Safety evaluation of the food enzyme ß-galactosidase from the genetically modified Bacillus licheniformis strain DSM 34099.

The food enzyme ß-galactosidase (ß-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.

Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the non-genetically modified Rhizopus arrhizus strain AE-TL(B).

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified Rhizopus arrhizus strain AE-TL(B) by Amano Enzyme Inc. 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 two food manufacturing processes. Subsequently, the applicant requested to extend its use to include four additional processes and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. As the food enzyme-total organic solids (TOS) are removed from one food manufacturing process, the dietary exposure to the food enzyme-TOS was estimated only for the remaining five processes. Dietary exposure was calculated to be up to 0.086 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level reported in the previous opinion (1960 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 22,791. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

Safety evaluation of the food enzyme preparation D-psicose 3-epimerase from the non-genetically modified Microbacterium foliorum strain SYG27B.

This assessment addresses a food enzyme preparation consisting of the immobilised non-viable cells of the non-genetically modified bacterium identified by the applicant (Samyang Corporation) as Microbacterium foliorum strain SYG27B. This strain produces the enzyme D-psicose 3-epimerase (EC 5.1.3.30). The food enzyme preparation is used for the isomerisation of fructose to produce the speciality carbohydrate D-allulose (synonym D-psicose). Since the hazard identification and characterisation could not be made and the identity of the production organism could not be established, the Panel was unable to complete the assessment of this food enzyme preparation containing D-psicose 3-epimerase.

Harmonising dietary datasets for global surveillance: methods and findings from the Global Dietary Database.

OBJECTIVE: The Global Dietary Database (GDD) expanded its previous methods to harmonise and publicly disseminate individual-level dietary data from nutrition surveys worldwide. DESIGN: Analysis of cross-sectional data. SETTING: Global. PARTICIPANTS: General population. METHODS: Comprehensive methods to streamline the harmonisation of primary, individual-level 24-h recall and food record data worldwide were developed. To standardise the varying food descriptions, FoodEx2 was used, a highly detailed food classification and description system developed and adapted for international use by European Food Safety Authority (EFSA). Standardised processes were developed to: identify eligible surveys; contact data owners; screen surveys for inclusion; harmonise data structure, variable definition and unit and food characterisation; perform data checks and publicly disseminate the harmonised datasets. The GDD joined forces with FAO and EFSA, given the shared goal of harmonising individual-level dietary data worldwide. RESULTS: Of 1500 dietary surveys identified, 600 met the eligibility criteria, and 156 were prioritised and contacted; fifty-five surveys were included for harmonisation and, ultimately, fifty two were harmonised. The included surveys were primarily nationally representative (59 %); included high- (39 %), upper-middle (21 %), lower-middle (27 %) and low- (13 %) income countries; usually collected multiple recalls/ records (64 %) and largely captured both sexes, all ages and both rural and urban areas. Surveys from low- and lower-middle v. high- and upper-middle income countries reported fewer nutrients (median 17 v. 30) and rarely included nutrients relevant to diet-related chronic diseases, such as n-3 fatty acids and Na. CONCLUSIONS: Diverse 24-h recalls/records can be harmonised to provide highly granular, standardised data, supporting nutrition programming, research and capacity development worldwide.

Safety evaluation of the food enzyme α-amylase from the non-genetically modified Aspergillus oryzae strain NZYM-NA.

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified Aspergillus oryzae strain NZYM-NA by Novozymes A/S. It was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: starch processing for the production of glucose and maltose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal-based processes, plant processing for production of dairy analogues and fruit and vegetable processing for juice production. Since residual amounts of food enzyme-total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups and distillation, dietary exposure was not calculated for these processes. For the remaining five food manufacturing processes, dietary exposure was estimated to be up to 0.134 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 1,862 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 13,896. 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 Panel considered that, under the intended conditions of use (other than distilled alcohol production), 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.

Safety evaluation of the food enzyme lysozyme from hens' eggs.

The food enzyme lysozyme (peptidoglycan N-acetylmuramoylhydrolase; EC 3.2.1.17) is produced with hens' eggs and submitted by DSM Food Specialties BV. It is intended to be used in brewing processes, milk processing for cheese production as well as wine and vinegar production. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 4.9 mg TOS/kg body weight per day. This exposure is lower than the intake of the corresponding fraction from eggs, for all population groups. Egg lysozyme is a known food allergen. The Panel considered that, under the intended conditions of use, the residual amounts of lysozyme in treated beers, cheese and cheese products as well as wine and wine vinegar may trigger adverse allergenic reactions in susceptible individuals. Based on the data provided, the origin of the food enzyme and an exposure to the food enzyme comparable to the intake from eggs, the Panel concluded that the food enzyme lysozyme does not give rise to safety concerns under the intended conditions of use, except for the known adverse allergic reactions that occur in susceptible individuals.

Safety evaluation of the food enzyme glucan-1,4-α-glucosidase from the non-genetically modified Rhizopus delemar strain CU634-1775.

