Investigation on possible allergenicity of 19 different commercial enzymes used in the food industry

Bindslev‐Jensen, Carsten; Skov, Per Stahl; Roggen, Erwin L.; Hvass, Peter; Brinch, D.S.

doi:10.1016/j.fct.2006.06.012

Cited by 36 publications

(16 citation statements)

References 15 publications

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“…The HERA Risk Assessment document gives a comprehensive overview of consumer safety in regards to enzyme application within the household cleaning sector. The safe use of enzymes in food processing has been documented in a recent study by Novozymes and the University Hospital of Odense, Denmark [149]. …”

Section: Problems Safety Concerns and Possible Future Strategy Tmentioning

confidence: 99%

A Broader View: Microbial Enzymes and Their Relevance in Industries, Medicine, and Beyond

Gurung

Ray

Bose

et al. 2013

BioMed Research International

563

234

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Enzymes are the large biomolecules that are required for the numerous chemical interconversions that sustain life. They accelerate all the metabolic processes in the body and carry out a specific task. Enzymes are highly efficient, which can increase reaction rates by 100 million to 10 billion times faster than any normal chemical reaction. Due to development in recombinant technology and protein engineering, enzymes have evolved as an important molecule that has been widely used in different industrial and therapeutical purposes. Microbial enzymes are currently acquiring much attention with rapid development of enzyme technology. Microbial enzymes are preferred due to their economic feasibility, high yields, consistency, ease of product modification and optimization, regular supply due to absence of seasonal fluctuations, rapid growth of microbes on inexpensive media, stability, and greater catalytic activity. Microbial enzymes play a major role in the diagnosis, treatment, biochemical investigation, and monitoring of various dreaded diseases. Amylase and lipase are two very important enzymes that have been vastly studied and have great importance in different industries and therapeutic industry. In this review, an approach has been made to highlight the importance of different enzymes with special emphasis on amylase and lipase in the different industrial and medical fields.

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Section: Problems Safety Concerns and Possible Future Strategy Tmentioning

confidence: 99%

A Broader View: Microbial Enzymes and Their Relevance in Industries, Medicine, and Beyond

Gurung

Ray

Bose

et al. 2013

BioMed Research International

563

234

View full text Add to dashboard Cite

show abstract

“…The potential cross reactivity of food enzymes was studied by Bindslev‐Jensen et al. () There were no indications of cross reactivity between 19 different commercial food enzymes and the main allergens represented by 400 patients (allergic to inhalation allergens, food allergens, allergens of bee or wasp or drugs) included in this study.…”

Section: Assessmentmentioning

confidence: 82%

Safety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S‐27588)

Silano¹,

Bolognesi²,

Castle³

et al. 2018

EFS2

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The food enzyme considered in this opinion is an endo-1,4-b-xylanase (4-b-D-xylan xylanohydrolase; EC 3.2.1.8) produced from the genetically modified Bacillus subtilis strain LMG S-27588 by the company Puratos N. V. The production strain was not detected in the food enzyme. The endo-1,4-b-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended 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 0.325 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme indicated no genotoxic concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (443 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; no match was found. The Panel considered that there are no indications for food allergic reactions to this endo-1,4-b-xylanase by dietary exposure. Based on the genetic modifications, the manufacturing process, the compositional and biochemical data, the dietary exposure assessment, 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. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.

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“…No oral or respiratory allergic reactions to this glucose oxidase have been reported. The applicant provided a study by Bindlev-Jensen et al (2006) who investigated the possible cross reactivity of 19 different commercial food enzymes in allergic patients (400 patients allergic to inhalation allergens, food allergens, allergens of bee or wasp). Glucose oxidase from a genetically modified A. oryzae donor organism was positive in the skin prick test in three patients.…”

Section: Repeated Dose 90-day Oral Toxicity Study In Rodentsmentioning

confidence: 99%

Safety evaluation of the food enzyme glucose oxidase from a genetically modified Aspergillus oryzae (strain NZYM‐KP)

Silano¹,

Bolognesi²,

Castle³

et al. 2018

EFS2

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The food enzyme is a glucose oxidase (beta-D-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) produced with a genetically modified strain of Aspergillus oryzae strain NZYM-KP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or DNA; therefore, there is no safety concern for the environment. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels recommended 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 0.156 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosome aberrations in human lymphocytes. 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 (341 mg TOS/kg bw per day), which compared with the estimated dietary exposure results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match with a fungal contact allergen was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the estimated dietary exposure and the findings in the toxicological studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

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Investigation on possible allergenicity of 19 different commercial enzymes used in the food industry

Cited by 36 publications

References 15 publications

A Broader View: Microbial Enzymes and Their Relevance in Industries, Medicine, and Beyond

A Broader View: Microbial Enzymes and Their Relevance in Industries, Medicine, and Beyond

Safety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S‐27588)

Safety evaluation of the food enzyme glucose oxidase from a genetically modified Aspergillus oryzae (strain NZYM‐KP)

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