Lebensmittelenzyme: EFSA-Sicherheitsbewertungen 2014 - 2016
Thrombin aus Rinder- und Schweineblut 28.01.2015 / 17.09.2015
EFSA CEF-Panel (2015): Scientific Opinion on thrombin from cattle (bovines) and pig's blood. EFSA-Journal 13, Issue2 , February 2015, 4018 | https://doi.org/10.2903/j.efsa.2015.4018
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2015.4018
The food enzyme considered in this opinion is thrombin (EC 3.4.21.5) obtained from blood plasma of cattle and pigs. It is obtained from cattle and pig's blood that is fit for human consumption and is processed hygienically, without artificial changes. As the food enzyme is derived from edible parts of animals, no toxicological tests are required. The dietary exposure was assessed in accordance with the EFSA Comprehensive European Food Consumption Database. Based on the origin of the food enzyme from edible parts of animals, the manufacturing process, and the compositional and biochemical data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
EFSA‐Q‐2014‐00499, EC 3.4.21.5, 2013/07 Keine Sicherheitsbedenken
Lipase - Aspergillus oryzae (Stamm NZYM-AL, GVO) 03.17.2014 / 04.12.2014
EFSA CEF-Panel (2014): Scientific Opinion on lipase from a genetically modified strain of Aspergillus oryzae (strain NZYM‐AL) EFSA-Journal | https://doi.org/10.2903/j.efsa.2014.3778
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3778
The food enzyme considered in this opinion is a lipase (triacylglycerol lipase; EC 3.1.1.3) produced with a genetically modified strain of Aspergillus oryzae. The genetic modifications do not give rise to safety concern. The food enzyme contains neither the production organism nor recombinant DNA. The lipase is intended to be used in a number of food manufacturing processes, such as baking, brewing and other cereal‐based processes, and immobilised onto an inert support for oils and fats processing. The dietary exposure was assessed according to the Budget method. The food enzyme did not induce gene mutations in bacteria nor micronuclei in human peripheral blood lymphocytes. Therefore, there is no concern with respect to genotoxicity. The systemic toxicity was assessed by means of a 90‐day subchronic 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. The Panel considered that the likelihood of food allergic reactions to the enzyme is low and therefore does not give rise to safety concern. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided and the toxicological studies, this food enzyme does not give rise to safety concern under the intended conditions of use.
EC 3.1.1.3, EFS-Q-2013/00198, 2013/01 Keine Sicherheitsbedenken
Lipase - Aspergillus oryzae (Stamm NZYM‐LH, GVO) 20.06.2014 / 03.09.2014
EFSA CEF-Panel (2014): Scientific Opinion on Lipase from a Genetically Modified Strain of Aspergillus oryzae (strain NZYM‐LH). EFSA Journal | https://doi.org/10.2903/j.efsa.2014.3763
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3763
The food enzyme considered in this opinion is a lipase (triacylglycerol lipase; EC 3.1.1.3) produced with a genetically modified strain of Aspergillus oryzae. The genetic modifications do not raise safety concern. The food enzyme contains neither the production organism nor recombinant DNA. The lipase is intended to be used in a number of food manufacturing processes, such as in baking and other cereal‐based processes. The dietary exposure was assessed on the basis of data retrieved from the EFSA Comprehensive European Food Consumption Database. The food enzyme did not induce gene mutations in bacteria nor micronuclei in human peripheral blood lymphocytes. Therefore, there is no concern with respect to genotoxicity. The systemic toxicity was assessed by means of a 90‐day subchronic 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. The Panel considered that the likelihood of food allergic reactions to the enzyme is low and therefore does not raise safety concern. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided and the toxicological studies, this food enzyme does not raise safety concern under the intended conditions of use.
EFSA‐Q‐2012‐01009, EC 3.1.1.3, 2012/03 Keine Sicherheitsbedenken
Lipase - Aspergillus oryzae (Stamm NZYM‐FL, GVO) 20.06.2014 / 03.09.2014
EFSA CEF Panel (2014): Scientific Opinion on Lipase from a Genetically Modified Strain of Aspergillus oryzae (strain NZYM‐FL). EFSA-Journal | https://doi.org/10.2903/j.efsa.2014.3762
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3762
The food enzyme considered in this opinion is a lipase (triacylglycerol lipase; EC 3.1.1.3) produced with a genetically modified strain of Aspergillus oryzae. The genetic modifications do not raise safety concern. The food enzyme contains neither the production organism nor recombinant DNA. The lipase is intended to be used in a number of food manufacturing processes, such as oils, fats and eggs processing. The dietary exposure was assessed on the basis of data retrieved from the EFSA Comprehensive European Food Consumption Database. The food enzyme did not induce gene mutations in bacteria nor chromosome aberrations in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The systemic toxicity was assessed by means of a 90‐day subchronic 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. The Panel considered that the likelihood of food allergic reactions to the enzyme is low and therefore does not raise safety concern. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided and the toxicological studies, this food enzyme does not raise safety concern under the intended conditions of use.
EFSA‐Q‐2013‐00197, EC 3.1.1.3, Keine Sicherheitsbedenken
ß-Xylanase - Aspergillus oryzae (Stamm NZYM‐FB, GVO) 09.04.2014 / 03.09.2014
EFSA CEF-Panel (2014): Scientific Opinion on Xylanase from a Genetically Modified Strain of Aspergillus oryzae (strain NZYM‐FB) EFSA Journal | https://doi.org/10.2903/j.efsa.2014.3645
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3645
The food enzyme considered in this opinion is a xylanase (endo‐1, 4‐β‐xylanase; EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae. The genetic modifications do not raise safety concern. The food enzyme contains neither the production organism nor recombinant DNA. The xylanase is intended to be used in a number of food manufacturing processes, such as starch processing, beverage alcohol (distilling), brewing, baking and other cereal based processes. The dietary exposure was assessed according to the Budget method. The food enzyme did not induce gene mutations in bacteria nor chromosome aberrations in human peripheral blood lymphocytes. Therefore, there is no concern with respect to genotoxicity. The systemic toxicity was assessed by means of a 90‐day subchronic 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. The Panel considered that the likelihood of food allergic reactions to the enzyme is low and therefore does not raise safety concern. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided and the toxicological studies, this food enzyme does not raise safety concern under the intended conditions of use.
EFSA‐Q‐2012‐00897, EC 3.2.1.8, Keine Sicherheitsbedenken