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)

• CELEX: Implementing Decision (EU) 2017/2375
• Articles: 5

Article 1

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.

Article 2

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

This Decision is addressed to Glycom A/S, Kogle Allé 4, 2970 Hørsholm, Denmark.

Schedules & Appendices

ANNEX I

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 II

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 ).