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 15 August 2019, the company Kemin Foods L.C. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place beta-glucan from Euglena gracilis microalgae (paramylon) on the Union market as a novel food. The applicant requested for beta-glucan from Euglena gracilis microalgae (paramylon) to be used in a number of foods as follows: cereal bars, total diet replacement for weight control as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council, food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council, yoghurt, yoghurt drinks, beverages based on fruit and/or vegetable juices, soft drinks and meal replacements for weight control (as drinks). Subsequently, on 25 January 2024, the applicant modified the initial request in the application on the use of Euglena gracilis microalgae to exclude use in yoghurt, yoghurt drinks, beverages based on fruit and/or vegetable juices, soft drinks and meal replacements for weight control (as drinks). The applicant also modified the initial request in the application on the use of beta-glucan from Euglena gracilis microalgae in food supplements to exclude infants and children under three years of age.
(4) On 15 August 2019, the applicant also made a request to the Commission for the protection of proprietary data, namely, in vitro fermentation studies, a bacterial reverse mutation test, an in vivo micronucleus test, an acute toxicity study in rats, a 14-day dietary toxicity/palatability study in rats, a 90-day toxicity studies in rats, a 90-day clinical trial, a particle size analysis, the characterization and comparison of paramylon to yeast products, a study on the effect of mechanical grinding on paramylon structure and particle size, stability reports, a mammalian erythrocyte micronucleus test and a repeated dose (90-day) oral toxicity study in rats.
(5) On 23 April 2021, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of beta-glucan from Euglena gracilis microalgae as a novel food.
(6) On 28 March 2023, the Authority adopted its scientific opinion on the ‘Safety of paramylon 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, beta-glucan from Euglena gracilis microalgae, is safe under the proposed conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that beta-glucan from Euglena gracilis microalgae, when used 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 (particle size analysis, the study on the effect of mechanical grinding on paramylon structure and particle size (Annex D), stability reports (Annex E), a transmission electron microscopy report (Annex D), a 90-day subchronic toxicity study (Annex I, Eurofins Advinus Limited, 2020, unpublished) without which it could not have assessed the novel food and reached its conclusion.
(9) 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.
(10) The applicant declared that it held proprietary and exclusive rights of reference to the particle size analysis, the study on the effect of mechanical grinding on paramylon structure and particle size (Annex D), stability reports (Annex E), a transmission electron microscopy report (Annex D) and repeated dose (90-day) oral toxicity study in rats (Annex I, Eurofins Advinus Limited, 2020, unpublished), at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data.
(11) 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 particle size analysis, the study on the effect of mechanical grinding on paramylon structure and particle size (Annex D), the stability reports (Annex E), the transmission electron microscopy report (Annex D) and the repeated dose (90-day) oral toxicity study in rats (Annex I, Eurofins Advinus Limited, 2020, unpublished) should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place beta-glucan from Euglena gracilis microalgae on the market within the Union during a period of 5 years from the entry into force of this Regulation.
(12) However, restricting the authorisation of beta-glucan from Euglena gracilis microalgae and the reference to the relevant data contained in the applicant’s file to the exclusive use by them 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.
(13) It is appropriate that the inclusion of beta-glucan from Euglena gracilis microalgae as a novel food 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 beta-glucan from Euglena gracilis microalgae as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers by appropriate labelling about the uses of food supplements containing beta-glucan from Euglena gracilis microalgae.
(14) Beta-glucan from Euglena gracilis microalgae 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,