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Abstract The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Bacillus licheniformis strain DSM 34099 by Kerry Group Services International, Ltd. (KGSI). 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 production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in two food manufacturing processes. Dietary exposure was estimated to be up to 7.263 mg total organic solids/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, other than an assessment of allergenicity, 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 one match with a food allergen from kiwi fruit was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to kiwi fruit, 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.

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.

Abstract The food enzyme lysophospholipase (2‐lysophosphatidylcholine acylhydrolase, EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain DP‐Nyc81 by Genencor International 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 its DNA. It is intended to be used in the processing of cereals and other grains for the production of glucose syrups and other starch hydrolysates. Since residual amounts of food enzyme–total organic solids are removed during these food manufacturing processes, dietary exposure was not calculated and toxicological studies were considered unnecessary. A search for the identity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. 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 The food enzyme inulinase (1‐β‐d‐fructan fructanohydrolase; EC 3.2.1.7) is produced with the non‐genetically modified Aspergillus welwitschiae strain NZYM‐KF by Novozymes A/S. The food enzyme is free from viable cells of the production organism. It is intended to be used in the processing of fructo‐polysaccharides for the production of fructo‐oligosaccharides. Since residual amounts of total organic solids (TOS) are removed during the food manufacturing process, toxicological studies other than allergenicity were considered unnecessary and dietary exposure was not calculated. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with tomato allergens were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to tomato, cannot be excluded, but is expected not to exceed that of tomato. As the prevalence of allergic reactions to tomato is low, also the likelihood of such reactions to occur to the food enzyme 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 sucrose phosphorylase (sucrose: phosphate α‐d‐glucosyltransferase; EC 2.4.1.7) is produced with the genetically modified Escherichia coli strain LE1B109‐pPB129 by c‐LEcta GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the production organism. It is intended to be used in combination with a cellobiose phosphorylase in the production of the specialty carbohydrate cellobiose. Since residual amounts of food enzyme–total organic solids are removed by the downstream purification steps, the Panel considered that toxicological studies other than assessment of allergenicity were unnecessary and a dietary exposure was not estimated. 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 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 The food enzyme with phospholipase A1 (phosphatidycholine 1‐acylhydrolase, EC 3.1.1.32) and lysophospholipase (2‐lysophosphatidylcholine acylhydrolase, EC 3.1.1.5) activities is produced with the genetically modified Aspergillus niger strain PLN by DSM. 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 for the production of refined edible fats and oils by degumming. Since residual amounts of total organic solids are removed during this process, dietary exposure was not calculated and toxicological studies were considered unnecessary 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 no matches were found. 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 The food enzyme carboxypeptidase D (EC 3.4.16.6) is produced with the genetically modified Aspergillus oryzae strain NZYM‐MK by Novozymes A/S. It is free from viable cells of the production organism and its DNA. The genetic modifications do not give rise to safety concerns. The food enzyme is intended to be used in five food manufacturing processes. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.908 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 2220 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 2445. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found, one with a food allergen (wheat). The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to wheat, cannot be excluded, but will not exceed that of wheat 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.

Abstract The food enzyme cellobiose phosphorylase (cellobiose: phosphate α‐d‐glucosyltransferase; EC 2.4.1.20) is produced with the genetically modified Escherichia coli strain LE1B109‐pPB130 by c‐LEcta GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in combination with a sucrose phosphorylase in the production of the specialty carbohydrate cellobiose. Since residual amounts of total organic solids are removed by downstream purification steps, the Panel considered that toxicological studies other than assessment of allergenicity were unnecessary and a dietary exposure was not estimated. 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, 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 The food enzyme subtilisin (EC 3.4.21.62) is produced with the genetically modified Bacillus licheniformis strain NZYM‐CB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes. The dietary exposure to the food enzyme‐TOS was estimated to be up to 0.722 mg TOS/kg body weight (bw) per day in European populations. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety approach to safety assessment. As no other concerns arising from the manufacturing process were identified, the Panel considered that toxicological tests were not required 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 20 matches were found, including two food allergens (melon and pomegranate). The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, particularly in individuals sensitised to melon and pomegranate, but would not exceed the risk from consumption of melon or pomegranate. 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 glutaminase (l‐glutamine amidohydrolase EC 3.5.1.2) is produced with the genetically modified Bacillus licheniformis strain NZYM‐JQ by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme is free from viable cells of the production organism and its DNA. The enzyme under assessment is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 0.148 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concern resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search was made for the similarity of the amino acid sequence to those of known allergens and one match with a pollen allergen was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, particularly for individuals sensitised to birch and oak pollen. The Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.

