Commission Implementing Decision (EU) 2017/1281 of 13 July 2017 authorising the placing on the market of L-ergothioneine as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 4844)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
The designation of L-ergothioneine authorised by this Decision on the labelling of the foodstuffs shall be ‘L-ergothioneine’.
This Decision is addressed to Tetrahedron, 14, avenue de l'Opéra, 75001 Paris, France.
ANNEX I SPECIFICATIONS OF L-ERGOTHIONEINE Definition Chemical name (IUPAC) (2S)-3-(2-thioxo-2,3-dihydro-1 H -imidazol-4-yl)-2-(trimethylammonio)-propanoate Chemical formula C 9 H 15 N 3 O 2 S Molecular mass 229,3 Da CAS No 497-30-3 IUPAC: International Union for Pure and Applied Chemistry Specifications Parameter Specification Method Appearance White powder Visual Optical rotation [α] D ≥ (+) 122° (c = 1, H 2 0) ( 1 ) 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 ( 2 ) ( 3 ) Lead < 3 ppm ICP/AES (Pb, Cd) Atomic fluorescence (Hg) Cadmium < 1 ppm Mercury < 0,1 ppm Microbiological specifications ( 2 ) Total viable aerobic count (TVAC) ≤ 1 × 10 3 CFU/g [Eur. Ph. 01/2011:50104] Total yeast and mould count (TYMC) ≤ 1 × 10 2 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. ( 1 ) Lit. [α] D = (+) 126,6° (c = 1, H 2 0) ( 2 ) Analyses conducted on each batch ( 3 ) Maximum levels in accordance with Commission Regulation (EC) No 1881/2006 ( OJ L 364, 20.12.2006, p. 5 ).
ANNEX II AUTHORISED USES OF L-ERGOTHIONEINE 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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.