Suchergebnisse

Abstract
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.

Abstract The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food. Furthermore, information needed in sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, toxicological information, nutritional information and allergenicity is also described. The applicant should integrate and interpret the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they are to be discussed in relation to the anticipated intake of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of Schizochytrium sp. oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single‐cell microalga. The strain FCC‐ 3204, used by the applicant (Fermentalg), belongs to the species Schizochytrium limacinum. The NF, an oil rich in docosahexaenoic acid (DHA), is obtained from microalgae after enzymatic lysis. The applicant proposed to use the NF in infant formulae (IF) and follow‐on formulae (FOF). The use level defined by the applicant was derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The intake of DHA resulting from the use of the NF in IF and FOF is not expected to pose safety concerns. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only'. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.