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. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in one food manufacturing process. Subsequently, the applicant requested to extend its use to include an additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of two food manufacturing processes: processing of dairy products for the production of modified milk proteins and the production of plant‐based analogues of milk and milk products. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.091 mg TOS/kg body weight (bw) per day in European populations. Using the no observed adverse effect level previously reported (2162 mg TOS/kg bw per day), the Panel derived a margin of exposure (MoE) of at least 23,758. Based on the data provided for the previous evaluation and the revised MoE, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

Abstract The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the genetically modified Aspergillus oryzae strain NZYM‐BU 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 its DNA. It is intended to be used in five food manufacturing processes. Dietary exposure to the food enzyme TOS was estimated to be up to 1.508 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 4,928 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 3,268. 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 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 the food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus oryzae strain AR‐962 by AB Enzymes GmbH. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in five food manufacturing processes. Subsequently, the applicant requested to extend its use to two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme for uses in a total of seven food manufacturing processes. As the food enzyme–total organic solids (TOS) is removed from the final foods in three food manufacturing processes, the dietary exposure to the food enzyme–TOS was estimated only for the remaining four processes. Dietary exposure was up to 0.575 mg TOS/kg body weight (bw) per day in European populations. When combined with the NOAEL reported in the previous opinion (1000 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 1739. Based on the data provided for the previous evaluation and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

Abstract The food enzyme α‐galactosidase (α‐d‐galactoside galactohydrolase; EC 3.2.1.22) is produced with the genetically modified Saccharomyces cerevisiae strain CBS 615.94 by Kerry Ingredients & Flavours Ltd. 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. As no other concerns arising from the genetically modified microbial source or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. The food enzyme is intended to be used in guar gum processing. The dietary exposure was estimated to be up to 0.828 mg TOS/kg body weight per day in European populations. 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 a 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 asparaginase (l‐asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified Aspergillus niger strain AGN 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 its DNA. It is intended to be used to prevent acrylamide formation in food processing. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.434 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with an asparaginase from A. niger (strain ASP). The Panel considered this food enzyme as a suitable substitute for the asparaginase to be used in the toxicological studies, because the genetic differences between the production strains are not expected to result in a different toxigenic potential, and the raw materials and manufacturing processes of both food enzymes are comparable. 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 1038 mg TOS/kg bw per day, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 724. 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 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 microbial collagenase (EC 3.4.24.3) is produced with the genetically modified Streptomyces violaceoruber strain pCol by Nagase (Europa) 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 two food manufacturing processes: the production of modified meat and fish products and the production of protein hydrolysates from meat and fish proteins. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.098 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 940 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 856. 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 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 protein–glutamine γ‐glutamyltransferase (protein–glutamine: amine γ‐glutamyltransferase; EC 2.3.2.13) is produced with the non‐genetically modified Streptomyces mobaraensis strain M2020197 by Taixing Dongsheng Bio‐Tech Co. Ltd. The identity of the production strain and the absence of viable cells could not be established. The food enzyme is intended to be used in eight food manufacturing processes: processing of cereals and other grains for the production of (1) baked products, (2) cereal‐based products other than baked; processing of dairy products for the production of (3) fermented dairy products, (4) cheese, (5) dairy desserts; processing of plant‐ and fungal‐derived products for the production of (6) meat analogues, (7) plant‐based analogues of milk and milk products; processing of meat and fish products for the production of (8) modified meat and fish products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 3.498 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 91 mg TOS/kg bw per day. The calculated margin of exposure for each age group was 36 (infants), 26 (toddlers), 50 (children), 99 (adolescents), 115 (adults) and 133 (the elderly). 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 a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is low. The safety of the food enzyme could not be established given the derived margins of exposure. Therefore, the Panel concluded that the food enzyme could not be considered safe under the intended conditions of use.

