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Safety evaluation of the food enzyme catalase from the genetically modified published by EFSA

European Union

Aug 19, 2021

On August 12, EFSA published a Safety evaluation of the food enzyme catalase from the genetically modified Aspergillus niger strain DP-Azw58.

The food enzyme catalase (hydrogen‐peroxide:hydrogen‐peroxide oxidoreductase; EC 1.11.1.6) is produced with the genetically modified Aspergillus niger strain DP‐Azw58 by Danisco US, Inc. The Panel identified a no observed adverse effect level of 1,288 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1.3 × 106. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. 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 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.

For further information (in English), click on the Link

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