To The Food Enzyme-total Organic Solids Research Articles

Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus oryzae strain NZYM-PP.

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 0.012mg 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 575.1mg 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.

Safety evaluation of the food enzyme 1,4-α-glucan branching enzyme from the non-genetically modified Geobacillus thermodenitrificans strain TRBE14.

The food enzyme 1,4-α-glucan branching enzyme ((1-4)-α-d-glucan:(1-4)-α-d-glucan 6-α-d-[(1-4)-α-d-glucano]-transferase; EC 2.4.1.18) is produced with the non-genetically modified Geobacillus thermodenitrificans strain TRBE14 by Nagase (Europa) GmbH. The production strain has been shown to qualify for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in cereal-based processes, baking processes as well as meat and fish processing. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.29mg TOS/kg body weight (bw) per day in European populations. Toxicological studies were not considered necessary given the QPS status of the production strain and the nature of the manufacturing process. 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 noted that the food enzyme contains lysozyme, a known allergen. Therefore, allergenicity 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.

Safety evaluation of the food enzyme catalase from the non-genetically modified Aspergillus niger strain CTS 2093.

The food enzyme catalase (hydrogen-peroxide:hydrogen-peroxide oxidoreductase; EC 1.11.1.6) is produced with the non-genetically modified Aspergillus niger strain CTS 2093 by Shin Nihon Chemical Co., Ltd. It is considered free from viable cells of the production organism. The food enzyme is intended to be used in eight food manufacturing processes: baking processes, cereal-based processes, coffee processing, egg processing, vegetable processing for juice production, processing of tea, herbal and fruit infusions, herring roe processing and milk processing for cheese production. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 3.61mg TOS/kg body weight (bw) per day in European populations. In addition, it is used in the production of acacia gum with the highest dietary exposure at the 95th percentile of 0.018mg TOS/kg bw per day in infants, when acacia gum is used as a food additive. 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 56mg TOS/kg bw per day, the mid-dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of 16. A search for 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, 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. Based on the data provided, the Panel considered the margin of exposure as insufficient to exclude safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme β-fructofuranosidase from the non-genetically modified Saccharomyces cerevisiae strain INV.

The food enzyme β-fructofuranosidase (β-d-fructofuranoside fructohydrolase; EC 3.2.1.26) is produced with the non-genetically modified Saccharomyces cerevisiae strain INV by DSM Food Specialties B.V. It is intended to be used in four food manufacturing processes: manufacture of specialty carbohydrates (invert sugar syrups), baking processes, production of sucrose-based fermented beverages and confectionary processes. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 2.51mg TOS/kg body weight (bw) per day in European populations. Toxicological studies were not considered necessary, given the qualified presumption of safety status of the production strain and the nature of the manufacturing process. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a tomato allergen was found. 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 to the β-fructofuranosidase from S. cerevisiae strain INV 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 reaction 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.

Safety evaluation of the food enzyme triacylglycerol lipase from the non-genetically modified Aspergillus luchuensis strain AE-L.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified Aspergillus luchuensis strain AE-L by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in the manufacture of enzyme-modified dairy ingredients (EMDI). Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.02mg 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 Panelidentified a no observed adverse effect level of 1,726mg 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 86,300. A search for the similarity of the amino acid sequence of the food enzyme to those of known allergens was made and no match was found. The Panelconsidered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood of such reactions is low. Based on the data provided, the Panelconcluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain GD-YNL.

The food enzyme β-galactosidase (β-D-galactoside galactohydrolase, EC 3.2.1.23) is produced with the non-genetically modified Kluyveromyces lactis strain GD-YNL by Godo Shusei Co., Ltd. The food enzyme is intended to be used for the hydrolysis of lactose in milk processing, production of fermented milk products and whey processing. The food enzyme 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 54mg TOS/kg body weight per day in European populations. As the production strain qualifies for the qualified presumption of safety approach of safety assessment and as no issue of concern raised from the production process, no toxicological studies other than assessment of allergenicity were 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 Panelconsidered 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 Panelconcluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme triacylglycerol lipase from the non-genetically modified Mucor circinelloides strain AE-LMH.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified Mucor circinelloides strain AE-LMH by Amano Enzyme Inc. The food enzyme is considered free from viable cells of the production organism. The food enzyme is intended to be used in baking processes, egg processing and the manufacture of enzyme-modified dairy ingredients (EMDI). Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.242mg 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 Panelidentified a no observed adverse effect level of 784mg 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 3,240. 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 Panelconsidered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood of such reactions is low. Based on the data provided, the Panelconcluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme glucan 1,4-α-glucosidase from the non-genetically modified Rhizopus arrhizus strain AE-G.

The food enzyme glucan 1,4-α-glucosidase (4-α-d-glucan glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified Rhizopus arrhizus strain AE-G by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. The applicant proposed the use of the food enzyme in baking processes, coffee processing and manufacture of enzymatically modified dairy ingredients (EMDI). The Panelconsidered only the baking processes as the relevant intended use of this food enzyme. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.94mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panelidentified a no observed adverse effect level of 1,868mg 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 1,987. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panelconsidered 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 Panelconcluded that this food enzyme does not give rise to safety concerns when used in baking processes under the intended conditions of use.

Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199.

