3′-Sialyllactose (3′-SL) sodium salt (produced using a derivative strain of E. coli W (ATCC 9637)): 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 under 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 under 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 under 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 under Regulation (EU) No 609/2013: 1,25 g/kg for products other than beverages
• Milk based drinks and similar products: 0,15 g/L (beverages) 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 under Regulation (EU) No 609/2013: 0,5 g/L (beverages)
• Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013: 5,0 g/kg (products other than beverages)
• Food for special medical purposes as defined under 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: 1,0 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 (3′-SL) sodium salt shall bear a statement that they should not be consumed: (a) if foods containing added 3′-Sialyllactose sodium salt are consumed on the same day; (b) by children under 3 years of age.

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, concentrated, white to off-white powder that is produced by a microbial process. It contains limited levels of Sialic acid, D-Lactose, D-Glucose, and 3′-Sialyllactulose and 6′-Sialyllactose sodium salts.

Source:

Genetically modified strain of Escherichia coli W (ATCC 9637)

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:

3′-Sialyllactose sodium salt (% w/w of dry matter): ≥ 82,0

Sialic acid (% w/w of dry matter): ≤ 6,0

D-Lactose (% w/w of dry matter): ≤ 3,0

D-Glucose (% w/w of dry matter): ≤ 3,0

Sum of 3′- Sialyllactulose and 6′-Sialyllactose sodium salts (% w/w of dry matter): ≤ 5,0

Sum of other carbohydratesa (% w/w of dry matter): ≤ 12,0

Moisture (% w/w): ≤ 10,5

Sodium (% w/w): ≤ 5,0

pH (25 °C, 5 % solution): 4,5 -7,5

Residual protein (% w/w): ≤ 0,01

Heavy metals and contaminants:

Arsenic (mg/kg): ≤ 0,2

Lead (mg/kg): ≤ 0,2

Cadmium (mg/kg): ≤ 0,2

Mercury (mg/kg): ≤ 0,1

Aflatoxin M1: < 0,025 (μg/kg)

Microbiological criteria:

Τοtal plate count: ≤ 1 000 CFU/g

Enterobacteriaceae: Absence in 10 g

Cronobacter spp.: Absence in 10 g

Salmonella spp.: Absence in 25 g

Yeasts and moulds: ≤ 100 CFU/g

Listeria monocytogenes: Absence in 25 g

Presumptive Bacillus cereus: ≤ 50 CFU/g

Residual endotoxins: ≤ 10 EU/mg

aSum of other carbohydrates = 100 % w/w of dry matter - 3′-Sialyllactose (acid, % w/w of dry matter) -quantified carbohydrates ((% w/w of dry matter), Sialic acid + D-Lactose + D-Glucose + (3′- Sialyllactulose and 6′-Sialyllactose (acids)) - sodium (w/w of dry matter); 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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