3'-Sialyllactose (3'-SL) sodium salt (microbial source): 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:

• Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products: 0,25 g/L
• Unflavoured fermented milk-based products: 0,25 g/L (beverages)
• Unflavoured fermented milk-based products: 0,5 g/kg (products other than beverages)
• Flavoured fermented milk-based products including heat-treated products: 0,25 g/L (beverages)
• Flavoured fermented milk-based products including heat-treated products: 2,5 g/kg (products other than beverages)
• Beverages (flavoured drinks, excluding drinks with a pH less than 5): 0,25 g/L
• Cereal bars: 2,5 g/kg
• Infant formula as defined in Regulation (EU) No 609/2013: 0,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Follow-on formula as defined in Regulation (EU) No 609/2013: 0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013: 0,15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013: 1,25 g/kg for products other than beverages
• Milk-based drinks and similar products intended for young children: 0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013: 0,5 g/L (beverages)
• Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013: 5 g/kg (products other than beverages)
• Food for special medical purposes as defined in Regulation (EU) No 609/2013: In accordance with the particular nutritional requirements of the persons for whom the products are intended
• Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children: 0,5 g/day

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3'-Sialyllactose sodium salt’. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children

Specification (Table 2)

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

Description:

3'-Sialyllactose (3'-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 3'-sialyl-lactulose, and sialic acid

Source: Genetically modified strain of Escherichia coli K-12 DH1

Definition:

Chemical formula: C23H38NO19Na

Chemical name: N-Acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt

Molecular mass: 655,53 Da

CAS No 128596-80-5

Characteristics/Composition:

Appearance: White to off-white powder or agglomerate

Sum of 3'-Sialyllactose sodium salt, D-Lactose, and Sialic acid (% of dry matter): ≥ 90,0 % (w/w)

3'-Sialyllactose sodium salt (% of dry matter): ≥ 88,0 % (w/w)

D-Lactose: ≤ 5,0 % (w/w)

Sialic acid: ≤ 1,5 % (w/w)

3'-Sialyl-lactulose: ≤ 5,0 % (w/w)

Sum of other carbohydrates: ≤ 3,0 % (w/w)

Moisture: ≤ 8,0 % (w/w)

Sodium: 2,5 - 4,5 % (w/w)

Chloride: ≤ 1,0 % (w/w)

pH (20 °C, 5 % solution): 4,5 -6,0

Residual protein: ≤ 0,01 % (w/w)

Microbiological criteria:

Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella sp.: Absence in 25 g

Yeast: ≤ 100 CFU/g

Mould: ≤ 100 CFU/g

Residual endotoxins: ≤ 10 EU/mg

CFU: Colony Forming Units; EU: Endotoxin Units.

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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