38 results on '"Natália Kovalkovičová"'
Search Results
2. Safety evaluation of the food enzyme pectin lyase from the genetically modified
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Magdalena, Andryszkiewicz, Ana, Gomes, Natália, Kovalkovičová, Yi, Liu, Kim Renée Rygaard, Nielsen, Giulio, di Piazza, Karl-Heinz, Engel, and Andrew, Chesson
- Abstract
The food enzyme pectin lyase ((1-4)-6-O-methyl-α-D-galacturonan lyase; EC 4.2.2.10) is produced with the genetically modified
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- 2022
3. Safety evaluation of the use of the non-genetically modified
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Lieve, Herman, Jaime, Aguilera, Magdalena, Andryszkiewicz, Natália, Kovalkovičová, Yi, Liu, Sandra, Ranieri, and Andrew, Chesson
- Abstract
This assessment addresses the enzyme β-galactosidase which is not separated from the yeast cells used for its production. The β-galactosidase (β-D-galactoside galactohydrolase, EC 3.2.1.23) is produced with the non-genetically modified
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- 2022
4. Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Natália, Kovalkovičová, Yi, Liu, Giulio, di Piazza, Sandra, Rainieri, Rita, Ferreira de Sousa, and Andrew, Chesson
- Abstract
The food enzyme β-galactosidase (β-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified
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- 2022
5. Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Natália, Kovalkovičová, Yi, Liu, Giulio, di Piazza, Rita, Ferreira de Sousa, and Andrew, Chesson
- Abstract
The food enzyme β-galactosidase (β-d-galactoside galatohydrolase, EC 3.2.1.23) is produced with the non-genetically modified
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- 2022
6. Safety evaluation of the thermolabile form of the food enzyme mucorpepsin from
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Jaime, Aguilera, Magdalena, Andryskiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, Joaquim, Maia, Sandra, Rainieri, and Andrew, Chesson
- Abstract
The food enzyme mucorpepsin (aspartic endopeptidase, EC 3.4.23.23) is produced with the non-genetically modified microorganism
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- 2022
7. Safety evaluation of the native and thermolabile forms of the food enzyme mucorpepsin from
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Jaime, Aguilera, Magdalena, Andryskiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, Joaquim, Maia, Sandra, Rainieri, and Andrew, Chesson
- Abstract
The food enzyme mucorpepsin (aspartic endopeptidase, EC 3.4.23.23) is produced with the non-genetically modified microorganism
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- 2022
8. Safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Magdalena, Andryszkiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, and Andrew, Chesson
- Abstract
The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified
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- 2022
9. Safety evaluation of the food enzyme glucan 1,4-α-glucosidase from
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Jaime, Aguilera, Natália, Kovalkovičová, Yi, Liu, and Andrew, Chesson
- Abstract
The food enzyme glucan 1,4-α-glucosidase (4-α-d-glucan glucohydrolase, EC 3.2.1.3) is produced with a non-genetically modified strain of
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- 2022
10. Safety evaluation of the food enzyme pectin lyase from the genetically modified
- Author
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Magdalena, Andryszkiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, and Andrew, Chesson
- Abstract
The food enzyme pectin lyase ((1→4)-6
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- 2022
11. Safety evaluation of the food enzyme mannan endo-1,4-β-mannosidase from the genetically modified
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Magdalena, Andryszkiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, and Andrew, Chesson
- Abstract
The food enzyme mannan endo-1,4-β-mannosidase (1,4-β-d-mannan mannanohydrolase, EC 3.2.1.78) is produced with the genetically modified
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- 2022
12. Safety evaluation of the food enzyme containing trypsin, chymotrypsin, α‐amylase and triacylglycerol lipase from porcine pancreas
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Claude, Lambré, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Ursula, Gundert-Remy, Lieve, Herman, Dominique, Turck, Magdalena, Andryszkiewicz, Natália, Kovalkovičová, Joaquim, Maia, Yi, Liu, Rainieri, Sandra, and Andrew, Chesson
- Subjects
Veterinary (miscellaneous) ,Animal Science and Zoology ,Parasitology ,Plant Science ,Microbiology ,Food Science - Abstract
The food enzyme complex, containing trypsin (EC 3.4.21.4), chymotrypsin (EC 3.4.21.1), α-amylase (1,4-α-d-glucan glucanohydrolase, EC 3.2.1.1) and triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3), is obtained from porcine pancreas by American Laboratories, Inc., USA. The food enzyme is intended primarily for the hydrolysis of milk proteins to be used in foods for special medical or nutritional dietary management. ■■■■■ is extensively used in the manufacturing process, and residual amounts of the solvent remain in the food enzyme. The applicant estimates a typical range of ■■■■■ in the food enzyme to be 10,000-13,000 mg/kg. Directive 2009/32/EC sets a maximum residue level of 10 mg/kg for foods and food ingredients produced in the EU or imported into the EU. The use of ■■■■■ for the production of a food enzyme falls within the scope of Directive 2009/32/EC. Consequently, the food enzyme does not comply with the existing requirements within the EU governing residual amount of solvent.
