- Legal basis
- UK FSA approved-additives list and assimilated EU Regulation 1333/2008 (Annex II). Individual protease enzyme preparations also undergo separate food enzyme assessments by EFSA under Regulation (EC) No 1332/2008 (the Food Enzymes Regulation), which requires pre-market authorisation for each preparation.
- Permitted foods
- Bread and rolls; Fine bakery wares (biscuits, crackers, cakes); Pizza bases; Pasta; Processed meat products; Beer and brewing
- Maximum levels
- Quantum satis (no fixed maximum; used at the level technologically necessary)
- Safe-intake limit (ADI)
- No numerical ADI set
- History
- Proteases have long been used as processing aids and flour treatment agents in European baking. The Food Enzymes Regulation (EC) No 1332/2008 introduced a unified EU authorisation process for food enzyme preparations; EFSA began systematic re-evaluations of individual protease preparations from around 2019. Specific protease preparations must appear on the EU Food Enzymes List to be marketed; this list was still being compiled as of EFSA's rolling review programme. In Great Britain post-Brexit, the domestic food enzyme authorisation list has not yet been established. In the interim, enzymes may continue to be used in food if they meet the requirements of assimilated Regulation (EC) No 1332/2008. From 1 April 2025, the market authorisation process was modernised so that any future GB authorisations will come into effect via ministerial decision and be published in an FSA/FSS-maintained register, rather than being prescribed by statutory instrument. The FSA online register for regulated products serves as the primary source for authorised products in Great Britain.