Commission Implementing Decision (EU) 2017/2201 of 27 November 2017 authorising the placing on the market of 2′-fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 7662)

• CELEX: Implementing Decision (EU) 2017/2201
• Articles: 5

Article 1

Without prejudice to Regulation (EU) No 609/2013, 2′-fucosyllactose powder and liquid concentrate as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient for the uses defined and at the maximum level established in Annex II to this Decision.

Article 2

The designation of 2′-fucosyllactose powder and liquid concentrate authorised by this Decision on the labelling of the foodstuffs shall be ‘2′-fucosyllactose’ for the powder and for the liquid concentrate.

Article 3

This Decision is addressed to Jennewein Biotechnologie GmbH, Maarweg 32, 53619 Rheinbreitbach, Germany.

Schedules & Appendices

ANNEX I

ANNEX I

SPECIFICATIONS OF 2′-FUCOSYLLACTOSE

Definition:

Chemical name

α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranoside

Chemical formula

C 18 H 32 O 15

Molecular mass

488,44 Da

CAS No.

41263-94-9

Description: 2′-fucosyllactose powder produced with a genetically modified strain of Escherichia coli BL21 is a white to ivory powder that is derived from 2′-fucosyllactose liquid concentrate by spray drying. The 2′-fucosyllactose liquid concentrate is a colourless to slight yellow clear 45 % w/v ± 5 % w/v aqueous solution.

Specifications of 2′-fucosyllactose powder

Specification Parameter

Limits

Physical parameter

White to ivory colour

Chemical analysis

2′-fucosyllactose

≥ 90 %

Lactose

≤ 5 %

3-fucosyllactose

≤ 5 %

Difucosyllactose

≤ 5 %

Fucosylgalactose

≤ 3 %

Glucose

≤ 3 %

Galactose

≤ 3 %

Fucose

≤ 3 %

GMO detection

Negative

Water content

≤ 9,0 %

Protein content

≤ 100 μg/g

Total Ash

≤ 0,5 %

Contaminants

Lead

≤ 0,02 mg/kg

Arsenic

≤ 0,2 mg/kg

Cadmium

≤ 0,1 mg/kg

Mercury

≤ 0,5 mg/kg

Aflatoxin M 1

≤ 0,025 μg/kg

Microbial Parameters

Total Plate Count (TPC)

≤ 10 4 CFU/g

Enterobacteria /Coliforms

absent in 11 g

Yeast and Mould

≤ 100 CFU/g

Salmonella spp.

Negative/100 g

Cronobacter spp.

Negative/100 g

Endotoxins

≤ 100 EU/g

CFU: Colony Forming Units; EU: Endotoxin Units

Specifications of 2′-fucosyllactose liquid concentrate

Specification Parameter

Limits

Physical parameter

Colourless to slightly yellow, clear solution

Solids content

45 % w/v (+/– 5 % w/v) dry matter in water

Chemical analysis

2′-fucosyllactose

≥ 90 %

Lactose

≤ 5 %

3-fucosyllactose

≤ 5 %

Difucosyllactose

≤ 5 %

Fucosylgalactose

≤ 3 %

Glucose

≤ 3 %

Galactose

≤ 3 %

Fucose

≤ 3 %

GMO detection

Negative

Protein content

≤ 100 μg/g

Total Ash

≤ 0,5 %

Contaminants

Lead

≤ 0,02 mg/kg

Arsenic

≤ 0,2 mg/kg

Cadmium

≤ 0,1 mg/kg

Mercury

≤ 0,5 mg/kg

Aflatoxin M 1

≤ 0,025 μg/kg

Microbial Parameters

Total Plate Count (TPC)

≤ 5 000 CFU/g

Enterobacteria /Coliforms

absent in 11 g

Yeast and Mould

≤ 50 CFU/g

Salmonella spp.

Negative/200 ml

Cronobacter spp.

Negative/200 ml

Endotoxins

≤ 100 EU/ml

CFU: Colony Forming Units; EU: Endotoxin Units

ANNEX II

ANNEX II

Authorised uses of 2′-fucosyllactose powder and liquid concentrate

Food category

Maximum level

Infant formulae and follow-on formulae

1,2 gram 2′-fucosyllactose per litre final product ready for use marketed as such or reconstituted as instructed by the manufacturer.