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- 2022
13. Safety evaluation of the food enzyme containing chymosin and pepsin from the abomasum of suckling lambs
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Jaime Aguilera, Magdalena Andryszkiewicz, Natália Kovalkovičová, Yi Liu, and Andrew Chesson
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EC 3.4.23.4 ,Nutrition. Foods and food supply ,Chemical technology ,Veterinary (miscellaneous) ,EC 3.4.23.1 ,rennet ,TP1-1185 ,Plant Science ,Microbiology ,food enzyme ,abomasum ,Scientific Opinion ,chymosin ,suckling lambs ,TX341-641 ,Animal Science and Zoology ,Parasitology ,Food Science ,pepsin - Abstract
The food enzyme rennet containing chymosin (EC 3.4.23.4) and pepsin (EC 3.4.23.1) is prepared from the abomasum (stomach) of suckling lambs, by Productos Nievi, SA. The food enzyme is intended to be used in milk processing for cheese production. As no concerns arise from the animal source of the food enzyme, from its manufacture, and based on the history of safe use and consumption, the Panel considered that toxicological data were not required and no exposure assessment was necessary. On the basis of literature data, the Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure could not be excluded, but the likelihood for this to occur was considered 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.
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- 2022
14. Safety evaluation of a food enzyme containing chymosin, pepsin and gastricsin from the abomasum of suckling goats
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Natália Kovalkovičová, Yi Liu, Joaquim Maia, and Andrew Chesson
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EC 3.4.23.4 ,EC 3.4.23.3 ,Nutrition. Foods and food supply ,Chemical technology ,EC 3.4.23.1 ,Veterinary (miscellaneous) ,TP1-1185 ,Plant Science ,suckling goats ,Microbiology ,food enzyme ,abomasum ,Scientific Opinion ,chymosin ,TX341-641 ,Animal Science and Zoology ,Parasitology ,Food8822 ,gastricsin ,pepsin ,Food Science - Abstract
The food enzyme containing chymosin (EC 3.4.23.4), pepsin (EC 3.4.23.1) and gastricsin (EC 3.4.23.3) is prepared from the abomasum of suckling goats by Consejo Regulador de la Denominación de Origen Queso Palmero and Consejo Regulador de la Denominación de Origen Queso Majorero. The food enzyme is intended to be used in milk processing for cheese production. As no concerns arise from the animal source of the food enzyme, from its manufacture, and based on the history of safe use and consumption, the Panel considered that toxicological data were not required and no exposure assessment was necessary. Similarity of the amino acid sequences of the three proteins (chymosin, pepsin and gastricsin) 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 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.
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- 2022
15. Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain DP‐Dzb52
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk van Loveren, Laurence Vernis, Holger Zorn, Sirpa Kärenlampi, André Penninks, Magdalena Andryszkiewicz, Ana Gomes, Natália Kovalkovičová, Yi Liu, Joaquim Maia, Karl‐Heinz Engel, and Andrew Chesson
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1,4‐α‐d‐glucan glucanohydrolase ,Nutrition. Foods and food supply ,Chemical technology ,Veterinary (miscellaneous) ,glycogenase ,TP1-1185 ,Plant Science ,EC 3.2.1.1 ,Microbiology ,food enzyme ,Scientific Opinion ,α‐amylase ,Bacillus licheniformis ,TX341-641 ,Animal Science and Zoology ,Parasitology ,genetically modified microorganism ,Food8822 ,Food Science - Abstract
The food enzyme α‐amylase (1,4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzb52 by Danisco US Inc. The production strain contains multiple copies of an 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 α‐amylase is intended to be used in starch processing for the production of glucose syrups, brewing processes and distilled alcohol production. Since residual amounts of the food enzyme are removed by the purification steps applied during the production of glucose syrups and distillation, no dietary exposure was calculated. Based on the maximum use levels recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the enzyme–total organic solids (TOS) was estimated to be up to 0.145 TOS/kg body weight per day in European populations. The toxicity studies were carried out with another α‐amylase from B. licheniformis strain DP‐Dzb54, considered by the Panel as a suitable substitute. Toxicological tests indicated that there was no concern with respect to genotoxicity or systemic toxicity. A no observed adverse effect level was identified in rats which, compared with the dietary exposure, results in a margin of exposure of at least 750. A search for similarity of the amino acid sequence 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 can be excluded in distilled alcohol production and is considered low when the enzyme is used in starch processing 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.
