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The EU evaluates the safety of α-amylase produced by the transgenic Bacillus subtilis strain AR-651

 foodmate 2023-02-21

On February 2023, 2, the European Food Safety Authority issued an opinion on the safety evaluation of a α-amylase (α‐amylase).

This food enzyme is known to be produced by the genetically modified Bacillus subtilis strain AR-651 and is intended for use in the baking process.

After evaluation, the Panel concluded that the risk of allergic and induced reactions from dietary exposure could not be ruled out under the intended conditions of use, but the likelihood of this occurring was low. Based on the data provided, the Panel concluded that this food enzyme does not pose a safety problem under the intended conditions of use. Some of the original articles are reported below:

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus subtilis strain AR-651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.19?mg TOS/kg body weight (bw) per day in European populations. The production strain carries known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel co nsiders that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found. The Panel considered that, under the intended co nditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

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The EU evaluates the safety of α-amylase produced by the transgenic Bacillus subtilis strain AR-651

The EU evaluates the safety of phospholipase A10 produced by the transgenic Streptomyces viasura strain AS-2

The EU identified six active substances that do not require MRL review

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