Scientific and technical assistance report on the evaluation of the safety of Lemna gibba and Lemna minor whole plant material as a novel food

EFSA was asked by the European Commission to provide scientific assistance with respect to the EFSA scientific opinion on “Safety of Lemna minor and Lemna gibba whole plant material as a novel food (NF) pursuant to Regulation (EU) 2015/2283”, which was adopted in 2022. In that Scientific Opinion, the Panel concluded that the NF, considering its proposed uses and the content of manganese as compared to the content of manganese normally present in other leafy vegetables, may be of safety concern and, therefore, the safety of the NF could not be established. In the context of this mandate, EFSA was requested to evaluate whether the additional information provided by the applicant addresses the increase of manganese intake from the NF, which was considered substantial as compared to the background manganese dietary intake. The applicant provided new data showing that by reducing the manganese concentrations in the cultivation medium, the manganese content in Lemna gibba does not exceed the manganese content in spinach. EFSA emphasizes that the rest of the production process should not deviate from what was reported and assessed in the original NF opinion. Data assessed in 2022 along with data provided for the current assessment show that under the same cultivation conditions Lemna gibba and Lemna minor display similar manganese contents. EFSA acknowledges that the composition of the NF should adhere to the specification levels established in 2022. However, regarding manganese, given the contents observed following these latest production processes, EFSA considers that the maximum specification level for manganese in the NF should be set at 6 mg/kg fresh weight. Based on the additional data provided, EFSA concludes that the contents of manganese in the NF have been reduced to levels not exceeding those in other leafy vegetables.