Exposure assessment of food enzymes

Silano, Vittorio; Bolognesi, Claudia; Castle, Laurence; Cravedi, Jean‐Pierre; Fowler, Paul; Franz, Roland; Grob, Konrad; Gürtler, Rainer; Husøy, Trine; Kärenlampi, Sirpa; Mennes, Wim; Milana, Maria Rosaria; Penninks, André; Smith, Andrew T.; Poças, Maria de Fátima Tavares; Tlustos, Christina; Wölfle, Detlef; Zorn, Holger; Zugravu, Corina‐Aurelia; Arcella, Davide; Liu, Yi; Engel, Karl‐Heinz

doi:10.2903/j.efsa.2016.4581

Cited by 88 publications

(96 citation statements)

References 6 publications

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“…The current Guidance on the submission of a dossier on food enzymes for safety evaluation (EFSA, 2009a) has been followed for the evaluation of the application with the exception of the exposure assessment, which was carried out in accordance to the methodology described in the CEF Panel statement on the exposure assessment of food enzymes (EFSA CEF Panel, ).…”

Section: Data and Methodologiesmentioning

confidence: 99%

Safety evaluation of the food enzyme xylanase from the genetically modified Trichoderma reesei strain RF5703

Silano¹,

Baviera²,

Bolognesi³

et al. 2020

EFS2

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The food enzyme xylanase (EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain RF5703 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 recombinant DNA. The food enzyme is intended to be used in brewing processes and grain treatment for the production of starch and gluten fractions. Since residual amounts of the food enzyme are removed during grain treatment, dietary exposure was only calculated for brewing processes. Based on the maximum recommended use levels for brewing processes, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.023 mg TOS/kg body weight (bw) per day. 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 at the highest dose tested of 1,000 mg TOS/kg bw per day, resulting in a high margin of exposure of at least 43,000. 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 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 and the removal of TOS during the intended food production process, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

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Section: Data and Methodologiesmentioning

confidence: 99%

Safety evaluation of the food enzyme xylanase from the genetically modified Trichoderma reesei strain RF5703

Silano¹,

Baviera²,

Bolognesi³

et al. 2020

EFS2

Self Cite

View full text Add to dashboard Cite

show abstract

“…The current guidance on the submission of a dossier for safety evaluation of a food enzyme (EFSA CEF Panel, 2009) has been followed by the CEF Panel for the evaluation of the application with the exception of the exposure assessment, which was carried out in accordance with the methodology described in the CEF Panel statement on the exposure assessment of food enzymes (EFSA CEF Panel, 2016). 232-800-2.…”

Section: Methodologiesmentioning

confidence: 99%

“…Exposure estimates were calculated using the methodology described in the CEF Panel statement on the exposure assessment of food enzymes (EFSA CEF Panel, 2016). The assessment of the food processes covered in this opinion involved selection of relevant food groups and application of process and technical conversion factors (Appendix B).…”

Section: Dietary Exposurementioning

confidence: 99%

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus niger (strain XEA)

Silano¹,

Bolognesi²,

Castle³

et al. 2018

EFS2

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The food enzyme is an endo-1,4-b-xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with this endo-1,4-b-xylanase, 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 sensitisation and elicitation reactions by dietary exposure to the food enzyme endo-1,4-b-xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

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“…Chronic exposure was calculated by combining the maximum recommended use level provided by the applicant with the relevant FoodEx categories (Annex B in EFSA CEF Panel, ), based on individual consumption data. Exposure from all FoodEx categories was subsequently summed up, averaged over the total survey period and normalised for bodyweight.…”

Section: Assessmentmentioning

confidence: 99%

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Silano¹,

Baviera²,

Bolognesi³

et al. 2019

EFS2

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The food enzyme β‐d‐galactosidase galactohydrolase (EC 3.2.1.23) is produced with Bacillus sp. strain M3‐1 by GenoFocus Inc. The food enzyme β‐galactosidase is intended to be used in the manufacture of galactooligosaccharides (GOS). Since residual amounts of total organic solids are removed by the purification steps applied during the production of GOS, toxicological studies were considered not necessary and no dietary exposure was calculated. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched 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 considered to be 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.

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Exposure assessment of food enzymes

Cited by 88 publications

References 6 publications

Safety evaluation of the food enzyme xylanase from the genetically modified Trichoderma reesei strain RF5703

Safety evaluation of the food enzyme xylanase from the genetically modified Trichoderma reesei strain RF5703

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus niger (strain XEA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

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