Das Lebensmittelenzym soll beim Einsatz der Entschleimung von Fetten und Ölen eingesetzt werden. Die Phospholipase C wird mit Hilfe des gentechnisch veränderten Bacillus licheniformis Stamm NZYM-VR von Novozymes A/S gewonnen. Die gentechnischen Änderungen geben keinen Anlass zu Sicherheitsbedenken. Das Lebensmittelenzym ist frei von lebensfähigen Zellen des Produktionsorganismus und rekombinanter DNA. Mit den Reinigungsschritte, die während der Entschleimung angewandt werden, erfolgt auch die Entfernung der gesamten organischen Feststoffen (TOS) entfernt. Es ergibt sich somit keine ernährungsbedingte Exposition. Genotoxizitätstests ergeben keinen Anlass zu Sicherheitsbedenken. Die systemische Toxizität wurde anhand einer 90-tägigen oralen Toxizitätsstudie mit wiederholter Verabreichung an Ratten bewertet und der NOAEL bei der höchsten getesteten Dosis von 714 mg TOS/kg Körpergewicht pro Tag berechnet. Der Sequenzvergleich des Lebensmittelenzyms mit bekannten Allergenen ergibt keine Übereinstimmungen. Eine allergische Sensibilisierung und Auslösereaktionen durch die ernährungsbedingte Exposition kann nicht ausgeschlossen werden.  Das Auftreten solcher Reaktionen wird als für  wenig wahrscheinlich angesehen. Auf der Grundlage der vorgelegten Daten kommt der Ausschuss zu dem Schluss, dass dieses Lebensmittelenzym unter den vorgesehenen Verwendungsbedingungen keinen Anlass zu Sicherheitsbedenken gibt.

EFSA CEP Panel ( 2020): Scientific Opinion on the safety evaluation of the food enzyme phospholipase C from the genetically modified Bacillus licheniformis strain NZYM-VR. EFSA Journal 2020;18(7):6184, 12 pp. https://doi.org/10.2903/j.efsa.2020.6184

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6184



17.06.2020 / 15.07.2020

Identitätsnr.     ?

EFSA-Q-Nr.      2019-00442

IUBMB-Nr. EC   3.1.4.3

Keine Sicherheitsbedenken

The food enzyme endo-1,4-b-xylanase (4-b-D-xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain RF5427 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 recombinant DNA. It is intended to be used in baking, brewing and cereal-based processes, distilled alcohol production and grain treatment for the production of starch and gluten fractions. Since residual amounts of the food enzyme are removed by distillation and during grain treatment, dietary exposure was only calculated for baking, brewing and cereal-based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.119 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The Panel identified a no observed adverse effect level at the highest dose tested of 939 mg TOS/kg bw per day in a repeated dose 90-day oral toxicity stud y in rats, resulting in a margin of exposure of at least 7,890. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and no matches were found. The Panel considered that allergenicity can be excluded for distilled alcohol production. The risk of allergic sensitisation and elicitation reactions cannot be excluded for baking, brewing and cereal-based processes, and for grain treatment for the production of starch and gluten fractions, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the removal of TOS during the production of distilled alcohol and grain treatment, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EFSA CEP Panel (2020):  Scientific Opinion of the safety evaluation of the food enzyme endo-1,4-b-xylanase from the genetically modified Trichoderma reesei strain RF5427. EFSA Journal 2020;18 (6):6127, 18 pp.| https://doi.org/10.2903/j.efsa.2020.6127

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6127



The food enzyme with b-glucanase and b-xylanase (4-b-D-xylan xylanohydrolase, EC 3.2.1.8) activities is produced with the non-genetically modified by DuPont. The food enzyme is intended to be used in brewing processes, grain treatment for the production of starch and gluten fractions, and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation and during grain treatment, dietary exposure was only calculated for brewing processes. Based on the maximum recommended use levels for brewing processes, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 4.585 mg TOS/kg body weight (bw) per day. Since the compositional data provided was insufficient to characterise the food enzyme batches used for toxicological testing, their suitability for use in the toxicological tests could not be established. As result, the toxicological studies provided were not further considered by the Panel. Similarities of the amino acid sequences to those of known allergens were searched and no matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is considered to be low. In the absence of compositional data sufficient to characterise the food enzyme batches used for toxicological testing, the Panel is unable to complete its assessment of the safety of the food enzyme.

