
Article 1 
Without prejudice to Directive 2002/46/EC, L-ergothioneine as specified in Annex I may be placed on the Union market as a novel food ingredient to be used in food supplements intended for the general population, excluding infants and young children, and pregnant and lactating women, for the uses defined and at the maximum levels established in Annex II.
Article 2 
The designation of L-ergothioneine authorised by this Decision on the labelling of the foodstuffs shall be ‘L-ergothioneine’.
Article 3 
This Decision is addressed to Tetrahedron, 14, avenue de l'Opéra, 75001 Paris, France.
Done at Brussels, 13 July 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX I

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
IUPAC: International Union for Pure and Applied Chemistry


Parameter Specification Method
Appearance White powder Visual
Optical rotation [α]D ≥ (+) 122° (c = 1, H20) Polarimetry
Chemical purity ≥ 99,5 % HPLC [Eur. Ph. 2.2.29]
≥ 99 % 1H-NMR
Identification Compliant with the structure 1H-NMR
C: 47,14 ± 0,4 % 
H: 6,59 ± 0,4 % 
N: 18,32 ± 0,4 % 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
Lead < 3 ppm ICP/AES(Pb, Cd)Atomic fluorescence (Hg)
Cadmium < 1 ppm
Mercury < 0,1 ppm
Microbiological specifications
Total viable aerobic count (TVAC) ≤ 1 × 103 CFU/g [Eur. Ph. 01/2011:50104]
Total yeast and mould count (TYMC) ≤ 1 × 102 CFU/g
Escherichia coli Absent 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.

ANNEX II

Food category Maximum levels
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