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)
(Only the German text is authentic)
Article 1
Article 2
Article 3
ANNEX I
SPECIFICATIONS OF 2′-FUCOSYLLACTOSE
Chemical name |
α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranoside |
Chemical formula |
C18H32O15 |
Molecular mass |
488,44 Da |
CAS No. |
41263-94-9 |
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 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 |
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 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 |
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. |