Safety evaluation of the food enzyme triacylglycerol lipase from Trichoderma reesei (strain RF10625).
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ABSTRACT:
SUBMITTER: EFSA Panel on Food Contact Materials, Triacylglycerol lipases and Processing Aids (EFSA CEP Panel)
PROVIDER: S-EPMC7008919 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:The food enzyme cellulase (4-(1,3;1,4)-beta-D-glucan 4-glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified Trichoderma reesei strain DP-Nzc36 by Danisco US Inc. 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. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups and brewing processes. Since residual amounts of the food enzyme are removed by distillation and 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 0.131 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 97.6 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 745. 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 can be excluded in distilled alcohol production and is considered to be low when the enzyme is used in starch processing and brewing processes. 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.
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Project description:The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. 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. The triacylglycerol lipase food enzyme 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 0.020 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an asparaginase from A. niger (strain ASP). The Panel considered this enzyme as a suitable substitute to be used in the toxicological studies, because they derive from the same recipient strain, the location of the inserts are comparable, no partial inserts were present and the production methods are essentially the same. 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 (NOAEL) at the highest dose of 1,038 and 1,194 mg TOS/kg bw per day (for males and females, respectively) that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (MoE) (of at least 51,900). 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 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.
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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 Trichoderma reesei by Danisco US Inc. 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 α-amylase 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 this 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-TOS was estimated to be up to 1.701 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 (NOAEL) at the highest dose of 230 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 is considered low. Based on the removal of residues of the food enzyme during distillation, the Panel concluded that the use of this enzyme in the distilled alcohol production is safe. When used in brewing processes, the margin of exposure calculated from the data provided is only (at least) 135, but no safety issues were identified.
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Project description:The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Trichoderma reesei strain RF6201 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, production of wine and wine vinegar, coffee demucilation and production of plant extracts as flavouring preparations. Since residual amounts of the total organic solids (TOS) are removed during the coffee demucilation and the production of flavouring extracts, dietary exposure was calculated only for the remaining three food processes. It was estimated to be up to 0.532 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 1,000 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 1,880. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found with pollen allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure, particularly in individuals sensitised to pollen allergens, 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.
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Project description:Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain NZYM?DB 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. The food enzyme is intended to be used in an immobilised form in the production of modified fats and oils by interesterification. Based on the estimated use levels recommended for interesterification of fats and oils 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 0.75 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 highest dose of 1,132 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,500. 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 of such reactions to occur is likely to be low. Based on the data provided, the immobilisation of the food enzyme and the removal of total organic solids during fats and oils processing, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.
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Project description:The food enzyme endo-1,4-?-xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP-Nzd22) by DuPont. 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. The endo-1,4-?-xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of distilled alcohol, consequently dietary exposure was not calculated. For baking and brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme-TOS was estimated to be up to 0.416 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 of 1,000 mg TOS/kg bw per day. A comparison of the no observed adverse effect level with the dietary exposure results in a sufficiently high margin of exposure (at least 2,400). Similarity of the amino acid sequence to those of known allergens was searched and no 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 removal of TOS during the production of distilled alcohol and the derived margin of exposure for baking and brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
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Project description:The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified Trichoderma reesei strain AR-852 by AB Enzymes GmbH. The genetic modifications did 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 five food manufacturing processes: baking processes, brewing processes, distilled alcohol production, wine and wine vinegar production, and fruit and vegetable processing for juice production. As residual amounts of total organic solids (TOS) are removed by distillation, dietary exposure was only calculated for the other four food processes. Dietary exposure to the food enzyme TOS was estimated to be up to 0.1 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 1,000 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 10,000. A search for 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 (other than distilled alcohol production) 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.
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