Submission, Safety Assessment and Authorisation

Submission of applications 

Regulation (EC) No 1332/2008 requires the submission to the European Commission (EC) of applications of all existing and new food enzymes for safety assessment by the European Food Safety Authority (EFSA) and their authorisation via their inclusion in a Union List of approved food enzymes. 

For food enzymes to be authorised in the EU, they should fulfil the following criteria:

  • must be safe when used
  • there must be a reasonable technological need for their use 
  • their use must not mislead the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product.

The timeframe for submission of applications was established by Regulation (EC) No 1332/2008. A 24-month period was originally established, from the 11th of September 2011 to the 11th of September 2013. This period was subsequently extended for an additional 18 months, until the 11th of March 2015 by Commission Regulation (EU) 1056/2012. Although the period for the submission of applications has expired, the Commission still accepts applications. Guidance on making a submission are detailed below:

  • Practical guidance prepared by the EC for applicants on the submission of applications on food additives, food enzymes and food flavourings (latest version March 2018).
  • Guidance document prepared by the EC in 2014 with the aim of providing informal guidance for food businesses and Competent Authorities on criteria for determining the status of a food enzyme either as an ingredient or as a processing aid in a given context of use, and hence whether it needs to be listed in the ingredient list of foods intended for the final consumer. Such criteria help applicants prepare a suitable application for authorisation of food enzymes. The guidance also includes a decision tree to facilitate this categorisation. 

Risk assessment by EFSA

In line with Article 14 of Regulation (EC) No 1332/2008, food enzymes have to be assessed by EFSA for safety before authorisation. Guidance on the preparation and nature of the data required for risk assessment by EFSA are detailed below:

  • Guidance document (2009) prepared by EFSA  to assist applicants in the preparation and submission of applications for the safety assessment of food enzymes. The document explains the required format of a formal application for the safety assessment of a food enzyme, the administrative and technical data required and the range of toxicological tests generally required. 
  • Supporting explanatory (2014) note prepared by EFSA that further clarifies and provides practical examples of data requirements. 

Authorisation Procedure

To ensure harmonisation, the risk assessment by EFSA of food enzymes and their inclusion in a Union List of approved food enzymes must be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 and its implementing regulations establishing a common authorisation procedure for ‘Food Improvement Agents’ which includes food enzymes, food additives, food flavourings and certain substances with flavouring properties for use in and on foods. 

  • Regulation (EC) No 1331/2008 (OJ L 354, p1, 31/12/2008) of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings.

Implementing rules:

  • Commission Regulation (EU) No 234/2011 (OJ L64, p15, 11/03/2011) of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
  • Commission Implementing Regulation (EU) No 562/2012 amending Commission Regulation (EU) No 234/2011 with regard to specific data required for risk assessment of food enzymes, lays down derogations from submitting toxicological data in some specific cases and the possibility of grouping food enzymes under one application under certain conditions. 

Information obligation

In line with Article 14 of Regulation (EC) No 1332/2008, a producer or user of a food enzyme shall inform the EC immediately of any new scientific or technical information which might affect the assessment of the safety of the food enzyme and shall, at the request of the EC, make available to the EC and Member States information in relation to the actual use of the food enzyme. 

In the case where a food enzyme approved under Regulation (EC) No 1332/2008 is prepared by production methods or using starting materials significantly different from those originally included in the risk assessment of EFSA, a producer or user shall, before marketing the food enzyme, submit to the EC the necessary data to allow an assessment of the food enzyme with regard to the modified production method or characteristics to be undertaken by EFSA.

Union List of approved Food Enzymes

Article 4 of Regulation (EC) No 1332/2008 sets out a provision for the establishment of the Union List of approved food enzymes. Only food enzymes included in the Union List may be placed on the EU market. However, as of May 2019 the Union List is not available yet. Until such a list is established, national rules on the marketing and use of food enzymes and food produced with food enzymes will continue to apply in those Member States that have national rules. In those Member States (including Ireland) where national rules do not exist, food enzymes can continue to be used until the Union List is established. 

In the interim period before the first version of the Union List is published, the EC has produced a list of the food enzyme applications submitted within the legal deadline (from the 11th of September 2011 to the 11th of March 2015). It is unlikely that any food enzyme application submitted after the deadline will make the first version of the Union List. However, it is envisaged that a transition period will allow these particular food enzymes to remain legally on the EU market after the first version of the Union List of food enzymes is published. By contrast, if no application for authorisation has been submitted to the EC, the food enzyme in question will not be authorised for use in the EU after the publication of the first version of the Union List of approved food enzymes.

The Union List will include a description of the approved enzymes and specify any conditions governing their use, including, where necessary, information on their function in the final food. The list will be supplemented by specifications, in particular on their origin, including where relevant, information about allergenic properties and purity criteria.

 

Last reviewed: 17/6/2019

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