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The EU evaluates the safety of phospholipase A2 produced by the transgenic Streptomyces viasura strain AS-10

 foodmate 2023-02-03

On February 1, 2023, the European Food Safety Authority issued an opinion on the safety evaluation of a food enzyme phospholipase A2.

This food enzyme is produced from the genetically modified Streptomyces viasura strain AS-10 and is intended for use in egg processing, baking processes, degumming of fats and oils, and milk processing to produce cheese.

After evaluation, the Panel concluded that the risk of allergic reactions and induced reactions through dietary exposure could not be ruled out under the intended conditions of use, but that the likelihood of such occurrence was low. Based on the data provided, the Panel concludes that the 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 phospholipase A2 (phosphatidylcholine 2-acylhydrolase EC 3.1.1.4) is produced with the genetically modified Streptomyces violaceoruber strain AS-10 by Nagase (Europa) GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in four food manufacturing processes, i.e. egg processing, baking processes, degumming of fats and oils and milk processing for cheese production. Since residual amounts of total organic solids (TOS) are removed in degumming of fats and oils, dietary exposure was calculated o nly for the remaining three food manufacturing processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.41 mg TOS/kg body weight (bw) per day in European populations. 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 191.2 mg TOS/kg bw per day, the mid-dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure above 460. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches 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 concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

phospholipase

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