Commission Implementing Regulation (EU) 2023/2215 of 23 October 2023 authorising the placing on the market of 6′-Sialyllactose sodium salt produced by derivative strain of Escherichia coli W (ATCC 9637) as a novel food and amending Implementing Regulation (EU) 2017/2470
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 ↗
1. 6′-Sialyllactose sodium salt produced with derivative strain of Escherichia coli W (ATCC 9637) is authorised to be placed on the market within the Union. 6′-Sialyllactose sodium salt produced with derivative strain of Escherichia coli W (ATCC 9637) shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. 2. The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Only the company Kyowa Hakko Bio Co., Ltd ( 19 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 13 November 2023, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Kyowa Hakko Bio Co., Ltd.
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Kyowa Hakko Bio Co., Ltd.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (‘Authorised novel foods’), the following entry is inserted in alphabetical order: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data Protection ‘ 6′-Sialyllactose (6′-SL) sodium salt (produced by derivative strain of E. coli W (ATCC 9637)) Specified food category Maximum levels (expressed as 6 ′ -Sialyllactose) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘6′-Sialyllactose sodium salt’. The labelling of food supplements containing 6′-Sialyllactose (6′-SL) sodium salt shall bear a statement that they should not be consumed: (a) if foods containing added 6′-Sialyllactose sodium salt are consumed on the same day; (b) by children under 3 years of age. Authorised on 13.11.2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Kyowa Hakko Bio Co., Ltd, 1-9-2, Otemachi, Choyoda-ku Tokyo, 100-0004, Japan. During the period of data protection, the novel food 6′-sialyllactose sodium salt produced by derivative strain of E. coli W (ATCC 9637) is authorised for placing on the market within the Union only by Kyowa Hakko Bio Co., Ltd, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Kyowa Hakko Bio Co., Ltd. End date of the data protection: 13.11.2028.’ Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products 0,5 g/L Unflavoured fermented milk-based products 0,5 g/L (beverages) 2,5 g/kg (products other than beverages) Flavoured fermented milk-based products including heat-treated products 0,5 g/L (beverages) 5,0 g/kg (products other than beverages) Beverages (flavoured drinks, excluding drinks with a pH less than 5) 0,5 g/L Cereal bars 5,0 g/kg Infant formula as defined under Regulation (EU) No 609/2013 0,4 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 0,3 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 0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 2,5 g/kg for products other than beverages Milk based drinks and similar products 0,3 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 1,0 g/L (beverages) 10,0 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 (2) in Table 2 (‘Specifications’), the following entry is inserted in alphabetical order: Authorised Novel Food Specification ‘ 6′ -Sialyllactose (6′-SL) sodium salt (produced by derivative strain of E. coli W (ATCC 9637)) Description: 6′-Sialyllactose (6′-SL) sodium salt is a purified, white to off-white powder that is produced by a microbial process, is further isolated, purified and concentrated. It contains limited levels of Sialic acid, D-Lactose, D-Glucose, 6′-Sialyllactulose, and 3′-Sialyllactose sodium salt. Source: Genetically modified strain of Escherichia coli W (ATCC 9637) Definition: Chemical formula: C 23 H 38 NO 19 Na Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt Molecular mass: 655,53 Da CAS No 157574-76-0 Characteristics/Composition: 6′-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 6′- Sialyllactulose and 3′-Sialyllactose sodium salt (% w/w of dry matter): ≤ 5,0 Sum of other carbohydrates a (% w/w of dry matter): ≤ 13,0 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 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 a Sum of other carbohydrates = 100 % w/w of dry matter – 6′-Sialyllactose (acid, % w/w of dry matter) –quantified carbohydrates ((% w/w of dry matter), Sialic acid + D-Lactose + D-Glucose + (6′- Sialyllactulose and 3′-Sialyllactose (acids)) – sodium (w/w of dry matter); CFU: Colony Forming Units; EU: Endotoxin Units’
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