EFSA Confirms Safety of Genetically Modified Enzyme with No Health Risks

On December 17, 2024, the European Food Safety Authority (EFSA) published its opinion on the safety assessment of the food enzyme fructan β-fructosidase. This food enzyme is produced by the genetically modified strain of Trichoderma reesei, known as AR-577, and is primarily used in grain processing for the production of baked and non-baked grain-based products.

After a thorough evaluation, the expert panel concluded that the food enzyme does not pose any safety concerns under the intended conditions of use. This enzyme, known as β-d-fructofuranosidase (EC 3.2.1.80), is produced by AB Enzymes GmbH using the genetically modified strain AR-577. The genetic modification process did not result in any safety risks. Moreover, this food enzyme does not contain viable cells or DNA from the producing organism. Its main applications are in the processing of grains and other cereals for baked and non-baked grain-based products. It is estimated that daily dietary exposure for the European population could reach 0.181 mg total organic solids (TOS)/kg body weight (bw).

Genotoxicity tests showed no safety issues. A 90-day repeated-dose oral toxicity study in rats assessed systemic toxicity, determining a no observed adverse effect level (NOAEL) of 1000 mg TOS/kg bw—the highest dose tested—compared to the estimated dietary exposure level, which is at least 5495 times lower. Furthermore, a search for homology in the amino acid sequence of the food enzyme with known allergens revealed no matches. Although a known food allergen source was used in the manufacturing process, the expert panel believes that while the possibility of allergic reactions due to dietary exposure cannot be entirely ruled out, the likelihood is very low. Based on the provided data, the panel concluded that the food enzyme will not pose safety issues under the expected conditions of use.