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 and Processing Aids (CEP). In 2021, the CEP Panel updated the guidance to applicants on technical data needed for the safety evaluation of food enzymes. Among the data required, applicants must submit information on the identity of the source organisms, the manufacturing process, an assessment of dietary exposure, and toxicological data.
Administrative information on the formal application and evaluation procedures can be found in a separate EFSA guidance from 2020. The administrative guidance is applicable to three food improvement agents –additives, enzymes and flavourings.
2021 EFSA publishes updated scientific guidance on the submission of food enzyme dossiers for safety evaluation.
2019 EFSA updates the criteria on the characterisation of microorganisms used for the production of food enzymes
2016 EFSA launches a call for data to enable dietary exposure estimation using actual consumption data, still open.
2016 EFSA updates the methodology applied to the exposure assessment of food enzymes.
2009 EFSA publishes its first guidance document on the submission of a dossier on food enzymes for safety evaluation.
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: