The word enzyme was first used by the German physiologist Wilhelm Kühne and is derived from the Greek term meaning “in yeast”. Although the use of enzymes in the production of food and drink, such as bread and wine, had been practised for thousands of years, the underlying process (and indeed many food processes) which used enzymes from microbial sources was not fully understood until the late 19th century.
What are enzymes and food enzymes?
Enzymes are proteins that enhance, i.e. catalyse biochemical reactions and are normally used to speed up and/or target specific chemical reactions. Enzymes are obtained from a wide variety of sources, but principally by extraction from plants or animals or by fermentation from microorganisms, including genetically modified microorganisms.
Food enzymes are enzymes that are safe for consumption and are used by the food industry during food production to help improve the safety and quality of foods and the efficiency of the process.
What specifically are food enzymes used for?
Food enzymes are extensively used in the manufacture, processing, preparation and treatment of a wide range of food products. Their precise uses are as wide-ranging, as the foods they are used in. Some common examples include:
- The removal of oxygen in bottled soft drinks to reduce browning due to oxidation
- The breakdown of plant cells to help improve efficiency of vegetable oil extraction
- The removal of pectins from fruit juice in order to produce clear fruit juices
- The conversion of starch to sugar in alcohol production
- The curdling of milk in order to produce cheese
- The removal (hydrolysis) of lactose from milk in order to give lactose-free milk
- The tenderisation of meat products
- The reduction of acrylamide in cooked potato products such as frozen chips.
How are enzymes named and classified?
Enzymes are classified by the kind of chemical reaction they catalyse. The most common enzyme classification scheme is defined by the International Union of Biochemistry and Molecular Biology (IUBMB), which classifies enzymes into six broad classes, i.e. Oxidoreductases; Transferases; Hydrolases; Lyases; Isomerases and Ligases, with various subclasses within each group. All enzymes are identified by a four-digit code which is prefixed by EC, which stands for Enzyme Commission.
What is the legal position in the European Union in relation to food enzymes?
Until 2008, in the European Union (EU), enzymes were considered safe to use in foods since they were naturally present in many ingredients used to make food. As such, until 2008 enzymes other than those used as food additives (e.g. invertase and lysozyme) were not regulated at an EU level, or were regulated as processing aids under the national legislation of individual Member States. Only France and Denmark required safety evaluations for enzymes used as processing aids before they could be used in food production. Ireland has no specific national legislation in relation to food enzymes.
Regulation (EC) No. 1331/2008 provides for a common assessment and authorisation procedure for food enzymes and other food improvement agents (FIAs), including a risk assessment carried by the European Food Safety Authority (EFSA). The latter provision is in accordance with the framework for risk assessment in matters of food safety established by Regulation (EC) No. 178/2002, which stipulates that the authorisation to place substances on the market must be preceded by an independent scientific assessment of the risks that they may pose to human health.
Regulation (EC) No. 1332/2008 harmonised the rules on food enzymes used in foods across the EU and stipulates that information on all food enzymes used in food processing must be submitted for risk assessment by the EFSA. This Regulation has applied since the 20 January 2009, with labelling provisions applicable since 20 January 2010.
Regulation (EU) No. 234/2011, implementing Regulation (EC) No. 1331/2008, provides a list of data required for dossier submissions to the EFSA. All submissions should have a risk assessment component in order to be evaluated by the EFSA; in addition, they should have a risk management component, which is evaluated by the European Commission (EC) and its Member States.
Food enzymes will be included in an EU list of authorised food enzymes if they do not pose health concerns for consumers; there is a technological need for their use, and their use does not mislead consumers. The inclusion of food enzymes in the EU list will be carried out in accordance with the procedures laid down in Regulation (EC) No. 1331/2008 and with the implementing rules set out in Regulation (EU) No. 234/2011, which specifies the general provisions on data required for risk assessment and risk management of food enzymes.
