a-Amylase - Aspergillus niger (Stamm NZYM‐SB, GVO)                                                            07.06.2018 / 20.07.2018

EFSA CEF Panel (2018): Scientific Opinion on the safety evaluation of the food enzyme a-amylase from a genetically modified Aspergillus niger (strain NZYM-SB). EFSA Journal 2018; 16(7):5320, 21 pp.  | https://doi.org/10.2903/j.efsa.2018.5320

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5320

The food enzyme is an a-amylase (4-a-D-glucan glucanohydrolase; EC 3.2.1.1), produced with the genetically modified Aspergillus niger strain NZYM-SB by Novozymes A/S. The food enzyme does not contain the production organism or its DNA; therefore, there is no safety concern for the environment. The a-amylase is intended for use in starch processing, beverage alcohol (distilling) processes and baking processes. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated for these two uses. Based on the maximum use levels recommended for the baking processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–TOS was estimated to be up to 3.075 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria or micronuclei in human lymphocytes. Subchronic toxicity was assessed by means of a repeated-dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived that, compared with the dietary exposure, resulted in a sufficiently high margin of exposure (MOE). Similarity of the amino acid sequence to those of known allergens was searched and two matches were found. The Panel considered that the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the genetic modifications, the manufacturing process, the compositional and biochemical data, the findings in the toxicological and genotoxicity studies, as well as the estimated dietary exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EC 3.2.1.1, EFSA-Q-2014-00413, 2014/13                                                                                                              keine Sicherheitsbedenken

a-Amylase - Bacillus licheniformis (Stam NZYM-AV, GVO)                                                             06.06.2018 / 12.07.2018

EFSA CEF Panel (2018):  Scientific Opinion on the safety evaluation of the food enzyme a-amylase from a genetically modified Bacillus licheniformis (strain NZYM-AV). EFSA Journal 2018; 16(7):5318, 14 pp. | https://doi.org/10.2903/j.efsa.2018.5318

The food enzyme is an a-amylase (4-a-D-glucan glucanohydrolase; EC 3.2.1.1) produced with the genetically modified Bacillus licheniformis strain NZYM-AV by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production microorganism or its DNA; therefore, there is no safety concern for the environment. The a-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. The Panel derived a no observed adverse effect level (NOAEL) at the highest dose level of 796 mg TOS/kg body weight (bw) per day. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intend ed food production processes and the toxicological and genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EC 3.2.1.1, EFSA-Q-2014-00794, 2014/26                                                                                                          keine Sicherheitsbedenken

a‐Amylase - Bacillus licheniformis (Stamm NZYM‐AN, GVO                                                           07.06.2018 / 06.07.2018

EFSA CEF Panel (2018):  Scientific Opinion on the safety evaluation of the food enzyme alpha-amylase from a genetically modified Bacillus licheniformis (strain NZYM-AN). EFSA Journal 2018; 16(7):5317, 14 pp.  | https://doi.org/10.2903/j.efsa.2018.5317  

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5317

The food enzyme is an a-amylase (4-a-D-glucan glucanohydrolase; EC 3.2.1.1) produced with a genetically modified Bacillus licheniformis strain NZYM-AN by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or recombinant DNA; therefore, there is no safety concern for the environment. The a-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests with the food enzyme did not raise a safety concern. The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the findings in the genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

 EC 3.2.1.1, EFSA-Q-2015-00084, 2015/02                                                                                                      keine Sicherheitsbedenken

Glucose Oxidase - Aspergillus oryzae (Stamm NZYM‐KP, GVO)                                               07.06.2018 / 06.07.2018

EFSA CEF Panel (2018): Scientific Opinion on the safety evaluation of the food enzyme glucose oxidase from a genetically modified Aspergillus oryzae (strain NZYM-KP). EFSA Journal 2018; 16(7):5319, 20 pp. https://doi.org/10.2903/j.efsa.2018.5319

