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Sensitising effects of genetically modified enzymes used in flavour, fragrance, detergence and pharmaceutical production: cross-sectional study
  1. Lygia T Budnik1,2,
  2. Edwin Scheer3,
  3. P Sherwood Burge2,4,
  4. Xaver Baur2,5
  1. 1Occupational Toxicology and Immunology Unit, Institute for Occupational and Maritime Medicine (ZfAM), University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  2. 2European Society for Environmental and Occupational Medicine, Berlin, Germany
  3. 3Consultant on Occupational Lung Diseases and Allergy, Berlin, Germany
  4. 4Occupational Lung Disease Unit, Birmingham Heartlands Hospital, Birmingham, UK
  5. 5Occupational Lung Diseases and Allergy Unit, Charité Institute for Occupational Medicine (CIOM), Campus Benjamin Franklin, Charité-School of Medicine, Berlin, Germany
  1. Correspondence to Professor Lygia T Budnik, Occupational Toxicology and Immunology Unit, Institute for Occupational and Maritime Medicine (ZfAM), University Medical Center Hamburg-Eppendorf, Marckmannstrasse 129 B, Hamburg 20539, Germany; l.budnik{at}


Objectives The use of genetically engineered enzymes in the synthesis of flavourings, fragrances and other applications has increased tremendously. There is, however, a paucity of data on sensitisation and/or allergy to the finished products. We aimed to review the use of genetically modified enzymes and the enormous challenges in human biomonitoring studies with suitable assays of specific IgE to a variety of modified enzyme proteins in occupational settings and measure specific IgE to modified enzymes in exposed workers.

Methods Specific IgE antibodies against workplace-specific individual enzymes were measured by the specific fluorescence enzyme-labelled immunoassay in 813 exposed workers seen in cross-sectional surveys.

Results Twenty-three per cent of all exposed workers showed type I sensitisation with IgE antibodies directed against respective workplace-specific enzymes. The highest sensitisation frequencies observed were for workers exposed enzymes derived from α-amylase (44%), followed by stainzyme (41%), pancreatinin (35%), savinase (31%), papain (31%), ovozyme (28%), phytase (16%), trypsin (15%) and lipase (4%). The highest individual antibody levels (up to 110 kU/L) were detected in workers exposed to phytase, xylanase and glucanase. In a subgroup comprising 134 workers, detailed clinical diagnostics confirmed work-related symptoms. There was a strong correlation (r=0.75, p<0.0001) between the symptoms and antibody levels. Workers with work-related respiratory symptoms showed a higher prevalence for the presence of specific IgE antibodies against workplace-specific enzymes than asymptomatic exposed workers (likelihood ratio 2.32, sensitivity 0.92, specificity 0.6).

Conclusions Our data confirm the previous findings showing that genetically engineered enzymes are potent allergens eliciting immediate-type sensitisation. Owing to lack of commercial diagnostic tests, few of those exposed receive regular surveillance including biomonitoring with relevant specific IgE assays.

  • type I allergy
  • genetically modified enzymes
  • sensitization
  • specific IgE antibodies
  • health risks

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  • Contributors LTB wrote the final manuscript draft, supervised the laboratory analyses and performed the data analysis. XB and ES provided patient data and samples. XB and PSB edited the text and performed clinical analyses. LTB, XB and PSB performed the literature analysis and prepared the final version of the manuscript. All authors have accepted this final version.

  • Competing interests LTB, ES, PSB and XB declare that they have no financial or personal relationship with any organisation or person that would inappropriately influence their work or to have any other conflict of interest within 3 years of beginning the work submitted. ES had consultant arrangements with some of the companies whose workers have been tested within the study. XB and PSB testified in occupational litigation cases on behalf of plaintiffs. LTB is co-chairing the task force ‘Immunological Methods in Occupational Settings’ from the German Society for Environmental and Occupational Medicine, DGAUM, and XB is chairing the study group ‘Allergic Disorders’ of the European Society for Environmental and Occupational Medicine,

  • Patient consent Obtained.

  • Ethics approval Institutional Review Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.