EFSA CEP Panel (2020):  Scientific Opinion on the safety evaluation of the food enzyme with b-glucanase and b-xylanase activities from the Trichoderma reesei strain DP-Nya67. EFSA Journal 2020;18(5):6128, 15 pp. | https://doi.org/10.2903/j.efsa.2020.6128

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6128

29.04.2020 /03.06. 2020

Identitätsnr.     2013/12

EFSA-Q-Nr.      2013-00876

     2014-00735

IUBMB-Nr. EC   3.2.1.8 

Keine Sicherheitsbedenken

29.04.2020 / 29.05.2020

Identitätsnr.     2015/166

EFSA-Q-Nr.      2017-00085

IUBMB-Nr. EC   3.2.1.8 

Keine Aussage zur Sicherheit

The food enzyme a-amylase (1,4-a-D-glucan glucanohydrolase; EC 3.2.1.1) is produced with a non-genetically modified Parageobacillus thermoglucosidasius strain DP-Gzb47 by Danisco US Inc. The a-amylase food enzyme is intended to be used in brewing processes and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation, dietary exposure was only calculated for brewing processes. Based on the maximum use levels recommended for brewing processes, and individual data from the EFSA Comprehensive Europea n Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.880 mg TOS/kg body weight (bw) per day in European populations. As the production strain of P. thermoglucosidasius meets the requirements for a Qualified Presumption of Safety (QPS) approach, no toxicological data are required. Similarity of the amino acid sequence to those of known allergens was searched for 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.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme alpa-amylase from the Parageobacillus thermoglucosidasius strain DP-Gzb47. EFSA Journal 2020;18(5):6129, 13 pp. | https://doi.org/10.2903/j.efsa.2020.6129

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6129



29.04.2020 / 27.05.2020

Identitätsnr.     ?

EFSA-Q-Nr.      2016/00145     

IUBMB-Nr. EC   3.2.1.1 

Keine Sicherheitsbedenken

The food enzyme is a lysophospholipase (2-lysophosphatidylcholine acylhydrolase; EC 3.1.1.5) produced with a genetically modified Aspergillus niger strain NZYM-LP 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 lysophospholipase food enzyme is intended to be used in starch processing for glucose syrups production, and for degumming of fats and oils. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, and washing and purification steps applied during degumming, consequently, dietary exposure estimation was considered not necessary. Genotoxicity tests did not raise safety concerns. The repeated dose 90-day oral toxicity study was carried out with a phospholipase A1 from A. niger (strain NZYM-FP). The Panel considered this enzyme as a suitable substitute to be used in this toxicity study in rats, because they derive from the same recipient strain, the location of the inserts are comparable, no partial inserts were present and the production methods are essentially the same. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose tested of 1,356 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this occurring is considered to be low. Based on the data provided, the removalof TOS during the starch processing for the production of glucose syrups and during the degumming of fats and oils, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme lysophospholipase from the genetically modified Aspergillus niger strain NZYM-LP. EFSA Journal 2020;18(5):6130, 14 pp. | https://doi.org/10.2903/j.efsa.2020.6130

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6130



30.04.2020 / 27.05.2020

Identitätsnr.    ?214/43

EFSA-Q-Nr.      2014-00919

IUBMB-Nr. EC   3.1.1.5 

Keine Sicherheitsbedenken

The food enzyme with 4-a-D-{(1->4)-a-D-glucano}trehalose trehalohydrolase ((4-a-D-[(1,4-a-D-glucano] trehalose glucanohydrolase (trehalose-producing)), EC 3.2.1.141) and (1->4)-a-

D-glucan 1-a-D-glucosylmutase ((1,4)-a-D-glucan 1-a-D-glucosylmutase, EC 5.4.99.15) activities is produced with a non-genetically modified microorganism Gryllotalpicola ginsengisoli (formally Arthrobacter ramosus) by Hayashibara Co., Ltd. The applicant states that the food enzyme will not be placed on the open market, but will only be used in-house in starch processing for trehalose production. Since residual amounts of total organic solids are removed by the purification steps applied during the production of trehalose, toxicological studies were considered not necessary and no dietary exposure was calculated. Similarities of the amino acid sequences to those of known allergens were searched and no matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is consider ed to be 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.