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- 2021
16. Safety evaluation of the food enzyme alternansucrase from
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Claude, Lambré, Evgenia, Lampi, Marcel, Mengelers, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, André, Penninks, Jaime, Aguilera, Margarita, Aguilera-Gomez, Magdalena, Andryszkiewicz, Natália, Kovalkovičová, Yi, Liu, Claudia, Roncancio Peña, and Andrew, Chesson
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sucrose:1,6(1,3)‐α‐d‐glucan 6(3)‐α‐d‐glucosyltransferase ,Leuconostoc citreum ,Scientific Opinion ,EC 2.4.1.140 ,food enzyme ,non‐genetically modified microorganism ,alternansucrase - Abstract
The food enzyme alternansucrase (sucrose:1,6(1,3)‐α‐d‐glucan 6(3)‐α‐d‐glucosyltransferase, EC 2.4.1.140) is produced with a non‐genetically modified Leuconostoc citreum strain NRRL B‐30894 by Cargill Incorporated. As a consequence of the absence of antimicrobial resistance genes identified in its genome, the production strain meets the criteria to qualify for the Qualified Presumption of Safety (QPS) approach to safety assessment. As no other concerns arising from the microbial source or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. The alternansucrase food enzyme is intended to be used for the manufacture of α‐d‐glucan oligosaccharides as a sweetening agent. The purification processes applied to syrups produced from sucrose with alternansucrase are expected to largely remove the food enzyme. Any residual TOS remaining in the final product would consist of non‐hazardous material. This is based on the QPS status of the production organism, the medium components and the identified material used in downstream processing. Consequently, the Panel decided that dietary exposure did not need to be calculated. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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- 2021
17. Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain NZYM‐DB
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Magdalena Andryszkiewicz, Ana Gomes, Natália Kovalkovičová, Yi Liu, Joaquim Maia, Sandra Rainieri, and Andrew Chesson
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No-observed-adverse-effect level ,TECNOLOGIA DE ALIMENTOS ,040301 veterinary sciences ,Interesterified fat ,Veterinary (miscellaneous) ,Triacylglycerol lipase ,TP1-1185 ,Plant Science ,010501 environmental sciences ,medicine.disease_cause ,01 natural sciences ,Microbiology ,Triacylglycerol acylhydrolase ,0403 veterinary science ,medicine ,Food enzyme ,TX341-641 ,Food science ,Lipase ,0105 earth and related environmental sciences ,chemistry.chemical_classification ,Genetically modified microorganism ,biology ,Nutrition. Foods and food supply ,Chemical technology ,Aspergillus niger ,04 agricultural and veterinary sciences ,biology.organism_classification ,Genetically modified organism ,Scientific Opinion ,Enzyme ,chemistry ,biology.protein ,Animal Science and Zoology ,Parasitology ,Genotoxicity ,EC 3.1.1.3 ,Food Science - Abstract
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain NZYM‐DB 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 recombinant DNA. The food enzyme is intended to be used in an immobilised form in the production of modified fats and oils by interesterification. Based on the estimated use levels recommended for interesterification of fats and oils 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 0.75 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 at the highest dose of 1,132 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,500. 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 of such reactions to occur is likely to be low. Based on the data provided, the immobilisation of the food enzyme and the removal of total organic solids during fats and oils processing, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.
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- 2021
18. Safety evaluation of the food enzyme glucose oxidase from
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Beat Johannes, Brüschweiler, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Klaus-Dieter, Jany, Sirpa, Kärenlampi, André, Penninks, Davor, Želježić, Margarita, Aguileria-Gómez, Davide, Arcella, Christine, Horn, Natália, Kovalkovičová, Yi, Liu, Joaquim Manuel, Maia, and Andrew, Chesson
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Food Ingredients and Packaging ,Scientific Opinion ,d‐glucose oxidase ,EC 1.1.3.4 ,beta‐d‐glucose:oxygen 1‐oxidoreductase ,Aspergillus niger ,genetically modified microorganism ,food enzyme ,glucose oxidase - Abstract
The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.004 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an asparaginase from A. niger (strain ASP). The Panel considered this enzyme as a suitable substitute to be used in the toxicological studies, 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. 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 1,038 and 1,194 mg TOS/kg bw per day (for males and females, respectively) that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (MoE) (of at least 260,000). 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 by dietary exposure cannot be excluded, but the likelihood 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.
- Published
- 2020
19. Safety evaluation of the food enzyme aqualysin 1 from a genetically modified
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Vittorio, Silano, Claudia, Bolognesi, Laurence, Castle, Kevin, Chipman, Jean-Pierre, Cravedi, Paul, Fowler, Roland, Franz, Konrad, Grob, Rainer, Gürtler, Trine, Husøy, Sirpa, Kärenlampi, Wim, Mennes, Maria Rosaria, Milana, Karla, Pfaff, Gilles, Riviere, Jannavi, Srinivasan, Maria de Fátima, Tavares Poças, Christina, Tlustos, Detlef, Wölfle, Holger, Zorn, Andrew, Chesson, Boet, Glandorf, Lieve, Herman, Klaus-Dieter, Jany, Francesca, Marcon, André, Penninks, Andrew, Smith, Davor, Želježić, Margarita, Aguilera-Gómez, Magdalena, Andryszkiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, and Karl-Heinz, Engel
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Scientific Opinion ,Bacillus subtilis ,aqualysin 1 ,EC 3.4.21.111 ,genetically modified microorganism ,food enzyme - Abstract
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 exposure as insufficient 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.
- Published
- 2020
20. Safety evaluation of the food enzyme xylanase from
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Klaus-Dieter, Jany, André, Penninks, Davide, Arcella, Margarita, Aguilera-Gómez, Natália, Kovalkovičová, Yi, Liu, Joaquim, Maia, Claudia, Roncancio Peña, and Andrew, Chesson
- Subjects
xylanase ,Scientific Opinion ,endo‐1,4‐β‐xylanase ,EC 3.2.1.8 ,1,4‐β‐d‐xylan xylanohydrolase ,food enzyme ,non‐genetically modified microorganism ,Bacillus pumilus - Abstract
The food enzyme 1,4‐β‐d‐xylan xylanohydrolase (EC 3.2.1.8) is produced with the non‐genetically modified strain Bacillus pumilus (strain BLXSC) by Advanced Enzyme Technologies Ltd. The food enzyme is intended to be used in baking 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 baking processes. Based on the maximum recommended use levels for 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 0.138 mg TOS/kg body weight (bw) per day. As the production strain of B. pumilus 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 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 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.
