COMMISSION IMPLEMENTING DECISION (EU) 2017/2375
of 15 December 2017
authorising the placing on the market of
(Only the English text is authentic)
Article 1
Article 2
Article 3
ANNEX I
Chemical name |
IUPAC names:
Synonyms: Sialic acid (dihydrate) |
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Chemical formula |
C11H19NO9 (acid) C11H23NO11 (C11H19NO9 *2H2O) (dihydrate) |
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Molecular mass |
309,3 Da (acid) 345,3 (309,3 + 36,0) (dihydrate) |
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CAS No. |
131-48-6 (free acid) 50795-27-2 (dihydrate) |
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 |
ANNEX II
Food category |
Maximum level |
Infant and follow-on formulae as defined by Regulation (EU) No 609/2013 |
0,05 g/L of reconstituted formula |
Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 |
0,05 g/kg for solid foods |
Foods for special medical purposes for infants and young children as defined by Regulation (EU) No 609/2013 |
In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than the maximum levels specified for the category mentioned in Annex II corresponding to the products, |
Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013 |
0,2 g/L (drinks) 1,7 g/kg (bars) |
Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014(1) |
1,25 g/kg |
Unflavoured pasteurised and sterilised (including UHT) milk-based products |
0,05 g/L |
Unflavoured fermented milk-based products, heat treated after fermentation, flavoured fermented milk products including heat-treated products |
0,05 g/L (beverages) 0,4 g/kg (solids) |
Dairy analogues, including beverage whiteners |
0,05 g/L (beverages) 0,25 g/kg (solids) |
Cereal bars |
0,5 g/kg |
Table top sweeteners |
8,3 g/kg |
Fruit and vegetable-based drinks |
0,05 g/L |
Flavoured drinks |
0,05 g/L |
Speciality coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions |
0,2 g/kg |
Food supplements as defined in Directive 2002/46/EC |
300 mg/day for general population older than 10 years 55 mg/day for infants 130 mg/day for young children 250 mg/day for children between 3 to 10 years of age |