Enzymes, Additives & Flavours
Food enzyme regulatory consultancy
Food enzymes, additives and flavourings are categorised in Europe as “food improvement agents” and are permitted on the market through a common authorisation procedure whereby the EU Union List of authorised food enzymes, additives and flavourings is updated.
Union Lists are already established for food additives and flavourings indicating which additives and flavourings are permitted in food, as well as their conditions of use. The Union List of authorised food enzymes is not yet established and until then, national legislations apply. The European Food Safety Authority (EFSA) has been evaluating over 300 food enzyme applications and it will thus take some years to establish the Union List. The current deadline is 2023/2024, although EFSA and the European Commission envision it may even take longer.
Do you want to add or remove a food improvement agent to the Union List? Would you like to change the conditions of use, specifications or restrictions of one of the substances and don’t know where to start?
Argenta can help unravel the complex maze of regulations and guidelines and advise which technical and scientific elements are required to amend the Union List.
Food improvement agents services
- Initial assessment of the legal status of the substance to identify the correct regulatory pathway and ensure fastest route to market
- Evaluate existing data and identify missing information in a GAP analysis
- Provide expert advice for the generation of additional data or justifications for omissions
- Assist collecting technical and scientific additional data, monitor studies and review study reports
- Estimate dietary exposure and provide scientific and regulatory support for the consumer safety assessment
- Compile, write and submit food enzyme, additive or flavourings dossiers
- Post-submission support: liaise with EFSA and European Commission, answer supplementary information requests and provide regulatory support