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)
(Only the English text is authentic)
Article 1
Article 2
Article 3
ANNEX I
SPECIFICATIONS OF L-ERGOTHIONEINE
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 |
IUPAC: International Union for Pure and Applied Chemistry |
Specifications
Parameter |
Specification |
Method |
Appearance |
White powder |
Visual |
Optical rotation |
[α]D ≥ (+) 122° (c = 1, H20)(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 × 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
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 |