Trehalase - Trichoderma reesei (Stamm DP-Nzs51, GVO)

EFSA CEP Panel (2019): Scientific Opinion on safety evaluation of the food enzyme a,a-trehalas e glucohydrolase from Trichoderma reesei (strain DP-Nzs51). EFSA Journal 2019; 17(7):5768, 10 pp. | https://doi.org/10.2903/j. efsa.2019.5768

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5768

The food enzyme trehalase (a,a-trehalase glucohydrolase, EC 3.2.1.28) is produced with a genetically modified Trichoderma reesei DP-Nzs51 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 trehalase is intended to be used in distilled alcohol production. Since residual amounts of total organic solids are removed by distillation (> 99%), toxicological data were not considered necessary and dietary exposure was not calculated. 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 by dietary exposure can 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.

Chitinase - Streptomyces violaceoruber (Stamm pChi, GVO)

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme chitinase from Streptomyces violaceoruber (strain pChi). EFSA Journal 2019; 17(7):5767, 15 pp. | https://doi.org/10.2903/j.efsa.2019.5767

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5767

The food enzyme, a chitinase (EC 3.2.1.14), is produced with the genetically modified Streptomyces violaceoruber strain pChi by Nagase. No information was provided regarding the presence of antimicrobial resistance genes in the production strain, other than that used in the genetic modification. The chitinase 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 on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. The exposure estimate is up to 0.829 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repea ted dose 90-days oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose tested of 791 mg TOS/kg body weight, which, compared with the dietary exposure, results in margin of exposure of at least 1,171. Similarity of the amino acid sequence to those of known allergens was searched and no matches were found. The Panel considered that there are no indications for food allergic reactions to this chitinase. Based on the data provided and the derived margin of exposure, the Panel concluded that the food enzyme chitinase produced with the genetically modified S. violaceo ruber strain pChi does not give rise to safety concerns arising from the toxicological studies and the production process under the intended conditions of use. The CEP Panel was unable to conclude on the absence of viable cells and DNA from the genetically modified production strain in the food enzyme, for which uncertainty remains on the possible presence of gene(s) conferring antimicrobial resistance

Ascorbat-Oxiase aus Cucurbita pepo L. and Cucurbita moschata Duchesne

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme L-ascorbate oxidase from Cucurbita pepo L. and Cucurbita moschata Duchesne. EFSA Journal 2019; 17(6):5740, 17 pp. | https://doi.org/10.2903/j.efsa.2019.5740

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5740

The food enzyme L-ascorbate: oxygen oxidoreductase (EC 1.10.3.3) is extracted from fruit peels of Cucurbita pepo L. and Cucurbita moschata Duchesne by Na gase (Europa) GmbH. This enzyme is intended to be used in baking and cereal-based processes. Based on 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 5.950 mg TOS/kg body weight per day in European populations. This exposure is in the same order of magnitude for infants and toddlers; but for children, adolescents, adults and the elderly it is one order of magnitude higher than the exposure to the fraction of the fruit peels comparable to the food enzyme–TOS. The Panel, while recognising the order of magnitude of difference in the exposure estimates, considers that any realistic exposure derived from the use of the food enzyme would be considerably lower and likely to be within the range of exposure through a typical diet. The Panel agreed that the requirements for exclusion of toxicological data were met. Amino acid sequence similarity to known allergens was searched and no match was found. The Panel considered that the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but are not expected to exceed the likelihood of the allergic reactions following consumption of pumpkin or zucchini per se, which is low. Based on the data provided and the origin of the food enzyme from edible parts of C. pepo L. and C. moschata Duchesne, the Panel considers that the food enzyme L-ascorbate oxidase does not raise safety

concerns under the intended conditions of use.

a-Amylase Bacillus licheniformis (Stamm DP-Dzb44, GVO)

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme a-amylase from Bacillus licheniformis (strain DP-Dzb44). EFSA Journal 2019; 17(6):5738, 11 pp. | https://doi.org/10.2903/j.efsa.2019.5738

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5738

The food enzyme a-amylase (1,4-a-D-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP-Dzb44 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 a-amylase is intended to be used in distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation, toxicological studies were not considered necessary and no dietary exposure was calculated. 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. 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.

