3′-Sialyllactose (‘3′-SL’) sodium salt (produced by derivative strains of E. coli BL21(DE3)): 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 formula as defined under Regulation (EU) No 609/2013: 0,28 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: 0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013: 0,28 g/L or 0,28 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Milk based drinks and similar products intended for young children: 0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Foods for special medical purposes for infants and young children as defined under 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 0,28 g/L or 0,28 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.
• Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children: 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, for the general population, excluding infants and young children: 0,7 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 (a) they should not be consumed by children under 3 years of age; (b) they should not be used if other foods containing added 3′-sialyllactose sodium salt are consumed the same day.

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 produced by a microbial process and contains limited levels of lactose, 3'-sialyl-lactulose, and sialic acid.

Definition:

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

Chemical formula: C23H38NO19Na

Molecular mass: 655,53 Da

CAS No: 128596-80-5

Source: Two genetically modified strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3)

Characteristics/Composition:

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

3′-Sialyl-lactulose (% of dry matter): ≤ 5,0 % (w/w)

D-Lactose (% of dry matter): ≤ 5,0 % (w/w)

Sialic acid (% of dry matter): ≤ 1,5 % (w/w)

N-acetyl-D-glucosamine (% of dry matter): ≤ 1,0 % (w/w)

Sum of other carbohydrates (% of dry matter)a: ≤ 5,0 % (w/w)

Moisture: ≤ 9,0 % (w/w)

Ash: ≤ 8,5 % (w/w)

Residual protein: ≤ 0,01 % (w/w)

Sodium: ≤ 4,2 % (w/w)

Microbiological criteria:

Standard plate count: ≤ 1 000 *CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella spp.: Absence in 25 g

Yeast and mould: ≤ 100 CFU/g

Cronobacter (Enterobacter) sakazakii: Absence in 10 g

Residual endotoxins: ≤ 10 **EU/mg

a Sum of other carbohydrates = 100 (% (w/w) of dry matter) - 3'-Sialyllactose sodium salt (% (w/w) of dry matter) - quantified carbohydrates (% (w/w) of dry matter) - Ash (% (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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