Assessment of soy leghemoglobin produced from genetically modified Komagataella phaffii, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐162)
Genetically modified <i>Komagataella phaffii</i> strain MXY0541 was developed to produce soy leghemoglobin by introducing the <i>LGB2</i> coding sequence encoding leghemoglobin from soybean (<i>Glycine max</i>). The molecular characterisation data and bioinformatic analyses do not raise any safety concerns. The safety of soy leghemoglobin as a food additive has already been assessed by the EFSA FAF Panel (EFSA-Q-2022-00031). The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of soy leghemoglobin protein as expressed in <i>K. phaffii</i>, and finds no evidence that the genetic modification would change its overall allergenicity. The GMO Panel concludes that the LegH Prep derived from genetically modified <i>K. phaffii</i> strain MXY0541 is safe for human consumption with regard to the effects of the genetic modification. No environmental impact from the use of this product is expected regarding the recombinant DNA sequences possibly remaining in the product. The GMO Panel concludes that LegH Prep from genetically modified <i>K. phaffii</i> strain MXY0541 is safe with respect to potential effects on human health and the environment at the proposed use and use level as far as the impact of the genetic modification is concerned. The overall conclusion is that the genetic modification does not lead to safety issues.
Authors
- Paolo Lenzi
- José Ángel Gómez Ruiz (ORCID: https://orcid.org/0000-0001-9386-6185)
- Aleksandra Lewandowska (ORCID: https://orcid.org/0000-0002-1694-5151)
- Jean‐Luc Gallois (ORCID: https://orcid.org/0000-0003-0451-1740)
- Ruud A. de Maagd (ORCID: https://orcid.org/0000-0001-7049-2029)
- Francisco Barro (ORCID: https://orcid.org/0000-0002-7652-229X)
- Alan H. Schulman (ORCID: https://orcid.org/0000-0002-4126-6177)
- Antoine Messéan (ORCID: https://orcid.org/0000-0002-6634-6288)
- Fabien Nogué (ORCID: https://orcid.org/0000-0003-0619-4638)
- Reinhilde Schoonjans (ORCID: https://orcid.org/0000-0003-4112-8951)
- Tilemachos Goumperis
- Frits Koning (ORCID: https://orcid.org/0000-0002-4007-5715)
- Josep Casacuberta (ORCID: https://orcid.org/0000-0002-5609-4152)
- Dafni Maria Kagkli (ORCID: https://orcid.org/0000-0002-7351-135X)
- Pietro Piffanelli
- Eve Veromann (ORCID: https://orcid.org/0000-0002-0977-5270)
- Albert Braeuning (ORCID: https://orcid.org/0000-0003-3810-027X)
- F. Javier Moreno (ORCID: https://orcid.org/0000-0002-7637-9542)
- M. Epstein (ORCID: https://orcid.org/0000-0002-4755-0224)
- Giovanni Savoini
- Thomas Frenzel
- Andrea Gennaro
- Christoph Tebbe
- Pilar Cubas
Institutions
- European Food Safety Authority (IT)
- University of Helsinki (FI)
- Consejo Superior de Investigaciones Científicas (ES)
- Estonian University of Life Sciences (EE)
- Leiden University Medical Center (NL)
- Federal Institute for Risk Assessment (DE)
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (FR)
- Institute for Biodiversity (DE)
- Département agronomie et sciences de l'environnement pour les agroécosystèmes (FR)
- Institut Jean-Pierre Bourgin (FR)
- Génétique et amélioration des fruits et légumes (FR)
- Instituto de Agricultura Sostenible (ES)
- Center for Research in Agricultural Genomics (ES)
- Saxon State Ministry for Science and the Arts (DE)
- Universidad Autónoma de Madrid (ES)
- University of Milano-Bicocca (IT)
- Universidad de Sevilla (ES)
- Wageningen University & Research (NL)
Publication Details
- Journal
- EFSA Journal
- Published
- 2024-11-01
- DOI
- https://doi.org/10.2903/j.efsa.2024.9060
- Citations
- 2
- Primary Topic
- Agricultural safety and regulations
- Type
- article
- Field-Weighted Citation Impact
- 0.70