1. 2′-Fucosyllactose obtained by microbial fermentation using a derivative strain of Escherichia coli (‘ E. coli ’) W (ATCC 9637) is authorised to be placed on the market within the Union.
2′-Fucosyllactose obtained by microbial fermentation using a derivative strain of E. 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 ( 21 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 19 August 2024, 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 studies and 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 .
ANNEXSupplementary provisions
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 produced with a genetically modified strain of Escherichia coli W (ATCC 9637) authorised on 19 August 2024. 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, 2′-Fucosyllactose produced with a genetically modified strain of Escherichia 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: 19 August 2029”.
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
Source: Genetically modified strain of Escherichia coli W ATCC 9637
Description:
2′-Fucosyllactose is a white to off-white powder that is produced by a microbiological process.
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.
Description:
2′-Fucosyllactose is a white to off white/ivory powder that is produced by a microbiological process.
Description:
2′-Fucosyllactose is a white to off white/ivory 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
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: ≤ 10 4 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
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
Purity:
2′-Fucosyllactose (w/w dry matter): ≥ 82,0 %
D-Lactose (w/w dry matter): ≤ 5,0 %
L-Fucose (w/w dry matter): ≤ 1,0 %
Fucosylgalactose (w/w dry matter): ≤ 3,0 %
Difucosyllactose (w/w dry matter): ≤ 3,0 %
Sum of D-Glucose and D-Galactose (w/w dry matter): ≤ 1,0 %
Sum of other carbohydrates a (w/w dry matter): ≤ 8,0 %
Water: ≤ 9,0 %
Ash: ≤ 0,5 %
Residual proteins: ≤ 0,01 %
pH (5 % solution, 25 °C): 4,5-8,5
Contaminants :
Arsenic: ≤ 0,2 mg/kg
Lead: ≤ 0,02 mg/kg
Cadmium: ≤ 0,1 mg/kg
Mercury: ≤ 0,1 mg/kg
Aflatoxin M1: ≤ 0,025 μg/kg
Microbiological criteria :
Total plate count: ≤ 1 000 CFU/g
Yeasts and Moulds: ≤ 100 CFU/g
Enterobacteriaceae: absence in 10 g
Salmonella : absence in 25 g
Cronobacter spp.: absence in 10 g
Listeria monocytogenes : absence in 25 g
Presumptive Bacillus cereus: ≤ 50 CFU/g
Endotoxins: ≤ 10 EU/mg
a Sum of other carbohydrates = 100 % w/w dry matter – 2′-FL (% w/w dry matter) – (% dry matter of quantified carbohydrates (i.e. D -lactose, L-fucose, D -glucose and D-galactose, fucosylgalactose, and difucosyllactose) – ash (% w/w dry matter)
CFU: Colony Forming Units; EU: Endotoxin Units
