Food Safety Evaluation of Recombinant Humanized Type III Collagen Produced by Komagataella phaffii SMD1168‐2COL3

Collagens are biofunctional proteins that have been widely used in many fields, including biomedical, cosmetics, and skin care for their value in maintaining the integrity of cellular membranes. Collagens are also commonly consumed in foods and provide a source of protein and amino acids. As part of the safety assessment for this particular recombinant humanized type III (RHTypeIII) collagen produced by Komagataella phaffii SMD1168-2COL3, a series of toxicological tests were conducted. This collagen has ≥ 90% amino acid sequence homology to bovine and porcine collagen. The RHTypeIII collagen showed no evidence of genotoxic potential in a battery of tests. It was not toxic in an acute oral study, with no effects at 10 g/kg BW. The RHTypeIII collagen was not developmentally toxic in Sprague Dawley (SD) rat, and the NOAEL was 4.5 g/kg BW/day. In a 90-day oral gavage study in rats, there were no adverse findings observed; therefore, the high dose level (4.5 g/kg BW/day) was considered the NOAEL. The protein sequence was subjected to homology searches against the AllergenOnline database (sliding 80-amino acid windows and full sequence searches). From the 80-amino acid alignment searches, 23 significant matches were identified (> 35% identity and E value < 1 × 10^-7) to allergens of bovine, fish, anisakis, feverfew pollen, ragweed pollen, and wheat origin. Although matches were identified, further assessment of the in silico results combined with a literature review demonstrates that the risk of allergenic cross-reactivity for this collagen is low. These results demonstrate RHTypeIII collagen is not toxic and unlikely to present a risk of allergy when used as a food ingredient.