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- 2020
21. Safety evaluation of the food enzyme endo-1,4-β-xylanase and β-glucanase from
- Author
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Francesca, Marcon, André, Penninks, Andrew, Smith, Margarita, Aguilera-Gomez, Magdalena, Andryszkiewicz, Davide, Arcella, Ana, Gomes, Natália, Kovalkovičová, Yi, Liu, Joaquim, Maia, Claudia, Roncancio Peña, and Andrew, Chesson
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Scientific Opinion ,EC 3.2.1.8 ,Disporotrichum dimorphosporum ,β‐glucanases ,food enzyme ,4‐β‐d‐xylan xylanohydrolase - Abstract
The food enzyme with xylanases (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) and glucanases active against β‐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 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 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 β‐glucanases to those of known allergens was searched. No matches were found for two endo‐1,4‐β‐glucanases and two endo‐1,4‐β‐xylanases. However, for a third endo‐β‐1,4‐glucanase the search resulted in matches with three mite protein sequences. While incidental cases of allergic reactions to endo‐1,4‐β‐xylanases and β‐glucanases have been reported after inhalation in respiratory sensitised individuals in the workplace, no allergic reactions to xylanases or β‐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.
- Published
- 2020
22. Safety of the food enzyme glucoamylase from a genetically modified
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Beat Johannes, Brüschweiler, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Alicja, Mortensen, Gilles, Riviere, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Klaus-Dieter, Jany, Sirpa, Kärenlampi, André, Penninks, Davor, Želježic, Margarita, Aguilera-Gómez, Magdalena, Andryszkiewicz, Davide, Arcella, Ana, Gomes, Natália, Kovalkovičová, Yi, Liu, Annamaria, Rossi, Karl-Heinz, Engel, and Andrew, Chesson
- Subjects
Food Ingredients and Packaging ,amyloglucosidase ,Scientific Opinion ,Aspergillus niger ,glucoamylase ,4‐α‐glucosidase ,glucan 1 ,genetically modified microorganism ,food enzyme ,EC 3.2.1.3 - Abstract
The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger 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 recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, consequently dietary exposure was not calculated. For brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme–TOS was estimated to be below 3.627 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 rodents. The Panel identified a no‐observed‐adverse‐effect level (NOAEL) at the highest dose of 1,360 mg TOS/kg bw per day. 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 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, the removal of TOS during the production of glucose syrups and the derived margin of exposure for brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
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- 2020
23. Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified
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Vittorio, Silano, Claudia, Bolognesi, Laurence, Castle, Kevin, Chipman, Jean-Pierre, Cravedi, Paul, Fowler, Roland, Franz, Konrad, Grob, Rainer, Gürtler, Trine, Husøy, Sirpa, Kärenlampi, Wim, Mennes, Maria Rosaria, Milana, Karla, Pfaff, Gilles, Riviere, Jannavi, Srinivasan, Maria de Fátima, Tavares Poças, Christina, Tlustos, Detlef, Wölfle, Holger, Zorn, Andrew, Chesson, Boet, Glandorf, Lieve, Herman, Klaus-Dieter, Jany, Francesca, Marcon, André, Penninks, Andrew, Smith, Henk, van Loveren, Davor, Želježić, Margarita, Aguilera-Gómez, Davide, Arcella, Natália, Kovalkovičová, Joaquim, Maia, Yi, Liu, and Karl-Heinz, Engel
- Subjects
Scientific Opinion ,EC 3.2.1.8 ,4‐β‐xylanase ,Aspergillus niger ,genetically modified microorganism ,food enzyme ,endo‐1 - Abstract
The food enzyme is an endo‐1,4‐β‐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‐β‐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‐β‐xylanase. Based 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.
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- 2020
24. Safety evaluation of the food enzyme xylanase from a genetically modified
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Vittorio, Silano, Claudia, Bolognesi, Laurence, Castle, Kevin, Chipman, Jean-Pierre, Cravedi, Paul, Fowler, Roland, Franz, Konrad, Grob, Rainer, Gürtler, Trine, Husøy, Sirpa, Kärenlampi, Wim, Mennes, Maria Rosaria, Milana, Karla, Pfaff, Gilles, Riviere, Jannavi, Srinivasan, Maria de Fátima, Tavares Poças, Christina, Tlustos, Detlef, Wölfle, Holger, Zorn, Andrew, Chesson, Boet, Glandorf, Lieve, Herman, Klaus-Dieter, Jany, Francesca, Marcon, André, Penninks, Andrew, Smith, Davor, Želježić, Margarita, Aguilera-Gómez, Magdalena, Andryszkiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, Joaquim, Maia, and Karl-Heinz, Engel
- Subjects
xylanase ,Scientific Opinion ,EC 3.2.1.8 ,Bacillus subtilis ,4‐β‐xylanase ,genetically modified microorganism ,food enzyme ,4‐β‐d‐xylan xylanohydrolase ,endo‐1 - Abstract
The food enzyme considered in this opinion is an endo‐1,4‐β‐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‐β‐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 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; 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.
