BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 has established a Union list of novel foods.
(3) On 28 December 2018, the company ABC Kroos BV (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place protein concentrate from Lemna gibba and Lemna minor on the Union market as a novel food. The applicant requested for the novel food to be used as a food in powdered drink bases, cereal bars, bread and rolls, noodles for the general population and in food supplements, as defined in Directive 2002/46/EC of the European Parliament and of the Council, for the adult population only.
(4) On 28 December 2018, the applicant also made a request to the Commission for the protection of the following proprietary data: compositional data, stability data, an ileal digestion analysis, a proteomic analysis, endophytic bacteria screening analyses, a bacterial reverse mutation test and an in vitro micronucleus test.
(5) On 13 May 2021, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of protein concentrate from Lemna gibba and Lemna minor as a novel food.
(6) On 28 February 2023, the Authority adopted its scientific opinion on the ‘Safety of water lentil protein concentrate from a mixture of Lemna gibba and Lemna minor as a novel food pursuant to Regulation (EU) 2015/2283’ in accordance with Article 11 of Regulation (EU) 2015/2283. 
(7) In its scientific opinion, the Authority concluded that the novel food, protein concentrate from Lemna gibba and Lemna minor, is safe under the proposed conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that protein concentrate from Lemna gibba and Lemna minor, under the proposed conditions of use, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.
(8) In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the compositional data, stability data, the ileal digestion analysis, the proteomic analysis, the endophytic bacteria screening analyses, the bacterial reverse mutation test and the in vitro micronucleus test, without which it could not have assessed the novel food and reached its conclusion.
(9) It is appropriate that the inclusion of protein concentrate from Lemna gibba and Lemna minor in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. In this regard, in line with the conditions of use of food supplements containing protein concentrate from Lemna gibba and Lemna minor as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers through the use of appropriate labelling that food supplements containing protein concentrate from Lemna gibba and Lemna minor should only be consumed by adults. The Authority in its opinion also noted that intake of the novel food may lead to intake of phylloquinone (vitamin K1) up to 480 μg/day for adults (160 μg/day from food supplements) and may constitute a risk for patients on anticoagulant medication. Therefore, where the final product contains a quantity of vitamin K that is considered significant in accordance with point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council, the nutrition declaration shall indicate the quantity of vitamin K.
(10) The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.
(11) The applicant declared that it held proprietary and exclusive rights of reference to the compositional data, stability data, the ileal digestion analysis, the proteomic analysis, the endophytic bacteria screening analyses, the bacterial reverse mutation test and the in vitro micronucleus test at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data.
(12) The Commission assessed all the information provided by the applicant and considered that it has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the compositional data, the stability data, the ileal digestion analysis, the proteomic analysis, the endophytic bacteria screening analyses, the bacterial reverse mutation test and the in vitro micronucleus test should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place protein concentrate from Lemna gibba and Lemna minor on the market within the Union during a period of five years from the entry into force of this Regulation.
(13) However, restricting the authorisation of protein concentrate from Lemna gibba and Lemna minor and the reference to the data contained in the applicant’s file for their sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.
(14) Protein concentrate from Lemna gibba and Lemna minor should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(15) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,