Proposed Safety Evaluation of Soy Leghemoglobin Derived from Genetically Modified Komagataella phaffii as a Food Colorant

In accordance with Regulation (EC) No 1331/2008, the proposed food additive LegH Prep, derived from genetically modified Komagataella phaffii, is intended for utilization as a colorant in meat analogue products. Specifically, the yeast strain MXY0541 of Komagataella phaffii has undergone genetic modification to produce soy leghemoglobin, and its safety in this context is currently under evaluation by the EFSA GMO Panel (EFSA-GMO-NL-2019-162). The haem iron content of soy leghemoglobin, when utilized in meat analogue products, is comparable to that found in similar quantities of various meat types. Furthermore, the exposure to iron from this proposed food additive, both at average and 95th percentile exposure levels, is expected to remain below the "safe levels of intake" determined by the NDA Panel for all population groups.

Given that the components of LegH Prep are digested into small peptides, amino acids, and haem B, and that the recipient (non-GM) strain meets the criteria for qualified presumption of safety status, the Panel has determined that there is no need to establish a numerical acceptable daily intake (ADI). Additionally, no genotoxicity concerns or adverse effects have been identified at the highest dose tested in available toxicological studies. Therefore, the Panel concludes that the use of soy leghemoglobin derived from genetically modified Komagataella phaffii MXY0541 as a food additive in food category 12.9, at the proposed maximum usage level, poses no safety concerns. However, this safety evaluation is considered provisional pending the completion of the ongoing safety assessment of the genetic modification of the production strain by the EFSA GMO Panel (EFSA-GMO-NL-2019-162).