A Food Enzyme Produced by Escherichia coli Strain SP-a Passed EFSA Safety Assessment

The food enzyme amidase (acylamide amidohydrolase, EC 3.5.1.4) is produced with the genetically modified Escherichia coli strain SP-a by c-LEcta GmbH. The genetic modifications did not give rise to safety concerns.

The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used for the hydrolysis of acrylamide in foods. Dietary exposure was estimated to be up to 0.478 mg total organic solids (TOS)/kg body weight (bw) per day in European populations.

The toxicity studies were carried out with a trehalose phosphorylase produced by E. coli strain PK-a. Based on the comparison of the genetic modifications of the two production strains, the raw materials and processes used to manufacture the food enzymes, the Panel considered the trehalose phosphorylase produced by E. coli strain PK-a as an acceptable surrogate test item for the toxicological studies.

Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1149 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2404.

A search for the homology of the amino acid sequence of the amidase 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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