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)

• CELEX: Implementing Decision (EU) 2017/1281
• Articles: 5

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.

Schedules & Appendices

ANNEX I

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

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