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 24 March 2021, the company AIDP Inc. (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place magnesium L-threonate on the Union market as a novel food. The applicant requested for the novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council intended for adults, excluding pregnant and lactating women. 

(4) On 24 March 2021, the applicant also made a request to the Commission for the protection of the following proprietary data: bioavailability study in rats, toxicological studies (in vitro bacterial reverse mutation assay, in vivo micronucleus test and toxicity studies) and a randomised, placebo-controlled human study.

(5) On 28 June 2021, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of magnesium L-threonate as a novel food. Furthermore, the Commission considered that magnesium L-threonate was to be considered as a source of magnesium in the context of Directive 2002/46/EC of the European Parliament and of the Council. Therefore, the Commission requested the Authority to evaluate, following the outcome of the novel food assessment, the safety and bioavailability of the novel food when added for nutritional purposes as a source of magnesium to food supplements.

(6) On 30 January 2024, the Authority adopted its scientific opinion on the ‘Safety of magnesium L-threonate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC’ in accordance with Article 11 of Regulation (EU) 2015/2283.

(7) In its scientific opinion, the Authority concluded that the novel food, magnesium L-threonate, is safe under the proposed conditions of use. The Authority also considered that the novel food is a source from which magnesium is bioavailable.

(8) Therefore, that scientific opinion gives sufficient grounds to establish that magnesium L-threonate, 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. 

(9) In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the bioavailability study in rats, the in vitro bacterial reverse mutation assay, the in vivo micronucleus test, and the randomised, placebo-controlled human study, without which it could not have assessed the novel food and reached its conclusion.

(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 bioavailability study in rats, the in vitro bacterial reverse mutation assay, the in vivo micronucleus test, and the randomised, placebo-controlled human study, 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 bioavailability study in rats, the in vitro bacterial reverse mutation assay, the in vivo micronucleus test, and the randomised, placebo-controlled human study should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place magnesium L-threonate 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 magnesium L-threonate 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) It is appropriate that the inclusion of magnesium L-threonate 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 line with the conditions of use of food supplements containing magnesium L-threonate as proposed by the applicant and assessed by the Authority, it is necessary to inform the consumers in that regard by appropriate labelling about the uses of food supplements containing magnesium L-threonate. 

(15) Magnesium L-threonate 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.

(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,