Peroxidase aus Sojabohnen                                                                                                  30.11.2017 / 21.12.2017

EFSA CEF Panel (2017): Scientific Opinion on the safety evaluation of the food enzyme peroxidase obtained from soybean (Glycine max) hulls. EFSA Journal 2017; 15(12) :5119, 21 pp.  | https://doi.org/10.2903/j.efsa.2017.5119

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.5119

The food enzyme considered in this opinion is a peroxidase (hydrogen-peroxide oxidoreductase; EC 1.11.1.7) obtained from hulls of soybeans (Glycine max) by the company Kerry Ingredients & Flavours. The compositional data provided were considered sufficient. The manufacturing process did not raise safety concerns. The enzyme is intended to be used in baking processes. Based on the maximum recommended use level, 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 lower than the exposure to the fraction of soybean comparable to the food enzyme TOS resulting from the consumption of whole soybean-derived foods by roughly an order of magnitude. As the food enzyme is derived from edible parts of soybean, in line with the requirements of the guidance document on food enzyme assessment, the Panel concluded that the provision of toxicological data was unnecessary. The potential allergenicity was evaluated by searching for similarity between the amino acid sequence of soybean peroxidase retrieved from the database Uniprot and the sequences of known food allergens; no match was found. Peroxidase from soybean hulls is not listed as an allergen in allergen databases. However, several soybean- and soybean hull proteins are known to be respiratory or food allergens. Based on the origin of the food enzyme from edible parts of soybean, the enzyme manufacturing process, the compositional and biochemical data provided, and the dietary exposure assessment, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. However, the Panel noted that this food enzyme may contain allergenic soybean proteins, thus, adverse reactions in susceptible soybean-allergic individuals cannot be ruled out.

EC 1.11.1.7, EFSA-Q-2013-00897, 2013/10                                                                                            keine Sicherheitsbedenken, aber

                                      allergene Reaktionen auf Sojaproteine können nicht ausgeschlossen werden

Pullulanase aus Pullulanibacillus naganoensis Stamm AE-PL                                              19.09.2017 / 25.10.2017

EFSA CEF Panel (2017): Scientific Opinion on the safety evaluation of the food enzyme pullulanase from Pullulanibacillus naganoensis strain AE-PL. EFSA Journal 2017; 15(10):5009, 11 pp.  | https://doi.org/10.2903/j.efsa.2017.5009

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.5009

The food enzyme considered in this opinion is a pullulanase (pullulan 6-a-glucanohydrolase; EC 3.2.1.41) produced with a non-genetically modified Pullulanibacillus naganoensis (strain AE-PL) by Amano Enzyme Inc. (Japan). The pullulanase food enzyme is intended to be used in starch processing for the production of glucose syrups. Since residual amounts of total organic solid (TOS) in glucose syrups are removed by filtration and purification during starch processing, dietary exposure assessment was not performed. Genotoxicity tests made with the food enzyme indicated no genotoxic potential. A repeated dose 90-day oral toxicity study in rode nts, carried out with the food enzyme, showed minor effects that were considered to be of no biological relevance. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and no match was found. The Panel considered that there are no indications for food allergic reactions to dietary intake of this food enzyme. Based on the removal of residual amounts of TOS from glucose syrups, consumer exposure is not expected. In addition, the safety of the manufacturing process, the compositional and biochemical data lead the Panel to conclude that the food enzyme pullulanase from P. naganoensis (strain AE-PL) does not give rise to safety concerns under the intended conditions of use.

EC 3.2.1.41, EFSA-Q-2015-00451, 2017/67                                                                                                    Keine Sicherheitsbedenken

Pullulanase - Bacillus subtilis (Stamm NZYM-AK, GVO)                                                            15.06.2017 / 18.08.2017

EFSA CEF Panel (2017): Scientific Opinion on the safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK. EFSA Journal 2017; 15(8):4895, 12 pp. | https://doi.org/10.2903/j.efsa.2017.4895

