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 12 November 2020, the company Merck & Cie KmG (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place monosodium salt of L-5-methyltetrahydrofolic acid 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, food intended for infants and young children (infant formula and follow-on formula; processed cereal-based food and baby food), food for special medical purposes and total diet replacement for weight control as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council, and fortified foods as defined in Regulation (EC) No 1925/2006 of the European Parliament and of the Council. Subsequently, on 13 February 2024, the applicant modified the initial request in the application on the use of monosodium salt of L-5-methyltetrahydrofolic acid in food supplements to exclude infants and children under three years of age.
(4) On 12 November 2020, the applicant also made a request to the Commission for the protection of the following proprietary data: analytical reports and methods of validation regarding the novel food identification, characterisation, solubility, particle size and distribution, a dissolution study, stability studies, a study on bioavailability, repeated-dose toxicity and genotoxicity studies and a HACCP plan.
(5) On 28 June 2021, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of monosodium salt of L-5-methyltetrahydrofolic acid as a novel food. Furthermore, the Commission considered that the novel food, monosodium salt of l-5-methyltetrahydrofolic acid, should be considered as a source of folate in the context of Directive 2002/46/EC of the European Parliament and of the Council, Regulation (EU) No 609/2013 of the European Parliament and of the Council and Regulation (EC) No 1925/2006 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 folate to food supplements, food intended for infants and young children (infant formula and follow-on formula; processed cereal-based food and baby food), food for special medical purposes, total diet replacement for weight control, fortified foods and food for the general population.
(6) On 26 October 2023, the Authority adopted its scientific opinion on the ‘Safety of monosodium salt of L-5-methyltetrahydrofolic acid as a novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of folate from this source in the context of Directive 2002/46/EC, Regulation (EU) No 609/2013 and Regulation (EC) No 1925/2006’ in accordance with Article 11 of Regulation (EU) 2015/2283. (7) In its scientific opinion, the Authority concluded that the novel food, monosodium salt of L-5-methyltetrahydrofolic acid, is safe under the applicant’s proposed conditions of use, as long as the combined intake of the novel food and other sources of folate under their authorised conditions of use is below the tolerable upper intake levels (UL) established for the different age groups of the general population. The Authority also considers that the novel food is a source from which folate is bioavailable. Therefore, that scientific opinion gives sufficient grounds to establish that monosodium salt of L-5-methyltetrahydrofolic acid, 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 analytical reports and methods of validation regarding the novel food identification, characterisation, solubility, particle size and distribution, the dissolution study, the stability studies, the study on bioavailability, the repeated-dose toxicity and the genotoxicity studies and the HACCP plan, 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 analytical reports and methods validation regarding the novel food identification, characterisation, solubility, particle size and distribution, the dissolution study, the stability studies, the study on bioavailability, the repeated-dose toxicity and the genotoxicity studies and the HACCP plan, 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 analytical reports and methods validation regarding the novel food identification, characterisation, solubility, particle size and distribution, the dissolution study, the stability studies, the study on bioavailability, the repeated-dose toxicity and genotoxicity studies and the HACCP plan should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place monosodium salt of L-5-methyltetrahydrofolic acid on the market within the Union during a period of five years from the entry into force of this Regulation.
(12) However, restricting the authorisation of monosodium salt of L-5-methyltetrahydrofolic acid 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.
(13) It is appropriate that the inclusion of monosodium salt of L-5-methyltetrahydrofolic acid 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.
(14) Monosodium salt of L-5-methyltetrahydrofolic acid 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,