(Utkast) Kommisjonsforordning (EU) .../... om endring av vedlegg II til europaparlaments- og rådsforordning (EF) nr. 1925/2006 og vedlegg II til europaparlaments- og rådsdirektiv 2002/46/EF med hensyn til mononatriumsalt av L-5-metyltetrahydrofolsyre som kilde til folat brukt i produksjon av kosttilskudd
Berikingsforordningen og Kosttilskuddsdirektivet: endringsbestemmelser om mononatriumsalt av L-5-metyltetrahydrofolsyre
(Draft) Commission Regulation (EU) .../... amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards monosodium salt of L-5-methyltetrahydrofolic acid as a source of folic acid added to foods and as a source of folate used in the manufacture of food supplements
Utkast til kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering og publisert i EUs komitologiregister 21.7.2025
Bakgrunn
(fra kommisjonsforordningen)
(1) Annexes I and II to Regulation (EC) No 1925/2006 establish the list of vitamin and mineral substances which may be added to foods and the forms in which they may be added.
(2) Annexes I and II to Directive 2002/46/EC establish the list of vitamin and mineral substances which may be used in the manufacture of food supplements and the forms in which they may be added.
(3) On 26 October 2023, the European Food Safety Authority (‘the Authority’) issued a scientific opinion in the framework of the procedure for authorisation of a novel food pursuant to Regulation (EU) 2015/2283. In the mandate, the Authority was asked to deliver an opinion on the safety of monosodium salt of l-5-methyltetrahydrofolic acid (5-MTHF) as a novel food and to address the bioavailability of folate from this source in the context of Directive 2002/46/EC, Regulation (EU) No 609/2013[1] and Regulation (EC) No 1925/2006. The Authority in the opinion concluded that monosodium salt of L-5-methyltetrahydrofolic acid is safe under the proposed conditions of use and that it is a source from which folate is bioavailable.
(4) Based on the favourable opinion of the Authority, Commission Implementing Regulation (EU) 2024/1037[2] authorised, in accordance with Regulation (EU) 2015/2283, the placing on the market of monosodium salt of L-5-methyltetrahydrofolic acidas a novel food for use in certain foods and food supplements, subject to specific conditions.
(5) The Commission considers that the Authority’s opinion gives sufficient grounds to establish that the use of monosodium salt of L-5-methyltetrahydrofolic acid as authorized by Implementing Regulation (EU) 2024/1037, is not of safety concern as a source of folic acid when added to foods and as a source of folate when used in the manufacture of food supplements.
(6) Based on the Authority’s favourable opinion and on the authorisation as a novel food, monosodium salt of L-5-methyltetrahydrofolic acid should be included in Annex II to Directive 2002/46/EC as a form of folate and in Annex II to Regulation (EC) No 1925/2006 as a form of folic acid.
(7) The Advisory Group on the Food Chain and Animal and Plant Health was consulted, and its comments were taken into consideration.
(8) Annex II to Directive 2002/46/EC and Annex II to Regulation (EC) No 1925/2006 should therefore be amended accordingly.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,