Enzymes are protein molecules that are present in all living things. They speed up and target chemical reactions, in many cases increasing the rate of reaction millions of times. For example, they aid digestion, metabolise and eliminate waste in humans and animals, and play a crucial role in muscle contraction.
Enzymes have been used unknowingly in food production, e.g. dough making, for centuries. They can be obtained by extraction from plants or animals or by fermentation from micro-organisms. They are usually purified but may contain varying traces of the other naturally occurring constituents of these three sources. They are normally added to perform a technological function in the manufacture, processing, preparation and treatment of foods. Examples include enzymes used to break down the structure of fruit so that manufacturers can extract more juice, or to convert starch into sugar in alcohol production.
Historically enzymes are considered to be non-toxic and not of safety concern for consumers since they are naturally present in ingredients used to make food. However, food enzymes produced industrially by extraction from plant and animal tissues, or by fermentation of microorganisms, are assessed for safety.
The risk assessment of food enzymes is carried out by EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). In 2009, the CEF Panel published guidance to applicants on the data needed for safety evaluation of food enzymes. This explains the 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. Among the data required, applicants must submit information on the identity of the source materials, the manufacturing process, an assessment of dietary exposure and toxicological data (except in those cases outlined above). In 2011, EFSA published a supporting explanatory note that further clarifies and provides practical examples of data requirements.
In relation to EFSA’s Qualified Presumption of Safety (QPS) list, the Authority would like to receive information, at the earliest possible moment, about any micro-organisms either already on the list or for possible inclusion on the list that are also likely to be submitted as part of a food enzyme application. Information, including the microbial strain used for enzyme production and the intended use, should be sent to: FIP@efsa.europa.eu.
Main work in progress
EFSA adopts scientific opinions and provides scientific advice for risk managers on the safety of enzymes used in food and feed. The Authority has already substantial experience in evaluating the safety and efficacy of enzymes used in feed materials. However this activity falls under a different legal framework and requires the consideration of different scientific information. Since the entry into force of new European legislation in 2009, the Authority has also taken on an important role in providing independent scientific advice to support the authorisation process for food enzymes.
EFSA has two main functions in relation to food enzymes:
- Evaluating all enzymes currently marketed or intended to be marketed in the European Union (EU) during a submission period defined by EU legislation.
- Assessing applications for the authorisation of new enzymes after an EU list of approved enzymes has been established.
Previously, food enzymes other than those used as food additives were not regulated at EU level or were regulated as processing aids under the legislation of Member States. Only France and Denmark have required safety evaluations for enzymes used as processing aids before they could be used in food production.
Due to differences between national rules on the assessment and authorisation of food enzymes, new EU framework legislation on food enzymes was adopted in 2008. This legislation has the aim eventually to establish an EU list of enzymes. 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 EU countries.
Regulation EC 1331/2008 introduced a common approval procedure for additives, enzymes and flavourings used in food. Regulation EC 1332/2008 harmonises rules on enzymes used in foods in the EU and requires the submission of applications for authorisation of all existing and new enzymes prior to their inclusion in an official EU list of approved food enzymes at a future date. This legislation requires EFSA to evaluate the safety of all these food enzymes before they can be authorised in the EU and added to the EU list. A food enzyme will be included in the EU list if it does not pose a health concern to the consumer; there is a technological need for its use; and its use does not mislead consumers. Labelling requirements for food enzymes are covered by Directive 2000/13/EC and Regulation EC 1332/2008.
The timeframe and the data requirements for submission of applications were established by Regulation EU 234/2011. This regulation establishes a submission period for existing food enzymes starting from 11 September 2011. The deadline for submitting such applications was extended from 24 to 42 months (11 March 2015) by Regulation EU 1056/2012. A further amendment by Regulation EU 562/2012 introduced the possibility of grouping food enzymes under one application to improve the efficiency of the evaluation process, as well as a derogation from submitting toxicological data under certain conditions. These provisions apply only to enzymes with the same catalytic class, manufactured substantially by the same process and originating from the same source, and for enzymes:
- Already evaluated by France or Denmark (with the exception of those produced by genetically-modified plants, animals or micro-organisms)
- Produced by microorganisms on EFSA’s Qualified Presumption of Safety list
- Produced from the edible parts of non-genetically modified plants and animals.
The above-mentioned EU legislation does not cover enzymes intended for human consumption, for example those used for nutritional or digestive purposes, or food enzymes used in the production of food additives (as defined by Regulation EC 1333/2008 on food additives). Also, 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.
More information on food enzyme legislation and the submission of food enzyme applications: