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Safety evaluation of the food enzyme d-psicose 3-epimerase from the genetically modified Escherichia coli strain K-12 W3110 (pWKLP).

ABSTRACT: The food enzyme d-psicose 3-epimerase (EC 5.1.3.30) is produced with the genetically modified Escherichia coli strain K-12 W3110 (pWKLP) by Matsutani Chemical Industry Co., Ltd. The production strain of the food enzyme 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 food enzyme is used as an immobilised preparation in processing fructose for the production of a speciality carbohydrate d-allulose (syn. d-psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d-allulose, dietary exposure was not calculated and toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the enzyme to known allergens was made and no match was found. The Panel notes that the food enzyme may contain traces of protein, including a known allergen, after processing of the food enzyme. Therefore, allergenicity cannot be excluded, but the Panel considers that the likelihood of allergic reactions to occur is low. Based on the data provided, the immobilisation process and the removal of TOS during the production of d-allulose products, the Panel concluded that this food enzyme does not give rise to safety concerns when used in the immobilised form.

SUBMITTER: EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)

PROVIDER: S-EPMC8085949 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Safety evaluation of the food enzyme d-psicose 3-epimerase from the genetically modified <i>Corynebacterium glutamicum</i> strain FIS002.

Project description:This assessment addresses a food enzyme preparation consisting of the immobilised intact but non-viable cells of the genetically modified Corynebacterium glutamicum strain FIS002 by CJ-Tereos Sweeteners Europe SAS. The production strain produces the food enzyme d-fructose 3-epimerase (d-psicose 3-epimerase; EC 5.1.3.30). The food enzyme preparation is used in processing fructose to produce a speciality carbohydrate d-allulose (synonym d-psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d-allulose, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 1,796 mg TOS/kg body weight (bw) per day, the highest dose tested. A search for similarity of the amino acid sequence of the enzyme to known allergens was made 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 low. The food enzyme preparation contains multiple copies of an antimicrobial resistance gene, which is considered a hazard. However, under the specific intended conditions of use described by the applicant, and based on the evidence showing the removal of TOS during the production of d-allulose and the absence of recombinant DNA in the d-allulose, the Panel concluded that the identified hazard associated with the food enzyme d-psicose 3-epimerase produced with the genetically modified C. glutamicum strain FIS002 will not result in a risk.

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Safety evaluation of the food enzyme d-tagatose 3-epimerase from the genetically modified <i>Escherichia coli</i> strain PS-Sav-001.

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Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM-BF).

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| S-EPMC7009475 | biostudies-literature

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Safety evaluation of the food enzyme ?-amylase from a genetically modified Aspergillus niger (strain NZYM-SB).

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| S-EPMC7009347 | biostudies-literature

Safety evaluation of the food enzyme ?-amylase from a genetically modified Aspergillus niger (strain NZYM-MC).

Project description:The food enzyme alpha-amylase (4-?-d-glucan glucanohydrolase; EC 3.2.1.1) 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 ?-amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking processes. 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 baking processes, based on the proposed maximum use levels, dietary exposure to the food enzyme-TOS was estimated to be up to 3.784 mg TOS/kg body weight 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 1,400 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and two matches were 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 baking processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

| S-EPMC7009399 | biostudies-literature

Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229).

Project description:The food enzyme considered in this opinion is an endo-1,4-?-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-?-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.

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