EFSA CEP Panel (2020): Scientifc Opinion on the safety evaluation of the food enzyme with 4-a-D-{(1->4)-a-D-glucano}trehalose trehalohydrolase and (1->4)-a-D-glucan 1-a-D-glucosylmutase activities from the Gryllotalpicola ginsengisoli strain S34. EFSA Journal 2020;18(5):6042, 11 pp. | https://doi.org/10.2903/j.efsa.2020.6042

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6042



 29.04.2020 / 27.05.2020

Identitätsnr.    2015/159

     2015/160

EFSA-Q-Nr.      2016-00135

     2016-00136

IUBMB-Nr. EC   3.3.2.1.141

      5.4.99.15

Keine Sicherheitsbedenken

The food enzym e phospholipase A1 (phosphatidycholine 1-acylhydrolase EC 3.1.1.32) is produced with the genetically modified Aspergillus niger strain NZYM-FP 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 phospholipase A1 food enzyme is intended to be used for degumming of fats and oils. Since residual amounts of Total Organic Solids (TOS) are removed by the purification steps applied during degumming, dietary exposure estimation was not considered necessary. Genotoxicity tests did not raise safety concerns. The repeated dose 90-day oral 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 1,356 mg TOS/kg body weight (bw) 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 upon 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 degumming of fats and oils, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EFSA CE Panel ( 2020). Scientific Opinion on the safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM-FP. EFSA Journal 2020;18(5):6131, 12 pp. | https://doi.org/10.2903/j.efsa.2020.6131

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6131



 30.04.2020 / 20.05.2020

Identitätsnr.    ?

EFSA-Q-Nr.      2019-00639

IUBMB-Nr. EC   3.1.1.32

Keine Sicherheitsbedenken

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 3.1.1.3) is produced with the genetically modified Ogataea polymorpha strain DP-Jzk33 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. It is intended to be used in baking and cereal-based processes. Based on the maximum use levels recommended for baking and cereal-based processes 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 0.520 mg TOS/kg body weight (bw) per day. 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 669 mg TOS/kg bw per day, the highest dose tested. Comparison with the estimated dietary exposure results in a margin of exposure of at least 1,287. A search was made of the similarity of the amino acid sequence of the lipase to those of known allergens 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 likely 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.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme

triacylglycerol lipase from the genetically modified Ogataea polymorpha strain DP-Jzk33. EFSA Journal 2020;18(3):6048, 15 pp. | https://doi.org/10.2903/j.efsa.2020.6048

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6048



06.02.2020 / 11.03.2020

Identitätsnr.    ?

EFSA-Q-Nr.      2015-00374

IUBMB-Nr. EC   3.1.1.3

Keine Sicherheitsbedenken

The food enzyme α-amylase (4-a-D-gluca n glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Pseudomonas fluorescens strain BD15754 by BASF Enzymes LLC1. The food enzyme is free from viable cells of the production organism and recombinant DNA. The a-amylase is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 887 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel consider ed 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 considered to be low. However, the food enzyme contains residual amounts of a highly important antimicrobial for human medicine, with the consequent risk of promoting the development of resistance. Therefore, the Panel concludes that the food enzyme a-amylase, produced with the genetically modified P. fluorescens strain BD15754 cannot be considered safe.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme a-amylase from the genetically modified Pseudomonas fluorescens strain

BD15754. EFSA Journal 2020;18(3):6043, 12 pp. |https://doi.org/10.2903/j.efsa.2020.6043