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4895

The food enzyme considered in this opinion is a pullulanase (pullulan 6-a-glucanohydrolase; EC 3.2.1.41), produced with the genetically modified Bacillus subtilis strain NZYM-AK by Novozymes A/S (Denmark). The pullulanase food enzyme is intended to be used in starch processing for the production of glucose syrups. Since the residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing were considered negligible, no dietary exposure was calculated. Genotoxicity tests made with the food enzyme indicated no genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with a pullulanase produced with a predecessor strain, 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 reactions. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the tox icological studies and allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EC 3.2.1.41, EFSA-Q-2015-00127, 2015/13                                                                                                       Keine Sicherheitsbedenken

ß-Amylase - Bacillus licheniformis (Stamm NZYM-JA, GVO)                                                        14.06.2017 / 18.08.2017

EFSA CEF Panel (2017): Scientific Opinion on the safety evaluation of the food enzyme ß-amylase from genetically modified Bacillus licheniformis strain NZYM-JA. EFSA Journal 2017; 15(8):4896, 13 pp. | https://doi.org/10.2903/j.efsa.2017.4896

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4896

The food enzyme considered in this opinion is a ß amylase (4-a-D-glucan maltohydrolase; EC 3.2.1.2), produced with genetically modified Bacillus licheniformis strain NZYM-JA by Novozymes A/S (Denmark). The ß-amylase food enzyme is intended to be used in starch processing for the production of glucose syrups. Since the residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing were considered negligible, no dietary exposure was calculated. Toxicological tests made with the food enzyme under application indicated that there was no concern with respect to genotoxicity, mutagenicity or 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 reactions. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EC 3.2.1.2., EFSA-Q-2015-00275, 2015/27                                                                                                         Keine Sicherheitsbedenken

ß-Amylase aus Sojabohnen                                                                                                             22.03.2017 / 10.05.2017

EFSA CEF Panel (2017): Scientific Opinion on the safety evaluation of the food enzyme ß-amylase obtained from soybean ( Glycine max). EFSA Journal 2017; 15(5):4757, 13 pp.  | doi: 10.2903/j.efsa.2017.4757

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4757

The food enzyme considered in this opinion is a ß-amylase (EC 3.2.1.2) from soybean submitted by Nagase (Europa) GmbH. This b-amylase is intended to be used in the starch processing for maltose syrup production and the manufacture of a Japanese rice cake type. Based on the maximum use levels recommended for the respective food processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of Japanese consumption data. Conservative average infant formula consumption, as reported in the EFSA Draft Guidance on risk assessment of substances present in food intended for infants below 16 weeks of age, was used to estimate the exposure to a fraction of soybean comparable to the food enzyme–TOS, resulting from the consumption of soybean-derived foods. The exposure estimate to the food enzyme–TOS was found to be lower than the comparable fraction from the source material. Potential allergenicity of the b-amylase was evaluated by searching for similarity of the amino acid sequence to those of known allergens, and no match was found. The ß-amylase is produced from soybean, which is a known allergenic food. Japanese rice cake, consequently, may contain traces of soybean allergens, which may give rise to safety concerns in soybean-allergic consumers. Based on the origin of the food enzyme from edible parts of soybean, the manufacturing process, the compositional and biochemical data provided and the dietary intake estimates, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use, except that Japanese rice cake produced with this food enzyme may contain traces of soybean allergen

EC 3.2.1.2, EFSA-Q-2016-00085, 2015/150                                                                                            keine Sicherheitsbedenken, kann aber

                                                                                                                                                 allergene Proteine aus den Sojabohnen enthalten

β-Amylase aus Gerste (Hordeum vulgare)                                                                          21.03.2017 / 10.05.17

EFSA CEF Panel (2017): Scientific Opinion on the safety evaluation of the food enzyme ß-amylase obtained from barley (Hordeum vulgare). EFSA Journal 2017; 15(5):4756, 22 pp. | https://doi.or g/10.2903/j.efsa.2017.4756