- Published
- 2020
25. Safety evaluation of food enzyme glucan 1,4-α-maltohydrolase produced with a genetically modified
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Vittorio, Silano, Claudia, Bolognesi, Laurence, Castle, Kevin, Chipman, Jean-Pierre, Cravedi, Paul, Fowler, Roland, Franz, Konrad, Grob, Rainer, Gürtler, Trine, Husøy, Sirpa, Kärenlampi, Wim, Mennes, Maria Rosaria, Milana, Karla, Pfaff, Gilles, Riviere, Jannavi, Srinivasan, Maria de Fátima, Tavares Poças, Christina, Tlustos, Detlef, Wölfle, Holger, Zorn, Lieve, Herman, Klaus-Dieter, Jany, Francesca, Marcon, André, Penninks, Andrew, Smith, Davide, Arcella, Ana, Gomes, Natália, Kovalkovičová, Yi, Liu, Joaquim, Maia, and Karl-Heinz, Engel
- Subjects
Scientific Opinion ,Bacillus subtilis ,4‐α‐maltohydrolase ,EC 3.2.1.133 ,glucan 1 ,maltogenic α‐amylase ,genetically modified microorganism ,food enzyme ,maltohydrolase - Abstract
The food enzyme considered in this opinion is a glucan 1,4‐α‐maltohydrolase (maltogenic α‐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‐α‐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‐α‐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.
- Published
- 2020
26. Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified
- Author
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Beat Johannes, Brüschweiler, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Alicja, Mortensen, Gilles, Riviere, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Francesca, Marcon, André, Penninks, Jaime, Aguilera, Margarita, Aguilera-Gómez, Magdalena, Andryszkiewicz, Davide, Arcella, Ana, Gomes, Natália, Kovalkovičová, Yi, Liu, and Andrew, Chesson
- Subjects
Food Ingredients and Packaging ,Scientific Opinion ,endo‐1,4‐β‐xylanase ,Trichoderma reesei ,glucoamylase ,genetically modified microorganism ,food enzyme ,EC 3.2.1.3 - Abstract
The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. 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 endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of distilled alcohol, consequently dietary exposure was not calculated. For baking and brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme–TOS was estimated to be up to 0.416 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 rodents. The Panel identified a No Observed Adverse Effect Level of 1,000 mg TOS/kg bw per day. A comparison of the no observed adverse effect level with the dietary exposure results in a sufficiently high margin of exposure (at least 2,400). Similarity of the amino acid sequence to those of known allergens was searched and no 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 removal of TOS during the production of distilled alcohol and the derived margin of exposure for baking and brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
- Published
- 2020
27. Safety evaluation of the food enzyme maltogenic amylase from a genetically modified
- Author
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Vittorio, Silano, Claudia, Bolognesi, Laurence, Castle, Kevin, Chipman, Jean-Pierre, Cravedi, Paul, Fowler, Roland, Franz, Konrad, Grob, Rainer, Gürtler, Trine, Husøy, Sirpa, Kärenlampi, Wim, Mennes, Maria Rosaria, Milana, Karla, Pfaff, Gilles, Riviere, Jannavi, Srinivasan, Maria de Fátima, Tavares Poças, Christina, Tlustos, Detlef, Wölfle, Holger, Zorn, Andrew, Chesson, Boet, Glandorf, Lieve, Herman, Klaus-Dieter, Jany, Francesca, Marcon, André, Penninks, Andrew, Smith, Henk, van Loveren, Davor, Želježic, Margarita, Aguilera-Gómez, Magdalena, Andryszkiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, and Karl-Heinz, Engel
- Subjects
Scientific Opinion ,Bacillus subtilis ,4‐α‐maltohydrolase ,EC 3.2.1.133 ,maltogenic amylase ,glucan 1 ,genetically modified microorganism ,food enzyme - Abstract
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.
