# Safety evaluation of the food enzyme asparaginase from the non‐genetically modified Saccharomyces cerevisiae strain ARY‐2

**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, Henk Van Loveren, Laurence Vernis, Cristina Fernàndez‐Fraguas, Daniele Cavanna, Silvia Peluso, Yi Liu

PMC · DOI: 10.2903/j.efsa.2025.9532 · EFSA Journal · 2025-07-30

## TL;DR

This study evaluates the safety of a food enzyme from yeast to reduce acrylamide in processed foods, finding it generally safe but with a possible risk of allergic reactions.

## Contribution

The study provides a safety evaluation of a non-genetically modified asparaginase enzyme for food use.

## Key findings

- The enzyme does not require separation from yeast cells during production.
- Dietary exposure estimates were up to 32.246 mg TOS/kg body weight per day.
- No safety concerns were identified under intended use conditions, though allergic reactions remain a potential risk.

## Abstract

The asparaginase (L‐asparagine amidohydrolase, EC 3.5.1.1) is produced by the non‐genetically modified Saccharomyces cerevisiae strain ARY‐2 by Renaissance BioScience Corporation. The food enzyme is not separated from the yeast cells during the enzyme production. The food enzyme is intended to be used to reduce acrylamide formation during food processing at high temperature and low moisture conditions by hydrolysing asparagine. Dietary exposure was estimated to be up to 32.246 mg TOS/kg body weight per day in European populations. Toxicity tests were considered unnecessary by the Panel because the production strain was considered safe and no issues of concern resulting from the food enzyme manufacturing process were identified. A search for the homology of the amino acid sequence of the asparaginase 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. 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.

## Linked entities

- **Chemicals:** acrylamide (PubChem CID 6579), asparagine (PubChem CID 236)
- **Species:** Saccharomyces cerevisiae (taxon 4932)

## Full-text entities

- **Diseases:** allergic reactions (MESH:D004342), cancer (MESH:D009369), infections (MESH:D007239), respiratory allergy (MESH:D012131), Toxicity (MESH:D064420)
- **Chemicals:** starch (MESH:D013213), L-aspartic acid (MESH:D001224), acrylamide (MESH:D020106), water (MESH:D014867), Pb (MESH:D007854), ARY-2 (-), L-asparagine (MESH:D001216), ammonia (MESH:D000641)
- **Species:** Saccharomyces cerevisiae (baker's yeast, species) [taxon 4932], Solanum tuberosum (potatoes, species) [taxon 4113], Escherichia coli (E. coli, species) [taxon 562], Homo sapiens (human, species) [taxon 9606], Salmonella (genus) [taxon 590]
- **Cell lines:** ARY-2 — Homo sapiens (Human), Colon carcinoma, Cancer cell line (CVCL_A628), S288C. — Homo sapiens (Human), Finite cell line (CVCL_L938)

## Full text

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## References

15 references — full list in the complete paper: https://tomesphere.com/paper/PMC12308217/full.md

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Source: https://tomesphere.com/paper/PMC12308217