The food enzyme glucan-1,4-α-glucosidase (4-α-d-glucan glucohydrolase; EC 3.1.2.3) is produced with the non-genetically modified Rhizopus delemar strain CU634-1775 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production strain. It is intended to be used in six food manufacturing processes: baking processes, starch processing for production of glucose syrups and other starch hydrolysates, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, brewing processes and distilled alcohol production. As residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food processes. For the remaining four food processes, dietary exposure to the food enzyme-total organic solids was estimated to be up to 1.238 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. 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 1,735 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 1,401. In a search for the similarity of the amino acid sequence of the food enzyme to known allergens, a single 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 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.

Dietary exposure to heavy metals and iodine intake via consumption of seaweeds and halophytes in the European population.

EFSA assessed the relevance of seaweed and halophyte consumption to the dietary exposure to heavy metals (arsenic, cadmium, lead and mercury) and the iodine intake in the European population. Based on sampling years 2011-2021, there were 2,093 analytical data available on cadmium, 1,988 on lead, 1,934 on total arsenic, 920 on inorganic arsenic (iAs), 1,499 on total mercury and 1,002 on iodine. A total of 697 eating occasions on halophytes, seaweeds and seaweed-related products were identified in the EFSA Comprehensive European Food Consumption Database (468 subjects, 19 European countries). From seaweed consumption, exposure estimates for cadmium in adult 'consumers only' are within the range of previous exposure estimates considering the whole diet, while for iAs and lead the exposure estimates represent between 10% and 30% of previous exposures from the whole diet for the adult population. Seaweeds were also identified as important sources of total arsenic that mainly refers, with some exceptions, to organic arsenic. As regards iodine, from seaweed consumption, mean intakes above 20 µg/kg body weight per day were identified among 'consumers only' of Kombu and Laver algae. The impact of a future increase in seaweed consumption ('per capita') on the dietary exposure to heavy metals and on iodine intake will strongly depend on the seaweeds consumed. The exposure estimates of heavy metals and iodine intakes in 'consumers only' of seaweeds were similar to those estimated in a replacement scenario with selected seaweed-based foods in the whole population. These results underline the relevance of the current consumption of seaweeds in the overall exposure to different heavy metals and in the intake of iodine. Recommendations are provided for further work needed on different areas to better understand the relationship between seaweed consumption and exposure to heavy metals and iodine intake.

Safety evaluation of the food enzyme ß-galactosidase from the non-genetically modified Aspergillus oryzae strain AE-LA.

The food enzyme ß-galactosidase (ß-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified Aspergillus oryzae strain AE-LA by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used for lactose hydrolysis in milk processing, production of fermented milk products, whey processing and the manufacture of enzyme-modified dairy ingredients. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1.651 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 1,656 mg TOS/kg bw per day, the highest dose tested. This results in a margin of exposure of at least 1,003. 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 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.

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

The food enzyme ß-galactosidase (ß-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 ß-galactosidase from the non-genetically modified Neobacillus sp. strain AE-LT.

The food enzyme ß-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 ß-galactosidase from the non-genetically modified Aspergillus oryzae strain GL 470.

The food enzyme ß-galactosidase (ß-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 food enzyme ß-galactosidase from the non-genetically modified Kluyveromyces lactis strain GAL.

The food enzyme ß-galactosidase (ß-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 ß-galactosidase from the non-genetically modified Kluyveromyces lactis strain AE-KL.

The food enzyme ß-galactosidase (ß-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 ß-galactosidase from the genetically modified Aspergillus niger strain TOL.

The food enzyme ß-galactosidase (ß-D-galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Aspergillus niger strain TOL 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 recombinant DNA. The food enzyme is intended to be used in whey processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.197 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 ß-galactosidase 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 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 1,038 mg TOS/kg bw per day, the highest dose tested. This results in a margin of exposure of at least 5,269. 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 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 mannan endo-1,4-ß-mannosidase from the genetically modified Trichoderma reesei strain RF6232.

The food enzyme mannan endo-1,4-ß-mannosidase (1,4-ß-d-mannan mannanohydrolase; EC 3.2.1.78) is produced with the genetically modified Trichoderma reesei strain RF6232 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 recombinant DNA. It is intended to be used in coffee processing, fruit and vegetable processing for juice production and for edible oil production. Since residual amounts of total organic solids (TOS) are removed during refined edible oil production by repeated washing, dietary exposure was calculated only for the remaining two food manufacturing 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 raise 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 100 mg TOS/kg bw per day, the lowest dose tested. This results in a margin of exposure above 1,100. 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, in particular for individuals allergic to avocado, 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.

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

The food enzyme ß-galactosidase (ß-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 α-amylase from the genetically modified Bacillus licheniformis strain NZYM-BC.

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-BC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain was shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was free from viable cells of the production organism and its DNA. It 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, cereal-based processes, refined and unrefined sugar production and fruit and vegetable processing for juice production. Since the residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food manufacturing processes. For the remaining four processes, the dietary exposure to the food enzyme-TOS was estimated to be up to 0.05 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise safety concern. The similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood was 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.

Safety evaluation of the food enzyme pullulanase from the genetically modified Bacillus licheniformis strain NZYM-LU.

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.

Safety evaluation of the food enzyme glucan 1,4-α-maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM-SD.

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-SD 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 processes 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 baking and brewing processes. Dietary exposure was estimated to be up to 0.57 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-SD does not give rise to safety concerns under the intended conditions of use.