- Published
- 2020
28. Safety evaluation of the food enzyme maltogenic amylase from a genetically modified
- Author
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Beat Johannes, Brüschweiler, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, André, Penninks, Andrew, Smith, Davor, Želježic, Jaime, Aguilera, Natália, Kovalkovičová, Yi, Liu, Joaquim, Maia, Claudia, Roncancio Peña, and Andrew, Chesson
- Subjects
Food Ingredients and Packaging ,Scientific Opinion ,4‐α‐d‐glucan α‐maltohydrolase ,Bacillus subtilis ,4‐α‐maltohydrolase ,EC 3.2.1.133 ,maltogenic amylase ,glucan 1 ,genetically modified microorganism ,food enzyme - Abstract
The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organic Solids (TOS) was estimated to be up to 0.556 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 at the mid‐dose of 318.4 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). 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 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 Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
- Published
- 2020
29. Safety evaluation of the food enzyme maltogenic amylase from a genetically modified
- Author
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Beat Johannes, Brüschweiler, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Alicja, Mortensen, Gilles, Rivière, Inger-Lise, Steffensen, Christina, Tlustos, Henk, van Loveren, Laurence, Vernis, Holger, Zorn, Lieve, Herman, André, Penninks, Davor, Želježic, Jaime, Aguilera, Natália, Kovalkovičová, Yi, Liu, Joaquim, Maia, Claudia, Roncancio Peña, and Andrew, Chesson
- Subjects
Food Ingredients and Packaging ,Scientific Opinion ,4‐α‐d‐glucan α‐maltohydrolase ,Bacillus subtilis ,4‐α‐maltohydrolase ,EC 3.2.1.133 ,maltogenic amylase ,glucan 1 ,genetically modified microorganism ,food enzyme - Abstract
The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.649 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 in rats. The Panel identified a no observed adverse effect level at the mid‐dose of 371 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). 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 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 Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
- Published
- 2020
30. Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified
- Author
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Vittorio, Silano, José Manuel, Barat Baviera, Claudia, Bolognesi, Beat Johannes, Brüschweiler, Pier Sandro, Cocconcelli, Riccardo, Crebelli, David Michael, Gott, Konrad, Grob, Evgenia, Lampi, Alicja, Mortensen, Gilles, Riviere, Inger-Lise, Steffensen, Christina, Tlustos, Henk, Van Loveren, Laurence, Vernis, Holger, Zorn, Boet, Glandorf, Lieve, Herman, Sirpa, Kärenlampi, André, Penninks, Davor, Željeżić, Margarita, Aguilera-Gómez, Magdalena, Andryszkiewicz, Davide, Arcella, Natália, Kovalkovičová, Yi, Liu, Claudia, Roncancio Peña, Christine, Horn, and Andrew, Chesson
- Subjects
Food Ingredients and Packaging ,xylanase ,1,4‐β‐D‐xylan xylanohydrolase ,Scientific Opinion ,EC 3.2.1.8 ,4‐β‐xylanase ,Aspergillus oryzae ,genetically modified microorganism ,food enzyme ,endo‐1 - Abstract
The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae 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 recombinant DNA. This xylanase is intended to be used in baking 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 0.027 mg TOS/kg body weight (bw) per day in European populations. 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. In this study, effects were seen in the control group on reproductive parameters (particularly the seminiferous epithelium atrophy in the testes) at incidences that far exceeded the background range. Consequently, a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, including haematological parameters and the immunology cohort, was conducted. The Panel identified a no observed adverse effect level at the highest dose tested of 1,101.3 mg TOS/kg bw per day. When compared with the dietary exposure, resulted in a sufficiently high margin of exposure (at least 40,000). 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 conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
- Published
- 2020
31. Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37
- Author
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Karl‐Heinz Engel, Andrew Smith, Davor Želježić, Margarita Aguilera‐Gómez, Ana Gomes, Natália Kovalkovičová, Yi Liu, Joaquim Maia, Sandra Rainieri, and Andrew Chesson
- Subjects
Xylose isomerase ,Glucose-6-phosphate isomerase ,No-observed-adverse-effect level ,040301 veterinary sciences ,D‐xylose aldose‐ketose‐isomerase ,Veterinary (miscellaneous) ,TP1-1185 ,Plant Science ,010501 environmental sciences ,medicine.disease_cause ,01 natural sciences ,Microbiology ,xylose isomerase ,0403 veterinary science ,medicine ,TX341-641 ,Food science ,0105 earth and related environmental sciences ,chemistry.chemical_classification ,Strain (chemistry) ,Nutrition. Foods and food supply ,Streptomyces rubiginosus ,Chemistry ,Chemical technology ,04 agricultural and veterinary sciences ,food enzyme ,Genetically modified organism ,Scientific Opinion ,EC 5.3.1.5 ,Enzyme ,glucose isomerase ,Animal Science and Zoology ,Parasitology ,Genotoxicity ,Food Science - Abstract
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.
- Published
- 2020
32. Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50
- Author
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Riviere, Inger‐Lise Steffensen, Christina Tlustos, Henk vanLoveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Magdalena Andryszkiewicz, Davide Arcella, Ana Gomes, Natália Kovalkovičová, Yi Liu, and Andrew Chesson
- Subjects
No-observed-adverse-effect level ,040301 veterinary sciences ,Starch ,Veterinary (miscellaneous) ,maltogenic amylase ,TP1-1185 ,Plant Science ,010501 environmental sciences ,medicine.disease_cause ,01 natural sciences ,Microbiology ,0403 veterinary science ,chemistry.chemical_compound ,medicine ,Bacillus licheniformis ,TX341-641 ,genetically modified microorganism ,Food science ,0105 earth and related environmental sciences ,Glucan ,glucan 1,4‐α‐maltohydrolase ,chemistry.chemical_classification ,biology ,Nutrition. Foods and food supply ,business.industry ,Chemical technology ,food and beverages ,04 agricultural and veterinary sciences ,biology.organism_classification ,food enzyme ,Genetically modified organism ,Scientific Opinion ,Enzyme ,chemistry ,EC 3.2.1.133 ,Brewing ,Animal Science and Zoology ,Parasitology ,business ,Genotoxicity ,Food Science - Abstract
The food enzyme maltogenic amylase (glucan 1,4‐α‐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 study 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.
