L-ergothioneine: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Alcohol-free beverages: 0,025 g/kg
• Milk-based drinks: 0,025 g/kg
• ‘Fresh’ milk products(*): 0,040 g/kg
• Cereal bars: 0,2 g/kg
• Chocolate confectionery: 0,25 g/kg
• Food supplements as defined in Directive 2002/46/EC: 30 mg/day for general population (excluding pregnant and lactating women) 20 mg/day for children older than 3 years
• (*) When used in milk products L-ergothioneine may not replace in whole or in part, any milk constituent

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘L-ergothioneine’

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Definition

Chemical name (IUPAC): (2S)-3-(2-thioxo-2,3-dihydro-1H-imidazol-4-yl)-2-(trimethylammonio)-Propanoate

Chemical formula: C9H15N3O2S

Molecular mass: 229,3 Da

CAS No.: 497-30-3

Parameter

Specification

Method

Appearance

White powder

Visual

Optical rotation

[α]D ≥ (+) 122° (c = 1, H2O)a)

Polarimetry

Chemical purity

≥ 99,5 %

≥ 99,0 %

HPLC [Eur. Ph. 2,2.29]

1H-NMR

Identification

Compliant with the structure

C: 47,14 ± 0,4 %

H: 6,59 ± 0,4 %

N: 18,32 ± 0,4 %

1H-NMR

Elemental analysis

Total residual solvents

(methanol, ethyl acetate, isopropanol, ethanol)

[Eur. Ph. 01/2008:50400]

< 1 000 ppm

Gas chromatography

[Eur. Ph. 01/2008:20424]

Loss on drying

Internal standard < 0,5 %

[Eur. Ph. 01/2008:20232]

Impurities

< 0,8 %

HPLC/GPC or 1H-NMR

Heavy metals b) c)

Lead

< 3,0 ppm

ICP/AES

Cadmium

< 1,0 ppm

(Pb, Cd)

Mercury

< 0,1 ppm

Atomic fluorescence (Hg)

Microbiological specifications b)

Total viable aerobic count (TVAC)

≤ 1 x 103 CFU/g

[Eur. Ph. 01/2011:50104]

Total yeast and mould count (TYMC)

≤ 1 x 102 CFU/g

Escherichia coli

Absence in 1 g

Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy;

CFU: colony-forming units.

a) Lit. [α]D = (+) 126,6o (c = 1, H2O)

b) Analyses conducted on each batch

c) Maximum levels in accordance with Regulation (EC) No 1881/2006

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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