
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.
Done at Brussels, 27 November 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX I
Definition:

Chemical name α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranoside
Chemical formula C18H32O15
Molecular mass 488,44 Da
CAS No. 41263-94-9Description: 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.


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 M1 ≤ 0,025 μg/kg
Microbial Parameters Total Plate Count (TPC) ≤ 104 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

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 M1 ≤ 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

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.