In the case of an application for a modification to the conditions of use of an authorised food enzyme or for a modification of the specifications of an authorised food enzyme, the data requested for risk assessment may not be required, as long as this can be justified by the applicant.
See updated information regarding all food enzyme legislation.
What is the scope of the Regulation on food enzymes?
Regulation (EC) No. 1332/2008 covers all food enzymes that are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food, including enzymes used as processing aids.
The Regulation does not cover enzymes intended for human consumption, e.g. for nutritional or digestive purposes and enzymes used in the production of food additives under Regulation (EC) No. 1333/2008 and in the production of processing aids.
Microbial cultures traditionally used in the production of food (cheese, wine), which may incidentally produce enzymes, but are not specifically used to produce them, are not considered food enzymes.
Is the EU list of authorised food enzymes available?
No, there is no EU list of authorised food enzymes. Article 17 of Regulation (EC) No. 1332/2008 on food enzymes established a period for which a food enzyme application could be submitted for inclusion in the EU list. This period began on 11 September 2011 and ended on 11 March 2015. During this period, the EC received over 300 food enzyme applications, i.e. dossiers.
The European Commission (EC) have a list of the food enzyme applications submitted to the EC within the legal deadline.
The (FSAI) understands from the EC that in order to ensure fair and equal conditions for all applicants, the EU list will be drawn up in a single step. The list will be established after completion of the risk assessment of all food enzymes for which sufficient information has been submitted during the initial application period. However, the EFSA risk assessments for individual enzymes will be published as soon as they are completed. Due to the large number of applications submitted during the initial application period, it will take some years to establish the EU list of food enzymes.
Can food enzymes be used in the absence of the authorised EU list?
Yes, until the EU list of food enzymes is established, national rules (in those Member States that have such rules) on the marketing and use of food enzymes, and food produced with food enzymes, will continue to apply in those EU countries.
In those Member States where national rules do not exist, food enzymes can continue to be used until the EU list is established. However, if no application has been submitted to the EC for subsequent risk assessment and authorisation of these food enzymes, they will not be authorised for use in the EU after the first publication of the EU list of food enzymes.
Note: Food enzymes found to be unsafe by the EFSA cannot be used in food under article 14 of Regulation (EC) No. 178/2002.
Can food enzyme applications still be submitted?
Yes, while the legal deadline for submission of applications for new food enzymes has passed, applications can still be made. However, the EC has indicated that it will prioritise those applications received before the legal deadline of 11 March 2015.Applications for enzymes submitted after 11 March 2015 will most likely not be part of the first EU list of food enzymes. However, it is envisaged that an interim period will allow these particular food enzymes to remain legally on the market after the first EU list of food enzymes is published and pending the completion of the EFSA’s risk assessment and authorisation.
How are food enzyme applications complied and submitted?
The EFSA has also published guidance on the submission of a dossier on food enzymes for risk assessment. In addition, see an explanatory note for the guidance on the submission of a dossier on food enzymes. Please note that in the following cases the enzyme manufacturer and/or end user of a food enzyme must inform the EC and provide the necessary data:
- If new scientific or technical information becomes available which may affect the risk assessment of the food enzyme by the EFSA
- If the food enzyme is already approved under Regulation (EC) No. 1332/2008 but is manufactured using different raw materials and/or production processes significantly different from those included in the initial risk assessment submitted to the EFSA
- On request, inform the EC of the actual use of the food enzyme. Such information will be made available to Member States by the EC.
How should food enzymes be labelled on food products?
Labelling rules related to food enzymes are set down in Regulation (EU) No. 1169/2011 on the provision of food information to consumers and also in Articles 10 to 13 of Regulation (EC) No. 1332/2008 on food enzymes. Further detailed information regarding the labelling requirements for food enzymes is also outlined on the FSAI website at the following link.
The EC has produced a guidance document 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 therefore whether it needs to be listed in the ingredient list of foods intended for the final consumer. Such criteria will help applicants prepare an appropriate application for authorisation of food enzymes. The guidance also includes a decision tree to facilitate this categorisation.