Abstract The food enzyme 3‐phytase (myo‐inositol‐hexakisphosphate 3‐phosphohydrolase EC 3.1.3.8) is produced with the genetically modified Aspergillus niger strain NPH by DSM Food Specialties. 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 three food manufacturing processes: processing of cereals and other grains for the production of (1) baked products and (2) distilled alcohol, and the processing of plant‐ and fungal‐derived products for the production of (3) plant‐based analogues of milk and milk products. Since no residual amounts of total organic solids (TOS) are carried over into distilled alcohol, dietary exposure was calculated only for the remaining two food manufacturing processes. It was estimated to be up to 0.553 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 833 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 1506. 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 the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Abstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Bacillus velezensis strain AR‐112 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 to the food enzyme–total organic solids (TOS) was estimated to be up to 0.024 mg TOS/kg body weight (bw) per day in European populations. As the production strain B. velezensis strain AR‐112 meets the requirements for the qualified presumption of safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data are required. 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 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 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 The food enzyme phosphoinositide phospholipase C (1‐phosphatidyl‐1D‐myo‐inositol‐4,5‐bisphosphate inositoltrisphosphohydrolase EC 3.1.4.11.) is produced with the genetically modified Pseudomonas fluorescens strain PIC 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 its DNA. It is intended to be used in the processing of fats and oils for the production of refined edible fats and oils by degumming. Since residual amounts of the total organic solids are removed by the washing and purification steps applied during degumming, dietary exposure estimation and toxicity testing were considered unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur 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 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.

Abstract The food enzyme α‐amylase (1,4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐AC by Novozymes A/S. The genetic modifications do not give rise to safety concerns and the production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of glucose syrups and other starch hydrolysates, cereal‐based products other than baked, brewed products and distilled alcohol; processing of fruits and vegetables for the production of juices and products other than juices; production of refined and unrefined sugars. Since the residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of concerns resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found with a respiratory allergen. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Abstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified microorganism Bacillus subtilis strain XAN 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 its DNA. The production strain of the food enzyme contains antimicrobial resistance genes. 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 baking processes and cereal‐based processes. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.02 mg TOS/kg body weight (bw) per day in European populations. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and 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.

Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Saccharomyces cerevisiae strain LALL‐LI by Lallemand Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism, but not from recombinant DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.42 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety (QPS) approach to safety assessment. Therefore, the Panel considered that toxicological tests are 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 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.

Abstract The food enzyme inulinase (1‐β‐d‐fructan fructanohydrolase; EC 3.2.1.7) is produced with the genetically modified Aspergillus oryzae strain MUCL 44346 by PURATOS NV. 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 production of fructo‐oligosaccharides (FOS) from inulin extracted from chicory roots. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.01 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 (NOAEL) of 100 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 10,000. 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 tomato allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to tomato, cannot be excluded. However, the likelihood of allergic reactions is expected not to exceed the likelihood of allergic reactions to tomato. As the prevalence of allergic reactions to tomato is low, also the likelihood of such reactions to occur to the food enzyme 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 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.

Abstract The food enzyme asparaginase (l‐asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified microorganism Aspergillus oryzae strain NZYM‐OA 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 its DNA. It is intended to be used in various food manufacturing processes to prevent acrylamide formation. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.051 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 1,182 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 23,176. 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.

