Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183
Ontology highlight
ABSTRACT:
SUBMITTER:
PROVIDER: S-EPMC10995818 | biostudies-literature | 2024 Apr
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Abstract The food enzyme endo‐polygalacturonase (1→4)‐α‐d‐galacturonan glycanohydrolase EC 3.2.1.15 is produced with the genetically modified Aspergillus oryzae strain AR‐183 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 its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juice, production of wine and wine vinegar, production of plant extracts as flavouring preparations and coffee demucilation. Since residual amounts of total organic solids (TOS) are removed by repeated washing or distillation, dietary exposure to the food enzyme TOS from coffee demucilation and from the production of flavouring extracts was considered not necessary. For the remaining three food processes, dietary exposure was estimated to be up to 0.087 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. 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 1,000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 11,494. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to pollen allergens, cannot be excluded. 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.
| S-EPMC9969048 | biostudies-literature
Project description:The food enzyme endo-polygalacturonase ((1→4)-α-d-galacturonan glycanohydrolase; EC 2.3.1.15), is produced with the genetically modified Aspergillus luchuensis strain FLYSC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in fruit and vegetable processing for juice production. Based on the maximum use level, 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 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 800 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 5,800. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and six matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded for individuals sensitised to cedar or grass pollen or maize. 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.
| S-EPMC9047700 | biostudies-literature
Project description:The food enzyme endo-polygalacturonase ((1-4)-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Aspergillus niger strain EPG 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 its DNA. It is intended to be used in fruit and vegetable processing for juice production. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.122 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1,014 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure at least 8,311. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 38 matches were found, two of which are food allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya or maize, but that the risk will not exceed that of consumption of papaya or maize. In addition, oral allergy reactions cannot be excluded in pollen-sensitised individuals. 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.
| S-EPMC9993135 | biostudies-literature
Project description:The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus oryzae strain AR-962 by AB Enzymes GmbH. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in five food manufacturing processes. Subsequently, the applicant requested to extend its use to two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme for uses in a total of seven food manufacturing processes. As the food enzyme-total organic solids (TOS) is removed from the final foods in three food manufacturing processes, the dietary exposure to the food enzyme-TOS was estimated only for the remaining four processes. Dietary exposure was up to 0.575 mg TOS/kg body weight (bw) per day in European populations. When combined with the NOAEL reported in the previous opinion (1000 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 1739. Based on the data provided for the previous evaluation and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
| S-EPMC10995844 | biostudies-literature
Project description:The food enzyme endo-polygalacturonase ((1→4)-α-d-galacturonan glycanohydrolase (endo-cleaving); EC 3.2.1.15)) is produced with the non-genetically modified Aspergillus tubingensis strain MUCL 55013 by Soufflet Biotechnologies. The food enzyme is free from viable cells of the production organism. It is intended to be used in 10 food manufacturing processes: processing of fruits and vegetables for the production of juices, other fruit and vegetable products, wine, distilled spirits from wine, alcoholic beverages other than grape wine; processing of plant-derived products for the production of refined and unrefined sugar, edible oils from plants, green coffee beans by demucilation, coffee extracts and tea and other herbal and fruit infusions. Since residual amounts of total organic solids (TOS) are removed in three processes, dietary exposure was calculated only for the remaining seven food manufacturing processes. Exposure was estimated to be up to 7.834 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. 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 2,097 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 268. A search for the similarity of the amino acid sequence of the food enzyme to known allergens found 14 matches, one of which was to a food allergen. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya, but that the risk will not exceed that of consumption of papaya. In addition, oral allergy reactions cannot be excluded in pollen-sensitised individuals. 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.
| S-EPMC10659768 | biostudies-literature
Project description:The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus oryzae strain AR-962 by AB Enzymes GmbH. The genetic modifications did not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juice, production of wine and wine vinegar, production of plant extracts as flavouring preparations and coffee demucilation. Since residual amounts of total organic solids are removed by repeated washing or distillation, dietary exposure to the food enzyme total organic solids (TOS) from the production of flavouring extracts and coffee demucilation was considered not necessary. For the remaining three food processes, dietary exposure to the food enzyme-TOS was estimated to be up to 0.647 mg TOS/kg bw per day in European populations. Genotoxicity tests did not indicate 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 margin of exposure of at least 1,546. A search for the similarity of the amino acid sequence to those of known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use the risk of allergic reactions by dietary exposure, particularly in individuals sensitised to pollen allergens, cannot be excluded. 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.
| S-EPMC9947621 | biostudies-literature
Project description: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.
| S-EPMC7009587 | biostudies-literature
Project description:The food enzyme has two declared activities, endo-polygalacuronase ((1→4)-α-D-galacturonan glycanohydrolase; EC 3.2.1.15) and endo-1,3(4)-β-glucanase (3-(1→3;1→4)-β-D-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) and is produced with the non-genetically modified Aspergillus fijiensis strain NZYM-RE by Novozymes A/S. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes, i.e. distilled alcohol production, brewing processes, baking processes, cereal-based processes, wine and wine vinegar production, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and refined olive oil production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and refined olive oil production, dietary exposure was not calculated for these two processes. For the remaining six food manufacturing processes, dietary exposure was estimated to be up to 0.553 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 3,677 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 6,649. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and nine matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure to this food enzyme, particularly in individuals suffering from the oral allergy syndrome or sensitised to papaya, cannot be excluded. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
| S-EPMC9768566 | biostudies-literature
Project description:The food enzyme with the declared activities endo-polygalacturonase ((1-4)-α-D-galacturonan glycanohydrolase; EC 3.2.1.15) and pectin lyase ((1-4)-6-O-methyl-α-D-galacturonan lyase; EC 4.2.2.10) is produced with the non-genetically modified Aspergillus tubingensis strain NZYM-PE by Novozymes A/S. It is intended to be used in four food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, refined olive oil production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during production, dietary exposure was not calculated for refined olive oil production. For the remaining three food processes, it was estimated to be up to 0.132 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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) of 1,430 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure above 10,833. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 13 matches were found, including one food allergen (papaya). The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya, but that the risk will not exceed that of consumption of papaya. In addition, oral allergy reactions cannot be excluded in pollen-sensitised individuals. 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.
| S-EPMC10369246 | biostudies-literature
Project description:The food enzyme endo-polygalacturonase ((1-4)-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Trichoderma reesei strain RF6197 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, production of wine and wine vinegar, coffee demucilation and production of plant extracts as flavouring preparations. Since residual amounts of the total organic solids (TOS) are removed during the coffee demucilation and the production of flavouring extracts, dietary exposure was calculated only for the remaining three food processes. It was estimated to be up to 0.156 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 margin of exposure of at least 6,410. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and matches were found with a number of pollen allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure, particularly in individuals sensitised to pollen cannot be excluded. 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.
| S-EPMC10308264 | biostudies-literature