Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain LP‐N836
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PROVIDER: S-EPMC10915719 | biostudies-literature | 2024 Mar
REPOSITORIES: biostudies-literature
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Project description:The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non-genetically modified Rhizomucor miehei strain FRO by DSM Food Specialties B.V. The enzyme can be chemically modified to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in three food manufacturing processes: processing of dairy products for the production of (1) cheese, (2) edible rennet casein, (3) fermented dairy products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to about 0.072 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 2000 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 27,778. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and five matches were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but is considered low, except for individuals sensitised to mustard proteins, for whom the risk will not exceed that of mustard consumption. 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-EPMC10797429 | biostudies-literature
Project description:The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non-genetically modified Rhizomucor miehei strain M19-21 by Meito Sangyo Co., Ltd. The enzyme is chemically modified to produce a thermolabile form. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the processing of dairy products for the production of cheese and fermented dairy products. Based on the maximum use levels, dietary exposure was estimated to be up to 0.108 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 226 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 2093. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches to respiratory allergens and one match to a food allergen (mustard) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to mustard proteins, cannot be excluded. 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-EPMC10895450 | biostudies-literature
Project description:The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non-genetically modified Rhizomucor miehei strain DSM 29547 by Chr. Hansen. The food enzyme is free from viable cells of the production organism. It is intended to be used in dairy processing for cheese production. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.26 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 a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 618 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 2,400. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made 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 cannot be excluded but is considered low except for individuals sensitised to mustard proteins, but this risk will not exceed that of mustard consumption. 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-EPMC9371598 | biostudies-literature
Project description:The food enzyme mucorpepsin (aspartic endopeptidase, EC 3.4.23.23) is produced with the non-genetically modified microorganism Rhizomucor miehei strain MMR 164. The enzyme is chemically modified by DuPont Nutrition Biosciences (now IFF) to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in milk processing for cheese production. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.98 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 1,320 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and five 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 is considered low except for individuals sensitised to mustard proteins, but this risk will not exceed that of mustard consumption. 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-EPMC9353654 | biostudies-literature
Project description:The food enzyme mucorpepsin (aspartic endopeptidase, EC 3.4.23.23) is produced with the non-genetically modified microorganism Rhizomucor miehei strain MMR 164 by Takabio. The enzyme is chemically modified to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in milk processing for cheese production. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.98 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 1,320 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and five 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 is considered low except for individuals sensitised to mustard proteins, but this risk will not exceed that of mustard consumption. 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-EPMC9347239 | biostudies-literature
Project description:Abstract The food enzyme peroxidase (phenolic donor: hydrogen‐peroxide oxidoreductase, EC 1.11.1.7) is produced with the genetically modified Aspergillus niger strain MOX by DSM Food Specialties B.V. 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. The food enzyme is intended to be used in whey processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.635 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 2,162 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure resulted in a margin of exposure of at least 3,405. A search for the 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, 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.
| S-EPMC10316123 | biostudies-literature
Project description: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.
| S-EPMC7009224 | biostudies-literature
Project description:The food enzyme glucoamylase (glucan 1,4-α-glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger 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 glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. 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 brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme-TOS was estimated to be below 3.627 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 rodents. The Panel identified a no-observed-adverse-effect level (NOAEL) at the highest dose of 1,360 mg TOS/kg bw per day. 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 condition 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 removal of TOS during the production of glucose syrups and the derived margin of exposure for brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
| S-EPMC7009475 | biostudies-literature
Project description:The food enzyme alpha-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with a non-genetically modified Aspergillus niger (strain DP-Azb60) by Danisco US Inc. The food enzyme is free from viable cells of the production organism. The α-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 0.503 mg TOS/kg body weight (bw) per day. 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 (NOAEL) at the highest dose of 1,000 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (of at least 1,988). Similarity of the amino acid sequence to those of known allergens was searched and one match was found to Asp o 21, an alpha-amylase from Aspergillus oryzae. 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 give rise to safety concerns under the intended conditions of use.
| S-EPMC7009225 | biostudies-literature
Project description: Not available
| S-EPMC10784861 | biostudies-literature