Article 1
Open ↗The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Source
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
Open ↗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
Open ↗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
Open ↗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
Open ↗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 Implementing Regulation (EU) 2022/1195 of 11 July 2022 establishing measures to eradicate and prevent the spread of Synchytrium endobioticum (Schilbersky) PercivalCommission Implementing Regulation (EU) 2022/1197 of 11 July 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 and correcting Annex XIV as regards an entry for the United Kingdom (Text with EEA relevance)Commission Delegated Regulation (EU) 2023/332 of 11 July 2022 supplementing Regulation (EU) 2019/818 of the European Parliament and of the Council as regards determining cases where identity data are considered as same or similar for the purpose of the multiple identity detectionCommission Delegated Regulation (EU) 2023/333 of 11 July 2022 supplementing Regulation (EU) 2019/817 of the European Parliament and of the Council as regards determining cases where identity data are considered as same or similar for the purpose of the multiple identity detectionCommission Regulation (EU) 2022/1181 of 8 July 2022 amending the preamble of Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)Commission Implementing Regulation (EU) 2022/1183 of 8 July 2022 amending Annexes II and IV to Implementing Regulation (EU) 2020/2002 as regards Union notification and Union reporting on the detection of certain listed diseases (Text with EEA relevance)Commission Implementing Regulation (EU) 2022/1184 of 8 July 2022 amending Regulation (EU) No 468/2010 establishing the EU list of vessels engaged in illegal, unreported and unregulated fishingCommission Implementing Regulation (EU) 2022/1185 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘Contec Hydrogen Peroxide Biocidal Product Family’ (Text with EEA relevance)Commission Implementing Regulation (EU) 2022/1186 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘L+R Propanol PT1 Family’ (Text with EEA relevance)Commission Implementing Regulation (EU) 2022/1216 of 8 July 2022 derogating in respect of the year 2022 from Implementing Regulations (EU) No 809/2014, (EU) No 180/2014, (EU) No 181/2014, (EU) 2017/892, (EU) 2016/1150, (EU) 2018/274, (EU) No 615/2014 and (EU) 2015/1368 as regards certain administrative and on-the-spot checks applicable within the common agricultural policy and amending Implementing Regulation (EU) 2021/725Commission Implementing Regulation (EU) 2022/1282 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘Knieler & Team Propanol Family’ (Text with EEA relevance)Commission Implementing Regulation (EU) 2022/1174 of 7 July 2022 amending Implementing Regulation (EU) 2015/1998 as regards certain detailed measures for the implementation of the common basic standards on aviation security (Text with EEA relevance)
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
What to look at next
Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislationEU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and yearEuropean Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview