Article 1
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
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)
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)
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 ↗
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 .
Supplementary provisions
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 (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
Other acts of the same type
Commission Delegated Regulation (EU) 2022/1408 of 16 June 2022 amending Regulation (EU) 2021/2116 of the European Parliament and of the Council as regards the payment of advances for certain interventions and support measures provided for in Regulations (EU) 2021/2115 and (EU) No 1308/2013 of the European Parliament and of the CouncilCommission Implementing Regulation (EU) 2022/926 of 15 June 2022 imposing a definitive anti-dumping duty on imports of tubes and pipes of ductile cast iron (also known as spheroidal graphite cast iron) originating in India following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the CouncilCommission Implementing Regulation (EU) 2022/927 of 15 June 2022 imposing a definitive countervailing duty on imports of tubes and pipes of ductile cast iron (also known as spheroidal graphite cast iron) originating in India following an expiry review pursuant to Article 18 of Regulation (EU) 2016/1037 of the European Parliament and of the CouncilCommission Implementing Regulation (EU) 2022/928 of 15 June 2022 amending Annexes V and XIV to Implementing Regulation (EU) 2021/404 as regards the entries for Canada, the United Kingdom and the United States in the lists of third countries authorised for the entry into the Union of consignments of poultry, germinal products of poultry and fresh meat of poultry and game birds (Text with EEA relevance)Commission Implementing Regulation (EU) 2022/925 of 14 June 2022 amending the Annex to Implementing Regulation (EU) 2018/1882 concerning listed diseases of aquatic animals and the list of species and groups of species posing a considerable risk for the spread of those listed diseases (Text with EEA relevance)Commission Implementing Regulation (EU) 2022/955 of 14 June 2022 approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Taleggio’ (PDO)Commission Implementing Regulation (EU) 2022/956 of 14 June 2022 approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Monte Etna’ (PDO))Commission Implementing Regulation (EU) 2022/957 of 14 June 2022 approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Radicchio di Verona’ (PGI))Commission Implementing Regulation (EU) 2022/958 of 14 June 2022 entering a name in the register of protected designations of origin and protected geographical indications (‘Äkta Gränna Polkagrisar’ (PGI))Commission Implementing Regulation (EU) 2022/996 of 14 June 2022 on rules to verify sustainability and greenhouse gas emissions saving criteria and low indirect land-use change-risk criteria (Text with EEA relevance)Commission Delegated Regulation (EU) 2022/2059 of 14 June 2022 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards specifying the technical details of back-testing and profit and loss attribution requirements under Articles 325bf and 325bg of Regulation (EU) No 575/2013 (Text with EEA relevance)Commission Delegated Regulation (EU) 2022/2060 of 14 June 2022 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards specifying the criteria for assessing the modellability of risk factors under the internal model approach (IMA) and specifying the frequency of that assessment under Article 325be(3) of that Regulation (Text with EEA relevance)
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