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5319

The food enzyme is a glucose oxidase (beta-D-glucose:oxygen 1-oxidoreductase ; EC 1.1.3.4) produced with a genetically modified strain of Aspergillus oryzae strain NZYM-KP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or DNA; therefore, there is no safety concern for the environment. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.156 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosome aberrations in human lymphocytes. The subchronic toxic ity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no-observed-adverse-effect level was derived (341 mg TOS/kg bw per day), which compared with the estimated dietary exposure result s in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match with a fungal contact allergen was found. The Panel considered that, under the intend ed condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the estimated dietary exposure and the findings in the toxicological studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EC 1.1.3.4, EFSA-Q-2013-00687, 2013/06                                                                                                   keine Sicherheitsbedenken

Maltogene‐α‐Amylase -  Bacillus subtilis (Stamm MAM, GVO)                                                 24.101.2018 / 02.05.2018

EFSA CEF Panel (2018): Scientific Opinion on the safety evaluation of food enzyme glucan 1,4- α -maltohydrolase produced with a genetically modified Bacillus subtilis (strain MAM). EFSA Journal 2018; 16(5):5168, 20 pp. | https://doi.org/10.2903/j.efsa.2018.5168

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5168

The food enzyme conside red in this opinion is a glucan 1,4-a-maltohydrolase (maltogenic a-amylase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain MAM by the company DSM Food Specialties B. V. The food enzyme contains neither the production microorganism nor recombinant DNA; therefore, no environmental risk assessment is required. However, the Panel emphasises that this conclusion only covers the food enzyme recovered via filter press. The glucan 1,4-a-maltohydrolase is intended for use in baking processes. Based on the maximum use levels recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.175 mg TOS/kg body weight (bw) per day in European populations. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (986 mg TOS/kg bw per day for both males and females), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; one match was found. However, the Panel considered that there are no indications for food allergic reactions to this glucan 1,4-a-maltohydrolase by dietary exposure. No safety concerns were identified in relation to the genetic modifications, the manufacturing process, the compositional data provided, as well as the exposure, allergenicity and systemic toxicity assessments. However, owing to the incompleteness of the genotoxicity data, the Panel is not able to conclude on the safety of the food enzyme.

EC 3.2.1.133 , EFSA-Q-2013-00790, 2013/08                                                                                   Keine Aussage zur Sicherheit möglich

ß-xylanase - Bacillus subtilis (Stamm LMG S‐27588, GVO)                                           24.01.2018 / 02.05.2018

EFSA CEF Panel (2018): Scientific Opinion on the safety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S-27588). EFSA Journal 2018; 16(5):5169, 19 pp. | https://doi.org/10.2903/j.efsa.2018.5169

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5169

The food enzyme considered in this opinion is an endo-1,4-b-xylanase (4-b-D-xylan xylanohydrolase; EC 3.2.1.8) produced from the genetically modified Bacillus subtilis strain LMG S-27588 by the company Puratos N. V. The production strain was not detected in the food enzyme. The endo-1,4-b-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.325 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme indicated no genotoxic concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (443 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; no match was found. The Panel considered that there are no indications for food allergic reactions to this endo-1,4-ß-xylanase by dietary exposure. Based on the genetic modifications, the manufacturing process, the compositional and biochemical data, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.

EC 3.2.1.8, EFSA-Q-2015-00408,                                                                   keine Sicherheitsbedenken, aber rDNA im Lebensmittelenzym

Aqualysin 1 - Bacillus subtilis (Stamm LMGS 25520, GVO)                                              24.01.2018 / 02.05.2018

EFSA CEF Panel (2018): Scientific Opinion on the safety evaluation of the food enzyme aqualysin 1 from a genetically modified Bacillus subtilis (strain LMGS 25520). EFSA Journal 2018; 16(5):5170, 20 pp.  | https://doi.org/10.2903/j.efsa.2018.5170

