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

• CELEX: Implementing Regulation (EU) 2023/2215
• Articles: 5

Article 1

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.

Article 2

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.

Article 3

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.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

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’