# Safety evaluation of the food enzyme cellobiose phosphorylase from the genetically modified Escherichia coli strain LE1B109‐pPB130

**Authors:** Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Yrjö Roos, Ana Gomes, Magdalena Andryszkiewicz, Erik Boinowitz, Cristina Fernàndez‐Fraguas, Yi Liu, Andrew Chesson

PMC · DOI: 10.2903/j.efsa.2024.8774 · EFSA Journal · 2024-05-23

## TL;DR

This study evaluates the safety of a food enzyme produced by a genetically modified Escherichia coli strain and concludes it is safe for use in producing the carbohydrate cellobiose.

## Contribution

The novelty lies in the safety evaluation of a genetically modified Escherichia coli-produced cellobiose phosphorylase for food use.

## Key findings

- The genetic modifications in Escherichia coli strain LE1B109-pPB130 do not raise safety concerns.
- The enzyme is free from viable cells and DNA of the production organism.
- Allergenicity risk is low, but not entirely ruled out under intended use conditions.

## Abstract

The food enzyme cellobiose phosphorylase (cellobiose: phosphate α‐d‐glucosyltransferase; EC 2.4.1.20) is produced with the genetically modified Escherichia coli strain LE1B109‐pPB130 by c‐LEcta GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in combination with a sucrose phosphorylase in the production of the specialty carbohydrate cellobiose. Since residual amounts of total organic solids are removed by downstream purification steps, the Panel considered that toxicological studies other than assessment of allergenicity were unnecessary and a dietary exposure was not estimated. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, but 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.

## Linked entities

- **Chemicals:** cellobiose (PubChem CID 439178), sucrose phosphorylase (PubChem CID 160315322)
- **Species:** Escherichia coli (taxon 562)

## Full-text entities

- **Diseases:** allergic reactions (MESH:D004342)
- **Species:** Escherichia coli (E. coli, species) [taxon 562]
- **Cell lines:** LE1B109-pPB130 — Homo sapiens (Human), Cutaneous melanoma, Cancer cell line (CVCL_C501)

## Full text

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## References

10 references — full list in the complete paper: https://tomesphere.com/paper/PMC11112453/full.md

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Source: https://tomesphere.com/paper/PMC11112453