Commission Implementing Regulation (EU) 2023/52 of 4 January 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/52
• Articles: 5

Article 1

(1)   3-Fucosyllactose produced with a derivative strain of E. coli BL21(DE3) is authorised to be placed on the market within the Union.

3-Fucosyllactose produced with a derivative strain of E. coli BL21(DE3) 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 Chr. Hansen A/S  ( 15 ) 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 25 January 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 Chr. Hansen A/S.

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 Chr. Hansen A/S.

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

‘ 3-Fucosyllactose (‘3-FL’)

(produced by a derivative strain of E. coli BL21(DE3))

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3-fucosyllactose’.

The labelling of food supplements containing 3-Fucosyllactose (3-FL) 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-Fucosyllactose are consumed on the same day.

Authorised on 25.1.2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: “Chr. Hansen A/S”, Bøge Allé 10-12, 2970 Hørsholm, Denmark. During the period of data protection, the novel food 3-Fucosyllactose is authorised for placing on the market within the Union only by Chr. Hansen A/S 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 “Chr. Hansen A/S”.

End date of the data protection: 25.1.2028.’

Infant formula as defined under Regulation (EU) No 609/2013

0,90 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

1,20 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

1,20 g/l or 1,20 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

1,20 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 0,9 g/l or 0,9 g/kg (if it is intended for infants from 0 until 6 months) and 1,2 g/l or 1,2 g/kg (if it is intended for infants of 6-12 months and/or for young children) 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

3 g/day

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order:

Authorised novel food

Specification

‘ 3-Fucosyllactose (‘3-FL’)

(produced by a derivative strain of E. coli BL21(DE3))

Description:

3-Fucosyllactose (3-FL) is a purified, white to off-white powder that is produced by microbial fermentation and contains limited levels of D-Lactose, L-Fucose, D-Galactose, and D-Glucose.

Definition:

Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranose

Chemical formula: C 18 H 32 O 15

Molecular mass: 488,44 Da

CAS No: 41312-47-4

Source: A genetically modified strain of Escherichia coli BL21(DE3)

Characteristics/Composition:

3-Fucosyllactose (% of dry matter): ≥ 90,0 % (w/w)

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

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

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

L-Fucose (% of dry matter): ≤ 3,0 % (w/w)

Sum of other carbohydrates (% of dry matter)  ( 1 ) : ≤ 5,0 % (w/w)

Moisture: ≤ 9,0 % (w/w)

Ash: ≤ 1,0 % (w/w)

Residual protein: ≤ 0,01 % (w/w)

Heavy metals and contaminants:

Arsenic: ≤ 0,2 mg/kg

Aflatoxin M1: ≤ 0,025 μg/kg

Microbiological criteria:

Standard plate count: ≤ 1 000 CFU  ( *1 ) /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  ( *2 ) /mg

( 1 )   Sum of other carbohydrates = 100 (% (w/w) of dry matter) – quantified carbohydrates (% (w/w) of dry matter) – Ash (% (w/w) of dry matter).

( *1 )   CFU: Colony Forming Units.

( *2 )   EU: Endotoxin Units.’