Report | |||
| Status | Finished | EFSA question number | EFSA-Q-2022-00001 |
| Adopted | 08-03-2023 | ||
| Previous authorisations | The applicant has submitted a dossier in support of the application for authorisation of the food enzyme lysozyme from hens’ egg. The dossier was submitted on 30 December 2021. Additional information was requested from the applicant during the assessment process on 14 March 2022 and was consequently provided on 21 April 2022 | ||
Production method | |||
| Manufacturing | On receipt from suppliers, eggs are [...] broken to separate the yolk from the egg white. | Formulation | Liquid formulation |
| Downstream processing | The pH is adjusted and the protein solution is passed through [...] column designed to selectively adsorb lysozyme. The column is then washed with [...] to remove albumin fractions. The lysozyme is then eluted from the column with [...] precipitated by pH adjustment and recovered by filtration. The recovered enzyme is mixed with and further purified and concentrated as lysozyme hydrochloride. Finally, the lysozyme hydrochloride may be spray-dried for use in a granular form or diluted for use in a liquid form |
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| Average TOS (w/w) | 0.0 | Average activity/TOS | 0.0 |
EFSA tested impurities | |||
| Production strain and recombinant DNA | / | Allergenicity | The Panel concluded that, under the intended conditions of use, the residual amounts of lysozyme in treated beers, cheese and cheese products, as well as wine may trigger adverse allergenic reactions in susceptible individuals. |
| Antimicrobial resistance | / | ||
| Antifoam agents | / | Other | / |
| Pathogens | |
Microbiological quality indicators | |
| Metals | |
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| Comments | LoDs: Pb = 5 mg/kg; As, Hg = 1 mg/kg each. | ||