New EFSA enzyme tool paves way for deeper safety evaluations

By Will Chu

- Last updated on GMT

The intention was to use the β-amylase in starch processing for production of glucose syrups containing maltose to be used as a food ingredient. ©iStock
The intention was to use the β-amylase in starch processing for production of glucose syrups containing maltose to be used as a food ingredient. ©iStock
The European Food and Safety Authority (EFSA) have revealed a new approach to assessing consumer exposure to food enzymes, tightening up their safety profile in line with current EU law.

Details of this technique were outlined in a series of evaluations in which one commonly used enzyme— β-amylase—was amongst the first to undergo examination via this new method.

“We have developed an exposure tool which can be tailored to each food process involving food enzymes,”​ said Dr Christina Tlustos, an exposure expert who sits on EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), which developed the approach.

“The tool uses technical conversion factors, which means we can combine food consumption data with enzyme use levels and take into account the level of transfer of food enzymes into food products.”

In the first evaluation, β-amylase, obtained from the grain of wheat (Triticum spp​.), was submitted by the French food ingredient specialists Roquette.

The intention was to use the β-amylase in starch processing for production of glucose syrups containing maltose to eventually be used as a food ingredient. 

The scientific panel were specifically looking at the gluten content of the enzyme, which was shown to be below the limit of quantification of the applied analytical method.

Additionally the gluten content was below the threshold value of 20 milligrams per kilogram (mg/kg) determined for ‘gluten-free’ products.

The potential allergenicity was evaluated by searching for similarity between the amino acid sequence of the β-amylase and the sequences of known food allergens. EFSA found no match.

‘Enzyme does not give rise to safety concerns’

soybean field, soy, Copyright fotokostic
In addition to β‑amylase’s safety profile in wheat, scientific opinion have also been produced for the enzyme’s actions in barley (Hordeum vulgare) and soybean (Glycine max) whey. ©iStock/FotoKostic

“Based on the origin of the food enzyme from edible parts of grain, the manufacturing process, and the compositional and biochemical data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use,”​ the panel concluded.

The enzyme is also the focus of two other studies that also use the exposure tool to reach definitive conclusions.

In addition to β‑amylase’s safety profile in wheat, scientific opinions have also been produced for the enzyme’s actions in barley​ (Hordeum vulgare​) and soybean​(Glycine max​) whey.

Safety evaluations​were also carried out on the food enzyme endo-1,4-β-xylanase obtained from genetically modified Aspergillus niger strain XYL.

“The experts on the working group decided which technical input data to use. During the development of the tool stakeholders provided some useful insights and additional data​,” said Professor Karl-Heinz Engel, the chair of the food enzymes working group and a CEF Panel member.

“By harmonising both food enzyme use levels and food consumption data we can estimate consumer exposure to these substances much more accurately than before.”

The tool’s role in determining the final outcome now paves the way for the evaluation of the remaining 300 applications that use enzymes in the food production process.

Enzyme evaluations

Industrially produced food enzymes currently undergo a strict scientific assessment to ensure they are safe for use in food production.

Here, under Regulation EC 1332/2008​,​ the assessment “…lays down rules on food enzymes used in foods, including such enzymes used as processing aids, with a view to ensuring a high level of protection of human health and a high level of consumer protection.”

In September 2016, the CEF Panel published a new methodology for dietary exposure to food enzymes based on actual consumption data collected from individual European citizens.

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