# Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Komagatella phaffii strain LALL‐LI2

**Authors:** Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Jaime Aguilera, Daniele Cavanna, Cristina Fernàndez‐Fraguas, Yi Liu

PMC · DOI: 10.2903/j.efsa.2025.9486 · EFSA Journal · 2025-06-12

## TL;DR

This paper evaluates the safety of a genetically modified enzyme used in food processing and concludes it is safe under intended use.

## Contribution

The study provides a safety evaluation of a triacylglycerol lipase enzyme from a genetically modified yeast strain.

## Key findings

- The enzyme is free from viable cells and DNA of the production organism.
- Exposure estimates in European populations are below safety thresholds.
- No homology to known allergens was found, though a low risk of allergic reactions cannot be excluded.

## Abstract

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Komagatella phaffii strain LALL‐LI2 by Danstar Ferment AG. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.071 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the triacylglycerol lipase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

## Full-text entities

- **Genes:** LIPC (lipase C, hepatic type) [NCBI Gene 3990] {aka HDLCQ12, HL, HTGL}, PNLIP (pancreatic lipase) [NCBI Gene 5406] {aka PL, PNLIPD, PTL}
- **Diseases:** toxicity (MESH:D064420), allergic reactions (MESH:D004342)

## Full text

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## References

13 references — full list in the complete paper: https://tomesphere.com/paper/PMC12159548/full.md

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Source: https://tomesphere.com/paper/PMC12159548