# Commission Implementing Decision (EU) 2017/2375 of 15 December 2017 authorising the placing on the market of N-acetyl-D-neuraminic acid as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 8431) (Only the English text is authentic), Division: Specifications:

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

Parameter
Specifications
Description
white to off-white crystalline powder
pH (20 °C, 5 % solution)
1,7 – 2,5
N-Acetyl-D-neuraminic acid (dihydrate)
> 97,0 %
Water (dihydrate calculates to 10,4 %)
≤ 12,5 % (w/w)
Ash, sulfated
< 0,2 % (w/w)
Acetic acid (as free acid and/or sodium acetate)
< 0,5 % (w/w)
Heavy Metals
Iron
< 20,0 mg/kg
Lead
< 0,1 mg/kg
Residual proteins
< 0,01 % (w/w)
Residual solvents
2-Propanol
< 0,1 % (w/w)
Acetone
< 0,1 % (w/w)
Ethyl acetate
< 0,1 % (w/w)
Microbiological specifications
Salmonella
Absent in 25 g
Aerobic mesophilic total count
< 500 CFU/g
Enterobacteriaceae
Absent in 10 g
Cronobacter (Enterobacter) sakazakii
Absent in 10 g
Listeria monocytogenes
Absent in 25 g
Bacillus cereus
< 50 CFU/g
Yeasts
< 10 CFU/g
Moulds
< 10 CFU/g
Residual endotoxins
< 10 EU/mg
CFU: Colony Forming Units; EU: Endotoxin Units.

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Source: https://www.legislation.gov.uk/eudn/2017/2375/annex/I/division/2 (the official version)
Page: https://openlegislation.uk/eu-decision-2017-2375/annex-I/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.