- Published
- 2020
33. Safety evaluation of the food enzyme xylanase from the genetically modified Aspergillus luchuensis Inui strain RF7398
- Author
-
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Riviere, Inger‐Lise Steffensen, Christina Tlustos, Henk vanLoveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Magdalena Andryszkiewicz, Davide Arcella, Ana Gomes, Natália Kovalkovičová, Yi Liu, Kim René Rygaard Nielsen, Karl‐Heinz Engel, and Andrew Chesson
- Subjects
No-observed-adverse-effect level ,EC 3.2.1.8 ,040301 veterinary sciences ,Veterinary (miscellaneous) ,TP1-1185 ,Plant Science ,010501 environmental sciences ,Biology ,medicine.disease_cause ,01 natural sciences ,Microbiology ,law.invention ,0403 veterinary science ,endo‐14‐β‐xylanase ,law ,Aspergillus luchuensis Inui ,medicine ,TX341-641 ,genetically modified microorganism ,Food science ,0105 earth and related environmental sciences ,chemistry.chemical_classification ,xylanase ,Nutrition. Foods and food supply ,Chemical technology ,Strain (biology) ,Aspergillus luchuensis ,04 agricultural and veterinary sciences ,food enzyme ,4‐β‐d‐xylan xylanohydrolase ,Genetically modified organism ,Scientific Opinion ,Enzyme ,chemistry ,Recombinant DNA ,Xylanase ,Animal Science and Zoology ,Parasitology ,Genotoxicity ,Food Science - Abstract
The food enzyme xylanase (4‐β‐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.
- Published
- 2020
34. Safety evaluation of the food enzyme α‐amylase and 1,4‐α‐glucan 6‐α‐glucosyltransferase from Paenibacillus alginolyticus
- Author
-
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Beat Johannes Brüschweiler, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Margarita Aguileria‐Gómez, Christine Horn, Natália Kovalkovičová, Yi Liu, Joaquim Manuel Maia, and Andrew Chesson
- Subjects
Paenibacillus alginolyticus ,040301 veterinary sciences ,Starch ,Veterinary (miscellaneous) ,Allergic sensitisation ,TP1-1185 ,Plant Science ,010501 environmental sciences ,EC 3.2.1.1 ,01 natural sciences ,Microbiology ,0403 veterinary science ,chemistry.chemical_compound ,α‐amylase ,1,4‐α‐glucan 6‐α‐glucosyltransferase ,TX341-641 ,Food science ,Amylase ,0105 earth and related environmental sciences ,Glucan ,chemistry.chemical_classification ,biology ,Nutrition. Foods and food supply ,Chemical technology ,04 agricultural and veterinary sciences ,food enzyme ,Amino acid ,(1→4)‐α‐d‐glucan:(1→4)‐α‐d‐glucan(d‐glucose) 6‐α‐d‐glucosyltransferase ,Scientific Opinion ,Enzyme ,chemistry ,biology.protein ,Animal Science and Zoology ,Parasitology ,Glucosyltransferase ,EC 2.4.1.24 ,Food Science - Abstract
The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase, EC 3.2.1.1) and 1,4‐α‐glucan 6‐α‐glucosyltransferase ((1→4)‐α‐d‐glucan:(1→4)‐α‐d‐glucan(d‐glucose) 6‐α‐d‐glucosyltransferase, EC 2.4.1.24) is produced with a Paenibacillus alginolyticus by Hayashibara Co., Ltd. The food enzyme is free from viable cells of the production organism. The α‐amylase and 1,4‐α‐glucan 6‐α‐glucosyltransferase is intended to be used in starch processing for the production of isomaltodextrins. Residual amounts of total organic solids are removed by the purification steps applied during the production of isomaltodextrins and consequently dietary exposure is considered negligible. Similarity of the amino acid sequences to those of known allergens was 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 to the food enzyme cannot be excluded, but the likelihood 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.
- Published
- 2019
35. Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)
- Author
-
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Beat Johannes Brüschweiler, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Klaus‐Dieter Jany, Sirpa Kärenlampi, André Penninks, Jaime Aguilera, Margarita Aguileria‐Gómez, Davide Arcella, Christine Horn, Natália Kovalkovičová, Yi Liu, Joaquim Manuel Maia, and Andrew Chesson
- Subjects
Asparaginase ,No-observed-adverse-effect level ,040301 veterinary sciences ,Veterinary (miscellaneous) ,Triacylglycerol lipase ,TP1-1185 ,Plant Science ,010501 environmental sciences ,triacylglycerol acylhydrolase ,medicine.disease_cause ,01 natural sciences ,Microbiology ,0403 veterinary science ,chemistry.chemical_compound ,lipase ,medicine ,TX341-641 ,genetically modified microorganism ,Food science ,Lipase ,0105 earth and related environmental sciences ,Food Ingredients and Packaging ,biology ,Nutrition. Foods and food supply ,Chemical technology ,Aspergillus niger ,04 agricultural and veterinary sciences ,triacylglycerol lipase ,biology.organism_classification ,food enzyme ,Genetically modified organism ,Scientific Opinion ,chemistry ,Toxicity ,biology.protein ,Animal Science and Zoology ,Parasitology ,Genotoxicity ,EC 3.1.1.3 ,Food Science - Abstract
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.020 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an asparaginase from A. niger (strain ASP). The Panel considered this enzyme as a suitable substitute to be used in the toxicological studies, 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. 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 1,038 and 1,194 mg TOS/kg bw per day (for males and females, respectively) that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (MoE) (of at least 51,900). 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 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.
