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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
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.
This Decision is addressed to Jennewein Biotechnologie GmbH, Maarweg 32, 53619 Rheinbreitbach, Germany.
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 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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.