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5170

The food enzyme considered in this opinion is aqualysin 1 (EC 3.4.21.111), produced from the genetically modified strain Bacillus subtilis LMGS 25520 by Puratos NV. The production strain was not detected in the food enzyme. Aqualysin 1 is intended to be used in baking processes. Based on the maximum use level recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme– total organic solids (TOS) was estimated to be up to 2.13 mg TOS/kg body weight per day in European populations. Genotoxicity tests indicated no genotoxic concerns. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens and 23 matches were found (20 respiratory and 3 dermal allergens). However, the Panel considered that there are no indications for food allergic reactions to the food enzyme. The genetic modifications performed, the manufacturing process, the compositional and biochemical data, the allergenicity and the genotoxicity assessment did not raise safety concerns. The Panel considered the margin of exposure (MOE) calculated from the no observed adverse effect level (NOAEL) determined from the repeated dose 90-day oral toxicity study and the estimated dietary exposur e as insufcient to conclude that there is no safety concern for this food enzyme under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.

EC 3.4.21.111, EFSA-Q-2014-00920, 2014/44                                              keine Sicherheitsbedenken, aber alle Proben enthalten r-DNA

Maltogene Amylase - Bacillus subtilis (Stamm NZYM-SM, GVO)                                         23.01.2018 / 02.05.2018

EFSA CEF Panel (2018). Scientific Opinion on the safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM-SM). EFSA Journal 2018; 16(5):5171, 21 pp. | https://doi.org/10.2903/j.efsa.2018.5171

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5171

The food enzyme considered is a maltogenic amylase (glucan 1,4- α -maltohydrolase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain NZYM-SM by Novozymes A/S. The food enzyme contains neither the production organism nor recombinant DNA. The maltogenic amylase is intended for use in baking processes and starch processing for glucose syrups production. Based on the maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.168 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosomal aberrations in human lymphocytes. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (320 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens. Three matches to occupational respiratory allergens were found, however, the Panel considered that there are no indications for food allergic reactions to the food enzyme. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concluded that the food enzyme maltogenic amylase from Bacillus subtilis strain NZYM-SM does not give rise to safety concerns under the intended conditions of use.

3.2.1.133, EFSA-Q-2015-00096, 2015/11                                                                                                      keine Sicherheitsbedenken

β‐Xylanase - Aspergillus niger (Stamm XEA, GVO)                                                                   08.03.2018 / 27.04.2018

EFSA CEF Panel (2018):  Scientific Opinion on the safety evaluation of the food enzyme endo-1,4-ß-xylanase from a genetically modified Aspergillus niger (strain XEA). EFSA Journal 2018; 16(4):5228, 20 pp. https://doi.org/10.2903/j.efsa.2018.5228

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5228

The food enzyme is an endo-1,4-ß-xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with this endo-1,4-ß-xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo-1,4-b-xylanase. Bas ed on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EC 3.2.1.8, EFSA-Q-2015-00045, 2014/50                                                                                                        keine Sicherheitsbedenken

ß-Xylanase - Bacillus subtilis strain TD160(229, GVO)                                                                19.09.2017 / 22.01.2018

EFSA CEF Panel (2018): Scientific Opinion on the safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229). EFSA Journal 2018; 16(1):5008, 20 pp.  | https://doi.org/10.2903/j.efsa.2018.5008

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5008

The food enzyme considered in this opinion is an endo -1,4-b-xylanase (EC 3.2.1.8) produced with a genetically modified Bacillus subtilis strain from Puratos N.V. (Belgium). The genetic modifications do not raise safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo-1,4-b-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is up to 0.008 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria nor clastogenic activity in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level was derived, which, compared with the dietary expo sure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no matches were found. The Panel considered that there are no indications for food allergic reactions to this xylanase. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, this food enzyme does not give rise to safety concerns under the intended conditions of use

EC 3.2.1.8, EFSA-Q-2014-00733,                                                                                                                         keine Sicherheitsbedenken