EU Update: EFSA Concludes Food Enzyme Dextransucrase Safe for Its Intended Use

The food enzyme dextransucrase (sucrose:1,6-α-d-glucan 6-α-d-glucosyltransferase; EC 2.4.1.5) is produced with the genetically modified Bacillus subtilis strain DP-Eyp97 by Genencor International B.V. The production strain met the requirements for the qualified presumption of safety. The food enzyme was considered free from viable cells of the production organism and its DNA.

The food enzyme is intended to be used in the processing of sugars for the production of oligo- and polysaccharides in situ.

Dietary exposure was estimated to be up to 27.598 mg total organic solids/kg body weight per day in European populations.

Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel.

A search for the homology of the amino acid sequence of the dextransucrase to known allergens was made, and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low.

Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

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The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% hold Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

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