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6043

04.02.2020 / 05.03.2020 

Identitätsnr.    2015/170

EFSA-Q-Nr.      2016-00200

IUBMB-Nr. EC   3.2.1.1

Sicherheitsbedenken

The food enzyme is a b-galactosidase (b-D-galactoside galactohydrolase; EC 3.2.1.23) produced with the genetically modifieded Escherichia coli strain NCIMB 30325 by Clasado Ingredients Ltd. The b-galactosidase encoding gene is introduced into the recipient strain of E. coli using a self-replicating plasmid which also contains a gene, which confers resistance to an antibiotic listed as a critically important antimicrobial. This gene was detected in the food enzyme. The absence of viable cells of the production strain in the food enzyme was not demonstrated. The food enzyme is intended to be used only for the production of a mixture of galacto-oligosaccharides (GOS). Genotoxicity tests did not raise a safety concern. Subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose tested of 900mg total organic solids (TOS)/kg body weight (bw) per day. Similarity of the amino acid sequence tothose of known allergens was searched and no match was found. The Panel considered that under the intended conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Given the risk associated with the presence of antibiotic resistance gene in the food enzyme and the lack of data showing the absence of viable cells, the Panel concludes that the use of b-galactosidase produced with the genetically modified E. coli NCIMB 30325 cannot be considered safe.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme ß-galactosidase from the genetically modified Escherichia coli NCIMB 30325. EFSA Journal 2020;18(1):5977, 13 pp. https://doi.org/10.2903/j.efsa.2020.5977

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.5977

12.12.2019 / 23.01.2020

Identitätsnr.    2014/19

EFSA-Q-Nr.      2015-00622

IUBMB-Nr. EC   3.2.1.23

Sicherheitsbedenken

The food enzyme xylanase (EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain RF5703 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 recombinant DNA. The food enzyme is intended to be used in brewing processes and grain treatment for the production of starch and gluten fractions. Since residual amounts of the food enzyme are removed during grain treatment, dietary exposure was only calculated for brewing processes. Based on the maximum recommended use levels for brewing processes, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.023 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose tested of 1,000 mg TOS/kg bw per day, resulting in a high margin of exposure of at least 43,000. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided and the removal of TOS during the intended food production process, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme xylanase from the genetically modified Trichoderma reesei strain RF5703. EFSA Journal 2020;18(1):5974, 16 pp. | https://doi.org/10.2903/j.efsa.2020.5974

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.5974



11.12.2019 / 23.01.2020

Identitätsnr.    2014/08

EFSA-Q-Nr.      2014-00410

IUBMB-Nr. EC   3.2.1.8

keine Sicherheitsbedenken

The food enzyme xylanase (4-ß-D-xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Aspergillus luchuensis Inui strain RF7398 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 recombinant DNA. The food enzyme is intended to be used in baking and cereal-based processes. Based on the maximum use levels, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.008 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 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a high margin of exposure of at least 125,000. 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 of this occurring 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.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme xylanase from the genetically modified Aspergillus luchuensis Inui strain RF7398. EFSA Journal 2020;18(1):5971, 16 pp.| https://doi.org/10.2903/j.efsa.2020.5971

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.5971

11.12.2019 / 20.01.2020

Identitätsnr.    ?

EFSA-Q-Nr.      2014-00165

IUBMB-Nr. EC   3.2.1.8

keine Sicherheitsbedenken

The food enzyme α-amylase (4-a-D-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified B. amyloliquefaciens strain BANSC by Advanced Enzyme Technologies Ltd. The a-amylase is intended to be used in brewing and baking processes and in starch processing for glucose syrups production and other starch hydrolysates. Since residual amounts of the food enzyme are removed during the starch processing for glucose syrups production, it is excluded from the dietary exposure estimation. Based on the maximum recommended use levels for brewing and baking processes, 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 0.468 mg TOS/kg body weight (bw) per day. The parental strain meets the required qualifications to be considered as a

Qualified Presumption of Safety (QPS) organism and is therefore presumed to be safe. The conclusions on safety of the food enzyme are made following the QPS approach in relation to the production strain, with additional consideration of the conditions of manufacture. Consequently, the Panel considers no toxicological studies other than assessment of allergenicity necessary. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered 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.

