The European Food Safety Authority (EFSA) has concluded that the food enzyme cyclomaltodextrin glucanotransferase produced from the genetically modified Escherichia coli K12 strain DSM 34229 does not pose a safety concern under its intended use, according to a scientific opinion published on 20 July 2026. The enzyme is used in the processing of sugars to produce specialty carbohydrates, specifically α-cyclodextrins. The EFSA Panel on Food Enzymes (FEZ) assessed the application submitted by Wacker Chemie AG and found that the genetic modifications did not raise safety issues, and the food enzyme was free from viable cells of the production organism, though it may contain recombinant DNA. Dietary exposure was not calculated because residual amounts of the enzyme are removed during production, and toxicological testing was deemed unnecessary. The panel noted a potential but low risk of allergic reactions based on homology to known respiratory allergens.
The opinion, adopted on 25 June 2026, follows the regulatory framework established by Regulation (EC) No 1332/2008 on food enzymes and Regulation (EC) No 1331/2008 on the common authorisation procedure. The application was submitted on 29 March 2023, and EFSA conducted a public consultation from 22 July to 12 August 2025, which received no comments. The assessment followed EFSA's guidance documents on transparency and dossier submission. The production strain, deposited at the German Collection of Microorganisms and Cell Cultures (DSMZ) as DSM 34229, was identified as E. coli by whole genome sequencing, and no antimicrobial resistance genes or virulence factors of concern were detected. The manufacturing process complies with food hygiene regulations and good manufacturing practices.
The enzyme is intended for use in the production of α-cyclodextrins, which are specialty carbohydrates used in food and other applications. The panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use, paving the way for potential EU authorisation. The European Commission will now consider the opinion in its decision to include the enzyme in the Union list of approved food enzymes.