EU List and Applications

EU List and Applications

EU List

Is there a list of authorised food enzymes?

The Regulation on food enzymes (FE), Regulation (EC) No 1332/2008 harmonises for the first time the provisions relating to the use of enzymes in foods in the European Union (EU). According to that regulation, all food enzymes have to be subject to safety evaluation by the European Food Safety Authority (EFSA) and subsequently approved by the European Commission by means of their inclusion into the Union list of food enzymes.

A food enzyme will be included in the EU list only if:

  • It does not pose a health concern to the consumer
  • There is a technological need
  • Its use does not mislead the consumer

The process to draw up the Union list requires the submission of applications for approval of food enzymes. Numerous applications were received and are undergoing the safety evaluation by the EFSA. There is currently no Union list of authorised food enzymes, it will be established once the evaluations are finalised. Until then, the placing on the market and the use of food enzymes and of food produced with food enzymes are subject to the EU Member States' legislation.

Applications

Article 17 of the food enzyme Regulation established a period during which enzyme applications may be submitted for the inclusion in the Union list. This period started on 11 September 2011 and finished on 11 March 2015.

During this period, the Commission has received over 300 food enzyme applications. Due to the large number of dossiers received and the fact that all applications have to go through a safety evaluation and subsequent approval, it will take some years to establish the Union list.

The Commission has established a Register of all food enzymes' applications to be considered for inclusion in the first Union list. The Register contains all applications which were submitted within the mentioned period (11 September 2011 – 11 March 2015) and which comply with the validity criteria laid down in Article 12 of Regulation (EU) 234/2011. Applications submitted after the deadline are not included in the Register but will be processed in accordance with the Common Authorisation Procedure.

The Union List of food enzymes will be adopted once the Authority has issued an opinion on each food enzyme included in the Register.

As soon as the Union list of food enzymes is applicable, it will not be allowed to place on the market or use food enzymes that are not included in that list.

In the meantime, without prejudice to other applicable Union legislation, including Regulation (EC) No 178/2002, national provisions in force concerning the placing on the market and use of food enzymes and food produced with food enzymes continue to apply.

Disclaimer: The Register listing the food enzyme applications cannot be considered as a Union list of authorised food enzymes