# 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), Division: Specifications

Extent: E+W+S+N.I.

Lit. [α]D = (+) 126,6° (c = 1, H20)
Analyses conducted on each batch
Maximum levels in accordance with Commission Regulation (EC) No 1881/2006 (OJ L 364, 20.12.2006, p. 5).
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.
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

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Source: https://www.legislation.gov.uk/eudn/2017/1281/annex/I/division/2 (the official version)
Page: https://openlegislation.uk/eu-decision-2017-1281/annex-I/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.