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, was fully applicable from January 2010 and harmonises for the first time the rules for FE in the European Union (EU). According to that regulation, all FE currently on the EU market as well as new FE have to be subject to safety evaluation by the European Food Safety Authority (EFSA) and subsequently approved by the European Commission by means of a Union list. The process of establishing the Union list is undertaken by the submission of FE applications. Currently, there is no Union list of authorised food enzymes and until the establishment of such list, EU countries' legislation applies.

A food enzyme is included in the EU list if:

  • It does not pose a health concern to the consumer

  • There is a technological need

  • Its use does not mislead the consumer

Applications

Article 17 of the food enzyme Regulation established a period for which an enzyme application 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 300 food enzyme applications. Due to the large number of dossiers received and the fact that all the applications have to go through an evaluation and subsequent authorisation, it will take some years to establish the Union list.

In the meantime, the Commission will establish a Public Register of all food enzymes for which an application has been submitted for inclusion in the EU list and has been considered as valid following the validity criteria laid down in Article 12 of Regulation (EU) 234/2011.

It is also necessary, for the purposes of information and transparency, to publish the Food enzyme applications submitted to the Commission.

Disclaimer: The document listing the food enzyme applications has no legal value and cannot be considered as the Register. The Commission declines any and all responsibility for any inaccuracy, error or omission in relation to the information on the list. The European Commission fully excludes any and all liability of any kind to any person or entity that chooses to rely upon the information in the list.

 

Is it possible to group food enzymes under one application?

Yes. The requirements for grouping food enzymes under one application are laid down in Article 8(5) of Regulation (EU) No 234/2011 as amended by Regulation (EU) No 562/2012.

One of the options listed in this Article is that an applicant may group food enzymes under one application provided that they have been obtained from micro-organisms which have been used in the production of food enzymes that have been evaluated and authorised by the competent authorities in either France or Denmark in accordance with the Scientific Committee on Food guidelines of 1992.

In order to facilitate the fulfilment of this criterion, the Commission together with the competent authorities of France and Denmark, and the Association of food enzyme producers (AMFEP) have developed a table where all the food enzymes complying with that criterion are listed.