Food manufacturing processes and technical data used in the exposure assessment of food enzymes

Lambré, Claude; Baviera, José Manuel Barat; Bolognesi, Claudia; Cocconcelli, Pier Sandro; Crebelli, Riccardo; Gott, David Michael; Grob, Konrad; Lampi, Evgenia; Mengelers, Marcel; Mortensen, Alicja; Rivière, Gilles; Steffensen, Inger‐Lise; Tlustos, Christina; Loveren, Henk Van; Vernis, Laurence; Zorn, Holger; Roos, Yrjö; Apergi, Kyriaki; Cavanna, Daniele; Liu, Yi; Pesce, Francesco; Piazza, Giulio di; Sousa, Rita Ferreira de; Chesson, Andrew

doi:10.2903/j.efsa.2023.8094

Cited by 76 publications

(221 citation statements)

References 4 publications

(15 reference statements)

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“…A data package originated from a joint dossier should fulfil the data requirements in the 'Submission of a Dossier on Food Enzymes for Safety Evaluation' (EFSA CEF Panel, 2009). During the evaluation, the Panel applied, whenever possible, the updated current 'Scientific Guidance for the submission of dossiers on Food Enzymes' (EFSA CEP Panel et al, 2021) and the guidance on the 'Food manufacturing processes and technical data used in the exposure assessment of food enzymes ' (EFSA CEP Panel et al, 2023). Endo-polygalacturonases catalyse the random hydrolysis of 1,4-α-D-glycosidic linkages between galacturonic acid residues in polygalacturonans resulting in their progressive depolymerisation.…”

Section: Methodologiesmentioning

confidence: 99%

“…5. and application of technical conversion factors (EFSA CEP Panel et al, 2023). Exposure from all FoodEx categories was subsequently summed up, averaged over the total survey period (days) and normalised for body weight.…”

Section: Dietary Exposure Estimationmentioning

confidence: 99%

“…Therefore, this assessment is limited to the use of this food enzyme in the production of refined olive oil only. The food enzyme-TOS is removed from the refined olive oil in the refinement process (EFSA CEP Panel et al, 2023).…”

Section: Intended Use Of the Food Enzymementioning

confidence: 99%

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Safety evaluation of the food enzyme endo‐polygalacturonase from the non‐genetically modified Aspergillus tubingensis strain MUCL 55013

Lambré,

Barat Baviera,

Bolognesi

et al. 2023

EFS2

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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. K E Y W O R D S (1→4)α-D-galacturonan glycanohydrolase, Aspergillus tubingensis, EC 3.2.1.15, endo-polygalacturonase, food enzyme, non-genetically modified microorganism 2 |

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Section: Methodologiesmentioning

confidence: 99%

Section: Dietary Exposure Estimationmentioning

confidence: 99%

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Safety evaluation of the food enzyme endo‐polygalacturonase from the non‐genetically modified Aspergillus tubingensis strain MUCL 55013

Lambré,

Barat Baviera,

Bolognesi

et al. 2023

EFS2

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“…24 The hydrolysis of starch by the glucan-1,4-α-maltohydrolase liberates maltose. The food enzyme-TOS is removed in the final processed syrups and other starch hydrolysates by treatment with activated charcoal or similar and with ion-exchange resins (EFSA CEP Panel, 2023).…”

Section: Intended Use Of the Food Enzymementioning

confidence: 99%

Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐513

Lambré,

Barat Baviera,

Bolognesi

et al. 2023

EFS2

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The food enzyme glucan 1,4α-maltohydrolase (4α-D-glucan α-maltohydrolase EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR-513 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 four food manufacturing processes: processing of cereals and other grains for the production of baked products, other cerealbased products and glucose syrups and other starch hydrolysates; processing of plant-and fungal-derived products for the production of plant-based analogues of milk and milk products. Since residual amounts of total organic solids (TOS) are removed in the production of glucose syrups and other starch hydrolysates, dietary exposure was not calculated for this process. For the remaining three food processes, exposure to the food enzyme-TOS was estimated to be up to 0.2 μg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR-513 meets the requirements for the qualified presumption of safety (QPS) approach and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and five matches with respiratory allergens and one with a mosquito allergen were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme did not give rise to safety concerns, under the intended conditions of use. K E Y W O R D S4α-D-glucan α-maltohydrolase, Bacillus subtilis, EC 3.2.1.133, food enzyme, genetically modified microorganism, glucan 1,4α-maltohydrolase, maltogenic amylase 2 of 13 |

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“…Chronic exposure to the food enzyme-TOS was calculated by combining the maximum recommended use level with individual consumption data (EFSA CEP Panel et al, 2021). the estimation involved selection of relevant food categories and application of technical conversion factors (EFSA CEP Panel, 2023). Exposure from all FoodEx categories was subsequently summed up, averaged over the total survey period (days) and normalised for bw.…”

Section: Dietary Exposure Via the Processing Of Egg And Egg Productsmentioning

confidence: 99%

Safety evaluation of the food enzyme phospholipase A2 from the genetically modified Aspergillus niger strain PLA

Lambré,

Barat Baviera,

Bolognesi

et al. 2023

EFS2

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The food enzyme phospholipase A 2 (phosphatidylcholine 2-acylhydrolase, EC 3.1.1.4) is produced with the genetically modified Aspergillus niger strain PLA 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 the processing of egg and egg products, in the processing of fats and oils by degumming and for the production of modified lecithins (lysolecithin). As residual total organic solids (TOS) are removed in the refined fats and oils during degumming, dietary exposure was calculated only for the remaining two food manufacturing processes. For egg processing, the dietary exposure was estimated to be up to 1.712 mg TOS/kg body weight (bw) per day in European populations. Wet gum can be used to produce lysolecithin with the highest dietary exposure of 1.61 mg TOS/kg bw per day in children at the 95th percentile when used as a food additive. Genotoxicity tests did not raise 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 1350 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated overall dietary exposure, resulted in a margin of exposure of at least 851. A search for the similarity of the amino acid sequence of the food enzyme to those of known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is 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. K E Y W O R D S food enzyme, phospholipase A 2 , phosphatidylcholine 2-acylhydrolase, EC 3.1.1.4, phosphatidolipase, Aspergillus niger, genetically modified microorganism 2 of 18 |

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Food manufacturing processes and technical data used in the exposure assessment of food enzymes

Cited by 76 publications

References 4 publications

Safety evaluation of the food enzyme endo‐polygalacturonase from the non‐genetically modified Aspergillus tubingensis strain MUCL 55013

Safety evaluation of the food enzyme endo‐polygalacturonase from the non‐genetically modified Aspergillus tubingensis strain MUCL 55013

Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐513

Safety evaluation of the food enzyme phospholipase A2 from the genetically modified Aspergillus niger strain PLA

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