Food enzymes in the European Union are subject to a harmonised regulatory framework, but the system is still in transition. While Regulation (EC) No 1332/2008 establishes the legal basis for the authorisation of food enzymes, the EU Union list of authorised food enzymes has not yet been adopted, creating a unique regulatory situation for companies.
This Q&A summarises the current legal framework, explains what applies in practice today, and outlines what to expect as the Union list is expected to be introduced.
What are food enzymes and how are they regulated in the EU?
Food enzymes are substances added to food to perform a technological function during the manufacture, processing, preparation, treatment, packaging, transport or storage of food. In the European Union, food enzymes are regulated under Regulation (EC) No 1332/2008.
The Regulation applies to enzymes used for technological purposes, including enzymes used as processing aids. However, it does not apply to enzymes intended for nutritional or digestive purposes, which may fall under other legislation depending on their intended use.
Do enzymes need to be authorised before use in the EU?
Historically, food enzymes were considered non‑toxic and were largely unregulated at EU level until 2008. Regulation (EC) No 1332/2008 changed this by introducing a harmonised EU‑wide system for the assessment and authorisation of food enzymes.
Under this Regulation, all food enzymes must be authorised by the European Commission and included in the Union list of authorised food enzymes before they can be placed on the EU market or used in food production. This requirement applies to both enzymes already on the market and any new enzymes intended for use in the EU.
Is the Union list of authorised food enzymes available?
Not yet. The EU Union list of authorised food enzymes has not been established. Until the Union list becomes applicable, national rules governing the marketing and use of food enzymes continue to apply in EU Member States.
Once the Union list is in force, only enzymes included in the list may be placed on the market or used in food production.
According to information provided by the European Commission, the Union list is estimated to be established in 2028.
How to apply for inclusion in the Union list?
Regulation (EC) No 1331/2008 sets out harmonised procedures for the application and assessment of food enzymes.
- European Food Safety Authority (EFSA) conducts the risk assessment.
- Currently, EFSA and stakeholders are discussing possible adaptations to the data requirements for food enzyme applications. One topic under consideration is whether the requirement for subchronic toxicity studies could be waived for certain enzymes, taking into account the generally low toxicity observed in previous evaluations.
- The European Commission manages the risk‑management and authorisation process.
Applications must be submitted by the company through the EU electronic submission portal.
How long does the scientific evaluation take?
Based on practical experience, EFSA’s scientific assessment of a complete and well-prepared dossier typically takes at least one year. However, the overall timeline may be longer if EFSA requests supplementary information or if additional clarifications are required during the evaluation process.
If you are planning to submit an enzyme application or need support in managing EFSA and EU regulatory procedures, contact Medfiles. We are an experienced partner in preparing and managing food enzyme dossiers, supporting companies through the EFSA evaluation process and EU authorisation steps. We are happy to assist you further and help ensure a smooth and compliant pathway for your enzyme application.
Author: Pia Karjalainen
Team leader, Health claims and Nutrition // Senior Regulatory Affairs Expert, Food and feed
Pia Karjalainen has advised companies on various topics within food regulatory and scientific affairs throughout the past 15 years. She has gained wide regulatory expertise for a vast range of food categories, such as food supplements, foods for special medical purposes, novel foods, food additives, flavourings and enzymes.
Since the beginning of her regulatory career, Pia has focused on health claims, which has become her key competence area. She also has in-depth expertise in designing regulatory strategies for innovative ingredients. Her ability to understand the bigger regulatory picture and work with a solution-oriented attitude has led her to leading and handling many complex projects related to different product categories and borderline products.
Pia has earned a master’s degree in health sciences (nutrition) from the University of Eastern Finland. Prior to joining Medfiles in 2014, she worked with food regulatory affairs and as a registered dietitian in healthcare.
