N-Acetyl-D-neuraminic acid: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Infant and follow-on formulae as defined by Regulation (EU) No 609/2013 (1): 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 the table 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 (2): 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 (3): 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

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘N-acetyl-D-neuraminic acid’ Food supplements containing N-acetyl-D-neuraminic acid shall bear a statement that the food supplement should not be given to infants, young children and children under 10 years of age where they consume breast milk or other foods with added N-acetyl-D-neuraminic acid within the same twenty four hour period.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description:

N-Acetyl-D-neuraminic acid is a white to off-white crystalline powder

Definition:

Chemical name:

IUPAC names:

N-Acetyl-D-neuraminic acid (dihydrate)

5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid (dihydrate)

Synonyms:

Sialic acid (dihydrate)

Chemical formula:

C11H19NO9 (acid)

C11H23NO11 (C11H19NO9 * 2H2O) (dihydrate)

Molecular mass:

309,3 Da (acid)

345,3 (309,3 + 36,0) (dihydrate)

CAS No.:

131-48-6 (free acid)

50795-27-2 (dihydrate)

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, sulphated: < 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 criteria:

Salmonella: Absence in 25 g

Aerobic mesophilic total count:< 500 CFU/g

Enterobacteriaceae: Absence in 10 g

Cronobacter (Enterobacter) sakazakii: Absence in 10 g

Listeria monocytogenes: Absence 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.

Notes

(1) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

(2) Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5, ELI: http://data.europa.eu/eli/reg_impl/2014/828/oj).

(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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