covers the food enzyme recovered via filter press. The glucan 1,4‐α‐maltohydrolase is intended for use in baking processes. Based on the maximum use levels recommended and individual consumption 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 0.175 mg TOS/kg body weight (bw) per day in European populations. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (986 mg TOS/kg bw per day for both males and females), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; one match was found. However, the Panel considered that there are no indications for food allergic reactions to this glucan 1,4‐α‐maltohydrolase by dietary exposure. No safety concerns were identified in relation to the genetic modifications, the manufacturing process, the compositional data provided, as well as the exposure, allergenicity and systemic toxicity assessments. However, owing to the incompleteness of the genotoxicity data, the Panel is not able to conclude on the safety of the food enzyme.

The food enzyme considered in this opinion is a glucan 1,4-α-maltohydrolase (maltogenic a-amylase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain MAM by the company DSM Food Specialties B. V. The food enzyme contains neither the production microorganism nor recombinant DNA; therefore, no environmental risk assessment is required. However, the Panel emphasises that this conclusion only covers the food enzyme recovered via filter press. The glucan 1,4-α-maltohydrolase is intended for use in baking processes. Based on the maximum use levels recommended and individual consumption 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 0.175 mg TOS/kg body weight (bw) per day in European populations. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (986 mg TOS/kg bw per day for both males and females), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; one match was found. However, the Panel considered that there are no indications for food allergic reactions to this glucan 1,4-α-maltohydrolase by dietary exposure. No safety concerns were identified in relation to the genetic modifications, the manufacturing process, the compositional data provided, as well as the exposure, allergenicity and systemic toxicity assessments. However, owing to the incompleteness of the genotoxicity data, the Panel is not able to conclude on the safety of the food enzyme. [ABSTRACT FROM AUTHOR]

The food enzyme considered is a maltogenic amylase (glucan 1,4-α-maltohydrolase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain NZYM-SM by Novozymes A/S. The food enzyme contains neither the production organism nor recombinant DNA. The maltogenic amylase is intended for use in baking processes and starch processing for glucose syrups production. Based on the maximum use levels recommended for the food processes and individual consumption 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 0.168 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosomal aberrations in human lymphocytes. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (320 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens. Three matches to occupational respiratory allergens were found, however, the Panel considered that there are no indications for food allergic reactions to the food enzyme. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concluded that the food enzyme maltogenic amylase from Bacillus subtilis strain NZYM-SM does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme, a maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133), is produced with a genetically modified Escherichia coli strain BLASC by Advanced Enzyme Technologies Ltd. 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 maltogenic amylase is intended to be used in baking and brewing processes and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated for this food process. For baking and brewing processes, based on the maximum use levels recommended for food processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.107 mg TOS/kg body weight (bw) per day. 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 at the highest dose tested of 838 mg TOS/kg bw per day that, compared with the estimated dietary exposure, resulted in a sufficiently high margin of exposure (at least 7,800). Similarity of the amino acid sequence to those of known allergens was searched and one match was found with respiratory allergen produced by Aspergillus oryzae. The Panel considered that, under the intended conditions of use, the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reaction to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.649 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 in rats. The Panel identified a no observed adverse effect level at the mid‐dose of 371 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). Similarity of the amino acid sequence to those of known allergens was searched and three 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 Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]