ß-Xylanase - Bacillus licheniformis (Stamm DP-Dzf24, GVO)

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme glucan 1,4-a-maltotetraohydrolase from Bacillus licheniformis (strain DP-Dzf24). EFSA Journal 2019; 17(6):5739, 15 pp. https://doi.org/10.2903/j.efsa.2019.5739

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5739

The food enzyme glucan 1,4-a-maltotetraohydrolase (EC 3.2.1.8) is produced with the genetically modified Bacillus licheniformis strain DP-Dzf24 by Danisco US Inc. The production strain contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in baking processes and starch processing for the production of glucose syrups. The residual amounts of the Total Organic Solids (TOS) in glucose syrups are removed by ultrafiltering and purification during starch processing. Consequently, dietary exposure was not calculated for this use. Based on the maximum use levels recommended for the baking 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 0.271 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 (NOAEL) was identified in rats, which, compared with the dietary exposure, results in a margin of exposure of at least 347. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that, under the intended conditions of use, the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, genetic modications, the manufacturing process, the compositional and biochemical data, the dietary exposure assessment and the findings in the toxicological studies, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

a-Amylase - Bacillus subtilis (Stamm NBA, GVO)  03.04.2019 / 14.05.2019

EFSA CEP-Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme alpha-amylase from a genetically modified Bacillus subtilis (strain NBA). EFSA Journal 2019; 17(5):5681, 15 pp. | https://doi.org/10.2903/j.efsa.2019.5681

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5681

The food enzyme alpha-amylase (4-a-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 a-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 parent al 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 population s. 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.

a-Amylase aus Aspergillus niger Stamm DP-Azb60, 03.04.2019 / 08.05.2019

EFSA CEP-Panel (2021): Scientific Opinion on the safety evaluation of the food enzyme alpha-amylase from non-genetically modified Aspergillus niger strain (strain DP-Azb60). EFSA Journal 2019; 17(5):5680, 14 pp. | https://doi.org/10.2903/j.efsa.2019.5680

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5680

The food enzyme alpha-amylase (4-a-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 a-amylase is intended to be used in baking processes. Based on the maximum use le vels, 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 o21, 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.

Glucan-Maltotetrahydrolase - Bacillus licheniformis (Stamm DP-Dzr46, GVO)

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme glucan 1,4-a-maltotetraohydrolase from Bacillus licheniformis (strain DP-Dzr46). EFSA Journal 2019; 17(5):5684, 16 pp. https://doi.org/10.2903/j.efsa.2019.5684

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5684

The food enzyme glucan 1,4-a-maltotetraohydrolase (4-a-D-glucan maltotetraohydrolase, EC 3.2.1.60) is produced with a genetically modified Bacillus licheniformis strain DP-Dzr46 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 glucan 1,4-a-maltotetraohydrolase 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 0.405 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with another glucan 1,4-a-maltotetraohydrolase from B. licheniformis (strain DP-Dzf24). The Panel considered this food enzyme as a suitable substitute to be used in the toxicological studies, because it derives from the same recipient strain as strain DP-Dzr46, the location of the inserts is comparable, no partial inserts were present and the production methods are comparable. 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 94 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure of at least 232. Similarity of the amino acid sequence to those of known allergens was searched and none 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 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.

a-Amylase und Glucan-Glucosyltransferase aus Paenibacillus alginolyticus

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme a-amylase and 1,4-a-glucan 6-a-glucosyltransferase from Paenibacillus alginolyticus. EFSA Journal 2019; 17(5):5683, 13 pp. | https://doi.org/10.2903/j.efsa.2019.5683

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5683

The food enzyme a-amylase (4-a-D-glucan glucanohydrolase, EC 3.2.1.1) and 1,4-a-glucan 6-a-glucosyl-transferase ((1?4)-a-D-glucan:(1?4)-a-D-glucan(D-glucose) 6-a-D-glucosyltransferase, EC 2.4.1.24) is produced with a Paenibacillus alginolyticus by Hayashibara Co., Ltd. The food enzyme is free from viable cells of the production organism. The a-amylase and 1,4-a-glucan 6-a-glucosyltransferase is intended to be used in starch processing for the production of isomaltodextrins. Residual amounts of total organic solids are removed by the purification steps applied during the production of isomaltodextrins and consequently dietary exposure is cons idered negligible. Similarity of the amino acid sequences 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 by dietary exposure to the food enzyme cannot be excluded, but the likelihood 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.