Abstract The food enzyme endo‐polygalacturonase ((1–4)‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Aspergillus niger strain EPG 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 its DNA. It is intended to be used in fruit and vegetable processing for juice production. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.122 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 1,014 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure at least 8,311. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 38 matches were found, two of which are food allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya or maize, but that the risk will not exceed that of consumption of papaya or maize. In addition, oral allergy reactions cannot be excluded in pollen‐sensitised individuals. 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 α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus subtilis strain AR‐651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.19 mg TOS/kg body weight (bw) per day in European populations. The production strain carries known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Abstract The food enzyme d‐tagatose 3‐epimerase (EC 5.1.3.31) is produced with the genetically modified Escherichia coli strain PS‐Sav‐001 by SAVANNA Ingredients GmbH. 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 used while retained inside a membrane reactor to convert d‐fructose into the speciality carbohydrate d‐allulose (syn. d‐psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d‐allulose, dietary exposure was not calculated and toxicological studies were not considered necessary. 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.

Abstract The food enzyme phospholipase A1 (phosphatidylcholine 1‐acylhydrolase; EC 3.1.1.32) is produced with the genetically modified Aspergillus oryzae strain NZYM‐PP by Novozymes A/S. 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 milk processing for cheese production. 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 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 575.1 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 47,925. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no 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 for this to occur is low. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Kluyveromyces lactis strain KLA by DSM Food Specialties B.V. The genetic modifications did not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used for the lactose hydrolysis in milk processing, production of fermented milk products and whey processing. It is also intended for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 11.876 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the Qualified Presumption of Safety (QPS) approach to safety assessment. As no concerns arising from its genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and 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 for this to occur is low. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐AY by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in starch processing for the production of glucose syrup and other starch hydrolysates, and distilled alcohol production. Since residual amounts of total organic solids are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure estimation was considered unnecessary. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety (QPS) approach to safety assessment. As no other concerns arising from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one 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 did not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Kluyveromyces lactis strain CIN 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 its recombinant DNA. It is intended to be used in milk processing for cheese production and for the production of fermented milk products. Dietary exposure was estimated to be up to 0.73 mg total organic solids (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 1,000 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 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and four matches were found. The Panel considered that under the intended conditions of use the risk of allergic sensitisation and elicitation reactions by dietary exposure, although unlikely, cannot be excluded, particularly for individuals sensitised to cedar pollen allergens. 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 chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. 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 milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur 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.

Abstract The food enzyme phosphoinositide phospholipase C (1‐phosphatidyl‐1D‐myo‐inositol‐4,5‐bisphosphate inositoltrisphosphohydrolase, EC 3.1.4.11) is produced with the genetically modified Bacillus licheniformis strain NZYM‐DI by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was co nsidered free from viable cells of the production organism and its DNA. It is intended to be used for degumming of fats and oils. Since residual amounts of total organic solids are removed during washing and purification steps applied during degumming, dietary exposure was not estimated. As the production strain B. licheniformis NZYM‐DI qualifies for the QPS approach to safety assessment and no issue of concern arose from the production process, no toxicological data were required. 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, the risk of allergic sensitisation and elicitation reactions by dietary exposure could not be excluded, but the likelihood for this to occur was 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.

Abstract 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.

Abstract The food enzyme phospholipase A1 (phosphatidylcholine 1‐acylhydrolase; EC 3.1.1.32) is produced with the genetically modified Aspergillus oryzae strain NZYM‐LJ 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 its DNA. The food enzyme is intended to be used in baking processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.09 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 957.3 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 10,600. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made 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 for this to occur is considered to be low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Bacillus licheniformis strain NZYM‐BT by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for the hydrolysis of lactose. Based on the assumption that all selected milk and milk products are enzymatically treated, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.34 mg TOS/kg body weight (bw) per day in European populations. Toxicological data were reported and were considered as supporting evidence of the safety of the food enzyme. 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 672 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 1,950. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made 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, especially in individuals sensitised to galactosidase or to the matching allergen of pollen from Platanus. 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 endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain NZYM‐ER by Novozymes A/S. 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 brewing processes, distilled alcohol production, grain treatment for the production of starch and gluten fractions and for palm oil production. Since residual amounts of total organic solids (TOS) are removed by distillation, in palm oil production and in grain treatment for the production of starch and gluten fraction, dietary exposure was only calculated for brewing processes. Dietary exposure to the food enzyme TOS was estimated to be up to 0.09 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 1,051 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 11,400. 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.

