# 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), Division: Specifications of 2′-fucosyllactose liquid concentrate

Extent: E+W+S+N.I.

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

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Source: https://www.legislation.gov.uk/eudn/2017/2201/annex/I/division/2 (the official version)
Page: https://openlegislation.uk/eu-decision-2017-2201/annex-I/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.