Is it safe to produce allulose using an enzyme?

Enzymes have been safely used in the production of everyday foods for years. They are used, for example, in baked goods, in the production of cheese as a substitute for rennet, or in fruit juice production. The production and use of our enzyme is of course carried out according to high quality standards and complies with the strict safety requirements of the European Union.

To produce highest quality allulose, we make sure that our enzyme does not get into the final product. This is guaranteed by our production process. The enzyme is retained during the production of the allulose by a closely monitored filtration unit and additional purification steps provide further safety. The produced allulose is also repeatedly controlled for absence of the enzyme using state-of-the-art analytical methods (SDS-Page, LoD 20 ng/mL). [1]

In addition to the absence of the enzyme in the final product, we also ensure that no DNA or viable cells from the production strain are detectable in the enzyme formulation. The analytics for this verification comply with the strict guidelines of the European Food Safety Authority. For more information on these requirements, please refer to the current EFSA Guidance. [2]

To ensure safety even for highly sensitive allergy sufferers, our enzyme has also been tested for potential allergenicity. Here, too, we followed the strict requirements of the EFSA (see the above-mentioned guidance). This also includes an in silico analysis using the amino acid sequence of the food enzyme and reporting any sequence identity greater than 35% to a known allergen using a sliding window of 80 amino acids. No potential allergens could be identified in this way (allergenonline.org; version 21, dated Feb. 14, 2021).

 

How is the safety of the enzyme and its production ensured?

Enzymes are commonly gained from growing microorganisms. This process is called fermentation. To ensure safety for people and the environment, this fermentation process is highly controlled. As an additional safety measure, the safety of the production strain used for enzyme production is ensured by meeting the standard EFSA requirements. Our production strain is a derivate of the well-established and already regarded as safe in other food production processes E. coli Bl21(DE3). The E. coli Bl21(DE3) strain was modified to produce the enzyme for allulose production.  The strain used for enzyme production is 99.9981% similar to the parental strain. The modified E. coli Bl21(DE3) does not harbor any antimicrobial resistance genes and potential virulence factor genes are not expected to cause any safety concern. Furthermore, the enzyme production strain is deposited at Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH (DSMZ) under collection number DSM 33294 to ensure genetic stability. [3]

Due to the validated production process and high levels of safety measures described above we can assure that our enzyme and our production strain meet all specifications and safety requirements. You can find the specification of our enzyme preparation here.