- Published
- 2019
36. Safety evaluation of the food enzyme pullulanase from a genetically modified Bacillus licheniformis (strain DP‐Dzp39)
- Author
-
EFSA Panel on Food Contact Materials, Enzymes, Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Beat Johannes Brüschweiler, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Lieve Herman, Sirpa Kärenlampi, Francesca Marcon, André Penninks, Andy Smith, Magdalena Andryszkiewicz, Davide Arcella, Natália Kovalkovičová, Yi Liu, Karl‐Heinz Engel, and Andrew Chesson
- Subjects
040301 veterinary sciences ,Starch ,Veterinary (miscellaneous) ,EC 3.2.1.41 ,TP1-1185 ,Plant Science ,010501 environmental sciences ,medicine.disease_cause ,01 natural sciences ,Microbiology ,0403 veterinary science ,chemistry.chemical_compound ,pullulan 6‐α‐glucanohydrolase ,medicine ,TX341-641 ,genetically modified microorganism ,Bacillus licheniformis ,Food science ,0105 earth and related environmental sciences ,pullulanase ,chemistry.chemical_classification ,biology ,Pullulanase ,Nutrition. Foods and food supply ,business.industry ,Chemical technology ,Pullulan ,04 agricultural and veterinary sciences ,biology.organism_classification ,food enzyme ,Genetically modified organism ,Scientific Opinion ,Enzyme ,chemistry ,Brewing ,Animal Science and Zoology ,Parasitology ,business ,Genotoxicity ,Food Science - Abstract
The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase; EC 3.2.1.41) is produced with a genetically modified Bacillus licheniformis (strain DP‐Dzp39) 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 its recombinant DNA. This pullulanase is intended to be used in brewing processes, starch processing for glucose syrups production 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, consequently, dietary exposure was not calculated for these food processes. For brewery products, based on the maximum use level recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.053 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme did not raise 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 of 500 mg TOS/kg bw per day that, compared to the estimated dietary exposure, results in sufficiently high margin of exposure (at least 9,400). The amino acid sequence of the food enzyme did not match 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 data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
- Published
- 2019
37. Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)
- Author
-
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Beat Johannes Brüschweiler, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk van Loveren, Laurence Vernis, Holger Zorn, Lieve Herman, André Penninks, Davor Želježic, Jaime Aguilera, Natália Kovalkovičová, Yi Liu, Joaquim Maia, Claudia Roncancio Peña, and Andrew Chesson
- Subjects
4‐α‐d‐glucan α‐maltohydrolase ,Nutrition. Foods and food supply ,Chemical technology ,Veterinary (miscellaneous) ,4‐α‐maltohydrolase ,EC 3.2.1.133 ,maltogenic amylase ,glucan 1 ,TP1-1185 ,Plant Science ,Microbiology ,food enzyme ,TX341-641 ,Animal Science and Zoology ,Parasitology ,Food Science - Abstract
The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.649 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 in rats. The Panel identified a no observed adverse effect level at the mid‐dose of 371 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (at least 570). 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 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 Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
- Published
- 2018
38. Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)
- Author
-
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Beat Johannes Brüschweiler, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Riviere, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Sirpa Kärenlampi, André Penninks, Davor Željeżić, Margarita Aguilera‐Gómez, Magdalena Andryszkiewicz, Davide Arcella, Natália Kovalkovičová, Yi Liu, Claudia Roncancio Peña, Christine Horn, and Andrew Chesson
- Subjects
1,4‐β‐D‐xylan xylanohydrolase ,Allergy ,No-observed-adverse-effect level ,EC 3.2.1.8 ,Veterinary (miscellaneous) ,Developmental toxicity ,TP1-1185 ,Plant Science ,Biology ,medicine.disease_cause ,Microbiology ,0404 agricultural biotechnology ,medicine ,TX341-641 ,Food science ,xylanase ,Nutrition. Foods and food supply ,business.industry ,Chemical technology ,04 agricultural and veterinary sciences ,Food safety ,medicine.disease ,040401 food science ,food enzyme ,endo‐1 ,Genetically modified organism ,4‐β‐xylanase ,Toxicity ,Xylanase ,Animal Science and Zoology ,Parasitology ,business ,Genotoxicity ,Food Science - Abstract
The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae 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 recombinant DNA. This xylanase is intended to be used in baking 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 0.027 mg TOS/kg body weight (bw) per day in European populations. 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. In this study, effects were seen in the control group on reproductive parameters (particularly the seminiferous epithelium atrophy in the testes) at incidences that far exceeded the background range. Consequently, a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, including haematological parameters and the immunology cohort, was conducted. The Panel identified a no observed adverse effect level at the highest dose tested of 1,101.3 mg TOS/kg bw per day. When compared with the dietary exposure, resulted in a sufficiently high margin of exposure (at least 40,000). 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 conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
- Published
- 2018
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