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4756

The food enzyme considered in this opinion is a 4-a-D-glucan maltohydrolase (EC 3.2.1.2) obtained from grain of barley (Hordeum vulgare), by the companies Genencor International B.V. and Senson Oy. This ß-amylase is intended to be used in several food-manufacturing processes: baking and brewing processes, distilled alcohol production, and starch processing for the production of glucose syrups. The compositional data provided for the food enzyme were considered sufficient. The manufacturing process did not raise safety concerns. Based on the maximum use levels recommended for the respective food 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 similar to or lower than the exposure to a fraction of barley comparable to the food enzyme–TOS, resulting from the consumption of barley-derived foods. As the food enzyme is derived from edible parts of barley, in line with the requirements of the guidance document on food enzyme assessment, the Panel accepted that there was no need for the provision of toxicological data for this food enzyme and the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. Considering the potential for allergenicity, the gluten content of the food enzyme was below the detection limit of the analytical method, which is well below the level of 20 mg/kg for ‘gluten-free’ products. The amino acid sequence of the b-amylase was compared to those of known allergen s and no match was found. The food enzyme b-amylase from barley is an occupational respiratory allergen and may contain low levels of other allergenic barley proteins that may trigger adverse reactions upon oral challenges in individuals with an oral sensitisation to cereals. The Panel considers that dietary exposure to the food enzyme ß-amylase from barley may result in incidental cases of food allergic reactions.

EC 3.2.1.2, EFSA-Q-2014-00731, 2014/23,                                                                                             keine Sicherheitsbedenken, kann aber

                                                                                                                                                           in seltenen Fällen Allergien auslösen

ß-Amylase aus Weizen (Triticum spp.)                                                                                 21.03.2017 /10.05.2017

EFSA CEF Panel (2017): Scientific Opinion on the safety evaluation of a ß-amylase food enzyme obtained from wheat (Triticum spp.). EFSA Journal 2017; 15(5):4754, 12 pp. | https://doi.org/10.2903/j.efsa.2017.4754

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4754

The food enzyme considered in this opinion is a ß-amylase (EC 3.2.1.2), obtained from the grain of wheat (Triticum spp.) by Roquette (France). The ß-amylase is intended to be used in starch processing for production of glucose syrups containing maltose to be used as a food ingredient. Since the presence of residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing is negligible, no dietary exposure was calculated. As the food enzyme is derived from edible parts of wheat, no toxicological tests are required. Wheat is known as a gluten-containing cereal. However, the gluten content of the food enzyme was shown to be below the limit of quantification of the applied analytical method and well below the threshold value of 20 mg/kg for ‘gluten-free’ products. Furthermore, the potential allergenicity was evaluated by searching for similarity between the amino acid sequence of the b-amylase and the sequences of known food allergens; no match was found. Although b-amylase from wheat is described as a potential occupational respiratory allergen, and oral wheat challenges in wheat allergic patients may result in clinical symptoms, the enzyme and the low levels of other wheat proteins will be removed from the final food ingredients through a downstream purification process. Based on the origin of the food enzyme from edible parts of grain, 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.

EC 3.2.1.2, EFSA-Q-2015-00083, 2015/01                                                                                                 keine Sicherheitsbedenken

ß-Xylanase - Aspergillus niger (Stamm XYL, GVO)                                                                  22.03.2017 / 10.05.2017

EFSA CEF Panel (2017): Scientific Opinion on the safety evaluation of the food enzyme endo-1,4-b-xylanase from genetically modified Aspergillus niger strain XYL. EFSA Journal 2017; 15(5):4755, 20 pp. |  https://doi.org/10.2903/j.efsa.2017.4755

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4755

The food enzyme considered in this opinion is an endo -1,4-ß-xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger. The genetic modifications do not give rise to safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo-1,4-ß-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the respective food process, dietary exposur e 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 below 0.013 mg TOS/kg body weight (bw) per day in European populations. No safety concerns were identified in relation to the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, allergenicity and exposure assessments. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; no match was found. The Panel considered that the likelihood of allergic reactions to dietary intake of endo-1,4- ß-xylanase is low and, therefore, does not give rise to safety concerns. The systemic toxicity was assessed by means of a repeated dose 90-d ay oral toxicity study in rodents. A no observed adverse effect level was derived (4,095 and 4,457 mg TOS/kg bw per day for males and females, respectively), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. However, the genotoxicity data were incomplete. Due to the absence of the recommended combination of microbial strains used in the Ames test (i.e. lack of Salmonella Typhimurium TA102 and Escherichia coli WP2), no conclusions can be drawn on potential DNA oxidising or cross-linking mechanisms giving rise to gene mutations. Consequently, no final conclusions can be drawn on genotoxicity.

EC 3.2.1.8, EFSA-Q-2014-00305, 2014/01                                                                                               keine Aussage zur Sicherheit möglich