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 Trichoderma reesei strain RF6199 by AB Enzymes 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 six manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for fruit brandies, fruit and vegetable processing for products other than juices, wine and wine vinegar production, refined and unrefined sugar production and coffee bean demucilation. Foods obtained from fruit processing for fruit brandies and coffee bean demucilation, as well as refined sugars, were excluded from dietary exposure estimation. For the remaining four processes, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.2mg 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 Panelidentified a no observed adverse effect level of 1,000mg 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 5,000. 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 Panelconsidered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood of such reactions is low. Based on the data provided, the Panelconcluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC.

The food enzyme pectinesterase (pectin pectylhydrolase, EC 3.1.1.11) is produced with the genetically modified Aspergillus luchuensis strain FLZSC by Advanced Enzyme Technologies Ltd. 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 fruit and vegetable processing for the production of juices and other fruit or vegetable products, as well as in the manufacture of alcoholic beverages from fruits other than grapes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.274mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panelidentified a no observed adverse effect level of 833mg 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 3,040. A search was made for the similarity of the amino acid sequence of the food enzyme to those of known allergens and three matches with respiratory allergens were found. The Panelconsidered that under the intended conditions of use, the risk of allergic reactions by dietary exposure, particularly in individuals sensitised to olive pollen, although unlikely, cannot be excluded. The Panelconcluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Aspergillus sp. strain GD-FAL.

The food enzyme β-galactosidase (EC 3.2.1.23) is produced with the non-genetically modified Aspergillus sp. strain GD-FAL by Godo Shusei Co., Ltd. The food enzyme is intended to be used in milk processing for the hydrolysis of lactose. The absence of viable cells of the production organism in the food enzyme was not demonstrated. Based on the assumption that all milk/dairy products are enzymatically treated, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.301mg TOS/kg body weight per day in European populations. The data provided did not allow concerns of genotoxicity of the food enzyme to be excluded. The systemic toxicity could not be assessed in the absence of an appropriate repeated dose 90-day oral toxicity study. Consequently, a margin of exposure was not calculated. 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 Panelconsidered 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. Based on the remaining concerns on genotoxicity, the inadequacies of the 90-day repeated dose oral toxicity study in rats and the missing data regarding the absence of viable cells of the production strain in the food enzyme, the Panelcould not conclude on the safety of this food enzyme.

Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Neobacillus sp. strain AE-LT.

The food enzyme β‐galactosidase (EC 3.2.1.23) is produced with the non‐genetically modified Neobacillus sp. strain AE‐LT by Amano Enzyme Inc. The strain is not cytotoxic and does not harbour any known virulence factor or antimicrobial resistance gene. The presence of viable cells of the production strain in the food enzyme could not be excluded, but the likelihood of this being a hazard is considered low. The food enzyme is intended to be used for lactose hydrolysis in milk processing and the manufacture of galacto‐oligosaccharides (GOS). The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.971 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,223 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 412. 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. 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.

Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain AE-KL.

The food enzyme β‐galactosidase (β‐d‐galactoside galatohydrolase, EC 3.2.1.23) is produced with the non‐genetically modified Kluyveromyces lactis strain AE‐KL by Amano Enzyme Inc. As the production strain meets the requirements for a Qualified Presumption of Safety (QPS) approach to safety assessment and as no other issues of concern were 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 for lactose hydrolysis in milk processing (including infant formulae), production of fermented milk products and manufacture of galacto‐oligosaccharides (GOS). The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 7.933 mg TOS/kg body weight (bw) per day in European populations. 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 considered to be low. Based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Safety evaluation of the food enzyme β-galactosidase from the genetically modified Kluyveromyces lactis strain KLA.

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.

Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain GAL.

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the non‐genetically modified Kluyveromyces lactis strain GAL by DSM Food Specialties B.V. It is intended to be used for the lactose hydrolysis in milk processing, production of fermented milk products and whey processing. It is also intended to be used for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 10.78 mg TOS/kg body weight per day in European populations. As the production strain of K. lactis strain GAL qualifies for the Qualified Presumption of Safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data are 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 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.

Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Aspergillus oryzae strain GL470.

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the Aspergillus oryzae strain GL 470 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in five food manufacturing processes; lactose hydrolysis in milk processing, production of fermented milk products, whey processing, manufacture of enzyme‐modified dairy ingredients and in the manufacture of galacto‐oligosaccharides. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.388 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 repeated dose 90‐day oral toxicity studies in rats. The Panel identified a no observed adverse effect level of 7,000 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 5,043. 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 concluded 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 considered to be low. Based on the data provided and considering the most recent complete toxicological data set, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the native and thermolabile forms of the food enzyme mucorpepsin from Rhizomucor miehei strain MMR 164.

The food enzyme mucorpepsin (aspartic endopeptidase, EC 3.4.23.23) is produced with the non‐genetically modified microorganism Rhizomucor miehei strain MMR 164 by Takabio. The enzyme is chemically modified to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in milk processing for cheese production. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.98 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,320 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and five matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but is considered low except for individuals sensitised to mustard proteins, but this risk will not exceed that of mustard consumption. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of a food enzyme containing aspergillopepsin I and II from the Aspergillus niger var. macrosporus strain PTG8398.

The food enzyme with aspergillopepsin I (EC 3.4.23.18) and aspergillopepsin II (EC 3.4.23.19) activities is produced with a non‐genetically modified Aspergillus niger var. macrosporus strain PTG8398 by Meiji Seika Pharma Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in wine production. Based on the maximum use levels, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.14 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 919 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 6,700. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and four 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.

Safety evaluation of the food enzyme β-galactosidase from the genetically modified Bacillus licheniformis strain NZYM-BT.

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.

Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus oryzae strain NZYM-LJ.

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.