Food Enzymes Approvals in EU
Amfep members are getting ready to submit food enzyme dossiers in the EU
The 24-month submission window for food enzyme dossiers, foreseen by the FIAP regulations, has started on 11 Sep. 2011.
Through extensive discussions with the EU authorities, Amfep now has a clear picture of the safety and analytical documentation – as well as production process description – that will need to be reviewed by the European Safety Authority (EFSA) in food enzyme dossiers. We are still engaged in the clarification of the risk management elements that will be reviewed by the Commission and Member States – in particular the demonstration of technological need.
EFSA has strongly voiced its request that each enzyme producer must file a separate dossier for each food enzyme that is placed on the EU market or used for the manufacturing of food imported into the EU.
Are you a food enzyme producer? Do you produce, formulate or import food enzymes into the European Union? Join Amfep now – and reap the benefits of our extensive FIAP knowledge!
Establishment of the First EU Positive list of food enzymes
constantly updated
> Food Enzymes Legislation in our documents section
Regulation 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes lays down rules on food enzymes used in food.
The Regulation specifies that “Only food enzymes included in the Community list [1] may be placed on the market as such and used in foods” (art. 4). In addition, art. 5 of the Regulation specifies that “No person shall place on the market any food prepared with a food enzyme if the use of the food enzyme does not comply with this Regulation and its implementing measures”. The EU Positive list will be established for the first time on the basis of applications from interested parties (art. 17).
The sequence of events until the publication of the first EU Positive list of food enzymes is laid down in Regulations 1332/2008 [2] (on food enzymes) and 1331/2008 [3] (establishing a common authorisation procedure for food additives, food enzymes and food flavourings) and can be described as follows:
- 11 Mar 2011: the EU Commission published Regulation implementing the common authorisation procedure (art. 9.1, 1331/2008). This Regulation inter alia describes the submission procedure for food enzyme dossiers.
- 11 Sep. 2011 – 11 Sep. 2013: the industry has two years for submitting dossiers for food enzymes which are already on the market in the EU (art. 17.2, 1332/2008).
- Sep./Oct. 2011 – Aug./Sep. 2013: the EU Commission will compile and publish a Register [4] of valid applications received from the industry (art. 17.3, 1332/2008).
- Sep./Oct. 2011 – unknown date: EFSA will perform a risk assessment on all valid food enzyme dossiers during an undefined time period (art. 17.4.a, 1332/2008 establishes a derogation from art. 5.1, 1331/2008).
- Sep/Oct. 2011 – unknown date: The EU Commission and the Member States will perform a risk management on all valid food enzyme dossiers
- After EFSA has completed all evaluations: the first EU Positive list of food enzymes will be established by the EU Commission in one step (art. 17.4, 1332/2008).
All in all and taking into account the formal deadlines and procedures foreseen for its adoption, the EU Positive list of food enzymes might not be published for the first time before several years after all dossiers have been submitted.
In the meantime, until the first EU Positive list is published:
- Food enzymes for which no application could be submitted by Aug./Sep. 2013 can be placed on the market according to existing provisions applicable in Member States (Art. 24, 1332/2008). These food enzymes will be evaluated and placed on the EU Positive list after its first publication. An interim period for these food enzymes will be created, if needed (art. 17.9)
- Food enzymes whose dossiers are being evaluated by EFSA can continue being placed on the market and used according to existing provisions applicable in Member States (Art. 24, 1332/2008). This means that no matter how long the evaluation takes, there will be no interruption of sales.