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Safety evaluation of the food enzyme Phospholipase A from the genetically modified Trichoderma reesei strain RF8793

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Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.

Abstract

The food enzyme phospholipase A2 (phosphatidylcholine 2‐acylhydrolase) is produced with the genetically modified Trichoderma reesei strain RF8793 by AB Enzymes 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. The food enzyme is intended to be used in degumming of fats and oils and modified lecithin production from egg. Due to lack of data on the compositional parameters, total organic solids (TOS) values could not be calculated. For this reason, the representativeness of the batch used for toxicological examination could not be established and dietary exposure could not be calculated. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered to be low. As TOS values form the basis of toxicological and exposure assessments, the Panel is not in a position to conclude its assessment of the food enzyme phospholipase A2 produced with the genetically modified Trichoderma reesei strain RF8793.