Commission Implementing Regulation (EU) 2023/859 of 25 April 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food 2’-Fucosyllactose (microbial source) to authorise its production by a derivative strain of Corynebacterium glutamicum ATCC 13032 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/859
• Articles: 5

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company ‘Advanced Protein Technologies Corporation’  ( 17 ) is authorised to place on the market within the Union the novel food 2′-Fucosyllactose (microbial source) produced with a derivative strain of Corynebacterium glutamicum ATCC 13032, for a period of five years from 16 May 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 ‘Advanced Protein Technologies Corporation’.

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 ‘Advanced Protein Technologies Corporation’.

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

In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470 the entry for 2′-Fucosyllactose (microbial source) is replaced by the following:

‘Specifications

Data protection

Definition:

Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose

Chemical formula: C 18 H 32 O 15

CAS No: 41263-94-9

Molecular weight: 488,44 g/mol

2′-Fucosyllactose produced with a genetically modified strain of Corynebacterium glutamicum ATCC 13032 authorised on 16 May 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: “Advanced Protein Technologies Corporation”, 7th Floor GyeongGi-BioCenter, 147, Gwanggyo-ro, Yeongtong-gu, Suwon-si Gyeonggi-do, 16229 South Korea. During the period of data protection, 2′-Fucosyllactose produced with a genetically modified strain of Corynebacterium glutamicum ATCC 13032 is authorised for placing on the market within the Union only by “Advanced Protein Technologies Corporation” 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 “Advanced Protein Technologies Corporation”.

End date of the data protection: 16 May 2028.’

2’-Fucosyllactose (microbial source)

Source: Genetically modified strain of Escherichia coli K-12

Source: Genetically modified strain of Escherichia coli BL-21

Source : Genetically modified strain of Corynebacterium glutamicum ATCC 13032

Description:

2′-Fucosyllactose is a white to off-white powder that is produced by a microbiological process.

Purity:

2′-Fucosyllactose: ≥ 83 %

D-Lactose: ≤ 10,0 %

L-Fucose: ≤ 2,0 %

Difucosyl-D-lactose: ≤ 5,0 %

2′-Fucosyl-D-lactulose: ≤ 1,5 %

Sum of saccharides (2′-Fucosyllactose, D-Lactose, L-Fucose, Difucosyl-D-lactose, 2′-Fucosyl-D-lactulose): ≥ 90 %

pH (20 C, 5 % solution): 3,0-7,5

Water: ≤ 9,0 %

Sulphated ash: ≤ 2,0 %

Acetic acid: ≤ 1,0 %

Residual proteins: ≤ 0,01 %

Microbiological criteria:

Aerobic mesophilic bacteria total count: ≤ 3 000 CFU/g

Yeasts: ≤ 100 CFU/g

Moulds: ≤ 100 CFU/g

Endotoxins: ≤ 10 EU/mg

CFU: Colony Forming Units; EU: Endotoxin Units

Description:

2′-Fucosyllactose is a white to off white powder and the liquid concentrate (45 % ± 5 % w/v) aqueous solution is a colourless to slight yellow clear aqueous solution. 2′-Fucosyllactose is produced by a microbiological process.

Purity:

2′-Fucosyllactose: ≥ 90 %

Lactose: ≤ 5,0 %

Fucose: ≤ 3,0 %

3-Fucosyllactose: ≤ 5,0 %

Fucosylgalactose: ≤ 3,0 %

Difucosyllactose: ≤ 5,0 %

Glucose: ≤ 3,0 %

Galactose: ≤ 3,0 %

Water: ≤ 9,0 % (powder)

Ash, sulphated: ≤ 0,5 % (powder and liquid)

Residual proteins: ≤ 0,01 % (powder and liquid)

Heavy Metals:

Lead: ≤ 0,02 mg/kg (powder and liquid)

Arsenic: ≤ 0,2 mg/kg (powder and liquid)

Cadmium: ≤ 0,1 mg/kg (powder and liquid)

Mercury: ≤ 0,5 mg/kg (powder and liquid)

Microbiological criteria:

Total plate count: ≤ 104 CFU/g (powder), ≤ 5 000 CFU/g (liquid)

Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid)

Enterobacteriaceae/Coliforms: absence in 11 g (powder and liquid)

Salmonella: negative/100 g (powder), negative/200 ml (liquid)

Cronobacter: negative/100 g (powder), negative/200 ml (liquid)

Endotoxins: ≤ 100 EU/g (powder), ≤ 100 EU/ml (liquid)

Aflatoxin M1: ≤ 0,025 μg/kg (powder and liquid)

CFU: Colony Forming Units; EU: Endotoxin Units

Description:

2′-Fucosyllactose is a white to off white/ivory powder that is produced by a microbiological process.

Purity:

2′-Fucosyllactose (w/w dry matter): ≥ 94,0 %

D-Lactose (w/w dry matter): ≤ 3,0 %

L-Fucose (w/w dry matter): ≤ 3,0 %

3-Fucosyllactose (w/w dry matter): ≤ 3,0 %

Difucosyllactose (w/w dry matter): ≤ 2,0 %

D-Glucose (w/w dry matter): ≤ 3,0 %

D-Galactose (w/w dry matter): ≤ 3,0 %

Water: ≤ 9,0 %

Ash: ≤ 0,5 %

Residual proteins: ≤ 0,005 %

Contaminants :

Arsenic: ≤ 0,03 mg/kg

Aflatoxin M1: ≤ 0,025 μg/kg

Ethanol: ≤ 1 000 mg/kg

Microbiological criteria :

Total plate count: ≤ 500 CFU/g

Yeasts and Moulds: ≤ 100 CFU/g

Enterobacteriaceae: absence in 10 g

Salmonella : absence in 25 g

Cronobacter spp.: absence in 10 g

Endotoxins: ≤ 100 EU/g

CFU: Colony Forming Units; EU: Endotoxin Units