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Regulatory aspects on food enzymes

EU harmonisation in progress

Regulation (EC) No 1332/2008 on food enzymes lays down rules for placing on the market and using food enzymes in the EU. It states that only food enzymes approved in the EU may be sold as such, and/or may be used to produce food which is sold in the EU. This also includes food enzymes used to produce food and food ingredients (including flavourings) outside of the EU, and subsequently imported into the EU.

The EU Food Enzymes Regulation was published in 2008, but will fully enter into force only after the first Union list of food enzymes is published. This publication is believed to take place in 2020-2021.

Several steps will take place for all food enzymes presently used in food processing tobe evaluated for their safety and technological need:

  • Interested parties (in most cases, the food enzyme producer) are invited to submit a dossier to the EU Commission by March 2015.
  • The EU Commission will seek a scientific opinion of the European Food Safety Authority (EFSA) on the safety of the food enzyme in its intended uses
  • The EU Member States will review the technological need of the food enzyme, if deemed safe by EFSA.
  • The EU Member States will vote on a Regulation authorizing the food enzymes for which both evaluations were positive.
  • This initial Union list will be published after all food enzymes for which a dossier was submitted have been evaluated.

With hundreds of food enzymes to evaluate, this process is expected to take several years. Until then, the existing set of EU and national rules will remain in force.

Until the establishment of the first Union list, all existing rules remain applicable:

a) Existing pre-market approval system in the EU

Under the existing EU legislation, a food enzyme can either be used as a food additive or as a processing aid, depending on the intended technological function. The definitions of these categories are given in the Food Additives Regulation (Regulation (EC) No 1333/2008).

  • Food additives are substances that are added to food – with the intention to exert a technological function within that the final food. Two food enzymes are presently approved under the EU Food Additives Regulation: lysozyme and invertase.
  • Processing aids, on the other hand, are substances that are added with the intention to exert a technological function during food processing – and not in the final food, even if still present in small amounts. All other food enzymes are exempted from the Food Additives Regulation because they are used solely as processing aids.

Food enzymes currently listed under the EU Food Additive Regulation will be transferred to the first Union list of food enzymes. Have a look at the Food Enzyme Regulation: timeline

The use of food enzymes as processing aids is still regulated at national level (see below). However, there are also some vertical harmonized EU rules, e.g. for fruit juices and winemaking, in which the use of food enzymes is regulated.

b) Existing pre-market approval system at national level

Prior to 2008, France and Denmark were the only EU Member States with national pre-market approval systems for food enzymes.

In France, approved food enzymes are mentioned on the list of processing aids, together with the food processes in which they can be used.

The list can be found in the order of 19 October 2006 on the use of processing aids in the manufacture of certain foodstuffs (in French: Arrêté du 19 octobre 2006 relatif à l’emploi d’auxiliaires technologiques dans la fabrication de certaines denrées alimentaires) as well as in its amendments.

A food enzyme mentioned on the French positive list can be sold and used in France provided that it complies with the restrictions of use – as laid down by the above-mentioned order.

In Denmark, approved food enzymes are not published on a positive list. The approval for each individual food enzyme is granted directly to the applicant (manufacturer, importer and/or user), specifying for which food application the food enzyme can be used.

The rules to follow are laid down in a recently updated implementing decree N 250 of 8 March 2013 (Bekendtgørelse om tilsætninger mv til fødevarer nr. 250 af 8. marts 2013).

c) Mutual recognition of authorisations

The principle of mutual recognition of authorisations between France and Denmark has been introduced recently, following the adoption of a harmonised EU food enzymes legislation (see above). This mutual recognition only applies when the national administration performed the safety assessment according to the 2009 EFSA Guidelines.

d) Specific vertical national legislation

Certain Member States have established rules regulating the use of food enzymes in specific food production processes (e.g. dairy and bread). These rules differ from country to country as far as the number and type of permitted food enzymes in various applications is concerned.

Note: CLP is also applicable to food enzymes, except when in the finished state intended for the final user.

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