Source

Commission Implementing Regulation (EU) 2023/1583 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food Lacto-N-neotetraose (microbial source) (Text with EEA relevance)

Implementing Regulation (EU) 2023/1583 · Regulation · 3 articles

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 1

Open ↗

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

Article 2

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 the Annex to Implementing Regulation (EU) 2017/2470, in Table 2 (Specifications), the entry for Lacto- N -neotetraose (microbial source) is replaced by the following: ‘ Lacto- N -neotetraose (microbial source) Definition Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose Chemical formula: C 26 H 45 NO 21 CAS No: 13007-32-4 Molecular weight: 707,63 g/mol Description/Source Lacto- N -neotetraose is a white to off-white powder that is produced by a microbiological process using genetically modified strain of Escherichia coli K-12, and/or of Escherichia coli BL21(DE3). An additional optional genetically modified degradation strain of Escherichia coli BL21(DE3) may be used in the production process to degrade intermediate carbohydrate by-products and remaining starting carbohydrate substrates. Purity Assay (water free): ≥ 80 % D-Lactose: ≤ 10,0 % Lacto- N -triose II: ≤ 3,0 % para -Lacto- N -neohexaose: ≤ 5,0 % Lacto- N -neotetraose fructose isomer: ≤ 1,0 % Sum of saccharides (Lacto- N -neotetraose, D-Lactose, Lacto- N -triose II, para -Lacto- N -neohexaose, Lacto- N -neotetraose fructose isomer): ≥ 92 % (% w/w dry matter) pH (20 °C, 5 % solution): 4,0-7,0 Water: ≤ 9,0 % Ash, sulphated: ≤ 1,0 % Residual solvents (methanol): ≤ 100 mg/kg Residual proteins: ≤ 0,01 % Microbiological criteria Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts and moulds: ≤ 50 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units’

Other acts of the same type

Council Implementing Regulation (EU) 2016/74 of 22 January 2016 implementing Regulation (EU) No 267/2012 concerning restrictive measures against Iran Commission Implementing Regulation (EU) 2016/68 of 21 January 2016 on common procedures and specifications necessary for the interconnection of electronic registers of driver cards Commission Regulation (EU) 2016/75 of 21 January 2016 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fosetyl in or on certain products (Text with EEA relevance)Commission Implementing Regulation (EU) 2016/84 of 20 January 2016 entering a name in the register of protected designations of origin and protected geographical indications [Ternera de Aliste (PGI)]Commission Regulation (EU) 2016/53 of 19 January 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diethofencarb, mesotrione, metosulam and pirimiphos-methyl in or on certain products (Text with EEA relevance)Commission Regulation (EU) 2016/54 of 19 January 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards inclusion of gamma-glutamyl-valyl-glycine in the Union list of flavouring substances (Text with EEA relevance)Commission Regulation (EU) 2016/55 of 19 January 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (Text with EEA relevance)Commission Regulation (EU) 2016/56 of 19 January 2016 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of extracts of rosemary (E 392) in spreadable fats (Text with EEA relevance)Commission Regulation (EU) 2016/60 of 19 January 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorpyrifos in or on certain products (Text with EEA relevance)Commission Regulation (EU) 2016/67 of 19 January 2016 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for ametoctradin, chlorothalonil, diphenylamine, flonicamid, fluazinam, fluoxastrobin, halauxifen-methyl, propamocarb, prothioconazole, thiacloprid and trifloxystrobin in or on certain products (Text with EEA relevance)Commission Implementing Regulation (EU) 2016/81 of 19 January 2016 entering a name in the register of protected designations of origin and protected geographical indications (Cantuccini Toscani/Cantucci Toscani (PGI))Commission Implementing Regulation (EU) 2016/82 of 19 January 2016 entering a name in the register of protected designations of origin and protected geographical indications (Asparago di Cantello (PGI))

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 legislation EU 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 year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview