Commission Implementing Regulation (EU) 2024/1037 of 9 April 2024 authorising the placing on the market of monosodium salt of L-5-methyltetrahydrofolic acid as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2024/1037
• Articles: 5

Article 1

1.   Monosodium salt of L-5-methyltetrahydrofolic acid is authorised to be placed on the market within the Union.

Monosodium salt of L-5-methyltetrahydrofolic acid shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company Merck & Cie KmG  ( 16 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 30 April 2024, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Merck & Cie KmG.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of Merck & Cie KmG.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Monosodium salt of L-5-methyltetrahydrofolic acid

Specified food category

Maximum levels

(expressed as folic acid)

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “Monosodium salt of L-5-methyltetrahydrofolic acid (folic acid)”.

2.

The labelling of food supplements containing monosodium salt of L-5-methyltetrahydrofolic acid shall bear a statement that the food supplements should not be consumed by infants and young children (children under 3 years of age)

Authorised on 30 April 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Merck & Cie KmG, Im Laternenacker 5, 8200 Schaffhausen, Switzerland. During the period of data protection, the novel food monosodium salt of L-5-methyltetrahydrofolic acid is authorised for placing on the market within the Union only by Merck & Cie KmG, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Merck & Cie KmG.

End date of the date protection: 30 April 2029.’

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

In accordance with Directive 2002/46/EC

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Food fortified in accordance with Regulation (EC) No 1925/2006

In accordance with Regulation (EC) No 1925/2006

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food

Specification

‘ Monosodium salt of L-5-methyltetrahydrofolic acid

Description/Definition:

The novel food is produced by chemical synthesis and consists of L-5-methyltetrahydrofolic acid.

Molecular formula: C 20 H 24 N 7 NaO 6

Chemical name: N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]-l-glutamic acid

CAS number: 2246974-96-7

Molecular weight: 481,44 g/mol

Characteristics/composition:

Appearance: White to yellow or beige powder

Assay & related compounds: Assay 5-MeTHFA-Na on dry basis: > 95 %; Sum of folate-related substances: ≤ 2,5

Sodium: 4 %–5 % w/w

Water: ≤ 1,0 %

Residual solvents: Ethanol: ≤ 0,5 %; Isopropanol: ≤ 0,5 %

Diastereomeric purity: (6R)-Mefolinate: ≤ 1,0 % area

Elemental impurities:

Boron: ≤ 10 mg/kg

Platinum: ≤ 10 mg/kg (for foods intended for infants and young children and food supplements intended for pregnant women then ≤ 2 mg/kg)

Arsenic: ≤ 1,5 mg/kg

Cadmium: ≤ 0,5 mg/kg

Lead: ≤ 1,0 mg/kg

Mercury: ≤ 1,5 mg/kg (for foods intended for infants and young children and food supplements intended for pregnant women then ≤ 1 mg/kg)

Microbiological criteria:

Total aerobic microbial count: ≤ 100 CFU/g

Total yeast and moulds count: ≤ 100 CFU/g

E. coli: Not detected in 10 g

Abbreviations: CFU: colony forming unit; IR: infra-red; MeTHFA: methyltetrahydrofolic acid.’