Abstract .................................................................................................................................................... 1
Summary .................................................................................................................................................. 3
Table of contents ...................................................................................................................................... 4
Background as provided by the European Commission ........................................................................... 5
Terms of reference as provided by the European Commission ................................................................ 5
Assessment ............................................................................................................................................... 6
1. Introduction ..................................................................................................................................... 6
2. Information on existing authorisations and evaluations .................................................................. 6
3. Technical data .................................................................................................................................. 7
3.1. Identity of the food enzyme .................................................................................................... 7
3.2. Chemical parameters ............................................................................................................... 7
3.3. Properties of the food enzyme ................................................................................................ 9
3.4. Information on the source materials ........................................................................................ 9
3.4.1. Information relating to the genetically modified microorganism ....................................... 9
3.5. Manufacturing process .......................................................................................................... 10
3.5.1. Information relating to the fermentation process .............................................................. 10
3.5.2. Information relating to the downstream processing ......................................................... 11
3.6. Reaction and fate in food ...................................................................................................... 11
3.7. Case of need and intended conditions of use ........................................................................ 11
4. Dietary exposure ............................................................................................................................ 12
5. Toxicological data ......................................................................................................................... 13
6. Allergenicity .................................................................................................................................. 14
7. Discussion ...................................................................................................................................... 15
Conclusions ............................................................................................................................................ 15
Documentation provided to EFSA ......................................................................................................... 15
References .............................................................................................................................................. 16
Abbreviations ......................................................................................................................................... 17