EUROPE – The European Food Safety Authority (EFSA) has developed an updated scientific guidance to assist applicants in the preparation of applications for food enzymes, following a request by the European Commission.

In May 2020 the European Commission mandated EFSA to update the scientific part of the guidance document with a deadline of 18 months. The new guidance took a bit less than 18 months to develop, fulfilling the set timeline.

The new document, takes into consideration recent scientific developments in various areas of risk assessment of food enzymes.

In particular, it includes new criteria for the characterization of microorganisms used in their production, an updated methodology for the dietary exposure estimation, and conditions under which toxicological tests are not required.

As per the guidance, a submission should start by indicating the identity of the enzyme activity or activities under application. This should be specified by the applicant and should be focused on the key activities necessary to fulfil the intended technological function of the food enzyme.

It recommends Whole genome sequence (WGS) analysis for the identification and characterization of bacterial and yeast strains, filamentous fungi and other eukaryotic microorganisms intended for use as production strains. WGS data provide information for the characterization of the strains regarding their potential functional traits of concern.

The guidance also suggests that a Qualified Presumption of Safety (QPS) approach should be adopted during toxicological studies which are required for all food enzymes unless specifically exempted. QPS is a generic approach to the safety assessment of microorganisms intentionally introduced into the food and feed chain and also used as a source of fermentation products.

For production strains meeting the criteria for a QPS approach to safety assessment, toxicological studies on the food enzyme will only be required in relation to possible safety concerns identified elsewhere in the assessment process, e.g. manufacturing.

Information relating to toxigenicity and virulence for humans should be provided for non-QPS production strains, including history of use of the strain or any close relative.

The purpose of toxicity testing is to enable a conclusion about the safety of the food enzyme as a component of an enzyme preparation. These will normally consist of in vitro tests for genotoxicity and in vivo studies for systemic toxicity. Only when the results of these tests indicate a potential issue, additional studies will be requested

The applicant should ensure that all other materials added to the food enzyme when formulating the preparation as placed on the market are compliant with EU food legislation and safe.

Food enzymes regulation in Europe

The first EFSA guidance document on the ‘Submission of a dossier on food enzymes for safety evaluation’ was published in 2009. Before then, food enzymes other than those used as food additives were not regulated or were regulated as processing aids under the regulatory frameworks of the Member States.

On 20 January 2009, Regulation (EC) No 1332/20081 on food enzymes entered into force. This regulation applies to 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.

At the same time, Regulation (EC) No 1331/20082 established the European Union (EU) harmonized procedures, for the safety assessment and the authorization of food additives, food enzymes and food flavorings.

During the development of the scientific guidance on food enzymes, EFSA piloted the engagement of Member States (MS) representatives to critically review the document during the drafting phase. This was to comply with the European General Food Law with the Regulation (EU) 2019/1381 which roots for transparency and sustainability of risk assessment in the food chain in the European Union.

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