Abstract The food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan glucohydrolase EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BE by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal‐based processes, and fruit and vegetable processing for juice production. Since residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied to produce glucose syrups, dietary exposure was not calculated for these two food processes. For the remaining four processes, dietary exposure to the food enzyme–TOS was estimated to be up to 7.7 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 3,795 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 490. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and one match 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.

Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐FR by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the baking and brewing processes. Dietary exposure was estimated to be up to 0.30 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four 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 QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐FR does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase, EC 3.2.1.41) is produced with the genetically modified Bacillus licheniformis strain NZYM‐LU by Novozyme A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in brewing processes and in starch processing for production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the brewing processes. It was estimated to be up to 0.59 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. The 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 for this to occur is low. Based on the data provided, the QPS status of the production strain and the absence of issues of concern arising from the production process, the Panel concluded that the food enzyme pullulanase produced with the genetically modified B. licheniformis strain NZYM‐LU does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme pectin lyase ((1→4)‐6‐O‐methyl‐α‐d‐galacturonan lyase; EC 4.2.2.10) is produced with the genetically modified Aspergillus luchuensis (formally Aspergillus niger) strain FLOSC 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 its DNA. The food enzyme is intended to be used in fruit and vegetable processing for juice production. Based on the maximum use level 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 0.268 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 794 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 2,900. 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 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 The food enzyme mannan endo‐1,4‐β‐mannosidase (1,4‐β‐d‐mannan mannanohydrolase, EC 3.2.1.78) is produced with the genetically modified Aspergillus niger strain NZYM‐NM by Novozymes A/S. 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 coffee processing. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.956 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 1,151.7 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 more than 1,200. 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 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 The food enzyme non‐reducing end α‐l‐arabinofuranosidase (α‐l‐arabinofuranoside non‐reducing end α‐l‐arabinofuranosidase; EC 3.2.1.55) is produced with the genetically modified Trichoderma reesei strain NZYM‐GV 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 its DNA. It is intended to be used in grain treatment for the production of starch and gluten fractions. Since residual amounts of total organic solids (TOS) are removed by washing and purification steps applied during grain treatment, the estimation of a dietary exposure is considered not necessary. 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 1,116 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 for this to occur is considered to be low. Based on the data provided and the removal of TOS during the grain treatment, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract This assessment addresses a food enzyme preparation consisting of the immobilised intact but non‐viable cells of the genetically modified Corynebacterium glutamicum strain FIS002 by CJ‐Tereos Sweeteners Europe SAS. The production strain produces the food enzyme d‐fructose 3‐epimerase (d‐psicose 3‐epimerase; EC 5.1.3.30). The food enzyme preparation is used in processing fructose to produce a speciality carbohydrate d‐allulose (synonym d‐psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d‐allulose, 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 (NOAEL) of 1,796 mg TOS/kg body weight (bw) per day, the highest dose tested. A search for similarity of the amino acid sequence of the 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 sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is low. The food enzyme preparation contains multiple copies of an antimicrobial resistance gene, which is considered a hazard. However, under the specific intended conditions of use described by the applicant, and based on the evidence showing the removal of TOS during the production of d‐allulose and the absence of recombinant DNA in the d‐allulose, the Panel concluded that the identified hazard associated with the food enzyme d‐psicose 3‐epimerase produced with the genetically modified C. glutamicum strain FIS002 will not result in a risk.

Abstract The food enzyme catalase (hydrogen‐peroxide:hydrogen‐peroxide oxidoreductase; EC 1.11.1.6) is produced with the genetically modified Aspergillus niger strain DP‐Azw58 by Danisco US, Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in egg processing. Based on the maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1 μg 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 1,288 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 1.3 × 106. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made 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 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.