Article 1
Open ↗N -acetyl-D-neuraminic acid as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II to this Decision.
Source
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)
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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗1. The designation of N -acetyl-D-neuraminic acid authorised by this Decision on the labelling of the foodstuffs shall be ‘ N -acetyl-D-neuraminic acid’. 2. Food supplements containing N -acetyl-D-neuraminic acid shall be labelled in line with the presentation requirements applied under Regulation (EU) No 1169/2011 with 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.
Article 3
Open ↗This Decision is addressed to Glycom A/S, Kogle Allé 4, 2970 Hørsholm, Denmark.
Supplementary provisions
ANNEX ISupplementary provisions
Open ↗ANNEX I SPECIFICATIONS OF N -ACETYL-D-NEURAMINIC ACID (DIHYDRATE) 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 C 11 H 19 NO 9 (acid) C 11 H 23 NO 11 (C 11 H 19 NO 9 *2H 2 O) (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) Description: N -Acetyl-D-neuraminic acid is a white to off-white crystalline powder. Specifications: 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.
ANNEX IISupplementary provisions
Open ↗ANNEX II Authorised uses of N -Acetyl-D-neuraminic acid 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 ( 1 ) 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 ).
Other acts of the same type
2014/423/EU: Commission Implementing Decision of 1 July 2014 authorising the placing on the market of citicoline as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 4252)2014/424/EU: Commission Implementing Decision of 1 July 2014 authorising the placing on the market of rapeseed protein as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 4256)2014/425/EU: Commission Decision of 1 July 2014 authorising Slovakia and the United Kingdom to derogate from certain common aviation safety rules pursuant to Article 14(6) of Regulation (EC) No 216/2008 of the European Parliament and of the Council (notified under document C(2014) 4344) Text with EEA relevance2014/426/EU: Commission Decision of 1 July 2014 authorising the United Kingdom to derogate from certain common aviation safety rules pursuant to Article 14(6) of Regulation (EC) No 216/2008 of the European Parliament and of the Council (notified under document C(2014) 4355) Text with EEA relevanceCouncil Decision 2014/400/CFSP of 26 June 2014 extending the mandate of the European Union Special Representative in KosovoCouncil Decision 2014/401/CFSP of 26 June 2014 on the European Union Satellite Centre and repealing Joint Action 2001/555/CFSP on the establishment of a European Union Satellite Centre2014/403/EU: Commission Implementing Decision of 26 June 2014 on granting derogations to Member States with respect to the transmission of statistics pursuant to Regulation (EU) No 549/2013 of the European Parliament and of the Council concerning the European system of national and regional accounts in the European Union (notified under document C(2014) 4164) Text with EEA relevance2014/431/EU: Commission Implementing Decision of 26 June 2014 concerning formats for reporting on the national programmes for the implementation of Council Directive 91/271/EEC (notified under document C(2014) 4208)2014/402/EU: Commission Implementing Decision of 25 June 2014 regarding restrictions of authorisations of biocidal products containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2014) 4167) Text with EEA relevance2014/765/EU: Commission Decision of 25 June 2014 on the State aid No SA.20949 (C 23/06) — Poland — Technologie Buczek (notified under document C(2014) 4099) Text with EEA relevance2014/791/EU: Commission Decision of 25 June 2014 on State aid SA.20350 — (C 17/08) (ex NN 1/06) implemented by the Czech Republic for several regional bus service operators in the Ústí Region (notified under document C(2014) 4081) Text with EEA relevance2014/392/EU: Commission Implementing Decision of 24 June 2014 on setting-up the Central European Research Infrastructure Consortium (CERIC-ERIC)
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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