EFSA CEP Panel (2020) Scientific Opinion on the safety evaluation of the food enzyme α-amylase from Bacillus amyloliquefaciens strain BANSC. EFSA Journal 2020;18(1):5976, 14 pp. | https://doi.org/10.2903/j.efsa.2020.5976

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.5976

12.12.2019 / 20.01.2020

Identitätsnr.    2014/22

EFSA-Q-Nr.      2014-00730

IUBMB-Nr. EC   3.2.1.1

keine Sicherheitsbedenken

The food enzyme is a D-xylose aldose-ketose-isomerase (EC 5.3.1.5) produced with the genetically modified Streptomyces rubiginosus strain DP-Pzn37 by Danisco US Inc. Although the production strain contains antibiotic resistance genes, the food enzyme was shown to be free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in an immobilised form for the isomerisation of glucose for the production of high fructose syrups. Residual amounts of total organic solids (TOS) are eliminated by the use of an immobilised food enzyme and further removed by the purification steps applied during the production of high fructose syrups using the immobilised enzyme; consequently, dietary exposure was not calculated. Genotoxicity tests did not raise safety concerns. 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 85.2 mg TOS/kg body weight (bw) per day, the highest dose tested. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered to be low. Based on the data provided, the immobilisation process and the removal of total organic solids during the production of high fructose syrups, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP-Pzn37. EFSA Journal 2020;18(1):5978, 12 pp. | https://doi.org/10.2903/j.efsa.2020.5978

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.5978

12.12.2019 / 20.01.2020

Identitätsnr.    2015/196

EFSA-Q-Nr.      2016-00203

IUBMB-Nr. EC   5.3.1.5

keine Sicherheitsbedenken

The food enzyme maltogenic amylase (glucan 1,4- a-maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, baking and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these processes. Based on the maximum use levels recommended for baking and brewing 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 0.199 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity stud y in rats. The Panel identified a no observed adverse effect level of at least 80 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 400. Similarity of the amino acid sequence to those of known allergens was searched and three matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure can be excluded in distilled alcohol production and is considered to be low in starch processing, baking and brewing. 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.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme from the genetically modified Bacillus licheniformis strain DP-Dzr50. EFSA Journal 2020;18(1):5972, 17 pp. | https://doi.org/10.2903/j.efsa.2020.5972

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.5972

11.12.2019 / 17.01.2020

Identitätsnr.    2015/139

EFSA-Q-Nr.      2016-00096

IUBMB-Nr. EC   3.2.1.133

keine Sicherheitsbedenken

The food enzyme with xylanases (4-b-D-xylan xylanohydrolase, EC 3.2.1.8) and glucanases active against b-1,4 linkages is produced with the non-genetically modified fungus Disporotrichum dimorphosporum strain DXL by DSM Food Specialities B.V. The food enzyme is intended to be used in brewing processes. 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 0.167 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The syste mic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 199 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a high Margin of Exposure of at least 1,100. Similarity of amino acid sequences of the identified xylanases and b-glucanases to those of known allergen s was searched. No matches were found for two endo-1,4-b-glucanases and two endo-1,4-b-xylanases. However, for a third endo-b-1,4- glucanase the search resulted in matches with three mite protein sequences. While incide ntal cases of allergic reactions to endo-1,4-b-xylanases and b-glucanases have been reported after inhalation in respiratory sensitised individuals in the workplace, no allergic reactions to xylanases or b-glucanases have been reported in the literature after oral exposure. The Panel considered that, 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.

EFSA CEP Panel (2020): Scientific Opinion on the safety evaluation of the food enzyme endo-1,4-b-xylanase and b-glucanase from Disporotrichum dimorphosporum strain DXL. EFSA Journal 2020;18(1):5975, 17 pp. | https://doi.org/10.2903/j.efsa.2020.5975

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.5975



11.12.2019 / 10.01.2020

Identitätsnr.   ?

EFSA-Q-Nr.      2014-00355

     2014-00356

IUBMB-Nr. EC   3.2.1.8

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