ß-Xylanase - Bacillus licheniformis (Stamm NZYM-CE, GVO) 04.04.2019 / 30.04.2019

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme endo-1,4-b-xylanase from a genetically modified Bacillus licheniformis (strain NZYM-CE). EFSA Journal 2019;17(4):5685, 16 pp. https://doi.org/10.2903/j.efsa.2019.5685

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5685

The food enzyme endo-1,4-b-xylanase (4-b -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 level s 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 identied a no observed adverse effect level (NOAEL) of at least 1,02 0 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 cond itions 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.

Phospholipase C - Komagataella phaffii (Stamm PRF, GVO)

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme phospholipase C from a genetically modified Komagataella phaffii (strain PRF). EFSA Journal 2019; 17(4):5682, 12 pp. | https://doi.org/10.2903/j.efsa.2019.5682

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5682

The food enzyme phospholipase C (EC 3.1.4.3) is produced with a genetically modified Komagataella phaffii (formerly Pichia pastoris) (strain PRF) by DSM. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cell s of the production organism and recombinant DNA. This phospholipase C is intended to be used in fats and oils processing for degumming. The residual amounts of total organic solids (TOS) are removed during refinement steps applied during fats and oils processing. Consequently, no dietary exposure was calculated. 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 (NOAEL) of at least 1,672 mg TOS/kg body weight per day, the highest dose tested. 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 is considered to be low. Based on the data provided and the removal of TOS during the fats and oils processing for degumming, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Lipase - Aspergillus niger (Stamm LFS, GVO)

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS). EFSA Journal 2019;17(3):5630, 16 pp. | https://doi.org/10.2903/j.efsa.2019.5630

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5630

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 suit able 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 sufciently 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.

Glucose-Oxidase - Aspergillus niger (Stamm ZGL, GVO)

EFSA CEP Panel ( 2019): Scientific Opinion on the safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL). EFSA Journal 2019;17(3):5629, 17 pp. | https://doi.org/10.2903/j.efsa.2019.5629

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5629

The food enzyme glucose oxidase (b-D-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL 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 glucose oxidase i 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 0.004 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 260,000). 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 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 conce rns under the intended conditions of use.

Glucanotransferas aus Aeribacillus pallid us (Stamm AE-SAS)

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme 4-a-glucanotransferase from Aeribacillus pallid us (strain AE-SAS). EFSA Journal 2019; 17(3):5628, 15 pp. https://doi.org/10.2903/j.efsa.2019.5628

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5628

The food enzyme 4-a-glucanotransferase (1,4-a-D-glucan:1,4-a-D-glucan 4-a-D-glycosyl transferase, EC 2.4.1.25) is produced with a non-genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended 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 0.050 mg TOS/kg body weight (bw) per day. Exposure assessment for the modified dextrins was not considered necessary. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 900 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure to the food enzyme us ed in baking, this results in a Margin of Exposure (MOE) of at least 18,000. The Panel con siders that any additional exposure to the food enzyme from the use of modified dextrins will be covered by the above MOE. A search was made for similarity of the amino acid sequence of the food enzyme with those of known allergens. One match was found with a known respiratory allergen, an a-amylase. The Panel considered that an allergic reaction upon oral ingestion of 4-a-glucanotransferase produced by A. pallidus AESAS in individuals respiratory sensitised to a-amylase cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.

ß-Glucanase, ß-Xylanase und Cellulase aus Mycothermus thermophiloides (Stamm NZYM-ST) 07.02.2019 / 08.03.2019

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme ß-glucanase, ß-Xylanase and cellulase from Mycothermus thermophiloides (strain NZYM-ST). EFSA Journal 2019; 17(3):5631, 15 pp. | https://doi.org/10.2903/j.efsa.2019.5631

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5631

The food enzyme has three declared activities (endo-1,3(4)-ß-glucanase EC 3.2.1.6, endo-1,4-ß-xylanase EC 3.2.1.8 and cellulase (endo-1,4-ß-D-glucanase EC 3.2.1.4)) and is produced with a non-genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo-1,3(4)-ß-glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM-ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.

Lysophospholispase - Trichoderma reesei (Stamm RF7206, GVO)

EFSA CEP Panel (2019): Scientific Opinion on the safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206). EFSA Journal 2019; 17(1):5548, 13 pp. | https://doi.org/10.2903/j.efsa.2019.5548

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5548

The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cell s of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the product ion 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. 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 927 mg TOS/kg body weight (bw) per day. 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 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 and the removal of TOS during the intend ed food production process, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.